This U.S. policy development is of special concern to Russians, as an increasing number of U.S. pharmaceutical companies conduct their drug trials in Russia, which currently lacks extensive regulations. Merrill Goozner is currently reporting on that country’s health care system, which he explains has the potential to become “ground zero” in the discussion over the FDA’s withdrawal from the Declaration.

Russian health care and longevity has fallen dramatically since the end of communism, and in some areas is just now starting to recover. In some of the most rural parts of Siberia, the first health clinics are just now being built. Even with the recent improvements, the lack of regulations regarding pharmaceutical companies conducting trials concerns Sergey V. Smirnov, the Russian director of the nongovernmental organization, Community of People Living with HIV. Goozner spoke with Smirnov for Scientific American about his activism on the regulation of pharmaceutical trials:

Two years ago, Smirnov joined an informal working group of scientists and bioethicists in drafting legislation designed to beef up clinical trial patient protections. Among backers: representatives of the Russian government’s Bioethics Commission, the Russian Academy of Sciences, and the local UNESCO office.

The legislative draft would give the government power to require greater disclosure of sponsors of and participants in clinical trials. It also provides a framework for protecting the patient privacy and safety in the trials, including requiring that they give their (noncoerced) consent to participate.

Smirnov hopes that the bill will be voted on sometime this year, remedying the current lack of effective regulations for clinical trials.

The decision by the FDA to withdraw from the Declaration of Helsinki has evoked much criticism, both at home and abroad. In recent years, the FDA has noticed that even with the Declaration in effect, many international drug trials run by American pharmaceutical companies are not reported until after they are conducted, and as such, the FDA cannot regulate them. The new guidelines may be an attempt to reassert control over these pharmaceutical companies, rather than rely on international law. By relaxing the rules, the FDA may either encourage more international drug trials—and therefore increase the number of drug trials that go unreported and unregulated—or it may find that companies are more likely to adhere to the slightly lower testing standards.

SEED’s Science and Society blog has posted video of its Science and Society Series with Drew Endy and Annie-Marie Mazaa of the Committee on Science, Technology and Law at the National Academies. The two discuss synthetic biology: the technology behind it, the current state of research, and the legal and regulatory dilemmas it faces.

Expect only one minute of science and environment coverage in five hours of cable news programming, writes Matthew Nisbet at Framing Science. Taking a hard look at the recently released Pew “State of the Media” report, he explores the lack of science coverage on cable news networks.

How to combat the rise of drug-resistant antibiotics? In the wake of a new study indicating that U.S. citizens often fail to complete prescribed courses of antibiotics or use them to treat the wrong kind of infection, 60 Second Science suggests “education, education, education.”

Derek Lowe at In the Pipeline critiques a proposal from MIT professors Stan Finkelstein and Peter Temin for rethinking the drug development process. In their new book, “Resonable Rx: Solving the Drug Price Crisis,” they suggest breaking up the pharmaceutical business into drug discovery firms and drug marketing firms.

Should we even expect commercially-useful information to originate from university research? We say yes, absolutely. Given the magnitude of current funding where the NIH spends $28 billion per year on grants for biological research, we are justified in asking where this money goes and what sort of return the public taxpayer should expect. For those who argue that university-based biological research should not be used for commercial purposes, but only training purposes, it is perhaps worthwhile to point out that many foreign students return to their own countries armed with the knowledge and experience, paid for by the American taxpayer, to commercialize science.

The authors also enumerate the benefits and pitfalls of various funding models and institutions that attempt to bridge the gap between basic lab research and products that will make people healthier. The overview is a set piece for their forthcoming work at the The Committee on Bioscience Innovations. Their efforts in this space could well be worth watching.

According to the panelists, off-label can increase the risk of joint pain, carpal tunnel syndrome, and even cancer. Specifics about HGH’s athletic benefits are still unknown because little clinical data exists on the subject and the few related case studies involve athletes using HGH in conjunction with steroids, making it difficult to link performance enhancement to HGH alone. Committee Chairman Henry Waxman (D-CA) cited a 2007 Stanford study which concluded that “HGH could not be recommended as an anti-aging therapy.” Yet the market for HGH anti-aging therapies continues to grow, raking in two billion dollars in sales last year. Panelists also pointed out the lack of physician supervision for off-label users means they may not know the correct doses, leading to the risk of acromegaly–a serious condition resulting from too much HGH in the body.

Tackling the problem of HGH abuse is difficult in a sports culture fixated on shortcuts and competitive advantages. And reports of use among professional baseball players only compounds the struggle to end steroid use among young athletes. Dr. Alan Rogol, of the University of Virginia and Indiana University School of Medicine, emphasized the importance of raising public awareness about the abuse of performance-enhancing drugs with the results of a startling survey indicating that 3 out of 5 kids in grades 8 through 12 who were using steroids were willing to continue use even if they knew the drugs could shorten their lives.

In light of such statistics, HGH is a public health priority. Panelists suggested developing drug tests that can detect HGH use among professional athletes and further restricting access to the hormone. Today, the the Committee held a second round of testimony on illegal steroid use in Major League baseball.

Pharmaceutical companies justify massive marketing budgets, which drive up drug costs, by citing large numbers of drug handouts. They claim that these free samples often go to the uninsured, who might not otherwise be able to afford these drugs. But according to the Chronicle, “More than four-fifths of the people receiving the freebies were covered by insurance all year…The groups that received a disproportionately high number of freebies were patients who were white… and had better access to medical care.” In addition to the disparity of access, there is also an increased likelihood that doctors will prescribe a drug that might not be right for the patient just because it is free.

The study demonstrates that pharmaceutical company marketing tactics that seem beneficent do not adequately compensate for a fundamentally flawed healthcare system that does not mandate a minimum level of care for all citizens regardless of income. Nevertheless, the Pharmaceutical Research and Manufacturers of America, a trade group, issued a statement saying that the studies, which use data from 2003, were “fatally flawed” since they do not take into account the outreach program that that the industry began in 2005. The statement goes on to point out that even though doctors are likely to consider patient income when giving free samples during an office visit, the uninsured often cannot make office visits in the first place.

But this is not the only recent news underscoring the threat an inequitable care system poses to public health. In an editorial published today, The New York Times argues for universal coverage and cites another study by Harvard Medical School finding that “uninsured near-elderly people got sicker at a faster rate than comparable people with insurance. Those disparities were sharply reduced when people turned 65 and became eligible for Medicare.” The NYT also pointed to a study from the American Cancer Society indicating that uninsured patients were less likely to receive cancer screenings, which means that cancers can go undetected until they progress and become more difficult to cure.

The inequities of the health industry present public health risks to an unacceptable number of Americans, and these recent studies provide more hard evidence of this unsustainable situation.

Image source: AP.

The deal is set to cover about 47,000 sets of plaintiffs, with the average plaintiff receiving just more than $100,000 before legal fees, which can amount to as much as 30 percent of the actual settlement sum. To receive settlements, plaintiffs will not need to prove that Vioxx caused their heart attacks or strokes. But they will have to provide evidence that they did suffer a heart attack or a stroke, that the heart attack or stroke occurred less than two weeks after they last took Vioxx, and that they had taken Vioxx for at least one month.

The agreement may reflect a new strategy for businesses defending themselves against lawsuits. Instead of agreeing to a quick, early settlement, Merck aggressively defended itself in more than 20 Vioxx civil trials over the past few years, successfully convincing juries of its innocence in the majority of the cases. Playing hardball paid off for the company, with its settlement a mere fraction of what analysts had predicted years earlier.

In a country with an underperforming health system and the average consumer more vulnerable than ever to the whims of insurance companies and financially strapped medical centers, news of corporations like Merck going to bat against the American public and winning is not inspiring news. If we are serious about improving the health of our nation, steps need to be taken to ensure that companies like Merck cannot expect to get away with settlements that do not reflect the irreparable harm caused by its actions.

The University of Virginia is home to a Johnson & Johnson-funded study on Topamax’s ability to treat alcoholism. The Health Blog describes claims from the Public Citizen’s Health Research Group, which says that the University of Virginia, where the study took place with funding from J&J, put out a press packet that encouraged doctors to prescribe the medication off-label. Doctors can prescribe drugs off-label for uses not formally approved by the Food and Drug Administration, but drug makers cannot advertise or promote these alternative uses. The Health Blog also notes that the scientist who led the study at UVA, Bankole Johnson, chairman of UVA’s Department of Psychiatric Medicine, has financial ties to J&J.

In their main article on the study (subscription), The Wall Street Journal relays Dr. Johnson’s comments about how the current drugs used to treat alcoholism are only prescribed after a person stops drinking or goes through detox. According to Johnson, a drug like Topamax is a welcome development because it can be introduced while a person is still drinking.

The Wall Street Journal also reports that a spokeswoman for Ortho-McNeil Neurologics, the J&J subsidiary that produces Topamax, says they have no intention of submitting the drug for FDA approval as a treatment for alcoholism. And in an article by MedPage Today, they quote a UVA spokeswoman:

“We are not suggesting a go-ahead for doctors, but we are stating a fact,” said a spokesperson. “Doctors who are interested are allowed to prescribe it. No off-label use is being proposed, advocated, or promoted.”

Looking a bit deeper into the specifics of the scientific methodology, Mark Willenbring, doctor at the National Institute on Alcohol Abuse and Alcoholism, commented in an editorial in The Journal of the American Medical Association that accompanied Johnson & Johnson’s paper on Topamax that alcoholic subjects who volunteer for a study such as this one are self-selecting, whereas many alcoholics who undergo specialty treatment are coerced by judges or employers. This self-selecting group mostly closely resembles patients likely to be seen in primary care where pharmacotherapy would be most appropriate.

The New Scientist goes into some detail about how much the patients actually improved and how the drug works by blocking the brain-chemical (or neurotransmitter) dopamine; the piece is more optimistic than The Wall Street Journal.

A letter to Food and Drug Administration Director Andrew von Eschenbach from Sidney Wolfe, MD of the Public Citizen’s Health Research Group, emphasizes the current FDA warnings that caution against taking the drug with alcohol and calls attention to the statistically significant increase in side effects mentioned in the study such as dizziness and trouble concentrating.

Although the results of the study look promising, the side effects seem substantial and even the authors admit that there was no follow-up to determine whether the patients relapsed.

The findings aren’t necessarily hype, but Public Citizen is right to call attention to the fact that FDA approval is more than red tape. Large studies must be done on diverse populations in order to ensure safety and effectiveness and assess the overall risk-benefit relationship. That’s why Topamax remains off-label for alcoholism treatment and should remain so until the FDA approves it. Although it may be worth asking whether news coverage of the study and controversy itself may spur more patients or doctors to consider off-label use.