# Does promoting your book constitute a conflict of interest?

## 2007-08-13

I give lots of talks and I usually put in a plug for my book, Statistical Evidence in Medical Trials. I even promote my book in the signature file that I put at the bottom of all my emails. My philosophy is that if you don’t promote yourself, who will?

I got an interesting email from someone associated with the Continuing Medical Education (CME) department of a site where I will be giving a talk that very politely called me to task for this self-promotion.

Thank you for agreeing to share your expertise during our CME program. ACCME guidelines mandate that CME organizations ensure that content provided to learners during CME offerings lack any appearance of bias. Accordingly, we respectfully request that you remove all references to your book within the context of your presentation/powerpoint. You may mention your book as a resource available to attendees at the end of your presentation, with qualifiers that you do/do not receive profits from all sales of books. Please make the appropriate changes to your presentation.

The web page with the self-promotion is less than a page, but it does include review comments from one of the more favorable reviews I have received. For the record, I do get royalties from the sale of this book and they amount to around three thousand dollars so far.

What are some other potential conflicts of interest that I might have? The guidelines of the Accreditation Council for Continuing Medical Education (ACCME) are worth reviewing and I may comment on them in a separate weblog entry. Here is a list of anything and everything that I might have done in my career that could be considered a potential conflict of interest.

• In 2004, I received consulting income (one hundred dollars per hour, total compensation approximately two thousand dollars) from a grant that I helped write. This grant was a small business initiative and was sponsored by Fertility Solutions. Every year I get a nice Christmas package from this company that includes a small package of chocolates (approximate value $2). • In 2004, 2005, and 2006, I received travel support (St. Louis in 2004, Indianapolis in 2005 and 2006) and a$500 honoraria from the Midwest Society for Pediatric Research for three separate seminars that I gave them. The honoraria were donated by a pharmaceutical company. I honestly don’t remember which company it was, but it was a big company. I will try to find out who this was.
• From 1996 through about 2004, I have received numerous free lunches (maybe 20 or so?) at the hospital (typical value $5-10) at various meeting and events where a drug company picked up the price of the food. Recently, the hospital has been discouraging this practice. I still get free lunches from time to time, but now the hospital picks up the tab. • On or around 2003, I received a free dinner (approximate value$20) from a pharmaceutical representative who was trying to encourage some collaborative research studies.
• On or around 1999, I received consulting income from an animal veterinary products company ( I can’t remember the name anymore) to help with . I received about two thousand dollars total for my efforts (one hundred dollars per hour).
• On or around 1989, I received consulting income from Ross Laboratories, a pharmaceutical firm. The compensation was approximately two thousand dollars total (one hundred dollars per hour).
• I have a Viagra pen that my wife (a doctor) picked up at one of her conferences.

I’ve consulted with other groups for money, the National Institute for Occupational Safety and Health, the Cleveland Chiropractic College, and the University of Missouri-Kansas City. These consultations are (in theory) not a potential conflict of interest because they do not represent compensation companies that make commercial products.

I have received travel support from the American Society of Andrology to participate in workshops in Baltimore MD (2005), Chicago IL (2006), and Tampa FL (2007). This also does not constitute a potential conflict of interest because this society does not market any medical products. I have also received honoraria from various local hospitals that I have given talks to.

I would argue that none of the potential conflicts of interest represented in the bulleted list above represent a conflict of interest that is reportable in any CME event that I might participate in. The reason is that none of my talks promotes a particular drug, medical device, or other commercial product. But I don’t mind reporting this sort of thing if the group that sponsors the talk feels that such reporting is necessary.

There apparently is a “statute of limitations” for these potential conflicts. You do not have to report any financial considerations that occurred more than twelve months prior to your talk. This is apparently based on an ACCME recommendation. Why twelve months is a mystery to me, but perhaps the reporting of potential conflicts would become to onerous if a larger time window were used.

It is possible to contrive some artificial examples where a conflict might exist, but in general a statistician has fewer problems with conflict of interest because almost all of our recommendations concern issues where there is no commercial advantage to any party. I would have more difficulty if I owned stock in a company like SPSS, Inc., that sells statistical software, but thankfully I don’t. I do have several tote bags that I received at the Joint Statistical Meetings, and these bags typically display the logo of various statistical software companies that have sponsored these meetings.

There is one big potential conflict of interest. I am co-inventor on a patent that is currently being reviewed by the U.S. Patent Office. The patent is actually held by Children’s Mercy Hospital, but through our intellectual property policy, I end up getting a share of any royalties that come from this patent. When I talk about some of the methodology that was incorporated in this grant, I should be careful to specify this. I haven’t gotten a dime yet on this patent, but the potential is there. I have not been as careful with this as I should be, mostly because the work on the patent has been seven years of agony with the promise of a payoff always hovering off somewhere in the distant future. The web pages that discuss date gap methodology are areas where this disclosure might be relevant, although most of these pages are discussing applications beyond the scope of the patent for which I do not have a commercial interest.

If the CME department wants me to remove this self-promotion from my talk, I have no problems doing so. I may have to be careful because I brag about my book the way some people brag about their children.

Does promoting a book produce a commercial bias in the talk? Does it constitute a conflict of interest that needs to be disclosed? I don’t pretend to have the answers to this question, but it is worth investigating further, if only to highlight some of the issues and controversies associated with conflict of interest policies.

You could argue that self-promotion is not in violation of the spirit of the regulations on CME events. The concern with commercial bias began with training events sponsored or promoted by pharmaceutical companies (and medical device manufacturers) that were intended not to educate but rather to promote a particular drug. There was special concern about training events that promoted off-label uses of a drug, because other forms of promotion of off-label uses were banned.

You can find an earlier version of this page on my old website.