Conflict of Interest and Practice Guidelines: A Call to Arms

ON THE LEVEL

I admit that I started out with the intention of writing a point/counter-point piece to Bob’s post on conflict of interest. As a laboratory genetic counselor and a member of the NSGC Practice Guidelines Committee, I figured if anyone should step up, it should be me. So I started doing my background research. First, I decided that perhaps Bob just couldn’t find the Conflict of Interest Policy on the NSGC website. I was determined to find it, right there, hidden in plain sight. But, no such luck. It’s not there. There is not even a mention of it on the page with our Code of Ethics link. OK, score one for Team Resta.

So what about our “sister” organizations like ACMG and ASHG? What do they do?  I went to the ACMG website and after searching for several minutes, I couldn’t find anything there, either. OK, so we weren’t the only ones who did not have a conflict of interest policy posted on our website. Team Strecker, makin’ a move. How about ASHG?  (At this point I was thinking, well, if ACMG didn’t have anything, I bet ASHG won’t either.) Wrong. In fact, waaaaaaay wrong. ASHG has a link to their Conflict of Interest & Disclosure Statement, prominently displayed under their Bylaws, which provides clear definitions regarding what constitutes a conflict of interest, how both real and potential conflicts of interest are handled, and to whom the policy applies. Yeah, I admit it; I was impressed.

TAKING A GOOD, HONEST LOOK AT OURSELVES

Next I decided to tackle Bob’s recommendation that we base NSGC’s conflict of interest policy for the development of practice guidelines on the Institute of Medicine’s (IOM) Committee on Conflict of Interest in Medical Research, Education and Practice recommendations. “It would not be that difficult to implement,” he tells us. All I could think was “Sure, easy for you to say.” But then I realized, that maybe, just maybe, Mr. Know-It-Almost-All Resta might just be right. Section 7 specifically addresses conflicts of interest with respect to developing practice guidelines. I’ll summarize it for you:

1) Don’t accept industry funding for the development of guidelines.

No problemo!!  I can tell you that on my watch, no one has ever offered money to help us get practice guidelines written. In fact, I almost laughed when I first read this one, because I feel like any of us would have the good sense to see the wolf dressed up in granny’s clothing here (My, what big stacks of cash you have, grandma!).

But then I reminded myself that when it comes to ethics, credibility, and money, we must assume nothing.

2) Exclude individuals with conflicts of interest from guideline development panels.

I have mixed feelings about this one because I’m not sure whether we are talking about individuals with (i) true conflicts of interest (in which case, I agree and they should have the good sense to recuse themselves) or (ii) the potential-for-the-perception-of-a-possible-conflict-of-interest.

For example, I take issue with unconditionally excluding laboratory genetic counselors from co-authoring guidelines simply because their laboratory offers a test for the condition about which the practice guideline is being written. Obviously we want the reputation of the NSGC and its practice guidelines to be above reproach, but we also need to be pragmatic. The expertise of laboratory genetic counselors should not be marginalized. Let’s use our judgment with this one, and if the magnitude of the conflict of interest is deemed significant, then it is fair to provide an option for participating as an advisor, rather than an author.

3) If there is difficulty identifying authors without any conflicts of interest, involve the public in an attempt to identify experts without any conflicts of interest.

I like this one. A lot. You know why? Because the public (and by public here, I really mean the NSGC membership) is no longer involved in any aspect of the Practice Guidelines process. Topics for upcoming practice guidelines are not provided or voted on by the membership. The fact is, as a volunteer-driven organization, we are entirely reliant upon the gracious volunteer efforts of our colleagues. So with no trace of disrespect whatsoever, you know what they say about beggars and choosers. The thing is, this method of ascertainment leaves me feeling like we’re in some sort of secret society. Apart from the Practice Guideline Committee members, the NSGC Board of Directors and the authors themselves, I’m not sure that anyone else even knows what practice guidelines the NSGC is working on for 2012-2013. (And they certainly don’t know our secret handshake. Kidding!)

In fact, most of the time, members don’t even know a practice guideline is in the works until it is made available for Membership Review. Oh wait, we don’t even have that anymore. This March, the Practice Guidelines Committee received feedback from the NSGC Board that guidelines were taking too long to complete, and in order to help “streamline the process” the NSGC Board determined that practice guidelines would no longer undergo Membership Review. This was none too popular with the Committee, but we were informed that the Board’s decision was final. So, this IOM recommendation got me to thinking that perhaps we could institute an open call to the NSGC membership once a practice guideline proposal has been accepted in order to allow interested individuals with relevant expertise the opportunity to volunteer as co-authors. This would allow us to identify as many conflict-of-interest-free potential co-authors and expert reviewers as possible, and although it wouldn’t be the same as re-instituting member review, it would be a step in the right direction.

4) If exclusion of authors with conflicts of interests is not feasible, the number of authors with potential conflicts of interest must comprise a minority of the author group.

Whew. Done and done.  We are good here – our policy already states this.

5) The chair of the guideline committee should have no conflicts of interest.

I am with Bob here – we need to revise our current Conflict of Interest Policy to reflect this. At present, our policy for practice guidelines authors states that “a conflict of interest does not exclude an individual from being appointed lead author if doing so is anticipated to improve the overall quality of the guideline.” It is a very well-intentioned statement, but in order to garner respect for our profession, our society and our practice guidelines, we have to toe the line on this one and make it clear that lead authors cannot have any relevant conflicts of interest.

6) Individuals with a potential conflict of interest should not be included in voting for the acceptance of a practice guideline.

Woohoo! Got that one! Oh wait, maybe not. Dang it! The reality is that the Practice Guideline Committee members with potential conflicts of interest have always recused themselves from voting on practice guideline proposals and final drafts of guidelines, but after re-reading our Conflict of Interest Policy, I realized that we don’t actually say that we do this in the document, and we need to.

DIVULGING OUR FINANACIAL AFFILIATIONS

So we have clearly established that Bob might, in fact be right about that whole IOM thing not being all that difficult to implement. But what about his challenge to make our corporate income sources publically available? I don’t have a problem with Bob’s suggestion to make a list of our corporate sponsors available, but rather than providing them with free advertising on our site, perhaps it could be made available on request. In addition, I would like to once again direct your attention to our colleagues at ASHG and their “Guidelines for Corporate Sponsorship” in which they delineate the steps that are taken to prevent concerns about undue financial influence on the society by outside sponsors. I think a similar policy would be a great addition to the NSGC website. Being upfront about our sources of income helps demonstrate that it is important to us to be free from undue external pressure and lends credibility to our professional society.

BRING IT!

I’ll close with the quote that appears on the title page of the IOM’s recommendations regarding conflict of interest:

“Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe

You see, Pom-Poms Resta, you sit comfortably on the sidelines, telling us that it is not your intention to actually DO anything about the issues you bring up; all the while, taunting the rest of us to “Buh-ring it!”.  OK. You know what have to say about that? In the immortal words of Priscilla in “Not Another Teen Movie” (Columbia, 2001) let me just say– “Oh it’s already been buh-roughten!”. (Insert sassy Z snap here for emphasis.)

I  have contacted the NSGC Practice Guidelines Committee’s Board liaison to propose a volunteer taskforce dedicated to strengthening our Conflict of Interest Policy and fortifying our efforts toward transparency in our corporate sponsorship ties.

So, the only question remaining is “Who is willing to get all Goethe on this issue with me?”

8 Comments

Filed under Michelle Strecker

8 responses to “Conflict of Interest and Practice Guidelines: A Call to Arms

  1. Barb Biesecker

    Well done Michelle! Kudos to you and Bob for raising awareness and uncovering sources. I eagerly await pom-pom-Resta’s responses. Your efforts reveal important documents that can be adapted for our specific needs. Gven the NYT article on Saturday raising public attention to the issue of potential COI in genetic counseling, your timing is exquisite. I am in strong support of a NSGC membership-wide vote to endorse a COI policy and will step up to join efforts to draft such a policy. Any others game?

  2. Dawn Laney

    Go Michelle! This post does a fabulous job of seeking, finding, and developing a grand plan! (and was fun to read to boot)
    I do have to put in one comment from the Lysosomal/metabolic world. In a similar way to the lab gc issue, the problem is that the pharmaceutical companies cherry pick off the experts in LSDs on a regular basis. Theoretically, and suddenly, your go-to academic, no-conflict-of-interest author can become employed by the conflict. It would be such a waste to then have to remove them as an author or not be able to consult them during the process of guideline creation and update. As more genetic therapies come on board, I think it’ll become a broader issue. Just a thought to add to the list. Unfortunately, I bet your comments above mean we lose that expertise. Anyway, I may have to be standing over here with Pom-Pom Bob, but I applaud (and dare I say cheer on) your effort.

  3. Jeanne Homer

    I just want to click the “Like” button🙂

  4. Well said. However, my experience is that it’s practically impossible to find people with no conflict of interest. The key is to define that that means very precisely. It seems like you’re zero-ing in on that now.

  5. Karen

    Per Steve’s comment above – I would like to see some exploration of the conflict of interest terminology. This discussion has been focused on “industry”, generally referred to for-profit laboratory (my employer) and pharmaceutical companies. But what about academic/university laboratories which charge for testing? Their “not-for-profit” status does not make self-interest disappear. What about individuals who receive government funding for research? Perhaps it could be in their best interest to promote certain types of guidelines in order to support current or future research projects. Finally, some professions have guidelines that recommend only their specific profession should provide a specific service; again, since individuals may depend on the income/revenue from such services for their livelihood, is such a recommendation a potential conflict of interest? I am not suggesting that our profession (or any profession) is filled with nefarious, self-serving deviants planning to take control of the world through practice guidelines. However, conflict of interest is a very broad term and can describe almost anyone, based on your point of view, and is almost impossible to completely avoid. This is not to say that all is lost. We should continue this very fine discussion (Thanks – DNA Exchange!!) in multiple forums. But perhaps the overarching principles for guideline development should focus more on quality and content, rather than personnel issues. Practice guidelines should be based on very solid science and their development and review should be performed by individuls across a specialty spectrum, as well as some external to the field. My 5 cents.

  6. Robert Resta

    It is terrific to read this lively and collegial discussion. From the many comments I have received publicly and privately –supportive and critical – it is clear that this a topic that needs exposure to air and sunlight. Note that in the very unscientific DNA Exchange poll about conflict of interest, more than 40% of respondents state they have experienced some conflict of interest on their jobs (Yes, yes, I know that number suffers from all kinds of methodological shortcomings, but it still shocked me).

    Steve and Karen bring up a good point about defining conflict of interest. Way back in my very first posting about conflict of interest – Blind Spot – I discussed possible conflict of interest situations faced by counselors who do not work in labs. I also encourage (again) everyone to read the Institute of Medicine Conflict of Interest publication, which more thoroughly discusses the various forms of conflict of interest, financial and otherwise. While genetic counselors of all stripes can and do have conflicts of interest in various settings, the concern about lab based counselors is the potential of direct financial gain, for their employers and their employer’s stock market value. Certainly other counselors could financially benefit from recommendations, through greater patient volumes and higher departmental incomes, and this is why it’s a good idea to have balancing views of “outsiders” like consumers, critics, and ethicists as committee members. But historically the most serious financial conflict of interest problems have come from direct corporate influences on recommendations for medical care. We genetic counselors all strive to be good and noble, but at the end of the day we are just people, and that’s all that we can be.

    Yes, quality and content are critical components to practice guidelines. But the reception and perception of those guidelines are equally important; if the public and other healthcare providers think there may be some financial bias in the guidelines, then even the best guidelines will carry no weight. Allowing lab-based counselors to advise on the guidelines but not vote on or author them seems to be a win-win situation for everyone. Important input is included, the public can feel that financial influences are minimized, and the labs look good in the eyes of patients because the labs look like the servants to the guidelines, not the masters.

    Because of my own blind spots, I will not answer Michelle’s call for volunteers to form an advisory committee. I’ve said my piece already. My own passionate belief in my views might make it difficult for me to see the views of others. So, I will stay a cheerleader on the sidelines; besides I think I look stunning in that blond wig. But beneath that wig, it’s still the same old me. To include another quote from Goethe, as Mephistopheles says to Faust:

    In the end, you are exactly–what you are.
    Put on a wig with a million curls,
    put the highest heeled boots on your feet,
    yet you remain in the end just what you are

  7. Barb Biesecker

    NSGC has convened a task force to examine the issue of COI. DNA Exchange has advanced an important conversation for the profession and encouraged us to examine the issues thoroughly. Well done!!

  8. Bob’s point is well made. It’s one thing for someone on a task force to be employed in a situation that has industry support or relationship, but quite another to be directly connected to a corporate stock option and retirement plan, and salary based on performance/volume, etc. The devil is in the details. Hopefully the task force can take account of some of the finer details.

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