Increasingly, reliable information about what pharmaceutical firms know–and how long they have known–about adverse product effects comes from the press.
by Dr. Robert E. Marx
When convincing evidence emerges that one pharmaceutical company or another knew of serious adverse events associated with their FDA-approved drugs yet did nothing about it, more often than not the facts come from medical, or even mainstream, media.
A century and a half of investigative journalism shows that injured patients, doctors, and drug companies know about deleterious effects of medications long before the general patient population does. As reported by the New York Times, the anti-inflammatory Vioxx was withdrawn from the market in September 2004, after a clinical trial proved that it increased the risks of heart attacks and strokes. But internal company documents showed that scientists employed by the drug company were concerned about the risks of Vioxx years earlier.
In fact, the journal The Lancet published a meta-analysis of data on Vioxx the same year, concluding that the cardiovascular risk was known and that the drug should have been withdrawn several years earlier. The medical journal placed blame squarely on the manufacturer and the FDA for the availability of Vioxx after 2000.
Even with examples such as the Vioxx withdrawal still fresh in its memory, the FDA seems unable (or unwilling) to move more assertively against the newer crop of problematic drugs. In 2010, the American Society for Bone and Mineral Research published a recommendation urging the government agency to issue a warning about thigh bone fractures after a study it conducted on the common osteoporosis drug type known as bisphosphonates. The Times then reported that “The FDA says labels and medication guides would be changed to show a [femur fracture] warning on oral and intravenous bisphosphonates.” That year, the agency also stated that it was “continuing to evaluate the safety and effectiveness of bisphosphonates when used for long periods.” They report “continued investigation” on the drugs’ correlation to kidney impairment, esophageal cancer, and bone death of the jaws. And, if you search the FDA website today for bisphosphonates and thigh fractures, there is no further update–five years later! One wonders how much cumulative damage these drugs must do before action is taken.
The rare bone breaks are known as subtrochanteric femur fractures, just below the hip joint, and diaphyseal femur fractures, in the long part of the femur. When we last heard from the FDA on this, it said it has not been proven that the bisphosphonates cause the unusual fractures, but they have shown up in disproportionate levels among patients taking the drugs, especially those who take them for more than five years.
All that’s left, when we consider the history, is for a journal like The Lancet or a paper like the Times to come out and report that the bisphosphonate hazards were previously known (and they have been), were purposely obfuscated, and that they, also, ought to have been withdrawn years ago. Unfortunately, for those who are suffering or have been suffering from sudden, seemingly spontaneous thigh fractures, kidney problems, esophageal cancer, or osteonecrosis of the jaws, the reports would be of little comfort, though they would certainly come way ahead of any news from the FDA.