3-19-12

Robin Lindley is a Seattle writer and attorney. He contributes interviews and other articles to the History News Network, Crosscut, Real Change, and others.

No one should approach the temple of science

with the soul of a moneychanger.

--Thomas Browne, Religio Medici

As demonstrated by the Occupy movement, citizens across the United States are increasingly concerned about how large corporations are encroaching on every aspect of their lives. They question rampant deregulation, corporate takeover of democratic processes, and the greed of a few that results in misery for many.

Biomedical ethicist and historian Harriet A. Washington has studied how this incursion into our lives is reflected in big medical technology and drug corporations—the “medical-industrial establishment.” She argues that these private companies have become more concerned with profits than patients as they rush to own and exploit the raw material of human life itself, especially since watershed legal changes in 1980 that have led to the granting of more than 40,000 patents on human genetic material, often without the consent of the human “donor.” As a result, she contends, corporate control of patented molecules and tissues has stymied critical innovation and competitive research that could save lives.

In her new book Deadly Monopolies: The Shocking Corporate Takeover of Life Itself—And the Consequences for Your Health and Our Medical Future (Doubleday), Ms. Washington recounts the transformation of medical research from the altruistic domain of universities and non-profit organizations to large corporations, and the development of drugs based more on fiscal gain than patient need. She also recounts the stunning erosion of informed consent in research—a core ethical value from the Nuremberg Protocols; the commoditization of human bodies; compromised medical ethics; and the use of the developing world as “the laboratory of the West.”

Ms. Washington also wrote Medical Apartheid, which won a National Book Critics Circle Award, the 2007 PEN Oakland Award, and the 2007 American Library Association Black Caucus Nonfiction Award. She has been a fellow in medical ethics at the Harvard Medical School, a senior research scholar at the National Center for Bioethics at Tuskegee University, a fellow at the Harvard School of Public Health, and the recipient of a John S. Knight Fellowship at Stanford University.

Ms. Washington recently discussed her research and stunning findings by telephone from her home in New York City.

What inspired you to take on the pharmaceutical industry in Deadly Monopolies?

I don’t see it as an attack on the pharmaceutical industry, and I don’t mean to be disingenuous. From my perspective, I am going to the defense of people who are too often ignored, people whose lives are not valued. That was my concern: that so many things were happening to separate people from medical treatment in this country and in the developing world. You have all these silent victims of drug company greed; people who are dying for lack of medications or who are abused in research studies.

Did this book grow out of your research for Medical Apartheid on the treatment of African-Americans in medical research through U.S. history?

What it has in common with Medical Apartheid is that I was thinking of faceless victims who are being used or affected. That was the reason for the book, and as I traced their story, I found so much was rooted in corporate greed.

It seems your study of biotechnology and the medical-industrial complex is almost a microcosm of concerns now about inequality, treatment of vulnerable people, and lack of regulation of private industry.

That’s right. The same issues and problems that we’re facing elsewhere politically, socially and economically are infecting the medical arena, too.

As I did the research, I found that concerns that traditionally affected marginalized people have encroached into larger populations. It used to be that [research was conducted] with African-Americans or Hispanics or Native Americans without consent, but now every American, any one of us—you and I—can be enrolled in a study without our consent. The abuses—the lack of informed consent, the lack of transparency, the coercive research—are happening in wider and wider populations. Now it’s not racial animus but economic greed unfortunately that motivates coercive research or abusive research.

Your larger story deals with the corporate takeover of human life itself. You posit that two developments in 1980, the Bayh-Dole Act and the U.S. Supreme Court decision in Chakrabarty v. Diamond, both opened the door to patenting of human genetic material and dramatically changed medical research.

1980 was a watershed year. Before 1980, medical research tended to attract people who were driven by things other than money: by making their mark on science or making landmark discoveries. Money was seen as an unworthy motivation.

There were many researchers who refused to sell patents, and some who sold patents for a dollar. Selman Waksman made a discovery [the antibiotic streptomycin in the 1940s] and licensed the patent to a company but was so afraid of what people would say if they knew he sold to a company for profit that he persuaded the company to return the patent and the drug was sold cheaply.

Jonas Salk developed the polio vaccine with funding from the March of Dimes. He knew he was sitting on a gold mine, yet he and the March of Dimes decided not to patent it but to keep it in the public domain. He was asked who had the patent on the vaccine and he said, “The American people I guess. Could you patent the sun?” For him, patenting this for money was unthinkable.

But in 1980 everything changed when [the Bayh-Dole Act permitted] researchers to legally use government funds for medically important molecules and modalities, and then sell these to industry.

The Bayh-Dole Act was initially defeated, but after Jimmy Carter’s defeat, there was an emergency session of Congress on financial legislation. Birch Bayh brought up the patent bill again, and it passed about an hour before the end of the session through political intrigue and not through a well-considered debate about its consequences.

The Chakrabarty decision for the first time established that a living thing could be patented. Up to then, living things could be patented that were technically products of nature [but] when you got a patent on one of these things, there was often a legal challenge. For example, when [Jokichi] Takemine got a patent on adrenaline the patent was challenged on this “product of nature,” which he did not invent but discovered. Louis Pasteur isolated yeast and got a patent on it and the argument was that he shouldn’t get a patent on it because it was a product of nature and he didn’t invent it.

But both times they used a “hand of man” argument that “the inventor” gave the entity value and did the work that made the entity patentable. They were not claiming the inventor made the entity out of whole cloth, but the inventor manipulated the entity in such a way to something that had a value. I have read enough lawyers’ work and spoke with experts in the field to know that there’s a lot of controversy about this issue. It is not universally accepted that the “hand of man” imparts value and provides a legal basis for a patent, and this is hotly debated.

[Since 1980] we have a situation where universities can sell or license to private companies the fruits of researchers’ labor that was subsidized by the tax dollars of the American people. Also, these patents include things that are living: organs, cell lines, tissues, anything. Medically, this has huge significance because corporations assume the control of medical research by paying to license the patent and then owning the patent.

It’s important what corporations do with the patent, but also what is not done. Researchers were working on the BRCA2 genes for breast cancer on which nine patents have prevented them from pursuing research. The [patent holder Myriad] said that we hold patents on these genes and you cannot do research on them without getting permission from us. Permission was only bought with a huge licensing fee. For breast cancer, this was significant because there were fewer people working on treatments and cures, and a corporation designated who could and could not work on treatments or cures.

That’s an example then of how patent law has restricted innovation.

Yes, it has—dramatically. I wrote a book about hepatitis C in 2000. I learned that Chiron has 100 patents on the hepatitis C virus. I asked researchers and they said, “It’s not a problem,” [but] I found that they are dependent on the goodwill of Chiron. If one company has a patent on the virus, you’re only working on that virus because they have allowed you to do so. Researchers are not interested in alienating the company that permits their research. I now understand that it indeed had a chilling effect. They were charging a very large licensing fee.

In England, another company devised an effective test for the hepatitis C virus that was being used by the National Health Service. Chiron told this company they could no longer do this and that they could not sell their test. The National Health Service now has to use Chiron’s test, and the test is now so expensive that they are pulling back on when they will give it now.

So there is a huge chilling effect multiplied many times by corporations that hold these patents.

The case of John Moore illustrates the effect of the new legal structure.

John Moore had leukemia and had surgery and his 22-pound spleen was extracted. I think a normal spleen weighs no more than four pounds.

Moore lived in Alaska, and was summoned periodically for follow-up tests. At some point, his doctor, David Golde, asked Moore to sign a form giving Golde all rights to the fluids and discarded tissue taken during surgery. Moore consulted a lawyer who discovered that Golde kept John Moore’s spleen in a laboratory, and also [had taken] out a patent on the products of Moore’s body. With that patent, Golde estimated the value of these tissues and what he would do with them at around three billion dollars.

Moore went to court and said no one told him that his tissues were valuable or that [Golde] appropriated them. He did not want a patent on the products of his body, and he sued to have the patent invalidated and returned to him.

What really struck me was not only that Dr. Golde and his university—the patent holders—but a lot of other research universities joined the opposition to Moore. All these powerful research organizations [opposed] this lone, sick patient. And the court went along with this argument for fear that medical research would be stymied. How much can one lone patient wield against a university and people who are eager to profit?

And there’s a sense that universities are altruistic and working for the public good.

That was true before 1980.

I don’t expect corporations to be altruistic. They’re in business to make money. But universities existed not to make money but for the public good. Research was done for things the people really needed such as drugs or treatments. But now, universities more resemble arms of corporations.

Can you talk about the role of the government and how money from taxpayers is used? Was it different before 1980?

Before 1980, universities could not hand over their patents to corporations and medicines were cheaper. Why did Medicare completely ignore prescription medication? It’s because Medicare was enacted in 1965 when medicines were not expensive. They’ve become expensive because corporations now control the pricing structure.

Now medications are very expensive. Some medications cost as much as $20,000 a year, or $100,000 a year, and even more. Why are they so expensive? The drug companies point to the costs of research and innovation and they only have a short time—20 years—to recoup those under patent. They [argue that they] pay for the cost of developing these drugs at $800 million to two billion dollars a year, and they also say they have to cover the costs of all those drugs that they try to bring on the market every year that fall by the way side.

Basically, when you remove all the distortions, you get research costs of closer to a million dollars, not the two billion dollars they cite. What really dictates drug costs is what people are willing and able to pay for their lives. It’s no accident that the highest prices are for [drugs] for the deadliest diseases, the most dreaded cancers, and they charge hundreds of thousands of dollars a year.

And the government has failed in its responsibility to impose a pricing structure on drug companies.

You suggest that the Food and Drug Administration is compromised now. I was surprised that much of its funding comes from the drug industry while it is responsible for insuring drug effectiveness and safety.

It’s sad. I think every agency should be independent of corporate or other extraneous influence.

To show how the FDA used to work, its pharmacologist Dr. Frances Kelsey refused to approve thalidomide [in 1962]. While other western countries wound up with thousands of babies with profound birth defects because of thalidomide, we escaped because the FDA saved us when the FDA was not driven by corporate concern. The company complained, and the FDA said we’re not going to approve your drug and you can go ahead and sue.

That doesn’t happen today, partly because [the FDA] takes so much money from corporations for the approval of drugs. I can’t imagine that you can take money from the companies and yet not have a conflict of interest.

The FDA really needs to be independent and it’s not. You have people within the FDA intent on doing the right thing, but the agency itself is causing problems.

The FDA story reflects the general eroding of regulations.

That’s right. [Corporations] have lobbyists who draft legislation that is diametrically opposed to the needs of the American people. I don’t expect these corporations to do the right thing for the American people so it’s so important for the government to control them. The government needs to exert pressure on these companies and make sure that, while they’re making large profits, they’re also addressing the health needs of Americans.

You also detail the erosion of informed consent in research conducted in this country. Today’s concept of informed consent arose from trials of Nazi war criminals after World War II.

Yes, it came out of the Nuremberg Trials. An American prosecutor confronted the Nazi physicians [who] used medical research as a cover for abuse, torture and murder of Jews.

The Nuremberg Code was developed by American physicians and the number one tenet was that the voluntary consent of the subject was absolutely essential. There’s no ambiguity. If you haven’t obtained voluntary consent after explaining everything about the research and its possible risks and benefits, then you’re committing a crime.

There was a strong feeling that the Nazi barbarians needed a code and needed strict scrutiny, but there wasn’t any corresponding sensibility about American physicians. The attitude was “we can police ourselves. We’re doing God’s work. We don’t need anyone looking over our shoulders.”

We in this country don’t take informed consent seriously enough, in my opinion, especially as something that physicians are bound to do. In 1996, the Code of Regulations was changed to exempt large portions of the American population from informed consent. The military was excluded. The Department of Defense wanted to test experimental anthrax vaccine and didn’t want to ask permission of millions of service people. They got a waiver of informed consent so they could force this [test] on the military, and they did that. People who refused were court-martialed and thrown out of the service. Many who accepted were injured—no one knows how many—and some people died. The company that developed [the vaccine] got a stream of letters from the FDA and was censured for poor laboratory conditions. It was a huge mess. Finally, in 2005, a federal judge invalidated the tests, and said you can’t use the military as guinea pigs this way.

And [with the 1996 regulation] anybody who is a trauma victim is at risk of being an experimental victim on the pretext that he or she is unconscious and unable to give informed consent and that’s still in effect.

The Northfield Laboratories tested their artificial blood PolyHeme in Atlanta on 720 people who never gave their consent, and it turned out that the people who received this product died or had heart attacks at a higher rate than people who had not. And the research is still underway [and], two years ago, they had used 14,000 patients who never gave their permission to be in a research study.

You lay out the elements of informed consent, and it’s more than simply signing a form, contrary to what many people think.

Yes, people think that way, but it’s not just signing a paper, despite what a doctor or researcher may say.

Informed consent means that a researcher has to explain to the subject why they’re doing the study, what is tested, how the study is structured, and what the person’s options are. You also have to reveal adverse reactions, and that other [problems may arise]. You also need to tell the person—no matter what the person has been paid—that the person can drop out of the study at any time. At no time can they be made to stay in the study. Many people don’t understand that, especially if they’ve been paid and signed an agreement. Finally, the informed consent responsibility of the researcher persists any time new information emerges that can have any effect on the person in the study.

So signing the paper is nothing more one bit of evidence that the researcher can use to document [that] he or she provided all of this information

You write of the use of tissues and other biological material from the recently deceased without consent.

That’s right. Municipal laws permit coroners to take tissues without telling [family members]. Technically, the tissues are not sold [but] go from the coroner’s office to a broker, to another broker, to a hospital, to a surgeon. At each point of transfer [someone] is paying.

The message given to everyday people is altruistic: you’re giving the gift of life as a donor. That’s very noble and very generous for people who depend on these organs to live, but we’re treating the “donor” as an altruist while everyone else is demanding fees for the tissues. And those are cases that are consensual. Many of these cases are not consensual.

Everyday people don’t know [that under] these “presumed consent” laws, the coroner, unbeknownst to the family and without permission, can take tissues from the person who passed away without anyone’s permission. Then the coroner and brokers, the hospitals and the surgeons, command large fees for the tissues.

Public service announcements on tissue and organ donation stress you’re being generous and it’s a good thing for society, and I agree with that. What I don’t agree with is “donation” based on altruism and everybody else making a hefty profit.

Also, people aren’t aware of how the tissue is used.

It was surprising that the bodies of infants and children are used in crash tests—without any consent for that use.

That was heartbreaking and I was shocked at the callousness. We need safer cars, but people need to know that this is what they’re agreeing to and it has to be voluntary. And in the case of children who can’t give their own consent under the law, it’s even trickier. I'm really uncomfortable in using children because they don’t have any basis for giving consent. I find this indefensible.

You also write of “biopiracy” or “biocolonialism” and how corporations use the developing world as the “laboratory of the West.”

We had never considered the needs of the people of the developing world as a priority. We have always used them for our own medical ends.

At medical history conferences, some experts say that before the Europeans went there, the average age of death was 30, and after the European incursion the live expectancy almost doubled. My first reaction was that is only seemed longer. (Laughter) The Europeans exploited the country, enslaved people, and forced them to work for them. But that point needed to be addressed. That also happened in America where people would point to slaves and say, “But they’re living longer than normally would be and we take good care of them because we need them.” But what about the quality of life? Was your health better? Your health and your fitness for work are two different things. It’s well known that disease was rampant and new diseases were introduced. So that’s a questionable argument.

If life expectancy was improved, it was so these people could work. The idea was that these people were viewed for their utility. What was their value? They could work in the mines or clean my house or care for my children.

The same thing happened in the medical arena. People exist from the point of view of the West to provide for the needs of the West. Research companies conduct research that they cannot or will not conduct in our own country. And for a long time, that’s exactly what was done.

I cite a letter on research in Africa that defends the lack of informed consent because the people are too ignorant so “we can do what we need to do.” If you look at early physician and researcher accounts, they’re often frank, saying we’re doing our research here to suit our needs in the West and not put white Europeans or Americans at risk.

Michael Kremer reported that, in a recent 20-year span, of approximately 1,300 drugs developed by pharmaceutical companies, only four medications were designed for people in the developing world.

So they’re not doing [research] for the people there. Even if they were developing for those nations, there’s not a market for them. The entire continent of Africa makes up only five percent of the market for pharmaceuticals. The people there cannot and do not buy overpriced medication.

According to the New England Journal of Medicine, now one of every three clinical trials by pharmaceutical companies is conducted in developing nations [because] they can be conducted much more cheaply and much more quickly than they can be done in this country.

People in the developing world are providing great advantages and value to Western researchers. When you devise a drug that is used in the developing world it is repurposed to something the people in the West can use. A drug for sleeping sickness is an example [which was developed as a depilatory in the West].

And aren’t the people in the developing world providing tissues and other genetic material that can be patented?

That’s right. And it is patented. Also, in the developing world, researchers will descend upon an area and take [indigenous] plants and animals and even tissue back to this country and get patents on them. And many times the people from whom these things are taken never know what use will be made of them.

Sometimes the researchers are sadly abusive. There was a patent taken out on neem [a tree native to east India with many traditional medicinal uses], for example, that’s been used and treasured in India for thousands of year. Yet a patent was taken out by a Western corporation. That patent was eventually reversed. But another patent that was not reversed was on yage [or ayahausca, a psychoactive plant used in traditional medicine in Brazil]. That was crazy.

These entities are appropriated and patented as used in this country. When they’re taken from another land, our government says we need to protect our intellectual property. But it’s not ours. When you take a thing like neem, it’s not a Westerner who [discovered] what it was used for, but the [Indians] knew of its use, so it’s their intellectual property, yet we [patent it] in the name of protecting our intellectual property.

Our laws are written in such a way as to destroy the intellectual property of the developing world. We only have to prove that something is novel in this country. The person who got the patent on yage had to prove only that nobody in the United States had used it, not that nobody on the Amazon had used it. So we completely disregard their intellectual property.