Headlines: April 23, 2010
by Meg Larkin
In bioethics news, the Havasupai people have won a lawsuit against the University of Arizona over research done on their DNA. The Havasupai tribe lives at the bottom of the Grand Canyon, and have long suffered from a high rate of diabetes. Starting in 1990 members of the tribe had provided DNA samples to researchers who said they would conduct diabetes research with the donations. But, recently, the Havasupai found that their DNA samples had been used to study many other conditions that donors had been unaware of. The lawsuit raised issues about what level of informed consent is necessary in genetic research and how much control donors have over what research can be done on their DNA. The settlement will be split among 41 members of the Havasupai tribe.
In research news, a blood test may reduce the need for heart tissue biopsies after transplants. A new study, published Thursday, found that patients who had the blood test instead of the biopsy had roughly the same outcomes. After a transplant, patients are frequently tested in order to monitor whether the body is rejecting the transplanted heart. However, the study did not include those patients most likely to suffer a rejection. The study has also raised questions about whether either the biopsy or the blood test is needed at all. According to the New York Times, “The least expensive approach might be to conduct less testing of either type. Only 6 of the 34 episodes of rejection in the group getting the genetic test were found solely by the test. The rest were detected by echocardiogram or because of symptoms.”
After years of disfavor, research on psychedelic drugs may be making a comeback. New studies are looking into whether the drugs can be used to treat conditions like cancer anxiety and post traumatic stress disorder. Despite the success of some initial trials, the research has a difficult time getting funding because of the effects of the war on drugs. However, with funding from private donors, a number of universities are reinvigorating the field in order to improve patient options.
Finally, in business news, Boston biotech company Genzyme is expected to pay a $175 million fine from the FDA. The fine is linked to shortages of two Genzyme drugs that are used to treat rare genetic conditions. The shortage was initially caused by virus contamination in Genzyme’s Allston factory last June, but it was exacerbated by a municipal power failure on March 29th that caused problems with the factory’s water supply. Patients who need the two drugs, Fabrezyme and Cerazyme, are currently restricted to receiving a portion of the normal dose until the shortage ends. According to the New York Times, “Under the proposed terms [of the FDA agree,emt], Genzyme would be subject to future fines of 18.5 percent of the sales of product from Allston if the packaging of drugs into vials was not moved out of that factory by a deadline not yet set. It could also face fines of $15,000 a day for other violations.”
Meg Larkin is a second year law student at Boston University. Please feel free to email any questions, comments, suggestions or concerns.
