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Warning: A new twist on fen-phen being prescribed as diet cocktail drug despite FDA concerns

AndyJo and DeeLeigh alerted me to this story appearing in today's New York Times:

"U.S. to Review Diet Treatment Once Rejected"

Some of you might have heard about the combination drug talked about in this article, phentermine and topiramate. Phentermine, if you remember, was the phen half of fen-phen. That's not to impugn phentermine by association, since the major side effects of fen-phen were seen to be caused by fenfluramine half.

However, make no mistake about it -- phentermine is a stimulant, that acts to suppress appetite much in the same way as ephedra does (phentermine is a congener of amphetamine). It's speed, and carries a similar range of side effects as other amphetamines like palpitations, dizziness, heart valve damage.

Topiramate (Topomax) side effects vary, mainly neurological (like dizziness, and pins-and-needles). There have been some cases of severe ocular side effects like glaucoma.

As for how effective the topa-phen combination is, I'm having a hard time finding long-term studies that aren't paywalled. There was one at 6 months (hardly useful); another at one year -- funded by Vivus, the makers of Qnexa (also hardly useful/reliable), another at two years -- again, funded by Vivus.

Additionally, from what I'm scraping up from the studies I can actually read, the weight loss effects of topiramate may in fact be temporary. This one study, conducted on children, says that weight was regained after tolerance was achieved at about 12 - 18 months.

The NYT article itself uses the problematic language one comes to expect in weight-related articles, like the euphemistic and largely meaningless term "obesity doctor" for a person who is in fact trying to reduce the incidence of obese people (recall, 'obesity' is not a disease). It's like a women's doctor whose mission is to reduce the number of women, or a pediatrician whose mission is to reduce the number of children. Definitions and language is important -- propaganda and redefinition of terms is the grease of the wheels of a moral panic.

The most important thing to take away from the article, and from this post, is that regardless of whether the topa-phen combination is 'effective' according to whatever the arbitrary standards of the FDA regarding weight loss drugs is today or tomorrow or ten years from now, phentermine is only approved for short-term use. Phentermine is an appetite suppressant. As soon as phentermine is not taken any more the individual will eat normally and gain back most if not all the lost weight.

Starvation is not a 'treatment' for fatness, especially not short-term starvation. The only long-term 'treatment' that seems to work is daily privation and semi-starvation -- an activity that will consume as much time as a part-time job -- for the rest of one's natural life. In short, the life of an ascetic. Which is a fine choice if that's what you want. But to expect that all fat people should live as ascetics is monstrous.

What I'm most concerned with is the stamp of "FDA approval" being used as a proxy for a treatment's effectiveness or long-term safety. Basically these treatments are designed to meet the approval minimums for the minimum necessary length of time. Doctors and patients are fooled into believing something is effective because it has that FDA approval stamp -- but how often as a patient did your doctor mention your weight loss drug was only effective or safe in 1- to 2-year trials, or that it hasn't been tested in the long term at all, or after the year you take it and lose some weight you can no longer take it anymore?

Even in the article we have this story:

“I can’t tell you how many people I sent to him because they saw the success I had,” said Lynn Adams, a retired teacher, referring to Dr. Thomas Najarian, the inventor of Qnexa who opened a weight-loss clinic here in 2001.

Ms. Adams said she took the two drugs for a year and lost about 80 pounds. She has taken the drugs from time to time since then but is off them now and has gained about half the weight back.

Who wants to bet that she recommended her friends jump on this new diet drug bandwagon at the peak of her weight loss and not after she gained half of it back? And how in the heck is she still being prescribed topa-phen if phentermine is only approved for short term use?

And just so we can be very clear about the responsibility for what looks to be like the next diet drug disaster, the doctors and clinicians who prescribe topa-phen are acting like mindless pharma-pushing automatons.

Doctors are just as susceptible to corruption as anyone else. A doctor who founds his career on weight loss and eliminating fat people needs dramatic success stories to promote himself, and is much more willing to throw caution to the wind if it gets him a success story and more word-of-mouth referrals.

The main danger is: weight loss happens on a curve that bottoms out over a period of months, giving an illusory 'permanent' success that is can then be paraded around to friends. A walking advertisement that, once it's served its purpose -- getting more butts into a weight-loss doc's waiting-room chairs -- regains and fades back into the shadows. We've seen that pattern with popular diet programs. Trumpet some minor celeb's loss at the bottom of the cycle and pretend it's permanent, then ignore their inevitable regain and queue up the next minor celeb to do it all over again.

My prediction is the short-term effectiveness of the topa-phen combination (6- to 12- months) will be sufficiently pushed by Vivus studies to get FDA approval for something like Qnexa. Then, as people start regaining as they tolerate topiramate and no longer can take the phentermine (which is only approved for short-term use), they will regain the weight they lost (12- to 24- months).

It will be the same old sad story, with the same old speed-related heart valve damage in addition to neurological side effects caused by the topiramate. And the population becomes less healthy, yet again, in its quest for thinness as a proxy for health.

Readers, beware the topa-phen mixture. And tell your friends.

REFERENCES

1. L. Vijaya. "Topiramate induced secondary angle closure glaucoma." JPGM, Vol. 52, 2006.

2. P. M. Levisohn, "Safety and Tolerability of Topiramate in Children." J Child Neurol December 2000 vol. 15 no. 1 suppl S22-S26. link

3. K. M. Gadde et al. "Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults (CONQUER): a randomised, placebo-controlled, phase 3 trial" The Lancet, Volume 377, Issue 9774, Pages 1341 - 1352, 16 April 2011 study funded by Vivus, makers of Qnexa link

Healing from Being Bullied | Fitness Epiphany

loniemc February 17th, 2012 | Link | Just more and more evidence

Just more and more evidence that the anti-fat push isn't about health. Now, they are prescribing meth for weight loss as well (http://www.drugs.com/pro/desoxyn.html). Prescribing addictive speed only harms the body and the soul and leaves people fatter and less healthy in the end. How can people not see THIS IS INSANE!!!

richie79's picture
richie79
February 17th, 2012 | Link | Great post BigLiberty.

Great post BigLiberty. Logical, meticulously researched, in short everything that the justifications for the inevitable approval of this cocktail ultimately won't be. How many times will Big Pharma and the FDA go down the same old road, relying on their potential customers' fear and hatred of fat to distract from the myriad side effects and ultimate ineffectuality of yet another supposed magic pill cure to a problem that doesn't really exist? How many more human guinea pigs will have to die or be left with long-term damage whilst these pills remain on sale? After all, it's OK, they're only fatties; whether from the drugs or 'obesity-related conditions' they've an early date with the Reaper one way or another (/sarcasm).

And, from the link Lonie posted:

"METHAMPHETAMINE HAS A HIGH POTENTIAL FOR ABUSE. IT SHOULD THUS BE TRIED ONLY IN WEIGHT REDUCTION PROGRAMS FOR PATIENTS IN WHOM ALTERNATIVE THERAPY HAS BEEN INEFFECTIVE. ADMINISTRATION OF METHAMPHETAMINE FOR PROLONGED PERIODS OF TIME IN OBESITY MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING METHAMPHETAMINE FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUG SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY. MISUSE OF METHAMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS."

They really are fresh out of ideas aren't they? Of course methamphetamine, like most habit-forming drugs of choice, ultimately makes you skinny, if only because feeding the habit takes priority over nourishment (and for that matter pretty much everything else). The question is whether being thin is worth the risks of becoming dependent on a substance which (as the endless parade of meth addicts on various 'reality' cop shows demonstrates) has the capacity to utterly ruin not only your life and health but those of everyone around you.

The answer, that some clearly believe it is, just serves to demonstrate how utterly, irredeemably screwed-up this world has become where fat and the zealous pursuit of its elimination is concerned. 'Health', illusory or otherwise, is not a term I'd generally apply to the unfortunates who find themselves dependent long-term on methamphetamine, and I can't see how use on a sufficiently short-term basis to avoid addiction could possibly assist in weight loss significant enough to warrant use EVEN in those 'for whom alternative theraby has been ineffective'. F**K getting them hooked on meth - how about maybe accepting they're MEANT to be fat and leaving them alone?

"What is right is not always popular and what is popular is not always right" - Albert Einstein

vesta44's picture
vesta44
February 17th, 2012 | Link | What's really scary about

What's really scary about this is that doctors are prescribing this now, before the FDA has ruled on whether it will be approved for sale as a combination drug. They're giving 2 separate prescriptions, one for phentermine and one for Topamax, and telling patients to take them together in order to lose weight (off label use isn't illegal as far as I know, just isn't recommended).
I take Topamax for migraines (minimal dosage) and it works for that. Now I'm wondering if the numbness I have in my right hand all the time is caused by the Topamax - I had carpal tunnel syndrome, had surgery to fix it, and according to the tests I had done afterward, I no longer have carpal tunnel, but my whole right hand is numb and tingly, all the time, and sometimes that numbness/tingling extends up past my wrist. Oh, and when my neurologist prescribed it, the first thing she said was that it might affect my appetite adversely and I would lose weight - a good thing, according to her (hasn't happened). She also said some people said it affects the taste of some foods, especially soda (I haven't noticed that either).
I don't know if I'd rather have migraines and not have the numbness/tingling in my hand, or stay with no migraines and keep the numbness/tingling in my hand (if the Topamax is causing it). Either way, my quality of life is affected, but at least with the numbness, I can function pretty close to normally, where with migraines, there's no normal functioning at all during one of them (and one can last anywhere from a couple of hours to a couple of days). I do know that, after having taken fen-phen 15 years ago, there is no way I would add phentermine to my Topamax, even if they could guarantee that it would make me permanently thin (I'm not willing to risk the side effects and complications from the mixture of those 2 drugs).

WLS - Sorry, not my preferred way of dying. *glares at doctor recommending it*

DeeLeigh's picture
DeeLeigh
February 18th, 2012 | Link | My understanding is that in

My understanding is that in the nineties, the fenfluramine and phentermine combo (fen-phen) was prescribed off label in the same way, and a related drug called Redux was later approved by the FDA. Fen-phen and Redux caused heart valve damage in 1/3 of the people who used them. The fen-phen story, as published in the New York Times in 1997, is here. There's another NYT story here.

vesta44's picture
vesta44
February 18th, 2012 | Link | Dee - This makes me wish I

Dee - This makes me wish I had access to my medical records from back then. I know what I was taking was fen-phen, but it was one pill, not two, that I took, and I know the label on the bottle didn't say Redux. Hmm, I may be able to get that information after all............I just found an insert that came with a medical bill from the clinic I go to, and it says "Do you want access to your medical record? If so, sign up for MyChart!" Once I sign up, I have access to my health summary, test results, medications, allergies and intolerances, immunizations, medical history, and current health issues. Since they have copies of my medical records from the clinic I went to when I was taking the fen-phen, that information should be in there. Will have to sign up, search for it, and get back to y'all.

WLS - Sorry, not my preferred way of dying. *glares at doctor recommending it*

DeeLeigh's picture
DeeLeigh
February 18th, 2012 | Link | It had another name too.

It had another name too. Looking it up... Pondimin. Same thing as Redux.
I hope both of you are in the lucky 2/3!

moxie3's picture
moxie3
February 18th, 2012 | Link | I was on the original

Smiling

moxie3's picture
moxie3
February 18th, 2012 | Link | I was on the original

I was on the original fen-phen a few months before it was taken off the market. At the time all the ladies in the neighborhood were getting it and so I thought I'd try it too. I had two young girls to get on the bus every morning and also was doing transcription work which you can imagine was extremely long and boring but had to get done.

Fen-phen's best side effect was the fact that I could breeze through my typing without needing a nap! It was the "speed" of the 90s. Not sure what the new cocktail will be like but I'm sure eventually it will be taken off the market due to whatever health probs/deaths it causes beside the fact that when you stop anything like this the weight always returns in full force and damages whatever metabolism you had prior!

Alyssa February 18th, 2012 | Link | The new phen-fen

I commend the FDA for not approving this drug. I hope they continue to stand their ground. That said, it does not surprise me that many doctors prescribe this "cocktail" off label. They know how to make a quick buck by taking advantage of society's fat-hatred. They themselves often hate fat people, and so have no qualms prescribing what is essentially an illegal drug combo. In fact, I have often thought that such doctors subconsciously wish fat people were dead. So what if they drug combo kills them? They don't deserve to live any way.

My own experience with diet drugs: A number of years ago the PCP I had at the time tried to prescribe Xenical. I already knew of its nasty side effect: fecal incompetence. I told her bluntly I would not take a drug that made me "shit my pants." Well, that shocked the sh** out of her! She then prescribed Meridia which had a raft of potential side effects, one of which was hypertension. Within two weeks of taking it, my normal BP skyrocketed, so I stopped it. No more "diet" drugs for me.

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