In preparing for the holidays, you may have missed the French scandal over the defective artificial breasts implanted in hundreds of thousands of women. According to NPR, an estimated 400,000 women worldwide have received the faulty implants, and 30,000 women in France have been urged to have them removed because the implants used an inferior, industrial-grade silicone and are more likely to rupture than those made from surgical silicone, causing damaging tissue inflammation. One woman with ruptured implants recently died of cancer, NPR reports.
The defective implants, made by a French company, should come as no surprise, says French public health specialist Dr. Alain Braillon. More than a year earlier, he published a letter in the Archives of Internal Medicine calling attention to the fact that the chief executive officer of the French regulatory counterpart to the FDA had an extremely cozy relationship with Medtronics, a medical device company. He and a Medtronics official apparently collaborated on a book about medical devices that criticized regulatory oversight as getting in the way of innovation.
While this amazingly conflicted official was eventually forced out and French regulations tightened in the wake of another drug scandal — see here – Braillon says the French response is late in coming and little more than “window-dressing.”
The French debacle serves as a vivid reminder of what’s at stake on this side of the Atlantic, as lobbyists for the medical device industry continue to push hard against recommendations by the national Institute of Medicine (IOM) to tighten up our own oversight of new medical devices. As the New York Times reported last fall, Republicans in Congress, at the industry’s bidding, have introduced a flurry of bills designed to speed up the FDA approval process for medical devices. Their legislative action flies in the face of the nation’s medical experts, who argue that we need to strengthen the process of approving new medical devices, not weaken it.
The IOM recommendations, of course, come in the wake of our own uniquely American scandals — faulty metal to metal hip implants that have injured thousands of Americans and a host of other unsafe medical devices that have made it to market. Here’s hoping that Congress and the FDA do the right thing in the New Year and adopt the IOM recommendations, instead of waiting for our own breast implant scandal.
On another note, a landmark trial against Johnson & Johnson is slated to begin Monday (January 9) in a Texas courtroom. As I and many others have blogged about here and here, J&J is charged with illegally marketing the off-label use of Risperdal and “subverting scientific integrity” by paying off academic psychiatrists and state officials to boost the use of its antipsychotic among children and adults. The case, as 1boringoldman writes, is more ambitious than previous state lawsuits against off-label drug marketing:
It’s about an active campaign to undermine Medicine itself and medical learning, and to bilk state governments.
1boringold man (a.k.a. psychiatrist Mickey Nardo) is hoping for a Watergate-sized expose to emerge from the trial. So stay tuned…