Prescription Drug Uses Depend on Who You Ask

By SAM URETSKY

On August 8, 1994, the New York Times published a report headlined “The Call of the Lox and Due Process at Zabar’s; A Salmon Slicer Claims Discrimination; Her Employers See Only Mangled Fish.”

The case involved a claim of sex discrimination against Zabar’s, a popular gourmet store in New York City. The plaintiff complained that she was being paid less than male salmon slicers because of sex discrimination, while her boss claimed that she was simply not as good at slicing salmon. What distinguishes the case is that the trial judge was Dennis Aloysius Dooley, who, as a boy, had been a lox slicer at Pincus Appetizing in Long Beach, Long Island. According to the Times, “The owners used to say, ‘He’s one of the goyim and he knows how to cut salmon like that?’” The judge said, “I never hacked up a salmon in my life.”

The art of slicing lox isn’t limited by race, religion or gender, but it did seem improbable to find a judge who understood the artistry of lox. There are two occupations that are expected to be able to learn esoteric subjects quickly – general assignment reporters and judges. A judge may handle a case involving accounting methods one day and medical malpractice the next, and is expected to be able to understand any particular aspects of each profession. Unfortunately, lawyers go on to become judges, and a knowledge of the law doesn’t assure an understanding of anything else. Some lawyers become politicians and write laws, and other lawyers become judges and interpret that laws. That may explain more than it’s helpful to know.

On August 7, 2015, Judge Paul A. Engelmayer of the Federal District Court in Manhattan ruled that Amarin pharmaceuticals could promote its drug Vascepa (icosapent ethyl) for uses that had not been approved by the Food & Drug Administration. This was considered a victory by the Medical Information Working Group, a coalition of large drug companies has been pressing the FDA to loosen its restrictions on promotion of drugs for unlabeled uses. One of the lawyers for the Working Group said “We expect this latest court decision will lead FDA to expedite review of its promotional policies to align them with First Amendment principles.”

The case for the drug company had been presented as a freedom of speech issue. It probably isn’t. Freedom of speech is a basic right, but like all other rights, it’s not absolute. Getting FDA approval to market a drug for a specific use can be expensive and laborious, and the drug companies would be delighted to be able to market their products without the regulatory process running up a bill. The other beneficiary would be insurance companies, since they commonly refuse to pay for investigational drugs, and any drug used outside of the FDA approved use is considered investigational.

In April 1982, the FDA relaxed its rules on the use of drugs for unlabeled uses. Under the old rules physicians were obligated to use drugs exactly according to the approved uses and dosages. Under the new rules, a physician was free to prescribe a marketed drug for any reasonably documented use; anything mentioned in the medical literature. The only restriction was that a drug company’s sales department couldn’t promote the drug for that use. If physicians wanted information on unapproved uses, they had to contact the drug company’s Medical Department. At the same time, anyone not involved in producing or selling the drug was free to talk about new uses of the product.

The restrictions made sense. It’s not unusual for two studies, even honest and well designed studies, to come up with results that disagree. To get to the truth about the safety and effectiveness of a drug requires multiple studies, and even these have to be evaluated by expert panels who may challenge the study methods used. Even after that, other experts may raise questions about the safety and effectiveness of a drug. A single study may be true by itself, but what it tells you about the drug may be completely false.

Finally, even peer-reviewed publications are inadequate protection. While the practice of sending a study to an expert who will determine whether the paper should be published is intended to weed out poorly designed studies, whether or not the errors are intentional, it doesn’t always work. Studies can be designed to give a specific outcome. It’s pretty well known that most drugs work better when the drug manufacturer is paying for the study.

Freedom of speech is among our most treasured rights, but it is, like other basic rights, subject to limitations, of which shouting “fire” in a crowded theater is only the best known. Even telling the truth maybe wrong if the truth is incomplete, as it may be when promoting a drug based on inadequate studies or studies that have been poorly designed.

The FDA’s limitations on promoting unlabeled uses of drugs were fair and reasonable and should have been left alone. We wanted sliced lox, and we’ll get gefilte fish instead.

Sam Uretsky is a writer and pharmacist living on Long Island, N.Y. Email sdu01@outlook.com.

From The Progressive Populist, April 15, 2016

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