Intro. Taxes and DeathToday, I am going to write about drug whores. Not the kind that get down on their knees in order to pay for their own drug habit. These are the whores that get down on their knees to help pharmaceutical companies post obscene profits. Some of them draw a second paycheck—paid for by you and me. And sometimes, our tax dollars are not enough. Sometimes we pay with our lives.
I.Follow Up From 2007: How the Bush FDA Helped GlaxoSmithKline Make Money By Banning Its CompetitorsIn 2007, the Bush FDA did something unprecedented. It decided to ban two old, generic medications which millions of people had been using for decades. One was quinine, used for nocturnal leg cramps. The other was cafergot, used for migraine headaches. Both of these medicines had been “grandfathered” in. In other words, like aspirin and morphine, they never had formal testing, because their use predated clinical drug trials.
What else did these two drugs have in common? They were both cheap generic alternatives to two of drug company Glaxo-Smith-Kline’s biggest money makers—Imitrex for migraine headaches, and Requip for restless leg syndrome. A prescription for Requip cost hundreds of dollars, whereas quinine might set you back a few bucks. Immetrex cost hundreds of dollars…
I think you get the picture. Note that GSK was doing an intensive direct to consumer advertising campaign for both medicines at the same time that the FDA banned its competition. Very convenient. If you were someone who used to take quinine for your nocturnal leg cramps (before the FDA banned it), you had probably seen an ad for Requip. Same for ergot users.
Here is a link to the story I wrote about this scam in 2007.
http://www.dailykos.com/story/2007/3/2/14243/36440At the time, I had a hunch that someone at the Bush FDA would eventually get a nice, cushy job with GSK. However, since I do not posses a crystal ball, I did not know who it would be. That is the problem with the revolving door between federal government regulators and the big businesses they are supposed to police. The federal employees get their reward after they have serviced their friends in the private sector.
II. Fast Forward to 2010: How GlaxoSmithKline Put Us at Risk for the Sake of ProfitsThe New York Times has an important story today.
http://www.nytimes.com/2010/07/13/health/policy/13avandia.html?_r=1&hpBack in 1999, GSK made Avandia, a diabetes drug. Its big competitor was Actos. GSK decided that they could increase profits by showing that Avandia was safer for the heart than Actos. So, they did their own studies.
Unfortunately, their research showed that Avandia was actually worse for the heart than Actos.
But instead of publishing the results, the company spent the next 11 years trying to cover them up, according to documents recently obtained by The New York Times. The company did not post the results on its Web site or submit them to federal drug regulators, as is required in most cases by law.
“This was done for the U.S. business, way under the radar,” Dr. Martin I. Freed, a SmithKline executive, wrote in an e-mail message dated March 29, 2001, about the study results that was obtained by The Times. “Per Sr. Mgmt request, these data should not see the light of day to anyone outside of GSK,” the corporate successor to SmithKline.
And for six more years, GSK kept a lid on its secrets. Then, in 2007, researchers at the Cleveland Clinic dropped this bombshell in the New England Journal of Medicine:
Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes
http://content.nejm.org/cgi/content/full/NEJMoa072761Oh brother. What a nightmare for GSK. Fortunately, the Bush FDA was there to take care of them. In summer of 2007, GSK boasted online that it was coming clean.
http://www.gsk.com/media/pressreleases/2007/2007_07_30_GSK1099.htmA few months later, the FDA gave them a wrist slap. In this case, a black box warning.
The U.S. Food and Drug Administration announced today that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug's labeling about potential increased risk for heart attacks.
People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.
In other words, the package insert would warn about possible heart problems associated with the medicine. But all the folks who were taking it would still have access to it. The FDA was not going to yank it from the market (the way they yanked Cafergot and quinine) just because it killed people. Some things are more important than human lives. Some things like drug company profits.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109026.htmThis attitude did not sit well with some folks at the FDA. In February of this year, thanks to two members of Congress we learned that way back in October, 2008, two FDA employees wrote a memo.
In an October 2008 memo released by the senators, FDA reviewers David Graham and Kate Gelperin concluded "the risks of (Avandia) are serious and exceed those for" Takeda Pharmaceutical Co's (4502.T) competitor Actos.
They said there was "strong evidence that (Avandia) confers an increased risk of" heart attack and heart failure when compared to Actos.
Snip
Sales of Avandia, known generically as rosiglitazone, topped $3 billion in 2006 but fell to $1.2 billion in 2009.
The FDA decided in November 2007 Avandia should carry a warning saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo. But it said overall data were "inconclusive."
http://www.reuters.com/article/idUSN2012873620100220Once this report became known, the FDA started taking a closer look at Avandia. In July of this year, they issued this report
http://www.nytimes.com/2010/07/10/health/10diabetes.htmlA federal drug official on Friday dealt a severe blow to the popular diabetes drug Avandia, issuing a scathing review of a major clinical trial that its manufacturer has been using to argue that the drug was safe.
The reviewer, Dr. Thomas Marciniak of the Food and Drug Administration, found a dozen instances in which patients taking Avandia appeared to suffer serious heart problems that were not counted in the study’s tally of adverse events.
Such repeated mistakes “should not be found even as single occurrences” and “suggest serious flaws with trial conduct,” Dr. Marciniak wrote.
And today, nine years after GSK learned that their medication was unsafe, the New York Times has (finally) told us that the company conspired for almost a decade to hide the evidence of their drug’s safety risks, so that they could continue to rake in billions of dollars a year in profits. This, despite the fact that they were caught doing the same thing before with Paxil. As part of the lawsuit settlement for that drug, GSK agreed that in the future it would make public all of its own research.
But after GlaxoSmithKline was found in 2004 to have hidden data that showed that its antidepressant, Paxil, led children and teenagers to have more suicidal thoughts and behaviors, the company settled a lawsuit by agreeing to publicly post data from all of its trials. In 2007, Congress mandated such disclosures. But the postings are often little more than cryptic references, so the issue is far from resolved.
This makes GSK a repeat offender.
III.Connect the Dots: Dan Troy and the Preemption PolicyWe know that the FDA intervened to keep Avandia on the market---which helped GSK make money. We know that the same FDA took two of GSK’s generic competitors off the market---which also helped the British pharmaceutical company make money. Favors like these usually result in someone within the regulatory agency getting offered a private sector job. Hmmm. Did anyone in the Bush FDA go to work for GSK? You bet.
Here is Dan Troy. You have probably never heard of him, unless you read Mother Jones.
http://motherjones.com/politics/2008/03/daniel-troys-poison-pillTroy, a lawyer who specialized in suing the FDA on behalf of tobacco and drug companies got right to work abusing the power of his new office to help his past (and future) clients. Under his direction as general counsel for the FDA., the agency started to intervene in local and state lawsuits against drug manufacturers. He established the so called preemption policy, which went something like “If the drug company bribes the FDA to say its product is safe, it should not have to worry about losing money in civil court.”
This policy was important. With the FDA increasingly lax when it came to patient safety, there was an increased risk that bad drugs would do a lot of harm to a lot of people, at which point lawyers would step in and sue the drug manufacturers. In the case of GSK, they knew that it was only a matter of time before the risks they were covering up would become public knowledge. They needed insurance against lawsuits. They needed someone like FDA general counsel Dan Troy.
Troy's work at the FDA didn't go unnoticed. In 2004, after he attracted some negative publicity for coming to the aid of his former client Pfizer in a lawsuit, Rep. Maurice Hinchey (D-N.Y.) attempted to defund his office. In November of that year, Troy retreated to private practice, where he continues to counsel companies regulated by the FDA. But before he left, he ensured that the preemption doctrine was firmly enshrined at the FDA in regulatory language covering drug labeling.
The "preemption preamble," as it's known, states that this rule preempts all state tort lawsuits against manufacturers who make drugs approved by the FDA. The regulation allows drug companies to invoke the FDA's approval to beat back lawsuits without actually having to get the agency to enter the case. This is a hedge against future Democratic presidents who might want to institute a change of course. The preamble was inserted into the regulation without any public input. Since then, lawyers have repeatedly invoked it when defending companies against personal-injury lawsuits.
Note that phrase “retreated to private practice."
IV.Dan Troy’s Reward: A Job at GlaxoSmithKlinehttp://www.gsk.com/media/pressreleases/2008/2008_pressrelease_10085.htmIn 2008, Dan Troy got a dream job with a private drug company. You can already guess which one.
Dan Troy has been appointed as Senior Vice President and General Counsel for GlaxoSmithKline (GSK), and will join the company on 2nd September 2008.
Dan was formerly Chief Counsel for the US Food and Drug Administration (FDA), where he served as a primary liaison to the White House and the US Department of Health and Human Services (HHS). While leading an office of attorneys who reviewed and approved all major regulations, Dan oversaw the legislative implications of many of the most important issues facing the pharmaceutical industry today, including the reform of the Hatch-Waxman Act and subsequent legislative ratification. His office also approved and managed all agency litigation, and Dan established new procedures for the FDA legal team to follow in preparing and then litigating high-profile cases.
Dan is currently a Partner at the Washington law firm Sidley Austin LLP, where he represents pharmaceutical companies and trade associations on matters related to the FDA and government regulations
And, as always in Washington D.C., federal regulators and big business lived together happily ever after. Or maybe, not so happily, for the folks described in this medical study, the victims of big business greed.
Compared with prescription of pioglitazone, prescription of rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality and an increased risk of the composite of AMI, stroke, heart failure, or all-cause mortality in patients 65 years or older.
From the Journal of the American Medical Association, 2010
Death for dollars. How American.
Printer-friendly format
Email this thread to a friend
Bookmark this thread
(1000+ posts)
Send PM |
Profile |
Ignore
