June 2010

I generally tend to support Democrats because they are usually more attentive to the needs of everyday Americans vs. those of the drug companies.  One notable exception is that of Republican Chuck Grassley.  He’s been a thorn in the side of many drug companies, so I’m not surprised that he’s so involved in the controversy over Avandia:

Sen. Chuck Grassley (R-Iowa) and Rep. Rosa DeLauro (D-Conn.) on Monday criticized the Food and Drug Administration’s stance on the diabetes drug Avandia in the wake of two new medical studies. The studies, in the Journal of the American Medical Association, found that Avandia caused “increased risk of stroke, heart failure, and death” for patients aged 65 and older.

Source: Grassley, DeLauro criticize FDA’s stance on Avandia following critical JAMA studies – The Hill’s Healthwatch

Still, I’m not entirely comfortable with politicians nudging the FDA towards making scientific decisions, even if I think those decisions are right.  What I would prefer is an FDA that is in no way beholden to the drug industry, and that is therefore able to make decisions that take ONLY safety and efficacy into consideration.

Living legend Dr. Steve Nissen wants the FDA to pay more attention to the cardiovascular risks of diabetes drugs in the future:

ORLANDO — Should new diabetes drugs submitted to the FDA have a higher bar for cardiovascular safety than other drugs was the focus of a debate here between Steve E. Nissen, MD, and David G. Orloff, MD.

“Drugs that lower blood sugar can make CV disease worse or they can make it better, and we ought to know which it is before we treat our patients,” Nissen, chairman of the department of CV medicine at Cleveland Clinic, said at the debate. “Clinical outcome trials comparing alternative diabetes therapies are essential to determine the optimal approach to prevent CV morbidity and mortality.”

Source: CV safety in diabetes treatments debated | Resource Center: Type 2 Diabetes

Dr. Nissen was one of the first doctors to link Vioxx to heart attacks and strokes, and also one of the first doctors to link Avandia to heart attacks and strokes.  If I had my way, this guy would have a ton of authority at the FDA.

I think one of the most dangerous practices out there is that of pharmaceutical companies wooing doctors with free gifts and meals.  In states where it is legal, you have a group of sales reps (most of whom aren’t doctors) coming into doctors offices, giving them gifts of tangible value, and telling them how safe and effective drug X is.  Doctors get lulled into a trusting relationship with these sales reps, and they prescribe medications without properly investigating the safety of the drugs. 

Well, two years ago Massachusetts put a stop to that practice.  Sadly, now they want to bring it back:

A two-year-old state ban on gifts in the medical and pharmaceutical industries would be repealed under an economic development bill that the House budget committee began polling its members on yesterday.

Source: Ban on drug industry gifts could be lifted – The Boston Globe

Why do they want to bring it back?  Because some businesses are complaining that they lost profits.  So what?  If doctors won’t prescribe drugs based upon the safety and efficacy of the drug, then they shouldn’t prescribe it because the nice sales rep brought lunch for the whole office from Cheesecake Factory.  (And sorry, Cheesecake Factory, if you can’t attract customers who aren’t basically using you as a bribe, you should be out of luck, too.)

This is a great step towards greater transparency:

WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about recently approved drugs and vaccines.

On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of a new drug or biologic, such as a vaccine, 18 months after approval or after 10,000 patients have used it, whichever comes later.

Source: New FDA website lets public find drug safety info – USATODAY.com

Here’s the direct link.

The bottom line is that pharmaceutical companies could put drug lawyers out of business if they just told the truth about the risks of taking specific drugs.  Instead, their marketing departments resist adding even the slightest warning to the package insert of a drug.  At least at this new site individuals will have the chance to see what kind of adverse event reports are coming in.