Filed under: Genetics, Health Insurance, Intellectual Property
Over the past year, two developments—one legal, and one economic—have hit Myriad Genetics, Inc. hard. These developments could have significant ramifications on the detection and treatment of cancer.
First, last summer, the Supreme Court ruled that Myriad could not patent the isolated BRCA 1 and BRCA 2 genes that the company used to develop tests to uncover mutations in the two genes. The presence of such mutations dramatically increases a woman’s risk of developing breast or ovarian cancer. In the Myriad case, the Court reversed the Federal Circuit, and held that the genetic sequences in question could not be patented because they were naturally occurring segments. To the Court, Myriad’s principal scientific contribution was identifying the precise location of a naturally occurring genetic sequence. Though the Court conceded this was a significant breakthrough, a gene is not patent eligible solely because of its isolation. The underlying principle is that products of nature are precluded from patent eligibility.
This Spring, the U.S. District Court for the District of Utah denied an injunction Myriad sought against competitor Ambry Genetics Corporation. Ambry had developed similar products to Myriad’s gene based cancer test. In the case before the Utah court, University of Utah Research Foundation et al. v. Ambry Genetics Corporation, Myriad claimed patent infringement and requested a preliminary injunction to prevent Ambry from selling its tests until the court reached its final determination. On March 10, the court held that Myriad was not entitled to the injunction.
Myriad’s shares fell twelve percent in the wake of the court’s holding.
Cigna’s decision in August 2013 to require genetic counseling before it covers genetic testing, including Myriad’s tests for breast cancer indicators, has only exacerbated these legal setbacks. Cigna is the first U.S. health insurer to require genetic counseling before it pays for hereditary breast and ovarian cancer tests. Cigna officials expressed hope that the policy would decrease the prevalence of unnecessary tests, as many doctors, fearing suit, accede to patient’s requests for testing. Cigna’s policy, which went into effect on September 15, 2013, requires evaluation by a certified counselor from the American Board of Medical Genetics or the American Board of Genetic Counseling before commencing genetic testing. Medical professionals, however, have criticized the policy, asserting that it could result in patients opting out of beneficial testing due to the need for additional referrals. This could ultimately result in less cancer detections, and less treatment.
Only time will tell if these developments will help or hurt cancer patients. On one hand, permitting Myriad to patent the ability to isolate and work with BRCA DNA sequences would certainly prevent other bioengineers from manipulating these sequences to reach new breakthroughs in the fight against cancer. Ambry Chief Executive Officer Charles Dunlop has assumed this stance, stating, in response the Utah court’s decision, that “[c]ompetition stemming from a free market drives all of us to improve and ultimately increases patient access to life-changing information.”
But on the other hand, blocking patents could preclude companies from entering into this sphere altogether as the venture might not be economically viable if competitors can flood the marketplace with similar tests. And if the critics of Cigna’s policy are correct, policies like Cigna’s would only aggravate this problem. As patients opt out of genetic testing because of the need for additional referrals, fewer tests would be conducted, and the financial incentives gained from this market could diminish.
Layne Feldman is a third-year law student at Seton Hall University School of Law who is concentrating in Health Law. We are very pleased to welcome Layne to the blog today.
Filed under: Bioethics, Food and Drug Administration (FDA), Genetics
Cross Posted at HealthLawProf Blog
23andMe, the Internet genetic testing company, which offered genetic testing for health conditions and ancestry, has received extensive publicity in recent months. In November 2013, the FDA ordered 23andMe to stop marketing its health-related genetic test results to customers because their product is a “device”, which requires FDA approval. In its letter to 23andMe the FDA focused on the harms of consumers’ interpretation of genetic test results without the appropriate medical guidance.
And for sure, consumers’ independent interpretation of genetic results is potentially harmful. But, another important concern not addressed by the FDA is the need to regulate and constrain the production of genetic information in the first place – at the time that a consumer decides which tests to take. Direct to consumer genetic testing companies, like 23andMe, usually offers a battery of multiple tests that the consumer purchases without careful selection of what information is desirable to her. And, although genetic information can help improve and control health outcomes, not all genetic information is made equal and not all tests results are similarly desirable for all people. In my essay Direct to Consumer Genetic Testing: Gatekeeping the Production of Genetic Information, I discuss the problem of indiscriminate production of genetic information and argue for the need for a medical gatekeeper not just for the interpretation of genetic test results but earlier on to guide consumers through the selection of tests.
The guidance of a medical practitioner (particularly a genetic counselor) at the test selection stage is important to avoid the production of genetic information that is unsuitable for the specific person who wants to undergo testing. First, some people may prefer not to know certain genetic information about themselves because there are no effective preventive measures, and they do not want to live with the knowledge that they are likely to incur a certain genetic disease. For example, currently, the most effective prevention for breast cancer is a mastectomy. Some women would welcome the information and the ability to prevent the disease. But, others may not view this as a preventive measure they can endure and would prefer not to undergo a genetic test for the breast cancer genetic mutations. Second, some genetic tests convey little information. Certain positive genetic test results indicate only a slightly higher probability of incurring the disease than the likelihood in the general population. Finally, some genetic tests may lack solid scientific validity, whether due to the state of the science or the effect of many mutations and environment factors that act in conjunction. For all these reasons, catering the selection of genetic information to the person testing can be as important as regulating the interpretation of the results stage.
Filed under: Ethics, Food and Drug Administration (FDA), Genetics
[Ed. Note: We are pleased to welcome Professor Gaia Bernstein to Health Reform Watch. Articles about her recent scholarship, "Over-parenting," may be found at the ABA Journal and The New York Times Magazine.]
Genetic testing for adult onset diseases used to be mainly a medical service. In most cases a person who had a certain genetic disease that was prevalent in her family would go to test to see if she carries the genetic mutation. For example, a woman who had several cases of breast cancer in her family would test for the breast cancer genetic mutation BRCA1/BRCA2 to see if she carries the mutation and has a high probability of getting the disease. But, the proliferation of direct to consumer genetic testing changes the nature of the service to a consumer service. Companies like 23andme and Pathway Genomics (who was planning to start selling its kits in Walgreens) offer consumers the option to buy packages of tests (ranging from 25 to over a 100 conditions). Consumers often buy the tests to satisfy their curiosity or they may even receive them as a gift. People purchasing the testing packages usually do not consult a medical professional when deciding to undergo the tests and receive the results alone by accessing a website.
Yesterday I spoke before the FDA, which is considering regulating direct to consumer genetic testing. My presentation was based on a symposium piece I am working on. I argued for the need for a medical professional to guide people throughout the process and advise them not just on the interpretation of the results but also earlier in the process to determine what genetic information they actually want to have.
Interpreting the results of genetic tests is not easy. Unlike other over the counter tests, like a pregnancy test, which gives a clear positive or negative result, genetic tests are about probabilities. Even a person who tests positive for a certain mutation may still not get sick depending on other non-genetic factors. People have a hard time understanding the results of genetic tests and for that reason there have been many calls to require the guidance of a medical professional for the delivery of the results.
But I believe focusing on the interpretation of the results is only half the issue. It is important to have professional guidance also at the outset to determine what tests to undergo. A medical professional should guide individuals and tailor the panel of tests to the individual who desires to test. Why is that? Well, first of all, some people, if they get a chance to give it some thought, may not want to know all their genetic information. For example, a person may prefer not to know that he is likely to get Alzheimer’s at a young age. Secondly, not all genetic information is made equal. Some genetic tests do not convey that much useful information. For example, a positive result in some tests may only demonstrate a slightly higher likelihood of getting the disease than the probability in the general population. Eliminating such tests at the outset will facilitate the interpretation of the results. It would be possible to focus on the truly important positive results at the end of the process.
To achieve all this it is important for the law to require the guidance of a medical professional who is not a representative of the genetic testing company. A medical professional working for the genetic testing company may have good knowledge of the tests, but could have an interest in having the consumer purchase as many tests as possible. This could place him in a conflict of interest with the consumer who could be best off by purchasing a more limited panel of tests tailored specifically for him.