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

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