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UK: Drug giants warned: Tell the truth on medicines

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" After antidepressant treatments are discredited, fears grow that other

products may be ineffective " - Vaccines, perhaps?

http://www.independent.couk/life-style/health-and-wellbeing/health-news/drug

-giants-warned-tell-the-trth-on-medicines-787907.html

OR

http://tinyurl.com/yv5a3l

Drug giants warned: Tell the truth on medicines

After antidepressant treatments are discredited, fears grow that other

products may be ineffective

By nce, Health Editor

Wednesday, 27 February 2008

The pharmaceutical industry came under assault from senior figures in

medical research yesterday over its practice of withholding information to

protect profits, exposing patients to drugs which could be useless or harmful.

Experts criticised the stranglehold exerted by multinational companies over

clinical trials, which has led to biased results, under-reporting of

negative findings and selective publication driven by the market, which was

worth £10.1bn in the UK in 2006, amounting to 11 per cent of total NHS costs.

The latest attack was triggered yesterday by an analysis of published and

unpublished trials of modern antidepressants, including Prozac and Seroxat,

showing they offer no clinically significant improvement over placebos

(dummy pills) in most patients. But doctors said patients on the drugs

should not stop taking them without consulting their GPs.

It was the first time researchers – from the UK, Canada and the US – had

successfully used freedom of information legislation to obtain all the data

presented to regulators when the companies applied to license their drugs.

In some cases it had not been made public for 20 years. Over the past two

decades the drugs, known as selective serotonin re-uptake inhibitors

(SSRIs), have been among the biggest selling of all time, earning billions

of pounds for their makers. Yesterday's finding suggests that the money may

have been misspent. Drug companies are required by law to provide all data

on a drug, published and unpublished, to the regulatory authorities when

applying for a licence. But this requirement does not apply to the National

Institute for Health and Clinical Excellence (Nice), which assesses cost

effectiveness and recommends which drugs should be used by the NHS.

Littlejohns, the clinical and public health director of Nice, said:

" The regulatory authorities have access to everything. Obviously we have

access to the published data and we do ask the industry for unpublished

data, but it is up to the companies whether to deliver it or not. We have

no power to demand it. The issue is that it relies on the good will of the

industry. "

Professor Mike e, the director of the UK Cochrane Centre, an

international collaboration between researchers in 100 countries which has

published more than 3,000 systematic reviews of published trials to

establish best medical practice, said lack of co-operation from the drug

industry was damaging medical care.

" When we ask for details of a trial the company might tell us nothing. We

have even less power than Nice. Researchers trying to make sense of trials

for decision-makers need to have access to this data. If we have only got

access to half of the data, when we see evidence that a drug works we don't

know whether to believe it or not.

" It makes us doubtful – that's the big worry. The companies are in the

business of making profits – but they are also in the business of providing

safe, effective health care. "

Legislation to compel the drug industry to publish its results was included

in Labour's manifesto at the 2005 election and last month the Commons

Health Select Committee demanded that Nice be given unfettered access to

all clinical trial results.

Yesterday, the Government said it had been told that compelling the

industry to publish trial data would not be allowed and it was instead

pursuing a voluntary approach, developing a " searchable register " of all

trials that have taken place in the UK and pressing the EU to make its own

confidential register public.

A spokesman for the Department of Health said: " The Government has

consistently supported open access to information about research when the

findings could affect decisions about treatment or health outcomes. We

planned to support the principle of mandatory registration of clinical

trials in the UK, but legal advice stated this would be illegal under EU

law. " A World Health Organisation working group is examining how to improve

reporting of clinical trials and is expected to announce a consultation

shortly.

The pharmaceutical industry was unrepentant about its strategy yesterday.

Tiner, the head of medicines at the Association of the British

Pharmaceutical Industries, said: " The regulatory authorities have access to

all the data – absolutely everything. Nice is not a regulatory authority –

it is making decisions on whether medicines should be available on the

NHS... There is no reason why the companies would restrict access – it

depends what they are asked for. The industry is very much more transparent

than it was 10 years ago. "

GlaxoKline, maker of Seroxat, said yesterday it " fully endorsed public

disclosure of all clinical trial results " and had published all data

relating to Seroxat on its website " regardless of study outcome " .

The antidepressant debate

Bough, 41: 'You name it, I've tried it: none of them worked'

" The findings of this latest report don't surprise me in the slightest. In

fact, they confirm what I already knew.

" I've been a depressive for most of my life, and all of my adult life.

After the umpteenth failed suicide attempt seven years ago my doctor said I

should try taking antidepressant drugs. You name it, I've tried it.

epam, Citalopram, Prozac, Seroxat, Atenolol [a beta-blocker], Efexor:

none worked. They turned me into a zombie, totally incapable of motivation

or movement and forced to vegetate on a sofa.

" I'd say to anyone on these drugs, you're better off going cold turkey.

Talk to people, have therapy, be sociable: but don't rely on these little

happy pills. Having tried the lot, I'm coming off – and staying off. "

Sylvia Genge, 59: 'Without these drugs I would lose hope altogether'

" The findings go against several decades of experience. I have suffered

three major traumas in my life – my father leaving home when I was 11, my

husband having an affair, and now an unpleasant divorce – and I'm convinced

these drugs helped me survive them. I've been close to suicide myself, but

now, in my 60th year, I'm feeling positive and able to survive all the

terrifying experiences each day throws at me. I take 20mg of Fluoxetine

each day, and it makes me feel I can cope. I simply don't buy the idea that

it's just a placebo – but then I suppose the point is even if it were I

wouldn't care. These drugs are my crutch and my comfort; without them I

would lose hope altogether. I'm staying on. "

Click here to have your say

--------------------------------------------------------

Sheri Nakken, former R.N., MA, Hahnemannian Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

Vaccines - http://www.wellwithin1.com/vaccine.htm Vaccine Dangers &

Childhood Disease & Homeopathy Email classes start in March

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