Back in September, the US Food & Drug Administration pulled diet drug Meridia off the market because of fears that it increased the risk of heart problems and strokes. Remember? Since a heart and a brain are both required for humans to live, the FDA concluded that maybe endangering these organs in the process of taking off a few pounds — a very few pounds; specifically, five pounds, on average — was unwise. I took this opportunity to write about what I called the defiant absurdity of the diet-drug business, focusing mainly on the fact that these companies continue to produce drugs that don’t actually work, and possibly do harm, and yet the FDA continues to approve them anyway. I also did a little run-down of the currently-approved diet drugs on the market, in case you want a refresher (NB: that post remains the first and only time I have used the word “shart” on this blog).
Yesterday, an expert panel finished their evaluation of new diet drug Contrave (I expect they will revisit the name once it goes to market, as Contrave sounds… weird) and recommended that the FDA approve it. Unsurprisingly, there are lingering concerns that Contrave may also cause cardiovascular problems, and the panel suggested that the FDA ask Orexigen Therapeutics really, really nicely to check that out a little more thoroughly.
But that’s not the thing that makes this news worth posting. The thing that makes this worth posting is here:
The advisers were not overly impressed with the modest weight loss seen in patients taking Contrave, but some said rejection could quash development of such drugs at a time when two out of three Americans are overweight or obese.
“My concern is … we will potentially kill development of these medications, and it is the most serious disease that the United States is facing,” said panel chairman Abraham Thomas, head of endocrinology at Henry Ford Hospital in Detroit.
Yes, it is just what it sounds like: this drug was not approved because it actually works, but to encourage the research and development of other weight-loss drugs. It’s especially preposterous that these experts can’t even be arsed to pretend that they think Contrave is a fantastic drug that will provide a safe and reliable solution for people trying to lose weight. Nope, their primary concern is that the FDA’s continued rejection of weight loss drugs — it happened twice just in October — will suffocate weight-loss drug research. If the FDA continues to reject weight-loss drugs, then companies will cease spending money to research them, because drug companies are in business to make money, and there’s no money to be made from a drug that won’t be approved by the FDA.
In the quote above, the panel chairman calls overweight/obesity “the most serious disease the United States is facing”, though I am bound to also note that cardiovascular problems are a pretty significant threat, and one often correlated — rightly or wrongly — with fatness. If he believes that fat is associated with cardiovascular problems, isn’t it wildly irresponsible to approve drugs that may cause cardiovascular problems on their own? Especially considering that one previously-approved drug, Meridia, was just recently pulled from the market for this very reason? Or are fat people disposable — their quality of life so unbearable that a premature death would be a mercy, and not a tragedy?
It all might make sense, in a twisted way, if these drugs were legitimately effective. The FDA requirements for effectiveness in diet drug trials is that at least 35% of participants lose at least 5% of their body weight. For a 300-pound person, that’s fifteen pounds. To break it down further, the drug needs to produce a minimum loss of fifteen pounds in roughly one out of every three 300-pound people who take it. Obviously, the loss would need to be even less for someone who weighs less to start with. That’s it. Given that the panel was not “overly impressed” with the “modest weight loss” results of Contrave, it’s probably safe to assume their numbers were not much above these minimum requirements.
It hardly seems worth the risk. But there’s money in it, and so the diet-drug charade ambles along, gamely pretending that obesity is not a complicated affair, produced by a number of intersecting factors, the order and composition of which differ for pretty much everyone.
Nope, all you need is a pill. It’s simple, guys. Maybe it is working, and we just aren’t believing hard enough in it! To bring back one of my favorite quotes ever, from an FDA panelist assessing former diet drug Meridia:
“I think that just because we didn’t measure the benefits scientifically doesn’t mean they don’t exist,” said Dr. Jessica Henderson of Western Oregon University.”
Clap your hands, children! Clap your hands.