This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
TheStreet Open House

EnteroMedics: Fat Zapper or Pulsing Placebo?

Stocks in this article: ETRM ARNA VVUS

The primary endpoint of the study was to demonstrate significantly greater "excess weight loss" (EWL) in the VBLOC treatment group compared to the control after 12 months.

EWL was calculated as a percentage equal to total weight loss in the trial (the numerator) divided by the difference in baseline weight and "ideal weight" using a BMI of 25 (the denominator.)

Initial EMPOWER study results were first reported in 2009 and published fully in Obesity Surgery three years later. The EWL for VBLOC-treated patients was 17% compared to 16% for control patients. Clearly, there was no statistically significant difference at all in excess weight loss between the two groups.

EnteroMedics has never disclosed or published actual numerical weight loss data from the EMPOWER study. However, if I use the same 5' 4" woman weighing 240 pounds as a typical patient, a 17% EWL translates into weight loss of 16 pounds, or 6.7% from baseline. That's slightly better than what you'd expect to see from Arena's Belviq but less than Vivus' Qsymia.

The sham device's 16% EWL translated into 15 pounds of weight loss, or 6.3%. Using our typical female patient as an example, once again.

EnteroMedics blamed the negative results on the unexpectedly high weight loss in the control group. Somehow, the low-intensity electrical signal of the control VBLOC devices contributed to weight loss, the company said.

Better performance (higher EWL scores) was also correlated directly with increased device usage in both the treated and control patients. Patients who used the active VBLOC device for more than 12 hours per day reported an EWL of 30% compared to 22% for patients using their control devices for more than 12 hours.

EnteroMedics' explanation for the negative EMPOWER study results don't fully gibe with the published data. At various times during the study, control patients lost more weight than actively treated patients. This is particularly true for patients who were more compliant (VBLOC use greater than 9 hours per day) and in patients who lost the most weight.

For instance, 30% EWL was achieved by 28% of VBLOC patients but 37% of control patients. At 35% EWL, the trend reverts back to VBLOC's advantage (23% vs. 20% of patients -- still close.) The same percentage of VBLOC and control patients (18%) achieved 40% EWL.

Looking at the published EMPOWER data, not only was the control VBLOC device active but at multiple times during the study, it was superior to the fully operational (and presumably more effective) VBLOC device. EnteroMedics has never offered an explanation for these data.

A more plausible, logical explanation for the negative EMPOWER results: VBLOC doesn't induce weight loss. Instead, patients who enrolled in the study lost weight through a mixture of placebo effect, adherence to healthier diet and more exercise.

Obese patients willing to have a device surgically implanted are going to be motivated to lose weight -- and they did just that in equal amounts in the treated and control arms of the study overall.

2 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Jim Cramer and Stephanie Link reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

Jim Cramer's protégé, David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
Try it NOW
Try it NOW
Try it NOW

Check Out Our Best Services for Investors

Dividend Stock Advisor

Jim Cramer's protégé, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

Our options trading pros provide over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
Try it NOW
Try it NOW
Try it NOW
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,164.95 -251.90 -1.45%
S&P 500 1,994.99 -26.26 -1.30%
NASDAQ 4,635.24 -48.1670 -1.03%

Partners Compare Online Brokers

Free Reports

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs