Orexigen Therapeutics Inc. has announced that it has reached agreement with the Food and Drug Administration on a new protocol to test for adverse cardiac events for it obesity-fighting compound, Contrave. Orexigen Therapeutics, Inc. – Press Release
NIH Recommends A1c Testing
January 26th, 2012 No comments »The National Institutes of Health has come out for expanded A1c testing. Their press release and fact sheet point out that the A1c test does not require fasting and helps identify diabetes and pre-diabetes. They recommend testing of anyone 45 years old or younger than 45 are overweight, inactive or have at least one risk factor for type 2 diabetes. New NIH fact sheet explains test for diabetes, prediabetes, January 26, 2012 News Release – National Institutes of Health (NIH)
Allergan Slapped on Marketing Lap-Band
December 27th, 2011 No comments »After the FDA slapped Allergan for the marketing campaign of one of its vendors, 2011 > 1 800 Get Thin LLC 12/12/11, the Los Angeles Times took on Allergan to do step up to the real work of corporate responsibility. Lap-Band maker needs to step up – Los Angeles Times. A lot of health care professionals who have worked with the company would not disagree with this position.
Below the Radar
December 23rd, 2011 No comments »Before leaving for his holiday in Hawaii, President Barack Obama signed the appropriations bill to keep the government running. Included in the bill is a provision establishing the National Center for Advancing Translational Sciences (NCATS). This center is the brainchild of NIH Director Francis Collins. Statement by NIH Director Dr. Francis Collins – NIH Launches National Center for Advancing Translational Sciences, December 23, 2011 – The NIH Director – National Institutes of Health (NIH) It is intended to develop resources at NIH to facilitate moving basic biomedical research into treatments and removing roadblocks to incorporating new findings into patient care. Off the record, NIH officials are concerned that one of the bigger roadblocks is the failure of new drugs to gain approval by the Food and Drug Administration. Obviously, this includes drugs to treat obesity. While addressing this specific issue is not part of the NCATS mission, it clearly provides a platform to move in this direction. The very first activity of this center is a collaboration with FDA and DARPA to develop a chip to screen new drugs for toxicity. NIH, DARPA and FDA collaborate to develop cutting-edge technologies to predict drug safety, September 16, 2011 News Release – National Institutes of Health (NIH)
As it happens, my paper on the FDA approval process, written with colleagues,] Christopher Still and Arya Sharma, specifically called for a NIH-FDA-industry-patient group collaboration to find ways to overcome obstacles to the approval of drugs to treat obesity. What’s Up with the FDA – Part 5 | The Downey Obesity Report
So, keep an eye on NCATS. It may become very important and relevant to advancing the treatment of obesity. Proposed NCATS « Feedback NIH
Vivus Inc. Announces Date for FDA AdCom; results of birth defect study
December 23rd, 2011 No comments »Vivus Inc. has announced that the FDA will hold an 
Advisory Committee meeting on February 22, 2012 for review of the obesity treatment, Qnexa. VIVUS, Inc. – VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of ObesityTwo days ago, Vivus Inc. released resulted of the FORTRESS study. The study looked retrospectively at women delivered infants while taking topiramate, one of the two active drugs in Qnexa. Compared to women who had taken topiramate earlier but not during their current pregnancy, those taking topiramate during pregnancy reported a higher rate of cleft palates in their children (0.29% v. 0.16%) VIVUS, Inc. – VIVUS Reports Topline Findings From FORTRESS An earlier study unrelated to topiramate reported a higher rate of birth defects overall and cleft palate, in particular, in women with obesity compared to women of normal weight.
The company’s current application would limit distribution to men and women beyond child-bearing age.
Child Food Marketing Guidelines Set Back…Again
December 16th, 2011 No comments »Food and beverage industry has won another victory in Congress (did you forget pizza?) , forcing through a provision which would require the three federal agencies involved in writing the new guidelines for marketing to children to undertake a cost benefit analysis. Lawmakers want cost-benefit analysis on child food marketing restrictions – The Washington Post Earlier in the year, the industry had forced the Administration to drastically curtail the age group covered by the proposed guidelines Food giants fight proposed nutrition guidelines – SFGate
Study Raises Prospect of Qnexa Approval
December 15th, 2011 No comments »A study published December 7, 2011in the American Journal of Clinical Nutrition provides two-year data on the safety and effectiveness of Vivus Inc.’s drug candidate, Qnexa in patients with cardiometabolic disease.
Qnexa is a combination drug composed of phentermine and topiramate. It was tested in two doses among 676 subjects. Changes in weight were -1.8% for placebo, -9.3% for low dose and -10.5% for the high dose. Significantly more subjects at each dose achieved more than 5%, 10%, 15% and 20% weight loss compared to placebo. Subjects on the drug had improved cardiovascular and metabolic metrics and decreased rates of diabetes. The high dose was significantly better in weight loss among the most severely obese subjects. Adverse events were modest and drop-out rates were similar between placebo and drug groups. There were no deaths. There were two pregnancies. One was carried to term. The other resulted in a miscarriage. The infant was born with no observed birth defects which was a concern of the FDA Advisory Committee which reviewed the drug last year.Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study
The very impressive weight loss and low side effect profile from this two-year study are expected to improve the odds of approval by the FDA. Another Advisory Committee hearing in early 2012 is expected.
Consumer Alert – HCG hormone
December 6th, 2011 No comments »The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have issued warning letters on HCG “homeopathic” products sold over-the-counter for weight loss. HCG or human chorionic gonadotropin is a hormone produced by the human placenta and found in the urine of pregnant women. It is approved as an injectable prescription drug for female infertility, among other conditions.
The letter warns companies that they are violating federal law by selling drugs that have not been approved and by making unsupported claims. There is no evidence, according to the agencies, that HCG improves weight loss beyond the recommended low calorie diet. For the press release, see Press Announcements > FDA, FTC act to remove “homeopathic” HCG weight loss products from the market