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The heparin story

The public may remember last year's heparin contamination incident for the headlines alleging it was caused by FDA negligence, but a close examination reveals another story, a tale of regulator-industry-academic collaboration and the kind of urgent sleuthing worthy of an episode of CSI. How the problem was discovered and fixed is a more interesting story - with far more relevant lessons for how to deal with future crises - than the simplistic FDA-bashing that has been reported.

FDA critics now concede that its success in rapidly developing and disseminating new screening protocols ended the crisis by making it possible to identify contaminated lots and clear safe heparin for use. This averted the potential calamity that could have occurred if the inability to distinguish good and bad heparin had prompted massive recalls, creating shortages of the widely used life-preserving drug.

More than 10 million Americans receive heparin every year. More than 70 million vials are sold for cardiac surgery, dialysis and a wide variety of other uses, and another 50 million units of heparin flush are used annually.

Thus, a year ago, Americans were shocked to learn that hundreds of patients had experienced life-threatening reactions to heparin. The crisis included nearly 150 deaths in patients who had experienced an allergic or hypotensive response after being exposed to heparin over the 17 months it took to discover the problem, identify the cause of the adulterated product, and instruct manufacturers and regulators on testing for the contamination.

The detective process enlisted multiple government agencies, university researchers and a biotech company that has a generic heparin under FDA review.

Although no one at the time knew what was causing the reactions, members of Congress jumped to the conclusion the problem was the result of "regulatory failure" based on news reports that FDA had not inspected a Chinese heparin manufacturing facility.

Congress continues to blame the crisis on inadequate international inspections, and the incident did highlight the lack of parity between FDA's compliance activities at home and abroad - and the lack of funds lawmakers have appropriated to increase the latter.

The fact, however, is that an outmoded standard for testing heparin meant that no amount of inspections could have prevented the contaminated product from reaching patients. Thus, one of the most important lessons from the experience is that preventing the recurrence of similar events will require more than simply posting more FDA inspectors in China and India (see "Behind the Times," A8).

At the same time, regulators and lawmakers both emphasize that industry will be held to account for supervising and assuring

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