Problems with oral bisphosphonates continue mounting atop agency’s Zofran woes.
by Dr. Robert E. Marx
Chronically underfunded and understaffed, the slow-moving Food and Drug Administration is often the last to acknowledge post-approval deleterious effects emerging in patient populations. That “holy grail” for drug companies, FDA approval, is key, ironically, in the corruption of pharmaceutical testing and safety.
As has been detailed in the media, the resulting injuries can be debilitating, even lethal. The stacks of cash adding up to over $70 billion in profits for the drug makers each year cast large shadows, and that’s one of the places where my upcoming novel Deadly Prescription will shine its light.
Zofran, a drug approved by the FDA for preventing nausea and vomiting related to cancer chemotherapy and surgery, has been used increasingly “off-label” to treat nausea and vomiting in pregnancy, according to FertililiyCenter.com and others. Based on recent studies regarding the association between Zofran use in early pregnancy and congenital cardiac malformations and oral clefts (cleft lip and palate), the FDA has cautioned against its use in pregnancy, the website reported. Of course, the agency’s “caution” came only after the drug manufacturer pled guilty (in 2012) to fraud and illegal promotion.
The New York Times reported in 2010 that the FDA had “issued a warning linking long-term use of popular osteoporosis drugs to an unusual fracture of the thigh bone.” But the paper also described how the agency was spending its time before issuing the caution on the drugs which have been heavily marketed to women since 1995, growing into an estimated $8 billion market worldwide. The agency said that “the labels and medication guides would be changed to show the new warning in oral bisphosphonates.” While the FDA changed the wording on medicine bottles lengthy, fine-print monographs, unwitting patients were experiencing sudden leg fractures without any external trauma.
Also disturbing, two spokespersons for the pharmaceutical companies admitted to the Times that their companies had been working closely with the FDA on the wording changes. Does this enormous regulatory agency require the drug companies’ assistance with even so basic a task?
Because of their more than two decades on the market, bisphosphonates have previously gained even the FDA’s attention for other safety concerns. These have included arrhythmias, esophageal cancer, and the cases of which I have seen way too many–osteonecrosis (or bone death) of the jaw. But patients and their doctors knew about all of these problems first, though there’s growing evidence that the drug companies knew even earlier.
Clearly, the FDA is the last to know, yet the public perceives that they are first–testing and testing new drugs for years before approving them. As part of my research and experience in oral and maxillofacial surgery, I have worked on many trials of new drugs, and I can tell you that, though we might like it to, it simply does not work that way The pharmaceutical companies are in no hurry to dispel the agency’s “first and last word” reputation, as they continue to promote the “FDA Approved” myth as your government’s guarantee of safety and efficacy.
Robert E. Marx, DDS is Chief of Research and Professor of Surgery at the University of Miami’s Miller School of Medicine’s Division of Oral and Maxillofacial Surgery. He is a graduate of Northwestern University.