Can We Scare Patients Away Any More?
Not only has the pharma industry been under fire lately for drug contamination issues and a faltering FDA, now it seems clinical trial scares are being thrown into the mix. For the past few weeks, I have seen way too many reports of clinical research gone wrong. And I don’t mean “wrong” in the sense that the drug being tested failed, but rather, the drug being tested either hadn’t been approved for trial research in the first place, or the trial results were reported inaccurately.
Exhibit A: InterMune CEO W. Scott Harkonen paid $37 million to settle felony charges of violating the Federal, Food, Drug, and Cosmetic Ac for falsely promoting Actimmune (interferon gamma-1b) for unapproved uses as a treatment for idiopathic pulmonary fibrosis. The California-based company released selective data from its clinical research.
Exhibit B: Houston neurologist Arthur Ericsson may be disqualified by FDA (let’s hope he is) for giving an investigational new drug for autoimmune/inflammatory conditions involving the nervous system to at least six patients without an approved IND application. He had 22 patients sign informed consent documents that were not legally accurate. Even scarier, Ericsson reportedly received a warning letter 15 years ago, in 1993, for violating a clinical hold on another investigational drug in which he failed to maintain adequate records of the drug or of the patients’ case histories. How is this guy still allowed into any labs?
Exhibit C: According to a recent study published in Acta Paediatrica by researchers at the University of Nottingham, out of 739 studied pediatric clinical trials, only 2% reported using independent safety monitoring committees. These committees can help lead to the early detection of adverse drug reactions. Compare the 2% statistic to the fact that 71% of the trials reviewed reported adverse events.
There are several other examples of clinical trials and research being conducted inappropriately. With this information in hand, I know I wouldn’t consider signing up for a clinical trial. How can industry expect others to? What proof do patients have that a trial, a researcher, a drug, is safe—or for that matter, legal?