If You’re Going To Look After Patients, Man Up

Pharmalot has just posted a piece – ‘Controversial FDA official, Tom Laughren, retires.’ [It is no longer at http://www.pharmalot.com/2012/12/controversial-fda-official-tom-laughren-retires/]

This is a must read for anyone with anything to do with mental health – both the post and the comments afterwards where some have posted that they still believe the Black Box warnings on antidepressants arose because of pressure from the Church of Scientology rather than in response to the data.

Despite my billing as a must-read, the Pharmalot post will likely seem boring to many. But the comments won’t – they seethe with anger. This is one of those cases in which if you weren’t there it’s hard to appreciate the depth of feeling this man generated in many as he – and a few others including Paul Leber and Bob Temple – appeared to stand in the way of natural justice and patient safety. The most comprehensive cover is on the AHRP website where Vera Sharav dubs Laughren a double-agent.

He seemed a quiet man. He was grey. He behaved like a functionary. But he was the focus of one of the most dramatic moments I have ever witnessed. This was at the FDA hearings about antidepressants and suicide in children, some 8 years ago now. Because of FDA procedures, the public get a chance to offer views. There were 73 three-minute slots. At this hearing a range of doctors and other men usually with affiliations to pharma spoke against the Black Box warnings and it was down to a series of mothers to plead for warnings.

Many of the pleas were aimed straight at the bureaucrats – Laughren and Temple. The moment is at the center of Pharmageddon, where I compared what happened then and happens over and over to the Greek Myth in which Demeter implores Zeus to restore her child to life. It is appropriate perhaps in that unlike the other Gods, who were dashing and colorful, Zeus often seems to have the character of the bureaucrat who ran Olympus rather an all-powerful Jehovah.

Demeter’s stories

Demeter was the Greek goddess of the Earth and of fertility whose daughter, Cora, was forcibly abducted and carried off to the underworld by Hades. Demeter protested to Zeus, who professed himself helpless, until Demeter threatened Earth with permanent Winter. Zeus intervened and restored Cora to her mother as Persephone. Because Persephone had eaten some pomegranate seeds while in the underworld, however, she must return to Hades each year, the several months of Winter each year.

Winter’s tale

Mary Ellen Winter confronted Laughren and the FDA about her 23-year-old daughter, Beth:

“Beth was looking forward to a career in communication and was experiencing some anxiety and having trouble sleeping when she consulted our family physician. He prescribed Paxil and said she would start feeling better in two weeks. Seven days later Beth took her own life.

We, like most of you in this room, grew up with confidence in the strides made in medicine and accepted with faith antibiotics and vaccinations prescribed. We believed the FDA would always act to protect our family’s well being. When my daughter went to our family GP last year, we trusted that our doctor was well educated and informed. We were wrong. We now know that pharmaceutical sales are a high stake business, driven to increase shareholder wealth. The consolidation of pharmaceutical companies like GlaxoSmithKline has resulted in increased sophistication in the quest to market and distribute pharmaceutical products. Priority has moved from health to profit. Not all doctors are equipped to understand the marketing targets they have become. The FDA has allowed our daughter to be the victim of a highly commercial enterprise that selectively releases clinical data to maximize sales efforts and seeks only to gain corporate profits…

As residents of the State of New York, we thank our Attorney General, Elliot Spitzer, for addressing issues that the FDA has been unwilling to address…”

[This action on the part of Ruth Firestein within Spitzer’s department in many ways triggered the Access to Data issues that have since engulfed GSK and gave rise to the recent EMA hearings and a debate within RxISK and its supporters about what to do with the data that arises from people reporting to RxISK].

Thy neighbour’s child

But Demeter came right into the room in the last but one slot when Mathy Downing singled out Tom Laughren:

“On January 10, 2004 our beautiful little girl, Candace, died by hanging four days after ingesting 100 mg of Zoloft. She was 12 years old. The autopsy report indicated that Zoloft was present in her system. We had no warning that this would happen. This was not a child who had ever been depressed or had suicidal ideation. She was a happy little girl and a friend to everyone. She had been prescribed Zoloft for generalized anxiety disorder, by a qualified child psychiatrist, which manifested in school anxiety… . She had the full support of a loving, caring, functional family and a nurturing school environment.

Her death not only affected us but rocked our community… When Candace died her school was closed for the day of her memorial service, a service that had to be held in the school gym in order to seat the thousand or so people who attended. How ironic, Dr. Laughren, that your family attended Candace’s memorial service. Our daughters had been in class together since kindergarten. How devastating to us that your daughter will graduate from the school that they both attended for the past eight years and that Candace will never have the opportunity to do so.

Candace’s death was entirely avoidable, had we been given appropriate warnings and implications of the possible effects of Zoloft. It should have been our choice to make and not yours. We are not comforted by the insensitive comments of a corrupt and uncaring FDA or pharmaceutical benefactors such as Pfizer who sit in their ivory towers, passing judgments on the lives and deaths of so many innocent children. The blood of these children is on your hands. To continue to blame the victim rather than the drug is wrong. To make such blatant statements that depressed children run the risk of becoming suicidal does not fit the profile of our little girl[1].”

Laughren’s defence

I cannot remember seeing anything ever about or by Tom Laughren where I have thought you know the man’s right on that – except the bits where he has been dragged screaming to a table and been forced to agree. But in the Pharmalot obituary on his career there for the first time was something where I jumped and said “Yes, he’s right on that”.

In another setting, faced with a barrage of criticism of FDA, “Tom Laughren, director of the FDA’s division of psychiatry products, told the panel that the agency could do little to fix the problem and, instead, pointed the finger at medical specialty societies, which he insisted must do a better job educating doctors about side effects”.

He’s right. Doctors are failing patients far more than FDA. (See Professional Suicide, Model Doctors, We need to talk about Doctors, Scaremongers of the world unite, So Long and Thanks for all the Fish). Doctors have become infantilized for whatever reason and turn to a parental figure, a Zeus, to rescue them. If you take on the responsibility of looking after people the very least you can do is Man up – or better again Mother up.

Crusoe

The next two Crusoe posts will deal with these issues. It seems right to mark the end of one year and the start of the next by stepping back from the realm of real human drama and place these in their mythic context. Taking the issues out of the domain of data, science and real clinical histories into the realm of myth seems to confuse some readers – the hope is rather to engage with a wider readership and get artists or story-tellers or poets to engage with RxISK and its issues – as Bill James has done with his cartoons and images. We are dealing here with lives and in particular the fact that we each have one life only. The two Crusoe posts attempt to capture the spirit of RxISK.

[1] Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Monday Sept 13th 2004, p 435.

[2] Joint Meeting of the CDER Psychopharmacologic Drugs Advisory committee and the FDA Pediatric Advisory Committee, Bethesda, Monday Sept 13th 2004, p 332.