When you say the sentence aloud, or read it, you almost pause at its incredulity. But for almost 20 years, Myriad Genetics, a Salt Lake City-based biotech laboratory, has held a patent on the BRCA genes, which are linked to breast and ovarian cancers.
That gene monopoly came to an end a few weeks ago when the U.S. Supreme Court ruled that a gene is not an invention of man, but rather a naturally occurring event – and a company cannot hold a patent on nature. The court’s ruling will open up abundant research opportunities for institutions within the Texas Medical Center and in other labs throughout the country to move forward with genetic sequencing and analysis aimed at finding new and better ways to treat diseases.
|Robert Robbins, M.D.,
Texas Medical Center
Texas Medical Center
With Myriad holding the patent for BRCA genes, doctors could only use one test – the BRCA Analysis test available through Myriad – to look at whether a patient was genetically predisposed to breast or ovarian cancer. This is the same test that recently garnered worldwide headlines when actress Angelina Jolie took the test and, based on the results, chose to undergo a double mastectomy after the test showed she had a strong hereditary link to breast cancer.
With the Supreme Court’s new ruling, a number of companies – not just one – can now generate their own BRCA analysis tests. When competition comes into play, costs go down. Most authorities who have weighed in on the Supreme Court ruling say patients are the real winners in this lawsuit. That’s the good news.
The not-so-good-news is that the court didn’t address another major concern generated by all this biotech research – how can we validate the results? Justices ruled biotech companies can still patent the tests done on genes, and can still treat the databases of these tests as proprietary information.
This concerns people like Dr. Howard Brody, director of the Institute for Medical Humanities at the University of Texas Medical Branch at Galveston. He says these databases are not available to either the public or doctors because, the biotech companies argue, making the databases available could put the biotech companies at a disadvantage in the marketplace.
So how do we know the testing is accurate and will accomplish what we want? We don’t, unless we have a chance to look at the data, but the court says the data doesn’t have to be made available.
Brody doesn’t necessarily favor creation of a new government office, but he and others would like a review panel of some sort to make sure the information gathered from these test results is not biased by the commercial needs of a company and its stockholders.
Other countries offer such supervision. For example, the Swiss Agency for Therapeutic Products inspects research data for drugs and tests offered to humans and animals alike, to guarantee safety and effectiveness.
During its annual meeting on June 18, the American Medical Association adopted a policy urging companies, labs and researchers to share information they discover on genetic variants and the significance of those variants. The AMA suggests creating a system that will assure patient privacy while allowing sharing of genetic analyses to advance genomic medicine.
Dr. Amy McGuire, director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine, also advocates for access to research databases in the name of medical progress.
To advance research and improve standards of medical practice, we must arm ourselves with all the facts. Going forward, we should introduce discussions on how we can share key information for the good of the patient while still protecting the rights of commercial researchers to make a profit.