Companies selectively report clinical trial results, medical journals say
Greater openness is needed to stop clinical drug trials being distorted, leading medical journals have said. In a joint editorial, the 11 journals told researchers and firms to register trials at the start so unflattering or unclear results cannot be covered up.
The journals, including the BMJ, have agreed not to publish studies not registered straight away.
The International Committee of Medical Journal Editors said it was acting as some trial results were being withheld.
The committee’s commentary, which is appearing in all their publications, said: “Honest reporting begins with revealing the existence of all clinical studies, even those that reflect unfavourably on a research sponsor’s product.
“Unfortunately, selective reporting of trials does occur, and it distorts the body of evidence available for clinical decision-making.”
The decision by the journals came after concern that certain anti-depressants may make youngsters more likely to commit suicide.
Last month, GlaxoSmithKline agreed to release information on all its clinical studies to settle a lawsuit filed by New York Attorney General Eliot Spitzer, who had accused the firm of suppressing data on the anti-depressant Paxil.
Journals demanding openness
New England Journal of Medicine
New Zealand Medical Journal
Norwegian Medical Journal
The Annals of Internal Medicine
Croatian Medical Journal
Dutch Journal of Medicine
Journal of Danish Medical Association
Medical Journal of Australia
In a letter to the British Medical Journal, Professor Toshi Furukawa, a specialist in psychiatry based in Japan, said one drug company he had had experience with mislabelled the results of trials into an anti-depressant drug and wrongly categorised others.
He said in one case a child with symptoms of hopelessness and suicidal thoughts, who “punched pictures, broke class and sustained lacerations that required six sutures” was categorised as a case of aggression rather than of having an emotional liability or suicidal tendencies.
The industry has already made moves to address concerns about transparency.
In the UK, the Association of the British Pharmaceutical Industry set up a register on its website just over a year ago and now has eight companies which post their results there.
An ABPI spokesman told BBC News Online the association was sympathetic to the journals’ concerns and was confident its list met the demands.
But he added: “I have not seen any scientific evidence that results are not accurate. It is just not in the industry’s interests to fiddle results, the truth would be found out in the end.”
Elsewhere, a Europe-wide register of all unpublished data is set to become available to regulatory authorities under a new European Union directive.
And on 1 October, an internet-based registry will be launched, containing summaries of findings since 2002, by the US lobby group Pharmaceutical Research and Manufacturers of America (PhRMA).
Caroline Loew, PhRMA’s vice president for scientific and regulatory affairs, said the website would make “meaningful clinical trial results available to doctors and patients”.
But others remain less convinced. Dr Drummond Rennie, a deputy editor of the Journal of the America Medical Association, expressed doubts that the industry would go far enough.
“Progress is being made, but previous experience suggests that because of inherent conflicts of interest it is unlikely that industry will ever be able to establish a large, common, complete, useful, trustworthy, up-to-date and easily accessible register.”
Glaxo settles New York drug suit
Glaxo will now publish all test results online
GlaxoSmithKline has agreed to publish results of clinical tests on its drugs, to settle a US lawsuit. The firm was sued by New York attorney-general Eliot Spitzer over allegations that it withheld negative information about its antidepressant pill, Paxil.
The firm had already agreed to publish data on Paxil, also known as Seroxat.
But the deal with Mr Spitzer, which includes a $2.5m (£1.4m) payment, means the firm will publish all tests since December 2000 by the end of 2005.
The December 2000 cut-off marks the point at which Glaxo Wellcome merged with Smithkline Beecham.
Mr Spitzer has been dubbed “The Sheriff of Wall Street” for his relentless pursuit of corporate wrongdoing in the name of middle and low-income Americans.
His targets have included air polluters, Wall Street investment banks and the mutual funds in which the majority of US households have savings.
His inquiries have left a trail of financial settlements down Wall Street, as the US stock market watchdog opened its own investigations into his targets.
Nor has Mr Spitzer hesitated to take his crusades to Capitol Hill, leading to speculation that he has political ambitions of his own.
Glaxo first agreed to publish some of the data on Paxil in a “Clinical Trials Register” in June, just weeks after Mr Spitzer’s lawsuit was launched.
At the time, it also agreed to publish results of tests on new drugs.
But it is now promising to put historical data – affecting drugs it currently sells – on the web as well.
Tests on new drugs will be posted within 10 months of a product’s approval, Glaxo said, while future tests on existing drugs will be published within 10 months of completion.
The register will contain summaries of the results of clinical trials in a standard format, Mr Spitzer said in a statement.
In his suit, the New York attorney general said Glaxo had carried out five studies on Paxil’s effects on children and young people, but had only published one.
The unpublished ones suggested a possible increased risk of suicidal thinking in some individuals, the suit alleged.
It also accused the firm of suppressing the data from its regular advice to doctors.
The case was based partly on an internal document from 1999 which said the firm wanted to “manage the dissemination of data in order to minimise any potential negative commercial impact”.
Marjorie Wallace, Chief Executive of the mental health charity Sane, said: “We are delighted that GSK have now taken the lead in making all the information from clinical trials available to doctors and the public.
“All drugs have side effects, and everyones biochemistry is different.
“This new move will enable both doctors and patients to assess the risk, benefit and choice of drugs more safely.”
GSK knew Seroxat wasn’t ‘effective’ on children
Drugs giant GlaxoSmithKline knew that the anti-depressant Seroxat could not be proved to work on children in 1998, according to a leaked internal document.The secret document, relating to two clinical trials held in the 1990s, reveals that drug trials had shown little or no effect on helping depression in minors.
The company was also advised to avoid publishing the full data because it would be “commercially unacceptable” and would “undermine the profile” of the drug.
The confidential paper, sent anonymously to BBC’s Panorama programme, reveals that the company were advised to publish only the positive aspects of one study and that there were no plans to publish a second – more negative – study.
It also urged GSK not to send the data to the regulators because they would have had to include a statement about the effectiveness of the drug.
Last year, government advisors said that Seroxat should not be prescribed to children. The Committee for Safety in Medicine concluded that the risks outweighed the potential benefits after receiving new research from GSK.
The target of the confidential paper was to: “effectively manage the dissemination of these data in order to minimise any potential negative commercial impact.”
It was produced by the Central Medical Affairs team, a division within SmithKline Beecham (the name GSK was known as in 1998), with the job of managing issues across their portfolio of drugs.
The document claims that in one trial the drug was no more effective in reducing depression in minors than a placebo pill. In a second study, the placebo drug seems to be more effective in combating feelings of depression in teenagers.
It was concluded “it would be commercially unacceptable to include a statement that efficacy had not been demonstrated.”
The company was also worried that such a statement would “undermine the profile of paroxetine (Seroxat’s medical name).”
The document recommended that GSK publish only the positive data from one of the studies (study 329). This report was made publicly available in July 2001.
This study was conducted within the USA from 1993 until early 1996. It was the single biggest trial of any of the family of anti-depressants known as selective serotonin reuptake inhibitors, undertaken in children.
The results showed that while Seroxat did seem to work across all types of depression, it failed to show that it was significantly more effective than a placebo pill.
A second study (Study 377) was carried out over 12 weeks across Europe, South America, South Africa and Saudi Arabia.
The results of this trial – which has never been published, although it was orally presented in 1999 – found that children responded better to the placebo than to Seroxat.
Panorama first raised concerns about the safety of the drug Seroxat in October 2002. It has made two award winning films about the potential side effects of the drug and problems that some people have had withdrawing from it.
Dr Alistair Benbow, head of European Clinical Psychiatry for GlaxoSmithKline, said: “The memo draws an inappropriate conclusion and is not consistent with the facts.
“All of the safety data was submitted to the US and European regulatory authorities and was publicly presented in a timely way. In fact safety data from study 329 had already been submitted to the regulatory authorities and had been presented publicly before this document was written.”
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