Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Deaths. Show all posts
Showing posts with label Deaths. Show all posts

Monday, December 11, 2017

British Medicines Watchdog Announce New Partnership




First off, watch the short announcement from the MHRA's CEO, Dr. Ian Hudson.



He looks almost apologetic, don't you think? Either that or he is embarrassed?

Before taking his role as CEO of the British Medicines Watchdog (MHRA), Hudson was the agency’s licensing director, responsible for the majority of its medicines licensing activities. Prior to that, he was the World Safety Officer for GlaxoSmithKline. He can be seen here defending Paxil, also known as Seroxat, (under oath) during a one-hour video deposition that was aired during the Tobin Vs GlaxoSmithKline case. A case which saw the Jury return a verdict against GlaxoSmithKline and, indeed, Paxil. (Fig 1)


Fig 1



Who Are The Gates Foundation?

Better known as the Bill & Melinda Gates Foundation, it was launched in 2000 and one of its primary aims is to "enhance healthcare and reduce extreme poverty."

What Are They Currently Involved In?

Well, aside from teaming up with the MHRA and having a say on the safety monitoring of medicines in low and middle-income countries, they are also embroiled in serious issues regarding a vaccine study they sponsored that was carried out in India in 2009.

Bill and Melinda's foundation funded the Program for Appropriate Technology in Health (PATH) to carry out the studies in which 5 young girls died after receiving the Human Papilloma Virus (HPV) vaccine, Gardasil, manufactured by Merck.

According to The India Times, "...consent for conducting these studies, in many cases, was taken from the hostel wardens, which was a flagrant violation of norms. In many other cases, thumbprint impressions of their poor and illiterate parents were duly affixed onto the consent form. The children also had no idea about the nature of the disease or the vaccine "

In 2015, Judges in India's Supreme Court demanded answers regarding the violations. An investigation carried out by the British newspaper, The Daily Mail, found that "children as young as nine suffered side-effects after being used as unwitting human guinea pigs for the new drug."

The Daily Mail adds:
An investigation by an Indian parliamentary committee had previously concluded that the trials amounted to a serious breach of trust and medical ethics amounting to child abuse and 'a clear cut violation of the human rights of these girl children and adolescents'.
The committee's report said it had been established that clinical trials of the vaccines had been carried out 'under the pretext of an observation/demonstration project' in violation of all laws and regulations laid down by the government for such trials.
GSK is also embroiled in the controversy. Shortly after the Gardasil debacle, two more deaths were reported from Vadodara, Gujarat, where tribal children were also vaccinated with another brand of HPV vaccine, GSK's Cervarix.

Earlier this year, things got so bad that India's health ministry decided to take over funding responsibility for the immunization program backed by the Bill & Melinda Gates Foundation. The reason? "A possible conflict of interest arising from the foundation's tied to pharmaceutical companies." (Business Standard)

MHRA

So now, we seem to have gone full circle with today's MHRA announcement from Dr. Ian Hudson, who claims...
"We are delighted to be involved in such an important global initiative. New drugs and vaccines are being brought to the market for the first time in public health programmes in settings where the safety monitoring and regulatory systems need strengthening. The expertise we can bring to the project will help national safety monitoring centres identify risks and benefits early and take appropriate regulatory action to support global health."
So, let's get this straight. Bill and Melinda Gates funded an immunization program in India. That program kills a number of children and the protocol was found to be 'a clear-cut violation of the human rights of children'. Next, Ian Hudson, the former World Safety Officer at GSK, announces that Bill and Melinda Gates will be teaming up with the MHRA to strengthen "the safety monitoring and regulatory systems."

Someone pinch me.

If this hasn't got you thinking outside of the box, ladies, and gentlemen, then maybe this will?

An article published in 2012 entitled, 'The Gates Foundation connection to the Glaxo drug fraud scandal', is a fascinating read. It highlights, amongst many things, that Tachi Yamada, former head of global health for the Bill & Melinda Gates Foundation was formerly the head of research and development for GSK.

Yamada, while he was head of global health for the Gates Foundation, was accused in a U.S. Senate hearing of bullying a scientist to not publish negative findings of a GSK diabetes drug called Avandia. The same drug that Glaxo failed to report important data to the FDA showing that it increased heart risks in patients by 43%. Despite agreeing to a misdemeanour count in 2012, GSK still maintains "the civil settlement is not an admission of any liability or wrongdoing in the selling and marketing of Avandia." However, they agreed to pay $3 billion imposed on them by The Department of Justice for failure to report Avandia safety data.

I'm sure Ian Hudson knows of the links between GSK and the Gates Foundation. Probably why his announcement (in the video at the top of this post) looks like it's being delivered by someone who has soiled his underpants. Either that or he has become nauseous after being trapped in the incestuous revolving door at the MHRA!

Bob Fiddaman












Friday, May 05, 2017

SSRI Deaths in Clinical Trials







Following on from MHRA Yell "Barracuda!", I have sent the following request (under the terms of the Freedom of Information Act) to the MHRA.

I can't see any reason why they can't answer, given they already confirmed to me, in writing, about the 22 deaths that occurred in Paxil clinical trials.

1. How many deaths occurred in the pediatric trials for Paxil/Seroxat. How many were by suicide and how many of those patients were taking Paxil/Seroxat at the time of their death?

2. How many deaths occurred in the pediatric trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

3. How many deaths occurred in the persons aged 24 or over in clinical trials for Prozac. How many were by suicide and how many of those patients were taking Prozac at the time of their death?

4. How many deaths occurred in the pediatric trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

5.  How many deaths occurred in the persons aged 24 or over in clinical trials for Celexa/citalopram. How many were by suicide and how many of those patients were taking Celexa/citalopram at the time of their death?

6. How many deaths occurred in the pediatric trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

7. How many deaths occurred in the persons aged 24 or over in clinical trials for Lexapro/escitalopram. How many were by suicide and how many of those patients were taking Lexapro/escitalopram at the time of their death?

8. How many deaths occurred in the pediatric trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

9. How many deaths occurred in the persons aged 24 or over in clinical trials for Zoloft/Sertraline. How many were by suicide and how many of those patients were taking Zoloft/Sertraline at the time of their death?

Bob Fiddaman








Sunday, December 30, 2012

Glaxo Finish in 26th Position... But Spin Victory




Back in November I wrote how GlaxoSmithKline had been shortlisted for Britain's most admired company. When I learned that they had been shortlisted I wrote a brief email to the editor of the Management Today, who were offering the award. In a nutshell, I aired my disgust at their nomination, citing Glaxo's various violations over the years.

Management Today never replied.

No surprise then that Glaxo were blowing their own trumpet on their Facebook page early in December after they had learned that they had won the most admired company in the Health & Household category. [Fig 1]

Fig 1

The Health & Household award was a sub-category and the reason why Glaxo felt the need to cover themselves in garlands on their Facebook page was probably due to the fact that they finished in 26th position overall. Now there's some spin for you, huh?


Friday, November 23, 2012

GlaxoSmithKline - You're An Embarrassment




In the words of Suggs, lead vocalist with Brit Ska/Pop band, Madness, "You're An Embarrassment."


Our uncle he don't wanna know he says
"We are a disgrace to the human race", he says
"How can you show your face
When you're a disgrace to the human race?"

No commitment, you're an embarrassment
Yes, an embarrassment, a living endorsement
The intention that you have booked
Was an intention that was overlooked


Now watch the video.





Sunday, May 31, 2009

GSK - A Catalogue of Disasters!

Holocaust - an act of mass destruction and loss of life.

Paxil
GSK misrepresented the results of its research to its sales representatives, saying it had "remarkable efficacy and safety in the treatment of adolescent depression".

Zyban
Eighteen smokers have died after taking Zyban - the new 'wonder cure' for nicotine addiction.

Wellbutrin
Wellbutrin was withdrawn in 1986 because of an unacceptable incidence of seizures. It was released back to the market in 1986 for unknown reasons.

Imitrex
Plaintiffs are Ronnie J. Brown, individually, as curator for his wife, Sharon GayDavis Brown, and as natural tutor for their son, Cory H. Brown. Plaintiffs sued for damages to Mrs. Brown caused by her use of the drug Imitrex.

Raxar
In 1999 Raxar was removed from the market after questions regarding its safety were raised. Raxar was shown to prolong the heart's QT interval.

Relenza
The FDA found 115 cases of psychiatric side effects linked to Relenza, including 74 in children. Most of the reports were from Japan.

Lotronex
After meetings with Food and Drug Administration (FDA), Glaxo Wellcome has made the decision to pull Lotronex (alosetron hydrochloride) from the market.

Myodil
Between 1946 and 1988 Glaxo made and sold a spinal x-ray contrast medium called Myodil. Injected into the spinal canal in order to show up problems on x-rays, the drug was sold in approximately fifty countries including the UK. But Myodil, an oil-based yellow dye, was far from harmless itself – once injected into the spine it has been shown to cause a disease called Adhesive Arachnoiditis.

Trivax vaccine
British drug giant GlaxoSmithKline has finally admitted that thousands of babies in this country were inoculated with a batch of toxic whooping cough vaccines in the 1970s. Some experts believe that these Trivax vaccines - which had not passed critical company safety tests - may have caused permanent brain damage and even fatalities in young children.

LYMErix vaccine
Jenny Marra, a New Jersey hospice nurse positive for HLA-DR4, said she had been living with "severe joint and muscle pain since vaccination in 1999. SmithKline did not include a warning about the potential risk for this information in the product labeling or inform the health care providers of this concern. Had I known this I personally would not have taken the vaccine." Physicians aware of the political controversy, she added, are turning the LYMErix vaccine victims away "with statements like, 'I don't want to get involved.'"

Serevent
FDA documents released yesterday indicate that about a year ago, the agency asked Glaxo to strengthen Serevent's existing so-called black box warning, the most serious a drug label can carry. The FDA wanted the label to say that a study found a "a small but significant" risk for asthma-related deaths in all Serevent users and not just African-Americans, as previously indicated.

Advair
Recent medical studies indicate that Advair and it's sister drug Serevent asthma inhaler may be responsible for increased number of asthma deaths in adults & children. The active ingredient salmeterol is also found in Advair, Serevent or Foradil maybe responsible for many of these asthma related deaths. Advair is manufactured by GlaxoSmithKline,(GSK). Advair (fluticasone/salmeterol) is an inhaled medication used to treat asthma and COPD. It is a combination medication consisting of an inhaled steroid and a long-acting form of albuterol, called salmeterol.

Avandia
A prominent US clinician has concluded that a diabetes drug produced by UK pharmaceutical company GlaxoSmithKline (GSK) increases the risks of heart attack and death. Steven Nissen from the Cleveland Clinic, Ohio, undertook a meta-analysis of clinical studies comparing patients treated with GSK's Avandia (rosiglitazone maleate) with controls. He concluded that Avandia was associated with a 43 per cent increase in the risk of heart attack. His article, published in the 14 June edition of the New England Journal of Medicine (NEJM), was released early by the journal's editors due to its public health concern.

Cervarix vaccine
A GROUP of British teenagers has launched the first legal action against the makers of a controversial ­cervical cancer jab.They have suffered symptoms ranging from paralysis and ­seizures to fatigue and muscle aches since being given the Cervarix vaccine.



"We have a challenging and inspiring
mission: to improve the quality of
human life by enabling people to do
more, feel better and live longer."




Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tuesday, May 26, 2009

The Money behind Falsified Drug Research

Source OpEd News

Last week we reported that a Dr. Karen Wagner, professor, psychiatrist and key researcher at the University of Texas was one of the latest targets caught in the net of U.S. Senator Chuck Grassley in his ongoing war against drug company corruption and undue financial influence on the U.S. Health industry.

Grassley's investigators initially found that pharmaceutical giant, GlaxoSmithKline paid the psychiatrist more than $160,000 between 2000 and 2005 while she was the director of child and adolescent psychiatry at the University of Texas Medical Branch in Galveston.

FULL STORY

Hat - Tip: The Truthman



Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Tuesday, May 19, 2009

MD Calls for immediate embargo of all antipsychotics and antidepressants

Newswire

Fred A. Baughman Jr., MD Announces: Vets' Sudden Cardiac Deaths Are Not Suicides or Overdoses

EL CAJON, Calif., May 19 /PRNewswire/ -- Fred A. Baughman Jr., MD today announced the results of his research into the "series" of veterans' deaths acknowledged by the Surgeon General of the Army.


Upon reading the May 24, 2008, Charleston (WV) Gazette article "Vets taking Post Traumatic Stress Disorder drugs die in sleep," Baughman began to investigate why these reported deaths were "different." And, why they were likely, the "tip of an iceberg."


Andrew White, Eric Layne, Nicholas Endicott and Derek Johnson were four West Virginia veterans who died in their sleep in early 2008. Baughman's research suggests that they did not commit suicide and did not overdose as suggested by the military. All were diagnosed with PTSD. All seemed "normal" when they went to bed. And, all were on Klonopin (a benzodiazepine), Paxil (an SSRI antidepressant) and Seroquel (an antipsychotic).


On January 15, 2009, the New England Journal of Medicine (Ray et al), reported that antipsychotics double the risk of sudden cardiac death.


On February 7, 2008, Surgeon General Eric B. Schoomaker, said there has been "a series of deaths in Warrior Training Units" -- "often as a consequence of the use of multiple prescription and nonprescription medicines and alcohol ... we all saw the unfortunate death of Heath Ledger, the 'Brokeback Mountain' star, who died from an accidental overdose."


But Ledger was not on any heart-toxic medication. When found, his pulse and respirations were intact! When found, none of the veterans were breathing or had pulse. There's, most likely, were sudden cardiac deaths!


Sudden cardiac death is an unexpected death due to cardiac causes occurring in a short time period (generally within 1 h of symptom onset) in a person with known or unknown cardiac disease in whom no previously diagnosed fatal condition is apparent. (Medscape e-Medicine 7/17/06)


As of April 16, 2009, veteran's wife, Diane Vande Burgt, had Googled 19 "dead in bed," 36 "dead in barracks," or "... room," and 19 "under investigation." Removing reported "suicides" shortened our original list by 15 names leaving a total of 74 probable sudden cardiac deaths - most in soldiers or veterans in their 20's. An article from the AP, San Antonio, 4/17/09, reported "The deaths of two soldiers are being investigated ... both men apparently died in their sleep."


It was reported in June, 2008, that 89% of veterans with PTSD are given antidepressants and 34% antipsychotics (Mohamed & Rosenheck, June 2008). A third, then, are exposed to the additive potential of both to cause sudden cardiac death. (Sicouri & Antzelevitch, 2008)


On April 13, 2009, Baughman wrote the Office of the Surgeon General of the Army: "the Surgeon General said there has been 'a series, a sequence of deaths' Has the study of these deaths been published?


On April 17, 2009, the response came: "The assessment is still pending and has not been released yet."


There being no such thing as an essential psychiatric drug, I call upon the military for an immediate embargo of all antipsychotics and antidepressants until there has been a complete, wholly public, clarification of the extent and causes of this epidemic of probable sudden cardiac deaths.

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Wednesday, May 13, 2009

Paxil [Seroxat] “defective and unreasonably dangerous product.”

Source: SSRi Stories

One day after his antidepressant medication was doubled, a Whitfield County man threw himself in front of a moving train, killing him.

Now, his widow is suing the drug manufacturer claiming the medication, Paxil, was to blame, and she is looking to be compensated the “full value” of her husband’s life and for the drug to carry severe warnings.

The widow, Donna Dietz, is suing the Smithkline Beecham Corporation, the makers of the drug she contends led to the death of her 33-year-old husband, and has enlisted the help of a Houston-based firm that specializes in these cases. Click here to view a copy of the lawsuit.

At the time of his death in 2002, according to a lawsuit filed in U.S. District Court in Rome, Garrison David Dietz had been prescribed the drug Paroxetine, branded as Paxil, by his doctor.

In the lawsuit, Dietz, who now lives in Gordon County, states a judgment of more than $75,000 is the goal of the suit.

Attorney Andy Vickery, who represents Dietz, said the amount would be a great deal more, saying a similar four-party suit in Wyoming in 2001 earned his clients $8 million in compensation.

One week after beginning the medication, the doctor doubled the dosage; one day later, April 10, 2002, Dietz’s husband committed suicide, the suit says.

The suit describes Paxil as a “defective and unreasonably dangerous product.”

Vickery said his goal is to strictly limit the prescription of this and similar drugs, selective serotonin reuptake inhibitors (SSRI), to that of psychiatrists.

Attorney’s for Smithkline Beecham could not be reached for comment Tuesday

----

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Monday, May 11, 2009

Top 20 Reported Adverse Reactions

A very interesting post on the Psychiatry, It's A Killing. blog from April 30th 2009.

The author of the blog has compiled a list of the top 20 adverse drug reactions, the author has also pointed out that the FDA's Jerry Phillips said in the year 2000:

"In the broader area of adverse drug reaction data, the 250,000 reports received annually probably represent only 5% of the actual reactions that occur."

No surprises which medication comes out on top:

List in alphabetical order.

Abilify: Suicidal Ideation, Suicide Attempt
Completed Suicide - 98 Cases
Adderall: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 29 cases
Celexa: Suicidal Ideation, Suicide Attempt
Completed Suicide - 232 cases
Clozapine: Suicidal Ideation, Suicide Attempt
Completed Suicides - 32 cases
Cymbalta: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicides - 81 cases
Depakote: Suicidal Ideation, Suicide Attempt
Completed Suicide -94 cases
Effexor: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicides - 133 cases
Geodon: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 57 Cases
Klonopin: Suicidal Ideation, Suicide Attempt
Completed Suicides - 88 cases
Lamactil: Suicidal Ideation, Suicide Attempt
Completed Suicides - 27 cases
Lexapro: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 189 cases
Neurontin: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 526 cases
Paxil/Seroxat: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 841 cases

Prozac: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 187 cases
Risperdal: Suicidal Ideation, Suicide Attempt
Completed Suicides - 51 cases
Ritalin/Concerta: Suicidal Ideation, Suicide Attempt
Completed Suicides - 20 cases
Seroquel: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicides - 143 cases
Strattera: Suicidal Ideation, Suicide Attempt
Completed Suicides - 34 cases
Tegretol: Suicidal Ideation, Suicide Attempt
Completed Suicide - 44 cases
Wellbutrin: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicide - 272 cases
Xanax: Suicidal Ideation, Suicide Attempt
Completed Suicide - 161 cases
Zoloft: Suicidal Ideation, Suicide Attempt
Completed Suicide - 154 cases
Zyprexa: Suicidal Behaviour, Suicidal Ideation, Suicide Attempt
Completed Suicides - 149 cases

Read full article HERE

Bob Fiddaman

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Saturday, May 09, 2009

GSK - Prescription Drugs and Other Products

Paxil/Seroxat/Aropax [1]

Manufactured, marketed, dispensed, despite GSK knowing that it could make people taking it suicidal.

Imitrex/Sumatriptan [2]

At least 43 deaths and 139 "life threatening" reactions have been linked through MedWatch reports to Imitrex [sumatriptan], a migraine drug introduced by Glaxo subsidiary Cerenex Pharmaceuticals as Imitrex after FDA approval at the end of December 1992. Reports began in 1993, less than a year after Imitrex went on the market. The company sent out "Dear Doctor" letters highlighting "drug-associated fatalities" last August. The revised label describes the death of a 41-year-old woman.

Avandia [3]

GlaxoSmithKline’s popular drug for treating type 2 diabetes, increased the risk of heart death by 64% and the risk of heart attack by 43%.


Advair [4]

The FDA says GSK's Advair and other long-acting beta 2 agonists have been associated with increased risk of severe asthma exacerbations and asthma-related death, and should carry warnings about the serious side-effects.

Lotronex [5]

FDA reviewers found that Lotronex improved symptoms in only 10% to 20% of the patients. Still, an FDA advisory committee, whose participants included a paid consultant to Glaxo, unanimously recommended approval. (The yes vote voiced by the Glaxo consultant, Dr. Arnold Wald of Pittsburgh, was invalid, agency officials say, because of his status as a temporary appointee.)

Lymerix [6]

Alleged that SmithKline violated state negligence and consumer laws by not warning of potential dangers. And they complain that Yale University may have had a conflict of interest in testing the vaccine because it stood to earn royalty payments from LYMErix sales.

Relenza [7]

Since 1999, when Relenza was approved, there have been 115 reports of psychiatric events, of which 74 were children.

Alli [8]

At 240 pounds, she thought Alli might do what dieting alone had not. On Alli, she lost ten pounds right away. Then her weight loss slowed, and the side effects began. They were so serious she ended up in the emergency room twice. "I couldn't control my bowels. I was running to the bathroom, leaving meetings, being in the car, and literally stuck," she recalled.

Cervarix [9]

A GROUP of British teenagers has launched the first legal action against the makers of a controversial ­cervical cancer jab. They have suffered symptoms ranging from paralysis and ­seizures to fatigue and muscle aches since being given the Cervarix vaccine.

Ribena [10]

Two 14-year-old New Zealand girls made the news recently when their school science project revealed that Ribena, the popular black currant drink, did not have the high levels of vitamin C it claimed to.

AZT [11] AND [12]

Orphans and babies as young as three months old have been used as guinea pigs in potentially dangerous medical experiments sponsored by pharmaceutical companies, an Observer investigation has revealed.

British drug giant GlaxoSmithKline is embroiled in the scandal. The firm sponsored experiments on the children from Incarnation Children's Centre, a New York care home that specialises in treating HIV sufferers and is run by Catholic charities.

[12]

President Mbeki's directive on 28 October 1999 that the safety of AZT be investigated on the basis that "there is a large volume of scientific evidence...that [AZT] is harmful to health" alerted the South African public to the fact that AZT is dangerously poisonous.

----

Combine the above with hidden studies, faked studies, ghost written studies, and huge sums of money paid to 'Key Opinion Leaders' and you have one hell of a psychopathic killer on your hands.

Fid




[1] Trail of Paxil Suicides Leads To GlaxoSmithKline
[2] What you--and maybe your doctor--don't know about your prescription's side effects could hurt you. Or even kill you
[3] 'Glaxo's diabetes drug Avandia raises heart-death risk'
[4]
Asthma drug warning hits GlaxoSmithKline
[5]
"Irritable bowel" remedy pulled after reports of serious injuries.
[6]
SmithKline Beecham Faces Lawsuit for Lyme-Disease Vaccine's Negative Effects.
[7]
Relenza Should Have Psychiatric Side Effects Warning, Say Regulators
[8]
Alli - Wonder Drug or Rip-Off?
[9]
Teenage Girls Sue over Cervarix Cancer Jab
[10]
Ribena ri-busted
[11] GlaxoSmithKline embroiled in scandal in which babies and children were allegedly used as 'laboratory animals'
[12] OPEN LETTER TO GLAXO-SMITH-KLINE


GlaxoSmithKline:

"We have a challenging and inspiring mission: to improve the quality of human life by enabling people to do more, feel better and live longer."


SEROXAT SUFFERERS STAND UP AND BE COUNTED

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
SIGNED COPIES HERE OR UNSIGNED FROM CHIPMUNKA PUBLISHING

Sunday, May 03, 2009

Look back at Panorama

This great article by Charles Medawar was posted a day after BBC TV aired their 4th, count them, 4th programme about GlaxoSmithKline's Seroxat.

It's well worth a read.


"What they’ve done is just despicable … "

Panorama (BBC-TV) last night broadcast its fourth programme on Seroxat® (paroxetine), a still deeper foray into the built-in nastiness of drug marketing and product promotion. All credit to the programme for sticking with the issue, if only to reveal how much more must be done to see this story through.

Thanks largely to Panorama and friends we now have a pretty clear picture of motive, opportunity, method and the sometimes awful consequences. Corrupting influence in pharmaceutical science has become almost natural and easy - the product not only of greed and self-interest, but of established professional and organisational practice. In some ways, collective lack of commitment and imagination seem to trump venality. Indifference rules, OK?
The more this story unfolds, the more scary seems the inter-dependence and over-connectedness of the three main powers. Between them, the Pharmas and their agents, governments and regulators, and doctors and research workers have constructed a ‘health-care’ system that now seems, almost routinely, to put health second and them on top.

Panorama of course illustrated the point in vivid microcosm and partly by reference to villains, heroes and victims. This was allegory, like John Le CarrĂ©’s The Constant Gardener: how else does one encapsulate the wider point and bring it home? Only in human scale, with familiar dimensions, does full meaning begin to come clear. Statistics may point to part of the reality, but they don’t bleed.

Now, in close-up, we see silky but sweaty denials from once trusted experts; they reveal not only grand arrogance, but also the crippling impact of institutional imperatives and their seductive, crushing effect on decent personal values. The human anguish that follows tops the iceberg that threatens to sink us all. The sickness feels palpable: what is happening to humanity, honest science and real health?

These words, "What they’ve done is just despicable", were spoken by the mother of a 16-year old girl, when she later came to understand the cause of her loss. She had returned home to find her daughter hanging from the upstairs loft hatch; her body was still warm, but beyond revival. A packet of Seroxat tablets was next to the suicide note. That was in 2003, less than a month before the UK regulators published warnings about this drug – don’t give it to under 18-year olds. This was on the basis of evidence from clinical trials that the manufacturers had held for several years.

In these circumstances, the word, ‘despicable’ seemed moderate. The case for meticulous investigation seems all the more compelling, when the victims include an eleven year old on paroxetine, who had used his puppy’s leash to hang himself in a closet in the family home. There are too many tragic cases to mention: Christopher Pittman is another. He was prescribed paroxetine, then sertraline, and is now in the early stages of a 30 year prison sentence; he shot his grandparents aged 12 years old.

The focus in this programme was on Study 329, the centrepiece of a small series of clinical trials to investigate the effects of paroxetine on depressed adolescents and children. The scientific evidence available to SmithKline Beecham in 1998 suggested both lack of effectiveness and a possible excess risk of drug-induced self-harm.

The company held back the evidence, until the UK regulators chanced on it, in May 2003. They issued warnings soon after, estimating that the risk of drug-induced suicidality was three times greater with paroxetine than with no drug treatment (placebo). Later, the US Food & Drug Administration required a proper re-examination of the raw data: this established (2006), that the risk of suicidality, on-drug, was actually six times greater for children (three times greater for adults) than originally assumed.

Initially, the company decided not to publish the results of Study 329: memoranda now in the public domain record advice that it would be "commercially unacceptable" to disclose the facts, because it "would undermine the profile of paroxetine". Instead, the decision was "to effectively manage the dissemination of these data". This was so well managed that even sales representatives were led to believe that the drug "demonstrates remarkable efficacy and safety in treating the adolescent population". Sales (detail) people thus become potentially dangerous (if willing) victims, like the doctors who too willingly take their advice.

At this point in the programme, Shelley Jofre, the Panorama reporter, asked US attorney, Karen Barth Menzies what she made of that claim: "remarkable safety and efficacy". It was a lie, and fraud, she replied. The question seemed almost redundant, not just because of the weight of the evidence – but also because both of them have been chasing the truth on these issues for years. They are among the heroes, along with the brave, indefatigable Professor David Healy. He is the shining exception to the general rule, that these accusations have come from outside the establishment, not within.

How was all this achieved? It was of course the product of a complex collective effort, but Panorama could fairly point the finger at some especially conspicuous players. Two were influential and hitherto well-respected US academic psychiatrists, Drs Martin Keller and Neal Ryan. Both earned and gained very handsomely by touting the product and fronting for the manufacturers, (now GlaxoSmithKline, GSK). They too casually lent their names to misleading, fine-woven conclusions in prestigious publications, the product of assiduous ghost-writing and marketing steer.

Also conspicuous was the scarily brazen editor of a leading US psychiatric journal, Child and Adolescent Psychiatry. She emphasised she had "no regrets at all" about publishing the invisibly concocted and misleading version of Study 329, on the grounds that, "it generated all sorts of useful discussion".

Then there is Dr. Alastair Benbow, the Head of European Clinical Psychiatry at GlaxoSmithKline, who featured so prominently in two earlier Panorama programmes. Five years after the company’s own evidence revealed no such thing, Benbow insisted that there was nothing to worry about. "The reality of the situation is that, in this trial (Study 329), Seroxat was generally well tolerated by this difficult to treat population," he claimed.

Meanwhile, GlaxoSmithKline has issued a bullish statement to Panorama: "In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients who suffer from depression and refutes any allegation that it has failed in this duty. GSK utterly rejects any suggestion that it has improperly withheld drug trial information …" The statement does not specifically address Panorama's concerns; the full text can be read here.

So what is to be done? The short answer is almost everything, given that the so-called competent authorities have repeatedly failed to put their house in order. Previous episodes of Panorama have documented the grovelling impotence of the drug regulators (notably the MHRA and the FDA) and the passive connivance of the medical profession – of course with countless individual exceptions (no doubt including your doctor as well as mine).

Where do we go from here? In the immediate future, there is potential for progress on three main fronts – none politically attractive, though central to the future health and reputation of pharmaceutical medicine.

First, we need urgently to examine the meaning of personal responsibility in corporate settings: specifically, the General Medical Council (GMC) should now investigate and rule on the conduct of Dr Alastair Benbow. Both would in some way be on trial. The GMC is a professional court with feudal if honourable traditions, with still some way to catch up with the climate of the late 20th century. As for Dr. Benbow, he seemed so sincere in his advocacy for the drug, so replete with reassurance, that his position must now be clarified. Did he critically review the relevant scientific evidence before making these claims? Was he a leader in some cynical process, or kept well ignorant and brilliantly coached in his denials? The latter seems much more probable, but we need to know for sure. Are these horrible and damaging drug disasters driven by knaves, fools, or victims - or some, none or all of the above? The GMC must now rise to the occasion: we need some definitive view.

Secondly, what of the proposed prosecution of GlaxoSmithKline by the UK authorities (led by the Medicines and Healthcare products Regulatory Agency)? In the USA, civil actions will progress later this year, seeking to link the now damning factual evidence with tragic human consequences. But in Britain, are we now due for a replay of Prime Minister Blair’s recent decision to abort the bribery investigation into British Aerospace (BAE), on the grounds of national interest and security? What is the MHRA up to? Their last word (7 April 2006) was this – but what’s new?

"The conduct of the investigation required the Enforcement Division of the MHRA to consider over a million pages of scientific and other documentation which comprised the factual background to the case. A team of medics and scientists from across the MHRA assisted with this. The process of considering documents is now completed and documents are only reviewed now if they come to light as new evidence. Potential witnesses from inside the MHRA have been interviewed and notes have been taken from them, from which statements will be drafted. These statements seek to convert the findings of the review of the scientific and regulatory documentation in to evidence suitable for the conduct of a criminal trial, if appropriate … Once the criminal investigation has been concluded a file will be forwarded to prosecuting lawyers within the legal department of the Department of Health. They will apply the Code for Crown Prosecutors to decide whether or not there will be a prosecution."

Thirdly, we urgently need some proper enquiry into the conduct and effectiveness of the UK drug regulators themselves - the Medicines and Healthcare products Regulatory Agency (MHRA) - in line with the 2005 recommendations of the Parliamentary Health Committee, in its report on ‘The Influence of the Pharmaceutical Industry’. The evidence from this and earlier Panorama programmes hugely underlines the importance of this main recommendation:
"During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency’s attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA …"

This may seem a tall order, but so much seems badly wrong. This Panorama programme was a potent reminder of that – an emphatic, evidence-based and well-focused scream for medicines that honestly do work.

Declaration of interest: I have a critical, passionate and long-standing interest in the SSRI antidepressant story: see Medicines out of Control? I played no part in the making of this Panorama, but undertook (with Dr Andrew Herxheimer) an analysis of viewers’ emails for the second programme in the series, for which I was paid about £1,350. I was also engaged (2004/5) as a specialist adviser on the Parliamentary Health Committee enquiry into The Influence of the Pharmaceutical Industry.

Charles Medawar
30 January 2007

Read more of Charles Medawar's brilliant website, Social Audit, HERE

____

Fid




Related links:

Seroxat update 14 Sep 06 Panorama

Secrets of the drugs trials: Transcript 31 Jan 07 Panorama

Taken on trust 21 Sep 04 Panorama

Seroxat: Emails from the edge 28 Apr 03 Panorama

The secrets of seroxat 10 Oct 02 Panorama


SEROXAT SUFFERERS STAND UP AND BE COUNTED

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Friday, May 01, 2009

Are SSRi's Behind Iraq Soldier Suicides?



Source: The Epoch Times

Are VA Protocols Behind Iraq Soldier Suicides?
By Martha Rosenberg

Why are suicides among Iraq war soldiers twice that of other wars?

One reason could be that 80 percent of troops with post-traumatic stress disorder (PTSD) are given drugs that didn’t exist during other wars.

Antidepressants like Prozac, Zoloft, Paxil, Celexa (selective serotonin reuptake inhibitors or SSRIs), Cymbalta, and Effexor (serotonin norepinephrine reuptake inhibitors or SRNIs) are so closely associated with suicide that they carry suicide warnings.

According to published newspaper reports, 660 people, including at least 17 Iraq war veterans, have killed themselves on SSRIs and SNRIs since 1988. Many more have attempted suicide and committed felonies, self-harm, police stand-offs, murders, murder/suicides, and mass murders with high-powered weapons.

Yet what does the U.S. Department of Veterans Affairs suggest as a treatment for PTSD?

“We recommend SSRIs as first-line medications for PTSD pharmacotherapy in men and women with military-related PTSD,” says the VA’s National Center for PSTD’s Iraq War Clinician Guide, 2nd Edition. “Findings from subsequent large-scale trials with paroxetine [Paxil] have demonstrated that SSRI treatment is clearly effective both for men in general and for combat veterans suffering with PTSD.” {what?}

In fact, 89 percent of veterans with PTSD are given antidepressants, and 34 percent are given antipsychotics, according to an article in the June 2008 Journal of Clinical Psychiatry.

In April, Dr. Fred Baughman and family survivors presented the deaths of two veterans who were taking the leading antipsychotic, Seroquel, to an FDA committee that is considering widening the drug’s use.

A January 2009 Journal of Affective Disorders article by VA authors recommends “close monitoring” for suicide for 12 weeks “following antidepressant starts,” when risk greatly rises. While scientific studies continue to confirm the danger of SSRI use in young and bipolar patients, another voice says it’s not what it looks like.

“Suicide attempt rates were lower among patients who were treated with antidepressants than among those who were not,” says an article in the July 2007 American Journal of Psychiatry (“Relationship Between Antidepressants and Suicide Attempts: An Analysis of the Veterans Health Administration Data Sets”) by Robert Gibbons, director of the Center for Health Statistics at the University of Illinois at Chicago. “These findings suggest that SSRI treatment has a protective effect in all adult age groups. They do not support the hypothesis that SSRI treatment places patients at greater risk of suicide.”

This is not the only time Gibbons has gone to bat for the controversial antidepressants.

In an article called “Early Evidence on the Effects of Regulators’ Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents” in the September 2007 American Journal of Psychiatry, he indicated “black box” suicide warnings that the FDA mandated in 2004 for a national rise in young peoples’ suicides. Why? Because the warnings discouraged doctors from prescribing SSRIs!

Of course the “SSRI deficiency” argument is as insipid as blaming the obesity epidemic on the unavailability of fen-phen. But many joined Gibbons in the round of big pharma “I-told-you-sos,” including Charles Nemeroff of Emory University School of Medicine, who was later disgraced for undisclosed pharma conflict of interests.

Unfortunately, Gibbons was wrong. The suicide stats he analyzed did not yet reflect the effect of the black box warnings and he ended up having to tell The New York Times the “early evidence” was actually not evidence at all, but “suggestive.”

Worse, Zoloft-maker Pfizer contributed $30,000 to the article’s belly flop, writes Alison Bass, author of “Side Effects: A Best-Selling Drug on Trial,” in the Boston Globe. Not much return on investment there.

Of course it should come as no surprise—except to journal editors—that Gibbons is financially linked to Effexor-maker Wyeth, now Pfizer, and that his second author, John Mann, is linked to Pfizer and GlaxoSmithKline.

A bigger surprise is that Gibbons is rolling in taxpayer-funded grants from the National Institute of Mental Health, including some to study antidepressants and suicide.

What firewalls are in place to keep pharma “science” from becoming government science, promoting deadly pills?

What protects U.S. taxpayers, public health monies, and, most importantly, our veterans?

Martha Rosenberg is a freelance writer.

May 01, 2009

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Fid


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Saturday, April 25, 2009

DEATH BY PRESCRIPTION





Death by Prescription is the new book by Terence Young. Terence is the founder and Chair of Drug Safety Canada, a research and public advocacy organization based in Oakville. He has been active in issues related to prescription drug safety since 2000, after losing his fifteen year old daughter Vanessa to the Johnson & Johnson prescription drug Prepulsid.

His website, http://www.deathbyprescription.com/ carries the tag:

DEATH BY PRESCRIPTION
A FATHER TAKES ON HIS DAUGHTER'S KILLER - THE MULTI-BILLION DOLLAR PHARMACEUTICAL INDUSTRY

Terence Young’s Book Launch Speech can be read HERE and HERE you can listen to Terence’s April 14, 2009 talk with Mike Stafford, host of the Stafford Show on AM640 Toronto Radio.

Terence, along with Neil Carlin and Mary Ann Murray, have all been campaigning for stronger measures to prevent such deaths in the future.

Their story can be read HERE


I stand right beside Terence, Neil and Mary in their quest for the truth.
You can order a copy of the book HERE



In Death by Prescription you will learn:

That the Canadian Pharmacists’ Association – who have good business reasons to want people to buy drugs, report that between $2 – $9 billion is wasted every year on inappropriately used drugs.

How forty-one drugs have been pulled off the market since the sixties and no one at Health Canada even kept a record of why.

How one drug was responsible for the deaths of as many U.S citizens as the Vietnam War.

How in Ontario, when a drug causes a patient death, the Coroner’s office routinely categorizes that as a ‘natural’ death.

How the big pharma companies cover up deaths by blaming them (in many cases with no evidence) on overdose, another drug, or the patient themselves.

How one decision by a lone drug reviewer at Health Canada could lead to over $100 million in sales for one drug if they approve it, yet reviewers attend closed-door meetings, where no minutes are taken, with drug company executives.

How doctors accept and distribute over $4 billion a year in ‘free samples’ of new drugs that are in fact in Phase Four of clinical trials, and any patient taking a new drug is part of a giant trial to which few have consented.

How the pharmaceutical companies spend $20,000 a year on average per doctor – mostly to “high scrip docs” – to create debts of gratitude the doctors have only one way to repay: by testing the newest and most expensive drugs on you and your family members.


Fid

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Monday, April 06, 2009

SSRi - The Video


Fid


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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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

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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Thursday, March 12, 2009

Reflections on an Obsession

I want to share with the readers of this blog an email that was sent to me from a fellow campaigner, they read my blog regularly and have also faced brick walls when searching for the truth.

What you are about to read is truly heart wrenching. You, I hope, will be able to see just how SSRi's affect not only those that take them but also family members.

The following article was written straight from the heart from a parent who lost his daughter. It echoes that of Sharise Gatchell and Sara Carlin, both of whom lost their lives as a result of taking SSRi's, a drug that they should never have been given.

I told the author of this article that this should be published. The people mentioned in this document are real, but for legal, and other reasons related to privacy - this man and his family have suffered enough, as have others mentioned in the story - hence the many redactions.

I asked the author why he wanted to use Seroxat Sufferers, they said some complimentary things about this blog and myself before adding:

"Maybe you, by posting the document on your Seroxat Sufferers blog will save some lives. I hope so."

The file can be downloaded in pdf format HERE

I have taken the liberty in re-publishing it in its entirety on this blog.

It's long but well worth the read.

Fid

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Here, below is my submission to the select committee 2004-2005, in it's original form,(now firmly lodged in the House of Lords library) I stressed that it was copyright and taken from notes, this in order the committee could not refuse to take it into evidence, The original documents have long since been lost to PC crashes, etc.


----------------------------
Reflections on an Obsession.

10/6/04.

On the morning of the sixtieth anniversary of D Day I had a respite from my obsessional research into the events which surrounded my daughter REDACTED death: As for a brief while I thought of the enormity of that assault on Hitler's Atlantic Wall defences.

I wondered at the sheer enormity of the task. At the stark horror and at the courage and determination of those who fought that day. Of those who died. And of what we owe to them and to that battles successful outcome.

I thought of the events which had led to that momentous day. Of the blundering foreign policy and diplomacy of self-interest-orientated nation states, which led to the rise to power of Hitler's Germany, with all that evil regimes monstrous consequences.

The reason that D Day was able to, and did succeed despite the high cost, was that the price of failure would have been immeasurably higher.

I remembered relating these facts to REDACTED. It was the year of her O level examinations, she was given “Hitler's Germany” for her history subject matter, and I recalled the way she quite shamelessly bullied, teased and cajoled me into all but actually writing the text for her examination essay, and it came as no surprise when We received an A grade. I remember the poignant regret in me, as I watched some of the child in her change as she learned how the Nazis came to power and she learned of the atrocities of Hitler’s Third Reich. And I recall the pride I felt, as I saw her develop a personal resolution that such a terrible thing should never happen again.

REDACTED learned of the process of natural justice, from the decision of the Allies to try war criminals, and the resultant Nuremberg Code. And the formation of the United Nations Charter and told me that she was going to be a barrister.

Her further A level studies including law, grammar, history and literature, took her beyond my limited knowledge, yet she still included her family in her further education and I remember her humorous observations on Cider with Rosie reducing her family to helpless tears.

At that point I broke down. Tears induced by other emotions than merriment streamed down my face.

They were the tears of grief. Gradually, although my sense of loss was a tangible knot of choking pain, the grief changed to a sense of outraged indignation and I realised that I had drawn a parallel between my reminiscences and my families current plight.

The War in Europe was the result of a nations schizophrenic support for a madman. The research into REDACTED Death, which I have been engaged in for over three years, was instigated by the corporate schizophrenia of a pharmaceutical company and my thoughts returned to the time of my daughters death and of how it came about.

Having taken two sleeping pills the evening before, I was a little groggy when REDACTED my wife woke me in the early hours of the 21st May 2001. I recall being quite confused by the fact that she was dressed in day attire and as I became more aware, the fact that she was fully clothed. REDACTED told me that REDACTED was being taken to REDACTED, our local hospital, and told me to hurry up and dress.It occurred to me that REDACTED had suffered a relapse into Guillian-Barre-Syndrome (GBS), which she had previously suffered in 1991. But as I was dressing and on the journey to the hospital, REDACTED related to me that REDACTED had collapsed and had gone into respiratory and cardiac arrest. I became fully awake as she related to me the fact that she, and our daughter REDACTED had performed CPR on REDACTED until the Para medics arrived.

The 13 mile journey seemed endless, yet oddly, I don’t recall arriving in the hospital, or the intensive care unit where they had taken REDACTED.

We were allowed into the ward and saw that REDACTED was on a life support respirator. As I stood beside the bed and looked at REDACTED, I somehow knew that we had lost her: But one of the anaesthetists informed us that they believed REDACTED had taken an overdose of the Selective Seretonin Re-Uptake Inhibitor (SSRI) Cipramil, and the treatment regime would be supportive therapy until she woke up. Gastric lavage was mentioned but disregarded as being dangerous.

Over the course of the next few days, and from as far as New Zealand, family members and friends arrived at the hospital. Those few days were a strange and even surreal time for everyone. For my part in the main, trying to be supportive to my wife and children.

During the first morning an Acting Detective Constable giving his name as REDACTED, turned up and questioned family members about what they knew of the events leading to REDACTED admission to hospital. I regarded the timing, his attitude and his persistent harrying of my family as inappropriate. I say the first morning, but time and circumstance, again became relative, sometimes it seemed to slow, and then literally fly away, so I cannot be sure of exactly when the Officer turned up.

I do remember not having a clue of what the Physicians meant when they told us that “REDACTED has taken an SSRI“, but was alarmed when I overheard the term - “half life of 36 hours”, and “16 hours to get information from the poisons unit at REDACTED”

These comments were to have a crucially important bearing on the future of my life and my families lives.

As hours became days, it became very apparent that REDACTED condition was deteriorating. I recall REDACTED husband REDACTED covering her feet with little ankle socks to hide the lividity of congealing blood in her extremities and his constant and passionate attempts to get her back and similar pleas and prayers from all of the family.

But her return to us was not to be, and after one young anaesthetist’s emotional outburst “this all a waste of time” (This was a Dr. who had helped save REDACTED life at the time she developed GBS in 1991.) We gathered around REDACTED bed, to be with her and surround her with love and support. The heart monitor went flat-line and it became unbearable for us to watch the respirator artificially pumping air into REDACTED chest.

REDACTED and the nurse in charge went to the switch. REDACTED our youngest son realised what for, gently covered his mum’s hand and together they turned it off.

As the life left REDACTED body, she gave my hand a gentle squeeze. As I felt that gentle pressure I heard REDACTED last words. In my mind, I heard her! In a calm and gentle but very firm manner, she said, “I didn’t do this dad!”

There had been many such incidents of, for want of a better term, telepathic communication in my life, and I shall relate one which I had .previously had about REDACTED.

It was 1991 and the year of REDACTED A level examinations. She was excelling and revelling in her work and life in general. REDACTED enjoyed playing hockey for her school, swimming and other extra curricular activities, she also had an active social life and had developed a relationship with a young man.

But then: One day REDACTED became ill, at first we all thought that she had contacted a flu bug, but asked our GP practice if one of the Doctors would attend. One of the junior partner GP.s came out and concurred that REDACTED had influenza. By the next day her symptoms had become worse. Again we asked that a doctor come. And the second junior partner called to see REDACTED. He said that in his opinion REDACTED was a bit depressed (pressure of work, her boyfriend had just left to fight in the Gulf etc.) We were a little unhappy with this and again telephoned the surgery. Dr. REDACTED, the senior partner came to see REDACTED. I recall he took REDACTED history in our kitchen with a proffered tumbler of whiskey in his hand. Dr. REDACTED, now deceased, although an eccentric, with a weakness for a good malt, was a much respected and liked man in our community and a good Physician.

After the almost obligatory libation and a little gossip, he examined REDACTED and came to the conclusion that something was affecting REDACTED nervous system and had her admitted to REDACTED Hospital.

REDACTED was duly processed into a ward and examined. Yet again, flu and depression were the suspects and she was put under a regime of observation. During this period, there were many messages of support and empathy from her school and friends and these were duly reported to REDACTED.

On what was to be her last evening on the general medical ward, I was taking REDACTED and REDACTED to visit REDACTED when I had a “telepathic experience.” It was so overwhelming that I felt bound to relate it to REDACTED, which with some trepidation, I did. “If we don’t do something, we’re going to lose her!” I stated.

As I previously mentioned, the journey to REDACTED is some thirteen miles, and after saying that, I spent near on seven of those miles in something which must be very close to purgatory.

Eventually, an uneasy calm prevailed in the car, after a decision to ask the doctor had been agreed. REDACTED did this soon after greeting REDACTED. And in due course I was asked to see the Registrar, a Dr REDACTED, in his room. “Your wife tells me you are very concerned about REDACTED” He said, gripping my hand with one of his and clapping me on the shoulder with the other. “Well I can tell you that as far as I can tell, REDACTED doing just fine. In fact she’ll probably be home tomorrow boyo.” I mumbled something in excuse, through choked down tears of relief.

If these telepathic experiences are a form of schizophrenia, then thank the gods for inflicting it on me.

REDACTED consultant was called to see her and to cut a very long story short, within two and a half hours, and after an anesthsatists best, but unsuccessful attempts to entubate REDACTED on the ward, REDACTED, REDACTED, I and various members of staff were running through cleared corridors to waiting lifts with REDACTED bed, to a prepared place in the intensive care ward, where she was put on life support. Her Consultant, Dr. REDACTED, explained to us that he suspected that REDACTED was suffering from a syndrome called GBS, (Gillian-Barre-Syndrome) which, in brief, was the bodies immune system acting incorrectly and attacking the myelin, or the nerve sheathing and that the process could, in some cases, lead to total paralysis.

The next day, March 1st 1991 REDACTED was transferred by ambulance, with a REDACTED Police escort, to the Intensive Therapy Unit of REDACTED Hospital, a centre of excellence of treatment for that terrifying disease. And there she stayed for the next six months.

Apart from the movement of one eye REDACTED became completely paralysed. The staff informed us, that although as the name of the ward implied, the treatment would be highly intensive, in the main it would be supportive and that eventually she would regain most, if not all of her movement.

I began to feel totally helpless, superfluous and depressed but with REDACTED and the families help and interaction, fought off the self pity and realised that if REDACTED were to come out of this a sane and whole person, she would need a proactive support system and the act of communication would necessarily be paramount to this process. My brain went into overdrive and I remembered seeing two plastic covered cards in the ICU at REDACTED, each having half the letters of the alphabet on. And improving on this, I made five sets of letters, representing portions for example, A to E being No 1. F to J=2 etc. We put this system into practice and successfully communicated with REDACTED with it until she was, some twelve weeks later, able to talk again. (REDACTED was a lot quicker at this than us.)

At no time during REDACTED disability did she become depressed. I believe the excellent staff of the unit would unreservedly concur with that statement.

The Head of Nursing was Mrs REDACTED, whom REDACTED brothers and sisters, nephews and nieces, would come to know as Aunty REDACTED, and to REDACTED and I as REDACTED. And upon more than one occasion by REDACTED , as Ratbag…. Ratbag! was the first word that REDACTED squawked via the airway access plug, left by the tracheostomy, after she was weaned off the ventilator.

REDACTED has the proverbial heart of gold, but is totally without mercy in administering nursing care to patients, regardless of how manipulatively they are able to communicate their disapproval, via the alphabet; or in any form. And although REDACTED was able to wind members of her family and most members of staff around her paralysed little finger, she couldn’t touch REDACTED sense of duty, but on more than one occasion I saw a tear in her eye, as she and other staff, gently tended my daughter.

In the main, the staff put up with REDACTED family, at first perhaps with an exasperated sigh, but later I dare to believe with a certain enthusiasm. I was even taught, and applied with a very shaky hand, the clean hand principle of using a catheter to clear REDACTED constantly obstructed airways. We were also conversant with most of the procedures and applied medications that became a part of REDACTED treatment.

About ten weeks on, we noted that a new medication had been added to REDACTED chart. It was called Amatriptyline, and consulted the British National Formulary of medicines. To our consternation we discovered that it was an anti-depressant.

It had been scripted by one of her consultant anaesetists,and I asked why he had prescribed it. He explained in very lay terms the process of brain activity and how he hoped to short circuit some of the pain receptors as the extremely painful process of regrowth of the myelin took place and emphasized that he did not script the medication for depression so the psychological side effects which sometimes accompanied this medical application should not apply to REDACTED as she was paralysed and still on intensive life support. She was hardly in a position to commit an act of self harm.

Although REDACTED was to spend many months in hospital, and many more attending as an outpatient. She regained her mobility to a great degree and this continued to improve with physiotherapy and general use until the day of her being prescribed Cipramil.

It was obvious to us that no person could go through an experience like REDACTED and not be affected by it, and she was affected. REDACTED had suffered a near death experience and twelve months of her life had been if not wasted, then delayed. She had suffered many necessary but never-the-less, humiliating events and in a very paradoxical way it changed her attitude and outlook on life. Although for a short while REDACTED attended college to catch up on her schoolwork, she no longer had the incentive or the ambition to help her fellow man, and soon left it behind.

REDACTED now thought that it was more important for her to live and enjoy her life and to that end concentrated her efforts. I for one didn’t blame her. I don’t mean that REDACTED didn’t care, in fact if anything she became more caring. She became more involved with family life, and in particular with the upbringing of her nieces and nephews. I doubt they will ever forget their Aunty REDACTED. She became more orientated towards friends and having a good time. Her intellect channelled itself into humour and laughter.

REDACTED would no longer suffer a fool gladly and her sharp and sometimes acerbic wit served that purpose well. REDACTED had always had a very stubborn personality and if anything her encounter with disability made this more so. She was always quick to take offence and that didn’t change, but she now seemed to find it easier to forgive and forget.

I’ll give you two examples of this different philosophy that my child had developed … The clichĂ©s: “Life’s to Short” … and … “Your cup’s always half full.” These were the new tenets of REDACTED life.

As a child, REDACTED had undergone one of the most distressing and debilitating experiences that it is possible for a young person to suffer and she came through with a wiser and more developed personality.

Although REDACTED would suffer from a permanently damaged peripheral nervous system and would suffer two further, but very minor episodes of GBS, she led a normal, indeed in some respects better than normal, life. The most apparent symptom of the Post GBS being pain and numbness in her feet, and to a lesser degree her hands. Sometimes she also suffered from fine tremor, which would become more apparent if she became ill or upset.

As time passed REDACTED developed a permanent relationship, as things turned out, with her husband to be, REDACTED, a part retained fireman with the REDACTED Fire Service, and her social life orientated itself more toward that relationship and fire service functions and events. I have to admit that at the time I didn’t approve of this young man. I didn’t believe that he could support her or look after her properly. But even had I voiced this disapproval, REDACTED, being REDACTED, would not have cared less. And of course she could always change her mind. Couldn’t she? And she was off to New Zealand for three months to visit her elder brother REDACTED and his wife REDACTED . REDACTED family and their mutual friends. REDACTED had a great time for the three months visit to Kiwi and was involved in many adventures whilst there backpacking North Island, including of all things, a freefall parachute jump. She had a great Christmas and New Year, but she missed her family, her home and REDACTED very much.

When REDACTED returned, they married. On the 18th of January, they got in his little car went, to REDACTED , and in her words “We just didn’t want any fuss, so we grabbed two very surprised, but happily pleased people off the street, for witnesses. Got married, shook hands all round and left” That was REDACTED and REDACTED wedding. “Sorted!” She says smiling and radiantly happy.

In the course of time, my reservations about REDACTED were dispelled and I came to like and then respect him. All the family became involved with his efforts to join the REDACTED Fire Brigade and took pleasure and pride in his success at achieving this aim. REDACTED travelled to REDACTED for his passing out parade, which because of all the hours they had spent together revising for the entrance examination and her ongoing support for him during his initial training, she regarded as being a joint honour. “All he had to do was wear his uniform and look pretty!” She complained to me with a smile. “I did all the hard work, getting him to up to par.” They adored and doted on each other but in the September of 2000, REDACTED went for a night out with the boys, got drunk and committed an act of infidelity. Being drunk is no excuse for what occurred that night. But at least it’s a reason for an insanity. Believe me, I know! (Not the infidelity, I hasten to include … I mean the alcohol-related insanity) REDACTED did an even more stupid thing when REDACTED spotted sand in his undies and becoming suspicious, asked him about it. He admitted his infidelity. REDACTED was incensed, and insisted that REDACTED should tell her who he had been with. But sometimes REDACTED ideas of natural justice were not concurrent with the laws of the land, and knowing this, REDACTED baulked and invented a cock and bull story of some stranger having come down for a holiday, presumably, in the mistaken hope that REDACTED wouldn’t find out and would not get put in jail for grievous bodily harm, or worse.

He didn’t know REDACTED as well as I did. Had he of asked me I could have told him that she would find out. That’s my single minded, stubborn daughter. However, she forgave him and in due course, he received a conditional discharge, But she didn’t forget the matter of who? and, as will become apparent, was not going to forgive that one!

So life went on. In this, the narrative of my obsession, one would imagine that there was nothing else in my life apart from REDACTED, which was obviously not the case, and whilst REDACTED needed her mum REDACTED, me and other family members. It was not to the exclusion of other things and people, and of course we also had other things to do and interacted as a family does. There was also the inter-relationships with other people from many walks of life and circumstances.

But this is about my obsession so to that I’ll return. To that monster and it’s mixed memories and emotions.

REDACTED returned to New Zealand in February of 2001 after a telephone call from REDACTED on the 6th of that month announcing the joy of the birth of his and REDACTED daughter REDACTED.

REDACTED booked her ticket that day, and was in Auckland to greet her new niece and REDACTED when they arrived home from the hospital a few days later. Again, REDACTED had a nice time in Kiwi but apart from almost sedate visits to tourist sites, she spent the majority of her time getting to know the baby. Whilst there, REDACTED was given the honour of being made REDACTED Godmother. When she returned home she her mum, her sisters and her sister in law, were absolutely full of baby talk, nappies, feeds baths, etc. I found it amusingly touching but a little nauseating. I believe that experience convinced REDACTED that she wanted to become a midwife, but I’m afraid I couldn’t help her much with that one. Visions of legs of screaming mums-to be in stirrups, and newborn infants squealing does nothing good for my constitution.

She and her mum and sisters talked about the matter!

REDACTED was one of those people who can’t pass a beggar without putting her last coin in the bowl, and has been known to drive out of her way to give a lift to someone who lives half a mile from where she’d picked them up.

I’m happy to say she has that in common with the rest of her family.

That was the case with one REDACTED . REDACTED did, on many occasions give this woman and her child a lift home from REDACTED to the little council house where she lives.

When REDACTED found out it was her that REDACTED had been with, she went to REDACTED house and confronted her. The woman brazenly and without apology admitted the offence, and at about this point, REDACTED lost her temper, not only had the trollop seduced her drunken husband, she’d added insult to injury by accepting offers of lifts from REDACTED.

My daughter hit that woman so hard, she broke her hand doing it.

Of course, there is a price for all that we do in life and when REDACTED saw the damaged face of that pathetic woman, she was quite contrite. There is no doubt the thought of retribution from the law played some part in her contrition.

And when REDACTED realised that her hand was broken, REDACTED injuries increased in REDACTED imagination, proportionately relative to the pain from her damaged hand, which was indeed, very painful.

REDACTED attended REDACTED General Hospital and after being administered an opiate, her offending limb was put into a plaster cast. REDACTED sported this cast to her family with mixed emotions. “That should put a stop to her (REDACTED) trying to take other women’s husbands. But: Oh mum what about the police?” and “I’ll never get to be a midwife, if I have a criminal record.” Her mum reassured her about her future and fussed, with open admiration, over her plaster cast.

I will add here that the woman in question had previously been held responsible for the dissolution of at least one marriage. The husband having been unfaithful with REDACTED, left his wife and two children to live with her. He died some time later of cancer. I don’t believe any of REDACTED family or friends had a great deal of sympathy for any injuries which that woman suffered. For that matter, I doubt if the police did either.

But … A whisper rippled through the community that the local bobbies wished to contact REDACTED. To this day, I don’t know if the police actually did inquire as to REDACTED whereabouts, but such is the nature of gossip in a place like REDACTED, that REDACTED was quickly made aware that this was apparently the case.

REDACTED and REDACTED telephoned the local police station and were informed that a complaint had been laid by REDACTED and an officer would like to see REDACTED regarding that matter. An appointment was made for them to meet the local officer on the following Sunday. I don’t know which officer saw them that day but the result was that REDACTED agreed to receive a police caution, which satisfied everyone, except REDACTED. Whose opinion no one cared about, under the circumstances.

This is a short history of my daughters life and the escapades which led her into attending our local GP.s surgery on the following Friday evening, with the fatal consequence which resulted from that visit.

Why did REDACTED go to the doctor on that fateful Friday evening? Maybe we’ll never really know. However, I have made certain assumptions based upon the fact that I knew my daughter and knew of the previously mentioned facts.

With absolute certitude, I can state that my daughter was not clinically depressed. Any attack of conscience which may have bothered REDACTED, would have been mitigated and mediated by her sense of right. She had satisfactorily resolved her anger over REDACTED aberration, some time previously and they were doing fine.

REDACTED says in evidence to the inquest: “REDACTED had a down day” And we know she was still in pain from the broken hand. We have to remember the post GBS symptom of pain in the extremities and the fact that her hand was still in plaster. Her GP must surely have asked about that before she wrote the script for the SSRI Cipramil, which after all was a medication designed to treat the severe effects of Clinical Depression, and even in it’s own prescribing notes at that time, warned of possible side effects.

The opiate which had been administered, prior to the application of the cast, was still present in trace quantity at the subsequent post mortem. But it added to a media myth of “a cocktail of drugs and alcohol” In truth Cipramil (Lundbeck AS’s main source of income, and advertised as safe in overdose) killed REDACTED.

REDACTED had that cast on when she died and now I know some of the rules about death and medical treatments and appliances going with the body to post. I often wander why the pathologist Dr C G B REDACTED didn’t include that fact in his evidence to Mr P REDACTED. Her Majesty’s’ Coroner. He did, for some unknown reason, include this damaging statement in his written conclusions: “This hypoxic episode was clearly due to the deceased’s having deliberately taken a cocktail of drugs at home prior to admission to REDACTED.” This piece of fiction, was sensational in nature, inaccurate and detrimental to our cause, so we instructed our, Then, solicitor, subsequently fired, Ms REDACTED of the firm, REDACTED, to have the statement removed from evidence. The offensive and inaccurate statement was withdrawn, but was still reported as fact by the media.

Earlier in this record, I mentioned overhearing the terms “SSRI and half life” This and the complete and utter conviction that REDACTED did not, deliberately, take her own life, led me to the family Personal Computer and enter the keyword search SSRI. It returned a catalogue of Severe Adverse Reactions. Including for suicide ideation, completed suicide and many Pharmaceutical Company adverts for the drug, anecdotal stories about the beneficial, and the not so beneficial effects of taking the drug, offers to sell me the drug on-line, a story of a man who had slaughtered his family and himself, after being administered the drug, (Now known to me as the Tobin case.) cases of complaint that the drug had caused dependence. (Some of which appeared true, whilst others seemed to me to be a transparent example of our ever increasingly litigious society.) And reports for and against the use of the drug, and some research data by eminent researchers, psychiatrists, physicians and various institutions and universities.

Thus it was that I took a bite of the apple of knowledge of clinical research into the safety and efficacy of SSRI’s And; thus it was that the monster of my obsession came into being.

Almost from the very beginning I realised that it was wholly unacceptable to prescribe such an invasive psychotropical application to people such as my daughter, but in the naivety of my early research I believed the drug’s properties might have a therapeutic value for clinically depressed patients. Consequently, I trod if not softly then with great care, for who was I to take a viable treatment away from a profession which did great good for those afflicted by that terrible disease which is known as depression? (And it is terrible and it is sometimes horribly disabling Who was I to contradict the evidence presented by the great and good of the Pharmaceutical Industry and what was at that time that most August of bodies the MCA? (The Medicines Control Agency.) Prior of course to the dissolution of that body, after a public outcry of internal corruption. And SSRI’s were safer than the older types of medication, remember Amatriptyline? That’s one, in the older, and according to the drug companies, less safe, class of antidepressants known as tri cyclics.

Those I’ll leave to the academics to continue their argument about.

For you see. That is the irony of what has happened to the ongoing saga of the Safety and Efficacy of all SSRI’s. It became an academic’s argument, and that argument is based on a false precept. That precept being that the drug worked. It never did. The science behind the drugs clinical application was tainted with the corruption of the corporate schizophrenia of the pharmaceutical companies research and development, and sales and marketing departments. And the lack of science behind the billions gained in revenues, has only recently come to public attention.

I learned that for the year 2001 (and this is from Lundbeck’s 2001 Annual report.) “Lundbecks revenue in 2001 was DKK 7.656 million, up 36% on 2000. The increase was driven by the continued growth in sales of Citalopram in Europe, Canada and Australia and in the USA in particular where Citalopram is marketed by Forest Laboratories, Inc.”

But I still tried very hard to gain information from the elegantly constructed mathematical charts and graphs, from which experts extrapolate and disseminate research data, and to some degree did indeed get some useful data. Should you be interested, read Dr David Healy’s work, and the Meta-Analysis of all published and unpublished studies into the safety of SSRI’s by Jureidini and colleagues. There are many others.

But the real evidence was there for me to see from the beginning. It was the evidence given to me by my daughter’s death. It is true that REDACTED shouldn’t have been scripted the SSRI. Cipramil. But the obvious having been stated again. It should have been safe. And it was the duty of the MCA to ensure that it was safe for her GP to prescribe, and for REDACTED to take.

To the academics, I say. Get away from your charts, graphs and the tainted non- evidence of the drugs industry. They are after all, profit orientated companies. Get your evidence from a real life source, the people who have been prescribed it and some who suffered as a result and the people left bereft by grief.

Extrapolate some data from the Inquests where Accidental Death, Suicide and Open Verdicts have been returned, and a so called therapeutic dose of an SSRI would certainly look there for evidence of the psycho-active properties of alcohol and THC (cannabis) I contend you’ll get similar results of SSRI-substance related death.

Of course it’s possible that pathologists/toxicologists do not record such therapeutic levels of SSRI. I say to the MHRA. (Medicines and Health Regulatory Authority. The Phoenix of the MCA ) Make it mandatory that they do so in future!

Do not grant licences to new drug applications, particularly psychotropic/active application, where the pharmaceutical industry has not included all data, regardless of that industries alleged fear of “Proprietary data and industrial espionage.” It is not the Industry or the professions that you work for, or have a duty to. It is the people, and the Government that the people have elected. They are the source of your income, The people are also the only source of income of the Pharmaceutical Company Giants.

It is to the people that the MHRA, have a duty of care.

However, I’ve again strayed from the monster of my obsession and it calls me back.

So I have to return.

When I had first tasked the family PC with that simple keyword search SSRI, Cipramil, many of the results which appeared on the screen were testaments to the Danish pharmaceutical Co. Lundbeck. This was a firm I wanted to learn a lot more about!

Lundbeck A/S of Denmark was the original manufacturer and licensee of Cipramil, (Citalopram) the version of SSRI which had been administered to REDACTED: Three days prior to her collapse and subsequent death.

I came to know a great deal about this company, it’s marketing strategies and it’s collaboration with the US firm, Forest Laboratories Inc, which led to Cipramil obtaining an FDA Marketing licence in the US, and as a result, acceptance by most of the rest of the worlds prescribing and licensing authorities.

After employing Erik Sprunk-Jansen, and a lot of infighting amongst Executive Officers, (“At the beginning I was called the Butcher from Greenland” he Quotes) H Lundbeck sold off their antibiotic market share to bankroll the sale of Cipramil, and went from a Net profit of 21 million Danish Kroner, to a multi-national Multi Million Dollar Co. “By the year 2000 sales of Cipramil/Celexa amounted to 86% of the Companies total turnover.”

In Lundbeck’s web-site, amongst a panoply of self-congratulatory advertising literature, I found “A profile of Erik Sprunk-Jansen,” who at the time of discovery was Lundbeck’s chief executive officer. an ex mining engineer. His employment as managing director with Greenex AS, having come to an end when their mine in Greenland ran out of ore, or so his profile says, but paradoxically, a Swedish company called Boliden bought Greenex and continued operations for some years.

In the same remarkable document I found, and this is verbatim. “Cipramil - or the “happy pill”, as it is popularly known (an expression that is strongly disapproved of at Lundbeck) - is an outstanding drug. First of all it works and is easy to take. But equally important is the fact that it has no side effects, even if it is taken together with other medicines,”

The simple fact is that no SSRI works as an effective treatment for depression. All! And there have been many, (Independent of pharmaceutical industry.) research studies report that SSRI’s do not work better than placebo - Sugar pill - for that distressing condition, and there can be very serious reactions with concomitant medications.

There are also many serious and even fatal side effects, including for some, Akesthesia, a horrible condition itself, dependence, confusion, aggression and increase in suicidal thoughts. The incidence of completed suicide where an SSRI has been applied is as great as five times more than an applied placebo.

But, oh how Cipramil changed Forests’ fortunes, when that Co. gained a marketing licence to sell it. On it’s back, they employed 200 sales staff and trained them up to sell Cipramil/Celexa to the American Public. (In the States, direct marketing is legal) It now accounts for 70% of Forests Gross income, which at March of this year stood at 1.6 Billion US Dollars.

The head of Forest Labs. Inc. is Howard Solomon, who suffered a tragic loss when his wife committed suicide. She took forty seconal. Understandably, Howard’s son Andrew was a severely depressed young man.

The thing that I found odd, and indeed still do, is that Howard Solomon purports to have come across Lundbecks’ Cipramil in his quest for a treatment for Andrew, and he discovered this wonder drug (Cipramil) in the mid nineties, but even though his company marketed it in 1998 and he implies that he was looking after Andrew, Andrew has never taken Cipramil/Celexa, yet Andrew certainly suffered another bout of depression in 1999, and Cipramil was available to Andrew from the mid nineties and Celexa was manufactured by the family business, since pre 1998.

Part of the pre-market application for licence reports to the FDA that 20000 patients had been treated with Cipramil, but only two fatalities occurred whilst taking only Cipramil. But when I read the report into the meta-analysis of all studies into the safety of SSRI.s for children. Jureidini and colleagues. I found that approximately 1 in 500 of the group of 7 to 17 year old children who had taken Cipramil died by suicide. By the way, no SSRI has been licensed for children by the MCA, (as was), the MHRA or the FDA: But, because it has been licensed for use for over 18 years, they can be used “Off Licence” for children, and is, by some physicians.

Cipramil is now banned for children to 18 yrs. ( But of course, not off licence.) But what of 18 yrs and 1 day? If that were not so potentially tragic, it would be laughable!

The monster of my obsession has driven me to the limits of human endurance and into the deepest of depression and a great deal of debt: One gratuitous example of which, is a subscription to the New York Times Online. I shall relate part of an alert sent by that excellent journal to me on the 21st of June written by Barry Meier. He writes that the American Journal of Psychiatry reported to it’s 37000 readers test results for Celexa/Cipramil indicating it could help children and teenagers. The studies authors had been asked to divulge any financial ties to the marketer, Forest Laboratories Incorporated, which sponsored the trial. And the report was sent to reviewers who checked to make sure that the article reflected other relevant research about the use of anti-depressants for youngsters. Three of the authors were employed by Forest. The study did not report or include for a study run by Lundbeck from 1996 to 2002 which although not reported, was eventually discovered last year on Page 96 of a textbook, in of course, Danish, and found that Celexa did not help depressed adolescents anymore than a placebo.

(It seems to me that at this point it becomes a case of the devil take the hindmost. profits aside, or that Lundbeck and Forest‘s spokespersons didn‘t synchronise, as it were)

When questioned, a spokesman for Lundbeck said the company reported the trials to Forest, although he couldn’t say when. And Forest executives did not respond to written enquiries from the Times seeking that information. (You can’t blame them really. The State Attorney General for New York is currently pursuing GlaxoSmithKline, another pharmaceutical company for not disclosing negative data about their SSRI. In relation to a matter of massive fraud.)

My monster demands that I relate another thing which I learned, about yet another pharmaceutical company in the course of researching the matter of REDACTED death. That household name Astra (Now Astra/Zeneca was the first company to successfully market an SSRI. Yes! there was an SSRI before GSK.s Seroxat! It was called Zimeledine, and that one was a wonderful cure for depression as well, but don’t tax yourself trying to find out where you can get it prescribed. It was withdrawn because it killed people. And it had a most peculiar side effect. It caused Guillian Barre-Syndrome!

REDACTED had that devastating illness in 1991 didn’t she.

When I look back on the media coverage of matters pertaining to REDACTED death, (and indeed the scarcity of same, at least on our part and despite our best efforts.) in the main they oozed sympathy towards us but didn’t address the question of whether Cipramil could have killed REDACTED.

At the time of the Inquest into REDACTED death, which was held on the REDACTED April 2002 and at which an Open Verdict was recorded, the media did report some of our complaints against the way that SSRI.s were being so freely prescribed. A local paper even went as far as to print my intent to have prescribing notes changed, but in my opinion, as “A cocktail of alcohol and drugs.” was mentioned, ( Which although not true, was mentioned at inquest, and therefore, could be and was reported in the media.) anything positive which may have resulted, was negated by that sensationalist statement, so there was no general outcry. SSRI.s were still good, efficacious and safe medicine.

At the time of the launch of our action group at the offices of REDACTED in June 2000, BBC and HTV news, on a share basis, filmed the proceedings for 2 hours. Most of the safety reservations, side effects and pecuniary interests of the usual suspects were gone into in some detail and were recorded on camera.

However, all they showed that evening was a short clip of REDACTED giving a warning not to stop taking an SSRI because that could be dangerous, and an interview with one Dr REDACTED, who at the time of being filmed, was in his surgery writing a script, ostensibly for Cipramil, whilst nattering on about how good SSRI.s in general, and Cipramil in particular were
.
Two years on and what do REDACTED and I see on BBC REDACTED news? REDACTED, Spokesman for the REDACTED in REDACTED, lamenting to the camera that GP.s are in the sad position that they “feel that they have to prescribe SSRI.s to patients, because the waiting list for specialist therapy is 6 weeks.” But this of course, was after the warning from the MHRA regarding the use of SSRI.s in young people.

I lament something about that too. Why didn’t the man do a little research at the time of the inception of the action group? and as he must surely have at least known about the ongoing controversy, why didn’t he keep his mouth shut?

A lot of people were probably prescribed SSRI.s on the back of that interview. And a little information for you personally Dr REDACTED. Do not prescribe an antidepressant to any patient, other than for moderate to severe depression, using at least one of the appropriate depression scales, and then, only with the greatest of circumspection! And only then, if you are prepared to give a lot of follow-up care.

For those patients whose illness permits them to attend a surgery, it will take about half an hour for an average person to fill out a depression scale inquiry form and some time for an experienced medical practitioner to evaluate same.

On the day of the inception of the action group, some enterprising person had informed Lundbeck UK, and asked them for their response. Their spokesperson was duly sympathetic with the families grief. Then added, this unfortunate young lady (REDACTED) had committed suicide. She was depressed and suffering from an STD. Sexually Transmitted Disease. REDACTED publicity dept had ensured that the action groups inception got in the news. It did. Their advert and Lundbecks response went out on the hour every hour until the evening news.

Of course none of this was true! REDACTED GP said in evidence at the inquest, that REDACTED was not suffering from a STD and that REDACTED had not presented to her as being suicidal.

In Dr David Healy’s evidence to the court, he states that in his opinion, REDACTED would not have been depressed, and had she presented to him as a trial subject, she would have been classed as a healthy volunteer. He also made the damming statement, That as a healthy volunteer REDACTED was at a two to tenfold greater risk of suicide after being prescribed Cipramil.

That sympathetic statement from Lundbeck grievously hurt four generations of REDACTED family, her husband, and her close friends, but that is the usual measured response from a pharmaceutical company, to a concern voiced about one of it’s products.

In my obsessional search for why my daughter died, I constantly trawled through English versions of international news media and in time came across an article in the Copenhagen Post dated the 4th February 1999, which reported the following … In a Danish Radio documentary, the Special Consultant Carl Hugod lodged a complaint to the Danish National Board of Health. According to the article he did this after examining the research material which Lundbeck had submitted to Denmark’s Licensing Authority, for Cipramil’s first licence application, and then finding a large percentage of the necessary material missing. The Post quotes him as stating. “In my opinion the National Board of Health should never have been satisfied with this utterly disgraceful lack of scientific documentation concerning the drug’s effectiveness.”

Lundbeck’s Claus Braestrup, was unwilling to discuss Dr Hugod’s complaint but in quotes, in the Article, he stated. “Health authorities in 60 countries have approved Cipramil. They have had material available for evaluation with information on every patient, and they have had the opportunity to read the same material as Hugod has, the result being that they have approved Cipramil as a safe product.”

It is patently apparent that 60 countries couldn’t have, and didn’t approve Cipramil prior to it’s first licence application in Denmark, which Dr Hugod’s complaint refers to. It is also apparent that either Dr Hugod and or the 60 countries did not have that data. Dr Hugod’s complaint was after all a “disgraceful lack of scientific documentation.” and the ramification of Dr Hugod’s statement are horrendous! I have drawn three possible conclusions from it.

1. If that data was missing from Lundbecks licence application because they didn’t do the research and they deliberately lied by omission. Then an ongoing “in life” experiment took place, which by it’s nature would have been a breach of the Nuremberg Code, and other laws and international conventions. This would certainly apply to the “20000 patients referred to in Forest’s application to the FDA.

2. If they did the research and stripped out negative data pertaining to Cipramil’s effectiveness, they are guilty of a massive fraud, which same is ongoing.

3. If they did the research and stripped out negative data pertaining to side effects, they are guilty of different crimes, up to and possibly including murder. Remember? I taught REDACTED about the Nuremberg Code for her O Level history exam on Hitler’s Germany. The Code came into being as a result of the discovery of the Crimes Against Humanity, which took place in the Nazi Extermination Camps, and the pseudo-medical trials that took place in them. That laudable and historic document was adopted into the United Nations Charter and subsequently, although modified, into the European Charter of Human Rights paramount in both of which, is the Right to Life.

In the clause of the Code pertaining to Clinical Trials, the sub-clauses read

1. The voluntary consent of the human subject is absolutely essential. (and further on those who initiate Trials) ….It is a personal duty and responsibility which may not be delegated to another with impunity. (And further)

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury, (And further)

10. During the course of the experiment, the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him, that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

If any of my conclusions about the “lack of scientific documentation” and or the stripping out of detrimental raw data, or their non-inclusion, are true. Lundbeck, Forest and their subsidiaries and partners are possibly guilty of breaching the Code and subsequent amendments and articles of the Charters of both the United Nations and European Charters.

It follows that they could, and should also be held responsible in law, by responsible nation states and or by any person where consequential harm has occurred as a result of an application of Cipramil.

My monster has taken me to many dark and previously unknown scenes. Places where I have witnessed the basest of deeds and actions: But for the main part, these deeds have not been perpetrated by individual human beings, rather by their inaction, self importance and even the good intentions of the ill informed. These are some of the fodder of the beast that I call Corporate Schizophrenia. These were also the things that empowered Hitler and his underlings.

It has also taken me to places where courage, hope and goodness reside. There are people who recognise the beast for what it is and fight it. Even in the knowledge that they may never defeat it, they fight, and they are at least modifying it’s behaviour.

They are teaching it that it cannot be all powerful, and in order to exist in a civilised society, it has to curb it’s appetite.

I hope that maybe and because of these people, that in the near future, clinical trials of new drugs will be more closely scrutinised, and where appropriate will be stopped. and that if a drug is licensed as a medical application, it will be monitored and if necessary, it will be withdrawn.

We the people, need good medicine, it follows that we need a pharmaceutical industry, and we need good science. But … It is absolutely essential that empowered and informed human beings of high integrity and good intent oversee that industry and the science behind it’s products, and hold in check the beast of corporate schizophrenia!

It is my hope that by leading me to write this article, my monster has laid itself to rest, and will to some degree leave me and my family in peace. Peace to grieve over REDACTED and maybe even come to some kind of terms with her death. But you never know. It may come across another beast ………

Correction. In my reference to the evidence presented at REDACTED inquest, I imply that Dr David Healy stated in verbal evidence that REDACTED would have been in the classification of a healthy volunteer.

This is incorrect. However, Dr Healy did submit a written report to the court dated the REDACTED March 2002 which states …REDACTED was at a very low risk of suicide from her nervous problem. The risk of suicide that stemmed from the treatment she was put lies somewhere between 2 and 10-fold higher than the risk from the underlying nervous problems she had.

That risk factor is the same as the Healy-Boardman Study into SSRI effects on healthy volunteers.

WARNING ADVICE. Should you read this and be taking an SSRI and wonder whether you or your prescriber made a mistake; DO NOT JUST STOP TAKING IT. Consult your G.P. or specialist. Discontinuation events can be distressing and for a minority of people DANGEROUS.

Ask your physician to consult the “Healy Protocol.”

This advice may seem an anomaly to the obvious content of this document, but it is a sad fact that once someone is prescribed an antidepressant, whether appropriate or not, and is taking antidepressant medication, discontinuation is best carried out with professional help

Updated and amended (Not Proofed) 10th July 2004 REDACTED

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Reflections On An Obsession. My monster Wakes
24th July 2004 A visit from DS REDACTED

REDACTED called today to tell us that Mr REDACTED of the CPS had decided they would not take the matter of REDACTED death any further.

Rather surprisingly, the news was a disappointment, and awoke the monster of my obsession. (Read the document - Reflections On An Obsession)

I think the monster again became wakeful when the rare gems of REDACTED scrupulously guarded hoard of tears dropped carelessly from her eyes, after she’d read the letter of refusal to prosecute Lundbeck A/S, which had been dutifully delivered to us by REDACTED.

I had expected a negative decision from the day that REDACTED first telephoned REDACTED Police Station and in a conversational manner registered a complaint of Unlawful Death, to what I have ever since imagined to be, a somewhat bewildered and slightly amused officer. I could only imagine his part of the conversation …“Yes Mrs REDACTED… you say your daughter … was killed? … I see. … And which sort of pills did her Doctor prescribe for her? … Cipramil! … Made by Lundbeck, you said?…and these pills are an SSRI? And that is … just let me write that down. Cipramil is a Selective Serotonin Reuptake Inhibitor. Umm! … Well I’ll get someone to contact you”

I temporised the officers’ responses as I watched REDACTED dispassionate expression, whilst she calmly related to him the facts of our daughter REDACTED death.

If that officer has stayed conversant with the complaint and the emergent evidence, I wonder whether he is still just tolerantly bemused.

Since then, many high profile media articles and television programs have questioned the safety and effectiveness of all SSRIs, and as a result of these investigations and ongoing disclosures by interested parties and whistle blowers, the issue of drug emergent suicidality and violence is now an established fact … To the extent that the MHRA has banned SSRI use in under 18yr olds and a suicide emergence warning has been issued to GP.s about their use in the 18 to 29yr old patient group and patient information will shortly include an SSRI drug-induced suicidality warning.

Meta-analysis of all known trials into SSRIs have also shown that in many instances, the drug is not as effective as a placebo (Sugar Pill.) for the treatment of depression.

The drug industry knew of these issues since the late nineteen eighties. Companies knew about the serious side effects of their SSRIs prior to their application for a licence to market them … but chose not to include these facts, because disclosure of such facts would have seriously affected their profits.

The Pharmaceutical Companies sold the medical profession, and thereby theirm patients, The Emperors Clothes.

The Emperors Clothes is a fairytale and a cautionary anecdote, and the only ones to suffer lasting harm, as a result of the story characters gullibility, were the villainous tailors who convinced the emperors advisors that the illusion which they displayed was the most fashionable and excellent of garments, and had it not been for the naĂ¯ve young boy who exclaimed “The kings got no clothes on!", the Emperor would still be promenading in his nudity.

The Emperors advisors had always espoused their great knowledge in all affairs pertinent to the Empires well-being and safety… So … when the world famous tailors presented the suit of clothes, (about which, they’d convinced the court advisors that madmen and the illiterate wouldn’t be enlightened enough to see) the Emperors advisors enthused over the non-existent apparel, which the conmen had so elaborately presented to them.

It’s also more than a possibility that the tailors paid some of the kings advisors to test the suit of clothes for their effectiveness and safety, and return positive comments.

The drug companies continually try to blind us with the esoteric chemical properties of their products and are constantly reinforcing the transparency of the fact that SSRIs work and if we can’t see their good effects, it’s because we’re mentally ill, depressed or illiterate.

They are more greedy than the tailors in the Emperors Clothes and their products can be dangerous.

They pay some eminent medical professionals to endorse their products.

The FDA has only recently and reluctantly admitted there are grave problems where SSRIs are concerned but have been aware of the dangers since the late eighties.

Dr Keith Jones of the MCA assured a colleague, Dr David Healy, that the MCA were going to issue a warning of induced suicidality, including a warning for families of patients, in the year 2000. Had they issued that warning REDACTED would still be alive.

The drug companies have tried to convince us that one suit (The antidepressant SSRI.s) fit most conditions of life and the mind, and if we catch a fatal pneumonia as a result of wearing the nothing of their product … their response is … you had to wear our suit because you had a cold anyway, whether we did or not.

And if wearing their suit of nothing, (taking an SSRI) initiates a feeling which is uncomfortable or embarrassing and makes us ill, or worse … the drug industry will maintain the position that our pre-existing condition, even where there was none, caused such unwanted effects.

Even if we‘re only window shopping for something which might enable us to cope a little more easily with life, we could be prescribed their, one suits all, SSRI and become ill, act aggressively, or end our lives prematurely, through the side effects of their products.

Unfortunately, the reality of the SSRI scandal is that the villains, (the pharmaceutical industry) have not only gotten away with their ill-gotten billions in profits, they are still allowed to market them and any other suits of clothes, (drugs for the mind) they carefully present to our advisors.

Unless, like the tailors in the Emperors Clothes they are taken to task, they will never learn that they must not market unsafe and or ineffective products.

GSK (GlaxoSmithKline) recently made an out of court settlement of 2.5 million dollars, to prevent Eliot Spitzer, The State Attorney General For New York, from taking that company to court for withholding data, which proved their version of an SSRI caused people to feel suicidal, and that their SSRI was not an effective treatment for patients.

All SSRIs work more or less in the same way and have the same side effects.

GSK has a slush fund set aside against legal actions, the 2.5 million they paid to settle Mr Spitzer’s suit was a negligible amount, and a spokesperson for GSK then stated that as the matter didn’t go to a court, their drug was vindicated.

Out of court settlements will not deter companies from selling ineffective or unsafe products, but company directors being hauled before courts for manslaughter, mayhem and fraud, may well do.

I have put the CPS on notice that I intend to take the matter of REDACTED death further.

The word “selective” was applied to Seroxat, a serotonin reuptake inhibitor manufactured by GSK, it was used as a marketing device, the term worked so well for sales it was then used by all drug makers to describe their SSRI products, and subsequently gained a pseudo application in medicine, as did all the SSRI group of drugs.

And SSRIs probably do increase serotonin in the brain, along with increasing thoughts and acts of suicide, self-harm, aggression, psychomotor malfunction, akathisia and dependence, but SSRIs don’t work for depression any better than a placebo. (sugar pill)

Our daughter REDACTED is dead! (See the document Reflections … ) She did not die in an accident. Her death was not an act of God. She died because of the greed of a pharmaceutical company and their suit of clothes.

If REDACTED had purchased an ineffective, or unsafe appliance and that appliance had caused her death, it’s makers would have been pursued by the Criminal Justice system and punished.

I accused Lundbeck A/S of Denmark of being her killer. My wife REDACTED registered that fact to the police. The police took the evidence we had and sent the matter to the CPS. They should have applied for a warrant of search and seizure, to obtain more evidence, and take REDACTED case further.

It is my sincere opinion that they have chosen not to do so, but not because Lundbeck is not guilty, and certainly not for a lack of evidence, Eliot Spitzer’s investigators have recently proved such evidence exists.

Forest Laboratories Incorporated, Lundbeck’s partner, and the manufacturer and seller of Cipramil, called Celexa in the USA, have also been invited to present their trial data for the SSRI that killed REDACTED, to Mr Spitzer’s office … for his investigators perusal, with reference to a matter of fraud and withheld safety data for children.

So I am left trying to sort out why the CPS haven‘t acted and at least brought Lundbeck A/S.s Corporate officers before a Criminal Court? and as REDACTED dad, how I will manage to obtain Justice for REDACTED and her family?

I shall do my best to succeed in doing that, and if I do, I might prevent further bad medicine from being marketed by the tailors of the pharmaceutical industry?

In pursuit of REDACTED and my families “Right to Justice”, I will try.

In the public interest, I will try. That’s all I can do.

REDACTED 19th September 2004

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