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Medical Minute 5-6: Genes for Sale

By: Vanessa Welch Email
By: Vanessa Welch Email

207,000 women will be told they have breast cancer this year. 39,000 will die.

"It was quite a struggle," said Lisbeth Ceriani.

Lisbeth Ceriani will not give in to this disease. A single mom -- diagnosed at 42 -- her cancer was aggressive -- a sure sign genetics are in play.

I felt like I had a ticking time bomb inside of me, and I really needed to know," she said.

After a bi-lateral mastectomy, Lisbeth wanted to know her chances of getting cancer again. The best way to find out is through testing the BRCA one and two genes with a blood test that targets and tests two genes we all have. If mutations are found, the risk of getting breast cancer is five-times more likely. The risk of getting ovarian cancer is 40-times more likely. The catch? That test, and the BRCA 1 and 2 genes are patented by a biotech company called Myriad Genetics.

"It's insane. It's my blood. It's my gene."

Myriad Genetics charges $3200 for the test. Some insurance policies cover it, but Myriad would not accept Lisbeth's plan because it would not pay the full amount.

"They basically own those genes."

Because Myriad owns the rights, no one else can legally test the BRCA genes, or look at them, or develop potential therapies without Myriad's consent. When it comes to inherited breast cancer, it's Myriad or nothing. Genetics Professor Steven Salzberg at the University of Maryland says the controversy comes in on the right to patent. Under the law, you cannot patent nature.

"You didn't invent it. The genes that you're inventing is a product of nature."

Myriad refused an on-camera interview but did send us this e-mail, saying Myriad believes that the claims under the BRCA patents to isolated DNA and method claims are patent-eligible subject matter. It says that isolated DNA is a chemical composition, which is not found in nature or the human body. It turns out, after a year and a half, Lisbeth did get the test when a grant became available to pay for the costs.

"I really did dodge a bullet. I was extremely lucky."

Lisbeth warns companies need to understand they're playing with people's lives.

"Stop looking at the bottom line and start looking at the women's faces and their children's faces."

For more information on other series produced by Ivanhoe Broadcast News contact John Cherry at (407) 691-1500, jcherry@ivanhoe.com.

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MEDICAL BREAKTHROUGHS - RESEARCH SUMMARY:

BACKGROUND: According to the National Cancer Institute, the BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. Mutations of these genes have been linked to the development of hereditary breast and ovarian cancer. BRCA1 stands for "breast cancer susceptibility gene 1," and BRCA2 stands for "breast cancer susceptibility gene 2." A woman's lifetime risk of developing breast and/or ovarian cancer is greatly increased if she inherits a harmful mutation in BRCA1 or BRCA2. Men with harmful BRCA1 mutations also have an increased risk of breast cancer and may have an increased risk of pancreatic cancer, testicular cancer and early-onset prostate cancer. However, male breast cancer, pancreatic cancer and prostate cancer appear to be more strongly associated with the BRCA2 gene mutations.

WHAT ARE THE RISKS? According to estimates, about 12 percent of women in the general population will develop breast cancer sometime during their lifetime compared to about 60 percent of women who have inherited a harmful mutation in BRCA1 or BRCA2. A woman who has inherited a harmful mutation in these genes is about five-times more likely to develop breast cancer than a woman who does not have such a mutation. Lifetime risk estimates for ovarian cancer among women in the general population show that 1.4 percent will be diagnosed with ovarian cancer compared to 15 to 40 percent of women who have a harmful BRCA1 or BRCA2 mutation.
(SOURCE: National Cancer Institute)

GENE PATENTING: According to the American Civil Liberties Union, the U.S. Patent and Trademark Office grants patents on human genes, which means patent holders own the exclusive rights to those genetic sequences, their usage, and their chemical composition. Anyone who makes or uses a patented gene without permission of the patent holder is committing infringements and can be sued. Gene patents are granted for 20 years. Currently, Myriad Genetics, a private biotechnology company based in Utah, controls patents on the BRCA1 and BRCA2 genes. Because of its patents, Myriad has the right to prevent anyone else from testing, studying or even looking at the genes. The company also holds the exclusive rights to any mutations along those genes. A 2005 study found that nearly 20 percent of human genes are patented.

CONCERNS ABOUT GENE PATENTING: Many patients and doctors are concerned about the implications of gene patenting. Some argue that genes are naturally-occurring parts of the body -- not inventions. They say researchers identify genes, but they don't invent them. However, the U.S. Patent and Trademark Office has continued to issue gene patents on the basis that genetic sequences are "isolated and purified."

FOR MORE INFORMATION, PLEASE CONTACT:
American Civil Liberties Union
http://www.aclu.org/free-speech/brca-genes-and-patents

Stephen Salzberg, Ph.D.
genome.fieldofscience.com

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THE FOLLOWING IS AN IN-DEPTH INTERVIEW WITH THE DOCTOR FROM THE STORY ABOVE:

Steven Salzberg, PhD, from the University of Maryland, talks about the ethical issues involving gene patenting.

Tell me about your position on gene patenting.

Dr. Steven Salzberg: I’ve thought a lot about this issue. And my position on this issue is that genes being a product of nature shouldn’t be patented at all. It simply doesn’t make sense because they’re not inventions.

Take me back to 20 years ago when all of this began... when people were seeking patents for genes. Tell me about that.

Dr. Steven Salzberg: Probably, going back to the 1980’s, when the very first DNA sequencing was going on, scientists and companies realized that some genes might be valuable for diagnosis or for perhaps treatment. So, they started applying for patents at a time when it was very difficult to sequence a gene. It was very expensive, very time-consuming and very hard to even discover what genes might be associated with what diseases or conditions. And so some patents were filed way back then, and the patent office decided to give them to the companies and individuals that applied for them. Even from the beginning, there were people who were objecting, saying, “Wait a minute. A gene is not an invention.” Patents are normally for inventions, things that you come up with.
When you sequence DNA, you purify DNA from a cell and then you run it through a machine that does the sequencing, but what you’re looking at is something that was naturally occurring in the cells. It’s not something you invented. So, there were scientists from the beginning, who were saying, “You really shouldn’t be patenting genes.” But the patent office allowed it and things just took off from there. Once it was allowed for one gene then, of course, it’s allowed for any gene.

And the difficulty for scientists, with having all these patents out there is what?

Dr. Steven Salzberg: So, what has evolved is there are thousands of human genes that have patent protection of one sort or another on them. The difficulty is that if you want to use any of those genes for anything, say to develop a new diagnostic test, or a new drug that would affect the way that gene functions, you now have to get licenses from the patent holders, and this might involve dozens, or even hundreds, of licenses just to make progress on a particular disease or condition that involves genes that are patented.

And it potentially can affect every day people out there who might be interested in his or her genetic makeup.

Dr. Steven Salzberg: It definitely affects everyday people. We all have the same gene content. Each of us has, on the order, of 20 – 25,000 genes. Each gene can have literally hundreds of different mutations. We haven’t mapped them all out yet. Any of those mutations might change the way you look, the way you feel. It may change your health, or risk for certain diseases. And the scientific community is very actively working on figuring all that out. But once someone files for a gene patent, the nature of these gene patents so far has been that the lawyers file for very broad protections. So, for example, the patents on the breast cancer genes, called BRCA1 and BRCA2, they give the patent holder, which is Myriad Genetics, the rights to any tests or any procedure that looks at any mutation in those genes, including undiscovered mutations. So, they basically own those genes, and if we discover tomorrow that there’s a mutation that was never before observed in one of those genes that leads to some condition that we could treat, that’s all well and good, but if we wanted to use that information in any product, we would have to pay a license fee. So, the patents are very broad, and they actually encompass all possible mutations that might be discovered in the future and in each of the genes that are covered. And that could be hundreds, or even thousands of mutations.

And even with the tests that that company holds it blocks out competition. The patent blocks out any kind of competition, anyone else from coming up with a similar test or anything that relates to that gene?

Dr. Steven Salzberg: That’s right. So, the BRCA1 and BRCA2, the breast cancer gene patent, that’s one of the genes that has the strongest correlations with increased risk of breast cancer and ovarian cancer, both those cancers. And, because of that, there’s a diagnostic test that can tell you whether or not you have a large and growing mutation in those two genes. The only way you can run that test and tell someone whether they have any increased risk of breast cancer or ovarian cancer is by paying a licensing fee to the company who owns the patent and that’s true for as many years as the patent has to run and that is some number of years still.

You said that in a few years that we will be able to access blueprints of our genes. Tell me how this will affect individuals’ desire to learn more about it.

Dr. Steven Salzberg: One thing that has changed a lot in the last few years is that gene sequencing, DNA sequencing, has gotten dramatically faster and dramatically cheaper. The human genome project took about 15 years, took hundreds of millions of dollars and a worldwide team of scientists. I was one of those thousands of scientists involved and we got the human genome done. That was one person’s genome. Today, you could actually pay a company $10,000 and have your genome sequenced. Your genome is your DNA; it’s in every cell in your body. It’s unique to you. So, it won’t cost hundreds of millions of dollars, it won’t take thousands of scientists. You can just order it up. Now, what’s somewhat ironic, or ridiculous, depending on how you look at it, is that if you want to look at a gene that’s patented from your own genome, you have to pay a licensing fee to the patent holder. So, you might say, “Well I’ve got my genome and now I want to look at it and see if I have a mutation in BRCA1 and BRCA2 that puts me at increased risk for cancer.” You can look but you have to pay a fee, even though it’s your DNA, and you paid for a company to do a sequencing of that yourself. You didn’t pay the licensing fee that covers that gene, so you’re not technically allowed to do that diagnostic test of your own genome, nor could your physician look at it for you and do that diagnostic test without paying a licensing fee.

Let’s talk a little bit about those who oppose doing away with those patents, who say that this is really going to interfere with innovation and this is really going to hurt the growth of the industry. What’s your response to that?

Dr. Steven Salzberg: Well, there’s a couple of ways of responding. One is that, of course, patent lawyers and patent holders have an investment in those patents, and they want to maintain them just as it is because they benefit. But the patent system is not in place so that particular individuals can benefit. And that’s not really a legitimate argument that their benefits need to be protected. The patent system is in place to benefit society. It’s there so that things can be brought to the market, so that innovation can occur and the protection will be in place long enough, so we can get products, inventions that we wouldn’t otherwise get. But, in the case of genes, they didn’t invent them. So, the fundamental argument that a lot of scientists make, including me, is that it doesn’t matter whether you’re profiting from these gene patents, what matters is whether or not you invented something that should have been protected in the first place. You didn’t invent it. The genes that you’re patenting are a product of nature. And, in fact, the patent, as I understand it, the patent laws say you’re not allowed to patent products of nature. It just so happens that the patent office, several decades ago, made the decision a different way and so the floodgates were open and many, many gene patents have been filed since. They probably never should have been. So, you may want the patent because you make a profit on it, but that doesn’t mean that you deserve it, and it certainly doesn’t mean that it benefits society. And, in response to the arguments about innovation, I just don’t see it. I see the field of DNA sequencing and genomics, which is what I do, moving forward incredibly rapidly, and patents merely, get in the way. This is the example that we are talking about. Today, you could be developing all sorts of diagnostic tests using discoveries that are being made at incredibly rapid pace, but you can’t do that in many cases because somebody has a patent they filed years ago that covers future discoveries because the patent covers the genes, and not particular mutations. And even if they did cover just particular mutation they still are not invented by the patent holder, they’re just products of nature.

We were talking about how this could possible, be time consuming for scientists who would be interested in pursuing or working with a particular gene that has a patent.

Dr. Steven Salzberg: Today, the field of genomics is moving ahead so rapidly that many scientists have a pretty wide choice of which genes they might work on. We see progress as possible all over the genome. So, there are 25,000 genes you can choose from. Right now, If I’m going to work on a gene, and I have a choice, I’ll probably avoid the ones that are patented, because I know that if I discover something that might be valuable, and interesting and useful, suddenly I’m going to reach this barrier, which is the license, which gets in the way of me doing anything more on that gene. So, I think today, patents are already putting barriers in the way and are probably slowing down progress on genes that are patented because scientists do have a choice. Instead, they will work on the genes that aren’t patented. It would be a lot better for us, for our health, and for society, if we just recognize that genes should not be patented at all and then scientists could work on whichever ones have the greatest promise for human health.

Do you support the removal of existing patents or future patents not being granted?

Dr. Steven Salzberg: I would invalidate all patents on all genes. I’m a little radical, not only on human genes, but also patents on animal genes and plant genes and there are plenty of other patents as well. I don’t think that any of those are inventions, so to be consistent, you really shouldn’t allow patents on any of them.

I was reading that those who support patents, that the policy of removing these patents could be extended to protein based drugs and antibiotics and that that could potentially be a problem. Your thoughts about that?

Dr. Steven Salzberg: That is a slippery slope argument. I don’t really think there is much merit to it. If you create a drug, you are actually inventing something. It wasn’t just found in nature, and I don’t really think that’s a legitimate argument. I don’t think there is anything to worry about there.

Okay, tell me about your computer program that you developed.

Dr. Steven Salzberg: Well, Okay. As a demonstration of how the technology has changed and why gene patents really don’t make sense in today’s scientific environment: A colleague of mine and I developed a computer program that can sequence your genome. If you go and have your genome sequenced, you can use our program to diagnose yourself for seventy different mutations. In this program, you just take your DNA sequence, which you do have to pay to get sequenced, you run it through this program, and it will report for you for each of those seventy mutations and the genes whether you have a risky mutation or not. And that’s something you can do at home. It’s a free program. We put it up on our program so anybody can download it. It will take a few hours to run on a standard desktop computer. So, you could do your own diagnosis of your own genome if you had the sequence. And this activity, diagnosing your own genome, is actually prohibited by patents. Patents wouldn’t allow you to do this without paying. It’s not prohibited, but you can’t do it without paying a fee. So, our program is a disruptive kind of technology because, in this respect, if you were to use our program you would be violating the patent on these two genes.

So, this is a wonderful advance, but it’s one that can’t even be tapped into.

Dr. Steven Salzberg: Right, and this program, the reason I call it “proof of concept” is that we could take this same program with fairly minor changes and we could modify it, and we are actually planning to modify it, so you could diagnose any other gene. Because once you have your genome, you have all your genes. And, if you tell me, I want to find mutations in genes that put me at risk for some other kind of cancer, or for some other kind of syndrome, we could code that into the program, and it could scan your genome for those as well. And this is the sort of thing that any person could do. In a few years, I see anybody being able to do this, or physicians being able to do this, in their offices routinely. But, with patents in the way, you can’t do it without paying perhaps hundreds of different license fees before you scan your own genome.


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