Drug Companies Hide Trial Results

Dear Reader,

Everyone who takes a prescription drug is stepping into the unknown. I mean EVERYONE. Including your doctor.

Your doctor MIGHT have a clue about the drugs he's prescribing. But that's the best you can expect. A clue.

That's because almost nobody outside of the inner circle of drug company employees gets a complete look at drug company trials.

Here's how trial transparency crusader Dr. Ben Goldacre puts it in a recent New York Times article… If you flip a coin, but hide it every time it comes up tails, it looks like the result is always heads.

Silence is golden


That's exactly what drug companies do with most of their studies. Dr. Goldacre notes that they only report about half of their research. And you can be certain there's no good news in those unreported trials.

Two attempts to fix this problem have been complete failures.

A few years ago, the American Food and Drug Administration (FDA) started a trial transparency programme. But the agency never enforced it.

What!? SHOCKING, right? Who could have predicted THAT?

The programme turned into a joke. Literally. I'm sure drug company honchos get a laugh every time they think of it.

Medical journal editors also gave transparency a try back in 2005. Under that programme, they would refuse to publish any trial unless it was entered in a publicly accessible registry before the trial began.

That plan? Gone with the wind.

Ironically, these two failed plans BENEFIT drug companies. That's because the industry pretends the plans were successful. They promote the fantasy that alert watchdogs are in place. In fact, those dogs are sound asleep in a doghouse out back somewhere.

Earlier this year, 53 people who have taken part in clinical trials have written an open letter to the European Medicines Agency (EMA) to point out that the lack of regulations requiring clinical trials to be published is a betrayal of their trust.

They have asked the agency to ensure that the protocols and results for all clinical trials published since the 1980s are posted on a public register.

Signatories include campaigners behind a public petition for full disclosure of clinical trial results and supporters of the British Medical Journal's (BMJ) open data campaign.

In fact, it looks as if the BMJ is one of the only respectable medical journals out there who is still trying to stamp out the fact that researchers and drug companies often withhold clinical trial results from doctors and patients.

According to the BMJ, half of all trials are never published. In many cases — such as those of oseltamivir (Tamiflu) and rimonabant — direct requests for information about trials have been refused.

As of January 2013, the BMJ no longer publishes any trial of drugs or devices where the authors do not commit to making the relevant data available.

The BMJ have also asked patients and doctors to help them catalogue drugs, devices, and treatments for which a lack of complete clinical trial data has resulted in a skewed view of its benefits.

In the UK, the next development is a parliamentary select committee hearing on the implications of hidden clinical trial data. The BMJ has committed themselves to submitting details to this committee.

Here's hoping that the BMJ's efforts aren't just another flash in the pan... leaving them banging their heads against a brick wall... It is Big Pharma we're talking about after all. 

... and another thing 

Drug company executives will be easy to spot later this year. They'll be the deliriously happy guys dancing around like court jesters. 

That happiness comes courtesy of the American Psychiatric Association (APA). APA officials are working on final edits for the Diagnostic and Statistical Manual of Mental Disorders (DSM). 

As I've mentioned before, the DSM provides guidelines for mental health practitioners worldwide. When editors bestow their official designation for a new disorder, drug companies rejoice. That means it's time for doctors to get out their prescription pads and start writing! 

In the upcoming edition, "bereavement" gets the nod. Apparently, the DSM will classify bereavement as a "major depressive disorder" when sadness, crying, poor concentration, etc., last longer than two weeks. 

Two weeks! That's it! That's your limit of grief after losing a parent, a spouse, or a child. They won't consider your deeply felt grief to be "normal" if it goes beyond 14 days. At that point, you'll have a disorder and you'll be a candidate for medication. 

I would ask… "What are they thinking?" But I believe it's pretty clear. 

According to a recent newspaper article, eight of the 11 members of the APA editorial committee have financial ties to drug companies. 

I think we can predict that the new DSM is going to give some drug company executives "major euphoria disorder." 

Here's to healthy living, 

Francois Lubbe
Editor

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