Shine Lecturer Sidney Wolfe: FDA’s Drug Review Process is Broken

Posted on: March 6, 2014 Topics: Bioethics & Human Rights, Health Law, Shine Lecture

When he turned 75 a few years ago, Dr. Sidney Wolfe’s daughter and son-in-law presented him with a doll custom-made to look like him, with a button on it that played one sentence, over and over:

“It’s an outrage!”

Dr. Sidney Wolfe emphasizes a point during the 2014 Shine Lecture.

Dr. Sidney Wolfe emphasizes a point during the 2014 Shine Lecture.

On Wednesday, as he delivered the 2014 Cathy Shine Lecture at the BU School of Public Health, Wolfe credited his sense of outrage with keeping him going for more than 40 years as head of the Public Citizen Health Research Group, which works to highlight lapses in oversight by the Food and Drug Administration and physician oversight boards.

Wolfe said lapses in the FDA’s drug approval process are worse than ever now, as pharmaceutical companies exert increasing influence over medical care. He noted that the U.S. is one of only two countries that allow direct-to-consumer drug advertising.

“Companies have extracted lots of concessions from the FDA, like faster approval times — or, if there’s a safety problem, ‘let’s study it after (we approve it),’” Wolfe said.

He argued that direct advertising by drug companies has done “an enormous amount of damage” to physicians’ prescribing practices and patients’ reliance on questionable medications.

In a talk entitled, “Do Government Agencies Protect Patients?” Wolfe described his organization’s battles to convince the FDA to withdraw unsafe drugs from the market. It took the Public Citizen Health Research Group, which he co-founded with consumer activist Ralph Nader, 32 years to convince the FDA to ban the painkiller Darvon, which was found to be dangerous to the heart. Now, the group is working to get a black box warning added to testosterone-containing drugs, after a recent study found an increased risk of heart attack in men who took the drugs.

As with many other medications, Wolfe said, testosterone use has climbed in the U.S. as marketing efforts have intensified. He said that about a quarter of American men who take testosterone have never had their testosterone levels checked.

He said physicians should be held accountable for inappropriate prescribing: “Doctors are too often ‘under the influence,’ so to speak, of drug companies.”

Wolfe’s group has pushed for stricter oversight of physicians who practice substandard medicine, publishing annual rankings that tally each state’s rate of disciplinary actions against doctors. Some states rarely take serious actions, while others revoke and suspend licenses more frequently. The health research group has found that even in cases where doctors’ lapses were deemed by hospitals to pose an immediate threat to health and safety, state medical boards failed to take any action against them.

Wolfe said that while the current focus on improving quality of care and safety protocols was laudable, “We will forever need discipline by hospitals and medical boards, and that is grossly inadequate in all but a few places.”

At the end of Wolfe’s talk, BUSPH Professor George Annas, who has known Wolfe for years, quipped: “Thank you very much for that uplifting presentation.”

The annual Shine lecture, endowed by the family of the late Cathy Shine, an advocate for human rights, is sponsored by the BUSPH Department of Health Law, Bioethics and Human Rights.

Cathy Shine died in 1992 from a severe asthma attack. Two years before her death, she suffered a traumatic experience in which medical treatment against her will damaged her trust in physicians. In a wrongful death suit filed by her family on Shine’s behalf, The Massachusetts Supreme Judicial Court later affirmed “the right of a competent individual to refuse medical treatment,” even life-saving treatment.

The Shine family gift recognizes the scholarly work of Annas, professor and chair of the health law department, who wrote about the Shine case in 1999 as an example of the importance of respecting patient rights. In making the gift, the Shine family noted that Cathy Shine admired Annas’s work, especially his book The Rights of Patients.

According to her family, Cathy Shine was a strong advocate for human rights and patient rights. Before her death, she co-authored a book about race-based discrimination in criminal justice administration, Does the Punishment Fit the Crime, published after her death by the Sentencing Project.

Submitted by Lisa Chedekel