Dr. Bremner shares the story of his research into the acne drug Accutane, an almost miraculous treatment for severe acne. He describes Hoffman – La Roche’s attempts to prevent the study, their adamant denials of any possibility that it could cause suicidal depression in some patients, and their desperate efforts to discredit him and his findings.

I was so fascinated (and horrified) once I started reading that I finished the book in a single day. Dr. Bremner shares not only the facts of the story, but the effects that Roche’s vindictive campaign to suppress his findings and destroy his career had on him personally. His story is a gripping, well-written tale of just how far people will go to protect their profits and avoid taking responsibility for their actions.

His book is open and honest, and provides miniature “case studies” of some of the patients who died as a result of taking Accutane. For example, this story:

“Our son here was prescribed Accutane for his acne,” the father
said. “It cleared up his acne real good, but after about two months, he changed. He got real withdrawn and stopped doing his homework. Didn’t talk at the dinner table. Then things got real strange–”
“Said that Jimmy Hendrix was talking to him in the form of a
monkey,” the mother interrupted.
“Gave him a specific date when he should kill himself,” the father
said. The teenager looked on with a blank expression.
“So what did you do?” I asked.
“We checked him in to a psychiatric hospital the night before the
date he was going to kill himself.”
“Sounds like a wise move.”
“Once we got him off the Accutane, he went back to his old self.
Hardly seems worth it just for a few pimples.” – quoted from The Goose that Laid the Golden Egg by Douglas Bremner

About now I can almost hear you thinking, “why should I care about an acne drug? I don’t have acne, and the drug is off the market now anyway.” The simple answer is that whether you have fibromyalgia, bipolar disorder, MS, IBS or any of a thousand other chronic illnesses; or even if you only get an infection; you and your loved ones take prescription medications. Many of those prescriptions are safe and effective, but some are deadly, and we need to support those doctors and researchers who are willing to stand up and SAY something when a drug is unsafe.

Without doctors who are willing to face ostracism from their peers and attacks by big pharma to expose unethical behavior and hidden side-effects, even more people would die from dangerous medications just to pad the pockets of pharmaceutical executives. We may never know exactly how many died because of Accutane, but estimates run from a low of 300 to a high of 3,000 young people who killed either themselves or others after taking it.

Read more of this review by Kimmie Collas here at the Transform Your Chronic Life blog.

This announcement caused an outpouring of vitriol (e.g. calling my study “faked” and “junk science”), first from lawyers working on behalf of pharma and device makers, writing in the Drug and Device Law blog, then from an MD who works as writer and marketer for pharma and pharma-sponsored CME. I felt I need to set the record straight on a number of points that were made.

First of all, it is not true that the study was “commissioned for the litigation”. Eighty percent of the study was paid for by money donated by Liam Grant of Ireland. Brain scans aren’t free. Roche refused to do a study. In fact, back in 1999, I met personally with John McLane, who unbenownst to me was a senior executive for Roche at the time, who refused to even provide medication for the study. I am not an expert in Liam Grant’s litigation (in Ireland you cannot get more than $50,000 in litigation, so he is hardly doing it for the money). I agreed to be an expert after the study was done, not before. Half of all research is supported by pharma. They “commission” research to serve their marketing goals all the time. The bias that introduces has been well documented. When a study is done that is not controlled by them, they go bananas.

Some of the missing data referred to as “bmax” was actually an erroneous term introduced in the course of the 15 depositions (8 hours each) I went through with Roche over this study. The inability to retrieve the numbers was temporary due to problems accessing old media (not an uncommon problem in imaging research). By the time the data was retrieved a court deadline had passed. But it is inaccurate to imply that they were never retrieved.

The reference to not following the study methodology refers to a questionnaire about satisfaction with skin condition (called the Skindex) that was not part of the original protocol, and that was added late, and was not the primary focus of the study.  The original article stated that it was given before and after treatment, but the after treatment results were not presented. As I wrote in a correction later the questionnaire was not given to all of the subjects after treatment.

Roche spent a lot of time and effort trying to debunk this study, in the course of which some data entry errors were found. A re-analysis of the study with corrected data continued to show a reduction in function of the orbitofrontal brain function, in fact the results were more statistically significant than before. Roche next accused me of fraud and asked the journal to retract the paper, which led to an inquiry at my university where the committee had access to all the data and legal documents, and cleared me of the charges of fraud, recommending a letter of correction based on the corrected data, which led to this single sentence correction published in the journal.

The conclusion that Accutane can cause depression shouldn’t rest on a single study, which it doesn’t, as the evidence that retinoids play a role in affective disorders continues to grow.