Sheila Kaplan for the Boston Globe reports that Dr. Robert Califf, the Obama administration’s nominee to lead the Food and Drug Administration (FDA), has removed his name from a series of scientific papers that he recently coauthored. The decision to remove his name, against publication ethics standards, has brought Califf under renewed criticism.
According to the Globe, Califf was the driving force behind the series of articles that focus on promoting pragmatic clinical trials (PCTs) and criticized current FDA standards for informed consent and determining patient risk.
Pragmatic clinical trials (PCTs) are designed to ascertain the effectiveness of an intervention in real-world settings with a study population that is as similar as possible to the population the intervention is intended to treat. The current scientific standard, randomized control trials (RCTs), are designed for “internal validity,” or the ability to determine cause and effect relationships within the study, but the results often fail to be generalizable to a larger population. One general thrust of the series of publications in question is the altering of current FDA policies to make pragmatic clinical trials more feasible.
Califf was nominated to serve as Commissioner of the FDA in September, after serving as the deputy commissioner for medical products and tobacco since March. A cardiologist by training, Califf has had a long research career and led a number of large studies involving both public and private interests.
He has previously been criticized for his extensive ties to industry. The New York Times, for instance, reported that Califf had received financial support from more than twenty medical device and pharmaceutical companies.
When speaking to the Globe, Shannon Brownlee, who runs a public health nonprofit, added: “We already know that he thinks financial relationships between places like Duke and the drug industry are OK, so we know that. I think it’s probably a good idea to know what he thinks about this kind of research.”
