Pandora’s Pill Box

This article is from the archive of The New York Sun before the launch of its new website in 2022. The Sun has neither altered nor updated such articles but will seek to correct any errors, mis-categorizations or other problems introduced during transfer.

The New York Sun

Wash your hands before cutting into a patient’s belly. It makes sense. That such an obvious practice took decades of mounting scientific study to finally make its way into routine medical practice should tell you something about the slow progress of science.


Everyone today knows that the dirtiness of a doctor’s fingernails is inversely proportional to patients’ survival-rates. Yet the seemingly simple scientific work that laid the foundation for modern antiseptic techniques took years, if not decades, of painstaking study to finally win the hearts and minds of an instinctively skeptical medical establishment.


There are rarely single scientific studies that change medical practice. Few medical articles close the book on important clinical questions. More often, significant questions about medicine are answered over time, as evidence slowly builds and careful scientific inquiry raises more precise questions that are followed by additional and more exacting study.


These simple, scientific truths are not the fault of the Food and Drug Administration, of Merck, or of Pfizer, although next week a Senate Committee will try to make it the fault of all of these establishments. The Senate Finance Committee is holding hearings into Merck’s handling of its withdrawal of the painkiller Vioxx, and whether the company put a rosy interpretation on its own medical evidence in the dubious hope that mounting profits could somehow trump mounting science.


At issue is the class of drugs known as Cox-II inhibitors, to which Merck’s Vioxx belonged. Vioxx, like other Cox-IIs, was long maligned by critics who charged it was no better than ordinary painkillers such as Motrin or Advil.


Drugs like Vioxx are called Cox-II inhibitors because they selectively inhibit pathways that cause pain but, unlike similar painkillers such as Advil, the Cox-IIs do not block pathways in the body that also produce chemicals that protect the tummy lining. Anyone who has ever taken Advil ’round the clock will attest to the stomach pain that it can cause. Drugs like Vioxx probably were overkill for many of the patients to whom they were prescribed. But for those who needed the extra stomach protection they afforded, Vioxx was an important alternative.


Last month, information became available that shed new light on an old scientific question – did Cox-IIs, and Vioxx in particular, put patients at risk for heart attacks? While nobody has a final theory to explain why, accumulating evidence shows that Vioxx raises a person’s risk of heart problems.


It was enough evidence to prompt the FDA to put a heart warning on the drug’s label a full two years ago. And when an additional study was stopped early last month, after it showed that that patients on daily doses of Vioxx for more than 18 months began experiencing heart attacks and strokes at twice the rate of patients on a sugar pill, Merck decided to pull the drug off the market.


The new study might have even been less alarming than the original study in 2000 that kicked off the Vioxx heart controversy. Also done by Merck, the 2000 study showed that regardless of how long they were on the drug, Vioxx users suffered two or three times as many heart “events” as a control group using naproxen, the ingredient in Aleve. The only advantage of the Vioxx study released last month, a study that was demanded by the FDA to confirm the 2000 results, wasn’t that the new results were more distressing. But the methodology that produced them was more rigorous and easier to take as face value.


The real question is how we can make the scientific process faster, so that uncertainties are resolved in a span of months or perhaps, at most, a few years. Should the National Institutes of Health be in the business of paying for more studies that answer questions about routine medical practice? Should we be doing a better job collecting medical information every time a new drug is given to a patient, so we can learn more from the real-world use of new medicines, and have more information to draw clear conclusions about them sooner?


The answer is we should be doing all of these things, but, unfortunately, the only question being asked on Capitol Hill and in the press is what did Merck know and when did they know it, since that’s the only question that can be asked and answered within a single reel of film. Now Pfizer has been drawn into the blame game over its Cox-II drug Bextra, having been accused Wednesday of suppressing evidence that its drug also caused heart attacks, although unlike Vioxx, it is not clear what “evidence” about that drug previously existed.


As the blame game ensues, there are fundamental medical questions that are not being asked since nobody wants to be within blast range of Merck right now. Or be seen proffering a cover for the company’s chairman, Ray Gilmartin, who was once a fixture in Washington, especially when he brought gifts.


Merck may well lose billions of dollars in the courtrooms at the hands of patients who claim they were harmed by its drug as scientifically dim state juries hear these cases. But not this, and not next week’s Senate hearing, is likely to prove clearly that the company tried to sit on hard medical evidence with hopes that it could run out the clock on its drugs’ patent, reaping big profits while patients piled up in the cardiac care units.


More likely, Merck made a plausible interpretation of the same scientific information everyone else had four years to look at, an explanation that happened to also be in its corporate interest. That’s about as surprising as learning that dirty fingernails kill surgical patients. And it is an opportunity for all of use to ask whether the scientific establishment is doing enough independent work to continue to learn about the optimal use for new medicines after they are put on the market – or leaving too much of it for a shrinking industry to solve.



Dr. Gottlieb is a physician and fellow at the American Enterprise Institute. Until October, he was senior adviser to the head of the Medicare and Medicaid Program, Dr. Mark McClellan. Previously, Dr.Gottlieb was director of medical policy development at the Food and Drug Administration.


The New York Sun

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