Category: Pharmaceuticals

Right for the Wrong Reason?

In 2007, Texas Governor Rick Perry signed an executive order mandating that teenage girls be vaccinated with Gardasil, a vaccine that helps prevent cervical cancer by providing protection against Human Pappillomavirus, or HPV. This was subsequently overturned by the Texas legislature. Now it’s a matter of discussion among Republican presidential candidates. Representative Michelle Bachmann has criticized not only that, ““To have innocent little 12-year-old girls be forced to have a government injection …is just flat out wrong,” but has also suggested that he was motivated by political donations from pharmaceutical company Merck.

We’ll have to see how things play out in regards to whether Governor Perry made his initial decision because of political donations, but it least has the appearance of impropriety.

From a medical point of view, I think he was right to mandate vaccination against HPV, even if he did so for the wrong reason. According to the CDC and the American Cancer Society, at least half of sexually active people will get infected with HPV in their life. Half of those people are infected between 15 and 24 year of age.

In the United States, about 12,000 women are diagnosed with cervical cancer, and 4,000 die from it, each year. HPV causes most of these, as well as many cases of anal and oropharyngeal (mouth and throat) cancer, and genital warts.

As a father of daughters, I get that when they’re 10 to 12-years-old, you don’t want to think of them being sexually active. But most people eventually are, and you can’t be certain that it will only be with one uninfected person the rest of their life. Once they’re infected, it’s too late.

The policy for vaccination against HPV should not be different than for other infectious disease, such as tetanus, polio, measles and chicken pox. If you love your children, you should seriously consider vaccinating them. Even if he had ulterior motives, I think Governor Perry had the right idea.

Glazed Donuts

A couple of pharmaceutical reps brought us lunch to discuss their new product, a testosterone gel that’s more concentrated, and thus lower volume, and applied to the inner thighs. Referring to their main competitor, that uses a larger volume applied to the shoulders and upper arms, one of the reps said that by using his product instead, one could avoid, “that whole glazed doughnut thing.”

Over-the-Counter Lipitor?

According to sources in the Wall Street Journal this week, Pfizer said they would apply to sell Lipitor over the counter. This is a bad, bad idea. Lipitor is in the class of medications commonly called statins. Although it’s an excellent drug, it can have serious side effects, including liver and muscle damage. Presumably an OTC dose would be low, and less likely to cause side effects, but it’s still likely patients would inadvertently take it in addition to statins prescribed by their doctor, or along with red yeast rice, a naturally occurring statin.

Even if there was zero risk of side effects, there is a high risk that patients would not use the medication properly. Lipid (cholesterol, triglycerides (fats), HDL (good cholesterol), LDL (bad cholesterol), etc.) management can be quite complex. One should know medical problems that might exacerbate the problem, such as diabetes and thyroid problems. There are many medications to choose besides statins, and different ones work better for some people than others. Then you have to know how aggressively to treat, which depends on the risk of cardiovascular disease, among other things.

Over-the-counter Lipitor would certainly be cheaper than the current prices, but it would likely be more than the generic price. Even if priced below generics, it could cost consumers more because their insurance would likely not cover it if it was available over-the-counter. This is what happened with the antihistamines Allegra and Zyrtec, though generic Claritin (loratadine) is quite cheap now.

So given all the down sides, why would Pfizer try to get OTC Lipitor approved? I wonder if it could have anything to do with their loss of patent protection when it goes generic 11/30/11?! Fortunately it’s unlikely the FDA will fall for this.

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