Showing posts with label ovarian cancer. Show all posts
Showing posts with label ovarian cancer. Show all posts

Should we test all women for breast cancer-causing mutations?

In this week’s Journal of the American Medical Association, famed geneticist Mary-Claire King argues that all women over age 30 should be tested for cancer-causing mutations in the BRCA1 and BRCA2 genes. King, who made the original discovery of the link between BRCA1 and breast cancer, is one of the world’s leading experts on how mutations in these genes cause cancer.

But her proposed new universal testing policy, which fellow Forbes contributor David Shaywitz calls “audacious,” goes far beyond what other experts recommend. Earlier this year, the highly regarded U.S. Preventative Services Task Force (USPSTF) recommended testing BRCA genes only in women with a family history of breast or ovarian cancer. 

Although there’s no question that King is an expert on BRCA gene testing, I think she’s gone much too far with her latest proposal. She has the science right, but she is far too optimistic about how her recommendation would actually play out. The policy might save some lives, but it would also cause a great deal of pain.

First, it’s worth explaining why King thinks universal BRCA testing is a good idea. In her JAMA article, King and colleagues describe a new study they conducted in Ashkenazy Jews that showed, somewhat surprisingly, that 
“50% of families found to harbor BRCA1 or BRCA2 mutations had no history of breast or ovarian cancer that would have triggered clinical attention." 
In other words, under current policy guidelines, 50% of people who have a damaging mutation in one of these genes will not have their genes tested. Many of them will eventually get breast or ovarian cancer—as King explains, women with harmful BRCA1 mutations have a 60% risk of cancer by age 60, and for BRCA2 the risk is 33% by age 60. That’s a very high risk, though it’s important to keep in mind that many women with these mutations will never get cancer.

With modern DNA sequencing technology, any large-scale genetic BRCA testing program is likely to uncover thousands of mutations that have no harmful effects, and thousands more whose effects are simply unknown. (Aside: each BRCA gene spans about 80-90 thousand nucleotides of DNA, and each of those letters can mutate in 4 ways, changing into one of the other 3 bases or just being deleted. This means there are at least 400,000 mutations possible in each gene, not counting larger deletions. A colleague and I published an article in 2010 describing one such BRCA test.) King is clearly aware that such reporting these mutations to patients would only sow confusion, and she recommends that:
“Testing for BRCA1 and BRCA2 should focus solely on unambiguously loss-of-function mutations with definitive effect on cancer risk…. A VUS [variant of unknown significance] can increase confusion and compromise clinical management; for population-based screening, these variants should not be reported.”
Herein lies one of the biggest problems with King’s idea. We don’t have universal agreement on which mutations have no significance, and even if we did, most physicians are not experts on cancer genetics. In our lawsuit-prone medical culture, there exists an unfortunate tendency to over-treat and over-report everything. 

Thus I fear that if we had wider BRCA testing, clinical labs would report all mutations back to physicians (how could they not?), and physicians in turn would report everything to the patients. The result would be that millions of women would be told "you have a mutation in BRCA1, and we don't know what it means." What's a patient supposed to do with that?

The other problem is that the only treatment to prevent breast and ovarian cancer is surgery to remove a woman’s breasts and ovaries. We don’t have a pill you can take, or lifestyle changes you can adopt, that will dramatically reduce your risk of hereditary cancer. But unlike a cancer diagnosis, the discovery of a BRCA mutation does not mean you have cancer. It simply means you have a risk, possibly a high risk, of getting cancer at a young age. We know from decades of research that people are not very good at evaluating risk. We tend to over-estimate the danger of events that seem very dramatic or visible to us, as cancer is to many people. 

By King’s own estimates, widespread BRCA testing would detect cancer-causing mutations in 250,000 to 415,000 women in the U.S. This estimate assumes the test doesn’t have false positives, which it almost certainly would. All of these women would then be faced with an extremely difficult dilemma: should they have both their breasts removed, or live the rest of their lives in fear of breast cancer? 

This dilemma was famously on display last year, when actress Angelina Jolie revealed in a New York Times article that she’d had a double mastectomy, after discovering that she carried high-risk BRCA mutations. Jolie’s mother died from cancer at the age of 56, and she explained in her article that as a result of the surgery, “ I can tell my children that they don’t need to fear they will lose me to breast cancer.”


King’s proposal is audacious, and it’s well worth debating. But without a better treatment option, telling hundreds of thousands of women that they have a high risk of breast and ovarian cancer carries a potentially enormous cost, both physical and emotional, for these women. Rather than putting huge numbers of women under the surgeon’s knife, we should instead double or triple our investments in research on treatments that may eventually make surgery unnecessary. 

Myriad Genetics CEO Claims He Owns Your DNA


With the Supreme Court about to hear a landmark case on gene patents, Myriad Genetics, the company that owns the patents under scrutiny, is going on the offensive.  I've written about this case before, when the patents were first thrown out by one court, and then restored by another.  Now the Supremes will have the final say.

Just last week, geneticists Jeffrey Rosenfeld and Chris Mason wrote a commentary for the Washington Post that warned about the consequences of companies owning the rights to our gene sequences.

Today, in a letter filled with non sequiturs and distortions, Myriad Genetics' CEO Peter Meldrum, worried about whether his company will be able to maintain their monopoly on a test for which they charge $4000, responded.  Let's look at his claims.

First, though, let me remind readers that the genes in question, BRCA1 and BRCA2, are linked to an increased risk of breast and ovarian cancer, a risk that was first discovered in 1994 by scientists at the University of Utah.  Myriad Genetics owns a patent on these genes, and as I wrote last year:
"Thanks to these patents, you can’t look these genes in your own body without paying a fee to Myriad. Sounds ridiculous, right? Well, that was the state of gene patents until last May [2011], when judge Robert Sweet ruled that the Myriad’s patents were invalid."
Myriad appealed the decision, and the appeals court overturned Judge Sweet, buying into the argument by Myriad's lawyers that "isolated DNA" is not the same as the natural DNA, and that this distinction allows companies to patent it.  This is scientific nonsense for many reasons: for one thing, the process of isolating DNA does not create an artificial molecule. The body's own cells isolate DNA all the time, in the process of turning it into proteins.  But the appeals court accepted the argument, perhaps just because they wanted to uphold the patents.  So now the Supreme Court will re-examine this scientifically ridiculous claim.

Now let's look at CEO Meldrum's letter.  He first claims that Myriad's patents
"were essential to developing diagnostic tools that have been used by more than 1 million women to understand their hereditary risks of breast cancer and ovarian cancer."
This claim is simply false.  Myriad's patents made no contribution at all (and certainly weren't "essential") to the diagnostic tools used to detect mutations.  I know something about these tools, which I've been using in my own research for over 15 years.  Furthermore, academic medical centers were offering their own diagnostic tests on the BRCA genes, at a lower cost than Myriad, until Myriad's lawyers forced them to stop.  So Myriad's patents have increased costs to patients and, if anything, slowed down progress on making the tests faster and cheaper.

Second, Meldrum writes:
"Were these molecules derived in part from natural material? Sure. But that is true of many patents. Labs routinely turn naturally found molecules into innovative medicines and get patent protection."
One's jaw drops at this irrelevant non sequitur.  Myriad has never created "innovative medicine" or any other sort of medicine.  And the BRCA gene tests are not medicine: they are a diagnostic test that reads your DNA and tells you if you have harmful mutations in two specific genes.  Myriad's patents have nothing to do with medicines that treat breast and ovarian cancer - although it's clear that Meldrum would like us to think otherwise.

Third, Meldrum claims:
"Our tests are also accessible; some 95 percent of patients get insurance coverage, and we offer the test for free to those who cannot afford it."
This too is irrelevant, and also untrue.  The fact that 95% of patients have insurance, even if true, has nothing to do with whether or not genes should be patented.  And this merely hides the fact that Myriad's test is outrageously overpriced, at $4000 per patient.  The actual costs of testing for this gene should be far lower: we can now sequence an entire genome for $4000, and this test only looks at 2 genes out of more than 20,000.

Meldrum also throws out the unproven claim that Myriad offers it for free to those who cannot afford it.  Really?  Who decides if someone can afford it? If a woman can scrape together the $4000 with great hardship, does Myriad give her a break on the price?  I doubt it.  And what does this have to do with Myriad's supposed right to own your genes?

Fourth, Meldrum makes the remarkable claim that
"Our patents have also promoted additional research; 18,000 scientists have studied the genes, resulting in 10,000 published papers."  
This is just unfounded bragging.  Even the most wildly successful scientists would be very careful about claiming that that 10,000 papers have been based on their work.  In the case of Myriad, this is just false.  If you do a PubMed search for BRCA1, you can indeed find over 9,600 papers, as I did today.  However, there is no evidence whatsoever that these papers were even remotely supported by Myriad's patents.  It is far more likely that the patents prevented additional research on the BRCA genes.  The vast majority of research on these genes was supported by the public, which in the U.S. means by the National Institutes of Health.  Meldrum's boastful claim is absurd.

It's worth noting that the original paper describing the link between BRCA1 and breast cancer was published by a multi-institutional team from the University of Utah and other places, who were supported by multiple grants from the NIH and from the Canadian government.  Myriad Genetics subsequently licensed the patent rights from Utah, and has used them ever since to maintain its monopoly and prevent others from developing tests on the BRCA genes.  To claim that its patents promote innovation is pure nonsense.

The bottom line is that no one invented your genes, and no private company should be able to tell you that you can't even read your own DNA.  Today, you can get your DNA sequenced for less than the cost of the Myriad test.  Using free software (developed by my lab), you can scan that DNA for mutations in BRCA1 and BRCA2. And no company should be able to tell you not to.

Peter Meldrum's letter reveals that he doesn't care very much about the truth.  Meldrum made $4.87 million in 2011 as CEO of Myriad, so it's pretty clear what motivates him. Myriad's use of its patents to charge exhorbitant prices to women at risk for breast and ovarian cancer does not demonstrate innovation. It just demonstrates greed.