Worst Pills, Best Pills

An expert, independent second opinion on more than 1,800 prescription drugs, over-the-counter medications, and supplements

Dr. Sidney Wolfe Turns Health Research Group Leadership Over to Dr. Michael Carome

Worst Pills, Best Pills Newsletter article July, 2013

Soon after Dr. Sidney Wolfe started Public Citizen’s Health Research Group in 1971, he told Ralph Nader that it would be the last job he would ever have. He was right.

After leading the group through everything from battles against the pharmaceutical industry to groundbreaking research on dangerous doctors, Wolfe on June 3 turned the reins over to Dr. Michael Carome, the program’s deputy director.

Although Wolfe has stepped aside, he’s not stepped out — he will continue to work...

Soon after Dr. Sidney Wolfe started Public Citizen’s Health Research Group in 1971, he told Ralph Nader that it would be the last job he would ever have. He was right.

After leading the group through everything from battles against the pharmaceutical industry to groundbreaking research on dangerous doctors, Wolfe on June 3 turned the reins over to Dr. Michael Carome, the program’s deputy director.

Although Wolfe has stepped aside, he’s not stepped out — he will continue to work at Public Citizen on the issues he cares so deeply about, which include drug and device safety, patient access to care, medical board oversight of doctors, worker health and much more. Wolfe’s new title: founder and senior adviser. “I am as — or more — enthused now as I was at the beginning,” Wolfe said recently. “We’ve accomplished a lot.”

It was Wolfe’s longtime plan to groom a successor who could lead the group. He knew that what he sought wouldn’t be easy to find: a medical expert committed to working in the public interest who is a sharp analyst, a solid researcher and a creative thinker. Wolfe found that in Carome.

“Sid Wolfe has never backed down in the face of enormous industry and government pressure, and the result is that our country is safer and healthier. His insistence on doing what’s right is now a defining trait of Public Citizen,” said Robert Weissman, Public Citizen president. “The good news about the leadership change at the Health Research Group is, first, that Sid has located such an excellent successor, and, second, that Sid himself will continue working with Public Citizen.”

Wolfe came to Public Citizen from the National Institutes of Health, where he had conducted medical research on blood. In early 1971, a doctor called Wolfe to complain about the government’s failure to ban contaminated intravenous fluids. Hundreds of patients who had received fluids from Abbott Laboratories had developed severe bacterial infections, and dozens had died. Instead of ordering a product recall, the government merely warned doctors to watch for infections and stop using the fluids if they spotted any. Wolfe called his then-acquaintance Nader, who suggested they write to the U.S. Food and Drug Administration and release the letter to the press.

Within a few days of the letter hitting the news, Abbott recalled the contaminated fluids. “I was very surprised that we’d won,” Wolfe said. “It was very satisfying to see that if you did your homework and had the facts on your side, you could succeed.”

Enamored of the work, Wolfe teamed up with Nader, and in the fall of 1971, launched Public Citizen’s Health Research Group, the first program division of Public Citizen, which Nader had formed in March of that year. Wolfe was named director of the group.

Wolfe hired doctors and other medical experts, expanding the scope of work to include harmful drugs and medical devices, dangerous doctors, access to health care, occupational health and the ethics of clinical trials. Under Wolfe’s guidance, the program not only has conducted new research but also has gathered and analyzed existing scientific data with an eye toward exposing health hazards, giving people the tools to protect themselves from a rapacious drug industry and challenging the anti-consumer aspects of the health care system.

“There were a large number of serious medical problems, where studies had been done or could be done, but where the public health issue had not been addressed,” Wolfe said. “I wanted to start this group to change things.”

Change things, he has. Under Wolfe’s guidance, Public Citizen has helped to force 25 dangerous medications off the market and has pushed the Occupational Safety and Health Administration to set more than a dozen worker-protective health standards. It got Red Dye No. 2 banned and warning labels about Reye’s syndrome on the side of aspirin bottles. It got silicone breast implants restricted.

One of Wolfe’s most effective projects was “Questionable Doctors,” a series of books that listed every doctor in the U.S. who had been disciplined over 10 years. It was a massive undertaking, involving gathering records from every medical board in the country, then compiling, checking and publishing them. Public Citizen published “Questionable Doctors” until medical boards began posting disciplinary information online.

Perhaps Wolfe’s landmark project, though, was “Worst Pills, Best Pills,” a book that provided people with information about the side effects of medications and warned of drug interactions. It was advice that people couldn’t get elsewhere but craved; the book has sold 2½ million copies since the first edition in 1988. The book has been supplemented by a website (WorstPills.org) that is updated regularly, as well as Worst Pills, Best Pills News, read by 150,000 people monthly. Though Wolfe will remain editor of the newsletter in the immediate future, Carome will ultimately become editor.

And the future? Says Wolfe, “I’ll keep working on pretty much the same topics as before, but Mike will be directing the group.”

Meet Dr. Michael Carome

Dr. Michael Carome, who on June 3 became director of Public Citizen’s Health Research Group, developed an interest in medicine when he was at a Jesuit high school in Cleveland.

He wanted to serve people, and he saw medicine as the way to do that. In college, he toyed with psychology, but a professor advised him against it and told him to become a doctor. “He was right,” Carome said recently. “I love medicine. It’s so challenging.”

Carome earned his medical degree from Case Western Reserve University in Cleveland – by coincidence, the same school from which Dr. Sidney Wolfe earned his medical degree.

To pay for school, Carome got a scholarship from the U.S. Army. As part of the deal, he had to remain on active duty in the Army for at least four years following his residency and fellowship training.

Carome was an internal medicine resident and nephrology fellow at Walter Reed Army Medical Center, a renowned military hospital, having developed an interest in the kidneys during medical school. He practiced as a staff nephrologist from 1992 to 2010.

In 1997, having completed his military service obligation, he transferred into the U.S. Public Health Service (PHS), the only nonmilitary uniformed service in the U.S. He stayed in the PHS until he completed a total of 24 years of uniformed service.

While at Walter Reed, Carome developed an interest in the ethics of human research. So while continuing his duties as a staff doctor at Walter Reed, he began working for the Office for Human Research Protections (OHRP) within the U.S. Department of Health and Human Services, eventually becoming director of the Division of Compliance Oversight, and then OHRP’s associate director for regulatory affairs. With Carome at the helm of OHRP’s compliance program, the department suspended research at many institutions that weren’t following the rules for conducting human research.

In 2010, he began searching for a new challenge. He heard that Public Citizen’s Health Research Group was looking for a deputy director. He knew and respected the organization, so he applied and was hired.

Carome lives in Annandale, Va., with his wife. He has five children, ages 14 to 25.

Carome plans to continue the scope and range of issues that Wolfe started working on 42 years ago, including drug and device safety, ethics of research, medical board oversight of doctors, health care delivery and more.

“Here, I have the freedom to do the right thing,” he said. “I love the work. I think we make a difference.”