"In a time of universal deceit telling the truth is a revolutionary act." -George Orwell

Biotech Corporations Are Patenting & Profiting From Human Genes And Tissues — Here’s Why That’s Terrifying

In Uncategorized on December 5, 2011 at 2:21 pm

Oldspeak:” Whether you like it or not, under current law a vital part of who you are actually belongs to someone else. Medical corporations are buying the property rights to the very essence of human life. Gene patents for a 1 third of the  human genome — or more than 10,000 genes — have been created, despite court precedent that says no one can own the “products of nature.”  If you’re hurt, medical research can be conducted on you without your permission. They’re putting human health second to their profit & they’re using your tax dollars and poor people’s tissues (without compensating them for using them) to do it, unscrupulously perversting the tenet of “informed consent” in their insatiable quest for more profit via patents and product monopolies. Using barely informed illiterate subjects for their medical research, their products contribute to unreported subject deaths, which help them glean the data they need to get their products approved by FDA they bought and paid for via campaign contributions to corrupt politicians who strip the FDA of any ability to regulate and populate the agency with medical industry cronies who do their bidding. Then don’t even provide access to the drugs produced to the poor people with unmet medical needs used to produce the drugs! This is the essence of  the Medical-Industrial Complex. A repeating loop profit machine, where human health is secondary, humans are guinea pigs and public dollars are used to fund private profits. Pumping out ‘medicines’ that sometimes cause more harm than good. All so a few very wealthy men can get more wealthy making drugs for people who can afford exorbitant costs for them, and not making the drugs available to the vast majority of people who need them. “Profit Is Paramount”

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Breast Cancer Court Case Pits Patients’ Genes vs. Gene Patents

Should Biotech Firms Be Able to Own Your Genes?

WHY GENES MUST REMAIN ELIGIBLE FOR PATENTING 

By Brad Jacobson @ AlterNet:

Do you think that granting corporations the rights of people in the Citizens United case is disturbing? Then contemplate the fact that corporations have been patenting human genes and tissues at alarming rates — in the last 30 years, more than 40,000 patents have been granted on genes alone.

As the Occupy movement fights against the unmitigated influence of corporations on our lives, author and medical ethicist Harriet Washington’s new book, Deadly Monopolies: The Shocking Corporate Takeover of Life Itself–And the Consequences for Your Health and Our Medical Future, is a timely wakeup call to protect the very essence of human life from the medical-industrial complex.

In a recent phone interview with AlterNet, Washington discussed the dark implications of corporate medical patents, how we find ourselves in this nightmarish scenario and what needs to be done to stop medical research profits from trumping human health. 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.

Brad Jacobson: The main piece of legislation that opened the door for corporations to begin patenting human life was the Bayh-Dole Act of 1980. Can you tell us how this law was sold to the American people?

Harriet Washington: Just to recap what the Bayh-Dole Act is, basically it was a law that permitted for the first time universities to legally transfer their patents to private corporations, to sell them, license them. That had been virtually prohibited in the past because most of these new inventions had been developed with tax dollars. And the thinking had been, “If you develop things with our tax dollars, then we shouldn’t allow them to go to private corporations who can establish a monopoly with their patents.”

It was sold to the American public primarily by [former Indiana Sen.] Birch Bayh, who of course partnered with [former Kansas Sen.] Bob Dole. But it was Birch Bayh who made the argument that we have all these patents lying around, no one’s doing anything with them. If we let corporations get them, then they’ll develop them into needed medications. So people were told this is the root to get the medications and treatments that we need.

However, what’s really interesting, though — I went behind the scenes and of course I saw that, rather than being any kind of groundswell of popular support, the law actually passed on the last hour of the last day of the last congressional session because of some good ol’ boy networking.

BJ: Also in 1980, the legal counterpart for this corporate opening came with the court decision Diamond v. Chakrabarty, in which a scientist’s patenting of an oil-eating bacteria was contested. But how is this different than what had been patentable in the past?

HW: It’s certainly a good question because living things have been patented in the past. That’s a misconception people have. Louis Pasteur had patented a yeast. Takamine [Hideo] had patented adrenaline. Numerous living things had been patented before. However, there were often legal challenges by people who would say, “This patent is not really valid because you can’t patent a product of nature.”

So in 1980, when Ananda Chakrabarty, a researcher at General Electric, decided to try to patent some bacteria that he had intensively engineered to be able to “eat crude oil,” the U.S.] patent office said, “We’ll patent the process you use, but we’re not going to patent these bacteria. They’re living things and only inventions can be patented. We can’t patent products of nature.”

So Chakrabarty and General Electric sued and the patent office decided to defer to the Supreme Court. The Supreme Court decided that, yes, living things can be patented, which is interesting because Chakrabarty insisted he was shocked by the ruling. He said that he fully expected he had made his case, but he was surprised they decided to more broadly permit the patenting of living things.

But now it’s being applied to things where the contribution of the researcher is nowhere near so extensive. So, of course, genetic sequences found in our body are being patented. Medically important animals — like Harvard’s OncoMouse which is guaranteed to get cancer — are being patented. And so these products of nature, including products of our bodies, being patented has created huge problems for us.

BJ: In 1951, Henrietta Lacks, an African-American woman, was being treated for cervical cancer without success at John Hopkins University. Without Henrietta’s or her family’s knowledge, John Hopkins University researcher Dr. George Gey obtained a sample of her tumor from her doctors, which eventually led to his creation of an immortalized cell line used in the development of the polio vaccine as well as drugs for numerous other diseases. It also generated millions of dollars in profits around the world, yet the Lacks family was never compensated, nor did they even have health insurance at the time. How was this case a harbinger for what would follow in the context of patient rights in regard to medical patents?

HW: I actually met with the Lacks family in the mid-1990s. I wrote about her case and I think there are some things that have been promulgated that are not exactly true. It’s true the family didn’t have any health insurance and weren’t compensated. But they never evinced concern about being paid. I think that was a focus that had been imposed later by people who I think had the best intentions in the world. Some of the people who wrote about them were very concerned they weren’t paid.

But the Lacks family expressed consistently that their mother had been a medical benefactor and no one knew this. Her name had been changed in the accounts so that nobody knew who she was. They were very upset about the autonomy.

And they didn’t like having been lied to of course.

BJ: You mention in the book the paternalistic nature that Dr. Gey had taken. The excuse he’d used was that he changed her name to protect her, but they didn’t really accept that.

HW: Her husband thought they didn’t want the world to know that this is a black lady helping science. And that seemed to be the prevailing attitude in the family. They resented that.

BJ: What’s the positive impact, however, of this cell line having never been patented?

HW: So what happened to Henrietta Lacks was an abuse of her and her family. But the dissemination of her cells very cheaply, not free but very cheaply, made a lot of medical advances possible. The reason they weren’t patented was this was before 1980 and it wasn’t legally possible. It also wasn’t part of the medical culture then. Medicine was being practiced by people in university settings. They had different motivations, not money.

Now it’s impossible to speculate about exactly what would’ve happened. But had her cells been patentable, had this happened after 1980, there’s a good chance that certainly recognizing their value, Dr. Gey or John Hopkins or some other researcher would’ve taken a patent out on it and then they would’ve, as is usual, only licensed them to the researchers and universities that would have paid them a hefty fee. Or perhaps not licensed them at all.

Which means the polio vaccine probably would still be developed, but it might’ve cost a lot more money than it did. It might not have been available to everybody as it was. So those are the differences.

BJ: John Moore, a leukemia patient in the 1980s, first had his spleen removed in 1976. Unbeknownst to him, it would lead to the creation of a cell line estimated to be worth $3 million by the pharmaceutical company Sandoz. Moore sued his doctor who had removed the spleen after he discovered the doctor had filed for a patent on his cells and proteins that led to this lucrative cell line. Can you talk about the difference between what happened in the case and its impact?

HW: When John Moore was initially treated, the Chakrabarty law had not been decided yet. Bayh-Dole hadn’t been passed. So, as living things, his cells weren’t eligible for patenting either. However, once these rulings were passed, his doctor, Dr. David Golde, and the University of California, immediately responded by taking out a patent on his cells.

His doctor recognized that his spleen and his cells were medically important. He knew that, but it was before he could take a patent out on them. I’m sure at that point he never dreamed that in a few years he would be able to take this collection and sample of his cells and tissues — that he had assiduously kept alive and was researching — and take out a patent on them and control the profits from them.

So when the law was passed, Dr. Golde had already established a laboratory to do research on it. He and another researcher and the university owned the patent. Now they went to Sandoz and established a contract for $3 million — $3 million 1980 dollars. Then [Sandoz] could plan to acquire huge profits. Before that, Dr. Golde had been interested for the usual reasons. He would be able to hopefully develop some medically useful compounds and, more to the point, become famous and get some publications. Now, there was a great deal of money to be made.

BJ: You write that today, however, as opposed to the case of Henrietta Lacks and John Moore, it is normal tissues in large quantities that provides a lot of wealth for people who hold patents. So are you saying that everyone is now vulnerable to the same kind of appropriation as what happened to Lacks and Moore?

HW: Yes. Lacks and Moore’s vulnerability was a bit different, but it was the same principle. And today, we’re all vulnerable to that. We’re vulnerable because if we undergo surgery in certain hospitals, such as the Harvard University hospitals or Duke and a number of others, we are given a consent form to sign, which will give a private corporation, in many cases Ardais [Corp.], the rights to any tissues or cells taken from our body, often described in the consent form as “discarded and worthless.” But they’re not worthless or the corporation wouldn’t have bought them.

Also, in many cities in this country — in fact, in more than half the states — have something called medical examiners laws, or presumed consent law. These laws dictate that a medical examiner or coroner in these cities, when someone dies, can take any tissues from your body that could have some medical value. Then they’re transferred to a broker or two, who then eventually transfers them to surgeons or hospitals. At each step, there is a hefty fee paid. And then the institution pays a fee. So although it’s against the law technically to sell an organ or sell these tissues, from my point of view they are actually being sold.

And then of course medical research conducted by private corporations or in which private corporations pay medical institutions to conduct research according to the corporations’ dictate, which means they control it. So one thing they have begun doing is exploiting a 1996 law that governs medical research, which says that if you are in the United States and you’re the victim of a trauma — shot in the chest, a heart attack, hit by a car — medical research can be conducted on you without your permission.

I have spoken to research subjects who had no idea that they were used in medical research until a member of their family told them. We all expect that we’re going to be offered informed consent. In medical research, this is an exception.

BJ: Is there any legislation you know of today that is being introduced to address these issues?

HW: I know of no legislation that is being promoted or that even has been suggested. I think it’s because so few members of the public even know it’s going on. You can’t fight something if you don’t know it exists. And I find it really interesting that, although a few medical journals have called me and interviewed me about this, it’s not being published someplace where a great many people will read it.

I wrote an article for a magazine — and I’ll be prudent and I won’t name it — a popular magazine with a very large circulation. They said they loved the article, they’d love to publish it, right up to the moment where I got a phone call saying they were killing it and then they paid me for it anyway.

BJ: And what about the “consensual” situation, when a patient is made to sign a consent form right before going into surgery? That might be legal, but it’s also very misleading, no?

HW: That’s consensual. But the legality of doing this is actually kind of shadowy. I don’t think it’s been well established whether it’s legal or not to take somebody’s tissues in surgery without asking their permission first. So what happened is researchers and corporations had decided to cover themselves by getting people in this scenario to sign a consent form and the difficulty, as you suggested, is whether people really understand what they’re signing.

But the piece of paper, the consent form, is not informed consent. If you have a signed consent form in a file and you go to court, that’s not proof of informed consent. That’s only one piece of evidence to support your claim that you informed the person. Actual informed consent is an ongoing process between the researcher and the subject. You have to not only tell them all the information about the study, about what’s known about the consequences, but also if new information emerges you have to keep the person apprised of that. That’s informed consent.

What they’re doing is they’re having signed a consent form to try to prove that they’ve given these people informed consent. But the truth is, you know, if you’re a hospital patient and it’s six o’clock in the morning, and you’re still groggy from your sleeping medication from the night before, you’re woken, handed a sheet of forms to sign for surgery you presumably need and there are staff people standing around you…that’s not conducive to informed consent.

Most patients don’t read it, but that’s kind of logical. You know, you need this surgery. The last thing you want to do the second before you go under the knife is antagonize the people who are doing your surgery.

BJ: How do these medical patent laws actually impede innovation?

HW: A really good example of this, because the court case is about to go to the Supreme Court soon, are the gene patents on the BRCA1 and BRCA2 genes that predispose women to breast cancer. They’re very important genes and there are nine patents held on them by Myriad Genetics. And Myriad Genetics has behaved like a very smart capitalist. For a long time, it has minimized the number of people whom it will license access to the genes. Researchers who have been working with the genes, trying to find better treatments for breast cancer, have received cease and desist letters from lawyers at Myriad’s behest, saying, “We control this gene, we hold the patent, you can’t work on it without our permission,” which they often decline to give.

So that’s a problem right now. Then look at the pricing of the test for women who want to characterize their risk for breast cancer. And most women of course don’t need this test but the direct-to-consumer advertising by Myriad confuses women and really makes it look like more women do, which will of course increase their profits. It will also unnecessarily scare a lot of women and induce many more women than should to pay Myriad’s $3,000 to $4,000 fee.

A recent development is especially nasty because now you can pay the $3,000 to $4,000 fee, but there’s also an additional test, a relatively new test, based again on the genes. And if you want that, you have to pay an additional $600. Obviously if you’re a woman at risk, you’re not going to consider that $600 optional. So that’s a huge amount of money.

BJ: What happens if within the legal framework of today’s medical patent process a researcher seeks a more altruistic route, similar to what Jonas Salk did with the polio vaccine? Is that even possible today or is that individual crushed by the system?

HW: It is possible today and that’s a great question because one of the really exciting positive things that has happened is that, you know, certainly not just me and people like me who are criticizing them — a lot of medical researchers, as I said before, are seeing how damaging this paradigm is and they’re coming up with viable alternatives.

The Gates Foundation is probably the best-known example. Bill Gates has worked with a longstanding initiative to bring vaccines to the developing world — its acronym is GAVI. He’s also worked with the governments in the developing world and come up with a model called Advanced Market Directives. Basically, what they’re doing is they’re coming up with funds and pooling their funds and saying to pharmaceutical companies, “If you will develop, for example, a malaria vaccine that’s cheap and works well for the developing world, we will pay you, we will make sure you earn a profit.” And they were successful. They came up with a vaccine — quite a few actually — but one in particular costs $70 in the United States. It only cost 50 cents in Nigeria because of their model.

Now, I hasten to say, we’re not out of the woods yet because all of the pharmaceutical companies that did it — which I think is wonderful that they’re going along with the model and giving it a try — but they counted this as something beneficial that they were doing. Which is not exactly the case.

They’re doing this because they’re paid and it’s being guaranteed by others. And GAVI, the group that helped guarantee the payment is already $3 billion in debt because of it. So that means that even though this has worked in a couple of cases, I’m worried that it may not be a viable long-term model.

We’ve seen this before when pharmaceutical companies, for example, provided sleeping sickness medication, Eflornithine. They provided it only on a short-term basis, for about five years, and then they left. Now the people who are at risk, and I think that’s like 60 million people in sub-Saharan Africa, don’t have access to that drug. So to me that’s a cautionary tale because we need long-term solutions.

And there are other groups of researchers around the world who are also embracing a different non-corporate model. A man named Alan Edwards in Toronto put together a coalition of a lot of researchers. His strategy is one that has worked before for the government. He does not want their discoveries patented. So what they do is every day — whatever they’ve been working on that day, whatever solution they come up with, whatever they’ve identified or characterized that could be medically important – they put it on the Internet. They make it public knowledge, which means it can’t be patented.

So there are strategies that are now being embraced to work around corporate control of medical research.

BJ: How has the medical patent gold rush affected the accessibility of life-saving vaccines for widespread diseases?

HW: Well, simply because maximizing the profit on the patent is the focus, not curing the maximum number of people. Michael Kremer, a Harvard economist, put it best. He pointed out that during the period between 1975 and 1997, of the 1,233 new drugs the pharmaceutical industry devised, only four of them were drugs designed for people in the developing world.

The bottom line is that, although it’s possible to devise vaccines that will save the lives of people in the developing world, it’s not done because people there cannot pay the inflated prices a corporation charges. So they ignored these people in the developing world.

And as I point out in the case of African sleeping sickness, where Eflornithine was found affective against it, people in areas affected by African sleeping sickness cannot afford to pay high prices for drugs. So after that couple of years where they provided it for free, they stopped making it for African sleeping sickness and the exact same molecule, this Eflornithine, is now the active component in Vaniqa, which is used in the West to help women rid their faces of unwanted hair. So women pay $50 a month for Vaniqa, but people in the developing world can’t pay that $50 a month to keep themselves alive, to protect themselves against sleeping sickness.

BJ: In your book, you cite a 2009 study from the New England Journal of Medicine, which found that one-third of U.S. clinical trials are conducted abroad, mostly in developing countries, where drugs can be tested more cheaply. Can you discuss the inequity of the fact that most of the test subjects partaking in these trials — on which corporations are saving millions to perform there — will either never be able to afford, or have a need for, the drugs being tested on them?

HW: Usually both. But even in the cases where it’s a drug, as you say, that could help them, it’s not going to help them because they’re going to be charged the same high prices as people in the West. And knowing they can’t afford it, they don’t even provide it to people in that country.

What I find fascinating is that if you think about it, these people in the developing world are providing opportunity to conduct clinical trials that are a lot cheaper and a lot faster for these corporations. Corporations would have to pay a lot more money if they conducted those trials in the developed world. And so actually we’re the ones in their debt.

We have a new cancer medication, for example, that has been devised by testing it on people in the developing world so that you and I can take it without fear that we’re going to drop dead, hopefully. We owe the people in the developing world that. The corporations save so much money by using those people for their tests. Speed is very important because it maximizes the amount of patent time so they can make more profit from their patent. Also the FDA requires that studies be completed within two and a half years, which is sometimes difficult to do.

So providing them with drugs that they have made possible would seem to be the very least we could do. Yet there’s constant reluctance to provide medications for people in the developing world.

BJ: Clinical trials in developing countries can also involve testing subjects in dangerous circumstances that wouldn’t even be legal in this country. You point to the example of Pfizer’s clinical trials for an antibiotic in Kano, Nigeria in the 1990s. What went wrong?

HW: They tested Trovan in Kano and they waited until — this is quite typical, actually — they waited until there was a meningitis epidemic to test their meningitis drug. First of all, these are people who typically go their whole life without getting any medical care. They can’t go to the doctor, can’t buy medicines. When they’re sick they just hope and do the best they can to treat each other.

So there’s an epidemic. You’ve got people, especially children, dying wholesale. And Doctors Without Borders had flown in and were working feverishly around the clock trying to save as many children as they could. Doctors Without Borders had a huge tent there for a clinic. Pfizer flew its people in and set up shop right next to them. The people of Kano could not discern the difference between the Pfizer tent and the Doctors Without Borders tent. All they knew was that there were doctors and medicines in both tents. If they couldn’t get into one, they went into the other one.

Now I don’t believe they received informed consent. First of all, the records were lost. Pfizer [said it] lost the records that would’ve proved informed consent. Then Pfizer produced some letters from local doctors and local medical boards saying there was informed consent, but they were clearly forged. One doctor admitted that they were forged. Another doctor pointed out that the medical institution that supposedly approved this trial had not even been set up until a year or two after the trial had ended. So all the evidence points to the probability that these people did not receive informed consent.

But then I also ask myself, even if they had gotten informed consent, did they have a real choice? They wanted their children to get any kind of medicine. So it was inherently a coercive environment.

And Pfizer would give this medication and it did not follow prescribed methods of conducting research in this country. Although some of the things they did were permissible in their country. For example, the young girl whose fate I chronicled — she was given Trovan, didn’t get any better, in fact she got worse. And had she been in, say, Connecticut or New York, if she had gotten worse, then they would’ve switched her from experimental therapy to one that was known to work. They didn’t do that there. And she died, other children died, other children went deaf, other children had all kinds of neurological problems. In fact, there were so many deaths and so many permanent serious problems resulting from it, the FDA would not approve the drug.

In the aftermath, there were these lawsuits and finally Pfizer had to pay out a fine. But the fine they were asked to pay was just dwarfed by their amount of profits every year. It’s just the cost of doing business to them. Certainly in a case like this, considering the final cost to them, you could argue it was worth it to them.

BJ: Do you see U.S. Occupy protests as a direct outgrowth of this kind of corporate encroachment on our lives?

HW: That is a parallel that’s made very often. And I’m just going to plead ignorance here. As much as I read and as much as I think about that, I think that there’s the same frustration with the degree of control corporations have over things that should not be controlled by monetary interests. And yet that’s our habitual practice of medicine today. So as far as the Occupy Wall Street protests echo that sentiment, then I agree with them. There are other elements of course in which I think there is not a parallel between them and the people I talk about.

I began this book being really concerned about poor people, people in the developing world, people who I thought and I still think are impacted most heavily by this. But I quickly came to realize that it affects all of us. I mean it’s also middle-class people. Because the drug prices are so high and because the corporate control of medical research is so extensive and our health policy so extensively protects them, middle-class people are not really faring any better. Middle-class people are caught in the same bind.

So I guess that’s sort of a qualified yes [laughs].

BJ: Since the Citizens United court ruling, we’re living in a time where, in effect, corporations are considered people, while simultaneously corporations are buying the property rights to the very essence of human life. You’ve eerily described them as our “biological landlords.” This already has a nightmarish quality today. In regard to the future of medical patents, do you see the pendulum swinging back or the situation growing worse?

HW: Unfortunately, if history’s taught us anything, it’s that things can always get worse. But I don’t think it will. The pendulum can swing back, but it’s going to need a big push from us. It’s not going to swing back on its own. Because the most powerful people in this country are being well served by this. The very wealthy people don’t have the worries that most of us have. And corporations certainly don’t have the worries we have. They’re not disturbed by their high prices. They’re constantly defending them. They’re not disturbed by the lack of care for people in the developing world. They have no problem claiming that, “Hey, don’t blame us — it’s not our patent, it’s their poverty.”

It can be done, but we’re going to have to push it. And the way to push it is to repeal Bayh-Dole and find those lawmakers. There are lawmakers out there who are trying to repeal parts of this problem, patents on genes, for example. And researchers also are beginning to see that his system is dysfunctional and starting to come up with different models.

So it’s going to be up to us to push the pendulum in the other way.

Brad Jacobson is a Brooklyn-based freelance journalist and contributing reporter for AlterNet. You can follow him on Twitter@bradpjacobson
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