Antidepressant Warnings Should Stay: Poll
6 CommentsBy Ed Silverman // September 11th, 2007 // 7:26 am
There was an outburst of news last week concerning antidepressants and whether Black Box warnings placed on product labeling was responsible for an increase in suicides. The link between the meds and suicide was already controversial, but the latest study fanned the debate because the increased suicide rate took place during the same year that there was significant publicity about the links. Yet, this was before the warnings were actually issued. Moreover, the new study was based on just one year of data.
So we asked you whether the Black Box should stay, given that the FDA is on record saying the warnings could be revoked, depending upon additional info. One caveat - this is not a scientific poll. However, the results clearly suggest that there is support for the warnings. Our thanks to those who took the time to vote.
What should the FDA do about the warnings?
Leave the Black Box warnings alone - 2,168 votes, or 96 percent;
Repeal the warnings - 82 votes, or 4 percent.
Total Voters - 2,250
Atlex
Does it clearly suggest that the warnings should stay or does it clearly suggest that one side is very good at marshalling themselves to skew a non-scientific poll?
Ed Silverman
Hi Atlex,
Good question, and I imagine the answer is - both.
A few further thoughts -
1 - I already acknowledged the poll isn’t scientific;
2 - No one is permitted to vote more than once, so if it was ’skewed’ it would have been because readers urged others to vote, not because people voted more than once;
3 - Nothing prevented anyone in favor of repealing the warnings from voting, or from ‘marshalling’ others to similarly vote for repeal.
Temperature readings are just that. We all need to take it for what it’s worth.
Cheers
ed
Lisa Van Syckel
Atlex,
Did you ever consider that, maybe, “patients” and their “families” want the “truth”,the “whole truth” and nothing but the “truth” in regards to the “SAFETY” an “EFFICACY” of the medications they ingest.
APA have thousands of members,they alone could have “BLOWN THIS POLL OUT OF THE WATER”
Maybe, they decided patient safety was more important than their ties to Industry…Just a thought
FYI— Individuals,within the “Medical Community” voted to keep the Black Box.
paula
FDA DATA show first 6 months of 2004, almost 8% INCREASE in Antidepressant prescriptions for children according to the American Psychiatric Association.
http://www.psychservices.psychiatryonline.org/cgi/content/full/55/10/1192
Psychiatr Serv 55:1192-1193, October 2004
© 2004 American Psychiatric Association
“…In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling…”
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Yolande Lucire’s full article stated:
“Yolande Lucire http://www.lucire.com.au
It is not safe to accept the statistics here, as they are not consistent with the American Psychiatric Association, which posted quite different information.
http://www.psychservices.psychiatryonline.org/cgi/content/full/55/10/1192
It could be that suicide numbers took a long time to come in. But prescribing increased according to the APA and suicide rates rose. The rest of the paper is so intellectually dishonest, as if these compromised authors will do anything to make antidepressants look good. I believe every word they write should be checked. They do declare conflicts of interest, but not their magnitude.
If it is the case that suicides then went on to increase on less prescribing, some of the increased numbers suicides might be attributed to cack handed warnings which did not contain information about how to taper slowly from antidepressants and the dangers of the withdrawal period. Some parents and doctors might have panicked and stopped meds suddenly, and may well have induced some withdrawal suicides. This is an empirical matter easily cleared up by examining coronial databases.
The authors of this study fail to see that the 272 trials reviewed by the USFDA to which they refer not only have some outcomes where suicide numbers were multiplied by 4.8 on active substance, but also they ignored withdrawal suicides. The US FDA did not, in any single review, look at withdrawal suicides, which might have doubled an already doubled even almost quintupled relative risk of suicide on treatment over placebo. As we are not told what the comparator drugs are and believe they were often just other perhaps more suicidogenic SSRIs, only true placebo has meaning, not placebo for a month after the withdrawal of active substance. Most trials demonstrated a relative risk of more than one and one would be ominous in a drug that is supposed to prevent suicide. It means we redistribute death to our advantage.
Most of the new suicides would be attributable to Zyprexa and Risperdal. Nowadays the medication craze has spread so far that seven out of every 1000 American kids are being medicated with antipsychotics, some as young as two and four.
Zyprexa and Risperdal were two of the most suicidogenic drugs in clinical trial history. They have never been licensed for kids. They are extensively used for children. Zyprexa and Risperdal were approved for use in bipolar.
For a variety of reasons best described as a ‘craze’ for psychotropic medication, the (mis) diagnosis of bipolar in kids for has gone up forty fold. So if you stop antidepressants and exchange them for atypical antipsychotics, which double suicide risk, (1 in 250) this outcome becomes inevitable.
Drugs actually behave worse in the community than they do in clinical trials. Rare side effects can become a public health problem when they are given to large populations, Community-based prescribers see patients less often than do clinical trial raters, do not know what phenomena (like hallucinosis) are side effects and what is a new illness and they co-prescribe more anti psychotics putting excess demand on scarce CYP 450 metabolism and cause further problems. Research and references can be found if you see my submission to the Productivity Commission in Australia.
http://www.pc.gov.au/study/medicaltechnology/subs/subpr047.pdf http://www.pc.gov.au/study/medicaltechnology/subs/subpr047.pdf “
paula
FDA DATA show first 6 months of 2004, almost 8% INCREASE in Antidepressant prescriptions for children according to the American Psychiatric Association.
http://www.psychservices.psychiatryonline.org/cgi/content/full/55/10/1192
Psychiatr Serv 55:1192-1193, October 2004
© 2004 American Psychiatric Association
“…In 2003, U.S. physicians wrote 15 million antidepressant prescriptions for patients under age 18, according to FDA data. In the first six months of 2004, antidepressant prescriptions for children increased by almost 8 percent, despite the new drug labeling…”
The above was found by looking at an article by Yolande Lucire, discussing the new information regarding ‘increased suicides on decreased prescriptions’:
“Yolande Lucire http://www.lucire.com.au/
It is not safe to accept the statistics here, as they are not consistent with the American Psychiatric Association, which posted quite different information.
http://www.psychservices.psychiatryonline.org/cgi/content/full/55/10/1192
It could be that suicide numbers took a long time to come in. But prescribing increased according to the APA and suicide rates rose. The rest of the paper is so intellectually dishonest, as if these compromised authors will do anything to make antidepressants look good. I believe every word they write should be checked. They do declare conflicts of interest, but not their magnitude…”
Too long to post in full (the comment won’t post), but link at the end which is also relevant is:
http://www.pc.gov.au/study/medicaltechnology/subs/subpr047.pdf
DaveD
Why did the suicide study fail to mention the 2004 eight percent increase in prescriptions to children? Or the fourty fold increase in antipsychotics (or the part of that increase that applied to 2004)?
I wish the authors of the study would go work for inland revenue, because the law on tax submissions at present is -
If I declared a business income of ‘X’ amount and failed to declare eight percent of one best-selling item and up to fourty fold of the other, I would soon find myself behind bars for fraud.
I would expect even higher standards in science and medicine where inaccuracies and omissions can kill - what a shock that the standards prove to be lower!