June 14

Rimonabant (Acomplia) bites the dust with the FDA

11  comments

The big news in the world of obesity therapy was that yesterday an FDA panel, in an outbreak of good sense, declined to approve rimonabant, AKA acomplia, or Zimulti, as it was going to be called in the U.S.
According to the New York Times:

The advisory panel voted unanimously, 14 to 0, against recommending the drug, saying there was inadequate evidence of its safety. The F.D.A. is not required to follow the advice of such panels, but it typically does.
The panel’s vote was a blow to Sanofi-Aventi, the French company that makes the drug, which is sold in many countries under the brand name Acomplia. As the advisory committee finished voting, the company’s stock, which trades in this country as American depositary receipts, closed at $43.07, down $1.31 or 2.95 percent. It fell another $1.02 in after-hours trading.
Sanofi had expressed hope that the drug would be a $3 billion seller, with much of that market in the United States, a country with a growing obesity problem.
In a statement issued after the panel’s vote, the company said it would continue to work with the F.D.A. to address the panel’s concerns, which included worries about a high dropout rate in clinical studies of the drug, evidence of a doubling of psychiatric events and questions about whether the drug induced seizures.

The fact that this panel voted against the drug doesn’t mean that the FDA will follow the panel’s recommendation, but it probably will.
According to Bloomburg, countless Americans are traveling to Europe to get this drug, while others are ordering through foreign websites.
In my opinion the FDA panel did the right thing. If this drug is approved, zillions of overweight people will rush to take it, virtually all will discover that it’s not a magic bullet (there is no such thing) and that substantial weight loss will still require denial and will power. Along the way there will be a ton of side effects and a bunch of people will die or be severely incapacitated. Many will sue contending that they didn’t realize the risks or they would never have taken the drug. Sanofi-Aventi will earn several billion dollars, it will pay out a few tens of millions in legal fees and awards, the FDA will withdraw the drug, and a lot of lawyers will get rich. And the population doesn’t get any thinner. Why not simply avoid the entire fiasco and not approve the drug in the first place.
That’s why I think the panel had an outbreak of good sense.
Interestingly, yesterday, the same day that rimonabant went down in flames, was the first day that another awful and ineffective anti-obesity drug hit the over-the-counter market. Alli (nee xenical), which I posted on earlier in the year, became available to anyone who wants to buy it without a prescription. If you decide to take the plunge with this drug, make sure you have a plunger because you’ll need it. And don’t say I didn’t warn you.
In the next post I’ll tell you about how the low-carb diet accomplishes the same thing that rimonabant tries to do, but without all the side effects. And much more effectively. I’ll explain how the low-carb diet acts to make leptin more effective in the prevention of hunger. Stay tuned.


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  1. Yesterday I made a rare stop at the local chain drug store and noticed a prominent display in the book/magazine aisle for an Alli (low dose Xenical – orlistat) guidebook. Of course I picked it up and flipped through it to see what would be said about the dreaded oily discharge and other nasty side effects. The book was more than an inch thick, had tips for use, a meal plan, recipes, exercise tips, etc., yet I couldn’t find “cosmic pizza grease” at all :-).
    I did find a half page on page 8 or 9 (in the entire book) about “treatment effects” or some euphamistic term for side effects that vaguely mentioned some mild symptoms when starting the “plan” or deviating from the “plan”. Hmmmph! But I doubt anyone seriously reading that book would be prepared for side effects that matched the descriptions in your earlier post on Alli.
    Cheers,
    Anna
    You mean they didn’t mention the ‘flatus with discharge’ so common with this drug?  I can’t imagine.  People will find out soon enough.  It would be hoped that if this drug were prescribed by a physician, said physician would caution the patient about eating fat along with it.  But such won’t be the case when the great unwashed hordes begin to buy it.  I can’t wait for the fun to begin.
    Cheers–
    MRE

  2. I have long been convinced of a low carb diet as a way to get lean. Your pithy comments on diet and health are a welcome breath of fresh air.
    Many thanks for your blog and please keep up the good work!
    As an aside, guys like Vince Gironda and Mike Mentzer advocated this same kind of diet. They also advocated short intense workouts rather than the grinding programs still on offer today. Mentzer in particular saw that the weight training industry was like a business whose primary purpose was profit rather than the benefit of the body builders themselves. This seems an obvious parallel with big pharmaceutical companies today. Mentzer shunned a lot of the supplements and training aids marketed out there. I guess my point being that when you get your advice from a marketing company you will lose through the wallet! If you try to live ‘closer’ to the ground in life, you will see that the real answer is often simpler than you think!
    Hi Chris–
    Thanks for the support.
    I’ve read Mentzer a lot over the years.  He’s a bright guy and on the money.
    Best–
    MRE 

  3. I would hope the FDA does no approve this drug but sadly it will probably be dependent on how much monetary pressure the drug company puts on them.
    The company will probably recruit some of the people on the panel, pay them large amounts of money to ‘test’ the drug more thoroughly, then get them as allies instead of adversaries.  I would be surprised if this drug doesn’t come to market in this country at some point.
    Cheers–
    MRE 

  4. Timely post Dr. Mike. And I couldn’t agree more about how foolish it is for anyone to expect a quick fix (or any fix) from a tablet or capsule. Sometime, maybe even in the near future, more folks will start to realize that they have to be proactive and take charge of their own health and well-being. On the nutrition side, it’s not really that hard as you have shown in PPLP, your other pubs and this blog. But folks will have to bestir themselves to find out what they need to know and sort through and discard the incredible amount of bum info out there – most notably the low fat/pyramid stuff and all the related, thoughtless blathering. Horrors, they may even need to turn off the TV or shut down the video games and ….pick up a book! (Or read your blog.)
    Thank you again and again for what you are doing.
    Regards,
    Wil
    Thanks for the kind words and support, Wil.
    I appreciate it.
    Cheers–
    MRE 

  5. While you may be correct about the premise that the drug shouldn’t be used, the problem with the entire system is that the FDA is a coercive agency, that violates our right to choose how to care for ourselves.
    The original idea, that entities should exist that would be able to recommend whether something is good for people, was sound. It would still be better done by private, competing organizations, but they had the right idea.
    It should never even have had the power to ban medical treatments, only to warn against them.
    But when the FDA gained the unconstitutional power to control ALL access to medicine, so that we had to get its active approval to use something, this was a horrible blow to the advancement of medicine, and health.
    People suffer, or die, every year, because of the FDA’s approval process. WE don’t even need to consider the many treatments wrongfully prohibited, actively or passively. We can simply count the number of cases of a disease during the time between discovery of a treatment, and its approval, and factor that by the degree to which the treatment mitigates it.
    Several dramatic cancer treatments, for example, have been discovered in the last ten years, which either took many years to approve, or still have not been. Each year, tens or hundreds of thousands of people may be suffering inferior, or unsuccessful, treatment because they aren’t getting into the test programs for these treatments.
    Imagine, if a 100% cancer treatment were found, it could easily take twenty years (a-la the chickenpox vaccine) to approve…but even if it only took five years, this would cost the lives of millions, and suffering (because of our barbaric radiation/toxin treatment methods, now) of many more.
    No committee, even when it’s unanimous, can be 100% correct about its decisions. And when it’s wrong, especially in banning something, it commits a grave injustice against everyone prevented from choosing…aside from their inherent right to chose, right or wrong, in the first place.
    “Better a hundred guilty men go free than one innocent man suffer” is Jefferson’s version of Blackstone’s Ratio…but it doesn’t just apply to giving the innocent the benefit of the doubt in the justice system. It is true of all coercion.
    In principle, it says that the harm of government coercion is a hundred times worse than the benefit of it, and this must be considered in accepting it. If the government takes away our choice in a way it estimates will save the lives of 100 people, but will cause the deaths of ten other people, then this is ten times worse than if the government had not interfered in the first place, and all 110 would have been free to choose, for themselves, which way to risk their lives.
    The famous insanity of the mandatory airbags killing dozens of innocent short people and children are a famous prime example of this, but the coercive power of the FDA is a far more gruesome one.
    This will probably come as a huge surprise to you, Kaz, but I agree with you on this one 100 percent.
    Somewhere buried in my voluminous piles of papers that are in storage right now is one that shows that since the FDA tightened its approval process after the thalidomide tragedies of the 1950s, just as many drugs have had to be withdrawn because of adverse reactions now as were withdrawn pre-thalidomide.
    To get FDA approval of a drug requires many millions of dollars of studies involving several thousand subjects. But these several thousand subjects in controlled studies are not the same as throwing the drug out to millions of people. What might not cause problems in a few thousand carefully-selected subjects often causes huge problems when administered to millions of uncarefully-selected subjects, i.e., the public at large.
    I don’t have a problem with the FDA making recommendations and even putting its imprimatur on drugs it feels are legit. But I don’t think it should be in the business of telling us what we can and cannot have access to.

    One of the problems with the situation as it stands is that once the FDA approves something – as it did with phen-fen – then people blindly put their faith in the medications without their own due diligence because they think it’s got to be okay because the government approved it. The press doesn’t scrutinize the drugs. Even the medical press often doesn’t scrutinize the drug. Then it blows up and the FDA rescinds its approval, and the drug goes off the market. Then the plaintiff’s attorneys start sharpening their knives.
    It’s a bad system. Especially now when information is so widely available and easily accessed. In the pre FDA days, the days of a thousand patent medicines, people were a little more skeptical. And even then, people weren’t dropping like flies from the stuff they took. I’ve had a ton of ancient relatives who went on to their rewards when I was just a kid, and I’ve heard about a zillion more that died before I was born. I can’t remember any of them dying of adverse drug reactions.
    So, I think the FDA makes legitimate treatments impossible to be made available (unless backed by the unlimited wealth of Big Pharma) and gives a false sense of security for those treatments it does approve.
    As it stands now, I don’t see the FDA being dissolved anytime soon, so we’ve got to live with the system we’ve got. And as such, I’m glad the panel turned down rimonabant because I don’t think it’s a good drug.  There are people who will be alive in two years from now who would be dead were the drug approved.  And they don’t even know who they are.
    Cheers–
    MRE 

  6. Thanks for the great article Dr. Eades. And on the topic of obesity, aren’t you just thrilled at what Kellogg’s is announcing to fight child obesity (see the article within Kellogg’s site)? Kind of surrealistic to click on the link within the Kellogg’s website while staring at pictures of their new sweet cereals. Thanks again.
    http://www.kelloggcompany.com/
    David and Susan Futoma
    PS: Keep posting pieces on golf – I love them.
    I was going to post on the Kellogg fiasco right after the leptin post, but you beat me to it.
    It is beyond the pale.  I can’t think of a single thing that Kellogg makes that is healthful for kids (or for anyone of any age for that matter).
    Cheers–
    MRE 

  7. I have no confidence in the FDA whatsoever.
    Back in 1962, my mom did what all good patients did back then, and swallowed without a single thought the FDA-approved pills that the OB prescribed while she was pregnant with me. Now I live with the effects of those pills otherwise known as DES. This was a drug that didn’t do squat and certainly never did what it was supposed to do which was to prevent miscarriages. Why my mother was given it I haven’t a clue. I was her first pregnancy so she didn’t have a history of miscarriages. The other thing that DES was supposed to do was create stronger, healthier babies so that may be why her OB had her take it for nearly the entire length of her pregnancy. And lucky me, I ended up with a very screwed up reproductive system along with several pre-cancerous scares out of the deal. What chaps my hide the most is that by 1962 DES was known to be ineffective but it wasn’t pulled off the market until about a decade later.
    Some days, I shudder to think what might have happened if the drug companies had been able to advertise back then the way they do today:
    “Pregnant? Do you want a strong, healthy baby without the risk of miscarriage? Ask your doctor today if DES is right for you.”
    Indeed.  MD is also a DES baby, but, thankfully, has had no problems from it.
    I can just imagine the ads.  But, if we didn’t have an FDA approving such drugs, the press, and especially the bloggers, would unearth the truth about them.  And people would become responsible for their own health instead of relying on Uncle Sam to tell them what to do.
    And physicians would become more responsible. 

    The phen-fen fiasco would probably have never taken place.  As it was the lawyers decided to eliminate the physicians from all the lawsuits because they could then count on the docs to send them all their records and not be in an adversarial position.  All the docs had to do was to say: Hey, I was prescribing as recommended by the FDA; you can’t blame me.
    Without the FDA the docs would be responsible to ascertain the safety of medications they gave to their patients; and they should be held accountable: they have many years of training that the patients don’t have.  The docs are much better qualified to determine the efficacy and risk of medications than are their patients.
    Don’t get me started.
    Best–
    MRE 

  8. I’m not entirely surprised, but certainly relieved, that you agree with me about the coercive powers of the FDA.
    Next time I should try running the harmful nature of our organ donor system, especially the ban on consensually selling organs, by you.
    Yes, I think that one sucks, too.  If it’s okay to donate a kidney to a relative, why shouldn’t you be able to sell it to the highest bidder?

    MRE 

  9. Not only should that be your right, as it’s your body, but fewer people would die.
    Imagine how hungry we’d all go if farmers were only allowed to grow food out of the goodness of their hearts. Or…well, literally anything else in the world, almost all of which is legal to sell, and therefore possible to obtain.
    But when our LIVES are on the line, suddenly the inescapable rules of supply and demand are forgotten? If people could sell organs, more organs would be available, obviously, by a huge scale. Every single family who loses a person while they wait on the organ list should sue the regulatory entity for causing a wrongful death.
    I am guessing that the anti-capitalist mentality was especially dominant in government at the time that organ transplants became common, producing this horrific system of waiting lists, suffering, and — all too often — death.
    Oh, and the whole thing makes me quite eager to have universal health care, to spread that system to all aspects of our medical lives!
    Well put! 

  10. Dr. Mike, I must weigh in with the Kellogg items above:
    [Mike said: It is beyond the pale. I can’t think of a single thing that Kellogg makes that is healthful for kids (or for anyone of any age for that matter].
    Allow me to go a bit further: I say that the company should probably consider using their products to make ethanol, rather then selling it as food, since using sugar as a feedstock for this fuel is much more efficient than using just corn. They could make a lot of money while at the same time help our country become truly energy self-sufficient; and our citizens would become healthier too. [My wife, watching me submit this comment suggests the following name for the new product: “Ethylogg”]
    P.S. Dr. Mike, if this little comment perhaps fails to pass moderation, I will understand. These are perhaps fighting words for the company involved, although they deserve a lot worse than what has been said here. So if this comment fails to survive, no problem; we can consider it just a personal communication.
    Best,
    Wil
    Hi Wil–
    I agree.
    Cheers–
    MRE 

  11. Youtube Alli spoof (I hope =D )
    ????
    I found one that I’m going to post.  I don’t know if it’s the one to which you are referring.
    Cheers–
    MRE 

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