She also provided information to investigators in two separate Congressional investigations that resulted in two hearings in 2004, at which drug company executives and FDA officials were interrogated and chastised by members of Congress.
In addition to Ms Menzies, one of the world's most highly regarded SSRI experts, Dr David Healy, a professor at North Wales Department of Psychological Medicine, at Cardiff University, will be flying in from the UK to testify at the hearing. He too will give a repeat performance.
Dr Healy has authored 12 books including, Let Them Eat Prozac, The Antidepressant Era, and The Creation of Psychopharmacology, and is known to be outspoken when he believes it is necessary. During his testimony at this hearing, Dr Healy says he plans to draw attention to the manipulation of the clinical trial data on SSRIs.
For over a decade, he has been trying to raise awareness about the link between SSRIs and suicide. Back in August 1991, Dr Healy authored the paper, "Antidepressant Induced Suicidal Ideation," in which he said that the cases of two patient "suggest that the emergence of suicidal ideation on antidepressants cannot always be attributed to a lifting of psychomotor retardation but rather that the ideas may in some instances be produced by antidepressants."
Three years later in 1994, he authored the paper, "The Fluoxetine and Suicide Controversy," and stated, "In the opinion of this author, the volume of case reports and other studies is sufficient to demonstrate that antidepressants and antipsychotics may induce suicidal ideation in certain individuals under certain conditions."
After the February 2004 advisory committee hearings, Dr Healy analyzed the data from the pediatric SSRI trials on suicidality and hostility, including those kept hidden for years, and sent his analysis to the FDA on February 19, 2004.
To distinguish the difference between suicide possibly caused by SSRIs verses suicide caused by an underlying illness of depression, Dr Healy broke down the studies into a group of children being treated for depression and a group of anxious children who were being treated for obsessive compulsive disorder or social phobia.
From a pool of 931 depressed patients taking SSRIs versus 811 depressed patients taking placebo, Dr Healy determined that there were 52 suicidal acts by patients on SSRI versus 18 in the placebo group.
In a pool of 638 anxious patients taking SSRIs versus 562 anxious patients taking a placebo, there were 10 suicidal acts in the SSRI group versus 1 in the placebo group.
When these data sets were combined, in the 1569 patients on SSRIs there were 62 episodes of suicidality versus only 19 episodes in 1373 patients on a placebo.
This analysis clearly shows that SSRIs can cause some children who were not depressed to begin with to become suicidal.
Dr Healy believes the FDA should do more about the industry's practice of paying medical professionals to publish fraudulent research papers ghostwritten by PR firms. "While it is not FDA's brief to regulate the academic literature," he states, "the possibilities of a close to fraudulent representation of data and of extensive ghostwriting does set up an argument that these apparently scientific articles are in fact infomercials rather than the real thing."
"If these articles are essentially advertisements," Dr Healy says, "it is much less clear that FDA can throw their hands up and plead an inability to do anything about the production of such materials."
Former Federal fraud investigator, Allen Jones, will also be testifying at the hearing and he too has testified before about the over-promotion and marketing of psychiatric drugs.
"The pervasive manipulation of clinical trials, the non-reporting of negative trials and the cover-up of debilitating and deadly side effects," Mr Jones says, "makes it impossible to prescribe, or take, these drugs with any level of meaningful informed consent."
"Doctors and patients alike," he states, "have been betrayed by the governmental entities and officials who are supposed to protect them."
