Pharmalot… Pharmalittle…
8 CommentsBy Ed Silverman // July 3rd, 2007 // 8:42 pm
The 4th of July slowdown appears to be officially under way in the US now. This gives us an opportunity to catch up on all sorts of things - family fun, reading and, of course, a little eating. So we hope you enjoy the following few items while we partake. However, do remember this favorite saying - every day has the potential for fireworks.
Patients Use Fewer Meds When They Must Pay More (Bloomberg News)
Bayer’s Higgins Looks Forward To A Healthy Future (The Financial Times*)
Suicide Attempts Fall After Depression Treatment Begins (Forbes/HealthDay)
* subscription may be required
jason
Lisa, where are you on this one?
Lisa Van Syckel
Jason,
I am so glad you asked…This article failed to mention that 1/3 of the more than 109,000 patients dropped out,and why?
That information is vitally important and should have been disclosed!….I am quite sure,that had they included that information,the outcome of that study would have been different.
1)The biased and vested interest of those proclaiming that the black box is the cause of the increase in rates of suicide rates between 2003 and 2004.Almost all of the “scientists” speaking out about the black box and its relationship to rising suicide rates have a vested interest(incuding an interest in defending their own actions of promoting the use of the drugs for children and adolescents despite an abscence of efficacy data)and most have Pharmaceutical industry ties.
2)The FDA’s analasys,which found that antidepressants cause a risk of suicide in children and adolescents was not announced until a September 2004 PDAC meeting.The FDA did not ask the manufacturers of antidepressants to place black box warnings in their labels until October 2004.
3)The Black Box warning didnt go into effect until January/February 2005,well beyond the CDC analysis time period.
4)Failure to consider lack of efficacy.The drugs have not been schown to be an effective treatment for child/adolescent depression,so why would rising suicide rates be related to their declining use? Quite frankly.its surprising the rate of antidepressant prescriptions for children hasnt declined even more dramatically given the drugs have repeatedly failed to demonstrate efficacy in this population.
As one of the advisory committee members who voted for the Black Box warnings(Dr.Thomas Newman,an epidemiologist and Pediatrician from the University of San Francisco) stated:
“We have I think very strong evidence of harm and really not very good evidence of efficacy….You bring people in,you start a medication,and you see an improvement,you are very,very likely to believe that the drug was effective,and the reason why we do randomized,double-blind trials is because personal experience,however compelling,is not a reliable way to tell whether drugs work.”
Dr. Newman later articulated his point when he wrote:
It is easy to see why the personal experience of clinicians and patients would lead them to believe the drug to be effective,since they would have no way of knowing that more than 85% of the benefit they observed would also have occurred with placebo.
In fact,the lack of proof of effectiveness was a consistent theme throughout both FDA advisory panel meetings,in February and September 2004,as well at the Congressional Hearings that took place in September 2004 concerning the FDA’s handling of the antidepressant issue.
There was even considerable discusion during the 2004 PDACs that language concerning the failure of the drugs to demonstrate efficay should be included in the black box.For whatever reason,the issue later disappeared from the radar screen.
Medications have levels of efficacy.In the risk benefit analysis,physicians and their patients have the right to know how effective the treatment is for their particular condition and compare that with the risks so they can decide whether its worth it or not.Otherwise,how is proper risk benefit analysis to be done?
There is no scientific evidence that shows antidepressants prevent suicide.Companies generally argue that only controlled clinical trials can answer questions concerning what is causing a particular outcome.
In fact,the double blind placebo controlled clinical trials show that antidepressants do not prevent suicide.According to a study by Gunnel et al.: “Surprisingly,direct evidence that antidepressants prevent suicide is hard to find….In the most comprehensive synthesis of data from randomised trials,Kahn and colleagues found no evidence of a beneficial effect of antidepressants on suicide.”Gunnell citing Kahn A, Kahn S, Kolts R,Brown WA.”Suicide rates in clinical trials of SSRIs,other antidepressants,and placebo:analysis of FDA reports,”Am J Psychiatry 2003;160: 790-2 Gunnell et al., Antidepressants and suicide: what is the balsnce and benefit and harm,” Brittish Medical Journal(BMJ)2004;329:34-38(3July)
According to another study, by Herman Van Praag, published recently in World Journal ofBiological Psychiatry titled” A Stubborn Behaviour: the failure of antidepressants to Reduce Suicide Rates,” despite the increased use of antidepressants “completed suicide has remained quite stable” and ” suicide attempts even seem to have increased.”
The current trend in suicides for children and adolescents could be the result of the Meteoric rise in pediatric prescriptions of atypical antipsychotics,such as Zyprexa and risperdal.
According to research conducted by Medco Health Solutions,Inc., in which the company reviewed prescription drug claims of some 370,000 youngsters age 10 to 19,the prevalence of adolescent girls taking antipsychotics has grown 117% in the past 5 years while it has increased 71% for boys.The suicide rates are even higher in patients taking antipsychotics than those on antidepressants.
Dr. Mann conducted a similar study a few years ago,it didnt wash then,its not going to wash now.
Enjoy your 4th of July…….
Lisa Van Syckel
Hi Ed,
Happy 4th of July.
I am disappointed that you didnt post Dr. Simon’s Financial ties to the Industry.Shame on you!..
Lisa Van Syckel
Hi Jason,
Happy 4th of July to you also….
I do have a response,but unfortunately it is six pages long.I will send it to Ed, and hopefully he will put it up on the site,or he can e-mail it to you directly.
Dr. Mann conducted a similar study a few years ago,it didnt wash then,and it wont wash today.
These are not placebo controled studies and patients shouldnt rely on this information in determining the safety and efficay of these particular class of drugs.
The reporter failed to report that 1/3 of the 109,000 patients dropped out of the study, and why.This is significant,because, had they included this, the outcome may have been different..
This reporter should have disclosed Dr. Simon’s and Dr.Mann’s extensive financial ties to the industry.
The biased and vested interest of those proclaiming that the Black Box warning is the cause of the increase in suicide rates between 2003 and 2004. Almost all of the “scientists speaking out about the black box and its relationship to rising suicide rates have a vested interest(including an interest in defending their own actions of promoting the use of the drugs for children and adolescents despite an abscence of efficay data)and most have pharmaceutical industry ties….
Lisa Van Syckel
Jason,
What.. no response…
Thought you were interested in what I thought…
Melody
(incuding an interest in defending their own actions of promoting the use of the drugs for children and adolescents despite an abscence of efficacy data)and most have Pharmaceutical industry ties.
They (doctors) not only need to defend their own actions . . . they need to take pre-emptive action to cover their own butts when a bad (or ineffective) drug therapy turns lethal. Yes, I know I paint with a broad brush . . . but DOCTORS are the only ones who can get Big Pharma’s patented drugs into a patient’s body.
jason
Lisa, sorry to disappoint you. I use this site to supplement my practice. I go out every day and try to help people - and a lot of times that involves pharmaceuticals. With a holiday in the middle of the week, it makes it hard to get anything done. Have you had an appt. the day after a holiday. Let’s just say it gets busy. You sent Ed 6 pages and he had no response. So I guess I was letting those with more information hash it out. It is unfortunate that people need medication, but meds have saved MANY more lives that they have taken.
Lisa Van Syckel
So, in your practice,or should we say your passion for Marketing, you find it appropiate to promote the off-label use of antidepressants,that FDA and Congress,have, after reviewing the placebo controlled clinical trials have concluded that these drugs have no efficacy and cause suicide/violence in the Child/adolescent depression population
Isnt this illegal?………