Magazine article Information Today

Publication of Clinical Trial Data

Magazine article Information Today

Publication of Clinical Trial Data

Article excerpt

In a November 2004 announcement describing measures intended to ensure that the pharmaceutical industry operates more openly and transparently, U.K. Health Minister Lord Warner demanded that companies be more diligent in publishing clinical trials data for medicines (http://www.dh.gov.uk).

At the same time, it was announced that patients and the public will be given a greater role in the regulation of medicines by allowing for two lay representatives in a new commission (likely to be named the Commission on the Safety and Efficacy of Medicines). Individuals with interests in the pharmaceutical industry will be excluded from the commission.

The new commission will restructure the present Medicines and Healthcare products Regulatory Agency (MHRA) by amalgamating the responsibilities of the present Medicines Commission and the Committee on Safety of Medicines. It will directly advise ministers on matters relating to medicines intended for human use.

Warner said: "We are also asking the pharmaceutical industry to play their part by fulfilling their agreement to publish their clinical trials data for medicines we currently use. By working together with patients and with the industry, we can ensure that people get the safe and effective treatment they deserve."

Earlier in 2004, following claims that GlaxoSmithKline's (GSK) antidepressant drug paroxetine (commonly known by the brand names Seroxat and Paxil) increased the risks of self-harm and suicide, particularly in children under 18, the BBC investigative program Panorama accused the MHRA of failing in its duty to ensure the safety of prescribed drugs (see http://news.bbc.co.uk/ 1/hi/programmes/panorama/2310197.stm).

Ian Gibson, chairman of the House of Commons Science and Technology Committee, cited the Panorama report in a Westminster Hall debate held the day before Warner's announcement. (Gibson was also the chairman for the U.K. Select Committee's deliberations over open access publishing, which took place last summer.)

In the Westminster debate, Gibson said: "It is time for the culture of secrecy to be dealt with. The legal basis for the giving and withholding of information by the MHRA will change with [the] implementation of the Freedom of Information Act 2000, but the damage done by the public believing that they have been lied to or defrauded is extremely difficult to repair. The workings of the agency need to be reviewed thoroughly. There should be more lay involvement on the committees, openly published minutes, and a greater engagement with the public."

Encouraging companies to publish all clinical trial results should allay Gibson's and the public's fear that drug companies may only publish selective trial data (i.e., exclude negative results) in order to improve their market position. GSK has now made available its full study reports on the safety and efficacy of paroxetine in adolescent and pediatric patients at http://www.gsk.com/media/paroxetine.htm.

Parallels with U.S. Legislation

Pressure to publish clinical trial data in the U.K. mirrors, to some extent, activity in the U.S. The FairAccess to Clinical Trials (FACT) Act (S 2933) was introduced in October 2004 by Sens. Dodd, Kennedy, Johnson, and Wyden. A companion bill (H 5252) was introduced in the House of Representatives by Reps. Waxman and Markey. This legislation would require companies to publish trial data with the National Institutes of Health's ClinicalTrials.gov site and to register trials for advance approval by U.S. institutional review boards.

Registration with ClinicalTrials.gov or with ClinicalStudyResults.org, run by the Pharmaceutical Research and Manufacturers of America (PhRMA) industry group, is presently voluntary. However, the International Committee of Medical Journal Editors (ICMJE) has decided to require, as a condition of consideration for publication, that companies register in a public registry in advance of patient enrollment. …

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