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.


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.