Per Adam F., "Eight endocrinologists/obesity experts sat on the Vivus FDA panel in February, with all but one voting to recommend Qnexa's approval. The overall panel vote was 20-2 in Qnexa's favor."
With the 5 new members being obesity/endocrinologist, I would reason their bias may be towards approval. Obesity experts recognize that obesity is a growing issue in the United States and we need more treatment options to combat it from an individual and macro perspective. The added endocrinologist should LOVE a medication that is not used to treat type 2 diabetes that drops the A1C by 0.9 while also meeting FDA criteria of weight loss in what is a hard class of patients to get weight loss.
Thank you AF for writing an objective, factual, reasonable article this time. Yes, it does boil down to benefits vs risks.... on that point I would only say that the efficacy profile for a targeted, selective drug does not follow the more is better turn up the volume pattern set by previous amphetamine-type drugs or non-selective combination drugs.
The fact that there is a greater spread between responders and non-responders (due to selectivity, single agent action, and individual patient variables) does NOT negate the fact that across a population, a MAJORITY of patients realize significant weight loss and the upper 1/3 of the better responders can get exceptional benefits.
This is self regulating: the 1/3 of patients on average that are non-responders (<5% BW loss) can simply shift to an alternative treatment; then 2/3 will realize > 5% BW (which can produce significant cardiometabolic benefits); and the upper 1/3 realizes exceptional weight loss and health benefits. Yeah, it's a long explanation, but a much more complete way to describe potential benefits.
BTW - These are "significant, clinically meaningful weight loss" benefits across a population... if this exceptionally mild tolerable treatment does not work adequately (you are in the 1/3 of non-responders, then maybe Qnexta is the nexta stepa for you....
Did some light bulbs come on for V-loyals? Like enlightened self-interest in having more than one weight loss treatment out there to support the entire industry? Like having a Target a block away from a Walmart?
I'll go with you based on that post.
So if they appear intent on passage of Q then LORC should be a SHOE IN!!!!!!!!!
People ya HAVE to take birth control on Q ,it causes cardio problems.......
Anyone here ever own a rat?????????? Most rats get tumors!!!!!!!! WITHOUT any meds.
Guess my point is that if Q gets approval there is NO REASON that LORC should not as well.
Speaking of rat tumors -- have you ever read anything about rats being fed 84 times the normal dosage of anything who didn't get tumors?? Aspartame anyone?
I'm impressed with the LDL/HDL improvement achieved with Lorcaserin. That is of equal importance as BMI - especially to overweight population, diabetics & heart disease patient.
I agree a positive. Also the doc that supposedly received a waiver is good also - he is involved in pediatric medicine. What pediatric doctor would prescribe a drug that has the risk of birth defects?
Women will not submit to chemotherapy while pregnant for fear of damage -- but the FDA is going to approve a weight loss drug that has a known risk of birth defects. No way.
There are other side effects from Topiramate that are also bad. Amazing that people support this combo drug for weight loss.
I'm sure Arena would love to have a higher weight loss efficacy - but clearly that is not possible without serious side effects. But, the information available states that after 50+ days the efficacy is excellent and the risks are minimal.