New Pharma Drug for Weight Loss Shows How It’s Done
Medical doctors reporting in the journal Diabetes Care on exenatide (an aglucagon-like peptide 1 receptor agonist) concluded that, based on a double-blind, placebo-controlled, crossover 35 week(!) study of 41 obese, non-diabetic women:
“…short-term exenatide treatment was associated with modest weight loss and decreased waist circumference in a cohort of obese nondiabetic women. A subset of individuals demonstrated robust weight loss that was detected very early in the course of treatment.”
Sounds great for the pharma company, as a weight loss pill is considered the “holy grail” of drugs due to the potential for huge demand. For example, 43% of the US population would be less likely to exercise if a magic pill for weight loss were to be found
(See: http://www.americansportsdata.com/pr-fitnessrevolution.asp).
Yet getting a weight loss drug through the FDA approval process has been quite challenging in recent years. In October, 2010, several “promising” weight loss drugs were rejected, including Qnexa (due to psychological issues and increased risk for heart problems and potential birth defects) and Lorcaserin (in part due to data of cancer in test animals). Makers of Qnexa are returning in 2012 with a revised formulation for another try.
Even after FDA approval, keeping a weight loss drug on the market can also be problematic usually due to pesky side effects. Most people are familiar with the drug Fen-Phen (fenfluramine/phentermine), the popular obesity drug that was pulled from the market about six months after its approval in 1997 because of an increased risk of heart valve problems. As a side note, its manufacturer WyethAyerst Laboratories ended up paying out more than $3.75B (that’s billion) in damages due to those pesky side effects. (See http://articles.cnn.com/1999-10-08/health/9910_08_fen.phen_1_heart-valve-pondimin-diet-drug?_s=PM:HEALTH)
In October, 2010, the maker of the obesity drug Meridia voluntarily agreed to remove it from the U.S. market because of increased risk of stroke and myocardial infarction (more heart problems). Further, Rimonabant was also removed as users experienced thoughts of suicide as well as other issues. (See http://abcnews.go.com/Health/Drugs/fda-rejects-weight-loss-drug-Qnexa/story?id=12003374).
Even over-the-counter supplement manufacturers can run into trouble when pesky side effects like dozens of complaints about liver damage/failure and one death crop up. The popular Hydroxycut weight loss product was pulled from the market in May 2009 because of such side effects. Hydroxycut reportedly sold more than 9 million units in 2008, estimated to be worth $180m (that’s $180 million).
Because the opportunity is huge, being able to present a drug as promising while being able to downplay the downsides can do wonders for a pharma company’s future and future stock price. And it can begin the process of gaining positive media momentum as a company moves towards submission for FDA approval.
So what is the positive message coming from researchers of Exenatide? Their conclusion is very positive:
“…short-term Exenatide treatment was associated with modest weight loss and decreased waist circumference in a cohort of obese nondiabetic women. A subset of individuals demonstrated robust weight loss that was detected very early in the course of treatment.”
Does it stand up? When you look at their data, yes, the average users of the new drug lost an average of 2.49 +/- .7 kg (5.5 lbs) while placebo users gained an average of .4 +/- .6 kG (~1 lb). And, yes, a total of 30% of users were “high responders who lost >5% of body weight (mean of -8% +/- .5%).” This appears promising. Although rejected due to side effects, one FDA commissioner remarked that Qnexa showed the greatest promise in the market for weight loss products because users could lose 6-10% of their body weight. So with exenatide showing similar outcomes, especially in the high responders segment, they have a real shot at weight loss drug industry stardom.
But what the data also shows, while reported, is not included in their conclusion. While 30% were high responders who lost more than 5% of their body weight, according to the researchers, “…39% were moderate responders who lost <5% body weight (−2.43 ± 0.45%), and 31% were nonresponders who gained weight (1.93 ± 0.53%).”
Doing the math, nearly 7 of 10 people who took the drug averaged a loss of a 1/2% of body weight (~1 lb for a person weighing 200 lbs). About one pound. In 35 weeks. After taking a “weight loss” drug once per day, every day, for 245 days.
I don’t know about you, but I would think that if my marketing slogan was “I can help 7 of 10 people drop 1 lb or more in 8 months by taking my super weight loss drug pill”, my customers may not be too impressed.
But this is how it’s done. The data is real. The focus is on the average 8% loss of body weight (16 lbs for a 200 lb person) over 8 months, by just taking a pill. Beautiful. Yet let’s check that data again. The number of people tested was somewhat small (sample n=41). If the researchers split the groups into a placebo group and the active pill group, then 21 people took the active pills. Then, if 30% dropped an average 8% of their body weight, that means just 7 people (.3 x 21) achieved the phenomenal results. Even if the group was split 30 active and 11 placebo, we’re still talking at most 9 people.
7-9 people.
Because their side effects appear limited (“Subjects experienced more nausea during exenatide treatment compared with placebo, but the severity decreased over time and did not correlate with weight loss.”), the company stands a good chance of getting approval. I wish that company good luck. If approved they will probably make millions, even hundreds of millions of dollars on their drug. Because doctors will issue prescriptions and insurance companies will pay, patients will take the weight loss pill because it may work and hey, it doesn’t cost anything other than a co-pay– like maybe $10-$20/month. For 8 months. For a one out of three chance to drop 8% of your body weight.
So what does it say about Loving Works and the Weight Balancing System when we can help more than 6 of 10 of our customers release 16 lbs in 8 weeks, without side effects?
You get to decide.
Read Full Post | Make a Comment ( None so far )
