Dr. Davis’ new book is an ambitious story of the search for the causes of cancer, extensively footnoted and supported by a website featuring links to scientific studies and corporate documents.

Her research reveals the extent to which official governmental anti-cancer efforts were spearheaded by leaders from the very industries producing cancer-causing materials and products. Her book is already generating considerable buzz, contributing to a lively debate about the nature of cancer risks, what can be done to avoid them, and who is responsible for keeping us safe from dangerous products.

Jeff Stryker’s interview with Dr. Davis for Science Progress has been edited and condensed for posting.

Science Progress: It has been more than 35 years since President Nixon declared “war” on cancer. How are we doing?

Devra Davis: For much of the enterprise we have been fighting the wrong war with the wrong weapons against the wrong enemies. The good news is we now in the United States have 10 million cancer survivors.

We have not dealt with the main causes of the disease. Think about it. In 1971, President Nixon officially declared war on cancer. But by 1936, the world’s leading cancer scientists understood that benzene caused cancer. It was known that diagnostic radiation, solar radiation, and hormones caused cancer in the 1930s. But the war on cancer started in 1971—leaving off the table tobacco, benzene, radiation, sunlight, hormones, mining, and other things then known to cause cancer.

SP: I suppose most casual observers would point to the 1964 U.S. Surgeon General’s report as the first major acknowledgement of the role of tobacco causing cancer, yet you identify the Nazi research as strong on this point.

Davis: The recognition of the dangers of tobacco goes back a hundred years and more. In the late 19th century, autopsies were reported in the literature showing the black lungs of people who smoked cigarettes. Yet individual clinical case reports such as these were basically ignored as the field of epidemiology grew as a science.

SP: How are we doing on some of the particular cancers? I mean, tobacco’s risks are now well known and we’re getting them under control.

Davis: Cancer deaths in the United States are dropping, because we have finally made some inroads against tobacco. If we had acted on tobacco when we first knew it was a hazard, we would never have addicted generations of GI’s in World War I and II to tobacco by giving them free cigarettes, which we did.

We are, in fact, seeing an increase in certain cancers not related to smoking and not as a result of improvements in screening.

SP: Your book left me a bit afraid to leave the house or stay in the house or eat or drink anything.

Davis: The point of the book is not to frighten, but to let people know what can be done to reduce the risk of cancer and its chance of recurrence. People also deserve to recognize that we have not been dealt fairly with by industries that make cancer-causing products.

We are doing amazing research at our Center for Environmental Oncology on the use of certain natural products that can basically extinguish cancer cells, things taken from broccoli or fish oil or yogurt or even sometimes dark chocolate.

SP: Epidemiologists face huge challenges in studying cancer. One hurdle is that they can’t study risky products without the help of the people and companies making and selling them.

Davis: It is hard to do epidemiology. It is expensive. It takes time. The early epidemiologists had to cooperate with industry or they would not have received any data whatsoever. Under our current system there are no incentives for companies to come forward with information about hazards relating to material that they produce.

I think we need a “truth and reconciliation commission” on toxic hazards. Companies could provide independent information with appropriate confidentiality protections concerning potential hazards. This would absolve them from punitive damages. They would still be responsible for paying medical costs for their own workers and to others that they may have injured.

As it stands now, there’s no reason for anyone to come forward with disclosures.

SP: Injured people can always sue. But you discuss the difficulties of doing this in your book—problems in forcing disclosure of trade secrets and with the Daubert rule (Daubert v. Merrell Pharmaceuticals, Inc., 509 U.S. 579 (1993)) if litigation gets underway.

Davis: One group of scholars called it, “The Most Influential Supreme Court Ruling You’ve Never Heard Of.”

The Daubert decision has had exactly the effect the defense bar intended. Namely, 90 percent of all judgments now are going against plaintiffs in tort cases. Daubert raised a very, very high bar of proof. It basically made the collecting of epidemiologic evidence in many cases a requirement before you could prove harm. But cancer is a disease that in humans can take 10, 20, 30, or 40 years to develop. Under Daubert, we have to wait until enough people have been harmed in order to prevent others from additional harm.

SP: What should be the standards of proof before products are deemed toxic or dangerous? Your book resurfaces some battles I thought had been fought and resolved, say, for example, Aspartame.

A recent Aspartame study should give us all cause for alarm. As you may be aware, the typical animal study takes two years, after which animals in both the experimental and control groups are sacrificed and examined for tumors.

SP: By animals you mean mice?

Davis: Rodents—rats or mice.

SP: How long do they usually live?

Davis: Their natural life is three years. But in most studies we sacrifice them at two years. Soffritti and his colleagues in the Ramazzini Foundation in Bologna, Italy exposed thousands of rodents to Aspartame prenatally and throughout their lifetime. He let them live to three years, which is equivalent to humans getting into our 70s, 80s, and 90s. Twice as many exposed animals developed tumors. Yet none of the tumors started to appear until that third year of animal life, corresponding to the last third of human life today. Two hundred million people in the United States today regularly consume Aspartame.

SP: So that horse is out the barn door and headed down the road a piece. How do you study something that’s so prevalent? Is it too late, for example, to be concerned about cell phone risks, now that everyone has one?

Davis: Cell phones are a great convenience and even save lives. It is also clear that the old cell phones, the clunky analog cell phones, were probably much more hazardous than the current generation of cell phones today. Even so, the British, Swedish, and German governments recommend that children not use cell phones. The cell microwave signal is known by industry to penetrate the skull and children’s heads have thinner skulls and are more vulnerable.

My advice is to use a cell phone with speaker phone whenever possible or with a hollow wired headpiece.

SP: Cell phones are changing rapidly. Isn’t the technology a moving target when it comes to pinning down risk?

Davis: Precisely. There’s also the problem that the epidemiology on cell phones, like the epidemiology on Aspartame, has involved studying limited exposures for short periods of time. In the case of cell phones, most studies absolving the technology of risk looked at people who used cell phones in the early 1990s and checked back five years later to see if they had brain cancer. Now, in both cases, that’s far too short a period of observation.

More troubling data has just emerged from a meta-analysis done by Leonard Hardell and his colleagues in Sweden. They found that people using cell phones for 10 years or more showed a doubled risk of certain brain cancers.

SP: Where are the regulators when it comes to toxic hazards? Lead paint in toys has been the scare du jour. Are regulatory agencies letting us down?

Davis: There has been a long-standing decline in the United States of funding for testing and monitoring and measurement. Enforcement on environmental issues is at an all-time low. We do not even have the in-house capacity of the Food and Drug Administration to evaluate toxicology information. We don’t have inspectors. By the way, the problem is not simply lead paint on wood or metal toys. Lead can be put into plastic, and plastics can also contain other toxic materials that can come out of them when children suck on them or when they are heated.

The government has really stopped doing its job. Our laws allow us to think we might be protected. But President Bush has shown a creative ability to ignore laws with his signing statements. Another way to undermine existing laws is to fail to fund the regulatory agencies established to implement them. In the case of the FDA and the Consumer Products Safety Commission, the problem is also their reach. It is clear that they do not have the authority to monitor, for example, contaminants in personal care products or a wide range of imported foods.

SP: Can you talk a bit about the difference between U.S. and European regulatory attitudes on personal care products? I was taken aback by your examples of the placenta-based beauty products.

Davis: It’s been a shock to a lot of us. Hospitals sold placentas to cosmetic companies. They were used in beauty products and marketed principally to the African-American community. These hormones do a good job of plumping up hair and skin all right, but they also penetrate into the body. One study you can find on our website found that black baby girls whose mothers applied skin creams to their scalps developed breasts between the ages of one and three. Dr. Chandra Tiwary, a pediatric endocrinologist treating these girls, asked the mothers what they were using. Dr. Tiwary found they were all applying these hormone creams. When they stopped, in every single case the baby girl’s breasts disappeared. If something can cause a baby girl to develop breasts, what might it do to older women? Could these products play a role in why young African-American women have more breast cancer than their white counterparts?

SP: Is this harder to find out because we don’t have the same kind of rules about ingredients in cosmetics as we do for drugs?

Davis: Absolutely. There are no requirements for approving the safety of the materials in cosmetics. The European Union, which covers a population larger than the United States, nearly half a billion people, has passed legislation requiring the evaluation and assessment of chemical hazards. So, in Europe, it is illegal to use many ingredients in personal care products that can still be used in the United States. For example, baby bubble bath and shampoo in the United States can contain a product known to cause cancer in male and female rats and mice, which is banned in Europe.

SP: Europe is generally ahead of us in warding off these risks?

Davis: Not only are they ahead of us, American business is losing its competitive edge because of this.

SP: You’re very critical of business and industries from many quarters, but also you point to them as the hope for change with the green movement.

Davis: The greening of business is one of the most positive developments we’ve seen. Our own hospital, the University of Pittsburgh Medical Center, is going green. UPMC covers more than 400 different buildings in five states and four countries. We’re saving water by changing the way we clean and mopping floors with removable micro-fiber mops. These mops help reduce infectious disease rates, use a third as much water and fewer toxic chemicals. Less run-off into our rivers and less damaging exposure to our workers will ultimately lead to less cancer.

SP: Beyond what companies are doing, what can we do as individuals to lessen our cancer risk from potentially hazardous products and chemicals?

Davis: We can look under our sinks and read labels. You can clean most things in your house with baking soda, vinegar, and toothpaste. You can get rid of roaches with boric acid powder. And smart companies are now marketing these things as pesticides. You can buy red pepper in a bottle that says, “repels ants.”

SP: So cleaning products that come with warnings about ventilation and fumes—maybe we shouldn’t be using them at all.

Davis: The world is not without risk. Nor am I advocating a return to the Stone Age. If we have outbreaks of potentially lethal infectious diseases, like dengue and yellow fever, which may come about as a result of the changing climate, we’re going to have to rely on pesticides on occasion. But we have to be smarter about what we use. And that’s the message of the book.

There is a lot of hope out there. As someone who has dealt with cancer in my own family, I know that for cancer patients, hope is the most powerful drug in the world. But meanwhile there’s a lot that you can do to reduce your risk of cancer for your families and yourself.

SP: This might be the place to reassure readers that The Secret History of the War on Cancer is more than an epidemiology textbook, given how the science in the book is interwoven with the stories of your relatives, friends, and colleagues who have battled cancer. Was it a hard book to write?

Davis: Yes. Parts of it were very difficult and even painful to write; other parts felt like they wrote themselves. Like when I was sitting talking to my good friend in Wyoming about discovering that the first organic gardens in the world were at Dachau. I was stunned to learn that the Nazis had an interest in organic farming and that my friend’s grandfather had run these gardens.

SP: There are many such stories in the book, and they help leaven the epidemiology.

Davis: Well, cancer epidemiology turns out to be hard work. There is a story from the Torah that I think is relevant. A group of workers are told they have a job to do and they say, “What are you talking about, this job is way too big. We don’t have the right tools. We’ll never ever be able to finish.” And the Rabbi replies, “It is not up to you to finish the job, but you must begin it.”

The basic federal rules for protecting research subjects, known as The Common Rule, are contained in Subpart A of Title 45 Part 46 of the Code of Federal Regulations (45 C.F.R. 46). Subsequent subparts spell out more specific rules for protecting vulnerable populations, such as children, fetuses, pregnant women—and prisoners, whose protections are detailed in “Subpart C”.

Subpart C’s regulations are highly restrictive, but they only apply to federally funded research carried out by three federal agencies under the jurisdiction of OHRP, excluding 14 others, including the Department of Justice’s Bureau of Prisons (BOP).

At the outset, the IOM report acknowledges that “[p]risoners have been exploited in the past, carrying a heavier burden of the risks of research than the general population.”

The IOM report argues for jettisoning Subpart C’s categorical restrictions on research with prisoners, favoring the adoption of new regulations permitting prisoner research to proceed. The proposed new regulations would clarify when such research might be appropriate (see sidebar). Such clarity would come, says the IOM, from better defining what is meant by “prisoner” and by adopting regulations for all sorts of prison research, regardless of the source of funding.

Arguing that categorically shutting prisoners out of research merely compounds their vulnerable status, the IOM would have regulators decide the appropriateness of including prisoners in research protocols on a case-by-case basis, weighing the risks and benefits in each instance. To assist in such calculations, the IOM calls for bolstering oversight mechanisms and including prisoners’ representatives in the deliberations.

At the outset, the IOM report acknowledges that “[p]risoners have been exploited in the past, carrying a heavier burden of the risks of research than the general population.” (p. 2) “Throughout its deliberations, the committee was well aware of the dark history of research involving prisoners.” (p. 3)

Temple University’s Allen Hornblum, whose writings are among those cited at the end of each of the forgoing sentences, has spent much of his academic life illuminating this dark history. His overview of the sorry history of prison research appeared in the British Medical Journal. He focused on the scandalous and shameful use of prisoners in decades of research at Philadelphia’s Holmesburg prison in his 1998 book, Acres of Skin. In his latest book, Sentenced to Science: One Black Man’s Story of Imprisonment in America, Professor Hornblum returns to Holmesburg to zero in on the story of a single prisoner’s life as an experimental subject.

In an epilogue to Sentenced to Science and in this Science Progress interview with Jeff Stryker, Allen Hornblum explains why he “begs to differ” with the IOM report and how he reads the lessons of history differently.

(Full disclosure: Jonathan Moreno, Editor-in-Chief of Science Progress, was a member of the IOM report committee, and is the author of Undue Risk [Routledge 2001], a history of human experiments conducted for national security purposes. The committee heard testimony from both Allen Hornblum and Anthony Edwards during its deliberations.)

Science Progress: This is a story about one man’s imprisonment. Could you summarize Edward Anthony’s criminal career before we get into his experience as a research subject?

Allen Hornblum: Eddie Anthony grew up in the Village, a tough Black neighborhood in North Philadelphia. He grew up in a large family, with hard-working, church-going parents. But he went in another direction. He got into alcohol, was introduced to pills and codeine, and by the time he was a teenager, he was shooting up heroin. He started to commit various low-level crimes to pay for the drugs. He wasn’t out to hurt anybody. He would steal packages of beef or meat and then sell them on the street, just enough to get another hit or two of heroin. He was about 20 or 21 when he ended up in Holmesburg Prison and first saw the clinical trials taking place there.

It looks pretty forbidding, just from the aerial photo you have in the book.

Yeah. It’s a pretty scary place. It was built in the classical spoke-and-wheel design back in the 1890s and there’s a good many horrendous stories of things that happened there. One of the longer-running ones was the use of the facility to become what I would call the “Macy’s of human experimentation.”

Others said that they had put so many things in their veins already, so being exposed to something else was no big deal.

I first walked into Holmesburg about 1971-72 as an adult literacy teacher. It gave me a shot in the solar plexus to see dozens and dozens of inmates wrapped in bandages and gauze pads and all sorts of medical tape. It looked like they had just had a gang war or some really nasty knife fights in the prison yard. I asked the guard. He said, “Oh, that’s nothing, just the perfume experiments for the University of Pennsylvania.” I just could not fathom that these men, who were pretty nasty and smelly, were testing perfumes. I continued to pepper the guard with questions. “This is a way the inmates make money, they give their skin up,” he said. “You and I wouldn’t do it, but these inmates are crazy. They’re desperate for money, and they rationalize that the University of Pennsylvania and the doctors involved are top-notch.” He said the experiments had been going on for twenty years. I was new, not the experiments.

Everybody took them for granted. I asked the inmates. “What kind of test are you on? How does it affect you? Does it burn? Does it hurt? How much money do you get? How many days?” Some of them were quite frightened of the tests, wanted nothing to do with them. Others said that they had put so many things in their veins already, so being exposed to something else was no big deal. There were all gradations of faith and logic.

The vast majority of experiments were patch tests where all sorts of chemicals and potions were being applied to the inmates. Others were being injected with things. Others were wearing little metal cubes on their foreheads, their armpits, their groins. All sorts of things were taking place in there. It really was a pretty bizarre experience. And that went on from 1951 until about mid-1974.

And these were all hosted or facilitated by the University of Pennsylvania?

You have to understand that Holmesburg Prison probably was the largest human experimentation facility in Cold War America. The doctor in charge, [now retired] Penn dermatologist Albert Kligman was doing Phase One experiments with all sorts of chemicals and potions. He took contracts from all sorts of private and public sector entities: Dow Chemical, the CIA, the Army, and R. J. Reynolds are just a few examples. It was a three-ring circus of investigatory opportunity for doctors and organizations wanting to test on prisoners. Penn and Holmesburg had developed a national reputation in the field of clinical trials. This was the place to come, particularly if you had something that was very potent, unsavory, or dangerous.

And this was basis for your first book on prison experimentation, Acres of Skin?

I spent five years tracking down inmates, doctors, medical assistants and technicians—anybody who had some involvement with the Holmesburg experience. The book got a lot of publicity when it came out in 1998. Former inmates came out of the woodwork, including many I wasn’t able to track down during my initial research. These guys started meeting, initially as a self-help group. Eventually they organized their own campaign to try to achieve justice.

I would periodically bring one or two of them into my classes at Temple. Edward Anthony was someone who had a particularly chilling story to tell. He wasn’t a trained public speaker, but his story really resonated with the students. Eventually I realized I could reach more people if I focused on one person as a narrative, in contrast to Acres of Skin, which is more of an academic overview.

Your descriptions of prison conditions are harrowing. They seem to aimed at explaining why, after literally being burned as an experimental subject, he opted to get involved a few more times.

Edward Anthony’s first test was a skin patch test. He wasn’t getting money from his family. So, needing cash for commissary items and toiletries, but afraid of the tests, he asked his cellmates about the safest test. They encouraged him to get on a skin patch test for—I think it was Johnson & Johnson shampoo or bubble bath.

It didn’t seem like bubble bath.

Not from the reaction he had. He went down to H Block where they turned a cell block into a facility for experimentation. They took off six patches of skin, using scotch tape to take off the first layer of skin. They applied medication on a piece of gauze pad and then they taped that to his back. Almost immediately, Anthony felt and tasted this chemical that they sprayed on his back to hold this large tape mechanism, and he gradually got very dizzy from that. By the time he got back to his cell, he passed out completely, smashed his head on the ground and was eventually revived by his cellmates.

The pain got progressively worse, and by the next day he had these blisters on each of these six sites, these puss-filled blisters. Over the course of the next 24, 48 hours, as he says, he turned into a Black man who looked like a strawberry. His became very, very red and inflamed, with pain and itching in his armpits and his groin. He couldn’t kill the pain. And this went on for a couple weeks. He was all broken out now with little white puss bumps all over his body. He couldn’t sleep at night and was moaning constantly. It got so bad that he was threatened when he went to the chow hall because he looked like he had some sort of bubonic plague. The other inmates said that if he got too near, they would beat the hell out of him.

He was finally visited in the middle of the night by a doctor who took him back to H Block and shot him up with something very potent, I’m presuming morphine, bathing his body in some sort of medication until gradually the situation receded.

Mr. Edwards’ involvement raises questions of medical ethics about payment and inducement and coercion and whether it’s ever possible to do a proper experiment in a prison setting. But for most readers, the biggest question would be, why on earth would he go back for more?

Oddly enough, yes, he subsequently went back for other tests. You have to realize what goes on in a maximum-security urban jail like Holmesburg. There was a tremendous amount of violence, with threats, fear, stabbings, periodic killings, a lot of rape and other sexual assaults. The men felt that having money on the books was one way to be protected. So, he was talked into doing another test and another and another. Some were pretty innocuous, but others really wrecked him, such as the psychotropic drug study for the Army.

What were the Army experiments?

Some of the more serious things were kept secret, not only from the inmates, but from the other people who were employed as medical staff.

Prison jobs paid maybe 15 to 25 cents a day. But being a guinea pig for the University of Pennsylvania could get you a dollar a day, a dollar and a half a day, possibly more for the Army experiments. These started in 1963 and lasted into the 1970s. They were basically a continuation of the U.S. Army’s Chemical Corps work at Edgewood Arsenal, Maryland. For years the Army had been doing experiments at Aberdeen Proving Ground using all sorts of chemical concoctions on inmates. They were looking for chemical incapacitants, things they could spray or give to a foreign enemy that would knock them out of commission.

The Army contacted Dr. Kligman in 1963 about collaborating. As usual, Dr. Kligman said, sure, why not, especially when he heard that there could be some serious money procured from it. Eventually the Pentagon spent hundreds of thousands of dollars, setting up three metal trailers between G and H Block to perform psychotropic drug tests on the inmates.

Edward Anthony was one of the test subjects. And he only went through a very initial phase of it. But it affected him greatly. Whatever the drug was—and it is not clear exactly what he got—did have serious impact on him. He went into a very striking depression, becoming extremely paranoid. He no longer communicated with his cellmates or anybody else on the cell block. Formerly a very upbeat, outgoing guy, he withdrew. He became afraid of people. He attacked another inmate because he thought he was going to be attacked. Eventually he became such a strange character the inmates dubbed him Outer Limits. His acting out on the drugs got him thrown in solitary.

And you never found out what the specific drug was?

No, the inmates were not always told, or what they were told turned out to be inaccurate or downright deception.

I obtained government documents showing that inmates received injections of radioactive isotopes as well as dioxin in experiments for Dow Chemical. It’s the only case I know of where humans purposely had dioxin applied on their faces, foreheads, and backs. Yet not a single inmate I interviewed ever knew about either the radioactive isotopes or dioxin. Some of the more serious things were kept secret, not only from the inmates, but from the other people who were employed as medical staff.

Did the inmates sign consent forms?

Early in the ‘60s there were no consent forms or at best they were merely waivers, signing away the rights to sue the prison, the university, or Dr. Kligman. As human subjects protections evolved in the outside world, by the late ‘60s and early ‘70s, there were more extensive declarations about medical experiments. But remember that most of these men had dropped out of high school and often had an abbreviated vocabulary. If you told them they were getting an analgesic, for example, they wouldn’t even know what that was.

I take it that their efforts to sue were pretty much unavailing?

When you go through some of the things he did, you know, for all your efforts you can’t jettison it.

Their first attorney tried unsuccessfully to cut some kind of deal with the city, the University of Pennsylvania, Dr. Kligman, and a couple of big corporations. But it came to naught and she didn’t even file a lawsuit. Subsequently, when another attorney did file suit, it was barred by the statute of limitations. There were hearings before city and state legislators and talk about helping the prisoners, but it never amounted to more than lip service. This whole experience gave the prisoners a sour perspective on the judicial system in this country to go along with their tremendous distrust of doctors and hospitals.

How’s Mr. Anthony today?

He occasionally is hearty and seemingly robust, but he’s got lots of medical problems. His hands blow up periodically on him. Other days he’s tremendously weak and has difficulty getting out of bed or functioning. He was recently diagnosed with prostate cancer. He’s been going to a mental health center facility for many, many years, diagnosed as paranoid schizophrenic. And it’s a shame, because when he’s feeling good, he wants to work and really can put in a hell of a day. But there are many days where he’s just really strung out physically and emotionally.

When you go through some of the things he did, you know, for all your efforts you can’t jettison it. That was one of the problems initially when I started bringing him to my classes. It brought back such bad memories. He couldn’t sleep before a class; he couldn’t sleep after a class. He really didn’t want to do it. But he realized people needed to hear his story.

Now that his story has been told, what does it mean for those concerned about research on prisoners today?

Going back into prison is a problematic venture. I would not only caution those leaning that way, but vociferously argue that we should follow the Nuremburg Code. As I read it, it basically states that if you are in a confined, constrained environment such as a prison you shouldn’t be used as a test subject for invasive medical procedures and experiments.

I suppose the folks behind the IOM report might say that line of reasoning denies the prisoners’ autonomy and takes away their choice to participate. How do you feel about research that involves prisoners’ actual medical problems, especially conditions more prevalent than in the public at large, say HIV or hepatitis C?

I believe that doing experiments in prisons is a risky, dangerous initiative. It should not be done. In theory, on paper, it looks viable. But as somebody who has spent years working in prisons, who has been in prisons all over the world, it is not something you want to risk doing in that sort of environment.

Take them out of the prison and put them in a hospital. What’s holding them back from doing that?

If people are so interested in protecting and safeguarding the health of prisoners, take them out of the prison and work with them in some other facility, such as a hospital. To think they want to do these cutting-edge medical research projects in prison really does not pass the smell test with me, because the vast majority of these prisons have absolutely putrid medical operations. These prisoners can’t even get aspirins. You mentioned hepatitis. There are cases where prisons just stopped doing tests for hepatitis C—they were finding too many inmates testing positive and it just cost too much. So they decide: don’t look; don’t find; don’t do; don’t spend. When I hear all of a sudden that researchers want to do cutting-edge experimental procedures, it does not ring true to me. There may be some people who have some altruistic goals and motives, but my experience of working in prisons and researching this issue lends me to believe it probably should not be done.

What about better oversight, including having prisoner representatives on the review boards?

The notion that you could have a series of safeguards—running the gamut from having a prisoner on the IRB [institutional review board] to making sure that no one knows who is HIV positive or a study subject—these just don’t not work in the prisons that I have been. Information travels very quickly through a prison.

Are you heaping more on the Holmesburg experience than it can bear? It seems to be the very worst of the prison experimentation experience. Could it be a mistake to extrapolate too far from the Holmesburg situation into the present day?

For those people who want to get research back in prisons, obviously, it is. From my perspective, no. You have the same population in prisons now as you did a quarter century ago.

What about the arguments from the AIDS era that access to clinical trials is itself a human right? What about inmates who are ill and have problems that can only be addressed by experimental therapies?

Take them out of the prison and put them in a hospital. What’s holding them back from doing that? Money. Money.

So, it still all comes back to money?

Absolutely. This is an ongoing story. Money drives this train.

Although sperm banking is now a vital part of this new frontier of baby making, the industry remains largely unregulated in the United States.

Only now, more than 100 years later, is third-party reproduction beginning to shake off this aura as policy changes roil the field in Europe and new attitudes begin to lap up on American shores. In the United States, the U.S. Food and Drug Administration requires that donors be tested for diseases such as HIV and hepatitis while their sperm are frozen and quarantined, only to be released six months later when certified disease free. But today’s “sperm banks” are under no obligation to report numbers of births, place any limits on births to individual donors, track the health of donors, or make information available to children born of donor insemination.

This poses some serious scientific, medical, and ethical questions. Should individual men be able to procreate perhaps hundreds of children anonymously? Over the long haul, what does this mean for human genetic diversity? What about genetic diseases? And should children “fathered” via sperm banks be allowed to know who their father is? These are questions that are only now being asked—despite the long history of “artificial insemination,” as it was once quaintly called—not just in the United States but also abroad. The answers, as we shall see, are as controversial as the questions.

How We Got Where We Are Today

Dr. Pancoast’s tactic—artificial insemination using another man’s sperm—was for decades the only way to redress male infertility. Doctors most often donated sperm surreptitiously in this manner, but the practice really took off after World War II when soldiers returning with war wounds and sexually transmitted diseases faced infertility.

In the 1950s came the advent of technologies to freeze and store sperm. Still, the sperm was most often secured from impecunious medical students who were paid modest sums to masturbate for posterity. Banked sperm was chosen to match the physical characteristics of the infertile husband, and the sperm of the husband and the donor was sometimes mixed to give the husband plausible deniability. Doctors told patients to lie to their offspring about how they came into the world.

Beginning in the 1960s, individual states began updating laws to recognize that, at least where a doctor or clinic was involved, the third-party sperm donor was not a father in any legal sense. Under such schemes, donors would not have any visitation rights or say in the rearing of their children, nor would they be responsible for any financial contributions. In the early decades of sperm banking, these arrangements were seldom called into question, not surprisingly, given how few donor offspring were told the truth about their conception.

Today, approximately two dozen commercial sperm banks operate in the United States. An untold number are also associated with university fertility clinics, banking sperm for pre-vasectomy and pre-chemotherapy and radiation treatment patients—no one keeps track of how many. Nor can it be said with any certainty how many children are born each year as a result of donor insemination, although the most frequently cited guesstimates range between 30,000 to 50,000.

Lesbian couples and women who are single by choice now comprise, by some rough estimates, two-thirds of sperm banking’s clients. The cost: between $255 to $315 for a vial of regular, unwashed sperm that is implanted through intracervical insemination at home; or slightly more costly for sperm that is washed, which means it was prepared for intrauterine insemination by a health care professional and comes with more information about the donor or the promise of donor identity release.

But shipping and storage fees also add up. “A typical bill for conception, which takes roughly six once-a-month inseminations, using IUI, identity-release sperm with a photo match, is between $2,345 and $2,945,” writes Lisa-Jean Moore, medical sociologist and gender studies scholar in her Sperm Counts: Overcome by Man’s Most Precious Fluid (2007).

If sperm donor is a misleading tag, sperm banking is not, at least insofar as it suggests a profit-seeking commercial enterprise.

And who are the sperm donors? Some are young men depositing sperm in anticipation of their own future infertility, including those about to go off to war. But the vast majority of donors—or perhaps more accurately, sperm vendors—are men who sell their semen for $40 to $60 per “donation.” No longer are donors almost exclusively medical men, though doctor semen remains in great demand. Education is still a highly sought-after attribute, with sperm banks seeking donors through advertisements in college newspapers.

If sperm donor is a misleading tag, sperm banking is not, at least insofar as it suggests a profit-seeking commercial enterprise. Market forces shape how the supply of sperm meets the demand. In the early days of sperm banking, race, hair color, and eye color were typically the only traits revealed. Nowadays, buyers still seek sperm of certain ethnicity and physical characteristics; taller men are the rule, no shorties need apply.

But it doesn’t stop there. Some banks offer “premium” sperm, which they maintain comes from donors with doctorates or other graduate degrees. This service is reminiscent of Robert Graham’s notorious “Repository for Germinal Choice,” the California sperm bank that claimed to offer sperm from “geniuses,” including that of a handful of Nobel Prize winners. Graham’s bank operated from 1980 to 1999, creating more than 200 children amid considerable controversy about its explicit eugenic goals and the expectations heaped upon the superbabies, as Slate deputy editor David Plotz recounts in his book, The Genius Factory: The Curious History of the Nobel Prize Sperm Bank (2005).

Today women shop from catalogues of donors in a process that has been called “yuppie genetics.” The banks provide potential buyers with “short form” questionnaires about the desired mix of genetic attributes in the sperm they are purchasing, often supplemented by a “long form” set of answers about the health history of parents and grandparents, interests and education of the sperm donor. Banks claim that questions about health histories are exhaustive, but college-age donors don’t always know all the relevant information about family history and the temptation is great to lie or omit information that might screen them out, in a version of resume fraud.

Increasingly, banks offer pictures of the men as children (and possibly adults) along with audio and even videotaped interviews and poignant and/or cloying “mission statements” about why they’ve chosen to become donors. Here’s one such site, which boasts the tagline Creating Families Through Innovation.

Although sperm banking is now a vital part of this new frontier of baby making, the industry remains largely unregulated in the United States. In other countries, fundamental changes are being wrought in sperm banking practices. Canada and Britain now ban payment to sperm donors. Britain, Sweden, Austria, the Netherlands, and parts of Australia no longer permit anonymous donation, insisting that donors be available to be contacted by their children when the offspring reach adulthood. Some of these countries are establishing registries to help make this possible. These restrictions were put in place despite concerns they could dry up the pool of willing donors.

Do U.S. Sperm Banks Need More Regulation?

Occasional sperm bank scandals have brought episodic attention to the state-wide industry, if not much reform. When Cecil Jacobson, the renowned physician and infertility specialist, was discovered in the early 1980s to have inseminated as many as 75 women coming to his Virginia clinic with his own sperm (unbeknownst to them), prosecutors weren’t sure he had committed any crime. He was eventually convicted of 52 counts of mail fraud, wire fraud, and perjury and served time in federal prison, losing his medical license.

Such occasional scandals are outliers, say the bankers, not cause for further regulation. “More regulation of sperm banking is a solution in search of a problem,” says Sean Tipton, a Washington, D.C.-based spokesperson for the American Society of Reproductive Medicine, which is headquartered in Birmingham, Alabama. “The danger with more regulation, like more genetic testing or changing the rules about anonymity, is that you give up important autonomy and privacy at great economic expense. It is not clear what you gain.”

Wendy Kramer, a Colorado single mother and founder of the Internet-based Donor Sibling Registry, doesn’t agree. She is perhaps sperm banking’s most vocal and visible critic. “Sure, there is some regulation at the front door, screening the men who come in,” she concedes. “But what about afterwards, when the births occur? No one in the industry cares by then.”

Kramer was inspired by her son to found the Donor Sibling Registry as a Yahoo users’ group chat room seven years ago. Her son Ryan, now a handsome 17-year-old in his fourth year of college studying aeronautical engineering at the University of Colorado at Boulder, was eager to find any half-siblings. In fact, Ryan’s curiosity was even more precocious. At age two she recalls him asking, “Is my Dad dead, or what?”

Wendy Kramer conceived her son Ryan with sperm from a local bank in Colorado. “The lady at the bank just suggested a sample from someone who looked like my husband.” (She’s now divorced.) “I suppose I got the ‘high octane,’” she joked, proudly sharing stories about her bright young son’s college career.

DSR has grown from a chat room into a thriving website. At last count, the registry had more than 9,000 registered members, including parents of donor-inseminated children, some children themselves and donors who post their donor numbers and profiles to facilitate matches with families of their offspring. More than 3,800 matches have been made with half siblings or donor fathers.

After six and a half years of searching, Ryan Kramer found a half sister and was match number 2,910. “This little 13-year-old girl was just beside herself to have an older brother,” says Ms. Kramer. “I don’t try to define their relationship. They’re teenagers. They ‘IM’ [instant message] each other,” says Ms. Kramer.

The sperm-banking industry tends to dismiss the yearning to find genetic heritage and the worrying stories from DSR match ups as “anecdotal.” Says ASRM spokesperson Sean Tipton: “I don’t draw any conclusions from the Donor Sibling Registry. I don’t know if there is any counterpart organization for happy children of sperm donors.”

But even if data is not the plural of anecdotes, some of the anecdotes are enough to give one pause. Medical concerns in particular are a frequent topic of discussion when families get together on the Donor Sibling Registry. As will be detailed further below, one set of families discovered that five different children born of the same donor were all autistic. Other parents of donor children suffering from genetic diseases have found half siblings sharing the same illness.

Yet sperm banks have frequently refused to contact other potentially affected children, track down the donor, or even pull the sperm from the shelf. Most of these discoveries have come from Internet-abetted detective work, but some are even more serendipitous.

Case in point is Laurence A. Boxer, a University of Michigan pediatric hematologist and an expert on severe congenital neutropenia, a disease of white blood cells affecting only one in 5 million children. Yet Dr. Boxer had four families show up in his office with children suffering from the disease. As Dr. Boxer and his colleagues reported in the Journal of Pediatrics last year, the culprit is almost certainly a sperm donor the children shared, donor #827 from International Cryogenics in Birmingham, Mich. The donor has moved and the sperm bank cannot locate him. The bank had supplied the donor’s sample to a university laboratory for testing, but the lab would not complete the tests because it could not secure the consent of the donor.

Such cautionary tales have inspired some Internet-age consumer activists. Kirk M. Maxey is a physician who was a paid sperm donor while working in Kalamazoo, Mich. and attending medical school in nearby Ann Arbor. He stopped donating after a worker at the sperm bank where he made his deposits claimed she had purloined his sperm to impregnate herself.

While still in medical school, Maxey had founded a company to produce biochemicals and assays for use in biomedical research. Three years ago, Dr. Maxey added a non-profit arm known as the Cayman Biomedical Research Institute. It operates the Donor Semen Archive. Says Maxey of his efforts:

“I come from a background of extreme mistrust of the banks. I don’t think they tell the truth. I don’t think they are careful because they have no real accountability. They hide all their records and no one can catch them unless they blunder over their own mistakes.”

Maxey’s Donor Semen Archive stores donor-related DNA samples retrieved from the vials and syringes used in insemination and from the children themselves, logging genetic sequences to make it easier when questions come up about genetic health and identity. “The Donor Semen Archive is just a molecular version of the Donor Sibling Registry,” explains Dr. Maxey. “If a bunch of Moms think their donor was ‘Donor No. 65,’ for example, we can tell whether it was really the same guy.” The Donor Semen Archive is poised to join forces and offer its services through the Donor Sibling Registry.

Ben now uses an Excel spreadsheet to manage relationships with the families of his 28—count ‘em, 28—donor offspring.

Concern about unwitting transmission of genetic disorders from sperm donors to many more children than would be possible in conventional families is one factor driving calls for more disclosure, traceability, and limits on the numbers of children born to a particular donor. Consider Ben, a 29-year-old practicing lawyer who masturbated his way through a Washington, D.C.,-area law school, earning about $30,000 to help pay for tuition.

Ben asked that we not publish his last name because he’s not ready for the whole world, including his professional colleagues, to know about his donor career. He explains that he saw the anguish two cousins endured trying to get pregnant, struggling through many expensive cycles of in vitro fertilization. He figured his sperm donations could help people experience the joy of parenthood, while helping to finance law school.

“It wasn’t exactly hard work,” Ben quipped in a recent phone interview. Yet as a frequent depositor at his local sperm bank, he may have spread more joy than he reckoned.

Ben, explains Wendy Kramer, is one of her “brave donors,” who posted his story with his donor number on the Donor Sibling Registry and permits contact from families who have purchased his sperm. Ben now uses an Excel spreadsheet to manage relationships with the families of his 28—count ‘em, 28—donor offspring.

“It is just easier not to mix them up that way,” he says. Ben is only a few years out of law school. His dozens of kids are still of pre-school age. Most of the contact from parents involves email questions about his health status and genetic history.

But Ben is not the bravest donor on Wendy and Ryan Kramer’s site. “I think our record is 64,” says Ms. Kramer of the number of offspring discovered by a donor registered with the Donor Sibling Registry. “We have other donors with children numbering in the 20s, 30s or 40s, says Kramer. “Some pull back after hearing about a few children, they just can’t take it emotionally.”

Other donors, however, are “lurkers,” she says, who visit the site to read the discussion threads but do not officially register, not sure whether they want to commit to being contacted. Official members pay DSR a $40 fee to be able to post information such as donor numbers or sperm bank and donor characteristics data to facilitate matching up with relatives. See how to use the site at www.donorsiblingregistry.com/howDoI.php

What To Do?

When told about Britain’s recent limit on donors to creating 10 families, Ben wasn’t sure about importing such restrictions to the United States. “Why not nine or 11,” he asked. “Any limit would have to be incredibly arbitrary.” Moreover, Ben is not sure that mandating donor identity release is warranted—even after opening up to contact from families who relied on his sperm for one or more of their children.

The question of whether to require identity release—that is, to allow children to contact their donor father when they come of age—is perhaps the hottest topic in sperm banking.

Ellen Singer, a social worker and adoption program specialist with The Center for Adoption Support and Education, Inc., a non-profit organization with three offices in Maryland, says that sperm banking lags far behind the adoption field in terms of regulation and oversight. “There are still professionals who advise parents not to tell their children that they were a result of donor insemination or donor eggs,” she says.

But views are evolving. Singer sees disclosure as a human rights issue. “Kids need to know the truth about their conception,” she argues. “That doesn’t mean the whole world has to know, but the kids should.”

Who knows what is in the best interest of children born to sperm donors? Clinicians? Regulators? Parents? What about the children themselves?

But Singer empathizes with parents who worry about stigma. “The secrecy can be well-meaning and intended to protect the children,” she says. “But children don’t need protection, they need the truth and ways to cope with the challenges that come with it.” The American Society for Reproductive Medicine now advises parents to disclose to their children the details of their conception, even though it opposes more regulation of the industry.

Some sperm banks have been factoring in those privacy vs. disclosure issues for some time now. The Sperm Bank of California, a non-profit outfit established in Berkeley to cater to a largely lesbian clientèle, has offered identity-release semen for more than 20 years. That means the first children born with the option to contact their donor when they turn 18 are now coming of age—and some are beginning to do so.

U.S. sperm banks are increasingly offering donor identity-release sperm as an option. “It goes faster and costs more,” says Lisa Jean Moore, who teaches at Purchase College, State University of New York. Moore is a former board president of The Sperm Bank of California. She is also the parent of two daughters, one born with sperm supplied by a friend, the other with sperm purchased from a bank.

But not everyone thinks imposing more regulations is a good idea. Gays and lesbians, as well as single mothers by choice, may have some misgivings about how sperm banking operates, but many are nevertheless wary of opening the door to regulators who may have much more cramped notions of what should constitute a family. A lesbian couple from Colorado who found out on DSR that their daughter has more than two dozen half siblings emailed the author to say:

We would not support government regulation at any level. The government has a history of discrimination against LGBT [lesbian, gay, bisexual and transgendered] families and individuals, and we would not want to open the door to the government prohibiting sales or contributions from LGBT people.

As journalist Liza Mundy writes in her wide-ranging Everything Conceivable: How Assisted Reproduction is Changing Men, Women and the World (2007), crafting progressive policies is a challenge in this field. “[I]n this area of reproductive science, ‘progressive’ is a hard concept to pin down.” Indeed, almost everyone connected in any way to the field of assisted reproduction gives lip service to the “best interests of the children,” even though sperm banks are set up to meet the needs of doctors, patients and parents.

But, in practice, children’s best interests can be notoriously difficult to pin down. Who knows what is in the best interest of children born to sperm donors? Clinicians? Regulators? Parents? What about the children themselves?

Deborah Spar, a professor at the Harvard Business School, has examined sperm banking as part of a larger look at the reproductive marketplace, including the practices of buying and selling sperm and eggs, renting wombs, and brokering adoptions. Spar, the author of The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (2006), says she attributes the lack of political interest in regulating sperm banks to the relatively small size of the industry, politicians’ reluctance to enter the fray of reproductive decision making, and a general squeamishness about semen.

“No one likes saying the word sperm,” she explains. “Plus, the egg extraction process is surgical, but the sperm extraction process is sexual.”

Still, Spar believes such squeamishness will give way to calls for more regulation, and does not buy the argument that “as soon as you let the government in they’ll be saying that only heterosexuals can have children.” She says “there are lots and lots of places to stop along the spectrum between no government regulation and the government telling me when I should have my child and what I should name him.”

Besides, a new vocal constituency for reform is about to come of age. “It is going to be the sperm babies who are going to push for donor identification and recordkeeping,” Spar predicts. “That is what is going to spur a political debate and wake people up to the medical issues involved.”

She may be on to something. As Wendy Kramer explained, “My son Ryan is 17 and he is the tip of the iceberg. Ryan can’t even be on the Board of Directors of the Donor Sibling Registry, even though he helped found it and he’s in his fourth year of college. At least until he turns 18, that is.”

Ryan Kramer turns 18 next spring. Watch out.

Jeff Stryker is a Connecticut writer specializing in health policy and bioethics.

Here is a list of the books mentioned in the article, with links to their pages on Amazon.com:

Lisa Jean Moore, Sperm Counts: Overcome by Man’s Most Precious Fluid (New York: New York University Press, 2007).

Liza Mundy, Everything Conceivable: How Assisted Reproduction is Changing Men, Women, and the World (New York: Alfred A. Knopf, 2007).

David Plotz, The Genius Factory: The Curious History of the Nobel Prize Sperm Bank (New York: Random House, 2005).

Debora L. Spar, The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception (Boston: Harvard Business School Press, 2006).