Saturday, July 17, 2010

Everybody Wants A Pill

I heard the other day that the pharmaceutical companies have submitted 3 new weight loss drugs to the FDA for approval.

Apparently, we learned nothing from the fen-phen debacle of a few years ago.

Everyone wants a quick fix...I'm diabetic/overweight/depressed/have high blood pressure but I don't want to change my diet and exercise. Can't you just give me a pill, Doc?

Americans are on all kinds of drugs. It's almost a surprise nowadays when I get a health history and the person is not taking any medication. That's just sad.

Then we have the drug companies.

Big pharma wants big profits. I don't have a problem with anyone making money. What I have a problem with is the unethical path to those riches. It's too often done at the expense of people's health.

Biased "research" funded by the drug companies, concealing side effects, publishing only studies that support a favorable outcome from a drug, continuing to push medication after problems arise and on and on.

These companies have become legal drug pushers. I detest the fact that they now advertise on television, prompting people to "ask their doctor" about this or that medication. When these insipid ads first started, you couldn't even tell what the drugs were suppose to "cure"! How ridiculous.

Here's a novel idea... how about letting physicians decide what course of treatment might be best for their patients? (I know, I know, two words- drug reps but that's a post for another day.)

Anyway, back to the new weight loss drugs.

The FDA has decided that weight loss drugs only need to reduce total body weight by at least 5% after a year to be considered effective. So if you tip the scales at 300 pounds, a drop of 15 pounds using a pill would be good enough for the FDA to consider that a success.

Fifteen pounds in a year is just 1-1/4 pounds a month. That's less than 1/3 pound per week! And we're talking about someone who's 300 pounds! With medication!

If you're "only" 200 pounds, the minimum weight loss to be considered effective would be 10 pounds in a year- less than 1 pound a month.

Can you imagine how much this medication will cost per month? I wonder what it'll work out to be per pound.

One of the drugs up for approval, Qnexa, an antidepressant/anticonvulsant, showed the best results in clinical trials. Participants lost between 13-15% of their body weight. (That's, of course, if the trials were on the up and up.)

Unfortunately, Qnexa, also had the highest level of participant dropouts due to side effects which included memory and concentration problems. In fact, 18% of study participants taking a high dose of Qnexa withdrew from the trials due to side effects and about 40% all participants taking Qnexa failed to complete the study.

Another submission, Contrave, is also an antidepressant/anticonvulsant combo. Study participants using it lost 5-10% of their body weight. Contrave's main side effect was nausea.

Drug #3 is Lorcaserin. As opposed to Qnexa and Contrave, it's not a combination of other drugs. It's a brand new medication that, according to its maker Arena Pharmaceuticals Inc., acts on serotonin- the feel good brain chemical.

Lorcaserin just made it within the FDA guideline. Patients in company trials shed just 5% of their body weight. The "good" news is that they reported the fewest side effects.

Is it really worth it? Besides the financial cost, what about the effects of these chemicals on your body?

You don't need a pill to dump fat and get healthier.

UPDATE: After I wrote this blog post, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-6 against recommending approval for Qnexa. They expressed concern about the increased risk of psychiatric and cognitive issues uncovered in the company's trials. They also said there was a lack of data to rule out cardiovascular risks and were concerned about the drug's potential to cause birth defects in women who become pregnant while taking it.

It's important to note, however, that regardless of the recommendations of the advisory committee, the FDA can still go ahead and approve the use of Qnexa.

Lorcaserin and Contrave go before the FDA for approval later this year.

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