Overruled


Setting Time Bombs in Our Chests: Our Unreliable FDA
March 31, 2009, 2:37 pm
Filed under: Ian | Tags: , ,

From my latest Huffington Post piece:

Like all potentially dangerous medical devices sold in this country, the devices which failed Ed and Joshua were approved by the Food and Drug Administration (FDA) before they could be sold in the United States. Yet these dangerous medical implants are only two of the hundreds of devices which have survived the FDA screening process, only to be pulled from the market after they caused numerous injuries or deaths.

According to a report released yesterday by the Center for Justice and Democracy, a shocking 573 recall notices were issued between 1992 and 2002, covering more than two million implants which had already been sold to doctors–and in many cases implanted into patients. Every one of these recalled devices were approved by an FDA approval process which is wholly inadequate to the task of protecting American consumers without significant help from private lawsuits.

The FDA can barely keep up with the volume of work it faces. In 2005 alone, the FDA approved nearly 3,200 applications to market a new device to physicians and patients. Yet the FDA employs only a fraction of the armies of scientists, physicians and other researchers who are employed by the medical device industry. Lacking sufficient resources to monitor thousands of medical devices on their own, the FDA relies on the industry itself to disclose potential problems in the devices it regulates.

Needless to say, device manufacturers are not always forthcoming. Throughout the 1980s and 1990s, a device known as the Björk-Shiley heart valve malfunctioned in hundreds of the 86,000 patients it was implanted in–resulting in at least 900 deaths. Yet, according to a year-long investigation conducted by the House Subcommittee on Oversight and Investigations, the product remained on the market for years because its manufacturer “continually provided the medical community with incomplete and misleading information regarding the number of strut fractures and the severity of the problem.” Significantly, the company failed to disclose to the FDA evidence showing that the valve was prone to fracture until after the device was approved, and it failed to reveal that–even as the device was being implanted in heart patients nationwide–the company was altering its own manufacturing practices because of concerns about the device’s safety.

And this was not an isolated incident.

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