Getting Real About Surgeon Disclosures

Last week Columbia University Professor and consultant to the North American Spine Society (NASS) Dr. David J. Rothman released a study that tracked researcher financial disclosures in The Journal of Bone and Joint Surgery (JBJS) and 25 other orthopedic peer review journals. The study reported that the journals and authors usually (55% of the time) failed to fully disclose payments made by manufacturers. It also reported that, of the major orthopedic manufacturers provided royalty or consulting payments, Biomet or Stryker’s recipients were most likely to disclose (71% and 75%, respectively) while researchers who’d received payments from Zimmer were least likely (26%).

Rothman's conclusions:

1. There is a “massive, dramatic system failure” in the reporting system at major orthopedic journals

2. There is an urgent need for stricter orthopedic scientific journal disclosure policies, including precise amounts of consulting payments to authors

3. Journal readers need complete financial information to consider the potential for bias in the article

The study, “From Disclosure to Transparency” by Susan Chimonas, Ph.D., Zachary Frosch, BA and David J. Rothman, Ph.D. was published online September 13, 2010, and is available from the Archives of Internal Medicine website at http://archinte.ama-assn.org.

Rothman’s study was not, however, without its own missing pieces. The study’s authors did not check to see if the articles in question actually addressed products from the companies providing payments. So, for example, an author receiving royalty payments for a hip or knee invention from Zimmer may have written about a product from DePuy. Additionally, the study's authors did not measure whether the content of the article was favorable or unfavorable to products from the paying company or whether the articles were Level 1, 2 or 3 studies or case reports or literature reviews or what. Finally, the authors did not explore the peer review mechanism to see if it was in place and whether each author’s work had been subjected to a blinded review.

In short, the authors found what appears to be a priori (independent of experience) evidence of bias but not, as some observers are claiming a posteriori (after experience or empirical knowledge) evidence of bias.

From Disclosure to Transparency

In the study, Rothman and his colleagues compared payment disclosures from the web sites of Biomet, DePuy, Smith & Nephew, Stryker, and Zimmer to disclosures in the acknowledgments section, conflict of interest statements, and financial disclosures of recipients’ articles published in JBJS and 25 other orthopedic journals. The researchers specifically chose to examine “consultant” payments in 2007. “Consultants” included individuals, as well as hospitals, academic medical centers, professional medical associations, foundations, and corporations who received payments for “services relating to hip and knee reconstruction and replacement.”

Then, to narrow the focus further, the study’s researchers selected recipients who’d received $1 million or more in direct payments from a single manufacturer. Finally, the researchers looked at articles from January 1, 2008 to January 15, 2009, to ensure that the authors had received the 2007 payment of $1 million or more by the time the article appeared in print.

The Results

Overall, less than half (45%) of the articles disclosed the name of the company providing payments. Only 8% of the articles stated that the payments “Exceeds $10, 000.”

Number of Publications and Disclosures of Payment of $1 Million or More per Company

Source: “From Disclosure to Transparency” by Susan Chimonas, Ph.D., Zachary Frosch, BA and David J. Rothman, Ph.D. published online September 13, 2010, in the Archives of Internal Medicine

Background

Professor David J. Rothman, who is a non-compensated advisor to NASS, has been studying and writing about medical ethics for more than a quarter century. In 1983, he formally started to examine and understand the unique ethical and moral problems that occur in medicine.

In 1991, Dr. Rothman put much of what he’d learned into an historical perspective in “ Strangers at the Bedside, a History of How Law and Bioethics Transformed Medicine”.

When he started looking into medical ethics, he found himself in a most unfamiliar world. As he spent time with physicians, he said that he felt a bit like an anthropologist exploring a new tribe. “I was a throwback to the anthropologists of the 1920s, an explorer of foreign parts, as though 168th Street in northern Manhattan was at one with the South Seas.”

But over time, he formed some opinions about physicians and their approach to patient ethics. Rather than, as he was accustomed, to taking general principles and applying them to the patient or situation, physicians, Dr. Rothman learned, were more apt to adopt what he referred to as “bedside ethics.”

“Physicians, as I have learned, frequently bring a case-by-case approach into the consideration of social and ethical issues. Offer a principle to consider (for example, that patients have the right to know their diagnosis), and they will often come up with a case (from their own experience) that they believe undercuts or thereby negates the principle (for instance, the seeming inappropriateness of informing a seventy-five-year-old woman about to go off to her grandchild’s wedding that she has an inoperable and slow-growing brain tumor." This suggests “how alien rules are to medical decision making and how dogged and persistent an effort to alter this orientation would have to be."

Transparency for Its Own Sake?

“What we were interested in was disclosure practices, not evidence of bias. Our goal in doing this study was to follow the money." Said Dr. Rothman to OTW. And why is that important? “There is a significant amount of study in the literature which shows that gifts invoke reciprocity. I think that the potential for bias in cases like this is self evident."

By “cases like this” Dr. Rothman was referring to authors who’d received $1 million or more in payments from manufacturers. So, we wondered what does a researcher/surgeon do to receive $1 million or more in payments?  

We checked and looked at Stryker’s disclosure records. Stryker’s surgeon consultants had the best disclosure record of any of the major manufacturers. Stryker’s disclosures are available at www.stryker.com/meetourconsultants.

Going alphabetically, the first million dollar recipient we found was Dr. Peter Bonutti. He received $2.5 million in 2010 in the form of royalty income from inventions and intellectual property. Stryker was good enough to list his patents—it is a long list. We continued searching and spent about 30 minutes looking at approximately a dozen other surgeon consultants on the Stryker site and they received between $25, 000 and $150, 000 for out of practice consulting with $25, 000 being by far the most frequent amount paid.

The only million dollar payment to a surgeon we found from our short search was for royalty income for inventions. Dr. Rothman and his colleagues also searched and they found 41 members of the million dollar club. The millionaire we found earned his royalties fair and square. It was not a gift, in other words.

We did not find million dollar payments to surgeons for either using Stryker’s products or teaching other surgeons to use Stryker products or giving talks about Stryker products or writing peer-reviewed articles about Stryker products.

So, if, as Dr. Rothman mentioned, that gifts invoke reciprocity what do royalty payments invoke? We suspect it is like any other business relationship—a fair price for a valued product or service. Can Dr. Bonutti write objectively about his own products? Who knows—but that is why the blinded peer review process is in place at JBJS and other journals. Can Dr. Bonutti write objectively about hip and knee surgery and treatment? I’ll bet he can and absolutely does.

Without searching for actual evidence of bias—like a statistical tendency to reach favorable conclusions regarding the products of the company providing payments—this study appears to be implying that transparency is valuable simply for its own sake. We don’t think it is. Transparency, in our view, must serve some greater good—otherwise it can become intrusive and oppressive.

Bias, whether explicit or implicit, is always an issue in scientific studies. This has been known and fought over since the beginning of the scientific method. Strict disclosures, a blinded peer review process, categorization of studies into Level 1 or 2 or 3 or case reports, etc. are critical tools to ensure that bias is reduced, potentially eliminated.

Because Rothman and his research colleagues decided to look only at authors who’d received $1 million or more they sent a clear message that money matters. One person who heard the message was Dr. Marcia Angell, a former editor of The New England Journal of Medicine. This is her quote from The New York Times article about Rothman’s study “It is one more indication of the widespread corruption of the medical profession by industry money.”

In fact, Rothman's study offered no evidence of corruption.

We note, finally, that Dr. Rothman’s study did take advantage of the many disclosures in place at company web sites like Biomet, Stryker, Zimmer, Smith & Nephew and DePuy—as well as ten other firms that disclose payments on their web sites even though they were not part of the Justice Department settlement. By 2013, according to the new health reform legislation, all manufacturer payments over $10 or more to physicians will need to be disclosed.

What do surgeons want from scientific papers in medical journals? Clinically relevant and robust studies that are strong enough for practices to lean on, we think. Did Rothman’s study further that cause? If it prompts journals to provide fuller disclosure, then ‘yes’. If, as is happening, the focus on million dollar payments (which we suspect are all royalty payments) fuels charges of surgeon corruption and bias then, we think, it sets the cause of better studies back. Our conclusion, the editors should have sent Rothman’s study back for more work.