By Karen Weintraub
Every cell in your body holds about 20,000 active genes. Companies hold patents on more than 20 percent of them.
The companies argue that patents reward their investment in gene discovery, and encourage drug development. But those patents also mean that you have to pay them to read your genetic code, second opinions are limited and researchers may not be able to study or diagnose them.
The American Civil Liberties Union this week launched a public campaign against such gene patenting, as it awaits a Supreme Court decision that could come as soon as Monday.
[module align="right" width="half" type="pull-quote"]Mutations in these genes have been linked to dramatically higher rates of breast and ovarian cancer. [/module]The rights organization is collecting stories of people who believe they have been harmed by gene patents, and posting them on its website.
In 2009, the ACLU filed suit against Myriad Genetics Inc., of Salt Lake City, which holds a series of patents on the breast cancer genes BRC1 and 2. Mutations in these genes have been linked to dramatically higher rates of breast and ovarian cancer. Women who find out they have this mutation are often convinced to have both breasts removed – rather than just a lump – as well as their ovaries.
But before they know whether they have a dangerous mutation, they need a genetic scan only offered by Myriad, at a cost of more than $3,000.
Myriad spokeswoman Rebecca Chambers said via e-mail that the “cost of the BRACAnalysis test is not prohibitive and patient access is extensive.” Patients can get second opinions from other companies, and Myriad’s patents have not impeded academic research, she wrote.
“Myriad has never denied, opposed or impeded any research studies on these, or any other, genes,” said Chambers, director of Investor Relations and Corporate Communications.
Newton mom Lisbeth Ceriani, who filed suit with the ACLU, had a different experience with Myriad. Ceriani said she spent 18 months trying to get a BRCA test from Myriad, which she could not afford to pay out of pocket and which would have been covered by her insurance had Myriad accepted it. (Myriad only accepts about half of American insurance coverage.)
Ceriani said she wanted the test before deciding whether to have her ovaries removed, after being diagnosed with breast cancer in her mid-30s.
“Who wants to take their ovaries out at 40 if you don’t have to?” she said. The test “gives you all the information you need to make an educated choice. Without that test, you’re really left in the dark.”
After fighting for 18 month, Ceriani found a grant to cover the cost of the test, and a second, $700 one to look for rare mutations. The first test came back negative, but the second found she had one of the rare genetic glitches that gave her an 80 percent likelihood of developing ovarian cancer. She had her ovaries removed two years ago to prevent that possibility.
“I’d probably not be talking to you right now if I hadn’t done this test,” she said.
Patenting genes prevents people from fully understanding their bodies and taking care of themselves, according to Judy Norsigian, executive director of Our Bodies Ourselves, the women’s health group that publishes a book by the same name.[module align="right" width="half" type="pull-quote"]“People shouldn’t be losing this kind of control over their own genetic information.”[/module]
"These broad patents are a barrier to any woman’s ability to know about her body and health history,” Norsigian said. “People shouldn’t be losing this kind of control over their own genetic information.”
There is 100 years of case law finding that companies can’t patent the products of nature. The government allowed gene patents initially, according to ACLU attorney Sandra Park, because the companies were isolating specific genes – a task that is not part of nature.
Patenting single genes also raises the question of what will happen in a few years when, as expected, scans of the whole genome will become common. Will doctors have to give patients only 70-80 percent of their results, requiring other tests for the remaining genes? No one knows.
At Boston University, the Center for Human Genetics was forced by another gene patent holder to desist from offering certain genetic screens.
“You can’t patent gold you can’t patent diamonds, how on earth can you patent genes?” the center’s director, Aubrey Milunsky, asks.
He’s cautiously optimistic that the Supreme Court will come to the same conclusion he has.
“We’re headed, I hope for a Supreme Court that has the wisdom to understand the complexities of the subject and see to it that patients are not deprived of the remarkable advances in human genetics,” he said.
Last Friday, the court discussed the ACLU-Myriad case, but didn’t make any public comments about it. Park said the court will make its next public statement on Monday; an answer could come then, or not for months, she said.
Karen Weintraub, a Cambridge-based Health/Science journalist, is a frequent contributor to CommonHealth.
Correction: An earlier version of the story noted that Ceriani's insurance company did not cover the test. She says it was Myriad who declined to accept her insurance, rather than the other way around.
This program aired on February 24, 2012. The audio for this program is not available.