Former drug rep slams off-label claims

A whistle-blower lawsuit alleges that Parke-Davis engaged in an improper marketing scheme.

By Jay Greene, amednews staff. Oct. 22/29, 2001.

A former drug company representative is charging that officials with the Parke-Davis division of Warner-Lambert Co. made false statements to physicians about "off-label" uses of the epilepsy drug Neurontin and that those statements caused false claims to be submitted to the Medicaid program.

The lawsuit also alleges that the Morris Plain, N.J.-based pharmaceutical company engaged in an illegal marketing campaign that rewarded certain physicians who prescribed higher levels of Neurontin (gabapentin) with cash and other gifts, including trips to resorts, dinners at expensive restaurants, and tickets to sporting events and the theater.

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During the past several years, physician leaders have bemoaned the increase in drug company spending on gifts to physicians. The AMA in August kicked off an educational campaign to inform physicians of the AMA's ethical guidelines on gifts. The Pharmaceutical Research and Manufacturers of America also is participating in the effort.

The AMA's ethical guidelines prohibit physicians from taking gifts of substantial value that do not directly benefit patients. In general, unethical behavior becomes illegal when gifts are accepted in exchange for prescribing medications that the physician knows will cause false billing to payers.

If the Parke-Davis lawsuit and another similar case recently settled in Illinois are any indication, the generally condemned practice of giving gifts to physicians to influence prescribing appears to be a continuing problem.

In a recently settled case, TAP Pharmaceutical Products, Lake Forest, Ill., agreed last month to pay $875 million and plead guilty to a criminal charge of conspiring with doctors to overcharge Medicare and Medicaid for its prostate cancer drug Lupron (leuprolide acetate).

Six TAP managers and a urologist in Plymouth, Mass., also were indicted by a federal grand jury with conspiring to pay kickbacks to physicians. Four other doctors had earlier pleaded guilty to charges of health care fraud. TAP officials admitted no wrongdoing.

The U.S. attorney's office in Boston involved in the TAP case said they and other jurisdictions are investigating similar practices at other drug companies.

In the Parke-Davis lawsuit, filed under the False Claims Act, whistle-blower David Franklin, PhD, alleges Parke-Davis deliberately avoided FDA regulations by promoting off-label uses of Neurontin to physicians. Dr. Franklin also contends that the improper prescribing caused the Medicaid program to reimburse for off-label prescriptions that were ineligible for coverage. Neurontin is prescribed by physicians for off-label uses that include pain control, bipolar disease and attention-deficit/hyperactivity disorder.

While several physicians are named in the Parke-Davis suit, none are being sued by Dr. Franklin. However, officials said, a federal grand jury in Boston is reviewing evidence against physicians who may be involved.

Dr. Franklin, a biologist, worked for Parke-Davis as a medical liaison for five months in 1996. While most medical liaisons work in research divisions, Dr. Franklin's job was in sales, where he was promoting drugs to physicians. Under the False Claims Act, individuals filing suits that uncover wrongdoing can share up to 25% of the civil damages recovered.

Medical liaisons "were instructed to make exaggerated or false claims concerning the safety and efficacy of Parke-Davis drugs for off-label uses," according to Dr. Franklin's complaint. "To bolster their representations to physicians, medical liaisons were encouraged to misrepresent their scientific credentials as to pose as research personnel, rather than as sales representatives."

Under FDA rules, physicians may prescribe drugs for uses that are different from those approved. Drug reps are not allowed to market or promote a drug for off-label uses, but may answer physician questions along those lines, an FDA spokesman said.

While Dr. Franklin filed the complaint in August 1996 in the U.S. District Court for the District of Massachusetts, the lawsuit remained under seal until January 2000 while the U.S. Dept. of Justice conducted a routine investigation.

But in a June 25 decision, U.S. District Court Judge Patti B. Saris ruled there are sufficient details in the complaint to proceed with the case on the allegations of making false statements to physicians. She also similarly ruled on the allegation that those statements caused false claims to be submitted for reimbursement by Medicaid.

However, Saris dismissed several of the counts against Parke-Davis. Those counts included allegations that Parke-Davis filed false claims to the U.S. Dept. of Veterans Affairs for off-label uses of Neurontin and recruited doctors to perform clinical trials in violation of FDA regulations. Saris also dismissed the allegation that drug reps made false statements about Accupril (quinapril hydrochloride), an ACE inhibitor used to control hypertension and heart failure.

On the allegation of physician kickbacks, the judge ruled the complaint had insufficient details to proceed. However, she noted that the practices "may be illegal," which opens the door for Dr. Franklin to provide more details.

In July, Dr. Franklin filed an amended complaint that is under court seal; full details were not known at press time. However, the court docket on the case suggests that the amended complaint further alleges that Parke-Davis violated the False Claims Act by paying kickbacks to physicians.

Dr. Franklin's attorney, Thomas Greene, of Greene & Hoffman in Boston, declined to comment on the case while the amended complaint remains under court seal. James Rouhandeh, attorney with Davis Polk & Wardwell in New York City, also declined comment. Rouhandeh represents Pfizer Inc., which acquired Warner-Lambert and Parke-Davis in 2000.

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