Lots of folks seem to think we have too much regulation of drugs and devices already—among them Paul Howard at the Manhattan Institute and Scott Gottlieb at the American Enterprise Institute—so much so that it is choking innovation to death. But, if that is so, then why are there so many scandals?

One possible answer is that the companies know they have problems but sit on that knowledge. If that’s sometimes (or oftentimes) the case, then we need a regulatory system that can get around that kind of immoral behavior. We don’t have that system.

What we have is a regulatory system that is too skewed toward looking at the earliest stages of research. Moreover, the way it is designed makes recalls almost inevitable. The diabetes drug Avandia is the latest in a long parade of failures of our current post-clinical trial drug approval process.

Avandia went through the usual approval process with the U.S. Food and Drug Administration. The drug was a blockbuster. But sales began to fall after a 2007 study of people taking the drug suggested that Avandia could cause heart attacks and strokes. I first learned about this while serving on a bioethics advisory board for GlaxoSmithKline, the developer of the drug—a panel that was looking at research ethics issues in poor nations. The panel, on which Science Progress Editor-in-chief Jonathan Moreno also served, came to an abrupt halt.

In response, the FDA put a black-box warning on the drug telling doctors of the heart attack risk. GlaxoSmithKline was not happy. There was a lot of back and forth about the safety of the drug. Over the past few months more evidence become public that shed doubt on Avandia’s safety. Worse, it appears the company withheld data about serious side-effects. The FDA appointed an advisory panel this July to consider these allegations, but the panel itself quickly got caught up in charges of conflict of interest among its members. It is likely that more black-box warnings to doctors will follow, should GlaxoSmithKline choose to keep Avandia on the market.

Avandia is not alone. The drug’s problems in the marketplace follow hard on the heels of Prempro, a hormone replacement therapy made by Wyeth Pharmaceuticals, now part of Pfizer Inc., which became caught up in lawsuits alleging it caused breast cancer. More recently, the FDA released a warning about the Afluria flu vaccine, made by CSL Ltd. of Australia, concerning high fever and seizures. Prior to that was Merck & Co.’s widely publicized recall of Vioxx, which came after problems with Astra Zeneca’s Seroquel, Abbott Laboratory’s Meridia, Pfizer’s Rezulin, C.R. Bard Inc.’s G2 filter, Bayer’s Baycoll, Boston Scientific Inc.’s Express Stent, and on and on.

So is there a real phenomenon here or just more PR associated with recalls? And if there are more recalls going on then what is wrong with the oversight of new drugs and devices?  It is not clear from the literature whether there are more recalls taking place in recent years—there is no real database that would show such a trend. There are certainly more stories about recalls and more people studying the objectivity of the marketplace surveillance being done by pharmaceutical, biotech, and device companies.

No one seems to have reliable numbers on recall trends, yet the Institute of Medicine and other groups still warn that the existing system of drug protections after the FDA approval process is complete does not seem adequate to handle the products that are reaching the market. Fortunately, there is a way to fix the system.

The major problem today is that too many lousy or dangerous drugs and devices get to you without adequate safety review because drug and device regulation is heavily weighted in the United States toward early stages of research. Every drug has to be tried in animals to roughly determine safety. Then drugs are introduced into a small number of humans to further check safety—so-called phase one trials. Then dose and mode of administration are checked for safety, biological activity, and signs of effectiveness—phase two. Only after all this safety testing is a drug or device ready to go to phase three clinical trials. In these studies hundreds or sometimes thousands of subjects are recruited to receive the drug or product for periods of time that range in nearly every case from a few months to a year.  Phase three trials are almost always placebo controlled randomized, blinded studies.

So there is a lot of effort to try and make sure that subjects are not hurt in phase three trials. The deaths of subjects in phase one clinical trials, among them Ellen Roche and Jesse Gelsinger in early stage studies over a decade ago seem to have reinforced regulatory anxiety about the risk of deaths in first in-human studies.

Meanwhile, the weakest link is the fourth and final step in the research process—phase four—in which drugs are to be monitored when out in actual use in the world for adverse events and problems. Drug companies sometimes promise to do these trials to get final product approval but don’t. These studies are heavily weighted to support the funders of these studies, Big Pharma, which results in much more rosy reporting then studies done by independent groups.

Reporting of problems in phase four is left to doctors and patients who rarely do so.  And there is no systematic tracking of a subpopulation taking new drugs or other medical products to see what is going on with real patients in real world conditions. Deaths have to mount rapidly and obviously to get regulatory or physician attention before phase four studies are ever seriously undertaken.

But a lack of independent, well designed phase four trials is not the only problem.  Approving drugs based on current standards for phase three testing has its own built-in limits. Testing drugs and devices in randomized, blinded, placebo control trials is great, but it means that approval is given on the basis of highly controlled studies on highly selective populations—often subjects who are not that old, not that sick and are highly compliant. That’s not the real world, where patients take lots of drugs, some legal some not, are poorly compliant, have multiple diseases, and can be very old or very young.

So what looks safe in a phase two or phase three study can prove lethal when given to real people in uncontrolled, unsupervised environments. What’s more, phase three studies are also relatively short. What looks safe after three months exposure or six may not be after three or six years.

The seemingly endless parade of horrors of FDA approved drugs gone bad merits a reexamination of a regulatory system that is not keeping us safe.  The issue is not too much bureaucracy and too much red tape, but a strategy of safety that puts the emphasis in the wrong place—early not late—and then uses techniques that by themselves cannot ensure safety for real people in the long run.

Update August 17 2010: CNN Money reported that the number of drug recalls in the U.S. surged to 1,742 in 2009, up 309 percent from the 2008 level. Recalls so far in 2010 are also on pace greatly exceed previous levels. However, not all of these recent recalls were due to the drugs themselves being unsafe—some were due to problems with the manufacturing process of generic, over-the-counter drugs.

Arthur Caplan, PhD, is the Director of the Center for Bioethics and the Sidney D Caplan Professor of Bioethics at the University of Pennsylvania

The findings challenge the assumption that the impacts of carbon dioxide pollution are the same regardless of location. The human-caused emissions of the heat-trapping gas are the leading cause of global climate change, but “domes” of CO₂ accumulate over cities, leading to additional health impacts on top of those related to global warming.

The author, Mark Z. Jacobson, concludes the domes of CO₂ have fundamentally local consequences. Cutting local emissions, he argues, would reduce the related premature deaths in that area:

“If locally emitted CO₂ increases local air pollution, then cities, counties, states, and small countries can reduce air pollution health problems by reducing their own CO₂ emissions, regardless of whether other air pollutants are reduced locally or whether other locations reduce CO₂.”

Of course, climate change also brings warmer temperatures and significant health consequences from heat waves. The Chicago heat wave of 1995 killed more than 700 people, and under lower emissions scenarios, similar heat waves are projected to happen every other year by the middle of the century. So reducing emissions is good for the health of cities in the short term and the long term.

Some six decades later, cigarette smoking causes about 443,000 deaths every year in this country, about 20 percent of the U.S. population smokes, and every day 1,000 young people pick up the habit.

That’s why the Food and Drug Administration issued new rules today banning cigarette company marketing tactics designed for getting their product into the hands of youth. The FDA authority comes from legislation passed last year that for the first time allowed the agency to regulate “unregulated drug delivery systems.”

The intellectual heirs of this strategy to defend corporate interests by assaulting science are the polluter-driven deniers of climate change research. And at the moment, climate scientists are under heavy assault.

The hopeful lesson from the new FDA rules is that no amount of corporate funding can suffocate the science indefinitely. But we shouldn’t have to wait 60 years to act on what we know about climate change. The impacts are already very real.

The 1998 paper hit the British public like a thunderclap, triggering a decline in use of the MMR vaccine as well as a resurgence of the measles. It was the opening shot in the vaccine-autism controversy that still rages today (albeit in varied forms, not all of which still focus on the MMR vaccine). But the credibility of Wakefield’s work has since taken a steady stream of hits, culminating in this last devastating blow.

On a scientific level, the most severe undermining of Wakefield’s study came in the form of a 2004 analysis by the Institute of Medicine, one wing of the U.S. National Academy of Sciences. The IOM examined no less than 16 separate studies on the purported dangers of the MMR vaccine, in addition to Wakefield’s. The latter they found “uninformative with respect to causality”; overall, they concluded that “the evidence favors rejection of a causal relationship between MMR vaccine and autism.”

Even prior to that, ten of Wakefield’s original coauthors (out of twelve in total) had backed away from the work in a 2004 letter to The Lancet. “We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient,” they wrote. “However, the possibility of such a link was raised and consequent events have had major implications for public health.”

Meanwhile, a series of investigative stories published in The Times of London unearthed Wakefield’s undisclosed ties to vaccine litigation in the U.K. The full Lancet retraction that occurred yesterday builds on all of these developments, including, most recently, an investigation into Wakefield by the U.K.’s General Medical Council which declared him “irresponsible” and questioned, among other matters, the risks imposed upon children in the original study.

Let’s pause for a moment here. We’re talking about a single, small study—on just 12 children—that stirred a mass anti-vaccine movement and a trend away from vaccination that threatens public health in some wealthy counties. Already, you should be wondering how it could be possible to build so much upon such a slender reed. But if you then consider the subsequent fate of the study, and the scandal that has attended it, a reasonable person would surely conclude that the original scare about the MMR vaccine and autism had no serious foundation whatsoever.

Here’s the thing, though. It seems obvious to all recent commentators—myself included—that the latest Wakefield news will have virtually no impact on Wakefield’s passionate followers, the anti-vaccine ideologues in the UK and United States who have long cheered him on, and will continue to do so. If anything, it will probably only make them still stronger in their convictions.

Following its original efflorescence in 1998, modern vaccine skepticism has taken many other forms than a focus on the MMR vaccine. In the United States, there has probably been much more concern about the mercury-containing preservative thimerosal, which used to be in many vaccines (however, thimerosal has long since been removed from most vaccines, and autism rates have not dropped). The movement is much bigger than Wakefield; but the continuing allegiance to Wakefield, despite all that has occurred, shows that we’re really dealing with something very irrational here, what Michael Specter calls “denialism.”

In a feature story for Discover magazine a year back, I surveyed the vaccine-autism debate and tried to pose a question I felt few others had adequately considered. What would it take—beyond the overwhelming scientific evidence, which already exists—for this battle to finally go away? A Lancet retraction isn’t going to do it, that’s for sure. For vaccine skeptics, that’s just more evidence of corruption and collusion in the medical establishment. Indeed, I doubt any individual scientific development has the strength to move these folks—because we aren’t dealing with a phenomenon that’s scientific in nature.

Instead, I believe we need some real attempts at bridge-building between medical institutions—which, let’s admit it, can often seem remote and haughty—and the leaders of the anti-vaccination movement. We need to get people in a room and try to get them to agree about something—anything. We need to encourage moderation, and break down a polarized situation in which the anti-vaccine crowd essentially rejects modern medical research based on the equivalent of conspiracy theory thinking, even as mainstream doctors just shake their heads at these advocates’ scientific cluelessness. Vaccine skepticism is turning into one of the largest and most threatening anti-science movements of modern times. Watching it grow, we should be very, very worried—and should not assume for a moment that the voice of scientific reason, in the form of new studies or the debunking of old, misleading ones, will make it go away.

Chris Mooney is the author of several books, including The Republican War on Scienceand Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

“It,” of course, was the year 2009—and for science in the United States and beyond, it featured developments and revelations variously exciting, disturbing, and above all, political.

It was the year of H1N1 flu, an unsettling test run with a less-than-catastrophic pandemic. The response called into question our capability, and our infrastructure, for dealing with the next threat.

It was the year the Large Hadron Collider finally got those protons smashing—despite being interrupted by various maintenance problems and, yes, even by bread dropped by a bird flying above the machine, which led to overheating.

It was the year of great scientific anniversaries—200 years since Darwin’s birth, 150 since his publication of the Origin of Species, and 400 since Galileo raised his telescope to the heavens. Unfortunately, some sought to exploit these occasions. Creationist Ray Comfort distributed thousands of special “editions” of the Origin to college campuses, each featuring his lengthy anti-Darwinian “introduction.” Only then came the words of Darwin himself, almost unreadable due to their tiny font size.

It was a year of complete U-turns in science policy. President Barack Obama reversed George W. Bush’s dramatic restrictions on embryonic stem cell research, and the first 13 new stem cell lines were approved for federally funded research since 2001. Meanwhile, the Obama Environmental Protection Agency moved to regulate carbon dioxide emissions, finding that they do indeed endanger the public.

It was also the year of the first-ever passage, by a 219-212 margin in the U.S. House of Representatives, of a cap-and-trade bill that would cut domestic greenhouse gas emissions—but not the year for any parallel action in the U.S. Senate.

It was the year that everyone seemed to own an iPhone and use the word “app” in regular conversation. It was the year Twitter went from being a mere annoyance to the epitome of web-based communication.

It was a year that saw the very first Nobel laureate scientist assume a cabinet position, in the figure of U.S. Secretary of Energy Stephen Chu.

It was the year in popular culture when science ceased to be nerdy and became world-saving cool. The disaster film 2012 epitomized the trend. Despite the plot’s scientific incoherence, the lead character is a scientist who is described in the film as a “deputy geologist” at the White House Office of Science and Technology Policy.

It was the year of new calls for science communication and public engagement: The Year of Science 2009 movement was launched, the second installment of the World Science Festival was held in New York City, and three books came out exhorting scientists to kick off their shoes and speak to real people, including Randy Olson’s Don’t Be Such a Scientist, Cornelia Dean’s Am I Making Myself Clear?, and my own (co-authored) Unscientific America.

It was the year in which scientists captured the first ever images of an exoplanet—a planet orbiting another star far from our own solar system.

It was the year that Russian scientists upped the ante on the increasingly prominent subject of geoengineering. They did so by running a small-scale field trial that blasted sulfate aerosols out of the back a helicopter and then measured their effect on diffusing sunlight at ground level. On a vastly larger scale, such an intervention could cool the planet.

It was the year that several groups across the country celebrated the 50-year anniversary of C.P. Snow’s “Two Cultures” lecture. There was general agreement that those cultures are as divided as ever, if not more so—but also that a newer and more important rift may like not between scientists and humanists, but rather, between scientists and intellectuals on the one hand, and everybody else on the other.

It was the year of the “largest single investment in clean energy in American history” in the form of the American Recovery and Reinvestment Act. The government put $80 billion into clean energy across a range of sectors, ranging from the construction of a smart grid to the weatherization of homes, as a means to jumpstart economic growth and create jobs.

Sadly, and finally, it was the year for the rebirth of what is now a wide-ranging war on science. Some of us may have thought it ended with the previous administration; but we underestimated the momentum that crusaders against the Obama administration, and against climate change action, could gain on this front. With “ClimateGate,” a smear against climate researchers so damaging that it may even have impelled a measurable drop in public trust of environmental researchers, we enter a new stage for political conflicts over science—one in which the gloves are off as never before.

But if that’s a sobering note to end on, we can make a more uplifting new years’ resolution. As the push to defeat global warming continues to eke out small bits of progress (most recently in Copenhagen), it is time to recognize that our scientists need aid and defending—which includes helping them help themselves through better public communication efforts.

The battle to restore scientific integrity isn’t over. It has only begun.

Chris Mooney is the author of several books, including The Republican War on Science and Unscientific America: How Scientific Illiteracy Threatens Our Future, co-authored by Sheril Kirshenbaum. He and Kirshenbaum blog at “The Intersection.”

But the story of the H1N1 vaccine has spawned other public relations wreckage. Notably, it provided a new vehicle for the anti-vaccine movement to launch attacks on some of our most vital tools for protecting public health. Other factors compounded the problems. The federal government set high expectations for how many vaccine doses it could deliver in a few short months and failed to meet its promises. Moreover, it appears that the severity of the H1N1 pandemic this season is much less than public health officials anticipated, leading to claims that the government unnecessarily exaggerated the crisis.

The Department of Health and Human Services and the CDC are fighting fears about vaccines and rumors about the dangers of the H1N1 vaccine more specifically. Fortunately, concerns about a pandemic have abated somewhat of late—due to improved treatment and vaccinations, it seems like the number of deaths will not be any higher than those caused normally by seasonal flu, and may even end up being lower. This is good news, but complacency would be dangerous, especially as the H1N1 virus could re-emerge in a more lethal form and young adults, one of the at-risk groups, are the most apathetic about getting vaccinated. The government should push drug companies and researchers to develop new, more efficient ways to produce the vaccine and enforce distribution policies to ensure that those most at risk get the vaccine. Long-term, health officials face a trust gap that may continue to undermine future public health campaigns. Too many people are skeptical of the safety of this vaccine and others. Efforts need to be focused not only on ensuring and publicizing vaccine safety, but also on educating the public that the small risks associated with vaccines pale in comparison to the dangers associated with illnesses like the flu.

If someone had told me a year ago that talk show hosts, provocateurs, and political polar opposites Glenn Beck and Bill Maher would publicly agree on something, I would have thought they were crazy. Then, just a couple of months ago, there Beck and Maher were—denouncing the H1N1 vaccine on their syndicated television programs and Twitter feeds as unsafe and foolish. Apparently, frustrations over the H1N1 vaccine have what it takes to promote bipartisanship. How can this be?

A recent ABC News-Washington Post poll shows that a clear majority, 62 percent, of the American public believes that the government has not exaggerated the dangers of the H1N1 flu virus (more commonly known as swine flu). The World Health Organization, or WHO, the CDC, and HHS have all heavily promoted the vaccine. In spite of these efforts, many Americans are unsure about whether they are in one of the at-risk groups. More importantly, the same ABC News-Washington Post poll indicated that nearly half, 45 percent, of all parents do not plan on having their children vaccinated, and two-thirds, 66 percent, do not plan on being vaccinated themselves. The backlash to the vaccine seems to be primarily driven by questions regarding safety and availability. Strangely, the way the government handled the H1N1 vaccine has managed to unite both vaccine foes and those desperate to get it. The former have exploited the newness of the vaccine to rehash concerns about preservatives, adequate testing, and the necessity of vaccines for public health. The latter have grown frustrated with a lack of access to vaccines when sufficient numbers were originally promised.

By June, WHO had raised the pandemic alert for H1N1 to its highest level and governments began to prepare plans for vaccine manufacture and distribution. Typically, flu vaccine design is an imperfect and slow process that relies on educated guesswork about which flu strain(s) will be present during the flu season. The H1N1 virus was robustly characterized, so this aspect of the process was not a concern. However, production was sped up in order to avert a pandemic and this has people concerned that it has not undergone sufficient, thorough testing. The vaccine has in fact been evaluated (in all age groups and in pregnant women) in a series of clinical trials sponsored by the National Institutes of Health, and since distribution began, careful monitoring has taken place to ensure that any irregularities are reported quickly. This system seems to be working well. Just this week, almost one million doses of a special H1N1 vaccine for infants (lacking preservatives) were voluntarily recalled because the vaccine manufacturer noticed that the potency of the vaccines had dropped since shipment.

But roughly one third, 33 percent, of the American public is not confident in the safety of the H1N1 vaccine. In 1976, vaccinations for a different strain of swine flu led to an inexplicable spike in diagnoses of Guillain-Barré syndrome (a rare autoimmune disease). While flu treatment options and vaccine design have improved since then, the CDC is aware that the general public may associate swine flu vaccines with adverse side effects. Bad news, like a novel virus, has a tendency to spread rapidly. For example, a clip of an Inside Edition piece on a young, healthy cheerleader who supposedly developed dystonia, a neurological disorder that causes uncontrolled muscle contractions and contortions, a few days after receiving the H1N1 vaccine already has more than 900,000 views on YouTube. Upon video evaluation, neurologists expressed doubt and dystonia advocacy groups distanced themselves from the report, but the story has already done its damage, judging by the comments posted on the video (and duplicates of it). As well, numerous anti-vaccine groups and blogs have distributed the cheerleader’s story, including Jenny McCarthy and Jim Carrey’s group Generation Rescue.

Widespread safety concerns seem largely specific to this vaccine, suggesting that past associations with Guillain-Barré syndrome and the perception that the vaccine was not adequately tested have affected its image. However, the release of the H1N1 vaccine also comes at a time of severe and growing distrust of vaccines in general, due to a supposed causal link with autism. Anti-vaccine advocates have grown particularly vocal in the past few years, despite repeated research demonstrating there is no credible evidence whatsoever linking vaccines to autism.

About one-third of people unconfident in the safety of the H1N1 vaccine also said they were not confident in the safety of any vaccine. In spite of numerous studies countering their claims, the anti-vaccine movement has managed to convince significant numbers of parents and guardians that routine childhood vaccinations are not just risky, but also unnecessary. Many of the medical students I spoke with believe that the anti-vaccine movement has contributed to the backlash against the H1N1 vaccine. In response to an emailed question, one student wrote: “The anti-vaccination movement has stepped up their efforts during this time, both on the Internet and in the mainstream media. They see this as an opportunity to further their agenda of casting doubt on the safety of vaccines.”  The success of the anti-vaccine movement in vilifying one of the greatest advances in modern medicine highlights the wide gaps in communication between researchers and the general public, the increased use of the Internet as a source of potentially untrustworthy information, as well as a general lack of familiarity with how horrible diseases such as flu can be.

In order to ensure protection for entire societies, vaccination rates for certain diseases must reach very high thresholds in order to protect people who either lack immunity or did not develop immunity from prior infection or vaccination. If enough people are vaccinated, the odds of the disease being present and spreading are significantly reduced, an effect called “herd immunity.”

Anti-vaccine advocates point to preservatives such as thimerasol, a mercury derivative that is present in the inactivated, injected H1N1 vaccine but not the intranasal spray vaccine, as a potential danger. Concerns stem from a study conducted by Dr. Andrew Wakefield and published by the medical journal Lancet in 1999. The study contended that the measles-mumps-rubella, or MMR, vaccine was linked to autism. Blame was immediately placed on thimerasol and although the initial report was refuted by numerous follow-up studies (and additionally, reports surfaced that Wakefield manipulated the data), the anti-vaccine crowd won—most vaccines no longer contain thimerasol. First, the mercury present in these vaccines is trivial when compared to the levels present in fish (and yet anti-vaccine activists do not recommend that we all stop eating fish). Second, preservatives are in fact very important for preventing multi-vial batches of vaccines from getting contaminated with bacteria, viruses, and fungi. In fact, vaccines without preservatives have led to serious complications and even death. This is not general knowledge and according to several medical students I spoke with, patients wary of the H1N1 vaccine have often cited concerns about preservatives. But so far, significant safety concerns have not materialized.

On December 4, the CDC released a safety review documenting the number and kinds of adverse reports received after administration of the H1N1 vaccine—both the inactivated, intramuscular shot and the weakened nasal spray. Through November 24, 46.2 million doses had been distributed and 3,783 reports of adverse effects had been received—almost 1,000 fewer than those reported for the seasonal flu vaccine—and 13 deaths, 9 of which were likely due to underlying illnesses in the victims. One of those deaths was due to a car crash and three are pending review. It will be interesting to see whether this report reassures worried Americans. Invalidated research and a few very loud voices have tarred the reputation of vaccines. It will take time and effort to restore public faith.

Health officials have tried hard to educate the public about the H1N1 virus and vaccine in order to encourage people, particularly those in at-risk groups, to get vaccinated. However, in promoting the vaccine the federal government promised too much and this likely contributed to the H1N1 vaccine backlash. It was unrealistic to expect that a few companies could produce and test enough vaccines in just a few months time to cover everyone in the at-risk groups, particularly as the number of people at risk is much higher than that for seasonal flu. Additionally, vaccines provided to Europe and Canada are not sanctioned here in the United States due to the inclusion of adjuvants, which improve the potency of the vaccine but have not been reviewed adequately, according to the U.S. Food and Drug Administration. Anecdotes from medical students indicate that many people are in fact eager to get vaccinated (one poll estimated that at the time of the vaccine release, 52 percent of Americans wanted it), but limited supplies and the necessity of first vaccinating at-risk groups have meant that many have been turned away from clinics. This is understandably frustrating.

While the H1N1 situation has provided an opportunity to knock vaccines and their distribution methods, the facts remain: vaccines are a safe and vital tool for protecting our health and well-being.

Saheli Sadanand is a Ph.D. candidate in the Department of Immunobiology at Yale University.

One potential way to ensure that a future push to generate massive quantities of vaccine will meet its projections is to invest in cell-based vaccine research. “For decades, most experts have agreed that the process of manufacturing influenza vaccine through hens’ eggs is archaic and needs to be improved,” explains Ricardo Rossello in a recent Science Progress feature. Growing the vaccines in cell cultures rather than eggs means manufacturers are not at the mercy of hen egg-laying cycles, nor would there be a need for extra precautions to ensure that egg-grown doses are free of bacterial contamination. In short, research into cell-based vaccine production could potentially build a system better able to meet the surge capacity of pandemics like the one we currently face.

If successful, the vaccine would be the first designed for use against an illegal drug. And as Mark Meier explained in an article last year at SP before the trial began, the project represents a novel scientific pathway built with novel sources of public-private funding. The National Institute on Drug Abuse supported the trial, run by Thomas Kosten, M.D., of Baylor College of Medicine in Houston.

The immune response triggered by the vaccine produces antibodies that attach themselves to the tiny cocaine molecules, neutralizing their ability to cross the blood-brain barrier. Unable to reach the brain, the drug cannot get the user high, severing the link between use and euphoria.

This problem needs to be addressed as soon as possible. The time is right: there is a great need to reduce or eliminate unnecessary government programs where possible, and the Obama administration has signaled its intention to place a new premium on using science to leverage investment in public programs.

The PRA and scientific research

Congress revised the PRA in 1995 and a broad bipartisan group supported its quest to reduce the burden to citizens associated with government data collections. The legislation has been overdue for reauthorization since 2001. As commonly understood by many Americans, the impetus for this law stemmed from mandatory reporting requirements like those imposed by the U.S. Census and tax forms. It was also intended to reduce the burden of repeated requests for the similar information required as a condition for receipt of services or benefits (e.g., federally funded insurance programs) or reporting from such programs. However, the language of the PRA was sufficiently broad to encompass federally sponsored public health data collections in which participation is voluntary and often compensated—for example, voluntary behavioral surveys, and projects that collect behavioral risk data collected in conjunction with the offering of disease screenings must be reviewed and approved by OMB before enrollment can begin.

For data collections by government agencies such as the CDC, the OMB administrative review process should require six to eight months after all human subjects reviews have been completed. In our experience, these timelines are minimum estimates, and many OMB reviews of public health research data collection protocols have taken much longer, often more than a year, and sometimes as long as three years. This results in delayed implementation of important public health data collections and forces public health decision makers to plan and implement programs without the benefit of timely and relevant data.

Ethical considerations

In considering PRA requirements in the context of public health research, policymakers must consider the principles espoused in the Belmont Report—the landmark statement on bioethics in human subjects research—which include respect for persons, beneficence, and justice. Unfortunately, delays in PRA reviews violate all three principles. With regard to respect for persons, delaying the opportunity of individuals to choose to participate voluntarily in a public health research study is not consistent with respect for the autonomy of persons to choose for themselves. With regard to beneficence—making efforts to secure the well-being of persons—if the OMB review process results in the delayed opportunity for voluntary research participation by those in greatest need (and in our experience it does), this clearly compromises the principle of beneficence. Unnecessarily long reviews also compromise the principle of justice by delaying access to voluntary participation in research studies. According to the Belmont report, “an injustice occurs when some benefit to which a person is entitled is denied without good reason.” This is especially evident in light of the fact that individuals choosing to participate in public health research studies may create direct and immediate benefits for themselves and those in their own communities by increasing knowledge about the impact of public health programs and by providing data to inform development of policies and improved programs.

The purpose and reality of PRA requirements

The stated purposes of the PRA include minimizing the burden of data collections on individuals, ensuring the greatest possible benefit from information collected, and reducing the cost to the federal government of collecting information. The principles are important, but the nature of CDC public health research fulfills them without additional review requirements. Moreover, OMB review can reduce the benefits of information gathering by duplicating existing review processes and delaying access to new health data. Here we address these purposes in turn as they relate to public health research and evaluation:

Minimizing the burden of data collections on individuals: Most citizens will identify the PRA with data collections that are mandatory and involuntary—for example, tax, census, and immigration forms. In fact, the PRA itself defines data collection as occurring when data collection “requirements [are] imposed on ten or more persons.” However, OMB review requirements have been increasing applied to CDC public health research programs in which participation is voluntary, and even for which participants are monetarily compensated for their time and effort. The OMB review process has been extended to cover activities which do not impose a burden on citizens, but instead offer them the choice to participate in research that is designed to promote the health of communities in which they may receive services not yet widely available, and for which their time is compensated. In other words, burden does not result when people are offered a choice as to whether they want to participate in a public health research or evaluation study and the choice does not affect any services they already have available. Therefore, requiring PRA oversight of such studies beyond peer review and Institutional Review Board examination does not reduce the burden to participants.

Implicit in this purpose is that reducing duplicative data collections supported by the federal government would reduce unnecessary burden. However, there are many other funding mechanisms, such as National Institutes of Health grants, for which OMB does not provide oversight of most data collections because of a “clinical exemption” in the PRA, or because funding mechanisms are used in which government scientists do not have substantial input or direction with respect to data collections. In these cases, truly duplicative data collections are relatively rare. This is because scientists take seriously our responsibility to be well-versed in the published literature, to keep abreast of other ongoing research through networking with colleagues, and to not conduct research that unnecessarily duplicates other ongoing efforts. NIH review processes also help identify potentially overlapping areas of investigation in the peer review process. CDC, which is increasingly using peer review processes consistent with those of NIH, should similarly rely on the integrity of scientists and the diligence of peer review committees to address concerns of duplicative research.

Ensuring the greatest possible benefit from information collected: To provide maximal benefit, public health data collections, whether research or part of non-research public health surveillance or evaluation efforts, must be timely. The greatest possible benefits of data collection are to have the right data at the right moment. There are a number of processes already in place to ensure that public health research studies are collecting the right data. Research proposals are peer reviewed by external experts, and, in the case of research cooperative agreements, have substantial input from CDC scientists. In our experience, the OMB review process is in part duplicative of the peer review process. For example in a recent OMB review of one of our studies, there were no questions about the burden of our study; in fact, the only questions raised dealt with sampling methods and other aspects of scientific study design that peer reviewers had already examined and found meritorious. In our case, this issue was exacerbated by the fact that the original study proposal to CDC, which detailed the sampling methods and rationale, was not even reviewed by OMB staff as part of their review process.

Timeliness of data collection also relates in important ways to maximizing benefits. The OMB process unequivocally delays the collection of crucial public health data—sometimes by years. But even the lost benefit of science delayed only tells part of the story: CDC scientists, daunted by the realties of how long OMB approval sometimes takes, may self-censor their best ideas about public health science because they understand that by the time required OMB processes are completed, the science will be out of date. Increasingly, academic and other non-federal scientists are choosing to limit their collaborations with CDC because of OMB delays, in favor of working with other funding agencies where OMB review is usually not required.

Minimize the cost to the federal government of information collected: There might be instances in which OMB review identifies duplicative data collections, and costs are reduced because OMB intervention prevents such redundancy. However, we believe that much more frequently, costs increase because review delays necessary, well-coordinated data collections. When CDC has funded scientists in partner institutions to conduct important public health research and those researchers sit idle waiting for OMB approval, dollars are wasted. When important science is not done in a timely manner, we can measure the costs of failing to implement effective prevention programs both in dollars, because in many situations preventing disease costs less than treating it, and in preventable morbidity and mortality.

A case study

We base our observations of the OMB process on our recent experience. A group from the University of Maryland and the University of Pennsylvania were awarded funds under a cooperative agreement with scientists from the CDC to conduct a project in Philadelphia and Baltimore to examine the impact of conducting rapid HIV testing in inpatient and outpatient mental health settings that predominantly serve African Americans. This cooperative agreement was funded to 1) increase the number of mental health providers who routinely provide HIV counseling, testing, and linkage to care in settings that provide mental health care; and 2) to describe the relationship between mental illness and HIV testing and care for persons with newly diagnosed HIV infection and risk behaviors in order to inform optimization of HIV prevention interventions for persons with chronic mental illness. The proposal went through peer review, was approved, and funded beginning in August 31, 2007. More than two years later, we have not started work on the project and continue to await OMB approval. These delays represent a combination of internal CDC processes in preparing and submitting the OMB package and in OMB review of the data collection. Whether the OMB-related delays reside within CDC, elsewhere within the Department of Health and Human Services, or within OMB itself, these delays arise because of the OMB review requirements.

A simple solution

These concerns can be easily addressed in the next reauthorization of the PRA by providing an exemption to the PRA for public health research, surveillance, and evaluation in which participation is voluntary. Exemptions to OMB review are not without precedent. Notably, the NIH and the Veterans Administration, both of which have substantial intramural and extramural research programs, frequently use an exemption for clinical research. The legislation authorizing the National Vaccine Program also specifically exempts this program from the requirements of OMB review under the PRA. Public health research deserves no less.

The threshold to justify implementation of lengthy governmental reviews that delay scientific progress should be very high. In the case of the OMB review requirements for voluntary data collections for public health research and program evaluation, we believe that this threshold is not met. Although put into place to make sure that the American public is not overly burdened by government data collections, the OMB review process is currently applied to voluntary participation in public health studies that do not mandate participation, and therefore cannot mandate burden in its commonly understood sense. Because the OMB functions as part of the executive branch, the review process could be used as a political tool to modify or delay research that is unpopular within a given administration. This review process costs the public in many ways—counted in dollars as well as in delays of important research in public health that could ultimately save lives. Alternatives exist to meet the goals of the PRA for public health research that minimize delays in study implementation.

We are hopeful that Congress will take aggressive steps to review these policies and ultimately extend to these specific types of public health data collections an exemption from PRA requirements.

Michael B. Blank, PhD, is Associate Professor of Psychology in Psychiatry at the University of Pennsylvania. He is affiliated with the Center for Mental Health Policy and Services Research as well as the Leonard Davis Institute of Health Economics.

Patrick S. Sullivan, DVM, PhD, is Associate Professor of Epidemiology at Emory University’s Rollins School of Public Health in Atlanta. Prior to his current appointment, he served in scientific management positions at the Centers for Disease Control and Prevention from 1999-2001 and 2003-2008.

Paul A. Lombardo, JD, PhD, is Professor of Law at Georgia State University’s College of Law. He is affiliated with the Center for Law, Health and Society and is a recognized expert in legal history and bioethics.

But how do we make the process faster? And how do we make it better? The first step on the path to a solution first requires understanding the virus, the current vaccine, and how it’s made. Without faster processes for producing influenza vaccines that protect against new strains, this pharmaceutical backstop won’t help us slow a pandemic.

Figure 1: Schematic of Influenza Virus, with H and N proteins in the surface (adapted from Wikipedia)

The influenza virus, in general, has evolved into a fuzzy, tennis-ball like shape with tiny legs coming out of it (Figure 1). On the surface, it carries a set of proteins that vary between strains, one of which acts as the legs that attach to healthy cells and infect them. Once they attach to the healthy cell, a cascade of events follows that essentially turn your healthy cells into generators of virus particles that will be released to your system (click here to see a nice animation of the process). Two of these surface proteins are what give the different strains their characteristic names; instead of the swine flu, we now call it the H1N1 influenza virus.

The “N” stands for neuraminidase, the component that enables newly generated virus particles in the cell to escape into the system. Several well-known flu medications like Tamiflu and Relenza target this protein, as it is important to dissemination of the virus. If N holds the passage to the exit, then “H,” which stands for hemagglutinin, is the proverbial key to entry. These proteins act as the legs or anchors that enable the virus to latch onto the cell and grant it access inside. More on H later.

There are more than 10 forms of H and 9 versions of N to watch. Those alterations on the surface of the viral ball are what the scientists and World Health Organization researchers continuously assess each season, so that they can effectively target the different strains of the flu.

Once they characterize the blueprint for the season, WHO sends it to the Centers for Disease Control and Prevention, where scientists grow a strain as an initial seed virus. That strain is then sent out to manufacturers who grow the influenza virus in a hen’s egg, purify it, and completely kill it with ethyl ethers or detergents. The purified, inactivated vaccine is then packaged into vials. This is a lengthy process that is tedious and dependent on the health of large flocks of hens. All in all, at highest efficiency, you are looking at 6-8 months from strain isolation to market distribution.

For decades, most experts have agreed that the process of manufacturing influenza vaccine through hens’ eggs is archaic and needs to be improved. However, because biotech funding seems to follow the trail of new super drugs generated by pharmaceutical companies, the standard has remained. But what if a deadlier strain hits? Will this process suffice?

Producing a vaccine to protect the entire U.S. population against a pandemic would require an enormous supply of eggs: 900 million are necessary to produce 300 million doses, according to the Department of Health and Human Services. In addition, avian strains have been difficult to grow in eggs. If strains hit that are too virulent and deadly, this process will fall short. We need alternatives. Fortunately, there are a few promising paths to faster production and better quality of flu vaccines.

Looks like a virus, smells like a virus…

The current approach described above involves taking the actual influenza virus, growing it, and inactivating or killing it. Aside from the time-consuming nature of the process, it also eliminates many of the surface proteins (recall the furry surface of the tennis ball) that may be important in the immune response. But what if you could make the process faster and keep the protein surface layer intact?

Combining cell-based and recombinant approaches may just do the trick. A cell-based vaccine uses viruses grown in cultured cells (typically kidney cells) rather than hens’ eggs. In this case, cells (as opposed to eggs) become the bio-generators of the virus. Because cells don’t have the limitations flocks of chickens do (hen health varies, as does biological timing; and some fail to produce embryonated eggs; eggs are prone to contamination, etc.), they can conceivably achieve higher production levels. The cells are just waiting in an incubator near you. Thus, this method could potentially meet the demands of “surge capacity” in the face of a pandemic, as cells can be frozen, while reducing the risk of contamination and reliability posed by egg-based methods.

Recombinant vaccines use cells, typically bacteria or yeast, to create large quantities of viruses (or parts of a virus) without disease-generating qualities—these are called virus-like particles or, VLPs. That is, they create what looks like a virus from the perspective of your immune system (it elicites an immune response), but it actually lacks the contents that would make it a dangerous entity. It looks like virus, smells like a virus, walks like a virus… but it’s not a virus. When VPLs are injected into a patient, the immune system reacts as if it were attacking a real virus, creating anti-bodies against it, and giving the patient immunity when the real strain attacks. Unlike traditional vaccines, these VLPs do not run the risk of becoming virulent again, making them safer to use.

With these two approaches, scientists could produce more powerful vaccines in a fraction of the time. In fact, instead of waiting 6-8 months, the process could take just 4 weeks. A small company called Novavax claims to have produced an effective vaccine this way. While this is only a start, it is certainly a promising one in our quest to make better vaccines and make them faster.

However, this does not change the fact that we will always be in a reactionary position with regard to the flu. As such, WHO and the CDC will always have to be observing, predicting, and blueprinting what comes next in the flu repertoire. That is, unless we have a way to create vaccines that don’t have to change with the varying flu strains.

A “conserved” approach

Recall that the proteins on the tennis-ball surface of the flu virus are always changing. But what if the flu vaccine instead targeted a region of the proteins that is not changing? Even better, what if it targeted a region that is consistent throughout most (if not all) influenza strains? This is referred to as a “conserved regions” approach, and the strategy is to find antibodies that latch into these conserved regions within the legs (or H proteins) of the viral ball (again, see Figure 1). Those regions are where the virus fuses to the cell it infects, and by binding to these stable areas, the antibodies prevent the virus from fusing with the host cells, incapacitating it.

But there’s more. Because these regions are conserved, this strategy has the potential makings of a super vaccine—one that can treat many, if not all, flu strains. Current research on this method is underway at the Dana Faber Cancer Institute and Scripps Research Institute, among others. From a practical perspective, a successful “conserved regions” vaccine would minimize the need to be on standby alert all of the time, and would allow for the continuous generation of antibody stock, in the event of a rapidly spreading flu outbreak. This means we won’t have to be running against the clock every time a potential influenza pandemic rears its ugly head.

Borrowing a phrase from popular seismology, the big one has yet to strike. Yet, it is important to understand that pandemics are not a question of “if,” but rather “when.” Although it is true, as the PCAST report states, that our methods now are more sophisticated than in 1918—when the Spanish flu pandemic, which was responsible for more deaths than World War I, struck—our tiny enemy, the flu virus, may also get more complex with time. Improving vaccine production will require significant investments, but the risk far outweighs the cost.

Ricardo Antonio Rossello, Ph.D., is a Doctor in Biomedical Engineering at the Duke University and an entrepreneur in bioengineering and technology.

As well, the President’s Council of Advisors on Science and Technology released a report today examining administration preparations for handling the expected resurgence of H1N1 as flu season approaches. They also point to hand washing in their bevy of recommendations for how small individual actions help curb outbreaks and preserve public health. A press release introducing the report underscored that the novel virus is not more deadly than seasonal strains, but it can move quickly through the population because few people are immune to it. This in turn could push medical providers beyond capacity.

One of the key recommendations of the report is that the Department of Homeland Security invest in public health surveillance systems (a suggestion CAP also made last year). In addition, PCAST recommends that the Centers for Disease Control and Prevention continue to expand its new media outreach, noting that the CDCemergency Twitter account had 30,000 follows when the spring H1N1 outbreak began. This afternoon there are more than 762,000.

As Bryce Hall explained recently here at SP, CDC has worked with Google on other new media surveillance methods like search trend analysis. Search habits are very strongly correlated with viral outbreaks, and search data allow epidemiologists “to identify flu outbreaks two to six weeks faster than by using any other method,” he reported.

But it will take a mix of high- and low-tech innovation to slow the spread of flu as best we can. As Nelson Hernandez and David Brown report in the Post, DC officials recommend a simple timing device to make sure kids have spent long enough scrubbing their hands: “sing the Happy Birthday or Row, Row, Row Your Boat songs twice.“

Since then, of course, the digital age has revolutionized the way medical information is collected, analyzed, and shared. Today, data is submitted to the CDC electronically, compiled in databases and published on the Internet. Medical information is so widely accessible on the web that a majority of Americans have now become active participants in their own medical care. And that’s all just the beginning.

Using the Internet to Predict Flu Outbreaks

Months before the recent outbreak of H1N1 influenza (“swine flu”), developers at Google revealed that they had created an ingenious method to predict flu outbreaks by tracking the frequency of search keywords. As it turns out, an increased frequency of searches for a family of words like “flu symptoms” and “runny nose” in a particular region is a reliable indicator that the flu is spreading there. Brilliant.

When this information is graphed by region and compared to data compiled by the CDC, it doesn’t just correlate-it matches almost exactly (see above). The difference is that the method the CDC uses to compile data from clinics and physicians takes much longer. Once people start to feel sick, it takes time to make an appointment to see the doctor, and for a physician to then report that information the CDC. Using search data reveals trends in real time, allowing epidemiologists to identify flu outbreaks two to six weeks faster than by using any other method.

Public health organizations like the CDC and the World Health Organization now use Google Flu Trends, where this information is publicly reported, as an additional tool for disease surveillance here in the United States and around the world. “Information like this can be extremely helpful in early detection,” according to Lynnette Brammer, an epidemiologist in the Influenza Division of the CDC. “We’ll look at Google Flu Trends particularly at the beginning of an outbreak to give us an indication or heads up.”

For public health officials this additional lead-time is incredibly useful, Brammer adds. Hospitals can be notified for “surge planning,” allowing them to be adequately staffed and stocked with medical supplies. This ability to plan ahead for surge capacity is particularly important for hospitals and medical centers aiming to spend limited dollars efficiently in an economic downturn. Early detection also helps tremendously in alerting the public and isolating outbreaks as much as possible.

But if this search data can be used to predict flu outbreaks, what else can it tell us? Actually, all kinds of things. “We’re just at the beginning of incredible new insights,” according to R.J. Pittman, Director of Project Management at Google, “It’s a wide open field.” Using this data to predict flu outbreaks may be just the tip of the iceberg.

When we type a keyword or phrase into Google, we get a list of relevant links with the information we’re looking for. But what most of us don’t realize is that this entire time Google has been has been recording each of these search words along with the IP addresses of the computers doing the search, forming a colossal cache of data-a byproduct of Internet searches. Google uses this highly confidential information primarily to improve its search engine, but other valuable uses are just now being discovered.

Google Flu Trends developed out of Google Trends, launched in 2006, which allows anyone to search for the frequency of keywords and phrases entered into Google since the beginning of 2004. Pittman, who oversees new development projects at Google Labs where Google Trends was designed, explains, “It was born out of engineering tinkering in the labs. There’s a lot of rapid prototyping.” But it’s only when programmers built a simple user interface and a data visualization tool to create graphs of the frequency of the searches over time that they started to understand what they had uncovered. “That’s what led to some ‘Aha!’ moments,” says Pittman.

People can now see what other people in the United States and around the world are searching for. Pittman describes it as “Internet searches turned inside out. We give back to the users the ability to search the searches.” In August 2008, without fanfare, Google pulled the curtain back further on its archived search data with the launch of Google Insights for Search, a much more sophisticated application targeted at a marketing audience, though available free for anyone to use. Now people can mine this data with much more precision and see much more detailed results, broken down by region on a shaded heat map. Only with this improvement did it become possible to use the technology to accurately track flu outbreaks.

Before anyone starts worrying about privacy infringement, Google posts its privacy policy on the Google Insights page and takes care to point out that this data is anonymized and aggregated. They won’t reveal the search history from any individual IP address, though that data is archived for nine months before being anonymized.

What makes Google search data so valuable is that so many of us search online before we do something, as David Leonhardt described in “The Internet Knows What You’ll Do Next” in the New York Times. We often search online before we buy a car, apply for college, watch movies, buy stocks, vote, go on vacation, or significantly in this case, before we go to the doctor. It’s most valuable to use search data for things like predicting flu outbreaks because there’s typically a longer gap of time between search indicators and any other method of detection.

But while Internet search data may provide the earliest indicators of an outbreak, there are serious limitations. For one, it’s heavily influenced by media reports. When reporters began writing stories about “swine flu,” Internet searches spiked, first in Latin America, then in the United States and around the world. Even Internet searches for specific symptoms typically spike as people rush to learn more about the disease-whether or not they actually have any symptoms. And other infections, like HIV, don’t have an associated family of symptom keywords that can be easily used to detect an outbreak. In addition, Internet search data doesn’t provide any additional information about the severity of the disease (how drug-resistant or fatal it is) or specific demographics involved.

“It’s sort of like a big puzzle, and of course, you want to have all the pieces,” says Brammer. So while Internet search data provides a new tool that helps with early detection, “It’s not going to replace the traditional methods. One system alone is not going to do the job,” she explains. Currently this data is used alongside detailed virologic data from the labs, outpatient surveys, and mortality reports to give public health officials the most complete picture of what’s really going on.

Mapping the Hot Zones

Other new digital technologies are also helping public health officials identify outbreaks around the world. Unlike Google Flu Trends, which uses Internet search data as an indicator, the HealthMap project collects and aggregates information from news reports, blogs, twitter feeds, and mailing lists. Public health officials used to monitor news reports manually, collecting clippings and trying to detect outbreaks. Now, a web crawler searches the Internet every hour and collects this data on a global map with a heat index that indicates the most current updates on emerging health threats.

“HealthMap collects information from the news media, which are typically among the fastest to report this data,” says Clark Freifeld, who developed HealthMap with John Brownstein in MIT’s New Media Medicine Department. It currently searches the web in six languages (English, Spanish, French, Portuguese, Russian, and Chinese) and there are plans to include more soon. Additionally, people can fill in any gaps by adding links to news feeds or sources HealthMap’s web crawler may have missed. As with Google Flu Trends, the main purpose of HealthMap is to provide early warning information.

“We’ve gotten a lot of interest and excitement from CDC and WHO. They use it a lot, and are some of the most frequent visitors to HealthMap,” Freifeld explains. But local public health officials might find it useful as well. A local outbreak of chicken pox would not be of interest to the WHO, but it would be very interesting for nearby health clinics or school districts, allowing them to cancel school activities and advise parents as soon as possible. These kinds of local reports are easy to miss, especially when everyone is being barraged with information. HealthMap allows users to customize their results by disease and by region, so “Instead of wading through a vast stream of data, it filters out the information of interest to a particular region,” Freifeld says.

While these new developments offer powerful tools for public health officials, each one has its strengths and weaknesses. In this case, the information on HealthMap comes from different sources, many of which are not verified. The trick with many of these new digital technologies is to crosscheck them with other sources and incorporate them into existing systems. If used properly, they have vast potential to improve public health.

Can Digital Health Records Improve Public Health?

Another significant technological development on the horizon with public health implications is the nationwide switch to electronic health records-but not simply for the reasons most people are talking about.

The Obama administration is encouraging health care providers to change over to a system of electronic health records that promises to save money, improve patient care, and reduce medical errors by reducing paperwork and making records available to other doctors and specialists. The American Recovery and Reinvestment Act includes $19.5 billion for health information technology, intended to incentivize this transition to electronic health records. While advocates commonly cite the cost savings and quality improvements from EHRs, using these systems has the potential for other surprising benefits.

These benefits can be seen on three levels, according to Dr. David Blumenthal, National Coordinator for Health Information Technology (also known as Obama’s Health IT Czar) at the Department of Health and Human Services, who will oversee this transition nationally. “On an individual level, it makes doctors better doctors,” he says. For example, the EHR systems can include pre-formatted treatment programs for specific conditions to help doctors make sure each patient is receiving the best care. It can also help doctors identify necessary follow-up tests and avoid dangerous drug interactions.

On a “middle level,” EHR systems allow hospitals and clinics to optimize care for groups of patients, allowing them to target certain diseases. “Where these systems are already in use, rates of compliance for diabetes and preventive services have gone up dramatically,” Blumenthal says. As a result, these hospitals are seeing lower mortality rates and lower costs.

Such a system could also help select patients for clinical trials. Patients who choose to be considered for clinical trials would be able to easily submit their health records. Doctors organizing the studies would then much more easily be able to select patients who meet certain criteria.

But other extraordinary benefits are also possible on a larger “population level.” In the same way that collecting Internet search data has created an incredibly valuable source of information, electronic health records would create another unprecedented resource for public health officials and medical researchers. Information that doctors and clinics already share with public health officials can be collected much more quickly and efficiently. “Once this data is collected, it’s relatively easy to assemble into a research database that is very powerful,” Blumenthal says. “With electronic health records, you learn a lot more a lot faster from manmade and natural events.” These systems could, for example, allow doctors to monitor new drugs and vaccines after they’ve been released-and more quickly identify which ones prove dangerous. If these EHR systems are properly designed, additional insights and discoveries would be possible that would ultimately expand our medical knowledge and improve public health.

Currently, the CDC collects information from thousands of participating doctors around the country by asking them to fill out surveys-about new cases they’ve seen of influenza-like illnesses, for example. While this system does work well, it’s inefficient and provides only limited information. Participating doctors are volunteers being asked to complete additional work. As a result, the CDC is sensitive not to overburden its sources and requests as little information as is absolutely necessary. With EHRs, this information would be much easier to transmit and analyze.

With nationwide electronic health records, these limited sets of data could, in theory, also be augmented with anonymous, or what Blumenthal emphasizes is “de-identified,” information that patients choose to share from their records for clinical research purposes. This would allow researchers to identify patterns using basic demographic data, for example. There’s still a long way to go before EHRs are the norm, but it’s important to consider now the possibilities they would afford for protecting public health, and to build systems that will simultaneously reduce cost, improve care, and safeguard personal information.

To do this, developers, of course, must first address privacy concerns, making sure that patients’ confidential medical information is secure. “We’re going to try to communicate early and often with patients to assure them that no stone is being left unturned in protecting the privacy of this information,” Blumenthal explains.

The Health Insurance Portability and Accountability Act, or HIPAA, which established privacy regulations for medical information, places no restrictions on using de-identified data for research purposes. However, for electronic records to play a role in public health, the systems will have to include a mechanism to securely de-identify these records. Currently, the HHS is creating guidelines to help private and public health care providers de-identify electronic health records to protect patients’ confidential medical information.

Unlike Google’s database of Internet search data, the electronic health records won’t be centralized in one enormous database. Furthermore, the records likely won’t all be in the same format; different hospitals, clinics and health care organizations will end up with different systems. Despite some misconceptions, EHR will not be a nationalized system and the government will not control records, though the goal is to set some uniform standards so individual records can easily be transferred between different EHR systems. This compatibility is critical so that when patients move to another state, see a specialist, or end up in an emergency room that uses a different system, authorized doctors will be able to pull up their health records.

Switching to electronic health records won’t happen overnight, and nationwide, it’s expected to take roughly seven years for most private and public health care providers to make the change. Thankfully, that gives people some time to examine different systems and choose ones that allow individual patients, doctors, hospitals and the public at large to take full advantage of these new technologies.

With more than $19 billion from the Recovery Act supporting the switch to electronic health records, the public should get as much return on its investment as possible. The cost savings they will enable in preventive care, coordination, and disease management are the first steps. Developing systems that allow researchers and public health officials to use de-identified health information promises to expand our medical knowledge and ultimately improve our public health-which should be the central goal of using all this fancy new technology anyway.

Bryce Hall is a Media Producer based in Washington, D.C.

Since many drainage systems and water treatment facilities are outdated in the Northeast, research suggests that New York, Chicago, Washington, Milwaukee, and Philadelphia are likely to be at a greater risk of water-borne diseases. Increased downpours that result from shifting weather patterns may also trigger contaminating sewage overflows in these cities, the USGCRP reports.

A World Bank report on climate change in Europe and Central Asia likewise forecasts greater risks of water contamination due to weak infrastructure in the former Soviet Bloc. If changing weather patterns increase flooding as forecasted, old toxic waste dumps may release dangerous substances into the water supply. As well, the International Institute for Sustainable Development’s most recent report projects that Middle Eastern coastal aquifers will be similarly overwhelmed and contaminated with salt water as sea levels rise around Lebanon. Increased flooding in the Pacific Islands, including Hawaii, may also foster water pollution and endanger drinking water quality, the USGCRP says.

The public health experts at Effect Measure have been following the discussion over what to call the world-wide epidemic, and interpreted the WHO press briefing like this: “everyone, WHO included, thinks a pandemic is well underway.” But they look to deeds, not dictionaries for solutions to an outbreak that has infected a reported 27,737 people worldwide:

Meanwhile we now have the long predicted influenza pandemic. It’s neither so scary nor so benign that we can afford to either hide under the bed or ignore it. What we must do is roll up our sleeves and manage the consequences.

The question of what the word “pandemic” means has gotten so entangled in the media coverage of the outbreak that The New York Times yesterday dug into the history of the term, revealing that the public health community hasn’t yet agreed on how to define it:

The word implies the rapid spread of an infectious disease to many countries in different regions, hitting each with more or less the same severity. But in fact, severity varies — not all people are infected at the same time, and not every country need be affected.

And there can be many other factors, including the numbers and percentages of people falling ill and dying; a population’s vulnerability to the disease, based on previous rates of infection; and the quality of health care facilities and disease monitoring systems.

Not least is that scientists do not know precisely how pandemics arise, what fuels them, why they vary in their lethality, why some occur in waves and why they stop.

Complicating matters further is the fact that the term gets applied to health problems like obesity and heart disease—very different from the international influenza outbreak.

Instead of tweaking the current alert system, the Effect Measure editors recommend an “up-to-date information” system. Sharing data in real time on the Internet would be helpful not just for national health systems, but would also allow media outlets to spend more time and effort looking at what is happening, rather than having to worry so much about what to call it. Fortunately, the Obama administration understands the issue clearly and has requested nearly $12 billion in additional funds to handle the ongoing outbreak, which has infected 13,217 people and killed 27 in the United States.

Image: CDC

The bill would provide the Food and Drug Administration with unprecedented control over the tobacco industry. This act allows FDA to require full disclosure of ingredient lists and to order tobacco companies to reduce the amount of harmful ingredients in their products. It would also change warning label content and increase label size, as well as ban marketing to minors. The Secretary of Health and Human Services reserves the authority to mandate additional changes to warning labels that benefit public health. The legislation also prohibits labeling cigarette packets with phrases like “light” and “low tar,” which are often deceiving to consumers and mask the health risks. It would also forbid the sale of most flavored cigarettes.

For the moment, cigarettes remain unregulated drug delivery systems. Here’s a look at some of the most recent data on national smoking trends:

19.8 percent of adults in the United States (43.4 million people) were current smokers in 2007.

30 percent of all cancer deaths involve smoking as the primary cause.

443,000 people died prematurely every year as a result of smoking and exposure to tobacco smoke during the period between 2000 and 2004.

During that same period, smoking caused $98 billion in productivity losses each year.

For every person who dies of a smoking-related disease, 20 more people suffer with at least one serious illness from smoking.

20 percent of high school students were smokers in 2007.

3,600 people between the ages of 12 and 17 pick up smoking everyday.

Image: flickr user Sami__

Here’s a look at some of the latest research on health impacts around the world plotted on the Science Progress interactive Human Toll of Climate Change map:

Scientific American’s review of the top ten places already affected by climate change reported that Europe’s first tropical disease epidemic in August 2007 resulted from climate change. More than 100 of 2,000 residents of a small village in Italy contracted a disease related to dengue fever because an abnormally mild winter allowed the Asian tiger mosquito, the disease vector, to breed early in India. A resident of the village visited India and introduced the disease to Italy.

The Centers for Disease Control discovered that a change to warmer, wetter weeks in the United States increased West Nile infections by up to 83 percent from 2001 to 2005. CDC scientists warn that increased rates of West Nile around the globe will lead to a significant number climate-change related dealths.

A study published in the journal Science found that there is a 90 percent chance that 3 billion people will be forced to choose between starving and moving to milder climates within 100 years because of climate change.

In a study released earlier this year, a Penn State entomologist emphasized that daily temperature fluctuations-not just changes in average monthly or annual temperatures-may alter malaria patterns. Whether the temperature fluctuations cause the incidence of malaria to increase or decrease depends largely on a region’s background conditions. Mosquitoes may fail to develop the malaria parasite before they die, or the parasite may develop faster, the study reports.

Image: AP/Lisa Poole

But the recommendations from existing research are relevant now more than ever, and what we know already about the relationship between health and climate is invaluable as communities in the United States and around the world adapt to a warming world.

Researchers first began to speculate that global warming could facilitate the spread of infectious diseases during the 1990s. Scientists understood that malaria, dengue fever, and other vector-borne diseases—those carried by mosquitoes, ticks, sandflies and other organisms—were endemic to tropical and subtropical regions, and thought their transmission rates were particularly sensitive to slight fluctuations in temperature and humidity. They theorized that rising temperatures and humidity, among other shifting climate patterns, could increase the number of cases by expanding the diseases’ reach.

Several studies done at the time examined the effects of global warming on disease transmission in Africa and found strong temperature dependencies in the correlations between disease rates and weather variations over spans of both weeks and years, and in the close geographic associations between major climate indices and the distributions of the diseases. Though most of these studies ultimately failed to pinpoint the exact causes of the increase in disease spread, the researchers involved concluded that continued warming would have a strong impact on pathogen development and disease transmission, increasing the risk of future outbreaks.

In 1997, the U.S. Global Change Research Program commissioned the creation of the National Assessment of the Potential Consequences of Climate Variability and Change to study the future impacts of climate change on the country and on several major national sectors, including health, over two periods-through 2030 and through 2100. The report, published in 2001, concluded that the number of deaths and illnesses resulting from extreme weather events, air pollution, and water- and foodborne diseases would likely increase, and that certain populations—particularly the poor, the elderly, and children—would face the most severe consequences.[1]

Heat waves would become more common and more severe, as would natural disasters like floods and storms. The combined effects of higher temperatures and increased pollutant emissions in urban areas could worsen air quality by enhancing the formation of ground-level ozone and spurring the use of air conditioning and other fossil fuel-dependent technologies. Changes in temperature, rainfall, and humidity could affect water quality by increasing the flow of urban and agricultural run-off to coastal waters and freshwater bodies, making it easier for waterborne disease agents like bacteria and viruses to spread. Similarly, weather variations could increase the number of cases of vector- and rodentborne illnesses by creating conditions amenable to the disease agents’ growth.

They cited the example of hantaviruses, a group of viruses carried by several rodent species and transmitted to humans through contact with feces and through the air, which caused an outbreak of Hantavirus Pulmonary Syndrome in the southwest when a previously undocumented strain, called Sin Nombre (“Without a Name”), emerged in 1993. The outbreak was attributed to a surge in the local mouse population that was caused by an increase in their food supply; this, in turn, was attributed to unusually high precipitation brought about by the 1991-1992 El Niño event.

To counter these trends and prepare for the worst, the authors recommended a series of adaptive responses. These included weather watch systems, improved disease monitoring and prevention programs, more vaccines, more robust sanitation systems, and better targeted research, among others. “Vigilance in the maintenance and improvement of public health systems and their responsiveness to changing climate conditions and to identified vulnerable subpopulations should help to protect the U.S. population from any adverse health outcomes of projected climate change,” they concluded.

Though the report may now seem dated, many of its conclusions and recommendations are as relevant ever. As its authors predicted, the United States has since experienced more heat waves and extreme weather events, including the devastating Hurricane Katrina (which a warmer Gulf of Mexico helped strengthen), though the federal and state governments have yet to implement many of their suggested adaptive responses.

In 2005, Paul R. Epstein of Harvard Medical School, one of the foremost experts on the relationship between climate and health, warned in an editorial in The New England Journal of Medicine that the consequences of further warming could be devastating to human well being worldwide.[2] Floods, like those that followed Hurricane Katrina, often create “disease clusters” by forming new mosquito-breeding sites, driving rodents from their burrows, and dumping large amounts of pathogens, nutrients, and chemicals into waterways. Prolonged droughts and heat waves, like those seen in the southwest, lay the ground for more wildfires, which can result in deaths from burns and respiratory illness, and draw on the region’s already overdrawn water supplies. One of the greatest threats to human health could come from an increase in the number of illnesses affecting wildlife, livestock, crops, and other organisms-illnesses that we’ve now realized can sometimes make the leap over to humans.

His conclusion echoed many of the points made in the 2001 report:

All in all, it would appear that we may be underestimating the breadth of biologic responses to changes in climate. Treating climate-related ills will require preparation, and early-warning systems forecasting extreme weather can help to reduce casualties and curtail the spread of disease. But primary prevention would require halting the extraction, mining, transport, refining, and combustion of fossil fuels-a transformation that many experts believe would have innumerable health and environmental benefits and would help to stabilize the climate.

The United States is on its way to enacting the country’s first meaningful climate legislation, which could, as Epstein and other scholars have noted in more recent work., pay some of its largest dividends in the area of health. Moreover, the Environmental Protection Agency’s decision to regulate carbon dioxide and other greenhouse gases as dangerous pollutants under the Clean Air Act signals the new administration’s intent to take the joint matters of climate change and health seriously.

As a recent study co-published by The Lancet and the University College London Institute for Global Health Commission, entitled “Managing the health effects of climate change” noted: “The move to a low-carbon economy will have global health benefits from both a reduction in the health effects of climate change and improvement in human lifestyles, and these must be emphasized.” The Obama administration’s embrace of this goal will jumpstart a clean-energy economy and simultaneously ensure a healthy society.

Jeremy Jacquot is a graduate student in marine environmental biology at the University of Southern California and is a contributing writer for Discover, Popular Mechanics, and DeSmogBlog.

Notes

[1] Patz, J.A. et al, “The Potential Health Impacts of Climate Variability and Change for the United States: Executive Summary of the Report of the Health Sector of the U.S. National Assessment,” Journal of Environmental Health 64(2)(2001): 20 – 28.

[2] Epstein, P.R, “Climate Change and Human Health,” The New England Journal of Medicine, 353(14)(2005): 1433 – 1436.

• 95.6 cents of each dollar paid for the social burdens of substance abuse and addiction, including the cost of prisons, health programs, schools, government payrolls, and child welfare, juvenile justice and mental health systems
• 1.9 cents funded prevention and treatment programs
• 1.4 cents covered the costs of collecting alcohol and tobacco taxes, regulating alcohol and tobacco products, and operating liquor stores
• 0.7 cents paid for federal drug prohibition
• 0.4 cents funded addiction-related research

When the government is dishing out a minimum of $1,486 per capita to cover the results of our failure to prevent and treat abuse and addiction, additional research on the problem might be worthy of additional investment, the report argues.

“For every dollar federal and state governments spent to prevent and treat substance abuse and addiction, they spent $59.83 in public programs shoveling up its wreckage, despite a substantial and growing body of scientific evidence confirming the efficacy of science-based interventions and treatment and their cost-saving potential,” says the CASA report.

However, the amount of tobacco research may soon increase. The bipartisan “Family Smoking Prevention and Tobacco Control Act” would give the Secretary of Health and Human Services the ability to request additional research findings from tobacco manufacturers or importers on the effects of tobacco products or on the potential to reduce the health risks of tobacco products with available technology. S.982 is in committee while the Senate will vote on cloture of the motion to proceed on H.R. 1256 today.

Image: flickr.com/SuperFantastic

WHO is pretty clear on the term:

A disease epidemic occurs when there are more cases of that disease than normal. A pandemic is a worldwide epidemic of a disease.

Though the editors are more wry in their explanation of the kerfuffle: “The argument boils down to this. We shouldn’t call a pandemic a pandemic, because people might misunderstand that this means it’s a pandemic.”

So far, 40 countries have reported 9,830 cases of H1N1 influenza.

(HT: ScienceInsider)

The detective work, still underway, indicates that the virus is “almost equidistant to swine viruses from the United States and Eurasia…It doesn’t have any close relatives.” Donis says this suggests that the genetic mixing (which Aysha Akhtar explain in her article, “Flu Farms?“) probably didn’t happen in Mexico. Donis explains: “The amazing thing is the hemagglutinins [proteins on the surface of a flu virus] we are seeing in this strain are a lonely branch that have been evolving somewhere and we didn’t know about it.”

The exclusive interview is worth a full read.

Simply put, the antiviral drugs and vaccines that have been the focus of much pandemic planning and media attention are of limited use or unavailable during this pivotal early stage of the current outbreak. We have badly needed a fuller, more frank national discussion of the importance and ethics of other methods that can limit the spread of the virus in communities and worldwide. These strategies include voluntary and involuntary social distancing, which reduces transmission by, for example, closing schools or other locations where large groups assemble; isolation; and quarantine. Developing thoughtful policies and broad support for them is difficult enough in the absence of an imminent public health emergency. Attempting to do so in the midst of an unfolding outbreak and resulting media frenzy is all but impossible.

Public health officials have long warned that antiviral drugs such as Tamiflu will be of uncertain value in a pandemic. Early evidence suggests that the current swine flu shows some susceptibility to this class of drugs. However, the modest benefits they provide for most influenza viruses, coupled with the rapid spread of the present threat suggest that antiviral stockpiles will be of limited use in reducing the extent or severity of this outbreak. Similarly, talk of a swine flu vaccine is highly premature, as it will require at least six months to produce the first doses of a new vaccine, a time frame identical to the forecast for an avian influenza vaccine. For this reason, several hundred million dollars in government contracts have been spent on so-called “pre-pandemic” avian flu vaccines, products intended to provide some benefit until a specific vaccine can be produced at the start of a pandemic. The rapid emergence of swine flu renders this option moot for the current outbreak.

In either case, producing sufficient pandemic flu vaccine doses for large numbers of Americans, let alone international populations, would take years, even if significant financing, production, safety, and distribution challenges could all be resolved successfully and quickly. Moreover, the unintended consequences of the 1976 swine flu vaccination program, which resulted in far more vaccine-related injuries and deaths than confirmed cases of the disease itself, is a clear reminder of the perils of a rapid mass vaccination effort against a threat of uncertain severity.

The limited value of pharmaceuticals and vaccines in the early stages of a potential influenza pandemic is well known to public health officials and diligent readers of the vast planning documents issued by the federal government since 2005. Instead, the severity of swine flu or any potential pandemic will be determined in large part by how quickly those infected or exposed are identified, located, and separated from the healthy. This is the decidedly low-tech but life-saving work upon which many of the achievements of public health in the past century have been based. Evidence from past pandemics, most notably research by Howard Markel and colleagues on the 1918-19 influenza pandemic, has shown the positive effects of such non-pharmaceutical interventions for those communities that used them early and extensively in disease control efforts.

The public stance of federal pandemic preparedness, however, has been overwhelmingly centered on vaccines and pharmaceuticals. Hardly a month has passed since 2005 without press releases announcing new contracts to fund several generations of pre-pandemic vaccines, additions to antiviral stockpiles, or further modifications to the complex framework developed to allocate scarce supplies of vaccines and drugs fairly and effectively. In this context, it is no surprise that media coverage of the current swine flu outbreak has repeatedly turned to vaccines, with health officials asked to explain if there is a vaccine available, why there is not, and when one may become available.

In contrast to vaccines and antivirals, discussions of the role of social distancing, isolation, and quarantine in pandemic influenza response have most often been buried deep within government websites or little-publicized reports. While a significant public engagement effort was developed to build support for vaccine and antiviral allocation strategies, no comparable program has aimed to educate Americans on the importance of non-pharmaceutical interventions in limiting the impact of an outbreak. This is unfortunate, as widespread public support for voluntary isolation and quarantine programs is critical for their success, while also reducing the likelihood that far more controversial and ethically problematic compulsory measures may be required.

How might this disparity in attention be explained? The medical profession and the general public have long been transfixed by the potential for “wonder drugs” or “magic bullets.” The allure of scientific innovation as the key to preventing mass casualties in a pandemic is understandably difficult for politicians or scientists to resist. Announcements of sizable contracts to develop and produce new vaccines or the image of a national stockpile ready to be deployed in a crisis are far more likely to attract headlines than, for example, a public education project on the benefits of simply staying home from work when showing flu-like symptoms during an outbreak. The development and production of drugs or vaccines also bring economic benefits to participating companies and their communities, part of the profitable, if not somewhat opportunistic, industry emerging around pandemic preparedness.

Beyond these cultural, political, and economic explanations for the focus on vaccines and drugs, non-pharmaceutical interventions have been largely overshadowed in pandemic planning likely because the mere suggestion of isolation and quarantine programs is certain to be controversial and alarming. Even if such programs were voluntary in all but the most severe and limited circumstances, the word “quarantine” calls to mind scenes from the movies of entire communities cordoned off and placed under military control—like in the 1995 movie Outbreak. These unrealistic fictional depictions, coupled with documented historical abuses of quarantine powers by public health officials, create considerable challenges for public health officials charged with organizing non-pharmaceutical interventions and building support for their use as part of effective and just disease control strategies.

In contrast to voluntary programs, compulsory isolation and quarantine force us to examine the tension between individual liberty and the common good in public health, in addition to the contentious political and ethical debate over the role of the state in restricting civil liberties during a crisis. The overwhelming public interest surrounding the 2007 case of Andrew Speaker, the American traveler infected with a drug-resistant form of tuberculosis and placed under a federal isolation order, provided clear evidence of the mass concern such actions can create, even when applied to only one individual. Since then, however, there has been no visible effort to engage stakeholders and the public regarding when similar measures may be required in a pandemic, how their use will be overseen, and why they are critical to preserving public health.

More practically, the reality of our vastly underfunded public health infrastructure makes it difficult to imagine how large-scale social distancing, isolation, or quarantine programs would succeed in the face of widespread public opposition, making preemptive public education programs inseparable from disease control goals. With respect to the eventual allocation of scarce supplies of vaccines and antivirals, pandemic planners have realized the importance of the methodical, thoughtful engagement with stakeholders and the public. An analogous program examining policies for voluntary or compulsory non-pharmaceutical interventions would have been similarly worthwhile.

For the unfolding swine flu outbreak, it is already far too late to begin this vital work. Government officials who are already justifiably concerned about creating unnecessary panic may be forced to introduce targeted social distancing, isolation, and quarantine programs to a public that has heard too little about their tremendous importance and too much about vaccines and antivirals that are barely relevant to the immediate health challenges at hand. Through the efforts of the public health community coupled with a bit of luck, swine flu may dissipate without becoming a full-blown pandemic, giving health policy-makers a second chance to revisit these critical aspects of a comprehensive, just approach to pandemic preparedness.

Jason L. Schwartz is a researcher at the Center for Bioethics and a doctoral student in the Department of History and Sociology of Science at the University of Pennsylvania. He is most recently the author of “Disease Control Policy: Individual Rights versus the Common Good” in the Penn Center Guide for Bioethics (Springer, 2009), from which parts of this essay are adapted.

The primary reservoir for influenza viruses is aquatic birds, but humans are not readily directly infected by the strains from those animals.[1] Pigs, however, are highly susceptible to both avian and human influenza A viruses. They are commonly referred to as “mixing vessels” in which avian and human viruses commingle. In pigs, viruses swap genes, and new influenza strains emerge with the potential to infect humans. Pigs may have been the intermediate hosts responsible for the birth of the last two flu pandemics in 1957 and 1968 and the current swine influenza A, called H1N1, is a triple hybrid avian/pig/human virus.[2]

In order to better avert the threat of epidemics like the one currently spreading around the globe, public health efforts must address the conditions that allow pigs to become breeding grounds for infectious disease. More focus needs to be placed on preventing pathogens from getting into the human population in the first place, and that means starting at the farm. The source of the current epidemic has not yet been identified, but the first confirmed case of swine flu occurred in La Gloria, Mexico, a town surrounded by industrial pig farms, partly owned by Smithfields Foods.[3] We should note of course that the Centers for Disease Control and Prevention have made it clear that consumers cannot get swine flu from eating pork or pork products. But even if these particular farms are not confirmed as the primary source, based on research into the previous outbreaks of swine flu, it makes sense to consider factory farms as very likely potential sites for the development of these pathogens.

For centuries, the evolution of the flu virus has remained relatively stable. However, in recent years the influenza virus has undergone an “evolutionary surge,” with new variants emerging rapidly. But this is not limited to influenza. According to the World Health Organization, we are seeing more new infectious diseases and epidemics than ever before, and they are appearing at an alarming rate.[4] What could be causing such a surge in new infections? Increased human travel is certainly a factor, but perhaps the most significant variable is the change in animal agricultural practices that have occurred in the last few decades.

Global demand for meat has increased substantially in recent years. In the U.S. alone, approximately 1 million land animals are slaughtered for food every hour.[5] By 2020, world meat production is expected to double.[6] As a result of the rise in animal product demand, traditional farming practices have been mostly replaced in developed countries by immense intensive animal operations, and developing countries are rapidly catching up.

Increasingly, thousands of animals are confined in these operations, often crowded into sheds. The percentage of operations in North America with 5,000 or more animals expanded from 18 percent in 1993 to 53 percent in 2002.[7] The crowding leads to stressful and profoundly unhygienic conditions. Animals continuously inhale and recirculate aerosolized fecal matter, methane, and ammonia. The wastes and fumes emanating from these intensive operations are so concentrated that nearby human communities commonly have substantial increases in respiratory illnesses such as asthma.[8] The combination of reduced immunity due to prolonged stress in the pigs and the high-density confinement render these operations perfect breeding grounds for new pathogens. Under these conditions, new strains of swine flu are rapidly generated and transmitted from one pig to another by the respiratory route.

In 1988, 2,400 pigs in a North Carolina operation were sickened by a strain of swine flu not seen before.[9] Since that time numerous new flu viruses have emerged and have swept across pig operations throughout North America. WHO and other organizations cite intensive pig farming and other animal factory operations as a significant contributing factor to zoonotic pathogens.[10] Because of the high infectious disease rates in these operations, farm animals are given a constant influx of antibiotics; half of all U.S. antibiotics are given to farm animals.[11] This inundation of medicine helps select for drug-resistant bacteria, which in turn could be transmitted to humans. In addition, vaccination for farm animals is now common. It is routine to vaccinate pigs against swine flu, but rather then ameliorating the problem, vaccinations may actually exacerbate the problem by selecting for new, vaccine-resistant viruses.[12] Vaccinating farm animals may not be an effective preventive measure.

Our high demand for animal products has trapped us in a never-ending cycle. To meet the demand economically, animals are placed into high-density confinement, which sickens them; they are given antibiotics and vaccines to prevent this, which in turn produces more virulent or drug-resistant pathogens. So how do we stop this?

The answer, according to many governments, is to control the spread of infection once it spreads to the human population with physical barriers, vaccination, and medication. This is certainly necessary, but it is not the whole solution. Because new influenza strains are popping up continuously, it is difficult to anticipate the next serious strain that warrants a vaccine. There can be a long lag time between an outbreak and the availability of an appropriate vaccine. Vaccines also might not confer total protection to all citizens, and although generally safe, might, on rare occasions, have unintended consequences, as was the case with the swine flu outbreak at Fort Dix, New Jersey in 1976, in which the influenza vaccine was associated with increased cases of Guillain-Barré disease, a neurological illness of acute paralysis.[13] Moreover, antivirals and antibiotics are becoming ineffective because of the development of new, resistant strains. The current swine flu is resistant to two out of four potential antiviral medicines.[14]

The high-density intensive animal operations need to go. Not only are they hotbeds for pathogens, but they are also environmentally unsustainable and cruel to the animals involved. The American Public Health Association, recognizing the adverse public health consequences of these intensive farms, has called for a moratorium.[15] That’s a great step in the right direction, but it is not enough. To reduce the supply, the demand for animal products must decrease.

With one exception thus far, the current swine flu cases outside of Mexico appear to be relatively mild in severity and the outbreaks may fizzle out. Even if it does, however, genes between different flu strains are being swapped and re-assorted in pig farms across the world. The next major pandemic is just a matter of time. If we learn anything from the current outbreaks, it is that we can’t afford to wait for the next one. We need to address the root of the problem: the intensive farm animal operations and our own appetites.

Aysha Akhtar MD, MPH is a fellow for the Oxford Center for Animal Ethics and a neurologist and public health specialist at the Food and Drug Administration.

The opinions expressed here are those of the author and do not represent the official position of the U.S. Food and Drug Administration or the U.S. government.

Notes

[1] Webby RJ, Rossow K, Erickson G, Sims Y, Webster R, “Multiple lineages of antigenically and genetically diverse influenza A virus co-circulate in the United States swine population,” Virus Research (2004) 103: 67-73.

[2] Wuetrich B., “Chasing the fickle swine flu,” Science (2003) 299:1502-1505.

[3] The Washington Post, “Little boy at the center of a viral storm,” April 29, 2009. Available at: http://www.washingtonpost.com/wp-dyn/content/article/2009/04/28/AR2009042804041.html?hpid=topnews&sid=ST2009042900988

[4] The World Health Report 2007, “A safer future: Global public health security in the 21^st century” (2007). Available at: www.who.int/entity/whr/2007/whr07_en.pdf

[5] USDA, “Livestock slaughter 2003 summary.” Available at: http://usda.mannlib.cornell.edu/usda/nass/LiveSlauSu//2000s/2004/LiveSlauSu-05-04-2004.txt; USDA, “Poultry slaughter 2003 annual summary,” (2004). Available at: http://usda.mannlib.cornell.edu/usda/nass/PoulSlauSu//2000s/2004/PoulSlauSu-03-08-2004.txt.

[6] Pearson J, Salman MD, BenJabara K, et al. “Global risks of infectious animal diseases,” Council for Agricultural Science and Technology, Issue Paper No. 28. (2005).

[7] Wuetrich, “Chasing the fickle swine flu.”

[8] Mirabelli MC, Wing S, Marshall SW, Wilcosky TC, “Asthma symptoms among adolescents who attend public schools that are located near confined swine feeding operations,” Pediatrics (2006) 118:e66 –75; Wing S, Wolf S., “Intensive livestock operations, health and quality of life among Eastern North Carolina residents,” Environ Health Perspect. (2000) 108:233–8; Merchant JA, Naleway AL, Svendsen ER, et al., “Asthma and farm exposures in a cohort of rural Iowa children,” Environ Health Perspect. (2005) 113:350–6.

[9] Wuetrich, “Chasing the fickle swine flu.”

[10] Wuetrich, “Chasing the fickle swine flu”; Washington Post, “Little boy at the center of a viral storm”; Pearson J, Salman MD, BenJabara K, et al., “Global risks of infectious animal diseases.”

[11] “Antimicrobial resistance: issues and options,” In: Harrison PF, Lederberg J, eds., “Forum on emerging infections,” Institute of Medicine, (Washington DC: National Academy Press, 1998); “Putting meat on the table: industrial farm animal production in America,” The Pew Charitable Trusts and Johns Hopkins Bloomberg School of Public Health, a report of the Pew Commission on industrial farm animal production (2008).

[12] Wuetrich, “Chasing the fickle swine flu.”

[13] Sencer DJ, Millar JD, “Reflections on the 1976 swine flu vaccination program,” Emerging Infectious Diseases (2006) 12: 29-33.

[14] Associated Press, “Global race is to contain swine flu outbreak,” April 27, 2009. Available at: www.msnbc.msn.com/id/30398682/this strain of A/H1N1 swine flu

[15] American Public Health Association, “Precautionary moratorium on new concentrated animal feed operations,” APHA policy statement number 20037 (2003). Available at: www.apha.org/advocacy/policy/policysearch/default.htm?id_1243

They also make the case for international coordination and investment in health systems around the world: “Contagious disease knows no boundaries, a strong argument for why the United States should help build competent institutions of government in other countries, even during a period of economic turmoil.”

But they also point out that the effective response is in spite of decades of under-investment in our national public health infrastructure. Art Caplan put it like this last fall: “Our public health system is a wheezing, uncoordinated, underfunded eyesore. It needs to be rebuilt to face the challenges that 21^st century living poses to health, ranging from asthma, to diabetes, to the flu. City and county health departments need federal help across the board. Proactive public health is a key element of our national security. The next administration should demand that Congress pay for it.”

Citizens can of course do their part. The CDC’s first recommendation is wash your hands. There are also a host of online resources that will let you learn about and follow the outbreak.

This morning, President Obama addressed the National Academies of Sciences, laying out the imperative for sustained government investment in scientific research. He said his administration would commit more funding to R&D than during the Apollo program (see Update below):

I am here today to set this goal: we will devote more than three percent of our GDP to research and development. We will not just meet, but we will exceed the level achieved at the height of the Space Race, through policies that invest in basic and applied research, create new incentives for private innovation, promote breakthroughs in energy and medicine, and improve education in math and science. This represents the largest commitment to scientific research and innovation in American history.

He also took the opportunity to explain the necessity of such investment in grappling with matters like the current outbreak of swine flu:

But one thing is clear – our capacity to deal with a public health challenge of this sort rests heavily on the work of our scientific and medical community. And this is one more example of why we cannot allow our nation to fall behind.

The renewed commitment to long-term science funding, building on the down payment in the American Recovery and Reinvestment Act, will ensure a healthy economy and populace in the years to come.

Here’s a look at the past three decades of federal R&D support in terms of GDP, as well as the full audio from the President’s remarks:

Here’s the full audio of the speech, as offered by the NAS:

Update: The 3 percent of GDP investment in R&D that Obama touted would include federal and private investment, a point this post originally confused. Here’s an explanation from our former colleague Rick Weiss about the necessary government investment to reach that goal:

Obama pledged to raise the country’s R&D budget to 3% of the national gross domestic product from today’s nearly 2.7% — an increase of roughly $46 billion annually. The government currently picks up about one third of the tab. Assuming that trend continues, public funding would need to increase by about $15 billion annually, says Rick Weiss, a spokesman for the White House Office of Science and Technology Policy.

Image: AP/Gerald Herbert

In an effort to halt the spread of infections, health groups are marking tomorrow, April 25, as the second World Malaria Day. To encourage breakthrough research in public health, the Gates Foundation sponsors a set of $100,000 grants to fund high-risk, high-return pilot studies, some of which focus on on new ways of stopping the parasite which, according to foundation officials, kills someone every 30 seconds.

To highlight some of this research, the foundation hosted a blogger conference call yesterday with three of the grant recipients.

Brian Foy, an assistant professor of Microbiology, Immunology and Pathology, at Colorado State University, used his funding to explore the potential of using endectocides, drugs that combat parasitic worms, to also stop mosquitoes. Malaria takes between 10 and 14 days to develop inside a mosquito before it is transmittable to another person, and that presents a window in which to kill the bugs. Foy tracked mosquitoes in Senegal and found that those that had bitten people taking ivermectin, an endectocide used to combat river blindness, died for up to a week. Thus, the drug has to potential to stop two infections at once.

“If you could just make one of those blood meals toxic to the mosquito, you could kill it before it’s able to transmit the disease,” Foy explained. “These same drugs that people are taking to clear out their worms could also be used to kill these mosquitoes.” His data is preliminary, and dosing would have to be adjusted to ensure that mosquitoes got a fatal portion endectocide but did not develop resistance. Christine Gorman at Global Health Report explains the technique further.

Szabolcs Marka, an assistant professor of experimental astrophysics at Columbia University, took a radically different approach in his preventative experiments. He studied the sensory systems of the mosquito species that are vectors for malaria and designed laser barriers that disrupt the insect’s ability to sense its environment. Flying into the beams, it “experiences a sudden or intense heat wave or light wave that disables it,” Marka explained, which stops it from reaching a human in the first place.

Another major problem is in designing antimalarial drugs that evade resistant strains. Pradipsinh Rathod, a chemistry professor at the University of Washington, looked at elements of the malaria genome that contribute to “hypermutagenesis,” a situation in which an the organism’s DNA mutates at rates so rapid that it dramatically increases the development drug resistance. In a second approach, his team looked at potential compounds that could disrupt the rapid mutation itself, which would provide a way for potential vaccines to remain effective.

Some research indicates that climate change may increase the likelihood of malaria transmission in various parts of the world by making those areas more hospitable to the mosquitoes that carry the parasites. Some of that research is plotted on our Human Toll of Climate Change map.

(Full disclosure: The Gates Foundation has funded grants for education policy work at CAP, but not Science Progress.)

Image: Flicker user bogdog Dan

The simple answer is that vaccine policy in the United States is riddled with inconsistencies that discriminate against those coming into the country.

On September 30, 1996, Congress amended the Immigration and Nationality Act, or INA, by adding the requirement that all immigrants prove receipt of all vaccinations recommended by the Advisory Committee on Immunization Practices.[3] Thus, vaccines that are only recommended to the U.S. population automatically became mandatory for immigrants. Many of the ACIP-recommended vaccines are actually mandated for children entering public schools, but parents can home-school their children if they prefer not to vaccinate. With the exception of girls in Virginia’s public schools, Gardasil is not required for any female in the United States, public school-educated or not. This left many immigration advocates asking why immigrant girls and women should be required to have a vaccine that’s not required of most U.S. citizens.

Should the government mandate those vaccines targeted against diseases that do not pose immediate public health threats?

A 1990 amendment to the INA authorized for the exclusion of immigrants officials felt have “communicable diseases of public health significance.”[4] It is reasonable to infer that this amendment was intended to protect the U.S. population from exposure to serious infectious diseases carried by immigrants entering the country, and that the later vaccination requirements were intended for the same reason. Yet these requirements don’t apply to all who enter the country. Refugees residing in the U.S. are exempt from the vaccination requirements (unless and until they apply for adjustment of status for permanent residence), as are temporary visitors.[5] If the purpose of the law is indeed to protect the U.S. population against infectious diseases, then it would follow that all visitors entering the country must be vaccinated, since any could be a potential carrier of vaccine-preventable contagious diseases.

Another glitch in this policy, if it is designed to protect against broad threats to public health, is that not all vaccine-preventable diseases are actually contagious. The toxin produced by the bacterium Clostridium tetani causes tetanus, and the tetanus vaccine is very effective at protecting against the development of this lethal disease. It is understandable that the vaccine is recommended by the ACIP, yet by default the vaccine is mandatory for all immigrants. However, tetanus is not spread from person to person. Why is this vaccine mandated for immigrants when it doesn’t confer any protection to the population at large, but only to the individual receiving the vaccine?

While HPV is transmissible from person to person, the cervical cancer that can result from HPV infection does not usually manifest until years or even decades after. HPV does not pose an immediate significant threat to the population, unless we decide to define genital ulcers as significant threats. Pharmaceutical companies are researching other vaccines like Gardasil intended to protect against diseases that manifest years or decades after infection. This is in contrast to traditional vaccines targeted against highly contagious diseases spread via the respiratory route, which do pose immediate threats to the population. Should the government mandate those vaccines targeted against diseases that do not pose immediate public health threats?

One could argue that the immigration vaccine policy is an economic protection because the financial burden for the treatment for tetanus, cancers, and other such diseases might be significant; thus it’s better to prevent them to reduce healthcare costs. One could also argue that the vaccines should be administered to immigrants for their own, individual benefit. But again, there is an inconsistency. If these are in fact the reasons behind the vaccine requirement for immigrants, then logically, the vaccines should be mandatory for U.S citizens, too.

Ultimately, the different rules for immigrants are a question of justice. The policy places a burden on immigrants that is not demanded of U.S. citizens. Vaccines are expensive. Gardasil, administered in three doses, costs about $360 for the series.[6] The high cost is a disadvantage to poorer immigrants. A physician may waive the vaccine requirements if there are medical contraindications, such as an allergy to the vaccine. An immigrant may also opt out of vaccines on the basis of religious or moral objections, but he or she must be opposed to vaccinations in all forms.[7] Immigrants are often desperate to enter the United States, and if there is any perception that opposition to vaccination could be used to deny them entry, it is unlikely they will protest such preconditions.

Unlike immigrants, U.S. citizens are allowed to cherry pick what vaccines, if any, they receive. While there is a set of mandatory vaccinations for children entering public school, parents can simply choose home schooling. Many adult vaccines, such as herpes zoster vaccines, are completely optional. If a young U.S. woman opposes the vaccine Gardasil on the grounds that she is not sexually active, she can do so without having to forgo other vaccines. Immigrant females do not have this choice. They must either take all or no vaccinations. This lack of choice leaves them in a precarious and vulnerable situation—in terms of health and cultural discrimination. Immigrants are already vulnerable to stigma due to language barriers, differences in appearance, and cultural practices. Mandatory vaccination of immigrants can compound negative views towards them by implying that they are sexually promiscuous, disease-ridden, and pose significant health risks to Americans.

The immigration vaccine policy should be rooted in sound scientific and public health rationales. As it stands, it is discriminatory and it can compound a sometimes-hostile environment toward immigrants. Moreover, the current inconsistencies of the immigration-related policy could undermine all vaccine-related policies and guidelines. A growing group of U.S. parents are opting out of vaccinating their children because of a lack of trust in the decision-making behind the vaccination guidelines. Misinformation in the media about an unsubstantiated link between vaccines and autism has fueled the anti-vaccine movement, though recent findings and a court ruling last month underscore the fact the opposition rests on little to no evidence.[8] Inconsistencies in vaccine policy for immigrants undermine the entire system. Moreover, continued opposition to vaccination could lead to a resurgence of very serious and immediately threatening diseases that have been largely absent in recent U.S. history, as exemplified by a recent Haemophilus influenzae type B (Hib) meningitis outbreak in Minnesota among five children, three of whose parents had opted not to have them vaccinated.[9] Further discussion of immigrant vaccination policy must involve what constitutes a significant public health threat, what is equitable, and what is reasonable given economic and political constraints. At the very least, however, the policy needs to be fair, effective, and re-evaluated.

Aysha Akhtar, MD, MPH a neurologist and public health specialist and a fellow of the Oxford Centre for Animal Ethics. She can be reached at: aysha.akhtar@oxfordanimalethics.com.

Notes

[1] Markowitz LE, Dunne EF, Saraiya M, Lawson HW, Chesson H, Unger ER, Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices (ACIP), “Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” MMWR Recomm Rep. 2007, 56(RR-2):1-24.

[2] “Merck lobbies for vaccine policy to become law,” Associated Press, January 30, 2007, available  at: http://www.foxnews.com/story/0,2933,248781,00.html (last accessed February 22, 2009).

[3] Mautino KS, “Vaccination requirements for immigrants to the United States,” Journal of Immigrant Health, 1999 (1): 61-63.

[4] Ibid.

[5] Ibid; CDC, “Adjustment of status for U.S permanent residence requirements: technical instructions for vaccination 2008,” available  at: http://www.cdc.gov/Ncidod/dq/civil.htm (last accessed January 12, 2009).

[6] Mary Engle, “Immigrant advocates decry cervical cancer vaccine order,” Los Angeles Times, October 22, 2008, available at: http://articles.latimes.com/2008/oct/22/science/sci-gardasil22 (last accessed January 20, 2009).

[7] U.S. Department of Justice Immigration and Naturalization Service, “Medical examinations, vaccination requirements, waivers of medical grounds of inadmissibility, and Designation of civil surgeons and revocation of such designation” (AD 01-03), October 17, 2002, available at: http://www.immigrationequality.org/uploadedfiles/2002%20HIV%20Immigration%20policy%20memo.pdf (last accessed January 20, 2009).

[8] WebMD, “Vaccine court rejects autism claim,” February 12, 2009, available at: http://www.webmd.com/brain/autism/news/20090212/vaccine-court-rejects-autism-claims (last accessed February 22, 2009).

[9] WebMD, “Hib outbreak kills unvaccinated child,” available at: http://children.webmd.com/vaccines/news/20090123/hib-outbreak-kills-unvaccinated-child (last accessed February 6, 2009).

Last week, the British Sunday Times reported that the original study which sparked a ten-year debate about vaccine safety and autism was based on faulty data. Days later, a special U.S. court ruled that there is little to no evidence linking vaccines to autism. Together, the two events may cool a simmering debate about how to protect young children’s health.

Amid the controversy and polarizing discussion, it’s easy to lose track of why vaccination is so important. Concerns over a link between vaccines and autism have become commonplace among some members of the public and within the media itself. Mainstream outlets typically frame the issue as a raging debate, but the truth is that the science is straightforward and overwhelmingly weighted towards the benefits of vaccination.

The furor of the argument is understandable. When pitting the emotional fears and worries of a parent against the unfeeling rationality of cold, hard science, it is hard to know if the two sides are even speaking the same language. Further, it is difficult to keep track of the criticisms and theories, and to understand the foundation of objections to vaccination protocols. This article will shed light on the discussion, beginning with an overview of how vaccines work, and then focusing on some of the popular criticisms.

How vaccines work

All vaccines do essentially the same thing; they train the immune system to recognize foreign bodies. That way, when a person’s body is exposed to the real thing, it will have specific antibodies that recognize and inactivate the germs before they can infect (this is sometimes referred to as humoral immunity), while a type of white blood cells called memory T cells eliminate any infection that occurs (a process called cellular immunity). Vaccines build specific defenses to a single disease, but sometimes multiple vaccines can be combined into a single dose, as in the case of the MMR (measles, mumps, and rubella) or the DTaP vaccines (diphtheria, tetanus, and pertussis).

There are two principal types of vaccines: killed and live attenuated. Killed vaccines are precisely what you would guess: the virus or bacteria is killed and mixed with chemicals designed to activate the immune system.  The entire germ or unique subunits can be used. Once the vaccine is administered, the immune system is able to pick up these unique identifiers of the pathogen and establish some memory of it. The second strategy is to expose the body to an attenuated infection, or to a related non-pathogenic strain. This has the added benefit of building much stronger immunity, but in some cases there is a risk of actual infection, particularly in patients with weakened immune systems.

Beyond protecting the individual, vaccines are broadly administered in order to establish what is referred to as “herd immunity.” Most infectious diseases require a ready supply of healthy hosts in order to continue spreading. So, if enough people get vaccinated, entire illnesses can go from serious public health threats to occasional isolated incidents. This way the young, the elderly, the sick, and even those who are unsuccessfully vaccinated are protected by the majority. Vaccination rates necessary to establish herd immunity vary by the pathogen, but they can be as high as 95 percent—very little room is left for those who voluntarily choose not to get vaccinated, which is why mandatory vaccinations are widely instituted.

To be clear, there is no such thing as a perfectly safe vaccine. Like any other medical treatment, there are side effects and risks involved. In rare cases, live attenuated vaccines could induce the illness they protect against, which could even be spread to those who are not vaccinated. Most of the known risks are rare and relatively minor—most people are familiar with the redness and swelling following a flu shot—and the benefits of vaccination far outweigh them. There currently exists no evidence that autism is a potential risk factor for vaccination, but a 1998 study speculated that there was a potential link, triggering a small but vocal anti-vaccine movement.

Andrew Wakefield and The Lancet Report

The origins of the controversy linking vaccination and developmental disorders dates to a clinical report published in the British medical journal The Lancet in 1998, although the first mention of the hypothesis dates back at least two years earlier. A group of British gastroenterologists led by Dr. Andrew Wakefield were interested in the association between autism spectrum disorders, or ASD, and colitis, a form of intestinal dysfunction. While this was a clinical report conducted by trained medical professionals, it is important to keep in mind that this was an observational report—no experiments were performed. The authors reported on 12 children (ages three to ten years, predominantly boys) with these symptoms. It was noted that eight of these children had received the live-attenuated MMR vaccine within two weeks of the onset of symptoms. In the discussion section of the paper the authors postulated that because viral encephalitis can give rise to autistic disorders, and that in some cases measles has been associated with some forms of colitis, it could be possible for the vaccine to lead to a full viral infection that was to blame for both the autism and the colitis. The authors emphasized that they were unable to show any causal association, but they did say that further virological studies were underway to resolve the question. No such study demonstrating a link was ever released.

Following the publication, Wakefield, the primary author of the report, held a press conference at which he deemed potential link between MMR and autism dangerous enough to suggest altering the vaccine schedule, despite not having done any research so support his claims. The controversy was widely reported by the media, leading to widespread doubts about the safety of vaccination. British vaccination rates fell from 92 to 79 percent, and in certain urban areas rates fell even lower—well below levels necessary to maintain herd immunity.

In February, 2004, a story by Brian Deer appeared in the Sunday Times which turned the public eye back towards Wakefield. It revealed that not only did Wakefield have a history of attacking the use of the MMR vaccine prior to conducting any relevant research, but he had also obtained £55,000 in research funding from a legal fund representing some of the children in the Lancet study. This funding was specifically intended to investigate the potential link between the vaccine and autism, and several of the participants of the study were actual litigants with a significant interest in revealing such a link. Although the doctors conducting the clinical exams were ignorant of the legal action, no conflicts of interest were reported to the journal. Deer quoted an editor of The Lancet as saying that had the journal known of these conflicts of interest, it would not have published the controversial study.

Six years after the original publication and less than a month following the Sunday Times piece, ten of the twelve authors on the study published a “Retraction of an Interpretation,” and reemphasized that they did not discover any causal links between autism spectrum disorders and vaccines. Wakefield responded by defending the original findings as published, rejecting any impropriety on his behalf, and argued that the vaccine should not be ruled out as a potential cause of ASD.

On February 8 of this year, almost exactly five years after his original Sunday Times story, Brian Deer wrote a follow up to the MMR-Autism study. It revealed that the published Lancet accounts for most of the original 12 children were falsified. The data in the study did not account with the hospital records. Only one of the children’s symptoms began soon after vaccination, and in most cases behavioral symptoms had manifested before the child received any vaccination.

The sum of these reports is that a gastroenterologist with a bias against vaccination recruited a series of autistic children whose parents blamed the vaccine for their condition. He was then paid to research these claims. Without any solid evidence he falsified a weak link, and began using the media to spread dire warnings based on a weakly formulated hypothesis. As a direct result of this, thousands of children have contracted preventable diseases, and a few have even died.

Thimerosal, another source of controversy

Following the Wakefield study, concerns arose that any link between autism and vaccination may be caused by the preservative thimerosal. Notably, thimerosal was not present in the British formulation of the MMR vaccine, and not relevant to the Wakefield hypothesis. Thimerosal is a mercury-containing compound that was long used a preservative for a range of vaccines. Like any preservative, thimerosal served to keep any bacteria or fungi from growing in vaccine preparations. Prior to its introduction, sepsis was a significant risk in vaccinated individuals, particularly from multi-dose vials of vaccine. In one case, prior to the widespread adoption of thimerosal, 12 of 21 children vaccinated from a staphylococci-contaminated vial died in Australia.

Concerns over the potential toxicity of thimerosal—as opposed to the toxic effects of elemental mercury—which are well established—came to the fore in 2001 following the publication of a literature review by Sallie Bernard, et al, in Medical Hypotheses, a journal known for publishing radical ideas. The article did not present any new data, but reviewed existing publications in order to build its argument. The main hypothesis again relied on parental reports of behavioral changes occurring following immunization schedules, including that of Bernard herself. It went further by detailing the similarity of neurological symptoms following mercury poisoning and ASD. Also, in order to accommodate the strong genetic linkage in autism spectrum disorders, the authors postulated that a genetic susceptibility to the effects of mercury in some people could lead to ASD.

In 1999, prior to the publication of the Bernard, et al. paper on thimerosol, the Food and Drug Administration conducted a study to determine whether the metabolites of thimerosal were safe. Allergic reactions were described—redness and swelling at the injection site. They were typically mild and only lasted a few days. In some isolated cases mercury poisoning has been demonstrated with thimerosal, but never in the context of a vaccination; in one case a child’s ears were directly irrigated with thimerosal. Toxic doses were on the order of 1,000 to 10,000 times the concentration of ethylmercury found on a routine vaccination schedule. Additional safety concerns were raised regarding the ability of infants to clear mercury compounds. Blood samples were analyzed from infants receiving routine vaccinations, and they were all found to be within reasonable safety limits

Despite the lack of evidence of toxicity at vaccination levels, as an extra precautionary measure, the FDA, the National Institutes of Health, the Centers for Disease Control, and the Health Resources and Services Administration urged vaccine manufacturers to reduce or eliminate thimerosal from their vaccine preparations. Today, the only vaccines recommended for children containing thimerosal are the inactivated flu vaccine (the shot, not the mist), and some DTaP preparations. Further, following the removal of thimerosal from the vast majority of vaccines, there has been no discernible decrease in the rate of autism—a mixed blessing for defenders of vaccination.

In 2001, the Institute of Medicine convened a board specifically to investigate the hypothesis raised by the Bernard paper. They did not find sufficient evidence to either reject or accept the hypothesis that thimerosal exposure was linked with any neurodevelopmental disorders. In 2004, the board reconvened to take into account the overwhelming new evidence, and rejected the causal relationship between thimerosal and autism. They also emphasized that vaccines were proven prophylactic agents, and that decreased vaccination rates imposed serious risks to public health.

Legal questions

Concerns over thimerosal inevitably left the realm of scientific discussion and public health policy, and entered the legal world. The United States actually has a special court to hear vaccine related injury cases. Following an earlier DPaT vaccine scare in 1988 (unrelated to autism), several lawsuits against vaccine manufacturers forced companies to cease production of DPaT out of fear of litigation. Congress responded by passing the National Childhood Vaccine Injury Act, directing the department of Health and Human Services set up the national Vaccine Injury Compensation Program, or VICP. The program provided an alternative to medical malpractice litigation, created the special vaccine court, and set a lower standard of proof for links to the injury. If a consensus of the board deemed an adverse reaction medically plausible and if it occurred soon after vaccination, then litigants were awarded compensation for medical expenses and pain and suffering. No causative link between the injury and vaccine was necessary, including arguments that directly contradicted scientific evidence. In one extreme case, a litigant successfully argued that a hepatitis B vaccine had caused multiple sclerosis, despite a preponderance of scientific evidence to the contrary

The court rewarded compensation for nearly half of all claims, sending confusing signals regarding the presumed safety of vaccines. Since 2001 more than 5,000 families have filed claims with the court claiming a link between autism and the MMR vaccine. The majority of claims regarding autism were aggregated into a set of proceedings for which hearings did not begin until 2007. One exception was the case of Hannah Poling, a girl who developed autism-like symptoms after receiving a series of vaccines. The child had a rare mitochondrial disorder which predisposed her to similar neurological conditions, but the court awarded her damages despite the lack of evidence that the vaccines in any way exacerbated her condition. Many concerned parents saw this as a confirmation that vaccines do indeed cause autism.

Just last week, the VCID made the first of several rulings for the Omnibus Autism Proceedings. It found that there was no link between vaccination and development of ASD. In a further blow to the litigants, according to one New York Times article, the court declared evidence for the link “weak, contradictory, and unpersuasive,” and that “the petitioners in this litigation have been the victims of bad science conducted to support litigation rather than advance medical and scientific understanding.” Further rulings are still pending regarding the safety of thimerosal and other related claims.

Policy considerations

The science is indisputable: There is no definitive link between autism spectrum disorders and vaccination. It now seems that legal opinion is falling in line with the science, but the greater concern is the need for broader public understanding. No matter what is published in academic journals or decided in specialized courts, in order to rectify public confidence in vaccination, there must be outreach from the scientific community. It is important to ease frustration among concerned parents, as well as to communicate the importance of herd immunity. Scary rumors and whispered implications will always trump the cold hard facts of negative data—but that is only further reason to encourage scientific mindedness. We are living in an age where entire generations of families have grown up without any exposure to many of the diseases we vaccinate against. It is easy to focus on the fear of perceived risks when the known threats of not vaccinating are unfamiliar, and mitigated by the vaccination of others. It is a standard “tragedy of the commons” scenario.

There is no doubt that there exist plausible theories that could account for links to autism, or any other unknown risk factors associated with vaccination. Those hypotheses should not be discarded, but should be researched and explored. As a scientific community, we should not become reactionary and discard viable avenues of research because of potential political fallout. But it should be emphatically and directly stated that hypotheses without firm supporting data, and hypotheses with overwhelming counterfactual data should not trump reasoned public health policy.

The long and short of it is simple. There has been no credible link formed between autism and vaccination. Hypotheses have been generated, questions have been asked, and confusion has dominated. The true risk factor is the lack of effective communication between scientists and the public.

Mike Pazos is a Ph.D. candidate in the Department of Microbiology and the Mount Sinai School of Medicine Graduate School of Biological Sciences.

Confirmed Human Cases of Avian Influenza

More on the state of pandemic preparedness in Rick Weiss’s report this week: “Readying the Global Flu Shot.“

Map: Confirmed Human Cases of Avian Influenza

Explore WHO data on human avian influenza infections in the countries where they have been reported since 2003.

The media have moved on from the avian influenza scare. Editors got bored when, after bird flu first jumped to humans a few years ago, a feared global pandemic did not swallow humanity. But the risk has not diminished. Indeed, scientists agree that it is inevitable that the avian influenza virus will at some point gain the lucky mutation or two that will allow it to spread not just from chickens to people but also quickly and easily from person to person. Such a strain could quickly kill two million Americans and incapacitate tens of millions more, according to government estimates. The global toll would be orders of magnitude higher, wreaking economic and social havoc and perhaps political instability.

A meeting in Washington last week sponsored by the Infectious Diseases Society of America offered a sobering update of what the disease is up to and the level of preparedness here at home and around the world. The facts are scary. But a lot more is known today than in 1918-1919, when the last massive flu pandemic swept around the globe, sickening one-third of all humanity and killing 50 to 100 million people. And it is inspiring to see how much scientific and logistical work is underway to help humanity survive the next pandemic relatively intact.

To speak of humanity being at risk may sound overly dire considering that the so-called H5N1 avian flu is still almost entirely a disease of birds. But the virulent virus is clearly developing an appetite for people. Since 2003, there have been 404 confirmed human cases of avian flu in 15 countries, most of them in Indonesia, Vietnam, and Egypt but with a recent serious uptick in China, which has reported seven cases and four deaths already this year.

Any single case could become the epicenter of a global epidemic in the event of a lucky mutation. And trust me, you don’t want to get infected with this bug. Two out of three people who fall ill from it die. “The potential to kill so many so quickly makes this the number one infectious threat” worldwide, said Keiji Fukuda, coordinator of the World Health Organization’s Global Influenza Program.

The good news is that the global stockpile of antiviral medicines, which will hopefully be at least somewhat effective against pandemic flu, is growing every year. Also growing is the world’s capacity to produce and stockpile large amounts of vaccine, including the 150 million doses that WHO is committed to distributing to low- and middle-income countries if needed.

But let’s not lose perspective on what this “good news” means. We’re talking here about a goal of being able to vaccinate perhaps two percent of the population of these countries—mostly healthcare workers and essential emergency and government personnel. And that is assuming that global distribution goes well. WHO is still considering which countries should serve as storage and distribution hubs, with one consideration being the likelihood that a given government might just grab what’s there for itself in a pinch. “It’s obviously a very political” issue, said Douglas Holtzman of the Bill and Melinda Gates Foundation, which is bankrolling a lot of the nuts–and-bolts planning for a global pandemic response.

Speaking of every man for himself, how are we doing in this country? Until recently Congress has generally been good about keeping the money flowing for federal pandemic preparedness. The nation is on track to accumulate enough vaccine to inoculate every American within 6 months of the first signs of an outbreak, for example. Shortsightedly, however, Senate negotiators last week agreed to remove a crucial $870 million allocation for further preparations to be coordinated by the Biomedical Advanced Research and Development Authority. (A look at what BARDA is up to says a lot about the government’s entirely appropriate worries in anticipation of flu-based “mass casualties.” In addition to speeding the commercialization of emergency medicines and vaccines, for example, there is an effort to mass-produce ventilators for rapid deployment to the countless Americans who would die from pandemic flu without respiratory assistance.) That money needs to be reinserted in conference with the House.

Equally worrisome, pandemic preparedness funding for states and localities—those crucial first responders—has been cut by 25 percent since 2005. It’s crucial that this funding be restored in the 2010 budget, said Jeffrey Levi, a public health policy specialist at George Washington University and executive director of Trust for America’s Health. Levi also worries about the longstanding expectation that private companies will purchase drug stockpiles for their employees. “In a recession this is the first thing to go,” Levi said.

In general, the U.S. preparedness plan needs a thorough freshening up to reflect current scientific and political realities and to highlight unmet priorities. Among them: Hospitals still have virtually no “surge capacity”—the ability to absorb added patients in the event of a pandemic. And only a few states (notably New York and California) have done the tough work of mapping out pandemic rules for hospitals and healthcare workers. Those rules reflect the cold realities of a pandemic, including orders to take older patients off their life-saving ventilators if younger flu victims show up and are deemed to have better odds of long-term survival with the help of that equipment.

Vaccine and drug makers are cranking hard, and should be applauded for their commitments to help prepare the nation for a pandemic. But check out what is behind them: Big federal grants for research and development, and government commitments to pay for about half the cost of new production facilities, which the companies can use to make other profitable pharmaceuticals during non-emergency years.

In short, no entity other than the federal government is going to make sure we are prepared for a pandemic (or bioterror or dirty bomb attacks, requiring similar preparations). There is no better example of your tax dollars at work. So if the sheer embarrassment of recent nomination withdrawals isn’t incentive enough, think about all that is being done on your behalf as you consider cutting corners on your Form 1040 this year.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

The organizers of National Handwashing Awareness Week, which runs through Saturday, want you to know that washing your hands with soap and warm water, or using an alcohol-based hand sanitizer, is the best way to stop the spread of germs. In fact, the Centers for Disease Control and Prevention cite handwashing as the “single most effective way to prevent the transmission of disease.”

Dr. William Sawyer’s Henry the Hand Foundation is the driving force behind the public awareness week, which began in 1999 in response to a flu vaccine shortage in Cincinnati, Ohio. “Spread the word, not the germs,” is a favorite catchphrase for the campaign that encourages everyone to follow the CDC recommendations for handwashing the right way.

But routine handwashing isn’t just about staying healthy through the winter. It’s also about improving public health for everyone, and getting better value out of health care.

The effects of poor hygiene in the medical system can be costly. As Rick Weiss noted recently, each time a health care professional fails to wash his or her hands, it costs a hospital $1.98. That may not sound like much, but, according to Duke University researchers, over the course of a year, it can add up to $1.77 million at a typical 200-bed hospital.

Handwashing can also help prevent the spread of infection, both in hospitals and at home. Remember the recent MRSA outbreaks? The methicillin-resistant Staphylococcus Aureus bacteria spreads largely through poor handwashing habits in hospitals and the community. What’s more, CDC estimates that between 78,000 and 90,000 people die from hospital-acquired illnesses each year, many of them directly linked to poor handwashing.

So this week—and this year—make an effort to wash your hands for 15 to 20 seconds with soap and running water, and dry them with a paper towel before and after eating, after using the toilet, during food preparation, when you arrive home, after leaving the hospital or doctor’s office, or any other time your hands seem dirty. Or reach for an alcohol-based hand sanitizer, which will also do the trick.

Image: flickr.com/kokopinto

The number of African Americans infected with HIV now exceeds the number of HIV-positive people in 7 of the 15 countries targeted by the President’s Emergency Plan for AIDS Relief, or PEPFAR.

The United States has increased its PEPFAR commitment for international HIV/AIDS prevention and treatment by $48 billion over the next five years.

The Centers for Disease Control and Prevention would need $4.8 billion over the next five years to reduce the annual number of new HIV infections in the United States.

Only 4 percent of the current share of HIV/AIDS domestic funding is devoted to prevention programs.

They go on to provide recommendations for the next administration to develop a National AIDS Strategy.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

“Personalized medicine” is the hot new buzz phrase in medicine. Why settle for diagnostic tests or therapies that were designed for the average patient, the thinking goes, when doctors can use new technology to pinpoint the specific details of your bodily biology and tailor tests and treatments to your exact medical situation?

The idea has potential and may gradually catch on as gene tests and other new technologies become more accurate and affordable. But a candid new report from the Department of Health and Human Services balances those lofty promises with a tally of the daunting challenges that scientists, doctors, patients, and insurers will face as the American healthcare behemoth tries to make the leap to the personalized medicine paradigm.

The issue is gaining importance because healthcare reform is high on the agendas of both Congress and the new president in the coming year. Proponents of personalized medicine want to make sure that whatever reforms are instituted do not undercut progress toward a more personalized future. At the same time, one can’t help but conclude, on the basis of the HHS report, that it is going to be an uphill battle to justify some of the upfront costs of the personalized medicine revolution, given the many technical, political, and educational hurdles that stand between where we are and where we want to get.

Some kind of reform is clearly needed. As HHS Secretary Michael O. Leavitt notes in his introduction to the 299-page report (a follow-up to one published a year ago), U.S. healthcare expenditures amounted to just 4 percent of the nation’s gross domestic product when he was born in 1951 but are now 16 percent of GDP and are projected to hit 20 percent by 2016—a trend he calls “not sustainable.” All told, today’s health expenditures of about $2 trillion are expected to double within less than a decade.

The core of the problem, as described in the report, is that Medicare—by far the nation’s largest healthcare payer and the standard-bearer that other insurers use as a model—bases its payouts on volume rather than on value.

Under this system, there is a positive economic incentive to deliver more care rather than better care since Medicare makes payments made irrespective of quality. Indeed, there is little or no incentive to make a proper diagnosis or choose the best treatment the first time around.

Among the many efficiencies that could be brought to this system, one shines brightest among proponents of personalized medicine: customize treatments based on individuals’ particular situations and especially on the basis of their genetic makeup. By one estimate, simply customizing the doses people get of the blood-thinning drug warfarin could save as much as $1 billion a year. The medicine is one of the most heavily prescribed in the country and can cause serious side effects if not calibrated precisely to a patient’s needs.

But there are a number of difficult hurdles to clear before we can realize that dream.

First, we must create a universally usable electronic health records system capable of managing, in a standardized way, the new kinds of genetic information that will be at the core of personalized medicine.

“At a time when information technology has transformed most other sectors, with particular benefit to the consumer, the health care sector, with its paper files, often inaccessible records, and incomplete patient data, stands out as primitive indeed,” Leavitt laments in the HHS report.

There is, at least, progress on this count. The department proposed standards for embedding genetic data and other family history information into electronic health records in 2008 and is in line to finalize those guidelines in 2009. HHS also set a national goal of getting most Americans switched over to electronic health records within five years, an ambitious if probably unrealistic aim.

But we will need a lot more than electronic records. By one account in the HHS report, patients (who are known in the lingo of personalized medicine as “consumers,” a worrisome shift in nomenclature I will address in a moment) will have to take on more of the job of keeping those records accurate and up to date with the help of “new consumer-friendly tools.”

For the most part we still don’t know when, if ever, medical professionals will understand enough of this information in a way that can really have a positive impact on people’s health or the national health care budget.

Take, for example, the time you generally spend at the beginning of a doctor visit, describing how you’re doing and giving the clues that a trained physician might recognize as medically important. That conversation “unnecessarily consumes precious time from providers,” according to a chapter in the HHS report contributed by Geisinger Health Systems. The solution? Spell out your woes to a touch-screen computer before the doctor comes into the exam room.

As it turns out, this is just one of several ways in which personalized medicine will demand a new (and rather impersonal) level of personal responsibility when it comes to health care. In fact, the hidden bomb in the word “personalized” in this new medical context is that it is going to be very much up to the “person”—that “consumer” we were talking about a moment ago—to decide how to deal with all the incoming information, including how to understand what it means and how to balance it against the economic realities of limited health coverage.

As the group FasterCures notes in the HHS report, a major hurdle for personalized medicine “is a lack of ‘genetic literacy’ among members of the general public. Informed patients are critical to patient-centered care, but as personalized medicine techniques become more sophisticated and information more complex, caregivers will face steeper challenges in communicating effectively with patients of all education levels and backgrounds.”

This education process will get even more dicey as doctors and other caregivers try to convince patents—er, consumers—to upload their personal medical information to giant databases in order to help researchers figure out what all these genetic signals really mean. “Discovery will come more rapidly if large amounts of clinical information are made available to researchers,” the report says. “The largest source of such information is ourselves,” it goes on, noting that this is one of the great advantages of getting people’s information into uniform “interoperable electronic health records”: It’s easier to suck personal data up into a data-crunching combine to speed discovery.

I did find one clause buried in those 299 pages acknowledging that “many issues, including privacy protection,” still need to be addressed.

No kidding.

Patient-consumers (or perhaps impatient consumers, waiting for that automated touch-screen to ask them where it hurts) are not the only ones who may find it difficult to adjust to the brave new world of personalized medicine. There are questions about whether pharmaceutical companies will find any economic incentive to develop medicines that are useful for only small, genetically specialized portions of the population. And then there is the looming question of how many of the countless genetic tests now under development are really going to prove themselves to be valuable at all.

As noted at a Personalized Healthcare Summit held in October, “Genetic and genomic knowledge relating to clinical outcome is missing – does value exist when these markers are used in a real clinical setting? The data don’t exist yet to guide physician action.”

In other words, for the most part we still don’t know when, if ever, medical professionals will understand enough of this information in a way that can really have a positive impact on people’s health or the national healthcare budget.

It doesn’t help that the Food and Drug Administration has opted not to regulate most gene tests, citing a shortage of resources; that HHS has so far resisted calls to create a proficiency testing program that would help ensure that test results are accurate and meaningful; or that the Medicare program for the most part does not reimburse for tests considered “predictive,” which pretty much blows the incentive to create these kinds of tests in the first place.

Health officials can say all they want to convince us “consumers” that it is empowering to take the reins of our own healthcare, but the truth is most people feel totally overwhelmed as it is and will be feeling even more so as health technology advances further. No wonder the HHS report acknowledges that the public may not be ready for personalized medicine.

“Patient education will play a prominent role in the acceptance of personalized healthcare, given that patients will need to become more involved in managing their own health portfolios….”

There’s a lot of work to be done by those designing this revolution before I’ll be waving a red flag at the barricades.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

Weiss’s Notebook

CAP Senior Fellow Rick Weiss covered science and medicine for The Washington Post for 15 years, and now he brings his investigative eye to science policy. From cloning and stem cells to agricultural biotechnology and nanotechnology, Weiss examines the issues at the intersection of cutting edge research and public policy.

Cleanliness is next to Godliness, it’s been said. And Godliness, like a Visa card, is arguably priceless. But that doesn’t mean you can’t put a price on cleanliness. And now someone has: $1.98.

That’s how much it costs a hospital every time a health care professional fails to wash his or her hands, according to a study released last week.

A doctor fails to wash her hands after examining a patient, spreading a few germs that could seed a new infection and perhaps necessitate a round of tests and antibiotics. Kaching! Ring up, on average, $1.98.

A nurse forgets to wash up after taking a patient’s blood pressure, then moves on to the next room. Kaching! Another $1.98.

An aide removes Patient A’s food tray and delivers a fresh one to Patient B without the benefit of a handwashing intermezzo. Kaching!

Two bucks may not seem like a lot of money, but it adds up fast when you consider the thousands of interactions that can occur in a hospital every day. To be precise, it adds up to a whopping $1.77 million a year at a typical 200-bed hospital, Duke University Medical School researchers reported at the Interscience Conference on Antimicrobial Agents and Chemotherapy, held in Washington.

Indeed, as we prepare to welcome a new administration, handwashing, I would argue, is the metaphor of the day.

The key to stemming this health care expense is simple and uncontroversial. Handwashing is highly effective. It takes less than half a minute. And one can hardly turn around in a hospital without bumping into a sink or a hand sanitizer dispenser. Yet even highly trained professionals either forget or semiconsciously cut corners with some regularity. And so do we non-medical personnel as we go about our days holding handrails and subway straps in this season of sniffles.

All of which raises the question: Why aren’t all of us—doctors and nurses especially, but all of us really—more diligent about washing our hands? Or more to the point: What would it take to make handwashing a higher priority?

As it turns out, a large number of studies have addressed that simple question, and the answers have relevance far beyond the sink. Indeed, without a stretch, they get to the very heart of human nature and, in doing so, they say something important about smart governance and policymaking on a larger scale—something worth considering as the country closes the door on an era of regulatory slumber and unencumbered greed and considers anew how to get people and institutions to behave in more socially responsible ways.

Indeed, as we prepare to welcome a new administration, handwashing, I would argue, is the metaphor of the day.

To start, let’s consider last year’s survey sponsored by the American Society for Microbiology and the Soap and Detergent Association—one in which the famed polling company Harris Interactive won the questionably attractive contract to go undercover in restrooms and observe, firsthand, what 6,076 adults actually did. It found that while 92 percent of adults claim they always wash their hands after using a public restroom, only three-quarters truly do. Other studies have found considerably lower rates, in the 40 to 50 percent range.

So the first challenge is getting people to face the problem squarely.

Here’s one way: In a 2002 study, researchers clandestinely observed whether doctors washed their hands after having direct contact with patients and confronted those who didn’t. Each offending doctor was then enrolled in an “importance-of-handwashing” educational program. When asked in followup interviews which part of the educational program was, in the doctor’s opinion, most effective in getting him or her to recommit to regular handwashing, it turned out that no part of the program had made as big an impression as the mere act of getting busted in the first place.

In short, every doctor already knew that handwashing is important. But, well, laxness happens (or “hand washing apathy,” as a 2002 research report called it). And there is nothing like enforcement—and the shame that comes with being made an enforcee— to revitalize one’s commitment to doing the right thing.

Fortunately, there are similarly effective ways of getting people to change their handwashing habits that do not involve being pulled over, cited and sentenced to a remedial hygiene class. All of us, it turns out, have the power to bring handwash scofflaws to the sink. In one study of women using a public restroom, only 11 of 28 washed their hands when they thought no one was there to see them, but 24 of 31 did so when a another woman was plainly in the room. In other words, the simple knowledge that one is perhaps being watched can cause significant changes in behavior—a truth familiar to anyone who has considered quietly reaching for the cookie jar, whether in the kitchen or on Wall Street.

A second study compared handwashing rates among women using the restroom in a bar, under two kinds of situations: when another woman was present and made eye contact and initiated a conversation, and when another woman was present but talked on a cell phone the whole time and did not make eye contact. The results were robust: Women in the first situation were twice as likely to wash their hands compared to their counterparts who thought they were being ignored, 56 percent to 27 percent.

This is not to say that handwashing or any other single behavior can singlehandedly (as it were) eliminate hospital-acquired infections, which affect up to 2 million Americans each year and kill an estimated 100,000. And some parts of the solution may come from other, unexpected places.

A 2004 study at a teaching hospital in New York, for example, found that about half of all neckties worn by doctors harbored disease-causing bacteria—a prevalence five times greater than for ties worn by other hospital staffers who had no contact with patients. No one knows if neckties really contribute to the spread of disease inside hospitals, but statistics like those led the British Medical Association in 2006 to recommend that doctors “refrain from wearing functionless pieces of clothing, such as ties” (and has helped launch renewed interest in bowties, which give doctors the professional look they want without flopping from one germy patient to the next).

Financial incentives can obviously help, too. In October, the federal Medicaid and Medicare programs announced they would no longer reimburse hospitals for the treatment of infections caused by those hospitals. No more sugar daddy picking up that $1.77 million tab.

All told, however, the lesson for anyone trying to encourage best practices, whether they are hospital administrators or government regulators, is that at least as important as making smart policy changes—fixing the “neckties” in the system—is creating a system that is truly transparent and that includes a real threat of enforcement, something there has been precious little of during the Bush administration.

A few plain-clothed observers could go a long way toward cleaning up the worlds of government and finance. No doctor, no mortgage derivatives trader, no recipient of a big defense department contract wants to be seen doing the perp walk to handwashing class.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

The program, which has been planned for a year and is called Grand Challenges Explorations, aims to operate more along the lines of Silicon Valley’s investment approach, in which venture capitalists provide relatively small amounts of capital to a large number of ideas in the hope that just a few will succeed and become the next Microsoft or Google.

This is also an instance of a major foundation endorsing the “high-risk, high-return” approach which understands both that the road to scientific breakthroughs winds past some unmitigated failures, and that pursuing ultimately unsuccessful projects is perfectly healthy when there are multiple paths to a solution. The Howard Hughes Medical Institute sent 56 researchers down this track earlier this year.

The Explorations proposals funded in this first round include researching “living antibiotics” that will send predator microbes to destroy harmful infections, employing mosquitoes as “flying syringes” to distribute vaccines, and investigating genetic resistance to HIV and tuberculosis.

The Gates Foundation press release describing the project is here.

flickr.com/morganmorgan

In a surprising move last week, the Environmental Protection Agency sided with science, environmentalists, and America’s children. It has been 30 years since the United States saw a reduction in lead emissions standards, but on October 15, EPA reduced the limits from 1.5 micrograms per cubic meter to 0.15. The move will force smelters, metal mines, and waste incinerators to reduce their emissions of the toxic metal. Since 1990, over 6,000 studies have confirmed the dangerous effects of lead, especially on children, as it lowers their IQ and damages learning and memory abilities. In adults, lead can cause brain, kidney, and cardiovascular damage.

The move garnered praise from bloggers at The Pump Handle and Switchboard, usual critics of the Bush administration’s environmental policy. But even with the new limits, the number of emissions monitoring stations has dropped from 800 in 1980 to around 130 stations currently, according to both blogs. The EPA plans to add or relocate 236 monitoring sites to meet requirements, still less than half of the previous number. Additionally, polluters will not need to comply with the new .15 μg/cubic meter standards until 2017. Gina Solomon at Switchboard writes: “That’s too late! We’ve already waited 30 years for this new lead standard, and it’s crazy to wait almost 10 more years for it to come into effect.”

But the history of lead in human civilization goes back even further. There have been several phases in the regulation of lead-based paint and leaded gasoline, taking nearly a century for public policy to catch up with scientific warnings. David Michaels, in his book, Doubt is Their Product: How Industry’s Assault on Science Threatens Your Health, describes the history of the battle between the paint and gas industry’s PR machines and public health advocates and environmentalists. Here’s a timeline of what’s happened in the United States over the past 100 years:

1900s: Lead was regarded as a highly toxic chemical, with lead-based paint regarded as the most identifiable hazard. If a child ate paint chips, people recognized it could cause seizure, coma, and death. If it didn’t traumatically harm the child, he or she may have learning and behavioral disabilities.

1922: Lead was first introduce into gasoline, immediately drawing headlines concerning public health. The form of lead in gasoline was known as tetraethyl lead and it raised the octane level of gasoline, resulting in “premium” gas for high-performance engines.

1924: Five workers at a New Jersey plant died, with four of them going “insane” before their death. The New York Times (subscription) covered the story, and New York City, Philadelphia, and other jurisdictions banned the sale of leaded gasoline.

1930s: The industries rejected scientific evidence, claiming there was no proof of causation and tried to blame the children and families as being irresponsible for allowing children to eat the paint chips, claiming that they were “sub-normal to start with.”

1965: A geochemist named Clair Patterson in Greenland brought the airborne lead issue into American consciousness. Until then, industry experts claimed only workers were at risk for lead poisoning, and that because lead has always been naturally in the air, it must be safe. Using ice core samples, Patterson found that higher levels of lead existed in recent samples than older ice. He further concluded that the amount of lead Americans had in their blood was 100 times greater than natural levels.

1970: Nixon signed the Clean Air Act of 1970 into law on December 31st, and the Environmental Protection Agency, formed on December 2, had a task worth attacking. “Year of the Environment came to an end on an extremely upbeat note with the signing of a major piece of environmental legislation. The Clean Air Act (CAA) of 1970 was the perfect bookend to balance the National Environmental Policy Act the President had signed with such a flourish on New Year’s Day,” states the EPA. Along with lead, the EPA was required to lower emissions of hydrocarbons, carbon monoxide, and nitrogen oxides by 90 percent in only a few years.

1971: President Richard Nixon signed the Lead-Based Paint Poisoning Prevention Act, which restricted the lead content in paint used in housing built with federal dollars and provided funds for states to reduce the amount of lead in paint. Subsequent legislation created the Consumer Product Safety Commission, which effectively banned leaded paint in 1976.

1984: The U.S. Senate considered banning the use of lead in gasoline, with Vernon Houk, director of the Centers for Disease Control and Prevention’s Center for Environmental Heath, reporting that “if no lead had been allowed in gasoline since 1977, there would have been approximately 80 percent fewer children identified with lead toxicity.”

1985: The EPA discussed a total ban on leaded gasoline by 1988.

1990: In amendments to the Clean Air Act, lead was banned from gasoline. The measures would take effect in 1995, giving gasoline companies five more years to completely phase out lead.

2002: According to a study, levels of lead found in human blood were reduced more than 80 percent from 1976 to 1999 in American children one to five years old, and these children had IQs that were, on average, 2.2-4.7 points higher than comparable groups in the 1970s. In terms of economic impact, the authors estimate that each IQ point raises worker productivity 1.76-2.38 percent. The estimated economic benefit for each year’s newborns ranges from $110 billion to $319 billion.

2008: EPA tightens air emission rules for lead, requiring industries to reduce levels to .15 μg/cubic meter. The new standard is 10 times greater than previous requirements set 30 years ago.

2013: States are required to submit state implementation plans outlining how they will reduce pollution to meet the standards no later than June.

2017: States are required to meet the new standards no later than January.

It’s been about a year since MRSA, or drug-resistant staph, last made major headlines, scaring officials from Virginia to Connecticut to Maryland to disinfect schools. After the Centers for Disease Control released a report last fall indicating that MRSA was responsible for more than 94,000 life-threatening infections and 19,000 deaths in 2005, drug-resistant staph infections sparked a national discussion about the overuse of antibiotics. But the news this October is about a form of Streptococcus pneumoniae, or pneumococcus, that is causing meningitis, pneumonia, and bloodstream infections, according to a report in The New York Times. Rather than resisting antibiotics, the organisms in this case may have outmaneuvered a proven vaccine.

Known as Serotype 19A, this strep bacteria is infecting more children and elderly people despite the longtime use of a Prevnar, a vaccine which immunizes children against all kinds of pneumococcus. Prevnar, has been around since 2000, but since 2002, rates of infection from Serotype 19A have risen from about 2 per 100,000 children to more than 10 per 100,000. A fourfold increase in life-threatening infections has also occurred among the elderly. Prevnar has been mostly successful in preventing infection from many of the 91 forms of pneumococcus, but now that it has eliminated much of microbial competition, 19A can grow and become a greater threat to humans. Prevnar may have prevented many of the pneumococcus infections in American children in 2000, but the drug is out-dated and doesn’t protect against other forms of pneumococcus.

But the NYT reports that experts say it is hard to know what role the introduction of Prevnar may have played in the rise of the bacteria, which was gaining momentum in some countries before the vaccine’s adoption.

Drug-resistant bacteria arise from strains that have survived through natural selection with traits rendering them unaffected by antibiotics. Of the 91 strains of pneumococcus, most are not dangerous. But pneumococci live in the nose and throat, constantly exchanging genetic material and forming new strains of bacteria. Finding vaccines and antibiotics to eliminate them is very difficult for drug companies.

Tuesday

Climate Change Legislation and Revenue Recycling
Environmental and Energy Study Institute
B369 Rayburn House Office Building
8 a.m.

Electric Vehicle Development/Outlook
Senate Energy and Natural Resources Committee
366 Dirksen Senate Office Building
10 a.m.

Domestic HIV Prevention
House Oversight and Government Reform Committee
2154 Rayburn House Office Building
10 a.m.

EPA Children’s Health Protection
Senate Environment and Public Works Committee
406 Dirksen Senate Office Building
10 a.m.

Why Broadband Matters
Senate Commerce, Science and Transportation Committee
253 Russell Senate Office Building
10:30 a.m.

Cybersecurity Recommendations for the Next Administration
House Homeland Security Committee; Emerging Threats, Cybersecurity, and Science and Technology Subcommittee
311 Cannon House Office Building
2 p.m.

CISTP Seminar Series on Science, Technology, and Innovation
The George Washington University, Center for International Science and Technology Policy
The Commons, 1957 E Street, NW, Suite 403, Washington, DC 20052
5 p.m.

Wednesday

Exporting Electronic Waste
House Foreign Affairs Committee
2172 Rayburn House Office Building
2 p.m.

Thursday

Antibiotics: Is a strong offense the best defense?
Koshland Science Museum
500 5th St NW, Washington, DC
6:30 p.m.

Preventing Climate Change
House Ways and Means Committee
1100 Longworth House Office Building
10:30 a.m.

EPA Scientific Integrity
House Energy and Commerce Committee
2322 Rayburn House Office Building
10 a.m.

Social Sciences’ Public Health Role
House Science and Technology Committee
2318 Rayburn House Office Building
10 a.m.

Emerging U.S. Water Contaminants
House Transportation and Infrastructure Committee
2167 Rayburn House Office Building
2 p.m.

Panel Discussion on Role of Science in Presidential Policy
Featuring Science Progress Editor-in-Chief Jonathan Moreno and Contributing Editor Chris Mooney
University of Mississippi
Live Web cast
4 p.m.

Rep. Dennis Cardoza (D-CA), Chairman of the House Agriculture Subcommittee on Horticulture and Organic Agriculture, called the Salmonella St. Paul outbreak the next saga of “outbreak roulette,” and asked “which industry will be next?” Rep. Diana DeGette (D-CO), sponsor of the TRACE Act, H.R. 3485, which would strengthen the food industry’s traceability system, did not hesitate to call the FDA and CDC out on their faults. She called the food safety system “agonizingly slow.” In her opening statement, she asked, “Why is it that the FDA has jurisdiction over cheese pizzas, but the CDC has jurisdiction over pepperoni pizzas?”

Yesterday Dr. David Acheson, assistant commissioner for food protection at the FDA, shocked the audience by admitting that only three FDA investigators were currently in Mexico, and that none were stationed there permanently to check the food supply that enters the United States. But he was able to escape the most severe questioning by breaking the news that the FDA had only hours before discovered Salmonella St. Paul in the groundwater of a farm in Mexico that produced serrano peppers.

That did not save Bill Hubbard, former senior associate commissioner for policy, planning and legislation at the FDA, this morning, as he testified in front of the House Energy and Commerce Committee. Hubbard was quick to discuss the flaws in his agency. He said that reduced funding has led to a reduced staff and a reduced ability to perform the agency’s essential duties. He also noted that while the Bioterrorism Act of 2002 requires that food industries be able to trace their food supply back one step and forward one step, the FDA receives only partial reports, if any, from many food producers.

DeGette came to his rescue by supporting his claim that not all of the FDA’s problems are their fault. The FDA had pushed for additions to the Bioterrorism Act that would have included electronic food tracing records, the identification of each box of tomatoes with individual farm lot numbers, and a consistent recording format, all of which were denied.

Ed Beckman of the California Tomato Cooperative argued today that his company could successfully trace back their tomatoes “in 35 minutes.” Parker Booth of Delta Prepack Company even brought physical evidence of how his company maintains efficient and reliable traceability. He held up a cardboard tomato box which had, printed on the side, the individual farm lot number that the tomatoes came from, along with other state identification codes. This code, provided by a commercial system called HarvestMark, labels all of his company’s tomato boxes, and costs about a penny per box. It could be a good idea to implement on a federal level.

flick.com/SuperFantastic

An estimated 20.8 percent of all adults (45.3 million people) smoke cigarettes in the United States.

With the support of cigarette manufacturer Phillip Morris USA, the House voted Wednesday to approve legislation that would give the Food and Drug Administration the power to regulate tobacco. According to The New York Times, the bill would give the FDA the authority to stipulate nicotine levels allowed in cigarettes sold to consumers, and the agency could mandate a nonaddictive threshold for the chemical.

Writing about the legislation in March, Michael Stebbins noted that without the ability to ban nicotine outright, the FDA would not have sufficient power:

A superficial glance at the bill reveals that it fails the logic test by requiring an agency charged with protecting the health of Americans with regulating a deadly product without the authority to ban it outright. But the alternative, of leaving Big Tobacco to freely manipulate their product to keep me and the rest of my stinky-fingered brethren addicted, is unacceptable.

Stebbins notes as well that “In the United States, cigarette smoking is responsible for about one in five deaths annually, or about 438,000 deaths per year; on average, these people die 13 years younger than non-smokers.” Moreover, “Annually, cigarette smoking costs more than $167 billion, based on lost productivity ($92 billion) and health care expenditures ($75.5 billion).” “Cigarettes,” he points out, “are unregulated drug delivery systems.”

With the ability to regulate tobacco, FDA could better protect the health of Americans and prevent young people from becoming early smokers. But if the lessons from past battles with the tobacco industry are any lesson, there may be fights on the horizon to defend the science that will put teeth in FDA’s authority. As David Michaels, author of Doubt Is Their Product, noted in an interview earlier this year, there are many industry tricks of the trade that “turn positive studies into negative ones or take one positive study and do a literature review which buries the positive study in what is essentially a whole mass of garbage so it looks like there is nothing there.” Let’s hope that legal arguments over the precise levels levels of nicotine allowed in cigarettes do not obscure the fact that the product kills.

Effect Measure wonders if the unpublished CDC study reporting that up to 50 percent more Americans have HIV than we thought was just another victim of the administration’s suppression.

Michael Stebbins posted on Scientists and Engineers for America’s blog about the new, searchable OTA archive and included a video of Rush Holt talking about why OTA was awesome.

JR Minkel on Scientific American comments on a study (which is hotly contested by the IMF) that finds a correlation between IMF loans and tuberculosis deaths.

Bioethics.net’s Summer Johnson draws our attention to a particularly undesirable effect of high gas prices: cuts in home health services.

Curtis Brainard at CJR provides a very thorough analysis of the renewed interest in GM crops and their potential to solve the food crisis.

Kaid Benfield at NRDC’s Switchboard chides the environmental movement for failing to be more vocal about obesity and its environmental causes, and later in the week posts about how Google Maps can now help.

This was the main message at a Capitol Hill briefing on global health and climate change yesterday hosted by the Select Committee for Energy Independence and Global Warming and the Congressional Global Health Caucus. Panelists included Michael St. Louis from the Centers for Disease Control, Paul Epstein from the Center for Health and the Global Environment at Harvard Medical School, and Pablo Suarez, a researcher on climate change and disasters for Oxfam America and Red Cross/Red Crescent Climate Centre. They spoke about severe weather events that are already changing the quality of life for many in sub-Saharan Africa and southeast Asia and emphasized that competition for land and water, and ensuing intertribal and international conflict, will only intensify in coming years due to an increasing world population and the mounting effects of global warming.

The panelists emphasized the need for adaptation policies to deal with these effects. Suarez provided an example of a village he has visited that, after several larger-than-normal floods, has switched from chickens to ducks as their main source of food, but many more adaptations are necessary to protect human health. Even if humans could stop emitting greenhouse gases today, we would continue to feel the effects of climate change for many years to come. To accompany the ambitious policies that are undoubtedly required to slow global warming, we also need to address the very real public health concerns that, according to Suarez, are already on the rise.

But the briefing was disappointingly incomplete in one major area, as it failed to address to health impacts that Americans will feel due to climate change. Epstein has been writing about the hazardous effect climate change will have on Americans’ health for years, but neglected to bring that to the conversation. Moreover, the Environmental Protection Agency released a report last week detailing the impacts climate change will have on the health of Americans, even as the agency announced it will continue to respond with inaction. Any movement on the issue will have to come from Congress, but without evidence that the health effects will reach industrialized nations, legislators and the public will feel little urgency.

When asked point blank about vulnerabilities in the United States, the most compelling example the panel offered is the increased number of asthma cases in inner city youth. However, the CDC Policy on Climate Change and Public Health offers up plenty of health concerns that are more severe and widespread, including vector-, food-, and water-borne diseases, as well as drowning and loss of property due to extreme weather events. A recent analysis even estimates that as a result of dehydration caused by warmer temperatures in the United States, there could be 2.25 million additional kidney stone cases each year, which would weigh down the health care industry with as much as $1.3 billion in additional annual treatment costs by 2050.

If activists want to change policy, these are the sorts of effects they need to hammer. Historically, the plight of sub-Saharan Africans or inner-city youth has not inspired the same fervent action as threats to the American way of life.

Moderator Edward Cameron of the World Bank was right to express his excitement that a focus on health can open up a new and influential avenue of discussion about climate change, just as the Stern Report did. For that focus to be effective though, it needs to be tailored to the audience.

According to the research, 90 percent of the African population express two copies of a mutation in DARC called DARC-negative. This mutation effectively removes the Duffy antigen from the surface of red blood cells, where it would normally bind to chemokines, small molecules that contribute to the immune response. Antigens like Duffy are large molecules that help generate antibodies and increase the response of the immune system.

However, the new study suggests that the mutated Duffy antigen that is so common in the African population actually helps the HIV virus attach to red blood cells, and more efficiently infect T cells. T cells are like the police chiefs of the immune system—they activate other cells and tell them to destroy various biological threats, such as cells that have been infected by viruses. Once T cells get infected by HIV, the body’s ability to destroy other cells infected by the virus is severely compromised.

But the DARC mutation is not completely devastating for those at risk of contracting HIV. The study indicates that “DARC-negative… is associated with slower disease progression.” In other words, HIV spreads slower when the body’s immune system is already slightly compromised by the mutation in DARC. So while individuals who are DARC negative are at a greater risk for contracting HIV, the same mutation may also slow the progression of the disease.

This research news comes just after the House and Senate passed bills allocating $50 billion for the global fight against AIDS and other diseases and lifting a travel ban for HIV-positive people that has been in place since 1987. However, this latest work on the mutation suggests that policymakers should also increase their commitment to funding HIV/AIDS research, especially because of further discouragement within the community about the possibilities for the development of a vaccine.

Life expectancy has grown by leaps and bounds in the past century. And to be sure, that success story has been written not by exotic anti-aging creams or wrinkle removers but by hard-won victories over infectious diseases, primarily through public health advances and antibiotics. A century ago, only about 40 percent of babies born in countries where births and deaths were reliably counted could be expected to live past the age of 65. Today, almost 90 percent do so. That’s one reason why in the United States alone, the number of people older than 85 is projected to quadruple by 2050, to 18 million from today’s 4 million.

But how do we keep that progress going in developed countries, now that infectious diseases have largely been tamed? The current approach to extending life, which has garnered some modest success in the past decade or so, has been to focus on curing those chronic diseases of aging that have become the modern era’s major killers, such as heart disease, stroke, cancer, diabetes, and Alzheimer’s disease.

Yet most of these diseases have proven remarkably resistant to treatment. More important, a number of research models have concluded that even if scientists were to score a complete home run by finding a “cure” for any single chronic disease such as cancer or stroke, life spans in developing countries would hardly grow longer. That’s because the other chronic diseases of old age are right there, waiting to kill us anyway at about the same age. You’d have to find cures for virtually all of them, these models suggest, to make any real progress at this point.

That’s where the anti-aging approach comes in. As it turns out, scientists studying the aging process in a wide variety of organisms—from worms to flies to fish to monkeys and people—have been finding that certain genes common to virtually all kinds of life play key roles in the metabolic and genetic processes that together underlie most diseases of aging. Some of these genes are important for repairing DNA damage caused by sunlight, chemicals, or other environmental insults. Others affect the levels of vital hormones. As scientists figure out what these key genes do, it becomes possible to envision developing medicines that mimic their activity, which typically wanes late in life.

Complementing that cross-species work, a number of ongoing research projects promise to clarify some of the most important anti-aging genes in people. In one project, described in this week’s issue of Technology Review, researchers are comparing DNA from two populations: people 80 or older who have never had serious illnesses and those who died of age-related ailments before they hit 80.

Two analyses to be published in the July 19 issue of the British medical journal, BMJ, make the case that such efforts could have big payoffs. Unlike conventional advances in lifespan, which in many cases have added years of disability and suffering to the end of life, the anti-aging approach would add healthy years, according to Colin Farrelly of the University of Waterloo in Canada. “There is a credible scientific basis for believing that we could slow aging in the foreseeable future,” he concludes. “And the amount of public funding we invest into such research will determine the likelihood and timescale of success for aging interventions.”

Others writing in that journal—including Robert Butler (a former head of the federal National Institute on Aging), S. Jay Olshansky (a leader in the field at the University of Chicago), and Daniel Perry (of the Alliance for Aging Research in Washington)—argue that $3 billion, or one percent of the Medicare budget, would be a “prudent” investment in anti-aging research. They make a convincing case that such an investment could pay for itself many times over by delaying not only the fatal diseases of old age but also the many debilitating conditions such as osteoporosis, arthritis, cataracts, and cognitive decline that typically take a big toll on quality of life in people’s final decade or two.

They call that benefit “a longevity dividend,” and it looks to me to have a much higher probable rate of return than most of the other dividends I’ve been counting on for my retirement. Meanwhile, hang in there, ol’ Ponce. Your reputation, if not your bod, may get rehabilitated yet.

Rick Weiss is a Senior Fellow at the Center for American Progress and Science Progress.

The organization has called the epidemic a “disaster” not only to draw media attention, but also to emphasize a “complex link” between natural disasters and the spread of HIV. According to chapter 6 of the report, natural disasters destroy crops, raise food prices, and contaminate drinking water, lowering the overall health of a population and creating conditions that can weaken the ability of individuals to combat the virus. Severe weather can also destroy roads, which leaves people unable to reach medical facilities and leaves medical facilities desperate for supplies.

The report reminds readers that 2007 was a “particularly bad year” for floods, forest fires, and other natural disasters. “Africa saw no less than 23 countries affected by some of the biggest floods in decades. In Asia, tens of millions were affected by floods in Bangladesh, India and Nepal.”

In response to these and other natural disasters, the United Nations issued 15 “Flash Appeals” in 2007. Flash Appeals help coordinate the response to and funding for the multiple agencies that respond to humanitarian crises. Of these 15 Flash Appeals, nine were issued for countries with a “generalized HIV epidemic,” meaning that over 1 percent of the adult population is HIV positive. The report cites this as evidence that due to natural disasters, “hundreds of thousands of people living with HIV would have been affected in one or more ways, and general populations exposed to increased risk of infection.”

The report raises increased concern about climate change, stating that because natural disasters can so severely impact the health of entire communities, climate change “may result in an increasingly harsh environment for some already vulnerable populations… An increase in climatic disasters would increase both the numbers of individuals suffering these impacts each year and their severity.”

In the conclusion, Sálvano Briceño, Director of the UN International Strategy for Disaster Reduction, argues that, “[d]isaster risk reduction is not an option, it is an urgent priority.” The report urges that HIV prevention programs mirror and complement disaster response programs:

Overall, the best approaches to HIV in the context of natural disasters is consistent with guidelines for all forms of disaster [sic]. Better emergency responses must be planned which take into account the specific epidemiological situation in the disaster area, strengthening existing institutions’ ability to withstand the disaster event and restore much needed health services as quickly as possible. At the same time, the development-related aspects of HIV responses must be taken into account, particularly in areas of chronic risk, addressing the epidemic’s contribution to weakening societies and economies and to undermining their ability to respond to disasters.

They examine studies of seven susceptibility alleles with low penetrance, or a small likelihood of causing a disease that individually play a very small role in increasing a woman’s risk for breast and ovarian cancer, but can have a significant cumulative effect. They do not examine low-frequency, high-penetrance mutations in genes like BRCA1 and 2, which increase the risk of breast and ovarian cancer, or TP53, which suppresses tumor formation. The study focused on an analysis of just how significant the cumulative effect of multiple mutations is and whether it is worth changing screening procedures in order to target women with a higher-than-average level of risk due to genetic predisposition.

This study, along with an increasing number of papers which identify cancer-susceptibility genes and meta-studies which analyze the statistical significance of those genes, focus attention on the question of how knowledge of our genes will shape public health in the future. The Pharoah article discussed several scenarios for screening programs and concluded that it would be possible and cost-effective to genotype every woman in the United Kingdom at all known susceptibility alleles and recommend personalized screening routines regarding what age the women should begin to get mammograms. Based on genetic susceptibility, the study concludes that only 0.1 percent of women in the United Kingdom should begin annual screenings at the age of 40, which is the current recommendation.

This targeted approach to cancer screening might save money, but there are certainly several obstacles to implementation of a measure like this in the United Kingdom, the United States, or anywhere else, including the issue of how to reach every woman in the population and how to insure the privacy promised in the Genetic Information Nondiscrimination Act while still delivering personalized screening recommendations. Nevertheless, our small but steadily increasing understanding of our genome ensures that more tests and treatments in the future will be tailored to our personal genetic makeup. As the Pharoah article concludes, “Policymakers should start to consider how this knowledge could be used to make a polygenic approach to disease prevention a reality.”

Interview with David Michaels on Doubt Is Their Product

Tobacco companies perfected the manufacture of scientific uncertainty, setting the example for numerous U.S. industries to follow. Realizing that studies demonstrating the fact that cigarettes cause cancer posed an immanent threat to their business model, tobacco executives hired public relations experts to attack the science behind the research. Their basic tactic, according to David Michaels, was to argue that the studies “weren’t correct enough.” Despite the wide acceptance of the link between smoking and cancer in the scientific community and the public at large, the strategy worked, and the controversy over the carcinogens in cigarette smoke bought the industry decades of time to continue profiting off a deadly product.

Michaels, an epidemiologist and the director of the Project on Scientific Knowledge and Public Policy at the George Washington School of Public Health, is an expert on how U.S. industries have hired mercenary scientists to use the same tactics to create scientific controversy where it did not previously exist. He spoke yesterday at the Center for American Progress about his new book, Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health, which chronicles the “tricks of the trade” employed by scientists-for-hire to systematically delay government action to curb the health risks of asbestos, beryllium, pharmaceuticals, diacetyl (which causes “popcorn lung”), and man-made climate change.

Digging through the documents made public in the multistate settlements against the tobacco industry, Michaels noticed that Hill & Knowlton, the PR firm leading the charge against science on behalf of the cigarette makers, was not a single-issue uncertainty shop. Hill & Knowlton, Michaels discovered, reached out over the years to many industries that exposed workers or the public to dangerous chemicals. Among their clients was DuPont, and the firm boasted about their success fending off regulation long enough for the chemical giant to develop an alternative to the chlorofluorocarbons that were tearing a hole in the ozone layer.

“Most scientists who work for industry are honest,” Michaels points out. Companies interested in delaying regulation will therefore hire consultants Michaels calls “sleazy.” After the success of groups like Hill & Knowlton, these scientists got into the lucrative “product defense” industry (now referred to by the friendlier “product support” moniker). These firms, Michaels explains, use methods “similar to the accounting done by Arthur Anderson for Enron.” They conduct “literature reviews” that include studies of good and poor quality, diluting the results of research identifying hazards to public health. They also take advantage of the uneven playing field by accessing and reanalyzing raw data from government studies. Aside from the Food and Drug Administration, which has access to raw data from drug makers’ clinical trials, most regulatory industries do not have access to the raw data from industry-funded studies. When corporations fight regulation with the results of industry-funded research, as well as with jerry-rigged reanalysises of government data that make health risks evaporate in statistical smoke, the public loses and industry profits.

But Michaels proposes a slate of reforms that can curb the manufacture of uncertainty and protect citizens and workers. He is a strong advocate for strict rules barring scientists with financial conflicts of interest from participating in government advisory panels, as they cannot be expected to provide unbiased interpretations of research. “We need transparency and full disclosure,” he says, explaining that “the interpretation has to be done by scientists who don’t have a financial interest.” With multibillion dollar issues like drug regulation at stake, and with public health a central question in industry regulation, Michaels argues that the government can afford to hire scientists without conflicts.

He also proposes a “Sarbanes-Oxley” for science—a legal framework similar to the one enacted after the accounting scandals that led to the fall of Enron. It would hold corporate executives responsible for the nefarious accounting that goes into product defense research for products that harm the public.

In addition, Michaels proposes equal treatment of public and private science: a level playing field that allows for bi-directional access to raw data. “Industry has the right to do its own studies,” he says, “That’s important.” But if the research will have an effect on public policy, data and methods have to be public information.

Ultimately, the key step to defending public health from underhanded industry tactics may be to follow the money. Prestigious medical journals, Michaels points out, require statements indicating who paid for a study, but smaller publications (sometimes set up by product defense firms themselves) and regulatory agencies don’t always have such rules. Scientists, journalists, and policy makers must always ask where the money comes from when there are controversies over research on public health. “Sunlight,” in the words of Justice Louis Brandeis, “is said to be the best of disinfectants.”

View full event video (CAP site)

Interview with David Michaels on Doubt Is Their Product

As a Government Accountability Office report dryly notes, an open-faced ham sandwich sold at a highway rest stop is the responsibility of the U.S. Department of Agriculture and subject to daily inspections. But add a second slice of bread and it becomes the Food and Drug Administration’s job to check in on the sandwich, which it does about once every five years.

And so it goes with just about every type of food Americans consume, resulting in a food safety system that verges on the absurd. The FDA regulates chicken broth, but beef broth is under the USDA’s watchful eye—except in the case of dried soups, in which case the agencies swap duties. Responsibility for packaged baked beans depends on whether the meat in the can is pork chunks (FDA) or bacon (USDA). And under which agency’s purview a pizza falls depends on whether it is of the cheese lover, meat lover, or seafood lover variety.

The American food supply chain’s remarkable ability to assemble a coherent meal independent of the season masks stunningly uneven oversight of the production and assembly process. A single cheeseburger purchased at the “to go” window of a fast food chain off any highway in America can contain a beef patty made from a hundred heads of cattle, cheese from the milk of a dozen dairy farms, lettuce from Arizona engineered to look fresh for days on end, and tomatoes “strip-mined in Texas,” as Garrison Keillor once joked. And yet the inspection of these ingredients rests with a bureaucratic alphabet soup of agencies. Take the 2004 case involving two USDA agencies, the Animal and Plant Health Inspection Service and the Food Safety and Inspection Service. At the very same time APHIS was testing the carcass of a cow infected with bovine spongiform encephalopathy, or “mad cow disease,” FSIS was clearing its beef to head out to market.

Food production today is a well-oiled system, as we saw in 2006 when spinach contaminated with E. coli spread quickly from California’s Salinas Valley out across the country, turning up from Oregon to West Virginia. But where the food supply is a symphony of cooperation, the federal oversight of that system is a nearly completely atonal chorus. More than a dozen different federal agencies share differing and overlapping areas of responsibilities and ways of doing business.

Plans for a single government public health body to take command have long foundered in Congress, but interest grows as the news today is filled with tales of outbreaks, from multi-million pound beef recalls to salmonella-tainted peanut butter and pot pies to melamine-laced imports from China. According to the CDC, each year in the United States an estimated 76 million illnesses and 5,000 deaths are tied to unsafe food.

Putting American eaters at risk is a fractured federal system overseeing what we put into our mouths—one crafted for days when Upton Sinclair’s 1906 book The Jungle turned Republican Theodore Roosevelt into the nation’s leading progressive food reformer. Since the days of The Jungle, the U.S. food safety system has evolved in fits and starts. When Franklin Roosevelt sponsored the creation of the FDA in the 1930s in response to food and drug scares, much responsibility was left behind at the USDA.

Visit the food section of Recalls.gov, a joint project of a collection of federal agencies, and the problem immediately becomes clear. To go any further on the website, you must opt to click the logo of either the FDA or USDA—leaving it to eaters to know which federal agency is responsible for overseeing the safety of which foods. What’s more, recall notices on a .gov website may be misleading, given that food recalls are nearly always voluntary.

The result is a system designed to put out fires, not for ensuring food safety in line with modern science. “When we had the spinach episode, everyone acted like it was a great surprise,” former FDA Commissioner Lester Crawford, a Bush-appointee and long-time federal food safety official, told Science Progress. “But the likelihood of something bad happening [with the food supply] is always quite high.”

The Wrong Recipe for Federal Food Oversight

Marion Nestle, New York University professor and the author of Safe Food who has served in a number of food positions on the federal level, describes “an overlapping system with huge gaps where everybody blames everybody else.” Indeed, asked about the working relationship between FDA and USDA officials, Crawford says, they “generally don’t bump into each other. I don’t know if I ever tried to make a phone call to the USDA. And if I did, I don’t know if it would have been returned.”

The GAO, which has long called for a single food agency, last year bumped the current system up to the level of “high-risk area.”

The GAO, which has long called for a single food agency, last year bumped the current system up to the level of “high-risk area.” When it comes to the FDA, part of the problem, says Lisa Shames, GAO’s Director of Food Safety and Agriculture Issues, is “a mismatch between funding and food oversight responsibility,” where the FDA oversees four-fifths of the food supply but receives just a fifth of the total federal budget for the effort. The FY2009 presidential budget calls for increasing the Food and Drug Administration’s funding level to $662 million, a meager 7 percent boost covering little more than inflation. The FDA itself says it needs an additional $275 million to beef up its overseas inspections.

Beyond FDA’s meager budget is the challenge of having an agency with so vast and diverse a mission, one responsible for the safety of America’s food and drug supply. Says former commissioner Crawford, “I just can’t recall an incident when I said, ‘My gosh, thank God we have the drug people with the food safety people.’” Crawford discounts the possibility of finding agency-level leadership equally skilled in food science and pharmaceuticals. “They just don’t make people like that,” he says.

USDA, home to the majority of agencies with food oversight duties, is an altogether different entity with its own special challenges. In 2003, then-Secretary Ann Veneman lamented that the department was bound by laws that pre-dated the Model T. Says Mike Doyle, director of the University of Georgia’s Center for Food Safety, “USDA is in the plant to look at gross morphology, basically looking for lesions. That was relevant back when the statutes were written,” in the turn-of-the-century days when Sinclair wrote of meat in Chicago’s packinghouses found to be “moldy and white, stinking and full of maggots.” But visible problems like rotting meat aren’t the modern concern, says Doyle. Today’s worry: bacterial pathogens such as E. coli and salmonella, both of which are invisible to the naked eye.

What’s more, USDA is a department internally conflicted. Its primary role in Washington is to promote the food trade—to boost the amount of American pork the Chinese eat, not to worry over whether the pork Americans consume is safe to eat. GAO recently profiled seven countries (Canada, Denmark, Germany, Ireland, the Netherlands, New Zealand and the United Kingdom) that have consolidated food oversight under one roof. Most interesting is the holistic farm-to-fork approach of EU member countries. Ireland is a typical case, moving its food safety agency under the auspices of its existing public health authority—in recognition of the fact that the raison d’etre of their own Department of Agriculture is promotion, not policing.

Added to those challenges is that we’re now pulling an enormous amount of food into our supply stream from overseas—up to 15 percent of what we eat, by volume—and inspecting a miniscule one percent of it at most. The current regime sends a message to food producers in the wake of the melamine scare, says NYU’s Nestle. “The Chinese were very frank about it,” she explains. “’You asked us to give it to you at the cheapest prices. You didn’t say anything about quality.’” Even occasional point-of-entry inspections can act as a deterrent. Nearly non-existent inspections simply set the expectation that the fractured U.S. food supply is willing to absorb foods of dubious quality.

Calls for a Single Federal Food Safety Agency

What’s the solution? For years now, diverse voices in Washington—from GAO to the National Academies’ Institute of Medicine and National Research Council to former Department of Homeland Security Secretary Tom Ridge—have been calling for the creation of a single food safety agency, a player in the federal bureaucracy with the necessary mission, might, and budget to ensure a safe food supply. On Capitol Hill, Sen. Richard Durbin (D-IL) and Rep. Rosa DeLauro (D-CT) routinely introduce the Safe Food Act, a legislative vehicle that not only creates a Food Safety Administration but establishes a firm schedule for inspections and gives the new body the power to invoke mandatory recalls.

Interestingly, given Ridge’s past support for the idea, GAO recently eased its strong call for single agency plans in response to the rocky process of getting the Department of Homeland Security up and running. A spokesperson for Rep. DeLauro counters GAO’s concerns by arguing that the creation of DHS was a different effort entirely—an attempt at unifying offices and agencies with unique aims and cultures. She argues that the creation of a Food Safety Administration would be more akin to federal reorganizations like the 1947 establishment of the Department of Defense, which united federal agencies and offices already committed to a common mission.

Even industry opponents of current single-agency proposals, such as the National Cattlemen’s Beef Association, are quick to say that they are united behind the common goal of ensuring a safe food supply. Reached via email, the Cattlemen’s Phyllis Marquitz objects to Durbin and DeLauro’s plans as “political solutions that rearrange agency structures but do little to show potential for real-world practical change.” But the beef industry spokesperson adds that she judges beef producers to be receptive to a convincing case that one unified federal food safety agency is indeed the best way to ensure safe food.

Former FDA Commissioner Crawford echoes the sentiment. In his experience, everyone involved in the food chain “agree[s] with the idea that we have to put safety first,” he says. “The question is how we get there.”

Of course, restructuring the way the federal government handles food safety is no easy task. Agency heads are generally loath to give up jurisdiction and budget. From deep-pocketed meat lobbyists to members of House and Senate agriculture committees, many in Washington with a role in the food supply chain have an interest in maintaining the idea that food safety is an industry issue, rather than a public health concern.

But perhaps most important is Congress’s limited supply of attention. It’s been nearly 70 years since the last time the public demand for safe food forced politicians to act. But given our globalized way of eating and the mounting reports of food-borne outbreaks, that time is likely coming again. The day has certainly arrived for Congress to consider the Safe Food Act with all the thoughtfulness that what we put in our mouths deserves.

Nancy Scola is a freelance writer in Brooklyn, NY.

Debating the science, David Michaels points out in his new book, Doubt Is Their Product: How Industry’s Assault on Science Threatens Your Health, is a lot easier for these companies than debating policy. He traces the same “tricks of the trade” that industry-funded scientists used to delay action to curb the health risks posed by tobacco, asbestos, beryllium, dangerous pharmaceuticals, diacetyl (which causes “popcorn lung”), and man-made climate change. Scientists, policymakers, journalists, and citizens deserve independent science that protects public health, says Michaels, an epidemiologist and the director of the Project on Scientific Knowledge and Public Policy at the George Washington School of Public Health. This interview transcript has been edited.

Andrew Plemmons Pratt, Science Progress: When did you know that you needed to write this book, and why?

David Michaels: During the Clinton administration, I served as assistant secretary of energy for Environment, Safety, and Health. I was responsible for the health of workers, the communities, and the environment around the nation’s nuclear weapons factories, some of the most polluted and dangerous places in the United States. One of the hazards I had to address was beryllium, an extremely toxic lightweight metal that’s used in the manufacture of our nuclear weapons. We had workers who were getting chronic beryllium disease, which a terrible, often deadly disease, after extremely low exposures. We had an accountant who got sick after working for a very brief time in a building in which beryllium had been used several years earlier.

In the Clinton administration, under the leadership of then-Secretary of Energy, now-New Mexico Governor Bill Richardson, we issued a beryllium protection rule that’s ten times stronger than the one that’s used by the Occupational Safety and Health Administration for private sector workers. As we were developing this rule, the beryllium industry submitted studies that I saw as attempts to obscure the issue. Instead of acknowledging that the old standard wasn’t adequately protective, they focused on what we didn’t know. They clearly wanted to delay our more protective regulation. Of course, we didn’t let their reports stop us and we issued a strong regulation.

But I continued to be interested in beryllium after leaving the Clinton administration. So if there was an “ah ha” moment, it was probably when, searching through the tobacco archives—millions of pages of previously-secret documents put up on the web as a result of the tobacco lawsuits—I discovered that the same scientists who had manufactured uncertainly for the beryllium industry were doing the same thing for the cigarette manufactures.

SP: That’s one of the key themes that you write about, the “manufacture of uncertainty.” Can you talk a little bit about the different kinds of methods that industries use to create this uncertainty where it did not exist before?

Michaels: In the book I call them “tricks of the trade,” which are tricks one can do as a scientist if you know how to do them. These are tricks that turn positive studies into negative ones or take one positive study and do a literature review which buries the positive study in what is essentially a whole mass of garbage so it looks like there is nothing there.

Comedian Lily Tomlin said, “No matter how cynical you become, it’s never enough to keep up.” I see these same techniques and these same approaches across the scientific literature, and not just in terms of chemical hazards. They’re used by the deniers of global warming, the people who are essentially fueled by the big oil and coal companies trying to say that humans aren’t causing global warming. After finding the initial information, I dove into the literature, court records, and dockets where corporations and trades associations file comments with agencies, and I found the same names, the same tactics—the same alchemy in campaigns run by all these different industries.

I found some very powerful smoking guns: the sales pitches made by these product defense firms. They boasted about how they were able to delay regulation, what they were able to do, how they needed to change scientific studies around.

I found one for example around freon, which we know causes a hole in the ozone layer. The Hill & Knowlton company was saying, “We were able to essentially delay regulation for a couple of years when we were working for DuPont on this.” So what I’ve done is put all these smoking guns up on our website, which is www.defendingscience.org so anyone can download them and read exactly how these people work.

SP: How can scientists, policy makers, and journalists learn to spot these tricks?

Michaels: It’s very tough, and you have to be somewhat of an expert in the field. I see things in epidemiology immediately, but I have more trouble with the toxicology. Given that it’s difficult to do, and a layperson can’t just pick it up, it’s very important, first of all, that scientists who are in the field who see these problems write letters about them and put critiques up on the web. But I think the other thing that is more fundamental is to have a screen around conflict of interest.

We know the basic problem is that scientists who are paid to find a certain result will find that result. That’s certainly what we see in these studies over and over again: that scientists who work for these companies that actually manufacture uncertainty never find a result the sponsor doesn’t want.

So one thing that we should be demanding on the part of our scientific journals, and on the part of the regulatory agencies, is to ask, “Who paid for this study, and under what contract were these studies done?” If they were done with a secret contract, as is often the case, or a contract that says the sponsor has the right to see the results before they’re published. Those studies should immediately be in question and they should be looked at much more carefully.

SP: And there is research on this “funding effect” demonstrating a link between who’s paying for the research and the results of it, correct?

Michaels: That’s true, and we see that across the board. We saw it in tobacco; we see it all over the pharmaceutical literature; most recently in bisphenol A, a plastic chemical that’s used in baby bottles. There are well over a hundred studies that have been done—there’s a small handful paid for by the producers, the chemical companies making bisphenol A—all those studies show no effect. But 90 percent of the studies done by scientists independent of these corporations find an effect. It’s very powerful. We know that to really trust a study, it should be done independently.

SP: You write about how the sustained assault on scientific integrity under the Bush administration has actually demoralized a whole lot of scientists who are working for the federal government. Shortly after your book came out, the Union of Concerned Scientists released a survey saying that about 60 percent of the respondents of scientists at the EPA had personally experienced political interference with their work in the past five years. What is the toll of this interference and of this manufacturing of uncertainty on scientists, and how can we make sure that the government has good researchers in the future?

Michaels: It is a significant problem. As you said, the morale of government scientists has plummeted. Out best scientists chose to work in government because they see—or at least they saw—public service as a higher calling. They want to help in the nation’s efforts to improve human health, to protect the environment. Now many of them feel they can no longer make a contribution to the public good in their current job and they’re getting out or they’re just fading away; they’ve become marginalized. We have to reverse this trend by making public service an appealing career choice again.

I think we have to do this on two levels. The first and somewhat more obvious one is to set up structures and policies to ensure that government scientists will be respected and listened to—that they can publish their studies; that they can meet with other scientists; that they can get training that they need to keep up. We need of course the best scientists in the country. When one of our regulatory agencies has to go nose-to-nose with a multi-billion dollar chemical or pharmaceutical company, they need to have the best scientists; they can’t have scientists who can no longer go to scientific meetings to keep up with their field. So we have to make the job of scientists one that good scientists want to go into.

But on a more fundamental level, we have to change the national view of government work. Idealistic young scientists should feel the call to public service. In the past, Presidents Franklin Roosevelt and John F. Kennedy called young professionals and activists to serve their country. Our next president needs to make public service a desirable career goal—not just Americorps or the Peace Corps, but signing up with the EPA or the Justice Department with the understanding that people will work there for multiple years. We should see this as an important part of any homeland security program, because it is our future and our children’s future.

SP: How can people who are working scientific fields, or are writing about them, or who are dealing with policy present these ideas without getting into the complexities of the science or of the regulatory policy, which can confuse people?

Michaels: It’s very tough. But one thing that I’ve seen people start to do is come together as scientists to look at the scientific literature—to step back to a minute and say, “Here is a chemical that is in our environment; we’re very interested in this; there are studies being produced by government scientists, by university scientists, by corporate scientists.” There is a group of us in any university town—let’s come together and look at the literature almost as a journal club. Let’s get together and see what we think of the interpretations done by these different groups of scientists and start writing ourselves: put up a blog post and weigh into the discussion. Scientists can do that with a lot of credibility and they bring a lot of expertise because there are so many toxic chemicals out there, and producers of these chemicals can hire scientists to create fictions about whether or not they’re dangerous or safe. But there are independent scientists who don’t take those issues on because they’re often not funded to do so. Just as volunteers, I think that’s something we could do—little chemical investigation groups.

SP: Let me ask another question about one of the “tricks of the trade” you point out that seems pervasive, which is reanalysis of existing data in order to come to different conclusions from those at which a particular study might have arrived. Part of the problem here has to do with access to raw data from scientific studies, and the FDA is one particular agency that does generally have access to raw data from studies when they’re making decisions about pharmaceuticals. Can you talk about why access to raw data is so important in combating these nefarious reanalyses?

Michaels: It’s a fascinating issue. There’s an unequal playing field. There was a law passed by Congress in the late 1990s called the Shelby Amendment that gives public access to any study done by the government or paid for by the government and done by, say, university scientists. What has happened over and over again is corporations have gotten this raw data and paid mercenary scientists to reanalyze the data and to essentially make positive results go away. If you have raw data, you can do that.

Now the FDA also understands that the interpretations done by scientists paid by drug companies can’t absolutely be trusted; they want to do the analyses themselves. So the FDA says, “Give us the raw data when you’re looking at a drug’s efficacy or safety, and we’ll analyze it ourselves.” But for other agencies—the Occupational Safety and Health Administration or parts of the EPA, for example—companies submit studies and the agencies have to rely on those interpretations done by, essentially, the corporate scientists. Those corporate scientists, or mercenary scientists in some cases, have access to the raw data for the work paid for by the universities and by the government. So you have this unequal playing field where the raw data of some studies are available, yet important studies that are produced by corporations can’t be reanalyzed.

Given that you have this unequal playing field, we think everyone’s data should be made available in a way that any researcher should be able to look at those data, but under certain conditions. They have to be able to say not that, “We’re going to go fishing and figure out how we can manipulate these studies to make a positive result disappear,” but rather, “We’re going to set our hypotheses out in advance; we’re going to say this is how it will work—in consultation with the people who wrote the studies.” And then everybody can essentially play equally in the same field.

SP: Well let me ask another question about federal rules that have an impact on this playing field. You devote an entire chapter of your book to what you call “the most important Supreme court case that you’ve never heard of,” Daubert v. Merrell Dow Pharmaceuticals, which gives trial judges the responsibility to determine the quality of scientific testimony from expert witnesses. Could you explain why this is a problem when we’re talking about public health?

Michaels: It’s an interesting problem because the Supreme court ruled in 1994 that judges must decide that the expert testimony to be given in court cases is “relevant and reliable.” Now most judges have no scientific training and they’re very much influenced by the attorneys—in many cases the corporate attorneys—who weigh in saying, “Don’t believe this study. This is junk science. Don’t let it in.” And so in some cases what judges are doing is saying, “Well this evidence doesn’t look like it makes any sense to me. I’m not going to let it in.”

That ends the court case, and the people who are suing a manufacturer of a dangerous product or a polluter essentially lose their case at that point. Litigation and court cases are a very important part of our public health protection system, especially now in the Bush years when the regulatory agencies have been handcuffed. There are numerous examples I talk about in the book of hazards that are under control only because we have lawsuits because the regulatory agencies really aren’t doing much. So you have this system now where the judges, in many cases very sympathetic to corporations, are using Daubert decisions as an opportunity to stop evidence from getting to juries so they can decide whether or not an injury is caused by a toxic substance.

Now in some cases, they’re very well meaning. But I think that it would be much more reasonable to let a jury decide whether or not there is evidence that some toxic exposure caused an illness. The judges don’t have a particular expertise in this and it’s too easy for them to throw evidence out. So I write about that quite a bit. It’s not a very well-know decision, but it’s a very important one. And I think it does have a big impact on public health.

SP: What do policy makers, journalists, or other readers most need to understand about the way that industry may manufacture uncertainty in dealing with science and public health?

Michaels: Well I think they have to see that this strategy—which tobacco came up with and is now so widely used—we have to expect it. Whenever independent scientists create some new information that shows a link between a toxic chemical, or something else, and human health or the environment, you expect to see the immediate response saying, “We’ve looked at this carefully; it’s not there; more research is needed.” You’ll hear the call for “sound science,” when in fact I think they’re looking for something that “sounds like science” but isn’t. I think what has to be done is that the public, the press, legislators, should demand independent evaluations of studies. You can’t trust interpretations or studies done by sponsors who have an interest in the outcome, and that’s the bottom line.

An alarming number of countries are failing to provide the most basic health services that would save lives, with 30 percent of children in developing countries not getting basic health intervention such as prenatal care, skilled assistance during birth, immunizations and treatment for diarrhea and pneumonia.

Wide disparities in health care for the poorest and best-off children are seen even in the highest-ranked countries, the report said.

…

Use of existing, low-cost tools and knowledge could save more than 6 million of the 9.7 million children who die yearly from easily preventable or curable causes, the report [by Save the Children] said.

They include antibiotics that cost less than $0.30 to treat pneumonia, the top killer of children under 5, and oral rehydration therapy—a simple solution of salt, sugar and potassium—for diarrhea, the second top killer.

This is as much a failure on the part of the rich developed world as it is one on the part of governments in the developing world. In addition to financial aid, there needs to be a focused effort to help developing countries set up sustainable primary care networks in socially and economically disadvantaged areas.

One wonders how much of a public health crisis we need before we rethink our vaccine exemption policies—particularly given that misconceptions floating around about a connection between vaccines and autism are driving more parents to opt against MMR.