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Two new diet drugs approved, doctors may not prescribe, but are still clueless about weightloss.

August 9, 2012

Trigger warning: This article is about weight loss drugs.

These two articles are related: “Diet Pills: Approved, Yes. Prescribed? Maybe” and “Readers: New Diet Drugs Won’t Change Practice.” Let’s take the first one, shall we?

According to the first article, the FDA has approved two new weight loss drugs, Qsymia (phentermine/topiramate) and Belviq (lorcaserin), for use as an aid for weight. The article isn’t clear on exactly when doctors will be able to start prescribing these drugs or when they’ll actually be available for use.

Qsymia may provide the bigger bang in terms of total weight loss, but it also requires an FDA risk evaluation and mitigation strategy (REMS), which means more paperwork for physicians.

Doctors don’t have enough time to spend with their patients, do they really need more paperwork/computer forms to fill out in order to prescribe a drug that may not work to make them permanently thin? Especially when they have serious side effects to consider:

The FDA required more postmarketing studies for Qsymia (a total of 10, compared with six for Belviq) and those studies focus on cardiovascular outcomes including stroke and MI for both.

The combination drug also carries more contraindications, with glaucoma and hyperthyroidism on the list of conditions that render patients ineligible. Those with recent or unstable heart disease are also excluded because of the drug’s potential to increase heart rate.

Neither drug can be used in pregnant women, but only the combination agent has a specific risk attached to it. Topiramate, a treatment for seizures and migraine, has been shown to up the risk of oral cleft in newborns. For this, FDA has recommended monthly pregnancy tests for women on the drug, another potential barrier to use, industry analysts say.

Aronne said topiramate also carriers a higher risk of cognitive side effects such as memory or attention disturbances, but the FDA only warned about these effects with Belviq.

With all of the above problems, why would a doctor want the additional hassles involved in prescribing Qsymia? Especially given that the makers of Qsymia can’t guarantee a weight loss of more than 10%, which, for most fat people, isn’t going to get them out of the obese category, let alone into the overweight or “normal” ones.

What’s really scary in all of this is that “more likely is that some clinicians may try combinations of the drugs.” The article gives an example of combining Belviq with phentermine.

Yeah, that’s just what we need, combining a new drug that we don’t know much about with one that we know doesn’t work and was part of a deadly combination 13 years ago (fen-phen, anyone?).

For the combination agent, phentermine is a known appetite suppressant and is currently prescribed for weight loss, but only for a short period of time – about 3 to 6 weeks.

[Louis Aronne, MD, of Columbia University, who has treated patients with both drugs in clinical trials] noted that it’s given in a much lower dose in the combination drug, which should also be reassuring to clinicians.

“Some will say they don’t want to prescribe it until the studies show that there’s no cardiovascular risk,” he said. “But the dose [of phentermine] is so low” that heart effects are less likely.

Phentermine isn’t all that successful for weight loss at the dosages prescribed now, and topiramate doesn’t always lead to weight loss either. Why they seem to think that combining the two drugs with a lowered dose of phentermine will be more successful is beyond me. Especially when clinical trials have shown that the amount of weight lost is 10% or less (and they have no idea how long that loss is sustained when the drug is stopped).

But Harlan Krumholz, MD, a cardiologist at Yale University, said he does have concerns about the new medications, given that efficacy studies are rarely large enough to turn up suspicious events.

“We need to have surveillance systems in place to get an early warning if these interventions turn out to cause a net harm,” Krumholz said in an email to MedPage Today. Since obese patients likely have a higher prevalence of heart disease, he added, surveillance studies need to demonstrate whether these patients are having more events than would be expected.

While I agree that efficacy studies usually aren’t large enough to turn up suspicious events, I disagree with the statement that “obese patients likely have a higher prevalence of heart disease.” I’ve always wondered if there were statistics that showed how many thin/”normal” people had heart disease compared to all thin/”normal” people, and how many overweight/obese people had heart disease compared to all overweight/obese people. If those statistics exist, how do the two percentages compare? Is there a huge difference between the number of thin people who have HD compared to all thin people versus the number of fat people who have HD compared to all fat people?

Other clinicians doubt their colleagues will be that interested in working with the new agents. Lee Green, MD, MPH, a family medicine professor at the University of Michigan in Ann Arbor, wasn’t enthusiastic about either option: “They really just don’t work that well.”

“I understand the desire for a miracle pill, a silver bullet, to deal with the very difficult and stubborn problem of obesity, but I don’t think it’s going to be that easy,” he added. “I will be surprised if either one is still on the market in 5 years.”

In a nutshell, the above is the problem when you’re equating health with weight. The focus needs to be on health and healthy behaviors and quit focusing on weight loss as the only way to attain that health.

Which brings me to the second article, which is the result of a survey taken to see if the approval of these two drugs would change how doctors treat their patients for obesity. Would they be more aggressive in their treatment? From the results, I’d say doctors have a long way to go in being educated about obesity, its causes, its outcomes, and how to effectively treat their fat patients.

Among the reasons commenters provided: obesity is the “choice” of the individual, education is more important than pills, and more drugs will only enrich the drug companies.

“Popping pills to ‘cure’ obesity is not the answer and will only serve to make the pharmaceutical companies money,” said one commenter.

Ignorance about why people are fat still seems to be rampant among those in the medical community, even after over 60 years of prescribing diets that don’t work, and passing out pills that have more/worse side effects than being fat (and still don’t turn fat people into permanently thin people).

Of course popping pills to “cure” obesity isn’t the answer, but as long as doctors keep thinking that obesity needs a “cure,” pharmaceutical companies are going to keep searching for that magic pill. So for doctors to complain about those same pills enriching the pharmaceutical companies is rather hypocritical.

Several of our readers mentioned the complex relationship people have with food. It’s an addiction; it’s comfort food; our food choices are made early in life. Pills, they said, will hardly make a difference in combating the psychological barriers that influence obesity.

And, of course, food and eating too much of it is the only reason people get fat (/sarcasm). I’m not even going to go into how much is wrong with those ASSumptions.

Others even lambasted bariatric surgery, noting that the 1-year results might look good, but at 5 and 10 years these patients tend to put the weight back on. Again, they said weight loss involves a more holistic approach — more than merely pills or surgery.

“Obesity belongs to a group of diseases called ‘complex diseases’ like diabetes, hypertension, alcoholism, drug addition, depression and others,” said one physician. These diseases “result from the interaction of multiple genes and the environment. Thus, only a multiple therapeutic plan would improve them.”

A multiple therapeutic plan? Try emphasizing healthy behaviors and concentrating on health instead of weight.

The last word comes from a reader who posed a seemingly simple solution: “The No S Diet: No sweets, no snacks, and no seconds, except on S days (Saturdays, Sundays, and special days such as celebrations).”

That simple solution? Is not so simple nor so easy to live by and I would love to see the person who suggested it try to live by it for the rest of hir life.

All of this shows that doctors/nurse practitioners/clinicians still think that weight is malleable, that our weight is our responsibility, and that if we just follow the advice/medication/diet plan they give us we’ll lose that weight and be healthy. They have their heads in the sand (or up their nether regions) when they refuse to accept that the remedies they’ve been prescribing for the last 60+ years haven’t worked in the past, aren’t working now, and probably won’t work in the future either.

By continuing to prescribe weight loss as the “cure” for every ailment a fat person has, they are the ones fueling the competition between the pharmaceutical companies to keep coming up with weight loss drugs — drugs that don’t work, that have lethal side effects, and that cause more problems than they solve. Then they complain that the drug companies are making billions of dollars off those same drugs. What do they expect?

They complained that “obesity” kills people, that “obesity” causes all these diseases, that a “cure” is needed for “obesity”. Then they complain when drug companies create drugs to “cure obesity” and make a lot of money doing so. WTF did they expect? That drug companies would do this for free, out of the goodness of their hearts? Altruism may exist, but I’ve not seen much of it in the business world.

5 Comments leave one →
  1. August 9, 2012 10:15 am

    Yeah, the weight loss for these pills is not much better than without them, especially when you compare the results of these studies to other weight loss studies that don’t use pills. When lorcaserin was approved, I wrote about the cost-benefit analysis and how despite little change in the results from the first few times they rejected it, they somehow approved it this time.

    I guess we can hope that the pills are too much of a burden to subscribe because it’s only a matter of time before they’re pulled from the market for their side effects.


  2. vesta44 permalink
    August 9, 2012 10:51 am

    I just read this article that says obese people who are diagnosed with diabetes live longer than thin/”normal-sized” people who are diagnosed with it. Another part of the obesity paradox that doctors/researchers don’t understand, so why are they so focused on turning fat people into thin people? Especially when it seems that fat people have better survival rates than thinner people for all of those “obesity-related” diseases that everyone (thin, average, fat) gets?

  3. violetyoshi permalink
    August 11, 2012 2:30 am

    “Qsymia”? Really? Can we please go back to the days when drugs sounded vaguely reminiscent of Pokemon names?

  4. Mulberry permalink
    August 11, 2012 3:49 am

    I may be a little naive here, but what would be the point of using a weight-loss drug during pregnancy, anyway?

    • vesta44 permalink
      August 11, 2012 10:14 am

      The point is that some doctors would prescribe a weight-loss drug to a pregnant woman in order to keep her from gaining what they see as “too much” weight during her pregnancy in order to keep her from having a fat baby (because only fat women have large babies, in their twisted logic).
      Some of those doctors won’t care about the possibility of a baby being born with birth defects, because any possible birth defects are so much easier to cope with than the possibility of having a fat baby, donchaknow? (/sarcasm) Now that I think about it, though, some mothers might actually feel the same way – recalling those polls where women have said they’d rather lose a limb/be blind/have some other disability than be fat, maybe they would rather have a child with a birth defect than a child that’s fat? Damn, what a fucking can of worms that would be to open……………

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