M

ore 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.

advertisement

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.”

Sign up to our Daily Recap newsletter

Please enter a valid email address.

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Many offices because of the “Sunshine Act” have closed off facilities to industry because of this. They are missing out on many things such as samples, latest clinical information, patient support programs, and patient education information. The “Sunshine Act” scared many physicians and support personal. Sorry I do not agree with you!!!

    • We haven’t allowed PharmaCo reps in our hospital in well over 10 years unless they are invited and then they must be accompanied by staff after obtaining a badge they wear visible to all that they are reps. I don’t need random nonsense from reps I need info and when I want it I know where to get it. I rely on CERTAIN reps to provide me with the info I need and I SURELY don’t need free lunch if I do accept the meal or CE course I care LESS if my name is on some website. For all I care they can error and put in that they donated $1M to me (as long as I am not obligated to pay taxes on the money) because anyone with a REAL reputation isn’t going to care about the stigma that the media as created that someone we are evil if we are paid to take courses, do research, learn about drug uses, or surgical techniques.
      Our hospital TRIED in vane to kick out surgical reps instead having the reps train the surgical nurses and the device use department to then train us based on a contract between the device companies and the hospital as aprt of the annual agreement that went over like a lead balloon. I don’t want my staff giving me the skinny after they digested it I want right from the horses mouth. Our staff hasn’t the time to vette all the various companies and make clinical decisions.
      Those docs who you suggested are “scared” are just out of touch with reality and or lack personal credibility to stand on their own abilities. I suggest far more of the former then the latter. Seriously this is a non-issue if we stop making it such.

  • Instead of modifying the Sunshine Act we all need to simply take the “who cares” approach to the reports and over time every one of us will have a huge list of reporting actions that no one with any reasonable mind will care about. Personally I care less if some PharmaCo has to report their free lunch to some website. I treat my patients as I see fit and if someone thinks I need to avoid outside of patient funding in order to be properly unbiased then that is quite fine. Most of us have more then enough patients to survive on so instead of fretting over some website and their announcement to all about how many lunches or CE courses or copies of articles we received we should focus on treating those patients who realize that no one really cares. It is called Political masturbation the DC polectorate has nothing else to do with itself but meddle in our profession this one isn’t worth fighting over let them do it their way we will do the same. Dr D

  • Great piece and agreed with you on most points of the article. I’ve been reading a lot about how physicians aren’t too fond of the Sunshine Act, as it, in a way, seemingly implicates them as pawns of big pharma. This is not the intention of the act, but definitely an unintended consequence, that I think stems from the fact that physicians aren’t putting in the effort to benefit from this act. Now that’s not to say that physicians are slacking off, but more that with their busy lives, they don’t necessarily have the time to scour through openpayments.cms.gov to make their CME decisions. My intuition is that they aren’t utilizing this data, which is why they are completely against this act and want it repealed (they get their reputations put into question, while not really getting much benefit out of it). Seems to me that instead of repealing this act, we really just need to make the data both: 1) more digestible (going through that database is a pain) and 2) more actionable. The latter is important, because I like to think that at the end of the day, physicians will make the right decision and not be influenced by pharma $$…but they only know so much. Any ideas on how this act can be used to make the Sunshine Act work for physicians (more)?

    • Very interesting article, with some valid points. There are, of course, unethical practices that take place. My company follows the Sunshine Act as best we can, albeit without much guidance in how to do so. What I found particularly interesting in the article was the references to “ghostwriting.” What is amazing is that the author of this article admits to doing the same thing he condemns in the article when he claims to be “the person who wrote the first draft of the Sunshine Act.” I was flabbergasted at first, until I realized that this is so typical of Congress in their, “Do as I say, and not as I do” attitude. Perhaps we need a Sunshine Law applied to Congress. Then we will really see what happens with all that lobbying money. In fact, I’ll be happy to ghost write the first draft.

Recommended Stories

Sign up for our biotech newsletter, The Readout

A guide to what’s new in biotech — delivered straight to your inbox every weekday morning.