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.

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

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.

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."

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.

Details Questionable Roles of Liz Cheney, Shaha Riza, and Others in Multi-Million Dollar Program

(Washington, D.C.) – A report released by the Government Accountability Project (GAP), based on documents obtained through nearly three years’ of U.S. Freedom of Information Act (FOIA) requests, exposes the highly irregular manner in which the Foundation for the Future (FFF) – 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.

“Liz Cheney had the preposterous idea that the Foundation for the Future would bring peace and democracy to the Middle East,” said GAP International Program Officer Shelley Walden, author of the report. “This overlong project wasted millions of taxpayer dollars.”

The report, which is based on 267 documents released by the Department of State over a period of 33 months, can be found here: (Full Report) (Executive Summary) (Key FOIA documents) (Appendix I)

Background

The Foundation for the Future first became an issue of public interest inquiry in 2007, when GAP published the payroll records of Riza, girlfriend of then-World Bank President Paul Wolfowitz. The records showed that Riza, a British national who worked as a World Bank communications officer, was seconded to the U.S. State Department after Wolfowitz was appointed, where she was responsible for establishing the Foundation for the Future (FFF). The FFF was a nonprofit organization tasked with promoting democracy and reform in the Broader Middle East and North Africa (BMENA) region.

While seconded from the Bank to the State Department in 2005 and 2006, Riza received salary raises in excess of what Bank rules allowed, earning far more than Secretary of State Condoleezza Rice. In October 2006, Riza’s secondment was transferred to the FFF itself, where she remained until returning to the Bank in early 2008, after Wolfowitz was forced to resign.

Liz Cheney’s Failed Pet Project

The documents released by the Department of State (DOS) show that Liz Cheney, as Principal Deputy Assistant Secretary of State for Near Eastern Affairs, envisioned Riza’s highly irregular secondment to the FFF in May 2005, well before it was established, and before Paul Wolfowitz became President of the Bank. In this unsupervised position, Riza promoted an overtly political U.S. agenda in the Middle East. Riza’s activities in this role were in apparent violation of conflict of interest regulations at the World Bank, as well as the national security, tax and visa regulations of the U.S. government. The report also shows that Cheney was instrumental in the Foundation’s launch and failure to obtain broad international support.

“The project was doomed from the start – State Department officials in the region warned that restrictive laws in the Persian Gulf states would make the Foundation ineffective; BMENA governments did not support a Foundation that would give their opposition a platform from which to oppose them; and potential donors had misgivings about the project’s lack of indigenous imprint,” stated Walden. “Despite these warning signs, Cheney and the Bush administration moved full steam ahead and established the Foundation anyway.”

In 2005, Cheney, Shaha Riza and Condoleezza Rice embarked on an international crusade to obtain financial and diplomatic support for FFF. But their efforts at diplomacy were a failure; they raised less than 25% of the goal (set by Cheney) of $25 million (USD) in contributions from other nations. The great majority of funding came from the United States, although the legislation creating the institution included a requirement for matching funding.

“The Foundation for the Future was to promote democracy, transparency and popular political participation on a multilateral basis in the Middle East,” said GAP International Program Director Bea Edwards. “So when Liz Cheney – who, in the view of many Middle Eastern leaders, occupied her position largely because she was the Vice President’s daughter – asked other nations for contributions, they balked. Add to this the fact that the Foundation’s board member selection process was directed by the former Deputy Secretary of Defense’s girlfriend and that the Foundation was managed by a personal friend of Wolfowitz’s with little expertise in the region, and it’s no wonder that many potential donors refused to fund it.”

Astroturfing

GAP’s report shows that the FFF was almost entirely financed and monitored by the U.S. government, even though the Bush administration repeatedly portrayed it to Congress as a multilateral, non-governmental organization created in response to democratic demands from grassroots organizations. Documents also show that the Bush administration intended to use the Foundation as a vehicle through which to demonstrate its purported commitment to democratic processes and human rights abroad, at a time when President Bush was subjected to increasing criticism for human rights violations in Iraq, Afghanistan, “black sites” around the world and Guantánamo Bay.

Dubious Lobbying and Funding Efforts

From 2005-2007, officials at the State Department executed a number of questionable legislative maneuvers in the US Congress that were favorable to the FFF. In the end, the Bush-Cheney administration successfully obtained the passage of three laws related to the Foundation and a disbursement of $21.3 million in public funds. They also secured $921,064 for the Eurasia Foundation – a non-profit organization set up by the State Department in the 1990s to promote democracy in the former Soviet Union – to help establish the FFF.

It appears that in order to obtain the disbursement to the FFF, State Department officials deliberately misled the US Congress about the funding pledged to the Foundation by other governments. Evidence strongly suggests that section 534(k) of US Public Law 109-102, which at that time stipulated that funds could only be made available to the Foundation to the extent that they had been matched by contributions from other governments, was violated; the Foundation’s own reports show that less than $6.4 million of the $22.26 million in “matching funds” listed by the State Department in its communications with Congress as pledged ever materialized.

Especially suspicious was the State Department’s representation of a murky $10 million pledge from Qatar, the largest “pledge” of any country other than the United States. Documents indicate that the State Department knew that this pledge would never materialize when it asked Congress to disburse matching funds.

GAP’s report also suggests that FFF management – including former FFF Chairman (and close friend of Paul Wolfowitz) Anwar Ibrahim, who is currently a Malaysian parliamentarian – misled the US Internal Revenue Service. The FFF’s financial statements for 2006 and 2007 state that the Foundation did not attempt to influence national legislation, an assertion contradicted by the cables and reports released by the Department of State. These documents suggest that several Foundation representatives actively lobbied the US Congress in 2006-07 for legislative changes favorable to the FFF.

Shaha Riza

State Department documents show generous travel allowances and salaries for the office of Shaha Riza, whose nebulous duties did not seem to require such lavish financial support. Riza was paid a net salary of $180,000 to perform such tasks as reviewing a translated draft of the FFF bylaws, a PowerPoint presentation of a business plan and a translated policies and procedures manual.

The Foundation for the Future continues to operate, although the departure of both Cheneys from public office appears to have weakened its financial support from Congress. Because the vast majority of its funding comes from the U.S. government, budgetary figures indicate that the FFF will be unsustainable after 2014.

Dylan Blaylock is Communications Director for the Government Accountability Project, the nation's leading whistleblower advocacy organization.

Reuters: Soldier Charged Over Leaked Video of Attack

Army Specialist Bradley Manning was charged yesterday with multiple criminal counts involving the alleged release of classified information to the website Wikileaks. The charges directly relate to the posting of the "Collateral Murder" video earlier this year, which shows an Army helicopter attack on civilians in Baghdad that killed several people, including two Reuters reporters.

Manning has been detained in Kuwait since May, awaiting charges. GAP Homeland Security & Human Rights Director Jesselyn Radack argues in this blog post that the charges against Manning, and those against NSA whistleblower Thomas Drake, are incorrect and wrongful actions for the Obama administration to take.

Click here to read more and comment at The Whistleblogger

Similar Articles: Washington Post, Los Angeles Times, Wall Street Journal

Propublica: BP Refinery Had Huge Toxic Release Just Before Gulf Blowout

This important story, which hasn't received much attention as it was released during the holiday weekend, details how a BP refinery in Texas spewed "tens of thousands of pounds of toxic chemicals into the skies" just weeks before the Deep Horizon disaster started.

The release lasted 40 days, and "stemmed from the company's decision to keep producing and selling gasoline while it attempted repairs on a key piece of equipment."

The escaped chemicals included "17,000 pounds of benzene, a known carcinogen; 37,000 pounds of nitrogen oxides, which contribute to respiratory problems; and 186,000 pounds of carbon monoxide."

Inside Higher Ed: Protection for Title IX Whistleblowers

This article details how a 2005 U.S. Supreme Court decision -- which found that "'retaliation against whistleblowers is included in' Title IX of the Education Amendments of 1972's 'broad, statutory prohibition on sex discrimination'" -- has paved the way for more favorable treatment of collegiate athletic whistleblowers since its passage. Positive results are seen in both court decisions since (which often are in favor of whistleblowers), and in steps taken by universities to adequately address internal concerns.

CNN: A Year Later, 'Heroic' E. coli Survivor Still Battling

This heartbreaking article details the story of a woman who ate E. coli-laden cookie dough last May, and is still in the hospital.


Dylan Blaylock is Communications Director for the Government Accountability Project, the nation's leading whistleblower advocacy organization.