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The New York Times: F.D.A. Panel Votes to Restrict Avandia
In the much-anticipated FDA advisory hearing looking into the safety of the diabetes drug Avandia, 12 members (out of 33) voted that the drug should be withdrawn from the market completely, 10 voted that sales should be restricted and much stronger warning put on the labels, seven voted "only to support enhanced warnings," and three voted for no changes whatsoever.
While this means that the majority of the panel voted that the drug should remain available to patients via some method, the vote really signifies the panel's skepticism and shrinking belief about the drug's safety, as any form of restricted distribution means an end to unfettered and open marketing of the drug.
The New York Times live-blogged the hearing yesterday, providing an excellent play-by-play of the various concerns that were raised. The vote is not binding - the FDA, which will take the vote (and panel discussion) into account when making its decision, will "come to a decision as soon as possible." The Times identified earlier in the week that Avandia's maker, GlaxoSmithKline, knew as early as 2001 that the drug increased the risk of heart attack and stroke, but chose to hide that information from the public and FDA.
GAP client and FDA safety officer Dr. David Graham has been speaking out about Avandia's risks for years. Recently, he published a study in the Journal of the American Medical Association showing the increased risk to patients from taking the drug - similar to what GSK knew for a decade.
Similar Article: New York Times editorial
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Today's Washington Post
has a 2000-word profile on former senior NSA official Thomas Drake, who blew the whistle on (in the article's antiseptic description) NSA's "willingness to compromise Americans' privacy without enhancing security"--something that we here at Kos used to call "secret domestic surveillance."
The article states that Drake is "awaiting trial in a criminal media leak case." He is actually indicted under the Espionage Act--a law under which the Russian spies were not even charged--and is only the fourth American in history to be charged under this law for allegedly (mis)handling classified information (the first was Penatgon Papers whistleblower Daniel Ellsberg).
While this article is one of the fuller portraits on Drake to date, I will add critical information below that for space limitations, editing, or whatever reason, didn't make it into the piece.
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The New York Times: Diabetes Drug Maker Hid Test Data on Risks, Files Indicate
This is the signal that GSK got from its Avandia study results in 2001.
On the day of a long-awaited FDA advisory committee meeting on the safety of the diabetes drug Avandia, this explosive, front page article details how drugmaker SmithKline Beecham (now GlaxoSmithKline, or GSK) knew in 2001 that the drug was unsafe. Specifically, the company commissioned a study on the drug's safety vs. a competing medication, Actos. The results "were disastrous. Not only was Avandia no better than Actos, but the study also provided clear signs that it was riskier to the heart."
The article states that, according to company documents, "instead of publishing the results, the company spent the next 11 years trying to cover them up."
There seem to be a lot of smoking gun emails. One from the article:
"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..."
Furthermore, documents suggest the company estimated the financial cost of the study's results becoming public would be $600 million from 2002-2004 alone.
Hiding 'negative' trial results is still practiced, because of inadequate federal oversight. In 2004, GSK settled a lawsuit involving the increase in child suicide rate because of the use of the antidepressant drug Paxil. In the lawsuit, GSK agreed "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."
GAP client and FDA safety officer Dr. David Graham has been speaking out about Avandia's risks for years. Recently, he published a study in the Journal of the American Medical Association showing the increased risk to patients from taking the drug - similar to what GSK seems to have known for a decade.
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USA Today: FDA to Consider Fate of Diabetes Drug Avandia
The internal battle at the FDA over dangerous diabetes medication Avandia will come to a head tomorrow at a long-awaited advisory board meeting. GAP client Dr. David Graham recently authored a study, published in the Journal of the American Medical Association, detailing the increased risk of heart attack or stroke for patients taking the drug.
The article above details an internal memo from an FDA scientist stating that one of the drug’s clinical trials "‘was inadequately designed and conducted to provide any reassurance’ that the controversial diabetes drug does not increase cardiovascular risk.” GAP published a report last year on the urgent need for FDA clinical trial reform.
Similar Article: Wall Street Journal
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On July 2nd, Senator Charles Grassley (R-Iowa) posed written questions to James Cole, the Obama administration’s nominee for the post of Deputy Attorney General. Many of these questions focused on Cole’s role as the Independent Consultant placed at AIG from 2005 through 2009 as part of two deferred prosecution agreements (DPAs). The first of these DPAs resulted from charges of aiding and abetting securities fraud in the AIG Financial Products subsidiary based in London, the AIG appendage that crashed the world economy in 2008 and required a $182 billion bailout courtesy of the US taxpayer. Some of Cole’s responses to Grassley’s questions were both puzzling and contradictory, and others we know to be misleading.
Under the terms of the 2006 DPA, Cole was asked to examine “the adequacy of whistleblower procedures designed to allow employees or others to report confidentially matters that may have a bearing on AIG’s financial reporting obligations.” In written questions Grassley asked Cole to provide a “discussion of the scope of your work under the 2006 DPA.” In response, Cole simply quotes from the DPA, which is, of course, available to Senator Grassley and the rest of the world on the DOJ website. A meaningful written discussion of whistleblower procedures at AIG would have to include an account of the layoff of ten compliance attorneys and officials in the aftermath of the corporation’s financial collapse in September 2008. Several of the ten were whistleblowers who had written to senior management at AIG about deficient compliance procedures. None of them was interviewed confidentially by Cole, who acceded to the demand of Suzanne Folsom, then Chief Compliance Officer, that Cole interview her staff only when she or her designee were present. As a result, the whistleblowers were summarily terminated under guise of a staff reduction.
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Mother Jones: Liz Cheney's Coalition of the Unwilling
A GAP report released today exposes the highly irregular manner in which the Foundation for the Future - an obscure project funded by the U.S. Department of State - was established and operated by Bush administration officials and appointees. Specifically, the report details how high-level State Department officials misled Congress as they sought millions in public money for the Foundation, which was a haven for people with political connections.
The report also shows that FFF was a pet project of Elizabeth Cheney, former Principal Deputy Assistant Secretary of State for Near Eastern Affairs. Cheney worked to set up the Foundation with Shaha Riza, Paul Wolfowitz's companion whose seconding to the State Department (and then to the FFF) was directly responsible for the 2007 World Bank scandal that resulted in Wolfowitz's departure from the Bank.
Click here to read more and comment on the Whistleblogger!
The New York Times: British Panel Clears Scientists
In yet another independent report, a British panel has found that the scientists involved in the so-called "Climategate" scandal did not manipulate their research to support the concept of global warming.
This is the fifth (and final) separate investigation that looked into charges of data manipulation by British and American scientists. All five reports "have come down largely on the side of the climate researchers, rejecting a number of criticisms raised by global-warming skeptics."
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If the United States is willing to give up an iron-clad classic espionage prosecution to get justice for Russian Igor Sutyagin--jailed for allegedly selling information about nuclear submarines and missile warning systems to a firm fronting for the CIA--then why is our government throwing the full weight of the criminal justice system on our own citizen for revealing gross waste, abuse and illegality by the National Security Agency (NSA)?
We don't tolerate it when Russia imprisons unjustly; in fact, we fight to get their citizens out. But when it comes to our own citizen speaking out against government abuses, the United States will do everything in its power to put him in jail.
It's a good thing we don't have a prison camp near the Arctic Circle.