Monsanto Roundup Lawsuit


Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Tuesday, March 31, 2009

A Month & Half on Paxil - Social Butterfly or Dr. Jeckyll & Mr. Hyde

Fascinating account of one man's journey on Paxil [Seroxat]

The following you are about to read rings so true for many people who have taken or are still taking Seroxat.

I have emailed the author and he has kindly gave me permission to reproduce his whole account here.

I hope the MHRA are looking in.


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A Month & Half on Paxil - Social Butterfly or Dr. Jeckyll & Mr. Hyde
Source

How a month and a half on Paxil taught me to love being shy.

I dread public speaking. I get nervous on first dates. I hate to be called on in classes or meetings. In short, I’m shy. Not debilitatingly so. I’m guessing many of you are no different.

I’ve often wondered what it’s like to be outgoing—a social butterfly, an extrovert. That’s why TV ads for Paxil caught my eye. You’ve seen them: They promise ease in a pill. An end to social anxiety. Does my degree of shyness warrant medication? It was enough to make me want to see what life was like without being shy. I wondered what Paxil could do for me. Was a smoother, suaver Seth just 20 milligrams away?

Skimming my insurance company’s list, I found a nearby general practitioner and made an appointment.

I. The Transformation

Day 1: After taking my blood pressure, the doc sits me down and asks a few questions. Am I shy? Yes, I’m uncomfortable speaking in groups. Have I suffered from depression? I’ve been blue but nothing serious. I tell him I’ve taken the self-test at Paxil.com (example: “I avoid having to give speeches—Not at all, A little bit, Somewhat, Very much, or Extremely”) and it said, “Your score suggests that you may be experiencing the symptoms of social anxiety disorder.” Of course, it wouldn’t surprise me if it always said that.

He lists Paxil’s side effects—headache, nausea, tremor, etc. “The most universal side effect,” he says, “is delayed orgasm. For some people, that’s a good thing.” I nod. He explains a little about the drug itself (it’s a Prozac-type antidepressant that later got approved for social anxiety treatment) but concludes, “No matter what anyone says, we basically have no clue how this works.” And that’s that. He writes out the prescription, for 20 milligrams a day. “If you’d like, we’ve got some counselors upstairs you can talk to, but it sounds like you just want the drug,” he says, and hands over the slip. “It could take a couple of weeks to kick in. Be patient.”

I walk around the corner to CVS. Boom: Fifteen minutes with a doctor, $15 at the pharmacy, and I’ve scored a month’s supply of a powerful, mood-altering substance. Back home, I pop my first pill and wait.

Day 2: I’m lying on the couch, wrapped in a blanket, staring at the wall. My head is buzzing. My eyes won’t focus. My stomach hurts and I’m shaking. I feel like a slo-mo version of Dr. Jeckyll’s violent transformation.

I do not feel outgoing.

Day 3: Ditto.

Day 4: No longer confined to the couch, but head still buzzing. Feeling totally detached from my surroundings. There’s a constant lump in my throat (apparently a common side effect), and the shaking is getting worse. Eating cereal, I spill milk from the spoon before it reaches my mouth. When the doc said tremor, I thought it could be cool—give me a little Katharine Hepburn style. Turns out tremors are not so cool.

Day 8: Delayed orgasm, beyond a reasonable point, is not a good thing. I will say nothing further about this.

Day 11: Side effects have mostly faded out, save for the orgasm thing, which is in for the long haul. I’m not seeing any personality changes, though. At a party a few nights ago (among good friends, so not a worthy testing ground), I did notice one thing: After a few drinks, I began to discourse freely on my Paxil experience.

Generally, talking about myself, even with close friends, is my least favorite thing to do (writing about myself is clearly a different [2,000-word] story). So this was odd. But was it the Paxil? The alcohol? Or just that, for a change, I had something to talk about?

II. The Unexamined Life

Day 16: Still no visible change. However, I can’t get a lick of work done. Unfinished articles are lying around, waiting for my attention. Motivation has dried up. Coincidence?

Day 25: A pattern is emerging. Since starting on Paxil, I’ve been drinking like a fish. For some reason, vitamin P combines incredibly well with alcohol. It’s more fun to drink than it was before. I want to be drunk every night. I don’t get hung over now, and I remain pretty lucid even when sloshed.

Day 27: Paxil is messing with my livelihood. I’m still not getting any work done. Could it be Paxil’s antidepressant effects? Perhaps I’m too content to be motivated. Do I require bile and unhappiness to write? I could clearly go the rest of my life on this stuff and never feel down again.

Another scary part: Before Paxil, while working on stories, turns of phrase would pop into my head, fully formed. Lying awake at night, or riding on the subway, poof—a neat arrangement of words would appear from nowhere. And would often show up in the article. It’s part of what makes writing fun and surprising. On Paxil, it’s gone. The words just aren’t coming.

Also, the last few days I’ve considered cutting down on free-lancing and getting a regular job—consulting or something. Previously, I couldn’t imagine a job like this. Regular hours and no creative outlet sounded like a nightmare. All wrong for me. But now, stability, routine, and boredom sounds A-OK. Pleasant, even. An easy way to make a buck and just live my life.

Day 29: A literati book party. My first real test, and it’s basically a failure. Upon meeting a gaggle of strangers, I still sprout flop sweat all over my torso, just like before. I still can’t introduce myself to people I’d like to meet. I still don’t know how to talk in big groups.

But then something magical happens. After deciding Paxil is worthless and downing three glasses of wine, I find I want to talk to people. No, it wasn’t the alcohol. I drink at parties all the time—and go from standing alone in the corner to standing drunk and alone in the corner. This time, I’m craving conversation. In fact, I want to talk about myself. And in the midst of a lively monologue delivered to a group of four people (previously unimaginable for me), I recognize the feeling: It’s like being on ecstasy! Relaxed, exceedingly comfortable with strangers, completely open. It makes some sense—both drugs noodle with your serotonin. Paxil, like Prozac and Zoloft, is a selective serotonin reuptake inhibitor. SSRIs block reabsorption of serotonin—a neurotransmitter—by your nerve endings, boosting serotonin levels in your brain. Ecstasy tweaks up your serotonin, too. But instead of paying $20 for a night on E, I paid $15 for a month on P. The catch: I seem to require alcohol as a trigger. Not sure why, and I doubt my doc could explain it.

Day 35: Drinking a lot, several nights a week. Liquor + Paxil = Wow!

Pre-Paxil, I was a social drinker. Now I’m walking a mile in someone else’s brain chemistry. I can see why some of you like to drink so much, maybe even need to drink so much. It’s fun for me now, in a way it just wasn’t before. On liquor and Paxil, strangers mean novelty, not fear. Group conversations are a chance to play raconteur, not a chance to smile weakly and shut up.

And it’s so much better than sobriety. Sober for me these days means extreme detachment. Movies, once a favorite hobby, do nothing for me now. Likewise books—I just don’t connect with the plots or characters. I can’t recall laughing (while sober) in the past couple of weeks. I’m never sad, but never happy. Why wouldn’t I drink?

Day 38: I spent the first semester of my freshman year of college in a haze. During the Southern California evenings, I often played tennis, pulling bong hits between games. I distilled homemade rum in my dorm room, using Sterno cans and plastic tubing. My roommate grew six ounces of weed in our closet. It was more fun than I’d ever had in my life. The day after I got home for Christmas break, I decided to transfer.

It occurs to me that the past month has been a bit like that semester. I’m living the unexamined life. It’s fantastic. I’m about ready to transfer.

Day 45: I stop my treatment. I had planned elaborate tests for myself—crashing formal parties, giving a dinner toast to a full restaurant, singing jazz standards in subway stations—but I decide these will prove nothing. Also, my lack of engagement with life is freaking out my girlfriend. And my seismic personality shift when drunk is freaking out me.

My day-to-day, sober interactions with people are unchanged by Paxil. A crisis along the lines of a public speaking engagement would still send sweat coursing down my spine (unless I downed a few scotch-and-sodas first). As best I can tell, Paxil works by creating massive detachment from your own emotions. If your social anxiety verges on looniness, detachment from those emotions is a good thing. For me, a milder case, hard-core detachment is just spooky. So, no more pills.

III. The Withdrawal

Day 46: At dinner, I feel the onset of mutation. While staring at a plate of artichoke hearts, my focus suddenly shifts, like the track-out/zoom-in camera trick in Vertigo. My brain is shifting out of Paxil gear and back to normal. It’s like coming down off a hallucinogen. Later in the evening, it happens a few more times.

Day 47: Cannot get out of bed. Pounding headache. Extreme intestinal unhappiness. Dizzy all day.

Day 48: More of the same. I’m exhibiting classic withdrawal, which I’ve read about on some anti-Paxil Web sites. The dizziness and lightheadedness are overwhelming and far scarier than mere stomach distress. I leave the house but have to sit down every 10 minutes for fear of keeling over.

Day 49: Not much better. I can’t describe how awful it is to be lightheaded for 72 straight hours. I try to lift my blood sugar by eating, but it makes no difference. Nothing helps. More alarmingly, the dreaded “zaps” have arrived. I’d read about these on the Paxil Database, a site for self-proclaimed Paxil victims, but I thought they were made up—there are so many hypochondriacs on the Web.

Turns out the zaps are for real. They’re hard to describe. Imagine low level electrical shocks all over your head, as though someone removed the top of your skull and dragged a staticky blanket across your brain. Zaps come in waves that last about 15 minutes then go away for a few hours. They do not hurt but are unnerving, to say the least.

Day 50: Zap waves all day. Have now been dizzy and burping for four days.

Day 51: Intestines happier. Dizziness comes and goes. Zaps still there.

Day 52: It’s mercifully over. But a new phenomenon has taken hold. When I get teary-eyed watching a horrid chick-flick on a cross-country flight, I recognize it: feelings. On Paxil, I barely noticed they were gone. Now that they’re back, even overcompensating, I never want to lose them again. Bitterness, anger, jealousy, sadness: They all make me happy.

IV. Epilogue

In retrospect, it was a bad idea to screw with my brain chemistry and possibly inflict lifelong damage just for the sake of experiment. I would not do something like this again. At the height of my withdrawal I was seriously terrified, thought it might never end, and repeatedly cursed my own stupidity. The fact that I considered a wholesale career change under the drug’s effects, and couldn’t complete any work, is alarming. Also, the zaps are for real. Fear them.

At the same time, I admit it was fascinating to try out a different personality. He only came out when I drank, but I caught a glimpse of an alternate me, and he wasn’t such a bad guy—if a little gabby. I think I gained some empathy for other types of folk, and maybe got an idea of how alcohol can mean different things to different people. I also sort of discovered what emotions are for and decided being shy isn’t so bad after all. Thanks, Paxil !

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Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

GlaxoSmithKline submits final study data to FDA for cervical cancer vaccine




PHILADELPHIA and LONDON, March 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today provided the following update regarding its application to the U.S. Food and Drug Administration (FDA) for approval of CERVARIX(R), its vaccine to prevent cervical cancer and cervical pre-cancer related to human papillomavirus types 16 and 18 - Source - http://pressrelated.com/press-release-cervarixr-us-regulatory-update.html

Difficult one to muster.

Cervical cancer is nasty and if there is a vaccine to cure it then I'd be the first to offer a round of applause to the pharmaceutical company that provides that cure.

I'm unsure about Cervarix though... and more unsure over it's manufacturers, GlaxoSmithKline.

It's a difficult decision to make for any parent. Shall we trust GlaxoSmithKline? [this time]

Personally, if I had a daughter, I wouldn't want any drug made by GSK going anywhere near her. I don't trust them you see. They have a history of not quite being forthright with the truth. That's just my personal opinion and far be it for me to challenge whether or not a parent makes the correct decision in allowing their daughter to be vaccinated by a GSK product.

I suggest every parent in the UK do their homework before they make that decision. I could point many parents to pages where GSK have showed contempt for children but Google is a much more powerful tool.

I would love to believe that GlaxoSmithKline had manufactured a vaccine for the prevention of cervical cancer... I truly would. Had they been more transparent in the past then they would have gained trust in members of the public. The fact remains that GSK have quite a tainted history of hiding the facts and I for one do not trust them.

As a parent I would get written confirmation from the CEO of GlaxoSmithKline, Andrew Witty, that Cervarix does exactly what it's manufacturers claim it does. I would ask for a full comprehensive list of possible side-effects both published and unpublished. I would then email/write to the CEO of the MHRA, Kent Woods, and ask him for the same. Then if anything untoward happened to my child as a result of them taking this vaccine I would hold both Andrew Witty and Kent Woods responsible. If I couldn't get these personal assurances from both CEO's then I would seriously consider allowing the vaccine into the body of any child of mine.

I'm trying not to scaremonger - I can see both sides of the debate. Thing is... the side of GSK and medicine regulators is painted with £ and $ signs. It all boils down to GSK making a huge amount of money - just like they did with Seroxat/Paxil.

The choice is yours.

Use Google.

Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Monday, March 30, 2009

"Seroxat Killed"

Interestingly, if you type the words "Seroxat Killed" into the Google search engine it throws up some revealing results.

Maker of 'happy pill' Seroxat is sued by man who killed wife while on drug

Glaxo escapes prosecution on Seroxat disclosure

My first few months, suicidal thoughts and hallucinations

Coroner calls for withdrawal of Seroxat (PAXIL)

Secrets of the Drug Trials: Seroxat and the Dangers of Antidepressant Medications

Man slashed wrists on Seroxat

Paxil Paxil Paxil: Seroxat Seroxat Seroxat: Killer in the bottle: Paxil Study 329

GPs accused of not reporting Seroxat suicides

Seroxat (Glaxosmithkline) The bad stuff it did to me

The Real Truth about Seroxat (paroxetine)

There is page after page. The above are just a few examples.

The truth is out there... but you won't find it on GlaxoSmithKline's website, why bad mouth your own best seller?

Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Sunday, March 29, 2009

3 REMINDERS - WHY SEROXAT COULD BE DEEMED AS DEFECTIVE

Overwork behind teacher suicide

"Ms Dibb, from Foxhole, north Cornwall, had complained to her father Alan, from Fowey in Cornwall, about the pressure of work and at the end of March she disappeared.

Her body was found on 2 April at an isolated spot on Dartmoor.

A post mortem examination revealed she died of burns and also found that she had been prescribed the anti-depressant drug Seroxat."



FULL STORY

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Diplomat cleared over 'air rage'

"The former army helicopter pilot told the jury he had been suffering from stress following the tsunami and that he had accidentally taken too much of the prescribed drug Seroxat which he was taking for depression.

The officer told the jury he had no memory of his behaviour on the plane."


FULL STORY

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The missing warning on a drug for desperate people.

"The government's watchdog, the medicines control agency, decided almost a year ago to ask drug companies including GlaxoSmithKline the world's biggest, to warn patients of a possible risk of suicide associated with Prozac-style drugs. Glaxo's Seroxat is one of the most prescribed."

FULL STORY

Hat-tip: The Truthman

Fid




Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Bad Batch of Paxil CR

It seems lawyers have negotiated a deal with consumers and GlaxoSmithKline over the faulty batches of Paxil CR that slipped through the system between 2002 and 2005. A $28M deal is on the table and will be shared amongst those who paid for their Paxil and insurance companies seeking to be reimbursed for their expenditures.

Full story here


Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Saturday, March 28, 2009

GSK Slipping through the net

A collection of GSK related news that slipped through the net.

French judges probe firms over vaccinations

Source: - reuters.com

Feb 2008

PARIS, Jan 31 (Reuters) - French authorities have opened a formal investigation into two managers from drugs groups GlaxoSmithKline (GSK.L) and Sanofi Pasteur over a vaccination campaign in the 1990s, a judicial source said late on Thursday.

Judge Marie-Odile Bertella-Geffroy also opened an investigation for manslaughter against Sanofi Pasteur MSD, a joint venture between Sanofi Aventis (SASY.PA) and Merck (MRK.N), the same source said.

The investigations follow allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used in a vaccination campaign between 1994 and 1998.

There was no immediate comment from the companies or the two managers involved.

From 1994 to 1998, almost two thirds of the French population and almost all newborn babies were vaccinated against hepatitis B, but the campaign was suspended after concerns arose about possible secondary effects from the treatments.

Some 30 plaintiffs have launched a civil action in the case, including the families of five people who died after vaccination. (Reporting by Thierry Leveque; Writing by James Mackenzie; Editing by David Holmes)

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Italian MDs in Kickback Scandal

Source: - Austin Kline

May 2004

A two-year investigation by the financial brigade found that the Italian subsidiary of Glaxo had mounted an illegal incentives scheme involving 4,713 people, including 4,440 doctors. Over 100 Glaxo employees, including top-level managers, are also accused of corruption or criminal association, a financial brigade official told a press conference. Freebies doled out to doctors across Italy included all-expenses-paid travel, cash or free pharmaceutical drugs, the police found.

The financial investigators, led by Guido Papalia, head prosecutor in the northern city of Verona, found evidence of kickback practices across Italy. ... [Glaxo] is not alone among drugs giants under scrutiny for alleged illegal incentives schemes in Italy. Several others have been accused by media for creating mock scientific conferences in the Caribbean in order to bequeath free luxury trips upon accommodating doctors.

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US VACCINE MAKER TARGET OF HOMOCIDE INVESTIGATION

Source:- newswithviews.com

March 2008

In a criminal case guaranteed to send shockwaves throughout the international pharmaceutical industry, French authorities are targeting a US-based drug company and its executives in a homicide investigation.

The multi-billion dollar corporation GlaxoSmithKline and one of its key executives are facing possible manslaughter charges stemming from allegations that the company failed to fully disclose side effects from an anti-Hepatitis "B" vaccine distributed between 1994 and 1998.

Also being investigated is the French-based drug company Sanofi Pasteur, which also sold doses of the Hepatitis "B" vaccine, according to French news sources

"The investigations are in response to allegations that the companies failed to fully disclose side effects from an anti-hepatitis B drug used between 1994 and 1998," stated the French source.

Hepatitis B is a serious disease caused by a virus that attacks the liver. The virus, which is called hepatitis B virus (HBV), can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death, according to the Centers for Disease Control.

This virus spread through having sex with an infected person without using a condom (the efficacy of latex condoms in preventing infection with Hepatitis "B" is unknown, but their proper use might reduce transmission), by sharing drugs, needles, or "works" when injecting drugs, through needlesticks or sharps exposures on the job, or from an infected mother to her baby during birth.

In the US, the Hep "B" vaccine is usually mandated by the states for physicians, nurses, hospital workers, law enforcement officers, prison guards and others who are likely to come into contact with those at-risk of carrying the virus.

Between 1994 and 1998, close to two-thirds of the French population, and almost all newborn babies, received a hepatitis B vaccine. The vaccination campaign was halted after concerns arose over the shot's side effects.

While more than 25 plaintiffs, including the families of five people who died after the vaccination, have launched a civil action in the case against the drug companies, it is the criminal charges that have had a chilling effect on pharmceutical companies.

"While conservatives may believe in limited government, when it comes to life and death, they usually favor government action including the use of the criminal justice system to protect American lives from amoral corporate executives," said political strategist Mike Baker.

"Maybe if the pharmaceutical [company] bigwigs see their colleagues frog-walked to prison, they will think twice before distributing shoddy vaccines," said Baker.

"I believe police departments should set up special units to investigate deaths attributed to vaccines, especially those that are mandatory for children," said former NYPD Detective Sid Frances.

"A killers are killers, whether they wear hip-hop outfits or three-piece Armani suits," he said. Det. Frances even believes investigators in the US should target government officials who mandate vaccinations, especially in the public schools.

In a related case, this time in Russia, prosecutors are actively investigating GlaxoSmithKline for illegal vaccine experiments on children. Experimental vaccine tests on minors are illegal in Russia, according to a report by the Alliance for Human Research Protection.

A statement posted on the Prosecutor General's Web site indicates that investigators began the probe at a hospital about 550 miles southeast of Moscow, after several children who received the experimental vaccines without parental consent fell ill and parents raised questions, according to the AHRP report.

The statement said that more than 100 children between the ages of one and two were vaccinated during the trials.The vaccines: Varilrix, for chickenpox, Priorix, for mumps, measles and rubella, and Priorix Tetra, would treat all four diseases, have since been halted.

Russian prosecutors said parents had been told the vaccines were humanitarian aid, while the deputy director of the hospital involved had been paid $50,000 to participate in the trials.

NewsWithViews.com contacted the Centers for Disease Control headquarters to obtain information on any investigations being conducted in the United States. According to the CDC Press Room, there are no US criminal investigations involving vaccines, and there are no criminal complaints involving vaccinations.

"The CDC is a public health organization, not a law enforcement agency. We should have police units at the state and/or local level to investigate deaths and suspicious illnesses due to vaccinations and products being sold by pharmaceutical companies," claims Mike Baker.

"Most of the companies have no allegiance to America. They view the US merely as the 'home office,'" he added.

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Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Friday, March 27, 2009

Nonprofit Hits JAMA, Seeks Inquiry...AHRP Letter of Complaint to AMA

I have just been sent the following email. Rather than write about it I will publish it in its entirety.

Hat-tip: Stuart Jones

ALLIANCE FOR HUMAN RESEARCH PROTECTION

Promoting Openness, Full Disclosure, and Accountability
http://www.ahrp.org/ and http://ahrp.blogspot.com/

FYI

http://online.wsj.com/article/SB123810131860651487.html

THE WALL STREET JOURNAL

Nonprofit Hits JAMA, Seeks Inquiry

By David Armstrong

MARCH 26, 2009

A non-profit group that monitors industry links to medical research called for the suspension of the top two editors of the Journal of the American Medical Association, and an investigation into allegations that they threatened a researcher who criticized a study published in the journal.

The Alliance for Human Research Protection, which is often critical of industry-academic ties, made the requests in a letter it sent Wednesday to the AMA and the journal, also known as JAMA.

(This story and related background material will be available on The Wall Street Journal Web site, WSJ.com.)

"We are deeply concerned about the unbecoming and unethical conduct of the editor-in-chief and executive deputy editor of the Journal of the American Medical Association, who were reported to have used unprofessional and intimidating tactics against a conscientious academic," the alliance wrote in a letter requesting the investigation. Many doctors and academics have criticized JAMA's reaction to the academic, Dr. Jonathan Leo, on Internet blogs in recent weeks.

The AMA and JAMA said they were reviewing the letters and declined further comment. Jordan J. Cohen, a professor of medicine at George Washington University, who is chairman of JAMA's oversight committee, hasn't returned telephone and email messages this week.

The controversy stems from a March 5 letter published by the British journal, BMJ, in which Leo criticized how results were reported in a JAMA study last year that looked at the use of the antidepressant Lexapro's use in stroke victims.

Leo also pointed out that JAMA didn't report that the study's author had a financial relationship with Lexapro's maker, Forrest Laboratories Inc.

Leo is a professor of neuro-anatomy at Lincoln Memorial University in Harrogate, Tenn.

Forrest acknowledged that it had paid the author for speeches, but said his research on Lexapro was independent.

The publication of the BMJ letter upset JAMA's editor in chief, Catherine DeAngelis, who acknowledges contacting Leo's dean in an effort to get Leo to retract the letter. Leo says JAMA's executive deputy editor, Dr. Phil Fontanarosa, also called him to request a retraction. Leo has said Fontanarosa told him "You are banned from JAMA for life. You will be sorry. Your school will be sorry. Your students will be sorry." Fontanarosa, through a spokeswoman, has said Leo's version of the conversation is "inaccurate."

JAMA editors have said they were "strong and emphatic" when discussing Leo's letter with him and his dean because of the importance of protecting JAMA's reputation. "We regret if anyone involved in these communications interpreted our intentions in any other way," the editors said in a special editorial published last week.

In an interview with The Wall Street Journal earlier this month, JAMA editor-in-chief Catherine DeAngelis called Leo "a nothing and a nobody."

DeAngelis later said he is "certainly is somebody doing something very important."

In the editorial, DeAngelis and Fontanarosa said Leo was guilty of a "serious breach of confidentiality" by writing about the problems with the JAMA study while it was still investigating the matter. JAMA said that from now on, anyone complaining of an author failing to report a conflict of interest will told not to disclose an investigation is under way.

That policy has been criticized by other medical journal editors as well as by some physicians and researchers. In her letter, Vera Sharav, the president of the Alliance for Human Research Protection, said journal editors have a responsibility to provide an open forum for scientific debate. "Not only have Drs. Fontanarosa and DeAngelis failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gate-keeping processes" Sharav wrote. Her organization has often criticized the efficacy and safety of antidepressants.

JAMA has a unique management structure that was born from another controversy a decade ago when DeAngelis' predecessor was fired by the AMA. George Lunderberg, who had edited the journal for 17 years, was fired in 1999 when he published a study that found most college students didn't consider "oral sex" as "having sex." The article was published during the debate over the impeachment of then-president Clinton.

In wake of that controversy, the AMA ceded direct editorial control of JAMA to its seven-member oversight committee made up of six outsiders and the journal's publisher.

~~~~~~~~~~~

See also, Medical Journal Decries Public Airing of Conflicts, WSJ March 22, 2009:

http://online.wsj.com/article_email/SB123776823117709555-lMyQjAxMDI5MzI3MzcyNjM4Wj.html

~~~~~~~~~~~~~

ALLIANCE FOR HUMAN RESEARCH PROTECTION
A catalyst for public debate
142 West End Avenue Suite 28P
New York, NY 10023
212-595-8974
http://www.ahrp.org/ and http://www.ahrp.blogspot.com/


March 25, 2009

Joseph M. Heyman, MD

Chairman, Board of Trustees

Jordan J. Cohen, MD

Chair, JAMA Oversight Committee

Nancy H. Nielsen, MD, PhD

President



American Medical Association

515 N. State Street
Chicago, IL 60654



Dear Dr. Cohen, Dr. Heyman, Dr. Nielsen, and members of the Board of Trustees, and members of the Journal Oversight Committee:



The Alliance for Human Research Protection (AHRP) was founded to ensure that clinical research, which relies on the volunteerism of human subjects, should be as safe as possible, in compliance with ethical and scientific standards [1] and be free of conflicts of interest that undermine both the safety of the subjects and the scientific integrity of the research. Our mission includes protecting the independence of conscientious researchers to analyze reported clinical research findings and, when they occur, to point out ethical lapses in research and publication.



We are deeply concerned about the unbecoming and unethical conduct of the Editor-in-chief and Executive Deputy Editor of the Journal of the American Medical Association, who were reported to have used unprofessional and intimidating tactics against a conscientious academic, Dr. Jonathan Leo. Their behavior undermines the integrity of the JAMA peer review process, first, by failing to properly vet a manuscript for the accuracy of scientific reporting and for author conflict of interest and bias and, second, by launching an ad hominem attack on the scientist who was attempting to correct the record.



The JAMA editors have endangered the public health by failing to correct false information about the comparative benefits and risks of an antidepressant drug. In doing so, the JAMA editors have violated Principle #2 of the AMA Code of Ethics, namely:



“A physician shall uphold the standards of professionalism, be honest in all professional interactions, and strive to report physicians deficient in character or competence, or engaging in fraud or deception, to appropriate entities.” See: http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/ama-code-medical-ethics/principles-medical-ethics.shtml.



Accordingly, the Alliance for Human Research Protection calls for a public apology to Dr. Jonathan Leo by the American Medical Association, the immediate suspension from duty of the two editors involved in this matter, a thorough investigation by the AMA board of directors, and a commitment to reviewing, clarifying and publishing JAMA's editorial policies to protect against future violations of standards for professional conduct.



The essential facts leading to our complaint follow.



The authors of a JAMA report (May, 2008) [2] recommended the off-label prophylactic use of the antidepressant, Lexapro (escitalopram) to prevent depression in post-stroke patients. The lead author promoted the expanded use of Lexapro in a flurry of media reports. In a letter to JAMA (published Oct, 2008) Dr. Leo, a neuroanatomy professor and assistant dean, and Dr. Jeffrey Lacasse, an assistant professor, raised an important scientific criticism: the authors’ failure to compare the two active arms of the study—non-pharmacological, problem-solving psychotherapy to Lexapro. The lead author responded, acknowledging the validity of their assessment, which was that psychotherapy was statistically equivalent to Lexapro.

http://jama.ama-assn.org/cgi/content/full/300/15/1757



Separately, Dr. Leo informed JAMA editors about the lead author’s failure to disclose his financial ties to Forest Labs, the manufacturer of Lexapro. After waiting 5 months for JAMA to disclose the author’s conflicts of interest to readers, Leo and Lacasse posted a letter in the online British Medical Journal in which they reported the conflict of interest and commented on its implications. [3]

http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503.



In response, the Wall Street Journal reported that JAMA’s Executive Deputy Editor, Phil Fontanarosa MD, threatened Dr. Leo, and JAMA Editor-in-chief, Catherine DeAngelis MD, called the dean of Leo’s college demanding a retraction. When interviewed by a Wall Street Journal reporter about this dust-up, JAMA’s Editor-in-chief called Leo, "a nobody and a nothing." [4] http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/



Medical journal editors are the gatekeepers of medical science.

Their responsibility is to provide an open forum for scientific debate, and to preserve the scientific integrity of the journal and its content by ensuring against concealed conflicts of interest. Not only have Drs. Fontanarosa and DeAngelis failed to meet this responsibility, they resorted to threatening retribution against a researcher who detected failures in their editing and gatekeeping processes.



This abuse of editorial power is breathtaking. First, the JAMA editors have violated the AMA Code of Ethics with respect to Principle #2 (as noted above) as well, Principle # 4:

“A physician shall respect the rights of patients, colleagues, and other health professionals…”



Instead, the JAMA editors attacked and attempted to intimidate and punish a responsible researcher who tried to correct the record regarding a misleading JAMA report (May 2008) [2] that failed to report that talk therapy proved equally effective to Lexapro.

It appears that the JAMA editors were enraged by the fact that their editorial failings were exposed in a reputable medical journal. In the first place, they had missed the sensitive point made by Drs. Leo and Lacasse that the evidence showed the antidepressant Lexapro was no better than talk therapy in preventing post-stroke depression. (Competent peer-review of the report should have brought up this point.) In the second place, it was evident that the JAMA editors had to be prodded to reveal conflicts of interest involving the first author of a JAMA report—only after Drs. Leo and Lacasse posted a letter on the BMJ website, ten months after the original publication of the widely cited JAMA report, and five months after Dr. Leo brought the conflict of interest issue to the attention of JAMA. http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208503.

Second, the JAMA editors have violated several principles of the International Committee of Medical Journal Editors (ICMJE), for example Principle II.D Conflicts of Interest:

“Public trust in the peer-review process and the credibility of published articles depend in part on how well conflict of interest is handled during writing, peer review, and editorial decision making.” See: http://www.icmje.org/.

The editors’ anger was compounded by their failure to suppress disclosure that JAMA’s editorial/peer review process leaves much to be desired. JAMA has more than once published promotional—as opposed to scientific—reports by authors with undisclosed financial ties to manufacturers whose products they recommended [5] [6] [7] http://www.ahrp.org/cms/content/view/544/9/

Third, the JAMA editors have violated several principles of the World Association of Medical Editors (WAME), most notably:



“Journal editors and authors have a responsibility to protect the integrity of the research record from bias related to the funding of research. This is best accomplished by revealing to readers the sponsorship of the research, any roles the sponsor played in the research, the institutional affiliations of the researchers and any relevant financial ties the researchers might have.”

See: http://www.wame.org/resources/policies.



The JAMA editors' outrageous unprofessional conduct has ignited quite a firestorm of discontent among physicians:

Questions are also being raised about whether drug advertising influences JAMA’s publication of biased reports? Many JAMA subscribers identify themselves as one of the "nothings" for whom Dr. DeAngelis has shown contempt. Her arrogance touched off an outpouring of 158 angry responses posted on the Wall Street Journal Health blog, the majority posted by physicians, several respondents indicated they are canceling their JAMA subscriptions.

http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/tab/comments; and http://blogs.wsj.com/health/2009/03/23/jama-sets-new-policy-in-wake-of-disclosure-flap/tab/comments/



The Editors’ response in a JAMA editorial (March 18) adds insult to injury.

In their response, posted online a week after The Wall Street Journal reported on their unethical conduct, Drs. DeAngelis and Fontanarosa failed to offer an apology to Dr. Leo or to address their own unconscionable behavior. Instead, they further demonstrated their arrogance by proposing total secrecy during the unspecified time that JAMA takes to verify allegations of conflicts of interest—in order to protect the reputation of authors alleged to have undisclosed conflicts of interest. Incredibly, they show a complete lack of regard for their readers and medical colleagues who rely on JAMA reviewers and editors to ferret out biased reports before they are published in JAMA.

Drs. DeAngelis and Fontanarosa propose “modifications” to the JAMA conflicts of interest policy requiring that a person who alleges conflicts of interest about a published JAMA author not only provide detailed “explanations” for the allegation, but take an oath of silence until JAMA deigns to complete its investigation! The arrogance and imperious tone of JAMA’s editors is stunning.

As one of the commentators (#98) on the WSJ Health Blog noted: “Since when is writing a thoughtful letter to a medical journal, that raises legitimate and accurate concerns, “inappropriate”? Dr. Leo does not work for JAMA. He does not need to abide by the internal “procedures” (which were never communicated to him in any event) forbidding his contacting other journals or the media.”

Clearly, the JAMA editors fail to recognize the logical absurdity of claiming the exclusive right to be the sole judge and communicator (in their own time and manner) of errors or omissions in JAMA—unless, their objective is to alienate, and therefore lose JAMA readership. As a consequence of their “modification”—which amounts to a declaration of unilateral control—conscientious scientists who find scientific errors and / or undisclosed conflicts of interest in JAMA reports, will be advised to report them to reputable medical journals such as, the BMJ (British Medical Journal).

Clearly, the editors show no concern about the adverse impact on patient care resulting from JAMA reports that are tainted by undisclosed conflicts of interest. Ten months elapsed between publication of the original paper, and delayed publication of a correction. The intent of the original paper, as demonstrated by the lead author’s role in the media flurry that followed it, was to broaden antidepressant prescribing prophylactically to stroke patients. [8] The lead author’s failure to (a) acknowledge that problem solving therapy was equally efficacious in the prevention of depression in the original paper, and (b) mention his financial conflict of interest, were likely designed to strengthen the paper’s promotional impact. Patient care suffers from such maneuvers.

Clearly, the editors show no concern about the reputation of Jonathan Leo. And they still have no idea how far over the line they have gone, and how they have lost all respect from their readership, including the eroding membership of the American Medical Association. [9] http://www.highbeam.com/doc/1G1-132978192.html



The Alliance for Human Research Protection calls for a public apology to Dr. Jonathan Leo by the American Medical Association, the immediate suspension from duty of the two editors involved in this matter, a thorough investigation, and a commitment to reviewing, clarifying and publishing JAMA's editorial policies.

Please kindly inform us of your actions with respect to this formal complaint.

Yours truly,



Vera Sharav, President

On behalf of the Board of Directors

Alliance for Human Research Protection







References:

World Medical Association. Declaration of Helsinki http://www.wma.net/e/policy/pdf/17c.pdf
Robert G. Robinson, MD; Ricardo E. Jorge, MD; David J. Moser, PhD; Laura Acion, MS; Ana Solodkin, PhD; Steven L. Small, PhD, MD; Pasquale Fonzetti, MD, PhD; Mark Hegel, PhD; Stephan Arndt, PhD. Escitalopram and Problem-Solving Therapy for Prevention of Poststroke Depression: A Randomized Controlled Trial JAMA. 2008;299(20):2391-2400.
Leo J and Lacasse J. Clinical Trials of Therapy versus Medication: Even in a Tie, Medication wins. Letter BMJ, 5 March 2009. http://www.bmj.com/cgi/eletters/338/feb05_1/b463#208422
Armstrong D. JAMA Editor Calls Critic a ‘Nobody and a Nothing’, Wall Street Journal Health Blog, March 13, 2009. http://blogs.wsj.com/health/2009/03/13/jama-editor-calls-critic-a-nobody-and-a-nothing/. See also, Armstrong D. Medical Journal Decries Public Airing of Conflicts, WSJ, March 23, 2009. http://online.wsj.com/article/SB123776823117709555.html
Hypericum Study Group. "Effect of Hypericum perforatum (St John's Wort) in Major Depressive Disorder: A Randomized Controlled Trial," JAMA Vol. 287, April 10, 2002. at: http://jama.ama-assn.org/issues/v287n14/rfull/joc11936.html.

6. Kupfer and Frank. Placebo in Clinical Trials for Depression:

Complexity and Necessity, JAMA.2002; 287: 1853-1854.

7. Kurth T, Gaziano JM, Cook NR, et al. Migraine and risk of cardiovascular disease

in women. JAMA. 2006;296:283-291.

8. “Antidepressants help stroke victims,” May 28, 2008: USA Today:

http://www.usatoday.com/news/health/2008-05-27-stroke-depression_N.htm

Associated Press:

http://www.foxnews.com/story/0,2933,358948,00.html?sPage=fnc/health/heart

9. Bloom M. New Leader Makes Plans to Revive a Faltering A.M.A., The New York

Times, December 4, 2001, F-6.


cc: AMA Board of Trustees:



Kendall S. Allred; Joseph P. Annis, MD; Peter W. Carmel, MD; William A. Dolan, MD; Andrew W. Gurman, MD; William A. Hazel Jr, MD; Cyril M. Hetsko, MD; Joseph M. Heyman, MD (chair); Ardis D. Hoven, MD; Christopher K. Kay; Edward L. Langston, MD (immediate past chair); Jeremy A. Lazarus, MD; Mary Anne McCaffree, MD; Nancy H. Nielsen, MD, PhD; Rebecca J. Patchin, MD (chair-elect); J. James Rohack, MD; Samantha L. Rosman, MD; Steven J. Stack, MD; Robert M. Wah, MD; Cecil B. Wilson, MD



Cc: JAMA Oversight Committee:



Jordan J. Cohen, MD (chair), George Washington University, Washington, DC

Karen Antman, MD, Boston University, Boston, Mass.

Kathleen Case, American Association for Cancer Research, Philadelphia, Pa.

Steven L. Kanter, MD, University of Pittsburgh School of Medicine, Pittsburgh, Pa.

Robert A. Musacchio, PhD, American Medical Association, Chicago, Ill.

Olufunmilayo Olopade, MD, University of Chicago School of Medicine, Chicago, Ill.

Edward H. Shortliffe, MD, PhD, University of Arizona College of Medicine, Arizona State University, Phoenix, Arizona



Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Tuesday, March 24, 2009

Hundreds of deaths linked to schizophrenia drug clozapine

Source: Times Online

Fifty people die each year and hundreds more suffer serious side-effects as the result of taking powerful tranquillisers prescribed by the NHS, The Times has learnt.

Data from the medicine watchdog’s own reporting scheme suggests that clozapine, a drug taken by schizophrenia patients, has been linked to 950 deaths since being licensed in 1990 — equivalent to nearly one fatality a week.

Recent figures record the deaths of 55 people taking the medication in four months, from October to January, despite the drug being prescribed to relatively few people.

The anti-psychotic drug is used as a treatment of last resort for schizophrenia patients but appears to increase the chances of having a heart attack or stroke, or of suffering other long-term health problems that are not adequately monitored by current checks, campaigners say. More than 11,600 adverse reactions linked to clozapine have been reported in 19 years, according to the Yellow Card reporting scheme of the Medicines and Healthcare products Regulatory Agency (MHRA), which is designed to flag up potentially harmful side-effects for licensed drugs.


Mind, the mental health charity, which analysed the figures, said that the number of deaths associated with the drug was “chilling”. The MHRA promised to look into the charity’s concerns.

The warning comes as the National Institute for Health and Clinical Excellence (NICE) is due to publish guidelines tomorrow on the treatment of schizophrenia, which affects about one in every 100 people in Britain. The watchdog will recommend that oral anti-psychotic medications should be offered to people with newly diagnosed schizophrenia, although patients should take clozapine only after trying at least two other drugs.

The drug, also known by the brand names Clozaril, Denzapine and Zaponex, was prescribed on 7,000 occasions last year — many of which will have been repeat prescriptions — to help to control delusions and hallucinations.

People who take clozapine must be given regular blood monitoring for the risk of a potentially fatal blood disorder known as agranulocytosis, but at present there is no mandatory requirement to monitor their health in other ways.

NICE will recommend tomorrow that GPs and other primary healthcare professionals should monitor the physical health of people with schizophrenia at least once a year, with a focus on their risks of heart disease.

Alison Cobb, senior policy officer at Mind, said that the drug could be effective for some patients and acknowledged that people with schizophrenia had a higher risk of death than the general population. “There are health risks and side-effects associated with all anti-psychotic medications but it is chilling to see this number of deaths associated with clozapine and the month-on-month increases,” she said. “The figures refer to heart disease, strokes, cancer and other long-term health problems that cannot be explained simply by suicides or an increased overall risk of death.

“We want to see the use of clozapine properly reviewed and for people taking it to be offered the full range of health checks and alternative treatment options that might mitigate any harmful effects.”

A study published in the British Journal of Psychiatry last month concluded that use of clozapine in patients with severe mental illness was associated with a significantly increased risk of death compared with the general population. However, the author of the study, David Taylor, the chief pharmacist at Maudsley Hospital, South London, defended the use of the drug, which he said had “transformed the lives of thousands of people around the world”.

“Most of the deaths reported could not be said to be a result of clozapine treatment; none could be definitively linked to its use,” he said. “Clozapine, it is widely agreed, is under-used in this country and in practice its use is delayed for much longer than NICE currently recommend.

“The safety of clozapine has been continuously monitored since its launch in 1990,” he added. “In fact, no other drug has been as closely monitored. Close and intensive physical monitoring should be mandatory for all people with severe mental illness, regardless of treatment.”


In a statement, the MHRA added: “We are aware of the particular concerns of Mind in relation to clozapine and have already indicated to them that we will look further into the concerns they have raised and consider whether the trends in reporting through the Yellow Card scheme raise any new issues that merit update to the product information or indeed require reminders to prescribers about the need for close monitoring of patients to optimise safe use."


Simon Hough was diagnosed with schizophrenia 14 years ago and still manages his condition with medication. Fellow patients warned him off clozapine, after those taking it compared the effects to “like coming off cocaine or heroin”.

“They described feeling really low and lethargic, and the side-effects such as weight gain and dry mouth were so much worse than other drugs,” he said. “One guy I knew was average weight, about 10 or 11 stone, and he just ballooned up to about 18 or 19 stone when he started taking the drug. That’s got to have some impact on your long-term health.”

Mr Hough, 42, who now works for Making Space, a mental health charity in Northwich, Cheshire, took part in the CUtLASS study, a large-scale trial comparing the effects of modern antipsychotic drugs with those of older treatments.

“I was offered clozapine but after all that I’d heard about it I preferred to be in the group that took quetiapine [an alternative drug] instead.”


Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Monday, March 23, 2009

GSK's Paxilcom... still a wealth of [dis]information

Search through the archives of GSK's, paxil.com and you'd be convinced that they had come up with a miracle cure for depression, panic disorder, Obsessive-compulsive disorder [OCD] and a host of other 'manufactured illnesses' as the years progressed through the paxil.com domain.

The beauty of the Internet is that it is a resourceful tool in an advocates fight for the truth. It's Pharma's achilles heel if you like.

Dec 12th 1998 - paxil.com:

A bland looking page, with animated icons:

PANIC DEPRESSION OCD

Let's click on 'PANIC'

Nothing much here from the manufacturers, at the time, SmithKline Beecham. Instead they opt for a supermodel to talk about panic disorder.

Here is some of what she had to say:

Supermodel Beverly Johnson talks about panic disorder:

When were you diagnosed?

With the help of my internist, he made the diagnosis, which was panic disorder, and I was given a prescription of Paxil® (paroxetine HCl). And, I am very happy to say that I no longer suffer from panic attacks.

What advice do you have for others?

So, if you think you have panic disorder, or suffer from panic attacks, ask your doctor, that's what I did.

---

Pretty clear then that Beverly Johnson was happy with her treatment, so much so that she promoted it for the manufacturers.

It is unknown whether she received a payment for this promotion.

A quick Google search shows that Beverly Johnson is quite the advocate.

In this article from 2008, Beverly speaks about Uterine Fibroids:

"It is my personal mission to help ensure that women are informed about uterine fibroids and feel empowered, if they think they have fibroids or are diagnosed with them, to talk with their healthcare providers about their treatment options," said Beverly Johnson. "When I was diagnosed with uterine fibroids, I didn't know a lot about the condition, and as a result I suffered for a long time, both physically and emotionally. My hope is that women will not be embarrassed to talk about uterine fibroids or afraid to discuss treatment options with their doctors."

Beverly's new Web site, Ask4tell4.com, highlights the four questions she thinks all women should ask themselves and their healthcare provider about uterine fibroids, whether they currently have the condition or not. The site also includes the answers to these questions and information about a variety of treatment options that wll help them have a more informed discussion with their doctor. Additionally, women can join Beverly's cause by sharing the information with four or more of their friends or family members through an instant email message sent from the Web site.

The Ask4Tell4 campaign is sponsored by BioSphere Medical, Inc. BioSphere is a pioneer in commercializing minimally invasive therapeutic applications based on proprietary bioengineered microsphere technology. BioSphere's principal focus is the treatment of symptomatic uterine fibroids using a procedure called uterine fibroid embolization, or UFE

----


Let's click on the next icon from SmithKline Beecham's 1998 home page, paxil.com

DEPRESSION

Once again, nothing much on the subject of depression from Paxil manufacturers. Once again they opt for a 'well-known' face, this time they go for a famous baseball player.

Here Professional baseball pitcher Pete Harnisch talks about depression:

What did your doctor recommend?

I went to see my doctor and he diagnosed the fact that I had depression. He recommended medication, an antidepressant, and it didn't work out for me - I had some side effects. I wound up switching to Paxil® (paroxetine HCl). I wound up taking that for the better part of 5 or 6 months.

What advice do you have for others?

I would tell the millions of Americans who are suffering that there is help. It seemed tough. I didn't know what was going on with me - it was really a hard thing on me. But I got the right kind of help and it's all worked out. There is definitely a light at the end of the tunnel no matter what it may seem.

----

You notice a pattern here?

It is unknown whether Pete Harnisch was paid for his Paxil promotion.

Yet again Google throws up an interesting fact about Harnisch and Paxil manufacturers.

This from the New York Times:

Harnisch a Reluctant Role Model

''I'm no crusader; don't give me this bold, stepping-out stuff,'' Harnisch said last week. ''I just think a guy should do what's right, which is letting people know you can get through this thing, you can get your life and your personality back.''

Harnisch, a bluff, direct 32-year-old, crew-cut and bull-necked, steered away from such abstract discussions last week during a two-hour conversation at a Freehold, N.J., diner near where he is living. The interview had been promoted by a public relations firm representing SmithKline Beecham, the pharmaceutical company that manufactures Paxil, the antidepressant Harnisch took for six months. The company pays Harnisch to make appearances and give interviews.

----

The third 'illness' to click on from SmithKline Beecham's 1998 page of paxil.com is:

OCD

Strangely, no spokesperson [promotor]... then again, OCD had just been 'invented' then so I guess they [SKB] would have found it pretty difficult to hire the services of someone who claimed to have been cured by Paxil for an illness that hadn't yet been recognised.

However...

Skip to paxil.com as it was by the end of December 2002 and SmithKline Beecham seem to become more actively involved rather than leave it to 'famous faces.'

Here they spin out the old chemical imbalance theory... though they are careful by placing the words 'may be' in front of their theory:

Paxil® (paroxetine HCl) is an agent in a newer class of antidepressant medication known as selective serotonin reuptake inhibitors (SSRIs). It is an effective treatment for OCD.

Disorders like obsessive compulsive disorder (OCD) may be caused by a chemical imbalance in the brain. One such chemical is serotonin, which helps send electrical signals from one nerve cell to another. In the process, serotonin is released from one nerve cell (the sender) and travels to the next (the receiver), where it is either absorbed or returns back to the original sender cell.


----

Can I become addicted to Paxil?

If you were asking me I would say, Yes. 21 to 22 months to taper would suggest an addiction problem. But let's stick to what SKB were saying back then.

Incidently, before I continue, SKB had added a further icon to click on in 1999. Social Anxiety Disorder [SAD] - they had also added a 'self test' to their website. By completing the test you could see if you had anything that could be treated by Paxil.

Anyway, addiction.

Up to and including Dec 2002, the website throws up a glossary, frequently asked questions.

In 2002 - Can I become addicted to Paxil was answered with:

Paxil is not a controlled substance. Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction.

They also added, "...Do not discontinue taking Paxil unless your doctor says it's all right. Even if you might be feeling better, you may need to continue taking Paxil to avoid having your symptoms return."

It's a genius bit of spin. On one hand your 'illness' may no longer require the treatment of Paxil, yet on the other hand if you 'discontinue' it, your symptoms may return? Sounds like a necessity rather than a stop gap doesn't it? Ironically the 'symptoms' they refer to are pretty much what one goes through when discontinuating [withdrawing] from Paxil. Glaxo, had their cake and ate it.

In 2003 the question had changed [only in wording structure] to, "Is Paxil addictive?"

GlaxoSmithKline [Now merged with Glaxo] answered:

'No. Paxil is not a controlled substance. Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction.'

So, a definitive answer it would seem.

But further on they add: "Don't stop taking Paxil before talking to your doctor since symptoms may result from stopping the medication or from your original condition. Some patients experience the following symptoms on stopping Paxil (particularly when abrupt): dizziness, sensory disturbances (including electric shock sensations), abnormal dreams, agitation, anxiety, nausea and sweating."

It seems 'discontinuation', what you and I know as withdrawing, was fast becoming an issue.

Step forward a year to 2004:

Same question, same answer.

2005:

IS PAXIL ADDICTIVE?

No. Paxil is not a controlled substance. Paxil belongs to a class of medications called SSRIs, which have not been shown to be associated with addiction. However, you may have symptoms on stopping Paxil (see "What do I need to know about stopping Paxil?").



Their advice on stopping:

Don’t stop taking Paxil before talking to your doctor since symptoms may result from stopping the medication, particularly when abrupt. Some patients have experienced symptoms on stopping Paxil, including: dizziness, sensory disturbances (including electric shock sensations and tinnitus), abnormal dreams, agitation, anxiety, nausea, sweating, mood fluctuations, headache, fatigue, nervousness and sleep disturbances.

Yet more side effects!

2006:

Dec 31:

"The Web site for Paxil® (paroxetine HCl) Tablets is no longer available."

Followed by:

Important Safety Information

Prescription Paxil CR and Paxil are not for everyone. Don't take with MAOIs, thioridazine, or pimozide. Paxil CR and Paxil are generally well tolerated. As with many medications, there can be side effects. Some of the side effects may include infection, injury, nausea, diarrhea, dry mouth, constipation, decreased appetite, sleepiness, dizziness, sexual side effects, nervousness, tremor, yawning, sweating, abnormal vision, weakness, or insomnia. Talk to your doctor if you are taking prescription medication known as triptans, which are used for migraine or cluster headaches. When used in combination with Paxil CR or other anti-depressant treatments, these drugs may lead to potentially life-threatening complications.

Paxil CR and Paxil are approved only for adults 18 years and over. In some children and teens, antidepressants increase suicidal thoughts or actions. Young adults, especially those with depression, may be at increased risk for suicidal actions. Whether or not you are taking antidepressants, you or your family should call the doctor right away if you have worsening depression, thoughts of suicide, or sudden or severe changes in mood or behavior (for example feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, hyperactive, overly excited, or not being able to sleep), especially at the beginning of treatment or after a change in dose.

Don't stop taking Paxil CR and Paxil before talking to your doctor since side effects may result from stopping the medicine, particularly when abrupt. Symptoms some patients have reported on stopping Paxil CR and Paxil include: dizziness, sensory disturbances (including electric shock sensations and tinnitus), abnormal dreams, agitation, anxiety, nausea, sweating, mood fluctuations, headache, fatigue, nervousness and sleep disturbances.

Tell your doctor if you are pregnant or plan to become pregnant, as there is a potential risk to the fetus with paroxetine. Some studies of paroxetine in pregnant women have suggested an increased risk of heart malformations. In addition, babies born to mothers who have taken antidepressants, including SSRIs such as Paxil CR and Paxil, in the latter half of pregnancy have reported complications, including difficulties with breathing, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, floppiness, stiffness, tremor, shakiness, irritability or constant crying. Tube feeding, help with breathing, and longer hospitalization may be needed. There have also been reports of premature births in pregnant women exposed to SSRIs, including Paxil CR and Paxil.

Like many antidepressants, Paxil CR and Paxil can be present in breast milk so tell your doctor if you are nursing.

Quite a U Turn from the days where Beverly Johnson would claim, "I was given a prescription of Paxil® (paroxetine HCl). And, I am very happy to say that I no longer suffer from panic attacks." Pete Harnisch's words also seemed to have been forgotten. Remember Pete spoke of his 5 or 6 months on Paxil: "I would tell the millions of Americans who are suffering that there is help. It seemed tough. I didn't know what was going on with me - it was really a hard thing on me. But I got the right kind of help and it's all worked out. There is definitely a light at the end of the tunnel no matter what it may seem."

Not to be outdone by Paxil's controvosy by the end of 2007 GlaxoSmithKline found a workaround. Paxil CR [Controlled Release]

Premenstrual dysphoric disorder [PMDD] was now added to list of Paxil treatments.

Strangely, no frequently asked questions appear on the site, instead there are links to:

Important Safety Information
Prescribing Information including Medication Guide
FDA Press Release on Updated warning May 2, 2007
FDA's revisions to Medication Guide

It seems their baby, Paxil, had taken one hell of a beating.

2008 is pretty much the same as 2007 which brings us to the current state of affairs on paxil.com.

The eye-opening tag reads:

'GET BACK TO FEELING LIKE YOU AGAIN'

Amazing isn't it? Here we have a product that started life on the Internet in 1998. It was 'bigged up' [promoted] by a couple of famous Americans. 10 years down the line, despite all the problems this drug has caused to men, women and children, despite all the out of court settlements made by GlaxoSmithKline, despite the MHRA investigation into GlaxoSmithKline... despite all this, the drug is still being promoted for use by GSK.

Meanwhile the good folk over at the MHRA bust small online pharmacies who sell fake Viagra even though it is blatently obvious that there is a much bigger problem with the supposed 'real drugs'.

I'll leave you with a quote from Alistair Benbow. Benbow is The Head of European Clinical Psychiatry at GlaxoSmithKline.

In 2003, Benbow went on national TV in front of millions of viewers and said that; "...the wording [addiction] was poorly understood by patients."

As you can see from the archives I've dragged from paxil.com, the 'wording' is pretty clear to those that read it at the time.

Paxil/Seroxat/Aropax, call it what you will, is one hell of a drug. A drug that has been promoted in such a way that leaves the consumer in no doubt that it is safe and effective.

The times [like paxil.com] are definately changing.

Fid

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Radio Caller... I can't get off Paxil

"If you try to get off this drug, you experience the worst side-effects and... like, I don't even know how to explain it... it's like having a whip, an electrical whip inside your body..."


Listen to the call




Hat-tip: The Truthman


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Sunday, March 22, 2009

Deception

I have about a third left of the brilliant novel 'Deception Point' by Dan Brown.

These lines struck home to me when I read them earlier.

Think Biederman, Keller, Benbow, Garnier.

----


Gabrielle's plan for dealing with Harper was something Sexton called 'overshooting' - an interrogation technique invented by the early Roman authorities to coax confessions from criminals they suspected were lying. The method was deceptively simple:

Assert the information you want confessed.
Then allege something far worse.



The object was to give the opponent a chance to choose the lesser of two evils - in this case, the truth.

The trick was exuding confidence, something Gabrielle was not feeling at the moment.

DAN BROWN - Deception Point


Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Anything Goes

As you all know I am a huge AC/DC fan. So let me indulge for a moment.

Enjoy





Fid




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Saturday, March 21, 2009

Biederman Protocol Breach

The most shocking disclosure: a Biederman study testing the use of powerful antipsychotics in PRESCHOOL CHILDREN "was beset by breaches of research protocol."

READ FULL SICKENING STORY OVER AT AHRP

Fid

*Hat-Tip: Stuart Jones


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Charles' firm rapped over campaign

Source: Press Association

Prince Charles' Duchy Originals company has been told to change the wording of a campaign promoting two herbal medicines, after a regulatory authority ruled claims in the advert were misleading.

Adverts for Duchy Herbals Echina-Relief Tincture and Duchy Herbals Hyperi-Lift Tincture appeared on the company's website in January.

But a member of the public complained about the adverts' claims concerning the effectiveness of the remedies.

The complainant alleged that the advert suggested the two products had been assessed for efficacy and was therefore misleading.

The Medicines and Healthcare products Regulatory Agency (MHRA) stepped in and upheld the complaint.

The MHRA gave Duchy Originals a licence to sell the remedies but did not enable it to make any claims about the effects of the remedies.

The Duchy Originals brand was established by the Prince in 1990 "to promote organic food and farming and to help protect and sustain the countryside and wildlife".

The company has now agreed to change the wording of the advert and remove the previous claims.

A MHRA spokesman said: "We upheld the complaint. Nelsons, the registration holder, on behalf of Duchy Originals agreed that they would amend their advertising and remove claims of efficacy from their website and all future advertising."

----

Perhaps the MHRA may be inclined to ask GlaxoSmithKline to remove claims of efficacy regarding paroxetine, seeing as it's a possible death sentence for 8-10% of the white population taking it.

More on that soon.

Fid


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Friday, March 20, 2009

The Joseph Biederman Song

Biederman, Biederman
Does whatever a liar can
Spins a web, of deceit
Playing God, his great feat
Look out! Here comes the Biederman!

Is he strong? Listen, Bud!
He's been totally misunderstood.
Can he fake trial results?
The Pharma brass he consults
Hey there, there goes the Biederman!

Some kid dies in the night,
He don't care a flying fuck
Data was not quite right
So he could make a fast buck

Biederman, Biederman
Not so friendly Dr Biederman
Health and safety, he's ignored
Money is his reward
To him, life is a great cover-up
Wherever there's a golden cup
You'll find the Biederman!




SEROXAT SUFFERERS STAND UP AND BE COUNTED

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Is this Dr. Joseph Biederman?





In a contentious Feb. 26 deposition between Dr. Biederman and lawyers for the states, he was asked what rank he held at Harvard. “Full professor,” he answered.

“What’s after that?” asked a lawyer, Fletch Trammell.

“God,” Dr. Biederman responded.

“Did you say God?” Mr. Trammell asked.

“Yeah,” Dr. Biederman said.


Full story HERE - Drug Maker Told Studies Would Aid It, Papers Say




Fid



**Hat-Tip - Stuart Jones


Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

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Email to MHRA Regarding Public Knowledge

Dear Sirs/Madam,

I have taken the unusual step in copying in both your CEO, Kent Woods and your Head of Pharmacovigilance Risk Management, Sarah Morgan. I have also blind copied interested parties in on this particular request as I feel any response you may give may put their minds at ease that we are being protected from harmful drugs.

What I am about to present to you is something that you may or may not already be aware of. If you are already aware then I would find it very strange as to why no public announcement has been made by the MHRA regarding the issue I am about to present to you.

This is more applicable to Sarah as she is the Head of Pharmacovigilance Risk Management and, as such, the responsibility falls, in the main, on her shoulders, for alerting the powers that be and, to an extent, the British public about serious matters that may arise regarding prescription drugs that may be harmful to a populous of those taking them [however small that populous may be]

Attached is a study ‘ Polymorphisms in the CYP 2D6 Gene: Association with Plasma Concentrations of Fluoxetine and Paroxetine’, by Corinne Charlier, PhD, Franck Broly, PhD, Michel Lhermitte, Emmanuel Pinto, Marc Ansseau, and Guy Plomteux.

Sarah will be in a much better position than I, and probably to anyone else at the MHRA, to offer her evaluation of the study.

I have met with both Sarah and Kent at a meeting last September where the issue of SSRi withdrawal was discussed. As yet, nothing has materialised from that meeting with regard to informing doctors, the BNF and to arrange a meeting with Dr. David Healy. I know these things take time but as each hour passes more and more consumers of these products are going through needless suffering. I am in no position to speed up the process, that, ladies and gentlemen, lays solely on you.

I digress.

As you will see from the attached PDF, there is a far more serious problem that needs to be brought to the table and addressed immediately.

The paper throws light on what happens to patients when they are prescribed a dose over 20mg of paroxetine. It’s a given that anything over 20mg of paroxetine is not beneficial to a patient, yet we all know that this is still happening throughout the UK.

Please correct me if I am wrong with the following:

Paroxetine uses a liver enzyme called 2D6 – to reduce the drug so that the body can clear it. If drugs are not cleared properly – with each dose taken the drug concentration in the blood will continue to increase to toxic levels. The thing that makes paroxetine quite unique and unsafe is that whilst it needs this 2D6 enzyme for metabolic reduction and clearance – it also acts as a inhibitor of production of the enzyme, basically, it shuts down the livers ability to produce the enzyme so that it cannot further metabolise the drug.

I take it that we all agree that there is no further clinical benefit in doses above 20 mg of paroxetine – there is also much greater increase for adverse reactions as the body cannot deal with or eliminate this increase in paroxetine drug quickly enough. For people who already have a genetic deficiency in production of 2D6 (about 8-10% of the white population) i.e.; their liver cannot/does not produce the enzyme – the drug is basically a death sentence for 8-10% of the white population.


My question to you all is thus:

What do the MHRA plan to do to warn people?

Regards

Bob Fiddaman

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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Wednesday, March 18, 2009

Why Paroxetine Dose Escalation is Not Effective in Major Depressive Disorder

A recently published paper sent to me via email by one of my readers.

Evidence Why Paroxetine Dose Escalation is Not Effective in Major Depressive Disorder: A Randomized Controlled Trial With Assessment of Serotonin Transporter Occupancy

For a copy of the paper please email me.

CONCLUSION:

Previous studies had failed to demonstrate a clinical benefit of dose escalation by SSRIs, but had methodological limitations (Ruhe et al, 2006; Adli et al, 2005; Baker et al, 2003). Addressing those limitations, our trial replicates that dose escalation of paroxetine above the 20 mg per day standard dose has no additional clinical benefit. As a novel extension, we revealed the underlying neurobiological mechanism for this inefficacy: maximum SERT occupancy was already reached with the standard dose. Similarly, high SERT occupancies reported with low doses of other SSRIs suggest that our conclusion may be applicable to the entire drug class. However, this does not exclude that dose escalation has clinical benefits for antidepressants with additional molecular targets, eg the norepinephrine transporter, such as venlafaxine. This drug has shown dose dependency of the clinical response in fixed dose studies (Thase et al, 2006; Rudolph et al, 1998).

If dose escalation is not promising for paroxetine and presumably other SSRIs, two clinical options remain for the treatment of nonresponders to standard doses. These are either continuation of treatment until 10 weeks while waiting for a potential delayed response, or a change to a different and potentially more effective treatment strategy.

Both strategies will further improve response rates, but studies directly comparing these strategies have not yet been performed.

Read the new book, The Evidence, However, Is Clear...The Seroxat Scandal

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman

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