Healthy Skepticism Library item: 2236

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Who Medicines Expert Calls For New Rules Against Commercial Bias In Medical Research
J Adv Nurs. 2001 Dec 17
http://www.ncbi.nlm.nih.gov/pubmed/12108409

Keywords:
* Bias (Epidemiology)* * Clinical Trials as Topic/standards* * Conflict of Interest* * Ethics * Guidelines as Topic * Humans * Research Support as Topic * World Health Organization

Full text:

The integrity of clinical trials – essential for the development of new drugs – is increasingly under threat from commercial influence, raising an urgent need for rules and guidelines to safeguard the reliability of such trials, according to an editorial in the latest issue of the Bulletin of the World Health Organization.

The writer, Dr Jonathan Quick, director of essential drugs and medicines policy at WHO, Geneva, says the reliability of clinical trials is being undermined by conflicts of interest on the part of researchers, “inappropriate” involvement of commercial sponsors in running the trials, and bias in publishing the results.

“In the last 50 years the world has seen a stunning output of new medicines and vaccines. Continued progress depends critically on the quality of clinical trials. It is in the interest of all stakeholders, including pharmaceutical firms, that the evidence on which clinical and policy decisions are based meets the highest standards of scientific and ethical integrity.” Quick writes.

Quick raises the idea of drawing up a “declaration on the rights and obligations of clinical investigators and on how to manage the entire clinical trials evidence base”, on the lines of the Helsinki Declaration adopted in 1964 by the World Medical Association. This declaration was designed to ensure that medical research involving human subjects is
conducted in accordance with ethical principles. Such a declaration could bind sponsors and researchers to rules ensuring intellectual independence of investigators; prohibiting legal action by sponsors against those investigators, except in cases of fraud; and protecting whistle-blowers who report unscientific and unethical research practices.

Quick writes: “In a highly competitive world, the pressures may be simply too great for individual researchers, universities, medical journals, or public agencies to stem the tide of commercial influence.” He quotes a statement by Arnold Relman, former editor of the New England Journal Medicine, to the effect that “The entire system of clinical investigation is driven by profit [and] we are seeing the corruption of a system of research that used to have high ideals and be clearly in the public interest.”

Among examples of conflicts of interest cited in the Bulletin editorial are financial links between researchers and manufacturers of cardiovascular drugs. Recent reviews have documented how industry sponsors can influence clinical trials to produce desired results.

Moreover, independently funded studies of cancer drugs have been shown to be seven times more likely to reach unfavourable conclusions on drug cost-effectiveness than studies sponsored by the pharmaceutical industry.

Bias in publicizing positive results and underreporting negative ones is also a threat to the clinical evidence base, Dr Quick says. A series of high-profile cases have shown how investigators who publish results contrary to the wishes of a sponsor face intimidation, efforts to discredit them professionally, and threats of legal action to recover the
value of “lost sales”.

“If clinical trials become a commercial venture in which self-interest overrules public interest and desire overrules science, then the social contract which allows research on human subjects in return for medical advances is broken,” he says.

WHO, Dr Quick notes, is tightening the rules for its staff and expert advisors, and is establishing a “firewall” between commercial interests and WHO’s decision-making process.