Archive for October, 2010

FDA Goes AWOL on Obesity

October 29th, 2010

Today the Food and Drug Administration (FDA) rejected the application of Vivus Pharmaceuticals Inc for approval of their drug, Qnexa, for the treatment of obesity.

According to Morgan Downey, Editor and Publisher of the Downey Obesity Report (www.downeyobesityreport.com), “This is the fourth drug to treat obesity the FDA has rejected since 2005. All they do is reject drugs for obesity. On the greatest health crisis of the 21st Century, the FDA has decided to thumb its nose at the White House and medical and scientific authorities. They have driven large pharmaceutical companies and smaller biotech companies out of the obesity business. The FDA is a great failure of governmental leadership to address the epidemic of obesity.”

“The FDA’s claims that they are concerned about Qnexa’s risk of birth anomalities is a smoke screen. The Qnexa studies showed no such events. The FDA says it is concerned that topirmate, at full strength as approved by the FDA, may cause birth defects. If they were really concerned about birth defects, they should take full strength topirmate (approved for prevention of migraines and seizures) off the market. Instead, they are spiking Qnexa which only a fraction of full-strength topirmate in its composition. Some women on Qnexa  became pregnant and had healthy happy babies. Evidently a woman who is obese and has a family is now an adverse event,” said Downey. (Birth defects are, unfortunately, not uncommon for women who are obese, see Birth Defects | The Downey Obesity Report)

According to Downey, “The FDA’s concern over safety of users of obesity drug are crocodile tears. They just rejected Meridia on the basis of a study establishing that those who should not take the drug, according to the label, should not take the drug. Yet, it left Avandia on the market even though two days of hearings showed it has serious and documented fatal effects. ”

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 addressing the obesity epidemic. His full biography is available at http://www.downeyobesityreport.com/morgan-downey-bio/

For additional information contact: Morgan Downey, 202-957-0085 and see www.downeyobesityreport.com

FDA Goes AWOL on Obesity

October 29th, 2010

 

October 28, 2010 Washington , D.C.

Today the Food and Drug Administration (FDA) rejected the application of Vivus Pharmaceuticals Inc for approval of their drug, Qnexa, for the treatment of obesity.

According to Morgan Downey, Editor and Publisher of the Downey Obesity Report (www.downeyobesityreport.com), “This is the fourth drug to treat obesity the FDA has rejected since 2005. All they do is reject drugs for obesity. On the greatest health crisis of the 21st Century, the FDA has decided to thumb its nose at the White House and medical and scientific authorities. They have driven large pharmaceutical companies and smaller biotech companies out of the obesity business. The FDA is a great failure of governmental leadership to address the epidemic of obesity.”

“The FDA’s claims that they are concerned about Qnexa’s risk of birth anomalities is a smoke screen. The Qnexa studies showed no such events. The FDA says it is concerned that topirmate, at full strength as approved by the FDA, may cause birth defects. If they were really concerned about birth defects, they should take full strength topirmate (approved for prevention of migraines and seizures) off the market. Instead, they are spiking Qnexa which only a fraction of full-strength topirmate in its composition. Some women on Qnexa  became pregnant and had healthy happy babies. Evidently a woman who is obese and has a family is now an adverse event,” said Downey. (Birth defects are, unfortunately, not uncommon for women who are obese, see Birth Defects | The Downey Obesity Report)

According to Downey, “The FDA’s concern over safety of users of obesity drug are crocodile tears. They just rejected Meridia on the basis of a study establishing that those who should not take the drug, according to the label, should not take the drug. Yet, it left Avandia on the market even though two days of hearings showed it has serious and documented fatal effects. ”

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 addressing the obesity epidemic. His full biography is available at http://www.downeyobesityreport.com/morgan-downey-bio/

For additional information contact: Morgan Downey, 202-957-0085 and see www.downeyobesityreport.com

LA Times cites Downey Obesity Report on FDA decision on Lorcaserin

October 24th, 2010

October 23, 2010

The Los An gels Times has picked up our press release on the FDA decision on lorcaserin. FDA shoots down another weight-loss drug – latimes.com. See the Daily Downey.

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)

More on Costs of Obesity

October 4th, 2010

Eric Finkelstein and colleagues have published new data adding to the considerable literature about the economic costs of obesity. Using the 2006 Medical Expenditure Panel Survey and the National Health and Wellness survey, they estimated per capita medical expenditures and the value of lost productivity, including absenteeism and presenteeism. For men, the estimates  of excess costs ranged from under $322 for overweight men to $6, 087 for those with grade III (severe) obesity. For women, estimates of excess costs ranged from $979 for overweight women to $6,694 for those with grade III obesity. The aggregated annual costs attributable to obesity among full-time employees is $73.1 billion. Individuals with a body mass index of 35 or greater represented 37% of the obese population but 61% of excess costs. See The Costs of Obesity in the Workplace. [J Occup Environ Med. 2010] – PubMed result

Marketing Efforts for Anti-psychotics Brings on Lawsuits

October 3rd, 2010

October 3rd, 2010 New York Times contains a long analysis of the problems in the marketing of antipsychotic drugs. These efforts have included ghost-writing medical journal articles, under-the-table financial inducements to medical speakers and generally pushing to expand the diagnostic criteria while burying side effects. These efforts have reaped huge profits for the companies but headaches as well in terms of lawsuits and government investigations. One of these cases involves AstraZeneca’s Seroquel. Documents revealed in lawsuits show that the company tried to hide the risks of weight gain and diabetes with the drug. One study showed that Seroquel users gained 11 pounds a year! Antipsychotic Drugs – Side Effects May Include Lawsuits – NYTimes.com

There are two lessons here. For one, this kind of behavior by pharmaceutical companies poisons the well for obesity drugs. Many in the medical community and at the FDA see in obesity drugs the same kind of fertile ground for abuse as in anti-psychotics. The second observation is that, for this category of anti-psychotics, the FDA tolerates safety problems which would be the death-knell for obesity drugs. Not the least of these safety signals is weight gain. The FDA is perfectly comfortable approving drugs which increase body weight and disapproving drugs which cause weight gain. That this pattern is so accepted by the medical community is a stunning. Why does medicine tolerate this?

Chance to influence NIH and FDA plans

October 2nd, 2010

The National Institutes of Health (NIH) has opened its Draft Strategic Plan for Obesity Research for public comment. You can review the draft plan and offer comments, but only up to October 14, 2010. See Strategic Plan for NIH Obesity Research 

Also, the Food and Drug Administration has issued its draft strategic plan for 2011-2015. Go to http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/StrategicActionPlan/UCM226907.pdf

40% of overweight/obese have functional impairment

October 2nd, 2010

 

New study in the September issue of Obesity shows relationship of obesity with functional disability. Heo and colleagues examined the Behavioral Risk Factor Surveillance Survey for the relationship of obesity, functional impairment and the influence of comorbidities. 40% of overweight or obese respondents had a functional impairment. 62.8% of respondents were overweight or obese and  25.6% had functional impairment. They found functional impairments increase with increased obesity and that this relationship is mostly mediated by the presence of medical comorbid conditions, which also increase with higher levels of body weight. See, Heo, M, et al, Obesity and Functional Impairment: Influence of Comorbidity, Joint Pain, and Mental Health,  Obesity, 2010, 18, 2030-2038.