E-drug: Deceptive practices of drug company
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BMJ 2003;326:620 (22 March 2003)
Whistleblower charges drug company with deceptive practices
Jeanne Lenzer, New York
A former drug company insider has spoken to reporters for the first
time since he filed a whistleblower lawsuit in 1996 in a US federal
court. At a press conference last week he gave details of the suit he
has filed.
The suit charges that Parke-Davis engaged in elaborate inducement
schemes to persuade doctors to promote the off-label use of one of its
best selling drugs, gabapentin (Neurontin), an anti-epileptic drug
approved as adjunctive treatment for partial seizures. It also says the
company ran ghost writing schemes, in which it paid specialists to
"author" articles that were actually written by technical writers hired
by the company.
Prescribing drugs off label accounts for over 78% of sales of
gabapentin, according to Parke-Davis. Although off-label prescribing is
legal, the US Food and Drug Administration prohibits drug companies
from promoting such use to doctors. Parke-Davis, which was a
division of Warner-Lambert when the promotional activities are alleged
to have occurred, was acquired by Pfizer in 2000.
Dr David Franklin, a microbiologist and former fellow of Harvard
Medical School, sought legal assistance from the Boston law firm
Greene and Hoffman when he became concerned about patients'
safety and that his employers might retaliate against him because of
questions he had been raising about apparent illegal marketing
practices.
Dr Franklin, 41, said he had been working as a "medical liaison"
employee for Parke-Davis for only four months when a company
executive warned that he "couldn't guarantee what is going to happen
to you or your career" if Dr Franklin continued to challenge the
marketing scheme.
Dr Franklin says Parke-Davis executives were worried about its market
for gabapentin, as its original patent was set to expire in December
1998 and because it was approved for use only as adjunctive
treatment in patients with partial seizures.
In an amended complaint filed in July 2001 Dr Franklin alleges: "After
performing extensive economic analysis, senior officials at Parke-Davis
determined that it was not sufficiently profitable for Parke-Davis to
obtain FDA approval for Neurontin's alternative uses."
Although federal regulations would not allow Parke-Davis to promote
gabapentin for un-approved uses, drug companies are allowed to
distribute third party publications promoting off-label use in response
to unsolicited requests.
Dr Franklin charges that the company undertook an elaborate
programme to exploit this "narrow window of opportunity." He said
"tens of thousands of payments" to doctors were made for
"consultations" and "studies" and served as a "surrogate sales force,"
violating Medicaid regulations on kickbacks.
According to Dr Franklin, "Significant ingenuity and resourcefulness
was necessary in order to execute this unlawful scheme without
detection."
A thinly disguised incentive scheme to get doctors to prescribe the
drug off label was to pay them as "consultants" to attend lavish, all
expenses paid trips to resorts where doctors were encouraged to
prescribe the drug for disorders ranging from migraine to bipolar
disor-der to attention deficit disorder.
Even though the doctors were listed as consultants, Dr Franklin says
their comments were not even recorded at some of the events.
"Studies" supporting such uses of the drug, alleges Dr Franklin, ranged
from occasional case reports falsely labelled as studies to non-existent
data. In the case of bipolar disorder no study has actually shown that
the drug has any benefit over placebo.
Dr Franklin also says that Parke-Davis paid specialists to "author"
articles that were actually ghost written by non-physician technical
writers hired by the company. The articles were then filtered through
"medical education" companies, which in turn submitted the articles
for publication. Court documents cite 20 articles produced in this
manner.
Pfizer would not comment on any aspects of the various actions,
saying only, "We acquired Warner-Lambert in June 2000, and the
events date back to many, many years before that. Pfizer does not
promote off-label use of drugs."
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