27 October 2004

Editorial: Vaccine crisis vexes

It turns out that the Pharmaceutical Research and Manufacturers Association and the Food & Drug Administration were right all along about the danger of imported medications. But it's not the drugs imported by American citizens from legitimate Canadian pharmacies that pose the threat. According to Health Canada (the equivalent of our FDA) there has never been a single instance of a counterfeit drug being sent from a registered Canadian pharmacy to the U.S. No, the biggest importer of drugs into the U.S. turns out to be the drug companies themselves - primarily the result of outsourcing manufacturing jobs - and the danger posed by this importation, we recently learned, is clear and present.

     The FDA was first informed of the problem in our supply of flu vaccine in August, when bacterial contamination was found in four million doses headed to the U.S. from a manufacturing plant in England. This started a process that culminated on Oct. 5, with the revocation, by the British Medicines and Healthcare Products Regulatory Authority (MHRA), of the plant's license to manufacture flu vaccine. A statement issued by the Chiron, the American company that owns the plant, explained the MHRA asserted, "the manufacturing process does not comply with U.K. good manufacturing regulations..."

     Why, you might wonder, was our FDA caught unaware by the British authority's closing of the plant, when 90 percent of the flu vaccine being produced there was headed for the U.S.? The FDA's failure to oversee the safety of half our supply of flu vaccine is particularly troubling since the FDA had identified similar inadequacies in the same plant back in 1999 and the plant has doubled its production of flu vaccine for the U.S. market since 2002.

     At least part of the explanation has to do with the allocation of the FDA's workforce. In order to shorten the time required for new drug approval, more than 1,000 FDA employees were added to the new drug-approval process during the 1990s. During that same period, according to a 2002 General Accounting Office report, the inadequacy of the FDA's funding forced the removal of 1,165 employees from other FDA activities, including "inspecting medical product manufacturing facilities."

     Even though the FDA apparently did not have adequate resources to oversee the safety of 48 million doses of flu vaccine headed for the U.S., it did have enough resources to issue a report in Feb. 2004, titled "Combating Counterfeit Drugs" (which might have been more appropriately titled "Discouraging Drug Importation from Canada"). The FDA reported the number of cases of counterfeit imports had, ominously, more than tripled. How many cases of counterfeit drugs really has the FDA been tracking? In 2000, there were a total of six and this increased to 22 in 2003. The report reassures Americans, however, that the FDA's vigilance has kept counterfeiting rare, "so that Americans can have a high degree of confidence in the drugs they obtain through legal channels."

     That confidence is eroding very quickly. The number of drugs approved by the FDA that were later recalled went up more than threefold in 1997-2000, compared to the previous three years. About one out of 10 adult Americans took a drug between 1997 and 2000 that was later recalled because of serious safety issues. And that was before the biggest-of-all-time Vioxx recall.

     Now the FDA's failure to pro-actively monitor the safety of our supply of flu vaccine will leave half of the Americans who were planning to receive a flu shot this year without protection. In 2001 the editor of the British journal The Lancet warned of "the extent to which the FDA... has become the servant of industry." Dr. Richard Horton explained, "It is an impossible conflict for safety issues to be overseen by a centre that receives funding from industry to review and approve new drugs." In 2003, more than half of the budget for the division of the FDA that approves new drugs came directly from the drug industry.

     Isn't it time Americans were protected by an adequately funded FDA that is not beholden to the drug industry, and can perform the basic safety functions that recent events show are so important to protecting Americans' health?

Hamilton Wenham Chronicle

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