Hektoen International

A Journal of Medical Humanities

Forty years a watchdog: Sidney Wolfe, M.D.

Howard Fischer
Uppsala, Sweden

FDA drug inspection, early 1990s. US Food and Drug Administration on Flickr. 

“Somebody has to look out for the people who are being manipulated by hospitals, doctors, insurance and drug companies.”
– Sidney Wolfe, MD, 1993

Sidney Wolfe, MD, (1937–2024) was the co-founder in 1971 of the Health Research Group (HRG), a consumer and health advocacy lobbying organization. After earning his medical degree from what is now Case Western Reserve University in 1965, he completed an internal medicine residency and did medical research at the National Institutes of Health. Later, at the HRG, he developed “research-based advocacy,” searching out and critically reading drug studies for the validity of their conclusions. He criticized the pharmaceutical industry and the US Food and Drug Administration (FDA) for high medication prices, dangerous side effects of medications, and overlooked health hazards. His 1990 book Worst Pills, Best Pills went through four editions and sold 2.2 million copies.1,2

His advocacy led to the discontinuation of certain artificial heart valves, pacemakers, contact lenses, and silicone gel-filled breast implants,3,4 as well as over a dozen drugs. Several nonsteroidal anti-inflammatory medications were banned because he clearly showed that their toxic effects on the kidneys or the liver had been found in medical studies. One anti-inflammatory drug was taken off the market because it produced anaphylaxis in a small number of people. At least one painkiller (propoxyphen) and one fever medication (phenacetin) were prohibited because of the HRG. Wolfe got the FDA to ban the Chinese herbal weight-loss drug ephedra (or ma huang) because of its cardiovascular side effects.5 Some medications he warned against are still being used (a statin and an oral contraceptive).6 He criticized the layout and design of advertisements to physicians for psychotropic drugs, proposing that they might cause them to “overprescribe medications to women.”7,8

The HRG waged a five-year battle with US regulatory agencies when the suspicion arose in 1981 that aspirin should be avoided in children with influenza or chickenpox. Studies had suggested as early as 1976 that aspirin had a role in the development of Reye syndrome in children with a viral illness. Reye syndrome consists of liver failure, encephalopathy, and intracranial hypertension. Despite intensive and invasive treatment, up to 40% of young patients with Reye syndrome died. In early 1982, the HRG petitioned the FDA to place a warning label about Reye syndrome on aspirin products. Later that year, they sued the FDA to get the warning label. In the summer of 1982, the secretary of the Department of Health and Human Services (HHS) ordered the FDA to mandate a warning label. He then met with aspirin industry executives (also in 1982) and withdrew the warning label requirement. HHS cancelled the FDA’s planned distribution of consumer warning pamphlets. In 1984, the US Court of Appeals found that the FDA was moving too slowly regarding this problem. The Centers for Disease Control studied the aspirin question, also in 1984, and found that children with influenza or chickenpox were 25 times more likely to develop Reye syndrome if given aspirin. The following year, the HRG again petitioned the FDA to require warning labels on aspirin products, which it finally did in 1986.9

Wolfe’s group showed that jails were used to house mentally ill people because of a shortage of public psychiatric treatment facilities.10 They also showed that deliveries attended by certified nurse-midwives had results that were as good as physician-attended deliveries, with fewer caesarean section deliveries, and at a lower cost. They pointed out a need to increase public awareness of the availability of certified nurse-midwives, and to reduce the practice restrictions originating in either hospital policies or in state laws affecting 64% of nurse-midwives.

Wolfe and the HRG never hesitated to criticize physicians and the bodies that were supposed to regulate them. They showed that 25% of physicians found guilty of sex-related crimes (including rape) did not have their license to practice revoked, but were merely placed on probation by their state medical board.12 Later, they showed that during a twenty-year period, 10,000 physicians had their privileges suspended or reduced by the hospitals in which they practiced because of incompetence, negligence, malpractice, fraud, narcotic law violations, substandard care, or sexual offenses. However, their respective state medical boards took disciplinary action against only 45% of them.13

Sometimes Wolfe’s advice was easy to follow. A newly-released drug has to be used by hundreds of thousands of different kinds of people before all its potential side effects become known. He cited a study that indicated that after seven years of use, most of the side effects are known. Therefore, he advised physicians to wait until a drug has been on the market for seven years before prescribing it to their patients.14 He quantified an adage I heard during my pediatric residency (1977–1980); namely, when a new drug appears, be neither the first nor the last to prescribe it.


  1. “Sidney M. Wolfe.” Wikipedia.
  2. Clay Risen. “Sidney M. Wolfe, scourge of the pharmaceutical industry, dies at 86.” New York Times, January 3, 2024.
  3. Susan Okie. “Running on outrage.” Washington Post, December 5, 1989.
  4. Risen, “Scourge.”
  5. Nortin Hadler. The Last Well Person. Montreal: McGill-Queen’s University Press, 2004.
  6. “Sidney M. Wolfe,” Wikipedia.
  7. Sidney Wolfe. “Drug advertisements that go straight to the hippocampus.” Health Letter, 12, 1996.
  8. Jonathan Metzel. “The pharmaceutical gaze,” in Lester Friedman, ed, Cultural Sutures, Durham (North Carolina): Duke University Press. 2004.
  9. Okie, “Running.”
  10. Edwin Torrey et al. “Criminalizing the serious mentally ill: The abuse of jails as mental hospitals.” Public Citizen’s Health Research Group, 1992.
  11. Mary Gabay and Sidney Wolfe. “Nurse-midwives: The beneficial alternative.”Public Health Rep, 113(3), 1998.
  12. Cristine Dehlendorf and Sidney Wolfe. “Physicians disciplined for sex-related offenses.” J Amer Med Assoc, 279(23), 1998.
  13. Alan Levine et al. “State medical boards fail to discipline doctors with hospital actions against them.” Public Citizen, March 2011. https://www.citizen.org/article/state-medical-boards-fail-to-discipline-doctors-with-hospital-actions-against-them/
  14. Sidney Wolfe. “The seven-year rule for safer prescribing.” Australian Prescriber, 3(5), 2012.

HOWARD FISCHER, M.D., was a professor of pediatrics at Wayne State University School of Medicine, Detroit, Michigan.

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.