Why should it take 14 years to learn a drug’s safety risks?

Depression More Common In People Who Talk About Themselves
Source: PostBulletin.com
John Scott
September 21, 2016

How would you describe the behavior of a teenager who takes 80 tablets of of an over-the-counter medication that’s deadly in high doses? Or an adolescent who had a disagreement with her mother, then overdoses on prescription pills? Or a child that had to be admitted to the hospital for severe suicidal and homicidal thinking?

Most people would call that becoming suicidal.

The makers of Paxil, in an influential 2001 research paper signed by some of the leading figures in child and adolescent psychiatry — including the current president of the American Academy of Child and Adolescent Psychiatry — called it “emotional lability.”

Why would you give such a confusing name to such apparently suicidal actions? To hide them, of course.

That’s the best explanation that comes to mind after the findings published in the journal BMJ last week — 14 years later — that the blockbuster antidepressant is neither safe nor effective in the treatment of depression in adolescents and children. In fact, the study found, it is far more dangerous than previously realized — the drug caused 11 out of 93 children to develop suicidal behaviors, compared to just 1 out of 87 on a placebo. The original paper only reported five such events on Paxil.

The recent news about the distortion of the clinical trial that put millions of kids on Paxil in the U.S. did not arise thanks to the makers of the pill, or the FDA, or the health media. As former Boston Globe reporter Allison Bass described in her 2008 book “Side Effects,” the data that paved the way for last week’s study came into public domain thanks to a series of accidents.

Paxil’s undisclosed liabilities came to light because a TV reporter in Scotland thought the term “emotional lability” made no sense, did a show about it, then an insider at the drug company leaked some emails showing the company knew the drug wasn’t safe or effective, which led then-New York attorney general Elliot Spitzer to sue the makers of the drug for fraud.

Almost no one was interested in that lawsuit — the makers of Paxil paid a fine and the world moved on. Except, thanks to Spitzer’s office, they had made public much of the data behind the trial, opaque decision-making that would have otherwise been called proprietary.

That means it’s not even clear that there is anything especially unique about Paxil. Other drugs, and especially drugs of this class, could have similar problems and yet we will never know because we do not get to see the soft underbelly of a clinical trial of a new drug — the many ways a manufacturer can use sleight-of-hand and ghostwriters to distort their findings and hide a drug’s problems.

Fast forward 14 years, and Dr. Peter Doshi, a University of Maryland researcher who made his name by learning that the evidence supporting the drug Tamiflu was not as apparent as we had been told (when our nation spent billions stockpiling it), wondered what could be learned by starting with the so-called “clinical study reports” from the clinical trial that put Paxil on the market.

To their credit, GSK, the company that now owns Paxil, let a tenacious set of researchers, including psychiatrists Dr. Jon Jureidini, Dr. David Healy and Dr. John Nardo, probe an even deeper level of transparency, the so-called “case report forms” — patient level paperwork stripped of all identification data — where side effects show up and are coded.

That’s where they found out how seriously suicidal the patients taking Paxil had become.

The authors stress that if a child is taking Paxil that parents should not stop the drug — there is the risk of a withdrawal syndrome in the same findings, which is why they should talk to their doctor about their concerns.

It has become fashionable for clinicians hoping to prescribe these drugs to youth and adolescents to say the side effects are overblown, and that the benefits of the drug outweigh their risks.

You will hear advocates of the pills say that children only think about suicide on the drug, but do not attempt it, or that Paxil is a unique case, but all the other antidepressants are not nearly as concerning.

But they do not have the raw data behind the trials that put those drugs on the market, and neither do the doctors who signed the published clinical trials that put those drugs on the market.

They remain the property of drug makers. It has to end. Science is numbers, and if the public is to be asked to trust the numbers, episodes like the publication this week of the news about Paxil tell us to trust, but verify.

Read More At: PostBulletin.com

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BreakawayConsciousness

Zy Marquiez is an avid book reviewer, an open-minded skeptic, yogi, and freelance writer who regularly studies subjects such as: Consciousness, Education, Creativity, The Individual, Ancient History & Ancient Civilizations, Forbidden Archaeology, Big Pharma, Alternative Health, Space, Geoengineering, Social Engineering, Propaganda, and much more. His own personal blog is BreakawayConsciousnessBlog.wordpress.com where his personal work is shared, while TheBreakaway.wordpress.com serves as a media portal which mirrors vital information usually ignored by mainstream press, but still highly crucial to our individual understanding of various facets of the world. My work can also be found on https://steemit.com/@zyphrex.

6 thoughts on “Why should it take 14 years to learn a drug’s safety risks?”

  1. I was prescribed Paxil in 2001 after the birth of my child. I was 19. I was working full-time and attending college full-time. It wasn’t but maybe a month or two after starting this medication that I attempted my first suicide. There were 2 more attempts within tue next week year. I always thought poorly of myself until just last year when I found out about the possible side effects. It’s sad that so many didn’t make it through like I did, but I sure hope something gets done about it.

    Liked by 1 person

    1. Sorry you had to go through that. Paxil has had quite a bit of issues over time. While haven’t taken any antidepressants myself, know a few that have. They’ve suffered varying degrees of issues. After having a friend go through some times, the whole issue became known to me due to two doctors [and many more now] talking about these issues. Those were Dr. Kelly Brogan who recently wrote ‘A Mind Of Your Own – The Truth About Depression’ and Dr. Peter Breggin who wrote a book called ‘Toxic Psychiatry’ nigh a decade ago. Both essentially come to the same conclusions. After learning so much from them its been part of the reason to run this blog to show people that the way the health care system is being used in this country isn’t always for health but more so for profits. Antidepressants are one of those drugs that are very dangerous, but aren’t portrayed as so. Hopefully more people become cognizant of this. Hope all is well.

      Liked by 1 person

      1. Thanks! I will definitely look into that info. It pains me to know now what I didn’t know as a young adult. Eventually I was diagnosed with food allergies that were the actual cause of my suffering. It’s too bad so many Dr’s jump to conclusions before fully vetting all possibilities. Currently I am on the path to becoming a Nurse Practitioner and hopefully one more person out there to help others in their healing.

        Liked by 1 person

        1. What you say about helping others sounds wonderful. We need more people out there like that. And there are some, although not many at are following similar paths. One of my goals is to try and show people who the doctors/nurses are who are open minded and are willing to consider all possibilities, because there really is quite a bit of solutions in a few respects. How long do you have left to become a Nurse Practitioner?

          Liked by 1 person

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