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FDA Fails to Protect Public Once Again.

For an inveterate FDA watcher like me it's been an interesting spring. First, the agency's failure
to police the safety of imported medical products became front-page news when it was revealed
that batches of the blood-thinner heparin caused fatal allergic reactions because of
contaminated ingredients imported from China. Coming on top of the lead-painted children’s toy
and poisoned pet food episodes of a year earlier, the incident confirmed that the FDA lacked
sufficient resources to carry out the requisite inspections of overseas manufacturers under its
jurisdiction.

The predictable result was a firestorm of criticism from Congress and the press. For the first
time that anyone could remember an FDA Commissioner violated the Washington protocol that
political appointees do not lobby Congress on behalf of their own agency. Andrew von
Eschenbach did just that in a letter to a key Senator requesting $275 million as a supplemental
appropriation. Predictably, a Bush Administration spokesperson said that the additional funds
are not necessary.

Besides introducing legislation to provide additional funding, lawmakers are considering a
requirement that imported drugs, medical devices and food products be labeled with the country
of origin and a special identification number to help FDA track unsafe products back to their
manufacturer. Legislation has also been proposed that would impose fees on manufacturers
and importers to fund overseas inspections of their manufacturing facilities. Significantly, some
lawmakers want to give the FDA the power to order recalls of unsafe imported food and medical
products. At present the FDA can only ask a manufacturer to withdraw its product.

On the domestic front, a report linking the antismoking drug Chantix to a large number of deaths
and serious injuries was released recently by the Institute for Safe Medication Practices (ISMP).
Earlier, the FDA had issued a Public Health Advisory warning that the drug was associated with
serious neuropsychiatric reactions, including suicide.

The ISMP researchers found that Chantix users had an inordinately large number of severe
injuries, major seizures, movement disorders and heart rhythm disturbances often leading to
loss of consciousness, as well as transient blindness.

Chantix, which is made by Pfizer, has become the most frequently mentioned drug in serious
injury reports to FDA after only 18 months of availability. From October to December 2007,
almost 1,000 Chantix injury reports were received by the FDA compared to a median of five
injury reports for other problem drugs over the same time span, according to the ISMP.

Because the antismoking drug’s side effects could render a user unconscious or temporarily
blind, the ISMP findings set off immediate alarms about Chantix’s risks to airline pilots, train,
bus, and subway operators, truck drivers and those who operate any other heavy machinery. To
avoid the possibility of a catastrophic airline accident, the FAA promptly banned the drug's use
by flight crews. And, the Federal Motor Carrier Safety Administration issued a warning advising
medical examiners "to not qualify anyone currently using this medication for commercial motor
vehicle licenses.”

Since drivers of motor vehicles include almost the entire U.S. population over age 16, the FDA
should be asking Pfizer to immediately withdraw Chantix from the market. Helping people stop
smoking may be an important public health goal but not when the trade-off is an even earlier
drug-related death.

Arthur A. Levin, MPH, Center for Medical Consumers © June 2008