Tuesday, June 19, 2007

In search of a miracle

I covered a rather depressing story for work today - thought I'd share the bare bones of it here with you. We all know about the rising levels of obesity in the US; over 127 million adults there are now classed as overweight, which is cracking on for nearly half the total population. Yes, they should be eating better and getting more exercise - we all should - but human nature dictates that many of us find it incredibly difficult to summon up the huge willpower required to lose more than a couple of pounds. Hence the continued success of so-called miracle cures, all of which, of course, turn out to be bogus.

Pharmaceutical companies - keen to market obesity as a metabolic disease rather a result of lifestyle choice - have been doing their utmost to get in on the action. The most eagerly anticipated weight-loss drug to be approved for sale anywhere in the world in recent years has been Acomplia, developed by French drug company Sanofi-Aventis. Acomplia can already be prescribed in several European and South American countries, but regulatory authorities in the United States have found reasons to delay the drug's US approval for nearly two years. The FDA recently revealed exactly why this was: Acomplia, taken at the higher of two possible doses during clinical trials, had a noticeably stronger link to incidences of suicidal thoughts or behaviour compared with a placebo.

The FDA is now widely expected to decide firmly against approving Acomplia for marketing in the US. However, there is already talk on the internet of alternative ways for obese Americans to get their hands on the drug from elsewhere. The number one destination is, perhaps unsurprisingly, Mexico. Acomplia is approved for sale in Mexico, meaning that legal versions of the drug are available for purchase there. But Acomplia - supposedly available by prescription only - is reported to be available over the counter in an increasing number of pharmacies in towns along the border with the United States, clearly destined for Americans making the trip across the border to buy them and sneak them back into the US. And it would be "sneaking": it is against the law to import medicines into the US that have not been approved by the FDA.

I'll eschew the business analysis side of things here - I write quite enough of that at work, thank you - but I will say that several things strike me as being very sad here.

Having read the findings from the clinical trials, I noticed that there are actually more incidences of attempted suicide among the placebo group of patients than among those who were given Acomplia (conversely, there were more incidences of suicidal thoughts and depression among the Acomplia group). The logical conclusion here seems to be that a fairly high number of patients that participated in the Acomplia trials are so depressed and unhappy about their size that they are more likely to consider suicide or self-harm as a means of coping, whether administered weight-loss drugs or not.

Also, the fact that cross-border drugs shopping in Mexico is even being considered as a serious option is an indication of just how high US hopes had been raised that Acomplia would be "the answer" to the American obesity epidemic. With over-the-counter purchases of drugs that are meant to be prescription-only to patients that are clearly arriving from another country, the safety standards of the Mexican border pharmacists selling Acomplia to US customers is at the very least crying out to be scrutinised. And, in cases where the pills are sold at cut-rate prices, there is a very good chance that the product is counterfeit, potentially a serious health risk to the consumer.

Finally, a small point, but one whose irony should not be lost. Acomplia is the drug's brand name in every country it has been approved in so far. In the United States, however, Sanofi-Aventis is attempting to gain marketing approval for it under an entirely different brand: Zimulti. Why is this? According to one source I've read, the FDA didn't like the idea of a weight-loss drug bearing a name that too closely resembled the word "Accomplished". This, it seems, might falsely convince patients that the drug's effect on obesity was unquestionable and that it would accomplish everything the patient hoped for. A pill-shaped miracle cure for obesity, it seems, is still a long way off.


At June 20, 2007 9:39 pm, Anonymous Anonymous said...

Glad to have you back on blogging!


At June 21, 2007 9:17 am, Blogger Lady M said...

Why thank you kindly, Robert. Will we be seeing you at the "reunion" next month?


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