Breast Cancer Test Patent Causing a Furor

By Karen Iris Tucker

Published August 05, 2005, issue of August 05, 2005.

An American firm’s new European patent on a screening test for a genetic mutation that causes breast cancer has created an uproar among geneticists in Israel and Europe, who say the patent raises ethical questions because it targets Ashkenazic Jews.

The firm, Myriad Genetics, of Salt Lake City, Utah, was granted the European patent for the BRCA2 screening test when it narrowed the patent’s language to state that the test, a simple blood test, was “for diagnosing a predisposition to breast cancer in Ashkenazic Jewish women.”

The claim outraged the European Society of Human Genetics, which saw it as a dangerous precedent.

“This is the first time that a racial or ethnic group has been specifically singled out as a diagnostic target in a gene patent claim [in Europe],” the ESHG said in a statement after the European Patent Office awarded Myriad the patent on June 29.

The ESHG, a nonprofit group that seeks to promote research in basic and applied human and medical genetics, feels the patent could promote genetic discrimination. The ESHG contended that, to enforce the patent, doctors will be required to ask women whether they are of an Ashkenazic Jewish background before conducting the screening. It claimed the awarding of the patent would lead medical providers to deny cancer screening to Ashkenazic Jewish women if the provider did not have a license to use Myriad’s test.

One in 100 Ashkenazic Jewish women carries the BRCA2 mutation, which predisposes her to breast cancer, giving her a 65% to 70% chance of developing the disease. The mutation exists in the general population but is found more frequently in Ashkenazic Jewish women. Because of the genetic homogeneity of Ashkenazic Jews, “abnormalities are a lot easier to find in that community,” according to Dr. Olufunmilayo Olopade, director of the University of Chicago’s Center for Clinical Cancer Genetics. In America, testing for the most common BRCA mutations costs about $500 for Jewish women, but about $3,000 for most other populations, she said.

The Myriad controversy does not affect the testing of American women. Myriad owns a patent here that is not Ashkenazic specific. It owns 20 patents worldwide on the BRCA1 and BRCA2 cancer genes.

In Israel, doctors and the Health Ministry are up in arms because they are afraid Myriad will seek to enforce its patent there. In Israel, which has socialized medicine, BRCA screening costs less than $100, and this fee usually is paid for by one of the health funds that insure all citizens. If the new patent were to extend to Israel, Israeli health care providers would be forced to use Myriad’s patented test, which costs $500. Given the increased cost, the Health Ministry would be under pressure either to curtail the number of tests it provides — perhaps by restricting it to women with relatives who have had the disease — or to levy some extra fee on the patients. Either scenario might result in women with the mutation not being diagnosed.

“Maybe women will say, ‘It’s so expensive, I won’t test for it,’ but the testing could save her life,” said Dr. Dorit Lev, director of Tel Aviv’s Institute of Medical Genetics.

Dr. Eliezer Robinson, professor of oncology and chairman of the National Council for Oncology and of the Israeli Cancer Association in Haifa, was even more vehement.

“An increase of the price of a test that is geared toward a specific group of the population, and can hurt that population, has a racist taste,” he said. Like some other geneticists and cancer-care experts, Robinson is worried that some health care providers now may not be able to afford a license for the test and so may be forced to deny it to the very women who need it most.

A spokesman for Myriad, William Hockett, denied that the patent would lead to such problems.

“This has been a campaign of misinformation, sponsored by a few who oppose all patenting of genes,” he told the Forward. “The cost for a test to detect this mutation,” he said, “is no more or less than it was before the patent was issued.”

“Public or private,” he added, “the royalties asked of our licensees on the mutation test are very reasonable.” As for the question of enforcing the patent in Israel, Hockett wrote in an e-mail, “We have not had any requests for licensing or running tests there.”

Although the patent’s language seems to indicate otherwise, Hockett insisted it “does not legally or otherwise require anything of doctors. No additional questions are required.”

Hank Greely, an ethicist at Stanford University Law School, noted that the relative ease with which one can test Ashkenazic Jewish women for breast cancer mutations could have been a factor in Myriad’s wording of its patent.

“The easiest and cleanest and cheapest test focuses on the Ashkenazim because they tend to have only a few very easily tested mutations,” Greely said, adding, “I don’t think this patent is racist. I do think it is a blunder.”

Greely was skeptical that Myriad could enforce its patent if clinicians weren’t legally bound to ask women if they were of Ashkenazic Jewish descent. Even if doctors are required to obtain such information, the patent still seems impossible to enforce. “What if women lie?” he asked.

The Myriad case begs the much larger question of whether it is ethically sound to harness race or ethnicity as a means of marketing a medicine or patenting a genetic test.

The Myriad patent recalls the recent controversy over Food and Drug Administration approval of BiDil, marketed by NitroMed Inc. BiDil is the first approved so-called “ethnic drug” in the United States, a heart failure medication targeted at blacks.

Jonathan Kahn, a law professor and ethicist at Hamline University in St. Paul, Minn., who wrote a history of BiDil’s development in the Yale Journal of Health Policy, Law and Ethics last year, sees similarities in the two cases.

Kahn said BiDil’s original 1987 patent, which was set to expire in 2007, was not race specific. NitroMed reapplied in 2001, this time receiving race-specific approval.

“They use race to transform a pre-existing patent purely to get extra, extended patent protection — or to extend the reach of the patent,” said Kahn, who said Myriad’s patent seemed similarly amended in that it became specific to Jews only when it faced a legal challenge. Both BiDil and the Myriad test were available to their desired subjects before the companies targeted their patents at them.

Kahn pointed out that Ashkenazic Jewish women already know by and large that they have a higher incidence of the BRCA mutation. “This special patent doesn’t help identify at-risk people,” he said. “They can already take the test.”

Kahn sees such legal maneuvering as disrupting the balance between commerce and medicine. It is fine, he said, to make money by diagnosing and identifying people, for example, who have a BRCA mutation. However, “trying to exploit their ethnic identity to make even more money for that process, I think, is not fine. That is the choice Myriad is making in styling this sort of patent.”

Having such a patent, said Kahn, implied that Ashkenazic Jews are “are biologically and genetically identifiable as different from everybody else.” From there, he said, it is not a big step to say some groups are better than others.

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