Wednesday, April 24, 2013

Global Medical (Mis) Information



I was sent a private email on Twitter a few days ago from Global Medical Education, known on Twitter as @GlobalMedEd. The blurb on their Twitter page reads, "GME is an online medical education resource that provides evidence-based medical education from faculty at Columbia, Duke, Harvard, Oxford, Stanford and more."

The content of the email was baffling considering I've been blogging about the dangers of antidepressants for over 7 years.

We're offering FREE access to 700 unbiased, evidence-based psychiatric videos Code: GMETwitter http://bit.ly/Pzvkhs  Limited time offer.

So, I checked out the GME website and watched a few of the videos on offer. Ones about ADHD, bipolar, depression and many other box-ticking illnesses.

I publicly tweeted GME and asked the following:



A day later they replied with...



So, I checked out the video.

I watched it... then I watched it again... and to be sure I wasn't hearing things I watched it for a third time.




The video features Manpreet K. Singh an Assistant Professor, Department of Psychiatry and Behavioral Sciences and Associate Director, Pediatric Bipolar Disorders Clinic. She's also a Pediatric/Adolescent Psychiatrist practicing from the Stanford University School of Medicine

I'll dissect Singh later in this post, first I want to highlight the video GME entitled, Can Antidepressants Cause Suicidality in Children and Adolescents?

There's even a slide show a separate audio commentary if watching videos isn't your thing.

Singh starts off by telling us that suicidal thoughts and behaviours are more common in adolescence than at any other time, but completion is more common among adults. Not in NZ where the highest suicide rates are in the 15-19 age group. She goes on to tell us that untreated depression increases the risk of suicide.

One can assume here that Singh is setting her stall.

She juxtaposes the FDA decision to add a black box warning to antidepressants with the following...

There were no cases of suicide in the cases they [FDA] studied. Autopsies of teenagers who have committed suicide show that very few of them had traces of an antidepressant, making the link between antidepressant use and suicide even weaker.
She then tells us...
Between 1992 and 2001, there was a large increase in the number of adolescents being prescribed antidepressants.

Adding...

But during that time the rate of suicide among American youth ages 10-19 dropped by more than 25%. This was the first time in nearly 50 years that the suicide rate declined in young people.

She makes no reference to the study, one can only assume she is refering to the [now debunked] studies of Robert Gibbons. His paper regarding suicide rates was described in the BMJ as “astonishing,” “misleading,” and “reckless.” Even one of his own researchers, Ron Herings, claimed, findings are “not right” and that it “ doesn't follow from the data, it is not true and serves just to scare people. It is hard to admit this, as I am one of the authors of the article and I attached my name to it …” [1]

Bob Whittaker, an award winning journalist and author, takes up the story of Gibbons here. Retired psychiatrist, Mickey Nardo, also highlights the flaws of Gibbons here.

Anyway, back to the video... or rather the star of the video, Manpreet K. Singh [Fig 1]

Fig 1

Her CV, at first glance, is impressive...if the field of psychiatry impresses you, that is. However, Singh fails to mention on her CV or the video message on GME that she has links to the pharmaceutical industry. She has, however, disclosed relevant financial relationships in various psychiatric journals. In 2007, for example, she disclosed she had relevant financial relationships with AstraZeneca, Otsuka, and Pfizer [2]. Also in 2007 she disclosed that she serves as a subinvestigator for Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Janssen, Pfizer, Abbott, and Shire Pharmaceuticals. [3]

Jump to 2010 and she declares that she has no financial ties or conflicts of interest to disclose. [4] Yet Pro Publica have her down as receiving $1,209 from Pfizer in 2010. [5]

As for the claims she makes in the video, let's just take a look at them once again.

There were no cases of suicide in the cases they [FDA] studied. Autopsies of teenagers who have committed suicide show that very few of them had traces of an antidepressant, making the link between antidepressant use and suicide even weaker.

What Singh fails to mention is the FDA were powerless to track down a large number of subjects in the clinical trials that were lost to follow up [IE; dropped out of the studies as a result of adverse reactions] These subjects were never followed up to see if they killed themselves. She also blatantly misses the point that when patients are prescribed antidepressants they are still part of a clinical trial, it's called the post-marketing phase.

Singh also fails to mention that the autopsies was just one method the FDA used to determine the risk factor of antidepressant use in adolescents. The FDA actually looked at data obtained from their British counterpart, the MHRA, who, after analyzing studies done by GlaxoSmithKline, found that  “These data do not demonstrate efficacy in depressive illness in this age group and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behaviour in the Seroxat group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with Seroxat [Paxil] compared to placebo.” [6]

Once the Paxil danger had hit the streets Wyeth soon announced via a letter warning physicians that venlafaxine (Effexor and Effexor XR) was associated with an increased rate of hostility and suicidal ideation in pediatric clinical trials.

To what length did the FDA go to see if there were traces of antidepressants? What tests were carried out and how stringent were they?

An independent report by Janne Larsson, analyzed the 2007 suicide data documented by the Swedish National Board of Health and Welfare (NBHW) and from the regional departments of the National Board of Forensic Medicine. The data, not readily available to the public, was obtained under Freedom of Information requests. [7]


In 2007, there were 1,126 suicides in Sweden (325 women and 801 men).  Autopsy reports were made for 1,109 of the suicides, which is 98%.

The majority of persons who died by suicide in Sweden in 2007 had received extensive treatment with psychiatric drugs within a year of death by suicide.

Janne Larrson, a Swedish investigative journalist, had requested the records under the Freedom of Information Act. He learned that , "In the forensic toxicological analyses traces of psychiatric drugs were found in 575 persons (52%) of the 1109 analyses done. Traces of antidepressant drugs were found in 132 (41%) of the women investigated." 

None of the documented 1,126 suicides were reported to the agency that maintains adverse drug reaction data.

These were adults.

If questioning the methods of the FDA analyzing teenage autopsies one need look no further than the case of 17 year old Toran Henry. Toran had been prescribed the generic form of Prozac [Fluox]. A change in mood, abnormal behaviour culminating in suicide - this just 15 days after he had first ingested Fluox.

During the inquest of Toran, his mother, Maria, called for a toxicology report. The first, taken on the 28th March 2008 found only alcohol in Toran's system. Knowing her son was taking Fluox at the time of his death Maria requested a further toxicology report. In the 14th April 2008 a second test was carried out. Here's a direct quote from the inquest transcript:

"No fluoxetine was detected in the blood, this analytical technique will detect therapeutic use of this antidepressant drug."
Once again Maria knew this was wrong. She pushed for a third toxicology report.

On 23rd July 2008 a third test was carried out. This from the inquest transcript:

"Blood was analyzed for the detection of fluoxetine - fluoxetine detected - 3rd test was carried out as requested by Ms Bradshaw, Toran's mom"
Three blood tests, the second apparently being so robust that "this analytical technique will detect therapeutic use of this antidepressant drug."

Truth is, it didn't.

The truth was outed but it took a grieving mother to out that truth.

For the purpose of this argument let's assume that 17 year old Toran Henry was a black box retrieved at the site of an airline crash. Let's assume that investigators found nothing within the black box that suggested any malfunction in the plane. Let's assume that after a second investigation of the black box, a more robust one, that, once again, nothing was found. Now, let's assume that after a third investigation something was found, that something was the cause of the airline crash. Would we, as members of the public, have faith in investigators one and two?

Five years down the line and both the New Zealand government and Mylan, the pharmaceutical company that manufacture Fluox, have admitted that the probable cause of Toran's suicide was down to the Fluox he ingested. [8] [9]

One would have to question then the methods used by the FDA in determining whether or not antidepressants were found in the autopsies they studied.

There are many tests carried out for toxicology, we've seen what happened in the case of Toran Henry. Were the FDA relying on autopsies that carried out toxicology tests just like the first two methods in the case of Toran Henry? I'm surprised nobody has asked them this.

There are a number of tests that can be carried out. Here's some for just one of the SSRi's, Prozac. Which ones did the autopsies the FDA studies use? Could it be argued that there were few adolescents with antidepressants in their system because the wrong type of toxicology test was carried out? It's a fair enough question, right?








Moving on the Singh's other claim in her 4 minute video...


Between 1992 and 2001, there was a large increase in the number of adolescents being prescribed antidepressants. But during that time the rate of suicide among American youth ages 10-19 dropped by more than 25%. This was the first time in nearly 50 years that the suicide rate declined in young people.


I'll use simple tit-for-tat here.

SSRi's were introduced to New Zealand in 1989. The table [Fig 2] shows a general increase in suicides since their introduction.

Fig 2
To take this one step further, let's now take a look at 2008 onwards.

Here's the prescription rates for antidepressants in NZ - 2008/2012 [Fig 3]

Fig 3

And now let's look at the NZ suicide statistics.


2008  - 540              
2009  - 531
2010  - 541
2011  - 558
2012  - 547


So many antidepressant prescriptions, so many suicides.

On top of this myself and Maria Bradshaw [CASPER] are in the middle of writing up a cohort study. We have, under the freedom of information act, obtained suicide data from the same district health boards [DHB's] seen in Fig 3. Initial findings see 90% of those who died under the care of DHB services were on or were recently on psychiatric medication at the time of their suicide. The figures we have will be made public once we have completed our study.

As for Global Medical Education and Manpreet K. Singh, I believe the information they provide with regard to suicidality in adolescents on antidepressants is very misleading, very one-sided and extremely dangerous.

Watching the performance of Singh left a terrible feeling of helplessness in the pit of my stomach. For a professional to go against the regulators and manufacturers of these dangerous medications means that less internet savvy members of the public may find themselves one day Googling whether or not antidepressants are safe in children and adolescents. Her biased [read from an auto-cue] performance may convince parents that antidepressants are safe when used by this vulnerable population. She may also have convinced healthcare professionals.

Here's the video

video



Global Medical Education carry the disclaimer at the foot of their website, "All material on this website is protected by copyright, Copyright © 2013 by GME Inc. This website also contains material copyrighted by 3rd parties."

If they feel I have infringed their copyright by posting their video on my blog then I request that they email me, they can do so by using the 'Contact' tab at the top of this blog.

Worryingly, Global Medical Education have over 5,000 followers on Twitter. If all of those 5,000 + received a private message from them, as I did, then it would appear that they are pushing the promotion of their website to all and sundry... even to those who vehemently believe that antidepressants can cause suicide.




Bob Fiddaman


[1] Coincidence a fine thing - David Healy [Link]
[2] Pharmacotherapy for Child and Adolescent Mood Disorders
Manpreet K. Singh, MD, MS; Jonathan C. Pfeifer, MD, MS; Drew Barzman, MD; Robert A. Kowatch, MD, PhD; Melissa P. DelBello, MD, MS [Link]
[3] Journal of the American Academy of Child & Adolescent Psychiatry Volume 46, Issue 3 , Pages 306-307, March 2007 [Link]
[4] Neural Correlates of Response Inhibition in Pediatric Bipolar Disorder
Manpreet K. Singh, M.D., M.S, Kiki D. Chang, M.D. Paul Mazaika, Ph.D., Amy Garrett, Ph.D., Nancy Adleman, Ph.D., Ryan Kelley, B.S., Meghan Howe, M.S.W., and Allan Reiss, M.D. [Link]
[5] Payment Disclosure - Singh, Manpreet, Kaur [Link]
[6] WHO Drug Information Vol. 17, No. 2, 2003 [Link]
[7] Psychiatric drugs & suicide in Sweden 2007 - Larsson [Link]
[8] Mylan's Fluox Can Probably Induce Suicide, admit Mylan [Link]
[9] CARM Assessment of Toran Henry's suicide [Link]






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