Osteonecrosis of the mandible—exactly as scary as it sounds—is a devastating side-effect of the most popular class of osteoporosis treatments. And it’s bad news for Pharma and the FDA.
The Chief Director of Research for University of Miami’s Division of Oral and Maxillofacial, Dr. Robert E. Marx, wants you to know that a class of drugs called bisphosphonates can cause “osteonecrosis” (bone death) of the jaws. Bisphosphonates (marketed by several drug companies as Fosamax, Reclast, Zometa, Denosumab, Actonel, and Boniva) are the most commonly prescribed treatments for osteoporosis and, throughout Dr. Marx’s decade-long study of them, he has personally documented a significant number of prospective cases of bisphosphonate-induced osteonecrosis of the jaws (BIONJ). Of those 50 patients, three lost at least half of their mandible because of it.
The problem with bisphosphonates is that they can over-suppress what scientists call “bone turnover,” a biological process by which bone tissue creates and replaces itself. Dr. Marx, who is also a professor of surgery at the university, says bisphosphonate over-suppression weakens and ultimately kills bone.
Also deeply troubling are Dr. Marx’s findings on the clinical trials required before drugs like the bisphosphonates are approved by the FDA. He points to seven key flaws in the trials themselves–flaws that, unsurprisingly, can be, and often are, exploited by the drug companies seeking FDA approval. (The seven major problems with these “randomized prospective, double-blinded, clinical trials,” or RCT, will be described in detail in future posts.)
The causes championed by the doctor are not without controversy. A few years back, a Mayo Clinic prosthodontist wrote an editorial for a dental journal in which he took the unusual liberty of aggressively criticizing an article in another publication. The piece he maligned was about BIONJ, was written by Dr. Marx and his colleagues, underwent peer-review (in line with that journal’s process), and contained verifiable data. So, the inevitable question is: What was the prosthodontist’s motivation for going out of his way to attack the article?
Between 2002 and 2012, according to the Huffington Post, the 11 largest drug companies in the world made $711 billion dollars in profits. Such numbers are staggering for most people, and anyone in such a state could be forgiven for stumbling down the path of “Well, pharmaceutical research and testing is very expensive…” Look again–that’s three quarters of a trillion dollars in profits! For regular folks who deal in thousands at best, that’s equivalent to 71.1 thousand million dollars per year. Okay, maybe that wasn’t so helpful after all.
What’s clear is that over 4,000 cases of BIONJ have been reported to the FDA regarding the intravenous versions of the drugs alone, says Dr. Marx. He pointedly asks, in his own editorial, how many cases of BIONJ it will take to gain the attention of naysayers, adding that one case is one too many, as far as he’s concerned.
Could a horrific side-effect of the most popular osteoporosis treatments, along with flawed testing methodologies, mean that Pharma and the FDA have finally met their match? These fraternal-twin colossi ought never be underestimated, but Dr. Marx has a powerful ally known as the truth. “Time, not editorial opinion will determine the true value of any test or treatment,” he says, following with a sobering quote from President John F. Kennedy: “… and we shall let history be the final judge of our deeds.”