Should we be alarmed about new drug warnings? Science changes with the data

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TheFDA!Over the course of the past few weeks, we ve seen some disturbing alerts about commonly used drugs: a month ago, a large study showed a significant increased risk of heart attack associated with heartburn remedies of the proton-pump inhibitor class (PPIs): OTC drugs like Nexium and Prilosec, among many others. And only last week, the FDA revised their earlier warning on prescription pain-relievers, NSAIDs, upgrading the may cause to causes an increased risk of heart attack and stroke. These drugs include Aleve, Motrin IB, Celebrex, and Advil. Generic names include naprosyn, ibuprofen, diclofenac, among others (but not aspirin).

Such changes are nothing new. Going back a few years, the commonly-prescribed drugs for menopausal symptoms, hormone-replacement therapy (HRT), were being given to younger women as well in the belief that female hormones would keep women younger, longer, and protect them from heart disease as well. The thinking was that since women had much less heart disease than men at similar ages, it must be the hormones. Then the Women s Health Initiative came out in 2002, and lo and behold, HRT seems to have increased the risk of heart disease. Prescription and sales of HRT plummeted. More recently, HRT has been linked to ovarian cancer as well.

These are some fairly specific examples of medical u-turns and detours regarding drugs. More general revisions of medical advice include numerous twists and turns regarding screening for cancer, and screening in general: routine annual mammograms, done with religious devotion for decades thanks to groups such as Susan G. Komen for the Cure and their pink ribbons, have been shown to cause more harm than benefit; the federal advisory panel designated to render official advice counseled fewer mammograms and none for women under 50.

Men had their turn at the forget what we said before, listen to the new advice window too: PSA tests for prostate cancer became de rigeur twenty-plus years ago. Recent studies show that the toll of prostate biopsies and total removals far outweighed the lifesaving benefits of PSA screening.

Even such an apparently obvious medical tool as screening for diabetes was dismissed by that same panel (the U.S. Preventive Services Task Force, USPSTF) as not contributing to long-term better outcomes for diabetics. Further, another large study showed that intensive diabetes care, which involves keeping blood sugars within normal range as much as possible via close monitoring, did not result in better control of the feared complications of diabetes (vascular, neurological, kidney and visual) than routine care.

Lastly, a major nutritional/dietary reversal bears highlighting: after all those years when food authorities were warning us about how much fat we should be ingesting, and why we should be replacing fat (especially saturated fat) with some combination of carbs or unsaturated fat, the worm has turned on that score. Fat has been deemed OK to consume in higher quantities, while now many are blaming the obesity onslaught of the first decade of the 21st century on...believe it or not...all those carbs!

So what s it all about? Should we just doubt any and all health advisories coming from on high, about our medicines, our health behaviors, our diets? Yes, we should but a doubt that is circumscribed by the knowledge that scientists and physicians are fallible. The silver lining is that science sound science is dynamic, is fluid. Only zealots and ideologues hold on to concepts that have been shown to be false, while real science marches on to the tune of new information, data, discoveries, and reverses course when it is appropriate to do so.