Saturday, February 7, 2009

Obesity to Yield Blockbuster Profits

"One drug expert calls the market the "biggest untapped goldmine in the industry" and speculates that it would be worth $10 billion per year."

Last October 2008, during the throes of the meltdown of the financial markets, I began subscribing to an online publication called MoneyMorning. I did so not because I own or purchase stocks, but rather, because the authors displayed a keen sense about the economy and market trends, as confirmed by other articles I read elsewhere. My romance ended today when I received advertising in my email inbox, which mailing included the following:

“On March 30th, there'll be an announcement of FDA results for a new drug that could create the single biggest return of any investment we've ever found, in 10 years.”

“Quite simply, we expect approval for a new drug unlike anything to ever go public in the 81-year history of modern biotech. It's a drug that simply hasn't existed, in any useable form ... until the company I'm telling you about invented it.”

“So far - the drug has successfully cleared both Phase 1 and 2 FDA clinical trials and and is just weeks from the announcement of Phase 3 results... the last trial before it could launch on a scale potentially unseen since the release of penicillin.”

“In short: as of Dec. 15, 2008, early clinical results suggest the drug is safe...has a near-perfect success rate... has a 500% efficiency... and finally, get this: will target 45% of the U.S. population - almost 1 out of 2 Americans.”

“In other words: if the results are positive for this new drug on March 30th as we expect ... a single stake in this company could make you a fortune, overnight. We estimate as much as $195,600... but only if you get in right now…”

“Big Pharma is pouring tens of millions into the effort. Many speculate a drug that successfully treats this problem … would be, "the last of the traditional blockbusters...drugs that weigh in over $1 billion annually."

“One drug expert calls the market the "biggest untapped goldmine in the industry" and speculates that it would be worth $10 billion per year. That's why shares of the little drug developer I've been telling you about could go through the roof on March 30th, on the announcement of Phase 3 test results.”

“With just a single pill...it lowers the patient's weight by at least 5% (the golden mean in weight loss). If a patient can lose 5% of fat - academic studies have shown that this significantly lowers blood pressure...risk of heart disease, and other harmful effects like diabetes... arthritis...and stroke.”

“Even more amazing - unlike almost every other weight-loss alternative, the drug works without a single ounce of effort from the patient... In other words: It requires no exercise ... no special diet ... and no risky operations in the hospital. You simply swallow the pill on a full or an empty stomach.”

Stunned and disgusted, I unsubscribed immediately. And here's why: The missive in my mailbox constitutes false and misleading advertising for a nummber of reasons. As a threshold matter, the advertised company is not the only one in a race to corner the obesity market: Neurosearch, a Scandinavian company, is well ahead with the development of Tesofensine, and published its phase III trial results in November 2008.

Second, the advertised company itself asserts that it is scheduled to release major Phase III trial results in September and thereafter file an application for the drug's approval by “late 2009.” Thus the rouse about March 30th is an effort to rope investors prior to release of Phase III trial results.

Moreover, the admen blatantly belie the FDA's statutory requirements for the approval of new drugs. Which means that there is no guarantee of FDA approval on March 30th. If the FDA does issue a statement on that day, such statement will pertain to the results of the Phase III clinical trials, not actual FDA approval, which usually takes at least six months. This misleading advertising also failed to disclose that companies are not limited to one Phase 3 trial; companies are often required to submit additional research regarding safety and efficacy, depending on the clinical results, third party comments and or the FDA’s response.

The obesity drug to be peddled to unwitting patients is Lorcaserin, and the penny stock company developer is Arena Pharmaceuticals (nasdaq: ARNA). Read a more detailed discussion here in an October 2007 Forbes article titled “The Next Fat Pill”. According to that piece, “[t]he closest thing to a real success weight-loss pill that's safe and reliable … was fen-phen, helped people lose as much as 30 pounds a year … but was pulled off the market in 1997 [because] it caused heart valve problems … and pulmonary hypertension…” Reportedly, the recall occured after Fen-phen maker Wyeth (now owned by Pfizer) paid $18.7 billion to settle the lawsuits.

Furthermore, according to Forbes, “Lorcaserin stimulates production of serotonin, the same brain chemical that fen-phen did. But Arena executives and obesity experts say it has none of the heart valve risks because it is targeted to the brain.” In fact, in June 2007 the FDA denied approval of Paris-based Sanofi-Aventis (nyse: SNY) brain targeted obesity drug, Acomplia, because of side effects that included suicidal thoughts and depression. SNY eventually withdrew Acomplia from the market.

Big Pharma apparently intends to prey on the American propensity for a quick fix and the expectation of a magic pill that will permit users to deny responsibility for their own health. Read a Wikipedia article specifically suggesting that Lorcaserin weight loss is succesfull only if one continues to take the the drug. All of which means continuous and indefinate purchases by the addicted obese - and in all likelihood, fabulous profits to Big Pharma manufacturers and distribution chains.

3 comments:

Jack Stickney said...

I'm a 54 year old male who just completed participation in a 2-year weight loss study of the new drug Lorcaserine. My starting weight was 295 pounds. In my experience (during the first year) I lost 60-pounds. During the second year I regained 30 pounds. This was a double-blind Phase III study, so I have no way of knowing during what period of time I was on the drug or the placebo. However based on my results, I believe that during the first year I was being given the study drug.
I was very happy with the results. The study was very thorough. I was given four echocardiograms; and monthly blood testing, urinalysis and blood pressure monitoring all of which proved that my health was not negatively affected by the drug.
I'm looking forward to the release of the drug. The advertising you received appeared to be less-than-totally-accurate concerning it being the only such drug being explored. However, if my results are at all indicative of the general outcome, investment in this small Rx company may be something to seriously consider (when the time is right).

Jack Stickney
Tremonton, Utah
jacklstickney@gmail.com

stewjean said...

Dear Mr. Stickney:

Thank you for commenting on my post. And I am happy that you did experience some success with Lorcaserine. Note that you did regain half of the weight that you originally lost. Also, note that my argument is not that the drug does not work, but rather, that the advertising soliciting investors was misleading in important respects. Further, I suggested that the addictive nature of the drug would require continuous use indefinately in order to maintain weight loss - leading to massive profits for Big Pharma, in light of the number of persons who have difficulty keeping their weight under controI.

Ultimately, it may be that humanism forces me to acknowledge ethical issues with corporate profiteering at the expense of those who may be medically compromised. Please accept my wishes for your good health and that you will soon locate a drug-free alternative to weight loss.

Stewjean

Anonymous said...

Hi Jeannette,

Very interesting read!

Adrian