Coming on the heels of its decision to ban Meridia, the FDA recently declined to approve Qnexa and lorcaserin, two new weight-loss drugs developed by the pharmaceutical industry. Qnexa (who thinks up these names?) was found to increase the incidence of suicidal thoughts, heart palpitations, memory lapses and birth defects, while lorcaserin increased the incidence of tumors in rats.
A group of investors in Arena Pharmaceuticals, the maker of lorcaserin, petitioned the FDA to reconsider its decision, on the grounds that not all the tumors caused by the drug were malignant. Oh, okay.
What these drugs didn’t do was to help patients to lose much weight. A study of Qnexa funded by its manufacturer Vivus (again, who thinks up these names?) found that patients taking the drug lost ten per cent of their body weight. (How this compared to a control group that received diet and exercise advice alone, the article didn’t say.) Let’s see, that means someone who weighs 400 pounds will end up weighing, uh, 360. You think that’s gonna make any difference? You think his life is gonna suck any less? And other weight-loss drugs have yielded even more disappointing results in terms of weight loss – on the order of five percent or so.
A study published in the journal Obesity found that most obese people who take these drugs are underwhelmed by the results and soon stop taking them.
The first NYT article I linked to above notes:
“’With a statin, patients rely on their doctor to tell them whether they should be taking it or not,’ said John A. Tucker, a pharmaceutical industry consultant in San Diego. ‘With an obesity drug, they can judge for themselves,’ and many are disappointed in the weight loss they achieve.”
Yes, and it’s anyone’s guess how many patients would continue taking statins if the had any idea how meager the reduction in risk conferred by those drugs is. But that’s a topic for another essay, another day.
The past month has not been a good one for the would-be manufacturers of weight-loss drugs. The same NYT article I linked to above quotes one Dr. Ken Fujioka, a consultant to Vivus, who states, “It’s tough to be a doctor and try to do something about the biggest problem in the U.S.” Bigger than, oh, say, global warming or nuclear terrorism? Oh, never mind. Maybe the good doctor ought to reconsider what his job consists of – or ought to consist of.
Doctors play a very small role in keeping us healthy. For most people in the developed world, for most of their lives, health or illness is a matter of personal choices. Exercising, eating sensibly, and refraining from smoking and excess drinking are the behaviors that produce health. Their opposites produce illness.
The doctor’s job ought to consist of doing for people what they cannot reasonably be expected to do for themselves. Doctors are great for emergencies. If I suffer from a brain tumor, or a heart attack, or a stroke, I want the most up-to-date, high-tech care, and damn the cost. But we don’t need someone with sixteen years of training to tell us to exercise and eat sensibly. When people are ready to hear that message, or any other message, almost anything will get it across to them, and if they are not ready, nothing will.
Why do we need weight-loss drugs? We were born with nervous and endocrine systems which tell us when we’ve had enough to eat, and they work very well. When you’re feeding a baby, and she’s had enough, she’ll let you know.
On the other hand, if you override those messages, and insist on putting food into your body it doesn’t need, and do this day after day, pretty soon your body will learn to ignore the signals it’s had enough. And if someone takes synthetic substitutes for the hormones which tell him that he’s had enough, what’s to stop him from overriding those messages, in a manner analogous to that of the patients who continue to overeat after lap band surgery until the new stomach stretches out to the same size as the old one?
I rather doubt that, for the vast majority of people, all this research into leptins and ghrelins and what-have-you is going to yield anything that is not subsumed under the commonsense observation that you become what you practice. Can we really justify continuing to spend all this money (not to mention torturing untold numbers of laboratory animals) just to tell us that?
As long as we’re on the subject, the table of contents of the same issue of Obesity I linked to boasts the following article titles:
“The Associations of LPIN1 Gene Expression in Adipose Tissue With Metabolic Phenotypes in the Chinese Population”
“The Gene Expression of the Main Lipogenic Enzymes is Downregulated in Visceral Adipose Tissue of Obese Subjects “
“Interaction of Leptin and Amylin in the Long-term Maintenance of Weight Loss in Diet-induced Obese Rats “
“Maté Tea Inhibits In Vitro Pancreatic Lipase Activity and Has Hypolipidemic Effect on High-fat Diet-induced Obese Mice “
That’s a pretty impressive display of brainpower arrayed against this particular problem. And as a result, are people any less obese? Um, no. Maybe it’s time to re-think our approach.
The same NYT article quotes Dr. Caroline Apovian, Director of the Center for Nutrition and Weight Management at Boston University Medical Center:
“’We’ve shown over and over again that it’s very difficult for anyone to lose weight and keep it off through diet and exercise alone.’ When that approach is successful, she said, it often requires intensive coaching, which is impractical for medical offices to provide on a large scale.”
Why should that surprise anyone? Your life is the product of the choices you make. Did anyone think that the effects of a lifetime of bad choices could be undone by some perfunctory counseling about diet and exercise? It turns out that all these stuffy old-fashioned notions we’d thrown out about building character and self-discipline turn out to be terribly important after all.
At this point, of course, I have set myself up to be accused of “fat-phobia,” or “blaming the victim,” or some such nonsense. I plead innocent. It’s not my business how much another human being weighs. I never said it was. It damn well is my business if I am made to subsidize ineffective and/or dangerous “medicines” for a condition which is 100% self-inflicted.
If you hang out with people who run, or who work out at a gym regularly, or who seriously practice a martial art (I’ve done all three), what do you think we talk about? How much we hate fat people? Nah. I’ll tell you what else we don’t talk about – we don’t talk about our diets. We don’t talk about counting calories. We don’t talk about pounds or inches or dress sizes. In fact, strong healthy people don’t usually even think much about how their bodies look. They concentrate on how their bodies feel and perform.
I studied and taught aikido for nine years, and whenever a fat person came into class while I was teaching, I did everything in my power to help that person get the most out of his or her body, same as with anyone else. But they are still the ones who have to do 99.9% of the work – or live with the consequences if they don’t.
The self-styled experts on this problem like to argue that our bodies evolved to store fat, which strikes me as an incredibly sad and defeatist way of looking at it. Our Paleolithic ancestors trekked for miles in search of game, ran down wooly mammoths, and battled giant cave bears – not to mention each other. After the invention of agriculture, our ancestors were for the most part subsistence farmers, doing back-breaking labor to survive – until two generations ago in my case, and I think I’m fairly typical in that regard. The same genetic endowment which enables us to put on hundreds of excess pounds of adipose tissue also enables us to walk or run hundreds of miles in a year. It’s all a matter of which ability you choose to maximize. What of it?
Of course, the article provides an answer to that question as well:
“[A]n effective diet pill could help cut medical costs over all and should, at least in theory, become a blockbuster.”
Oh no, not the health care cost argument again. As you have probably guessed, I am no great friend of the “fat rights” crowd. But blaming soaring medical costs on fat people is ridiculous. The reason medical costs are soaring is because we have a Medical-Industrial Complex which takes our money and uses it to saturate us with the message that we are all fragile creatures who cannot function without pills to control our appetite and pills for depression and pills to help us go to sleep and pills for cholesterol and pills for blood sugar and pills for allergies and pills for restless leg syndrome and pills pills pills pills pills pills pills pills pills. Trying to control medical costs by giving more money to this bunch is like putting out a fire with gasoline.
For the life of me, I cannot see what is so attractive about this vision of ourselves as beings who have no need for self-control, self-discipline, or free will. The advocates for treating obesity as a medical problem, rather than a moral one, like to imagine their approach is more compassionate. But I think we need to be very wary of folks whose idea of “compassion” always seems to coincide with their own financial self-interest.
The NYT article closes with these words of wisdom:
“’We have over 50 antihypertensive agents on the market,” Dr. Apovian said. “We have lots of drugs on the market for diabetes. With the epidemic of obesity, how is it possible that we have only two drugs on the market?’ “
Is that their vision of the future? Fifty different drugs on the market for weight loss? All I have to say is, thanks for the warning.
Obese man illustration via National Library of Medicine
Baby photo by author
Mouse photo via Wikimedia Commons
UPDATE 23 SEPTEMBER 2011: In a press release dated 15 September, Vivus announced that the FDA has agreed to plans to re-submit Qnexa for approval for men and “women of non-childbearing potential.” Meanwhile, the company is going ahead with a clinical trial, called FORTRESS, to assess the risk of major congenital malformations and oral cleft in women exposed to topimirate, the active ingredient in Qnexa. If the FORTRESS results are favorable, the company expects to file for full indication in late 2012.
UPDATE 11 MAY 2012: The May 10 2012 edition of the New York Times reported that an advisory panel to the FDA voted Thursday to approve lorcaserin. The FDA’s final decision on this matter is expected by 27 June. Two clinical trials had shown that patients taking the drug lost 3.3% more of their body weight than those taking a placebo. Some panel members expressed concern that lorcaserin could damage heart valves, but it was decided that patients taking the drug could be monitored for signs of such damage. While testifying at the panel hearings, Arena investor Reza Ganjavi complained that the company “did not have unlimited funds and is under constant attack,” referring to hedge funds that have bet against Arena stock. After news of the panel vote was announced, the price of Arena shares nearly doubled.
UPDATE 28 JUNE 2012: The Los Angeles Times reported today that the FDA had given the green light to lorcaserin for patients with a body mass index of at least 30, or those with a BMI of at least 27 with at least one other comorbidity, such as high blood pressure, high blood sugar, or high cholesterol. The same article noted that the average amount of weight lost by patients taking the drug in clinical trials was 17-18 pounds. According to the New York Times, annual sales for the drug, which will be marketed under the brand name Belviq, are projected to exceed one billion dollars.UPDATE 18 JULY 2012: The Los Angeles Times reported that the FDA voted yesterday to approve Qnexa, which will be marketed under the name Qsymia. Women of childbearing age will be reuired to have a negative pregnancy test before going on the drug and every month thereafter, and to commit to contraceptive use. The agency also required Vivus to sponsor a multiyear study of as many as 10,000 obese patients to assess the long-term safety of the drug. FDA Chief of Drug Evaluation Janet Woodcock said the drug is to be taken by patients who have increased physical activity and cut back on caloric intake. The article reported that patients taking the drug lot 6.7-8.9% more of their body weight than those getting a placebo.