Posted by: bridget | 11 February 2007

Pharmaceuticals Abound

In recent news, the FDA has just approved a diet pill for over the counter use, and Merck continues to pressure states to require young girls to receive the HPV vaccine.

The FDA allows drugs to be sold over the counter if they are recognised as safe and effective for use by the general public without a doctor’s prescription. (Nutritional supplements are not regulated by the FDA, so they can be sold but cannot make medical claims.) Orlistat works by limiting production of pancreatic and gastric enzymes, which reduces absorption of fat into the body. It is to be used in conjunction with a low-fat diet and exercise. As vitamins A, D, E, and K are fat soluble (and therefore will be in the fat that is not absorbed into the body), people who take orlistat should also take a supplement. Side effects include loose bowels, abdominal pain, and precancerous lesions of the colon. It cannot be taken by people who have had an organ transplant, have diabetes, or hypertension. The efficacy of Orlistat is in question.

Generally, the FDA will allow drugs to be sold over-the-counter when their benefits outweigh their risks, their potential for misuse is low, consumers can diagnose themselves, they can be adequately labeled, and health practioners are not needed for safe and effective ues of the product. Orlistat does not meet these criteria. Its benefits are questionable (as it needs to be used in conjunction with a low-fat diet and does not necessarily produce the health benefits that accrue to those who are not obese); the user must follow a low-fat diet or the side effects will be worsened; the user needs to take multivitamin supplements containing vitamins A, D, E, and K; and the side effects may be severe. Such a drug should be dispensed by prescription; it is hardly aspirin or cough syrup.

In other pharmaceutical news, Merck is pressuring states to make its new vaccine, Gardasil, mandatory for middle school girls. As previously blogged, this is a bad idea. The pachyderm is all for eliminating cancer, but mandatory vaccination of middle schoolers to prevent STDs is not the way to go. If parents want to protect their children, there is no law stopping them. If girls want to receive the vaccine before they are sexually active, they can talk to the doctor at the same time they get the Pill. If girls want to get it, they can also get it, with equal efficacy, at age 18. There are choices involved in HPV and the vaccine that are not present with smallpox and polio.

Mandatory school vaccinations should only be used where the disease spreads through casual contact or through air, has immediate or near-immediate consequences, and is devastating. Essentially, schools should only make vaccinations mandatory when the disease, if it were to be introduced to the school, would spread through it quickly and require shutting the school down to prevent further transmission. Polio, pertussis (once suffered by a very phlegm-filled pachyderm), and measles are prime candidates for mandatory vaccines. The chicken pox and HPV are diseases that do not threaten the school population.

“Merck, best known for such blockbuster drugs as Singulair for the treatment of asthma and Zocor, a cholesterol-lowering medication, has a powerful financial incentive to push for the mandate sooner rather than later. A rival drugmaker, GlaxoSmithKline, is pushing its own HPV vaccine through the approval process. Mandating the vaccine quickly would help Merck corner the market before then — helping to explain the intensity of the company’s marketing and lobbying campaign toward consumers, physicians and politicians.”

This isn’t about the kids. Now, we have virtual unregulated dispensation of a weight-loss pill of questionable efficacy and even more questionable side effects and a mandate for a vaccine against STDs. No where in this debate have the Platonic virtues of temperance and prudence, nor the Christian virtues of chastity and abstinence, been mentioned.

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