Pfizer, Geodon (Ziprasidone ) & The Twist

In the New York Times:

“The pharmaceutical giant Pfizer agreed to pay $2.3 billion to settle civil and criminal allegations that it had illegally marketed its painkiller Bextra, which has been withdrawn.”

“The government charged that executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain. While the government said the fine was a record sum, the $2.3 billion fine amounts to less than three weeks of Pfizer’s sales.”

My main interest is in the antipsychotic Geodon (Ziprasidone )

  
From Reuters:
“Geodon is FDA-approved only to treat patients ages 18-65 diagnosed with schizophrenia or acute manic or mixed episodes associated with bipolar disorder. However, according to the whistleblower suit unsealed today, Pfizer illegally promoted the sale and use of Geodon for a variety of off-label conditions,
 including depression, bipolar maintenance, mood disorder, anxiety, aggression, dementia, attention deficit hyperactivity disorder, obsessive compulsive disorder, autism, posttraumatic stress disorder, and for pediatric, adolescent and geriatric patients.”
That sounds like every known condition!!!
"Pfizer targeted pediatrics and adolescents to expand off-label use and maintained on its payroll an army of more than 250 child psychiatrists nationwide."  Kenney stated that, "Pfizer regularly paid generous speaking fees to these child psychiatrists to give what were basically promotional lectures about the benefits of Geodon to their peers, who were naturally also child psychiatrists, despite the fact the drug is not FDA-approved or medically indicated to treat children at all." 

  
"……the purpose and intent of paying so many child psychiatrists is clear-- to gain a foothold within the fastest growing market for antipsychotics --children.  The practice of expansive off-label use is dangerous, particularly in children because the drug has not been evaluated for its safety for the unique physiological make up of children." 

  
"……less than 5% of the United States population is diagnosed with schizophrenia or bipolar disorder, yet in 2008 Geodon surpassed the blockbuster benchmark of $1 billion in sales."

  
"……after drug makers obtain initial FDA approval for a specific use, they often don't bother with expensive testing that would allow them to request a label extension for other uses.  They just market the drug off-label."

  
Danger:
  
"……among Geodon's most dangerous side effects is its potential to affect the heart's rhythm, a condition known as QT prolongation, which increases the risk of sudden cardiac death."  

  
Antibiotic as well?
  
As part of the overall settlement, Pfizer agreed to pay $100 million to resolve allegations that it engaged in the marketing of Zyvox for a variety of off-label conditions beyond the methicillin-resistent Staphylococcus aureus ("MRSA") infections for which Zyvox was FDA-approved.

  
 

Is anything sacred anymore?

The twist: this is better than a John Grisham Novel

Associated Press:

“Authorities called Pfizer a repeat offender, noting it is the company's fourth such settlement of government charges in the last decade. The allegations surround the marketing of 13 different drugs, including big sellers such as Viagra, Zoloft, and Lipitor.”

I was wondering why they could be so blatant:

“In an unusual twist, the head of the Justice Department, Attorney General Eric Holder, did not participate in the record settlement, because he had represented Pfizer on these issues while in private practice.”

What other corporations did he represent?

“Eric Holder, has a net worth of $5.7 million and lobbied on behalf of three companies in the past five years, according to a questionnaire filed by Holder with the Senate Judiciary Committee.

“In the year before Obama appointed him Attorney General, he made more than $2.1 million as a partner at Covington & Burling, a prominent Washington law firm. The money is unsurprising given his high-profile client list, which includes companies like UBS Financial Services, Merck & Co., and Hewlett-Packard. He was also paid to sit on the boards of MCI and Eastman Kodak Company.”

Grande Rounds: Voume5, No 51 at Medic999

Links: Eric Holder,Pfizer Whistleblower, Associated Press, Reuters.

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