Monday, September 14, 2009

Obesity Drugs

I have never held back my concerns about the treatment of obesity. I feel that the best treatment is weight loss that occurs naturally from energy intake and expenditure changes. Still, treatment for the morbidly obese and those close to it, often does involve invasive, and I mean, life changing, invasive surgery or some type of prescription medication. The medications often involve some type of neurotransmitter activation or metabolism adjustments and to date have lacked efficacy or have been effective but lethal.

You must know that publicly traded and independent drug companies are constantly at work trying to find the chemical compound that will take calorie reduction out of the equation. Pills do not, or have not, come without a price and I mean more than a dollar price, but we want the easy way.... It saddens me. I see all these ads, "is your job making you fat?", " is stress making you fat?" NO ... food is making you fat.... and I am digressing from my point.

In a recent article about a drug that looked promising in a previous trial but less so in a current one, additional information about obesity drug qualifications was explained.

In past posts, I have explained that everyone cannot make drugs and sell them without showing the FDA that there is a need. To meet this need, the drug must treat a condition that there is no drug for, or treat it much more effectively than an existing drug, or treat a condition with less side effects than an existing drug does. With obesity drugs there are a few more elements.

The subjects in the clinical trial must lose 5% of their body weight over those taking a placebo. OR 35% of the experimental group has to lose 5% of their body weight and double the proportion of the placebo group. At least we have some high standards here. Also the results have to be statistically significant and not just something that could be seen through chance. (there are statisticians who figure that part out)

It is important to note that last piece because some commercials that say " X was effective in a clinical trial" do not clarify if that was statistically significant. Also, those that say their product was developed with clinical trials are not saying anything about efficacy!


Jim Purdy said...

Placebos are interesting. If a study were done using a group of obese persons who were given a placebo and told it would help them lose weight, and a group of anorexics were given the same placebo and told it would make them gain weight, what would happen? Also, for those people who doubt the power of placebos, would they say that it is impossible to commit suicide by a placebo overdose? If someone believed they had ingested a toxic level of poison, could their anxiety cause a panic attack which could cause a fatal heart attack? If so, wouldn't that prove the power of placebos?

Deirdre Dingman, MPH, CTTS, CHES, PAPHS said...

Jim, I absolutely believe in the placebo and nocebo effect. Thanks for sharing... btw, the anorexics wouldn't take it!

Jim Purdy said...

I guess you're right about anorexics ... and it probably wouldn't work with bulimics either, for obvious reasons.