Posts Tagged ‘Meridia’

What’s Up with the FDA? – Part 2

May 15th, 2011

I’m sorry are we bothering you with all this obesity stuff?

As you know the FDA was quite busy this last 12 months or so with reviews of Meridia, Qnexa, lorcaserin and Contrave. Meridia is off the market now while the other three are holding on for dear life. It came as no shock to those closely watching the meetings of the Endocrinologic and Metabolic  Advisory Committee that the FDA really doesn’t much like dealing with obesity. Now, we know why. They are not curing hypertension or diabetes. That’s what the head of the FDA drug center, Janet Woodcock, right,  wanted to see. And that’s what she told Reuters in this interview. FDA official sees drug approvals rising | Reuters

So, think about this for a moment, the top FDA drug official casually tosses off the FDA’s own guidances for developers of obesity drugs regarding efficacy and says, well, she wishes they were other drugs entirely. Imagine if she said, well, we have turned down this drug for breast cancer because it didn’t  improve Alzheimer’s disease or  cure multiple sclerosis. Or if she said of a drug rejected  for HIV/AIDs, that she would like to have seen it cure Parkinson’s disease?  Would she stay in office the rest of the day? Would it not be a huge embarrassment to the FDA, the HHS, the medical community, the Administration? Why is it  ok for obesity? Is is any less intellectually vapid?  Is that why one of people who works for her, running the Endocrinologic and Metabolic Advisory Committee process this year, apologized, APOLOGIZED! to the panel for “putting them through this unpleasantness.” The “unpleasantness” Dr. Coleman was referring to was the Committee’s job, namely, reviewing new drug applications for obesity. Dr. Coleman, went on to add, “I guess you should be thankful you don’t have to do this everyday for your living.” (See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM232443.pdf at page  304) Is this a cry for an intervention, a plea for a new job? Or a sign of an institution so biased against all this obesity that no obesity drug will ever be approved no way, no how? Can these people give obesity drugs a fair hearing? The FDA has rules on Conflicts of Interest. How about rules on Lack of Interest?

What’s Up with the FDA? Part 1

May 6th, 2011

Faithful readers will recall that I spent two days last July at the FDA Endocrinologic and Metabolic Advisory Committee reviewing rosiglitizone (Trade name Avandia). Avandia, for type 2 diabetes has been interesting to follow not just because so many persons with obesity develop type 2 diabetes but because, due to its review coming amid the same Advisory Committee’s review of four obesity drugs, provided additional insights, especially into how the FDA evaluated safety concerns.

This became all the more interesting when the FDA decided to keep Avandia on the market, albeit with endhanced warning, but had Abbott Laboratories take sibutramine (trade name Meridia) off the market.  The point was made that Avandia had a number of fatal events, in its intended population while Meridia had no fatal events in a population which was specifically excluded on its label. Yet Meridia was spiked and Avandia was not.

Now comes a meta-analysis of Avandia’s class of drugs, called thiazolidinediones, which also includes pioglitazone, (Trade name Actos). The study, covering 16 studies with 810,000 patients found 170 excess myocardial infactions, 649 excess cases of heart failure and 431 excess deaths for every 100,000 patients who receive Avandia rather than Actos. Probably, this will not be enough for the FDA to take any stronger action against Avandia. See Comparative cardiovascular effects of thiazolidine… [BMJ. 2011] – PubMed result

FDA Spikes Another Obesity Drug

February 1st, 2011

Orexigen Therapeutics Inc. indicated today that the Food and Drug Administration (FDA) has, in effect, decided not to approve the company’s obesity drug, Contrave ® in spite of a federal advisory panel vote of 13-7 in favor of approval in December of 2010. The FDA is requiring the company to complete a lengthy and expensive pre-approval of cardiovascular risks. Previously, the FDA had rejected two other new compounds: one developed by Vivus Inc. (Qnexa®) and the other, lorcaserin, by Arena Pharmaceutical Inc. (Lorquess ®) The FDA also pressured Abbott Laboratories to take orlistat (Meridia®) off the market.

According to Morgan Downey, editor and publisher of the Downey Obesity Report, “The FDA has decided that the most significant threat to public health will not be treated by any drug. In the current environment, tap water could not be approved. This is the first time in the FDA’s history that it has decided to abandon a major public health challenge. No doubt the FDA will continue to regularly approve drugs which cause weight gain and to half-heartedly police dangerous and unproven dietary supplements claiming to achieve weight loss. These actions have driven both large pharmaceutical companies and small biotech companies out of obesity research and development. At this time, only Vivus Inc.’s Qnexa has a hope of meeting FDA’s approval.” The FDA has asked Vivus Inc. to explore databases to rule out birth malformations due to one of its elements.

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December 30th, 2009

December 29, 2009

Study disputes ‘healthy and obese’ fallacy  Study Debunks Notion of ‘Healthy Obese’ Man – BusinessWeek

December 29, 2009

Vivus announces plans to submit Qnexa for FDA approval Vivus says it asked FDA for marketing approval of its obesity drug candidate Qnexa — latimes.com

December 24, 2009

Arena Pharmaceuticals submits New Drug Application for lorcaserin to FDA. Arena Pharma seeks US FDA approval for obesity drug lorcaserin – International

December 11, 2009

New York Times feature on poor children getting obesity-inducing anti-psychotic medications on Medicaid Children on Medicaid Found More Likely to Get Antipsychotics – NYTimes.com

December 7, 2009 Lincoln University ends controversial BMI-graduation policy Lincoln Ends BMI Requirement – The Paper Trail (usnews.com)

December 4, 2009

America Samoa tops lists of world’s most obese countries Size matters: American Samoa tops ‘globesity’ scale

December,  2009

Diabetes cases and costs expected to double in next 25 years. Projecting the future diabetes population size and… [Diabetes Care. 2009] – PubMed result

November 27, 2009

University takes flak for singeling out obese students A University Takes Aim at Obesity – The Choice Blog – NYTimes.com

November 24, 2009

CDC releases county obesity rates.  Obesity and Overweight for Professionals: Data and Statistics: U.S. Obesity Trends | DNPAO | CDC

See interesting commentary from Richard Florida of the Atlantic The Geography of Obesity – Richard Florida

November 23, 2009

It seems obesity drugs can’t catch a break. Now there is news that Abbott’s Meridia is being watched by the Food and Drug Administration for increased cardiovascular deaths. It was widely known to increase blood pressure. New Meridia SCOUT Trial has Major Implications for Obesity Drug Development – GLG News This means that for companies bringing new products to the FDA for approval will find even greater scrunity.

November 17, 2009

USA Reports rising costs of obesity epidemic Rising obesity will cost U.S. health care $344 billion a year – USATODAY.com

ACOG issues guidelines on bariatric surgery and pregnancy Bariatric surgery and pregnancy.

Yale course by Kelly Brownell on psychology, biology and politics of food available on line for free The Psychology, Biology and Politics of Food — Open Yale Courses

ASMBS offers on line CEU course on bariatric surgery American Society for Metabolic and Bariatric Surgery

America’s Health Rankings sets obesity state by state projections to 2013 Projected Prevalence of Obesity

November 11, 2009

HHS issues report on health care reform and diabetes Preventing and Treating Diabetes: Health Insurance Reform and Diabetes in America

Dr. Sharma takes on lifestyle choice or chance? Dr. Sharma’s Obesity Notes » Blog Archive » Obesity: Lifestyle Choice or Lifestyle Chance?

November 9, 2009

Downey Obesity Report joins call for health reform to address morbid obesity 15 Million Americans at Greatest Risk of Disease/Death Have Been Left Out of Health Reform Debate – SmartBrief

Study confirms link between swine flu and extra weight

November 5, 2009

California reports important link between obesity and swine flu

Obesity causes over 100,00 new cases of cancer Obesity linked to specific cancers – USATODAY.com

Obesity causing problems in military recruiting Obesity, poor education big obstacles to military recruiting – washingtonpost.com

November 4, 2009

California swine flu report point to obesity risk. In a study published today in JAMA, researchers looked at deaths and hospitalizations due to H1N1 flu in California. They state, “A large proportion of our adult cases had other comorbidities that are not established risk factors for severe influenza, including hypertension and obesity. Of adults with BMI data available, more than half were obese and one-quarter were morbidly obese…Almost one-third ob obese cases did not have other established risk factors for severe influenza, although 27% had other comorbidities (eg, hypertension) Others have reported this novel association in pandemic 2009 influenza A (H1N1) infection; diabetes and obesity were the most frequently identified underlying conditions in fatal cases older than 20 years worldwide, and anecdotal observations of high prevalence of obesity in severe and fatal cases have been reported from Chile, Manitoba and Mexico. Factors associated with death or hospitalization d… [JAMA. 2009] – PubMed result

New evidence from mouse studies on genetic transmission Do Fat Parents Have Taller Babies? Mice study indicates surprising relationships between food, height, and families. – The Human Condition Blog – Newsweek.com

October 28, 2009

DPP 10 year results A Decade Later, Lifestyle Changes or Metformin Still Lower Type 2 Diabetes Risk, October 29, 2009 News Release – National Institutes of Health (NIH)  10-year follow-up of diabetes incidence and weight… [Lancet. 2009] – PubMed result