Source: US News and World Report
Date: 26 April 2004

The New Pill Pushers

Big Pharma watches lawsuit over
'off-label' prescription drug marketing

By Megan Barnett

While aspirin has been a common pain reliever for more than 100 years, in 1988 doctors began recommending its use in preventing heart attacks. Many drugs are found to remedy ailments other than those they were originally intended to treat, and as prescription drug use has soared, patients are increasingly taking them for off-label purposes--those that the Food and Drug Administration has not sanctioned.

For the pharmaceutical companies, though, the promotion of brand-name drugs for secondary purposes has become controversial. The industry is keeping a keen eye on a case brought by a former medical liaison for Parke-Davis, now part of Pfizer, who claims it illegally marketed the epilepsy drug Neurontin for a host of unrelated illnesses ranging from pain to bipolar and attention deficit disorders. The lawsuit is near settlement and goes to the heart of what the industry sees as a Catch-22: While doctors can prescribe drugs for uses other than those approved by the FDA, drugmakers themselves cannot hawk their products for such secondary uses.

The lawsuit relies on the False Claims Act, an obscure federal law designed to protect the government--in this case Medicare and Medicaid--from fraud. Previously, the law has been used by whistleblowers against defense companies accused of gouging the Pentagon. The government can either join in the case or allow private citizens to pursue their own claims, for which they receive a portion of any award or settlement. Pfizer has earmarked $427 million for the settlement. "We believe the provisions we are taking will be sufficient to resolve all outstanding investigations relating to Neurontin," says Pfizer spokesman Paul Fitzhenry.

The settlement could send ripples through the rest of the industry. There are several investigations into their marketing and promotion practices underway by U.S. attorneys in Philadelphia and Boston, and probes by the inspector general of the Health and Human Services Department and the Office of Personnel Management. Eli Lilly, Schering-Plough, Wyeth, Bristol-Myers Squibb, Johnson & Johnson, and Forest Laboratories have all disclosed that they are targets of government investigations into their marketing and promoting practices. "It is clear there will be more cases," says Stephen Mahinka, a law partner with Morgan, Lewis & Bockius. "This is a very serious issue for the pharmaceutical industry."

Extended use. For pill makers, the battle is worth fighting. An estimated 23 percent of prescriptions are written for off-label uses. Drug development is a long and costly affair. In many cases, once a drug has won patent approval and its clinical trials have garnered the nod from the FDA, researchers will discover that the drug helps with other illnesses. Given the length and cost of getting a drug approved, it's easy to see why drug makers would rather just market it for other uses.

The suit against Parke-Davis concerns the fact that Neurontin was approved by the FDA to treat only epileptic seizures. David Franklin, the whistleblower who brought the case, worked as a medical liaison for the company in 1996. Franklin, with a Ph.D. in biology, says he was told to present himself as a cardiovascular and neurological specialist to physicians, and he educated them about the broad spectrum of Neurontin's uses. The complaint outlines myriad ways the company paid physicians to attend seminars about secondary uses, write articles and studies about the effects of Neurontin, and speak at events about the drug.

Medicare and Medicaid are regulated by antikickback laws, which aim to prevent doctors from being induced into prescribing drugs for which the government will reimburse them. Franklin's lawsuit alleges that by offering doctors payments in return for writing more Neurontin prescriptions, physicians were led to make false claims for reimbursement from Medicaid. "I believe this is happening across the board," says Thomas Greene, Franklin's attorney. Greene says he has gotten calls from "many people who have evidence of illegal off-label promotion." Franklin will receive a portion of the settlement proceeds.

The feds have not intervened in the case, but the U.S. attorney in Boston filed a brief in support of the plaintiff's charges. Franklin, the filing reads, "has presented evidence of an illegal off-label marketing scheme that is rife with false statements and fraudulent conduct, all of which had one intended purpose and result--increasing sales and, therefore, the claims for off-label uses of Neurontin submitted to Medicaid."

The pharmaceutical industry did win one marketing battle. In 2000, the Washington Legal Foundation won a lawsuit against the FDA for denying the industry's First Amendment right by regulating its off-label promotions. The ruling allowed pharmaceutical manufacturers to distribute independent, scientific publications about off-label uses of their drugs to doctors.

Misunderstood. Richard Samp, chief counsel for the foundation, argues that the Neurontin case is a misrepresentation of the False Claims Act and another erosion of the industry's First Amendment rights. "I don't think they fully understand what off-label usage is all about," he says.

Indeed, off-label drugs maintain a precarious position amid patient care, pharmaceutical sales, physician behavior, and regulatory power. In some medical fields, such as oncology, many patients are alive only because of taking drugs that are not specifically approved by the FDA for their illness. An estimated 60 percent of cancer physicians administer drugs for off-label uses. "If we only went with FDA-approved uses, science would progress much more slowly," says Nancy Nielsen, speaker of the American Medical Association's board of delegates. "We need to make decisions on medications that are in the best interest of the patient." Nielsen says it's important that physicians get information about off-label drug uses only from peer-reviewed journals. "We know very well it is illegal for the sales reps to discuss them," she says.

One reason that the government is increasing its scrutiny in this area may be a result of last year's legislation to overhaul Medicare and provide seniors with prescription drug coverage. Because the bill makes the government an even bigger buyer of drugs, Mahinka suspects the crackdown on off-label drugs is an effort to contain costs. "The only way to keep costs down is to limit the products and services given to people," he says. In other words, the government may end up saving taxpayers money by denying them beneficial medical treatments.

A large settlement in the Neurontin case will widely be seen as a victory for the plaintiff, even though it will not amount to new regulatory policy. "This is going to be the seminal case for off-label False Claims Act litigation," says T. Reed Stephens, a partner with Sonnenschein Nath & Rosenthal and former Justice Department lawyer. "The Neurontin case is a wake-up call to the manufacturer community to take a hard look at how their compliance and training is set up."

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