Monsanto Roundup Lawsuit


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

Sunday, June 28, 2009

DAVID HEALY **NEW WITHDRAWAL PROTOCOL

Last September I met with the MHRA and asked them if they would be prepared to meet with David Healy to discuss the serious withdrawal issue regarding SSRi's.

I'm pleased to announce that David has now met with them and laid a new, revised withdrawal protocol on the table.

As I understand, notes were taken at the meeting and should be available soon.

Hopefully, the MHRA will now have a better understanding of the struggles people have when withdrawing from SSRi's.

The new withdrawal protocol can be downloaded here.

NOW UPDATED WITH A REVISED PROTOCOL JULY 09

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Saturday, June 27, 2009

The Sun List Paxil as one of Michael Jackson's choices of Medication




This from The Sun Newspaper, UK

Medication with potential to kill

This is the cocktail of drugs being linked to Michael Jackson’s death.

Each drug on its own is potentially dangerous.

But if taken together with another drug they can have deadly consequences.


The dangerous mix contains painkillers, anti-depressants, muscle relaxants and anti-anxiety tablets. Some can only be administered by medics.

Vicodin

Prescription painkiller containing paracetamol and the opiate hydrocodone.

It usually comes in a tablet form. US rapper Eminem was addicted to the drug.

Dilaudid

Powerful painkiller derived from morphine.

Used to numb post-surgery pain, chronic back pain and broken bones.

Users can become anxious and suffer severe mood swings.

Xanax

An anti-anxiety pill that fights panic attacks and aids sleep, meant for short-term use only.

The drug is also thought to boost the risk of heart problems.

Soma

These muscle relaxant tablets are known to be highly addictive but they are particularly effective for tackling back pain.

They can cause severe drowsiness in users.

Prilosec

Treats acid reflux (when stomach acid leaks to the gullet) and ulcers.

Such conditions are common in those with irregular eating patterns and disorders like anorexia.

Paxil

American name for anti-depressant Seroxat.

Treats severe depression, social phobia, anxiety, obsessive compulsive disorder.

Linked to heightened suicide risk and increased depression.


Demerol

Morphine based potent painkiller, used to numb pain after ops or birth.

Only medics may administer it.

Drug puts pressure on heart. Users can struggle to breathe.


Zoloft

Anti-anxiety tablets taken to stave off panic attacks and depression.

They should not be used with any other anti-depressants.

They have been known to cause insomnia in users.

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Fid

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Friday, June 26, 2009

The Death of Michael Jackson - Possibly Prescription Drug Related?

When a star as huge as Michael Jackson dies, the wheels of conspiracy begin to turn. We are in the early stages of what will probably be the biggest conspiracy the Internet and media will ever witness.

Already, 'close family members' and 'close personal friends' of the troubled star are beginning to come forward with stories that once remained behind closed doors. I find it astounding how these very same people now wish to speak of their personal conversations with Michael Jackson.

It's been well documented that Jackson had a tough upbringing, from a very tender age he was plummeted into the world of showbiz, a world of falseness compared to the life he would have led from his modest Gary, Indiana, surroundings.

There can be no question that Jackson was 'different' - he knew no other world. He was never allowed to be a child and in later years would act out his childhood.

From the very early age of 5 Michael was performing with his brothers, pushed by his father at the cost of losing the pure innocence of one so young.

With the pressures of child abuse allegations and demands of record companies it is no surprise that Jackson sought solace in prescription drugs. Fame comes at a price and whilst we all wished for the riches of Jackson, we all would have hated losing our childhood.

In a Michael Jackson deposition from July 25, 2007 it is interesting to note how confused he was - at the time some may say he was merely being evasive but knowing how these drugs cloud the mind and destroy the memory, I beg to differ.

Throughout many interviews/depositions, Jackson had claimed that he forgot putting his signature to certain documents. Eyebrows were obviously raised but here we have someone who has signed millions of autographs all over the world.

Q Were you impaired by the taking of prescription medications or something else at the time you signed these two documents?

A I could have been.

Q Is that best of recollection, that you signed these while impaired, not knowing what they meant?

A I could maybe say so, but I'm not — I don't remember them.

Further on in his deposition:

Q How long in 2003 were you impaired because of the taking of prescription medication?

A I don't know.

Q Was it most of 2003?

A I'm not sure.

Q Did Dr. Farshchian prescribe that medication for you?

A No, it wasn't Farshchian. I think it was a local.

The following was also exchanged.

Q As of March 31, 2003, were you still impaired because of the taking of prescription medication?

A I could have been.

Q During the period of time you were impaired by the taking of prescription medication, was this an impairment that lasted like all your waking hours, or did it come and go?

A It comes and goes, not all of the waking hours, of course not. Yes.

Q Now, during the period of time you were taking this medication when you weren't impaired, did you ever tell one of your advisors that you were [concerned] about your impairment and they better watch what you were signing during this period of time?

A Not that I recall.


----

Ask anyone who has taken mind altering prescription drugs if they felt impaired and you will probably unlock or begin to understand the mind of Michael Jackson.

Michael Jackson was 50 when he died.

I believe his soul died when he was just 5 years old.


R.I.P.


Fid

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Tuesday, June 23, 2009

Generation of Kids Hooked on Psych Drugs

By Evie Pringle


Campbell Brown anchors a daily prime-time news program on CNN. On June 17, 2009, in a segment of the program called the “Great Debate,” the question was, Ritalin, Prozac, Adderall, are we “pushing pills on our kids and raising a generation hooked on meds.”

Featured in the debate were, Kelly O’Meara, author of the book, “Psyched Out: How Psychiatry Sells Mental Illness and Pushes Pills that Kill,” and Dr Charles Sophy, a psychiatrist in private practice in Los Angeles, who serves as medical director of the LA County Department of Children and Family Services. They were each given 30 seconds for an opening statement.

FULL STORY HERE

Fid

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Sunday, June 21, 2009

"Promptly" or "Reasonably Practical"? MHRA Semantics

I have in my possession a letter sent to The Rt. Hon. Alan Johnson MP, Secretary of State, from Jim Dobbin MP for Heywood & Middleton.

Dobbin clearly highlights the frustrations when dealing with the semantics of the UK Medicine Regulator [MHRA]

It's well worth a read as it focuses on the MHRA investigation into GlaxoSmithKline regarding the suppression of important data that, in essence, could have saved lives.

As you may recall, GlaxoSmithKline were investigated by the MHRA, an investigation that took over 4 years to complete. Basically, the MHRA concluded that GlaxoSmithKline could not be prosecuted because of a weakness in the law. Instead, Jean Pierre Garnier, the then CEO of Glaxo, was issued with a schoolboy reprimand from the CEO of the MHRA, Kent Woods.

Personally, and they already know my thoughts on this, I believe the investigation was pretty abysmal. Arrests should have been made regardless of whether Glaxo employees would have chosen to talk to MHRA investigators. Glaxo have once again been let off the hook.

Dobbin, now believes the MHRA are playing around with words such as 'Reasonably Practical' and 'Promptly'

I have a pdf copy of the letter should any of you wish to view it [click on mailbox, right hand side of this blog]

Here is the letter:

The Rt. Hon. Alan Johnson MP
Secretary of State
Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS

Tuesday 12th May 2009

Dear Alan,

Further to my previous unanswered correspondence of 28/04/09, I would like to bring your attention to matters arising from my P.Q. 264951 and the subsequent clarifications provided by the Department of Health and the MHRA.

The MHRA investigated the Pharmaceutical Company Glaxo Smith Kline for withholding safety information concerning their product SEROXAT; specifically Glaxo Smith Kline concealed increased rates of suicide in children given SEROXAT. The MHRA concluded that Glaxo Smith Kline should not be prosecuted because of a weakness in the law.

The Health Minister Dawn Primarolo M.P. announced that the law would be strengthened to make sure this could not happen again. On the 3rd of April 2008 Dawn Primarolo M.P. stated, in answer to a Parliamentary Question by myself:

The MHRA plans further stringent regulations to place obligations on companies to report safety issues timeously.

The MHRA produced a draft amendment to the law which used the word “promptly.” After a consultation process the amendment was altered to “reasonably practicable.”

My Parliamentary Questions 261391 and 264951 were intended to establish the wording of the amendment and the meaning of these words. When I asked the Department of Health for further clarification of the answers I was given I was put in touch with Dr Julie Williams of the MHRA and then Beryl Keeley of the MHRA.

There was then an additional complication, in order to place the words “reasonably practicable” in their full context it was necessary to obtain and juxtapose three separate documents.

i) The Medicines for Human Use (Marketing Authorisations etc) Regulations 1994.
ii) Medicines (Codifications Amendments etc) Regulations 2002.
iii) SI 2008 Amendment Regulations (3097)

According to Beryl Keeley ‘consolidated regulations’ do exist but they are not available to M.P.’s. This is the first point I want to bring to your attention; that the most complete and up to date copy of legislation should be available to M.P.’s, so that they can carry out their work.

In response to my main question, the meaning of the words “reasonably practicable”, Beryl Keeley directed me to an MHRA Explanatory Memorandum on the 2008 Amendments. Paragraph 8.5 states:

On balance, use of “as soon as reasonably practicable” can be argued to give those required to comply a clearer understanding than the insertion of the word promptly. There is more case law around use of this phrase and it is more commonly used in offence-creating legislation.”

However, when I asked Beryl Keeley for the reference to the case law to which the memorandum refers she was “unable to identify any.” In other words there is no pharmaceutical case law on which to base the introduction of the words “as soon as reasonably practicable” or which could clarify the meaning of these words.

“Reasonably practicable” is in my opinion a vague and subjective phrase. It could easily be interpreted by a pharmaceutical company to mean a long process which could extend into years.

In my opinion the wording suggested by MIND in response to the consultation would have been appropriate. MIND suggested “quickly, as soon as it comes to light”, also “urgently”, or a defined period of time.

There have been no prosecutions of pharmaceutical companies for withholding safety information since 1992, according to a recent answer to a parliamentary question. To the best of my knowledge there were no prosecutions prior to 1992 either.

In my opinion the withholding of safety information by pharmaceutical manufacturers has been widespread and has resulted in thousands of deaths and drug injuries. A clear example is the benzodiazepine tranquillisers such as Valium and Ativan which were claimed by the manufacturers to be safe and non-addictive.

The 2008 amendments were an opportunity to have closed at least one loophole in the regulations and provide some improved protection to the public. My second point is that this amendment was introduced by the MHRA on the basis of case law that does not exist, and that the amendment is weak and should be corrected.

Thirdly, I would like to point out that in my opinion the MHRA have not handled this matter effectively. The MHRA was heavily criticised by the Health Select Committee enquiry 2004-5, “The Influence of the Pharmaceutical Industry,” the MHRA was seen as too closely connected to the pharmaceutical industry. My third point is that this connection remains the case and that this change to the law should have been carried out by Parliament, not the MHRA.

I would appreciate it if you could answer this letter personally.

Yours sincerely,

Jim Dobbin MP
Chair of the All-Party Parliamentary Group on Involuntary Tranquilliser Addiction

cc. Phil Woolas MP
MIND


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Fid

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

...over at the Seroxat Secrets blog.

The truth about how addictive Seroxat (Paxil) is…

Well not actually the truth, I’m afraid – read on and you’ll see Glaxo actually has a couple of conflicting things to say Seroxat and addiction – and they both can’t be truth.

You might think that after all the years of doctors and patients all around the world saying Seroxat is highly addictive – oops, sorry, causes dependence and severe withdrawal reactions – that Glaxo would simply undertake the definitive study to prove us all wrong and to really show the world once and for all how safe and non-addictive Seroxat is… READ MORE

And

MHRA and Ian Hudson – still questions to be answered

Things have moved on at the MHRA so they tell us… it wants to be more open, it wants to engage with us…

Well, I’d like it to be more open about one of its employees, Ian Hudson.
I’ve been wanting to get to the truth since January 2005 when the House of Commons Health Select Committee questioned some senior MHRA members about Seroxat (Paxil).

Here’s some background: Ian Hudson worked at SmithKline Beecham for 11 years (Glaxo 2 weeks) as Worldwide Director of Safety. He then joined the MHRA as its Head of Drug Licensing. READ MORE

The Seroxat Secrets author has been quiet of late due to other commitments but his latest posts show that he still has his finger on the pulse.

Fid

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Saturday, June 20, 2009

GlaxoSmithKline's VARILRIX Vaccine

Source

GlaxoSmithKline developed and launched Varilrix, a preparation of live, attenuated Oka-strain varicella zoster virus, for immunization against varicella zoster infections. By the end of 1998, Varilrix was available in a few European countries and in India By 2001, the vaccine was also available in Brazil and Hong Kong. [1]

Varicella zoster virus causes an acute infection that affects most children globally, but the age of infection can be greater in residents of tropical areas. It has generally been considered a mild disease, although there are accumulating data to show that it can cause significant morbidity and mortality in immunocompetent as well as immunocompromised children and adults. Oka-strain live attenuated varicella vaccines were developed in the 1970s. Varilrix developed by GlaxoSmithKline Biologicals (Rixensart, Belgium), is one of the vaccines produced and marketed in over 80 countries. [2]

Friday March 2, 2007
By Olesya Dmitracova

MOSCOW (Reuters) - Russian prosecutors are investigating a local hospital on suspicions it illegally tested vaccines made by GlaxoSmithKline Plc on toddlers, making them ill and hampering their development.

Europe's biggest drugmaker denied the claims and said there was no evidence of adverse events or misconduct in the way the study had been carried out.

Glaxo vaccines were tested on more than 100 children between one and two years of age at the hospital in Volgograd after Russian health authorities approved the trials in 2005. But prosecutors claim parents were not properly informed and they thought these were routine vaccinations.

According to the prosecutors, Glaxo paid the clinic in southwestern Russia $50,000 to conduct the trials, which made some children ill. 'According to the contract, only healthy children can take part in this experiment,' said a spokeswoman for the Volgograd region prosecutors, Lydia Sergeyeva.

'In this case all children were sent for trials, healthy or unhealthy, and many of them had been diagnosed with diseases. They had no right to put children with health problems through these clinical tests because ... it can lead to a deterioration in the child's condition, as happened with one girl for instance.'

Sergeyeva told Reuters of a 2-1/2-year-old girl whose neurological illness progressed sharply after she was vaccinated. The girl can hardly speak and shows other signs of arrested development, she said. [3]

The Russian side of the story [Translated]

A routine visit of a children's polyclinic had frightening consequences for Vika Geraskina. One year ago the one-and-a-half-year-old native of the Volgograd area has ceased to talk after being submitted to varicella (chicken pox) vaccination which had been made to the girl in a local railway polyclinic, using a ‘high quality imported’ vaccine. The girl received a Varilrix shot, the Belgian vaccine which has already been in troubles in Europe and USA and not licensed for use in Russia.

According to Vika’s grandmother, having noticed complications after an injection, she had addressed tp a local polyclinic where a shot had been made, but there she had been assured that complications after vaccination are a usual business. However speech has not returned to the girl, and parents have brought a legal action against doctors.

The Office of Public Prosecutor became interested in that legal case. As a result of the investigation which continued for over one year, the head physician of the polyclinic and the Belgian pharmacists who have paid for illegal tests of the vaccines in Russia have been recognized culprits. Vika Geraskina is just one of the victims of medical experiment in which several dozens children have been used as guinea pigs for GlaxoSmithKline vaccine illegal clinical trials. [4]



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Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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[1] PMID: 12186278 [PubMed - indexed for MEDLINE]
[2] Review of the Varilrix varicella vaccine. [
LINK]
[3] Russian Prosecutors Launch Probe Into Illegal Vaccine Tests on Children [
LINK]
[4] Малышей использовали в чудовищном эксперименте [
LINK]


SEROXAT BRAIN SHIVERS

Seroxat Brain Shivers, also known as the Zaps have been widely reported. There are a plethora of anecdotal stories across the Internet. Years ago, many people thought they were going crazy with these alien-like zaps ripping through their heads/bodies.

GlaxoSmithKline have offered no solution to this severe side-effect that their antidepressant causes. They offer no help to the patients who took their drug on trust. They leave them on the scrap heap to fend for themselves.

The word 'uncaring' springs to mind.

Here's a few 'anecdotes' for the top Glaxo brass to mull over whilst eating their croissants and sipping on their Darjeeling whilst they browse the latest stock quotes from their ever so caring company:

"During my worst Paxil withdrawals-my head feels like it is all over the place, my brain has turned into liquid, my brain swooshes around in my skull. It feels as is (static electricity)? is shooting through my brain; I can feel it travel down my arms into my hands. The world spins. No sense, no comprehension. All I care about is the meds. I am a Paxil junkie-beaten and broken."

---

"Try to explain "brain tremors to your family doctors or even your Psych.M.D. and experience the look of total lack of comprehension. I took Paxil for 4 months and knowing that my doctor was going to change my meds on a Wednesday I stopped my paxil Tuesday night. It wasn't only the brain tremors, but the "sloshing sound coming from the brain" that no doctor understood. My Psych. told me that I was just really dperessed and anxious. I had to stop driving my car as the confusionand just the inability to drive made me to frightened. Still my doctor felt I was depressed."

---

"Hi, Been off Paxil for 5 days & still have brain shivers."


---

"I've been cold turkey off my seroxat for three days and I'm getting my script tonight for it, and I've got serious "brain shivers" and it's bloody terrifying! It really feels like something is going wrong in my brain, and it's so scary I am crying. I hate being on the tablets anyway but it's better than slashing my arms and ruining all my closest friend's lives."

---

"It's an incapatating sensation that leaves me nauseous, jittery and dizzy. It can take up to 3 days before I get any sense of relief. The tremors in my head can go from every half hour up to every 30 seconds. The thing that scares me most is, if it gets this intense when I have forgotten to take it how bad will it be when I try to go off it completely. I am only 21 years old and do not want to be on this forever."

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"It feels more like some one is scratching my Brain with Sand paper and sending electrical pulse blasts through my whole upper torso. My face is numb."

---

"I have been on paxil for 15 years everytime I try to get off the side effects are awful, nausea, headaches, lightheaded, brain shivers."

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"I experienced "brain shivers" while taking a large dosage of paxil. I thought I was going crazy. They would usually occur while trying to fall asleep. Right when I started to feel sleepy I experienced a kind of electrical jolt going down from my head through my arms and out my fingers."

---



“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.”

ENJOY THOSE CROISSANTS!

Fid

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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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Stone Age Seroxat Withdrawal Update

On June the 18th I wrote about the difficulty a patient was having convincing her doctor that she needed the liquid form of Seroxat to help her taper. I was appalled at the treatment this patient was receiving from this 'so called doctor', so appalled that I wrote to the MHRA and asked for guidance.

Earlier today I was contacted by the MHRA and given a phone number for the patient to ring. Hopefully, the MHRA will give this patient the information she requires and help her on the road to a safe taper.

This patient is one of many who face ignorance by uneducated doctors.

It is impossible to taper 'slowly' from a single tablet. If a patient is struggling to taper then the liquid is a must. All SSRi's need a liquid formulation. To expect a patient to shave a tablet just so they can taper correctly is absurd!

I sincerely hope this 'doctor' listens to her patient. If she doesn't then a Seroxat Sufferers Dumbass award will be winging its way to her!


Fid

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Friday, June 19, 2009

GSK - Not So Pretty Poligrip!

June 2nd, 2009 Source: AboutLawsuits.com

Earlier this month, a lawsuit was filed in the U.S. District Court for the Eastern District of New York on behalf of two couples who allege that severe and disabling injuries were caused by zinc poisoning from Super Poligrip denture adhesive cream.

The denture cream lawsuit alleges that Super Poligrip contains zinc, which can enter the body at high and dangerous levels, potentially resulting in zinc poisoning and depleted copper levels. This can cause a number of neurological symptoms generally referred to as neuropathy.

Super Poligrip, which is manufactured by GlaxoSmithKline, is an adhesive cream used to help hold dentures in place. It is sold over-the-counter, and is classified by the FDA as a low-risk medical device, which means that Glaxo is not required to list the ingredients on the product label.

The Super Poligrip lawsuit was filed on behalf of Horace Daniels and Theodore Micklazavage, together with their respective spouses, alleging that GlaxoSmithKline failed to warn about the risk of zinc poisoning from the denture cream or that the Super PoliGrip even contains zinc. They also alleged that Glaxo failed to inform the plaintiffs about the correct dosage and use of Super PoliGrip, which resulted in overuse and excessive absorption zinc.

Daniels, who is 72 years old and received dentures about 8 years ago, alleged that his use of Super PoliGrip resulted in a diagnosis of copper-deficiency-induced myelopathy, resulting in permanent neurological and other injuries that impact his day to day life.

Micklasavage, who is 57 years old and has worn dentures for approximately 10 years, alleged that he was diagnosed with hyperzincemia due to Super PoliGrip, which have left him with similar neurological damage.

**Potential PoliGrip lawsuits are being pursued against GlaxoSmithKline for failing to warn about the possibility of high levels of zinc entering the body and for failing to properly instruct users about the safe use of their product.

Fid

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Thursday, June 18, 2009

Stone Age Seroxat Withdrawal!

I wasn't going to write about this but I mulled over a conversation I had with a patient yesterday who contacted me because she was having difficulty explaining/educating her stubborn GP regarding her withdrawal.

The patient's original dose of paroxetine [Seroxat] was 30mg, this was started in 1997. She stayed on this dose until 2005, that's 8 years! She was tapered off by her doctor at an unbelievable rate, the process took four and a half months. By April, 2006, she was back on Seroxat, her dose,20mg.

By November 2007 a different tapering regime - this time slowly tapering by 2mg per month, 1/2mg per week. She is now down to 5mg and having to cope with severe anxiety.

Here's where the story gets rather interesting.

The patient visited her doctor's surgery, her usual doctor was not on duty so she saw a replacement doctor.

Here is her email to me:

Have just been reading through your site once again and I have another complaint for you

I visited my doctor yet again, the first issue was for an infected cyst, she prescribed CLARITHROMYCIN,the second issue was undoubtedly the horrific withdrawals created by this seroxat slow taper.

She asked me to increase the dose, of course i refused, knowing the drug is causing my problems.

She then offered me more drugs, i again refused, knowing this is gonna add to the problem and cause further w/d effects when discontinuing.

She then, tells me she is gonna refer me to the MENTAL HEALTH TEAM, for my MENTAL PROBLEMS, so i told her i never had any, prior to tapering off this medication.

She then asks me if i have tried ST JOHNS WORT?

How the hell can you take a herbal antidepressant like this when taking an SSRI, it can cause Serotonin Syndrome which we all know can be FATAL.

I hasten to add, that the drug she prescribed for my cyst, is again bad news, and that can cause the same effects as serotonin syndrome.

So, I guess my question is this;-

Who the hell can you trust with your healthcare, these plonkers are paid in excess of 100K per year to try and kill us off.

And I sure believe she deserves your DUMB *** AWARD.

No wonder all of us in w/d feel so alone with our problems, when no doctor understands or is willing to admit, just HOW BAD this really is, especially after ingesting there poison for the last 12 yrs, and spending the last four yrs tapering off.

----

I spoke with the patient over the telephone last night. I asked her if she was on the liquid Seroxat. She told me she had asked to be put onto it for ease of withdrawal but was told by this cretinous GP that, "Seroxat liquid is expensive and as she is an adult there is no need for her to use it."

Can you believe it?

What kind of half-arsed doctor is she?

If this arrogant, self-indulgent doctor claims there is no need for this patient to be put onto the liquid because she "is an adult" then it begs the question if this very same doctor only gives liquid to children! Remember, Seroxat should not be given to children.

The patient is currently using a razor blade to shave her pills. This is stone age and it's high time something was done about this. Last time I looked it was 2009AD NOT BC.

This ignorant doctor needs her licence revoked. It is plainly obvious, to me at least, that she is not fit to practice with such a uncaring and unprofessional attitude.

I have wrote to the MHRA about this matter, the patient and "doctor" have not been named. I want the MHRA to offer this patient some sort of guidance.


Dr. David Healy meets with the MHRA later this month to discuss SSRi withdrawal issues.

Fid

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Wednesday, June 17, 2009

Bob Ingram - GlaxoSmithKline

Interesting thread going on over at Cafe Pharma. The thread, entitled, 'Bob Ingram got the ball rolling', certainly raises some eyebrows.

According to the GlaxoSmithKline website, Bob Ingram is Vice Chairman Pharmaceuticals, GlaxoSmithKline and a special consultant to the CET and the Group.

Here's how he is portrayed over at Cafe Pharma.


With all the illegal marketing tactics, now alleged in various investigations etc. A perfect merge with Garnier in 2000. BOTH of them crooks and Medicaid-Medicare robbers. Where is he now, other than playing around with people on various "boards", doing nothing for millions. HE belongs in Jail with Garnier for plotting and scheming that is going to bring this company down. Taxes, investigations... follow the money and depose the limp wrist..The buck stops with these two living high on the hog from Federally funded programs. If Ingram and Garneir are responsible for alleged fraud and corruption - Why should the stockholders (and ultimately patients) foot the bill while they are living high on the hog. Jailbirds. Get them.

BIG PHARMA GREASES PALMS

Ouch!, a bulletin (http://www.ouch.org/) issued by Public Campaign, the finance reform group, notes that George W. Bush ostentatiously thanked Robert Ingram for his fine work chairing a fundraising dinner that garnered $30 million for the Republican Congressional Committee. Ouch! further notes that Ingram is CEO of GlaxoSmithKline, which markets Lanoxin, a drug widely used by seniors to avert congestive heart failure. Lanoxin's price has risen 58.1 percent since 1997, or almost five times the rate of inflation. The rising cost of drugs is the reason a prescription drug benefit should be added to Medicare, yet the Bush Administration opposes such legislation. So do Glaxo and the other big pharmaceutical companies, and they've contributed $11.3 million to the 2002 election--three-fourths of that to the Republicans--to make sure it doesn't happen. Follow the $$$.

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Manicured hands that were greased and filthy with corruption. I was there. He thought he could get out unscathed...maybe he did or hopefully he did not. Remember the 7 million dollar national meeting where he had Colin Powell come in to talk (how much Ingram ?) Real inspiring speech to the sales force comparing our sales job to Desert Storm !!! What a joke-then he brought in Stormin Norman Schwarzkopf.. same deal ..MILLIONS of dollars spent on entertainment and Republican money mongers. Ingram did not get where he was with his little bachelors degree from his home town college.. An ass kissing smooth talker, thought he had everyone fooled. Did not fool me or any other ethical reps. he knew exactly what was going on, every step of the way. Right Bobby, now tell the truth, please.

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I don't know the accuracy of the above, however I will say that Bob Ingram is the only executive at GSK that I know of that valued sales reps.

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Now that's the Biggest Crock of Bull SHIT EVER!!!! Bob Ingram Ruined Glaxo. Glaxo was a Fantastic company BEFORE he took it over. When he came into power he Merkerized it. Everyone in home office used to have a sign on there desk. "nothing gets done until someone sells something". They treated the sales people like Gold before Bobby came. Commissions went Way down after little bobby.

----

I will say that if Mr. Ingram ever valued sales rep's it was because they were viewed as tools to achieve all of GSK's Return on Investment goals, which as recently reported included huge payoffs to physicians participating in GSK studies, unlimited resources to entertain and ultimately "bribe" physicians into being on the GSK bandwagon, and finally all the marketing schemes that have been uncovered that were not in any grey area, but violations of the law and ultimately put the patient at risk. The Representatives had the proverbial Ingram "carrot" hung out in front of them to perform as directed by marketing, (legal or illegal). He knew they were the troops on the front line as he himself put it, and had to do anything, anyway, anyhow-to keep the huge amounts of money coming in. Yes, the ROI was well done, Mr. Ingram....but at what cost to the public, not only financially but physically in many cases innocent children ? Then along comes the worst CEO in the history if the industry, JP Garnier to join hands with Ingram and push the limit further. it was the combination of the two that brought this company to where it is today. Basically common white collar criminals, it is as simple as that. They will never pay the price for what went on under their watch, however. It will be business as usual, a few small fines in proportion to what was gained, absorbed by the stockholders and they will live in the lap of luxury until the day they die. That is how it works, unfortunately.

----

Yeah - i will never forget Ingram hugging Colin Powell like he was his long lost Bro'.. on the stage--While Powell was stashing GSK blood money into his bank account. Disgusting little worm. Big into the payolas for GSK prostitutes..... let the record show that-not this post. Follow the money and put the little worm under oath.

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Tip of the iceberg- many Washington connections ... Made every rep feel like shit if they did not contribute part of their paycheck to the GSK Political Action Committee.. Actually stood himself at the meetings...garnishing wages. Oh, but then you got to attend all the shrimp and lobster happy hours, with the Grey Goose and caviar- no joke. Scavenger for Lobbying money from the sales force. Yeah, he loved those reps, didn't he Fools. Put the asshole in jail.

----

The problem is they sell harmless widgets and you sold Paxil to kids, knowing that it 1. Did not work and 2. Kids were committing suicide due to the drug. That is only one example...There are many as you know, read the fucking news. You are an idiot and the reason why this shithole is going down the toilet, or bidet --take your pick, dumb ass.

----

#1... you are using horrible language, which is sad....#2... I was referring to nasal sprays and topical steroids...(Flonase and Cutivate, Temovate) The latter two you may not even be familiar with if you were not around 10 - 15 years ago...All 3 of these drugs were excellent and had excellent competitors such as Vancanese, Elocon and Diprolene...Glaxo and the competitors helped thousands of people every year who suffered from allergic rhinitis, sinusitus and topical dermatological problems and should not feel anything but great about that..(Ask an Allergist where we would be right now without nasal steroids, or a Derm or FP without medium and high potency topical steroids)...#3 Any parent who is gutless enough to blame a kids mental problems on medicines such as Paxil, which has helped thousands of people with anxiety issues who are willing to exercise eat right and want to get better, needs to look in the mirror and take some responsibility and also quit listening to bad advice and find a higher quality lawyers.....60 minutes ran a garbage piece years ago on this topic aimed at Prozac and Zoloft and it was full of flaws...I hope I have cleared up this topic enough for you to understand we were doing the right thing....Selling our products...Great products....Have a good night....

----

All I can say is I am speechless...you have to be kidding me, right. Please, tell me you are not that naive or clueless. Please. Yeah, this company was built on Flonase !!! and steroid me-too creams..Flonase no better than Beconase that went off patent, which was copycat Vancenase. Paxil and thousands of people with Anxiety, right sold for years off label for that too, now people are hooked, aren't they. Oh, my God please help this poor reppie.

----

READ MORE HERE

Fid

ORDER THE PAPERBACK
'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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TONIGHT ON BBC 2 [UK]




Hat - Tip: Ashley

Price of Life

21:00 on BBC Two

On a finite budget, the NHS cannot afford to offer every treatment on the market, so how is it decided which medications should be made available?

Award-winning director Adam Wishart follows the nail-biting decision about one drug, with unprecedented access to decision-makers the National Institute for Health and Clinical Excellence, the patients who need a life-extending treatment, and the American company that discovered and will profit from it.

Fid

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Tuesday, June 16, 2009

Treating Panic Disorder - What the NHS Say.

Thanks once again to Ruth for pointing me to the following web page on the NHS website.

The NHS write about SSRi treatment for panic disorder:

"There are two main forms of treatment for panic disorder - psychological therapy and medication. Depending on your individual circumstances, you may require either one of these types of treatment or a combination of the two."

On one hand, I'd like to applaud them for going into psychological therapy, on the other hand, their advice on SSRi treatment does not clearly explain the consequences for the patient. In fact, it throws up more questions.

Here is what they say about treating panic disorder with SSRi's:

Section One - [My comments in yellow]

Selective serotonin reuptake inhibitors (SSRIs) are a form of antidepressant which work by increasing the level of a chemical in your brain called serotonin.

Out goes the chemical imbalance theory and in comes, 'let's just flood your brain with extra serotonin'. Maybe the NHS should add; Nobody knows how SSRi's work - not even the manufacturers of SSRi's.


They merely condense 'how SSRi's work' into one line. It's sugar-coated pharma talk.

Here's my take:

SSRi stands for, Selective Serotonin Reuptake Inhibitor. In layman's terms, SSRi's try to boost serotonin by selectively stopping the reuptake of it among brain cells.

The areas of the brain responsible for release and reuptake are similar, they work on the same molecule. SSRi's cannot understand which one it is supposed to work on. So it may block both. This can result in no coping molecules in the brain.

SSRI's block another coping molecule in the brain called dopamine. It has been suggested that dopamine is the chemical that releases the euphoria you feel when you are happy. If SSRi's suppress...or block this molecule, your brain becomes confused, it's akin to taking the handles off a working clock.

If you cannot seem to cope because you have marital problems, financial problems, are grieving, feel shy, feel panicky, then stop and think if SSRi treatment will 'fix' this or add to your woes.


To use an analogy
, if you had problems enjoying sex, would you wish for your genitals to be removed?

If your brain is not functioning correctly... or is invaded by chemicals that don't belong in there then expect some sort of backlash. The agitation listed as a 'common' side effect is more than just 'agitation' - it's basically your brain trying to figure out why it has stopped working properly, why its molecules are being blocked and why it is being flooded [invaded] with extra serotonin.

With confusion comes frustration - which in turn could lead to anger, an anger so uncontrollable [because your brain cannot control it] that it could lead to homicidal behaviour [1], [2]

SSRIs are the most commonly prescribed form of antidepressant for the treatment of panic disorder. They are normally started at a low dose before gradually being increased as your body adjusts to the medicine. Common side effects of SSRIs include:

•nausea,
•low sex drive,
•blurred vision,
•diarrhoea or constipation,
•dizziness,
•dry mouth,
•loss of appetite,
•sweating,
•feeling agitated, and
•insomnia (not being able to sleep).


Talk about playing down adverse reactions! Okay, granted they list the above as 'common' side effects - maybe they should list the other side effects to redress the balance and to give the patient [and doctor] a better understanding of what lays ahead for them should they decide to journey down the road of SSRi treatment. Maybe the NHS should add:

There is an established direct link between suicide and violent behaviour and the use of SSRIs [3]

Drug companies selectively publish studies on antidepressants. They have published nearly all the studies that show benefit - but almost none of the studies that show these drugs are ineffective. [4]

For a full list of SSRi side effects and not the sugar coated NHS/Pharma one, visit http://www.antidepressantsfacts.com/LongTermSSRI.htm

When you first start taking SSRIs, your feelings of anxiety and panic may seem to get worse. However, in the majority of cases this is only temporary, and you will usually find that your symptoms start to return to normal levels within a few days of taking the medicine. Speak to your GP if you feel that your symptoms have worsened, and are not showing signs of returning to normal levels after a few days.

Speak to your GP? Why? Your GP has just prescribed you a drug that he/she DOES NOT know the mechanics of. He/she DOES NOT know how it works. Why then would any patient want to go back to a person who had given them something that they knew nothing about other than what the manufacturers of these drugs had told them? You, the patient, are taking these drugs on trust. It's basically a religion, you either believe or you don't - Doctor's believe, that's why they prescribe it, they do so on trust. You, the patient, put your trust in your doctor because... well, because that's what is expected of you, isn't it?

When you start taking a SSRI, you should see your GP after two, four, six, and 12 weeks in order to check your progress, and to see if you are responding to the medicine. Not everyone responds well to antidepressant medicines, so it is important that your progress is carefully monitored.

The guideline the NHS offer here is absurd. How can a doctor 'carefully' monitor someone he/she sees once every two weeks? What about the space in between? The definition of 'Careful' is: [5]

1. Attentive to potential danger, error, or harm.
2. Thorough and painstaking in action or execution.
3. Protective; solicitous.
4. Full of cares or anxiety.


Donald Schell, 60, had been taking Seroxat for just 48 hours when he shot and killed his wife, his daughter, his granddaughter and himself. The jury found SmithKline Beecham (now GlaxoSmithKline) liable for deaths caused by a patient taking an antidepressant. A federal jury in Cheyenne, Wyo., ordered SmithKline Beecham (now GlaxoSmithKline) to pay $6.4 million to relatives of Donald Schell. [2]

Was Schell told,"When you start taking a SSRI, you should see your GP after two, four, six, and 12 weeks in order to check your progress, and to see if you are responding to the medicine?"



If your GP feels it is necessary, you may require regular blood tests or blood pressure checks when taking antidepressant medication. If after 12 weeks of taking the medication you do not show any signs of improvement, your GP may try prescribing an alternative SSRI for you to see if that has any effect.

When recommending a blood test for you to take you may wish to ask your doctor to see if it can ascertain whether or not you are 2D6 deficient. Genetic testing is available to identify people who are likely to have difficulty with about 25% of all drugs, including Prozac, Seroxat, codeine, ibuprofen, Viagra, Claritin, and propranolol. These folks have variations in the gene responsible for an enzyme needed to metabolize these drugs, known as 2D6. Without 2D6 to break them down, the drugs can build up to toxic levels in the body, causing adverse effects including death. [6]

This test is expensive and would cost the NHS millions of pounds should it become mandatory. If you have the 2D6 deficiency you will not be able to break down certain drugs which will result in toxic poisoning.

Your doctor or the NHS would not have told you this. The one thing that HAS been scientifically proven is kept from you.


How long will I have to take an SSRI for?

The length of time that you have to take an SSRI will vary, depending on how well you respond to the treatment.

No study has ever been done regarding long term use of SSRi's. In essence, YOU ARE part of the study. You are the lab rat. These drugs were granted a licence without a 'long term study' - most drugs are.

Even if you feel that your panic disorder has been successfully treated, it is likely that you will need to keep taking the medication for at least six to 12 months. If this is the case, and you stop taking your SSRI medication before this time, the risk of your symptoms recurring once you stop taking the medication may be increased. Some people may have to take SSRIs for longer than six to 12 months.

Straight from the pharmaceutical handbook of 'Talking Nonsense' and a game of Russian Roulette for those with the 2D6 deficiency. What the above para is basically saying is, it's impossible to judge if your 'illness' has gone away so keep taking the medication regardless of the consequences. Remember, not even the manufacturers of SSRi's know how they work, they assume, which is in essence making an ass out of you and me. [7]

What the NHS fail to tell you when they state, "Some people may have to take SSRi's for longer than six to 12 months," is the reason.


Ask current and former patients if they've ever had physical withdrawal symptoms after stopping use of an SSRi. A good place to start is Paxil Progress [8]. Don't expect the manufacturers, doctors or medicine regulators to tell you about the addiction problems with SSRi's. You are on your own. You are left to deal with the addiction. The only help you will get will be from current and former patients, unless of course you are in a strong financial position to book into a detox clinic.

When you and your GP decide that it is appropriate for you to stop taking your SSRI medication, you will gradually be weaned off it, by slowly reducing your dosage. However, you should never stop taking your medication unless your GP specifically advises you to.

Sugar coated and merely playing down risk. Here's another example of 'sugar-coating'.

If‘discontinuation reactions’ occur in patients stopping [Seroxat], the majority will experience symptoms that are mild to moderate in intensity, and are usually limited to two weeks.
Mary Anne Rhyne
GlaxoSmithKline spokesperson
2005


Never mention the word 'Addiction' - it will devastate sales!

If you want to know how difficult it is to taper, view the Seroxat withdrawal complaints pdf file. [9]


Even when taken for a suitable length of time, approximately half of all people whose symptoms have been treated while taking SSRIs find that their panic attacks return once they stop taking the medication.

Which catagorically means - There is NO cure. How can the NHS make a statement like this? Isn't the return of the 'illness' after stopping medication, simply the patient craving his/her serotonin fix? It's reasonable to suggest that isn't it? Why are the NHS claiming it's the 'illness' returning? How is this measured?

A study by Irving Kirsch et al showed that antidepressant use in people with mild to moderate depression is useless. [10]


For some people this means having to take SSRIs on a long-term basis. For others, a course of cognitive behavioural therapy can help to reduce the risk of your symptoms recurring.

There we have it in a nutshell, "For some people this means having to take SSRi's on a long-term basis."

What started as 'treatment' now ends up in addiction. The NHS are claiming that 'some people' may have to take SSRi's on a long term basis - despite the fact that no study has ever been undertaken regarding long term use of SSRi's.

To recap:

The areas of the brain responsible for release and reuptake are similar, they work on the same molecule. SSRi's cannot understand which one it is supposed to work on. So it may block both. This can result in no coping molecules in the brain.


Nobody knows how SSRi's work, not even the manufacturers. It's based on theory.

If you are 2D6 deficient, chances are you will get toxic poisoning from certain SSRi's. This is a fact.

No study has ever been undertaken regarding long term use of SSRi's.

In its study, the U.S. Centers for Disease Control and Prevention looked at 2.4 billion drugs prescribed in visits to doctors and hospitals in 2005. Of those, 118 million were for antidepressants.

High blood pressure drugs were the next most-common with 113 million prescriptions.

The use of antidepressants and other psychotropic drugs -- those that affect brain chemistry -- has skyrocketed over the last decade. [11]


Your brain is your hardware, SSRi's are software that have not been fully tested, they have been put out on the market pretty much like a beta version of new software one can download off the Internet. Any glitches are reported back to the programmer/s, the glitches are then rectified until the product is ready to launch.

Can you imagine if I created software for aviation radar systems and my selling point was, "Hi, I've created some software for your radar systems. I don't have a clue how it works but my theory suggests that it does. I'm not totally sure if there are any bugs in the software that may make your radar systems to shut down, but hey, that's only a minor point."

I'd be laughed out the office and the men in white coats would be sent for.

SSRi's are basically promoted on the same principle.


Fid

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

By Bob Fiddaman

ISBN: 978-1-84991-120-7
CHIPMUNKA PUBLISHING

AVAILABLE FOR DOWNLOAD HERE


PAPERBACK COMING SOON





1. School Shootings Linked to Psychotropic Drugs. http://www.antidepressantsfacts.com/2000-05-16-School-Shootings-Psychotropic-Drugs.htm

2. Paxil Maker Held Liable in Murder/Suicide.
http://www.baumhedlundlaw.com/media/ssri/Paxil_murder.htm

3 - Glenmullen, J. (2000) Prozac Backlash: overcoming the dangers of Prozac, Zoloft, Seroxat, and other antidepressants with safe, effective alternatives. Simon & Schuster.

4 - Turner EH et al. 2007. Selective publication of antidepressant trials and its influence on apparent efficacy. New England Journal of Medicine. 358: 252-260.

5 - Definition of 'Careful'.
http://www.thefreedictionary.com/carefully

6 - Testing for enzyme deficiency.
http://findarticles.com/p/articles/mi_m0ISW/is_245/ai_111496944/

7 - “When you assume, you make an ass out of u and me.” ~ Oscar Wilde on Assumption.

8 - Paxil Progress.
http://www.paxilprogress.org/forums/

9 - Withdrawal Complaints [Seroxat].
http://www.fileden.com/files/2008/5/6/1899375/WITHDRAW.pdf

10 - Initial Severity and Antidepressant Benefits.
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045

11 - Antidepressants most prescribed drugs in U.S.
http://www.cnn.com/2007/HEALTH/07/09/antidepressants/index.html




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Sunday, June 14, 2009

...And They Say It's Not Defective!

Not only has Seroxat caused misery to families who have lost loved ones, to families that have been torn apart as they watch loved ones turn into violent monsters, it now seems we can add damaged sperm to the endless list of adverse side effects that Glaxo's 'miracle pill' brings!

The Chicago Tribune reports:

"In a new study, New York researchers report that as many as half of men taking the anti-depressant paroxetine (brand names, Seroxat and Paxil) have higher levels of sperm fragmentation."

They add:

"Dr. Cigdem Tanrikut speculated that the anti-depressant caused mens’ sperm to slow down as it makes its way through the male reproductive tract. Sperm gets “hung up,” she said in a statement, allowing it to age and become damaged."

Thanks Glaxo!

Fid

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Saturday, June 13, 2009

MHRA's June Raine Honoured with CBE

I see June Raine of the MHRA has been awarded CBE. [Link]

Rather than run the risk of being beheaded for writing anything negative about her, I shall point you to the following letter that Dr. David Healy sent her in the year 2000 - 9 years ago!

It clearly shows how Raine was made aware of the severe side effects of Seroxat.

Dr June Raine is the Director of the Post-Licensing Division at the Medicines and Healthcare Products Regulatory Agency (MHRA) and her responsibilities include all the issues that relate to medicines once they are authorised for use on the market.

The following letter is hosted on the Social Audit website


Dr June Raine, Director of
Post-Licensing Division, MCA
Market Towers, 1 Nine Elms Lane
LONDON SW8 5NQ

7 June 2000

Dear Dr Raine,

You may or may not have heard that yesterday in Cheyenne, Wyoming a Court found Glaxo SmithKline guilty on several accounts including the count that Paroxetine can cause suicidality, that it specifically did so and contributed to the wrongful death of Don and Rita Schell as well as Deborah and Alyssa Tobin and that the company had been responsible for a failure to test and a failure to warn. You may also be aware of a verdict in the Hawkins case in New South Wales some weeks ago where a Supreme Court Judge made it clear that in his opinion Mr David Hawkins would not have murdered his wife but for the influence of Sertraline.

In the course of my work as an expert witness in Tobin versus SmithKline I got the chance to look at SmithKline's healthy volunteer database in Harlow. Their characterisation of this for you was that: "There were no reports of suicidal thoughts in any of the volunteer studies. There were few reports of 'emotional lability', however these reactions were not found to be related to suicidal thoughts or behaviour. Some volunteers reported anxiety, nervousness and agitation while taking paroxetine, however the most commonly reported adverse events were nausea, diarrhoea, drowsiness and insomnia".

What I found was that approximately 25% of the volunteers in the studies that I reviewed which were all of the healthy volunteer studies done prior to the filing of this drug for registration in the US and in the UK - 34 studies approximately in all. These yielded a 25% agitation, nervousness/akathisia rate. Some of the multiple does studies in healthy volunteers lasting 2-3 weeks yielded an up to 85% withdrawal rate in the volunteers.

All of their healthy volunteer studies were supposed to have been made available to me but not all were. Of the ones that were missing there was trace correspondence left in once indicating that the investigator had never witnessed such a level of problems in a study with healthy volunteers. Another study was a single dose study which in a dose dependent fashion yielded a 75% rate of severe adverse events most of which involved the central nervous system. There were other disturbing indications from one of the other missing studies.

Volunteers who had participated in the programme went on to suicidal acts. The relationship between their intake of paroxetine and later suicidal acts is a matter about which neither you nor SmithKline Beecham should be sanguine.

These studies were for the most part done on company employees. None of the studies bar the missing ones were done by investigators with a background in psychiatry. The investigators were general physicians with a primary interest in gastrointestinal problems who could not have been expected to detect mental problems of this sort that have concerned me and I would have thought should concern you.

My testimony in this case also bore witness to sealed studies and other unreported data. It commented on the Montgomery Baldwin Study which yielded a projected rate of 45 suicide attempts in a group of recurrent brief depressive disordered patients on paroxetine per annum versus 12 on placebo. The figures were not statistically significant in great part one has to suggest because the company had terminated the study early. This termination and subsequent non-publication I would imagine the jury will have found and others will find significant.

Dr Hudson, currently of the MCA, was a witness for SmithKline in this case. He may well be able to give you further details on some of the issues involved. His testimony involved repeated reference to the fact that SmithKline Beecham cannot decide whether their drug had caused problems such as the wrongful death of Don and Rita Schell or Deborah and Alyssa Tobin or the wrongful deaths of many other people whose deaths have been reported to SmithKline even when these reports have been accompanied by the opinions of their treating physicians that the drug had indeed contributed to the problem. Dr Hudson's testimony was that until controlled trials or other similar studies had proven in general that paroxetine could cause such problems that the company could not make decisions on any specific case.

This appears to me a Black Hole defence. It is entirely conceivable that tens of thousands of suicides could disappear into this Black Hole without either SmithKline Beecham, Pfizer or Eli Lilly being called upon to make any judgements as to whether their drug was contributing to the problem. The lack of evidence from randomised controlled trials or epidemiological studies in this context is not evidence of a lack of a problem. It stems explicitly from failures of SmithKline Beecham, Pfizer or Lilly to do the requisite studies. Both David Wheadon and Christine Blumhardt from SmithKline as well as Roger Lane from Pfizer and Charles Beasley from Eli Lilly along with outside experts such as Daniel Casey and John Mann have testified under oath in the course of the last year that there have been no studies undertaken by any of these companies or others that have been designed to test whether the SSRIs could cause a problem. I believe that this will in due course be seen for the extraordinary state of affairs that it is.

I think what will also be clear is that SmithKline Beecham recognised the presence of withdrawal syndromes in their volunteers from the early to mid 1980s. That withdrawal syndromes occurred at a much higher rate than occur on benzodiazepines. Nevertheless they applied for and have received from you and other regulators a licence to claim that their drug is effective in the prophylaxis of depression and these claims have been based on designs which almost certainly are designs better suited to show the presence of a withdrawal syndrome than designs suited to demonstrate prophylaxis in depressive disorders. A great number of people have in recent years been told that when they begin to feel ill on discontinuing treatment that this is the recrudescence of their mood disorder rather than a discontinuation syndrome from their drug. I would imagine that a great many such people and others on their behalf will feel extraordinarily let down and angry when faced with the evidence that I've been faced with.

Yours sincerely

David Healy MD FRCPsych
Director, North Wales Department of Psychological Medicine


**********

Dr. David Healy meets with the MHRA at the end of this month. Some 9 years after the above letter.

Fid

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NHS - Too little, too late?

A link was sent to me from one of my readers that points to the NHS page on depression.

Ruth, who often sends me various links, added, 'Oh how times have changed' to the body of the email. She's right.

The NHS now point to N.I.C.E. guidelines regarding SSRi treatment. Some interesting points are:

Patients should have access to accessible information about treatments and self-help and support groups.

Mild depression: further assessment, usually within two weeks. The patient may recover without intervention. Antidepressants are not recommended for the initial treatment of mild depression. Guided self help, such as computerised cognitive behavioural therap, should be considered.

Mild and moderate depression: psychological treatments (such as CBT or counselling) should be considered.

Antidepressants: selective serotonin reuptake inhibitors (SSRIs) should be considered over tricyclic antidepressants because of better safety and fewer side effects. All patients should be informed that withdrawal symptoms may occur when stopping, missing doses, or reducing the dose.

----

It's good to see that N.I.C.E. are recognising the SSRi withdrawal problem and it's good to see that the NHS are now highlighting it on their page. It's also refreshing to see the MHRA are now taking this matter seriously - a meeting they have with David Healy later this month should prove very interesting.

Personally, I'd like humungous changes to the packaging. The Americans have black box warnings, so why can't we?

Maybe the Patient Information Leaflet [PIL] should start with:

"Your doctor has prescribed you this medication because you have depression. Your depression has been deemed to be worse than mild to moderate by your doctor. If you need to ask your doctor why he feels your depression is worse than mild to moderate then we suggest you go back to see him/her and ask him/her how they arrived at their diagnosis."

They may even wish to add:

"By taking this medication you could possibly make your depression worse. We don't know how this medication works, we just go on theories and not facts. If at any time you feel suicidal or have homicidal thoughts then please go back to your doctor. He/she will then have to play a guessing game of whether or not your dosage needs to be increased or if it is the actual medication that is making you have these thoughts. At no point will we intervene or show you or your doctor any negative trial results from your medication. We don't have to because we are covered by the EU Law so na na na na na."

Maybe some sort of literature for parents too?

"Your son, daughter has been prescribed this medication 'off label' by their doctor. This basically covers our ass as the medication is not meant for minors. The onus is on your doctor and any lawsuits you may bring against us in the future will be defended by our highly paid law team, using the 'off label' decision by your doctor as our defence. If your son/daughter takes their own life our law team will either blame the illness or state catagorically that our medication is not approved for children - thus putting the onus on the person who prescribed our drug to your child."

Finally, the PIL could carry the disclaimer:

"This medication has been granted a licence by the MHRA, they think it is suitable after shifting through all the evidence that proves efficacy. We never provided the MHRA will all the data, in particular the data that showed that this medication is about as effective as a placebo [dummy pill] - Again, we are doing nothing illegal, we are protected by EU Law."


It would certainly make a change from the current literature on patient information leaflets wouldn't it? You know, the bog-standard:

"This medication may cause dizziness, nausea, headaches."

Yeh right.

Now who was it that once said, "Education, education, education?"

Fid

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Friday, June 12, 2009

Death By Prescription - Terence Young [Prepulsid]




If you can get past the first two Chapters of this book without shedding a tear then you may wish to ask yourself if you have a heart made of stone.

Terence Young writes with his heart and investigates every last detail of the failure of Health Canada and pharmaceutical giants, Johnson & Johnson with regard to a prescription drug called Prepulsid.

The story is about his 15 year old daughter, Vanessa, whom was prescribed Prepulsid for an eating disorder.

Terence goes into graphic detail about his daughter's final hours before she suddenly collapsed at the foot of the stairs in his Ontario home.

Vanessa died of a heart arrhythmia.

Prepulsid caused heart arrhythmia's but the manufacturer, Johnson & Johnson, didn't wish for this information to be made public because it no doubt would have affected the sales figures for their blockbuster drug.

What follows is a story of great courage and determination to get to the core of the truth of why Vanessa died.

You will witness the underhand tactics of pharmaceutical company lawyers, the incompetence of the Canadian medicine regulators, Health Canada, and a family ripped apart at the seams because nobody in Canada would hold up their hand and take responsibility for being a part of this girl's death.

Vanessa Young would still be alive today if Johnson & Johnson had acted properly, if Health Canada had actually done the job they were paid to do, if doctors had bothered to read warnings regarding Prepulsid.

No parent should have to bury their child, particularly because of a prescription drug that was supposed to make them better.

Prepulsid was a bullet for Vanessa Young, the gun into which that bullet was loaded was held by the manufacturers, Johnson and Johnson, their hand was steadied by Health Canada and incompetent doctors who prescribed a drug that killed her.

The outcome.... well, you will just have to read the book but have some tissues handy.

Fid

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FDA Panel Throws Life Line to Antipsychotic Pushers

Article by Evelyn Pringle


On June 11, 2009, FDA News reported that AstraZeneca’s Seroquel, Pfizer’s Geodon and Eli Lilly’s Zyprexa atypical antipsychotics "won an FDA advisory panel’s recommendations for approval to treat schizophrenia and bipolar disorder in pediatric and adolescent patients."

"The FDA's expanded marketing approval process for antipsychotics, highly toxic drugs, is unaffected by evidence uncovered by the US Justice Department showing that the studies submitted by drug manufacturers were often flawed, if not fraudulent," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, in a June 8, 2009 infomail alert.

"Rather than focus on protecting children's safety,  FDA officials are doing their utmost to legitimize irresponsible, off-label prescribing of exceedingly toxic antipsychotics for children--thereby ensuring that far greater numbers of children will be victimized and die," according to Sharav.

A recent report by the consulting firm Decision Resources found antipsychotics makers spent $993,000,000 in 2006, to promote these drugs to doctors and patients, she reports. In 2008, at more than $14 billion, antipsychotic revenues topped all other classes of drugs in the US, even cholesterol and diabetes medications.

On November 17, 2008, on the popular Furious Seasons website, Philip Dawdy reported that Zyprexa had killed 3,455 people between 1997 and early 2008, based on a review of an FDA staff document with a summary of adverse events in the agency's database.

From 1993 through the first three months of 2008, 1,207 children on Risperdal suffered serious adverse events, including 31 who died, according to a report in the November 18, 2008 New York Times.

The deaths included a 9-year-old child, receiving Risperdal for the unapproved use of ADHD, who suffered a stroke twelve days after starting the drug. At least 11 of the deaths were in children whose treatment was for an unapproved use.

In May 2009, CBS News reported that Risperdal was causing boys to grow breasts due to increased prolactin levels caused by the drug. The news segment featured a boy who was prescribed Risperdal for ADHD, and had to undergo a double mastectomy to remove the breasts.

Philadelphia attorney, Steve Sheller, represents six boys who developed breasts after taking Risperdal, in lawsuits against Johnson & Johnson. Two have had mastectomies.

On June 3, 2009, Medscape reported that findings presented at the American Psychiatric Association annual Meeting, on the preliminary results from the "Metabolic Effects of Antipsychotics in Children" study, "show that 12 weeks of initial antipsychotic treatment was associated with significant mean increases in overall adiposity and percentage of body fat, as well as a decrease in whole-body insulin sensitivity."

"Further," Medscape said, "the investigators found antipsychotic treatment was also linked to significant increases in body-mass index (BMI) percentile and fasting plasma triglyceride levels, both clinically available indicators of adverse metabolic changes associated with increased adiposity."

In terms of live-long health issues: "This is a serious problem," says Dr Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, and past president of the American College of Cardiology.

"The substantial increase in body fat and increased insulin resistance will almost certainly lead to a higher lifelong incidence of diabetes," he warns.

"Diabetes is a major cause of heart attack, stroke, kidney failure, blindness, and limb amputation," Dr Nissen points out.

In an April 2008, editorial, in Psychotherapy and Psychosomatics, titled, "Irrational Healers," Dr David Healy, author of the new book, "Mania: A Short History of Bipolar Disorder," writes:

"For fifty years, the antipsychotics were viewed as too dangerous to use outside secondary care and were largely restricted to those with chronic psychotic disorders where the trade-off between hazards and benefits justified treatment."

"Yet now a new generation of possibly even more problematic antipsychotics is being given to preschoolers, in North America, on the basis that they might have a disorder that most of the rest of the world does not believe happens in children."

"FDA officials are ignoring the real world tragedies--drug-induced deaths of children," Sharav warns.

On June 6, 2009, the Topeca Capital Journal reported on the death of a Kansas toddler, Destiny Hager, and the confirmation by an autopsy that the child died of fecal impaction, after taking Seroquel and Geodon, with "antipsychotic drugs present in concentrations considered therapeutic in adults."

Child psychiatrist, Vernon Kliewer, diagnosed Destiny with bipolar disorder and prescribed the drugs. State regulators recently "completed a two-year investigation of Kliewer that found the doctor violated Kansas law while treating Destiny and five other children," the Journal reported.

A September 14, 2007 petition filed by the Kansas Board of Healing Arts, says Kliewer diagnosed Destiny with Bipolar Disorder in March 2006, at 3-years-old, and she died on April 4, 2006.

The petition contains 6 counts and details the prescribing of multiple drugs by Kliewer to six children including two more 3-year-olds, one 4-year-old and two 2-year-olds. In one case, he began treating a child at 2-years-old and between January 2003 and November 2006, prescribed a total of 9 drugs for the girl, including Risperdal, Abilify, Seroquel, and Geodon.

"The doctor negotiated a settlement in February with the Board of Healing Arts that didn’t require him to admit wrongdoing," the Journal said. "He voluntarily stopped treating patients under age 6."

The Board placed Kliewer's medical license on indefinite probation and ordered him to pay $13,079 to cover the investigation expenses, the Journal reported. Kliewer must also have another physician monitor his treatment of bipolar patients.

"Tragically, most physicians have not been trained or encouraged to think rationally about the hazards of monotherapy, let alone polypharmacy in children," says Dr Grace Jackson, author of, "Rethinking Psychiatric Drugs: A Guide to Informed Consent, and the new book, "Drug Induced Dementia - a perfect crime."

"Mental health professionals have an ethical duty to inform parents about the potential lethality of drug combinations," she advises.

On June 5, 2009, Dawdy posted a link to the FDA's briefing package on Furious Seasons, available to members of the advisory panel, and posted portions of the introduction by FDA psychiatry products chief, Thomas Laughren, including the following comments on side effects caused by the drugs:

"Adverse reactions that can occur with drugs in the class of atypical antipsychotic drugs include, among others, somnolence, weight gain, increases in blood lipids and glucose, acute extrapyramidal symptoms, and tardive dyskinesia.

"These risks are of particular concern in pediatric patients because of the life-long nature of these disorders and the fact that these patients are considered particularly vulnerable, in part because they may be exposed for many decades, and in part because of possible effects on growth and development," Laughren noted.

In April 2009, Gabriel Meyers, a 7-year-old Florida boy, committed suicide by hanging in the bathroom of a foster care home. In the last few days of his life: "He was told his mother no longer had visitation rights, that he would probably be going back to Ohio, where he alleged he had been abused; the doctor changed his medication, he changed foster homes and he got a new counselor," George Sheldon, secretary of the Department of Children and Families, stated in the May 12, 2009 St Petersburg Times.

In the year leading up to his suicide, Gabriel had been on the stimulant drugs Adderall and Vyvanse, the SSRI antidepressant Lexapro, Zyprexa, and Eli Lilly's Symbyax, a drug containing both Zyprexa and Prozac, recently FDA approved for "treatment resistant" depression.

Gabriel was on Symbyax and Vyvanse when he died and neither prescription had been authorized by either his parents, or a court order signed by a judge, in violation of Florida law. He was listed as being on only Adderall in the Department of Children and Families' database.

"On six separate occasions, Gabriel's caseworker, Lawrence Chusid, documented that DCF had "parental consent" for the child's medications," according the May 9, 2009, St Petersburg Times "But in the hundreds of records in Gabriel's file released by DCF late last month, there is only one form signed by his mother, Candace, a blanket authorization for medical treatment for her son," dated June 29, 2008, the Times reports.

The labeling on Prozac and Symbyax, contains a black box warning of an increased risk of suicide in children. Instead of discouraging the concomitant use of these two powerful medications, Lilly has encouraged such practices by "designing its own "combination" capsule which contains both Prozac and Zyprexa," says attorney, Andy Vickery, of the Houston law firm, Vickery, Waldner & Mallia, who is involved in Zyprexa suicide litigation.

"The actual number and rate of completed suicides for patients in clinical trials on antipsychotic drugs, as submitted to the FDA, is higher on Zyprexa than on any of the other drugs in this class," he reports.

"Specifically," he says, "Lilly reported that, of 2500 patients on Zyprexa, there were 12 completed suicides, as compared to none on placebo."

For several years, a system called the "Medicaid Drug Therapy Management Program," was supposed to be monitoring the prescribing habits of doctors for children covered by Florida Medicaid. However, Gabriel's shrink, Dr Sohail Punjwani, had been red-flagged as having "problematic" prescribing practices in every quarter since the monitoring began in 2006.

According to the Miami Herald: "Punjwani defended the use of psychiatric drugs on children, even if they are not approved for such use, saying the lack of approval stems from the reluctance of drug makers and the medical establishment to launch clinical trials on children."

"The anti-psychotic drugs, he added, are used routinely to treat mood instability and insomnia among children," the Herald reported.

The doctor told the Herald that he did not even remember Gabriel. On May 12, 2009, the Herald reported that a "lawmaker who chairs a state Senate committee on children has asked the state to investigate the doctor who treated a foster child who killed himself."

"In separate letters to the Florida Board of Medicine and the Agency for Health Care Administration, state Sen. Ronda R. Storms, a Brandon Republican who chairs the Children, Families and Elder Affairs Committee, requested investigations leading to a "full report," according to the Herald.

Following Gabriel's death, DCF Secretary Sheldon directed a review of the files for every Florida foster child to ensure that any child prescribed psychotropic drugs was accurately recorded in the Department’s system. He also directed a verification of the existence of a parental consent, or a court order signed by a judge, authorizing each child to receive such medication.

The results of the review in a May 28, 2009 report indicate: "No record of consent or judicial order was found for 16.2% of the 2,669 children receiving psychotropic medication."

On December 13, 2006, four-year-old Rebecca Riley died in a Hull, Massachusetts as a result of a drug overdose.  At a mere 28-months-old, Dr Kayoko Kifuji, a psychiatrist at Tufts New England Medical Center in Boston, diagnosed Rebecca with ADHD and bipolar disorder, and subsequently prescribed, Seroquel, Depakote, an antiseizure drug, and clonidine, a blood pressure medication.

The medical examiner noted that "Rebecca's heart and lungs were damaged and found that this was due to prolonged abuse of these prescription drugs, rather than one incident," according to police reports.

The legal filings show the two other Riley children, ages 6 and 11 at the time of Rebecca's death, were also diagnosed with bipolar disorder and ADHD, by the same doctor, and kept on the same 3-drug cocktail for years.

Rebecca's parent have been charged with murder under the theory that they overdosed the child in attempt to sedate her and she did not bring in government disability payments.

On February 7, 2007, the day after the parents pleaded not guilty to the charges, Dr Kifuji entered into a voluntary agreement with the Massachusetts Board of Registration in Medicine to not practice medicine pending an investigation. “The Agreement entered into by Dr. Kifuji will remain in effect until further order of the Board,” the Board's February 7, 2007 press release stated.

In April 2008, attorney, Andrew Meyer Jr, filed a malpractice lawsuit against Dr Kifuji on behalf of Rebecca's estate. "This child was subject to mostly telephone prescriptions and a slipshod diagnosis," he told the Boston Globe on April 4, 2008.

In an editorial titled, "How many more Rebecca Rileys?, in the January 9, 2009 Patriot Ledger, the author of, “From Difficult to Delightful in Just 30 Days,” Dr Jacob Azerrad, wrote: "To diagnose a 2-year-old as bipolar by adult standards is crazy."

"A key issue is the misuse of psychiatric diagnostic labels to explain bad behavior in children," he wrote. "This has resulted in the drugging of young children to a degree unprecedented in our history."

"Our preschool children are far too young to defend themselves," he said. "It’s up to parents to “say no to drugs” and teach their children that life is meant to be learned and experienced – it’s not just a pill to be swallowed."

On March 5, 2009, Weymouth News reported that a "psychiatrist who prescribed drugs for the late Rebecca Riley, who was four at the time of her death, can be charged with malpractice."

"A Suffolk County tribunal determined on March 5 that there was enough evidence to charge Dr. Kayoko Kifuji," the News noted.

"Rebecca Riley’s doctor now the target of a grand jury," was the headline in the May 1, 2009 Patriot Ledger. "Already the target of a civil medical malpractice lawsuit, the psychiatrist who prescribed the drugs that killed 4-year-old Rebecca Riley is now the subject of a grand jury criminal investigation," reporter Lane Lambert wrote.

"If the grand jury does find the ... psychiatrist criminally liable for Rebecca’s death, she could face involuntary-manslaughter charges," Lambert noted.

Evidence of the grand jury investigation surfaced "amid fresh legal action in both the civil and criminal cases," Lambert said. "Kifuji’s lawyers asked a Suffolk County judge to postpone her deposition in the civil case indefinitely, and close the entire court record to the public."

Kifuji’s attorney "said a deposition would force the doctor to claim her Fifth Amendment right not to incriminate herself while the grand jury was looking at the case," according to the report. The judge denied both motions, it noted.

An attorney for Rebecca estate said Kifuji is scheduled to give a deposition in the civil case on July 6, 2009, after the grand jury is finished. In the March 5, Weymouth News article, Kifuji’s attorney said the murder charges against the Rileys make it difficult to decide if she can be faulted for Rebecca’s death.

"This is not something bizarre that she (Kifuji) did,” he said. “A number of fine doctors feel this was appropriate.”

Back on September 30, 2007, Katie Couric interviewed Dr Joseph Biederman, whose research Dr Kifuji has said influenced her, in a 60 Minutes segment tiled “What Killed Rebecca Riley?”

When questioned about the rise in young children with bipolar disorder, Biederman told Couric: "The average age of onset is about four."

"It's solidly in the preschool years," he stated.

The results of an investigation led by Senator Charles Grassley, on behalf of the Senate Finance Committee, revealed that between 2000 to 2007, Biederman earned at least $1.6 million from drug companies but failed to report at least $1.4 to Harvard University.

On February 26, 2009, Biederman was questioned under oath in a deposition for litigation titled, In re Risperdal/Seroquel/Zyprexa Litigation, Case Code 274, Alma Avila as next fried of Amber Avila versus Johnson & Johnson Company et al, in the Superior Court of New Jersey, Middlesex County.

At one point, when questioned about his participation in medical education events as a paid speaker, he blamed a decline in invitations to speak over the past year on Grassley's investigation and inferred that the investigation was brought on by media hype over Rebecca's death.

When asked if he had any idea why he received fewer invitations, Biederman said: "There has been some accusations by Senator Grassley about issues of conflict of interest; and while the investigation is going on, I agreed not to speak."

"What is the nature of Senator Grassley's investigation of you?" attorney, Fletch Trammell, asked.

"Senator Grassley read, there was an article in The Boston Globe about a little girl in town that the parents are accused of first-degree murder," Biederman noted.

"In fact, you may have seen it," he told the attorney.

"The accusation has been upgraded from second-degree to first-degree murder," he pointed out.

"But because the child was diagnosed with bipolar illness, it captured the imagination of the media and there was an article in The Boston Globe that talked about the diagnosis and how controversial that is and particularly as it pertains to preschoolers," Biederman continued.

"And in the article the reporter got -- I sent my standard disclosure forms, so he wrote that I have extensive relationships with fifteen or so pharmaceutical companies," he stated.

"So Senator Grassley wrote a letter to the institution, to Harvard and Mass. General, asking for details," he said. "And that has been the cascade of events."

"So Senator Grassley became interested in you because of these people who were accused of killing their kid?" the attorney asked Biederman.

"Senator Grassley claims to be interested in issues of conflict of interest and is interested in making sure that the universities have tight conflict-of-interest rules," Biederman said. "I have no dispute with that."

"What interactions have you had with Senator Grassley or his staff?" the attorney asked.

"None," Biederman stated. "Senator Grassley's interactions are with Mass. General and with Harvard, not with me directly."

Biederman said the hospital was paying a law firm to represent him in the matter of Grassley's investigation and for the deposition.

He acknowledged having a professional relationship with Janssen, Eli Lilly, Bristol-Myers Squibb, AstraZeneca and Pfizer, the makers of atypical antipsychotics. "I have a professional relationship with dozens of manufacturers," Biederman said.

"In the course of carrying out these relationships with all these drug manufacturers, does the relationship always involve them giving you money?" the attorney asked.

"Most of the time," Biederman replied.

On March 27, 2009, the New York Times reported that, "Federal prosecutors have issued a subpoena seeking information about the work and statements of three prominent Harvard researchers who have been the focus of a Congressional investigation into conflicts of interest in medicine."

The researchers, Doctors Joseph Biederman, Thomas Spencer and Timothy Wilens - "are named in the subpoena, which was sent ... to Fletch Trammel, a lawyer who represents state attorneys general in lawsuits that claim makers of antipsychotic drugs defrauded state Medicaid programs by improperly marketing their medicines," the Times noted.

Up until June 10, the researchers and doctors in the field of psychiatry identified by Grassley's investigation included Charles Nemeroff from Emory University; Melissa DelBello at the University of Cincinnati; Alan Schatzberg, president of the American Psychiatric Association, from Stanford University; Martin Keller at Brown University; Karen Wagner and Augustus John Rush from the University of Texas; and Fred Goodwin, the former host of the radio show, "Infinite Minds," broadcast for years by National Pubic Radio.

But on June 10, the name Zachary Stowe was added to the list, with a Wall Street Journal headline: "Emory Psychiatrist Cited in Conflicts of Interest."
"Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women," the Journal wrote.

Stowe is the director of the "Women's Mental Health Program" at Emory. Its website says the focus his "clinical research is the use of psychotropic medications during pregnancy and lactation, the psychobiology of mood disorders during pregnancy and the postpartum period, and the impact of maternal mental illness on fetal and neonatal exposures."

The latest off-label marketing scheme in the works involves federal legislation expected to come up for a vote soon in the US Senate called the Mothers Act. This one involves a plan to screen all pregnant women for a long list of pregnancy related "mood" and "anxiety" disorders.

After covering the Pharma's off-label marketing schemes using mental illness screening scams since mid-2004, beginning with TeenScreen, the Mothers Act is no different than the others, aside from the fact that a whole new treatment industry was built up around it, and more profiteers are involved. But then, Pharma could hardly expect to keep selling drugs through middle-man pushers forever, while keeping the massive profits to itself.

Amy Philo, the leader of "Unite for Life," a coalition of 50 groups against the bill, warns that the Mother's Act is: "Trolling for Mental Patients in a Maternity Ward Near You."

"If you’ve never been “Teen Screened” in high school, quizzed by a college counselor about your potential perfectionism, mood swings, or alcohol use- or told you might go crazy if you don’t start taking drug x, consider yourself among the fortunate, fading few," Amy advises.

"Imagine yourself pushing a baby into the world in a hospital somewhere in America," Amy says, "only to be greeted by a friendly, neighborhood-psychological-screener the very moment baby begins munching down on his first meal."

"Would either of you like a DSM-IV Mental Disorder diagnosis code with that milk?”

With no psychiatric drugs FDA approved as safe for use by pregnant and nursing mothers and doctors rightfully reluctant to prescribe any drugs harmful to the fetus, a new customer recruitment scheme was needed and the Mothers Act fit the bill.

Opposition to the Act stems from the certainty that it will lead to more forced drugging of infants with no voice of their own to prevent it, with antidepressants, antipsychotics, and antiseizure drugs that cause birth defects, a withdrawal syndrome and many other serious health problems, through pregnant and nursing mothers.

The Act is modeled after a mandatory screening law enacted in New Jersey, the home state of the bill's main sponsor, Senator Robert Menendez, and also the home state for many drug companies. Attempts to pass the federal version have failed for the past 8 years.

The postpartum websites strung out all over the internet to promote the bill, many run by people benefiting financially from the new treatment industry they created, argue that the Act does not call for mandatory screening, without mentioning that the screening language was removed last year due to strong opposition.

"There is NO MANDATED screening," Susan Stone wrote in a blog on the website for her treatment center, PerinatalPro, on May 29, 2009.

On May 12, 2009, the Herald News reported that the Act "lacks one vote for approval" in the US Senate, citing a speech made by Menendez, during a press conference. Menendez told the Herald that the national bill would not mandate screening. "Hopefully, states would adopt screening," he said.

This statement, in May of this year, clearly shows that the goal of passing the federal legislation is to set the stage for states to pass mandatory screening laws, like the one in New Jersey.

A June 16, 2006, press release, by Menendez and Senator Richard Durbin, announcing the bill stated, the "Act was introduced in response to a recently passed, first-of-its-kind New Jersey law requiring doctors and nurses to educate and screen expectant mothers about PPD."

The Theraurus on my computer lists "require," as an alternate word for "mandatory."

On June 8, 2009, New Jersey.com, ran the headline: "E-mail: Drug lobbyist targeted Menendez to help with importation bill," and reported that the subject line of the email said: “URGENT”

The email called for New Jersey drug companies to ask Menendez to be their champion on an amendment that would effectively kill any attempt to allow cheaper drugs to be imported from other countries, according to the report.

"We need to locate a Democratic lead cosponsor for the second degree amendment,” the e-mail said.

"Can … [Johnson & Johnson], Merck, Novartis, Pfizer and the other New Jersey companies coordinate and contact Senator Menendez's office and ask him to take the lead?”

The strategy to pursue Menendez became known when the email from the Pharmaceutical Research and Manufacturers of America, the industry trade group, ended up with Senator John McCain, a drug importation advocate. "And McCain read it on the Senate floor – twice," the article notes.

"Menendez’s office said that while he supports the drug companies’ position, he did not act as their champion," according to New Jersey.com.


The Mothers Act refers to “entities,” as being eligible for grants and participating in research and the development of screening methods and treatments and delivery.

The bill states: "The Secretary may make grants to eligible entities for projects for the establishment, operation, and coordination of effective and cost-efficient systems for the delivery of essential services to individuals with a postpartum condition and their families."

Under definitions, it says the term ‘eligible entity’– "means a public or nonprofit private entity;" and "includes a State or local government, public-private partnership, recipient of a grant under section 330H (relating to the Healthy Start Initiative), public or nonprofit private hospital, community-based organization, hospice, ambulatory care facility, community health center, migrant health center, public housing primary care center, or homeless health center."

"Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing," according to Kelly Patricia O'Meara in May 7, 2009 article, "Stress Testing the Mothers Act."

"Where is the guarantee that the “entities” are not pharmaceutical front-men?", she writes.

"Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse," O'Meara points out.

The Act also calls for a "a coordinated national campaign to increase the awareness and knowledge of postpartum conditions." Activities under such a campaign may– "include public service announcements through television, radio, and other means;" which will basically provide the new pregnancy-related treatment industry with a tax-payer funded mass advertising campaign.

It would be interesting to know whether "entities" would include the treatment centers owned by Susan Stone and Karen Kleiman, and whether their programs would be eligible for funding. At the "Postpartum Stress Center," Kleiman teaches seminars for professional training with ads on her website and the heading: "Become an Expert in the Treatment of Postpartum Mood Disorders."

The first sentence in "Highlights" for this training states: "This is a crash course on diagnosis, screening, assessment, treatment options." The fee is $750 for a 10-hour course, but they do throw in a book titled, "The Postpartum Stress Center's Guide to Enhancing your PPD Private Practice: A checklist for successful practice," for the $750.

For this gig alone, Karen could make $7,500 per seminar by simply recruiting 10 trainees. Nearly all the websites pitch in to promote conferences and seminars, so rounding up 10, or even 20, trainees would likely not be too difficult.

The website shows 4 seminars a year, meaning Karen could earn roughly $30,000 for 40 hours of teaching people how to "Become an Expert." And if she could round up 20 trainees per class, she could make $60,000 a year, putting her up there with all the other highly paid speakers within the new industry.

In her May 29, 2009 blog, Susan mentions how the Act might help fund "inpatient maternal mental health" programs all across the US. "Just this morning," she says, "I completed an interview with Parenting Magazine, which plans to feature an article about the nation’s first inpatient maternal mental health unit at UNC, Chapel Hill, NC, as well as focus on the federal legislation and how this bill might help fund other such programs across the country."

Many sites provide links to "experts" and treatment programs. For instance, Katherine Stone runs “Postpartum Progress," and in December 2008, she had links to the “Top Women’s PPMD Treatment Programs & Specialists.”

The first program on the list was Dr Stowe's at Emory, which primarily focuses on "the evaluation and treatment of emotional disorders during pregnancy and the postpartum period," the website states.

In 2008, Dr Stowe was the primary investigator of an National Institutes of Health grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to Grassley's June 2, 2009 letter to the president of Emory.

During a 2008 deposition in a Paxil birth defect case, Stowe said that around "80% of his Emory salary ($187,000) comes from his NIH grants," the letter notes. His total Emory salary was $232,000.

In 2007, Paxil maker, GlaxoSmithKline, paid Stowe $154,400 for 57 promotional talks. He also received $99,300 in the first ten months of 2008 for 38 promotional talks for antidepressant drugs, according to Grassley.

Stowe's undisclosed income above was from one drug maker. In August 2007, he was listed as an author on a study titled, "Atypical Antipsychotic Administration During Late Pregnancy: Placental Passage and Obstetrical Outcomes," in the American Journal of Psychiatry.

According to the disclosure section, Stowe has received research support from Glaxo, Pfizer, and Wyeth. He has served on advisory boards for Wyeth, Bristol-Myers Squibb, and Glaxo, and he has served on speaker’s bureaus and/or received honoraria from Lilly, Glaxo, Pfizer, and Wyeth.

Dr Jeffrey Newport is the associate director of Emory's Women’s Program. Newport was also an author on the "Antipsychotic," study. He has received research support from Lilly, Glaxo, Janssen, the National Alliance for Research on Schizophrenia and Depression, NIH, and Wyeth, and, he has served on speaker’s bureaus for AstraZeneca, Lilly, Glaxo, Pfizer, and Wyeth, according to the disclosures.

On June 14, 2007, Katherine Stone posted a blog with the headline: "Upcoming Event in Asheville Features My Psychiatrist!", in an evening for prescribing clinicians called "Postpartum Mood Disorders: A Systemic Approach to Biopsychosocial Treatment."

"The key speaker will be Dr. Jeffrey Newport, associate director of the Emory Women's Mental Health Program here in Atlanta and also my psychiatrist!!!!", she said. "I have firsthand knowledge that Dr. Newport rocks."

An online announcement shows Dr Stowe gave a seminar titled, "Atypical Antipsychotics in Major Depressive Disorder: When Current Treatments Are Not Enough." The moderator for the seminar was Charles Nemeroff, who earned more than $2.8 million from drug companies between 2000 and 2007, but failed to disclose at least $1.2 million to Emory, according to Grassley.

On July 23, 2008, an article by Nemeroff titled: “Weighing Risk and Benefit for Treatment of Depression in Pregnancy and PostPartum,” was available on Medscape. The Medscape website stated, “This article is temporarily unavailable,” on March 17, 2009.
Nemeroff stepped down as chair of the psychiatry department in 2008 after an Emory found he had failed to report more than $800,000 from Glaxo from 2000 to 2006. "That matter is now being probed by the inspector general for the U.S. Department of Health and Human Services," according to the Wall Street Journal.

Evelyn Pringle
epringle05@yahoo.com


(Evelyn Pringle is a columnist for Scoop Independent News and an investigative journalist focused on exposing corruption in government and corporate America)



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