“A Small Class of Suicidal Children…. “


“A small class of suicidal children” , were the words of GSK Seroxat spokesman- Dr Alastair Benbow -when confronted by BBC reporter -Shelley Jofre- on damning evidence  broadcasted by the BBC about Seroxat killing children.

It is difficult to comprehend how this drug is still on the market. It is even more difficult to comprehend how GSK have gotten away with all this. Not one criminal charge has been brought against them in the UK. GSK made billions off Seroxat (Paxil in the US) -but in the pursuit of profit, lives were put at risk and lives were lost.

Shocking.

This article is from 2006 but it is still as relevant today as it was then. It’s from the BBC. 

http://news.bbc.co.uk/2/hi/programmes/panorama/4771287.stm

Seroxat makes adults suicidal too
Panorama reporter Shelley Jofre

By Panorama reporter Shelley Jofre It is four years since Panorama started investigating Britain’s best-selling anti-depressant, Seroxat which is also known as paroxetine. GlaxoSmithKline (GSK) makes the drug and has finally been forced to admit that the medication can make adults, as well as children, suicidal. Panorama first broadcast claims that Seroxat could provoke self-harm, aggression and suicide in October 2002 in Secrets of Seroxat.

That programme prompted an official inquiry into the drug and a flood of responses from our viewers, many of whom said they had experience similar problems while on Seroxat. Their evidence formed the basis for our second programme Seroxat: Emails from the Edge.

A Seroxat pill

Panorama was first to reveal evidence that GSK’s own trials of Seroxat on children showed the drug was making some suicidal. Afterwards, the Medicines and Healthcare Regulatory Agency (MHRA), banned the drug’s use in under-18s. This latest twist in the story comes as a result of a re-analysis of GSK’s clinical trial data, ordered by the US medicines regulator, the Food and Drug Administration (FDA). Here in Britain, the MHRA has until now steadfastly refused to admit that Seroxat can cause suicidal behaviour in adults. Speaking about the third of our investigations into the subject, Taken on Trust (October 2004), the chairman of the MHRA Alasdair Breckenridge told us: “In the adult population the drugs are effective. There are over 300 studies which have been analysed and studies using epidemiological databases the drugs do not cause suicide, they do not cause suicidal thought.” Now that GSK acknowledges its own data shows the drug can cause suicidal behaviour in adults, it has led to criticism that the MHRA has failed to listen to patients’ complaints and to protect public health. Professor David Healy, who first raised his concerns about Seroxat with the regulator seven years ago, said: “I think in due course we may look at all of this and think this was one of the biggest medical scandals ever. “The risk of suicidal behaviour in placebo controlled trials in all adults was over six fold higher on Seroxat than on placebo.

Generic drugs

“This completely contradicts the information GSK gave to the MHRA within the last three years. “GSK now say they have spotted the risk thanks to the help of outside experts. The MHRA had outside experts also. “One of the things that has changed is that until very recently GSK and the MHRA were agreed that there were three placebo suicides in the Seroxat placebo controlled trials. There weren’t. This was a fiction. None of the experts bothered to check out the implausibility of these suicides. Neither did the MHRA. “There is nothing about this story that could reassure anyone about pharmaceutical companies or the regulator.An estimated 300,000 people in Britain were prescribed Seroxat last year. It is GSK’s biggest-selling drug, earning the company billions of pounds since its launch in 1991.

Blog Word Searches November 2012


Sometimes I like to post about the blog search  key words which people use in search engines to stumble upon my blog- it’s a little bit nerdy I know… but I am a bit of a nerd so anyhow…

I find it interesting, and often rewarding, when I see some search key words which indicate to me that the information about Seroxat is being found by those suffering in a Seroxat haze… I hope that the information that I have provided is, at the least informative, and at best maybe validating..

As you can see, there are a lot of people out there still suffering the effects of Seroxat… I hope they can get through it.

Nobody should have had to suffer the effects of Seroxat…

It is poison.

 

Some Key Word Searches Nov 2012

never been the same after seroxat
holding down a job on seroxat but falling apart emotionally
seroxat gave me psychiatric problems i didn’t have
is seroxat bad for you
psychiatry
gsk
is seroxat still prescribed

 

seroxat+paranoia
seroxat 20 mg and anger
dangers of long seroxat term
paroxetine causes suicide
seroxat+rage
can seroxat cause me to have a fit
gsk trial in indian that kill 500
fda drug paxil homicidal and suicidal
corporate culture of gsk
ssri drug murder
how many people did avandia kill?

 

how to withdraw from paroxetine
long term effects of seroxat

 

 

paxil
sir andrew witty
the horror of seroxat
glaxosmithkline ethical issues
emotional blunting
do ssris cause brain damage
seroxat adrian keegan
paroxetine scandal
how long seroxat withdrawal
long term effects of ssri use
seroxat is poison
database on seroxat deaths
andrew witty different era for the company
documentary: paxil
british seroxat addicts

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

GSK, Andrew Witty, David Healy And The ‘Transparency’ Principle


GlaxoSmithKline CEO- Andrew Witty- is undoubtedly a clever man- you don’t rise to the top of one of the richest (and incidentally one of the most corrupt) corporations in the world without being clever. But cleverness is not wisdom, nor is it necessarily a sign of deep insight or understanding. It can be- however- a combination of astuteness, shrewdness, cunning and deviousness. The most successful confidence tricksters are usually very clever- they know how to seduce, they know how to charm- they know the game, and they know how to play it… they use their skills to swindle, con and cheat- they are very clever, but they are not wise. Wisdom is an entirely different animal- it has a particular value, but just as important- it also has a ‘resonance‘. Compared to mere cleverness, wisdom is what we should trust.

David Healy is not just clever, he is extraordinarily wise and he is also extremely intelligent. He has exceptional insight and he is an excellent academic and writer. He has acute awareness, understanding and comprehension, he sees the big picture, and along with his finely tuned intuition, he possesses quite a brilliant skill – he has a ‘bullshit detector’.

Andrew Witty has been a GSK corporate minion for most of his working life, he’s an expert at generating spin, propaganda and PR. David Healy is an expert at exposing devious agendas, lies and deceit.

Clever men are never a match for wise men.

Andrew Witty’s sole purpose in life is to generate profits for GSK. David Healy, on the other hand, is a patient advocate- and he has long been a critic of GSK’s ethics- in particular because of its concealment of data in relation to the suicide-drug Seroxat.

Who would you trust? The drugs sales man who presides over a company with a long history of corporate crime? or the ethical doctor who has spent his entire career speaking out for patients harmed by dangerous drugs? 

Over on Dr Healy’s blog- Healy has opened up a fascinating debate about data-transparency. Being the wise man that he is- Healy suspects that GSK’s latest claim of transparency is little more than a smokescreen for a wider agenda.

Healy has set up his own website, and he aims to collect real-world data on the side effects of pharmaceutical drugs.

It’s called RxISK and here is the link : 

https://www.rxisk.org/Default.aspx

David Healy’s website can be found here :

http://davidhealy.org/

Access to RxISK data: conflicts of interest

November 26, 2012 5 Comments

Won’t get fooled again outlined a stunning propaganda coup by GSK. On the back of a campaign for open access to clinical trial data that has drawn its inspiration from efforts by the Cochrane Tamiflu reviewers to get access to Roche’s clinical trial data, Andrew Witty came out and proclaimed that GSK were all in favor of access to clinical trial data. The BMJ threw its hat in the air and said whoopee.

In fact GSK had only issued a press release. They don’t have a policy. They have at best an aspiration or perhaps more ominously a strategy. Getting such great publicity out of a press release shows considerable tactical skills at the very least.

The GSK press release came a week before a key European Medicines’ Agency meeting on access to clinical trial data. It was aimed at shutting an open door – EMA have granted access, industry want to close it down. Industry representatives at the EMA Access to Data meeting on November 22nd sang from the same song sheet as GSK – of course we are in favor of access and transparency but we have to respect patient privacy and we have to have good governance. Access should be restricted to serious scientists. (These are red herrings – see the next post Access to data: privacy issues).

RxISK has data that GSK should want 

At the end of Won’t get fooled again, I said the post had been written against the background of a serious undeclared conflict of interest. Since then, coincidentally probably, I’ve been critiqued by Arthur Schafer on Biojest for an overly casual approach to conflict of interest. This makes it of even greater importance to spell out the conflict (see Medical Partisans).

Here it is. We on Rxisk.org have data GSK should want, should need. We have raised the issue of accessing the data with them. They don’t seem to want access. They do not seem keen to have the issue raised. Interests seem to be conflicting.

data on hazards – the key to good medical care

So let’s back up a minute. The campaign for access to clinical trial data is about getting a proper picture of the effects of a drug, both the possible therapeutic effects and the hazards. Restricting access is in fact more about restricting access to information about the hazards than about the relative inefficacy of treatment.

Clinical trials are not the correct way to establish the hazards of a drug – the diseases in which they are conducted commonly mask the hazards of treatment (The Spin that no Data can OvercomeCri de CoeurOnce is NeverThe Unbearable Lightness of Being.)

The best approach to hazards is to do what RxISK is trying to do. That is harness the real world experience of people taking a medication to get best quality descriptions of events as well as applying standard approaches to causality such as checking for dose response, challenge-dechallenge-rechallenge and other related methods. The best way to determine risk-benefit ratios is to ask doctors and patients what they think of the possible trade-offs between the effects of a drug – as RxISK asks but clinical trials don’t. We get both doctors and patients to look at the wider impact of an event in a person’s life in addition to reporting on just the event.

There is an industry out there almost it seems aimed at ensuring that we get the most degraded possible descriptions of events with no accompanying details (American Woman,American Woman 2). An industry that has succeeded in building a culture in which even good descriptions of the effects of drugs are dismissed as anecdotes – except of course for patients reporting stunning benefits on treatment. Those who unwittingly repeat the mantra of RCTs offering gold standard evidence on the effects of drugs play straight into industry’s hand in this regard. Words come before numbers – without the right words, the numbers are meaningless.

Andrew Witty eavesdropping on the train

The second consideration is this. If Andrew Witty was to take a train tomorrow and I was sitting in the seat behind him and he overheard me mention a side effect I was having on one of GSK’s drugs he is legally bound to report this to the regulator. Here is Leigh Thompson then the Chief Scientific Officer of Eli Lilly being deposed by Paul Smith on this issue in 1994 for the Fentress trial in Louisville Kentucky after Joseph Wesbecker, shortly after going on Prozac, had shot dead 8 of his co-workers and seriously injured 12 more before killing himself.

Q. The other day you said something that I have a
question about. You said something about….
employees calling adverse event reports in?
A. I can’t recall that. The
rules under the DEN system that I put in place, I
think it was ’83 or maybe ’84 — no, it was ’83 we
began it, was that any Lilly employee anywhere in
the world that learns of any adverse event through
any source, and I’ve done it from cocktail parties
and overhearing conversations, should in fact
report by telecommunications to DEN within
twenty-four or seventy-two hours, depending on
where they are in the world. So, yes, we got a
lot of adverse events, including ones I report
because I’ve literally called up DEN and said, you
know, that I overheard a conversation in the
hallway just now that somebody’s wife was taking
Ceclor and had an allergic reaction.
Q. Do you usually stop and
ask for more information about that adverse event
or do you just report what you overheard in a
conversation in the hallway?
A. Depending on who the
individual is, but, for example, you remember you
showed me the document about that meeting of the
expert opinion leaders that I had gone to
wherever it was, I had another Lilly employee come
to that meeting and follow me around so that that
person could in fact report all the adverse events
that I was hearing, so that I wouldn’t have to do
it myself.
A. I think it
fulfills a regulatory requirement.. if you
right now told me that you had heard of a patient
who had taken one of our drugs and who had their
hair turn blue, I will guarantee you that I would
call DEN up within two days and that would be in
the DEN database. And I may or may not ask you
for more information, but I would identify you.
Q. What if their hair turned loose?
A. You’re the lawyer, but if
you read the law and the regulations, I think
that’s exactly what it requires. The NDA, for
example, requires all information…
Q. So let me make sure I
understand. You feel it is your absolute duty to
report a conversation that you have overheard in
the hallway, but you don’t necessarily feel it’s
your duty to report an issue raised by another
regulatory agency and the analyses that were done
by the drug company in response to that issue
being raised?
A. Under the FDA laws and
regulations, I think you’ve stated it correctly.

Writing to GSK about access to data

Against this background it seemed appropriate to alert Andrew Witty last March to the fact that we expected RxISK to start generating data on GSK’s and other drugs – mentioning that despite everything many still considered GSK to be among the more responsible pharmaceutical companies. GSK’s response was to misattribute the remark that they were a responsible company to me and to thank me for this recognition, but to turn down a possible collaboration while in a follow up letter stating their full commitment to their regulatory obligations.

The growing Data Set

It is now November and RxISK.org has been up and functioning for two months. It is getting on average 10 treatment effects reported per day directly from the public. In two months it has had more patients report effects to it than the Irish Medicine’s Board has had since opening up for patient adverse event reporting in 2009. RxISK has had more treatment effects reported to it by Germans than Germany has ever had – reporting by the public is still not facilitated in Germany. Within a year we expect to have more treatment effect reports from the public than anyone except FDA.

RxISK & free appetizers?

FDA have 4.1 million adverse event reports from around the world collected since 2004. A number of companies have set up businesses, selling these reports to doctors, patients or anyone else for $200 for basic information on a drug and a possible problem linked to it – we make this information available for free to anyone who accesses RxISK.

We are on our way to having a substantial amount of RxISK data. We will make the key components of this available for free from the get-go. We are particularly keen not just to give people the number of reports of Leigh Thompson’s side effect – Hair turning blue on Prozac – but want to make the data local in the belief that if people in Baltimore, Brisbane, Birmingham or Bordeaux find its happening there and not in Calgary, Cologne, Chicago or Chenai, they may be able to bring local knowledge to bear on the issue and help work out what is going on.

We also want to bring the stories to life so that people can identify their own stories with those of others. These collected stories can help us all understanding the real story about these drugs. We think everyone can play a part in understanding and interpreting the stories – that access should not be restricted to just a few people who want to “guide” the narrative.

Leigh Thompson is now dead. But from his testimony above it seems like he would probably have been delighted to know we have a Hair Zone opening up soon, to complement the Violence and Suicide Zones already on RxISK, and the Skin and Sex and Relationships Zones still to come.

But then again maybe not. There are endless ways to adhere to the letter of a regulation but not its spirit. This is why you hire lawyers. Or perhaps GSK thought we were at the press release before the policy stage. Or perhaps they don’t have a policy on access to data yet.

how does RxISK move forward?

The issues for anyone reading this blog from Arthur Schafer to Andrew Witty, to Aetna Insurance, to lawyers like Andy Vickery, to Anne-Marie and all the people who have reported on RxISK stories and our still anonymous American Woman are:

  • what interests conflict,
  • where exactly do the conflicts arise, and
  • what should RxISK be doing with its data?

We welcome your ideas and will respond.

http://davidhealy.org/access-to-data-conflicts-of-interest/

Joanna Moncrieff asks : Is Psychiatry For Sale?


Joanna Moncrieff is a well respected psychiatrist who asks the hard questions that most mainstream psychiatrists are  not just afraid to approach, but also, in some cases-  refuse to even address. Denial does not an argument make, and unlike some psychiatrists who think that denial is enough to counter differing opinions, criticism and dissent-  Joanna makes an excellent argument- she also writes really well. This is a long academic paper, but it’s well worth reading.  Thankfully we have psychiatrists like David Healy and Joanna Moncrieff who put the patient first- they just might be the saving grace of the psychiatric profession. 

 http://www.critpsynet.freeuk.com/pharmaceuticalindustry.htm

 

IS PSYCHIATRY FOR SALE?

AN EXAMININATION OF THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY ON ACADEMIC AND PRACTICAL PSYCHIATRY.

BY

JOANNA MONCRIEFF

Published June 2003

This was prepared as a MAUDSLEY DISCUSSION PAPER and is available for £4 as a booklet from the Sarah Smith at the Institute of Psychiatry, de Crespigny Park, London SE5 8AF, tel 0207836 5454, e mail sarah.smith@iop.kcl.ac.uk

SUMMARY

Western society is consuming ever larger quantities of prescription drugs and many of these are for psychiatric complaints. Drugs are central to modern psychiatric practice and to much psychiatric thought about the nature and causation of mental disorders. Psychiatry has therefore become an important target for the large and powerful pharmaceutical industry. Drug companies direct lavish advertising and hospitality towards psychiatrists and provide funding for much medical education and some mental health service initiatives. The industry is now heavily involved in the organisation of research into psychiatric drugs and the dissemination of research findings. This raises questions about the scientific objectivity of this research and the extent to which the industry is able to shape the research agenda. Drug companies also provide funds for pro drug patient and carer groups and address advertising or disease promotion campaigns to the general public. They exert influence at a political level through lobbying and direct funding of political bodies including drug regulatory agencies.

This influence has helped to create and reinforce a narrow biological approach to the explanation and treatment of mental disorders and has led to the exclusion of alternative explanatory paradigms. The coercive function of psychiatry has been strengthened by promoting the idea that psychiatric disorders are akin to medical conditions and that they are amenable to technical solutions in the form of drugs. In addition, alternative treatment approaches are neglected and it is likely that drugs are currently used for overly long periods and in excessive doses. The adverse effects of drugs are neglected.

Psychiatry provides fertile ground for pharmaceutical industry profits because it provides opportunities for expanding definitions of sickness to include more and more areas of social and personal difficulty. This paper gives examples of how the industry has been involved in promoting and expanding concepts such as depression, social phobia, attention deficit hyperactivity disorder and psychosis.

The current extent of drug company influence threatens the integrity of psychiatry and some suggestions are made about steps that could be taken to address this. The influence of the industry must be curbed for political reasons too. We are rapidly becoming a society that seeks a “pill for every ill;” one that looks for simplistic, technical solutions to complex social problems. This helps to divert attention away from the profound social and political changes that have occurred during the last few decades. Psychiatrists should not be colluding in this process.

BACKGROUND

The place of drug treatment in modern psychiatry

Drugs are the central focus of treatment in modern day psychiatry. The vast majority of psychiatric inpatients are prescribed at least one psychoactive drug and many are on several. The same is true for only a slightly smaller proportion of psychiatric outpatients and many more people are prescribed psychoactive drugs, especially antidepressants and benzodiazepines, in General Practice. Furthermore, most patients who are prescribed psychiatric drugs are told to take them for a period of months, and many are told that they will need to take them for many years or even for life. Psychiatric textbooks devote large sections to drug treatment and related aetiological theories and psychiatric journals are filled with results of drug trials and related brain research.

Almost all drugs in current use have been introduced into psychiatry since the 1950s. Although drug treatment was common before that time, with extensive use of barbiturates and other sedatives and some use of stimulants, it was rarely given much attention. This was because drugs were generally regarded as having only crude effects, usually acting as chemical forms of restraint (Braslow, 1997). However, from the 1950s, drug treatment came to be seen as important and glamorous. The drugs that were introduced from that time onwards came to be regarded as specific treatments for specific conditions and became the basis for speculations about the aetiology of mental illness (Moncrieff, 1999). A vast research into possible abnormalities in transmitter and receptor systems was spawned, epitomised by the dopamine theory of schizophrenia and the monoamine theory of depression.

The pharmaceutical industry undoubtedly played an important part in establishing drug treatment as central to psychiatry. It was involved from the beginning of the “psychopharmacological” era, for example with the huge marketing campaign that helped to introduce chlorpromazine (Thorazine) into America in the mid 1950s (Swazey, 1974). The industry has been described as the “ultimate force behind the adoption of new drugs such as chlorpromazine” and credited with transforming psychiatry into a genuine and modern medical specialism (Shorter, 1997).

Recent developments

Over the last ten to fifteen years psychiatric drugs have become much more widely prescribed and increasingly familiar to the general public. Drugs such as Prozac and Ritalin have become household names and books about them have become best sellers (Kramer, 1993). This is part of a more general increase in consumption of all types of medicines, indicated by the fact that prescriptions issued increased by 56% between 1988 and 2001 in the United Kingdom. The average the number of annual prescriptions per head of population increased from 8 to 12 in the same period. However, increases in the use of psychotropic drugs have contributed disproportionately to this increase, with prescriptions of antidepressants rising by 173% in the ten years between 1991 and 2001 (Department of Health, 2002). The rise in cost has been even more marked since the majority of the increases in prescribing have been for expensive new classes of psychiatric drugs such as the Selective Serotonin Re-uptake Inhibitor (SSRI) antidepressants and the “atypical” antipsychotics. In the United States antidepressants are now the top selling class of prescription drug, with antipsychotics, anti-anxiety agents and stimulants all also ranking highly and/or showing rapidly increasing sales (National Institute of Health Care Management, 2002).

This increase in use of prescribed drugs has been achieved firstly by extending the boundaries of well recognised conditions like depression and psychosis. Secondly, lesser known disorders such as panic disorder and social phobia have been publicised, and thirdly, drug treatment has started to colonise areas where it was previously thought to be unhelpful such as substance misuse and personality disorder.

INFLUENCE OF THE PHARMACEUTICAL INDUSTRY

Over the 20th century pharmaceutical companies transformed themselves from small enterprises, often the offshoot of chemical companies, into some of the largest commercial concerns in the world. By the beginning of the 21st century they were making greater levels of profit than their counterparts in other commercial sectors (see Figure 1). In 2001, US pharmaceutical company profits averaged 18.5% of revenue compared with 2.2% for the rest of the Fortune 500 companies (Fortune magazine, April, 2002).

The Pharmaceutical industry exerts its influence at many different levels:

  • The Medical Profession

The medical profession is the industry’s primary target. Routine marketing strategies include the provision of “hospitality” which can vary from the provision of lunchtime refreshments for local meetings to the financing of meals in expensive restaurants or the provision of expenses paid trips to attractive foreign locations for company presentations. When psychiatrists refuse to see company representatives, they may persuade other members of the mental health team to accept hospitality. The provision of small gifts to doctors such as mugs, pens, books and diaries is also endemic. Drug company logos adorn many psychiatrists’ offices and are encountered throughout psychiatric hospitals and wards.

Many medical educational events such as conferences now receive substantial income from commercial sources. In a recent article, respected American psychiatrist E. Fuller Torrey described the extravagant promotional methods employed at the 7th World Congress of Biological Psychiatry held in Berlin in 2001. Several drug companies constructed elaborate installations to attract delegates’ attention. These included an artificial garden (Janssen-Cilag), a running stream (Lundbeck), a 40-foot rotating tower (Novartis) and a tent with costumed women offering fortune telling (Organon) (Torrey, 2002). The drug companies had also sponsored more than half of the conference delegates, paying for airfares, accommodation and entertainments and paid fees of between $2000 and $5000 to the speakers at the numerous industry sponsored symposia. In all, the conference was said to have cost the industry at least 10 million dollars (Torrey, 2002). This is not so extraordinary. The American Psychiatric Association and UK Royal College of Psychiatrists annual conferences have also come to resemble trade fairs due to the prominence of drug company stands.

It has been repeatedly shown that doctors prescribing practices are influenced by interaction with industry representatives and attendance at drug company sponsored events (Wazana, 2000). The fact that the industry invested $15.7 billion in marketing in 2000, and that in the United States there is about one drug rep per 15 doctors, also indicates the importance the industry attaches to its marketing activities (Shaunessy & Slawson, 1996, BMJ).

  • Medical research

Organisation of research

In the 1960s large clinical trials were funded by state funds through the NIMH in the United States and the MRC in the UK. At that time there was a belief that the commercial sector should play only a limited role (Healy, 2002). However, the industry now underwrites 70% of research into drug treatments (Bodenheimer, 2000). In addition most drug trials in United States are now conducted by commercial research organisations, called Contract Research Organisations. These organisations have emerged recently and hire out their services to drug companies. Thomas Bodenheimer describes a situation in which hundreds of commercial research organisations as well as academic medical centres and other independent non academic sites compete with each other for contracts to do industry funded research (Bodenheimer, 2000). Obviously if the studies do not achieve the desired results, the organisation may jeopardise future contracts. In addition, payment is usually awarded according to how many patients are entered into the trial, creating the incentive to stretch and expand diagnostic concepts. Evidence suggests that commercial research organisations conduct research more rapidly and more cheaply than academic medical centres (Commonwealth Fund, 1999). Bodenhemier (2000) concluded that “trials conducted in the commercial sector are heavily tipped towards industry interests.”

Contract Research Organisations have argued that they are heavily regulated and have to follow internationally agreed Good Clinical Practice guidelines on the ethical and safe conduct of research (Beach, 2001). However, a few years ago, figures revealed by one audit company suggested that compliance with guidelines was frequently inadequate (Boyhachuk & Ball, 1999). Since audit results are not routinely published it is impossible to know whether this situation has improved or not. A recent audit of 17 Contract Research Organisations in Germany suggested quality was generally high but 31 cases of significant deviations from Good Clinical Practice guidelines were still found (Chase et al, 2001). In any case it may be difficult to detect the subtle influences that commercial pressures have upon the research process.

The case of Borison and Diamond, who were psychiatrists who set up a Contract Research Organisation in the United States, revealed the huge profits that can be made in this business. They were convicted of defrauding the University where they were employed. The investigation revealed not only their huge personal wealth, but also that large bonuses were paid to staff who enrolled the most patients and that patients were also offered cash inducements. Although Borison and Diamond were not indicted for research fraud, revelations about the operation of their business sheds a worrying light on the conduct of trials in the current highly competitive climate. Borison was, incidentally, principal investigator in two of the pivotal trials that led to approval of the atypical antipsychotic risperidone in the United States (see Whitaker, 2002, chap 11).

At an individual level, links between academic doctors and the industry are proliferating and include payment for speaking at conferences, consultancy fees, payment for sitting on advisory boards or boards of directors, and holding equity in a company (Boyd & Bero, 2000). A study of published papers found that 34% of primary authors had substantial financial interests in the work they published (Wadman, 1997). In psychiatry the situation may be even worse. In 2000, the New England Journal of Medicine did not have space to print all the financial interests of the authors of a paper on the antidepressant nefazadone and had great difficulty in identifying an academic psychiatrist to write an editorial on the subject who did not have financial ties with companies that make antidepressants (Angell, 2000).

It was also shown recently that 87% of authors of clinical practice guidelines had some interaction with the pharmaceutical industry, and 38% had served as consultants or employees of companies. Despite this, only 4.5% of guidelines contained any declaration of the personal financial interests of authors (Choudhry et al, 2002). This is a cause of concern since guidelines usually command professional respect and have a strong impact on practice.

Research findings

Research findings can be effected both by the way a study is designed and by the way results are presented. The fact that drug firms now control most of the process of most clinical trials from design and implementation through to data analysis and publication is therefore a cause of concern for some commentators and researchers (Bodenheimer, 2000; Healy & Cattell, in press; Bero & Rennie, 1996).

The design of studies is a particular issue in psychiatry where disorders are highly variable and in most cases wax and wane, meaning it is easy to be deceived about the benefits of intervention. The history of psychiatry is full of treatments that were thought to be effective scientific treatments but turned out to be useless, not to mention harmful (for example see Whitaker, 2002, chapter 4, on the history of Insulin Coma Therapy). Although there is a consensus that psychiatric drugs including antidepressants, antipsychotics and mood stabilisers are effective and useful, problems with the design of studies means that questions remain about the reliability of some of the evidence base for this consensus. In antidepressant trials, problems such as the subjectivity of outcome measures and unblinding, have lead several authors to conclude that their efficacy is not firmly established (Antonnucio et al, 1999; Moncrieff , 2001). It has been suggested that the apparent benefits of atypical antipsychotics in relation to side effects were partly a result of comparison with high doses of standard drugs, which were popular at the time the atypicals were first introduced (Geddes et al, 2000). In addition, studies of long-term treatment have neglected the possibility that withdrawal related problems in people who stop drugs may inflate the apparent benefits of drugs such as lithium (Suppes et al, 1991) and antipsychotics (Baldessarini & Viguera, 1995).

The results of studies can be presented in a number of ways to give an exaggerated view of a drugs benefits (Bero & Rennie, 1996). These include failure to publish negative results, the use of multiple outcome measures, and selective presentation of ones that are positive, multiple publication of positive study results, and the exclusion of subjects from the analysis. For example, one review of psychotropic drug trials reported that hundreds of significance tests were conducted and that 50% of trials excluded subjects from the analysis (Hemminki, 1981).

These problems are not confined to studies conducted by the pharmaceutical industry, but it seems likely that commercial pressures may increase the risk of methodological biases and misleading reporting. In Bodenheimer’s investigation 6 out of the 12 clinical investigators he interviewed reported cases in which publication of papers had been blocked, or the content of papers altered by a drug firm (Bodenheimer, 2000). Peter Breggin’s analysis of FDA files claimed that several negative studies of fluoxetine (Prozac) were not published and that some published trials did not report negative outcomes (Breggin & Breggin, 1995). A recent review of company sponsored comparative drug trials for psychiatric disorders describes how various design and reporting modifications were apparent that appeared to serve the company’s marketing objectives (Safer, 2002). The author describes instances of the use of inappropriate doses of comparator drugs, use of questionable definitions of outcome, the selection of major findings and end-points post hoc, the masking of unfavorable side effects, duplicate publication, emphasising favorable but not statistically significant differences, withholding unfavourable results and masking sponsorship.

Indirect evidence that drug company sponsorship effects trial quality is the finding that studies sponsored by drug companies are more likely to find evidence in favour of the sponsor’s product than studies that do not have commercial sponsorship. Research conducted in the 1980s found that 43% of trials that favoured a new therapy were sponsored compared with 13% that favoured the standard therapy or placebo (Davidson, 1986). A recent study found that authors’ conclusions were more likely to be favourable towards an intervention where the study was fully funded by a for-profit organisation than where funding came from other sources (Kjaergard & Als-Nielson, 2002). Drug company sponsorship was associated with greater apparent benefit from the company’s drug in trials of clozapine (Wahlbeck et al, 2000) and antidepressants (Freemantle et al, 2000).

The research agenda

The extent of drug company funding for research and the interactions between academic personnel and the industry mean that much research activity is oriented towards drug treatments and related areas.

In addition, marketing strategies now include attempts to shape psychiatric thought through the academic arena. This is done by a strategy that is conceived long before a product is officially marketed and may involve the promotion of disease concepts and their frequency. A recent guide to pharmaceutical marketing suggests the need to “create dissatisfaction in the market,” “establish a need,” and “create a desire”. A portfolio of articles which promote the disease concept in question and/or the company’s product is constructed for the medical audience. The articles will often be written by a medical writing or education agency and then academic authors will be approached to become authors, a practice known as “ghost writing.” Medical “opinion leaders” are also identified and cultivated as part of this strategy to act as “product champions” (Pharmaceutical Marketing, 2002).

Evidence suggests this practice is not uncommon, with one study finding that 11% of articles in 6 major peer reviewed journals involved the use of ghost writers (Flanagin, 1998). A recent study of articles on the therapeutics of the antidepressant sertraline found that over half were produced by a medical information company employed by Pfizer Pharmaceuticals. These articles had higher citation rates and a higher profile within the medical literature than articles written independently (Healy & Cattel, in press).

Advertising in major academic journals provides another mechanism for influencing the message that reaches the public domain. Drug advertisements are now a prominent feature of major British and American psychiatric journals. A typical issue of the American Journal of Psychiatry consisting of about 200 pages of scientific content has around 35 pages of drug advertisements and a further 18 pages of adverts for drug company sponsored “educational” meetings (see for example May 2002 and Jan 2002). Issues of the British Journal of Psychiatry in 2002 had between 5 and 16 pages of advertisements for around 100 pages of scientific content.

In the 1960s a United States Congress investigation revealed that editors of some journals were allowing drug companies that were contributing advertising revenue, to advise rejection or alteration of articles that were unflattering to their products (Frank Ayd interveiwed in Healy, 1996). Recent cases involve papers concerning the dangers of the sleeping tablet Halcion (Ian Oswald, interviewed in Healy, 2000) and a paper reporting adverse effects of SSRIs (reported in Valenstein, 1998, chap 6, P191-2). Although many editors are making substantial efforts to make potential influences on research more transparent by requiring “conflict of interest” declarations by authors, it remains a concern that journals that receive a substantial amount of revenue from drug company advertising may be endangering their impartiality.

3) The Public and Patient Groups

In the United States and New Zealand, drug companies are permitted to advertise their products directly to consumers. Figure 2 shows that in the year 2000 alone, 2.5 billion dollars was spent on advertising prescription drugs to consumers in the United States (Public Citizen, 2002). In 1999, it was estimated that the average American saw nine adverts for drugs every day (market research quoted in Mintzes, 2002). Non compliance with advertising standards and regulations is common. The Food and Drug Administration in the United States reported that 1 in 4 advertisements violated their regulations (Aitkin & Holt, 2000) and higher levels of non compliance have been reported from New Zealand (Medawar, 2001). The pharmaceutical industry has also been trying for some years now to introduce direct to consumer advertising into Europe (Medawar, 2001). In 2000, the then director of the Association of the British Pharmaceutical Industry described how “the ABPI battle plan is to employ ground troops in the form of patient support groups, sympathetic medical opinion and healthcare professionals….which will lead the debate on the informed patient issue. This will have the effect of weakening political, ideological and professional defences.” (Pharmaceutical Marketing, 2000). After lobbying by industry and industry funded patient groups, the European Commission proposed some limited reduction in restrictions on advertising to consumers. Although the European Parliament overwhelmingly rejected these proposals, they have not been shelved and are now being considered by the European Council of Ministers (Medawar, personal communication, May 15th 2003).

There is no doubt that direct to consumer advertising leads to increased prescription of drugs. A recent survey showed that one in five Americans was prompted to call or visit their doctor to discuss an advertised drug (British Medical Journal, BMJ, News, 19th October, 2002). Mintzes et al (2002) showed that exposure to advertising lead patients to request more drugs, and that these requests were usually complied with despite doctors reservations about the appropriateness of the treatment. Drug company promotion to the public includes disease awareness campaigns that can be run in countries that do not permit direct to consumer advertising as well as those that do. Patient groups are recruited to give the campaign a human face and supply stories for the media. In some cases high profile celebrities have been included to help the campaigns reach prime time television audiences (BMJ News, 1st June, 2002).

Relationships with patient groups is another channel of influence for the industry. In some instances patient groups appear to have been set up by drug companies. The American magazine, Mother Jones found that the Social Anxiety Disorder Coalition, the Post Traumatic Stress Disorder Alliance and the National Mental Health Awareness Campaign operated out of public relations firms hired by drug companies. They appeared to have been set up for the purposes of disease awareness campaigns (Mother Jones, 2002). Two international groups are also linked to the industry and have been active in lobbying the European Commission to introduce direct to consumer advertising. IAPO (International Alliance of Patients Organisations) was founded and is funded by Pharmaceutical Partners for Better Healthcare, a consortium of about 30 companies, and GAMIAN (Global Alliance for Mental Illness Advocacy) was originally founded by Bristol Myers Squibb. Neither discloses its current sources of funding (Herxheimer, draft).

As well as setting up new groups, the industry is increasingly acting in co-operation with existing groups of patients and carers. In the mental health field it gives funding to groups that promote biological views of mental illness and drug treatments, including the National Alliance for the Mentally Ill (NAMI) and the National Mental Health Association in the United States and SANE and the Depression Alliance in the UK. It often gives funding for these organisations to run specific campaigns aimed at increasing the number of people seeking treatment. An example is the current CHADD (Children and Adults with Attention Deficit Disorder) campaign to extend diagnosis and drug treatment into under-served communities (see below).

  • Political Institutions

John Abrahams (2002) has described the process whereby European and American drug regulatory agencies became more responsive to the needs of the pharmaceutical industry. This was achieved by increasing the reliance of these agencies on funding from the industry through license applications, and reducing state support. As a consequence there has been a strong emphasis on reducing drug approval times. In the UK these have shrunk from 154 to 44 days since the changes came into force when the Medicines Control Agency was formed in 1989.

The industry is also increasing its influence over central government policy in the United Kingdom through recently established government bodies such as the Pharmaceutical Industry Competitiveness Task Force, the Industry Strategy group and partnerships with health service bodies. The National Institute for Mental Health England (NIMHE) and the pharmaceutical industry, represented by the Association of the British Pharmaceutical Industry (ABPI), recently announced a formal partnership. The first production of this partnership is a compendium describing collaborative projects around the country entitled “Meeting of Minds.” These projects are diverse and include the publication of guidelines, audit packs, toolkits, websites, directories and funding additional personnel including a pharmacist and a primary care liaison worker (NIMHE & ABPI, 2002). Many of the projects undoubtedly contain valuable information and advice, but there must be a concern that projects such as the development of guidelines for the treatment of schizophrenia, and projects designed to improve recognition of depression in primary care might over-emphasise the role of certain drug treatments. However, the main concern about these projects, and the NIMHE statement that it “expects that partnership with the industry will become routine in the development and implementation of mental health policy,” is that incorporating the industry into the fabric of the health service in this way increases its influence enormously and may make it very difficult to identify and resist commercial pressures. There seems to be little acknowledgement that there might be conflicts of interest between the aims of industry and those of a public service.

In Scotland concerns have been raised about the level of financial interests of members of the newly established Scottish Medicines Consortium (Sunday Herald, 13thFebruary, 2003). This body was set up to try to advise the Scottish Executive on National Health Service drug expenditure. More than half the members were revealed to have personal or non-personal (research grants) financial interests in the pharmaceutical industry.

The industry also seeks direct influence at a parliamentary level by employing political lobbyists and contributing large sums of money to political parties and campaigns. In the United States, there are more pharmaceutical industry lobbyists than Congress members. The lobby budget for 1999 and 2000, at 197 million dollars, was 50 million dollars larger than the drug industry’s nearest rivals, the insurance and telecommunications industries. On top of this the industry makes generous contributions to election campaigns, mostly to Republican Party candidates (New York Times, 4th November, 2001).

ADVERSE EFFECTS ON PSYCHIATRY

So how does all this influence effect psychiatry and why should we be concerned about it? The alliance between psychiatry and the pharmaceutical industry has several important negative consequences. Firstly, it helps to reinforce a narrow biological conception of the nature of mental disorder. Secondly, it drives the expansion of this conception into more and more areas of everyday life. Thirdly, it is likely to play down the impact of the adverse effects of psychiatric drugs.

I THE PROMOTION OF BIOLOGICAL PSYCHIATRY

Explanatory paradigms in psychiatry

Psychiatry as an institution has long been obsessed with identifying biological causes of mental disorders and with the narrow technical solutions that flow from such a paradigm (Moncrieff & Crawford, 2001). The pharmaceutical industry has helped to reinforce this approach by the promotion of drug treatments, funding biological research and by promoting claims that psychiatric disorders are caused by simplistic biological notions such “chemical imbalances.” Although the Food and Drug Administration in the US prohibits such claims in advertisements that mention individual drugs, because they are not regarded as sufficiently established, they can be made in other promotional material. In 1995, the pharmaceutical industry provided funding for a campaign in the United States organised by the National Alliance for Research on Schizophrenia and Depression, entitled “Depression, a flaw in chemistry not character”. This was an offshoot organisation formed by the National Alliance for the Mentally Ill (NAMI), and two other patient advocacy groups from the US, which also receive other financial support from the pharmaceutical industry. Advertisements in the national press and leaflets distributed as part of this campaign asserted that depression had been shown to be due to “an insufficient level of the neurotransmitter serotonin ….in the frontal lobes of the brain” (reproduced in Valenstein, 1998, chap 6, P 178). The pharmaceutical industry has also taken up this theme in its own promotional material. Eli Lily asserted that “like arthritis or diabetes, depression is a physical illness” (reproduced in Valenstein, 1996, chap 6, P 181).

The hegemony of biological psychiatry that now exists stifles other approaches to understanding the complex behaviours that constitute psychiatric conditions. It elevates quantitative positivist research methods, borrowed from the natural sciences. This approach depends on the notion that psychiatric conditions can be conceptualised as discrete entities occurring in individuals, which can be defined independently of their social context. Other philosophical and sociological approaches that seek to understand the meaning of psychiatric disorders at both an individual and social level are relegated to the fringes of psychiatric academia. The biological hegemony has consequences at a social and political level too. By locating the problem as a disease within an individual brain, biological psychiatry diverts attention away from the social and political conditions that help to determine how psychiatric disorders occur and how they are identified and defined (Conrad, 1992).

Psychiatry and coercion

The alliance between psychiatry and the drug industry also helps to strengthen the more coercive aspects of psychiatry. The coercion enshrined in much Mental Health legislation is justified on the basis that psychiatric conditions are discrete medical entities that respond to specific treatments. The planned extension of coercion into the community in the new Mental Health Bill for England and Wales is based on the simplistic idea that if patients would only comply with their drug treatment all would be well. However, it is acknowledged that a substantial proportion of patients with psychosis, for example, fail to make even an initial response to drugs and many more relapse despite ongoing drug treatment (Crow et al, 1986; Gilbert et al, 1995; Adams et al, 2001). Despite this reality, the dominance of drug treatment helps to create the impression that psychiatric conditions are easily treatable. This helps to justify coercion on medical grounds thus avoiding the scrutiny that would be entailed in legislation that was more transparently concerned with social control. I have argued elsewhere that it is the medicalisation of psychiatric legislation that has facilitated the expansion of coercion that is represented by the measures proposed in the new Mental Health Bill (Moncrieff, in press).

Foucault described psychiatry as “a moral tactic… overlaid by the myths of positivism.” The modern psychiatrist wields an “authority he has borrowed from order, morality and the family” although from the 19th century onwards he “no longer quite knew what was the nature of the power he had inherited..” (Foucault, 1971, quotations P 274 to 276). This is what makes the marketing of psychiatric drugs into a force for social control and conformity. Personal or social problems are defined as diseases and the authority of psychiatry, backed by the financial muscle of the drug companies, is used to enforce this view. In the process we are encouraged to radically alter our view of ourselves and the world. We are encouraged to aspire to narrow norms of behaviour and taught that anything else is not only undesirable but unnatural or diseased. We are encouraged to think that changes should be effected not by ourselves on our environment, but by technology on ourselves.

Effects on psychiatric practice

Drugs so dominate psychiatric practice that it is not easy to develop alternative forms of treatment, even though some research suggests that patients with severe mental disorders may do well without them (Mosher, 1999; Lehtinen et al, 2000). In the UK, inpatient psychiatric units, in particular, have become more and more focused around drug treatment in recent years, with little else of therapeutic value on offer. One report found that 40% of inpatients had no social or recreational activities available to them and that occupational therapy and psychology services were very limited (Sainsbury Centre for Mental Health, 1998). Family therapy and Cognitive Behavioural Therapy have both been shown to be of value in the treatment of psychosis but they are rarely available in ordinary clinical practice in Britain.

Although there is increasing demand for counseling services and psychotherapy for the treatment of less severe mental disorders, this does not appear to represent a serious challenge to the medicalisation of such problems achieved by the widespread prescription of drugs. It appears to be rather another expression of an increasing demand for medical services that is encouraged by the marketing of drugs.

The pharmaceutical industry has supported the emphasis on long-term prescribing for psychiatric disorders and may also have encouraged the use of unnecessarily high doses of psychiatric drugs. Recent studies purporting to show the benefits of long-term treatment in a range of disorders including depression (Claxton et al, 2000), bulaemia (Romano et al, 2002) and obsessive compulsive disorder (Koran et al, 2002) were all supported by the pharmaceutical industry. Patients with chronic disorders often stabilise and many might benefit from attempts to reduce or stop medication (Gilbert et al, 1995). However, this can prove practically difficult in a culture that is so dependent on drug treatment. In a recent book, Jay S Cohen (2001) suggests that doses are tailored to make prescribing easier and inflate efficacy findings; he cites the fact that the recommended doses of one in five drugs is lowered years after the drugs are licensed. A review of the evidence on dose ranges for antipsychotics suggested that moderately low doses are preferable to the higher doses that are commonly used (Bollini et al, 1994).

II EXPANDING MENTAL DISORDERS

Psychiatric diagnoses are based on behaviours and mental experiences that are deemed to be abnormal or dysfunctional. They are notoriously difficult to define consistently and even the painstaking construction of standardised definitions, such as those first produced in the Diagnostic and Statistical Manual (DSM) version III, and subsequently revised in DSM IIIR and DSM IV, yield fairly poor reliability statistics (for a review of reliability studies see Kirk & Kutchins, 1999). Because there are no natural or physical boundaries to the definition of abnormality in relation to behaviour and mental experience, psychiatric disorders are particularly fluid and what counts as disorder is highly dependent on prevalent social norms and beliefs. Thus many commentators are concerned that the incorporation of more and more forms of ordinary difficulties, such as shyness and childhood behavioural problems under a psychiatric umbrella is an example of the encroaching and inappropriate medicalisation of everyday life (Moynihan et al, 2002; Double, 2002).

Examples of the expansion of psychiatric concepts include:

The promotion of Depression

The promotion of depression is not new to psychiatry. In the 1950s, Merck, the company that had just launched the antidepressant amitriptyline, bought up and distributed 50,000 copies of a book, entitled “Recognising the Depressed Patient” by psychiatrist Frank Ayd, which suggested that depression was much more common than usually thought (Healy, 1997a). Then, from the late 1980s with the introduction of a new generation of antidepressants called SSRIs, interest in depression increased dramatically. The pharmaceutical industry and the medical profession joined forces in campaigns such as the Defeat Depression Campaign in the United Kingdom, which set out to increase the numbers of patients diagnosed with depression and treated with antidepressants in General Practice. In order to achieve this, the campaign tried to convince General Practitioners of the high prevalence of the condition and combat the general public’s resistance to taking antidepressants. The campaign and associated literature claimed that depression affects 5% of the general population at any one time but also that up to a third of people might experience depression at some time in their lives (Paykell & Priest, 1992). It was also suggested that 20% of General Practice attenders might have some symptoms of depression and that around half of these might need treatment (Paykell & Priest, 1992).

It is difficult to demonstrate that the increased number of people taking antidepressants over the last decade has had any objective benefits. Long-term disability due to depressive disorders has been increasing over the same period (Moncrieff & Pommerleau, 2000). Although some authors, with extensive links to companies producing antidepressants, have claimed to show an association between increased use of antidepressants and lowered suicide rates (Hall et al, 2003), their own data has been shown to give the opposite results (Moncrieff, 2003). Others have noted that suicide rates have not fallen in line with increases in prescribing, and that rates of self harm have been increasing (van Praag, 2002). It has been suggested that the drug industry turned its attention to depression because of the disintegration of the market for benzodiazepines after the discovery of their addictive potential (Healy, 1999). Hence it seems that the escalating rates of use of antidepressants may have more to do with marketing imperatives than any benefits to mental health.

Recent interest in depressive disorders has focused on the extent of problems in the developing world and in children. A recent World Health Organisation (WHO) report suggests that 10% of women worldwide suffer from a depressive episode in every 12 month period (WHO, 2001). The American National Institute for Mental Health’s new mood strategy prioritises the detection and treatment of depression in children (Costello et al, 2002). These moves potentially pave the way for massive expansion of antidepressant markets in the developing world and among children in the developed world. There are indeed already indications of increasing use of antidepressants, as well as other drugs, among children, including the very young (Zito et al, 2000).

The “Creation” of Social phobia

In 1998, the pharmaceutical giant SmithKline French applied to the FDA in the United States for a license to market its antidepressant, Paxil (paroxetine) as a treatment for Social Anxiety Disorder, or social phobia. Although there is a description of these conditions in the DSM and the WHO diagnostic classification systems, they were not previously regarded as amenable to drug treatments nor considered to be a significant public health problem. The pharmaceutical companies involved would argue that they were trying to raise awareness of a then little known and little treated, but potentially debilitating, disorder. In contrast, it has been suggested that the SmithKlineFrench campaign was prompted by the need to find a wider market than the market for depression, which was then dominated by two other antidepressants, Prozac and Zoloft (Mother Jones, 2002).

An investigation by Mother Jones magazine relates how in early 1999 Cohn & Wolfe, a PR firm working for SmithKline, started a campaign to persuade people that social anxiety disorder was a serious and common disorder. Poster campaigns with slogans such as “Imagine being allergic to people” were conducted and video and radio news releases were created. Journalists were given a press pack stating that up to 13% of the population suffer from Social Anixety Disorder and that it is the third most common mental disorder after depression and alcoholism (Mother Jones, 2002). Cohn & Wolf also supplied journalists with eloquent patients and two Professors of psychiatry, both of whom worked as consultants to drug companies, including SmithKline, were featured on numerous television programmes. By May 1999, when the license for Paxil for Social Anxiety Disorder was approved by the FDA, there were hundreds of stories about the condition in the American media. A few months later, SmithKline launched advertisements promoting the use of Paxil for Social Anxiety Disorder, and by the end of the year it had become the United States second best selling SSRI with sales on a par with Prozac.

In Australia, Roche, makers of another new antidepressant moclobomide, launched a similar disease awareness campaign about social anxiety disorder, or social phobia. Moynihan et al (2002) have described how the promotion campaign seemed designed to “change the common perception of shyness from a personal difficulty to a psychiatric condition.” A senior Roche official recently admitted that company promotion had exaggerated the prevalence of the condition (BMJ News, 13thApril, 2002).

Pharmaceutical Marketing held up social phobia as an example of the importance of shaping public and medical opinion about disease concepts: “You may need to reinforce the actual existence of a disease and/or the value of treating it” (Pharmaceutical Marketing, 2002)

Pathologising childhood and the marketing of stimulants

The pharmaceutical industry has helped to promote the idea of the “hyperactive child” since Ritalin, manufactured by Ciba pharmaceuticals (who merged with Sandoz to become Novartis), was approved for use in children in the 1950s. In an early study Schrag & Divoky (1975) catalogued Ciba’s aggressive promotional tactics in the United States, including presentations to Parent Teacher Associations and other parent groups, at a time when direct to consumer advertising was illegal in the US.

There is currently an epidemic of stimulant use among school age and younger children. One survey in the United States in 1995 found that 30 to 40% of school children were taking stimulants (Runnheim, 1996). Prescription rates in the United Kingdom are also rising rapidly. Numbers of prescriptions increased by around 30% in 3 years between 1998 and 2001, and the cost of these prescriptions more than doubled (Department of Health, 2002). Although common stimulants are relatively cheap drugs, drug companies have recently been producing new and expensive preparations. This has fuelled huge growth in costs of stimulant prescribing. Stimulants showed the largest increase in financial sales, at 51%, between 2000 and 2001 of all classes of prescription drugs in the US (NIHCM, 2002).

The conditions for which these drugs are prescribed are now called Attention Deficit Hyperactivity Disorder (ADHD) or Attention Deficit Disorder (ADD). Despite the insistence of the advocates of a neurobiological approach in a recent “International Consensus Statement” (Barkley et al, 2002), the validity of the disorder is far from established. Critics have catalogued the wide variations in diagnostic practice and how definitions of the disorder have been widened to include more and more children over the last couple of decades (Timimi, 2002). Even the American National Institute of Health concluded that there was no evidence that ADHD was a biological brain disorder (National Institute of Health, 1998). Although trials demonstrate that stimulants have short term effects on concentration and attention, a recent Cochrane review found that there was little longer term research and questioned the overall value of using stimulant medication (Schachter et al, 2001). The publication of the International Consensus Statement (Barkley et al, 2002) is an explicit attempt to cut short debate on these issues and it is therefore of great concern that the authors were not required to divulge potential conflicts of interests.

The pharmaceutical companies have been actively involved in the promotional campaigns that have brought about this situation. In the United States they have achieved this partly in co-operation with CHADD (Children and Adults with Attention Deficit Disorder), which is predominantly a parent’s organisation, set up in 1987. It is highly active in promoting biological views of the nature of ADD, and acceptance of drug treatment. Material produced by Novartis and CHADD promotes the idea that ADD is an established “neurobiological disability” and that stimulants work by “correcting for a neurochemical imbalance” (quoted in Breggin, 2001, chap 14, P225). CHADD also runs national “information” campaigns, and is currently organising a campaign to reach sections of the community that are currently “under-served” in terms of diagnosis and treatment of ADD (www.CHADD.org). It is also engaged in vigorously opposing any moves to restrict the prescribing of stimulants to children. In addition, it produces publications, supports research, lobbies national and local government and holds annual conventions and conferences. It currently receives around 20% of its funding from pharmaceutical companies (www.CHADD.org).

The expansion of psychosis

The new or atypical antipsychotics have proved to be very profitable for the drug companies that produce them. In 2001 they were ranked 13th among the top selling drugs in the United States and their use had increased by 12.5% in one year (NIHCM, 2001). Their popularity has been unaffected by concerns about the validity of their research base (Geddes et al, 2000, see above).

Shortly after the introduction of the atypicals, various concepts about the early treatment and prevention of psychosis started to become fashionable, which are likely to result in increased rates of prescribing of these drugs. Early intervention is usually taken to mean early treatment for someone who has developed full-blown psychotic symptoms. Trials of preventive treatment involve “high risk” individuals, usually young people, who are defined by having a family history of schizophrenia, or having “attenuated” psychotic symptoms. There is obviously the potential for considerable overlap between the concepts of early intervention and prophylactic treatment, since they depend on judgements about what constitute full-blown psychotic symptoms and what do not. Both concepts suggest that the boundaries of when to initiate treatment for psychosis should be extended and should not depend on making a definitive diagnosis, or on the current degree of impairment of functioning. Both concepts are popular and fashionable, but contentious, and the strength of evidence on which they are based is disputed. Critics have argued that such programmes expose many people to the adverse effects of drugs who would never develop psychosis or schizophrenia, and that non drug treatments are neglected (Verdoux, 2002; Bentall & Morrison, 2002).

The drug companies, notably the makers of new antipsychotics, have provided funding for conferences and journal supplements on Early Intervention and preventive treatment, and are also funding, or part funding drug trials involving treatment of young people judged to be at “high risk.” The only completed and published randomised drug trial to date was small and not conducted double blind. Results showed small preventive effects that were not sustained over the follow up period. In addition, only 27% of the sample went on to develop a full blown psychosis and only 12% were diagnosed as having schizophrenia one year later (McGorry et al, 2002).

Colonising and inventing other conditions

I have illustrated only a selection of the expansion of psychiatric drug markets over the last decade or so. The marketing of drugs for other types of anxiety disorders such as panic disorder, generalised anxiety disorder and obsessive compulsive disorder and of drugs for alcohol problems, drug misuse, buleamia, post traumatic stress disorder, menstrual dysphoric disorder, compulsive shopping and intermittent explosive personality disorder, have helped to convince more and more people that they have a mental disorder that needs treatment. In the process, a market for drug treatments has been created in areas where they were formerly not frequently used. The common factor is the identification of a diagnosis or concept that is constituted by behaviours and emotions that have a substantial overlap with normal experience. The condition is then inherently expandable, which allows the drug companies and their advocates to claim that they abhor the inappropriate over-prescribing of their drugs (Barrett, 2002), safe in the knowledge that this will almost certainly occur anyway.

III NEGLECT OF ADVERSE EFFECTS

Adverse effects of drugs represent a major public health problem with recent estimates indicating that 1.5 million Americans are hospitalised and 100,000 die each year, making drug related adverse effects one of the leading causes of death (Lazarou & Pomeranz, 1998). 51% of drugs of approved drugs have serious adverse effects that are not detected prior to approval (US General Accounting Office, 1990). It has been suggested that the system for monitoring adverse effects in the United States and elsewhere is wholly inadequate (Moore et al, 1998; Woods, 1999). For example, neither the Food and Drug Administration in America, nor the Medicines Control Agency in Britain, collect routine data on the prevalence and consequences of adverse effects.

It has long been known that patients with severe mental disorders have much reduced life expectancy, but there has been little attention until recently to the possibility that some of this risk may be associated with drug treatment. A recent study found that death rates in people on long-term treatment with commonly used antipsychotics were three to six times higher than patients taking medication for other non fatal medical conditions (Henessy et al, 2002). Lifestyle factors such as high rates of smoking are likely to account for a part of these high death rates, but the study appeared to confirm other evidence that suggests that antipsychotics can induce fatal cardiac arrythmias (Zarate & Patel, 2001). This propensity has been known about for many years, but drugs such as droperidol and thioridazine, which had been in widespread use for decades, have only recently been withdrawn due to their cardiotoxicity. There is also growing concern about the side effects of the newer atypical antipsychotics, especially their tendency to cause severe obesity and diabetes (Kero et al, 2002) and they have also been associated with adverse cardiac events (Hennessy et al, 2002).

Some companies have been accused of minimising the adverse effects of their products. Eminent psychopharmacologists claimed that drug companies attempted to impede publication of the adverse effects of Halcion and sulpiride (Ian Oswald and Pierre Simon interviewed in Healy, 2000). Bodenheimer (2000) also describes two cases in which companies have attempted to prevent the publication of papers about adverse effects. In the UK, solicitors for the Seroxat Users Group are currently considering whether to launch a lawsuit against GlaxoSmithKline for failing to warn patients about the discontinuation reactions experienced after stopping their best selling drug Seroxat (paroxetine).

CRITICISM OF THE INFLUENCE OF THE PHARMACEUTICAL INDUSTRY

Several sections of the general media have recently featured critical discussions of the relationship between medicine and the pharmaceutical industry, including British newspapers the Guardian and Scottish Herald and American magazines USA Today, Public Citizen and Mother Jones. Criticism has also come from major academic medical publications such as the New England Journal of Medicine (NEJM), the Journal of the American Medical Association (JAMA), the Lancet and the British Medical Journal (BMJ). The NEJM was so concerned about the extent of the influence of the industry that it published an editorial entitled “Is academic medicine for sale?” (Angell, 2000).

Certain patient advocacy groups have taken a stand against the sponsorship of psychiatry. In July 2001, the user group Mad Pride organised a demonstration outside the annual Royal College of Psychiatrists conference in London about the level of commercial sponsorship underpinning the meeting. They were joined by members of the Critical Psychiatry Network, a group of UK based psychiatrists also concerned about the relationship between psychiatry and the drug industry.

Other web-based organisations have emerged to oppose corrupt marketing practices and their effects on medicine, including Social Audit in the United Kingdom (www.socialaudit.org.uk), No Free Lunch (www.nofreelunch.org) and Healthy Skepticism (www.healthyskepticism.org). No Free Lunch urges doctors to refuse drug company gifts and hospitality by taking a pledge. Healthy Skepticism is currently campaigning to stop direct to consumer advertising in New Zealand, and Social Audit is arguing against the relaxation of legislation preventing direct to consumer advertising in Europe. Consumer organisations including Health Which in the UK and Public Citizen in the US are also critical of the pharmaceutical industry’s power and influence.

WHAT SHOULD PSYCHIATRISTS DO?

The current situation seems to many outsiders and some insiders to indicate that the pharmaceutical industry has a substantial influence on the theory and practice of psychiatry. It also appears that there may be a serious conflict for psychiatrists between satisfying the needs of patients and the wider community, and serving the interests of the corporations. Political pressure is rightly demanding that all institutions become more accountable and more transparent. In response the Royal College of Psychiatrists is initiating a review of its relationship with the pharmaceutical industry. It is drafting guidelines on the relationship between the College and the industry and on relationships between individuals and the industry (Paul Jessop, personal communication, March 2003).

I suggest that there are some further steps that should be taken to improve the integrity of psychiatry in the United Kingdom.

    • The Royal College of Psychiatrists should publish in its accounts the exact amount of funding it receives each year from different pharmaceutical corporations.
    • The Royal College of Psychiatrists should create and publish a register of member’s interests that should be made publicly available.
    • The Royal College should initiate a discussion among its members about the ethics of receiving drug company hospitality and discussions should also be initiated at a local level.
    • Psychiatric institutions, including the Royal College, should stop accepting commercial sponsorship for educational events
    • Full disclosure of interests should be required by all psychiatric journals and for conference presentations. Torrey (2002) provides an example of the latter: “prominently displayed next to the speakers lectern should be a sign reading ‘For this talk Dr Smith is being paid $3,500, business class air fare and four star accommodation by Eli Lilly and Company.’”
    • Conflicting interests of authors of clinical guidelines should be reported and guideline committees should develop policies for managing these situations.
    • Guidelines should be drawn up for research personnel, which should set limits on fees received from companies and should prohibit researchers from holding stock in companies whose drugs they are investigating (Torrey, 2002).
    • Funding bodies should support research into treatment approaches that genuinely represent alternatives to a reliance on drugs.

CONCLUSIONS

As a society we are consuming more medicinal drugs than ever and a large proportion of these are for psychological conditions and complaints. This is making a major contribution to spiraling health costs and takes money away from other health services. Psychiatric practice is now firmly centered around drug treatment, and millions of other people, who have no contact with a psychiatrist, are receiving psychotropic drugs in General Practice. In recent years we have been encouraged to view more and more problems that were previously considered to be normal and manageable parts of the human condition as mental diseases that require treatment. The promotion of the idea of technical and professional solutions, the medical colonisation of everyday life, has profound consequences. At the individual level it seems likely to reduce personal coping strategies, to “gnaw away at our self confidence” (Payer, 1992). This is true in the area of mental health more than any other, since mental health involves our view of our own capabilities; the nature of our very selves. At the social level, the medicalisation of various problems obscures the effects of social changes that have taken place in the UK over the last couple of decades. For example, the retraction of the welfare state, increasing working hours, job insecurity and the dismantling of pension schemes have made life more difficult and more uncertain for many ordinary people. A society obsessed with its own navel is unlikely to be able to mount an effective challenge to these trends.

Psychiatry and the pharmaceutical industry make a formidable combination. Modern psychiatry derives its legitimacy from the notion that mental disorders are equivalent to medical diseases and it is this that justifies the coercion of psychiatric patients. Drug treatments that are aimed at specific diagnoses help to endorse this view, and the industry has the financial capacity to ensure that this view becomes accepted and respectable. In turn, the authority of psychiatry enables it to define what is considered as mental disorder and what is appropriate treatment, thus creating markets and opportunities for the pharmaceutical industry.

The influence of the pharmaceutical industry over political processes and research is an example of what George Monbiot has termed the corporate take-over of Britain (Monbiot, 2000). The power of the pharmaceutical industry is particularly worrying, because the commercial incentive to promote disease and sell pills potentially changes our view of what it is to be human. Fortunately, there are signs of unease within the medical community about the degree and consequences of drug company influence. It is time for the psychiatric profession to reflect on its relationship with the pharmaceutical industry and attempt to reclaim its integrity.

ACKNOWLEDGEMENTS

I would like to thank Professor Robin Murray and Dr Peter Mansfield for their helpful comments on a previous draft of this paper, Madeline Moncrieff for legal advice and Michelle Blythe for her help in locating material.

REFERENCES

Abrahams J (2002) Making regulation responsive to commercial interests: streamlining drug industry watchdogs. British Medical Journal, 325, 1164-1167.

Adams CE, Fenton MK, Quraishi S, David AS (2001) Systematic meta-review of depot antipsychotic drugs for people with schizophrenia. British Journal of Psychiatry, 179, 290-299.

Aitkin M & Holt F (2000) A prescription for direct drug marketing. The McKinsey Quarterly, 22 March 2000, 82.

Angell M (2000) Is academic medicine for sale? New England Journal of Medicine, 342, 1516-1518.

Antonuccio DO, Danton WG, DeNelsky GY, et al (1999) Raising questions about antidepressants. Psychotherapy & Psychosomatics, 68, 3-14.

Baldessarini RJ & Viguera AC (1995) Neuroleptic withdrawal in schizophrenic patients. Archives of General Psychiatry, 52, 189-192.

Barkley RA, Cook Jr EH, Diamond A et al (2002) International consensus statement on ADHD, Clinical Child and Family Psychology review, 5, 89-91.

Barrett, J (2002) speaking on Woman’s Hour, BBC Radio 4, September 5th 2002

Beach JE (2001) Clinical trials integrity: a CRO perspective. Accountability in Research, 8, 245-260.

Bentall RP & Morrison AP (2002) More harm than good: The case against using antipsychotic drugs to prevent severe mental illness. Journal of Mental Health, 11, 351-356.

Bero LA & Rennie D (1996) International Journal of Technology Assessment in Health Care, 12:2 209-237.

BMJ News, 13th April (2002). Drug firms hype disease as sales ploy, industry chief claims. British Medical Journal, 324, 867.

BMJ News, 1st June (2002) Celebrity selling. British Medical Journal News, 324, 1342.

BMJ News, 19th Oct (2002). A fifth of Americans contact their doctor as a result of drug advertising. British Medical Journal, 325, 854.

Bodenheimer T (2000) Uneasy alliance- clinical investigators and the pharmaceutical industry. New England Journal of Medicine, 342, 1539-1544.

Bohaychuk W, Ball G (1999) Conducting GCP Compliant Clinical Research. Chichester: John Wiley & Sons.

Bollini P, Pampallona S, Orza MJ, Adams ME, Chalmers TC (1994) Antipsychotic drugs: is more worse? A meta-analysis of the published randomized control trials. Psychological Medicine, 24, 307-316.

Boyd EA & Bero LA (2000) Assessing faculty financial relationships with industry. Journal of the American Medical Association, 284, 2209-2214.

Braslow J (1997) Mental Ills and Bodily Cures: psychiatric treatment in the first half of the twentieth century. Berkely, CA: University of California Press.

Breggin P (2001) Talking Back to Ritalin. Cambridge, MA: Perseus Publishing.

Breggin P & Breggin GR (1995) Talking Back to Prozac. New York: St Martin’s Press.

Chase D, Gierend M, Letzel H, Ludwig S (2001) System audit of contract research organisations in Germany. International Journal of Pharmaceutical Medicine, 15, 191-193.

Choudhry NK, Stelfox HT, Allan D (2002) Relationships between authors of clinical practice guidelines and the pharmaceutical industry. Journal of the American Medical Association, 287, 612-617.

Claxton AJ, Li Z, McKendrick J (2000) Selective serotonin re-uptake inhibitor treatment in the UK: risk of relapse or recurrence of depression. British Journal of Psychiatry, 177, 163-168.

Cohen JS (2001) Overdose: the case against the drug companies. New york: Penguin Putnam Inc.

Commonwealth Fund (1999) From bench to bedside: preserving the research mission of academic health centres. New York: Commonwealth Fund.

Conrad P (1992) Medicalisation and social control. Annual Review of Sociology, 18, 209-232.

Costello EJ, Pine DS, Hammen C et al (2002) Development and natural history of mood disorders. Biological Psychiatry, 52, 529-542.

Crow TJ, Macmillan JF, Johnson AL, Johnstone EC (1986) A randomsied controlled trial of prophylactic neuroleptic treatment. British Journal of Psychiatry, 148, 120-127.

Davidson RA (1986) Source of funding and outcome of clinical trials. Journal of General Internal Medicine, 1, 155-158.

Department of Health (2002) Prescription Cost Analysis 2001. London: HMSO.

Double D (2002) The limits of psychiatry. British Medical Journal, 324, 900-904.

Flanagin A, Carey LA, Fontanarosa PB et al (1998) Prevalence of articles with honorary authors and ghost authors in peer reviewed medical journals. Journal of the American Medical Association, 280, 222-224.

Fortune magazine (2002), April issue, 2002.

Foucault M (1967) Madness and Civilisation. London: Tavistock

Freemantle N, Anderson IM, Young P (2000) Predictive value of pharmacological activity for the relative efficacy of antidepressant drugs: meta-regression analysis. British Journal of Psychiatry, 177, 292-302.

Geddes J, Freemantle N, Harrison P et al (2000) Atypical antipsychotic drugs in the treatment of schizophrenia: systematic review and meta-analysis. British Medical Journal, 321, 1371-1376.

Gilbert P,L, Harris MJ, McAdams LA, Jeste DV (1995) Neuroleptic withdrawal in schizophrneic patients. Archives of General Psychiatry, 52, 173-188.

Hall WD, Mant A, Mitchell PB, Rendle VA et al (2003) Association between antidepressant prescribing and suicide in Australia, 1991-2000: trend analysis. British Medical Journal, 326, 1008-1111.

Healy D (1997) The Antidepressant Era. Cambridge, MA: Harvard University Press.

Healy D (1996) The Psychopharmacologists vol 1. London: Arnold

Healy, D. (1999) The three faces of antidepressants. Journal of Nervous and Mental Disease, 187, 174-180.

Healy, D. (2000) The Psychopharmacologists vol 3. London: Arnold.

Healy D (2002) The Creation of Psychopharmacology. Cambridge, MA: Harvard University Press.

Healy D & Cattell D (in press) The interface between authorship, industry and science in the domain of therapeutics. British Journal of Psychiatry, in press.

Hemminki E (1981) Quality of reports of clinical trials submitted by the drug industry to Finnish and Swedish control authorities. European Journal of Clinical Pharmacology, 19, 157-165.

Hennessy S, Bilker WB, Knauss JS et al (2002) Cardiac arrest and ventricular arrhythmia in patients taking antipsychotic drugs: cohort study using administrative data. British Medical Journal, 325, 1070-1072.

Herxheimer A (draft) Relationships between the pharma industry and patients organisations. Draft paper prepared for British Medical Journal.

Huston P & Moher D (1996) Redundancy, disaggregation and the integrity of medical research. Lancet, 347, 1024-1026.

Kero CE, Fedder DO, L’Italien GJ et al (2002) Assessment of independent effect of olanzapine and risperidone on risk of diabetes among patients with schizophrenia: population based nested case- control study. British Medical Journal, 325, 243-247.

Kirk H & Kutchins SA (1999) Making us Crazy. London: Constable.

Kjaergard LL & Als-Nielson, B (2002) Association between authors competing interests and authors conclusions: epidemiological study of randomised clinical trials published in the BMJ. British Medical Journal, 325, 249-251.

Koran LM, Hakett E, Rubin A et al (2002) Efficacy of sertraline in the long-term treatment of obsessive compulsive disorder. American Journal of Psychiatry, 159, 88-95.

Kramer PD (1993) Listening to Prozac. New York: Viking.

Lazarou J, Pomeranz BH, Corey PN (1998) Incidence of adverse drug reactions in hospitalised patients: a meta-analysis of prospective studies. Journal of the American Medical Association, 279, 1200-1204.

Lehtinen V, Aaltonen J, Koffert T et al (2000) Two year outcome in first episode psychosis treated according to an integrated model. Is immediate neuroleptisation always needed? European Psychiatry, 15, 312-320.

McGorry PD, Yung AR, Phillips LJ et al (2002) Randomised controlled trial of interventions designed to reduce the risk of progression to first episode psychosis in a clinical sample with subthreshold symptoms. Archives of General Psychiatry, 59, 921-928.

Medawar C (2001) Health, pharma and the EU. A briefing for members of the European Parliament on direct to consumer advertising. http://www.socialaudit.org.uk

Mintzes B (2002) Direct to consumer advertising is medicalising normal human experience. British medical journal, 324, 908-909.

Mintzes B, Barer ML, Kravitz RL et al (2002) Influence of direct to consumer advertising and patients requests on prescribing decisions: a two site cross sectional survey. British Medical Journal, 324, 278-279.

Monbiot G (2000) Captive State: the corporate takeover of Britain. London: Macmillan.

Moncrieff J (1999). An investigation into the precedents of modern psychiatry. History of Psychiatry, 10, 475-490.

Moncrieff J & Pommerleau, J. (2000) Trends in sickness benefits in Great Britain and the contribution of mental disorders. Journal of Public Health Medicine, 22, 59-67.

Moncrieff J (2001) Are antidepressants over-rated? A review of methodological problems in antidepressant trials. Journal of Nervous and Mental Disease, 189, 288-295.

Moncrieff J (2003) Misleading analysis. BMJ e correspondence at http://www.bmj.com/

Moncrieff (in press) The politics of a new mental health act. British Journal of Psychiatry.

Moore TJ, Psaty BM, Furberg CD (1998) Time to act on drug Safety. Journal of the American Medical Association, 279, 1571-1573.

Mosher L (1999) Soteria and other alternatives to acute psychiatric hospitalisation. Journal of Nervous and Mental Disease, 187, 142-149.

Mother Jones (2002) Disorders made to order. Mother Jones magazine July/August 2002. http://www.motherjones.com

Moynihan R, Heath I, Henry D (2002). Selling sickness: the pharmaceutical industry and disease mongering. British Medical Journal, 324, 886-891.

National Institute of health (1998) Consensus statement: diagnosis and treatment of attention deficit hyperactivity disorders. Rockville MD: National Institute of Mental Health.

National Institute for Health Care Management (2002). Prescription drug expenditures in 2001. www.nihcm.org.

National Institute for Mental Health England (NIMHE) & Association of the British Pharmaceutical Industry (ABPI) Partnership (2002). Meeting of Minds.www.nimhe.org.uk

New York Times (2001) A muscular lobby tries to shape the nation’s bioterror plan. New York Times, November 4th 2001.

Payer L (1992) Disease Mongers. New York: John Wiley.

Paykell ES & priest RG (1992) Recognition and management of depression in general practice: consensus statement. British Medical Journal, 305, 1198-1202.

Pharmaceutical Marketting (2000). The mark of Zorro. Pharmaceutical Marketing, May 2000. http://www.pmlive.com

Pharmaceutical Marketting (2002) Practical Guides: Medical Education parts I & II. Pharmaceutical Marketing, 2002. http://www.pmlive.com

Public Citizen (2002) America’s other drug problem: a briefing book on the prescription drug debate. www.citizen.org/rxfacts.

Romano SJ, Halmi KA, Sarker NP et al (2002) A placebo controlled study of fluoxetine in continued treatment of bulimia nervosa after successful acute fluoxetine treatment. American Journal of Psychiatry, 159, 96-102.

Runnheim VA (1996) Medicating students with emotional and behavioural disorders and ADHD: a state survey. Behavioural Disorders, 21, 316-314.

Safer DJ (2002) Design and reporting modifications in industry sponsored comparative psychopharmacology trials. Journal of Nervous and Mental Disease, 190, 583-592.

Sainsbury Centre for Mental Health (1998) Acute problems. A survey of the quality of care in acute psychiatric wards. London: SCMH.

Schachter HM, Pham B, King J et al (2001) How efficacious and safe is short acting methylphenidate for the treatment of attention deficit disorder in children and adolescents? A meta-analysis. Canadian Medical Association journal, 165, 1475-1488.

Schrag P & Divoky D (1975) The Myth of the Hyperactive Child. New York: Pantheon.

Swazey J (1974) Chlorpromazine in Psychiatry. Cambridge, MA: Massachusetts Institute of Technology.

Shorter E (1997). A History of Psychiatry: from the age of the asylum to the age of prozac. New York: John Wiley & Sons.

Sunday Herald, Feb 23rd (2003) Fury at Holyrood’s medicine panel as members reveal drug firm links.

Suppes T, Baldessarini RJ, Faedda GL (1991) Risk of recurrence following lithium discontinuation of lithium treatment in bipolar disorder. Archives of General Psychiatry, 48, 1082-1088.

Timimi S (2002) Pathological child psychiatry and the medicalisation of childhood. Hove, East Sussex: Brunner-Routledge.

Torrey EF (2002) The going rate on shrinks. The American Prospect, volume 13, issue 13, 2002. www.prospect.org.

United States General Accounting Office (1990) FDA drug review: post approval risks, 1976-85. Washington DC: US General Accounting Office; April 26, 1990.

Van Praag HM (2002) Why has the antidepressant era not shown a significant drop in suicide rates? Crisis, 23, 77-82.

Wadman M (1997) Study discloses financial interests behind papers. Nature, 385, 376.

Wahlbeck K, Tuunainen A, Gilbody S, Adams CE (2000) Influence of methodology on outcomes of randomised clozapine trials. Pharmacopsychiatry, 33, 54-59.

Wazana A (2000) Physicians and the pharmaceutical industry. Is a gift ever just a gift? Journal of the American Medical Association, 283, 373-380.

Whitaker R (2002) Mad in America. Cambridge, MA: Perseus Publishing.

Wood A. the safety of new medicines: the importance of asking the right questions. Journal of the American Medical Association, 281, 1753-1754.

World Health Organisation (2001) World Health Report, 2001. http://www.who.int/whr/2001

Valenstein E (1998) Blaming the Brain. The truth about drugs and mental health. New York: Free Press.

Verdoux H. (2001) Have the times come for early intervention in psychosis? Acta Psychiatrica Sandinavica, 103, 321-322.

Zarate CA Jr, Patel J (2001) Sudden cardiac death and antipsychotic drugs: do we know enough? Archives of General Psychiatry, 58, 1168-71.

Zito JM, Safer DJ, dos Reis S et al (2000) Trends in the prescribing of psychotropic to preschoolers. Journal of the American Medical Association, 283, 1025-30.

The Critical Psychiatry Network – Introducing Joanna Moncrieff


http://madamedotty.blogspot.ie/2012/07/dr-moncrieff-on-depression-and-drugs.html

http://www.criticalpsychiatry.co.uk/

http://www.academyanalyticarts.org/moncrieff.htm

Psychiatric Imperialism: The Medicalisation of Modern Living

 

Introduction

The institution of psychiatry grew up in the 19th century during the emergence and consolidation of industrial capitalism. Its function was to deal with abnormal and bizarre behaviour which, without breaking the law, did not comply with the demands of the new social and economic order. Its association with medicine concealed this political function of social control by endowing it with the objectivity and neutrality of science. The medical model of mental disorder has served ever since to obscure the social processes that produce and define deviance by locating problems in individual biology. This obsfucation lends itself to the perpetuation of the established order by side-stepping the challenge that is implicit in deviant behaviour and thereby undermining a source of criticism and opposition. During the 20th century, a fierce attack on psychiatry has condemned this misleading medical characterisation of the problems of living and the repressive measures that masquerade as psychiatric treatment. However, at the same time more sophisticated technology has enabled the psychiatric profession not only to weather the storm, but to strengthen its claim to the jurisdiction of ‘mental illness.’ Opportunities for social control and the suppression of dissent in the guise of psychiatry have increased.

In some respects psychiatry has never been as confident and respectable as it is at present. In the 1950s and 1960s a pharmacological revolution produced an array of drugs for use in disorders such as schizophrenia, depression and anxiety which enabled psychiatry to move closer to the paradigm of physical medicine of administering specific cures for specific conditions. Starting in this period also, psychiatric care relocated physically away from the discredited asylums and into general hospitals, in closer proximity to the rest of the medical community. This move embodied the attempts of the psychiatric profession to disentangle itself from the stigma of caring for the chronically insane and instead to forge a role curing the acutely disturbed. Community care is the concession to the chronic and recurrent nature of psychiatric conditions.

Similarly, the endeavour to locate the biological origins of mental illness has been revitalised by the introduction of new technology for studying the brain and by the development of molecular genetics and the human genome project. Despite a disappointing lack of consistent results, the quantity of resources devoted to this research has, in itself, leant the medical model of mental illness further credibility.

However, the 20th century has also produced an influential critique of psychiatry articulated by academics and some rebel psychiatrists (famously, R.D. Laing, Thomas Szasz & David Cooper). Sociological theories of deviance, medicalisation and the organisation of professions helped to expose the political functions and processes involved in the institution of psychiatry. The paternalism of psychiatry was attacked and medical treatment was accused of being more oppressive than legal sanctions or punishment.

These ideas were expressed in concrete form in the activities of protest movements, patient advocacy groups and experiments in alternative care. In the early 1970s in the Netherlands and the United States, where protest movements were particularly strong, there were demonstrations against the use of electro convulsive therapy (ECT), university lectures were disrupted and some prominent biological psychiatrists had to have police protection. There were famous attempts to create therapeutic communities which renounced staff patient distinctions and hierarchies (such as R.D. Laing’s Kingsley Hall and David Cooper’s Ward 21in the United Kingdom) and in Italy a politically conscious democratic psychiatry movement instituted mental health care reforms. The patient advocacy movement, which took inspiration from civil rights organisations, was another important development. Although the activism has diminished, patient or survivor groups remain strong and individuals and groups of professionals continue to promote alternative approaches to the problems of the so-called mentally ill . The ‘antipsychiatry’ movement also had a significant impact on social policy resulting in increasing restrictions on involuntary confinement and treatment and a diminishing use of physical techniques such as psychosurgery and ECT.

However, recent developments in the definition and management of two major psychiatric conditions, depression and schizophrenia, illustrate that the social influence and formal powers of institutional psychiatry may now be expanding. The criticism that was first expressed over three decades ago may therefore be more relevant than ever.

Depression: medicalising discontent

The Defeat Depression Campaign (DDC), launched in 1992 was organised by the Royal College of Psychiatrists in association with the Royal College of General Practitioners with funding from the pharmaceutical industry. The literature of this campaign suggests that around 10% of the population suffer from a depressive disorder at any one time, a third will suffer at some time during their lives and antidepressant drugs are recommended for all those with moderate to severe symptoms. These claims seem to suggest that a large proportion of human unhappiness is biologically based and can be similarly corrected. The publicity surrounding the new antidepressant fluoxetine (prozac) has become only slightly more extreme with claims that it has personality altering and general life enhancing properties.

A recent collection of interviews with prominent psychopharmacologists who were involved with the discovery and introduction of modern psychiatric drugs provides an interesting historical backdrop to the DDC. In psychiatric hospital practise in the 1950s depression was a relatively rare disorder and there was no concept of a specifically antidepressant drug as opposed to a general stimulant. When antidepressant action of certain compounds was first proposed drug companies were initially reluctant to develop and launch such drugs. In an unconscious alliance of interests, influential psychiatrists developed and popularised the view of depression as a common biologically based disorder, amenable to drug treatment and as yet frequently unrecognised. This concept had the dual benefits of vastly expanding the market for psychiatric drugs and extending the boundaries of psychiatry outside the asylum. Since this time the psychiatric profession and the drug industry have continued to try and inculcate this idea into the consciousness of both the general public and other doctors. The DDC is the latest offensive.

Numerous biochemical mechanisms responsible for depressive illness have been proposed implicating a variety of biochemical and hormonal mechanisms, partly determined by fashion. The evidence for all these theories has been inconsistent and the consensus about the efficacy of antidepressant drugs remains the strongest support for the thesis that depression is a physiological condition. Perusing the psychiatric literature indicates that this consensus developed in the mid 1970s based on evidence from randomised controlled trials of the original and still widely used antidepressants, the tricyclics. However, early reviews of this evidence portray an ambiguous situation with a large proportion of trials failing to find a positive effect. In addition, more recently some researchers have suggested that antidepressants are not specifically active against depression but merely exert a placebo effect in a receptive condition.  They appear to perform better than an inert placebo because their side effects increase their suggestive power and may admit bias into the assessment procedure by enabling investigators to guess whether patients are on the active drug or the placebo. A recent meta-analysis of placebo controlled trials of prozac found that the likelihood of recovery was indeed associated with experiencing side effects . A review of seven studies which used an active substance as a placebo to mimic antidepressant side effects found that only one showed the drug to be superior.

Variation in mood is a characteristically human way of responding to circumstances but unhappiness has become taboo in the late 20th century, perhaps because it undermines the image that society wishes to project. Medicalisation diminishes the legitimacy of grief and discontent and therefore reduces the repertoire of acceptable human responses to events and denies people the opportunity to indulge their feelings. At the same time it diverts attention away from the political and environmental factors that can make modern life so difficult and distressing. It may be no co-incidence that the concept of depression has reached its present peak of popularity in western societies reeling from two decades of economic events and political policies which have been blamed for increased unemployment and marginalisation of a substantial section of the population.

However, it is also important to acknowledge that people have different propensities to experience intense moods and that, for those at the extremes of this spectrum, such as those with manic depressive disorder, life can be very difficult. Prophylactic medication is promoted by psychiatrists for long-term use in this condition primarily in the form of lithium. However, in a similar way to antidepressants, claims of the efficacy of lithium seem to have been based on insubstantial evidence and follow up studies of people with manic depression do not indicate that it has improved the outlook of the condition. It is possible therefore that prophylactic drug treatment constitutes a false hope held out to people who feel desperate, by a profession that feels helpless. But it may only further undermine the self assurance of people who are already vulnerable. Instead of aspiring to complete cure, natural remission of episodes should be encouraged by providing care and security, and attempts should be made to enhance people’s confidence in their own ability to manage or survive their condition.

Schizophrenia: disguising social control

The enormous investment in the investigation of the biological basis of schizophrenia has produced no conclusive information. Decades of increasingly sophisticated technological research has revealed a possible weak genetic predisposition, often much exaggerated by psychiatric commentators who ignore the shortcomings of the main studies . Molecular genetic studies have publicised initial findings implicating several different genes which then transpired to be due to chance when attempts at replication failed. The most recent pan European study boldly concludes that the genetic associations revealed are involved in the pathogenesis of the disorder. However, the gene implicated is common in the general population, it is only slightly more common in people diagnosed with schizophrenia and the similarity of the comparison group in this study was ensured only for ethnicity and not for other factors. As regards brain function and anatomy, the only consistent finding is the larger size of the lateral ventricle, one of the brain cavities, in people with schizophrenia. Again there is a substantial overlap with the ‘normal’ population and most studies have been conducted on people with long histories of drug treatment. However, the possibility that drugs may be responsible for causing the brain abnormalities observed has received little attention in the psychiatric literature .

Drugs variously termed ‘major tranquillisers,’ ‘neuroleptics’ or ‘antipsychotics’ form the mainstay of psychiatric treatment for schizophrenia. They have been claimed to have specific action against psychotic symptoms such as delusions and hallucinations, but critics suggest that they act in a much cruder way by producing a chemical lobotomy or straight jacket which inhibits all creative thought processes . Psychiatry applauds the role of these drugs in emptying the asylums but an alternative perspective suggests that they merely helped to replace expensive custodial care with long-term drug-induced control.

A consequence of the move towards community care is that public and political anxiety has replaced the concern for patients rights with concern for protection of the community and psychiatric treatment has become the panacea for this complex social problem. In response to a few highly publicised cases of violent or dangerous acts by former psychiatric patients, amendments were made to the Mental Health Act (1983) which came into force in April 1996 and which introduce a power of ‘supervised discharge.’ This power enables psychiatric personnel to have access to the patient if deemed necessary and to enforce attendance at psychiatric facilities. It does not confer the right to enforce medical treatment but it does require that an assessment for admission to hospital be conducted if the patient is uncompliant with aftercare arrangements such as refusing medication. The justification for this legislation is the assumption that medical treatment can cure disturbance and prevent relapse. However the evidence indicates that a substantial proportion of people with a psychotic episode fail to respond to medication at all, a further significant proportion relapse despite taking long-term medication (in clinical trials the relapse rates on medication is around 30%) and, like other people, they may behave antisocially when they are not actively psychotic.

The social control element of the changes to the Mental Health Act is only thinly veiled and they have been strongly opposed by civil and patients rights groups. Their significance lies in the introduction of a new precedent of control over people after discharge from hospital. The use of the former 1983 Mental Health Act for these purposes was successfully challenged in the courts in the 1980s. The exact form of the new provisions when implemented is uncertain and is likely to vary according to the predisposition of local professionals. Although there is much unease among psychiatrists about shouldering increased responsibility for the actions of people labelled mentally ill, many in the profession have called for stronger powers to enforce medical treatment in the community.

The medical model of mental illness has facilitated the move towards greater restriction by cloaking it under the mantle of treatment. This process of medicalisation of deviant behaviour conceals complex political issues about the tolerance of diversity, the control of disruptive behaviour and the management of dependency. It enables a society that professes liberal values and individualism to impose and reinforce conformity. It disguises the economics of a system in which human labour is valued only for the profit it can generate, marginalising all those who are not fit or not willing to be so exploited.

Characterisation of schizophrenia as a physically based disease of the brain also forecloses any debate about the meaning of the experiences and actions associated with it. Attempts to render schizophrenic symptoms intelligible and to understand their communicative value help both to illuminate ordinary experience and to increase empathy for people with this condition. Other interesting findings point to the association of schizophrenia with features of social structure. Nothing resembling schizophrenia was described prior to the early 19th century, suggesting an association with the emergence of industrial capitalism. In modern societies schizophrenia is more frequently diagnosed in urban centres, among people of lower social class and in certain immigrant groups when compared to their country of origin, particularly second generation afro-Caribbean people in the UK. Research in the third world has shown that people with schizophrenia have a better prognosis with a lower chance of relapse and functional decline than their counterparts in the developed world . It appears therefore that social conditions play a part in determining the expression of schizophrenic symptoms and so schizophrenia may be regarded as a mirror on the deficiencies of the current social structure.

Tolerance of the diversity of human lives and a respect for the autonomy of all must be the foundation of a progressive alternative approach. Enhancing people’s control over their lives means providing genuine choices and opportunities for people of all different propensities. It means creating a society where there are niches available that allow a diversity of lifestyles. It involves accepting that some people may chose to lead lives that appear bizarre or impoverished. Although some people with schizophrenia will find drug treatment useful, psychiatrists frequent complaints about non compliance illustrate that many chose not to take medication. Similarly, some people with chronic mental illness gravitate away from the structured, rehabilitating environment of the mental health services to homeless hostels and to the streets. It is commonplace to blame the underfunding of community care for this phenomena but research has found that most of the homeless psychiatrically ill had not come straight from closing hospitals but had been settled in adequate community accommodation before drifting away . An alternative explanation might be that the long-term mentally ill prefer the undemanding nature of the homeless situation to the intrusive demands of family, community and mental health services.

The management of disruptive and dangerous behaviour is a problem for every society. Involuntary confinement and treatment continue to be a major area of contention with opposition emphasising the need to respect people’s autonomy and opposing the imposition of a relative set of values about what is normal and sane. It is argued that it should be possible to deal with behaviour that is genuinely harming or harassing other people using normal legal sanctions. It is an area which requires further and wider consideration. Whatever solution is adopted, it must be developed openly and democratically, with proper provision for representation and public scrutiny, so that measures taken can not be subverted to serve the ends of certain groups above others.

Conclusion

Despite the political and professional retrenchment of recent years, there are many developments which presage the ultimate transformation of the psychiatric system. The burgeoning patients rights movement and the anti-psychiatry critique are some of these. Rejection of paternalism is also embodied in the increasingly important role of consumers in medicine in general and the demand for justification of treatments and involvement in decision making. The medical profession is also placing more emphasis on objective evidence about the effectiveness of procedures and showing less inclination to support the principle of clinical freedom. Many individual psychiatrists are aware of the political conflicts that beset their practice and try to address these thoughtfully and with respect for their patients and philosophical debate, which inevitable touches on political issues, is flourishing within the profession at present. It is unlikely however that psychiatry will be radically transformed without profound social and political change. The control of deviance and the enforcement of conformity are too central to the smooth functioning of the divisive and exploitative social system in which we live.

 

 

GlaxoSmithKline – You’re An Embarrassment (From Seroxat Sufferers)


Fid’s Seroxat Blog :

http://fiddaman.blogspot.ie/2012/11/glaxosmithkline-youre-embarrassment.html?utm_source=twitterfeed&utm_medium=twitter&utm_term=Seroxat,+Fiddaman

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

Our uncle he don’t wanna know he says
“We are a disgrace to the human race”, he says
“How can you show your face

When you’re a disgrace to the human race?”

No commitment, you’re an embarrassment
Yes, an embarrassment, a living endorsement

The intention that you have booked

Was an intention that was overlooked

Glaxo Wellcome – The All New Accelerators


Nice little punk track from The All New Accelerators , presumably not singing about GSK in a good light?  (if anyone can work out what the bloke is saying – please let me know!)

http://www.nme.com/nme-video/youtube/id/0tJIiKwMmBw

From Shrub Monkey : Cunt of the Day 

http://shrubmonkey.com/cunt-of-the-day/28/728-october-28th-2010-glaxosmithkline

GlaxoSmithKline is today’s Cunt of the Day.

Cheryl Eckard used to work for drug maker GlaxoSmithKline as a quality assurance manager. When she discovered manufacturing deficiencies in a plant in Puerto Rico she reported them to her bosses who, instead of addressing the problems, decided to cover them up and remove Ms Eckard.

Yesterday, we learned that Eckard will collect at least $96m “for her role in helping the government secure a criminal guilty plea and a $750 million payment from Glaxo to settle an investigation of manufacturing deficiencies“. This is excellent news.

http://shrubmonkey.com/cunt-of-the-day/28/728-october-28th-2010-glaxosmithkline

GSK And The Advair Controversy


From Pharmalot: 

Full Story –  

http://www.pharmalot.com/2012/11/breathe-deeply-glaxo-advair-close-connections/

“It is very hard for many of us,” David Schoenfeld, a Harvard University medical professor who served on the FDA 2008 advisory panel and has been a drug company consultant, “to make decisions that are against the American pharmaceutical industry.”

When GlaxoSmithKline reached its infamous $3 billion settlement with the US Department of Justice last summer, much of the attention was focused on the guilty pleas for misbranding the Paxil and Wellbutrin antidepressants and for failing to report safety data about the Avandia diabetes pill to the FDA (back story).

In fact, however, there were several transgressions, such as reporting false best prices and underpaying rebates owed under the Medicaid Drug Rebate Program and off-label promotion of several medications. One of these was the Advair asthma treatment and, as it turns out, the drug got an extra push from yet another dicey, behind-the-scenes scheme.

And that was? The growth in Advair sales – revenue has topped $4 billion annually for several years – followed new asthma treatment recommendations that were written in 2007 largely by doctors who received money from Glaxo and other drugmakers that market similar medications, according to The Milwaukee Journal-Sentinel and MedPage Today (read here).

Of the 18 members of the panel that wrote the guidelines, 15 had financial ties at the time to Glaxo (GSK) or other drugmakers that market long-acting beta-agonists. And from 2009 through 2011, drugmakers that made long-acting beta-agonists paid more than $400,000 to nine doctors on the panel, according to ProPublica data cited by the news outlets.

The government, however, alleged that Glaxo fraudulently promoted Advair as a first-line therapy for mild asthma patients, although the medication was not approved or medically appropriate for such cases. A Glaxo spokeswoman told the web sites that “it is absolutely against GSK’s policies and practices to inappropriately influence prescribing decisions,” and adding that such practices do not reflect “the company we are today.”

Comment :

It is likely the case that each of GSK’s “blockbuster” drugs acquired that status through various forms of fraud. Advair’s rise to pre-eminence was based largely on the SMART study, which internal documents called a failed study. That didn’t stop GSK from applying its vast array of Junk Science and Junk Statistics techniques to promote that study as vindication of Advair’s safety and efficacy.

GSK could have been criminally prosecuted based on that one study alone, and even widespread adverse publicity, such ashttp://www.pharmalot.com/2008/06/does-glaxo-study-resolve-advair-concerns/ was not enough to overcome its well-practiced doctor bribery and intimidation program.

Does this company make ANY product that is not harmful to humans? Not so’s you can tell…

GSK and Anonymous


Looks like the radical internet activist hacking group ‘anonymous‘ have their sights set on the pharmaceutical industry…

Interesting..

From Youtube: 

while the bankers and their corrupt politician counterparts tremble, your crimes
got very little airtime and detail, on our corrupt mainstream media.
the term “a good day to bury bad news” would be apt for this subject.
while bankers will rob you and con you,drug companies kill people with no recourse
then empty their pocket money to the corrupt government that they lobby every
four years.
you have earned your place on our list of the most highly corrupt corporations in the world
and our attention has now turned to you
we are anonymous we do not forgive we do not forget,expect us

 

November 2012: Pregnant Irish Woman Kills Herself – Seroxat Involved


It is simply unimaginable how this poor woman must have felt after being prescribed Seroxat for 10 years. Seroxat is lethal– particularly when it is withdrawn. When will the medical profession be held accountable? 

“He said she had been depressed since her early 20s and had been on the anti-depressant Seroxat for ten years”

http://www.rte.ie/news/2012/1119/inquest-into-death-of-woman-pregnant-with-twins.html

http://www.independent.ie/national-news/family-of-tragic-pregnant-mum-want-mental-health-notes-shared-3297168.html

Family of tragic pregnant mum want mental health notes shared

THE devastated family of a heavily pregnant woman who is believed to have taken her own life want psychiatrists to share their notes on depressed expectant mothers with doctors who deliver their babies.

The body of Anna Byrne, a 35-year-old nurse from Dunboyne, Co Meath, was found last March on rocks near the Bailey Lighthouse at the bottom of Howth Head.

The mother of two was 38 weeks’ pregnant with twin boys and had been suffering from depression for several years.

An inquest will open in Dublin today, and it is expected her family will appeal for hospitals to ensure psychiatrists treating pregnant women with mental health issues share their notes with obstetricians.

Mrs Byrne was being treated with medications including the anti-depressant Seroxat during part of her pregnancy.

The mother of two young boys attended psychiatrists and received support from the mental health team at Dublin’sRotunda Hospital during her pregnancy.

Kathrin Coleman, solicitor for Mrs Byrne’s husband, Terry, told the Irish Independent it was “very clear” from the devastating events that unfolded that hospitals’ practice of keeping mental health notes separate from obstetric notes needed to be changed.

“A more transparent medical record system may assist in preventing such tragedy in the future,” said Ms Coleman.

When she went missing, Mrs Byrne’s brother, Ciaran Deeney, organised a late-night search in Dun Laoghaire.

Mr Deeney desperately tried to get the message out and sought the public’s help. He tweeted: “My heavily pregnant sister expecting twins has gone missing, possibly in Dun Laoghaire area. Please RT (re-tweet).”

Mrs Byrne’s body was discovered shortly after her car was found at Howth Head.

– Dearbhail McDonald Legal Editor

http://www.independent.ie/national-news/i-love-you-annas-last-words-3300455.html

‘I love you’ – Anna’s last words

Mrs Byrne had been taking the anti-depressant Seroxat for 10 years but had stopped during her pregnancy.

Mrs Byrne’s GP had started her on Sertraline – an anti-depressant regularly used during pregnancy – and Dr Sheehan doubled her dosage, prescribed an anti-histamine to help her sleep and advised her to seek a referral to a counsellor in her area.

She was suffering a recurrence of depression associated with an adjustment disorder to her twin pregnancy of boys, he said. Mrs Byrne presented a low risk given that she did not indicate that she was suicidal and had made future plans, he told the court.

He said that although he was not saying that Mrs Byrne did not take her own life, the evidence heard in court did not satisfy the legal test for a verdict of suicide. He returned an open verdict.