Real Quick: Defiant absurdity redux!

By | December 8, 2010

Oh, I've been on this ride before.

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.

Image by Daryl Mitchell, via Wikimedia Commons.


14 Comments

Janet on December 8, 2010 at 10:57 am.

Wow. I don’t know what to say. My eyes have been opened and I thank you for that.

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JonelB on December 8, 2010 at 11:07 am.

Rather than focusing on saftey of Americans, they’re worried most about the Business of Diet Drugs–what does this say?
Also, it’s -never- just fats who take these, my mom has taken them, and she is -not- overweight, my sister has taken them, and both have always gained the weight back. There are plenty of other women, looking to get rid of those last 5 pounds, who will take these, who aren’t fat–so even if they don’t give a CRAP about fat people, they need to care about the young girls who will acquire these and take them to lose weight they don’t need to lose.
WL Meds are dangerous, and The ending–almost blaming people who don’t see the benefits for not seeing the emperor’s clothes, shows you how delusional these people are on the FDA panels. If the science, the actual data, says that it doesn’t do anything—IT DOESN’T DO ANYTHING. It’s like the people who see that prayer studies don’t do ANYTHING for the people prayed for, and yet people still believe that prayer does something because of the 0.0002% of people that got better or less sick.

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lizalou on December 8, 2010 at 11:33 am.

So… with that last quote… the takers of these drugs just need to have faith??? The results are not measureable… but really… it’s good that you’re taking a drug that messing with your system and creating side effects? JonelB, I was thinking the same way about equating this line of thinking to prayer and religion. Faith… you just have to have faith. Apparently. Hell no, not this proud fat lady.

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Jennie C on December 8, 2010 at 12:59 pm.

Heaven forbid we would do anything to make it easier for people to eat healthier or build exercise into their life without giving up having a life. I guess they think making people buy an ineffective pill is better than building walkable sidewalks. We just continue to demand an unrealistic lifestyle, especially for anyone who has family/caretaking responsibilities, and then denigrate those whose bodies don’t conform to maintaining thinness (not health, we know that’s a different thing) under those conditions.

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SweetAsCake on December 8, 2010 at 1:03 pm.

Yet more evidence that the government belongs entirely to big business…

And yeah, 10.5 lbs. I’m totally going to take a dangerous drug to lose TEN FUCKING POUNDS. How much you wanna bet that neither ads nor doctors mention that, once it’s on the market?

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SA on December 8, 2010 at 3:41 pm.

Thanks for writing about this, Lesley. I saw this story a day or two ago, did a little quick math, and decided that having a 35% chance of losing 10 pounds from my 200-pound frame was probably not something to write home to Mom about, let alone risk my (perfectly tip-top right now) heart health for. Especially since it wouldn’t actually make me not-obese.

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Christine on December 8, 2010 at 5:09 pm.

Wow, I so 15 pounds, eh? So I could theoretically weight 280lbs, but now with cardiac problems! YAY?

I really really just cannot.

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Ashley on December 8, 2010 at 5:30 pm.

“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.”

Couldn’t have said it better myself.

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Dayna on December 8, 2010 at 6:43 pm.

First let me say how much I <3 you. I've been reading the blog for ages now and every time I see a new post I fan-girl just a little.

Secondly saying that obesity is the most serious disease that the US is facing makes me want to punch someone – preferably the person who said that – in the face.

What about HIV and AIDS? What about cancer?

I mean really, my fat ass is worse than both of those combined, really? Are you fucking serious!?

My head, it hurts from the lack of thinking.

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G on December 8, 2010 at 7:44 pm.

It boggles my mind that being overweight/obese is somehow labeled a “disease” now. I certainly don’t *feel* sick.

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Marcia on December 10, 2010 at 12:02 am.

Hi, I’m a lurker.
This is from the NYT article on the Contrave.
“In four clinical trials involving a total of about 4,500 people, those who took Contrave lost an average of 4.2 percentage points of their weight more than those taking a placebo after one year. That fell short of the standard set by the F.D.A. that a drug should produce a weight loss at least 5 percentage points greater than placebo.”

“However, in most of the trials, Contrave did meet a second F.D.A. requirement that twice as many patients on the drug as on placebo lose at least 5 percent of their weight. Meeting only one of the two standards is enough for approval.”

So it didn’t even cause a 5% weight loss in 1/3 of the takers. And it only
It also mentioned that the stuffs in this drug are already in drugs that people take for smoking cessation, and that some of the stuffs can cause seizures.
But I think the fact that the FDA has already approved the components of this drug for other uses is a factor in their approving them now, and it also makes me think that the drug company isn’t just weight-loss profiteering, but also seeking to mix up’n repackage it’s old drugs to try to get more people on them. I also worry that now drug companies will purposefully under test their new stuff in order to get approval without any results, leaving them free to use the public as uninformed test subjects for 5 years and then covering up or excusing the negative side effects for who knows how many years after that.

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Marilyn Wann on December 10, 2010 at 9:01 pm.

One of the test subjects taking this pill DIED from it.

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thegirlfrommarz on December 15, 2010 at 1:32 pm.

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.

As if they will be discouraged! Given that pretty much everyone in the developed world has been conditioned to want to lose weight thanks to the current dominant cultural narrative, there’s a billion dollar market out there for anyone that develops a weight-loss drug that actually works (never mind that, as you rightly say, Lesley, they are “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”). They don’t need encouragement to develop diet drugs. They need encouragement to develop safe diet drugs.

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thegirlfrommarz on December 15, 2010 at 1:36 pm.

Oops, that emphatic as if was aimed at the panel, in case that wasn’t clear!

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