The all-time poster child for a drug illegally promoted for off-label uses, is Neurontin, marketed by Warner-Lambert, and its Parke-Davis division, until Pfizer acquired the company in 2000.
The term "off-label" means prescribing a drug for indications not listed on the label, upping the recommended dose, prescribing a drug in combination with other medications, or using a drug with a patient population, such as children, not listed on the label.
As part of the approval process, the FDA reviews the drug's labeling, which must include the proposed claims about the drug's risks and benefits, as well as the directions for use.
If an indication is not listed, it means the drug maker has not submitted the required studies to prove the drug is safe and effective for that use. While physicians may prescribe a drug approved by the FDA for an unapproved use, it's against the law for a drug maker to influence doctors to prescribe a drug for uses outside the label.
Pfizer completed the acquisition of Warner-Lambert in June 2000, and four years later in May 2004, Pfizer pleaded guilty to illegally marketing Neurontin for unapproved uses and agreed to pay a $430 million, the second-largest settlement ever in a health care fraud prosecution, to settle charges brought by the US Department of Justice that included defrauding public health care programs.
The case specifically sought to recover the losses to public programs resulting from the off-label promotion of a drug and focused primarily on Medicaid, which spent an estimated $422 million on Neurontin between 1994 to mid-2000.
In the end, Pfizer paid $83.6 million to the federal government and $68.4 million to the 50 states and the District of Columbia. In addition, Pfizer agreed to pay the states a total of $38 million to settle liabilities under state consumer protection laws, and a $240 million criminal fine, according to the DOJ.
However, the settlement with the DOJ did not include damage awards for patients who may have been injured by Neurontin and many patients, or families representing deceased Neurontin victims, have filed lawsuits against the company.
Many of the cases are wrongful death actions based on the company's failure to warn about the risk of suicidality associated with the drug. In 2004, attorneys Derek braslow and Harris Pogust of the Pennsylvania law firm, Pogust & Braslow, began filing lawsuits on behalf of victims who became suicidal.
Pogust & Braslow represent plaintiff, Natalie Biedenbender, whose husband Mark committed suicide on July 9, 2005, at age 39, after being prescribed Neurontin off-label for back pain, in a wrongful death lawsuit.
According to the lawsuit, from July 1995 through at least August 5, 2002, the company engaged in a marketing program "to induce physicians to prescribe Neurontin, for medical conditions for which the FDA had not approved Neurontin to be used."
That program, the complaint charges, included (a) illegally promoting the sale and use of Neurontin for a variety of conditions "for which defendants had not performed the required FDA testing or established safety and efficacy;" and (b) offering and paying illegal remuneration to doctors, "either directly or through third parties, to induce them to promote and prescribe Neurontin for off-label uses."
On May 17, 2004, Andrew Finkelstein, of the New York law firm of Finkelstein & Partners, submitted a citizen's petition to the FDA requesting that a black box suicide warning be added to the label and that a Dear Doctor letter be sent out to instructing physicians to be on alert for increased depression in patients taking the drug.
Mr Finkelstein also continued to remind the FDA about the rising number of suicides. In a March 21, 2005, letter to Dr Russell Katz, he wrote in part: "Enclosed you will find two hundred fifty eight MedWatch forms ... Each represents a suicide of an American who was on Neurontin when he or she took his or her own life."
"Many of these suicides likely could have been prevented," he said, "had both the treating physician and unsuspecting families been armed with full knowledge of the risks of suicide that was known to both the FDA and the manufacturer."
But as it turns out, the FDA was fully aware of the suicidality risk when Neurontin was recommended for approval in 1992, and Dr Katz oversaw the FDA's analysis of the clinical data provided to support the New Drug Application.
Psychotherapy and especially alcohol also up suicide risk?
There is evidence (Bridge JA, et al, 2005) that cognitive and behavioral therapies also increase suicide risk to about the same level as prescription drugs.
I look forward to Ms Pringle's articles on this little psychotherapy secret.
And let us not forget that alcohol is involved in 30-50% of completed suicides (in some eastern European countries it is as high as 90%). Yet breweries and distilleries are not required to put black-box warnings on their products. It is time this scandal was exposed.
by
slothman (0 articles, 0 quicklinks, 0 diaries, 1 comments)
on Tuesday, February 20, 2007 at 6:14:40 PM
