Did you know that Vitamin A, taken in excess, is believed to cause depression? Accutane, that remarkably popular drug once prescribed to teens and still available in generic [...]]]> A review of Goose That Laid the Golden Egg by freelance writer Bob Etier, follow her on twitter @katelier, and read the full review here.

Did you know that Vitamin A, taken in excess, is believed to cause depression? Accutane, that remarkably popular drug once prescribed to teens and still available in generic form, is a “molecular cousin” of Vitamin A.

Accutane was prescribed for people suffering from “extreme scarring acne,” but in 2001, Dr. Doug Bremner began research that indicated a very different, extreme effect of Accutane. He found a causal relationship between Accutane and depression—a relationship believed to have resulted in hundreds of teen suicides and homicides.

Manufacturer Hoffman-LaRoche did not welcome Bremner’s findings. In fact, according to Bremner, the drug giant launched a campaign to discredit him that was “designed to suppress his findings and destroy his career and livelihood.” Written in a tremendously informal, nearly stream-of-consciousness style [...]

I was attracted to The Goose That Laid The Golden Egg by Doug Bremner because it is the story of the psychiatrist who took down Accutane. You know, that [...]]]> Book Review reposted from Sassy Peach Book Reviewer. Read more book reviews here and follow her blog here and twitter @niccilor here.

I was attracted to The Goose That Laid The Golden Egg by Doug Bremner because it is the story of the psychiatrist who took down Accutane. You know, that drug that the pharmaceutical companies don’t want you to believe changes brain composition and causes depression? Doug Bremner was that very psychiatrist and faced demons of his own, both professionally and personally.

You may remember the whole, “No one really knows…” news segments about this drug. However, reading this book confirmed my suspicions that what you see released to news sources is exactly what they with the most money want you to hear, see, and believe–the spin. You may or may not believe it…

[read more]

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.

What people are saying about The Goose That Laid the Golden Egg: Accutane – the truth that had to be told.

“Riveting, compelling, fascinating.”

“Frighteningly well written.”

“This is an amazing book, especially since it is non-fiction.”

“I could not put this book down until I got to the end… Thankfully, his writing is [...]]]> Reviews

What people are saying about The Goose That Laid the Golden Egg: Accutane – the truth that had to be told.

“Riveting, compelling, fascinating.”

“Frighteningly well written.”

“This is an amazing book, especially since it is non-fiction.”

“I could not put this book down until I got to the end… Thankfully, his writing is succinct. It is also quite poignant, surprising, revealing and at times even hilarious.”

“Poignant and heart-wrenching.”

“Frightening, moving, personal and redemptive.”

“A raw, honest, prescient page-turner.”

“A moving account weaving together his personal struggles of loss and shame.”

“A must read for everyone who believes in justice for all.”

“A very important tale stunningly well told.”

“A riveting and excellent read – I read it in one sitting. I highly recommend it.”

***

CHAPTER 1

Palm trees lined the road leading from the Orlando airport. A few puffs of white clouds sat unmoving in the brilliant blue Florida sky. My seven-year-old son, Lucca, played a hand-held computer game in the back seat of the cab. My wife, Viola, and twelve-year-old daughter, Lucia, looked out the window. I rode up front, thinking about how much I would be paid for the lectures I would be giving over the next year or so. The year was 2001.

We checked into the Disney World Hotel and went up to our rooms. Lucca grabbed the room key and ran ahead. He opened the door, ran in and jumped on the bed.

“Is this our room?” he asked, excitedly.

“Get your bags, Lucca,” I said.

When the family was settled, I headed for the courtesy room of the private company that organized medical education events on behalf of GlaxoSmithKline (GSK), the makers of the antidepressant drug, Paxil. They had invited me to give the kick-off lecture for their initiative to push Paxil into the market for people with anxiety disorders. They called it Psychnet. The plan was for me to give a lecture to a bunch of psychiatrists from across the country, educating them about the benefits of Paxil in the treatment of anxiety disorders, and they would in turn, for pay, fan out across the country giving lectures to other psychiatrists on the same topic. Not only would I get paid for doing this, but I would be tagged as a preferred speaker for their nationwide lecture series for psychiatrists. Over the next year or two, I would give about 15 talks across the country, with the usual price being $2,000 plus travel expenses. However, I learned that many of the speakers canceled at the last moment, so I could squeeze out as much as $5,000 for giving a talk at the last minute’s notice.

I stood for a moment before the door and checked my suit to see if it had any spots on it. Then I knocked.

“Come on in, Dr. Bremner,” an attractive and smiling Asian woman said as she opened the door. “We’re going over your slides now.”

The room was filled with a bunch of good-looking young people hunched over laptops who seemed bright and energetic. A floor-to-ceiling plain glass window looked out over palm trees evenly spaced over a closely cut green lawn with the blue of the Florida sea just beyond.

“How does this look?” The woman waved me over to one of the laptops.

I scrolled through the slides.

“You’ve got some great graphic art support,” I responded. That brought on a spontaneous smile.

“Thanks, Doctor. Any corrections?”

“No, these look great. When do I go out?”

“Your talk is in 30 minutes.”

There was a knock at the door. She walked over and opened it.

Scott Sproul entered the room. We had hung out together at a bar the year before and gossiped about the ups and downs of the pharmaceutical industry. Scott was one of the most up-beat people I ever met. He was now head of the Paxil marketing team.

“Thanks for coming down, Doug.” He slapped me on the back. “How’s the family?”

“They’re doing great.” The attention made me feel uncomfortable.

“Have they ever been to Disney World before?”

“No, this is the first time. Thanks for the invite.”

“Well, it’s great to have you here, Doug. I think you’re gonna really help us get our message out about Paxil.”

“Glad to help.” And I meant it.

“Here’re some tickets for Disney World for you and your family, for the weekend.”

“Wow, that’s really nice of you. I really appreciate it.”

“No problem. Ready for your lecture?”

“Yeah, OK.”

We walked toward the lecture hall. He opened the door and slapped me on the back.

“Go on out there and sell some Paxil, Doug!”

* * *

A few weeks later I was coming back through the Hartsfield-Jackson International Airport in Atlanta after giving an out-of-town lecture, when I ran into Charlie Nemeroff, M.D., Chairman of the Department of Psychiatry at Emory University School of Medicine, in Atlanta, where I had just been recruited. He was an energetic and gregarious man who was in constant motion. Nemeroff was known as one of the leaders in the field of academic psychiatry, what we called a “shining light.” A recent magazine article about him was called “Boss of Bosses,” and prominently featured him on the cover, in a white jacket with his arms folded across his chest.

“How’s it going, Doug?” he asked.

“Great. Thanks for the recommendation to be a speaker for the Psychnet program.”

“We take care of our faculty at Emory. Hey, Doug. About that Accutane study you’re doing?”

“Yeah?”

“Make sure you meet with the dean about it. He’s a dermatologist. We don’t want any political hot potatoes. And get the dermatologists involved. They can refer acne patients to you.”

He looked tired. He’d probably been on the road for a while.

“OK, no problem.”

“Well, I’ve got to run. Catching a plane to Fort Lauderdale to give a talk about norepinephrine and depression. Are you interested in norepinephrine, Doug?”

“Yeah, sure.” Nemeroff had done some research on the effects of Paxil on the norepinephrine system. GSK was using that angle to market Paxil as being better than the other SSRI antidepressants. They were eager to get people like Nemeroff out there talking about the science behind it all.

“Ok, catch you later.” He turned and walked off, pulling his rolling suitcase behind him.

I stood there and watched him walk away. While waiting for an appointment with him just after moving to Atlanta, I had seen his curriculum vitae sitting out on a table. It listed work as a consultant for the maker of Accutane, but it didn’t look active, and he was consulting for a gazillion other drug companies, so I figured it was no big deal. Nevertheless, I felt a little uneasy. Whenever there was money involved, you had to be careful.

Don’t worry about it, I thought. Just meet with the people like he asked you to do, don’t make any waves, do what you’re told, and everything will work out fine.

Read all the reviews for The Goose here.

Continue reading THE GOOSE THAT LAID THE GOLDEN EGG on Kindle for $0.99 here or paperback here.

Sign the petition calling on Hoffmann-La Roche to tell the truth about the side effects of Accutane (Roaccutane) here.

Link to my book The Goose That Laid the Golden Egg: Accutane, the truth that had to be told here.

View Part 2 here.

From ex-accutane user Stefan Alexander Lay, see all of his youtube videos here.