Ex-UCSD Plastic Surgeon Takes On FDA Regulation

Published in the San Diego Union-Tribune, August 24, 2014

Breasts. That is what is called a provocative lead. But the truth is that breast implants are a complex subject, and Dr. Jack Fisher has a lot to say on the topic.

After retiring as head of the division of plastic and reconstructive surgery at UC San Diego for 20 years, Fisher could have spent his time fishing and playing golf. Instead, he earned a master’s degree at UCSD in U.S. political and economic history and began the next chapter of his life — in-depth research on how we regulate our food, drug and medical device industries and his conclusion that our current system impedes innovation and entrepreneurship.

Note: Imagine coming to the conclusion that the system is broken and doesn’t promote innovation. Who would ever have thought that?

In his recently published book, “Silicone on Trial: Breast Implants and the Politics of Risk,” Fisher focuses on the hysteria in the 1990s over silicone breast implants, and he offers recommendations on how the Food and Drug Administration should be changed to better serve patients. Medical device companies spend millions seeking approvals from the government, but Fisher learned “that government regulation is a political process and not a scientific one, even when the product is based on technology.”

Let me remind you of 1990, when CBS-TV correspondent Connie Chung’s story about the “dangers” of silicone breast implants raised alarms throughout the country. According to Fisher, Chung’s story was based on interviews with only four women and two medical experts who were later disqualified as witnesses in American courtrooms because of fraudulent qualifications. “Omitted entirely was mention of a clinical study showing no increase in breast cancer among implanted women,” said Fisher.

Fisher notes that what happened next was a wave of terror, and when the results of an actual patient survey were released, the media largely ignored it. In 1992, FDA Commissioner David Kessler called for a moratorium on the use of silicone gel breast implants. A slew of lawsuits were filed, and surgeons were suddenly limited in the choice of available devices, even for breast reconstruction following mastectomy. Not until 1999 did silicone devices receive a “full pardon,” and it was from the National Academy of Science’s Institute of Medicine, not the FDA. But this came too late to help the silicone industry that had spent billions of dollars fighting lawsuits and paying what he believes were phony claims, Fisher writes.

“While I can hope this book might provide comfort for all prior implant recipients, I would like the data to be equally valuable to women considering breast implants for the first time,” said Fisher.

In his book, Fisher offers several recommendations on how to correct the problems that plague the Food and Drug Administration. He begins with the premise: “We overreact to risk in America. We should rely more on scientific evidence. For example, restricting breast implants on the basis of a few cases of illness that later proved to be coincidental is not rational regulation. Sometimes we confuse coincidences with cause and effect.”

Currently, the FDA approves for both safety and efficacy both drugs and devices, and naturally it takes much longer to approve efficacy. Fisher believes that we should move to the European model — approve drugs and devices for safety and then measure efficacy after a drug gets to the marketplace.

Note: Sort of like the lean startup model.

He quotes former FDA commissioner Margaret Hamburg who said, “The FDA is relying on 20th-century regulatory science to evaluate 21st-century medical products.” He also notes that former FDA Director Henry Miller has recommended using the successful model of the nonprofit Underwriters Laboratories (UL) that tests and certifies thousands of consumer products (some of them hazardous) at “a fraction of the cost the FDA imposes.”

“The challenge for policy makers and regulators is to find a balance between risk estimates and statutory limits, between product innovation and market barriers, between unanticipated outcomes and rational compensation for avoidable hazards,” Fisher concludes.

The measurement of real risk is a challenge across all sectors from manufacturing to drugs to personal privacy to crossing the street at rush hour. And how to assess risk and then balance risk with regulation has massive impacts on the economics of your adventure.

Rule No. 432

Risk is not a board game anymore.

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