Genetic tests stopped in B.C.

Patenting of detection process stalls cancer procedure affecting Jews.

PAT JOHNSON REPORTER

The provincial government, citing a massive increase in the cost, has stopped funding a test that detects a breast cancer gene that is prevalent among Jewish women. The issue has opened a new debate on the medical ethics of patenting genetic technologies.

Myriad Technologies, a Utah-based biotechnology firm, has patented the process by which the BRCA1 and BRCA2 genes are identified. These genes, which are associated with breast cancer, are thought to be carried by one per cent of Ashkenazi women - about 10 times the proportion in the general community.

About 200 to 300 women are screened annually at the B.C. Cancer Centre, with each test costing about $600. Since Myriad patented the process, they have charged $3,850 per test, which are performed in their American labs. They have also warned medical facilities like the B.C. Cancer Agency that they can continue to perform the tests themselves, but they are required to remit $3,850 for every procedure to Myriad.

Dr. Joseph Ragaz, a medical oncologist at the B.C. Cancer Agency, said the medical community was stunned by the patent. "None of the previous medical discoveries have been patented," he said. The development is the result of a confluence of factors, he said, including the fact that genetic technologies are a new field. The first gene associated with breast cancer was found only in the mid-1990s.

Another factor, he said, is the growing relationship between pharmaceutical companies and academic institutions. As intricate scientific research becomes ever more laborious and expensive, universities are increasingly forced to rely on funding from corporations. These companies expect to see financial gains from their investments.

There is a legal challenge that was launched on the subject of patenting these gene tests by the government of Ontario, as well as another case in France.

Once the gene was identified and the procedure for finding it was created, the B.C. Cancer Agency started screening for the gene, making a particular effort to educate Jewish women of Ashkenazi descent about their vulnerability. The National Council of Jewish Women has been active in educating and encouraging preventative screening tests.

Women who carry the gene are able to take some precautions, such as the drug Tamoxifen and to increase regular mammographies. In some cases, women have opted for preventative mastectomies.

Michelle Stewart, a spokesperson for British Columbia's Ministry of Health, said the government is trying to determine whether a company has the right to patent a process that identifies a gene.

"The ministry is officially seeking a legal opinion at this time to determine the validity of Myriad's claim of patent ownership of these [tests]," said Stewart.

In the meantime, the ministry has suspended tests since they were notified by Myriad in the summer that to proceed would be in contravention of the company's patent rights. British Columbians who want the test must pay for it through MDS Metro Laboratory Services.

The novel nature of the patent has also led to jurisdictional confusion. The Patented Medicines Prices Review Board, a federal agency that regulates the cost of prescription drugs in Canada, said that they do not have authority over the Myriad patent because it does not involve pharmaceuticals. Similarly, Rx&D, a corporate umbrella agency formerly known as the Pharmaceuticals Manufacturers Association of Canada, said they have no comment on the matter, because the genetic testing is outside the pharmaceuticals industry.

Meanwhile, a spokesperson for MDS Metro, which provides the test in Canada, defended the patent. If governments opt not to pay for the tests, that is unfortunate, said Pat Everitt. However, the patent is similar to that used in other industries, she said.

"If you think about it, you can't patent iron, because iron is an element," she said. "But you can patent the process for making steel. In this case, Myriad has not patented the gene, but it has patented the process."

Hundreds of tests have been postponed at the B.C. Cancer Agency since the patent was announced, said Ragaz.

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