Celebrity Breasts and Patented Genes: Why the test that may save Angelina Jolie’s life is too expensive for the BoP (Bi-Weekly Checkup – 5/24/13)
When I first read the headline, I thought it was a crude hoax – one of those satirical news reports that often fool unsuspecting readers on the Internet:
“Angelina Jolie Has Both Breasts Removed”
Of course, as you’ve no doubt heard, the news was true. In an op-ed in the New York Times, Jolie candidly described her decision to undergo a preventive double mastectomy. “I carry a ‘faulty’ gene, BRCA1, which sharply increases my risk of developing breast cancer and ovarian cancer,” she wrote. “My doctors estimated that I had an 87 percent risk of breast cancer and a 50 percent risk of ovarian cancer.” She addressed the higher risk first, and implied that ovarian surgery will eventually follow.
Predictably, the news caused quite a stir – and even some controversy, as some publicly questioned whether such a drastic step was warranted. But the conversation largely overlooked an important point that the actress herself mentioned in her op-ed. “Breast cancer alone kills some 458,000 people each year … mainly in low- and middle-income countries,” she wrote. “It has got to be a priority to ensure that more women can access gene testing and lifesaving preventive treatment, whatever their means and background, wherever they live. The cost of testing for BRCA1 and BRCA2, at more than $3,000 in the United States, remains an obstacle for many women.”
Why is it so expensive to test for BRCA? Because Myriad Genetics, a U.S.-based company that develops and markets tests for hereditary cancers, has a patent on the genes themselves. As the patent holder, Myriad is the only company that can offer genetic tests for BRCA – so it can charge whatever it pleases.
In order for the cost of this test to come down to the point where the developing world could afford it, one of two things will have to happen:
- Myriad Genetics will have to voluntarily (and dramatically) cut the price
- The company’s patent will have to either expire or be invalidated, so that other companies can produce cheaper alternatives
I’m going to go out on a limb and say that option 1 is unlikely – but what about option 2? We may know in a few weeks.
Myriad Genetics’ patents are at the heart of a legal battle that started in 2009, and that could be decided this summer by the U.S. Supreme Court. The plaintiffs in the case include the Association for Molecular Pathology and the American Civil Liberties Union. They make a point that seems pretty intuitive: private companies should not be allowed to patent genes, because they merely extracted naturally-occurring material and did not invent or modify it.
Allowing companies to patent genes, the plaintiffs argue, has drastic negative consequences not only for patients, but for science. In a recent press release, the ACLU stated: “The U.S. Patent and Trademark Office (PTO) has granted thousands of patents on human genes – in fact, about 20 percent of our genes are patented. A gene patent holder has the right to prevent anyone from studying, testing or even looking at a gene. As a result, scientific research and genetic testing has been delayed, limited or even shut down due to concerns about gene patents.”
But Myriad Genetics argues that isolating the BRCA genes required a tremendous amount of research and ingenuity, and that patent protection should reward this. It says it invested around $500 million in developing and producing the genetic test, which has benefited about 1 million people so far – and which currently provides over three quarters of the company’s total revenue. Its CEO has insisted that strong patent protection is necessary to encourage companies and investors to continue to invest billions of dollars in risky R&D in the hopes of developing the next medical breakthrough.
Myriad also says that 95 percent of U.S. patients have access to its test through medical insurance, allowing most patients to pay just $100. And the U.S. government has announced that doctor-recommended BRCA testing will be covered without co-payment for qualifying patients under Obamacare’s health insurance regulations.
I see the company’s point about the need to reward R&D investment, and balancing that against the public’s need for affordable medicine is a core dilemma of modern health care. But there are alternatives to the high-risk, high-reward pharmaceutical R&D model. And the fact that Obamacare will make the BRCA test accessible to Americans does nothing to help patients at the BoP. So I’m hoping that the Supreme Court decides to invalidate the patent – though its recent rulings cast some doubt on that possibility. A decision is expected as early as June.
But if the U.S. government doesn’t act to rein in gene patents, other governments might. India in particular has shown a willingness to prioritize public need over patent protection when it comes to medical products. It has granted licenses to generic drug manufacturers to make inexpensive copies of drugs patented by foreign companies like Bayer and Pfizer. And its Supreme Court recently upheld generic manufacturers’ right to produce low-cost copycats of the Novartis leukemia drug Gleevec, setting an important precedent.
What do you think? Should private companies have the right to patent live-saving medicines, tests, and even genes themselves, if that makes them inaccessible for much of the world? Should countries like India have the right to ignore those patents for the sake of public health? Feel free to share your opinion in the comments.