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.