In the face of two studies critical of the FDA's approval processes, an agency official told The New York Times that it will urge manufacturers to develop well-defined targets for their trials on humans and measure them more closely.
Dr. Jeffrey Shuren, acting director of the Center for Devices and Radiological Health, told The Times that in late 2007 the agency started making improvements, which included a checklist for gauging the scientific merits of manufacturers' proposed designs. But he said he expects the agency will put out guidelines in the next year with explicit expectations regarding the scientific data that manufacturers present in clinical studies.
His comments preceded Tuesday's release of two studies that found the approval processes for high-risk heart devices such as coronary stents, pacemakers and implanted defibrillators suffered from a lack of high-quality data. Both studies reviewed clinical trials submitted for FDA approval from 2000 to 2007.
One study was conducted by the FDA and researchers from the Beth Israel Deaconess Medical Center in Boston. The other, published in The Journal of the American Medical Association, was led by researchers at the University of California, San Francisco.
The FDA-led study found enough problems with the quality of data submitted to warrant making policy changes, Shuren said. "It is not acceptable, and that is the reason we are making the changes in the program we are making," he told The Times.
U.S. Cocaine Laced With Deadly Horse Drug
Cocaine users in the United States may also be ingesting a dangerous drug used to deworm horses, San Francisco health officials say.
The drug, levamisole, can amplify cocaine's effect, but it also reduces white blood cells in humans. Levamisole has killed at least one cocaine user in New Mexico, according to the Centers for Disease Control and Prevention, and it has sickened at least eight in San Francisco. Symptoms include fever, oral and anal sores and virulent infections, United Press International reported.
Not everyone exposed to the drug becomes sick, however. The San Francisco Chronicle noted that 90 percent of 200 people who tested positive for cocaine also tested positive for levamisole in a recent study.
"The big question we have right now is, if 90 percent of cocaine users in San Francisco are positive for levamisole and are being exposed to this compound, then why aren't 90 percent of them in the emergency room with these side effects?" said Kara Lynch, associate head of the chemistry and toxicology lab at San Francisco General.