Trudo Lemmens of the University of Toronto critiques the recently distributed draft EMA Clinical Trials Data Release Policy.

[First published in the PLOS Blog.  Click here for the original post.] Things were looking good recently in Europe for data transparency, a necessary, albeit not sufficient, tool to promote integrity of pharmaceutical data. The European Court’s Vice-President overturned in November 2013 two lower court interim suspensions of EMA’s data access decision in relation to Abbvie’s drug Humira and … [Read more...]

Odysseus come home

Odysseus was in his 70s. Coming up to the 50th anniversary of a very happy marriage. He had formerly been a respected professional, a longtime member of the bowling and social clubs – a pillar of the community. He had had minor episodes of anxiety primarily since retirement but no diagnosis of nervous problems. He went to his primary care doctor and was given a sleeping pill for poor sleep but … [Read more...]

The Dram of Eale

They told me the 80 year old man who'd had a stroke must be depressed – he wasn’t rehabilitating properly. Could I see him and look at whether the citalopram he’d been started on a week before needed tweaking? Jeff was solidly middle class, professional. He had never been ill before his stroke and never ever been mentally ill. He had a large loving close-knit family who came to see him every day. … [Read more...]

Homeland security

In the latest hit series Homeland Claire Danes plays Carrie Mathison a CIA agent with bipolar disorder taking Clozapine. She takes the drug to prevent herself tipping over into frank paranoia in a world where being paranoid is necessary for survival. Anyone who knows anything about Clozapine knows Claire Danes is definitely not on it – she would not be as slim and svelte as she is if she were … [Read more...]

We need to talk about doctors

Randomized controlled trials (RCTs) came into favor in the wake of thalidomide as a method to evaluate drugs and their risks. They were supposed to keep ineffective drugs off the market, but companies have learned that you can do any number of trials and if even some show a marginal benefit they can get their drug on the market and the others can be suppressed so no one has a true picture of the … [Read more...]

Notes on a scandal

In 1996 Zoe Heller, the author of Notes on a Scandal, took part in a widely reported debate with Roy Porter about Prozac. She defended the drug. It had restored her to life. He said today’s miracle invariably ended up in tomorrow’s tragedy and asked, Why is it that we never learn? The story of a schoolteacher who seduced one of her male pupils. In 2003, Notes on a Scandal came out. It was made … [Read more...]

Model doctors?

Another inquest may bring out the risks to doctors from their professional associations behaving as the American Psychiatric Association (APA) or the Irish College of Psychiatry has done (see Professional suicide – the Clancy case). She posed no suicide risk. She was put on citalopram. Yvonne Woodley, a 42-year-old woman with two young daughters, ran into difficulties with her husband. They began … [Read more...]

Professional suicide – the Clancy case

Shane Clancy, a 22-year-old going to University in Dublin, broke up with his girlfriend, Jennifer Hannigan, in April 2009. Despite his having broken the relationship off, he found it difficult without her. She, meanwhile, had found someone new: Sebastian Creane. Shane took a trip to Thailand and Australia, but aborted his travel and came home unhappy. His mother took him to his doctor on July 18. … [Read more...]

Professional suicide

On October 15, 2004, after FDA had put a Black Box Warning on antidepressants to draw attention to the risk that they can cause suicide, the American Psychiatric Association (APA) came out with a news release whose key statement was:    ‘The American Psychiatric Association believes that Antidepressants save lives.” This was perhaps the first professional suicide note in history, but there have … [Read more...]

Mystery in Leeds

In my blog post The best bias that money can buy I outlined how doing trials of their drugs in conditions like depression is the ultimate way companies hide bodies. That what is needed instead are studies of drugs in healthy volunteers. Here’s a good example of what a healthy volunteer (phase 1) study can show, and how the story of antidepressants and suicide might have unfolded in an entirely … [Read more...]

The best bias that money can buy

Randomized controlled trials (RCTs) were adopted by FDA in 1962 following the thalidomide disaster. This was a way to manage the risks posed by potential poisons. If the toxicity from a drug could be shown to overcome to some extent the toxicity stemming from the illness, a risk-benefit ratio would be set up that would warrant taking the risk of giving the poison. But what happens when both the … [Read more...]

The Spin that no Data can overcome

Roger Shepard's above illustration shows two tables of exactly the same size and shape. It’s an extraordinary example of how even when you know that the table tops are the same, the data changes nothing. The dynamics of perspective mean we continue to see things in the wrong way. Early on in the Prozac and Suicide controversy, Eli Lilly adopted a strategy that has “put things in perspective” ever … [Read more...]

False friends

‘Evidence’ is what the French call a false friend. You think you understand the word but you don’t. In French or Dutch, the Evidence in Evidence Based Medicine means that something is self-evident – as in using a parachute when jumping from a plane or penicillin for septicemia or an antipsychotic to tranquilize. You don’t need a clinical trial to work out what the right thing to do is or to prove … [Read more...]