Drug Marketers Are Above the Law

The Boston Globe reported Oct. 18 that David Waterbury, assistant attorney general of Washington state, announced that he is leading an investigation of whether Warner-Lambert, a division of Pfizer Pharmaceuticals, made illegal payments to physicians to prescribe the drug gabapentin (Neurontin). The investigation, which will cover 47 states and the District of Columbia, will determine whether Pfizer followed illegal marketing practices in order to induce physicians to prescribe the drug for unlabeled uses.

The odds are, Pfizer did nothing illegal. That says a lot less about Pfizer than it does about the law.

Many of the current laws regarding drug sales, stem from the 1937 Elixir of Sulfanilamide tragedy. That year, the S.E. Massengill Company decided to market a liquid form of sulfanilamide. Their chief chemist formulated a product using diethylene glycol as the solvent. Tragically, he neglected to check the toxicity of the solvent. Two hundred and forty gallons of the liquid were distributed, causing 107 deaths. Under the law as it existed at that time, the drug couldn't be recalled even though it was a deadly poison. The government was only able to stop the distribution of the material because it was labeled "elixir," and under the law an elixir had to use alcohol as the solvent. The chemist committed suicide, but the company argued, correctly, that it had not violated the law. The following year, the law was rewritten.

There were a number of other laws passed regarding the marketing of drugs. In 1950, in Alberty Food Products vs. US, an appeals court ruled that the labeling of a drug had to contain a statement of what conditions it was intended to treat. The 1951 Durham-Humphrey Amendment to the 1938 Food & Drug Act required prescriptions for the sales of some drugs. For the most part, the history of drug regulation over the first half of the 20th century was a progression of greater consumer protection. In 1960, the Food & Drug Administration issued a notice that drugs were to be used only according to the labeling. The labeling specified both the appropriate conditions to be treated, and the doses to be used. Anything else was considered an investigational use, and was to be reported to the FDA.

This policy remained in force until 1982, when the Reagan administration reversed that policy, saying that drugs, once approved for sale, could be used for any purpose which was documented in the medical literature. The drug manufacturers could not legally promote the drugs for off-label use, but prescribers were not under any limitation.

At best, this was a rational policy which both reversed an unenforceable one, and made valuable drugs available to patients more quickly than would have been the case if the manufacturers had been required to conduct lengthy tests in order to get FDA approval. That's at best. Many drugs have turned out to have important uses other than those for which they were approved. Methotrexate, a cancer drug, has important benefits in severe arthritis and psoriasis. Lidocaine, an anesthetic, is a valuable heart drug. Even thalidomide, which was never approved for use because it causes severe fetal malformations, turns out to be useful in some types of bone marrow cancer. The FDA made these drugs available for use long before they could have wound their way through the regulatory channels for formal approval. That's good.

It also made the United States a nation of guinea pigs. Instead of limiting drugs to those uses where they'd been carefully tested, it opened the gates to uses that had been subject only to small, poorly designed studies. In some cases, an anecdotal report might be enough to induce a physician to try a drug for an unlabeled use. Since the types of formal studies needed to win FDA approval are expensive and time consuming, drug companies might try to find ways around the system in order to make sales while reducing research costs.

According to the Globe report, Parke-Davis, now a division of Pfizer, was busily engaged in back-door marketing of gabapentin, brand name Neurotin, a drug which is approved only in treatment of some types of epilepsy, and then only in combination with other drugs. Although gabapentin appears to be useful in a number of neurological conditions, it can't be marketed for those purposes. So, the complaint says, Parke-Davis found other approaches to the problem. The New York Times, May 15, reported that the lawsuit alleges that Parke-Davis paid doctors $350 or more for each day they allowed sales representatives to watch as they examined patients; paid doctors to sign their names to articles ghost-written for medical journals; paid physicians to enter patients in clinical trials; pressed doctors to prescribe higher doses than those approved by the FDA; and paid physicians to promote Neurontin to their colleagues. These practices became apparent when the number of Medicaid claims for Neurontin began to increase dramatically, costing the states tens of millions of dollars. In 2000, Neurontin was the 17th most prescribed drug in the United States, with retail sales of $1,131,678,000.

This type of marketing, bypassing the proper means of studying the drug, may cause indignation, but it's likely that the public ability to be outraged by corporate behavior has reached the saturation point. Besides, while the marketing methods may have been of questionable ethics, they were probably legal, just as S.E. Massengill's action was legal in 1937. The difference is, in 1938, we got a newer, stronger law. Don't expect any action this time around.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y.

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