The Irish Medical Times: Good Or Bad Information?

Further to my last post concerning the opinion piece in the Irish medical Times on SSRI suicide rates, I thought it would be useful for my readers to see an example of mainstream medical opinion about SSRI drugs. For some background on the Irish Medical Times see here .

The Irish Medical Times is one of the more influential webzines in the Irish medical world. Considering its opinion is far reaching within Irish medical circles, just what is its general opinion on the dangers of SSRI medications? Strangely, it seems the Irish Medical Times is at once pro-SSRI but also slightly anti-SSRI. Back in 2008, this article ‘Anxiety Disorders: A Modern Problem‘ from their website suggests that SSRI treatment should be used as a first line medication for the treatment of Anxiety Disorders and related phobias etc.

Medications involve the evidence-based support of antidepressants, namely, the selective seretonin reuptake inhibitors (SSRIs) as first line options and also benzodiazepines as rapid, but short-term relief.

There is a small mention within the article of the standard pharmaceutical mantra that :

All patients should be monitored for an initial increase in anxiety, agitation, akathisisa and emergence of suicidal ideation.

Is this adequate or sufficient advice? No mention of dependence, addiction, severe withdrawal and suicidal thoughts and aggression while on and coming off the drug. Why?

In the same year (2008) there is also an article titled ‘ Power, Politics and Pharmaceuticals‘ about the drugs industry in Ireland, there is some mention of the Seroxat Scandal :

There appears to be general agreement that patients should be better informed about the risks of newly-released medicines. Post-marketing surveillance of new drugs should be more thorough, but it is way down the scale in comparison with getting of approval for the sale of new drugs.

It might be worth mentioning in this context that it is found that few health professionals report the drug reactions that they encounter. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) is regarded as one of the best such organisations in the world, but it took a BBC ‘Panorama’ television programme to alert the public to the withdrawal side-effects of Seroxat.

Yet, the original licence application recorded that when patients stopped taking this drug, 30 per cent suffered withdrawal reactions. Dr Andrew Herscheimer, who founded the Drug and Therapeutic Bulletin, states in his essay that the discovery of the problems with the selective serotonin reuptake inhibitors showed serious deficiencies in the UK regulatory system.

So, in the same year, the Irish Medical Times highlights the dangers of suppression of data by the pharmaceutical industry with drugs like Seroxat, while at the same time promoting SSRI’s as a first line treatment-without adequate warning of the (very serious) adverse reactions that can occur.

Confused? I am too.

Irish Medical Times : Suicide prevention by drugs questioned

The following article is from the Irish Medical Times. I have always had a problem with the pro-SSRI stance of the Irish medical Times (more on this in a future post) and particularly its published articles on the ‘benefits’ of SSRI medications, so it was surprising for me to see this opinion piece from the Irish Medical Times online about the dangers of these drugs. Check it out :

http://www.imt.ie/opinion/2010/08/suicide-prevention-by-drugs-questioned.html

Suicide prevention by drugs questioned
August 26, 2010 By admin Leave a Comment
Dear Editor,

An article on July 30 carried the headline ‘Antidepressants prevent suicides in young people’ (see www.imt.ie/clinical/2010/07/antidepressants-prevent-suicides-in-young-people.html). Obviously, this is an important public health issue given that in 2009, four persons age 14 and under and 90 aged 15-24 were recorded as dying by suicide.

A further three aged 14 and under, in addition to 24 aged 15-24, were returned as ‘deaths of undetermined intent’, generally regarded as probable suicides. But does the evidence presented justify the headline?
Your contributor relies heavily on the work of Gibbons et al, based on reductions in prescriptions for selective SSRIs in young persons in the US from 2003-05 following the FDA ‘black box’ warnings of possible suidicogenic side-effects.

They found that SSRI prescriptions for persons up to 19 declined by 22 per cent and that youth suicide rates increased by 14 per cent between 2003 and 2004 and noted a similar correlation in the Netherlands.
Despite the association of these two observations, the authors nevertheless concluded: “The aggregate nature of these observational data precludes a direct causal interpretation of the results.” Indeed, in an earlier publication, Gibbons et al concluded that “the overall relationship between antidepressant medication and suicide was not significant” in a US county-level investigation.

The data on youth SSRI prescriptions came from a sample of US pharmacies and the deduction is made that prescription equates to ingestion – a notably fragile assumption, particularly in psychiatric practice. In addition, there were no data about the number of persons to whom the prescriptions related, whether they had changed over time and the duration of medication compliance.

The data presented relate to a narrow window of time rather than a time-series and short-run fluctuations in suicide rates are notorious – witness the difference in Irish rates between 2008 and 2009. The number of suicides in children and younger adolescents is, in any case, so small as to reduce statistical power meaningfully to establish effects.

Much of the data and conclusions provided by other authors quoted rely on an inverse relationship between antidepressant prescription and suicide rates and ignore those in the contrary direction such as in Ireland. All of these take little account of the contemporaneous influence of ecological confounders, which are so important in a phenomenon as complex as suicide. Even more importantly, the conflation of correlation with cause is a primary deductive fallacy.

Finally, there are two serious concerns about the administration of antidepressants to children and young adolescents. The prescription of these drugs may reduce the likelihood of other modalities of care and intervention; and there is the obvious danger of the exposure of the developing brain of young people to the possible, as yet unknown, long-term adverse consequence of these potent substances.

Dr Dermot Walsh, Ballsbridge, Dublin 4.

A Scandal Emerging: Glaxo’s Irish Vaccine Trials

Bob Fiddaman over at the ‘Seroxat Sufferers’ blog is hot on the pulse today with his post about GSK’s vaccine trials in Ireland. Although this blog is primarily about the Seroxat Scandal, it seems that the controversial vaccine trials on Irish orphans could become yet another big scandal for GSK. The reason why I’m bringing attention to this is not because it is more bad news for GSK but because I believe that those who were prescribed Seroxat were guinea pigs too. Seroxat was inadequately tested before GSK obtained a license for it. Those who were prescribed Seroxat over the past 20 years were the public clinical trial.

This from the Irish Times:

http://www.irishtimes.com/newspaper/ireland/2010/0821/1224277318309.html

Call for inquiry into vaccine trials in institutions

FIONA GARTLAND

AN INDEPENDENT inquiry should be set up to examine vaccine trials carried out on babies and children in orphanages and mother-and-baby homes in the 1960s and 1970s, a former resident has said.

Victor Boyhan, former chairman of Past Residents of Smyly Homes and Cottage Homes, said that after almost 20 years of seeking answers from the State, it was time the truth came out about the drugs trials.

The call came after it emerged a woman adopted from Ireland in 1961, who was involved in a vaccine trial as a baby without the permission of her mother, is to take legal action against the drugs company involved.

Mari Steed (50), who lives in the US, is to take action along with three others against GlaxoSmithKline, which as “The Wellcome Foundation” at the time the trials were conducted.

Ms Steed was administered the experimental vaccine while at the Sacred Heart Convent, Bessborough, Co Cork, between December 1960 and October 1961 when aged between nine and 18 months old. She also hopes to bring legal action against the Sacred Heart order in the Irish courts.

In the 1960s, clinical trials compared a 3-in-1 vaccine for Diphtheria, Tetanus and Pertussis and separate polio immunisation to a 4-in-1 vaccine for the illnesses. The studies in the 1970s looked at two different types of 3-in-1 vaccines.

The trials took place in institutions including the Bessboro home, St Patrick’s Home, Navan Road, Dublin, Cottage Home for Little Children, Dun Laoghaire and the Bird’s Nest Home, Dun Laoghaire.

In 1993, then minister for health Labour Party deputy Brendan Howlin, through his private secretary, wrote to a past resident of one of the homes about the trials. He said his department had inquired into them and he was satisfied there was “no added risk whatsoever” to the children who received the vaccines.

A report published by the Department of Health in 2000, showed that at least 211 children in homes and orphanages were given test vaccines during three separate drug trials in 1960/1961, 1970 and in 1973.

The Laffoy commission on Child Abuse was then asked by the Government to investigate those trials and any others carried out in institutions between January 1940 and December 1987. But the commission’s investigation was dropped following court action taken by the medical practitioners involved.

There has been no further progress in establishing the details of the trials or if the drugs had any long-term effects on the individuals involved.

Mr Boyhan, who is also a councillor in Dún Laoghaire Rathdown County Council, called for an independent inquiry to be set up to establish the facts. He said a lot of information had been received by the Laffoy Commission before its investigation was closed down and the records of many of the institutions involved were still “surprisingly intact”.

“Bodily integrity is a fundamental right of every citizen, it is not unreasonable to want to know what happened,” he said.

And from the Belfast Telegraph :

http://www.belfasttelegraph.co.uk/news/local-national/republic-of-ireland/irelands-hidden-scandal-child-vaccine-trials-14918544.htm

Ireland’s hidden scandal: child vaccine trials

By Patricia McDonagh
Friday, 20 August 2010

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Suspicions that vaccine trials had taken place on vulnerable Irish children — many of whom were in state care — first surfaced in the early 1990s.

As the current decade dawned, former residents of children’s homes began to publicly raise concerns that they had been the subject of experimental trials.

However, it was not until 1997 that the State gave an assurance that it would formally inquire into the issue.

Brian Cowen, who was then Health Minister, directed the chief medical officer at the Department of Health, Dr James Kiely, to investigate the allegations.

In 2000, a report — entitled the “Report On Three Clinical Trials Involving Babies And Children In Institutional Settings, 1960/61, 1970 and 1973″ — was finally drawn up.

The document found that 211 children had been administered vaccines during three separate vaccine trials conducted on behalf of a drugs company, The Wellcome Foundation.

More than 123 of these infants and toddlers were residents in children’s homes in Dublin, Cork and the midlands when the trials took place in the 1960s and 1970s.

Trial one involved 58 children in five children’s homes in Dublin, Cork, Westmeath and Meath. The trial investigated what would happen if four vaccines — diphtheria, pertussis (also known as whooping cough), tetanus and polio — were combined in one overall four-in-one shot.

The trial was published in the ‘British Medical Journal’ in 1962. The final paragraph of it read: “We are indebted to the medical officers in charge of the children’s homes. . . for permission to carry out this investigation on infants under their care.”

Trial two, which was conducted during the summer of 1970, saw 35 children administered with the intra-nasal rubella vaccine.

It involved children from St Anne’s Industrial School in Booterstown, Co Dublin, and children living in the Killucan area of Westmeath.

Published in the ‘Cambridge Journal of Hygiene’ in 1971, the trial attempted to find out if German measles vaccine, administered intranasally, could spread to susceptible contacts.

Both trials were carried out by Professor Irene Hillery and Professor Patrick Meenan, from the department of Medical Microbiology in University College Dublin, and other doctors.

The final trial involved 53 children from institutional homes. The homes were: St Patrick’s Home, Madonna House, Cottage Home, Bird’s Nest and Boheennaburna. A further 65 children living at home in Dublin also took part.

The purpose of the trial was to compare commercially available batches of the three-in-one vaccine, Trivax and Trivax AD, with that of a modified vaccine prepared for the trial.

Dr Kiely’s report said the decision to conduct such clinical trials was acceptable, given the diseases that the vaccines sought to counter.

But, crucially, he insisted the lack of documentation available meant it had not been possible to confirm if consent had been given by the parents or guardians of the children involved or what arrangements were arrived at with managers of the homes.

He added that this lack of information also meant he could not confirm if the Therapeutic Substances Act 1932 had been complied with in relation to the licensing of the trials.

The damning document was laid before the Houses of the Oireachtas on November 7, 2000.

On November 9, the then Health Minister Micheal Martin told the Dail an important part of the probe was to establish if the State had fulfilled its obligations to children in its care.

But he admitted that the report was incomplete.

“It raises as many questions as it answers. Some of those questions go to the heart of our attitudes to children and their rights,” he said at the time

“The report is incomplete because in some areas, the most rigorous interrogation of the system failed to produce documentary records of the trials.”

Mr Martin said the Government had no evidence that any child had contracted a serious illness as a result of the trials.

But he branded the lack of documentation “puzzling” and insisted that the report had to be the “beginning and not the end” of the matter.

The minister referred the report of the investigation to the Commission to Inquire into Child Abuse — known then as the Laffoy Commission.

A government order was subsequently made on June 19, 2001 to provide the commission with the powers to create a separate module to formally investigate the issues involved.

The ‘Vaccines Module’ initially convened a public sitting on January 23, 2002, to outline its terms of reference. It then began investigating the trials.

It obtained documents from GlaxoSmithKline, the successor of Wellcome, which allowed it to definitively identify the homes and people involved in the trials.

Investigators received so much information relating to trial one that they were able to identify the children given the ‘four-in-one’ vaccine.

It also conducted private interviews with witnesses to get a more accurate picture.

But just before the start of public hearings into the first trials, which were due to begin on June 17, 2003, the work of the commission was dealt a severe blow when the Supreme Court ruled that Prof Meenan did not have to give evidence.

Prof Meenan had appealed a High Court order requiring him to comply with the commission’s direction to give evidence about his involvement in the trial.

The inquiry received a further setback when the Government’s order directing the Laffoy Commission probe was held to be invalid by the High Court in November 2003.

Mr Justice Aindrias O Caoimh gave his decision in a challenge brought by Prof Hillery. However, he ruled that other machinery could exist for an appropriate inquiry.

On November 25, 2003, an undertaking was given to the High Court by the commission that it would not conduct any hearings in relation to matters within the ambit of the order.

It had been hoped that the Government would appeal this decision. But on November 2006, Health Minister Mary Harney ordered the vaccine module to be closed down.

Now, some of the victims have been left with no alternative but to seek redress in a US court after Ms Harney again firmly ruled out any further inquiries into existing or new allegations.

The victims’ basic requests appear to be far from unreasonable; an apology for what was done to them; full medical screening to see if they have suffered any damaging long-term effects from the trials; and psychiatric counselling to help them get over their ordeal.

But even this, it appears, is beyond the capacity or willingness of the State to deliver.

Read more: http://www.belfasttelegraph.co.uk/news/local-national/republic-of-ireland/irelands-hidden-scandal-child-vaccine-trials-14918544.html#ixzz0xLdiCaXt

Seroxat/Paxil Kids Studies: Jailed Psychiatrist Pleads Guilty

News just in today from CNBC News, I will post more on this later, but first here’s the articles :

http://www.cnbc.com/id/38783181

Jailed psychiatrist pleads guilty
Published: Friday, 20 Aug 2010 | 5:01 AM ET Text Size

NEW ORLEANS - A 58-year-old psychiatrist involved in two clinical trials evaluating the drug Paxil’s safety and effectiveness in children and adolescents has pleaded guilty to 15 federal counts of failing to prepare and maintain records, with intent to defraud and mislead, in connection with those clinical trials.

Dr. Maria Carmen Palazzo was a clinical investigator for SmithKline Beecham doing business as GlaxoSmithKline. Prosecutors say that during those studies she included psychiatric diagnoses inconsistent with patients’ psychiatric histories; prepared multiple psychiatric evaluations on study patients which contained different diagnoses and reported symptoms she knew the study subject did not demonstrate.

She entered the plea Thursday before U.S. District Judge Mary Ann Vial Lemmon, who sentenced her to 13 months in prison. That term will run at the same time as her current 87-month prison term for health care fraud.

And check this out from Bnet :

http://www.bnet.com/blog/drug-business/10-years-later-glaxo-still-haunted-by-faked-studies-of-paxil-in-kids/5545

10 Years Later, Glaxo Still Haunted by Faked Studies of Paxil in Kids

By Jim Edwards | August 19, 2010

A crooked doctor who faked data in a GlaxoSmithKline (GSK) study of the antidepressant Paxil in children pled guilty to criminal charges today, causing groans among GSK’s senior management as the company hopes to fend off a different criminal investigation into whether it manipulated clinical data on its diabetes drug, Avandia. She was sentenced to 13 months in prison.

The two cases are technically completely separate, but they’re both about data manipulation. GSK has been accused of sitting on data showing risks on both drugs; and the FDA previously shut down one of GSK’s factories where both drugs were made.

Thus, the expected guilty plea of Dr. Maria Carmen Palazzo today is a reminder to managers everywhere that cutting ethical corners can cause unwanted chickens to return to their roosts, even years later.

Palazzo was indicted in 2007 on 40 counts of defrauding Medicare and Medicaid at her New Orleans clinic, and 15 counts of conducting fraudulent clinical trials. The charges followed an FDA accusation that she had enrolled 26 children in studies of Paxil for obsessive-compulsive disorder and major depressive disorder. She included children in the trial — which was given the cutesey nickname “Kiddie-Sads-Present and Lifetime” — who did not have the diagnoses being studied. GSK gave her more than $5,000 for each child she enrolled.

At trial, Palazzo was convicted on 39 counts of healthcare fraud and was sentenced to 87 months in prison and forfeiture of $655,000. The clinical trial fraud charges were thrown out, but prosecutors appealed and won a ruling this year reinstating those charges. That appears to be the reason Palazzo is reappearing in court to make a plea.

The use of Paxil in children became extremely controversial after it emerged that GSK knew for 15 years, but didn’t tell anyone until 2006, that the drug may carry a risk for suicide. The drug now carries a black-box warning for suicide risk in children.

The business lesson here is that bad decisions often have lengthy lives as well as unintended consequences: the Palazzo episode started in 2000, when GSK first approached Palazzo to do the studies. Ten years later, that lousy choice is still on GSK’s agenda as the FDA decides whether its maneuvering on Avandia data is worthy of referral to criminal prosecutors.

Seroxat : “Let’s talk about side effects”…

What are ‘side effects’?

Drug companies like to list side effects as “undesirable” or “unwanted effects” and I suppose that is somewhat true, side effects from Seroxat can include homicide and suicide, and let’s face it, who would want that? These effects are considered ‘adverse‘, in that they are unintended, yet just because an effect is unintended doesn’t mean it isn’t just as potent. But, there is a darker issue afoot when we talk about ‘side effects’ of psychiatric medications. “Side effects” are not really side effects at all, to call them ‘side effects’ is clever wording, it makes us think that they are minimal secondary effects as opposed to the primary effect of what we are being prescribed the drug for. Side effects are just direct effects of a medication, but they are relegated to ‘side effects’ because the drug is not being marketed primarily to induce these symptoms. In the case of Seroxat, the primary effect is meant to alleviate depressive or anxious symptoms and to generally improve mood and give a better sense of wellbeing. It is this primary effect, which Seroxat supposedly induces, that the drug companies concentrate on in order to sell the drug to consumers. A consumer rarely thinks of the side effects as they are usually so keen to experience the promised ‘primary effect’. Although the ‘side effects’ are just as direct as what the drug is being marketed for, a drug company is obviously not going to market seroxat as a prescription for suicide or homicide, even though these effects can often be induced by Seroxat in some people.

So, if the primary effect is apparently beneficial, and the “secondary” are not, how do we weigh the total effects up? How do we make an ‘informed decision’? Well, considering that ‘side effects’ are really not minimal secondary effects but actually direct effects, it would be safe to assume that if the ‘side effects’ (or other direct effects) of the drug outweigh the promised primary effect then the medication is in fact not beneficial overall. Seroxat has horrific side effects (which seem to be growing in number year to year), and quite simply the overall effects of the drug are not beneficial. If we think of an analogy, it might help us to understand. Take alcohol for example- drink companies promote alcohol and the experience of ‘drinking’ as a social, fun and euphoric experience, most people like a few drinks to relax,to unwind or to socialize, at the weekends etc. Alcohol is a socially acceptable drug and chemical; it has been for a long time. Yet, we all know that the the direct effect of alcohol can also induce liver damage, blackouts, alcoholism and worse. These are direct effects just as much as having a good time on alcohol can end in an awful hangover the next day, the hangover is just as much from the alcohol as the good time in the pub before it.

The problem with a lot of medications today is not that they work or they don’t work, it is that drug companies often don’t tell people the truth about ‘direct effects’ (side effects). And also, they often hype (or doctor) the beneficial aspects and downplay (suppress) the negatives. This means that consumers don’t have a chance to make an ‘informed decision‘. Without an ‘informed decision’, people are being prescribed drugs which can have effects that they are completley unaware of, and often the doctors who prescribe them are too. This is the crux of the Seroxat problem and it is the same for many drugs that come on to market. ‘Misinformed‘ consent is false marketing, fraud and deception.

It seems to be a theme in the pharmaceutical industry today to release drugs on to the market of which the total ‘effects’ are unknown until years after, it also seems to be a theme that drug companies just continue to deny the truth until litigation forces them to. Why is it this way? Well, the way I see it is, the pharmaceutical industry is highly competitive and drug companies know that by the time the profit on a drugs lifespan is made, the cost of future litigation hardly puts a small dent in the profits. In other words, by the time the fraud is discovered and the legal system begins to investigate, potentially millions of people have ingested the drug and massive profits are made. Part of these profits go into the pharmaceutical legal war chest and in the end, a huge profit is still made at the expense of hoodwinking the public. It is this total disregard for those harmed by medications that has resulted in such a dark image of Big Pharma in the mind of the public, the individual and the consumer. Only the pharmaceutical industry can rectify this image problem, and it could begin by being truthful, ethical and honest about the ‘direct effects’ of the drugs it promotes.

SSRI’s : Emotional Blunting

Much has been said about SSRI’s and their effects over the years but in this post I would like to raise the issue of SSRI’s and ‘emotional blunting‘. When I was on Seroxat I often felt numb and completely disconnected from my emotions, looking back I realize it had nothing to do with my depression (for which I was originally prescribed Seroxat for). If anything, Depression deepens emotions and intensifies feelings to a very high level of sensitivity. With depression- emotions are felt deeply. There is a huge sense of apathy in depression, but with that comes a good sense of empathy for suffering- both with your own and that of those around you. You might not feel able to help others, or yourself when you are depressed, but you are definitely very much aware of emotion and feelings, in fact often this can be hyper-awareness. With SSRI’s it’s different, your feelings and emotions get completely suppressed, you become disconnected from how you feel, you don’t really care how you feel, everything feels kind of muddled and the longer you are on them, the more un-empathetic you become-for yourself and those around you.

This is what they call ‘Emotional Blunting’. SSRI’s actually induce this effect very quickly upon treatment. Your emotions are literally blunted on an SSRI, they are suppressed, unclear, dampened and confused. SSRI’s are actually designed for this effect and it is this effect that psychiatrists depend on to claim that SSRI’s are useful for depression and anxiety. When presented with an emotional, depressed, anxious, upset or volatile patient, the psychiatrist seeks first to anesthetize the symptoms. SSRI’s are actually thymoanaesthetics, they don’t improve mood but rather blunt it or numb it. While, of course this might seem like a good solution in the short term, in the long term it is nothing short of chemical lobotomization. By removing the patients ability to experience their emotions in real-time, the emotions get suppressed, and of course when anything is suppressed, it begins (very quickly) to fester.

Numbing is not healing and anesthetics do not cure a wound although they might provide the temporary relief and illusion by removing the symptoms of immediate pain. Often post-SSRI ‘treatment’ many people feel worse than before the SSRI. This is not because their ‘depression or anxiety has returned’, this is mainly because of the SSRI withdrawal affect and also because their original problems were not dealt with. If a chemical lobotomy is what psychiatry considers the best option for depression then psychiatry clearly does not understand what depression is. Depression is primarily an emotional response. If there are chemical changes (such as changes in dopamine or serotonin production etc) these changes are no different than the changes that happen in conjunction with any emotive response- such as the increase in cortisol and adrenaline from stress, fear, anger etc. These changes in brain chemicals are not abnormal and SSRI’s are crude implements at best. A ‘chemical’ cannot replace the loss of a childhood, the stress of a divorce or any of the general life events that happen to us. These life events will continue to happen and SSRI’s are not the answer.

So are SSRI’s an effective treatment for depression? Isn’t this the old question that we keep asking ourselves?

Personally, having experienced over 3 years on an SSRI, I would have to say, not at all. In fact, while I was in the throes of Seroxat withdrawal, I prayed that I could have my original depression instead of the absolute horror my body and mind were enduring at that time. While I was on Seroxat, I was far from cured and my mood swings were all over the place. Depression, is quite literally like disneyland compared to a severe Seroxat withdrawal, and even when I was on the drug, I never felt quite right, actually I often felt very wrong. SSRI’s are one of the biggest con jobs in History, and I feel that in about 50 years time, when humanity has evolved past the primitive psychiatric paradigm that now covets ‘mental health’, society and history will look back on the SSRI age as completely barbaric, unsound and unscientific.

Seroxat/Paxil : Voices From The Edge

While trawling the deep vortex of the web tonight, I came across one the first web sites dedicated to Seroxat/Paxil withdrawal.

The website ‘quitpaxil.info’ was set up in 1999. The quitpaxil website has had over 1.2 million visitors since then. Quite a lot of hits for a drug that GSK claims is ‘safe and effective’ don’t you think? It is simply astounding the amount of Paxil/Seroxat related articles/links/blogs and websites that have sprung up about this drug. It has to be unprecedented for any drug to have developed such a massive notoriety. But, we could say, for Seroxat-that notoriety has been well earned. And as they say, ‘there’s no smoke without fire’ and the story of Seroxat seems to rage on like christmas at Dante’s inferno

. Quitpaxil.org has gathered his website’s collection of Seroxat/Paxil horror stories and created a book. Great Idea, and worth checking out I reckon :

http://www.quitpaxil.info/Main/paxil-withdrawal-the-book.html

Seroxat : A Shape Of A Dead Body

I found this Video Promo for “Seroxat: Secrets of the drug trials” earlier on tonight, and since this blog includes everything Seroxat related, I though it was worthy of a post and a link (also I think it’s very artistic)

So here ya go readers :

http://vimeo.com/10977155

Are Drug Firms Unfit To Practice?

With every passing year, more and more scandals come out of the pharmaceutical industry than any other industry that I am aware of.

These scandals usually involve the discovery of doctored results, the burying of negative data, suppression of data, dangerous and defective drug issues and litigation. In the Guardian today, there is an excellent piece of journalism about these repeatedly unethical issues. Drug companies should be held as a beacon of ethics and good practice but they are fast becoming amongst the most untrusted organizations of any industry. I thinks this is a terrible shame, but also I am glad that awareness of this behavior is touched upon more and more within the mainstream media. Also, I would like to applaud the consistent and well balanced reporting from the Guardian news about these issues over the years. For more on this, check out the excellent Seroxat Secrets Blog :

http://seroxatsecrets.wordpress.com/2010/08/14/drug-firms-hiding-negative-research-are-unfit-to-experiment-on-people-writes-dr-ben-goldacre/

http://www.guardian.co.uk/commentisfree/2010/aug/14/drug-companies-bury-negative-research

From the Guardian:

Drug firms hiding negative research are unfit to experiment on people

Another pharmaceutical giant has settled a big compensation claim. So why are they allowed to go on misleading the public?

Ben Goldacre
The Guardian, Saturday 14 August 2010
Article history

GlaxoSmithKline was sued by the New York attorney general for ‘illegal and deceptive’ reporting of the risks of its anti-depressant Seroxat.

This week the drug company AstraZeneca paid out £125m to settle a class action. More than 17,500 patients claim the company withheld information showing that schizophrenia drug quetiapine (tradename Seroquel) can cause diabetes. So why do companies pay out money before cases get to court?

An interesting feature of litigation is that various documents enter the public domain. This is how we know about the tobacco industry’s evil plans to target children, the fake academic journal that Elsevier created for Merck’s marketing department, and so on.

One of the most revealing documents ever to come out of a drug company emerged from an earlier quetiapine case: an email from John Tumas, publications manager at AstraZeneca. In it, he helpfully admits that they do everything I say drug companies do.

“Please allow me to join the fray,” Tumas begins, in response to a colleague. “There has been a precedent set regarding ‘cherry picking’ of data.” Cherry picking is where you report only flattering data, and ignore or bury data you don’t like. The ears of lawyers prick up at any use of the word “bury” in relation to drug company data, as it implies something deliberate, and luckily John uses this word himself. The precedent, he explains, is “the recent … presentations of cognitive function data from trial 15 (one of the buried trials)”.

In trial 15, commissioned by AstraZeneca, patients with schizophrenia who were in remission were randomly assigned to receive either AstraZeneca’s quetiapine, or a cheap, old-fashioned drug called haloperidol. After a year, the patients on Seroquel were doing worse: they had more relapses and worse ratings on various symptom scales. These negative findings were left unpublished: to use Tumas’s word, they were “buried”.

But in among all these important negative findings, on a few measures of “cognitive functioning” – an attention task, a verbal memory test – Seroquel did better. This finding alone was published in a research paper in 2002. AstraZeneca kept quiet about the fact that patients on Seroquel had worse outcomes for schizophrenia. The research paper went on to become a highly influential piece of work, cited by more than 100 academic research papers. Many researchers can only dream of publishing such a well cited piece of work.

Trial 15 also found that patients on Seroquel gained, on average, 5kg in weight over a year. This put them at increased risk of diabetes, which is what AstraZeneca is now paying to settle on (and in any case, a 5kg weight gain is a serious side-effect in itself).

Psychiatric drugs can do more good than harm overall, but many have serious, common side-effects. It is especially important that doctors and patients know all the risks, so that sensible and informed trade-offs can be made.

Here is the opening of another email in that quetiapine case. Richard Lawrence writes in an internal memo to colleagues: “Lisa has done a great smoke and mirrors job” on trial 15.

The pharmaceutical industry’s behaviour has collapsed into farce. Doctors and academics – who should feel optimism at working with the drug companies to develop new treatments – feel nausea instead, knowing that there are only informal systems to deal with buried data, and these have clearly failed.

In 2005 the International Committee of Medical Journal Editors put its foot down and said its journals would only publish trials that were fully registered before they started, which should make any that went missing much easier to spot. Several years later, as recorded in this column, fewer than half of all the trials that the editors published had been adequately registered, and more than a quarter were not registered at all.

After the New York attorney general sued GlaxoSmithKline over its “illegal and deceptive” reporting of the risks of its anti-depressant paroxetine (tradename Seroxat), GSK agreed to publish all trial data on a website. But, several years later, we saw last month that GSK and the Food and Drug Administration had sat on data showing that rosiglitazone (tradename Avandia) increased the risk of heart problems.

I can’t see why any company withholding data should be allowed to conduct further experiments on people. I can’t see why the state doesn’t impose crippling fines. I hope it’s because politicians don’t understand the scale of the harm.

Astounding Article : Is Big Pharma Abandoning Psychiatry?

The following article is astounding and insightful on so many levels. It not only raises the issue of questionable ‘science‘ that surrounds psychiatric diagnoses but is also examines the ‘profitability‘ agenda by drug companies who have been exploiting the ‘mentally’ ill for such a long time now. We were told for years that the SSRI class of drugs were an improvement on previous classes of anti-depressants, and it was the same with anti-psychotics; we know now that this was far from the reality. It seems that creating psychiatric drugs for psychiatrists to test on patients are no longer as viable for pharmaceutical companies to invest in. Surely this is ironic? For decades, pharmaceutical companies and psychiatry have been selling us the idea that these drugs are vital for the treatment of ‘mental illness‘- depression/anxiety etc. So why the U-turn now? Could it be because of the backlash against these drugs? Could it be because these drugs were really of no benefit in the first place? Could it be perhaps because of the amount of litigation pharmaceutical companies have been dealing with over the past 10 years over psychiatric drug side effects? Or is the answer more complex and a combination of all these factors? Has the biological psychiatry gravy train finally burned out? From Mind Hacks Website -This article is essential reading:

http://mindhacksblog.wordpress.com/2010/08/03/is-big-pharma-abandoning-psychiatry/

Is Big Pharma abandoning psychiatry?

This week’s Science has a thought-provoking article charting how several of the world’s biggest pharmaceutical companies have canned their development of psychiatric drugs, citing the medications as unlikely to be profitable given the difficulties in understanding the neurobiology of mental illness.

On 4 February, GlaxoSmithKline (GSK) announced that it planned to pull the plug on drug discovery in some areas of neuroscience, including pain and depression. A few weeks later, news came that AstraZeneca was closing research facilities in the United States and Europe and ceasing drug-discovery work in schizophrenia, bipolar disorder, depression, and anxiety.

These cutbacks by two of the top players in drug development for disorders of the central nervous system have raised concerns that the pharmaceutical industry is pulling out, or at least pulling back, in this area. In direct response to the cuts at GSK and AstraZeneca, the Institute of Medicine Forum on Neuroscience and Nervous System Disorders organized a meeting in late June that brought together leaders from government, academia, and private foundations to take stock.

But the biggest problem, researchers say, is that there is almost nothing in the pipeline that gives any hope for a transformation in the treatment of mental illness. That’s worrying, they say, because the need for better treatments for neurological and psychiatric disorders is vast. Hundreds of millions of people are afflicted worldwide. Yet for some common disorders, like Alzheimer’s disease, no truly effective treatments exist; for others, like depression, the existing drugs have limited efficacy and substantial side effects.

Sadly, the full article is locked behind a paywall (news kills people) but the author, science journalist Greg Miller, discusses the topic in the freely available Science podcast which covers the same ground.

One theme to consistently emerge is how, for years, Big Pharma has been chasing easy profits by making slightly tweaked versions of existing drugs rather than investing in research aimed at developing genuinely new treatments.

It seems this short-term-ism is starting to run out of steam

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Pod Cast : http://www.sciencemag.org/cgi/content/full/329/5991/576-b

http://www.sciencemag.org/cgi/content/summary/329/5991/502