Before You Take That Pill » pharmaceutical industry

Follow the Conversation on What Doctors Don’t Tell You, on Jane Alexander Blog

Doug Bremner — Wed, 08 Feb 2012 14:50:02 +0000

Follow the conversation on what doctors don’t tell, medications, and side effects on the blog of UK writer a href=”http://www.janealexander.org/” title=”Jane Alexander” target=”_blank”>Jane Alexander “Diary of a Desperate Exmoor Woman here. Read Jane’s books on alternative and wholistic health care here and catch her excellent YA fiction book Walker here. Current conversation is psychiatric side effects of Chantix, Accutane/Roaccutane, and antibiotics.

Georgia Medical Schools Take Steps to Stop Flow of Pharmaceutical Money

Doug Bremner — Wed, 11 Jan 2012 16:13:28 +0000

Story from PBA originally posted today here where you can also listen to the radio interview.

ATLANTA, GA (WABE) – In recent years, doctors have come under increased scrutiny about the money they receive from drug companies.

Medical schools across the state are now taking steps to better police these relationships in order to avoid the appearance of biased research.

The Medical College of Georgia in Augusta has recently limited the gift amount doctors can receive from drugmakers to $25.

“Essentially you’re not to accept a gift in any dollar amount that directly influences your work or improperly influences it,” said Lee Little, a spokeswoman for the school. “We’re actually looking to adopt an electronic system for conflicts of interest reporting.”

It’s part of growing trend to limit the influence of pharmaceutical money and protect the integrity of academic research. Studies have found that when doctors receive gifts or fees from a drug company, those doctors are more likely to prescribe that company’s products.

In a high profile case from 2008, a congressional investigation revealed that the head of Emory’s psychiatry department failed to report more than a million dollars of consulting fees from companies whose drugs he was evaluating in academic journals.

That doctor was forced to resign from his chairmanship and later left the school.

Emory has since adopted a strict disclosure policy and a preapproval process for any payments taken from drugmakers.

Kathy Kinlaw of the Emory Center for Ethics helped develop the policy.

“We basically have eliminated all contact for our medical students and our faculty as much as possible,” said Kinlaw.

However, with the arrival of these restrictions, some physicians are quietly complaining. They say the relationship exists in order for doctors to meet peers and learn about new research and drugs.

“The increase in requirements in disclosure and the requirements for preapproval that’s more coming from administration,” said Emory psychiatry professor Dr. Douglas Bremner. “I think the academic physicians are just watching their outside consulting income melt away and grumbling about it behind close doors.”

In any event, drugmakers are still spending big money. The investigative news website ProPublica says in the last three years, $20 million has been spent on Georgia’s medical practitioners, in and outside of medical school.

Donald Palmisano of the Medical Association of Georgia says these are important relationships, but doctors should disclose them if the patient has concerns.

“As long as the physician is disclosing and answering questions honestly about what their relationship is to a pharmaceutical company, I think it’s something if the patient has concerns about, then they should ask those questions,” said Palmisano.

Patients will have more information to go by in March when a new federal sunshine law will force drug companies to publicly disclose all payments made to doctors and other health professionals. © Copyright 2012, WABE

Book Review: Roaccutane: The Truth, by Stefan Lay

Doug Bremner — Tue, 06 Dec 2011 16:51:33 +0000

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.

Bird Flu Drugs are for Bird Brains (podcast)

Doug Bremner — Fri, 18 Nov 2011 16:08:41 +0000

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In today’s news a guy who is trying to create a more virulent form of bird flu. Is he trying to kill us or something?

Listen to more podcasts at www.dougbremner.podbean.com. Subscribe to my podcast feed here.

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Podcast: DSM-5

Doug Bremner — Wed, 16 Nov 2011 02:41:33 +0000

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Wacky-doodle diagnoses from the DSM committee, including internet addiction disorder, expanded ADD and GAD, temperament dysregulation disorder, and giving your soul away to meet criteria for PTSD.

Listen to more podcasts at www.dougbremner.podbean.com. Subscribe to my podcast feed here.

New Questionable Diagnoses on the Horizon from the DSM-5 Committee

Doug Bremner — Tue, 08 Nov 2011 17:13:39 +0000

“Oh, what are you getting so excited about? I told you I was bi-polar.”

I just signed a recent petition from a committee of the American Psychological Association (APA) and the Society for Humanistic Psychology protesting the proposed Diagnostic and Statistical Manual (DSM)-5 committee’s new diagnostic structure (read more about it and Dr. Kupfer’s response here). I agree with the concerns about the loosening of diagnoses that will increase the number of people who officially meet criteria for psychiatric disorders, the changing of language that makes individuals who stand apart from prevalent societal and political mores as “mental”, and the creation of a dynamic range within the personality disorders that is not based on any empirical evidence.

In particular DSM-5 has come up with these wacky-doodle “disorders.”

“Attenuated Psychosis Syndrome,” which describes experiences common in the general population and is based on a concept of risk of proneness to the development of psychosis but has not been demonstrated to commonly “convert” to a real disorder. This just gives people an excuse to give powerful anti-psychotic drugs to normal people. Let my people go!

The medicalization of grief. By removing the bereavement exclusion from Major Depressive Disorder we are now no longer able to undergo the normal ’s bereavement exclusion, which currently prevents the pathologization of grief, a normal life process. Come on, guys, grief is not a medical disorder so stop looking for more excuses to put people on antidepressants.

Further opening the flood gates for Attention Deficit Disorder (ADD) by reducing the number of criteria necessary for the diagnosis. This disorder continues to rise in number of “diagnosed” and we don’t need anymore reason for kids to be medicated with drugs that can stunt growth, inhibit playfullness, and have other side effects unless they absolutely need it.

Loosening of the criteria for Generalized Anxiety Disorder.

Disruptive Mood Dysregulation Disorder – bad babies now have to take Risperdal.

Internet Addiction Disorder – I already wrote about this one and I am particularly against this one because I am afraid they will use it to lock me up in a mental hospital, lol.

A new PTSD criterian A that by removing the reaction to the event (e.g. “intense fear horror or helplessness” required for the current diagnosis) and generalizing to include threatening events to anyone you have ever known or talked to effectively makes the entire US population eligible to be diagnosed with PTSD. Oh, um, except for atheists, since they probably won’t get the symptom “I lost my soul forever” which is part of the proposed new criteria.

Pushing for Gender Identity Disorder on political grounds so they can get money for sex change operations.

Female Sexual Dysfunction Disorder (I mean, maybe their boyfriends are smelly or gross or something, think about that, huh?)

I wrote about this before which provoked some pretty strong blow back to say the least. I think academic psychiatry is going down the wrong road by thumbing their noses at the entire discipline of psychology, ignoring the general public, and conducting a process of revising diagnostic criteria cloaked in secrecy, not to mention the conflict of interest involved in the American Psychiatric Association receiving a lot of its income from selling the DSM books, which require successive new editions in turn requiring more revisions, which are not always based on scientific evidence.

Recovering From Accutane, Part 1, by Fireyourdoctor (Youtube)

Doug Bremner — Mon, 31 Oct 2011 01:17:58 +0000

View Part 2 here.

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

Health News You Won’t Read About in the New York Times

Doug Bremner — Wed, 19 Oct 2011 15:49:38 +0000

Here’s a forgotten chapter from pharmaceutical history. The acne drug, Accutane, manufactured by Roche Pharmaceuticals, has been associated with hundreds of birth defects. Since 2005 the iPLEDGE program has required that patients, doctors, and pharmacists register and that patients prove they are on birth control before they can be prescribed this potentially dangerous drug. But it wasn’t always that way.

When Accutane came out on the American market, after being rushed through the FDA approval process, it was listed as a category C drug for risk of birth defects, meaning that it was only of moderate risk. The PDR said that women “should not” get pregnant while on Accutane. Moderate risk means that there are some studies in animals showing birth defects, but it isn’t clear that it is really relevant to humans. There was no requirement that doctors test for pregnancy, or that women take birth control.

Accutane hit the media and was hailed as a wonder drug. Sales soared far being the wildest expectations of Roche executives. Soon every girl with pimples was demanding that pill that her school-mate got that had made her blemishes vanish away.

But not everyone was so sanguine. The Europeans weren’t impressed by Accutane. It was banned in Sweden and Italy and sharply curtailed in other countries, probably related to the results of those trials, which might have included birth defects associated with the use of Accutane.

If there were any birth defects in the European trials, were they reported to the FDA?

Nobody seems to remember. Hmm…

In a series of articles over a decade ago in a newspaper called the Columbus (Ohio) Dispatch, Mark Somerson reported on this story in a series of investigative journalism articles. Remarkably this story about a drug that was equally dangerous as thalidomide never made it beyond the shores of the Wabash River.

Thanks New York Times!

Here’s a scoop for you guys, Mike and Juliet, to add to your ongoing Accutane “investigations”!

It wasn’t only the Europeans that were wary of Accutane, some American dermatologists were as well. In fact, Frank W Yoder, MD, who with Gary L. Peck MD was the first to report on the use of isotretinoin for the treatment of acne in 1977, long before Roche picked it up, warned against the dangers of the drug in the January 1983 edition of the Journal of the American Medical Association, saying that “the potential toxicity of this drug has been seriously underemphasized”. Both American doctors and scientists working for Roche later testified that is was known before it came out on the market that Accutane potentially had a very dangerous risk of birth defects, based on the fact that it was derived from Vitamin A related compounds, well known for many years to cause birth defects in women. Yoder and another doctor involved in the US trials remembered discussing birth defects that occurred during the European trials, although exact names of individuals involved were never produced.

In fact, Roche had known about Accutane for years before the American dermatologists had written about it, but did nothing with the drug. Somerson reported that Dr Werner Bollage, a scientist with the company, wrote in 1971 that it was “inconceivable to develop an agent” that caused birth defects for such a “common complaint as acne.”

For their US clinical trial in the early 1980s, Roche required that all women get tested for pregnancy, and one woman who got pregnant was advised to get an abortion. However, once the drug went on the market, this was no longer required, according to reporting by Somerson.

Henry H. Roenigk MD, another dermatologist who had been involved in the US Accutane trial, was quoted as saying that he published a letter in the May 1982 edition of the journal Dermatology warning of the risk of birth defects, and stating that there had already been birth defects with Accutane (presumably in Europe). Following this Roche wrote a letter to all doctors who had been involved in the US trial and told them not to “divulge trade secrets.”

Nine months after Accutane went on the market in May 1982, babies with birth defects started to appear.

In Sept 8 1983, after the first US birth defect cases were reported, Health Research Group wrote to the FDA urging them to require pregnancy tests and not to bury the warnings about birth defects in the “fine print” at the end of the product labeling.

By 1988 the FDA estimated there could be as many as 1,300 babies born with birth defects because of Accutane. Some of the babies were so deformed that they died in pain after only a few years of life in an institution. Probably many times more babies had mild cognitive defects. And what is worse, despite all efforts, rates of birth defects never went down until iPLEDGE.

Noone deserves that, for any reason.

Originally posted September 28, 2008

My book The Goose That Laid the Golden Egg: Accutane, the truth that had to be told, has been released with 39/42 five star reviews on Amazon and available in paperback or $0.99 on Kindle here. See here for all outlets where it can be obtained.

Review: The Evidence, However, Is Clear: The Seroxat Scandal

Doug Bremner — Sun, 07 Aug 2011 22:54:20 +0000

The Evidence, However, Is Clear: The Seroxat Scandal, by Bob Fiddaman.

Bobby Fiddaman has written an interesting and well written book about his personal experiences taking the antidepressant Seroxat (Paxil, or paroxetine in the US), his struggles with withdrawal, and his work as an advocate raising attention related to the potential side effects of this drug. Fiddaman has a popular blog (Seroxat Sufferers: Stand Up and Be Counted) where he has worked tirelessley to get members of the Medicines and Healthcare Regulatory Agency (MHRA, the equivalent of the FDA in the US) to highlight potential side effects of the drug, most notably the range of cognitive and neurological and psychiatric problems that some people experience coming off the drug, such as himself. Fiddaman highlights the marketing campaign by the maker of Seroxat, GSK and others, to “sell” depression as deficiency of the neurotransmitter serotonin in the brain (it’s not) and their drug as the cure that will boost serotonin and cure depression (researchers have known for years that this explanation was bogus, but were too cowed by the drug companies to pipe up about it, I guess). He also highlights the revolving door where doctors go from high positions in drug companies, to drug regulatory agencies, and sometimes to academic jobs and then back through the wheel again. Fiddaman’s story is a testament to what health care consumers can achieve when they take charge of their treatments instead of passively following doctors advice without informing themselves about their own healthcare. He highlights the fact that pharmaceutical companies do not always have your best interests at heart (they are there to profit from their medications, after all) and you have to watch out.

By way of disclosure the author has told me on twitter (@dougbremner) that he is reading my latest book The Goose That Laid the Golden Egg in which I describe my experiences as a doctor giving paid speeches for GSK about Paxil as well as working as an expert on drug safety related issues in the courts. He also wrote a blog about the Goose book last year.

I recommend this book for anyone who has personal experiences with antidepressants or depression for themselves or family members, or for more insight into drug regulation and consumer advocacy. The writing is excellent and refreshingly honest.

You can follow the author on twitter @Fiddaman and read more about his book here.

The Goose That Laid the Golden Egg

Doug Bremner — Sat, 23 Jul 2011 14:35:36 +0000

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 $2.99 here or paperback here.