Showdown in Genetown
Most observers concede that both private rights and the public good need to be balanced in some way. The question is how. Will market forces afford a solution, or will the courts and policy-makers be forced to step in, breaking up gene monopolies in the name of society? Many would like to see the market work its wonders. But in the near term, it’s the opinion of Q. Todd Dickinson, director of the Patent Office, that “those who own the genes have a heavy responsibility that they are used for the good of all mankind.”
Service to humanity is a nice idea. But it’s already breaking down in a mounting dispute over genetic testing. Discoveries of the gene mutations that cause inherited diseases or susceptibility to cancer have been among the first practical payoffs of genomics research. But now physicians at academic medical centers around the country are complaining bitterly that stiff fees and onerous licensing terms are prohibiting them from performing diagnostic tests.
For instance, biomedical researchers at the Miami Children’s Hospital in Miami, Fla., helped discover (and then patented) the mutations that cause Canavan disease, an inherited neurological disorder that affects Ashkenazi Jews. The scientific advance allows doctors to test parents who fear they might be carriers of the defect by taking blood samples and checking for specific DNA mutations on chromosome 17, where the Canavan gene is located. The catch? Miami Children’s is charging a $12.50 royalty for every test performed.
Physicians are balking at having to pay to use what they consider to be medical knowledge. The financial restrictions, they argue, hurt their ability to teach, perform research and care for patients. “We would be happy to pay for some kind of test kit that is faster, better, cheaper. But they are trying to control manual testing, which is not appropriate,” says Michael Watson, a professor of pediatrics at Washington University in St. Louis.
The Canavan test is not the only one that’s kept behind a patent wall. Companies with patents on genes that can predict the onset of breast cancer and Alzheimer’s disease have angered physicians by exercising their right to keep commercial testing in-house. Tired of receiving letters bringing news that yet another gene has been patented-and that it’s time to pay up-Watson is among the physicians pushing for strong action. After tipping off the press to the controversy, he helped draft a resolution endorsed by the American College of Medical Genetics that calls for a moratorium on human gene patenting. The resolution is now being considered by the American Medical Association, which has supported gene patents in the past.
With patient groups and physicians rallying against gene patents, the trade group BIO has moved to stem the growing public relations debacle. In an interview, Chuck Ludlam, BIO’s VP of government relations, offered dire warnings. “Any move that compromises issuance of patents on genetic tests could have an impact on drug research. They are not separable. If there is an idea around of changing the law or the licensing on diagnostics, I think that is dangerous and misguided.”
Watson quickly dismisses the argument. “They [the biotech industry] talk about saving the children, but their angst comes primarily from the loss of market valuation. I don’t think that our side has a whole lot of interest [in] coming to an agreement.”
With the rhetoric from both sides heating up, the dispute over diagnostics could be a warning sign that commerce and medicine just can’t get along when it comes to gene patents. Diagnostics “is where the shooting is going to be for the next few years,” says University of Pennsylvania bioethicist David Magnus. “This is the cutting edge of the clash of values between the business world and the scientific and medical worlds.”