The new ebook Roaccutane: The Truth, by Stefan Lay of Norwich, United Kingdom, offers an honest and informative view from a patient’s (or should we say victim?) perspective on the side effects of the acne drug Accutane (Roaccutane in the UK and Europe, generic isotretinoin) which I have

The new ebook Roaccutane: The Truth, by Stefan Lay of Norwich, United Kingdom, offers an honest and informative view from a patient’s (or should we say victim?) perspective on the side effects of the acne drug Accutane (Roaccutane in the UK and Europe, generic isotretinoin) which I have written about previously on this blog. Stefan writes clearly and informatively about his own situation, which sadly is paralleled by many other people. Given Roaccutane for acne that had not proceeded to the stage of potentially scarring cystic acne, he was initially eager to get rid of his acne at whatever cost. In retrospect he realizes that he would have been better off to have stayed away from this potentially toxic drug, which he points out is used to treat cancer, and is therefore a chemotherapy agent. He describes his research and personal experience with depression, suicidality, dry eyes, sexual dysfunction, bowel disease, and liver damage. I recommend this book for someone who wants to validate their own experiences with the drug or to get a quick overview of side effects, which unfortunately the medical community has failed miserably to provide information about. He also has some entertaining and informative videos on Youtube you can view here.

My book on Accutane is The Goose That Laid the Golden Egg: Accutane, the truth that had to be told.

Charles Bishop crashed this plane into a building in Tampa after becoming suicidal and psychotic while on Accutane

Rather than admit that one of their silver bullets, Accutane (isotretinoin), which was a “goose laying the golden egg” for F. Hoffmann-La Roche Pharmaceuticals (and their various “Roche” associates world-wide) to the tune [...]]]>

Charles Bishop crashed this plane into a building in Tampa after becoming suicidal and psychotic while on Accutane

Rather than admit that one of their silver bullets, Accutane (isotretinoin), which was a “goose laying the golden egg” for F. Hoffmann-La Roche Pharmaceuticals (and their various “Roche” associates world-wide) to the tune of a billion dollars a year, could make kids depressed or kill themselves or cause grotesque birth defects in the kids of over half of women exposed when pregnant, dermatologists have sung themselves a lullaby that their magic pills don’t make kids depressed, they actually make them better, by clearing up pimples that drive them to despair. In what can only be described as a tragic collusion of conflicts of interest (COI) amongst their Key Opinion Leaders (KOLs) and willful denial amongst the lowly rank and file, they have decided to say “What? Me Worry?”

When the heat got turned up on Roche Pharmaceuticals after the son of Congressman Bart Stupak’s (D-Mich) son Bart Jr. died of suicide while on Accutane in 2000, they got busy and called a “Scientific Advisory Board” meeting at the Ritz Carlton in Alexandria, Virginia, to opine on the topic of the relationship between Accutane treatment and depression. This meeting included figures from psychiatry like Kathleen Merikangas, PhD, Stuart Montgomery, PhD, and David Nutt, MD, Chair of Dermatology David Bickers MD, and psychiatrist Douglas Jacobs, MD. Between the lot of them I think they have written about one paper total in the literature on the subject. But they did get paid a nice consulting fee for their efforts.

Their conclusion? No relationship, of course.

Fact is Accutane’s efficacy for acne was discovered a decade before Roche put a patent on it, in a paper in the New England Journal of Medicine.

I have communicated with two of the authors, both dermatologists, Frank Yoder MD and Gary Peck, MD.

Both of them agreed with my opinion that Accutane can cause depression in some individuals.

What is really sad about this whole sordid tale is how degenerated the so-called dermatology “literature” has become on the topic.

For example, the most commonly cited study to support the statement that acne is associated with depression, a study that has been cited several hundred times by dermatologists writing in the literature, involved only ten patients with acne and no comparison subjects (Gupta et al., 1990). No statistics were performed (obviously since there was no comparison group). Scores on the questionnaires for anxiety and depression were not related to severity of acne.

And the fact is that the rest of the literature isn’t any better. Objective measures of acne do not correlate with severity of anxiety or depression. Acne does not cause major depression. It is simple as that.

Sure, kids worry about their zits and feel better when they go away, but the studies do not support the conclusion that acne causes major depression, and that treatment of acne cures depression.

In spite of this the manufacturer of Accutane, Hoffmann-LaRoche, has consistently downplayed the risks of suicide and depression and has denied a causal association (McCoy, 2004). The dermatology community has joined with the manufacturer in praising the merits of this medication for the treatment of acne which they describe as the “penicillin of dermatology”. It took only 10 months for the FDA to approve Accutane for the treatment of cystic and nodular acne in May of 1982, however controversy has followed it from the time of its initial launch. In January of 1983 one of the authors of the first paper to describe the use of isotretinoin for the treatment of acne in 1977, Dr. Frank Yoder, wrote about the potential dangers of Accutane (Yoder, 1983). In 1990 Dr. David Graham of the FDA highlighted the inability of the Dermatological Medications Advisory Committee to the FDA to be impartial since it was made up entirely of dermatologists (Green & Hutt, 2002). At that time he stated that Accutane should be taken off of the market, mainly because of the risk of birth defects. Indeed its use has always been curtailed or highly restricted in European countries, unlike the US where it is often prescribed for minor blemishes. Strong feelings about the utility of isotretinoin for the treatment of acne in the dermatology community, and forceful marketing by the manufacturer in the US, have caused a delay in awareness of the potential risks in the US. In 1998, the year that the FDA first approached Hoffmann-LaRoche about adding a warning related to suicide with Accutane to its label, the manufacturer ran an ad that stated, “Effective treatment of severe recalcitrant nodular acne minimizes progressive physical scarring, as well as negative psychosocial effects such as depression and poor self image” (Green & Hutt, 2002). This was in spite of the fact that less than half of patients prescribed the medication actually had nodular acne. The FDA required that Hoffman-LaRoche pull the ad.

In 2000 Congressman Bart Stupak’s son, Bart Jr., committed suicide while on Accutane. Congressman Stupak called for congressional hearings on the safety of the drug and in September of that year the FDA called a Dermatologic Advisory Committee meeting on the topic. In November of 2001 an educational grant from Roche funded a supplement of the Journal of the American Academy of Dermatology on isotretinoin which followed the Scientific Advisory Board Meeting in Alexandria VA they held on the topic. The basic science-related articles focused on retinoids and the skin, essentially ignoring the large extant literature on retinoids and the central nervous system. Psychiatric side effects merited literally two sentences, and one article, written by one of Roche’s hired guns, stated that there was no evidence for any association (Jacobs et al., 2001), ignoring the reported challenge-rechallenge cases which have been cited in the pharmacoepidemiology literature as adequate in and of themselves to establish causality (Strom, 2005). This led members of the FDA to write a letter of response, “in the interest of public health,” admonishing the authors of these articles for the short shrift they paid to the issue of Accutane and psychiatric side effects (O’Connell, Wilkin, Pitts, 2002).

The degree to which dermatologists have thrown science and logic out of the window in order to protect their magic bullet is simply remarkable. For instance in a 2004 article entitled “Myths of Isotretinoin Therapy” (Alcalay, 2004) “isotretinoin causes depression and suicide attempts” was listed as a “myth”. The article went on to state that any risk needed to be “weighed against the increasing prevalence of depression among adolescents and young adults and the psychological impact of acne.” [In fact, depression is not increasing amongst teenagers and acne has not been associated with clinical depression, rather only changes in self esteem].

Aktan, S., Ozmen, E., Sanli, B. (2000). Anxiety, depression, and nature of acne vulgaris in adolescents. International Journal of Dermatology, 39, 354-357.

Alcalay, J. (2004). Myths of isotretinoin therapy in patients with acne: A personal opinion. Journal of Drugs in Dermatology, 3(2), 179-182.

Green, J., Hutt, P. (2002). Babies, blemishes, and FDA: A history of Accutane regulation in the United States., Leda. Cambridge, MA.

Gupta, M. A., Gupta, A. K., Schork, N. J., Ellis, C. N., Voorhees, J. J. (1990). Psychiatric aspects of the treatment of mild to moderate facial acne: Some preliminary observations. International Journal of Dermatology, 29(10), 719-721.

Jacobs, D. G., Deutsch, N., Brewer, M. (2001). Suicide, depression, and isotretinoin: Is there a causal link? Journal of the American Academy of Dermatology, 45, S168.

Kellett, S. C., Gawkrodger, D. J. (1999). The psychological and emotional impact of acne and the effect of treatment with isotretinoin. British Journal of Dermatology, 273-282.

McCoy, K. (2004, December 7, 2004). Drug Maker rebuffed call to monitor users. USA Today, pp. 1-2.

O’Connell, K. A., Wilkin, J. K., Pitts, M. (2002). Isotretinoin (Accutane) and serious psychiatric adverse events. Journal of the American Academy of Dermatology, 48(2), 306-307.

Shuster, S., Fisher, G. H., Harris, E., Binnel, D. (1978). The effect of skin disease on self-image. British Journal of Dermatology, 99(Suppl 16), 18-19.

Smithard, A., Glazebrook, C., Williams, H. C. (2001). Acne prevalence, knowledge about acne and psychological morbidity in mid-adolescence: a community-based study. British Journal of Dermatology, 145, 274-279.

Strom, B. L. (Ed.). (2005). Pharmacoepidemiology (4 ed.). New York: Wiley.

Van der Meeren, H. L. M., van der Schaar, W. W., van den Hurk, C. M. A. M. (1985). The psychological impact of severe acne. Cutis, 36(1), 84-86.

Wu, S. F., Kinder, B. N., Trunnell, T. N., Fulton, J. E. (1988). Role of anxiety and anger in acne patients: Relationship with the severity of the disorder. Journal of the American Academy of Dermatology, 18, 325-333.

Yoder, F. W. (1983). Isotretinoin: A word of caution. Journal of the American Medical Association, 249(3), 350-351.

Originally posted Jan 5 2008

EDT: Accutane was taken off the market in June 2009, the manufacturer citing “business-related reasons”. It continues to be sold in generic form as isotretinoin and cases of suicide and depression have been reported with generic use. Our article “Retinoic Acid and Affective Disorders: the evidence for an association” was published this year in the Journal of Clinical Psychiatry (access it here).

My book The Goose that Laid the Golden Egg: Accutane, the truth that had to be told is now out and available on Amazon in the US and UK.

5.0 out of 5 stars Frightening well written, June 28, 2011
By Reader – See all my reviewsThis review [...]]]> The first five six reviews for The Goose That Laid the Golden Egg are all five star and reproduced below. The book is available on amazon now in kindle and paperback editions.

5.0 out of 5 stars Frightening well written, June 28, 2011
By Reader – See all my reviewsThis review is from: The Goose That Laid The Golden Egg (Kindle Edition)
The Goose That Laid the Golden Egg is the kind of insider tale which every consumer fears reading and which we all should read. Long shadows have always lain over the pharmaceutical industry and in the deftly written hands of Dr. Bremner the reader comes to realize that just because you are paranoid doesnt mean nobodys following you. Accutane was a hugely popular drug and I wont give a spoiler here because this reads like a thriller but ugh is all the truth and you need to find out for yourself.

For some reason this book brought back memories of the old Johnson and Johnson poisoned Tylenol scandal. Well the pharmaceutical giant Dr. Bremner writes about isnt attacked by some random lunatic who wants to see people die, the bad guys here are fully informed and they are wearing Brooks Brothers. Woodward and Bernstein would love this book I do too.

5.0 out of 5 stars Review of “The Goose That Laid the Golden Egg“, June 28, 2011
By Garry Wilson – See all my reviewsThis review is from: The Goose That Laid The Golden Egg (Kindle Edition)
I just finished reading “The Goose That Laid The Golden Egg.” I enjoyed it very much. What a journey Doug had. I should not have been surprised at how many medical and drug company professionals turned a blind eye to a dangerous drug for personal gain; but I was. I think most of us still believe most doctors and especially psychiatrists are altruistic. I guess doctors are not immune from human nature: people are reluctant to “kill the golden goose.” I was also surprised that a major reputable drug company would continue to push a drug that might be leading to suicide. Even if you don’t expect them to take a suspect drug off the market on moral grounds, selling drugs that may be killing people is very bad for business. After all, trust and Goodwill are fundamental to long term success. In this story Doug reminded me of Don Quixote: not a knight by profession, but someone who could not tolerate the way some scoundrels were treating Dulcinea — who, by the way turns out to be much more than a metaphor in this story; but I don’t want to ruin the surprise. Sometimes life presents us with real dragons. Maybe it’s only then we find out what we’re made of.

5.0 out of 5 stars A book to take your breath away, June 26, 2011
By T. Hewtson LE ROUX – See all my reviews
(REAL NAME) This review is from: The Goose That Laid The Golden Egg (Kindle Edition)
Having worked for a highly ethical pharmaceutical company who if a single rat died in Asia pulled the drug worldwide immediately, I am nonethless aware of the way pharmaceuticals are marketed which, like all marketing, is a sophisticated way of bending the truth to make it more appealing than it would be warts ‘n’ all.

With chocolate bars or clothing, the high gloss endorsements of movie stars are simply ‘sales puff’, but when it comes down to drugs, burying some uncomfortable truths can actually kill people – in the case of Accutane, maybe even 3,000 or more. The misapplication of drugs is the biggest killer of people from hospital-generated causes in US hospitals, running into hundreds of thousands of deaths a year.

The power of ‘The Golden Goose’ is partly in the story itself, the detailing of the tricks used by one drugs company to bury uncomfortable facts and the purveyors of those uncomfortable facts alongside them, but it is mostly in the searing writing which immediately has you sitting on the edge of your seat wanting to hear more.

It is a very important tale stunningly well told. It also explains some of the motivations of at least this one whistleblower beyond maybe the fame of standing up for the truth to a longstanding burning anger from his childhood as to how maybe the most important truth in his world at the time was witheld from him and even distorted.

A truly fascinating read.

5.0 out of 5 stars Frightening, moving, personal and redemptive., June 30, 2011
By Timothy Murphy, MD – See all my reviewsAmazon Verified Purchase(What’s this?)
This review is from: The Goose That Laid The Golden Egg (Kindle Edition)
Dr Bremner has written a moving account weaving together his personal struggles of loss and shame, with the professional struggles he faces in mid-career when a large pharmaceutical firm goes on the offensive to discredit his research, which threatens the profits they are making on Accutane.

As a research physician, I have been lucky to have avoided the pitfalls Dr. Bremner faced. But the profits made on medications are driving the research almost entirely now, and that financial concern will inevitably force patient safety to the rear. I remember a research scientist with a large international firm telling me that the profits associated with the antibiotic I was researching – amounting to some 300 million a year – was “like the money left over in your office coffee fund at the end of the month” in the view of the controlling pharmaceutical company. It was then that I started to grasp the scale of profits that they are interested in and how they make choices about drugs.

When Dr. Bremner started to look into the neurologic changes in the brain associated with Accutane, he met determined resistance from colleagues, and the industry. This then turned into personal and professional attacks on his integrity and his science itself. The extent of the steps that Roche took to ruin his career are stunning, and will serve as a warning shot to any other scientist considering facing them down. The degree of direct and immoral complicity in that attack by members of the academic faculty are equally stunning.

But unlike the movies, where the hero just bravely and boldly takes on the big bad boys (win or lose), this narrative moves instead into a honest account of how terrifying this really is. The honesty in the book is stunningly clear, straightforward and blunt. Dr. Bremner is unsparing in detailing his own personal failings in coping with the stress of being attacked in such a personal and vicious manner.

As he struggles with a tendency to withdraw into fantasy, he begins to connect how his personal struggle in coping with the attacks by Roche is influenced by his unresolved grief over the loss of his mother. He details how he gradually started to look for her story – covered up and denied by his surviving father and step-mother – and how that search finally leads him to a healing place. It is so clear that he had to go straight into his pain, to be able to deal with his marital and professional struggles.

This book details perfectly the personal struggles one would face who had lost a parent at a very young age. It exposes the fraudulent and decadent practices of the high-flying academic physicians who are sometimes in the pocket of Big Pharma. The book details how we can retreat into fantasy to numb our pain, but also how facing it heals our pain. It shows us how poorly families can deal with death and loss, often for the simple reason that they did not know any better – even smart folks like psychiatrists.

This book is a riveting and excellent read – I read it in one sitting. I highly recommend it.

Timothy Murphy, MD
University of Pittsburgh

5.0 out of 5 stars Thumbs Up for the “The Goose”, June 29, 2011
By Neil Shulman MD – See all my reviewsThis review is from: The Goose That Laid The Golden Egg (Kindle Edition)
Doug Bremner is a an academic doctor who studied psychiatry and nuclear medicine. He took on a major pharmaceutical company because he did research that demonstrated that a drug used for acne could be causing kids to commit suicide. That drug was making a lot of money, as much as a billion dollars a year, for a pharmaceutical company. Doug tells how the company spent lots of money on lawyers and investigators to challenge his findings which demeaned his character. Doug did not sit on the sidelines, he came out swinging with an ultimate aim to defend the results of his research and to defend his research so that proper precautions could be taken to avoid potential life-threatening side-effects of the medication. This book is a compelling read about what happened after that.

—-NEIL SHULMAN MD, AUTHOR OF “DOC HOLLYWOOD” AND “YOUR BODY’S RED LIGHT WARNING SIGNALS”

5.0 out of 5 stars Stand up and be prepared to fight!, July 7, 2011
By Soooz Burke – See all my reviewsThis review is from: The Goose That Laid The Golden Egg (Kindle Edition)
Thank you. Two small words, and I mean them wholeheartedly. Author Doug Bremner made a stand against a ‘Goliath’ he made that stand by exposing his jugular to a huge and powerful drug company. A company that should have been accountable to more than their enormous bank accounts. They were not.

His research was poo-pooed by those Academics who sought to defame and vilify his good name. His journey into exploring the drug and its side effects makes for a breathless read, I had to keep reminding myself that this work is a work of Non-Fiction. NON-FICTION! That makes it all the more compelling. Author Bremner does not paint himself as ‘David’ facing “Goliath” in fact he allows us to see him as a man, a man with fears, hopes, dreams and his own set of nightmares to contend with.

He suffered humiliation at the hands of ‘paid’ so-called experts. He faced ridicule and snide comments from people who had taken the ‘Hippocratic’ oath. People who didn’t have the vaguest intention of allowing that oath to stand in the way of them protecting their overloaded bank accounts.

This book is a must read for everyone who believes in justice for all. The facts don’t lie. Neither does this author.

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Part 2

Part 3

Part 4

Part 5