I will never understand the motives of FUDsters who claim not to own ARNA but spend inordinate amount of time posting useless and incorrect information. I will not respond to todzun directly because it is a total waste of time. I am responding to serious misinformation but todzun can respond all he wishes on this thread but after this I will have him on ignore.
Physicians can legally prescribe medications off-label. The Federal Food, Drug, and Cosmetic Act (FD&C) does not limit the manner in which a physician may use an approved drug. It is not illegal to prescribe drugs for unlabeled purposes. In fact, it is a very common practice. Furthermore, the FDA cannot prohibit drug companies from distributing information to physicians about off-label use of drugs or devices, or those applications outside the use specifically approved by the FDA. The FDA cannot prevent manufacturers from distributing articles (i.e., BLOOM DM study) or portions of studies on unapproved uses published in bona fide, peer-reviewed professional journals).
There are many drugs that are prescribed for other indications other than what has been approved by the FDA.
The point is that physicians have the legal right to prescribe medications for off label use if there is data to support this use. This is different from a pharmacy company or a manufacturer promoting off label use. As more studies are completed regarding Belviq and T2DM benefits there will be no need for promotion of T2DM benefits by any of Arena's partners - most physicians are well read and become aware of a medications usefulness from peer reviewed journals.
So Todzun's attempt at misleading, though his information is factual regarding a company's attempt to promote and its implications on the legality of it, it does NOT apply to physicians who write the prescriptions.
The medications that I and members of our medical group do not prescribe off label medications because of promotion by the drug companies, we prescribe based on the clinical studies demonstrating the benefits that we are prescribing it off label.
I think its useful to repost diogenes response to todzun because, as I have mentioned before, useful information tends to be lost in this YMB format:
"1) Todzun is just another disgruntled VivOZ toad.... in other words: V-Todzun (haha).
2) T2DM is a co-morbidity of obesity and thus off-label treatment is not necessary (read the label). Hint: Overweight patients that also have T2DM indications fit right into the current label.
3) Eisai is a top 25 pharma partner..... the kind the V would love to have, but their products and IP are not generating interest among BP partners even though they have stated that they have been actively seeking partnerships for around 2 years now. So they go it alone and try to get going with a contract sales force of people that can't get a REAL job. Good luck with that.
4) Q only produces 3%BW greater weight loss than P alone and now there are low dose and timed release formulations of P available, so do MD's need Q with all those requirements? The testing period is over, so MITT-LOCF is not as relevant (primarily intended to produce blinded split numbers for statistical analysis).... so, now it important and legitimate to consider the potential weight loss among those that actually completed treatment and followed the protocols: AVERAGE weight loss among all 1775 patients that completed a year on Belviq was 8%BW. The 2/3 of responders has AT LEAST 5%BW loss, for an average of about 17lbs. Drop outs due to adverse events were 7.9% for Belviq = close to placebo.... drops outs due to adverse side effects were over 18% and 5 side effects exceeded placebo by greater than the FDA benchmark of 5%.
5) Good luck with your investment in the biggest go-it-alone joke in biotech..... maybe if they are successful they can buy some real scientific capability (Leewilly and the rest of those dorks will be long gone before that)."
PHARMACY REPRESENTATIVES AND/OR MANUFACTURER REPRESENTATIVES MAY OR MAY NOT ADVERTISE OFF LABEL USES (ie recent New York ruling regarding free speech and off label promotion).
HOWEVER, PHYSICIANS ARE NOT RESTRICTED AND IT IS NOT ILLEGALTO PRESCRIBE FOR OFF LABEL USES BY ANYONE!!!!!
Sentiment: Strong Buy
That's quite a conflagration of issues you brought up in an attempt to obscure the central issue I was addressing. Let us return to the questions at hand:
1. Does Lorcaserin cause a lowering of a1c independent of weight loss?
These two experts in the field of obesity have publicly stated infront of their peers of obesity experts at the 2012 Obesity Society in San Antonio, TX that you ARE WRONG Dr Dan! "The a1c mechanism of action for lorcaserin is weight loss." (source 88:13 minutes into presentation Interactive Q&A "Translating Science Into Strategy: Contemporary Clinical Approaches in the Management of Obesity Review the pathophysiology of obesity and evaluate evidence-based strategies to achieve therapeutic goals in these patients")
These experts have their credentials on the table. Where are your credentials anonymous Dr Dan?
Ken Fujioka, MD Director, Nutrition and Metabolic Research, Department of Diabetes and Endocrinology, Scripps Clinic, San Diego, California
Robert Kushner, MD
Professor of Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois
2. Is it legal for Eisai to market to Belviq as a1c lowering drug to physicans independent of weight loss?
I think Keeler vs Eisai says enough....
Just one more thing Dr Dan...
I laugh at Belviq's 0.9% reduction in a1c.
Qsymia 1.6% reduction in a1c
The DM-230 study met its primary endpoint of demonstrating glycemic control as measured by a reduction of hemoglobin A1c of 1.6% from 8.8% to 7.2% for subjects treated with Qnexa, as compared to 1.1% from 8.5% to 7.4% in the placebo group (ITT LOCF p=0.0381) at 56 weeks. Subjects in the study were actively managed according to American Diabetes Association (ADA) standards of care with respect to diabetes medications and lifestyle. For subjects treated with placebo, significant increases in the number and doses of concurrent anti-diabetic medications were required to bring about the observed reduction in HbA1c. By contrast, concurrent anti-diabetic medications were actually reduced over the course of the trial in subjects treated with Qnexa (p
There is a difference of prescribing off label and combining 2 drugs to simulate another RX which was tested and approved in different quantities. See your lawyer. Your inference here is very misleading. Pumper fraud.
They do now. The example I gave regarding nifedipine is completely covered and there are many more examples. Furthermore, 80-90% of Type 2 DM's are obese. You can easily prescribe Belviq for the obesity indication and counsel your patient on the benefits of Belviq in the prevention and treatment of Type 2 DM. The only potential reason that it would not be covered would be the few 10-20% that are not obese and even then these are usually borderline obese. Regardless with time this will not be a problem as more studies are done and the benefits in T2DM will have science based evidence for this indication. Most large medical groups have pharmacy review committees that evaluate all new drugs. As the benefits of Belviq become more apparent all they have to do is make recommendations to have the drug covered. For example, in Kaiser, where I have sat on the Pharmacy Review Committee , we can recommend drugs for coverage to the insurance aspect of Kaiser Permanente. Most large medical groups have Pharmacy Review Committees made up of physicians who evaluate all drugs and make recommendations to the Insurer which drugs will be covvered or not.
In short, to answer your question - Yes they can cover drugs for off-label use as long as the indication is supported by peer review scientific studies reported in the medical literature.The FDA approved indication is not a limiting factor.
Sentiment: Strong Sell
Hey Dr. Dan, sorry to jump in on your thread but I wanted to get your thoughts on this but it gets buried on the avalanche of nonsense posts and/or yahoo won't post it.
I noticed after looking at the Q label that a 92mg dose of top increases plasma exposure of phen 15mg by 42% AUC/13% Cmax (table 7). Compare this to the well-known grapefruit juice/lipitor interaction in which grapefruit increases lipitor exposure 37%/16% (which is a big enough increase to cause clear warnings about combining the two) (table 3 of lipitor label).
So, in effect, the combination of top/phen is causing an increase in phen dose. Therefore Q 92/15 is more like 92/22, and the combination is not pharm additive but pk-driven. Heck, maybe Vivus should combine grapefruit and atorvastatin and call it a superior drug!
And why was this never discussed in the slightest at the adcom? The combination is effectively upping the phen dose and cardio effects with it.
What are your thoughts?
Nice response and description--this is why I said he was flinging inneuendo! I didn;t bother to correct all his junk---good reponses.
The plain fact of the matter is any doctor can use belviq off-label surrounding diabetes. its just the company that is constrained by how they market it. They can;t to the doctors!
Further ARNA can go ask for a meeting with the FDA and work thru a plan to develp a "line-extension approval" for this indication specifically, can develop a program with the FDA requirements under an IND number dossier,, run the study (s) the FDA prescribes and then submit an sNDA for that indication (s=supplemental). Then ARNA would be able to market a diabetic indication along with the doctors having additional protections in using the drug in diabetes.
Tod is amusing, but he is a putz! He invested in the wrong weight loss drug and this will be proven over time. he had his fun off the market pump and its about done! Period! And he won;t even know what hits him in his investment when it crashes until its too late and its closer than he thinks!
We are just touching on what he says from the marketing angle---he is loading yahoo with a bunch of other scientifically arguable points that are at the very least weak arguments. He specifically does not understand how drug labeling works and claims to see very clearly about belviq lack of prospects while he clearly has gigantic corneal opacities regarding his own company and drug. He should smarten up and stay over on his less medically and less regulatory experienced board!
I he can say is efficacy efficacy efficacy and never defends his own drugs shortcomings. he doesn;t get it--it not just about efficacy and even within efficacy his little drug combi ain;t all that at most doses!
Sentiment: Strong Buy