My curriculum vitae is probably as extensive as yours if not more relevant since my experience also includes education and work experience in the pharma industry for six years, also have an MBA in healthcare administration in addition to a clinical degree (don't practice anymore) to name a few; my other half works for a major medical school and is involved in clinical research with numerous of PhDs and MDs--mostly grants through NIH (national institute of health), focusing on "translational medicine," which simply means that labs to bedside, etc.
I just want to say, it is naturally for so much attention is given to any, real or not, potential side effects of arna's L, but I don't know of any prescription medications out there without some serious side effects. For that reason, it is not OTC (over the counter) and it is designated and called prescription meds (need doc's monitoring and guidance, etc.). It is also routine practice to conduct periodic lab tests, ekgs, and other monitoring to ensure no negative and adverse events, etc. Mostly all serious medications treating serious conditions requires routine and periodic moniotoring due to "known" negative outcomes, etc.
In short, in my opinion, arna's L is as safe as any other "prescription" drugs out there if not safer (obvious to all), etc. Therefore, I don't see why it shouldn't approved, etc.
I am a doctor as well...I agree with u generally speaking, though I think u may have overstated the valvulopathy issue. The studies did NOT show a statistically significant increase in valve problems with lorcaserin...rather, it could not rule out valve problems because the total number of observations were so low that it was underpowered to rule out/in the possibility of valve problems. We can conclude that if it does cause valve problems it would be a very small increase. Now, will the FDA see it that way...who knows.
LOL.....i read that article too, I think you will see we are on opposite sides of the spectrum!
I base my practice on retrospective randomized double-blind studies.....LOL! It's called practicing evidenced based medicine. I don't 9/10 of what people post on here......just what I can prove doing my due diligence!
As a ciolleague of 42 years in FM i agree with you 100%. excellent medical summary. I am tired of preaching diet and excercises(although important) but getting nowhere and my patient are getting heavier. I am glad you menttioned Obesity surpassed Smoking as number one killer in America.
Thank you.....after approval, I am thinking about putting together a consortium of people as a think tank to spec pharmaceutical and medical related socks.......if you are interested, here is my email....
From a physician who has alot invested in this drug...ie....I own stock in it......but it will also change my current medical practice....I disagree.....
The valvulopathy has still not been cleared up. I believe based on the current environment, there is a huge push by the FDA and doctors as well as advocates to pass this drug....and I still believe the drug will be voted in the 27th. My money is on it.....but the echocardiogram study was inconclusive and more echos will be done after approval. I am holding my shares for about 1 year, then selling them prior to the new study being released. Its not that I don't think the drug will go through the US and EU. But after approval, I am taking my money off the table....because even if there is a 5% risk the drug will be pulled later, I am not willing to take the risk. This is my strategy.
Will it change my prescription habits if there is a small increase in valve problems noted in the later studies...no....I will stay place my patients on the drug when the benefits outweigh the risks. Take in consideration a gastric bypass......major risks involved in putting a 400lb pt under general anesthesia and doing a major procedure....but once again it depends if the patients quality of life is improved, and the benefits outweigh the risks.
One last note, I have worked with the board of pharmacy in the past.......these people want new drugs on the market. It good for patients and good for the economy. They are not there to bash every drug that comes up for approval. Their job is to guide the pharmaceutical companies along the path of approval and make sure they are doing the necessary steps required ( once again see the link above). I believe the FDA has been hand holding Arena over the last year to facilitate approval (see old posts about the pathologists recommended to Arena and the new questions that needed to be answered prior to its approval). I am confident because of this it will get approved........
now onto Contrave.........this is my next big endevor.....LOL!
I work with many Doctors whom all think the Science of this drug will prevail in the end.
We have been long now 3 years.
Do not let the improper trading activities chase you out.