But because of a group of unusual patents obtained by Salt Lake City-based Myriad Genetics Inc., the test for the BRCA1 and BRCA2 genes is only available through that company -- potentially limiting access to any number of patients who may not have the insurance or the cash to be able to afford the $3,000 test.
On Tuesday, a group of physicians, researchers and patients filed a potentially ground-breaking lawsuit against Myriad in federal court in New York, challenging not only the company, but the U.S. Patent and Trademark Office, as well.
The lawsuit, filed by the American Civil Liberties Union, brings to light not only issues over patent law (Can a company patent something that is naturally occurring?) but medical ethics, as well (Should a company restrict access to a valuable diagnostic tool for profit?)
The plaintiffs allege that Myriad's patents prohibit any other lab from doing routine screening for the genes in question, and have therefore created for Myriad a monopoly on the technology.
They cite as an example of Myriad's diligence in protecting the patents that the company has sent cease and desist letters to labs at the University of Pennsylvania to stop work occurring there and has enforced the patents at least nine times.
But Richard Marsh, general counsel for Myriad, said that the only enforcement actions that have occurred were for labs that were doing commercial BRCA1 and BRCA2 testing to generate revenue and not for purely scientific research.
"I think we are being falsely accused of stifling the potential for research," Mr. Marsh said.
Further, he believes that the handful of patients named in the lawsuit who have had difficulty obtaining the testing are an exception.
"It's an important exception for these folks, and we're obviously sensitive to that," he said. "If that's the case, get in touch with the company, and we'll make [the test] happen."
The most important element of the lawsuit, Mr. Marsh said, is the question of whether genes can be patented.
Citing a 1980 Supreme Court decision, he said the answer is clearly yes.
Patients are not even able to get a second opinion on BRCA1 and BRCA2 results from Myriad because no other lab is allowed to perform the test.
"The limitations they have placed on ordering this test are indescribable," said Ellen Matloff, a genetic counselor at a leading cancer center in Connecticut.
Women with a significant mutation of the BRCA1 or BRCA2 genes have an approximate 40 to 85 percent lifetime risk of developing breast cancer, the lawsuit said.
"For those of us in the field who see how much good this test can do, having our hands tied and not being able to order the test is unbelievable," said Ms. Matloff.
Saralouis Reis, 56, of Squirrel Hill, had the BRCA screening about six years ago.
Her younger sister developed breast cancer at age 30 and underwent a single mastectomy. About 12 years later, she went back to her oncologist for prophylactic surgery.
When the doctor inquired about the woman's ancestry, she said she was Jewish, of Eastern European descent.
The doctor then recommended BRCA screening, because mutations are more common in Ashkenazi Jews. After the blood test -- it can also be administered through a cheek swab -- was done, it showed that Ms. Reis' sister did have the mutation.
Then she and her older sister had the test, as well.
Her older sister's test was positive, and her doctor recommended having her ovaries removed. When the surgery was performed, doctors found she already had Stage-1 ovarian cancer. She continues on a maintenance course of chemotherapy.
Ms. Reis' test was positive, too. She had a bilateral mastectomy 51/2 years ago.
"My little sister really saved our lives by having the test," she said.
With her family's history, Ms. Reis didn't have any trouble with insurance paying for the cost of the test.
"I would like the test to be available to as many women -- at a reasonable price -- as possible, because it's important," she said.
When Ms. Matloff first began ordering the test in the late 1990s, it cost just $1,600. Now, she said, the cost has more than doubled.
"The improvements in technology should have driven that cost down significantly, and certainly not up," she said
The plaintiffs contend that the government's policy of allowing the patenting of products of nature violates the U.S. Constitution and patent statute.
That, however, should be addressed by Congress, and not through a lawsuit, said Alan Meisel, the director of the Center for Bioethics and Health Law at the University of Pittsburgh.
Further, he said, if the patent system didn't exist, then the test may have never been developed because there would not have been a financial incentive for private industry.
The other option, he added, is to have universal access to health care, so that the BRCA1 and BRCA2 screening is covered for everyone.
He did note, though, that his sympathies lie with the plaintiffs.
"People's lives are at stake. They ought to be willing to be more humane than this."
Thursday, May 14, 2009
By Paula Reed Ward, Pittsburgh Post-Gazette
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