Tagged: Chemical Imbalance

Dr Terry Lynch’s ‘Depression Delusion’ Released Now On Amazon.Com


TERRY

http://www.recoveryourmentalhealth.com/my-next-book-depression-delusion-volume-one-the-myth-of-the-brain-chemical-imbalance-publication-date-02-sept-2015/
Professor Ivor Browne, consultant psychiatrist, former professor of psychiatry at University College, Dublin said of Dr Terry Lynch:

…“The following is my endorsement of Dr. Terry Lynch and his work: The prevailing approach to psychiatry reduces people to a biological collection of tissues and organs, human suffering to unidentified brain abnormalities, and the alleviation of human suffering to various substances whose main action is to change how people feel rather than any specific or necessary remedial effect within the body. If anything, the situation is getting worse as the years pass. For the past ten years or more, Terry Lynch has been one of the very few doctors within the medical profession in Ireland who has been prepared to question the psychiatric understanding of and approach to human suffering. He has consistently called for a reappraisal of how human suffering and distress is interpreted and responded to within modern western societies, a reappraisal that I support, that I believe is urgently required in the public interest. Would that there were more enlightened doctors and psychiatrists in the country”…

(Letter, 16th September 2013).


I am delighted to announce that Dr Terry Lynch’s new book ‘Depression Delusion‘ is out now on Amazon. Terry is most well known for his book best selling book ‘Beyond Prozac‘, and his other book ‘Selfhood‘ comes also highly recommended, however personally I think that ‘Depression Delusion‘ will rock the psychiatric establishment and psychiatric drugs industry to its foundations (or at least it should!). The more widely read it becomes the more unstable the ‘chemical imbalance theory’ will become. It’s about time that someone buried this absurd theory, and Terry has done just that.

My review of ‘Depression Delusion’ can be found here.

Phil Hickey, and Leonie’s Fennel’s, reviews of ‘Depression Delusion‘ can be found here:

https://leoniefennell.wordpress.com/2015/05/24/dr-terry-lynch-depression-delusion-volume-one-the-myth-of-the-brain-chemical-imbalance/

http://www.madinamerica.com/2015/08/book-review-depression-delusion-by-terry-lynch-md-ma/

“…In this truly remarkable — and meticulously researched — volume, Dr. Lynch annihilates psychiatry’s cherished chemical imbalance theory of depression.  Every facet of this theory, which the author correctly calls a delusion, is critically analyzed and found wanting.  Example after example is provided of psychiatrists promoting this fiction, the factual and logical errors of which are clearly exposed in Dr. Lynch’s lucid, seamless, and highly readable prose.” (Phil Hickey)


“..This fabulous book is a must for everyone who believes that they are suffering from a brain chemical imbalance (an unwitting Bressie springs to mind). Dr Lynch is one very brave man to take on the so-called ‘experts’ in this forthright manner. It’s a David and Goliath situation. Will the truth win out? Is this generation ready to see that the so-called ‘experts’ are in fact philistines? I sure hope so! Huge respect to Dr Terry Lynch for this much-needed exposé. His book is out in September and I look forward to the fall-out. ‘Depression Delusion Volume One: The Myth of the Brain Chemical Imbalance’ is most definitely a keeper…” (Leonie Fennell)

The following videos give a glimpse into the amazing work Dr Terry Lynch has been doing for sufferers of mental health problems for the past two decades. Dr Lynch is a sincere patient advocate and I recommend ‘Depression Delusion’ to anybody who is suffering from depression, and/or has been told by their doctor or psychiatrist that they have a so called ‘chemical imbalance’. Maybe you are aware that this imbalance is incorrect but you need a reference book to show your doctor? if so, then this book is ideal.

I wish it was written back when my doctor told me that I had a chemical imbalance in 1998. He told me I would have it for life and needed SSRI’s to correct it. Lo and behold, he was wrong .I was conned. We all were. The chemical imbalance is a fraud which has caused immeasurable damage to our understanding of depression and how it should be approached.  There are many people that should never have been prescribed SSRI’s, most of these people, suffering distress, could have done better with talk therapy (or at the very least should have been warned of the side effects and withdrawal symptoms of the drugs). The SSRI age has caused a new societal problem, it has created damage to many people, and these people are now left with SSRI induced damage on top of their original condition. We are in the post-SSRI age, the post ‘chemical imbalance’ age, and we are now definitely in the age of the SSRI survivors. Terry’s book ‘Depression Delusion‘ gives validation to all SSRI survivors, and all sufferers of depression. It is essential reading for anyone who is interested in these topics.

Daily Mail UK: Happy Pills Can Give You Digestive Problems And Make You More Depressed


http://www.dailymail.co.uk/health/article-2144406/Happy-pills-digestive-problems-make-MORE-depressed.html?ito=feeds-newsxml

Depression levels in Britain continue to spiral.
Last year alone, more than 43 million prescriptions for antidepressants were handed out — 25 per cent more than three years before.
But are antidepressants the panacea we hope them to be?
Drugs such as Prozac were hailed in the early Nineties as wonder pills that would banish depressive blues for good.

But in the past five years, growing scientific evidence has shown these drugs work for only a minority of people.
And now controversial research in a respected journal claims that these antidepressants can make many patients’ depression worse.

This alarming suggestion centres on the very chemical that is targeted by antidepressants — serotonin.
Drugs such as Prozac are known as selective serotonin reuptake inhibitors (or SSRIs).
Their aim is to boost the level of this ‘feel-good’ chemical in the brain.
But the new research, published in the journal Frontiers In Evolutionary Psychology, points out that serotonin is like a chemical Swiss Army knife, performing a very wide range of jobs in the brain and body.
And when we start deliberately altering serotonin levels, it may cause a wide range of unwanted effects.

More…
Dozy experts wake up to fact sleepwalking is twice as common as previously thought
Moggie lovers beware! One bite from a cat can put you on the critical list
These can include digestive problems, sexual difficulties and even strokes and premature deaths in older people, according to the study’s lead researcher Paul Andrews.
‘We need to be much more cautious about the widespread use of these drugs,’ says Andrews, an assistant professor of evolutionary psychology at McMaster University in Ontario, Canada.
Previous research has suggested that the drugs provide little benefit for most people with mild and moderate depression, and actively help only a few of the most severely depressed.
Eminent psychologist Irving Kirsch has found that for many patients, SSRIs are no more effective than a placebo pill.
Two years ago, the Canadian Medical Association Journal reported a 68 per cent increase in risk of miscarriage in women on antidepressants.

Drugs such as Prozac are known as selective serotonin reuptake inhibitors (or SSRIs). Their aim is to boost the level of this ‘feel-good’ chemical in the brain
And research in 2009 on Danish children found a small, but significant, increase in the risk of heart defects among babies whose mothers had used SSRIs in early pregnancy.
There is also growing evidence that long-term use in adults is linked to bleeding in the gut and increased risk of stroke.

The key to understanding these side-effects is serotonin, says Andrews. Serotonin is also the reason why patients can often end up feeling still more depressed after they have finished a course of SSRI drugs.
He argues that SSRI antidepressants interfere with the brain, leaving the patient vulnerable to a ‘rebound’ depression of even greater intensity than before.
‘After prolonged use [when a patient stops taking SSRIs], the brain compensates by lowering its levels of serotonin production,’ he says, adding that it also changes the way receptors in the brain respond to serotonin, making the brain less sensitive to the chemical.
These changes are believed to be temporary, but studies indicate that the effects may linger for up to two years.

Relapsing is not exclusive to SSRI drugs — it is, in fact, seen in all the classes of antidepressant medications —

but Andrews believes that the risk is particularly strong with SSRI drugs.
Moreover, he warns that antidepressants can disrupt all the physical processes that are normally regulated by serotonin, adding that animal studies show only about 5  per cent of the body’s serotonin resides in the brain. Most is housed in the gut.
It is used, among other things, to control digestion, form blood clots at wound sites, and regulate reproduction and growth.
So a drug that interferes with serotonin may cause developmental problems in infants, problems with sexual stimulation and sperm development in adults, digestive problems such as constipation, diarrhoea, indigestion and bloating, and abnormal bleeding and stroke in the elderly.
The drugs may also raise the risk of dementia.
Most disturbingly of all, Andrews’ review features three recent studies which, he says, show that elderly antidepressant users are more likely to die prematurely than non-users, even after taking other important variables into account.

One study, published in the British Medical Journal last year, found patients given SSRIs were more than 4 per cent more likely to die in the next year than those not on the drugs.

‘Serotonin is an ancient chemical,’ says Andrews.

‘It is intimately regulating many different processes, and when you interfere with these things, you can expect that it is going to cause some harm.’

Stafford Lightman, professor of medicine at the University of Bristol, and a leading UK expert in brain chemicals and hormones, says Andrews’ review highlights some important problems, yet it should also be taken with a pinch of salt.
‘This report is doing the opposite of what drug companies do,’ he says.
‘While drug companies selectively present all the positives in their research, this selectively presents all the negatives that can be found.
Both approaches are simplistic. And while SSRIs might possibly cause rebound depression, it is also sadly natural to expect that people with severe depression will see their illness come back, and often in a worse state.
‘Nevertheless, the study is useful in that it is always worth pointing out that there is a downside to any medicine.’
Professor Lightman adds that there is still a great deal we don’t know about SSRIs — not least what they actually do in our brains.

‘It’s a bit embarrassing, but the bottom line is that we don’t really know how they work,’ he says.
‘Basically, we started using these drugs before we understood what they do, because they showed some effectiveness.’

When it comes to understanding why the drugs work only for a limited proportion of patients, U.S. scientists think they might now have the answer.
They think that in many clinically depressed patients, it’s not only the lack of feel-good serotonin causing their depression, but also a failure in the area of the brain that produces new cells throughout our lives.
This area, the hippocampus, is also responsible for regulating mood and memory. Research suggests that in patients whose hippocampus has lost the ability to produce new cells, SSRIs do not bring any benefit.
But why the hippocampus should do this — and how it should be treated — is not clear.
And even if those answers were found, they might still not produce a cure for many cases of depression, because the condition varies so widely in its causes and is so little understood.
What should be sure is that the days of doctors habitually prescribing SSRIs to all and sundry on the basis that they might work, and won’t do any harm anyway, really should be behind us.

Read more: http://www.dailymail.co.uk/health/article-2144406/Happy-pills-digestive-problems-make-MORE-depressed.html#ixzz1utU6CSkv

Seroxat Videos : Staggering …


Bob Fiddaman has just posted links to 49 available Seroxat videos on youtube. This is a staggering amount of web video’s documenting the side effects of a very dangerous drug. And GSK still claim that this drug is effective. Many would beg to differ, GSK.

http://fiddaman.blogspot.com/2012/05/seroxatpaxilaropaxand-some-videos.html

SATURDAY, MAY 12, 2012

Seroxat/Paxil/Aropax…and Some – The Videos

Fid

ORDER THE PAPERBACK ‘THE EVIDENCE, HOWEVER, IS CLEAR…THE SEROXAT SCANDAL’ By Bob Fiddaman US and CANADA HERE OR UK HERE

AUSTRALIAN ORDERS HERE

try{ clicky.init(17508); }catch(e){}

Performancing Metrics

_gos=’c3.gostats.com’;_goa=359698;
_got=5;_goi=1;_gol=’php webstats’;_GoStatsRun();
php webstats

GSK: Drug Firms and Their Ties to Doctors


http://www.gazettenet.com/2012/04/21/rules-shine-light-on-drug-firms039-ties-to-doctors

Rules shine light on drug firms’ ties to doctors, raising questions about ethics

By KRISTIN PALPINI
Staff Writer

Saturday, April 21, 2012

This photo shows 40-milligram tablets of Lipitor, one kind of statin used for lowering blood cholesterol.
• How this story was developed
• How much area doctors were paid

Helen Carcio, a South Deerfield nurse practitioner, says she’s on a mission to educate other health professionals about treatment for overactive bladders – a quest paid for, in part, by Pfizer, the maker of a drug that treats the condition.

She is among 16 area medical professionals who have received anywhere from $280 to $254,000 from pharmaceutical companies for making speeches, consulting, doing research and for travel and meals, according to recently released documentation about medical professionals’ financial arrangements with pharmaceutical companies.

Carcio, founder and director of the Health & Continence Institute, is a member of Pfizer’s national speakers bureau. The drug company pays her $1,000 to $1,500 per event to speak about overactive bladders. In 2010 she spoke to medical professionals at 11 events.

From July 2009 through 2010, Pfizer paid Carcio $11,649 for consulting, speaking and travel expenses. She also earned $3,750 in 2009 speaking on behalf of GlaxoSmithKline.

Carcio said she lectures for Pfizer because many medical professionals don’t understand overactive bladders.

“I’m trying to take it out of the closet, to talk to providers that are clueless that something can be done about it,” she said. “First you want to get people better, and the majority of us want to be paid for it, but mainly we want to be helpful.”

While legal, the cash relationship between doctors and pharmaceutical/medical device representatives raises questions about conflicts of interest and other ethical issues, leading to federal legislation that will soon require public disclosure of these kinds of transactions.

Carcio is concerned about how people might interpret her relationship with Pfizer.

“I have a passion for making sure women are not incontinent. The more I raise awareness the better, but it’s a Catch-22,” she said. “I’d hate for someone to think I’m on the take, that I’m doing it for the money.”

Carcio says she’s one of the good ones.

“Some do it for the money,” she said of medical professionals who speak on behalf of drug companies. “Some make $150,000 in a year. That would bother me.”

Among the drug companies that have paid Valley doctors are GlaxoSmithKline, Pfizer, Novartis, Eli Lilly, Johnson & Johnson and Merck.

In 2010, Massachusetts doctors received $64 million from pharmaceutical companies, according to the Massachusetts Prescription Reform Coalition, an arm of the Boston-based advocacy group Health Care for All.

The financial relationships between drug companies and doctors will soon be even more transparent. Legislation for the 2010 federal health care overhaul included the Physician Payment Sunshine Act, which will require drug companies to disclose payments to medical professionals.

The details of the act are still being worked out by the Centers for Medicare and Medicaid Services.

The first report detailing the who, what, where, when and how muchof financial arrangements between doctors and pharmaceutical companies will be issued in September 2013.

In the meantime, 12 drug companies are already providing this information either voluntarily or as the result of legal settlements. ProPublica, a nonprofit investigative news outlet, has compiled the payments into a searchable, though incomplete, database (see related story).

Since 2008, the Massachusetts Executive Office of Health and Human Services has been tracking cash transactions between medical professionals and drug and medical device companies through the state’s gift ban law.

Proponents of the Sunshine Act contend that it’s important to make such relationships clear. They say money from drug companies could influence a doctor’s treatment decisions, even if only on a subconscious level.

According to an article titled “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” published in the Journal of the American Medical Association, studies have shown that physicians who meet with drug representatives are more likely to prescribe the drugs the representatives are promoting and decrease the number of generic prescriptions they write.

Alyssa Vangeli, a policy analyst for the Massachusetts Prescription Reform Coalition, said physicians and other health care providers who prescribe medications almost always have the best interest of the patient in mind, “but any kind of payment or financial transaction could potentially influence a doctor,” she said.

“Patients should never have to wonder if their doctor prescribed something because it was best for me or they’ve recently been taken out to an expensive meal by a pharmaceutical company pushing a certain drug,” said Vangeli.

Area doctors, however, say they are not influenced by money, gifts or meals.

“I can only speak for myself,” said Jonathan Bayuk, an allergist and clinical immunologist with offices in Florence, Springfield and Westfield, “but I’ve never been persuaded by a sandwich to change how I take care of patients.”

Marketing with wide reach

The pharmaceutical/medical device industry spends an estimated $20 billion to $57 billion annually to market its products. According to the Pew Research Center, detailing – face-to-face encounters between doctors and representatives – is the largest industry marketing expenditure after pharmaceutical samples.

Most doctors engage in some form of detailing.

More than 90 percent of physicians have some kind of relationship with a drug company representative, according to “A National Survey of Physician-Industry Relationships,” a 2007 article in the New England Journal of Medicine.

The survey reported that, in one year, nearly 80 percent of doctors nationwide received drug samples, 83 percent accepted food or drinks in the workplace, 26 percent received reimbursement or were subsidized for continued medical education, 18 percent were paid for consulting services, 16 percent were paid to speak at events, 9 percent sat on advisory boards and 3 percent enrolled patients in clinical trials.

Since 2008, Massachusetts doctors have been barred by state law from accepting samples, food, drinks or entertainment.

For the most part, Valley doctors who have received money from pharmaceutical companies are being paid to lecture at informational events. Some area physicians have spoken at more than 60 events in a single year, according to the Massachusetts Executive Office of Health and Human Services. Several local medical officials have been hired as consultants and a few received money for research.

Bayuk, for example, has spoken at scores of medical events, and said such engagements can range from small-scale affairs to large conferences. From 2009 to March 2011, Bayuk received at least $124,550 from pharmaceutical companies, mostly compensation for speaking engagements.

Typically pharmaceutical companies ask doctors to speak about the diseases and conditions the drug targets, not about the drug itself. Medical professionals also must follow U.S. Food and Drug Administration regulations about how they talk about drugs. For example, a drug’s risk factors must be addressed.

But Alison Bass, author of “Side Effects,” a book about the suppression of unfavorable research on the antidepressant Paxil, says that typically a speaker will mention a drug manufactured by the sponsoring pharmaceutical firm, saying it is an effective treatment for the disease.

Bass, a journalism professor at Mount Holyoke College in South Hadley, said doctors may be sincere in their endorsements of drugs, based on the data presented in clinical trials. But

she maintains these trials are often flawed.

Drug researchers are more likely to report positive outcomes when a pharmaceutical firm pays for the study, Bass said.

Studies that show negative results may go unpublished, or may even be falsified to present a better outcome. That was the case with Paxil, Bass said.

Brown University professor Martin Keller was paid hundreds of thousands of dollars by SmithKline Beecham (now GlaxoSmithKline) to perform research on Paxil’s effect on teenagers.

 

Teen participants who reported having suicidal thoughts were miscoded and counted as “noncompliant

,” Bass said. Court documents filed in 2008 in lawsuits against GlaxoSmithKline revealed that adolescents were six times more likely to become suicidal after taking Paxil.

“Money is too influential,” said Bass. She maintains the government, not drug companies, should pay for clinical trials.

From 2009 through March 2011, Bayuk earned speaker’s fees from AstraZeneca, GlaxoSmithKline and Novartis. He said drug companies and the medical community both benefit when he talks at an event. The drug companies spread awareness of their products, and his peers learn of advances in the field.

Bayuk said his medical decisions are in no way influenced by speakers fees he is paid from drug companies. “Not me, but there are some,” he said.

He also noted that when speaking, he may discuss several competing treatment options.

Bayuk says he sees no point in documenting pharmaceutical-physician relationships.

“It’s a total waste of time and money,” he said. “There’s been no impropriety done by me, and I think that’s the truth for 99.9 percent of physicians.”

“I’m a young guy,” he continued. “Maybe in the past there was a problem, but I’ve never seen one. … There’s nothing wrong with disclosing exactly what happens.”

Disclosure can be confusing

But disclosing exactly what happenscan be tricky and it’s one of the sticking points the Centers for Medicare and Medicaid Services are taking comments on as they work on the law’s language. For example, research money is a category that can both compensate a doctor as well as pay for patient care and supplies. Reporting that a doctor received research money could imply that the entire amount was compensation for his work.

Pharmaceutical interest groups and disclosure advocates agree: Financial transactions between pharmaceutical companies and doctors need to be reported with context.

“Patients need to understand that a relationship between their physician and a company does not mean their physician is compromised,” Kate Connors, a spokeswoman for the pharmaceutical industry interest group PhRMA, said in an email. “If anything, they should know that their physician is seen as an expert in his or her field.”

The CME Coalition, a lobbying group for continuing medical education providers, notes that the potential for misinterpretation could encourage doctors to forgo educational opportunities.

Dennis J. Rosen, an Amherst pediatrician, is concerned about how people will look at payments he has received from drug companies.

Rosen, who has been treating children with learning, emotional and attention problems for 42 years, received a total of $254,965 in speaking and consulting fees from Novartis and Shire Pharmaceuticals in 2009 and 2010.

He said he ended those relationships more than a year agobecause he no longer has time for speaking engagements. But he called his work with drug companies “meaningful and educational,” and said it benefited doctors, and subsequently, their patients. When he spoke, Rosen said, he was “fair and honest” about the use of drugs for particular disorders.

The money is not an indication of impropriety, he said.

“I don’t play favorites,” Rosen said of prescriptions. “I use whatever is necessary.”

Kristin Palpini can be contacted at kpalpini@gazettenet.com

Irish Radio: Depression and SSRI’s.


http://classichits.ie/the-late-show-depression-april-19th-2012/

Great radio show about the dangers of SSRI medications.

GSK Videos on YouTube


Some interesting GSK related video’s popping up on YouTube…

“The Key with Avandia was to be transparent”

“You have to be rigorous about the science”

“You have to be rigorous about the safety profile of every drug”

(Dr Anne Phillips – Medicine Development Leader for GlaxoSmithKline)

http://www.youtube.com/watch?v=ZPgwF7jKM-A

Irish former state pathologist claims: “Too many suicides linked to anti-depressants’…


http://www.irishexaminer.com/ireland/too-many-suicides-linked-to-depression-tablets-186006.html

‘Too many’ suicides linked to depression tablets

By Jennifer Hough
Monday, March 05, 2012
A former assistant state pathologist has expressed serious concern about the growing link between anti-depressants and suicide.

Dr Declan Gilsenan said in his 30-year experience carrying out postmortems, he had seen “too many suicides” after people had started taking the drugs and questioned whether GPs were over-prescribing them.

He said the evidence is “more than anecdotal” and he is willing to meet the minister with responsibility for mental health on the issue, as part of a delegation organised by campaigner Leonie Fennell.

Ms Fennell is the mother of Shane Clancy, who took his own life after killing his friend Sebastian Creane.

He had just started a course of anti-depressants and it is believed he took more than the prescribed amount.

At Mr Clancy’s inquest, Dr Gilsenan testified that there were “toxic” levels of citalopram (brand name Celexa or Cipramil) in Mr Clancy’s blood.

Ms Fennell has been campaigning since Mr Clancy’s death to raise awareness about the potential dangers of anti-depressants and is seeking a meeting with Kathleen Lynch, minister of state with responsibility for mental health.

She has enlisted the help of Dr Gilsenan and a former minister, who does not want to be named at this time, but who also has serious concerns regarding side-effects and over-prescribing of the drugs, whose popular brands include Prozac, Zoloft, Lexapro Paxil and Celexa.

“Based on my experience of doing postmortems on people where anti-depressants have been started fairly recently I would have concerns about the link to suicide,” Dr Gilsenan said.

He said the argument will be made that people who start taking anti -depressants are of course depressed, and so could be at risk of suicide. “This will be used against what I am saying, but in my work I have just seen too many cases. There are things like accumulation in the system and dose-related concerns, where people go over a safe level, and I am willing to sit down with the minister and talk to her about these things.”

Dr Gilsenan said doctors need to be more careful when prescribing anti-depressants and people need to be monitored more carefully. “It certainly seems GPs are using anti-depressants very frequently.

These are very important drugs to psychiatry and if they are deemed to be harmful then it’s a big blow to them and that’s why they are defended so much.”

Another expert, Professor David Healy, who also gave evidence at Mr Clancy’s inquest, maintains the pharmaceutical industry is being protected by psychiatry.

In the case of Mr Clancy, the Irish College of Psychiatry came out in defence of the drugs at a time when families in grief were going through a high-profile inquest.
Prof Healy said that although companies are legally obliged to agree that their drugs can cause people to take their lives, psychiatry is not. “Here they offer one of the greatest services they can to companies — they can and regularly do offer apologias for industry. They state in public that not only did the drugs not cause a problem, but that they cannot cause a problem,” he said.

At Mr Clancy’s inquest, Prof Healy stated that in a small but significant minority of patients, using anti-depressants can give rise to violent behaviour.

Read more: http://www.irishexaminer.com/ireland/too-many-suicides-linked-to-depression-tablets-186006.html#ixzz1sEJTAc00

GSK And The M.H.R.A. : Corrupt bastards?..


Definition of corruption:

“dishonest or fraudulent conduct by those in power”..

corrupt |kəˈrəpt|
adjective
1 having or showing a willingness to act dishonestly in return for money or personal gain : unscrupulous logging companies assisted by corrupt officials.
• evil or morally depraved : the play can do no harm since its audience is already corrupt.
See note at depraved .

Bastard :

2 informal an unpleasant or despicable person : he lied to me, the bastard!
• [with adj. ]

Bob Fiddaman of “Seroxat Sufferers” has some great posts on the ‘revolving door’ syndrome which regularly occurs between pharmaceutical companies and the regulators (whom allegedly are supposed to police them), Bob’s beef (and mine) is about GSK and the MHRA (the UK drug regulators). But you can be damn sure that the same thing happens across the globe in regards to all pharmaceutical companies and all regulators. This is a post from 2010, but it is just as significant to raise these issues today.


http://fiddaman.blogspot.com/2010/06/glaxosmithklinemhra-when-ignorance_07.html

Initially, this was going to be a two-parter, however, more research has led me to another witness for GlaxoSmithKline in the UK Seroxat Group Action – more about him in Part III.

Part IV will show you how another of GSK’s witnesses, they are using for the up and coming UK Seroxat Group Action, works for a company who are in receipt of huge funds from The Wellcome Trust.

Following on from my previous post where I have tried to highlight instances where both GlaxoSmithKline and the MHRA either failed to spot or chose to ignore warnings about Seroxat withdrawal.

I turn my attention now to the UK Seroxat Litigation.

The defining issues of this group action are thus:

Does Seroxat have a capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as prevent or make more difficult the ability of users to discontinue, withdrawal from or remain free from taking Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (SSRIs)

As I have said, my previous post highlighted the reasons why I think this litigation will be a failure for GlaxoSmithKline. I’m not a lawyer, nor do I work for lawyers. I can, however, determine what is wrong from right.

Before I move on to name one of the ‘expert witnesses’ for GlaxoSmithKline in this litigation I will recap on the evidence I have found just by searching the Internet.

In 1993, the Committee on Safety of Medicines (“CSM”), the UK’s counterpart to the FDA, reported 78 cases of withdrawal after discontinuation of paroxetine, reporting that “such reactions have been reported more often with paroxetine than with other SSRI’s.” (“Current Problems in Pharmacovigilance” (1993; 19:1).

GSK, then SKB, and the MHRA, then the MCA, did not react to this warning.

In 1997, Dr. Haddad reported that the highest incidence of discontinuation reactions among the SSRI’s was paroxetine. (J Clin Psychiatry 1997; 58 Supp l7:17-1; discussion 220.)

In 1997, Young and Currie of Newcastle reported on their survey indicating that a sizeable minority of physicians were aware of the existence of antidepressant withdrawal reactions. This included psychiatrists, 28% of whom expressed no awareness that antidepressant medications could induce discontinuation reactions. The conclusion of the authors was that “education about discontinuation reactions is needed for both psychiatrists and family practice physicians.” (J Clin Psychiatry 1997;58 Suppl &:28-30.)

This particular paper is of interest to me as it was co authored by Allan Young. At the time of the publication [1998] Young was Senior lecturer in psychiatry at Hadrian Clinic, Newcastle General Hospital, Newcastle upon Tyne. The conclusion of Young, along with the other two authors of the publication, Peter Haddad and Michel Lejoyeux, is evident for all to see – “education about discontinuation reactions is needed for both psychiatrists and family practice physicians.”

It is interesting because Allan Young will be one of the expert witnesses on behalf of the defendants, GSK, in the UK Seroxat Group Action. It seems rather odd, to me at least, that GSK would want a witness who has in the past wrote about antidepressant withdrawal reactions.

This is just one of the witnesses for GSK. Another is Dr. Rashmi Shah.

Dr. Rashmi Shah is the owner of Rashmi Shah Consultancy Ltd, located in Slough, Berkshire, UK.

Shah’s previous employment history will shock quite a few people who read this article.

Shah was employed by the MHRA between 1987 and 2004. Positions held were:

Senior Medical Officer, Senior Clinical Assessor and Senior Medical Assessor.

An employee of the MHRA for 17 years.

Now a witness for the defence [GSK] in the UK Seroxat Group Action.

Shah retired from the MHRA in 2004.

A summary of the Committee on Safety of Medicines meeting, held on the 25th of November, 2004, attests to this:

1. Apologies and Announcements

1.4 The Chairman informed the Committee that Rashmi Shah’s was retiring and that this was his last meeting and on behalf of the Committee thanked Rashmi for his outstanding contributions to the work of the Committee over a 17 year period and wished him well in his retirement.

I, along with many others, have always been weary of the relationship the regulators have with the pharmaceutical industry so this revelation should come as no surprise.

It would appear that the MHRA’s long standing relationship with GlaxoSmithKline will continue through the High Court in London.

For those of you that don’t know, the MHRA spent four years investigating GlaxoSmithKline.

The investigation focused on whether GSK had failed to inform the agency in a timely manner of information it had on the safety of Seroxat in the under 18’s. The investigation, the largest of its kind in the UK, was undertaken with a view to a potential criminal prosecution for breach of drug safety legislation, and included the scrutiny of over 1 million pages of evidence. The decision taken by Government Prosecutors, based on the investigation findings and legal advice, is that “there is no realistic prospect of a conviction in this case, and that the case should not proceed to criminal prosecution.

The punishment for Glaxo? A “Whose been a naughty boy?” type of letter sent to the then CEO of GSK, JP Garnier. Garnier later went on record to say that GSK had been cleared and that they had done nothing wrong [See audio recording left hand sidebar of this blog]

It’s also worthy to point out that the Chairman of the MHRA, Alasdair Breckenridge, is a former employee of GSK, then SmithKline Beecham [SKB] – As is the Head of Licensing at the MHRA, Dr. Ian Hudson.

Breckenridge has appeared on national TV defending Seroxat, he has also made his feelings known about Seroxat in various publications, one such being the New Statesman in 2005. Here’s what the Chairman of the MHRA [and ex- SmithKline Beecham employee] had to say about Seroxat:

“If you go back – and I read this out to the Health Select Committee to the data sheet on Seroxat when it was licensed in 1991, we spelt out word for word the problems of withdrawal from Seroxat, in words that we could not improve now. This idea that the regulators have been hiding the data is just not true. The so-called scandal of Seroxat is something I want to nail every time I speak in front of compatriots because it is absolute rubbish”.

What Breckenridge ‘read out’ to the Health Select Committee is even more confusing:

“…What the expert working group did was to look at three issues about antidepressants: firstly, the question of withdrawal; secondly, the question of suicidal ideation; and, thirdly, the question of dose. The problem of withdrawal has been well known with antidepressants, especially Seroxat, and I happen to have before me the information sheet, the data sheet which we published, which the MCA published in 1990 when Seroxat was first licensed. If I can just read it to you, it says, ‘As with many psychoactive medicines, it may be advisable to discontinue therapy gradually as abrupt discontinuation may lead to symptoms, such as dizziness, sensory disturbances, sleep disturbances, agitation or anxiety, nausea, sweating and confusion’. That was in 1990″.

There was no mention of this on any patient information leaflet that accompanied Seroxat in 1990. There was no advice to ‘discontinue therapy gradually’ either.

Breckenridge further embarrassed himself and the MHRA with his performance on BBC TV’s Panorama [Taken on Trust BBC TV 2004] where he was reduced to a stuttering wreck by journalist, Shelley Jofre. [A condensed version of his performance can be seen HERE – http://www.youtube.com/watch?v=TozBgI5LyGc

I don’t know why Breckenridge remains at the MHRA, it’s hard to decipher what he actually does. I can only assume that he won’t ever be allowed to appear in front of a TV camera anymore defending Seroxat, not after his display of arrogance back in 2004.

The MHRA’s Head of Licensing, Dr. Ian Hudson, is also a former employee of SmithKline Beecham [now GSK]. Hudson is no stranger to litigation, particularly where GlaxoSmithKline are concerned.

In the Tobin vs SmithKline Beecham trial in 2005, Hudson gave the following deposition http://www.healyprozac.com/Trials/Tobin/Depositions/hudson-depo.txt

Hudson had previously worked for GlaxoSmithKline for 11 years where he held the position of Worldwide Director of Safety.

In a public Declaration of Interests document, Hudson openly admitted that he had a significant involvement with a number of drugs during his time at Glaxo [then SKB] – one of which was Seroxat.
[Source] http://seroxatsecrets.files.wordpress.com/2007/03/dr-ian-hudsons-interests.pdf

Sarah Boseley, then health editor for The Guardian newspaper wrote in 2000, “Alarm as drug company chief joins watchdog.”

A top executive at one of the world’s leading pharmaceutical companies is to become director of drugs licensing at the medicines control agency, raising questions about the independence of the MCA from the industry that it is supposed to police.

Ian Hudson will take up his new job in February. He has worked in the drugs industry for the past 11 years and until recently was director and vice- president of Worldwide Clinical Safety, at SmithKline Beecham, and was to have led the worldwide drug safety group after the merger of SKB with Glaxo Wellcome, which came into effect yesterday.

Boseley also wrote in 2002, “Antidepressant Seroxat tops table of drug withdrawal symptoms.”

Seroxat, the British-made antidepressant which outsells Prozac, causes more people distressing withdrawal problems when they try to stop taking it than any other drug in the UK.

Seroxat – known generically as paroxetine – leads the top 20 table of drugs causing withdrawal problems, with 1,281 complaints from doctors under the “yellow card” scheme set up for the reporting of medicines’ side-effects. More reports have been filed about Seroxat than about the rest of the top 20 put together. In the top six, five of the drugs said to be causing withdrawal problems are SSRIs – second after Seroxat comes Efexor (venlafaxine), with 272 complaints.

So, now, 6 years on from Alasdair Breckenridge’s embarrassing performance on BBC TV where he defended GlaxoSmithKline’s Seroxat and 5 years on from Head of Licensing for the MHRA, Dr. Ian Hudson, offering his services as a witness for GSK, we have yet another MHRA connection in Rashmi Shah.

This shower of regulatory authoritarians [MHRA] have sat with Seroxat advocates, myself included. They have nodded and empathised upon hearing personal stories of withdrawal. All the time, it appears, they knew there was a withdrawal problem with Seroxat but instead of tackling it head on, they decided, like GlaxoSmithKline, to ignore the warning signs from as early as 1993 [Current Problems in Pharmacovigilance] (1993; 19:1).

It’s staggering that they have the audacity to collect their wages each month from their bank accounts.

It’s astounding that they failed to prosecute GlaxoSmithKline after a four year investigation.

It’s appalling that they have not one but two ex-GSK employees working for them, one a Chairman who doesn’t really seem to do much, the other the Head of Licensing, one who grants licenses to the drugs you and I take.

It’s sickening that an ex MHRA employee, in Rashmi Shah, is now defending Seroxat by being a witness for GlaxoSmithKline in the UK Seroxat Group Action.

I cut off all communications with the MHRA last year after they failed to answer a simple question I put to them, Is Seroxat a teratogen?

It would appear that the MHRA have merely been offering token gestures to Seroxat advocates, all the time keeping a close eye on what their paymasters [GSK] might think of them discussing Seroxat with patients.

I’m not the first to pick up on the MHRA’s close ties with GlaxoSmithKline. In 2004, the Daily Mail, a UK tabloid, ran with the headline, “Agency blamed for promoting Seroxat.”

The mental health charity, Mind, said the MHRA were playing Russian Roulette with people’s lives over the common antidepressant drug Seroxat.

Mind chief executive Richard Brook said the MHRA had not listened to the experiences of people who had taken Seroxat.

“Many of these people have suffered terrible side effects when taking or trying to come off the drug and some people, it is believed, have died,” he said.

There is a terrible stench throughout the MHRA Headquarters, it reeks of back slapping and complete and utter disdain for the patient, particularly those who have ever had to experience the horrific side-effects of Seroxat.

The MHRA are not just in bed with GlaxoSmithKline – they are copulating with them.

I am not totally sure but it’s my belief that the expert witness owes a duty to the court to give independent and unbiased evidence, and must avoid assuming the role of advocate for his client.

Rashmi Shah worked for the MCA/MHRA for 17 years. Shah was an employee of the MCA/MHRA when they first granted a licence for GlaxoSmithKline’s Seroxat. He was also employed by them during the time when they received many adverse reaction reports about Seroxat.

I, for one, shall be looking forward to Rashmi Shah’s unbiased evidence when, or if, this group action lands in the High Court later this year.

Coming up in Part III – How another of GSK’s witnesses once called for the FDA to lift its black box warning on antidepressants.

Other stories of interest:

Antidepressant Seroxat tops table of drug withdrawal symptoms

Glaxo ‘played down Seroxat side effects’

Agency blamed for promoting Seroxat

Antidepressant addiction warning

Alarm as drug company chief joins watchdog

DEPENDENCE ON PAROXETINE?

Drug firm issues addiction warning

Keep Seroxat dose low, doctors told

Why I resigned over ‘happy pill’ cover-up

Fid

%d bloggers like this: