A New York Times article yesterday on the Zimmer Durom Cup’s problems underscores the post-market surveillance problem with drugs and medical devices, pointing to the Zimmer Durom Cup problems that have led to Zimmer recalling their hip replacement component. This is a Zimmer fault; they should have a system of tracking and honestly responding to reports of problems with their hip replacement components. But we clearly cannot expect drug and medical device companies to police themselves. In this case, the Zimmer Durom Cup recall was precipitated by Larry Dorr, an orthopedic surgeon who is the medical director of the Dorr Institute for Arthritis Research and Education in California, essentially outing Zimmer by courageously (he was well paid by Zimmer as a consultant) speaking up in public about the problems and Zimmer’s blind eye to them.
Safety and speed are the yin and yang of the regulation of drugs and medical devices. Americans want both; we want safe medical devices that have been tested, but we also want instant access to breakthrough products. But the reality is that not all new drugs and devices should be treated equally. We needed to rush new AIDS drugs onto the market without much testing 10 years ago because the risk-benefit analysis demanded it. But some of this other stuff? Sure, the marketing department of the drug and device companies would prefer it that way, but is that the best thing for the consumer or even the pharmaceutical company in the long run?
Adding to the problem is the Prescription Drug User Fee Act in 1992, which was a deal between the FDA and the drug industry. Drug and medical device companies agreed to pay millions of dollars in fees, and the FDA promised that drug and medical device reviews would be completed within a year for those products on the fast track.
But as I pointed out last year, all of this new FDA money was for clinical trials and other pre-market efforts. No investment was made into the post-market surveillance once the product was actually being used by consumers. While the FDA still looked at drugs and medical devices after they were put on the market, this wing of the FDA became the odd man out with respect to funding, which means it lost the best people and resources.
The Prescription Drug User Fee Act in 1992 was well intended. But we need to focus more energies and money on trying to find new funding and give more attention to these products after they are on the market. As the Times article points out, many believe that a starting point is a national database — employed by such countries as Australia, Britain, Norway and Sweden – to register these problems and require the companies to explain the reports.
For a real life example, Zimmer still sells in the United States a knee implant, known as the Unispacer, even though Australian doctors stopped using it three years ago after registry data showed it had quickly failed in more than half the 40 patients who received it there.
While a national registry and more accountability would not be a panacea, it would be a great starting place. We have 1 million hip replacements in this country each year. From an economic standpoint alone – for those of your who are not moved by human suffering – wouldn’t it make sense if we monitor how well the replacements are working?
We are investigating Zimmer Durom Cup recall claims. Call 800-553-8082 or click here for a free Zimmer free consultation.