Posts Tagged ‘lorcaserin’

FDA Denial of Lorcaserin a setback for obesity treatment

October 23rd, 2010

 PRESS RELEASE 

October 23, 2010 Washington , D.C.

Today the Food and Drug Administration rejected the application of Arena Pharmaceuticals Inc for approval of their drug, lorcaserin, for the treatment of obesity.

According to Morgan Downey, Editor and Publisher of the Downey Obesity Report (www.downeyobesityreport.com), “This action of the FDA is consistent with the pattern that no drug for obesity can be approved. They are searching for an unrealistic ‘magic bullet.’ The FDA has painted itself into a corner. They believe that a very effective drug will be taken by so many people that unforeseen adverse events will occur. They also believe that a drug which achieves moderate weight loss for patients is not worth any risk. This is an intolerable knot. This action is not about the effects of obesity and the benefits of weight loss. It is about the FDA fear of some future embarrassment.”

“In 2005, when the FDA turned down rimonabant, big pharmaceutical companies withdrew from obesity research and development. Since then, the only companies pursuing new drugs are small pharmaceutical companies. After this record of rejection, it will likely be 20 years before anyone tries to develop a drug to treat obesity,” said Downey.

Mr. Downey is the former executive director of  both the American Obesity Association and The Obesity Society. He is an advocate for obesity prevention and treatment. He works with many research and clinical organizations, including Arena Pharmaceuticals, addressing the obesity epidemic. His full biography is available at http://www.downeyobesityreport.com/morgan-downey-bio/

Information on the FDA letter is at FDA Issues Complete Response Letter for Lorcaserin New Drug Application (NASDAQ:ARNA)

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