Monday, November 30, 2009

Primary Care Drugs

That term, primary care drug, is a new one to me. It came up in the article I read regarding Lipitor. I am wondering what to pull from this five page article. The most interesting points and the most important or relevant might be worthy. I will start with what I had not known, as you may not know either.

Lipitor is a cholesterol (LDL or low density lipoprotein) lowering drug. There are several drugs in this class (statins) that are available. Lipitor has been the most aggressively marketing and promoted, now the most expensive and the most profitable. It is due to come off its patent in 2011. It is considered a block buster mega drug for Pfizer. I have always considered it with disdain and by default, all of the cholesterol lowering drugs.

In reading the FT article by Andrew Jack I did develop a new respect for the medications which were created from research beginning in the 1950s, in Japan, by scientist Akira Endo. Dr. Endo studied the properties of thousands of fungi, in an effort to produce the medicine naturally, much in the same way that penicillin was created. I was somewhat startled to read that in the late 1960s, Endo expressed concern about the lifestyle habits of baby boomers and that they were suffering heart attacks at high rates and young ages and at the same time had high cholesterol. He began to think that the cholesterol levels should be lowered and he worked for years to find a medicine to do that.

A number statins were developed/created and are indeed available for use. Several companies and several scientists contributed to this. It was interesting also to read about medications that failed in trials, that killed animals, that were too similar to other drugs and to know that the FDA was actually on the ball in this regard.

It was funny to read about the first statin that came out, as it was a very gritty powder that was mixed with water and drank. Someone likened it to drinking sand. I think that was Mevacor. Whatever the name, my father took it. I well remember his little containers where he shook it up and drank it and the round can that it came in.

Still the lowering of high cholesterol was a grand thing, but the important thing was reducing the number of heart attacks and doing so with the least side effects. Lipitor pretty much won that contest and when the original company, Warner Lambert, partnered with Pfizer, the marketing campaign began. This was 1997. (My dad died of a heart attack in 2002)

The end of the 90s was indeed the time that the drug companies went crazy with direct to consumer marketing, but before that, they were aggressively pushing medications to doctors and nurses, residents and interns in both private practice, health clinics and hospitals. Having worked in the medical field during the early 00s, I can promise you this, the wining and dining was extensive and elaborate. My mother, in the restaurant industry, can tell you the same thing. (You might also recall that Pfizer has been sued several times and has had settlement judgments because of this marketing - among other things)

Lipitor was originally less expensive then the other drugs, but the sheer numbers of prescriptions made it the billion dollar drug that it still is. Pfizer fought a good hard fight to get the drug patent extended. Ways to do this include changing pills to extended release, or once a week from daily, that sort of thing. Pfizer was working to combine this LDL lowering drug with an HDL enhancing one, but the clinical trials were halted due to adverse health effects (death).

Pfizer, in my opinion, has not taken any of the law suits seriously, but they have cut back on staff and made other changes as they accept that the patent is not going to be extended and they are going to lose money. They also note that governments and insurance companies are (GASP) asking for more rigorous clinical trials and proof of efficacy and safety. In fact, these primary care drugs are not going to be profitable anymore, instead companies look for speciality drugs and I expect cancer drugs are where the real money is.

Pfizer is still being aggressive in commercials. Nearly ever day I hear the one about how generic statins are out there, but there is no generic Lipitor. So, the commercial says, if your doctor switches you to a less expensive generic it is NOT the same medicine you have been taking. And of course, based on the earlier research, Lipitor was superior to the other statins, but even that has been challenged of late.

From reading the article, I come away with more respect for statins, ones that lower cholesterol AND reduce heart attacks, but even less respect for Pfizer because of the ads I hear on my radio today. And I absolutely hunger for comparative research so that I can look at the statin meds side by side and compare the efficacy and the side effects of each. (there are websites that allow me to do this, but it's work!)

I am worried about the lack of prevention that has occurred since the concern of heart disease and heart disease deaths related to diet and tobacco were raised over 50 years ago. The baby boomers may have started this, but it is their grandchildren who are the obese who will be suffering these primary care illnesses at far too young of an age and who will likely experience the first decrease in life expectancy compared to the generations preceding them.

No comments: