Direct Association Between Paxil (Paroxetine), an Antidepressant, and Suicide

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A few years ago, a neighbor, having just switched antidepressant drugs, walked into his daughter’s room, exchanged a few words and then walked into the bathroom and blew his brains out.  At the time, according to news agencies, there had been a rise in suicides among individuals taking anti-depressants, particularly in the population that was switching their prescription.  My neighbor became one of those statistics.

I do not remember whether my neighbor had been on Paxil (Paroxetine) or had just switched to Paroxetine.  However, the British Journal of Medicine recently published a re-analysis of Paroxetine.  Unfortunately, the corrected analysis showed that Paroxetine indeed increases risks of suicide in young people and adolescents.

There were clinically significant increases in harms, including suicidal ideation and behaviour and other serious adverse events in the paroxetine group and cardiovascular problems in the imipramine group.

Conclusions Neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs.1

A study funded by SmithKline Beecham (SKB; subsequently GlaxoSmithKline, GSK), the British multi-national pharmaceutical company that produced Paxil, had been done in 2001 that claimed no association between Paxil and suicide.

A group of international researchers concerned by the amount of selective reporting of outcomes found in research papers created an initiative called “restoring invisible and abandoned trials” (RIAT).  Doing their own research into publishing undisclosed outcomes or correct misleading publications, the initiative has been actively seeking and correcting publications that fit this profile.  Their findings dispute the claims made by GSK regarding Paxil.

According to the British Journal of Medicine (BJM)

We acknowledge the work of the original investigators. This double blinded randomised controlled trial to evaluate the efficacy and safety of paroxetine and imipramine compared with placebo for adolescents diagnosed with major depression was reported in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001, with Martin Keller as the primary author.2

According to BJM

The RIAT researchers identified Study 329 [study done on Paroxetine] as an example of a misreported trial in need of restoration. The article by Keller and colleagues, which was largely ghostwritten,3 claimed efficacy and safety for paroxetine that was at odds with the data.4 This is problematic because the article has been influential in the literature supporting the use of antidepressants in adolescents.

Martha Rosenberg, an award-winning investigative public health reporter, found that the 22 doctors and researchers listed as authors in the original research paper

were not authors at all and that the research was actually written by a medical communication company (MCC) that GSK  hired. Such ghostwriting is disturbingly common in establishing drug safety.

“You did a superb job with this,” wrote the paper’s first “author,” Brown University’s Martin Keller to Sally Laden, a ghostwriter working for the MCC Scientific Therapeutics Information. “It is excellent. Enclosed are rather minor changes from me. In 2006, Keller, former Brown Professor Emeritus of Psychiatry, acknowledged that GSK had given him tens of thousands of dollars during and after the time the study was conducted.

When RIAT approached GSK in 2013 asking whether they would produce a corrected paper on the side effects of paroxetine, GSK

did not signal any intent to publish a corrected version of any of its trials. In later correspondence, GSK stated that the study by Keller and colleagues “accurately reflects the honestly-held views of the clinical investigator authors” and that GSK did ‘not agree that the article is false, fraudulent or misleading.’

Research studies are not cheap to perform.  Thus, many pharmaceutical studies are based on how much money the potential drug can produce rather than on the efficacy of the drug.  We live in times when money speaks much more loudly than services or health [please check the many articles in this blog that I have written on the abuses expressed by pharmaceutical companies].

Although there are governmental bodies in place that have been created to protect consumers,  often these bodies turn a blind eye.   In fact, the health industry presently is one of the largest profit bearing industries and when there is a lot of money involved, much gets overlooked.  Obviously not all drugs produced have fraudulent studies or focus their studies on the monetary benefits rather than the health benefits of a drug.  But there are too many drugs being allowed on the market that have not been sufficiently researched.

Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative. The reanalysis of Study 329 illustrates the necessity of making primary trial data and protocols available to increase the rigour of the evidence base.

Pharmaceutical companies have to take more responsibility than small print warnings scrolling across the bottom of the Television screen as idyllic scenes with a soothing voice-over laud the benefits of a drug.  They also need to reflect on the potential impropriety of buying doctors a huge lunch in order to have their ear regarding the latest and greatest drug they are marketing.  On the other hand, doctors need to take more time to do their own research before prescribing a drug and consumers need to be more vigilant in the doctor’s office.

copyright Yvonne Behrens 2015

 

Multitasking Video Games that Stimulate the Brain

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Back in 2006, I was sitting at a dinner table with my husband, a friend of ours (to whom my husband was also a consultant), and a Scientist.  The Scientist, who had been involved in creating a computer program to help children with learning disabilities (a program our friend was using in her Rehabilitation Center) was excitedly sharing with us that the same group that had created this program for children with learning disabilities had just come up with a new program to help re-stimulate the aging brain.

My maternal grandmother had succumbed to dementia.  She had been living alone for many years and although she had been living in a small French town where she knew many people and she had had a livelihood as an artist, arthritis had set in, impeding her ability to go out and paint.   My father, diagnosed with Parkinson’s disease, also developed memory loss.  My mother-in-law, a brilliant woman who was living with us at the time, in her 93rd year (albeit that is a nice old age) started to loose her mind.  It is not comfortable watching someone who was such a part of life fade into nothingness.  I suppose it will happen to many of us if something else does not get to us first, but…I digress.  Back to the dinner.

Needless to say, when I heard about this program, my ears pricked up and I recognized that this would be the next big step in extending the aging process.  I asked the Scientist how I could learn more about the program.  Our friend agreed that this program could be incorporated into her business, but that I would remain an independent representative of the company providing the Brain Fitness Program, Posit Science.

I loved the program and I loved introducing it to people.  Because it was the first of its kind, there were a lot of rough spots that the company kept tumbling over.  Some of it was proving the claims they were making, but most of it had to do with “meeting those profits.”  In the end, they never permitted their representatives to own a part of the company or even be a franchise, thus it could never develop into a business for me.  At around the same time that I recognized this, the company decided to only market via the internet.  Nevertheless, the concept is a sound one and since that time, other companies have developed their own programs.

Just recently, I came across an article that spoke about a Scientist who is using video games to the same effect.  In reading the article in The New York Times, I see that some of the same arguments are being put forth that were constantly surrounding the Brain Fitness Program: what are the positive effects; what are the negative effects; what are the long-term effects.  In spite of this, there seems to be positive responses for this new study:

The latest research was the product of a four-year $300,000 study done at the University of California, San Francisco. Neuroscientists there, led by Dr. Adam Gazzaley, worked with developers to create NeuroRacer,  a relatively simple video game in which players drive and try to identify specific road signs that pop up on the screen, while ignoring other signs deemed irrelevant.

Studies have shown that multi-tasking abilities diminish with age, starting in one’s ’20′s!  By the time people reach their ’60′s, the ability to multi-task has dropped by 64%.

But after the older adults trained at the game, they became more proficient than untrained people in their 20s. The performance levels were sustained for six months, even without additional training. Also, the older adults performed better at memory and attention tests outside the game.

“That is the most grabbing thing here,” Dr. Gazzaley said. “We transferred the benefits from inside the game to different cognitive abilities.”

In spite of these findings, the Scientists remain cautious.  It is not just playing video games that will re-stimulate one’s aging attention span and Dr. Gazzaley emphasizes the need to remain within the confines of scientific rigor. His study does include a further validation of the effectiveness of video games:

The researchers created a second layer of proof by monitoring the brain waves of participants using electroencephalography. What they found was that in older participants, in their 60s to 80s, there were increases in a brain wave called theta, a low-level frequency associated with attention. When older subjects trained on the game, they showed increased bursts of theta, the very types of bursts seen regularly in people in their 20s.

“We made the activity in older adults’ prefrontal cortex look like the activity in younger adults’ prefrontal cortex,” said Dr. Gazzaley, referring to a part of the brain heavily involved with attention.

All of this sounds very positive to me.  I still believe in the benefits of re-stimulating our neurons through interactive technology.  But I also appreciate that the brain is a sensitive organ which we are still in the process of understanding and, thus,  understand the Scientists’ caution.  In the meanwhile, just in case, I will buy myself some video games…..

 

© Yvonne Behrens, M.Ed  2013