Bad Medicine: GlaxoSmithKline’s Fraud and Gross Negligence One drug maker’s adventures in “truthiness”


http://www.psychologytoday.com/blog/side-effects/201101/bad-medicine-glaxosmithklines-fraud-and-gross-negligence

Side Effects
From quirky to serious, trends in psychology and psychiatry.
by Christopher Lane, Ph.D.

Bad Medicine: GlaxoSmithKline’s Fraud and Gross Negligence

One drug maker’s adventures in “truthiness”

Published on January 7, 2011 by Christopher Lane, Ph.D. in Side Effects
Those who missed 60 Minutes’ report last Sunday on the problems plaguing GlaxoSmithKline’s manufacturing plant at Cidra, Puerto Rico, will find most of the information detailed by the program online. The bad publicity that 60 Minutes and whistle-blower Cheryl Eckard have brought the Anglo-American drug giant, whose Cidra plant was closed in 2009 after “federal agents executed a search warrant at the plant and ultimately seized defective drugs worth hundreds of millions of dollars,” has been extensive and costly: $750 million in settlement alone, after GSK pleaded guilty to felony-fraud.

In hopes of downplaying the criminal charges, the seizing of defective drugs by federal agents, and of course the bad publicity resulting from this major federal investigation, the drug maker responded immediately to the program, trying to present its own case, which, needless to say, aims to put the company in the best possible light. But though some of Ms. Eckard’s and 60 Minutes’ claims rest on allegations that are now difficult to corroborate (patients alleged to have been harmed by contaminated and mislabeled drugs, who can’t be traced because their identities weren’t disclosed in the original documents; GSK colleagues to whom Ms. Eckard complained who have since left the company), one learns a fair amount about the case simply by comparing GSK’s account with that of 60 Minutes.

First and most glaringly, GSK never acknowledges in its response–posted earlier this week as a press release–that the drug maker itself pleaded guilty to, and was successfully convicted of, felony-fraud. Nor, of course, does it mention the hefty $750 million fine ($96 million of which, under federal rules for whistle-blowers, will go directly to Ms. Eckard). Nor is there any mention, in the press release, of the hundreds of millions of dollars’ worth of defective drugs, seized in 2009, which led to the plant’s closure in the first place.

Instead, GSK wants readers to believe that the drug maker went voluntarily to the FDA in 2002, out of safety concerns about the plant, and that it worked consistently and proactively with federal agents ever since: “GSK worked to bring the Cidra facility to a high level of operating performance that satisfied both GSK and the FDA. The plant was closed in 2009 due to a declining demand for the medicines made there.”

That last claim would be more persuasive if we didn’t learn from the 60 Minutes report that the 900 people working at the plant made “20 drugs for patients in the U.S.,” among them such blockbusters as Avandia for diabetes, Paxil antidepressants, Tagamet antacids, and the anti-bacterial ointment Bactroban. Or that “it was an FDA inspection that first revealed problems at Cidra… That’s why Glaxo sent Eckard’s team in to resolve those FDA concerns.” It had to, in short.

Cheryl Eckard asserts that she discovered far worse infractions and contaminations of the drugs than even the FDA investigators, and that, despite repeatedly alerting her colleagues at GSK to these problems–colleagues who had trusted her judgment enough to make her a manager of global quality assurance, after ten years’ work for Glaxo in quality control–senior management at the corporation both ignored her documented concerns, then lied to federal investigators about them, saying it was “extremely unlikely” that its plant had sent out batches of Paxil containing two different doses, despite pharmacists calling the plant directly when patients showed up with different colored pills in their medicine (signaling different doses of the antidepressant). The opening of sealed packets of Paxil revealed the same problem. One of the people affected was an 8 year-old boy whose prescription included adult doses of the powerful anticholinergic antidepressant.

According to 60 Minutes, Eckard nevertheless produced a chart for company executives documenting “the kinds of mix-ups that were happening at Cidra. She identified nine, including Avandia diabetes pills mixed in packages with over-the-counter Tagamet antacids and Paxil antidepressants, mixed with the Avandia diabetes drug.” According to Eckard, she went to the FDA–and taped the conversation as proof, given GSK’s repeated disputes of her findings–after those and many other infractions were ignored.

In pleading guilty to the felony, Glaxo admitted that it distributed “adulterated drugs Paxil CR, Avandamet (a diabetes drug), Kytril (a drug given to cancer patients), and Bactroban,” which strongly suggests that Eckard was telling an inconvenient truth all along.

Among the lessons we can take from this case is, first and foremost, how readily and extensively a vast corporation such as GSK will mask, dispute, or spin the truth, when it suits the corporation, to avoid addressing even glaring safety concerns. This is perhaps the most shocking part of the scandal at Cidra. Not only can we not trust a drug giant like GSK to avoid distributing defective medication, contaminated by bacteria and adulterated in dose, but we also discover just how far such corporations will go to ensure that we never learn the full extent of such problems in the first place.

I discovered this myself when reading confidential documents written and distributed among Glaxo executives, about the poor safety record of Paxil, with one-in-five patients experiencing serious side effects after just a few weeks’ participation in drug trials for the antidepressant. The executives’ recommendation for their colleagues on the frontlines of “truthiness,” which we have in their own words, was to change the subject, repeat platitudes such as “not all antidepressants are the same,” and, as a last resort, to try to downplay the glaring side effects by putting them “in context.”

A second lesson from this scandal is perhaps even more unnerving: As 60 Minutes puts it, “FDA inspections of drug plants are only occasional, so it’s up to drug companies to police themselves.” Given all that we’ve learned about GSK’s safety record and capacity for masking it, the problems arising from that statement should be self-evident.

For the record, though I applaud Ms. Eckard’s courage and insistence on due diligence (where would we be without it? Would GSK still be distributing Tagamet as Avandia, and Avandia as Paxil?), I nonetheless think the $96 million she’ll receive for whistle-blowing is excessive. Although that amount sends a clear message to drug makers to take product safety more seriously, and hopefully therefore will have a knock-on effect, it should leave us wondering why such a vast sum of money is thought a necessary incentive now for people to do their job, speak the truth, and work with integrity.

You’ll find the 60 Minutes article here, GSK’s response here, and further details about the drug maker’s adventures in truthiness over Paxil here.

http://www.christopherlane.org

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