Showing posts with label pharmaceutical-companies. Show all posts
Showing posts with label pharmaceutical-companies. Show all posts

Monday, March 14, 2005

LUNATICS RUNNING THE ASYLUM

Mental Health Conference To Be Held In Casino

On September 2nd, 2005, the Gold Coast Institute of Mental Health will be holding the 6th International Mental Health Conference at Conrad Jupiters Casino on the Gold Coast. Its theme will be "What's new in mood disorders?"

Although regrettable, it is far from unusual for such events to be take place at elite, five star venues with attendance fees and venue security calculated to discourage all but the very well heeled from attending. However, in choosing Jupiters, the organisers of this conference have set a new standard of exclusivity and poor taste.

Jupiters Casino is one of the country's chief promoters of a mental disorder that afflicts almost 400,000 Australians and directly affects many thousand more - compulsive gambling. Over 90% of suffers report depression due to their gambling and one in five will attempt suicide. Every year, over two dozen succeed in killing themselves.

To hold a mental health conference at Jupiters Casino is akin to arranging a seminar on drug and alcohol addiction at an inner city pub. Consumers, survivors and victims of mental health services will feel themselves thoroughly excluded from this conference, particularly if they are living with a gambling problem.

The mental health industry is currently facing widespread criticism for its close relationship with pharmaceutical corporations. Indeed, the GCIMH boasts of its sponsorship by some of the world's most unethical purveyors of ineffective and dangerous psychiatric medications. But by joining hands with the gambling industry, the Institute has shown it has learned nothing from psychiatry's unsavoury past associations with some of history's most abusive and exploitative industries and regimes.

Justice Action calls on the Gold Coast Institute of Mental Health to immediately cancel its arrangements with Jupiters and rebook its conference at a more appropriate venue. We also call on the Institute to 'just say no' to drug company money, so as to avoid a conflict of interest.

Justice Action calls on all organisations who are sincerely concerned with the poor standard of mental health care in Australia to boycott the 6th International Mental Health Conference and to send a strong letter to the GCIMH explaining why they will not be attending.

Contact: Michael Strutt 9660-9111, Brett Collins 0438 705 003

By JusticeAction 14 March 05

Related:

The 6th International Mental Health Conference
Papers which address the themes of the conference are especially welcome, although other papers will be considered...

Mental Health Tribunal recommendations on forensic inmates
Below is the answer we have received from the Minister for Health regarding prisoners recommended for parole or release by the Mental Health Tribunal FYI.

Tuesday, October 5, 2004

The drugs industry and its watchdog: a relationship too close for comfort?

It would appear to be a happy and satisfying relationship. "Our priorities are aligned," says one document.

There have been "notable successes" says another, citing "another example" of where the two sides "cooperated well". In business partners, this would seem to indicate a harmony of views. The documents obtained however, relate to meetings between the drug industry and the watchdog body set up by government to police it.

Critics say the drug regulator and the industry are too close. Their proceedings have long been shrouded in secrecy because of the drug companies' insistence on the commercial sensitivity of information relating to their products.

The open government code revealed the reality of relations between the Medicines and Healthcare products Regulatory Agency (MHRA) and the trade association of the industry it regulates. The documents show that:

- the regulator and the industry have been engaged in a joint lobbying campaign in Europe;
- the industry privately drew up its own detailed blueprint of how the MHRA should be run;
- the industry has been pushing for higher level representation at the MHRA against ministers' wishes.

Since 1989, when the then prime minister, Margaret Thatcher, took drug regulation out of the hands of the Department of Health, the MHRA has been 100% funded by the pharmaceutical companies.

The MHRA's chief executive, Kent Woods, appointed in January, has no drug company background, but critics say the agency continues in the unquestioning belief that the regulator and the industry are working together in the mutual interests of public health.

John Abraham, professor of sociology at Sussex University, who is well respected for his books on drug regulation, says that in 1989 there was a reconstruction of the regulators' mission alongside the new fees relationship. The MHRA came to believe the interests of public health are coherent with the promotion of the industry.

"The criticism of the old Department of Health medicines department in the 70s was that it didn't have any teeth. Not only does it now not have any teeth, but it is not motivated to bite," he said.

The MHRA told the Commons health select committee inquiry into the influence of the industry that it does not consider the fee relationship to be a problem.

"I would suggest to a lay person there is a big problem with the concept of independence from industry of a body that is fully funded by industry," said Professor Abraham. The UK's regulatory agency competes with those of other countries to approve drugs for the whole of Europe.

But Professor Woods says that neither industry funding nor close liaison is a problem. "It is important that the regulator understands the regulated industry.

"I have to say that our areas of overlapping interests are not 100%. There are some things where we have common cause but our prime responsibility is to ensure we protect public health. These are aims which the industry shares. I don't think there is a necessary antipathy between what the ABPI [The Association of the British Pharmaceutical Industry] is trying to achieve and what we are trying to achieve. But there are other areas in which we can't agree."

Richard Ley, spokesman for the ABPI, denied that the ABPI had the MHRA "in its pocket". "The objective of the MHRA is to ensure that medicines are assessed to be effective and as safe as possible. Those are also our aims. We have an absolute desire to have good quality medicines."

The documents record the regular meetings and dinners between the MHRA and the ABPI over the past year.

Among the "notable successes" of its close collaboration with the industry, the MHRA paper cited how it "cooperated well" with the trade association to lobby other European governments and the European commission on a review of legislation governing drug companies. It was, according to the briefing paper, "another example where the Association of the British Pharmaceutical Industry and the MHRA worked closely together".

Minutes of a meeting between the ABPI and senior MHRA officials in April record that the "ABPI thought there was a remarkable concordance between MHRA and their priorities..."

At their meeting with the MHRA top officials in June, the ABPI presented an eight-page blueprint detailing how it thinks the MHRA should be run to "build upon the excellent working relationship" between the industry and the regulator. According to this document, "our priorities are aligned [ABPI/MHRA]".

Following this meeting, Nicky Lilliott, the ABPI's head of regulatory affairs, wrote to Professor Woods, to confirm that, as agreed, the ABPI would develop an action plan to discuss a wide range of issues for the future of the agency. "I would propose that over the summer the ABPI drafts an action plan and this is then circulated to yourself and colleagues for comments, with the intention to agree the action plan at our meeting in September."

"The action plan would need assigned topic leaders, joint ABPI/MHRA, in order to achieve the agreed objectives/milestones. The main driver for the actions and timelines for these issues will be the implementation (of) the new pharmaceutical legislation by October 2005". Professor Woods said the action plan related to establishing a framework for bilateral meetings. The documents show the ABPI is unhappy at proposed changes to the structure of the MHRA. It used to have three people on the ministerial advisory board and two on the Medicines Commission, the drug licensing appeal body.

Pressure

In a letter to Professor Sir Alistair Breckenridge in January, Dr John Patterson, the ABPI president, wrote: "We remain concerned at the lack of representation of the pharmaceutical industry at board level within the MHRA ... As the only regulatory agency that is fully industry-funded, we believe it is essential that we have a say on a variety of issues, not least financial matters relating to fees and service levels."

After more pressure, MHRA officials discussed alternative arrangements. Roy Alder, a senior MHRA official, suggested in March that "there could be scope for industry to make a similar input to MHRA business and operational policy" through other ways. He wrote: "Ministers are clear that the MHRA board should have no current industry people. There seems no option on this issue." He suggested someone recently retired from the industry could possibly be put on the board, "but ministers may want to avoid any perception of industry interests at board level."

The Committee on the Safety of Medicines (CSM), made up of independent experts, advises the MHRA on which drugs to license after studying clinical trial data on safety and efficacy. Its members are supposed to declare any sponsorship or payments they receive for lectures or advice from industry. The last complete declaration of interests of CSM members, for 2001, shows 17 out of 36 members had personal financial links to the industry, while others have declared non-personal interests such as research grants.

The documents show that industry has been agitated about ministers' "unrealistic" plans to tighten the rules on conflicts of interests. The ABPI complained ministers were "being too restrictive in the requirement for experts to not hold any personal interests in the pharmaceutical industry."

Professor Abraham claims there is too much of the "revolving door" syndrome at the MHRA. Not only do CSM members take fees from industry, but many agency officials used to work for drug companies, such as the former head of worldwide drug safety at GlaxoSmithKline, who is now the MHRA's head of licensing.

By Rob Evans and Sarah Boseley posted 5 October 04

Related:

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Prozac must have suicide warning
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NT activists await Supreme Court decision
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Research points to corporate journalists alcohol-schizophrenia link
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Fremantle police at centre of missing cannabis claims
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Canadian PM pledges to decriminalise marijuana
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Don't bash us on Saturday
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Heroin: Hazy logic dictates a painful prohibition
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Port Lincoln Mayor has lost the plot!
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Sign, sign everywhere a sign
The Syringe Festival was first held in Darwin in August 2002. The event, organised by the Network Against Prohibition was held as a protest against the Territory's new "drug house" laws that came into effect on August 1 last year, as well as a celebration of drug culture.

QANTAS pooping on people?
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NSW Ombudsman to probe police 'move-on' powers
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Drug law blamed for hep C epidemic
THE federal Government's conservative tough-on-drugs policies have triggered an explosion in hepatitis C infections, a secret health department report has found.

Jail trade in 'sex for favours'
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CWA wants pot legalised
PERCEIVED as the height of conservatism, the Country Women's Association has had a reputation for baking and handicrafts until now. The organisation yesterday confirmed it is seeking to have cannabis legalised for health reasons. A recommendation to be put forward to the annual meeting in May calls for the legalisation of the drug for the treatment of terminally ill patients.

The Thai Drug Users' Network is a group of individuals who use or have used drugs We have come together to respond to the deplorable health and human rights situation of drug users in our country, and in particular the current climate of fear caused by the extrajudicial killing of people allegedly involved with drugs.

Another lethal party drug article...
This is another lethal party drug article by the Daily Telegraph's (DT)'s Super Crime Buster Division, but I'll try to straighten it out a bit so you can understand it.

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Police selling drugs? Bikies selling drugs? Pharmacies prescribing drugs Of course there will be criticism when you cross that thin blue line! You have to realise how the government itself has been corrupted because of the drug scene and the money involved.

Drug rehabilitation: Threats, threats and more threats!
But a spokesperson for Citizens Against Being Forced Mr Ihave Amind Ofmyown said, "Major Watters is John Howard's adviser because he's a bully. Citizens make their own decisions about what is best for them and if you don't like that step down."

MPs told of police corruption
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Monday, October 4, 2004

Drugs licensing flaws exposed

Special report: Pfizer advised on how to get antidepressant approved by member of body deciding on application.

A leading figure in the world of psychiatry gave a pharmaceutical company advice on how to get its new drug approved while he was sitting on the committee which was deciding the licence application.

An internal memorandum from Pfizer, the world's largest drug company, says Stuart Montgomery would be happy to become a paid adviser and declare an interest to the Committee on the Safety of Medicines (CSM) once the drug, an antidepressant to rival Prozac, had been through the licensing process.

The drug, sertraline, which acquired the brand name Lustral, became a billion-dollar success, but is now one of several banned from use in children in the UK because of evidence they can cause them to become suicidal. Their use in adults is under investigation.

Dr Montgomery says his ad vice to Pfizer in 1989 was permissible because he was not receiving money from the company at the time. But Kent Woods, chief executive of the drug regulatory body which grants licences on the advice of the CSM, said such conduct was "absolutely unacceptable".

"Not only does each member [of the CSM] on appointment sign a letter ensuring confidentiality but at every meeting, the chair as a matter of routine reminds everybody that proceedings are confidential," he said. If the company had questions, they should have talked to officials of the Medicines and Healthcare products Regulatory Agency (MHRA), not the independent CSM experts.

Critics say the case exposes weaknesses in the drug licensing system, run by a regulatory body which, other papers obtained reveal, it has an unquestioning relationship with drug companies.

That relationship is so close that the pharmaceutical trade body in June drew up a business plan for the regulator, concluding: "Our priorities are aligned."

In the first of a two-part investigation into the influence of the drug companies over doctors and government intimacy between the industry and the regulator.

The MHRA is responsible for licensing medicines and regulating the industry. It relies on the advice of the independent experts on the CSM when it grants a new product licence. These experts, from all fields of medicine, are supposed to declare any pharmaceutical company interests, such as consultancies, fees and shareholdings, and must leave the room when drugs from companies that have paid them are discussed.

During his time on the CSM, Dr Montgomery disclosed payments for lectures and advice from Eli Lilly, the makers of Prozac, and from Organon, Beecham, Merck, Sanofi, Glaxo, Novo, Jouveinal, Duphar, Wyeth and Almirall.

Dr Montgomery, who held a joint post with St Mary's hospital, Paddington, and Imperial College in London, was a psychiatric expert on the CSM. His opinion was crucial in 1989, when the Medicines Control Agency as it was then known was considering an application from Pfizer for a licence for sertraline.

A confidential internal memorandum from Pfizer, dated April 24 1989, which was submitted in evidence to a recent court case in the US, has together with Mind, the national association for mental health, which has been campaigning for better drug regulation. Richard Brook, its chief executive, will today call for an external inquiry. "There is clear confusion about the role that Dr Montgomery was playing in this situation," he said.

"It also makes it very difficult for outsiders to believe there was not a serious conflict of interest when one of the major experts on depression involved in the CSM is actually speaking to a drug company about how they best present their results for licencing."

Dr Montgomery became a professor of psychiatry at Imperial College in 1993. The journal he edits, International Psychopharmacology, regularly publishes company-funded studies of antidepressants, as other journals do. He authors many of the papers, often jointly with other senior figures in the field.

The memo reveals that Dr Montgomery met Pfizer officials at St Mary's. He told them the committee had accepted that the drug was effective but "the safety analyses require re-presentation" and he advised them how to go about it.

He told Pfizer they must appeal against the CSM's initial decision. The memo reveals that Dr Montgomery is not going to declare an interest in Pfizer.

"He would still like to remain a disinterested party at the CSM till the appeal was heard," says the memo. "Thereafter he would be happy to act as an adviser to Pfizer and declare an interest."

The Pfizer drug got its approval first in the UK. Other European regulators were not happy that the data from clinical trials proved it worked.

Dr Montgomery said he had no conflict of interest over Pfizer. "My comments to Pfizer in 1989 were the usual clarification of the objections of the CSM to their application. At that time I had no conflict of interest with Pfizer, I was not a paid consultant, I was not in receipt of research grants from Pfizer, and I did not own shares in Pfizer," he said.

"The extracts from the memorandum make it clear that I was a disinterested party and was not prepared to consider a relationship with Pfizer while an application was under review."

By Sarah Boseley posted 6 October 04

Prozac must have suicide warning

All antidepressant drugs must carry the strongest possible public warning that they could cause children to harm themselves or commit suicide, US authorities said yesterday in a landmark ruling which has repercussions for the whole class of drugs.

Related:

Big Pharma snared by net
What if ants could turn the microscopes on the scientists studying them and, after beady-eyed surveillance, demand a revolution in their scrutinisers' accustomed ways?

Aspartame, medication and prison mental health
Justice Health and Corrective Services under 'Duty of Care' provide a lethal cocktail to its prisoners' by way of a so-called sweetener! This on its own is considered a lethal cocktail!

Medical trials of cannabis show positive results
Research could soon show that cannabis could be a helpful long-term treatment for multiple sclerosis sufferers. Patients who took part in a 15-week study - published in the Lancet last year - went on to try the effectiveness of the banned drug, [herb], for a 52-week course, John Zajicek of the Peninsula medical school told the British Association science festival which ended in Exeter.

NT activists await Supreme Court decision
Four human rights activists facing jail for a protest in the Northern Territory Parliament now face a tense wait for an appeal decision against the conviction to be handed down by the NT Supreme Court. The group were protesting against the Labor Government's "drug house" legislation and continued racism in the Northern Territory.

Research points to corporate journalists alcohol-schizophrenia link
New research has revealed more evidence of a link between corporate media journalists and schizophrenia. A national conference beginning in Melbourne today will examine international studies about the issue.

Fremantle police at centre of missing cannabis claims
One sunny day I was riding my bike, and smokin' a joint, 'cause that's what I like. A police man stopped me and began to stare and he said "hey sonny, whatcha smokin' there?"

Canadian PM pledges to decriminalise marijuana
Prime Minister Paul Martin has pledged to reintroduce legislation this year to decriminalise the possession and use of small amounts of marijuana.

Don't bash us on Saturday
Human rights activists in Darwin are concerned for their safety and the safety of the public at this week's Network Against Prohibition (NAP) Community Smoke-In for Human Rights.

Heroin: Hazy logic dictates a painful prohibition
Between moments of pungent humour, The Barbarian Invasions is a confronting movie. Facing a painful death to cancer, Remy, a self-described "socialist, hedonist lecher", accepts Montreal's crumbling, cramped public health system as his left-wing fate.

Port Lincoln Mayor has lost the plot!
Controversial Port Lincoln Mayor Peter Davis has called for drug addicts to be given a lethal injection to cut rising illicit drug use on South Australia's Eyre Peninsula.

Sign, sign everywhere a sign
The Syringe Festival was first held in Darwin in August 2002. The event, organised by the Network Against Prohibition was held as a protest against the Territory's new "drug house" laws that came into effect on August 1 last year, as well as a celebration of drug culture.

QANTAS pooping on people?
Ten unions are involved in the campaign against the program. They say they do not oppose drug and alcohol testing to prevent and determine impairment, but they are concerned that the trial will force workers to reveal use of prescription medicines or over-the-counter drugs.

NSW Ombudsman to probe police 'move-on' powers
Concerns have been raised that police may be unfairly targeting young people. The audit is part of a review of the extra powers officers were given to help tackle the illegal drug trade in Cabramatta in south-west Sydney.

Drug law blamed for hep C epidemic
THE federal Government's conservative tough-on-drugs policies have triggered an explosion in hepatitis C infections, a secret health department report has found.

Jail trade in 'sex for favours'
Professor Harding found evidence of bullying and standover tactics at the jail, often associated with the distribution of illegal drugs.

CWA wants pot legalised
PERCEIVED as the height of conservatism, the Country Women's Association has had a reputation for baking and handicrafts until now. The organisation yesterday confirmed it is seeking to have cannabis legalised for health reasons. A recommendation to be put forward to the annual meeting in May calls for the legalisation of the drug for the treatment of terminally ill patients.

The Thai Drug Users' Network is a group of individuals who use or have used drugs We have come together to respond to the deplorable health and human rights situation of drug users in our country, and in particular the current climate of fear caused by the extrajudicial killing of people allegedly involved with drugs.

Another lethal party drug article...
This is another lethal party drug article by the Daily Telegraph's (DT)'s Super Crime Buster Division, but I'll try to straighten it out a bit so you can understand it.

Poison Ivy: Drugs and Substances
Everything is a drug love, money, vegemite, and honey so why the hang up on coke? Things go better with Coke. at least that's what we're told each and every day by advertising. [?] So why the big hang up on alcohol, amphetamines, cigarettes, marijuana, speed, ecstasy and cocaine?

Police selling drugs? Bikies selling drugs? Pharmacies prescribing drugs Of course there will be criticism when you cross that thin blue line! You have to realise how the government itself has been corrupted because of the drug scene and the money involved.

Drug rehabilitation: Threats, threats and more threats!
But a spokesperson for Citizens Against Being Forced Mr Ihave Amind Ofmyown said, "Major Watters is John Howard's adviser because he's a bully. Citizens make their own decisions about what is best for them and if you don't like that step down."

MPs told of police corruption
Corruption and mismanagement are still entrenched in the NSW Police, and problems at the highest levels are "whitewashed", according to evidence given yesterday to a federal parliamentary committee.

Alcohol is just the beginning
People who start using alcohol by their mid teens are more than twice as likely as others to experiment with different drugs and to become dependent on drugs a major Australian study has found.

Tobacco, alcohol top the drug abuse toll
Tobacco and alcohol accounted for 83 per cent of the cost of drug abuse in Australia, dwarfing the financial impact of illegal drugs, a Commonwealth Government report has found.

NSW police cracked up on antisocial behaviour
Hundreds of extra police will be on the streets of Sydney from this afternoon as part of a major blitz on crime and activities as "antisocial behaviour" says the ABC online last Fri 24 May 2002.

Alcohol pickles your brain
The only two social drugs the Government sanction are cigarettes and alcohol as legal, yet they cause the most damage." He said.

Monday, September 27, 2004

Big Pharma snared by net

UK The web has helped consumers turn tables on the drug giants, says Cheryll Barron.

What if ants could turn the microscopes on the scientists studying them and, after beady-eyed surveillance, demand a revolution in their scrutinisers' accustomed ways?

This is more than a variation on Lilliputians for a new Jonathan Swift to consider; it's a metaphor for a real-life reversal of multinational power that has no precedent.

Management tomes of the late 1990s - like Bill Gates's droning Business, the Speed of Thought - explained how the internet might be used to study customer behaviour minutely, through, for instance, 'data mining'.

Companies, they said, could use the intimate understanding so acquired to address customers' needs and preferences, on the companies' terms. What no one foresaw was the shocking extent to which the internet would change the terms of trade between corporations and society.

Certainly not that one of the world's largest drug companies, which is among the richest and most influential industries of all time, would be the first victim of the shift.

The crisis that began the containment of pharma power is a runaway rate of drug injury. In England alone, reactions to drugs that led to hospitalisation followed by death are estimated at 5,700 a year and could actually be closer to 10,000, according to a study in The British Medical Journal in July. The researchers reckon that adverse drug reactions are costing the NHS £466m a year.

Drug injury has been worrying experts for decades. But after the thalidomide tragedies of the 1950s, the subject failed to catch fire for politicians and the public until the recent antidepressant controversy.

Last month, that debate made headlines when Britain's GlaxoSmithKline, the world's second-largest pharma, denied any wrongdoing, but agreed to pay $2.5m to settle a lawsuit filed by the State of New York accusing it of fraud for concealing evidence of its antidepressant Seroxat's potential for harming children, while doing them no measurable good.

In a sequel last week, a group of about two dozen American parents sued GSK seeking refunds for treatment of their children with the drug. The GSK suit created the tipping point in the pharmas' change of fortune and has revealed the force behind it.

The formal complaint drew heavily on research by public health campaigners and consumer advocates about the hazards of antidepressant use. These activists had toiled in deepest obscurity - some of them, for a decade - until their discoveries were featured on a Panorama programme, 'Secrets of Seroxat', in autumn 2002.

A follow-up broadcast the next spring, 'Emails from the edge', analysed 1,370 messages from viewers about the first programme, mostly from people reporting antidepressant withdrawal reactions including shock-like sensations in their heads, and thoughts about self-mutilation, violence and suicide.

The outcry that followed forced GSK to make a stunning admission. In June 2003, it corrected its prescribing instructions for Seroxat, revising its estimate of the risk of withdrawal symptoms from one in 500 to one in four.

Infinitely more frightening than that reluctant confirmation of a drug's potential for harm was that in the years GSK spent denying it, this pharma had the backing of institutions that we, the public, rely on to protect us from poisoning by prescription.

The Royal College of Psychiatrists had insisted only a year earlier that 'there is no evidence that antidepressant drugs can cause dependence syndromes'; a patient information leaflet approved by a regulatory body also said as much. The events that led to Seroxat's exposure would seem to suggest that it was television power that forced GSK to recant. But it was really the internet that allowed public health activists to do an end run around GSK's and the medical authorities' denials of the drug's risks. An explosion of websites dedicated to vivid accounts of antidepressant reactions told these campaigners about hundreds of thousands affected by a problem that officially did not exist.

The internet was 'groaning with evidence'; over time, the 'cover-up became more obvious as the weight of scientific evidence got stronger and public protest grew'. Those are quotations from a magisterial history and analysis of the antidepressant crisis by two leading campaigners, Charles Medawar and Anita Hardon, in Medicines Out of Control?, a new book recommended by the Lancet as essential reading for members of the parliamentary committee examining pharma influence on health policy, whose hearings began last week.

As critical to the pharmas' outing as the raw data on the internet was this medium's capacity for handling complexity - at the speed of firing neurons. Mood medicines are arguably even more complicated than computers. Software's complexity is largely restricted to the science behind it, and to products and their intermeshing with other products. Pills have extra intricacies that follow from variations in formulations of the same types of drugs, in the range of possible reactions, some of them subtle, in patients - even to different doses, in the same person - and consequences not just from interactions with other drugs but with non-pharmaceutical treatment and lifestyle aspects such as diet.

Health campaigners trying to decide what the pharmas could reasonably be blamed for shared vast stores of data about such complexities by - among other means - encyclopaedic technical postings on their websites. Some of these sites also feature open access to years of correspondence between the activists and regulatory officials and pharma executives. Postings like these have allowed rapid international co-ordination between the campaigners.

Pharmas bent on redeeming their reputations have suddenly begun to use the internet to publish what they once fought for the right to conceal. GSK's first notable response to the filing of the recent lawsuit was to start posting both negative and positive findings from drug tests on its web site. But it is far from the only pharma with a history of secretiveness about trials, and at least three of its rivals have copied its turnabout, with Eli Lilly and Merck making the most radical moves towards transparency.

Even top-ranking pharma executives might not yet grasp that this is only the start of a progressive stripping away of power. They could do worse than adopt for a model Gulliver, who reacted to his entrapment by the Lilliputians with a 'promise of honour', for fear that the showers of tiny arrows his captors used to disable him might be far from the worst they could do.

Bitter pills

Bit by bit, health activists in Britain and America have uncovered the core of pharma might: a sinister mesh of hidden influences in the regulation and practice of medicine that is painstakingly dissected in Medicines Out of Control? by Charles Medawar and Anita Hardon.

In both countries, clinical drug tests are paid for by the pharmas, who tweak the trials' design for the best possible results. Until recently, only the most favourable findings got published in the 20,000-odd biomedical journals, many of them dependent on pharmas for funding.

The drugs are approved for marketing by regulators, whose salaries are mostly financed by the subjects of their evaluations - since pharmas pay to have their products vetted. The medicines are then prescribed by doctors routinely courted with pharma gifts - from free pens to family skiing holidays - meant to persuade them to change their prescribing habits.

By Just Us posted 27 September 04

Prozac must have suicide warning

All antidepressant drugs must carry the strongest possible public warning that they could cause children to harm themselves or commit suicide, US authorities said yesterday in a landmark ruling which has repercussions for the whole class of drugs.

Related:

Aspartame, medication and prison mental health
Justice Health and Corrective Services under 'Duty of Care' provide a lethal cocktail to its prisoners' by way of a so-called sweetener! This on its own is considered a lethal cocktail!

Medical trials of cannabis show positive results
Research could soon show that cannabis could be a helpful long-term treatment for multiple sclerosis sufferers. Patients who took part in a 15-week study - published in the Lancet last year - went on to try the effectiveness of the banned drug, [herb], for a 52-week course, John Zajicek of the Peninsula medical school told the British Association science festival which ended in Exeter.

NT activists await Supreme Court decision
Four human rights activists facing jail for a protest in the Northern Territory Parliament now face a tense wait for an appeal decision against the conviction to be handed down by the NT Supreme Court. The group were protesting against the Labor Government's "drug house" legislation and continued racism in the Northern Territory.

Research points to corporate journalists alcohol-schizophrenia link
New research has revealed more evidence of a link between corporate media journalists and schizophrenia. A national conference beginning in Melbourne today will examine international studies about the issue.

Fremantle police at centre of missing cannabis claims
One sunny day I was riding my bike, and smokin' a joint, 'cause that's what I like. A police man stopped me and began to stare and he said "hey sonny, whatcha smokin' there?"

Canadian PM pledges to decriminalise marijuana
Prime Minister Paul Martin has pledged to reintroduce legislation this year to decriminalise the possession and use of small amounts of marijuana.

Don't bash us on Saturday
Human rights activists in Darwin are concerned for their safety and the safety of the public at this week's Network Against Prohibition (NAP) Community Smoke-In for Human Rights.

Heroin: Hazy logic dictates a painful prohibition
Between moments of pungent humour, The Barbarian Invasions is a confronting movie. Facing a painful death to cancer, Remy, a self-described "socialist, hedonist lecher", accepts Montreal's crumbling, cramped public health system as his left-wing fate.

Port Lincoln Mayor has lost the plot!
Controversial Port Lincoln Mayor Peter Davis has called for drug addicts to be given a lethal injection to cut rising illicit drug use on South Australia's Eyre Peninsula.

Sign, sign everywhere a sign
The Syringe Festival was first held in Darwin in August 2002. The event, organised by the Network Against Prohibition was held as a protest against the Territory's new "drug house" laws that came into effect on August 1 last year, as well as a celebration of drug culture.

QANTAS pooping on people?
Ten unions are involved in the campaign against the program. They say they do not oppose drug and alcohol testing to prevent and determine impairment, but they are concerned that the trial will force workers to reveal use of prescription medicines or over-the-counter drugs.

NSW Ombudsman to probe police 'move-on' powers
Concerns have been raised that police may be unfairly targeting young people. The audit is part of a review of the extra powers officers were given to help tackle the illegal drug trade in Cabramatta in south-west Sydney.

Drug law blamed for hep C epidemic
THE federal Government's conservative tough-on-drugs policies have triggered an explosion in hepatitis C infections, a secret health department report has found.

Jail trade in 'sex for favours'
Professor Harding found evidence of bullying and standover tactics at the jail, often associated with the distribution of illegal drugs.

CWA wants pot legalised
PERCEIVED as the height of conservatism, the Country Women's Association has had a reputation for baking and handicrafts until now. The organisation yesterday confirmed it is seeking to have cannabis legalised for health reasons. A recommendation to be put forward to the annual meeting in May calls for the legalisation of the drug for the treatment of terminally ill patients.

The Thai Drug Users' Network is a group of individuals who use or have used drugs We have come together to respond to the deplorable health and human rights situation of drug users in our country, and in particular the current climate of fear caused by the extrajudicial killing of people allegedly involved with drugs.

Another lethal party drug article...
This is another lethal party drug article by the Daily Telegraph's (DT)'s Super Crime Buster Division, but I'll try to straighten it out a bit so you can understand it.

Poison Ivy: Drugs and Substances
Everything is a drug love, money, vegemite, and honey so why the hang up on coke? Things go better with Coke. at least that's what we're told each and every day by advertising. [?] So why the big hang up on alcohol, amphetamines, cigarettes, marijuana, speed, ecstasy and cocaine?

Police selling drugs? Bikies selling drugs? Pharmacies prescribing drugs Of course there will be criticism when you cross that thin blue line! You have to realise how the government itself has been corrupted because of the drug scene and the money involved.

Drug rehabilitation: Threats, threats and more threats!
But a spokesperson for Citizens Against Being Forced Mr Ihave Amind Ofmyown said, "Major Watters is John Howard's adviser because he's a bully. Citizens make their own decisions about what is best for them and if you don't like that step down."

MPs told of police corruption
Corruption and mismanagement are still entrenched in the NSW Police, and problems at the highest levels are "whitewashed", according to evidence given yesterday to a federal parliamentary committee.

Alcohol is just the beginning
People who start using alcohol by their mid teens are more than twice as likely as others to experiment with different drugs and to become dependent on drugs a major Australian study has found.

Tobacco, alcohol top the drug abuse toll
Tobacco and alcohol accounted for 83 per cent of the cost of drug abuse in Australia, dwarfing the financial impact of illegal drugs, a Commonwealth Government report has found.

NSW police cracked up on antisocial behaviour
Hundreds of extra police will be on the streets of Sydney from this afternoon as part of a major blitz on crime and activities as "antisocial behaviour" says the ABC online last Fri 24 May 2002.

Alcohol pickles your brain
The only two social drugs the Government sanction are cigarettes and alcohol as legal, yet they cause the most damage." He said.

Friday, December 12, 2003

UK bans SSRIs for kids

Modern antidepressant drugs which have made billions for the pharmaceutical industry will be banned from use in children today because of evidence, suppressed for years, that they can cause young patients to become suicidal.

The Medicines and Healthcare Products Regulatory Agency (MHRA) told doctors last night not to prescribe all but one of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs). The exception is Prozac, which is licensed for use in depressed children in the US. But the MHRA will warn that, at best, it helps only one child in 10.

The decision has big implications for drug regulation.

The agency - which is the government's watchdog body on drug safety has reached this point only after intense pressure from patients and campaigners. They were concerned about patients - at first mainly adults - who appeared to have become suicidal on the drugs, and others who had got hooked and suffered distressing symptoms when they tried to stop taking them.

Public unease about these potential side-effects prompted the agency to investigate last year. It has looked at the details of clinical trials of depressed children that were in the hands of the drug companies in the late 1990s.

These studies revealed the problem of suicidal behaviour in children, but the companies did not draw it to the attention of the regulators in the US or the UK. It has become clear from the investigation that the regulators generally see only a summary of the data resulting from trials. It is prepared for them by the drug company only when it is seeking a licence.

The agency became aware of a problem with Seroxat in children this year only when the manufacturer, GlaxoSmithKline, submitted data from trials which finished in 1996. Pressure for a change in the regulatory system will inevitably grow.

Two of the SSRI class of drugs have already been banned - or, technically, contra-indicated in children - by the agency. The first, in June, was Seroxat, which goes by the generic name paroxetine; the second, in September, was Efexor (venlafaxine); joining them now will be Lustral (sertraline), Cipramil (citalopram), Cipralex (escitalopram) and Faverin (fluvoxamine).

Trials on children have not been carried out in all the drugs, but the completed studies show a worrying increase in suicidal behaviour among those on SSRIs compared with those given a placebo (sugar pill). None of the drugs has a licence for use in children with depression in the UK, but GPs have prescribed more and more SSRIs for children.

It is estimated that as many as 50,000 children on antidepressants in Britain.

The agency will warn that patients should not stop their medication suddenly to avoid withdrawal symptoms.

The ban will cause problems for doctors because insufficient counsellors and psychotherapists are available to offer the alternative treatment of therapy, and the bill to the NHS for such treatment would be much higher than the cost of the drug prescriptions.

Drug companies began clinical trials on the safety and efficacy of the SSRIs in children only after prompting by the US food and drug administration in the early 90s. David Healy, the director of the North Wales department of psychological medicine, said: "It was standard practice for the FDA approving drugs like Seroxat (Paxil in the US) for adults in 1991 to write to the company and say this drug will also be used in children - it would be helpful if you could run trials in children so we can see what the safety profile is."

But trials that did not produce favourable results were neither published nor sent to the FDA or the MHRA.

The first major Seroxat trial in children was finished by 1996, but the results were not published until 2001. Data was also gathered in 1996 after a trial of Lustral, manufactured by Pfizer, showing that 9% of depressed children on the drug became suicidal.

Dr Healy, whose own researches led to the establishment of the SSRI review, said yesterday: "They should have known by 1996 that there was a problem. GSK and Pfizer were asked to do this by the regulators so that we knew what the safety issues were." The drug companies dispute that a problem exists.

Only a tiny minority of children taking the drug become suicidal and their depression could be the real cause, they claim. GSK says several trials, not just one, were needed to establish whether its drug caused problems.

The SSRI review group, which has advised the Committee on the Safety of Medicines of the agency to ban the drugs from use in children, will now look at the safety and efficacy of the drugs in adults.

Sarah Boseley, health editor Posted 11 December 03

THE DOG: Seems Britain has finally bitten the bullet and banned SSRI prescriptions for kids - with a similar review of their use by adults now underway. The exception is Prozac, which considering the strong evidence that it is no better than the other SSRIs seems to be more a reflection of the PR muscle of Eli Lilly than an evidence based medical decision.

The Aus psychiatric establishment is firmly in the pocket of these companies - a situation that only continues to get worse as they tighten their grip on the Royal Australian & NZ College of Psychiatry, Beyond Blue, individual practitioners and 'consumer groups' like the Schizophrenia. So don't expect to see a similar ban here until the bodies have piled up too high to be ignored.


Drugs for depressed children banned

They ain't Goth and they ain't yuppie. They won't get you the hottest date for the prom and they won't lose your virginity for you. And they ain't as cheap as your sister's Happy Meal. In fact, the latest trend doesn't come in your size at the Gap. But it does come with side effects nausea, vomiting, weight gain and sleep disorders, just to name a few.

Related:

UK: Broadmoor lets out woman, 94, after 40 years
A woman of 94 has been released from Broadmoor high-security hospital after being kept there for 40 years, it is disclosed today.

Eli Lilly buys Schizophrenia Fellowship
I think anyone concerned about the capture of community/consumer groups by pharmaceutical companies will not feel reassured by the current website of the Schizophrenia Fellowship of NSW.

Submissions to the Inebriates Inquiry?
The Social Issues Committee is doing this inquiry. It came out of the alcohol summit. The Act allows detention of inebriates in proclaimed places, which no longer exist. The chief magistrate, Derek Price probably kicked it off with his submission to the Alcohol Summit. He also gave evidence, which was basically, 'Repeal the act as it does not work, and get a new act based on the Mental Health Act'.

Port Lincoln Mayor has lost the plot!
Controversial Port Lincoln Mayor Peter Davis has called for drug addicts to be given a lethal injection to cut rising illicit drug use on South Australia's Eyre Peninsula.

NT Drug house laws: Sign, sign everywhere a sign...
Tracks of a different kind will be laid in the Northern Territory of Australia in September as dozens of illicit drug users converge on the city of Darwin for the 2nd Darwin International Syringe Festival.

QANTAS drug testing: Pooping on people?
Some people struggle more than others do in order to survive. People take drugs to get through their life. Whether it's illegal or not has no bearing on what an employee can do for you as an employer.

Alcohol Abuse: You're one of my kind?
Special Minister of state John Della Bosca says there is only a small percentage of people who are alcoholics, but that small percentage has a disproportionate impact on their own health and costs to society. Small percentage? Excuse me? Do I need a calculator? Or do I need a new set of eyes? According to the statistics at least two million people abuse alcohol?

Australia: Wine glut alert?
Wine glut alerts bank to grape grower debt and we need to be aware there's no magic bullet here either, it is a chronic condition just like the other one? You know, Abra Cadabra.

Australian Alcohol Abuse: Abra Cadabra, I want to reach out and grab ya No magic bullet? This is a chronic condition! Government's Legal Drug Alcohol is costing Australia billions: study. Alcohol-related incidents cost the Australian taxpayer more than $7 billion in a single year. Of that sum, $2 billion arose from loss of life, pain and suffering. The report says in 1998 alone more than 2,000 Australians died from alcohol abuse.

Drug law blamed for hep C epidemic
THE federal Government's conservative tough-on-drugs policies have triggered an explosion in hepatitis C infections, a secret health department report has found. And the disease has become an "epidemic", with half a million Australians likely to have the debilitating virus by 2020.

MJA - BBCD Outbreaks in NSW prisons
Seems some of our friends in & around Corrections Health Service (CHS) were able to take advantage of a couple of recognised cases of needle sharing by HIV positive prisoners to gather data for a study.

Medicinal cannabis trial approved or not marijuana still remains a big hit! THE nation's first trial of cannabis for medical relief will begin in NSW by the end of the year, a move that Premier Bob Carr said yesterday would stop decent people feeling like criminals.

CWA wants pot legalised
PERCEIVED as the height of conservatism, the Country Women's Association has had a reputation for baking and handicrafts until now. The organisation yesterday confirmed it is seeking to have cannabis legalised for health reasons. A recommendation to be put forward to the annual meeting in May calls for the legalisation of the drug for the treatment of terminally ill patients.

Drunks propel rise in violent crimes! But who promotes drinking really?
Every day NSW police deal with more than 300 violent offences committed by people who are drunk and they say the number is rising. But they don't say because the government promotes alcohol and only alcohol.

Another lethal party drug article...
This is another lethal party drug article by the Daily Telegraph's (DT)'s Super Crime Buster Division, but I'll try to straighten it out a bit so you can understand it.

Poison Ivy: Drugs and Substances
Everything is a drug love, money, vegemite, and honey so why the hang up on coke? Things go better with Coke. at least that's what we're told each and every day by advertising. [?] So why the big hang up on alcohol, amphetamines, cigarettes, marijuana, speed, ecstasy and cocaine?

Police selling drugs? Bikies selling drugs? Pharmacies prescribing drugs Of course there will be criticism when you cross that thin blue line! You have to realise how the government itself has been corrupted because of the drug scene and the money involved.

Drug rehabilitation: Threats, threats and more threats!
But a spokesperson for Citizens Against Being Forced Mr Ihave Amind Ofmyown said, "Major Watters is John Howard's adviser because he's a bully. Citizens make their own decisions about what is best for them and if you don't like that step down."

MPs told of police corruption
Corruption and mismanagement are still entrenched in the NSW Police, and problems at the highest levels are "whitewashed", according to evidence given yesterday to a federal parliamentary committee.

Alcohol is just the beginning
People who start using alcohol by their mid teens are more than twice as likely as others to experiment with different drugs and to become dependent on drugs a major Australian study has found.

Tobacco, alcohol top the drug abuse toll
Tobacco and alcohol accounted for 83 per cent of the cost of drug abuse in Australia, dwarfing the financial impact of illegal drugs, a Commonwealth Government report has found.

NSW police cracked up on antisocial behaviour
Hundreds of extra police will be on the streets of Sydney from this afternoon as part of a major blitz on crime and activities as "antisocial behaviour" says the ABC online last Fri 24 May 2002.

Alcohol pickles your brain
The only two social drugs the Government sanction are cigarettes and alcohol as legal, yet they cause the most damage." He said.

Wednesday, December 3, 2003

Eli Lilly buys Schizophrenia Fellowship

I think anyone concerned about the capture of community/consumer groups by pharmaceutical companies will not feel reassured by the current website of the Schizophrenia Fellowship of NSW.

New Section on Quality of Life!

The Schizophrenia Fellowship of New South Wales recently developed best practice guidelines for the treatment of schizophrenia in conjunction with the NSW Centre for Mental Health, entitled "The Schizophrenias: Guidelines for a holistic approach to clinical practice". During this process, quality of life issues were identified as an important contributing factor to the recovery process.

With the financial support of Eli Lilly, this section of the web site is dedicated to these issues. Topics such as legal and human rights, homelessness and accommodation, consumer empowerment, family and partnerships, rural health, children of parents with a mental illness, sex and gender issues, late life schizophrenia and employment and vocational rehabilitation are addressed, taking into account the many situations that people living with a mental illness are faced with.

By Mental Health 3 December 03