When Regulators Become Enablers, Inside Bush’s FDA

Published on counterpunch.org, by EVELYN PRINGLE, July 17, 2007.

2 excerpts: Americans need to stop and consider how many consumers will be killed and injured by dangerous drugs by the time George Bush heads back to Texas at the end of his Presidency, as a direct result of his allowing the interests of the pharmaceutical industry to take control of the FDA.

For nearly 70 years, the common-law tort systems in the individual states have provided a remedy for citizens injured by prescription drugs. However, in one of the most blatant paybacks for political contributions in US history, in January 2006, Bush-appointed officials at the FDA announced that the agency’s approval of a drug and its labeling acts to preempt product liability lawsuits filed by patients against the pharmaceutical giants.

On February 23, 2006, Democratic lawmakers Rep Henry Waxman, of the Committee on Government Reform, and Reps John Dingell and Sherrod Brown of the Committee on Energy and Commerce, sent a letter to the Secretary of Health and Human Services, and voiced their outrage.

“The announcement,” the lawmakers wrote, “provides unfortunate evidence that the Bush Administration is more committed to protecting drug industry profits than to building a sound system for ensuring drug safety.”

“The FDA’s preemption announcement,” the letter said, “is particularly troubling at a time when FDA’s own ability to protect Americans from unsafe drugs has been called into question by a series of cases in which the FDA was slow to warn consumers of significant drug risks.”

The new rules went into effect on June 30, 2006, and preemption is now being used in litigation all over the country in an attempt to dismiss lawsuits filed by private citizens against drug companies …

… In the Times, Mr Harris noted that Vermont officials reported that drug company payments to Vermont psychiatrists more than doubled last year, from an average of $20,835 in 2005, up to $45,692 in 2006, and that antipsychotics were among the largest expenses for the Vermont Medicaid program.

He also reported a similar pattern in Minnesota where psychiatrists earned the most money,with payments ranging from $51 to $689,000, and the psychiatrists who took the most money from the makers of antipsychotics prescribed the drugs to children most often.

The atypical antipsychotic makers are currently under investigation by congressional committees and federal and state law enforcement agencies for defrauding public health care programs by marketing the drugs off-label to kids as young as toddlers, as well as elderly citizens in nursinghomes, and causing serious injury and death to many patients.

However, Lilly recently purchased a new insurance policy of sorts to keep federal regulators at bay, in hiring Alex Azar II, the former Deputy Secretary of the US Health and Human Services Department, who quit his government job in February 2007 and became a senior vice presidentat Lilly in May 2007.

According to Lilly’s press release, Mr Azar formerly supervised all operations at the HHS, and one of the agencies under his direction was the FDA.

When considering the tens of thousands of lawsuits that have been filed by plaintiffs injured by the new antipsychotics, a favorable ruling on preemption could be worth billions of dollars to the drug makers.

Persons seeking legal advice regarding Avandia can contact the Baum Hedlund Law Firm at: (800) 827-0087, website: Baum Hedlund. (full long text).

Evelyn Pringle is an investigative journalist.

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