David Rose
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An election pledge to require drugs companies to publish full details of clinical trials for medicines cannot be fulfilled because it is illegal under EU law, the Government has admitted.
Psychiatrists and health campaigners renewed a call yesterday for all data on the effectiveness of medicines to be published after a review of clinical trials concluded that antidepressant drugs were no more effective than a placebo for patients suffering from depression.
The pharmaceutical industry is encouraged to publish findings of all clinical trials online but is still, to a large extent, allowed to regulate itself. Critics argue that this system is not enough to ensure that patients, doctors and watchdogs, such as the the National Institute for Health and Clinical Excellence (NICE), get the information that they need to assess the effectiveness of drugs properly.
The review referred to trials submitted in the 1980s and 1990s when four antidepressant medications were being licensed by the US Food and Drug Administration.
The team, led by Irving Kirsch at the University of Hull, examined published and unpublished data from clinical trials obtained under Freedom of Information rules in the United States.
NICE said that it will consider the findings when it reviews its guidance on treatments for depression in December.
It is a criminal offence to withold information about safety issues or adverse drug reactions to the European Medicines Agency or the Medicines and Healthcare Regulatory
Authority, which licence medicines. But companies can still choose to not publish negative studies or supply full details to NICE, which rates the clinical effectiveness and value-for-money of treatments.
The 2005 election manifesto of Labour promised to “require registration of all clinical trials and publication of their findings for all trials of medicinal products with a marketing authorisation in the UK”. But the Department of Health said that it would be illegal, under European regulations, to make companies do this.
Tim Kendall, deputy director of the Royal College of Psychiatrists, who helped to create NICE’s guidance on treating depression, said: “We have called on the Government to change this and it is extraordinary that we did not know about this legal barrier before.”
A spokesman for the Department of Health said: “We planned to support the principle of mandatory registration of clinical trials but legal advice stated this would be illegal under EU law. For that reason we have adopted a voluntary approach in the UK.”
The spokesman said that the department had created a register of trials, which was available publicly, and that it was encouraging the EU to make public its medicines agency register.
The Association of the British Pharmaceutical Industry said that since 2005 all its members have been required to publish findings online within a year of clinical trials taking place.
In the review Professor Kirsch and his team found that even trials suggesting benefit for the depressed did not provide evidence of clear clinical benefit when compared with a placebo.
Louis Appleby, the National Clinical director for Mental Health, said: “New guidance on the treatment of depression will be issued later in the year. Until then the message to patients and doctors remains that antidepressants are an appropriate treatment.”
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How many more people will have their lives ruined before the drug companies, who cleverly disguise their GREED for profit as HELP for unfortunate customers, are asked to be accountable? We expect health providers to be effective and improve our wellbeing, but do they do this? Are they too more interested in making a quick buck than the welfare if others?
THIS HAS TO STOP AND STOP NOW.
Mary Maddock, Rochestown, Cork, Cork, Ireland
You must very soon forget about using any oils, vitamins or alternative health remedies. We are already signed up to THE CODEX AGENDA.
Under Codex rules common foods such as garlic and peppermint are classified as drugs or a third category (neither food nor drugs) that only big pharmaceutical companies regulate and sell. Any food with any therapeutic effect is considered a drug, even benign everyday substances like water. Dietary supplements can not be sold for preventive (prophylactic) or therapeutic use. Potencies are limited to extremely low dosages. Only the drug companies and the big phytopharmaceutical companies have the right to produce and sell the higher potency products (at inflated prices). Any product that is not covered by a patent is illegal to sell or use.
Germany and Norway have already put these rules into effect. There is now a push on the rest of the members to start complying. Mass public protest is a must if this agenda is to be halted.
Caroline Carter, Weybridge, Surrey, UK
As long as corporations can hide results not deemed to be in the corporate interest many of them of course will, thus undermining the whole meta-study process and rendering such studies utterly unscientific. That European regulations forbid legislation compelling publication of negative results has such profoundly negative public-policy implications for the entire world, I simply fail to see any legitimate argument for its continued existence. I would expect the scientific community, at least, to vigorously campaign to undo this heinous legislation. Indeed, I can't understand why it hasn't already done so, instead of publishing fundamentally flawed meta-studies. What does it say about the peer review process that scientists haven't exposed this "non-science" long before now? And what does it say about our politicians that they merely throw up their hands in despair? This is corrupt legislation designed to benefit corrupt corporations against the public interest. Ditch it!
Carl Olsen, Gibsons, Canada
There is a simple answer to this.
Pull out of Europe, so we can make our own laws again!
The government will ban super-casino's, because a handful of gamblers, but they wont make a law to protect hundreds of thousands of people, from drugs which either do not help, or can actually harm.
Arthur, Newcastle,
I was prescribed some SSRIs when I was unhappy about a relationship.
After a couple of days, my heart started racing and I got the shakes so bad that we called an ambulance. They told me to stop taking the pills immediately, but it took more than a day before I felt completely normal again.
Then I read that people in northern countries take fish oil to counteract seasonal depression, so I started taking 4 capsules of highly refined DHA and EPA (the best I could find.)
Its been 5 years, and I've never been depressed a single day after I started taking them, and I feel WONDERFUL!
Unfortunately, fish oil is not nearly as profitable, so don't expect your doctor to even mention the possibility to you!
Brian, London,
Hi: I was dealing with depression for several reasons. I tried some pills earlier, and wound up driving to the wrong city, while working (he didn't take me off work BTW; the pills said clearly "no operating vehicles"). So, I approached my doctor and he immediately prescribed more pills, before i was even done telling him my symptoms. I told him i did not want pills, just talk therapy. He kept trying to get me to take different types, i again stated "no".
My point is, he came across as some kind of drug dealer ,standing on a corner peddling his "junk" for his drug lords.
Finally, i had to tell him in no uncertain terms that i did not want pills, and if he kept pushing them on me i would take him to court for sending me to work while on the other ones. He then referred me to a phsycologist who implied i was being a wimp, and mostly rambled on about how tough she was during WWII. My point is,lets heal ourselves and leave these monkies to their own devices. Say 'NO" to Pills.
mr_bellows, Thunder Bay, Canada
They prescribed them for me when my mother was dying and my oldest child was moving out of state... Yeah, a pill should fix that...
I was one of the 1 in 10 with horrific side effects - 4 suicide attempts were the tip of the ice berg. These things are poison to the wrong people, then we are tossed under the bus. Two years after stopping ALL antidepressant or anti-anxiety meds, I finally fell human again. But my mother is still dead, and my baby girl went and grew up on me anyway. Hmmm, maybe there was not a pill for that after all?
Claire, Boise, USA
If these test results were published, at least the large proportion of the public that considers animal testing to be relevant would see the truth at last. But of course, profit before morality.
As for anti-depressants, chemicals treat chemical problems, not lifestyle problems. If you are depressed due to chemical imbalances then anti-depressants work. But if you are depressed due to the loss of a loved one, for example, they won't help one little bit. Talking therapy will. But trying to get that (or CBT) on the NHS is like trying to get the facts out of a pharmaceutical company!
Jennifer Hynes, Plymouth, England
what about open information about the products which DO work where no money can be made by pharmaceutical giants, natural progesterone being one very obvious case! not able to patent it, so any findings deemed to be helping people rubbished or supressed!
mary foord brown, suffolk coastal,
Another example of European corruption whereby a law that would protect us has been passed in the EU and we apparently cant override it. I'm sorry but this cannot go on we have to take back our powers and try to return to our higher moral standards.
allen, worcester, England
It's VERY important. Anti depressants are prescribed very lightly and quite often to people who aren't depressed at all. Even if the doctors are hoping for a placebo effect or to satisfy the client by prescribing antidepressants to the patients claim to being depressed or to be in good terms with pharmaceutical companies--- the bottom line is drugs are quite strong overall and psychiatry is at a very primitive state, despite the agressiveness of it's drugs and treatments, so I beleive much work is needed specially in the terms of mental health to healthier people instead of heading to an overmedicated society that beleives in the magical (placebo) effects of pills. Aditionally, some studies, despite not finding a benefit to psychiatric meds and or following wrong methods, recomend them. That's a horror!
Anne, Buenos Aires,