The Life Ledger

Fitness is a way of life.

The FDA released a news alert today about purchasing Ambien and other drugs over the Internet.  Apparently, some people who order these drugs are instead receiving Haloperidol, an anti-psychotic drug used to control symptoms of schizophrenia and other neurological disorders:

The Food and Drug Administration (FDA) has become aware that a number of Americans who placed orders for specific drug products over the Internet (Ambien, Xanax, Lexapro, and Ativan), instead received a product that, according to preliminary analysis, contains haloperidol, a powerful anti-psychotic drug…  Haloperidol can cause muscle stiffness and spasms, agitation, and sedation…  FDA laboratory analysis of the misrepresented tablets is ongoing, but preliminary analysis indicates they contain haloperidol, the active ingredient in a prescription drug used primarily to treat schizophrenia.

More at the FDA’s site.

Honestly, I have no idea why the hell someone would buy prescription meds off the Internet anyway.  Why do people feel they have the knowledge and education to self-medicate??  Personally, I think a lot has to do with advertisements - now that pharmaceuticals advertise directly to consumers, they feel empowered and emotionally hooked.  They see fluttery luminescent butterflies, cholesterol scores dropping and couples holding hands in floating bathtubs.  They hear a list of “common side effects include” and feel empowered to make the decision for themselves to balance side effects versus the perceived benefits.

“Ask your doctor for Requip.”  In years past, your doctor would spend a good half an hour doing a basic yearly exam, taking time to diagnose and treat your body as a whole, not just the symptoms you display.  Now, people see commercials, decide for themselves they suffer from all kinds of ailments, and doctors who are tired of fighting their patients simply fill out the prescription.  Soon you’ll be paying your $68 doctor’s visit fee to your television.

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All this news about alli and I’m wondering, how many people are actually considering taking this new drug? If you don’t mind, take a second and vote here, and pass this around to your friends and myspace buds.

If you’re viewing this in a feed reader, you may have to read this post to see the poll.

Have comments about alli? I’d love to see them - you can leave us comments below.

What do you think about alli? Take my poll.

I’ve been thinking a lot about GSK’s orlistat/alli since the FDA released their approval last week, and I believe alli is only half of GSK’s plan for orlistat.  The other half?  Multi-vitamins.

I’ve talked a little about alli in general; I even did some math to figure out exactly how many calories alli will block - around 180 calories per day based on a 2300 cal/day diet and following GSK’s recommended maximum fat consumption.  If someone can simply drink one less Mountain Dew a day and get the same benefits as taking alli without all the nasty side effects, why is GSK spending the money to bring alli to the market?

Alli will be marketed as a weight-loss pill lifestyle-change pill.  Broadcast advertisements for OTC drugs are regulated by the Federal Trade Commission, as opposed to ads for prescription drugs, which are regulated by the FDA.  Under the Federal Trade Commission Act:

• advertising must be truthful and non-deceptive;
• advertisers must have evidence to back up their claims; and
• advertisements cannot be unfair.

Because the FTC carries a less-onerous test for drug advertising, GSK will be able to make much craftier claims about the drug and have much more leeway than Roche had with Xenical.  Specifically, there is no requirement for listing side effects, limitations in use and a balance between effectiveness/advertising and indications/side effects.  Likely, we will soon begin seeing commercials that focus on losing 8lbs for every 5 you would normally lose.  If they’re crafty enough, they’ll even create an emotion-based illusion that the alli pill inspires the lifestyle changes suggested by the myalli.com program without the hard work associated with making lifestyle changes.  Effectively, they will market a lifestyle-change pill.  Never mind the skidmarks.

GSK sells multivitamins.  Since alli blocks fat, it will also block the body’s ingestion of fat-soluble vitamins, like A, D, E and K.  If I were a marketing consultant at GSK (and surely they’ve already thought of this), I’d be putting this fact in all alli literature as a preemptive disclosure and use it to my advantage by selling multivitamins either stocked next to alli on the shelves or even boxed with alli as a “kit.”  GSK already sells multivitamins in the US - Geritol already has A, D, E and K in the formula.

So, let’s do a little more math.  We’ll take that unscientific MSNBC poll I mentioned before - 59% of 137,301 respondents are in favor of taking alli.  Walgreens sells Geritol Complete for $5.00 per 40 pills.  If just the 81,008 respondents polling favorably take alli along with Geritol Complete, that’s an additional $405,040.00 per month for GSK - and that’s just based on 137,301 respondents.  I’m betting it won’t be long after alli’s release that GSK releases a specially-formulated multivitamin containing just the fat-soluble vitamins (and omega-3 for buzzword recognition), and I guarantee their profit margin will be higher on that pill.  Using organic growth methods, GSK will double their consumer base using a complementary pill they already manufacture - no R&D cost, very little marketing cost, very high profit margin.

All in the name of Americans refusing to eat one less hotdog a day.

What do you think about alli? Take my poll.

Dr. Sanjay Gupta has written a short article over at CNN about Orlistat / OTC alli.  Among the more poignant (and sure to be lost once the advertising starts airing during Wheel of Fortune) points in his laundry-list of “things you should keep in mind before considering this drug:”

1) Diet and exercise are still going to be your longest-lasting weight-loss solution.

2) The manufacturers of alli and the FDA emphasize that this medication cannot work alone. It must be combined with low-fat diet and multivitamin taken at bedtime.

5) This is not a miracle drug. You will still have to work for the weight loss.

10) And the big question: How much will you lose? Expect modest weight loss. If you lose 5 pounds through diet and exercise, the FDA says you can expect to lose 2 to 3 more pounds by taking this pill. By the way, the weight loss plateaus after six months.

4 out of 10 items echo the sentiments I’ve previously discussed and are growing in the blogosphere - the drug provides minimal weight-loss assistance and is not intended as a weight-loss pill.  That won’t stop GSK from skirting penalties from the FTC when advertising it as a weight-loss pill, and it won’t stop people from buying it in droves.

In fact, I suspect most people trying this drug will be those needing to drop 10-40 lbs before the wedding/birthday/cruise/date, who would otherwise turn to dietary supplements, who have no intention of implementing the lifestyle changes recommended by GSK, and look at the weight-loss as a short-term cosmetic refresher. 

According to a MSNBC Live Vote (not scientific, of course), Americans are pretty excited about putting skidmarks in their undies - currently 59% of 137301 respondents are in favor of taking OTC alli, 15% are against and 25% are unsure.  Personally, I’m still skeptical - messing with my body’s natural internal plumbing by ingesting God knows what just isn’t worth the extra couple of pounds.

What do you think about alli? Take my poll.

The FDA approved an over-the-counter version of Orlistat today, alli.  My opinion?  Eat less, exercise more, keep a journal, and pocket the money you would spend on alli.  Even the FDA says

“This drug is only going to be effective if it’s used along with a weight-loss program,” [Dr. Charles J. Ganley, the FDA's director of the Division of Over-The-Counter Drug Products,] said. “That means a reduced fat diet, decreased calories and an exercise program.”

 

“If someone uses the drug without a weight-loss program, it’s not going to be very effective,” he added.

Why do I think this drug is stupid and useless?  Let me break it down:

It will be marketed as a weight-loss pill, but it still requires lifestyle eating changes.  Calorie-counting, general awareness of the fat and caloric content of the foods you eat, limiting your caloric intake, reading labels, exercise - these are all lifestyle changes suggested by GSK before taking Orlistat / alli.  In fact, the pill itself is being promoted as only one part of a package:

Unlike other products on store shelves, alli is a proven medicine with a comprehensive support program. To help consumers get off to a successful start, the alli package will include Welcome and Companion Guides, a Guide to Healthy Eating, a Daily Journal, a Calorie and Fat Counter, Quick Fact Cards, and free access to an individualized online action plan at myalli.com.

 

“With alli, we’re excited to offer a revolutionary approach to weight loss,” says Steven L. Burton, Vice President, Weight Control, GlaxoSmithKline Consumer Healthcare. “alli is more than a pill - it’s a comprehensive program that works in conjunction with a sensible diet to increase weight loss. Because weight loss doesn’t happen overnight, we’re starting to educate consumers now about the importance of realistic expectations, gradual weight loss and lifestyle changes. That’s the way to see results, and with alli, we know they can do it.”

A comprehensive program in a bottle?  I can just implement the components of the program and lose weight without the side-effects of taking patent medicines.  When the pill is marketed, regardless of what verbage GSK puts in their commercials to appease the FTC, people will react to alli as if it’s a magic weight-loss pill, take it until their digestive side-affects become too unbearable, and stop - all without making the necessary lifestyle changes.  Meanwhile, GSK makes a killing - until the inevitable class-action lawsuit, of course.

The suggested maximum fat intake alone will help people lose weight without alli.  Quoting from the GSK alli press release,

Taken at meal-time, alli works by blocking about 25 percent of the fat in the food a person eats. Because of the way it works, alli must be used in conjunction with a reduced-calorie, low-fat diet containing about 15 grams of fat per meal.

MedlinePlus adds the following:

Each time you take orlistat, your meal should contain no more than about 30% of calories from fat.

Fat is 9 calories per gram.  By cutting your fat intake per meal down to GSK’s recommended allowance, you are limiting your meal to 135 calories from fat.  If you’re eating a daily caloric amount of 2300 calories, for instance, you are limiting your daily fat intake to 690 total calories before even taking the pills.  I would guess that change alone will account for substantial weight-loss in most people taking this pill!  As quoted above, the pill blocks 25% of your fat intake during meals.  So, the pill will block a futher maximum amount of 172.5 calories a day.  Realistically, you could cut 180 calories out of your daily eating and have the same benefits of the pill, without the disgusting side-effects. 

I talked about lifestyle diet changes required before even taking this pill.  Let’s look at some foods you can no longer eat.  An obvious one is fast-food: KFC (153 [or 45%] calories from fat per serving, original recipe chicken) is out.  McDonalds fries (270 [or 47%] calories from fat per serving), burgers (263 [or 32%] calories from fat per sandwich [105g]) - even some salads (asian salad has 90 [or 29%] calories from fat per serving) are all out.  I doubt anything else is good - it’s all smothered in dressing, cheese, refried beans and breads.  Classic Americana cuisine like peanut butter & jelly sandwiches (one serving of peanut butter has 145 [or 72%] calories from fat per serving) and hot dogs (167 [or 52%] calories in one dog w/bun and ketchup) are also too high in fat content.

So those are all “unhealthy foods” we shouldn’t be eating anyway.  Did you know the average salmon has 56% calories from fat per serving?  Lean top sirloin has 30% calories per serving?  Sure, salmon might have “good fats”, but it’s still fat, which leads me to my next problem with alli:

Orlistat makes no distinction between which fats are blocked.  Our bodies need fat.  Some vitamins are fat-soluble (like A, D, E and K).  Fats are important to cellular health and hormonal function.  Monunsaturated fats may protect against heart disease.  Orlistat blocks 25% of all fats, which may block our intake of fat-soluble vitamins and have other affects we aren’t yet aware of.  It also indirectly promotes the use of multivitamins and herbal supplements, which may not be as healthy or reliable a source of vitamins as food.  (As a related side note, I’m finishing Dan Hurley’s Natural Causes, a fascinating book that I’ll talk more about later.)

Orlistat only blocks calories from fats.  High-fructose corn syrup, carbohydrates, starches, simple sugars - many sources of weight gain are not blocked at all.

Orlistat is “taken with meals”, but we consume fats and calories from drinks too.  The Coffee-mate powder sitting in my desk has 3g of fat per serving, or 25(4%) - one serving is 4 tsp, and I doubt I use just 4 tsp per cup of coffee.  1 bottle of Dr. Pepper has 150 calories and none from fat - all 150 calories slip right on through, Orlistat or not.  Whole milk has 146 calories per cup, 71 from fat - if not consumed with a meal, Orlistat doesn’t help block those fats either.  People on alli may become a little more conscious of what they eat, but still drink beverages high in syrups and calories.

The alli way: make lifestyle changes, spend $25/week to lose up to 50% more pounds per week than lifestyle changes alone, and have runny underwear and gas.

My way: make lifestyle changes, invest $25/week in a 5.05% APY savings account (which will leave me with approximately $1260 at the end of the year - almost a Disney trip!), and enjoy clean underwear.