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« on: December 11, 2015, 12:09:03 AM »

The value of the FDA’s MAUDE database as an early warning system is undermined by two key problems: underreporting of the numerator (the number of adverse events), and the lack of a denominator (the total number of exposures). One cause of underreporting is that manufacturers do not have to report serious adverse events, including deaths, if they decide that the event is not related to the device. Jerome Hoffman, an expert in clinical epidemiology at the University of California, Los Angeles, is critical of the FDA’s policy of allowing manufacturers to make that determination. “The manufacturer has a powerful motive to find an alternative explanation for an adverse event. There’s always the possibility of a separate cause.” Dr Hoffman says that the agency should insist on independent adjudication of serious adverse events.

The database’s value could be further improved, says Dr Hoffman, by including denominator data. “It’s often claimed that even when bad events occur, they have to be relatively rare, given the huge number of exposures. That certainly may be true in some cases. But it’s hard to know for sure in any individual instance, because the FDA doesn’t track the number of exposures. It shouldn’t be that hard … considering that WalMart can apparently track every head of lettuce they sell, at every point of its existence. Of course the FDA would have to require that companies submit data on the quantity of devices sold, and in use.”

Ultimately, says Dr Hoffman, the process of ensuring device safety will continue to be compromised unless the thorny problem of interference from politicians and industry is tackled. “None of this occurs in a vacuum, of course. If we want to see fewer of these debacles in the future, it seems only logical that we’re going to have to look to root causes, such as how campaigns are financed, and how the wealthy and powerful get to have so much more influence on laws, regulations and policies, than do scientists and others who would advocate for making the public health more important than corporate profit.”

However, it is not clear that Dr Hoffman’s wish that scientists have greater influence on regulation than industry is likely to be realised any time soon. President Obama has appointed Margaret Hamburg as FDA commissioner. She has said she will step down as director with Henry Schein—the largest supplier of medical devices in North America and Europe. Hamburg and her husband, who is a hedge fund executive, reported their 2008 income at $10m.17

Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ. 2010;341:c4753

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