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FDA refuses to approve another diet drug

By Rob Stein

There's more bad news for those hoping for new drugs to help fight the obesity epidemic: The Food and Drug Administration has refused to approve yet another new diet pill.

The agency sent a letter to the drugmaker raising a variety of concerns about Qnexa, according to Vivus Inc., of Mountain View, Calif., which had sought the drug's approval. The letter does not bode well for the drug winning approval.

The move was expected, given that an FDA advisory panel had voted against the drug's approval in July because of evidence it may have adverse side effects, including increasing the risks for birth defects during pregnancy.

But the step is the latest in a series of setbacks in the effort to develop new weight-loss drugs. The FDA last week rejected approval of lorcaserin because of it appeared to cause tumors in rats. And earlier this month the agency forced the removal of the the drug Meridia from the market because it appears to increase the risk for heart attacks and strokes.


A Roche Holding AG's Accutane acne pill package, Pfizer's Bextra painkiller and Abbott Laboratories' weight-loss drug Meridia in a pharmacy in Wilmette, Illinois in 2004. Meridia is one of three diet pills rejected this month by the FDA. (Tannen Maury/Bloomberg News)

Despite millions of dollars in research, only a handful of government-approved weight-loss drugs remain on the market. Only one can be used long term, and none is considered very effective. The last time the FDA approved a new diet drug was in 1999.

The setbacks come as public health experts are alarmed about the number of Americans who are overweight and obese, which increases the risk for a host of health problems, including heart attacks, strokes, diabetes and cancer.

The FDA's actions have prompted criticism from some obesity experts, who argue that the agency is holding diet drugs to too high a standard. They say the FDA should be willing to accept some risks from the drugs, given the health hazards of obesity But others say that any new diet pill is likely to be used by large numbers of people, which means even rare side effects would be worrisome.

By Rob Stein  | October 29, 2010; 10:37 AM ET
Categories:  Cardiovascular Health, Childhood obesity, Obesity  
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Comments

Vitamin D levels in the body at the start of a low-calorie diet predict weight loss success, a new study found. The results, which suggest a possible role for vitamin D in weight loss, were presented at The Endocrine Society's 91st Annual Meeting in Washington, D.C.


On average, subjects had vitamin D levels that many experts would consider to be in the insufficient range, according to Sibley. However, the authors found that baseline, or pre-diet, vitamin D levels predicted weight loss in a linear relationship. For every increase of 1 ng/mL in level of 25-hydroxycholecalciferol - the precursor form of vitamin D and a commonly used indicator of vitamin D status - subjects ended up losing almost a half pound (0.196 kg) more on their calorie-restricted diet. For each 1-ng/mL increase in the active or "hormonal" form of vitamin D (1,25-dihydroxycholecalciferol), subjects lost nearly one-quarter pound (0.107 kg) more.

Additionally, higher baseline vitamin D levels (both the precursor and active forms) predicted greater loss of abdominal fat.


"Our results suggest the possibility that the addition of vitamin D to a reduced-calorie diet will lead to better weight loss," Sibley said.

Posted by: dokadow | October 29, 2010 10:47 AM | Report abuse

Link Between Successful Weight Loss And Vitamin D Levels


Vitamin D levels in the body at the start of a low-calorie diet predict weight loss success, a new study found. The results, which suggest a possible role for vitamin D in weight loss, were presented at The Endocrine Society's 91st Annual Meeting in Washington, D.C.


On average, subjects had vitamin D levels that many experts would consider to be in the insufficient range, according to Sibley. However, the authors found that baseline, or pre-diet, vitamin D levels predicted weight loss in a linear relationship. For every increase of 1 ng/mL in level of 25-hydroxycholecalciferol - the precursor form of vitamin D and a commonly used indicator of vitamin D status - subjects ended up losing almost a half pound (0.196 kg) more on their calorie-restricted diet. For each 1-ng/mL increase in the active or "hormonal" form of vitamin D (1,25-dihydroxycholecalciferol), subjects lost nearly one-quarter pound (0.107 kg) more.

Additionally, higher baseline vitamin D levels (both the precursor and active forms) predicted greater loss of abdominal fat.


"Our results suggest the possibility that the addition of vitamin D to a reduced-calorie diet will lead to better weight loss," Sibley said.


The optimal range of vitamin D circulating in the human body is 50-80 ng/ml, NOT just 30 ng/ml. 30 ng/ml DOES NOT achieve a state of vitamin D repletion, that is when enough vitamin D is available for EVERY cell to make use of this all important hormone.


Link:


http://www.medicalnewstoday.com/articles/153669.php

Posted by: dokadow | October 29, 2010 10:54 AM | Report abuse

The relatively benign CRL for Qnexa is not really surprising. VVUS is an FDA/Wall St./media darling.

David Orloff had been promoting the concept of combination therapies since at least 2004 while he was still at the FDA. When he suddenly resigned from the FDA in the middle of controversy over questionable drug approvals in his office, he was fortunate to get a job at Medpace.

While at Medpace, Dr. Orloff oversaw clinical trials of Qnexa and “crafted” the Qnexa NDA, which was reviewed at the FDA by Eric Colman, the person who Orloff had supervised and worked closely with while at the FDA.

The fact that Qnexa does not meet the requirements for combination therapies based on the component efficacies does not matter. The fact that the advisory committee panel requested additional clinical trials for cardiovascular concerns does not matter. The fact that topiramate causes cognitive problems and birth defects does not matter.

This drug was a foregone decision that has been in the works at FDA since at least 2004, where it was discussed by the theraputics subcommittee at the FDA obesity working group.

An FDA official tainted by scandal, leaving to test a drug already being discussed by FDA, and submitting the application for approval back to the same office where he worked, for review by his former associate, reeks of cronyism.

Cheers to your good news today VVUS shareholders! Qnexa will be approved soon, but as a citizen I am sadly disappointed in our FDA drug approval process.

Deal making is a part of life. Que sera sera. This is not the first time a hopefully objective function of government is drenched in cronyism. The outrage one experiences then becomes a function of whether you benefit or suffer from the cronyism.

The real test of Qnexa will be when it hits the market. The cognitive side effects of topiramate will be more of a problem than birth defects associated with the drug. Confusion and memory loss may be an acceptable price to pay for epileptics when the alternative is seizures, maybe not for obesity treatment.

Hopefully alternatives will soon available to treat obesity without the very real mental confusion known to be caused by topiramate, and also shown to occur during Qnexa clinical trials.

Posted by: erewenguy | October 29, 2010 12:52 PM | Report abuse


Major brands always give out their popular brand samples (in a way it is similar to coupons) I use these guys to get mine http://bit.ly/aJWSXv enjoy your samples

Posted by: robinhook30 | October 30, 2010 5:18 AM | Report abuse

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