December 2, 2011
While science and technology continue to exceed new levels never before reached by humankind, the chance of the human race becoming more of a scientific research project increases along with it.
Over the past 30 years, over 40,000 patents were created and accepted on genes alone.
Companies have been patenting genes for over 100 years.
As the patents continue to be created, so does the potential for a large amount of the human genetic coding to be owned by major corporations.
Interestingly enough, these companies simply copy and alter human genes and subsequently claim ownership.
According to the government, these gene patents are intellectual property to the companies who have created them. If in the future these patented genes are utilized in the creation of experimental animals or controversial hybrids, companies will essentially own a portion of the living creature itself.
Many people are worried about what this means for the future of mankind, long term and short term. This kind of practice is much more intrusive than influential on the human race. No one truly knows just how impactful gene patents will be on the population, or even how the possibility of negative outcomes can be properly dealt with.
Certainly not everyone supports the genetic modification of human food, let alone on the human race. We have already seen how genetic modification of the food supply can pose health hazards. In fact, GMO’s are seeing such opposition that GMO crops are continually being banned around the world in display of health freedom. People don’t want to be eating man-made genes anymore, and they certainly do not want living organisms to be made out of them.
In a recent phone interview with Harriet Washington, author of Deadly Monopolies: The Shocking Corporate Takeover of Life Itself-And the Consequences for Your Health and Our Medical Future, Harriett discusses the negative implications of corporate medical patents and what needs to be done to stop the research profits from ruining our 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 decisionDiamond 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.
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