Should The FDA Repeal Black Box Warnings On Antidepressants? Vote Here
17 CommentsBy Ed Silverman // July 11th, 2007 // 7:39 pm
A few days ago, we noted that FDA official Tom Laughren was quoted as saying he wouldn’t rule out repealing the warning, depending upon CDC suicide data for 2005, which becomes available late this year. Why is that worth waiting for? The FDA warnings took effect in early 2005 and, since then, many psychiatrists worry that docs and patients are being scared away from the drugs. So we asked you whether repealing the warnings was a good idea. The polls are open two more days. Please vote here.
jeanne erickson
LEAVE THE BLACK BOX ALONE
Lisa Van Syckel
I would like to thank all who voted for keeping the Black Box.I am extremely concerned over the many personal attacks that have occured over the last several days,especially the personal attacks against the children and their parents.This is an issue about Clinical Trial Data that was withheld from the Public,Data that clearly showed a causal role of suicide in those under the age of 18 & FDA’s failure to act,and conflicts of interest.THIS ISSUE IS NOT ABOUT TOM CRUISE AND HIS RELIGION!!NOR IS IT ABOUT BROOKE SHIELDS AND HER DISEASE.So Please if you truly care’ than stop the personal attacks on the kids.Contact your Congressional Represenative in Washington and ask them to Investigate Dr. Laughren’s possible conflict on this issue.I dont believe any member of Congress,who has FDA oversight responsibilities will allow FDA to repeal the black box or allow Dr. Laughren to be a one man band here.Im sure members of Congress are already asking questions.
Lisa Van Syckel
Jason—-I will not engage in further conversation with you,and provide you with a platform to degrade others especially someone’s child,Or allow you to pretend to be someone your not.
Sally-Anne Cooke
Leave the black box warnings alone!
jason
Lisa,
I am OK with that, good luck!
sil
I hate Tom Cruise!!!!! Drugs are good, how could anyone take the same side as that freak?
You guys are funny! You make me laugh, what a joke! Whatever. Kids are crazy, just like parents. You guys are all nuts posting on this site every chance you get. FREAKS!!!! Don’t you guys realize you aren’t changing anything on a forum such as this? Again, whatever
jason
Lisa, I do feel bad you feel this way. Take a look at my other posts, obviously I have an opinion on things other than this one. I help people, I am actually the only doc who would go into this tiny community, so I am the only medical person that is willing to help this rural area. So I know you think I am a bad guy, and that actually makes me a little sad.
But I did see 43 patients today, did 10 phone consults (this is a very rural area), and just delivered a tiny, cute little baby this evening! Great day!!!! The miracle of life is priceless, I do kind of wish I was an OB/Gyn at times. Medicine is wonderful and I am happy to help people. Here I am at 11pm, after a long day looking to see if there is any new information to incorporate into my practice. So I guess, although I feel bad, luckily my patients love me - I would gladly have one or two send you an e-mail to let you know I am not a bad guy…….. Wait, that doesn’t matter to you. Never mind, my community is happy I am here, I am glad to help them. Life is good. Vacation was good, although cut short by an ER call. But I am dedicated to helping my patients and community - just like you feel you are. So I hope you get over a doc who works 60-70 hours a week in the office, spends 10-20 hours looking at new data, and never stops praying for his patients. I feel bad you don’t like me, I really do. Luckily the community around me is happy that I am willing to sacrifice my life to help them. God is good, life is good. I am unwilling to let you bring me down. But I am sorry you feel that I am a bad guy - and more disturbed about the words you said about me.
Hank
I initially didn’t vote - I wanted to get a better idea of the new studies first. My own assessment is that they show very little that is substantial about ssri’s _lowering_ suicide risk. What the show is that _treatment_ lowers risk, or the initial decision to enter treatment (which may be psychotherapy with or without meds). That is hardly surprising since so many suicides are based on the feeling of “no options.”
One of the studies was a bit more suggestive re: an association between ssris and lower rates of _completed_ suicide (not attempts). But the associations were potentially complicated by so many intervening variables that I am not convinced that they change the core conclusions that led to the black boxes.
Reality
I’m withholding judgment for the time being, but everybody, regardless of agenda, should follow the science. Period. I didn’t read every single post from the previous entry, but I didn’t see anyone mention the 2 studies (Simon & Savarino, and Gibbons, et al.) published in the July issue of Am J Psych, and I’m surprised Ed didn’t link to them.
Without going into detail, the first study showed that suicide attempts were highest in the month before starting treatment, and lower thereafter. The second study showed lower suicide rates in those receiving SSRIs and tricyclics vs. no treatment. As with the first study, the second study showed higher attempt rates before treatment. The accompanying editorial by Brent is worth reading, too.
The overall bottom line from these studies is that antidepressants, including SSRIs, protect against suicidal behavior.
Laurie
I’ve read both of those studies. What’s especially sad about this whole experience is that I trust no study done by psychiatry. While I read in the studies that suicide decreases with ssri use, I talk to thousands of ssri’s users everyday whose experience is far from that reported in the studies.
One aspect that has never had a study done is the suicide related to withdrawal from an ssri.While thousands are suffering getting off these drugs, their situation is never given serious consideration.
So for now…I tend to believe those who have been there, instead of those that make their living off of prescribing.
One thing that I have learned. in becoming educated in the clinical trial and study field, is that you can make a study show anything you want it to. Jaded…probably, but after reading GSK’s study 329 you’d have to be.
http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html
Reality
Laurie,
I’m sure you talk to many people, but personal communication has no credibility when stacked against a trial, even an observational or cohort trial like those in AJP.
Case in point: I know many people who have been helped tremendously by SSRIs, so who’s right? Both of us? Neither? I don’t know — that’s why we run trials. And it’s not dissimilar to reading any product review: the disgruntled are much more likely to come forward and complain than are the satisfied to compliment.
I hate to say it, and please don’t take this the wrong way, but people like you and Lisa seem to let your emotion rule all, where even neutral science is ignored or brushed off. When you come at an issue like that, you have as much bias as those you claim to rail against. If you’re unwilling to even consider new data you become someone with an axe to grind, and end up merely preaching to the choir rather than someone who is engaged in a legitimate scientific debate. In fact, I couldn’t slog through the earlier post with 140 comments because it degenerated so rapidly on both sides.
D
No, they should not repeal the black warning. Anti depressant’s have very powerful side-effects. Drug companies can’t be trusted and cover up negative data, this is fact. Can’t dispute it. We as adults cannot make an informed decision with regard to anti-depressants because of inadequate information, that can’t be trusted because of primarily financial conflicts from so called respectable institutions, for example Harvard, Mass Gen. Who as a responsible parent would inflict this on their children, now, that we know the facts about big pharma. These poor parents who suffered as a result of these criminals, who will not be prosecuted and live the rest of their lives living a luxury life as a result of blood money. it is a modern day tragedy, and will only be acknowledged as such, many years from now and I am being hopeful saying that. Hopefully the internet and blogs can make people aware of the corruption in our society. Please forgive me if I sound too much to the left, or angry or any of those other labels, but I think it is the truth. If only one child dies because of the financial gain of others, I see it as an awful crime, but others don’t (pharmaceuticals) which I cannot understand. Data is not difficult to understand. if a child commits suicide on a trial then the risk increases for the rest of the patient population. Big Pharma should not hide behind data and stats. Our children are too precious.
Laurie
“but people like you and Lisa seem to let your emotion rule all, where even neutral science is ignored or brushed off.”
But if you took the time to read all of the posts you would see that Lisa and I don’t call for a ban on these drugs. We call for honesty in reporting and warning about the potential downside of these drugs.
Yes, some people are doing fine on ssri’s, but there are also a growing number of people who are not doing fine. Do we ignore that group that have horrible reactions because some do fine? No, we put out all of the information so that people can make an informed decision. That’s all I’m asking for.
As for the “the disgruntled are much more likely to come forward and complain than are the satisfied to compliment”, do we totally discount the firsthand reports of those who don’t do well? That’s what is happening. A drug that has no evidence of efficacy except for the firsthand reports of the user, how do we ignore the firsthand reports of those who had bad reactions? That’s what I don’t get. The FDA has thousands of Adverse Reaction reports with symptoms that are stunningly similar, yet these are not included in any “study”. These reports are dismissed as “anecdotal”, “unreliable” and unscientific. Yet a study using the same criteria that comes out with a positive end is “scientific”. Why, because someone created a questionaire? Because they can choose who participates and screen out those to don’t meet the criteria of the study? That is not a real life study. Well the Medwatch program does not prescreen the participants. It’s real people, real doctors reporting what has happened to them and their patients. I find that more scientific and unbiased.
Emotional, you bet I am, and it’s not only due to what happened to my son. It’s fueled everyday by those who feel they were lied to when they started taking these drugs, and after 10 years use find themselves in withdrawal while still taking the pill at the maximum dose. Honesty..that’s all I’m looking for.
sid
Please everyone, learn that “anecdotal” is a stat term. It literally means that it is a reaction that is unexpected and not necessarily a causal event. There is no causality that can be ascribed to a drug in a retrospective report.
Also an anecdotal reaction is one that is unexpected and not found in phase 3 trials (
Melody
personal communication has no credibility when stacked against a trial, even an observational or cohort trial like those in AJP.
If “scientific integrity†still had any real meaning, Reality, I might agree with you. Countless websites and blogs discuss how “science†today is skewed by the deep pockets of Big Pharma. Today’s researcher is oftentimes given an answer and then told to design a study and enlist patients who will affirm the predetermined answer. NOT GOOD SCIENCE! [Interesting reading is often found in the footnotes to determine who was included and EXCLUDED from the trial population. Other gems can be gleaned by examining who dropped out of a study/trial, and for what reason.]
Does “anecdotal†trump scientific trials? Probably not. But until we see a return to scientific methodology that is not influenced/controlled by Big Pharma bucks, the best we can hope for (sadly) is DISCLOSURE.
sid
wow, websites AND blogs from untrained people discussing issues they have limited knowledge on. I am sure “blogs” carry more weight than say the New England Journal of Medicine, but I still trust peer reviewed articles more than blogs.
clinicaltrial.gov was a great start to transparency. Drug companies can no longer conduct a trial and bury it if the results don’t match the outcome they want. Every trial excludes people, that is to evenly match controls with treatment groups and to eliminating confounding variables.
So who do you want to do research if you are opposed to pharma doing it?
Melody
So who do you want to do research if you are opposed to pharma doing it?
Pharma would obviously have to do research to “create†a product . . . but as to safety and efficacy research, how about independent, non-industry financed universities and med schools? Would that work for you? Ooops! I don’t know that such institutions exist any more. Once upon a time, independent research permitted side-by-side evaluations, and the reporting/distribution of ALL conclusions. But apparently “new science†has replaced “old science†. . . and we are left with the dregs.
Before you too arduously disparage blogs and websites, you may find that many are maintained or written by “insiders†who do, in truth, speak from experience and training. When they shine light onto their own profession, I would, indeed, give a bit of credence to their perspectives. As for your highly touted NEJM reporting . . . you might want to take a look sometime at expert testimony given before Congressional committees from experts who have more than a passing acquaintance with this (and other) prestigious medical journals. These experts (former editors, doctors) reveal that even these bastions of medical expertise have chinks.