Don’t rewrite history: ‘Sunshine’ law was meant to protect docs from undue influence

More than 100 state and national medical societies are trying to water down the Physician Payments Sunshine Act, a law that protects doctors and their patients from undue influence by pharmaceutical and medical device companies. They’re welcome to do that. But they can’t rewrite history in the process.

Senator John Barrasso (R-Wyo.) recently introduced the Protect Continuing Physician Education and Patient Care Act. It would roll back the Sunshine Act requirement that drug and device companies report payments they’ve made to fund continuing medical education for doctors or to send them copies of research studies. The various medical societies support the new bill, arguing that it wasn’t the “intent” of Congress to exclude doctors from receiving “independent” and “high quality” scientific information.

As the person who wrote the first draft of the Sunshine Act, and then worked for years to get it passed, I’d like to notify American doctors: “Your professional societies are misleading you.” In fact, our concern about corporate bias and poor quality in medical education and scientific publishing was one thing that led us to promote the bill in the first place.

Even before writing the Sunshine Act, my colleagues on the Senate Finance Committee released a report about industry’s undue influence on continuing medical education. These are the hours of training doctors need each year to maintain expertise. The report showed that drug and device companies routinely funded continuing medical education as part of their marketing strategies, spending $1 billion on the practice in 2004, and that this system guided doctors toward more expensive and less-tested products.

When the Senate Aging Committee held a hearing on continuing medical education in 2009, Senator Herb Kohl (D-Wis.), the committee chair, was blunt in his remarks. “Large corporations do not typically spend these sums unless they think they will get something out of it,” he said. As cosponsor of the Sunshine Act, he recommended greater financial transparency.

The top Republican at the hearing, Senator Mel Martinez (R-Fla.) agreed. “Sometimes the line between promotion and education can be blurred. This is the reason … transparency and appropriate common sense safeguards are absolutely necessary,” he noted.

The influence of pharmaceutical and device companies in scientific publishing is equally alarming. Take ghostwriting in medical literature. This happens when drug and device companies hire public relations firms to write scientific studies which are then “authored” by researchers who sometimes make only minor changes before the articles are published in science journals. I was part of the Senate Finance Committee investigative team that reported that ghostwriting is quite common and journals can do little to stop it.

Volumes of evidence led us to conclude that corporate funding was transforming continuing medical education and science publishing into marketing and public relations vehicles. Although Senate staffers were heavily lobbied to exclude these materials from the Sunshine Act because they were purportedly independent sources of information, we rejected those arguments because they had little merit.

Senate investigations of medicine that brought scandals to light have often been met by special interest claims that these were “past practices” by “bad apples.” Yet these bad habits continue. Last year, the Journal of Medical Ethics published a study examining 14 accredited continuing medical education courses that had been designed to teach doctors about low sexual desire in women. In reality, these courses were littered with marketing messages to promote Addyi, a new drug for hypoactive sexual desire in women, or what the study authors called “a condition that was sponsored by industry to prepare the market for a specific treatment.” The journal followed up with a commentary castigating the medical education industry for replacing education with commercial marketing.

Journals themselves don’t always guard against such deceptive practices. In dozens of instances where industry was found to ghostwrite or secretly fund studies, journals have done little to correct the record, sometimes ignoring a mountain of evidence. Take this case in which investigators combed through documents made public in lawsuits and found that a high-profile medical journal article published to promote an antidepressant drug contained gross misrepresentations of data and clear evidence that the study was ghostwritten by a public relations firm. The journal that published the study did nothing to acknowledge this.

In an effort to explain the lack of incentives to address ethical problems by scientific publishers, Richard Smith, a former editor of The BMJ, wrote, “What is clear is that it will continue to be easy to publish weak science, but hard to publish well-argued and supported accusations of fraud and misconduct.”

Nothing in the Physician Payments Sunshine Act prohibits companies from funding researchers, medical education, or scientific research. It simply requires them to drag this money out of the shadows and report it publicly.

I am proud of what my colleagues and I accomplished in writing and passing the Sunshine Act. It gives doctors better tools to evaluate the quality of information they get in continuing medical education courses or in journal articles sent to them by sales representatives, and so can help them better serve their patients. But it was a small, conservative step forward. And that’s the direction we need to keep moving. Not backwards.

Paul D. Thacker, a former investigator on the United States Senate Finance Committee, is a writer living in Spain.