Big Pharma & ‘Best’ Medical Practices

To the Editors:

Jerome Groopman [“Health Care: Who Knows ‘Best’?,” NYR, February 11] is right that treatment guidelines often do not improve quality of care because they fail to take into account variability in co-morbidity and course of illness. They fail for other reasons as well, particularly the objectivity of those making the guidelines. So many “experts” are influenced by emoluments from pharmaceutical and medical device companies that finding any with unencumbered objectivity is difficult. Interestingly, every example Groopman gives of “best practices” that went awry, and that involved drugs, erred on the side of what proved to be excessive use.

Dr. Groopman points out “that there are numerous companies…issuing standards for treatment that are congenial to the insurance industry” but he fails to mention how “standards” issued by pharmaceutical and medical device manufacturers influence doctors. Pharmaceutical companies dispatch thousands of representatives to persuade doctors to use their companies’ drugs and spend billions of dollars on advertising to consumers and physicians.

Finally, he fails to consider how the development of guidelines can be improved. One step is to prohibit physicians and others with conflicts of interest from serving on expert panels. Taken together with strict limitations on what any physician can receive from drug and device companies, it could improve quality of care.

Neil A. Holtzman, M.D., M.P.H.
Emeritus Professor, School of Medicine The Johns Hopkins University Baltimore, Maryland

Jerome Groopman replies:

Dr. Holtzman raises an important and urgent issue. Not only has there been considerable marketing by pharmaceutical companies to individual physicians, but the government has outsourced the task of creating treatment guidelines to expert panels where some members may have significant conflicts of interest.

National guidelines that are adopted by Medicare should not be outsourced. Rather, there should be direct federal oversight of “in-house” panels, similar to the process used by the Food and Drug Administration to evaluate data and approve or deny drugs for specific clinical indications.

Expert panels assembled by the Center for Medicare and Medicaid Services should be rigorously vetted for potential conflicts, and an expert should not be writing guidelines that would financially benefit a pharmaceutical company that supports him as a consultant or researcher. The Institute of Medicine of the National Academy of Science is currently pondering recommendations to the government on how to regulate such conflicts of interest.

The concerns raised by Dr. Holtzman and others are valid and should inform new federal policies that result in better guidelines.