Clinical Trial Transparency

Against this background, one government entity has already taken matters into its own hands. In June, New York's attorney general Eliot Spitzer filed suit in State Supreme Court in Manhattan seeking compensation for the “fraud” GlaxoSmithKline allegedly perpetrated against New York doctors and patients when it selectively chose not to reveal unfavorable test results that would have revealed the dangers young people faced in taking Paxil.

A Call for Information

Now, regulators and consumers are not the only ones calling for more information. In June, the International Committee of Medical Journal Editors (ICMJE) began considering a proposal to require drug manufacturers to register all clinical trials in an international database before beginning tests. The purpose of the registry would be to force drug developers to disclose the results of all tests, not just those that will tend to make a drug more commercially viable. The ICMJE, made up of 12 prestigious member publications, including The New England Journal of Medicine and The Lancet, would, under the proposed plan, decline to publish study results concerning pharmaceutical products whose research plans were not pre-registered and followed up in the database. Drug researchers might still be able to get their studies published in other medical journals, but the publications represented in the ICMJE are some of the most prestigious in the world and publication in them is considered a powerful marketing tool.

The participants at the American Medical Association's annual meeting in mid-June adopted a resolution calling for the federal government to set up a database for drug trial registration. The AMA's doctors want full information on test results so that they will be aware of possible side effects that might impact on their patients' health. Then, on June 18, The New York Times reported that representatives of the Merck pharmaceutical company said the manufacturer also supports a clinical trial registry.

A New Set of Principles

In response to all this activity, the Executive Committee of the Pharmaceutical Research and Manufacturers (PhRMA) unanimously adopted a set of principles for the conduct of clinical trials and the communication of results of clinical trials. The resolution, announced June 30, calls for PhRma member companies and others involved in clinical research to conduct trials according to a set of principles that include these: Clinical trials should be conducted in accordance with Good Clinical Practice, no matter where in the world the trials take place; clinical investigators should be independent and should be reasonably compensated, but not with stock from the trial's sponsor; trials should be reviewed by Institution of Review Boards or Ethics Committees before they are begun; trial participants should give their informed consent before taking part in clinical studies; study results should be timely reported, whether favorable or unfavorable, in an unbiased manner; study sponsors should not suppress publication of results; and only those who make substantial contributions to the clinical trial should be given authorship credit in publications of the results.

Although PhRMA asserts that adherence to ethics rules similar to these has been the norm for most pharmaceutical companies, its Executive Committee was moved to set these principles down in one place in order to restore confidence in the clinical trial process following the recent spate of media attention to the issue of unreported negative drug trial results. Although the PhRMA principles are voluntary only and not binding on PhRMA member companies, the organization expects that compliance will be ensured by the pressures of public opinion. PhRMA's updated principles for conduct of clinical trials and communication of clinical trial results are in effect for all trials begun after Oct. 1, 2002.

There's a newly urgent push from outside the pharmaceutical research and development community to get drug firms to disclose the results of all tests conducted on new drugs, even those that don't lead to the marketing of new medications.

The latest impetus for the movement apparently came from public outrage over undisclosed unfavorable results in tests of Paxil', the antidepressant manufactured by GlaxoSmithKline. The pharmaceutical manufacturer had published test results that showed Paxil's advantages in treating depression, but did not disclose certain problems that could develop when taking the drug. Some of those unfavorable test results came to light when a researcher who had worked on the development of Paxil disclosed them at a conference. Members of the public began to ask the question: “What else are the drug companies keeping from us?” When British regulators last year asked for and received unpublished test findings for several antidepressants, they got the full story. The British conclusion: Drug manufacturers had evidence that antidepressants could engender suicidal ideation in children and adolescents, but they had failed to clue the public in to these findings. Disclosure of this information, of course, caused a good deal of consternation in the medical world, with parents and medical practitioners questioning the wisdom of giving youngsters such medications at all.

New York Files Suit

Against this background, one government entity has already taken matters into its own hands. In June, New York's attorney general Eliot Spitzer filed suit in State Supreme Court in Manhattan seeking compensation for the “fraud” GlaxoSmithKline allegedly perpetrated against New York doctors and patients when it selectively chose not to reveal unfavorable test results that would have revealed the dangers young people faced in taking Paxil.

A Call for Information

Now, regulators and consumers are not the only ones calling for more information. In June, the International Committee of Medical Journal Editors (ICMJE) began considering a proposal to require drug manufacturers to register all clinical trials in an international database before beginning tests. The purpose of the registry would be to force drug developers to disclose the results of all tests, not just those that will tend to make a drug more commercially viable. The ICMJE, made up of 12 prestigious member publications, including The New England Journal of Medicine and The Lancet, would, under the proposed plan, decline to publish study results concerning pharmaceutical products whose research plans were not pre-registered and followed up in the database. Drug researchers might still be able to get their studies published in other medical journals, but the publications represented in the ICMJE are some of the most prestigious in the world and publication in them is considered a powerful marketing tool.

The participants at the American Medical Association's annual meeting in mid-June adopted a resolution calling for the federal government to set up a database for drug trial registration. The AMA's doctors want full information on test results so that they will be aware of possible side effects that might impact on their patients' health. Then, on June 18, The New York Times reported that representatives of the Merck pharmaceutical company said the manufacturer also supports a clinical trial registry.

A New Set of Principles

In response to all this activity, the Executive Committee of the Pharmaceutical Research and Manufacturers (PhRMA) unanimously adopted a set of principles for the conduct of clinical trials and the communication of results of clinical trials. The resolution, announced June 30, calls for PhRma member companies and others involved in clinical research to conduct trials according to a set of principles that include these: Clinical trials should be conducted in accordance with Good Clinical Practice, no matter where in the world the trials take place; clinical investigators should be independent and should be reasonably compensated, but not with stock from the trial's sponsor; trials should be reviewed by Institution of Review Boards or Ethics Committees before they are begun; trial participants should give their informed consent before taking part in clinical studies; study results should be timely reported, whether favorable or unfavorable, in an unbiased manner; study sponsors should not suppress publication of results; and only those who make substantial contributions to the clinical trial should be given authorship credit in publications of the results.

Although PhRMA asserts that adherence to ethics rules similar to these has been the norm for most pharmaceutical companies, its Executive Committee was moved to set these principles down in one place in order to restore confidence in the clinical trial process following the recent spate of media attention to the issue of unreported negative drug trial results. Although the PhRMA principles are voluntary only and not binding on PhRMA member companies, the organization expects that compliance will be ensured by the pressures of public opinion. PhRMA's updated principles for conduct of clinical trials and communication of clinical trial results are in effect for all trials begun after Oct. 1, 2002.