It’s national heart health month and that means that every diet and weight loss company is trying to incorporate heart health into their ads. Except the folks over at Vivus pharmaceuticals who say “screw your heart, buy our drug”.
Qnexa, a weight loss drug produced by Vivus, was rejected by the FDA in 2010 because of it’s pesky tendency to cause side effects like elevated heart rate that may lead to severe cardiovascular problems, such as heart attacks and arrhythmias, birth defects, psychiatric problems, kidney stones, decreased bone mineral density and memory impairment.
Today an FDA panel voted to recommend that the full FDA approve THE SAME DRUG which has THE SAME SIDE EFFECTS. The drug is made up of a combination of Topmax – an anti-seizure/anti-migraine drug that is supposed to make people feel “satiated” while it’s partner drug, and phentermine suppresses appetite. If Pentermine sounds familiar you’re not alone – it was half of the drug combination Fen-Phen, that was linked to heart valve problems. People died.
So what would make this panel decide that te drug is suddenly safe enough? It would seem that most of the subjects lost 10% of their body weight while on the drug. What the panel does not seem to care about is what happens when patients go off the drug, and what are the weight regain rates, not to mention those side effects we already chatted about.
Apparently they were swayed by testimony from people like Dr. Arya Sharma, who is a paid consultant to Vivus (you know, the company that manufactures and hopes to sell and profit wildly from this drug…). Dr. Sharma said “Back in medical school, I was taught that when the risk of not treating the condition exceeds the risk of treating it, we should treat. We have an obligation to change how we measure obesity. Qnexa addresses an urgent and substantial unmet medical need for our patients.”
I call bullshit Dr. Sharma. First of all, losing 10% of your body weight is possible with a variety of interventions for many people – the problem is that almost all of them gain that weight back, plus more in 2-5 years. So we’re risking all those side effects for an intervention that is likely to last less than 2 years? Also, weight loss is not really an appropriate treatment protocol since fat is not a diagnosis. It’s a descriptor. Obesity is not a disease, it’s a ratio of weight and height. There are perfectly healthy obese people (and very unhealthy thin people). Also, for many obese people, losing 10% of their body weight doesn’t actually move them out of the obese category so by Dr. Sharma’s your own logic (with which I disagree) their risk factors are the same as they were before, except now their risk factors include the risk of side effects from a weight loss drug, and from the yo-yo dieting that they are likely to experience.
There are no “fat people diseases”, thin people get all the same diseases that fat people get and there are behavior-based treatment protocols for all of these diseases that have nothing to do with weight loss.
Since we already know how to make people healthier (adding healthy foods and moving about 30 minutes a day about 5 days a week), and we have behavior based treatment protocols for every disease that do not involved weight loss, there’s no reason to put anyone at this much risk for what is not only little benefit, but also possible harm. And it doesn’t matter how much money Dr. Sharma is paid to say otherwise, or how much money Vivus will make if the FDA approves the drug,
But here’s the thing. Even if the FDA approves this drug, we don’t have to buy it. Some analysts have said that the drug company will have 10 million customers when it comes out. That only happens if 10 million of us buy the drug. If none of us buy the drug, it goes over like a lead balloon and we’ve made them irrelevant, and the drug company wasted all of the money they spent buying the testimony of doctors. We can take this into our own hands and refuse to risk our health for someone else’s profit. The bully only gets our lunch money if we give it him. It’s time to stand up and say no.
The situation that Dr. Sharma is in is EXACTLY why my work is supported by my readers rather than corporate ads. If you feel that you get value out of the blog, can afford it, and want to support my work and activism, please consider a paid subscription or a one-time contribution. The regular e-mail subscription (available at the top right hand side of this page) is always completely free. Thanks for reading! ~Ragen
Dances With Fat 
Here’s a little scoop on Topamax. I was prescribed it some six years ago because one of the side effects of the drug was increased impulse control. It was never officially approved as a weight-loss drug because that would have meant stringent trials and going through the FDA all over again, so instead they simply talked up the side effects of the drug to docs who listened and who then prescribed it for the side effects.
Later experiments revealed that the impulse control effects only lasted about one year before they tapered off, so I’m really flummoxed that they would include this.
I’m really, really upset to hear that Dr. Sharma supports the approval of this poison. I’ve had my run ins with him over some of his posts, but I’ve met him in person and had a long chat with him and he struck me as being one of the most open-minded bariatric doctors around. It’s very distressing to hear what he’s done.
BTW, please excuse the grammar police in me, but I just have to correct one thing I often see in your posts. “It’s” is a contraction of “it is”. “Its” as a possessive (as in, “it made its way through my digestive tract”) does not take an apostrophe.
Thanks for the grammar police, I do know the difference, I’m just horrible at proofreading my own work and since I blog once a day I have a strong tendency to type really fast.
~Ragen
________________________________
I pride myself on using apostrophes correctly, but “its” and “it’s” do tend to trip me up!
*spews soda everywhere*
I’m on Topamax for my debilitating migraines which have nothing to do with my fat, and they want to give it to people to lose weight? I honestly feel like my crippling headaches have just been made “less than” OMGDETHFATZ. What’s the bigger problem? My fat, or my “dear god make the pain stop” migraines?
Well, I know what the pharamceutical industry thinks! 😛
I am sorry about your migraine headaches. I hope you find successful relief for them.
I doubt that the pharmaceutical company considers them less important than weight, though.
I’m pretty sure the one aspect they are most interest in is your money. In their pockets. Whatever it takes. Even if the treatment is worse than the made-up disease.
I too was given Topamax for migranes and it worked. It also made my toes tingle and completely took away my dreams!
I finally stopped when I find a good migrane prevention – magnesium. I kid you not – 1500mg every day plus 3mg of Melatonin at nightand I am migrane free. I was suffering 3-5 days a week with sick migranes.
For those who are fat and suffering severe continual headaches (not just fluctuating like classic migraines), look into the possibility of Idiopathic Intracranial Hypertension, http://www.ihrfoundation.org). It’s also known as pseudotumor cerebri or “benign” intracranial hypertension but there’s NOTHING pseudo or benign about it, trust me.
Women who are heavy and of childbearing age (and especially those with PCOS) are prone to it. I’ll be blogging about it more in the future in conjunction with the PCOS series.
Isn’t magnesium given for hypertension? I know hypertension can also cause headaches. It seems unlikely that they would miss it when they got your vitals, but perhaps it is something to look into. I’m glad you’re feeling better!
I read Dr. Sharma’s blog and I occasionally agree with something he says. However, I’m very disturbed by his openness to taking money that clearly puts him in the position of having a conflict of interest. He’s talked about taking food industry money as well.
They are beginning The Extermination Of The Fatties. I’m so glad we have informed, intelligent people like you fighting for us, Regan. Please don’t ever give up.
Actually, it was the “fen” part of fen-phen (fenfluramine, and its cousin dexfenfluramine) that was considered the culprit in the heart disease cases. Phentermine (the “phen” part) itself has never been taken off the market.
But Topamax? Hoo boy. I’ve never taken the stuff myself, but my psychiatrist offered it to me to curb some of the polyphagia effects of Remeron (we’re talking Cookie-Monter-snarf-the-furniture time here; I eventually found other meds to counteract it). I refused, and he said he didn’t blame me, because it does have the side effects profile from hell. Specifically, it can make you a complete and total space case who can’t even remember your own name, or alter your personality so drastically people don’t even recognize you anymore. Yeah, no thanks.
Topamax is probably a fabulous drug for a small percentage of people, and if they get something out of it with no horrible sequelae, great. But it should not be handed out like (ahem) candy. Ever. I can just imagine the lawsuits that are going to come from this one!
I was going to say the same thing about phentermine.
A doctor put me on Topomax for depression, when all I wanted was to be treated for sleep apnea, but she told me she wouldn’t let me have a sleep study if I didn’t take Topomax. She also told me she didn’t know if was worth her time to treat me since I obviously didn’t care about myself since I was so fat. Anyway, I had terrible side effects from and often didn’t even know where I was. I nearly lost my job.
She wouldn’t let you take a sleep study if you didn’t take Topomax? WTF?
What the hell!? That’s horrible. No pressure, but please consider writing a letter to the AMA describing your (mis)treatment and its consequences, naming the doctor, and so forth. If only to prevent this happening to someone else.
This has got to stop. Wouldn’t it marvelous if we could organize a massive letter-writing campaign where every person who’s ever been mistreated or misdiagnosed or abused by a medical professional reports that professional to the AMA? Goldang, it would make my fat heart soar.
“Cookie Monster Snarf the Furniture Time…” *laughing*
I’m on Remeron too, and I totally understand what you mean. My psych looked at me for a long moment when I asked to be put on it (chronic insomnia is teh suck and I was developing a tolerance to the Celexa…) and said – very carefully – that the medication does tend to cause cravings for starch. Since my weight has never been a bone of contention between us, he was obviously uncomfortable with bringing it up. (He also told me I was going to have to give up coffee. I pointed out that I don’t drink, I don’t smoke, and I don’t do any drugs he didn’t prescribe, so I only have the one vice, and he will pry it from my cold, dead, and still twitching, fingers. I love him, because I can say that sort of thing, and he doesn’t get all huffy.)
I’ve gotten around it by taking up sunflower seeds as a fifth food group. They’re low fat, high protein, and because I eat them with the shells on, I have to work at it, at least a little. *grinning* My friends and family mock my “problem” some, but it helps with the constant munchies. I have a heart murmur, so I have to be careful about the salt thing, but I don’t eat more than a cup or two a day all told (and mostly at work), so I think I’m okay. That, and a LOT of sugarless chewing gum. I always have some in my purse. ALWAYS. Weight and measurements haven’t changed in three years, so I guess I’m holding the cravings more or less at bay.
Might I ask (if it’s not too much of a sidetrack), what you ended up on to help control the “Death Muncheez of Doom [tm]”? I understand that the drug is an insulin inhibitor as well as a serotonin inhibitor, and it seems like Metformin might help in that regard. (I also have PCOS, so my endocrinological profile is a bit whacked to begin with.)
-Betty-
Wellbutrin 150 mg when I get up, dextroamphetamine 5 mg when I get up and 4 to 5 hours after that, with potentially a third dose if I’m short on sleep. Metformin hates me (or at least, my digestive tract).
I have chronic migraine, so of course I know about Topamax. The side effects alarm me. (I know people who have taken it with no problem, and definite relief of migraine – I know people who’ve gone off it because their side effects were worse than the pain.) If my pain was more severe, I’d still look into it, because, well, constant severe debilitating pain has its own negative effects… but I’d rather deal with constant *mild, somewhat* debilitating pain than risk Topamax.
I cannot *imagine* taking it for anything less.
And the whole “satiety” issue bothers me. It continues the incorrect perception that we’re all eating too much. Some of us undoubtedly eat more than we truly need to maintain health (as do many thin people I know) and some of us do not. “Feeling full” won’t help people who don’t eat more than they need – unless they want to starve…
Dr. Sharma is officially on my Shit List for this.
Goddamn these straddlers. I’m sorry, but this just pisses me right off. I’m sick of people wearing a HAES veneer and then going and doing stuff like this.
Why the hell do we even have an FDA?! Ugh, this is sickening. Thanks for putting the info out there and hopefully enough people will get it before it’s too late.
Yeah. Things like this are one of the reasons I’m an anarchist. The idea of an impartial protective body with that much power and ability to generate millions/billions of dollars for an industry with the flick of a pen isn’t realistic.
But my politics are neither here nor there; rather, this just stresses that each of us needs to put the preservation of our bodily autonomy near the top of our political priorities, regardless in what system we believe.
Dr. Frances Oldham Kelsey prevented the approval of thalidomide in the US back in the 1960s. She’s a national hero.
Do you think there’s anyone like that looking out for us left at the FDA?
Fenfluramine was never recommended for use for more than a few weeks at a time. However, like many patients, I was prescribed this drug for several months on its own, and then for eight or so more months in combination with Phentermine (the infamous fen-phen). I experienced a small amount of weight loss in the first few weeks because I would literally forget to eat regular meals. The weight loss was of course not maintained in the long term.
What Fenfluramine DID do was make me really, really stupid and slow. When Phentermine (speed) was added, I was still stupid but had better reflexes and appeared less impaired than before. Awesome.
Oh — and once off the medication, my PCP of many years noticed that I now have a heart murmur. In my entire life of regular medical care up to that point, no one had EVER diagnosed me with a heart murmur before. Coincidence? I somehow doubt it.
(Fortunately, the murmur was investigated further via echocardiogram and found to be benign.)
One “minor” problem I have with patients who are on Topomax is that any move toward intuitive eating is out the window. Sensations of hunger are lost, and the result is far from a healthy intake. I wish someone was looking at outcomes outside of simply pounds loss–even if that were a valid consideration!
Great piece!
BTW, I hope your readers are equally outraged by the media hype about “overeating” and memory based on crappy science! (see my latest post for my response)
Yes, Lori, I’ve seen that, and I’ve been wondering if it and a few other, similarly dubious stories over the past few years aren’t some kind of attempt to connect fatness in the public mind with dementia. Dementia being serious, expensive to care for and increasingly common with an ageing population, and fat being ‘self-inflicted’, therefore ripe for insurers and health providers to claim any condition ’caused’ by it shouldn’t be covered. You get the picture – not a pretty one.
Topamax for weight loss would be bad enough, but combining it with phentermine? I wish I could say I don’t believe this.
I’ve been on Topamax for epilepsy, and the side effects were as bad as the commenters here have said. (Disclaimer here: this is my personal experience, and if Topamax gives you relief from seizures or migraines, awesome! I mean that seriously. I wish I could find a drug that worked on my seizures.)
The cognitive impairment was gruesome. It was like trying to think through a thick layer of cotton. Between that and the appetite suppression, my parents had to remind me to eat regular meals or I would forget and skip them entirely.
But that’s healthy, of course, because I was and am fat. And obesity is so much worse for the workplace than a worker who has to struggle twice as hard for half the results at her job. /sarcasm
Topamax never made me feel satiated ( I was prescribed it for epilepsy) , it just removed all sensation of hunger, and made most food taste awful. I also had such bad short term memory on it I had to constantly carry a PDA to keep track of normal everyday stuff and taking care of my kids.( My neurologist jokingly calls it dopamax) It also leeches potassium from your system which is bad for your heart and can cause weird tingling,your hair tends to thin too, there is a risk of glaucoma and I had trails when I moved my head too fast. It did help the seizures and yes I lost 60 lbs ( didn’t want or need to) and it triggerd my eating disorder even after getting off it it took a couple of years to eat normally well as close as I get. I can not see why anyone would even want to put someone on this especially for something I feel is non serious as weight loss. I even thought having seizures was better then being on it. ( and I was having about 5 to 8 a day at the time before taking it) also kidney stones are quite common while on it. Yeah sounds like a great idea to put a lot of folks on it * sarcasm*.
Haha Dopamax… yeah. I definitely have lost some of my brain being on this but luckily I have a lot of brain. If it weren’t for the immensity of the problem it were solving for me I wouldn’t put up with the side effects but some annoying tingling and mild aphasia and forgetfulness are worth being able to get out of bed again. But er. STILL FAT! It didn’t do a thing for that.
thank you thank you thank you for this. i have always been bright, have 2 degrees and associated debt from UMC. IQ over 150. (though hyperactive) at age 32 i had my first siezure after 16 years of being a binge/purge bulimic. i went on depakote er for about 6 month, and then no seizures again for 3 years. now, since aug i have had 3 more seizure episodes (one in early aug, one in nov and then a new series of 6 on fri) they put me on keppra in aug but i had tapered back off again it was making me stupid. they put me back on depakote on fri.
my seziuires seem triggered by dehydration and have ALWAYS happened in conjunction with vomiting. im really coming to terms with 1. having epilepsy in the first place and 2. having to take care of myself. i have been dysfunctional for a very long time. not eating right, not drinking enough, refusal to see drs or take meds. i was healthy i didnt need it. now i do and its SCARY. and how do i make that call? how do i decide my seizures are dangerous “enough” im not in pain all day every day. hell im not even debilitated weekly. but every once in a while if im puking or dehydrated i have 2-6 seizures and this last time i didnt regain consciousness for 12 hours.
the keppra makes me completely NOT hungry and i seem to lose weight without trying, but makes me dumb (luckily i have plenty to spare) and the seizures take away my licence which remove my ability to work running group homes which is what i used to do for a living.
Not all people who experience binge and compulsive eating are fat, and more than 90% of all people who are fat have never experienced binge or compulsive eating, so I am not seeing how Topamax would be useful to people who do not have those issues. GRRRRRRRRR.
Should have said “those issues or any of the other issues for which Topamax is prescribed.” But just not seeing how it works as a weight-loss panacea, even if I were to accept that that was in and of itself A Good Thing, which I don’t.
I’m on Topamax for migraines. I had them so bad I was pretty much completely disabled. I had friends warn me about terrible side effects I might have but I am one of the lucky ones who had very few. As far as it changing my taste buds or satiety levels, I’ve not noticed a thing. It’s given me my life back, because I no longer feel like someone is sticking an ice pick through my head all day long anymore, along with seeing constant little spots of colored light + tv static fuzz from the migraine aura, not because it’s made me slim and tiny or anything like that. I weigh the same as the day it was first prescribed to me two years ago. The other thing people take it for are seizures. Topamax is a powerful brain drug. You take it if something is going very wrong with your brain. It can seriously hurt your kidneys and I have to have my kidney function monitored by my doctor – people who take it are at increased risk of kidney stones, glaucoma, and other problems like weird metabolic things that can suddenly kill you. It’s not a drug to take lightly.
I’m glad Topomax is helping you. I guess we’ve all had a lot of bad things to say about it, but we need to keep in mind that topomax has it’s place. I’m on a different drug to control a chronic condition that people malign all the the time.
A lot of people do find the side effects intolerable. I’m just lucky I’m not one of them. Oh and I forgot to mention, and this is concerning – if you are on enough of it, you can’t just stop taking it. You have to taper down your dose to avoid having seizures, even if you never had seizures before. So it boggles me that they would even consider prescribing it to people without brain disorders. It just goes to show the sheer hate they have for fat people, IMO. “We don’t care if we put you at risk of kidney disease, heart disease, seizures, severe metabolic disorder, and death, just as long as you lose some weight already!”
The fen-phen drug that caused heart problems was the other fen, the downer. The one still in use is the upper. Of course you lose weight, you are on SPEED! I did it many many years ago, lost a pound a day and then lost my gall bladder. Very bad idea, like most to all diets.
The news report I heard today on this drug combo (NPR?) stated that women using it will be required to be on birth control AND to take pregnancy tests. They said the drug would be limited to a few mail order pharmacies so the manufacturer could “control” who gets it.
My first thought is, holy crap this must be dangerous! My second thought is, hen guarding the hen house…
Of course, Topomax is known to make birth control fail. But it’s link to birth defects (cleft palate) is pretty slender – mainly when taken in combination with other epilepsy drugs. It’s probably the other drug in combination with it that is dangerous.
My daughter was put on Dopamax, er, Topamax for a while for her severe headaches. It turned her into a zombie. She literally could not remember the names of common objects all around her. Thank goodness it wasn’t during the school year.
I know it works well for the migraines of some people, and it can help those with certain eating disorders, so it’s worth keeping in the toolbox. But not for obesity itself, and especially not if it turns you into a blithering idiot.
Wonder how many will die or be injured before they take this one off the market? Ugh.
it’s also called “Stupamax,” the “Barbie Doll drug” over on the CrazyMeds site (http://crazymeds.us) As someone who takes brain cootie drugs for actual brain cooties, I recommend staying away from them unless you really, really need them. Like, can’t function without them. I wouldn’t do this for funsies or to get into one size smaller jeans.
I have a huge issue with them wanting to prescribe it for people at BMI 30 or above who have NO comorbidities. Yep, let’s give healthy people powerful drugs that mess with their mental processes. I also wonder what “co-morbidities” they’ll consider adequate to prescribe it down to BMI 27, especially since they keep defining those downward.
I’m generally more pro-med than not, because I know they can be a godsend. The problem is, there’s a lot more money to be made convincing healthy people to take drugs. Hence, the stunning advances in the past few years in stiffy pills.
I wonder how high the toll will be this time? *sigh* My aunt took fen/phen and is having serious heart problems now, she isn’t even 60. I hope the fallout from this drug isn’t as terrible as the fen/phen disaster.
Topomax has multiple uses. It’s a necessity for many people – my partner is on it because of muscle spasms that cause her hands to lock up painfully and cause her to be unable to move her fingers. It also has a nasty list of side effects – including appetite suppression, nausea, mood changes and personality changes. And the withdrawl when she misses a dose is ugly too. I can’t believe that OMGTEHFATZ is going to make those risky, horrible side effects ok.
Thank you for bringing this to our attention, and for suggesting a market solution.
Your wallet will vote louder than the ballot box every time.
My cousin was on Topomax for very serious headache/migraine problems for quite a while – because it’s so habit-forming. She lost her appetite in addition to other issues and became a shadow of herself. Frankly, it was awful. I understand that many people HAVE to take it because of serious illness and the side effects of the drug are the lesser evil, but to electively take it seems downright crazy. I really hate that parts of our society have become so soaked in this weight-loss/moneymaking crap that it’s come to OK-ing a drug like this for something like weight loss. Thankfully, my cousin was able to wean herself off the meds once her symptoms subsided, but you’d have to force her, kicking and screaming, to take them again.