Samizdat has just published Children of the Cure – the Preface of which is here This Book is not a Game.
Quotes from the text are in Hand of History on davidhealy.org. Most of the first chapter is below.
Shelley Jofre was 32 when she got on a plane to Philadelphia in May 2002. People teased her about looking even younger. She is short and slight. She’s from Glasgow so her accent is distinctive even within the UK.
She joined the British Broadcasting Corporation’s (BBC) flagship investigative program Panorama from BBC Scotland in 2000.
Philadelphia was hosting the American Psychiatric Association’s 2002 annual jamboree. There were close to 20,000 delegates. Jofre was travelling with her producer Ed Harriman, a suave, articulate American, who had persuaded the broadcaster to take on the practices of the pharmaceutical industry, now that GlaxoSmithKline (GSK) had become the world’s largest pharmaceutical company and was based only a few miles away from BBC headquarters. He had an ace angle on a story about GSK’s paroxetine—one of the best-selling drugs in the world.
After Jofre got on the flight, Harriman handed her an article by Martin Keller, Neal Ryan and others, referred to then as Keller et al or the Keller paper and later called Study 329. It was published in July 2001 in the Journal of the American Academy of Child and Adolescent Psychopharmacology—JAACAP to insiders. The leading journal in the field as it turned out.
Study 329 is a randomized clinical trial (RCT) of GSK’s paroxetine, branded as Paxil in America, Seroxat in Britain, Deroxat in parts of Europe and Aropax in Australia. The trial involved depressed children recruited from centres in America and Canada. Harriman’s angle was that he was pretty sure the children were being recruited from poor and deprived neighbourhoods and were likely to be mostly black. The mission—to document what was going on. Study 329 was one of the first major RCTs done with children. Harriman was sure it offered an opening on an unsavoury reality.
The flight from London was 8 hours. Time to read the article several times. There isn’t much in it about the treatment centres. The article confidently claims Paxil is safe and effective—in its abstract, discussion and conclusion. But it also describes some of the children as becoming emotionally labile. Before they landed, Jofre told Harriman she was not clear this drug worked very well and wondered if it caused problems. This is not the story he said.
After landing, when interviewing American child psychiatrists attending APA, Harriman insisted Jofre stick to his script. But the questions he had given her got nowhere. Everyone looked puzzled at any hints the testing was happening in centres of deprivation.
One more interview left. With Neal Ryan, the second author on 329 and as it turned out the person who drew up the protocol for the study. At the best of times, Ryan looks uncomfortable but faced with questions about the treatment centres he looked very comfortable. Jofre ran out of questions early with some time left on the tape so she asked him about emotional lability. All of a sudden, Ryan looked intensely uncomfortable and she knew she was on to something but there wasn’t time to find out what and Ryan wasn’t hanging about.
As Neal Ryan retreated from the interview room, everyone’s future changed. Ed Harriman didn’t know it. He was right about a great deal, as it later turned out. GSK were running another trial, Study 377, which fit his bill. But he was not right about Study 329. He got dropped by Panorama who decided to follow Jofre’s lead.
What came to light about Study 329 applies to every single drug anyone of any age takes for any medical condition. What came to light should shape the attitude everyone takes to every single academic article published in any area of medicine—it’s bogus or semi-bogus until proven otherwise. Peer review is useless. Approval of a drug by a regulator means nothing. The greater the prestige of a medical journal the more it has invested in what drug companies want.
A few days later Jofre found that the April 2002 edition of JAACAP carried letters by Alex Weintrob from New York and Mitch Parsons from Edmonton about Study 329, mentioning their concerns about children becoming suicidal on SSRIs. A confident response from Keller and Ryan about the merits of controlled trials compared to anecdotes—the plural of anecdotes is not data—seemed like, for most people, it would deal a knockout blow to these anecdotes.
But Jofre was an anecdote person, as everyone who has anything go wrong on a drug necessarily is, and these letters fit her hunch.
Four years later at an APA meeting in Toronto, she interviewed Martin Keller. This time she came armed. She had been working with George W Murgatroyd III, Skip to everyone who knows him. Skip is a lawyer who shares a gift with her—that of being able to vanish into the background.
It worked when Skip deposed Marty Keller the apparent author of Study 329 under oath and then when he deposed the real author of the study, whose name features nowhere.
It worked in Toronto when Jofre interviewed Keller, a tall, slim, handsome and confident man, whose photographs don’t do him justice. He is as comfortable in his body as Ryan is uncomfortable. He didn’t smell danger when Jofre approached him for a quick question after his lecture. This was not a formal interview setting. Who could think such a young-looking girl could pose a threat? Not a camera or tape recorder in sight.
jofre: What about suicide attempts on Paxil?
keller: None of these attempts led to suicide and very few of them led to hospitalization. The thing is, you have to consider what are the alternatives? Right?
jofre: So some of the unpublished studies showed that placebo actually seemed to have more of an effect?
keller: Come on, you know better than that.
And reaching down from a height he stroked Shelley Jofre under the chin. A touch that Hans Christian Andersen missed.