Zantac Lawsuit

Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Wednesday, December 31, 2008

HAPPY 2009



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


Tuesday, December 30, 2008

Da Blues

Minus 3 outside.

Minus £98 in bank account.

Bank charges looming and pre-paid electric running low.

Doncha just love the Yuletide season.


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


Monday, December 29, 2008

GlaxoSmithKline's Motto

Committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Let's see how they do that:

Ad for Drug Is Challenged - Published: February 26, 1991 Genentech Inc. filed a lawsuit today in United States District Court here accusing SmithKline Beecham P.L.C. of false advertising.

SMITHKLINE AND ROHM & HAAS TO CLEAN UP TOXIC SITE - Published: September 18, 1992 The Rohm & Haas Company and SmithKline Beecham P.L.C. have agreed to spend about $125 million to clean up the former Whitmoyer Laboratories site in Myerstown, Pa., the Justice Department said. Whitmoyer Laboratories manufactured veterinary pharmaceuticals from 1934 to 1984. During that time, toxic materials -- aniline and soluble arsenic compounds -- were produced, stored and disposed at the site. The Whitmoyer installation is one of the Environmental Protection Agency's so-called Superfund cleanup sites.

Glaxo-F.D.A. Dispute - Published: March 8, 1993 The United States Food and Drug Administration has accused Glaxo Holdings P.L.C. of illegally promoting its top-selling ulcer drug Zantac, The Sunday Times of London reported today. The article said the F.D.A. sent a letter to Glaxo in January warning that its advertising for Zantac had "statements, suggestions or implications that are false and/or misleading."

F.D.A. PANELS REJECT SMITHKLINE DRUG REQUEST - Published: September 10, 1993 Two advisory committees to the Food and Drug Administration yesterday turned down a request by SmithKline Beecham P.L.C. to recommend F.D.A. approval of its prescription heartburn drug Tagamet for over-the-counter sale. The panels said the company's tests did not show Tagamet was superior to placebos.

Seven Big Drug Makers Are Sued Over Pricing - Published: October 15, 1993 Struggling with growing competition from cheaper mail-order pharmacies and health maintenance organizations, 20 drugstore companies filed a lawsuit yesterday accusing large drug makers of price fixing and Federal antitrust violations. The other defendants are the American Home Products Corporation, SmithKline Beecham, the Ciba-Geigy Corporation, the Searle unit of the Monsanto Corporation and Glaxo Holdings P.L.C.

SmithKline Ulcer Drug Challenged - Published: July 29, 1994 SmithKline Beecham P.L.C. was dealt a second setback today in its regulatory quest to turn its prescription ulcer drug Tagamet into an over-the-counter treatment for heartburn.

Glaxo to Alter Drug Label - Published: August 17, 1994 The Food and Drug Administration has ordered Glaxo Holdings P.L.C. to change the labels of its anti-migraine drug Imitrex to include information about the death of an American woman who used the drug, Glaxo said today.

F.T.C. TO REVIEW SMITHKLINE'S DIVERSIFIED PURCHASE - Published: November 15, 1994 A week after restricting a major drug industry merger, the Federal Trade Commission is examining another -- the purchase by SmithKline Beecham P.L.C. of Diversified Pharmaceutical Services Inc

Drug Makers Settle Suit on Price Fixing - Published: February 10, 1996 Fifteen big drug companies formally agreed yesterday to pay more than $408 million to settle a class action lawsuit charging them with conspiring to illegally fix prices that they charged to thousands of independent pharmacies. In the settlement, which is subject to approval by a Federal district judge in Chicago, the 15 companies agreed to pay more than $388 million in cash. One of the defendants, SmithKline Beecham P.L.C. of London, agreed to supply the plaintiffs with a generic version of cimetidine, SmithKline's Tagamet brand ulcer treatment, valued at $20 million, as well as $30 million in cash.

SmithKline Beecham in Settlement With U.S. - Published: September 7, 1996 In the latest big settlement by a clinical laboratory company of Federal Medicare fraud charges, SmithKline Beecham P.L.C. expects to pay the Government about $300 million this year, without admitting any wrongdoing. Analysts said the Laboratory Corporation of America also expects to settle similar charges by the end of the year.

Merck Files Suit Over Vaccine Distribution - Published: December 25, 1996 Merck & Company, saying it has exclusive rights to distribute a chicken pox vaccine in the United States and Canada, has sued four affiliates of SmithKline Beecham P.L.C. in an effort to block them from distributing their vaccine in the United States.

37 Health Insurers Suing SmithKline - Published: August 25, 1997 SmithKline Beecham P.L.C. has been sued by 37 private health insurers contending that the company's clinical laboratory division overbilled them by hundreds of millions of dollars.

Concerns Grow Over Reactions To Lyme Shots - Published: November 21, 2000 Federal health authorities are investigating whether some people who received the vaccine against Lyme disease later developed severe cases of arthritis and even Lyme disease itself as a result. The Food and Drug Administration has received reports of such problems, mainly from doctors and researchers in the Northeast. The vaccine, made by SmithKline Beecham Biologicals, a subsidiary of the British pharmaceutical giant SmithKline Beecham, was approved by the drug agency two years ago, and about 440,000 Americans have received it. SmithKline Beecham defends it as safe.

U.S. Looking at SmithKline Effort to Block Generic Drug - Published: December 7, 2000 The Federal Trade Commission is investigating whether SmithKline Beecham, the British drug company, has engaged in illegal trade practices by keeping competitors from selling generic, lower-cost versions of Paxil, its popular antidepressant, according to court papers.

5 Drug Makers Use Material With Possible Mad Cow Link - Published: February 8, 2001 For the last eight years, the Food and Drug Administration has repeatedly asked pharmaceutical companies not to use materials from cattle raised in countries where there is a risk of mad cow disease. All five vaccine makers, which include GlaxoSmithKline, Aventis and American Home Products, have now agreed to stop using the suspect materials, which include blood, fetal calf serum and meat broth.

DRUG MAKERS DROP SOUTH AFRICA SUIT OVER AIDS MEDICINE - Published: April 20, 2001 Bowing to mounting public pressure, the pharmaceutical industry today dropped its legal effort to prevent South Africa from importing cheaper anti-AIDS drugs and other medicines. The companies that began the negotiations that led to today's settlement were Bristol-Myers Squibb and Merck, both of the United States, GlaxoSmithKline of Britain, Hoffmann-La Roche of Switzerland and Boehringer Ingelheim of Germany.

Genentech Wins GlaxoSmithKline Dispute - Published: May 5, 2001 Genentech Inc. said yesterday that it had defeated a patent infringement suit brought by GlaxoSmithKline P.L.C. over two oncology drugs.

Jury Awards $6.4 Million In Killings Tied to Drug - Published: June 8, 2001 A Wyoming jury has awarded $6.4 million to the family of a man who killed three relatives and himself after taking the antidepressant Paxil. Charles F. Preuss, a lawyer for the manufacturer, GlaxoSmithKline said the verdict on Wednesday was a surprise.

Glaxo Is Sued Over Antidepressant - Published: August 27, 2001 A lawsuit accuses Glaxo SmithKline, the maker of the popular antidepressant Paxil, of concealing evidence that the drug can be addictive.

IN STUDY, LILLY CALLS ITS ANTIDEPRESSANT MORE EFFECTIVE - Published: November 20, 2001 Eli Lilly has released clinical data showing that its experimental antidepressant, duloxetine, was more effective in reducing symptoms of depression than GlaxoSmithKline's Paxil.

Rockies: Montana: Suit Against Drug Companies - Published: February 26, 2002 The state attorney general sued 18 drug makers and marketers, accusing them of illegally inflating prices and costing the state and consumers tens of millions of dollars. The scheme hurt taxpayers because they finance the Medicaid and Medicare programs that were forced to pay the exaggerated drug prices, Attorney General Mike McGrath, left, said. The lawsuit names Abbott Laboratories; American Home Products; Amgen; AstraZeneca; Aventis Pharma and Hoechst Marion Roussel, both owned by Aventis; Baxter Pharmaceutical Products; Bristol-Myers Squibb; Eli Lilly; Chiron; Dey; GlaxoSmithKline and SmithKline Beecham, which have merged

Sole Lyme Vaccine Is Pulled Off Market - Published: February 28, 2002 With tick season approaching, the maker of the nation's only vaccine against Lyme disease pulled it off the market, citing poor sales. The vaccine, Lymerix, had caused controversy in recent years, as patients said they were sickened by it and asked the government to restrict sales. Some filed lawsuits against the maker, GlaxoSmithKline.

RULING FAVORS GENERIC ANTIDEPRESSANT FROM ANDRX - Published: March 2, 2002 The Andrx Group said a judge ruled that its generic version of GlaxoSmithKline's Wellbutrin antidepressant did not infringe a Glaxo patent

JUDGE ALLOWS A GENERIC VERSION OF GLAXO ANTIBIOTIC - Published: March 14, 2002 The British drug maker GlaxoSmithKline said yesterday that a judge had ruled in favor of Teva Pharmaceutical Industries of Israel in Teva's bid to market a generic version of Glaxo's antibiotic Augmentin in America.

Warnings Added To Diabetes Drugs - Published: April 27, 2002 GlaxoSmithKline and Eli Lilly & Company have added warnings about heart and liver risks to the labels of their diabetes drugs, which are similar to a medication that was withdrawn from the market in 2000 because of links to fatal liver damage.

Judge Orders Drug Company To Alter Ads - Published: August 21, 2002 Federal Judge Mariana R Pfzelzer orders GlaxoSmithKline to stop saying in its advertisements for Paxil, top-selling antidepressant, that drug is 'nonhabit-forming'

Asthma Drug Health Risks Are Suspected - Published: January 24, 2003 GlaxoSmithKline said yesterday that Serevent, one of its popular asthma drugs, might pose a risk of death and serious asthma-related illness in some patients.

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


Sunday, December 28, 2008

More on Sara Carlin Inquest

Regular readers of this blog will know that I have followed this story closely. Each time I write about the plight of the Carlin's I am overcome with emotion. Sara's death echoes that of Sharise Gatchell, they were both roughly the same age, both beautiful girls, both hanged themselves... both were taking GlaxoSmithKline's Seroxat.

I've almost finished Alison Bass' book, 'Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial.' Alison goes to great length to show how GlaxoSmithKline and their legal team tried to fight their wrong doings over the suppression of data from the Paxil 329 Study. It also highlights the failings of the Food and Drug Administration [FDA]

GlaxoSmithKline owe The Carlin's and Gatchell's an explaination as to why they were not forthcoming with the pediatric trial data. If, at the time, they had came out and stated that under no circumstances should Paxil be administered to children or adolescents then maybe, just maybe, Sara and Sharise would be both looking forward to 2009. Instead, Glaxo, then SmithKline Beecham, suppressed the results because it would have had a detrimental effect on their sales. They put profit before human life. They knew their product could cause suicide in some children yet they wrote papers, that were later passed off as being written by key opinion leaders, such as Martin Keller. His opinion swayed doctors. It's an utterly shameful act on behalf of GSK to be part of this wanton neglect for children and when I read comments left by GSK spokespersons regarding the death of Sara Carlin, I feel sickened.

Sara's parents, Neil and Rhonda Carlin, have now been granted an inquest into the death of their daughter. Neil has applauded the decision. He shouldn't have had to. Any child or adolescent that kills themselves whilst on Glaxo's Paxil [Seroxat] should be granted an inquest. There should be no argument about that.

I hope Ontario's chief coroner researches the resources on the Internet. A good start would be Healthy Skepticism and also new internal documents that have appeared on Christopher Lane's website.

My behaviour whilst tapering from Seroxat was that of a violent person. There are literally thousands of other patients, both children and adults, who have experienced those same violent traits whilst on or tapering from Glaxo's drug.

There is no protocol for tapering from Seroxat other than 'you must taper slowly' - it's a nonsense. People and doctors need guidance, they need to be told breaking a tablet in half is too drastic and it could possibly cause untold side effects. People and doctors need to be told that a liquid formulation exists for Seroxat and the only way to safely taper is by using this liquid.

I am aware of the term 'one size does not fit all' - I think this term is used loosely and was probably behind GSK/SKB and Keller's thinking when they give this drug the thumbs up for children. Remember GSK's Internal memo to its sales reps claimed Paxil's REMARKABLE safety and efficacy [The word 'remarkable' was written with capital letters]

On September the 9th, 2005, Rep. Peter Deutsch wanted to know whether David Wheadon, GSK's senior vice president for regulatory affairs, thought Paxil did in fact have "remarkable" safety and efficacy. Wheadon backpedalled and said, "We, in the case of Paxil, have not been able to discern a significant effect versus placebo"

Let's take a closer look at Wheadon's deposition from October 19, 2000:

Deposition of David Wheadon of GSK on issue of counting washout suicides against placebo.

Q: So in this whole period, we only have 2 placebo suicides, correct?

A: That is correct.

Q: Now, got back to the final page, which is Appendix 1, we haven’t looked at that page before, it has got a number of SB020 at the back. And at the bottom, we have an asterisk, and it says both—I will read it. ‘Suicides were committed during the placebo wash-out phase of an active control study. These acts were committed two days and seven days prior to the baseline evaluation.’ What does that mean?

A: That means that the suicides were committed while the patients were on placebo in the placebo run-in or wash-out phase, which way you want to describe it.

Q: That was my question. Is wash-out and run-in the same?

A: Yes.

Q: Why were they counted? If it didn’t occur during the baseline period, why were they counted at all?

A: Because it happened during the control phase of the trial.

Q: Was that consistent with protocol, that these – maybe I’m operating under a mistaken assumption. I thought data that occurred during these wash-out, lead-in phases were not counted in the data.

A: That is not correct. The way this data was collected – and I need to correct myself. It wasn’t because they happened during the control phase of the trial. The way these data were collected, any suicide that occurred during the course of observation of a clinical trial was included in this data base…So –just a minute—Placebo run-ins were counted as placebo, because they were on placebo. There were also suicides that occurred in patients that were on Paxil, for example, in long term extension, where there was no placebo, there was no active comparator, so the full breadth of the experience was accommodated in this particular analyses.

Q: I agree, that’s what happened, that’s exactly what the data represents, but my question is whether that is a valid scientific measuring device for conducting clinical trials.

A: Absolutely.

Q: Well, you have rules for collecting data, right? You had rules for establishing a wash-out phase. I mean that concept --

A: You have to recall, Mr. Farber, the protocol for these studies were for different purposes. They were for treating depression. The protocol for establishing an answer to the question of the occurrence of suicides on placebo or drug or active comparator did included that as I described, and that is collecting all suicides that occurred during observation in a clinical trial, regardless of whether it happened in placebo run-in, during randomization or during extension, open label extension, where people were on Paxil, and they, in some cases, knew they were on Paxil.

Q: And you consider this a valid scientific practice?

A: Absolutely.

(Wheadon deposition transcript P404 L17 through P407 L17)

Remember, Wheadon was under oath during this deposition.

Corporate manslaughter?

I certainly hope that Sara Carlin's and Sharise Gatchell's parents will one day find closure as to why their daughters were given a drug that was known not to work in their age group and that there was a high risk of suicide should they ever be prescribed it.

Time will tell.


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


Corporate Manslaughter: Food for Thought for GSK

I'm sure GlaxoSmithKline and their legal team are well aware of the implications they face if they lose the current UK litigation. If the presiding Judge rules in favour of the claimants and deems Seroxat a defective drug under the terms of the consumer protection act then the floodgates could possibly open and they could be up on a corporate manslaughter charge. It's not beyond the realms of comprehension is it?

The Corporate Manslaughter and Corporate Homicide Act 2007 came into effect in the UK on 6th April 2008. According to the act an offence is when:

(1)An organisation to which this section applies is guilty of an offence if the way in which its activities are managed or organised

(a) causes a person’s death, and

(b) amounts to a gross breach of a relevant duty of care owed by the organisation to the deceased.

Can we safely assume that GlaxoSmithKline would be deemed as causing this offence if found guilty of manufacturing a defective drug under the consumer protection act?

I'm not a lawyer but if I had lost a family member through suicide and that suicide leaned toward GlaxoSmithKline's Seroxat then it would certainly be worth pursuing a corporate manslaughter charge if Seroxat was deemed defective.

I'm sure many lawyers are keeping a close eye on the outcome of the UK litigation... or maybe I'm wrong?


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


Saturday, December 27, 2008

GSK European Promotion of Medicines Code of Practice

Clause 4 Promotion and Its Substantiation

Page 10. Clause 4, 4:10

"It must not be stated that a product has no side-effects, toxic hazards or risks of addiction or dependency."

"These tablets are not addictive" and "Remember you cannot become addicted to Seroxat."
Seroxat Patient Information Leaflet 1996

"It was quite clear from talking to patients and as a doctor that’s very, very important to me, it’s quite clear that the phrase “Seroxat is not addictive” was poorly understood by them."
Dr. Alastair Benbow
Head of European Psychiatry for GlaxoSmithKline

"Everybody who has looked at this the FDA, American Psychiatric Association, National Mental Health Association all those groups agree that SSRIs, like Paxil, are not addicting and not habit forming."
Andrew T. Bayman
Attorney for GlaxoSmithKline
King & Spalding

"These problems [’discontinuation reactions’] are just the body’s adjustment when you stop taking medicines. It takes more than that to be addictive."
Mary Anne Rhyne
GlaxoSmithKline spokesperson

----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Saturday, December 15, 2007 7:04 AM

Subject: Dear Sirs

Simple question that merely requires a yes or no answer. This shouldn't take 20 working days to answer.

Is Seroxat addictive?


Bob Fiddaman


----- Original Message -----
From: MHRA Information Centre
To: fiddaman
Sent: Thursday, December 20, 2007 10:15 AM

Subject: RE: Dear Sirs

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA.

The Agency's position, informed by expert advice, on whether Seroxat is addictive has been clearly communicated in the report of the CSM Expert Working Group on the Safety of SSRIs - this report is available on the MHRA website


----- Original Message -----
From: fiddaman
To: MHRA Information Centre
Sent: Thursday, December 20, 2007 2:32 PM
Subject: Re: Dear Sirs
Dear Sir/Madam,

Could you point me to the paragraph where an official MHRA statement has been made as to whether Seroxat is addictive or not.


----- Original Message -----
From: MHRA Information Centre
To: fiddaman

Sent: Monday, December 31, 2007 11:39 AM

Subject: RE: Dear Sirs

Dear Mr Fiddaman,

Thank you for your recent enquiry to the MHRA. The risk of dependence (addiction) and withdrawal reactions in associations with Seroxat and others SSRIs was covered in Chapter 8 - pages 119-157 and is also covered in the executive summary pages 3-4 of the report.


----- Original Message -----
From: fiddaman
To: MHRA Information Centre

Sent: Tuesday, January 01, 2008 5:10 PM

Subject: Re: Dear Sirs

Thank you for pointing me to the correct statement. However, you have still failed to answer whether or not this is still the MHRA's position on the subject of addiction/dependency.

Is it?


Bob Fiddaman


----- Original Message -----
From: MHRA Information Centre
To: fiddaman

Sent: Thursday, January 03, 2008 10:40 AM

Subject: RE: Dear Sirs

Dear Bob Fiddaman,

Thank you for your recent enquiry to the MHRA. We can confirm that this is the latest MHRA position on the subject of addiction/dependency.


Consumer Fraud?


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


Friday, December 26, 2008

The Simpsons - Bart diagnosed with Attention Deficit Disorder

When Bart is hastily diagnosed with Attention Deficit Disorder, he becomes the latest victim of "Focusin," a new drug touted to boost academic attention spans.

The Simpsons 1102 Brother's Little Helper

A light hearted look at how American kids are being used as guinea pigs by Pharma.

Only thing missing is an appearance by Martin Keller!


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


Thursday, December 25, 2008

Best Christmas Present... Ever!

Inquest into the death of Sara Carlin announced

Dr. Andrew McCallum, Chief Coroner for Ontario, today announced that an inquest will be held into the death of Sara Carlin.

Ms. Carlin, 18, died on May 6, 2007, at her residence in Oakville.

The inquest will focus on the role of Selective Serotonin Reuptake Inhibitor antidepressants in teenage suicides. The inquest jury may make recommendations aimed at preventing deaths in similar circumstances.

The date, time, location and duration of the inquest will be announced at a later date.

Thank goodness Toronto's Chief Coroner has humanity. Let's hope something good comes out of something so bad.

I've just finished writing a chapter in my book about the death of Sara and also Sharise Gatchell. Two beautiful girls. Two needless deaths caused by Seroxat.

Here's a snippet:

Sharise Gatchell and Sara Carlin didn't need to die. Had GlaxoSmithKline, then SmithKline Beecham, been open about the dangers of Seroxat in children then their respective doctors would never have prescribed it for them. Doctors seek knowledge in medical journals and conferences. Often, the articles that appear in these journals are written by key opinion leaders [KOLs] and it is these same KOLs that speak at conferences. GSK have business relationships with several KOLs, one such person is Martin Keller, Chair of Psychiatry at Brown University, Rhode Island, US. Internal documents obtained by Panorama revealed the darker side of Keller. He was, apparently, the author of the now infamous Paxil 329 study but in a memo Keller thanks somebody else for writing the study. He wrote: “You did a superb job with this. Thank you very much. It is excellent. Enclosed are some rather minor changes from me.”

Much has been written about Martin Keller so I won't go into any great length in this book. In essence, Keller is a pusher of drugs, drugs known to cause harm. He could have said 'No' but the lure of money killed his conscience. My opinion of Keller is that he is sub-human scum and the sooner he is behind bars, the safer it will be for all concerned. For more on Keller I recommend 'Side Effects - A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial' - ISBN-13: 978-1565125537, Publisher: Algonquin Books, Author, Alison Bass.

Sharise and Sara took their own lives. They both hanged themselves. They both took Seroxat. They both should never have been given Seroxat. The buck stops with GlaxoSmithKline because they are at the root of these needless suicides. Seroxat isn't a natural herb, it does not grow on trees or from the ground. It was made, marketed and sold by GSK. When problems arose, GSK, didn't want to accept accountability. It's fraud, plain and simple.

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


Tuesday, December 23, 2008

Christmas starts here folks.

Taking a break until after Christmas. I have been busy of late writing. I'm on page 96 of my draft. It's all about Seroxat/MHRA and GSK and other things that have happened along the way.

Wishing you all a very Happy Christmas... even my stalker!


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


Avandia and Actos Pose Increased Bone Fracture Dangers to Women Suffering From Type 2 Diabetes

Source: Health and Fitness Online

"Of the thiazolidinediones, is the commonly prescribed Avandia therapy from GlaxoSmithKline, which was released in May 1999. in addition to bone fracture as an Avandia side effect, there are several other risk factors associated with consuming the drug..."

A recent issue of the Canadian Medical Association Journal (CMAJ) reported the results of a study indicating that type 2 diabetes women who consume Avandia (rosiglitazone) or Actos (pioglitazone) are "at an increased risk of non-vertebral fractures with a near doubling in the risk of hip fractures."

The study, which was conducted by researchers at the University of East Anglia in Norwich, evaluated the risks of bone density degradation among women who consumed the diabetic therapy treatment. Of the 13,715 participants involved in 10 radomized clinical trials, a large portion were found to have "a significantly increased risk of fractures," according to the CMAJ article.

Scientists were able to identify an increase in bone mineral density loss among women patients specifically in the lumbar spine, which is the largest movable section of the vertebrae that is located above the tailbone.

The study found no risk of bone density loss among men, but women who were already at risk for developing bone fractures were said to be affected with one out of every 21 women developing the condition, while those women not at a predisposed bone fracture risk were said to be affected with one out of every 55 women developing bone density loss.

Full Article.


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


Monday, December 22, 2008

Team to probe vaccine approvals


An inspection team has been set up to investigate allegations that drug-makers ran inappropriate lobbying campaigns before their cancer vaccines were approved for use in Vietnam.

Vietnamese Health Minister Nguyen Quoc Trieu said the teams would investigate the actions of Merck Sharp & Dohme (MSD) and GlaxosmithKline (GSK), the makers of the Gardasil and Cervarix cervical cancer vaccines.

MSD’s Gardasil, which protects women against four strains of human papillomavirus (HPV) -- HPV-6, 11, 16, and 18 -- and GSK’s Cervarix HPV, which targets HPV-16 and HPV-18, were approved by Deputy Health Minister Cao Minh Quang.

However, questions have been raised about approval for the drugs to be used for women aged 10 to 55 instead of only for women aged 10 to 25.

Inspectors will review the research and assessment procedures for the drugs and whether drug-makers’ lobbying was appropriate.

Deputy Health Minister Trinh Quan Huan was assigned to lead the 15-day investigation. The results of the probe will be reported to the ministry.

More about GSK’s Cervarix:



More debate on GSK's Cervarix

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


Sunday, December 21, 2008

Inaugural A Hoy Awards

Avid readers would have noticed the following picture on my blog for the last few weeks. I'm Co-Founder of the A Hoy Awards and yesterday awarded 7 blogs that have caught my eye recently.

The A Hoy award was conceived by Matt Holford who writes the 'It's Quite An Experience' blog.

It's basically a group of people paying their respects to people who put time and effort into their writing.

I kept away from the usual suspects bar one who I feel deserved the award for his behind the scenes efforts and for compiling such an insightful blog.

Here are my winners, in no particular order:

Illegitimis Nil Carborundum -
It was the template used by this blogger that caught my eye. It's a beautiful layout and pleasant on the eye. The writing is top notch too.

AC/DC News -
I'm a big fan of AC/DC and anyone who writes about them with such passion deserves an award. Some of the photo's on this blog are quite stunning, even if the author didn't take them himself. It's a great blog for any hardcore fan of AC/DC.

University Diaries -
I stumbled upon Margaret's blog whilst researching Charles Nemeroff. She shoots straight from the hip with her writing and chooses various topics to get her teeth into.

The Paranormal Casebook -
Updated on a daily basis and it certainly gives you food for thought. I don't necessarily agree with everything written on this blog but it sure does open your mind.

Grand_Anglais -
Fellow Brummie who has a passion for photography. His photos are excellent and have brought back many memories for me.

Last but definitely not least is the Truthman's excellent blog:

GSK Licence To [K]ill -
I have become good friends with the author of this blog over the years we have known one another, albeit from the perspective of cyberspace. His blog is a wealth of information and, for me, one of the best Seroxat blogs out there. It shames GSK, at least it should shame them. Truthman has documented the rise of Seroxat from its birth. His research should be highly commended.

Rules for Making an Award

1. Pick five blogs that you consider deserve this award based upon any criteria - for example, the quality of the commentary, wit, humour, artwork, overall design, value to you of the information being provided, and so on.

2. The awarding blogger should choose at least two blogs not on his or her own blogroll, the purpose being to encourage variety of reading matter, and to have the person making the award think about what they like to see and read.

3. Your five choices must be published in a dedicated post on your own blog. This post must contain the name of the author (which may be their logon name), and also a link to his or her blog to be visited by everyone. This post should contain brief details of what attracted you to the blog. Details may also be posted in the comments section of "What is a Hoy?"

4. In the same dedicated post, each winner has to show the award and acknowledge the blog that has given him or her the award.

5. Both those awarding and receiving A Hoy must show the link to A Hoy blog, so that everyone will know the origin of this award.

6. When publishing details of the blogs to which you have made your awards, these Rules must be published for recipients to follow.

A Hoy Awards Blog


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


Saturday, December 20, 2008

Paroxetine Toxicity in a Newborn After In Utero Exposure

Abstract: There are several case reports and case series that have examined the acute effects of selective serotonin reuptake inhibitors(SSRIs) on the newborn. There is considerable controversy whether the reported symptoms represent withdrawal from the SSRI or toxicity caused by the SSRI. A case of an infant who was exposed to
paroxetine during pregnancy is presented. This case supports the notion of serotonin toxicity and is believed to be the first report that substantiates clinical symptoms with serum levels of the offending SSRI.

Knoppert-Paroxetine Toxicity in a Newborn After in Utero Exposure-TDM-2006

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


Tribute to the Lady Campaigners



In no particular order.


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


Friday, December 19, 2008


Earlier this year I pointed out that disgraced psychiatrist, Charles Nemeroff held key positions at Skyland Trail.

Skyland Trail claim to serve adults with mental illness through innovative and individualized treatment that improves mental, physical and social well being. They also claim to specialize in the following disorders:

• Bipolar

• Depression

• Dual Diagnosis

• Schizophrenia

Millionaire psychiatrist Charles Nemeroff holds the following positions at Skyland Trail:

Board of Directors
Charles B. Nemeroff, M.D., Ph.D.

Professional Advisory Board
Charles Nemeroff, M.D., Ph.D.

National Advisory Board Members
Charles B. Nemeroff, M.D., Ph.D

Since my first post about this I have recieved comments from a former patient at Skyland Trail. It makes harrowing reading and begs the question; What on earth is going on at Skyland Trail, more importantly, why is this disgraced psychiatrist, Charles Nemeroff, part of [what sounds like] a living hell?

I don't know the authenticity of 'A Former Patient' but their comments are worth publishing, if only for others to come forward. I'm sure Sen. Grassley would be interested.

Comments left by 'A Former Patient'

I was a patient at Skyland for two months at the South Residence.

I was viciously retraumatized by the experience, and I was already suffering from severe PTSD.

I won't even go into all the details of what I observed, much less what I heard from patients who were there before me. There aren't words for Skyland Trail... it is a legal torture prison. Some of the shit they did there would have been outlawed at Guantanamo.

But I am going to expose them for what they are because the "mentally ill" are already helpless, misunderstood, and traumatized enough. I'm not going to let another patient be driven to suicide after their "hopeful, healing therapy." It's happened for far too long and the "mentally ill" are conditioned that no one will take them seriously if they start talking about what goes on at treatment centers, so we don't speak out.

And more people suffer. And more people die.

I can't "do nothing" any longer.

This is a copy of an e-mail I sent to my mother while I was living there, detailing just a few instances of what went on there.

(The things I've written in parentheses is hearsay and thus has no valid authority for me to be bringing up, but taken into context with the things I have witnessed, I feel it is important to include these "rumors" and "hearsay" for the sake helping to possibly establish a long-running "culture of irresponsibility" at Skyland Trail)

The two most important issues I have concerns about concerning Skyland Trail is the high staff turnover rate and the policies about clients at the Skyland South residence. The first time I had an appointment with my counselor, Lori, I searched for her office but only found rooms identified "Counselor 1, Counselor 2, Counselor 3 and Counselor 4." I had to guess which one she was in because there was no documentation or nameplate as to whom each office belonged. When I finally found Lori, I suggested that the counselors put some kind of identification outside their doors, and Lori replied that they switched offices so much and people came and went so often that it was too much hassle.

In the short time that I have been at Skyland Trail, I have heard a lot about people's counselors leaving. I witnessed the breakdown of one individual who had grown very close to her counselor and asked the other patients if that kind of thing happened often. They responded that counselors frequently come and go. My anxiety increased a little because I was wondering if my counselor would also be frequently changing, as this is the main person in charge of my treatment, and in order for me to progress at Skyland Trail, I have to have a trust and background with the person treating me. I don't understand how I can develop that if the person I am working with will be changing once or more a month.

Yesterday during my check-in group, the woman who was leading asked if we had heard the news about Lori. None of us had heard any news, and asked her what she was talking about. She responded that it wasn't her place to say and that Lori would obviously tell us that day (Friday, September 8) if she hadn't already.

Later that day, I had my first individual meeting with Lori. I was honest to her about what I wished to accomplish and she appeared earnest in wanting to help me. She said that we'd work together on my issues and I left the meeting feeling hopeful that I would be able to become an independent, fully-functioning adult through the resources at Skyland Trail.

At the very end of the day, another woman who has Lori as her counselor confided that she'd just had a meeting with Lori, and Lori had told her that she was going to wait until Tuesday as to not ruin the woman's weekend and had actually been trying to avoid encountering the patient during the day, but since the patient had tracked her down (to ask her a question), she told her she felt obligated to talk. Lori told the woman that both she and her intern (the woman who substitutes for Lori) would be leaving. Lori also told her that I was the only person who did not know the news yet, leaving me to wonder exactly how long she would have strung me along, working with me on my issues before she finally told me. Lori still does not know that I know that she is leaving.

Seeing as how the counselors are probably the most important staple in a client's treatment, it concerns me greatly to know that they come and go so often. Being a counselor at Skyland Trail appears to be more of a temporary position than a job people apply for seeking a career. I've become suspicious as to how things are being run behind-the-scenes that causes people to leave so quickly. I do not know what to expect with regards to my treatment, as it seems to be handled by someone who doesn't have the capability to inform her patients of something as important as her leaving, and also how often this change of counselors will happen to me, as it seems to have happened several times with other patients.

The second most pressing concern I have with Skyland Trail concerns the safety of the environment at Skyland South. I've come to understand that several of the male patients at Skyland South come here directly from jail, and are here not because they wish to get treatment, but as a condition of their parole. I've learned at least one of the male patients here was in jail for assault and battery. The staff are just now beginning to plan room assignments divided by floor, with most of the males upstairs and females downstairs. However, there are still some females upstairs.

(I have heard disturbing accounts of some male patients stalking females and exposing themselves, and even though this was repeatedly brought up at community meeting and the patients told that they were "handling it," nothing actually happened until the father of one of the patients threatened to go to the news stations with the story. A common selling point of Skyland Trail is how only "3 out of every 10 applicants are accepted into the program," making it seem like there are rigorous standards and only very stable individuals are accepted. However, I have heard things about some clients who are still here - such as an individual who refuses to wear underwear, even on her period, or wash her clothes - the latter of which I've observed, as there are many stains on her outfits - that make me more inclined to believe that the only reason 7 people out of 10 who apply are denied is because they can't sign the check.)

Adding to the instability of the environment is the level of responsibility of the staff. Yesterday, I listened to a patient tell me that staff slept during the night in the media room and family room area, and this morning I walked into the media room upstairs to see Law & Order DVDs and blankets on the sofas. After a few minutes, a member of the staff came into the room, collected the blankets and turned off the tv. This is very scary to me, because if this member of staff is laying there, sleeping or watching tv upstairs, how are they going to notice if a male client comes out of their room at night and goes downstairs? The fact that when I woke up, there were only two females working makes me wonder how they would handle it if a patient assaulted another patient. Would these two women, sleepy and distracted, react in time to be able to pull a male off of a patient? Would they even have the strength to do so?

I've discussed this concern with another patient, only to be informed that when physical altercations do occur, the staff does nothing to intervene. The patients are told that the staff is not allowed to physically break up a conflict between patients. If someone broke into my room at night and started assaulting me, and I screamed, would the staff (after waking up and coming downstairs) simply call the police and stand outside my door because they "are not allowed to put themselves at risk?"

The third thing that concerns me about my stay at Skyland Trail is the air of unprofessionalism the staff has about them. Besides the sleeping at watching TV during the night, I've observed the staff using patient money - the "petty cash" that they are given every week that actually comes out of the patients' payments to Skyland - to purchase things for themselves. Yesterday evening, we went to Bruster's for ice cream, and not only did the patients get ice cream, but the staff member who took us used our money to buy ice cream to bring back for all of the staff.

At Menninger, only a qualified R.N. was allowed to dispense medication to the patients. At Skyland South, there are no R.Ns on staff and unqualified individuals dispense medication. They prepare the daily medications in advance for the week for each patient into a plastic container with separate tabs for each day of the week, and the patient is responsible for getting up and getting their meds on time. When you walk up to the office area, they open the tab for your day and empty the section into your hand. If you have a prescription for something that does not fit into the little divided section - for example, a liquid, or a nasal spray - you have to ask for it. This means that even though I have a prescription for Flonase to be taken every morning, they do not give it to me. I have to ask for it.

(I have heard about patients getting their medications messed up and the staff not being able to do anything about it because they don't know what each person is supposed to be taking.)

There are several personal reasons why I do not feel safe living at Skyland Trail. Allegedly, in order to be a resident, you have to be mentally stable, yet I am still very unnerved living with a male born-again Christian (also directly from jail) who talks a lot about Christianity and watches The Passion of the Christ several times a day upstairs in Media Room (which I have to listen to if I'm on the computer). Thursday, September 7th on the way back from LEAP at the HEC, we stopped at QuikTrip. There is one patient here who has a reputation of being very adamant about riding in the front seat, to the point where she's only allowed to ride it on Mondays. However, this evening the regular van driver who enforces this rule was not driving, and this patient was in the front seat this past Thursday. Apparently this patient has to be able to control the radio if she is in the front seat, and when another patient reached to turn the volume down a little, this woman got so upset that she jumped out of the van while it was still moving and ran off. In the handbook, there are certain guidelines that you have to follow or you risk being kicked out of Skyland Trail, such as passing room checks or attending groups. However, there is one patient who sleeps throughout most of his groups in the library at the HEC - causing it to be locked and unavailable for patients to use even in the hours when it's supposed to be open - and one patient who has been here several months and never passes a room check (the same female patient who doesn't wear underwear) and also smokes in her room at night, which filters through the vents and causes my room to reek of smoke. Neither patient seems to be on the verge of being kicked out for not following the rules, leaving me to believe that as long as you keep paying, they will keep you here.

There is a van that takes patients to and from the HEC every weekday. Only when the van is filled to absolute capacity, will they add a second trip. This means that only when there are 15 passengers who need to be transported will they do two runs. This would be okay if there were 15 functioning seat belts, but there are only about four seat belts that work in the entire van, two of them being the two front seats. In the very back row where four individuals are expected to sit, there aren't even four seat belt clasps (most of the lap seat belts appear to have been cut or torn off, leaving the occasional buckle/clasp in the seats).

(in regard to my mothers' assertion that large passenger vans aren't recommended or required to have occupants wear seat belts, I direct to this site: Department of Transportation - where it states:

"Insist that all occupants wear seat belts at all times. Eighty percent of those who died in 15-passenger van rollovers nationwide in the year 2000 were not buckled up. Wearing seat belts dramatically increases the chances of survival during a rollover crash. In fatal, single-vehicle rollovers involving 15-passenger vans over the past decade, 92 percent of belted occupants survived compared to 23 percent for unbelted occupants."

Further documentation about the danger Skyland Trail is putting its clients in with the use of these vans: Roll Over Lawyer)

The last thing that affects me from a personal and not professional standpoint, is the environment in regards to my eating disorder. In the handbook, it states that clients are provided three nutritious meals a day and snack times are posted. Snack times are not posted, and staff keeps the door to the pantry area locked at all times, so if we need to refill the fridge with water or need to get a vegetarian option from the fridge, we can't. There is one small fridge available to store things like yogurt and water. Staff is responsible for refilling the cereal - the only thing of substance that is available to clients 24/7, seeing as how they keep the door to the pantry locked - which only occasionally gets done. One staff member complained that she was the only person who ever refilled the cereal bins. The only yogurt flavor available is strawberry-banana, which not only do I dislike in taste but it has chunks of strawberries in it, making it difficult to take mix my medicine and swallow it with. In fact, a couple days ago we appeared to completely run out of yogurt and I was about to take my medicine in oatmeal when a staff found one strawberry-banana yogurt in the staffs' personal fridge. Staff does not appear to do regular inventory of the food stocking, and it is up to clients to inform staff when we are out of certain items - and then, we have to wait until the "grocery day," when we are driven to Krogers and staff uses the petty cash - again, taken from clients' accounts - to purchase foodstuffs. Keep in mind, staff also eats these items, particularly at breakfast.

The food that is available is restricted. During the weekdays, we eat lunch at the HEC and they are always running out of food, to the point where it is now rationed and occasionally the server will give you your portion and you can only get seconds after everyone else has gone through the line. However, staff members are allowed to walk in and get their portions first before the buffet area is even open to clients, and when it is open to clients, they cut in line. The group before lunch lets out at 11:45 a.m., and they will only open the doors to clients to eat at noon, though staff is allowed to go back and get their meals ahead of this time. As a result, by the time clients are allowed to get lunch, the food is lukewarm to cold and there is no microwave available. Back at the residence, there are only two vegetarian meals brought with dinner (and lunch, on the weekends), and if those are gone and the entree is pork or beef, I eat cereal for lunch or dinner. I could go into the pantry and get a veggie burger, but the pantry is kept locked and the evening staff will only allow you to go into the back during certain times.

On the weekends, apparently the food for Saturday and Sunday are both delivered on Friday, so we eat the hot food Friday and then have sandwiches every Saturday and Sunday. The food for the weekend meals are stored in the pantry, and as such the fruit that gets delivered isn't very fresh by the time we eat it. At the HEC, you are only allowed to take one small bowl of fruit - and it's mostly melon, with some pineapple, grapes, and watermelon. I talked to my dietician about this and she said that they would prepare a special bowl of fruit for me without melon, but I've only received it twice.

The quality of the food is bad, and the options that are available are all geared to encourage patient dieting, and I've been told as much - a major concern is that clients will gain weight, but I don't think that's the rationale as much as it is that they cut costs with food and food quality. Fruit Loops and Frosted Flakes used to be available, but they stopped being purchased with the rationale that the diabetics couldn't eat them, so they stopped - even though Special K and Raisin Bran was also available. Now Special K and Raisin Bran are the only cereal options available. Snacks like Lorna Doone and Oreo cookies also used to be available, but they were also stopped with the excuse that "clients wanted healthier options." These changes happened awhile ago, but the justifications for the changes are still on the door to the pantry and they tried to make it seem like it was really the clients who motivated the change, but the excuses they gave were less than believable. I really don't think that the diabetics were so bothered by the presence of cereal they couldn't eat, even though there were options they could eat available, that they complained. I also don't think the clients really complained about having cookies available for a snack - and even if they both were the case, even if there was a push for healthier alternatives, why did they need to take away the "junk food" as well? Why can't they purchase both healthier alternatives and indulgences? That's the obvious compromise, but instead all they stopped buying all the junk food and left patients with no choice but to eat the healthier alternatives. I am in a "dieting" environment.

Oh, and there's so much more. They had us have rigid "room inspections" twice a week, and every room (with a single bed) had its own bathroom. However, there was a woman who worked there named Vivian and EVERYONE hated when she was in charge of room inspections. Vicious Vivian. I (and others) had mold on our shower curtains. My shower stall wasn't as spic and span as Vivian wanted, so she told me to clean it better. I told her I only had one brush, and I used it for the toilet.

She told me that it didn't matter, I could use the same brush to clean the toilet... AND the shower.

We had a trash can while we were there, a huge nasty trash bin. The lid was absolutely disgusting to touch to open it. We were responsible for cleaning every single square foot of the South Residence, under the guise of establishing "personal responsibility." People were shelling out thousands for us to clean the facilities. There were two washers and dryers, but only one dryer (or maybe it was a dryer) worked for a residence of dozens of people. Any time you "acted up", you were sent to Ridgeview, but they were very curiously selective in how badly they allowed someone to get before they sent them there. A close friend of mine was sent there after they made up that she was suicidal and practically took an act of fucking Congress for her husband to find out where she was at. Some people ran away. Some people attempted suicide (including myself) while we were there. No one at the HEC cared, and no one at the residence gave a flying fuck about the patients.

Like I said... I think Guantanamo Bay provides a better healing environment than Skyland Trail.

I'm sorry, just another thing about the van (which I've learned they've since bought a bus, but the fact that they went for years doing this to patients makes me think that they will only do the very minimum to ensure that they are not sued or exposed): when the (VERY lazy) staff didn't feel like making multiple trips to a location, we'd actually sit on the floor of the van.

Thousands of dollars for that. They were actually paid to do what they did.

They need to be exposed and they need to be taken down.

This post has been sent to the following for comment:

Ray Kotwicki, MD, MPH
Medical Director

Chris Cline, LCSW
Admissions Director

Delphia Williams
Human Resources Director

Julie Dudkowski, MS, LPC
Community Relations Coordinator

Tara McDaniel, MS, LPC
Community Educations Series and Advocacy

Paulette Graham, LCSW
Director of Residential Services


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


Thursday, December 18, 2008


More stories appearing about disgraced psychiatrist, Dr. Charles Nemeroff, in today's press and blogs.

The Wall Street Journal carries the headline: 'Grassley Blasts Emory over ‘CME-Like’ Defense of Nemeroff' and reports how Sen. Charles Grassley is accusing Emory University of making up a new term in an effort to defend its star psychiatrist from accusations he failed to properly report hundreds of thousands of dollars in payments from drug companies during this decade.

In explaining why psychiatrist Charles Nemeroff failed to report payments from GlaxoSmithKline, Emory said Nemeroff reported to them that some of the payments from Glaxo, maker of antidepressant Paxil, were for talks that weren’t promotional in nature but instead were “CME-like.” Calls to Emory and Nemeroff for comment weren’t returned immediately.

The Wall Street Journal Blog reports on how Nemeroff wrote himself a cheque for $3000 for writing an article on Effexor, an antidepressant.

Meantime, The New York Times goes with a story where psychiatrists are 'revising the book of human troubles'.

If we let these psychiatrists write what I think they are going to write then we are going to have one major problem on our hands. It seems some of the questions being thrown into the pot are, Is compulsive shopping a mental problem? Do children who continually recoil from sights and sounds suffer from sensory problems — or just need extra attention? Should a fetish be considered a mental disorder, as many now are?

The book, the Diagnostic and Statistical Manual of Mental Disorders or [DSM-V] is both a medical guidebook and a cultural institution. It helps doctors make a diagnosis. We are heading into the abyss folks and Pharma will be throwing us one by one into that abyss is this book of absurdity sees the light of day.

It's been said that scientists who accepted the invitation to work on the new manual agreed to limit their income from drug makers and other sources to $10,000 a year for the duration of the job.

Hopefully they may find a cure for Pharmaceutical greed.



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


Interview with Shelley Jofre

Here we have an Interview with Panorama investigative reporter, Shelley Jofre.

Shelley was instrumental in exposing GlaxoSmithKline and the MHRA plus fraudulant psychiatrists with her reports concerning Seroxat.

The first documentary, 'The Secrets of Seroxat' was aired in 2002 and saw 65,000 people ring the BBC helpline and they received over 1,500 emails. This prompted Shelley to make a follow-up programme called 'Emails from the Edge', which was broadcast on BBC TV on the 11th May 2003. 'Taken on Trust', her third investigation in to Seroxat, shook the foundations of the MHRA to the core as she exposed how they had failed the British public regarding thier ignorance and incompetence. Her fourth and final installment [thus far] of the whole Seroxat scandal was called 'Secrets of the Drug Trials', she showed how GlaxoSmithKline (GSK) attempted to show that Seroxat worked for depressed children despite failed clinical trials. This was aired in 2007.

On November the 1st, 2007, Shelley shed further light on her investigations into Seroxat when she was interviewed at Coventry University as part of the 'Coventry Conversations' series. The interview is available for download and is over an hour in length.

The interview with Shelley is a pretty amazing insight into how GlaxoSmithKline saw her as a major nuisance as she kept chipping away at them, digging for answers.

Shelley Jofre is a terrific reporter, a constant thorn in the side of GlaxoSmithKline and the MHRA. If there were any justice in this world then Shelley should recieve all the accolades. She put the dangers of Seroxat on the map here in the UK, she exposed the clandestine goings-on at the world's second largest pharmaceutical company and the body that regulate them, the MHRA.

A key point in these four documentaries was when she asked Head of European Psychiatry , for GlaxoSmithKline, Alistair Benbow, if Seroxat could be safe in children. His reply still baffles me to this day, he answered, "Absolutely. It could be. We haven't got a license in children yet..."

Quite why Benbow would suggest that Seroxat could be safe in children and would suggest that they hadn't got a license in children 'yet', is quite revealing. His company, GlaxoSmithKline, had documents from 1998 that showed that medication for adolescent depression failed to demonstrate any benefit for paroxetine over placebo in adolescents and demonstrated a worrying profile of adverse events for paroxetine.

I think it is fair to assume that Benbow was either lying or he didn't know that his company knew Seroxat was not beneficial to children, in fact it was quite the reverse. If the latter is true then Benbow as Head of European Psychiatry , at GlaxoSmithKline should ask himself why his employers never told him.

I got myself in to hot water when I created a video with comments from Benbow and juxtaposed them with comments from patients and the mainstream media. Apparently I had caused Benbow distress. Surely, as a consumer of their product, Seroxat, I had every right to question Benbow? Glaxo's lawyers were not happy with a comment I made regarding Benbow, I likened him to a Nazi dictator. In hindsight that was wrong, however, the question of whether Benbow lied on national TV has still not been answered.

Here is the interview with Shelley. It was conducted by John Mair and recorded in front of an audience at Coventry University.

It is an audio recording and not a video.

Right click and 'save as'


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


Tuesday, December 16, 2008

The Great SmithKline Cover-Up

My postman rang my bell today, he had a package for me. There I was thinking my stalker had decided to send me an early Christmas present... in fact it was better than that, so much better.

I'm about to start reading 'Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Antidepressant on Trial' , a book written by Alison Bass.

From the Inside Flap
As the mental health reporter for the Boston Globe, Alison Bass's front-page reporting on conflicts of interest in medical research stunned readers, and her series on sexual misconduct among psychiatrists earned her a Pulitzer Prize nomination. Now she turns her investigative skills to a landmark case that exposed increased suicide rates among adolescents taking popular antidepressants such as Paxil, Prozac, and Zoloft.

In Side Effects we meet a courageous Ivy League university employee who risked her job to expose suspicious practices at her lab, a feisty assistant attorney general who spearheaded an unprecedented lawsuit against a pharmaceutical giant, plus the medical researchers who were being paid by the drug companies whose products they were testing. And Bass introduces us to the vulnerable children and adults placed at risk because of greed, corruption, and negligence.

Though pediatric prescriptions of Paxil—at the time one of the world's bestselling antidepressants—were soaring, there was no hard proof that the drug performed any better than sugar pills in children and adolescents. Bass reveals how data from drug trials and the suicide risk the drug posed were withheld, allowing GlaxoSmithKline, the maker of Paxil, to mislead physicians and consumers about the safety and efficacy of the drug.

When the New York State attorney general's office brought its lawsuit against GlaxoSmithKline for consumer fraud, it launched a tidal wave of protest. As a result of this case, drug companies agreed to publish negative results from their research studies. A congressional investigation into industry practices finally prompted the FDA to mandate strict warnings for all antidepressants.

In the tradition of A Civil Action, Side Effects goes behind the scenes of the headline-making case that forced the government to start protecting its citizens. It lays bare the unhealthy state of our country's pharmaceutical industry.


Alison has placed some documents on her blog. She writes:

The first document here is from the final GlaxoSmithKline report of study 329 (publicly available on its website), which shows that a 14-year-old boy who was in the Paxil arm of the study lost control, punching pictures, breaking glass and injuring himself in November 1994. He was hospitalized and seen as suicidal by the psychiatrists treating him. Yet this patient , known as #65 in the study, was not labeled as suicidal when the study was published in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. (The following year, Paxil became the most widely prescribed antidepressant in the U.S.).

The second document here is a memo to Brown University's Institutional Review Board from Martin Keller, chief of psychiatry at Brown and principal investigator of study 329. In the memo, Keller reports that a teenager in the Paxil study was hospitalized in September 1995 due to becoming combative and suicidal. Yet in the memo, Keller says he has labeled this patient (#106) as noncompliant instead of suicidal as a result of taking Paxil. Likewise in the published 2001 study, this teenager is labeled noncomplaint and not included in the list of adolescents withdrawn from the study as the result of adverse side effects.

The third and perhaps most mysterious
document is a memo from Keller to the IRBs at Brown and two of its affiliated hospitals, Butler and Bradley. In this January 30, 1995 memo, Keller reports that a teenage girl, patient #70 in study 329, ingested 82 Tylenol pills on January 19 and was hospitalized at St. Ann's Hospital. She was discontinued from the study at the end of January and coded as noncompliant according to another memo from Keller to Brown's IRB here. Yet according to the GlaxoSmithKline's final report, patient #70 in the same study was a 12-year-old boy enrolled in the trial on February, 22, 1995 and withdrawn on March 24 after suffering from chest pains. This patient had been randomized to the imipramine arm of study 329.

So the question remains: how did patient #70 go from being a teenage girl who overdosed on Tylenol to a 12-year-old boy with chest pains?

How indeed?


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


How GSK Duped Doctor's, Regulator's and the British Public

The Paxil Papers [Source - Christopher Lane]

This Paxil Fact File, containing confidential information, was drafted and distributed by SmithKline Beecham in 1998--for internal use only.

Foreword by Paul N. Jenner, Director and Vice President of Neuroscience and Strategic Product Development

Section 1: Towards the Second Billion -- All SSRIs Are Not the Same

Section 2: New Indications: Social Anxiety Disorder / Social Phobia

Section 3: Issues Management: Managing the Discontinuation Issue.

Related Papers

"Duration of Treatment and Depression: Relapse and Recurrence Rates" (February 2001; GlaxoSmithKline Confidential--Internal Use Only).

"Paxil CR" Product Monograph (GlaxoSmithKline; November 1, 2005).

Paxil Litigation Documents (Filed Under Seal; November 11, 2007).

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


Please contact me if you would like a guest post considered for publication on my blog.