Applied Clinical Trials
Industry professionals address critical commentary of the drug development process.
Senior clinical researchers have reacted strongly to an analytical article and commentary that are deeply critical of the drug evaluation process.
Professor Silvio Garattini, director, Mario Negri Institute for Pharmacological Research in Milan, and Sir Iain Chalmers, editor, James Lind Library in Oxford, have called for major changes in drug evaluation.1 Their controversial views have been supplemented by a commentary from Michael Tremblay, PhD, partner of Tremblay Consulting, Ashford, UK.2 Both appeared on bmj.com in March.
"As a citizen and at times a patient or a parent of an ill child, I resent the tendency of the authors to represent patients and prescribing doctors as dumb victims who are stupid enough to be lured into morally and medically wrong behavior by a devious industry," said Beat Widler, PhD, a clinical quality assurance executive from Switzerland.
"This is profoundly dishonest and might be acceptable when coming from a blinkered political activist who is on an anticapitalist crusade. I consider myself as a man of ethics with firm moral principles, not an instrument of greedy fat cats who are just out to make a quick buck," Widler added.
It is cheap propaganda to infer that the wrong doings that have happened on the margin of clinical trials is common practice. The authors overlook the fact that major disasters in the field were caused by nonindustry researchers. Also, the new medicines have cured many serious illnesses, and pharma has played a leading role in developing today's essential medicines, he noted.
"The authors are right in affirming that our industry has a credibility problem, but the solution is not to replace effective discovery and development processes but to better engage the stakeholders in a fair and balanced debate. The pariahs of this article, health authorities and industry, must be partners in this," said Widler.
Garattini and Chalmers ask the right questions, but not everybody will agree with their answers, according to Professor Gerfried Nell, president of the International Federation of Associations of Pharmaceutical Physicians. Nell thinks the drug development process needs major improvements but believes that some of the shortcomings, such as restricted patient populations, cannot be blamed solely on industry.
"Transparency is obviously the key to building trust," he said. "However, I am not so sure that further improvements in this direction should be enforced by law. It is probably better to build public pressure in order to change attitudes."
Overall, the authors present a weak case, noted Uwe Gudat, MD, Applied Clinical Trials Editorial Advisory Board member and medical director in the office of the chief medical officer at Merck Serono. The many treatments developed by industry are witness to the fact that it is providing a public service. Numerous innovations that have revolutionized medical practice are off patent, allowing patients access to fairly inexpensive therapeutics.
Dr. Gudat supports more patient involvement in clinical research, but fears it may highlight the conflicting interests of stakeholders. Patients are often keen on small improvements in well being that outcome-focused physicians discount as unimportant. Similarly, patients may favor treating minor ailments, leading to what may be seen by some as disease-mongering.—Philip Ward
S. Garattini, I. Chalmers, "Patients and the Public Deserve Big Changes in Evaluation of Drugs," BMJ, 338, b1025 (2009).
I. Tremblay, "Risks of Doing as the Romans Do," BMJ, 338, b1107 (2009).