Critics say this language is absurd because it extends protection to all the doctors who are boosting sales for the drug makers by prescribing drugs off-label, and the FDA labeling carries no prescribing information for an unapproved use and no warnings about the risks that may be associated with a drug in treating patients for an off-label condition.
"The unqualified language of this statement," Mr Waxman's letter states, "would appear to preempt cases against physicians for failure to warn a patient of risks associated with an off-label (unapproved) use, since, by definition, such risks rarely appear in the approved drug label."
However, drug companies have been immunizing doctors who prescribe their drugs off-label for years. For instance, in Eli Lilly's first out-of-court settlement with 8,000 plaintiffs in litigation involving the off-label marketing of the antipsychotic Zyprexa in late 2004, the settlement agreement included a ban on suing the doctors who prescribed Zyprexa off-label, according to a plaintiff involved in the case.
A July 7, 2003, Lilly document entitled, "Diabetes Update," recently made public as a result of litigation, describes a plan to immunize doctors so they would continue to prescribe Zyprexa off-label when Lilly learned that the warning about high blood sugar levels and diabetes was about to be announced by the FDA and the American Diabetes Association.
"We must embrace the fact that many physicians are curtailing their use of Zyprexa (particularly in the moderately-ill patient and in the maintenance phase)," the Lilly memo states, "solely on the basis of personal fear (of being sued)."
"Indemnification," the document notes, "represents the most meaningful demonstration of confidence in Zyprexa--both with our customers and with our employees."
The memo brags about the success of the scheme when used with doctors prescribing the company's SSRI. "Our experience with Prozac," it states, "confirms the impact and goodwill of such an initiative."
The drug makers are well aware that the steady flow of profits from off-label marketing schemes would come to a screeching halt without the participation of the prescribing doctors. However, the termination date for the immunization coverage extended to the doctors prescribing Zyprexa by Eli Lilly or the FDA is right around the corner, because the fraudulent billings that have resulted from off-label prescribing of the new class of antipsychotics are bankrupting state Medicaid programs all over the US.
Also, state officials are zeroing in on the money paid to the prescribing doctors. On June 26, in the New York Times, Gardiner Harris reported that states are finding that psychiatrists earn more money from drug companies than doctors in any other specialty, and the psychiatrists who receive the most money from antipsychotic makers prescribe antipsychotics like Zyprexa to children most often.
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 nursing homes, 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 president at 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; http://www.baumhedlundlaw.com/
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