The Doctor Weighs In

On February 7, the Food and Drug Administration (FDA) approved the first drug for weight loss that is scientifically proven to be effective to be sold over the counter (AKA OTC). That means you can buy it when and where you want. It also means experts deemed the drug safe enough that mere consumers can decide for themselves whether or not they want to use it.

The drug’s generic name is orlistat. It will be marketed under the brand name of Alli. (Alli?) The brand name of orlistat available by prescription is Xenical. It turns out  Xenical has not been a blockbuster for its company, Roche, despite being relatively safe and modestly effective – the average weight loss is 5-10% of body weight).

Here’s why. orlistat works by blocking the breakdown and absorption of fat from the intestine. If you eat a lot of fat while taking the drug, it does not get broken down and absorbed from your gut. That means it stays inside of the intestines and is eventually passed (if you know what I mean) as a greasy stool that floats in the toilet bowl, generally making a mess. The unmetabolized fat that you ingest can also be passed when you fart (sorry, have flatulence). That means smelly, oily, fecal stains on your underpants. I am sorry to be so graphic, but that is just the way it is. Oh, by the way, if you take orlistat, you also have to take a multivitamin because orlistat-induced fat malabsorption can impair absorption of fat-soluble vitamins, vitamin A, E, D and K.

For some people who are motivated to lose weight, these nasty side effects are enough to make them avoid fatty foods. That is good since fat is the biggest calorie bomb of all of the nutrients we ingest. However, lots of folks continue to eat fat and choose instead to give up the orlistat instead.

The FDA, in its wisdom, has approved over-the-counter orlistat to be sold in 60 mg doses, half of the usual prescription dose of 120 mg – like consumers can't figure out that taking two OTC pills is the same as taking one of prescription dose pills. Duh?

Roche has licensed orlistat OTC, Alli, to GlaxoSmithKline (GSK), a pharmaceutical company with lots of experience marketing directly to consumers. Be prepared, there will be, for sure, a barrage of TV and magazine ads with smiling, singing, dancing slim (and beautiful people) telling us how they got slim and beautiful by taking Alli.

According to the NY Times, GSK will package Alli capsules with seven pocket reference guides that “provide advice on meal-planning, what to order when eating out, a fat and calories counter, and a journal for recording daily food intake. GSK will also make available a website, myalli.com, where “customers taking Alli will be able to log in, track their progress and obtain personalized advice.” Alli will sell for $2-3 per day (that is $60-90/month). So, these additional health educational materials are no big deal when it come to profit for GSK.  I am willing to bet that these additional weight loss “aids” will cost the company just a few pennies on the dollar.

And, let’s be honest, folks who turn to Alli probably already know what they should and shouldn’t eat. This is not about a  lack of knowledge.  It is, rather, a matter of will power. Frankly, some of us may be motivated enough to lose weight so that we are willing to take a pill that causes fat malabsorption.  To avoid that, we may forgo dietary fat in order to avoid an oily “discharge” – to the degree that happens, orlistat will be “part of the solution” even though it clearly creates some other problems -- at least for the person who has to do the laundry.

Cynicism aside, overall, I think it is a good thing that orlistat will be available over-the counter. But, heck, I also think statins (lipid-lowering agents) should also be over the counter. We need more low-cost, convenient options to help folks get healthy.

And, by the way, the consuming public can buy lots of things more dangerous than orlistat and statins. As a former emergency physician, I can tell you that aspirin and Tylenol overdoses were far more common causes for ER visits than complications related to statins or concern about fecally stained undies. But no one is advocating changing  these common pain-killers from OTC to  prescription drugs. Why not?  It should come as no surprise that our approach to pharmaceuticals is not grounded solely in patient safety – rather the real driver is$$$$.

While I do think, in the long run, we need a more sustainable solution to the country’s “obesity crisis,” orlistat OTC is one small step that may help some motivated folks lose weight. If you can deal with the “icky” factor, maybe, just maybe, Alli is a drug for you.