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Editors call for drug-trial registry

17-Jun-2004

Related topics: Drug Delivery

A proposal requiring drug companies to register clinical trials in a public database to be considered for later publication - regardless of results - is being considered by top medical journals, writes Wai Lang Chu.

Adoption of this registration by the International Committee of Medical Journal Editors is certain to put pressure on drug companies to be more open about the clinical trials they conduct. The group has a significant voice, having 12 of the major medical journals including The Journal of the American Medical Association, The New England Journal of Medicine, The Lancet and the Annals of Internal Medicine within its ranks.

Under current regulations, pharmaceutical companies are not generally required to disclose results of a trial or even whether one was conducted. The tendancy by drug companies to focus on positive results has led to calls by academic researchers for a full registry of drug trials.

 

Calls for the introduction of a registry comes after an ongoing investigation that claimed GlaxoSmithKline (GSK) suppressed negative results of trials that tested the safety and efficacy of Paxil (paroxetine), its leading antidepressant drug.

 

The lawsuit was filed by Eliot Spitzer, the attorney-general of New York, who alleges that GSK: "misrepresented, concealed and otherwise failed to disclose to physicians" the negative results of four studies. These reported that Paxil was no more effective than placebo for depressed young people.

 

Paxil was prescribed to some 2.1 million US youngsters in 2002, an indication which earned about $55 million (€45 million) for the company that year, out of total worldwide sales of $3.8 billion. The drug lost US patent protection in 2003 and now faces stiff generic competition, with sales last year dipping to $3.4 billion.

 

Only this week, GSK responded to the lawsuit by publishing results of trials on its website showing the drug is broadly ineffective in children and adolescents and could increase risks of suicidal behaviour.

 

Glaxo has always denied the allegations, saying it has already publicised the results, either in medical journals or at scientific meetings.

 

The case of GlaxoSmithKline has highlighted an added motivation for the drug companies to join the proposed registry. Often drug companies use a publication of their drug in one of the respected journals to persuade doctors of its effectiveness and efficacy.

 

But it could be that drug companies who do not want to make their results public could still get the data published in less prominant medical journals, receiving lesser attention from the medical world.

 

Meanwhile, a resolution passed on Tuesday by the American Medical Association (AMA), the US's largest doctors' group, recommended that the federal government require drug manufacturers to create a national registry that would carry the results of all clinical drug trials and be accessible to doctors and patients.

 

The AMA said it was concerned that sponsorship of clinical trials by the drug industry was affecting quality and medical journals were tending to spotlight those tests with positive findings.

 

The drug companies responded by stating that they voluntarily disclose the results of all conducted clinical trials either at scientific conferences or through publications.

 

Chris Hunter-Ward, a spokesman for GSK responded to In-pharmatechnologist.com by saying: "We are sensitive to the needs regarding the AMA's resolution."

 

"Our policy at GSK has always been to communicate data from trials. We work to guidelines such as those of the Pharmaceutical Research and Manufacturers of America (PhRMA) which we helped to draft and which we fully endorse."

 

While progress has been made, the absence of a central registry in which all drug companies contribute and in which results are freely available makes it difficult for researchers to track all studies on a given drug.

 

Supporters of a central registry have said the database should ideally show when a trial was started, its objectives listed and any updated information with the trial's results or the reason it was terninated.

 

Only last week, a proposal to accept a trial registration as a requirement for publication was discussed at the journal editors' group meeting with an announcement of a decison due to come in the summer.