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The stakes were somewhat higher last September, when Pfizer and related companies settled a number of charges for a total of $2.3 billion (O’Reilly and Capaccio 2009). This settlement set a new record for a criminal fine – $1.2 billion – plus civil penalties of $1 billion. Subsidiary Pharmacia & Upjohn pleaded guilty to one count of a felony, misbranding of a pharmaceutical, and was assessed a forfeiture of $100 million.

 

A number of fraudulent marketing practices were involved for a number of different Pfizer or subsidiary products. The criminal charges focused on the illegal promotion of several Pfizer brands – Bextra (valdecoxib, a pain medication, since removed from the market), Geodon (ziprasidone HCl, an atypical antipsychotic), Zyvox (linezolid, an antibiotic) and Lyrica (pregabalin, a seizure medication). These were promoted for “off-label” use, i.e., for uses other than those approved by the FDA.3 But there were also kickbacks to physicians and the use of unverified and misleading marketing materials to promote the prescribing of several other Pfizer brands, including Viagra (sildenafil) and Lipitor (atorvastatin).

 

This was by no means Pfizer’s first offence. In 2007, Pfizer subsidiary Pharmacia & Upjohn paid $34 million and pleaded guilty to paying kickbacks for formulary placement of its drugs and entered into a Deferred Prosecution Agreement for off-label distribution of Genotropin, its brand for the human growth hormone somatropin (US Department of Health & Human Services and US Department of Justice n.d.).

 

In 2004, Pfizer subsidiary Warner–Lambert pleaded guilty and paid more than $430 million to resolve criminal charges and civil liability arising from its fraudulent marketing practices with respect to Neurontin, its brand for the drug gabapentin. Originally developed for the treatment of epilepsy, Neurontin was illegally promoted off-label for the treatment of various forms of neurological pain, and in particular for migraine.

 

In 2002, Pfizer and its subsidiaries Warner–Lambert and Parke–Davis paid $49 million to resolve civil claims that it had failed to report best prices for its drug Lipitor as is required under the Medicaid Drug Rebate Statute.

 

As this is being written, gabapentin is back in the news. The CBC (2010) reports that Pfizer has been ordered to pay $142 million US in damages for fraudulently marketing gabapentin, an anti-seizure drug marketed under the name Neurontin. A federal jury in Boston ruled Thursday that Pfizer fraudulently marketed the drug and promoted it for unapproved uses.

 

This case demonstrates one reason why drug companies often prefer to settle rather than go to trial. The CBC report continues :

 

Data revealed in a string of U.S. lawsuits indicates the drug was promoted by the drug company as a treatment for pain, migraines and bipolar disorder – even though it wasn’t effective in treating these conditions and was actually toxic in certain cases, according to the Therapeutics Initiative, an independent drug research group at the University of British Columbia.

 

The trials forced the company to release all of its studies on the drug, including the ones it kept hidden.

 

A new analysis of those unpublished trials by the Therapeutics Initiative suggests that gabapentin works for one out of every six or eight people who use it, at best. The review also concluded that one in eight people had an adverse reaction to the drug.

 

Dr. Tom Perry, quoted in the story, estimates that Neurontin sales in Canada are around $300 million per year. Since the drug has been in use since the late 1990s, at least a billion dollars has been spent on an illegally promoted drug with few benefits and serious side effects.

 

In response to this record of persistent criminal behaviour, the September 2009 settlement included Pfizer’s signing of an “integrity agreement” to be overseen by the US Department of Health & Human Services. In essence, while denying virtually all charges of wrong-doing, Pfizer accepted a form of trusteeship for a period of years, to try to prevent the company from doing in the future what it denied having done in the past.

 

The integrity agreement, however, imposed the further requirement that Pfizer make public its cash payments to practitioners. On March 31, 2010, the New York Times reported that Pfizer … paid about $20 million to 4,500 doctors and other medical professionals in the United States for consulting and speaking on its behalf in the last six months of 2009 … [and] $15.3 million to 250 academic medical centers and other research groups for clinical trials …. (Wilson 2010)

 

While most of the disclosures were required by the integrity agreement, “[c]ompany executives said they had long planned to be more transparent.” The “skepticism [of] some outside experts” may have been reinforced by the fact that Pfizer’s website (like those of Eli Lilly, Merck and GlaxoSmithKline) is “set up in ways that make it difficult to download and analyze the entire database” (Wilson 2010). It is also notable that the integrity agreement does not apply to payments made to physicians outside the United States – in Canada, for example – and accordingly, none of these were disclosed.

Tough on Crime ? Pfizer and the CIHR