Law
11:36 am
Mon October 24, 2011

'Deadly Monopolies'? Patenting The Human Body

Originally published on Mon October 24, 2011 2:52 pm

In 1980, the Supreme Court ruled that living, human-made microorganisms could be patented by their developers. The ruling opened the gateway for cells, tissues, genetically modified plants and animals, and genes to be patented.

In the past 30 years, more than 40,000 patents have been granted on genes alone, says medical ethicist Harriet Washington. In her new book, Deadly Monopolies, Washington details how our tissues and genes are increasingly being patented by pharmaceutical and biotechnology companies. Those firms, she argues, are focused more on their profits than on the medical needs of patients.

Restrictive patents on genes prevent competition that can keep the medical cost of treatment down, says Washington. In addition to genes, she also points to tissue samples, which are also being patented — sometimes without patients' detailed knowledge and consent. Washington details one landmark case in California in which medically valuable tissue samples from a patient's spleen were patented by a physician overseeing his treatment for hairy-cell leukemia. The physician then established a laboratory to determine whether tissue samples could be used to create various drugs without informing the patient.

"[The patient] was told that he had to come to [the physician's] lab for tests ... in the name of vigilance to treat his cancer and keep him healthy," says Washington.

The patient, a man named John Moore, was never told that his discarded body parts could be used in other ways. He sued his doctor and the University of California, where the procedure took place, for lying to him about his tissue — and because he did not want to be the subject of a patent. The case went all the way to the California Supreme Court, where Moore lost. In the decision, the court noted that Moore had no right to any share of the profits obtained from anything developed from his discarded body parts.

"If they're his cells and medically viable agents are being derived from his body, it seems intuitive to me that he should be the one to decide what's done with it," says Washington. "I think we can't forget that money is not the only question here. Money is important for the corporations ... Money may be less important to [the patient] than his bodily integrity and about his rights to informed consent and his rights of autonomy to choose what should be done with his body."

Another patient, a hemophiliac, was told by his doctor that his blood contained highly concentrated amounts of antibodies that could be highly valuable for other patients. He started a company to market his blood. But he also gave his blood away for free to other companies and noncommercial researchers. Washington writes that the patient "rewrote the rulebook" by understanding that "donating and selling tissues are not mutually exclusive."

The Relationship Between Universities And Pharmaceutical Companies

Before the 1980s, it was rare for university researchers to obtain patents on their products, says Washington. She points to Jonas Salk, who developed the polio vaccine.

"Edward R. Murrow said to [Salk]: 'This vaccine is going to be in great demand. Everyone's going to want it. It's potentially very lucrative. Who holds the patent?' And Salk said, 'The American people, I guess. Could you patent the sun?' This was the norm," she says.

But since the 1980s, researchers at universities and the pharmaceutical industry have become collaborators in ways that they weren't before, says Washington. The 1980 Bayh-Dole Act gave universities and small businesses control of their intellectual property — which allowed them to sell their patents.

"Before the 1980s ... most researchers worked within a university culture which encouraged free discourse without necessarily a potential product in mind," she says. "It encouraged collaboration and data-sharing, and the values held by medical researchers were values of academic excellence, medical achievement, altruism ... these were the motivations. Now that the patent is based upon the value of exclusivity, the corporation discouraged very strongly and prohibited data sharing. ... This culture of the corporation has overtaken the medical research culture."

Universities get money and support from the pharmaceutical companies for their research efforts. In turn, a pharmaceutical company can potentially buy or license a patent for a molecule or gene from the researcher — which is even more lucrative, says Washington.

"Once they have done that, they will hopefully emerge with a medicine," says Washington. "Now they can decide what to charge for it. And in this country they can charge anything they like."

She notes that the relationship between universities and pharmaceutical companies is different now than it was in the past.

"Very often, medical researchers would not sell a patent. [They] would hold the patent on the medicine — not sell it to anybody — which means that it could still be manufactured and sold by corporations, but they had no exclusivity," she says. "[The pharmaceutical companies] could not charge this astronomical price, because customers could simply go elsewhere for it."

Washington is also the author of Medical Apartheid, which received the National Book Critics Circle Award. She has been a fellow in medical ethics at Harvard Medical School, a senior research scholar at the National Center for Bioethics at Tuskegee University and a fellow at the Harvard School of Public Health.

Copyright 2013 NPR. To see more, visit http://www.npr.org/.

Transcript

TERRY GROSS, host: When you think about patents, you probably think about new inventions and products. But now genes, tissues and living organisms are being patented. How these new biological patents are affecting medical and pharmaceutical research is explored in the new book "Deadly Monopolies" by my guest Harriet Washington. She's been a fellow in Medical Ethics at the Harvard Medical School, and is senior research scholar at the National Center for Bioethics at Tuskegee University. Her earlier book, "Medical Apartheid," won a national Book Critics Circle Award.

Harriet Washington, welcome to FRESH AIR. So living organisms, plants, are now being patented, which is a really kind of interesting development. Would you give us an overview of some of the living material that's being patented now?

HARRIET WASHINGTON: Well, according to a 1980 Supreme Court decision, Diamond versus Chakrabarty, anything that's living can be patented, in theory. Now, usually, experts exclude entire human beings from that, because it's thought to be precluded by anti-slavery statutes. But aside from that, your cells, your tissues, almost anything - medically important plants and animals such as Harvard's Uncle Mouse, a mouse that was genetically modified to (unintelligible) certain cancers. Anything can be patented. And once patented by a university, the patent is then sold or licensed to corporations typically, and the corporations exploit those patents.

GROSS: So tell us the story of John Moore, whose tissues were patented. He discovered that his doctor had patented the unusual products of his oversized spleen. What was the doctor patenting from John Moore's spleen?

WASHINGTON: Exactly. This happened shortly after the 1980 ruling that allowed patenting of living things. John Moore had developed hairy-cell leukemia, and his doctor told him that he would need immediate surgery to save his life. His father, Moore's father, who was also a doctor, urged him to come back to L.A. and be treated by a blood expert there, Dr. Golde. Dr. Golde oversaw John Moore's surgery, and during the surgery, Moore's 22-pounds spleen was excised. It's a mammoth spleen - roughly, you know, 10 times the size of a normal spleen.

It was producing medically valuable products - antibodies, cytokines, various things that were very medically valuable - and Dr. Golde realized this. Dr. Golde established a laboratory and entered in partnership with Sandoz on the basis of the patent he took out on John Moore's spleen. But none of this was shared with John Moore. John Moore was told only that he had to come repeatedly to Dr. Golde's lab for tests and for Dr. Golde to collect blood, semen, tissues. And he was told all this was being done in the name of vigilance against cancer to keep him healthy and to treat his cancer.

GROSS: So what are the cells from John Moore's oversized spleen being used for?

WASHINGTON: Well, Sandoz decided that the cells were worth $3 billion, and had given Dr. Golde hundreds of thousands of dollars in order to establish this laboratory. The hope was that John Moore's extraordinarily potent anti-cancer elements would actually be used to develop a cancer remedy, but this never happened. But very often, people find that their bodies have been transformed by medical treatment. That wasn't the case with John Moore, but it's a very good example. And they find the treatments they have given give their bodies the ability to crank out, on their own, potent anti-disease factors.

A really good example was a man named Ted Slavin, who was a hemophiliac. He'd been treated with traditional hemophiliac factors. However, his body an unusual response. His body, in response, began cranking out the same medical factors he was given, only in a highly concentrated way. And Slavin's doctor warned him: Your blood is extraordinarily valuable. You can make a lot of money selling your blood. And Slavin did. He started a company called Essential Biologicals, and he began selling his blood.

However, Slavin also began giving his blood away to researchers who were seeking disease cures. He began giving his blood away to benefit charities. So Slavin recognized that there is more than money at stake here. He also recognize that there's a market here. But one isn't constrained to only fulfilling market criteria. One can exercise altruism and be part of the market, being knee-deep in the stream of commerce at the same time.

GROSS: So it's not just one company that has access to this blood for research purposes. It's several. So there's more of a possibility that something will come of it.

WASHINGTON: I think so. I think you increase, you know, the possibility that you're going to have a successful result when researchers collaborate, or when researchers at least are able to work on the product unrestrained. That's another problem with the patent system. When you patent an entity, you are able to block anybody else from working with it. You can keep anybody else, any other researcher from working on that gene unless you choose to sell them a license. And often, companies choose not to sell a license, effectively barring anyone from working on it.

And what does that mean? That means that a very important gene that predisposes people to cancer is only being worked on by one company, whereas there are many researchers who would like to work on it, and work on a cure, and in fact, have been sent cease and desist letters and so cannot do that. So we're immediately winnowing our chances of coming up with an effective cure or treatment.

GROSS: Let's go back to the Salk vaccine, which did so much to end the polio epidemic. Did Jonas Salk patent the vaccine or try to patent the virus from which the vaccine was derived?

WASHINGTON: No. And there was a very interesting exchange about that. Edward R. Murrow said to him: This vaccine is going to be in great demand, in global demand. Everyone's going to want it. It's potentially very lucrative. Who holds the patent? And Salk said, the American people, I guess. Could you patent the sun? This was the norm. During this period, researchers tended not to patent their discoveries.

GROSS: So he had the option of patenting it, and he chose not to.

WASHINGTON: Exactly.

GROSS: And was the Salk vaccine connected to a pharmaceutical company, or was it invented in an independent research organization?

WASHINGTON: It was a combination of - no, corporations were not involved. The March of Dimes contributed extremely heavily. Salk himself got some modest funding from other sources, including university funding. Some funds came from the government. But frankly, it was the American people that largely funded the development of this vaccine.

GROSS: Through tax money?

WASHINGTON: Through...

GROSS: Oh, no, through March of Dimes money. Yeah.

WASHINGTON: Through contributions. Yeah, March of Dimes money.

GROSS: Right.

WASHINGTON: I'm actually old enough to remember the March of Dimes campaign. And even school children were encouraged to save their nickels and dimes and, you know, collect them in these clever little cardboard slots. It was actually a national obsession at the time.

GROSS: My guest is medical ethicist Harriet Washington, author of new book "Deadly Monopolies." More after a break. This is FRESH AIR.

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GROSS: If you're just joining us, my guest is medical ethicist Harriet Washington. She writes about the history of medicine, African-American health issues, and the intersection of medicine, ethics and culture. Her new book is called "Deadly Monopolies."

Let's talk a little bit about generic drugs, which you also write about in your new book. Can you explain when a drug can go generic?

WASHINGTON: Sure. The long governing patent rights gives the patent holder 20 years of exclusivity, 20 years during which nobody else can work on that entity, no one else can sell that entity without the patent holder's permission. After that 20 years, in theory, the drug goes into the public domain, and any corporation can apply to the FDA to sell its version of that drug. But in reality, corporations have become geniuses at extending patent life. So what they will do is come up with many, many ways in which to extend the life.

Some of them are pretty straightforward. For example, if you have a drug that has not been tested in children and you're willing to take tests in children, that automatically gives you an extension - a patent extension of six months. Also, patents are extended by suddenly changing the formulation of drugs - I mean, very subtly changing them. And patent extensions are also achieved by - or even new patents. New 20-year patents can be achieved by taking a molecule that's not changed, but changing the formulation of the drug.

So a drug that had been sold in pill form now becomes a powder, or a lotion or a cream or a liquid, and each one of these formulations will achieve either an extension of the patent or a brand-new, 20-year patent. So in reality, this 20-year patent is bolstered by the corporation's fleets of lawyers into, you know, perhaps another decade of life. It can go as long as 30 years.

After all the patent permutations are exhausted, the drug now goes into the private domain and individual companies can apply to the FDA to market their version of the drug. It has the exact same active ingredient, but the formulations of generic drugs can differ. So what...

GROSS: How do they differ?

WASHINGTON: In many ways. For example, a drug that had been a liquid can now become a pill. Or another really popular way of changing it is having two different drugs - both of which are now generic - being combined, and the combination now has a patent. But even on the formulation of inert ingredients - the fillers being used in pills, that sort of thing - those are changed frequently by the generics company, so that you end up with a - the same active ingredient, but a formulation that's different.

GROSS: So, you know, when you're getting a medication, if you have insurance, you're kind of automatically, I think, in most cases, going to get the generic version of it, because it's cheaper. So are generic versions of drugs the same as the original in terms of their efficacy? I know the non-active ingredients are probably a little bit different. You know, like the stuff in the pill or the stuff in the cream or the stuff in the suppository, it's not going to necessarily be the same stuff that was in the original medication. It's the active ingredient that's the same. So does that make a difference?

WASHINGTON: To some people, it makes a difference. The FDA says that it has to be bioequivalent. That means essentially performing the same way as the branded drug did. But, you know, these subtle changes can have import for some people, because if you have allergies, for example, perhaps your allergies are provoked by the inert ingredients in the generic drug, and they're not provoked by that in the branded drug. So there are subtle differences, and for some of us, they're not so subtle. For most people, they performed pretty much identically. And that, of course, is a legal requirement.

But I have to point out that the bio-identical label is much more a legal label that a medical label. You will often have physicians, you know, bemoaning the fact that generics do not behave exactly as do the branded drugs.

GROSS: So let me change the subject to a new development in medicine. And this is about a new malaria vaccine. The first large-scale trial of the first vaccine against malaria shows that it lowers the risk of infection by about 50 percent. And this is based on results of a trial on children between the ages of five and 17 months of age in sub-Saharan Africa. And this study was sponsored by a group called PATH Malaria Vaccine Initiative. It's a non-profit that's received $200 million in funding from the Gates Foundation. And the pharmaceutical company that is manufacturing and researching this vaccine is GlaxoSmithKline.

So I don't know how familiar you are with this trial, but what do you think of this model of, you know, of a non-profit funded by the Gates Foundation, working in conjunction with a pharmaceutical company?

WASHINGTON: This model should sound very, very familiar, because this model is actually the old model. Before 1980, this is how researchers worked. They collaborated, because, of course, we have the Gates Foundation. We have PATH. And there are other vaccine initiatives that have been very, very successful recently. And they all include funding from entities such as the governments of developing countries, the Gates Foundation, PATH, groups of independent researchers, and often in collaboration with pharmaceutical companies. I think what's really important, though, to note is that pharmaceutical companies are, indeed, understanding that the people of the developing world represent a rich new market for them.

And the other thing to understand is that they're not doing a lot of this research in a vacuum. The pharmaceutical companies are working with these organizations, and in many of the recent successful vaccines trials for sub-Saharan Africa and for India, and many of the recent successful attempts to develop drugs for illnesses that affect people in the developing world, they are working subsidized by the people in developing countries.

GROSS: Well, Harriet Washington, I want to thank you so much for talking with us.

WASHINGTON: Terry, it has been a great pleasure. Thank you so much for having me.

GROSS: Harriet Washington is the author of the new book "Deadly Monopolies." You can read an excerpt on our website, freshair.npr.org, where you can also download podcasts of our show. And you can join us on Facebook and follow us on Twitter @nprfreshair. Transcript provided by NPR, Copyright NPR.