Whistleblower charges drug company with deceptive practices

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Collections under which this article appears:

Regulation

Medicine and the law (incl forensic medicine)

BMJ 2003;326:620 ( 22 March )

 

News

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 1998and

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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© 2003 BMJ Publishing Group Ltd

 

 

© 2003 BMJ Publishing Group Ltd