May 16, 2016
FDA Follies, Part 2
By Michael D. Shaw
Part 1 of this series appeared just over a year ago, and detailed a few of the agency’s recent missteps. Prominently mentioned was the sad case of certain diabetes meds, including Actos, once touted as “a safer alternative to Avandia.” Avandia was taken off the market in 2011, but reappeared subject to severe limitations of use. These limitations were later removed—although current usage of the drug is small.
Oddly, Actos (FDA approved in July, 1999) was showing some problems (bladder cancer) as early as 2005, even though this information was not widely disseminated at the time. Some might even say it was suppressed, in that it was not disclosed in the original study. But, it did finally appear in 2009 and 2011.
Meanwhile, in August, 2007, the FDA issued a “boxed warning” aka a “black box warning”—appearing on the drug’s label, designed to call attention to serious or life-threatening risks—concerning Actos and other similar drugs. No worries, though. In 2008, Actos became the tenth most-prescribed drug in the US.
In 2010 and 2011, whistle-blower lawsuits were filed against Actos’ manufacturer Takeda, and more negative data came out on the drug. In June, 2011 the drug was banned in France and Germany. By the end of 2011, sources indicated that more than 10,000 Actos lawsuits would be filed against Takeda.
But here’s the best part: In August, 2012, the FDA approved a generic version of the drug. Wow, now you could damage yourself for less money. The sordid history of diabetes drugs is one of the worst—if not THE worst—failure in the history of the agency. Bear in mind that the studies most damaging to Avandia were financed by its competitor (Takeda). Trust me, you do not want to go down the type 2 diabetes rabbit hole. I’ll leave that to medical historians of the future.
Lost in the shuffle here is any consideration of how much risk to the patient is tolerable, to achieve glycemic control—at best a dubious goal in itself, for many type 2 diabetics. Cui bono?
This column has devoted a number of articles to the disgraceful matter of endoscope-related infections and deaths. Alas, the FDA’s record here has been abject failure.
I’ll spare you the details of botched 510(k) clearances; slowness in reacting to the problem at all; giving mixed signals as to whether ethylene oxide sterilization would prevent the infections; or even questioning whether some of the nearly 700,000 procedures performed annually using Endoscopic Retrograde Cholangiopancreatograph (ERCP) endoscopes may be necessary or worth the risk. We could add FDA’s grotesquely inappropriate secrecy policy, whereby the names of hospitals involved in several of the deaths have still not been revealed.
The latest wrinkle involves FDA literally backing off from a recall of around 2800 so-called automated endoscope reprocessors (AERs)—machines used to clean and disinfect endoscopes. This recall was issued in November 2015 to Custom Ultrasonics, Inc. of Ivyland, PA. More than that, Sen. Patty Murray’s January 2016 report linked Custom’s machines to several superbug outbreaks across the country. Among other things, the FDA press release announcing the recall quoted William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health:
“We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations. The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.”
Well, maybe not…
While no official FDA communication seems to exist, the agency told Outpatient Surgery magazine (as reported on May 9):
“Based on information provided by the company [Custom Ultrasonics], the FDA has determined that the products may remain in the field for reprocessing other endoscopes [other than duodenoscopes] during this validation. We expect that the company will be providing additional information to its customers regarding its corrective action in the near future.”
No further details from FDA or Custom have been made available. According to infection control expert and friend of this column Lawrence Muscarella, PhD:
“It is certainly troubling for the FDA to order the removal of a medical device it has linked to patient injuries and deaths and then to abruptly reverse course with no clear explanation. This may be unprecedented in the history of medical device regulation.”
Muscarella is too polite to add that there is absolutely no mechanism in place to prevent the 2800 machines in question from being used to process duodenoscopes. After all, as Custom has aptly demonstrated, you needn’t listen to the FDA.