While there are arguments on both sides of whether corruption is involved in this long delay I believe that there is more evidence on the side of nefarious activity than on honest delay due ot excess number of comments - which, btw, was completely unnecessary and only gave an excuse for the DEA to delay.
First, all the data necessary to respond has been done both by Arena.
Second, the literature is readily accessible that demonstrates that 5 HT2c agonists are anti-addictive and that new drugs that bind to these receptors will be used in the future to combat drug addiction
Third, Arena has demonstrated convincingly that Belviq has very little functional activity at the 5HT2a receptor sites and therefore has minimal potential for addiction
Fourth, it would only take a weekend to perform a literature search to have enough scientific support to write a response
Fifth, it only took a few days for the "so-called" scientific articles to bring doubt about the potential addictive properties of Belviq - why would it take the DEA months to write a response to such superficial information
SIxth, the FDA took less time to modify the REMS despite the fact that they are overwhelmed with new drugs to evaluate than it has taken the DEA to respond one drug
Belviq is a novel new drug that has gone above and beyond to demonstrate that it is a 5HT2c agonist primarily - there is very little to support any addictive properties. It is not that difficult to demonstrate that it has little or no addictive properties. The DEA was not asked to perform new studies, it was asked to evaluate the data that has been provided by years of work by legitimate scientists. Remember, they are responding to amateurs, with the possible exception of 2 or 3, and yet they come up with an answer?
If, I, a busy physician can review the literature on any drug and write a reasonable conclusion within a very short period of time, why can't someone whose sole job to the same in a month's time.
Sentiment: Strong Buy
thanks again doc for the comment, you are one of the few here i respect, also jd stevens and some others.I have no idea concerning fraud inside FDA,DEA . You have a lot of guys like madoff etc. in the U.S. so it would not surprise me. i just expect approval here in europe, timelines are oke, people,companies,docters,patients etc. can rely on it. like in the U.S. we also have a lot of obese people here, The tv progamme Obese is very popular, we have our own version. I can imagine that most people have not the will power to change it bij themselves. Others who have I would say: throw away all the white pasta,white bread en white rice and all the canned food and all sodas,regular and light. Gas gas as you passes bij, any Mc,piza,chicken and other fast food resaturants. Spip eating meat inmediatly, go on food to the grocery store9or bij bike) and start eating lots of veggies, whole grain bread and fruit (no juice). Drink at least 8 glasses of water.My wife had sugar ,she had before breakfast 17 and on average 12. she was prescribed metformin, but we decided to throw it away. I was already a vegetarian for 30 years, and my wife now too. In six weeks she lost 20 pounds and her sugarlevel lowered to about 6 to 7 , average 8.Pain in feet and legs disappeared ., In fact you can throw away all medical literature and just read genesis 29;1 ( I have given you every plant yielding seed that is on the face of all the earth and every tree with seed in its fruit, you shall have them for food.) Nowhere is written you should kill pigs,cows and chicken, cut them to pieces,cook of fry them and then eat them.dr Vogel (93 when he died) i know many say he is not a real docter, but his knowledge of spices and herbs was fenominal) said already back in the fifties and sixties, that most of the cancers start from the liver. dr . Moerman(95 when he died) a Dutch docter also fouhgt cancers bij eating healthy vegetarian food. he said: no meat,fish or poultry. this sais it all !!!
Sentiment: Strong Buy
"there is very little to support any addicitive properties". Belviq will be prescribed to treat addictions for smoking gambling etc , How could it be addictive in of itself.
Thanks for good article Doctor Dan !!!
while many question the dea, it is the fda that needs to answer questions. the fda accidentally or intentionally delayed arna approval on a faulty basis. they have continuously showed bias toward vvus. this bias was clear when they immediately asked vvus to apply for reducing rems requirements. so while I don't believe in conspiracy I think the bias has been clear. the fda needs to be investigated not the dea.
Please do not allow Europe to beat you to the punch. Please do not allow Europe to show how corrupt you are! Please do not let Europe show how efficient multiple countries can be vs. just one American beauracracy!
A concerned US Citizen
I like your fact based, scientific, articles that throw the truth out there for all to see. This one has too much conjecture and innuendo to be held in the same light as your previous articles. No doubt frustration has gotten to you as well, Dr. Dan. I prescribe 2 sessions of Yoga per week to relieve you of any anxiety before we have to resort to klonopin. Have a good day.
Thanks dont delay. My objectivity was put aside when I saw the lifting of restrictions without any scientific or legit reason to do so. I also need a little venting once in awhile. It was easier to refute bogus scientific articles with scientific argumentation. I have tried to ignore the temptation to comment on all of this but that lifting of restrictions crossed the line...that was the straw that broke my objective back!!!
Sentiment: Strong Buy
Those people in the DEA doing the review on Belviq should be investigated. Why is it that it is taking them
so long to make an opinion on a drug that has been tested scientifically for years and has been approve by
the FDA. Is the DEA incompetent to make a ruling?
Jeremiah: There was no good medical reason to lift restrictions within VVUS REMS. There have not been enough doses of that stuff dispensed to change anything. The agency is kissing Kauls #$%$ Nothing much has changed from the approval date----!
I am telling you later the FDA is going to get burned over this development where they loosened and then something will happen making them titghten on the safety side! The the agency will then look like total morons! These days they basically are! This ain;t the FDA of the 80s and 90s!
Sentiment: Strong Buy
Congress got the wrong information from the H.F's and are probaly short arena. A very good reason to teach all these dirt bags a lesson. New article today pretty well tells anyone how corrupt our system has become.
"While almost no one was looking, a law making it easier for congressional and top executive branch staffers to engage in corrupt trading was signed into law Monday.
The law is a modification of the Stop Trading on Congressional Knowledge (STOCK) Act. The modification was passed by unanimous consent by the House and the Senate last week with no debate or even discussion." (they act like your dog that craps on the floor-they know it is wrong so they are sneaky about it- my comment...couldn't help it)
"The STOCK Act, which became law just a year ago, was designed to discourage insider trading by members of Congress and top government officials. In addition to outlawing trading based on non-public information gleaned by government officials during the course of their public duties, the law required extensive disclosure of financial holdings by Congressional staffers and 28,000 senior executive branch employees.
(More From CNBC: These 12 Banks Got the Fed Minutes a Day Early)
The financial disclosures of these officials were to be posted in an online database open to the public.
The disclosure requirements were an important part of the law. They would have allowed researchers to detect abnormally successful trading activity by unelected senior government staffers-just as similar disclosure requirements for Congressmen and Senators had allowed scholars to produce evidence that suggested members of Congress were benefiting from non-public information.
Currently, although the reports of staff financial positions are officially part of the public record, they aren't readily available. Often they have to be requested from individual agencies usin