Wednesday, April 17, 2013

While FDA Worked to Get Electronic Cigarettes off the Market and Obsessed about Substantial Equivalence Applications, It Ignored Information that Could Have Prevented Deadly Meningitis Outbreak

Evidence reported today by the Boston Globe reveals that the Food and Drug Administration (FDA) apparently ignored information, provided by multiple sources over many years, that could have prevented a massive meningitis outbreak caused by a Massachusetts compounding pharmacy.

According to the article:

"House lawmakers said Tuesday that the Food and Drug Administration had numerous opportunities over nearly a decade to stop the Massachusetts pharmacy responsible for a deadly meningitis outbreak that has killed more than 50 Americans. Republicans and Democrats took turns chastising the FDA for not being aggressive enough in going after compounding pharmacies like the New England Compounding Center, the specialty pharmacy which produced tainted pain injections that have sickened more than 700 people and killed 53 others." ...

"The NECC halted operations in October and faces over 100 lawsuits in federal court. But more than half a year later, lawmakers in Washington continue to debate who should be held accountable for the outbreak and whether it could have been prevented. Republicans said Tuesday that the FDA should have shut down the NECC based on complaints from doctors, patients, hospitals and state pharmacy regulators. The FDA first inspected the NECC in 2002 and issued a warning letter in 2006 over the pharmacy’s production of copies of manufactured drugs without patient prescriptions. Between 2007 and 2012 the FDA continued to receive complaints about the company from anonymous whistleblowers and state pharmacy regulators, according to internal documents released by the committee."

"‘‘Ten years of warning signs, alarm bells, and flashing red lights were deliberately ignored,’’ said Rep. Tim Murphy, R-Pa., who chairs the House Energy and Commerce Subcommittee on Oversight and Investigations. Murphy and other Republicans pointed to correspondence in thousands of pages of FDA documents turned over to the committee."

The Rest of the Story

The rest of the story is that while the FDA worked to get electronic cigarettes off the market and obsessed about thousands of essentially meaningless substantial equivalence applications, it ignored information that could have prevented a deadly meningitis outbreak.

This story just adds to my earlier commentaries about the misplaced priorities of the FDA and the wisdom of placing tobacco jurisdiction in the hands of an agency that is already having a difficult enough time completing its traditional mission of protecting the nation's food and drug supply.

Apparently, the FDA had substantial evidence of the lack of safety of the New England Compounding Center yet ignored these warnings. At the same time, the agency was trying to ban electronic cigarettes without any substantial evidence showing that they posed a significant risk to the public's health. And also at the same time, the agency was obsessing about thousands of applications to make minor changes in tobacco products, changes which would have no substantial impact on the public's health given the magnitude of the risk associated with cigarette smoking in the first place.

Because of the misplaced priorities of the FDA, the FDA has done nothing substantial to protect the public's health from the known hazards of cigarettes. As I opined on Monday, not a single one of the actions that the FDA boasts about did anything to substantially reduce tobacco-related disease or death.

The problem is not just with the FDA, but with the Tobacco Act in the first place. It was never intended to protect the public's health. It was intended to take politically easy steps by which politicians and anti-smoking groups could claim victory, but without having to actually make a dent in cigarette sales. While the FDA is busy processing substantial equivalence applications, it and the anti-smoking groups can pretend that they have accomplished something meaningful, but the only thing happening is that they are putting a huge and unnecessary delay in front of tobacco companies. This is no public health achievement.

I can't help but take readers back to a 2009 column by Igor Derysh in the Congress Examiner, which called the FDA legislation a "cheap political ploy" that allows politicians to tell the American public that they did something about the problem when they actually did nothing to actually make a difference in smoking, other than perhaps get rid of the banana-flavored cigarettes that are such a pervasive problem. Noting that the bill gets rid of all the flavorings that are not used but exempts the one flavoring (menthol) that is actually used to addict thousands of young people, Derysh concludes: "Protecting the public, my ass."

Derysh writes: "Earning cheap political points by going after easy targets has always been high on Congress' agenda. Respecting the American public has not. And so, when the recent tobacco regulation bill passed overwhelmingly in Congress it was both a cheap political ploy and another example of Congress disregarding the possible intelligence of the American people. The bill itself transferred regulation of the tobacco industry to the Food and Drug Administration (a government agency that is run by the same people that it regulates), strengthens warning labels, demands that tobacco companies disclose their ingredients, and bans flavored cigarettes. All flavored cigarettes except for menthol cigarettes. Menthol cigarettes of course have a considerably higher amount of harmful chemicals than others do and are targeted towards the black community just like guns. Protecting the public, my ass."

"The passage of the Tobacco Control Act is just another attack on the intelligence of the American individual. We do not need to be told that cigarettes are bad for you, we are bombarded with that message all day long. What we need is a Congress that accomplishes something worthwhile or just stays the hell home instead of celebrating cheap victories in which they banned banana flavored cigarettes."

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