On The Media

Thank you so much for your story. The only reason I am still alive is because of a site called PaxilProgress.org. I am 19 months post Paxil, and while I'm just starting to heal I have a long way to go. The 6.7 years I was on Paxil my life turned into sheer hell. This drug destroyed me emotionally, physically and financially. I was never told by my doctor that this drug was 1) addictive, 2) the drug would poop-out eventually and put me into withdrawal while still on it, and 3) getting off would be the nightmare of a lifetime. I wish NPR would report more how dangerous SSRIs are. So, for me and thousands and thousands of others, I thank you for reporting on this.

The host suggested there should be a requirement to post

results of clinical trials on the internet. In fact, such a requirement is included in recently passed legislation.

Time will tell if companies comply with the law, whether the law is enforced, and whether science and public health benefits.

See in particular Title VIII (starting pg 82) of the law.

http://www.fda.gov/oc/initiatives/HR3580.pdf

This section addresses both identifying what trials are going on as well as reporting the results of trials.

Nick says that the new law (he is referring to the 2007 FDAAA) requires researchers to post results of clinical trials on theinternet. Unfortunately, there are multiple loopholes and weaknesses in FDAAA that will allow researchers to continue to conceal the deaths of human volunteers like Traci Johnson - unless the FDA acts to close those loopholes. In addition, he law does nothing to address underlying data from studies - given how researchers are known to spin their results as positive even when the underlying data from their own study are negative - such a mandate is critical to genuine data transparency.

for a more coherent (and grammar checked) follow up on data transparency than what I just posted, please see the upcoming issue of the British medical journal (BMJ).

As a psychotherapist with 15 years clinical experience working primarily with adolescents, I feel this story is an important contribution to the slowly developing public debate on psychoactive medications.

Instead of being seen as the first line of response - as they usually are - meds should one of the last options. Meds are routinely considered the answer before clinicians fully evaluate such quality of life basics as parenting, nutrition and sleep. (If, for example, a teen is getting less that 8-9 hours of sleep each and every night they are sleep deprived and it will impact their behavior and learning.)

Other issues like substance abuse, family loss, bullying, learning disorders, computer use and lack of physical activity need evaluation.

Given lack of true privacy of medical records from the prying eyes of the insurance industry, there needs to be greater care before labeling a child with a diagnosis or placing them on a needless medication.

We need to eucate kids, parents and the medical community about the basic nature of emotions. We need more of a focus on skills and less on pills.

Parents, please be aware that bi-polar is the latest diagnostic fad for children. The rate of bi-polar diagnosis of children is a scandal and great dis-service to our young patients. Before accepting such a diagnosis for your child, seek a second or third opinion and explore every other avenue of therapeutic support.

Thanks "On the Media" for a great report!

Medical journals are taking partial steps in the direction of resolving the issues addressed in Lenzer's report. See Archives of Pediatrics and Adolescent Medicine, 2008;162:22 for an example and links to more widespread efforts. Still, legislative backup is needed.

I think there are two sides to this problem. The most apparent to US Citizens are advertisements in mass media. Advertisements tell individuals to self diagnose themselves, then go tell their doctors that there's something wrong.

As the report mentions, mass media companies are "owned" by the companies who pay to advertise or publish through the medium. If the government could regulate companies and force them to publish all trials, either data would disappear or pharmaceutical companies would disappear.

For now, things are getting better. A “quick fix” would cause more problems and possibly cause good medicine to be discontinued. As long as people and insurance companies are willing to buy and support huge pharmaceutical companies, the power lies where the money is. Welcome to America.

Hi Jeanne,

Very nice piece. What these companies also fail to document or acknowledge are cases of malingering, or more bluntly, faking in the clinical subject population, and how that affects the results of these trials.

About three years ago, I went on the ETC section of craigslist.org, being a broke young actor looking for quick cash (and a new bass guitar). I found an ad that went something like this: "Sad? Depressed?" The ad listed the symptoms of depressive disorder.

So what did I do? I faked my way into the study by acting depressed, following the symptoms they described in the ad. They put me on SSRIs and I got paid. In the process, I learned how little these research institutes (funded by big pharma money) really know about depression, and how little they screen potential subjects.

The troubling thing to me was that they were giving basic strangers a vested interest in the whole process. Depression is no doubt a serious issue in America, and I learned that this data, gleaned from craigslist, was ultimately being used to shape the marketplace for anti-depressants.

So, like a good/vain actor, I wrote a one man show about it. I've been trying to get the word out by poking fun at the whole situation, while bringing up serious issues about the nature of the industry. I've been touring the US and Canada with the show, "How to Fake Clinical Depression."

http://blogs.citybeat.com/fringe07/2007/06/how_to_fake_a_c.html