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