Genetic testing company should free data

June 17, 2013 

Now that the Supreme Court has ruled that merely isolating a DNA sequence does not make it eligible to patent, the question arises, “What will happen to the crucially important data accumulated by an overly broad monopoly?”

The answer to this question has implications for people who may have an inherited risk for breast and ovarian cancer and to the scientists who hope to use that data for life-saving decisions about cancer surgery.

For the past 15 years, Myriad Genetics of Salt Lake City, Utah, has performed more than a million diagnostic tests for mutations in two genes -- BRCA1 and BRCA2 -- that are associated with inherited risk of breast and ovarian cancer. The Supreme Court ruling means Myriad has enjoyed a 15-year monopoly far broader than it should have been. The company now faces a fateful decision about what to do with that data it collected as a monopolist.

Will Myriad’s data be kept as proprietary assets to give Myriad a leg up on the competition that has already arisen, with four companies announcing after the Court’s decision they will introduce BRCA genetic testing? Or will Myriad share the data so others outside Myriad can know the basis for interpreting the tests?

Interpreting test results, regardless of what laboratory does the testing, depends crucially on access to data and objectively verifiable interpretation of test results. Data about test results and their clinical significance should be publicly available and objectively verifiable, not secreted in a proprietary database.

Women (and some men) sending their samples to Myriad were not told their data would be kept as trade secrets. When there was a legal presumption of patent-enforceable monopoly, it would not have mattered. But now it does.

Accumulating the data was perfectly legal; and exclusive rights are the very purpose of patents. Moreoever, there is no law against hoarding data of commercial value; indeed, state laws protect trade secrets.

But data about people’s cancer risk are not the same as the secret formula for Coca-Cola. If someone wants a cola, she can buy Pepsi or Diet Rite. But for the past 15 years, Myriad has offered the only commercial test for BRCA mutations in the United States. That means the data about BRCA mutations flowed to Myriad and there they stopped.

Now the Court has ruled that the data are not protected by patent. But the data remain in private hands, and that is wrong.

Just to be clear, Myriad does a good job of testing, and its prices are in line with other tests of similar type. Myriad reports results quickly and clearly. It has committed resources to educating women at risk and their doctors about its tests. It works with its customers to secure payment, so that the vast majority have at least the initial test covered by insurance or a health plan. And Myriad will even do free testing for families harboring mutations whose clinical significance is unknown and for some customers without health coverage (.5 percent of its tests have been done at no cost to customers).

Myriad can therefore compete on quality, cost, speed and ease of payment, but it should not withhold clinically relevant data and try to compete on the basis of secret data.

Hoarding data may or may not be legal, but it is certainly irresponsible and antithetical to good medicine. Good medicine is based on science, which by definition entails sharing of data and giving an explanation how they are interpreted sufficient for independent scientists (or clinicians) to reach the same conclusions. That’s how science and evidence-based medicine work.

The people, mainly women, who send their samples to Myriad are largely unaware that Myriad is treating the resulting data as trade secrets. As they learn otherwise, they will not be happy. Myriad never announced its 2004 decision to stop sharing data with public databases, and indeed many of us learned of it only by reading Federal District Court Judge Robert Sweet’s March 2010 ruling, the first court ruling in the case just decided by the Supreme Court.

Does Myriad really want physicians and genetic counselors to be telling women that other laboratories share their data with public databases so women all over the world can benefit, but Myriad does not?

Myriad, please don’t put us in that position. Do the right thing. Free the data.

Robert Cook-Deegan, MD, is a research professor at Duke University’s Institute for Genome Sciences & Policy and Sanford School of Public Policy.

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