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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