Unwitting Guinea Pigs EU Seeks To Reduce Patient Protection in Medical Trials

Strict regulations currently protect patients from being unwittingly used to test medications. But the EU is proposing changes to its Clinical Trials Directive that would eliminate the need for informed consent -- and be a boon to the pharmaceutical industry and other researchers.

Proposed new EU regulations could make clinical studies easier conduct, but they would also erode patients' rights.

Proposed new EU regulations could make clinical studies easier conduct, but they would also erode patients' rights.

"Study participants sought! Do you suffer from irritable bowel syndrome?"

So read the kind of ads that pharmaceutical research institutes post on buses and trains to attract volunteers looking to earn a bit of cash by being a guinea pig for drug tests. Sometimes it's about high blood pressure, sometimes about eczema, and sometimes the thing being researched remains unspecified. The important thing is rounding up enough participants for a clinical study.

If the European Commission gets its way with amendments to its Clinical Trial Directive, though, the search for subjects in tests involving not entirely new active ingredients will soon become much easier. According to its proposed amendment, it will suffice for a patient to land in a hospital currently running a certain clinical study. Whether a cancer patient or accident victim, the person will automatically become part of the test -- unless he or she explicitly declines to do so. If patients aren't in a position to decline because they are unconscious, they would have to be carrying a patient decree specifying that they do not want to be included in the tests. Such a regulation would even violate the EU's Charter of Fundamental Rights, which stipulates that patients must give their informed consent to be included in a test. Indeed, it would jeopardize one's right to bodily self-determination.

Negotiators in Brussels are still wrestling over every word in the draft regulation. Among its main opponents are German politicians focused on health issues. "Waiving the express consent of patients overturns the good rules of clinical praxis," says Peter Liese, a member of the European Parliament representing Chancellor Angela Merkel's center-right Christian Democratic Union (CDU).

In the coming weeks, physicians, politicians and industry representatives will meet to discuss the planned reform at a symposium in Berlin. They will address the issues of protecting human dignity and whether patients can unwittingly be put at the disposal of medical research.

The push for the regulation from Brussels has primarily economic motives. When presenting the plans last fall, then-European Commissioner for Health and Consumer Policy John Dalli said that there was an "urgent need to empower the pharmaceutical industry in Europe." He also noted that, between 2007 and 2005, the number of applications for clinical trials had dropped by 25 percent while test costs have continued to rise. Likewise, he added that many tests are now being conducted in newly industrializing countries -- which he saw as unacceptable for an already industrialized region like Europe.

Associations of medical specialists have also been criticizing the current situation in Europe. The German Society of Hematology and Oncology (DGHO), for example, claims that the situation has dramatically worsened in recent years "as a result of excessive bureaucracy." It also cites a recent survey of cancer researchers reportedly finding that a third of all trial-conducting institutions in Germany would like to cut back their study activities even further.

Many physicians back the reform in the belief that it will strengthen independent research by also making it easier to conduct non-commercial studies.

Sacrificing Rights for Expedience?

What is at issue now is whether the Commission can find the right way to, if possible, make desirable reductions in bureaucracy while safeguarding patients' inalienable rights. Seven hundred proposed amendments have already been submitted to the draft. Proposals from all 27 EU member states landed on the wish lists in the European Parliament, and lobbying groups have made their voices heard, as well.

The most controversial issue revolves around the roll of the ethics commissions. Under the current system, such bodies are responsible for approving a study before testing is allowed to begin on patients. But, under the amended version, ethics experts will examine such plans and only issue nonbinding opinions on them.

The current system is admittedly time-consuming and complicated. Under the federal structure of Germany, more than 50 ethics commissions have to authorize such studies regardless of the number of participating hospitals. Nevertheless, other researchers are voicing warnings about the plans from Brussels. Bernd Mühlbauer, a pharmacologist who sits on the board of the Drug Commission of the German Medical Association (DCGMA), says it is "completely incomprehensible" why the EU now wants to do away with all the important rules that the medical community worked out over the course of many years.

Mühlbauer believes that one could create exceptions to the rules for studies conducted by independent researchers. But, as it happens, even these kinds of research studies are frequently co-financed by pharmaceutical companies, for example, in an attempt to expand a drug's range of applications to include additional ailments.

Among the most far-reaching of the planned chances is that auditing authorities would only have 10 days to make a decision on whether to give a study the green light. If the experts miss this deadline, the application would be accepted by default. "That is completely unrealistic and gives rise to the question of whether the Commission and the Parliament are really taking seriously the reviewing of experiments on humans," says Otmar Kloiber, the general secretary of the World Medical Association. Allowing this to happen, he continues, virtually precludes the effective safeguarding of patients.

Translated from the German by Josh Ward

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