Reported Side Effects of Prescription Drugs

Have you ever tried to read and understand the entire list of reported side effects (called Adverse Drug Events, or ADEs, by the industry) that comes with your prescription drugs? Or been able to follow the rapid-fire verbal description of possible side effects in a television commercial for a prescription drug?

If you can’t, you’re not alone. An article in the Archives of Internal Medicine reveals that the top 200 prescribed drugs list an average of over 100 ADEs each. Some drugs even have two opposite symptoms, such as diarrhea and constipation, or drowsiness and insomnia, among their possible side effects. That’s because drug companies would rather list all ADEs ever reported by any patient who ever took the drug, than risk a lawsuit later if they are accused of failing to warn the consumer adequately.

In fact, for many ADEs there is insufficient data to support a causal relationship between the drug and the reported ADE. Most of the symptoms attributed to ADEs occur in the general population from time to time anyway. Most of us have had diarrhea, for example, or felt drowsy and “lethargic” at one time or another, even when we were not taking any medications.

It would be nice if drug companies could find a way to separate out the important or frequent side effects from the unimportant or infrequent, without putting themselves at risk for failing to warn consumers adequately. But in our litigious society, this may be hard to do.

Reference: Duke, Jon, et al. A Quantitative Analysis of Adverse Events and “Overwarning” in Drug Labeling. Arch. Int. Med. 171:944-946, 2011.

Rules for Sunscreen Advertising

After 33 years of inaction, last week the Food and Drug Administration (FDA) finally established new rules for advertising sunscreen lotions. Under the new rules, sunscreens with less than 15 SPF protection must include a warning label stating that the product has not been shown to help prevent skin cancer or early aging. In addition, in order to be allowed to claim “broad-spectrum” protection the product must protect equally against UVB radiation, which causes burning, and UVA radiation, which causes wrinkling; both UVB and UVA rays increase the risk of cancer. Finally, words like “waterproof” and “sweatproof” will no longer be allowed, as no product is truly waterproof or sweatproof. But manufacturers will be allowed to advertise the length of time that the product is “water-resistant”, provided that the claim can be backed by test data.

The new rules are being hailed as a significant advance by most dermatologists, who will now have an easier time deciding which sunscreens to recommend to their patients. The new rules go into effect in one year.

Smallpox – NOT Yet Gone Forever…

On this blog site (Feb. 9, 2011) I reported that the World Health Assembly (WHA) would be deciding soon whether to recommend the final destruction of all remaining stocks of the deadly smallpox virus, which presumably has been eradicated from the planet except for stocks held in several research labs in the U.S and Russia. And true to form, in May the WHA voted to put the decision off for another three years. The vote comes after intense lobbying by the U.S. and Russia against final destruction. Both countries argue that the smallpox virus is worthy of further study, of course.

Votes to delay the decision to destroy the last stocks of the virus are becoming the norm; they’ve been happening since the early 1990s. It’ll be at least 2014 before the issue is brought up again.

New York City Bans Smoking in Public Parks

A smoking ban in New York City’s public parks and beaches went into effect on May 23.

The ban makes good sense if the idea is that non-smokers should never have to smell even a whiff of smoke, or if the goal is to get smokers to quit. But too often, the proponents of such bans try to convince the public that even the occasional smell of smoke in an outdoor setting is enough to cause cancer or disease in the non-smoker. People, the data just aren't there to support such a claim! I'll be happy to change my tune when I see the evidence.

There’s plenty of evidence that smokers have a higher risk of cancer and other disease. Surely we'd get farther if we were just brutally honest with smokers, as in, "Cigarettes will kill you!"

Setback for Induced Pluripotent Stem Cells

Ever heard of induced pluripotent stem cells (iPSCs)? They were supposed to be the answer to the politically-charged issue of the use of embryonic stem cells in research or disease treatment. The idea has always been that if fully differentiated somatic cells could somehow be induced to return to an undifferentiated state (i.e. become pluripotent stem cells), then they could replace embryonic stem cells altogether. In addition, since iPSCs could be derived from the patient for which they would be used, it was presumed that they would not induce an immune response in the patient.

That presumption now is in doubt. A recent paper reports that iPSCs derived from mouse cells cause an immune response when injected back into genetically identical mice, leading ultimately to rejection of the iPSCs.

Scientists generally were surprised by these findings, since iPSCs were not supposed to be immunogenic in genetically identical animals. But further analysis revealed that these iPSP’s may be over-expressing certain genes, leading to the production of proteins seen as foreign by the immune systems of the recipient mice. Whatever the reason, the finding casts doubt on the idea that iPSPs could replace embryonic stem cells any time soon.

The Food Pyramid is History

Yesterday the U.S. Department of Agriculture (USDA) retired its graphical representation of dietary guidelines for Americans, known as the food pyramid. Its been replaced by a much simpler round plate that has only four elements, representing fruits, vegetables, grains, proteins. Dairy products are represented by a smaller circle next to the plate. Officials believe that the take-home message that half of our daily intake should consist of fruits and vegetables is more easily grasped by the plate than the old pyramid. You can see the new nutrition plate at ChooseMyPlate.gov.

Already the plate has received criticism. For one, protein is found not just in meats, poultry and fish, but also in grains and dairy. Nevertheless, most nutritionists see the very simplicity of the plate as an improvement over the pyramid. The pyramid tried to do too much, they say. The rest of the USDA’s dietary guidelines and advice, including a document entitled “Dietary Guidelines for Americans, 2010” that came out in January of this year, can be found conveniently on the site but are not part of the plate graphic.