Your priorities are showing

From Broadsheet: looks like the FDA doesn’t like fat chicks: an advisory panel of the FDA has endorsed over-the-counter sales of orlistat, otherwise known as the prescription diet pill Xenical:

An FDA advisory panel voted 11-3 late Monday to recommend that the regulatory agency approve the nonprescription form of orlistat, which Glaxo would market as Alli (pronounced ”ally”). The agency is not bound by the recommendation but usually follows the advice of its expert panels.

”We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss,” Quesnelle said.

When taken with meals, orlistat blocks the absorption of about one-quarter of any fat consumed. That fat — about 150 to 200 calories’ worth — is passed out of the body in stools, which can be loose as a result. About half of patients in trials experienced gastrointestinal side effects, the company said.

What kind of gastrointestinal side effects? Glad you asked:

A bevy of potentially distasteful and embarrassing side effects struck about half the participants in trials of the drug. Those side effects, including fecal incontinence, gas and oily discharge that spotted the undergarments of trial participants, are likely to limit the appeal of the pill.

”Have you considered placing a warning on the box, ‘Don’t take this product while wearing your new La Perla underwear?”’ panel chairman Dr. Alastair Wood, referring to the Italian brand of lingerie, asked company executives.

You’ll be crampy, gassy, leaking grease from your anus and unable to control your bowels, but by damn, at least you’ll be thin!

Or will you?

Glaxo officials cautioned that orlistat is no magic pill: In six-month clinical trials, obese people who took the pills lost on average 5.3 pounds to 6.2 pounds more than did those who were given dummy pills. Once they ceased taking the drug, its effect stopped and they began to regain the weight they had lost, said Dr. Julie Golden, a medical officer in the FDA’s division of metabolism and endocrinology products.

Six pounds. Oily anal leakage for six bloody pounds. Which won’t stay off unless you keep taking the drug that gives you greasy runs and wrecks your undies.

But the gastrointestinal turbulence isn’t all that may be a problem:

Several panel members said they were concerned about the potential for abuse, especially by teens, as well as possible interactions with other drugs. Those drugs include cyclosporine, used by organ transplant patients, and warfarin, a blood thinner.

”In my mind there are some profound safety concerns regarding cyclosporine and warfarin and I think the labeling needs to be very explicit and very conspicuous to inform people about these possible safety hazards,” said panel member and consumer representative Sonia Patten, an anthropologist at Macalester College in St. Paul, Minn.

Dr. Sidney Wolfe of the watchdog group Public Citizen urged the panel to reject the company’s application, calling it a ”desperate attempt to revive this barely effective drug by an OTC switch.”

Okay, so here we have a drug that’s not terribly effective, has unpleasant if not dangerous side effects for half the people who take it, has potentially dangerous drug interactions, and a high potential for abuse, especially by teenagers.

So the FDA advisory panel is A-OK with it being sold over the counter, and it seems likely that the FDA will go along with the committee’s advice.

Yet I seem to recall another drug, one that’s much more effective, has fewer side effects, has been used successfully for many years and also approved by an advisory committee. A drug that nonetheless remains prescription-only because top officials at the FDA overrode the panel’s recommendations, citing concerns about teenagers getting hold of the drug. That would be Plan B:

From 1994 to 2004, F.D.A. advisory committees reviewed 23 applications to switch drugs from prescription to over-the-counter status. Plan B was the only one of those 23 in which the agency went against the committee’s advice.

Dr. Galson said in a May 2004 news conference that while he had consulted other top officials at the agency, the decision to reject the Plan B application was his alone. He decided to issue a “non-approvable” letter to Barr, he said, because only 29 of 585 participants in a Barr study of the drug had been ages 14 to 16. None was under 14.

Dr. Galson said younger teenagers might act differently than older ones and might engage in riskier sex if they knew an emergency contraceptive was easily available. The company needed more data to ensure that this was not true, he said.

But surely it’s safe to give teenagers, at prime age for body dysmorphia and eating disorders, access to a potentially harmful diet pill. But letting them have EC? Would be putting them at risk.

Here’s the lesson I’m drawing from here: the cultural imperative to be thin is so strong that the FDA is willing to put out a product that’s not terribly effective, prone to abuse, and potentially dangerous. Because there is no risk or discomfort too great to be endured for the sake of being thin. And heavens, no, we’ve never had any problems whatsoever with FDA-approved diet pills **coughphen-fencough**!

And people are going to buy it, and abuse it, mark my words. We live in a society where trolls like the ones who were posting about Jill can think of no graver insult to a woman than to call her fat, knowing that it stings no matter how secure she is in herself. Where one’s weight is subject to scrutiny and criticism and is used by health professionals as a proxy for health even in the absence of any other indicators of health — I know that if I went into my doctor 50 pounds thinner than I am now, he’d be happy and wouldn’t question how I’d lost it, even if it was all due to taking something that made oil leak from my ass or starving myself. But if I were running 10 miles a day and eating healthy but still the same weight, I’d get a lecture about my weight and no acknowledgement of my healthy habits.

And on the other end of it, we also live in a society so afraid of women’s sexuality that something like Plan B, safe and effective, is kept away from the public out of feigned concern for teenagers. Can’t have them thinking that sex doesn’t have consequences. Can’t have them thinking that they can escape public approbation for their sluttiness. Can’t have them thinking they can control their own bodies.

So, skinny is good but slutty is bad.


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34 Responses to Your priorities are showing

  1. Thomas says:

    Zuzu, I feel like I ought to add something, but you’ve covered it so well. They will let people take dangerous weight-loss drugs that do more harm than good because there is so much social support for getting thin by any means, but anything that decouples sex from pregnancy or disease is criticized as “dangerous” even when the “danger” is not medical at all but rather an affront to conservative views of social roles and sexual mores.

    About women and weight: one of my deepest frustrations in life is that my wife can’t be happy with her body. She’s a rubenesque woman. She beats herself up for it. She uses the F word, which I never use. She’s mean to herself and judgmental of other rounder women. She often asks rhetorically why she can’t just take a pill to be thin, and I remind her that the pill that works causes heart-valve damage. I’m fine with her just the way she is. If she wants to lose weight, I’ll support her (and I’ll go on weightwatchers with her and exercise with her), but I really just want her to be able to feel good and sexy and beautiful whatever weight she’s at.

  2. piny says:

    This sounds like the chemical they were using to make chips a few years back–Olestra and Olean. Same mechanism, and same indigestibility problems, although IIRC those were actually indigestible fats.

    Six pounds. Oily anal leakage for six bloody pounds. Which won’t stay off unless you keep taking the drug that gives you greasy runs and wrecks your undies.

    I’m pretty sure that “obese” means more than six pounds overweight. And how does this affect your ability to absorb other parts of your food? Can long-term use damage your intestines?

    And people are going to buy it, and abuse it, mark my words. We live in a society where trolls like the ones who were posting about Jill can think of no graver insult to a woman than to call her fat, knowing that it stings no matter how secure she is in herself. Where one’s weight is subject to scrutiny and criticism and is used by health professionals as a proxy for health even in the absence of any other indicators of health — I know that if I went into my doctor 50 pounds thinner than I am now, he’d be happy and wouldn’t question how I’d lost it, even if it was all due to taking something that made oil leak from my ass or starving myself. But if I were running 10 miles a day and eating healthy but still the same weight, I’d get a lecture about my weight and no acknowledgement of my healthy habits.

    This is what worries me. I suspect that people will start taking this stuff precisely because it punishes the stomach. Laxative abuse is already common.

  3. zuzu says:

    I’m pretty sure that “obese” means more than six pounds overweight.

    And did you notice, that was the amount over the six-month study? So a pound a month, or about half a pound a week. 250 calories a day.

  4. Marksman2000 says:

    It ain’t natural. I don’t trust the FDA, nor do I trust doctors.

    If you need to lose weight, exercise more and eat less. There is no safe magic pill.

  5. piny says:

    And did you notice, that was the amount over the six-month study? So a pound a month, or about half a pound a week. 250 calories a day.

    Oh, that’s just ridiculous.

  6. How about the FDA approves both drugs for OTC, and individuals with a brain in their head get to decide what they’d like to take. It’s interesting that same argument that doesn’t wash for teenagers about plan B – “what if they think it gives them license to have risky sex?” – is used in your argument to slam Alli (“a high potential for abuse, especially by teenagers”). Teenagers can – and do – already abuse laxatives to achieve similar effects. Shall we “protect” them from those substances as well?

  7. Thomas says:

    a pound a month would be a quarter pound a week. Meanwhile, I managed once to drop 45 lbs at better than a pound a week, gradually, just by reducing my caloric intake and getting regular exercise. No oily anal leakage.

    Of course, when work got crazy and I started stress-eating in the conference rooms again, I put it all back on. But that’s another issue.

  8. a nut says:

    The FDA also wants to ban some non-prescription inhalers because they are harmful to the environment. Why do they care about this now? Especially when most of the inhalers on the ban list have been around for decades?

    Yeah, I do think their priorities are a little screwy, the *fat* pill v. Plan B being a perfect example.

  9. Starla says:

    Things like this just bother me. We have a society that is so obsessed with body image that we promote possibly dangerous or even dangerous products to come out onto the market, but yet that same society is so puritan in its outlook on sex.

    Care about how you look, but don’t think twice about sex! Don’t those kind of go hand in hand? I mean, I like to think that looks don’t particularly matter, but we as a society, usually try to look our best to attract someone of the opposite or same sex, whether it be for a relationship or a one night stand or even just a friendship.

    So here you go folks, work really, really hard to get that killer body, but don’t share it with anyone but yourself, unless your married because then it’s okay.

    Sheesh.

    Oh, and as far as the word fat goes, I embrace it. I’ve been on both sides of the spectrum skinny/thin to chubby/fat. I use the word fat to describe myself because that is what I am. Just like someone is tall or short or tan or pale. Some people are fat, it’s a descriptive word, nothing more. The word fat is damaging to oneself only if you let it be.

  10. zuzu says:

    It’s interesting that same argument that doesn’t wash for teenagers about plan B – “what if they think it gives them license to have risky sex?” – is used in your argument to slam Alli (”a high potential for abuse, especially by teenagers”).

    I’m not sure if you misunderstand me or missed the snark. The advisory panel for Plan B endorsed the application for OTC status, but Dr. Galson swooped in and vetoed that on the grounds that it might encourage teenagers to have sex. That had nothing to do with the safety or efficacy of the drug, or of potential abuse of the drug. In fact, there was limited information available for assessing whether the availability of the drug OTC would in fact increase risky sexual behavior in young teenagers.

    Now we have a case where the FDA seems to have ignored concerns about teenagers abusingthe drug under consideration for OTC status, particularly in light of the side effects and a well-documented history of diet drugs and laxatives being abused.

    A bit inconsistent, no? If protecting teenagers is the standard by which drugs are granted OTC status, it would seem that the diet drug rather than the EC should be turned down. But the fact that the diet drug will be approved while the EC will not just highlights the bogusness of the reasons given for denying the Plan B application.

  11. I heard about this the other night. What kills me is that you go through all this drama for 6 pounds? Pfft.

    It would actually be better to stay fat, somewhat active, and stay at a consistent weight, than to get on this drug, suffer all the known (and god knows whatelse) side effects, to loose the weight, then just gain it back.

    I consider this as big as a scam as the BMI. Everyone KNOW that shit doesn’t work, but the insurance companies pushed for it, now everyone uses it…even though it’s completely useless.

  12. Lauren says:

    I, for one, remember the Olean/Olestra trend. My poor bowels remember it as well.

  13. piny says:

    I’m not sure if you misunderstand me or missed the snark. The advisory panel for Plan B endorsed the application for OTC status, but Dr. Galson swooped in and vetoed that on the grounds that it might encourage teenagers to have sex. That had nothing to do with the safety or efficacy of the drug, or of potential abuse of the drug. In fact, there was limited information available for assessing whether the availability of the drug OTC would in fact increase risky sexual behavior in young teenagers.

    By that standard, the FDA wouldn’t just have to ban this drug because of the potential for abuse. They’d have to ban all diet drugs because they might give people license to eat more.

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  16. piny says:

    I, for one, remember the Olean/Olestra trend. My poor bowels remember it as well

    .

    I don’t think my parents allowed that shit in the house.

    I remember reading about it, though. It’s just…why would you upset your stomach on purpose? Doesn’t that sound like it could cause problems? What about chronic irritation?

    Gah.

  17. Kyra says:

    By that standard, the FDA wouldn’t just have to ban this drug because of the potential for abuse. They’d have to ban all diet drugs because they might give people license to eat more.

    Exactly. They ought to ban or approve things based on how well it does what it’s supposed to do, and how well it avoids causing harm in the way of severe side effects. Other than that, they shouldn’t screw it up for all of us based on how you worry that some people *might* use it, and they shouldn’t classify normal use as “abuse,” just because of their moral issues with the age of the people engaging in that normal use.

    It is supposed to prevent pregnancy up to three days after intercourse, and it does that very well. There are no significant side effects. And fucking while teenaged is not a crime. Having sex and then preventing pregnancy does NOT cause greater harm than having sex and then getting stuck an unwanted pregnancy.

    In any case, they need to approve it because the way in which it’s being distributed now is already causing widespread abuse, specifically by pharmacists who override doctors’ orders without having the authority to do so. Not having Plan B when you need it is FAR more harmful than having it when you don’t. In any case it doesn’t make you high or make you lose weight or do anything else that might lead people to want to take it even if they don’t need it. And if you’re going to need pregnancy prevention often, it’s much more cost-effective to use the Pill.

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  19. Chet says:

    Grrr…. Olestra.

    If the bag of damn Doritos had said “Warning – may cause you to crap yourself, with no warning, right in the middle of a Wal Mart”, I doubt I would have eaten them. How was there not an FDA warning on those things? I didn’t even draw the connection until years after the embarassing event in question.

  20. Lauren says:

    “Warning – may cause you to crap yourself, with no warning, right in the middle of a Wal Mart”

    Oh my. I once blacked out in the chip aisle at the grocery store, but that doesn’t even compare. On the other hand, I know a guy that shat himself at a corporate lunch and managed to hide it from his coworkers.

  21. fattest says:

    is that alli=”ally” pronounced the same as “ally mcbeal”? How scarily appropriate, no? Maybe the FDA thinks us fat chicks are so dumb we’ll think a 6 pound weight loss will make us as thin as ally mcbeal.

  22. Helen says:

    Fattest Says: …
    is that alli=”ally” pronounced the same as “ally mcbeal”? How scarily appropriate, no? Maybe the FDA thinks us fat chicks are so dumb we’ll think a 6 pound weight loss will make us as thin as ally mcbeal.

    Yes, I thought that too… Also, “Kirstie Alli”?!

  23. zuzu says:

    I think it’s supposed to be prounounced ally, like it’s your ally in the Fight Against Obesity Because Obesity Is The Enemy And Must Be Stopped.

    Though I’m sure the though crossed somebody’s mind that people would mispronounce it and think of Calista Flockhart.

  24. We blogged about this on Body Impolitic today. I’m especially furious about the effects on teen age girls. This will be awful enough for girls with “body images issues”. I don’t even want to think about how this combines with anorexia and bulimia

    Since this hasn’t been approved for over the counter sale yet, this is a good time for a letter writing campaign to the FDA!

  25. Amanda says:

    Margaret Cho’s latest video has her doing a bit about taking pills that made her crap herself. Quite funny, highly recommended.

  26. Marksman2000 says:

    Call me a skeptic.

    I won’t even use margarine or anything close to it, much less some drug the FDA approves on a whim.

    10 years from now when it starts to cause gastrointestinal cancer in 3% of the people who take OTC, I’ll say, “I told you so.”

  27. Peggy Nature says:

    One thing that concerns me is the effect of this drug on the fat-soluble vitamins (A,D,E, and K.)

    In fact, this abstract at PubMed indicates that the drug could complicate vitamin D absorption in adolescents.

    http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12126214&dopt=Abstract

    Now, I don’t know if they are planning to market this widely to be used for young people, or if that’s just one small segment of the market they are targeting, but have any of y’all ever heard of RICKETS? That’s what vitamin D deficiency can do to people whose bones are still forming. This is more of a concern for younger children who are going through rapid bone growth, but bones continue to form in adolescents until the early 20s (approximately.) So, ostensibly, this could affect teenagers too, if not handled properly.

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  29. piny says:

    Now, I don’t know if they are planning to market this widely to be used for young people, or if that’s just one small segment of the market they are targeting, but have any of y’all ever heard of RICKETS?

    Best class-action lawsuit ever.

    I’d be worried, as well, about chronically irritating your stomach lining and the lining of your intestines. That could definitely affect your ability to absorb nutrients.

  30. Elizabeth says:

    The key question is, when they did clinical trials, what fraction of the participants were teenagers?

  31. Courtney says:

    You know, if they sold these pills along with an adult diaper coupon maybe people would get the hint. It would be a lot more attention grabbing than the fine print on the back of the bottle. HeeHee!

    Great site!

  32. Peggy Nature says:

    Oooh Courtney…that’s a great idea for a bit of activism. Maybe people could hang around outside the door with a big sign that says,
    “ADULT DIAPERS – FREE SAMPLE UPON SHOWING YOUR RECEIPT FOR ALLI.” And anyone gutsy enough to show their receipt, well…free diapers!

  33. Jackie says:

    This sounds like the chemical they were using to make chips a few years back–Olestra and Olean. Same mechanism, and same indigestibility problems, although IIRC those were actually indigestible fats.

    Olean, NO THE HORROR, THE HORROR! Man, I hate Olestra, it’s like, the oil of Satan. Or something.

  34. Mary Garden says:

    About Olean/Olestra – – -it didn’t die! Frito-Lay has put the old anal-dribble chips back on the shelf and labeled them “Light” in a deliberate ploy to sucker people into thinking they were buying something more benign. They are being sued by someone in Massachussetts.

    The story is online at the Center for Science in the Public Interest: http://www.cspinet.org/new/200601041.html

    Thanks for an excellent post, Zuzu! Though I rarely comment, I am a long-time reader, and I’ve always looked forward to reading your comments on subjects that interest me. I’m glad you’re getting a star turn here!

    MG

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