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Saturday, 31 March 2012

To pull Seroxat would have a devastating effect on the outcome of any lawsuit - feeding FIDDAMAN greed

As far as I'm aware Seroxat is the only SSRi in the UK that is currently going through the High Court with regard to it being a defective product. With the recent press reports, it would appear that it is defective. GSK lawyers can argue that it is only as defective as other SSRi's on the market - not much of an argument but one that they will no doubt use. Probably another reason why the MHRA won't intervene and say 'enough is enough.' To pull Seroxat would have a devastating effect on the outcome of any lawsuit.

from the google cache of -

SEROXAT must be removed from market before media can highlight other SSRI - stated FIDDAMAN

It's pretty obvious really, well to me at least. If Seroxat was pulled from the market it would raise concerns about other SSRi's, concerns that are only raised by campaigners and get very little coverage in the mainstream media. Seroxat seems to be the daddy of all SSRi's, the Coca Cola of the soft drinks world. Remove it from the market and the mainstream media would probably focus on the next SSRi.

I can see no benefit of Seroxat, none whatsoever. The longer it remains on the market will mean countless suffering for people on other SSRi's. Once removed, it will open the doors for other SSRi's to be thoroughly investigated and maybe other bloggers, campaigners, advocates can start banging the drum and asking the regulator about Prozac, Zoloft and other SSRi related drugs.

source -

SEROXAT declines due in the main to four BBC how did they manage to withdraw FIDDAMAN?


" ..Seroxat is one of many SSRi's, prescription figures would have declined due, in the main, to four [count them] programmes on BBC TV's Panorama that have highlighted the dangers of this particular SSRi. ...."

"SEROXAT IN THE MEDIA " why not try google news + seroxat & see if FIDDAMAN is lying as usual !


from the google cache of -

GlaxoSmithKline's Seroxat seems to have had a lot of coverage in the mainstream media over the past couple of weeks. All for the wrong reasons it seems.

Any time the words 'antidepressant ' or 'SSRi' are used, Seroxat seems to be in the forefront of any particular news story, in the UK at least.

I cannot think of any other product that has received so much bad press that still remains on the market. The manufacturers, GlaxoSmithKline, continue to robustly defend it whilst the UK medicine regulator [MHRA] remain tight-lipped about the current news events.

Personally, I cannot see why Seroxat still remains on the market. With reports and academic papers suggesting that it causes a vast array of severe problems, I am astounded as to why it has not been either recalled or banned.

Seroxat is one of many SSRi's, prescription figures would have declined due, in the main, to four [count them] programmes on BBC TV's Panorama that have highlighted the dangers of this particular SSRi.

What would the consequences be if Seroxat was pulled from the market?

It's pretty obvious really, well to me at least. If Seroxat was pulled from the market it would raise concerns about other SSRi's, concerns that are only raised by campaigners and get very little coverage in the mainstream media. Seroxat seems to be the daddy of all SSRi's, the Coca Cola of the soft drinks world. Remove it from the market and the mainstream media would probably focus on the next SSRi.

I can see no benefit of Seroxat, none whatsoever. The longer it remains on the market will mean countless suffering for people on other SSRi's. Once removed, it will open the doors for other SSRi's to be thoroughly investigated and maybe other bloggers, campaigners, advocates can start banging the drum and asking the regulator about Prozac, Zoloft and other SSRi related drugs.

In Seroxat we have one drug of a whole class. To play down it's side-effects is playing down the side-effects of every other SSRi. Seroxat is a celebrity, it's one that the media have got their fingers into. Once this celebrity is dead and gone they will move on to something else. Then, and only then, will other SSRi's get the press coverage other advocates seem to be calling for.

As far as I'm aware Seroxat is the only SSRi in the UK that is currently going through the High Court with regard to it being a defective product. With the recent press reports, it would appear that it is defective. GSK lawyers can argue that it is only as defective as other SSRi's on the market - not much of an argument but one that they will no doubt use. Probably another reason why the MHRA won't intervene and say 'enough is enough.' To pull Seroxat would have a devastating effect on the outcome of any lawsuit.

I never used to be in the camp of banning Seroxat but if one looks at the bigger picture you will see that it is the only way forward. There is no benefit of Seroxat... and even if it could be argued that there was then the risks would far outweigh any benefit. When a drug is licensed by the MHRA the main focus on whether it is safe and effective is the risk/benefit ratio. Somewhere along the line we have been lied to - either that or we have a bunch of very incompetent people regulating the drugs you, I and our children take.

Ban Seroxat... then start looking closely at the other SSRi's. Glaxo are not the only pharmaceutical company who have been less than forthright with the truth.

Friday, 30 March 2012

Quaker Oats man loses his double chin - did CCHR Canada aribrush FIDDAMAN

The Quaker Oats man featured on the boxes of the popular oatmeal shed five pounds and is sporting a more youthful look in the brand's new logo to highlight its healthy products.

PepsiCo Inc, owner of the cereal company, also decided to give the jolly-faced character a haircut and broader shoulders so consumers can associate the image with 'energy and healthy choices.'

The makeover for the rosy-cheeked man known as 'Larry' is part of a direction to make the 134-year-old brand 'fresh and innovative.'

Thursday, 29 March 2012

Senator David Norris a benefit cheat .....where is the outcry Mr FIDDAMAN?

Independent presidential candidate David Norris received a disability payment for 16 years while out of work as a Trinity College lecturer -- even though he was a "full-time" senator for the entire period.

Mr Norris confirmed to the Irish Independent last night he received the payment, but could not specify exactly how much it was worth.

He also refused to say what his disability is.

He said the payment was around a quarter of his annual salary, but said he "wasn't getting anything like they get now".

The 67-year-old Joycean scholar worked as a tutor and lecturer in Trinity between 1968 and 1994, when he took the disability payment and stopped working in the college.

The payment began in 1994 and ended in July of last year, when he reached pension age. He has since received a pension from the college, worth around €2,500 a month.

Mr Norris, who took part in last night's TV3 debate with his six Aras rivals, also receives a senator's salary of €61,073.

He also said he spent his annual leader's allowance -- the €23,383 Independent senators receive in unvouched expenses every year -- on his Seanad work.

Mr Norris, who was first elected as a senator for Trinity in 1987 and has been returned at every election since, focused on his Seanad career after 1994. However, he would not say what the disability was, and insisted it did not stand in his way of being president, insisting he is in "perfect health".

"And if you look at my Seanad record you see that. I hope we're not going down the medical route of all this but I will do any medical test you want. I just think this is getting daft. It shows how open I am, my life is an open book."

But he asked not to go into the disability payment, saying there "was a whole story about that".

Ireland is a key global location for the pharmaceutical industry - yet only 3% adults on Antidepressants FIDDAMAN

Ireland is a key global location for the pharmaceutical industry. Foreign direct investment for the pharmaceutical sector is forty years old with Squibb (now Bristol-Myers Squibb) being the first pharmaceutical company to locate in Ireland in 1964. Currently thirteen of the top fifteen companies in the world have substantial operations in Ireland. More than 17,000 people are employed directly in the industry.

source -

Ireland is now one of the world's largest exporters of pharmaceuticals with €34 billion of intermediates and finished pharmaceuticals exported in 2002. Six out of ten and twelve out of 25 of the world's top selling drugs are produced in Ireland including Lipitor and Zocor. Products are manufactured for global markets.

Many of the pharmaceutical companies in Ireland have established multiple activities, including

Fermentation e.g. Schering-Plough, Wyeth

API e.g. Merck, Pfizer, Yamanouchi,

Sterile Fill/Finish e.g. Genzyme, Allergan

Formulation e.g. Wyeth, Takeda, Pfizer

Shared Services/ Supply Chain Management e.g. Allergan, Pfizer, Novartis

R&D/ Process Development e.g. Wyeth, GlaxoSmithKline, Bristol- Myers Squibb

The sector has become increasingly integrated in recent years. Early investment in fine chemical plants producing bulk active materials has been followed by investment in finished product pharmaceuticals. Many plants are now engaged in product development for Irish and other plants.

This report comprises full profile information for each company, including:

- Full Company Contact Information – Addresses, Telephone and Fax numbers, Emails, Websites

- Key Company Decision Makers – from CEO and Main Board to Key Senior Managers

- Specialised Fields such as Employment, Company Activities, Turnover, Year Established, Ownership

- SIC and NAICS Classifications

Report Target Market:

(1) Pharmaceutical Manufacturing Companies - Usage: Competitive/Financial Analysis and Partner/Alliance Identification

(2) Suppliers to Pharmaceutical Manufacturing Companies - Usage: Identification of Top Potential Customers and Key Decision Makers

(3) Pharmaceutical Distributors/Wholesalers/Retailers - Usage: Identification of Suppliers

Research Facts' reports help you make informed decisions about the markets and firms that affect your business:

REMEMBER only 3% on antidepressants link Leonie Fennell blog

Irish suicide rates - 25 year trend, & Irish v's EU suicide rates per 100,000 - facts from FIDDAMAN blog

Antidepressant statistics N Ireland - by health board 3X times higher than Truthman30 claim - FIDDAMAN blog proves

3% Irish adults on antidepressants claims Truthman30 ...........but is that accurate FIDDAMAN?

Antidepressant statistics Ireland - by health board - FIDDAMAN counterpoint blog ** Exclusive

3% Irish adults on antidepressants claims Truthman30 ...........but is that accurate FIDDAMAN?

Wednesday, 28 March 2012

Senator David Norris classic paedophilia ...remember we don't claim this but the Daily Mail does, so it must be true FIDDAMAN?

.... in terms of classic paedophilia, as practised by the Greeks, for example, where it is an older man introducing a younger man or boy to adult life, I think that there can be something to be said for it.’

While Mr Norris reiterates that he is not attracted to the very young, he again endorses ‘classical paedophilia’ as something he would have enjoyed.

‘Now again, this is not something that appeals to me, although when I was younger it would most certainly have appealed to me in the sense that I would have greatly relished the prospect of an older, attractive, mature man taking me under his wing, lovingly introducing me to sexual realities, and treating me with affection and teaching me about life – yes, I think that would be lovely; I would have enjoyed that.’

Read more:

why does Leonie Fennell lionise Senator David Norris - is she courting controversy FIDDAMAN style

Sex abuse survivor: My anger at Senator David Norris for his 'disturbing' views on paedophilia - from Daily Mail

5 June 2011

On child sexual abuse: ‘Children in some instances are more damaged by the condemnation than the experience’

Asked if incest was acceptable, he said there was a case to ban it... but only for girls who might have an ‘undesirable’ pregnancy

On paedophilia: ‘There’s a lot of nonsense about paedophilia... I think there is a complete and utter hysteria about this subject’

Challenged on whether a child can give ‘informed consent’ to sex: ‘The law should take into account consent rather than age’

Senator David Norris - link

Read more:

Sunday, 25 March 2012

SoulfulSepulcher Twitter being used by Fiddaman's all about control

 If you do not remove the fiddaman parody account from your followers list by blocking, I will not allow you to follow me

Friday, 23 March 2012

Dr David Healy STOPPED patients citalopram ....there was no withdrawal reaction - why not FIDDAMAN?

source - The Dram of Eale

March 23, 2012 Leave a Comment

original URL -

They told me the 80 year old man who’d had a stroke must be depressed – he wasn’t rehabilitating properly. Could I see him and look at whether the citalopram he’d been started on a week before needed tweaking?

Jeff was solidly middle class, professional. He had never been ill before his stroke and never ever been mentally ill. He had a large loving close-knit family who came to see him every day. He didn’t seem depressed to me. I stopped his SSRI and said I would come back in a week to see how things looked – perhaps his depression would be more obvious then.

A week later, Jeff seemed much better than he had been on citalopram. He clearly didn’t need an antidepressant – if he wasn’t rehabilitating it was because of where his stroke had struck.

‘While on those pills I had a terrible urge to get up and strangle him. I’ve never seen him before.’

I got up to leave just as his family came in. He grabbed my arm. ‘I’ve something to tell you before you go. You see the man across the room’. There was another older man confined to his bed.

‘Well while on those pills you know I had a terrible urge to get up from my bed in the night and go over and strangle him. I don’t know why. I’ve never seen him before. Those feelings have gone since you stopped my pills.’

This makes it about as Evident as you can get that SSRIs cause violence. The only thing possibly more convincing would be data from healthy volunteer studies where aggressive episodes have been relatively common

Book review - The Anti-Depressant Fact Book - by Peter Breggin from Dr Duncan Double on FIDDAMAN blog

This book focuses on the newer antidepressants, especially the selective serotonin reuptake inhibitors (SSRIs). As its title suggests, it contains many interesting facts. In particular there are insights about the role of pharmaceutical companies in controlling information about antidepressants. Breggin has obtained his awareness through his expert testimony in litigation against the drug companies.

The book also contains much speculation. Breggin is inconsistent in this respect as he is sceptical about biological claims for the effectiveness of antidepressants. He does not always seem to apply the same degree of rigour to scrutiny of assertions about the risks of these drugs.

Clearly the dangers of SSRIs is a topical issue. On June 6, 2001, too late to be included in Breggin's book, a unanimous jury in Wyoming, USA found that Paxil “can cause some individuals to commit suicide and/or homicide,” and that it caused Donald Schell to shoot his wife, daughter, and granddaughter, before turning the gun on himself. The jury awarded a total of $8 million in damages to the two families, although the award will be limited to the 80% of “fault” found against the pharmaceutical company GlaxoSmithKline.

Legal judgment is not necessarily the same as scientific fact. There is controversy about the causal role of antidepressants in producing manic switch, akithisia, suicide and violence. Breggin regards these relationships as facts. Furthermore, he regards discontinuations reactions, which are increasingly acknowledged to be problematic, as produced by the recovery of physiological functions following removal of the drug. However, psychological factors, which he does not consider, may also be important. The placebo effect in treatment can be powerful. Hence withdrawing a drug, which is thought to improve mood, may be expected potentially to cause discontinuation symptoms.

The overstatement in the book is a pity. It detracts from Breggin's more critical analysis. For example, it is very valid to point out that brain research has concentrated on the short-term effects of antidepressants. There has hardly been any study of the long‑term consequences and whether the brain recovers from the homeostatic effects of brain change as a reaction to the presence of antidepressant drugs.

The last chapter does not contain any facts or speculation about antidepressants. Instead it describes Breggin's principles of therapy of depression. He focuses on the importance of relationship and argues for drug‑free therapy. Certainly there needs to be more of an opportunity for drug-free care and treatment in mental health practice.

Breggin's position is principled. He has maintained his independence as a private therapist since 1968. Although there was overstatement in Toxic Psychiatry, his first book, his humane interest was apparent. It is still there, but it may be a little battle‑worn through conflict with pharmaceutical companies that will do virtually anything to protect their multi-billion dollar drugs. Breggin's bravery should be acknowledged. Whether he has got the facts about antidepressants correct remains to be confirmed. I fear he has not got them all right.

© 2001 Duncan Double

Duncan Double, Consultant Psychiatrist and Honorary Senior Lecturer, Norfolk Mental Health Care Trust and University of East Anglia, UK; Website Editor, Critical Psychiatry Network.

Karen Barth Menzies - propaganda piece on B0B Fiddaman blog

The law aims to protect men and women equally. Yet some types of cases nearly beg for female representation-and don't get it. That's why Karen Barth Menzies, partner at Robinson Calcagnie Robinson Shapiro & Davis, has devoted her career to taking on the cases that need her most.

Menzies is one of 8 partners at the 40-year-old firm known for its expertise in plaintiff consumer, patient protection, and consumer safety cases. Of them, her greatest legal battles have been won in the field of SSRI antidepressant litigation and cases pertaining to issues of women's health.,0,1200800.story

Menzies began her career in juvenile justice, where she first discovered her passion for protecting the "little guy." She did just that when she won a major settlement on behalf of babies born with birth defects caused by certain SSRI antidepressants. The settlement provided enough money to support the children's care and medical expenses even after the parents had died. "After five years of litigation, to be able to tell the parents their kids will be taken care of no matter what happens meant everything to me," Menzies says.

RCRSD attorneys Jennifer Liakos and Janine Sperandeo are also fighting the SSRI Antidepressant birth defects cases, including Zoloft, Effexor, Celexa, Lexapro and Prozac.

Menzies continued to take on cases in the pharmaceutical industry

for good reason: She was increasingly concerned how large corporations

targeted specific populations-namely women-without warning them of

the downsides of their medications. From seeing internal company documents, she became convinced they were putting profits over safety because they knew that women were more likely than anyone to see a doctor and make health decisions for their families-a perfect way to increase their market share and thus profits.

Menzies and her team struck back when they took on the cause of post-menopausal women who'd been prescribed Fosamax as a preventative

treatment for osteoporosis. Fosamax, like most drugs Menzies tends to work with, is widely prescribed among older women whether they need it or not thanks to the defendant's marketing efforts.

In one typical case, a longtime user of Fosamax collapsed while walking down the street after her femur snapped in half. Menzies' team, including attorneys Lexi Myer, Jennifer Greene and Karen Karavatos, have helped hundreds of women who have banded together to spread awareness about the potentially traumatic side effects of the drug. "These women are so compelling," Menzies says of the victims who inspire her. "The easy part of my job is letting them talk. The hard part is fighting the defendants to disclose what they know are the dangers of these drugs."

Menzies accompanied 18 of the affected women to a meeting with 11 FDA officials. Six months later, the FDA issued an advisory. A trial is slated for Oct. 3, 2012. "We have a unique opportunity though litigation, to get on the inside of these companies and expose what they are trying to hide," Menzies says. "That's the stuff I try to get into the hands of the doctors."

In issues of women's health, female representation can help build clients' trust. And Menzies is grateful to her fellow partners for bringing on a team of powerful and dedicated women lawyers to serve them.

RCRSD attorney Shannon Lukei expressed compassion for her clients

commenting that the transvaginal mesh cases involve uniquely gruesome

damages that "detrimentally affect the spousal relationship-one of the most private and coveted in a woman's life." Lukei and Amanda Robinson are part

of the RCRSD team.

"Our female clients are relieved they can talk to another woman when describing their injuries and damages, which can involve very personal or private matters," Menzies explains. That hard-won trust pays huge dividends. Clients who share their private battles help Menzies make a public case against drugs that pose a threat to women everywhere.

—Marley Gibbons


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Thursday, 22 March 2012

reports of discontinuation reactions have appeared since antidepressants were D Double on FIDDAMAN blog

The recognition of antidepressant discontinuation reactions

The recently published clinical guideline on the management of depression from the
National Institute for Clinical Excellence contains advice that patients prescribed
antidepressants should be given a disclaimer about the risk of
discontinuation/withdrawal symptoms.1 By comparison, not so long ago, a key
message of the Defeat Depression Campaign of the Royal Colleges of Psychiatrists
and General Practitioners was that patients should be informed clearly when first
prescribed antidepressants that discontinuing treatment in due course will not be a
problem.2 Furthermore the general public were criticised in the campaign for
believing that antidepressants are addictive.

Although the debate about whether antidepressant discontinuation reactions amount to
evidence of dependence may be largely semantic, there is a general perception that
withdrawal reactions are indicative of dependence.3 However, the presence of a
withdrawal state is neither sufficient nor necessary for a diagnosis of dependence in
the current International Classification of Diseases (ICD-10). Semantic confusion
about discontinuation, withdrawal and relapse can be traced to dissatisfaction with the
definitions of addiction and habituation, leading to the introduction of the single term
'drug dependence' by a World Health Organisation Expert Committee in 1964.4 Since
then, there have been varying shades of meaning of dependence. Developments, such
as the syndromal approach to the diagnosis of drug dependence,5 and
operationalisation of diagnostic criteria to improve diagnostic reliability, have been
incorporated into modern classificatory systems. The Diagnostic and Statistical
Manual of the American Psychiatric Association made tolerance or withdrawal a
required criterion in DSM-III, and in DSM-IIIR dependence was redefined as the
antisocial syndrome of clinically significant behaviours and symptoms indicating loss
of control of substance use and continued use despite adverse consequences.

Case reports of discontinuation reactions have appeared since antidepressants were
first introduced. However, systematic recognition had to wait until a BMJ editorial in
1998.6 Even then the problems were minimised. A few years later the authors of the
editorial updated their views to admit that such reactions are common.7 Some of the
pharmaceutical companies may not have helped scientific debate because of
misleading promotion of their products. For example, GlaxoSmithKline eventually
dropped its insistence that paroxetine is not addictive.8 This is at least partly because
of confusion about the technical and lay definitions of dependence and addiction. A
drug which is thought to improve mood is likely to be habit forming, so however
much the medical profession may declare that antidepressants are not primarily
reinforcing like psychostimulants, the public understand that there may be problems
discontinuing antidepressants.

The earlier distinction between physical and psychological dependence may,
therefore, still have some relevance in clinical practice. People may form attachments
to their medications more because of what they mean to them than what they do.

Psychiatric patients often stay on medications, maybe several at once, even though
their actual benefit is questionable. Any change threatens an equilibrium related to a
complex set of meanings that their medications have acquired. These issues of
reliance on medication should not be minimised, yet commonly compliance with
treatment was reinforced by emphasising that antidepressants are not addictive. The


NICE guidelines should eliminate this practice. Antidepressants are often prescribed
in life crises reinforcing defensive mechanisms against overwhelming anxiety, and the
power of the placebo effect should be recognised. As suggestion can play an
important part in initial response to treatment, expectations are as likely to play a role
in withdrawal, producing a nocebo reaction.

The relapse rate in randomised controlled trials of discontinuation of antidepressant
treatment is substantial.9 Discontinuation reactions may be confused with relapse, and
may also trigger or be a sign of potential relapse. There is also evidence of a loss of
benefit emerging with long-term treatment and also on retreatment after
discontinuation of antidepressants.10 There is some naturalistic evidence to support
the view that people treated without antidepressants may do better over the long term.

The possibility that antidepressants may, therefore, create a vulnerability to relapse
needs to be taken seriously.11

Even in short-term trials SSRIs do not apparently work that much better than
placebo.12 More evidence is needed from longer-term controlled studies to assess
whether patients who work through their difficulties without medication have a better
outcome over the longer term. Besides the methodological difficulties of testing this
hypothesis, there will be ideological barriers to considering it. However, the lessons
of the history of the resistance to the recognition of antidepressant discontinuation
reactions should help create a more open attitude to examination of this important

(I declare that the answer to the questions on your competing interest form
( are all No and therefore have

nothing to declare)

1. National Institute for Clinical Excellence. Management of depression in
primary and secondary care. (Clinical guideline 23) London: NICE 2004

2. Priest RG, Vize C, Roberts A, Roberts M, Tylee A. Lay people's attitude to
treatment of depression: results of opinion poll for Defeat Depression

Campaign just before its launch. BMJ 1996; 313: 858-859 [Abstract/Free
Full Text].

3. Russell MAH. What is dependence? In Drugs and drug dependence. (Eds. G

Edwards et al). Saxon House: Westmead, 1976

4. World Health Organization Expert Committee on Addiction-producing Drugs:

Thirteenth report. Geneva: WHO, 1964

5. Edwards G. Nomenclature and classification of drug- and alcohol-related

problems: a WHO memorandum. Bull WHO 1981; 59: 225-42

6. Haddad P, Lejoyeux M, Young A. Antidepressant discontinuation reactions.

Are preventable and simple to treat. BMJ 1998; 316: 1105-6

7. Young A, Haddad P. Discontinuation symptoms and psychotropic drugs.

Lancet 2000; 355:1184

8. Boseley S. Seroxat maker abandons 'no addiction' claim. The Guardian, 3

May 2003 [Full text]

People may become psychologically dependent on antidepressants - Criticalpsychiatry Duncan Double on FIDDAMAN blog

Reprinted from BMJ 1997;314:829 [Full text]

People may become psychologically dependent on antidepressants

Editor–Robert G Priest and colleagues advocate educating patients that discontinuing antidepressant treatment will not be a problem but remarkably do not cite any evidence to support their recommendation.1 They also complain that many lay people regard antidepressants as addictive. They suggest that people may be extrapolating from what they have heard about benzodiazopines. This may be, but it is also common sense to believe that discontinuing taking a drug that is thought to improve mood may be difficult. I think that the general public understands this issue better than the Royal Colleges of Psychiatrists and General Practitioners, which are responsible for the Defeat Depression Campaign.

Of course what Priest and colleagues mean is that there is little evidence of physical dependence caused by antidepressants, but this is not what they say. There are, however, case reports of a withdrawal syndrome.2 Clinical experience is that it can be difficult to withdraw treatment with antidepressants for various reasons. The general public might reasonably expect psychiatrists specialising in disorders of the mind to recognise psychological dependence, base their advice on clinical experience, and use their common sense.

Randomised controlled trials of discontinuation of antidepressant treatment have a relapse rate varying from 92%3 to 36%4 in the placebo group. Relapse rate is significantly reduced by continuing antidepressant treatment. Some patients therefore do maintain their therapeutic gains when antidepressants are withdrawn, but the relapse rate is not insubstantial and seems to support the general public's commonsense view rather than the Defeat Depression Campaign's purist scientific statement. Perhaps the public needs to be suspicious of the motives of a campaign that encourages them to seek medical treatment and also tries to help doctors recognise depression. Patronising misinformation is not constructive.

D B Double, Consultant psychiatrist

West Norwich City Community Team, Norfolk Mental Health Care NHS Trust, Norwich NR6 5BE


Priest RG, Vize C, Roberts A, Roberts M, Tylee A. Lay people's attitudes to treatment of depression: results of opinion poll for Defeat Depression Campaign just before its launch. BMJ 1996;313:858-9. (5 October.)

Charney DS, Heninger GR, Sternberg DE, Landis H. Abrupt discontinuation of tricyclic antidepressant: evidence for noradrenergic hyperactivity. Br J Psychiatry 1982;141:377-86. [Medline]

Prien RF, Klett CJ, Caffey EM. Lithium prophylaxis in recurrent affective illness. Am J Psychiatry 1974;131:198-203.

Klerman GL, Dimascio A, Weissman M, Prusoff B, Paykel ES. Treatment of depression by drugs and psychotherapy. Am J Psychiatry 1974;131:186-91.

Dr. Duncan Double: Antidepressant discontinuation reactions - seen Surviving Antidepressants FIDDAMAN blog

Highly informative page by a UK psychiatrist and principal in the Critical Psychiatry Network. This is undated but appears to be from 2006(?). (Emphases below are mine.)

Since 1990 a warning has been printed in the British National Formulary about withdrawal from antidepressants - "Gastro-intestinal symptoms of nausea, vomiting, and anorexia, accompanied by headache, giddiness, 'chills', and insomnia, and sometimes by hypomania, panic-anxiety and extreme motor restlessness may occur if an antidepressant (particularly an MAOI) is stopped suddenly after regular administration for 8 weeks or more. Reduction in dosage should preferably be carried out over a period of about 4 weeks."1 Case reports of discontinuation reactions have appeared since antidepressants were introduced.2 However, the problems of withdrawal have been underestimated and even denied. More recently the importance of discontinuation reactions has generally been conceded,3,4 although there is still controversy.5,6,7,22

NICE guidelines23 have recently stated that:-


All patients prescribed antidepressants should be informed that, although the drugs are not associated with tolerance and craving, discontinuation/withdrawal symptoms may occur on stopping, missing doses or, occasionally, on reducing the dose of the drug. These symptoms are usually mild and self-limiting but can occasionally be severe, particularly if the drug is stopped abruptly.

There has been a reluctance to concede that people can become dependent on antidepressants.24 ....

The definition of dependence changed in the International Classification of Diseases between ICD-9 and ICD-10.11,12 (See ICD-9 and ICD-10 definitions.) In ICD-9, dependence was not necessarily associated with the development of tolerance and physical dependence. Consistent with this view, Russell, in attempting to define dependence, suggested that the "notion of dependence ... requires the crucial feature of a negative affect experienced in its absence. The degree of dependence can be equated with the amount of this negative affect, which may range from mild discomfort to extreme distress, or it may be equated with the amount of difficulty or effort required to do without the drug".13 This commonsense definition was amended following the syndromal approach of Edwards et al,14 and the operationalisation of diagnostic criteria. The presence of a withdrawal state is neither sufficient nor necessary for a diagnosis of dependence in ICD-10.

....Antidepressants do not have primary reinforcing effects like psychostimulants, such as amphetamines and cocaine. Tolerance and physical dependence are said to develop not only with opioids, ethanol and hypnotics, but also after long-term administration of a wide variety of drugs which are not self-administered by animals or used compulsively by man eg. anticholinergics, dopaminergic antagonists and imipramine.10

The crucial issue is whether discontinuation reactions are characteristic for particular antidepressants, which implies physical dependence due to neuroadaptation. This has been particularly suggested with paroxetine and is now incorporated in the BNF warning. There are a few reports of suspected neonatal withdrawal reactions resulting from maternal SSRI use in pregnancy.16 Reported cases of SSRI-induced neonatal withdrawal syndrome, including convulsions, to the WHO database of adverse drug reactions are more frequent than expected,25 although inconsistent spontaneous reporting makes this data difficult to interpret.26 Among the SSRIs fluoxetine is reported to be less likely to cause discontinuation reactions, maybe because of its longer half-life,17, 18 although there is conflict of interest in this work.19

Suspicion has been raised that the reluctance by authorities to acknowledge the dependence potential of antidepressants is affected by commercial interests.20 The dependence potential of benzadiazepines was eventually officially accepted, leading to restrictive guidelines about their use. Nonetheless, there are those who advocate the use of the SSRI antidepressants as "lifestyle" drugs.21 If SSRIs continue to be "abused" in this way, perhaps they will even meet ICD-10 criteria for drug dependence


1. British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. London: BMA and Pharmaceutical Press, 1990.

2. Mann AM, MacPherson AS. Clinical experience with imipramine (G22355) in the treatment of depression. Can Psychiatr Assoc J 1959;4:38-47.

3. Haddad P, Lejoyeux M &Young A. Antidepressant discontinuation reactions. Are preventable and simple to treat. BMJ 1998;316:1105-1106 Full text]

4. Anon. Withdrawing patients from antidepressants. Drugs and Therapeutics Bulletin 1999;37:49-52

5. Double DB. Antidepressant discontinuation reactions - dependence on antidepressants is significant. (1 May 1998)

6. Medawar C. Industry sponsored consensus statements? Reflections on a BMJ editorial.

7. Medawar C. A suitable case for re-evaluation?

8. Priest RG, Vize C, Roberts A, Robert A, Tylee A. Lay people's attitudes to treatment of depression: result of opinion poll for Defeat Depression Campaign just before its launch. BMJ 1996; 313: 858-859 [Medline].

9. Double DB. Prescribing antidepressants in general practice. People may become psychologically dependent on antidepressants. [letter] [Full text] BMJ 1997;314:829

10. Jaffe JH. Drug addiction and drug abuse. In Goodman and Gilman's The pharmacological basis of therapeutics. eds. Gilman et al. Eighth edition. McGraw-Hill: New York, 1990.

11. World Health Organisation. International Classification of Diseases, ninth revision (ICD-9). WHO: Geneva, 1977.

12. World Health Organisation. The ICD-10 classification of mental and behavioural disorders. WHO: Geneva, 1992

13. Russell MAH. What is dependence? In Drugs and drug dependence. Eds. G Edwards et al. Saxon House: Westmead, 1976

14. Edwards G. Nomenclature and classification of drug- and alcohol-related problems: a WHO memorandum. Bull WHO 1981; 59:225-42

15. Raftery EB. Cardiovascular drug withdrawal syndromes. A potential problem with calcium antagonists? Drugs 1984;28:371-4

16. Kent LSW and Laidlaw JDD. Suspected congenital sertraline dependence. Br J Psychiatry 1995;167:412-3

17. Zajecka J, Fawcett J, Amsterdam J, Quitkin F, Reimherr F, Rosenbaum J et al. Safety of abrupt discontinuation of fluoxetine: A randomised, placebo-controlled study. J Clin Psychiatry 1998;18:193-7

18. Rosenbaum JF, Fava M, Hoog SL, Ascroft RC, Krebs WB. Selective reuptake inhibitor discontinuation syndrome: A randomised clinical trial. Biol Psychiatry 1998;44:77-87

19. Medawar C.

20. Medawar C. The antidepressant web. International Journal of Risk and Safety in Medicine 1997;10:75-126 and

21. Charlton BG. Psychopharmacology and the human condition. J Roy Soc Med 1998;91:699-601

22. Young A, Haddad P. Discontinuation symptoms and psychotropic drugs. Lancet 2000; 355:1184 [Full text]

23. National Institute for Clinical Excellence Management of depression in primary and secondary care. NICE: London, 2004

24. DB Double. The recognition of antidepressant discontinuation reactions.

25. Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibiotrs in pregant women and neonatal withdrawal syndrome: a database analysis. Lancet 2005;365:482-487

26. Ruchkin V, Martin A. SSRIs and the developing brain. Lancet 2005;365:451-453

About Duncan Double

His blog

Doctors sued for creating 'Valium addicts' - but FIDDAMAN lawyer wouldn't sue Seroxat GP's

Doctors are being sued for creating prescription drug addicts amid claims they have failed to follow safety guidelines published more than 20 years ago.

Lawyers and medical experts have reported an increase in clinical negligence cases by patients left physically and psychologically broken by "indefensible" long-term prescribing of addictive tranquillisers such as Valium, collectively known as benzodiazepines.

Patients taken off the drugs too quickly, leaving them disabled with pain for months if not years, are also seeking legal redress. Many say they were never told about the dangers of rapid detoxification, which can lead to seizures and even death in severe cases. Doctors have been accused of being "in denial" about the problem.

Experts have warned of a coming flood of legal action against doctors who failed to inform their patients about the addictive nature of some tranquillisers, currently given to millions of people worldwide. They are prescribed to deal with common social and psychological complaints, from exam stress to relationship problems and bereavement.

Professor Malcolm Lader, whose research in the 1980s suggested a link between long-term tranquilliser use and brain damage, said he now gives legal advice about negligent prescribing and dangerous detoxifications "at least every three months".

He told The Independent: "There is no sign that such prescribing is diminishing. The Royal College of GPs is in denial about this because they fear being sued. With around a million long-term users, the [legal] defence unions will at some point decide that these cases are indefensible and GPs will have to pay their own costs." A report by the All Party Parliamentary Group on Drug Misuse estimated in 2009 that there were 1.5 million involuntary tranquilliser addicts in the UK. More than 6.6 million benzodiazepine prescriptions for anxiety were dispensed by England's pharmacies in 2010, a 15 per cent increase in 10 years. Prescriptions for Valium have increased by 20 per cent over the same period.

The first successful legal claim against individual doctors dates back to 2002, when Ray Nimmo, who was prescribed Valium for 14 years, won his case against GPs in Scunthorpe. His lawyer, Caroline Moore, has had five new referrals in the past month.

Some people develop a tolerance after regular use for two weeks, needing a higher dose to induce the same effects; others report using them for years with few adverse effects. For most, stopping is the problem: they can experience a range of painful psychological and physical symptoms, worse than their original complaint.

Dr Adrian Rogers, a GP who is also an expert in medico-legal cases, said: "I can't believe there aren't more claims. The fact that lots of doctors are prescribing long-term isn't an excuse – no responsible GP would do it."

There are only a handful of specialist tranquilliser withdrawal services across the UK. Most people rely on inexpert help from GPs or addiction services aimed at illegal-drug addicts. Recovery Road, a new helpline, receives around 250 calls a month, mainly from those who have detoxified too rapidly. "These poor people describe being in a kind of torture chamber," said Baylissa Frederick, of the organisation.

The Bridge Project in Bradford tracks down long-term benzodiazepine users. In five months this year, one of its specialist drugs workers helped 102 patients.

Dr Chris Ford, a GP and benzodiazepine expert, is drafting new guidance to help doctors avoid creating addicts and advise them on the best way safely to detoxify those who are already dependent. Controversially, it will endorse long-term use for a limited number of patients. "These are good drugs – they work, but it is a slippery slope if doctors do not have systems in place to make sure they are only used in the short term," she said.

"These people should not be treated like illicit drug users. Any detox has to be done very slowly. These drugs can cause serious long-term problems, so GPs should encourage people to come off them, but, for some, it is necessary to compromise. No one should be forced to withdraw," she added.

A Department of Health spokeswoman said: "The Government's drug strategy set out [in the White Paper Healthy Lives, Healthy People] an ambition to tackle dependence on all drugs, including prescription and over-the-counter medicines. It is clear that this is a problem that affects some people in most areas and is much unreported. Public health bodies will be responsible for the commissioning of services to support people recovering from dependence."

Case studies: Lives blighted by addiction

'It was like the doctors were my drug dealers'

Rachel, 62, from the Midlands. Rachel (not her real name) is trying to sue an NHS clinic that detoxed her from tranquillisers so rapidly she has been left bedridden

"Around nine years ago my GP prescribed me Valium. I didn't know it was addictive; my doctor kept giving me repeat prescriptions over the phone. I didn't have any problems until five years ago when I started to get numbness in my face and irregular heartbeats.

"I was offered a detox in an NHS rehab unit... I was in for five weeks, and they cut me down 1mg every other day, which they insisted was very slow. It was absolute hell.

"I didn't want to go back on the drug but I had no choice. Most days I can't stand up... my memory has gone. Listening to those detox people is the biggest mistake I ever made. The doctor won't accept the pain is caused by the withdrawal."

'Listening to those NHS detox people is the biggest mistake I ever made'

Janet Marshall, 53, from Wakefield, West Yorkshire, won £25,000 in an out-of-court settlement from her GP after "losing" 28 years to prescribed benzodiazepines

"I was 26, I'd just had my fourth baby, and I had a panic attack. I called the GP because I thought I was dying, and was prescribed oxazepam, even though I was breast-feeding. I became hooked, taking 15 10mg tablets a day at one point.

My fifth child was born an addict; he suffered withdrawal symptoms, but by this time I couldn't cope without them. Sometimes my pharmacist would give me some to tide me over the weekend if I'd run out. Five years ago, I changed GP, and she said I had a problem and started cutting me down, but far too quickly. It was like the doctors were my drug dealers. I couldn't talk properly or stop shaking. It lasted for months, but I felt so much more alert and got my senses back.

"I feel angry and bitter at the Government, the pharmaceutical companies, the GPs – they all knew about it. I was a healthy normal person before the benzos; I was a good mother but I was robbed of that. I feel so guilty about my kids."

The Creation of Psychopharmacology by David Healy - book review Duncan Double criticalpsychiatry - FIDDAMAN

Review of The Creation of Psychopharmacology by David Healy. Harvard University Press, 2002

Reprinted from Health Service Journal 20 June 2002 pp42-3

David Healy has recently gained notoriety after an invitation to be Professor of Psychiatry at the University of Toronto was withdrawn. Healy claimed that the pharmaceutical companies, and certain influential psychiatrists, who receive consultancy fees from the companies, swayed the decision to rescind the job offer. He sought redress for breach of contract, libel and violation of academic freedom leading to an out of court settlement. Healy is prepared to confront the all-pervasive influence of the pharmaceutical industry in psychiatry.

A principal thread running through the conflict is Healy's controversial belief that the SSRI group of antidepressants, which includes the well-known drug Prozac, may have the potential to trigger suicidality in a subgroup of users.

Whilst taking paroxetine, an SSRI antidepressant, Donald Schell shot his wife, daughter, and granddaughter, before turning the gun on himself. A unanimous jury, primarily on Healy's evidence, found that paroxetine can cause some individuals to commit suicide and/or homicide and awarded a total of $8 million in damages to the families involved.

I suspect that Healy enjoys the limelight. He tends to adopt an idiosyncratic, maverick position in psychiatry. His best book is probably The Antidepressant Era. It gives an account of the phenomenon of the antidepressants. The Creation of Psychopharmacology is a follow-up, telling the story of the discovery and development of anti-psychotic medication, such as chlorpromazine and haloperidol. There are nuggets of information in this book. Most of them derive from interviews with prominent people in the field of psychopharmacology, which Healy has published in three volumes entitled The Psychopharmacologists.

For example, I was not previously aware that Jean Delay, who, with Pierre Deniker, was the first to proclaim the anti-psychotic properties of chlorpromazine, had his office ransacked by students in the protests of 1968 at the University of Paris. Healy makes grand links between this event and the overall history of psychopharmacology that he describes. He sees 1968 as the culmination of the Enlightenment begun by Rousseau and Voltaire. He makes connections, however tenuous, with the anti-psychiatry movement.

But the generalisations and tangentiality of this book are serious weaknesses. At times it is difficult to follow the juxtaposition of ideas.

Some of the references Healy gives are useful and well worth following. However, more time and effort should have been expended in distilling the essence of the material and providing coherence to the argument.

Commentators have made these criticisms in reviews of his books since his first book the Suspended Revolution. He has never hidden his personal style and approach, which is why it is surprising that a rather rambling lecture led to the revocation of the job offer in Toronto. The University should have known what kind of person they were taking on.

The commendation for the book on the back cover comes from Edward Shorter, social historian of medicine at the University of Toronto. Shorter suggests that The Creation of Psychopharmacology is the most important contribution to the history of psychiatry since Ellenberger's Discovery of the Unconcious. Do not believe the blurb. Healy's book is not without value. But more work is needed to produce a longlasting, consequential account from his material.

Associated Octel 7x more pollution than GLAXO Ulverston - B0B FIDDAMAN blog reveals

Dothiepin - Sedative antidepressants impair visual detection mechanisms in humans.- B0B FIDDAMAN blog

Sedative antidepressants impair visual detection mechanisms in humans.

Weinstein A, Wilson S, Bailey J, Nutt D.

SourcePsychopharmacology Unit, University of Bristol, School of Medical Sciences, University Walk, Bristol BS8 1TD, UK.


The safety of sedative antidepressants is a topical issue in the treatment of depression, with driving impairment being of particular concern. We have recently completed a study with normal male volunteers comparing the actions of dothiepin (a traditional, sedating antidepressant) with those of fluvoxamine (one of the selective serotonin re-uptake-inhibiting SSRI class of newer antidepressants) on psychomotor functions relevant to driving. We set out to investigate whether these drugs impair visual selective attention (focused and divided) by employing the 'odd-ball' task. Subjects were required to respond to letters of the alphabet (T for target and other letters for non-targets) that were presented at the centre and/or periphery of the computer screen. The task has been shown to be useful in detecting differences between drugs in their effects on selective attention. Preliminary results show that dothiepin delayed responses to single targets compared with fluvoxamine and placebo. There was also preliminary evidence that it mainly affected response times to peripheral targets. Furthermore, there was preliminary evidence that both drugs delayed responses to central targets compared with placebo on the divided attention trials. Finally, response accuracy in detecting peripheral targets was greater under placebo compared with fluvoxamine and dothiepin. The impairment produced by dothiepin is presumably a consequence of the central blockade of cholinergic muscarinic or histaminergic H1 receptors. It could contribute to the reported association between the tricyclic class of antidepressants and road traffic accidents, and would be worth further investigation in depressed patients taking both classes of drug.

PMID:22302891[PubMed - in process]

GSK Boosts UK Investment After Budget Moves - this won't help FIDDAMAN anger issues

GSK Boosts UK Investment After Budget Moves

GlaxoSmithKline has announced plans to build its first new pharmaceutical plant in the UK for 40 years, encouraged by measures in the Budget to boost home-grown research and development.

The nation's biggest medicine maker has selected Ulverston, Cumbria, as the site for the biopharmaceutical factory as it ramps up investment in Britain.

GSK has also confirmed it will invest more than £500m to boost production of key active ingredients for its pharmaceutical products and vaccines across its UK factories.

The figure includes £100m of spending earmarked for its two factories in Scotland, and will create up to 1,000 new jobs across the nation.

GSK said its decision to commit resources in Britain was helped by measures in the Budget to encourage research and development.

The 'patent box' imposes a lower rate of corporation tax on profits generated from UK-owned intellectual property.

The firm's chief executive Sir Andrew Witty said: "The introduction of the patent box has transformed the way in which we view the UK as a location for new investments, ensuring that the medicines of the future will not only be discovered, but can also continue to be made here in Britain."

The company anticipates the projects will benefit the wider economy by boosting the construction industry and GSK's suppliers.

Sir Andrew added that the company is also "actively considering" other investments which would reinforce the nation's international standing as a leader in life sciences.

The Prime Minister welcomed the news of the investment and said it showed the Government's strategy was already working.

David Cameron said: "It shows why we are right to cut business tax and focus on making the UK a dynamic and competitive place that can attract exactly this type of high-tech investment.

"We have a world-class life sciences industry, and I am determined not just to keep it here in the UK but significantly increase it too. We cannot be complacent, the industry is changing, and we must change with it.

"Our innovative life sciences strategy and ground breaking patent box are already making a difference, helping to grow this important industry and ensure the great discoveries of the next decade happen here in British laboratories."

GSK plans to spend £350m on the new Ulverston site, but said it may double the investment "depending on continued improvements in the environment for innovation in the UK".

However construction, which is expected to take six years, will not begin until 2014/15.

:: Meanwhile Britain's high streets have been seeing an improved environment.

Clothing retailer Next reported pre-tax profits in line with analyst expectations of £570m.

Kingfisher, which owns the DIY chain B&Q, saw its annual profits rise by nearly a fifth to £809m.

Wednesday, 21 March 2012

British people are committing suicide to escape poverty. Is this what the State wants?

British people are committing suicide to escape poverty. Is this what the State wants?


PUBLISHED: 17:23, 20 March 2012
UPDATED: 20:52, 20 March 2012

Comments (66)


In the last few months of his life, Craig Monk attempted several overdoses and was described as 'vulnerable' by his family.

An accident a few years before had resulted in the partial amputation of his leg and he had suffered unnecessary, and anxiety-inducing, obstructions in receiving state assistance - even though his disability was clear for all see.

Over time he slipped further into poverty, the ends could no longer meet
read on -

@GSK @Fiddaman - why try to give out Witty details - u want to intimidate a 15 year old girl?

extract from -

18.Salary £1,000,000.00

19.Bonus £1,177,000.00

20.Restricted stock awards £0.00

21.All other compensation £126,000.00

22.Option awards $ £0.00

23.Non-equity incentive plan compensation £0.00

24.Change in pension value and nonqualified deferred compensation earnings £0.00

25.Total Compensation £2,303,000.00



28.Personal and Education:

29.Spouse: Caroline M. Witty (née Hall)

30.Children: 15 year old girl (plays netball), 19 year old boy

31.Andrew has a Joint Honours BA in Economics from the University of Nottingham.




35.4 *******

A_Witty_Parody post video link - i hope they don't do this at my house. @Fiddaman

GlaxoSmithKline download FIDDAMAN associated SeroxatKills Andrew Witty pastebin - intimidation

Dr Terry Lynch, author of Beyond Prozac no one should stop taking medication without professional assistance - like FIDDAMAN

Lynch to meet group to discuss anti-depressants

By Jennifer Hough

Wednesday, March 21, 2012

The minister with responsibility for mental health will meet a delegation concerned about serious side-effects of anti-depressants.

Kathleen Lynch has agreed to meet with former state pathologist Declan Gilsenan, the mother of Shane Clancy, who killed a man and took his own life, psychiatrist Prof David Healy, and a former government minister.

Earlier this month, Dr Gilsenan raised concern about the number of suicides he had seen where the person had recently started taking SSRI anti-depressants. He said in his 30-year experience carrying out postmortems, he had seen "too many suicides" after people had recently started taking the drugs. At Mr Clancy’s inquest, Dr Gilsenan testified there were "toxic" levels of citalopram (brand name Celexa or Cipramil) in Mr Clancy’s blood.

Mr Clancy’s mother Leonie Fennell has been campaigning on the issue since her son’s death. While she said she is aware she may come across as simply "a grieving mother", she said experts such as Dr Gilsenan and Prof Healy cannot be ignored.

Prof Healy believes there should be compulsory monitoring of patients in the initial period after starting to take the drugs.

He maintains the danger period is generally within the first two weeks.

The Irish-born psychopharmacologist has been involved as an expert witness in homicide and suicide trials involving psychotropic drugs, and in bringing problems with these drugs to the attention of American and British regulators.

He works to raise awareness of how pharmaceutical companies sell drugs by marketing diseases and co-opting academic opinion-leaders, ghostwriting their articles.

Dr Terry Lynch, author of Beyond Prozac, says there is a role for medication for people, but drugs should not be seen as a long-term solution to emotional problems. Dr Lynch said no one should stop taking medication without professional assistance.

The College of Psychiatry of Ireland and the Irish Medicine’s Board recommend monitoring of all individuals who have started on antidepressant therapy.

Read more:

SeroxatKills wordpress still giving personal security details of GSK - Andrew Witty - why FIDDAMAN any answers?

Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why, - but FIDDAMAN isns't

Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.

By Steve Silberman 08.24.09

Photo: Nick Veasey

Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn't introduced a truly new product in three years, and its stock price was plummeting.

In interviews with the press, Edward Scolnick, Merck's research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company's reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. "To remain dominant in the future," he told Forbes, "we need to dominate the central nervous system."

His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive's dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.

Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people's health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.

Ultimately, Merck's foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.

MK-869 wasn't the only highly anticipated medical breakthrough to be undone in recent years by the placebo effect. From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson's disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn's disease, an intestinal ailment, citing an "unusually high" response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It's not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late '90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It's not that the old meds are getting weaker, drug developers say. It's as if the placebo effect is somehow getting stronger.

The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today's economy, the fate of a long-established company can hang on the outcome of a handful of tests.

Why are inert pills suddenly overwhelming promising new drugs and established medicines alike? The reasons are only just beginning to be understood. A network of independent researchers is doggedly uncovering the inner workings—and potential therapeutic applications—of the placebo effect. At the same time, drugmakers are realizing they need to fully understand the mechanisms behind it so they can design trials that differentiate more clearly between the beneficial effects of their products and the body's innate ability to heal itself. A special task force of the Foundation for the National Institutes of Health is seeking to stem the crisis by quietly undertaking one of the most ambitious data-sharing efforts in the history of the drug industry. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom.

Placebo Response Persists in Depression ..shows you how suggestible people are - FIDDAMAN blog

Placebo Response Persists in Depression

By John M. Grohol, PsyD

Founder & Editor-in-Chief

There has been considerable debate ever since PLoS Medicine published a study in February suggesting that antidepressants are largely no better than a placebo (sugar pill) for the treatment of depression. The only condition where the researchers found a significant difference was in severe depression, and this was only because the placebo response dropped off — not because the antidepressant medication’s response increased.

I commented on the study at the time suggesting that while adding to our understanding of antidepressant medications, it was hardly without faults. Other meta-analyses published since then support antidepressants’ effectiveness in older adults (Nelson et. al., 2008) and present a more mixed picture for long-term use (Deshauer et. al., 2008). With over 1,000 clinical studies conducted in the past few decades on the effectiveness of antidepressant medications, it’s hard to throw all that research out the window as “biased” or without value in adding to our knowledge and understanding.

However, one can’t argue with the finding from the PLoS February research showing how some research data is skewed toward the positive (Ioannidis, 2008):

“Negative” trials were either left unpublished or were distorted to present “positive” results. The average benefit of these drugs based on the FDA data was of small magnitude, while the published literature suggested larger benefits.

Indeed, if there’s one take-away from this controversy, it’s that research data will apparently always be portrayed in the best possible light by whoever is funding it. Negative results will be de-emphasized or simply ignored (even though they may still be found in the data), and positive results will often be raised up and highlighted.

So one of the questions being asked by researchers nowadays is, how long-lasting is this placebo response? In other words, if a person continues receiving a placebo instead of an antidepressant, does their depression get worse over time?

Khan and colleagues (2008) have an answer. They conducted a meta-analysis on 8 placebo-controlled antidepressant trials that included a total of 3,063 patients. They found research where patients were continued on placebo for more than 12 weeks and examined whether they relapsed back into depression or not.

The researchers found that 79% of those receiving placebo continued to be depression-free 4 months after their initial treatment (4 out of 5 people), compared with 93% of those taking an antidepressant medication. This study demonstrates that while placebos appear to still continue to work for most people taking them, they are still significantly less effective than an antidepressant.

I think that antidepressants remain an effective treatment modality for depression, although as STAR*D demonstrated, patients and their doctors will usually have to try multiple medications before finding one that works for them.


Deshauer D, Moher D, Fergusson D, Moher E, Sampson M, Grimshaw J. (2008). Selective serotonin reuptake inhibitors for unipolar depression: a systematic review of classic long-term randomized controlled trials. CMAJ, 178(10):1293-301.

Ioannidis JP. (2008). Effectiveness of antidepressants: an evidence myth constructed from a thousand randomized trials? Philos Ethics Humanit Med., 3:14.

Khan A, Redding N, Brown WA. (2008). The persistence of the placebo response in antidepressant clinical trials. J Psychiatr Res., 42(10):791-6.

Nelson JC, Delucchi K, Schneider LS. (2008). Efficacy of second generation antidepressants in late-life depression: a meta-analysis of the evidence. Am J Geriatr Psychiatry, 16(7):558-67.

Placebo response in depression: a search for predictors ...interesting article from 1988 - FIDDAMAN blog

Psychiatry Res. 1988 Dec;26(3):259-64.

Placebo response in depression: a search for predictors.

Brown WA, Dornseif BE, Wernicke JF.

SourceBrown University, Providence, RI.


Although 30-40% of depressed patients respond to placebo treatment, few predictors of placebo response have been identified. We evaluated patients with moderate to severe depression who had received placebo for 3-6 weeks in multicenter clinical trials (Study 1, n = 125; Study 2, n = 88). Placebo response rates (greater than 50% improvement in Hamilton total depression score) were 38.4% and 30.7%, respectively. Despite differences in treatment outcome, baseline clinical and demographic characteristics were similar for responders and nonresponders. The studies confirmed the substantial placebo response in moderately to severely depressed patients and suggested chronicity may be a predictor.

PMID:3065807[PubMed - indexed for MEDLINE]

Antidepressants little better than placebo ...but placebo responds at 30% ...see B0B Fiddaman blogspot

Placebo Response in Studies of Major DepressionVariable, Substantial, and GrowingB. Timothy Walsh, MD; Stuart N. Seidman, MD; Robyn Sysko, BA; Madelyn Gould, PhD

[+] Author Affiliations

Author Affiliations: Department of Psychiatry, College of Physicians and Surgeons of Columbia University (Drs Walsh, Seidman, and Gould), and New York State Psychiatric Institute (Drs Walsh, Seidman, Gould, and Ms Sysko), New York, NY.

AbstractContext Intense debate persists about the need for placebo-controlled groups in clinical trials of medications for major depressive disorder (MDD). There is continuing interest in the development of new medications, but because effective antidepressants are already available, ethical concerns have been raised about the need for placebo groups in new trials.

Objective To determine whether the characteristics of placebo control groups in antidepressant trials have changed over time.

Data Sources and Study Selection We searched MEDLINE and PsychLit for all controlled trials published in English between January 1981 and December 2000 in which adult outpatients with MDD were randomly assigned to receive medication or placebo. Seventy-five trials met our criteria for inclusion.

Data Extraction Data were extracted from the articles by 2 of the authors and discrepancies were resolved via discussion and additional review by a third author.

Data Synthesis The mean (SD) proportion of patients in the placebo group who responded was 29.7% (8.3%) (range, 12.5%-51.8%). Most studies examined more than a single active medication, and, in the active medication group with the greatest response, the mean (SD) proportion of patients responding was 50.1% (9.0%) (range, 31.6%-70.4%). Both the proportion of patients responding to placebo and the proportion responding to medication were significantly positively correlated with the year of publication (for placebo: n = 75; r = 0.45; 95% confidence interval [CI], 0.25-0.61; P<.001; for medication: n = 75; r = 0.26; 95% CI, 0.03-0.46; P = .02). The association between year of publication and response rate was more statistically robust for placebo than medication.

Conclusions The response to placebo in published trials of antidepressant medication for MDD is highly variable and often substantial and has increased significantly in recent years, as has the response to medication. These observations support the view that the inclusion of a placebo group has major scientific importance in trials of new antidepressant medications and indicate that efforts should continue to minimize the risks of such studies so that they may be conducted in an ethically acceptable manner.

Tuesday, 20 March 2012

Prior Antidepressant Use May Affect Patients' Response to New Drugs — see FIDDAMAN blog

Prior Antidepressant Use May Affect Patients' Response to New Drugs — and Placebo

By Maia Szalavitz
March 20, 2012

Having previous experience with antidepressants can change a person's future response to both medications and to placebo, according to a new study. The findings could have implications for clinical trials designed to test new drugs.

For the new study, researchers led by Aimee Hunter, assistant professor of psychiatry at University of California, Los Angeles, studied the brain activity of 89 depressed adults who were enrolled in clinical trials of the antidepressant drug Prozac (fluoxetine) or Effexor (venlafaxine).

During the first week of each trial, all participants took placebo and then after that, they were given either a study drug or placebo. Using a technique called quantitative electroencephalography (QEEG), which involves a cap of electrodes placed painlessly on the scalp, researchers measured and mapped the participants' brain activity.

They found differences based on the participants' previous history of antidepressant use — a factor that wasn't taken into account in the trials. "We found that prior history affects the response to placebo," Hunter says. "If they had a prior history of taking antidepressants and were given placebo, the brain changes were indistinguishable from those of the people given medication."

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