Myriad Genetics Can't "Make Business Case" for Sharing Genomic Information
Posted Jan 14 2013 12:00am
I served on the Institutional Review Board (IRB) of an academic health system for a number of years. During this time, I had occasion to review a number of clinical trials by researchers working on various genomic projects. Some of the sponsoring companies were more "generous" than others in terms of their willingness to share the information generated as part of the project. A related topic was addressed in The Pathology Blawg recently (see: Myriad Genetics CEO admits sharing data “doesn’t make a lot of business sense” ). Below is an excerpt from the note:
Over the last few months, I have posted several articles about the lawsuit brought against Myriad Genetics by the Association for Molecular Pathology, the College of American Pathologists and other plaintiffs regarding the patents it (Myriad) holds on BRCA1 and BRCA2. The plaintiffs argue the patents should be invalidated and that no one should be able to patent a product of nature. Myriad argues the truncated DNA sequences in question exist only in a laboratory setting and therefore can be patented. Among other issues raised by critics is the contention that Myriad, by holding these patents, stifles research and clinical testing into hereditary cancers involving BRCA gene mutations. Myriad has always vehemently denied this, but in this recent article from Bloomberg, Myriad’s CEO seems to admit the opposite (see: Myriad Stymies Cancer Answers by Impeding Data Sharing )....The Myriad case has been in the judicial system for some time now. Originally, a federal court found the patents to be invalid. Myriad appealed to the US Court of Appeals for the Federal Circuit, which found in favor of Myriad. Following its decision in the Mayo v. Prometheus case, the US Supreme Court vacated the appellate court’s decision and ordered it to re-review the Myriad case using the Mayo decision for guidance. The appellate court upheld its own decision on re-review. The plaintiffs appealed to the US Supreme Court, which agreed to hear the case on November 30, 2012.The Bloomberg article discusses how Myriad, despite its denials, allegedly refuses to share data with others in the scientific community. The article points to a consortium of 48 US companies and universities that have all agreed to contribute data to a government-run database that will catalogue genetic mutations. Myriad has yet to contribute to this database. And here comes the most important part of the article, at least for me. The CEO of Myriad, Dr. Peter Meldrum, when asked why Myriad has not contributed data to the new database, said the sharing of data “doesn’t make a lot of business sense”. Before now I had not seen any proof of Myriad’s unwillingness to share data. To me this quote from Myriad’s CEO essentially proves what Myriad’s critics have been saying all along and is one (and perhaps the best) reason why I agree with the plaintiffs that genes should not be patentable.
It's important to understand that when Myriad tests for BRCA1 and BRCA2 , it performs genomic testing on the patient sample and also supplies an interpretation of the results. This interpretive portion is a critical part of the test. The company's internal knowledge base is thus a critical business asset. There are both common and uncommon mutations a the BRCA1 and BRCA2 genetic loci. It is essential that such data be broadly shared in order to better understand the clinical implications of all of the mutations. From a business perspective, I am understand why Myriad is reluctant to share such data. From a patient care and scientific perspective, the development of a "government-run database [to] catalogue genetic mutations" at the loci is very important. I personally hope that the Supreme Courts comes down on the side of broad sharing of the genomic information generated in both research studies and clinical patient testing.