Painkiller panic

Depending on which of two recent studies you may have read about, you might suppose the pain reliever Alleve (naproxen) will either reduce or increase the risk of heart attacks.

On Dec. 13, the Financial Times reported, “Widely used anti-inflammatory drugs such as ibuprofen and naproxen could help reduce the risk of heart attacks, while abruptly halting the usage increases the risks, according to a large U.K. study.”

On Dec. 21, The Washington Post dished out the opposite advice, noting, “Federal officials announced that naproxen, a painkiller sold by prescription and also over the counter as Aleve, might increase people’s risk of having a heart attack.”

Between those dates, my periodontist prescribed naproxen. What the press described as a “quick review of the data” in the United States may have suggested to equally hasty readers I should stop using naproxen or risk a heart attack. But the larger British study said stopping naproxen would risk a heart attack. So, I decided to take a closer look at the U.S. version.

It turns out that in a study of about 2,400 older people, 70 of those using naproxen had some “cardiovascular event,” such as a stroke or heart attack, but only two or three died. The 70 was said to be twice the rate among those taking a placebo. Press reports promptly ascribed that minor difference (1 percent) to the added risk of taking a large daily dose of naproxen for three years.

For all we know, the difference might be because those taking naproxen ate fatter foods than most other participants, exercised less, were older, had worse family histories or smoked more cigarettes. Nobody said these other risk factors were properly taken into account, so the quick review lacks statistical credibility.

Even in the case of Vioxx, nobody claims it is dangerous if the normal 25 mg dose is taken only a couple of weeks, as I would still like to do for an arthritic big toe on vacations (because I’m allergic to Celebrex).

I am now denied the opportunity to use Vioxx responsibly, not to eliminate even the slightest health risk (impossible), but in hopes of reducing litigation risk. Typing “Vioxx” into Google generates about 14 million hits, mostly ads inviting people to share in the fabulous riches from class-action suits. One says, “Vioxx lawsuit is the easiest way to make you a millionaire.”

Mass tort lawyers must love David Graham, an associate director in the Food and Drug Administration’s Office of Drug Safety. Mr. Graham became an instant media darling when he testified against the FDA at a November hearing of the Senate Finance Committee. Yet Mr. Graham’s testimony was not so much about blowing whistles as it was about tooting horns.

“During my career, I believe I have made a real difference for the cause of patient safety. … I have recommended the market withdrawal of 12 drugs. Only two of these remain on the market today — Accutane and Arava.” He then recommended banning several other FDA-approved medications.

Mr. Graham’s urge to banish risk reflects the mindset of aspiring regulatory czars. The fewer drug choices left to doctors and patients, the better job Mr. Graham imagines he has done. Yet if zero risk from new drugs was really ideal, then it would be best to simply ban all new drugs.

The FDA does not go quite that far, but the agency has certainly slowed introduction of many drugs that could have saved or improved many lives if available sooner. A classic example was beta-blockers, which an American Heart Association study says “lengthen the lives of people at risk of sudden death due to irregular heart beats.” Beta-blockers were available in Europe in 1967; the FDA banned them until 1976.

Mr. Graham said: “The FDA, as currently configured, is incapable of protecting America against another Vioxx. We are virtually defenseless.” From his standpoint, the only sure way of “protecting America against another Vioxx” is to greatly increase the regulatory cost and time involved in bringing new drugs to market.

But every day in which a lifesaving drug is delayed for further testing is a day in which the FDA approval process may kill more people. Suffering with acute or chronic pain is not death, to be sure, but it can be horrible enough to warrant taking major health risks (as with codeine or morphine).

Mr. Graham noted that a single drug — thalidomide — was the reason the FDA first began its dangerous campaign to stall or thwart introduction of new drugs: “In 1962, Congress enacted the Kefauver-Harris Amendments,” he testified, “in response to the thalidomide disaster in Europe. Oversees, between 1957 and 1961, an estimated 5,000 to 10,000 children were born with thalidomide-related birth defects.”

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