A Congressional Investigation uncovered secret payoffs to a key psychiatrist opinion leader who conducted SSRI drug studies and gave lectures to other doctors. These drugs have been found no better than placebo in hidden research documents revealed through drug litigation. The FDA issued a suicide warning for SSRI drugs after reviewing data which showed a doubling of suicide rate for SSRI use compared to placebo.
"One of the nation's most influential psychiatrists, Charles Nemeroff, earned more than $2.8 million in consulting arrangements with drug makers between 2000 and 2007, failed to report at least $1.2 million of this income to his university, and violated federal research rules."
"A prominent psychiatric doctor who promoted antidepressant drugs has been stripped of his chairmanship at Emory University (again!) after investigators from Senator Charles Grassley's office uncovered secret financial ties to Big Pharma. Dr. Charles B. Nemeroff received $800,000 from GlaxoSmithKline."
No Better than Placebo
According to Irving Kirsch in Prevention & Treatment, “there is now unanimous agreement that the mean difference between response to SSRI antidepressant drugs and response to inert placebo is very small. It is so small that, despite sample sizes involving hundreds of participants, 57% of the SSRI trials funded by the pharmaceutical industry failed to show a significant difference between drug and placebo. Most of these negative data were not published and were accessible only by gaining access to US Food and Drug Administration (FDA) documents.
How to Manipulate the Studies to Get Favorable Results
Various methods were used to manipulate the results of SSRI drug studies to insure a favorable outcome:
1) Responders to the placebo are eliminated at the beginning of the study. (Placebo washout)
2) Benzodiazepine sedatives were given to mask the SSRI induced agitation.
3) Unfavorable drug studies are buried in the file cabinet and not disclosed to the public.
4) Miscoding suicidal events as "emotional lability", and homicidal events as "aggression" to hide suicidal events from regulators.
5) False attribution of suicide to the placebo arm.
6) Hiring ghost writers to make the medical articles more favorable.
7) Cash settlements for SSRI drug litigants which seals records and withholds unfavorable drug studies from the public.
Jeffrey Dach MD
References
http://online.wsj.com/article/SB122304669813202429.html
OCTOBER 4, 2008 Doctor Didn't Disclose Glaxo Payments, Senator Says Wall Street Journal
A prominent Emory University psychiatrist failed to tell the school about $500,000 he received from drug maker GlaxoSmithKline PLC while heading a government-funded research project studying Glaxo drugs, Sen. Charles Grassley alleged.
The payments to Charles Nemeroff, chairman of the Atlanta university's psychiatry department, compensated him for making presentations to doctors about Glaxo drugs, including its big-selling antidepressant Paxil, according to records Sen. Grassley obtained from Emory and Glaxo. The senator made the allegations in a letter to Emory President James W. Wagner dated Thursday.
http://www.nytimes.com/2008/10/04/health/policy/04drug.html?_r=1
Top Psychiatrist Didn’t Report Drug Makers’ Pay . New York Times By GARDINER HARRIS October 3, 2008
http://graphics8.nytimes.com/packages/pdf/health/04DRUG/2004-07-15GSK.pdf
Letter to Nemeroff from Emory SChool of Medicine
Pillar of Psychiatry Nemeroff Failed to Report Drug $$$
http://psycinfo2.apa.org/doi/index.cfm?doi=10.1037/1522-3736.5.1.533r
http://jeffreydach.com/2007/05/14/paxil-prozac-and-ssri-induced-suicide-by-jeffrey-dach-md.aspx
Brain Shocks
http://blogs.msdn.com/sebby1234/archive/2007/05/17/more-details-about-my-brain-zaps.aspx
Brain shocks or zaps are a fairly common adverse side effext of SSRI drugs.
SSRIs and Suicide Risk
www.lucire.com.au/documents/pps/Do-SSRIs-cause-Suicide.pps
www.lucire.com.au/documents/pps/Prozac_Geelong.pps
http://www.lucire.com.au/documents/Re-focussing-Upstream-New-Generation-Drugs-and-Public-Health.aspx
http://www.scribd.com/doc/2220665/Dr-Yolande-Lucire-Letter-to-Sun-Herald-280208 Dr Yolande Lucire Letter to Sun Herald (28!02!08)
http://ajp.psychiatryonline.org/cgi/content/full/160/4/790
Am J Psychiatry 160:790-792, April 2003
Suicide Rates in Clinical Trials of SSRIs, Other Antidepressants, and Placebo: Analysis of FDA Reports Arif Khan, M.D., Shirin Khan, Russell Kolts, Ph.D., and Walter A. Brown, M.D.
CONCLUSIONS: These findings fail to support either an overall difference in suicide risk between antidepressant- and placebo-treated depressed subjects in controlled trials or a difference between SSRIs and either other types of antidepressants or placebo
http://www.healyprozac.com/GhostlyData/JPCNDHealy.pdf
ANTIDEPRESSANTS & SUICIDE: RISK-BENEFIT CONUNDRUMS
David Healy MD FRC Psych Department of Psychological Medicine
University of Wales College of Medicine Results: The original clinical studies raising concerns about SSRIs and suicide induction
produced evidence of a dose-dependent link present on a challenge-dechallenge and rechallenge basis between SSRIs and both agitation and suicidality. Meta-analyses of RCTs conducted around this time indicate that SSRIs may reduce suicidal ideation in some patients. These same RCTs however yield an excess of suicidal acts on active treatments compared to placebos with an Odds Ratio of 2.2 (95% Confidence Interval 1.4 – 3.5). This excess of suicidal acts also appears in epidemiological studies.
Conclusions: The data reviewed make it difficult to sustain a null hypothesis that SSRIs do not cause problems in some individuals to whom they are given.
Antidepressant Medications for Children and Adolescents: Information for Parents and Caregivers What Did the FDA Review Find?
In the FDA review, no completed suicides occurred among nearly 2,200 children treated with SSRI medications. However, about 4 percent of those taking SSRI medications experienced suicidal thinking or behavior, including actual suicide attempts—twice the rate of those taking placebo, or sugar pills.
In response, the FDA adopted a "black box" label warning indicating that antidepressants may increase the risk of suicidal thinking and behavior in some children and adolescents with MDD. A black-box warning is the most serious type of warning in prescription drug labeling.
The warning also notes that children and adolescents taking SSRI medications should be closely monitored for any worsening in depression, emergence of suicidal thinking or behavior, or unusual changes in behavior, such as sleeplessness, agitation, or withdrawal from normal social situations. Close monitoring is especially important during the first four weeks of treatment. SSRI medications usually have few side effects in children and adolescents, but for unknown reasons, they may trigger agitation and abnormal behavior in certain individuals.
http://www.bmj.com/cgi/content/full/330/7488/396
BMJ 2005;330:396 (19 February) Primary care- Association between suicide attempts and selective serotonin reuptake inhibitors: systematic review of randomised controlled trials.
What is already known on this topic - Selective serotonin reuptake inhibitors (SSRIs) are a widely prescribed medication. SSRIs are used to treat an expanding list of indications, Divergent studies exist on whether SSRIs are associated with an increase in suicidal events. What this study adds.
Evidence from this study supports the association between the use of SSRIs and increased risk of fatal and non-fatal suicide attempts
While the incremental risk is low, the widespread use of SSRIs makes this a population health concern. A number of major methodological limitations of the published trials may have led to an underestimate of the risk of suicide attempts.
http://www.ahrp.org/risks/SSRI0904/HealySSRI.php
The correct interpretation of the results is that our best estimate of the risk of suicide on SSRIs is that it is 2.6 times greater on SSRIs than on placebo, and that the scientific data is in fact consistent with the risk being greater than 8 times more on SSRI than on placebo
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Comments
This type of corporate corruption is not limited to the pharmaceutical industry. It is considered busines as usual thoughout the oil and gas industry, food industry, financial industry (wall street), and other idustries, with extensive corruption of government regulatory agencies, and corruption of university level scientific and medical research. Welcome to America where the profit comes first.
What is your agenda, and why are you advancing it here on a non-commercial site devoted to personal writing? I have known many practitioners of "natural medicine" in my life and to the person they all turned out to be scam artists. The vitamin industry is astonishingly audacious profit deal, as you well know. You seem like a reasonable and pleasant person, but I think you are doing at least as much harm than good here.
If you are actually composing and writing these pieces here, only here, and only for this audience, I defer to your equal right to use this space to say whatever you have to say. If not, please consider posting something personal, with a link to your website or whatever, and without the copyright notice and disclaimer and blablabla, instead. Please, sir.
Further I comment not.
FYI, the editors of OS encourage bloggers to post in multiple locations even having an automatic update feature that will take blog posts from other sites and duplicate them here. So again, get over yourself.
Excellent post Dr, Dach. It is getting so you can't trust anybody and you especially can't trust the FDA. monkey fingered.
Telling the difference between placebo and SSRI is not the issue. Efficacy as an antidepressant is the issue. They were found to be no better than placebo in 57% of the studies. SSRI drugs increase the suicide rate twice over a placebo. The top researchers were bribed to push them onto other doctors.
Let me ask you a question. Who is performing the scam here? The drug industry who made cash payoffs to Nemeroff, the lead SSRI reseracher? Or am I the scam artist raking in the milllions by informing the public informatin that is already in the public domain in newspapers and in journals? My income so far has been zero. Where is all this money you seem sure is out there, I would like to know.
Rick, there is no money in natural medicine. The money is in drugs like SSRI's. That is why there is all this corruption.
There is little profit in vitamins and natural products because there is no patent protection. Vitamins are cheap. And you can buy them anywhere. Go to Walmart or Kmart and look at their vitamin prices. Dirt Cheap.
There is no money in natural medicine. If there was, corporate medicine would be doing it. Think about it.
What is your agenda Rick? Are you a representative or paid agent of a drug company? What is your story?
You want something personal?
Try reading , Finding God in Mr Foleys IV
By the way, congrats on making the cover.
jd
Rick said Each SSRI is different. I would bet an arm I could tell you the difference between a placebo and Lexapro, ten out of ten times. I would not be alive if it weren't for it. (Anecdotal, of course.)
What is your agenda, and why are you advancing it here on a non-commercial site devoted to personal writing? I have known many practitioners of "natural medicine" in my life and to the person they all turned out to be scam artists. The vitamin industry is astonishingly audacious profit deal, as you well know. You seem like a reasonable and pleasant person, but I think you are doing at least as much harm than good here.
If you are actually composing and writing these pieces here, only here, and only for this audience, I defer to your equal right to use this space to say whatever you have to say. If not, please consider posting something personal, with a link to your website or whatever, and without the copyright notice and disclaimer and blablabla, instead. Please, sir.
Further I comment not.