The corporation claiming a patent on breast cancer-linked genes does not have that right, the Supreme Court said today, at least until after further legal review. The case involves patents on the human genes known as BRCA1 and BRCA2 (for “Breast Cancer” 1 and 2) held by Myriad Genetics, Inc.
Although at least 90 percent of the time breast cancer is sporadic, these two mutations alone are believed to cause most hereditary breast cancer. In families suspected of having or already identified as having a mutation, women can choose to take a blood test that reveals significant information about their individual risk. The patents, however, have effectively given Myriad a monopoly in the U.S. on breast and ovarian cancer screening tests since 1994.
A lawsuit filed in 2009 claimed the patents violated patent law, restricting scientific research and patients' access to medical care. One barrier for patients has been the cost of the test: it ranges from about $300 to $3,000. The less expensive test only examines the few areas of the gene where the mutation is commonly found.
When it’s no longer academic
Many healthcare consumers and breast cancer patient advocates will be glad to hear the Supreme Court decision. That’s because competition in the marketplace for genetic testing may help empower patients and their families by eliminating barriers to the flow of BRCA status information.
While mutation carriers are not doomed to cancer and certainly not to death by cancer, women diagnosed with cancer who are facing treatment decisions are also motivated to get this information from their genome. The mutation raises serious, specific treatment issues, for example: when is mastectomy the best choice? When should a woman consider having her ovaries removed? And what about chemoprevention?
Yet genomics information can only take us so far toward actual decisions:
Each of us has a set of deeply rooted beliefs whose profound influence we may not realize when we make medical decisions. How much trust we place in authority figures, in statistics or in other patients’ stories, in science and technology or in natural healing, whether we seek the most or the least treatment - all are key factors that shape our choices. (Jerome Groopman, MD and Pamela Hartzband, MD: Your Medical Mind)
And access problems won’t be fully solved by the free marketplace. “Most physicians feel uncomfortable with genetic tests, and many have never ordered one,” wrote Robert Klitzman, MD in a recent article, Genetics as Rohrshachs: Pondering Genes and Fate. “Doctors trained more than 10 years ago often have little knowledge about these new assays.”
Hereditary cancer is fraught with social and psychological concerns. The NCI urges healthcare consumers to consider the usefulness of genetic counseling. Only when we confer with a qualified individual to discuss our personal and family medical history as well as the accuracy of the test and implications of its results do we achieve the decision-making trinity: information, in context, with support.
Klitzman recounts a newly diagnosed woman who told him "I thought the (BRCA) test would give me answers…but it's just left me with a lot of questions."
Information, context, support
When physicians collaborate with patients and caregivers to make medical care decisions, patients feel more comfortable with and confident in his or her treatment-related decisions, according to the Agency for Healthcare Research and Quality (AHRQ)
When patients shift from being “passengers” to being responsible “drivers” of their health -- with their healthcare providers’ encouragement – we see participatory medicine emerge. Patient empowerment includes getting access to more and more precise information. But in breast cancer, genomic information is only one leg of a sometimes wobbly stool.