Practice Guidelines are the collective clinical and ethical face that a healthcare profession presents to other care providers and to the public. The National Society of Genetic Counselors (NSGC) has authored a dozen guidelines on topics such as cystic fibrosis, pedigree nomenclature, and cancer risk assessment. I have been involved with developing some of these guidelines, and have found them to be thoughtful, insightful, and clinically helpful.
Where NSGC’s Practice Guidelines fall short, however, is in the underlying conflict of interest policy. The most recent conflict of interest policy I could find, dated August of 2011, indicates that NSGC members who wish to be part of a practice guideline committee must sign a conflict of interest disclosure and, if a potential conflict of interest is identified, outlines how the conflict will be managed or resolved. The conflict of interest guidelines further state that members with conflicts of interest should comprise a minority of the committee. NSGC’s Conflict of Interest Advisory Group is responsible for ensuring that conflict of interest guidelines are properly carried out.
These are important checks and balances, but in my view, they do not go far enough in assuring that clinical practice guidelines are free of undue influences or of the appearance of financial conflicts of interest. In matters of clinical policy, even the appearance of a conflict of interest can be critical to the ethical integrity of the guidelines and how they are perceived.
Steps For Improvement
So how can the NSGC financial conflict of interest policy be improved? The first step is modify the policy to be fully in line with the recommendations of the Institute of Medicine (US) Committee on Conflict of Interest in Medical Research, Education, and Practice. The IOM’s recommendations would not be that difficult to implement, and subscribing to them would assure the public that NSGC strives hard to follow high national ethical standards. And, as I have noted previously about other NSGC conflict of interest policies, the policy should be prominently displayed on the publicly available portion of the NSGC website.
Second, NSGC must restrict the role of genetic counselors who work for or have a financial stake in (such as owning individual stock in a laboratory, being paid consulting fees, or receiving speaking honoraria) private laboratories when the practice guidelines relate to a service or test provided by that laboratory.
Think about it for a moment. If NSGC were to issue guidelines that recommend, say, a panel of genetic tests for autism on all newborns, would it not look questionable if the chair of the practice guideline committee and one or two of the committee members were employed by or had stock in a lab that ran a large number of autism panels? Judges recuse themselves from legal cases where there is even a remote possibility of conflict of interest; genetic counselors should have the same good sense to do so as well.
In my view, genetic counselors with a potential conflict of interest should not chair the committee, should not have a voting role on the acceptance of the guidelines, and they should not be listed as an author of published guidelines. Of course, lab-based genetic counselors have unique expertise and insight that could be valuable in developing practice guidelines, and it is reasonable to include such counselors as expert advisors to the committee.
I have one more controversial recommendation: NSGC should make its sources of corporate income publicly available. If NSGC supports a policy that could directly benefit private corporations, the public has a right to know about the financial relationships between NSGC and those corporations.
Keeping Our Moral Compass Pointed To True North
One might counter that NSGC is a small organization and excluding lab-based counselors from certain practice guidelines committees would be impractical. But I do not buy that argument. Lab-based counselors could still have an advisory role, and there are plenty of non lab-based counselors with expertise in all areas of genetic counseling. After all, those labs serve genetic counselors who use the tests to provide clinical care and thus presumably are also experts on the topic. And in those rare instances where there might truly be an inadequate number of clinically based counselors with adequate expertise, NSGC should consider partnering with other genetics organizations to develop the guidelines.
I can already hear hooting and hollering, and calls from my good colleagues in the Industry SIG and NSGC leadership to have me boiled with my own pudding. Please do not get me wrong. I am not criticizing lab-based counselors or NSGC leadership, nor am I suggesting that any genetic counselor is less than ethical. Indeed, I think lab-based counselors play a critical role for their fellow genetic counselors, for other clinicians, and for patients. NSGC leadership typically works very hard to be an ethically sound organization, and NSGC is not alone in having a conflict of interest policy that could be enhanced. This is an opportunity for NSGC to be a leader and set a model for all professional medical organizations.
Surveying the landscape of genetic counseling practice and guideline development, I am not aware of major problems that have resulted from financial conflicts of interest (of course, that could be the result of my own blind spots). But we are in the midst of a rapid expansion of genomic medicine, and we must not appear to be ethically compromised as we branch out into new professional services. The blind spots that we all possess, as well as the public perception of our motivations, make it critical for us take great pains to stay as ethically transparent as possible. Reputations take a long time to be earned, are stunningly easy to lose, and painfully difficult to re-establish. To borrow a line from the late Ray Bradbury, I am not writing about conflict of interest to predict its future – I am writing to prevent it.
3 responses to “The NSGC Financial Conflict of Interest Policy for The Development of Practice Guidelines: Good But Not Good Enough”
As one of the co-founder’s of the Industry SIG and a genetic counselor whose 25+ years of experience include 15 in industry, I feel I must write in support of Bob Resta’s piece on “conflict of interest.” He will hear hooting and hollering from others–not me.
Just as Elena Kagan recused herself from the recent Supreme Court decision on Immigration, because she had worked on the issue in the Justice Dept, counselors should have the good sense to recuse themselves from any role but that of advisor on a guidelines committee “where there is even a remote possibility of conflict of interest.”
We have a code of ethics that all counselors follow, including counselors in Industry. Yes, doubters–including your colleagues in industry. However, since there are doubters within us, there are doubters outside our community too.
Genetic counselors must take the high road and avoid even a hint of conflict of interest. The policy should be enhanced; it should be clear and transparent. It is best for the profession, the dedicated people of the counseling community, and the public.
The best way to predict the future is to invent it
The meaning of the saying, which you paraphrase, is closer to another saying: “put your money where your mouth is”. That is, if you actually believe something is important, you would make personal sacrifices to see that it was important. For example, you can talk about the plight of the homeless, or you can actually work part time at a soup kitchen. You can talk about politics, or you can actually make a donation to your candidate.
And you can talk about genomic medicine, or you can actually go out there and do it. This can mean taking a pay cut to work at a personalized medicine startup. You don’t have the name brand of the hospital you left. You don’t have the academic medical center behind you anymore. All you have is your equity stake in the company that you believe can change the world.
And, phrased incorrectly, your proposed regulation would take even that away from people who have given up everything else.
After all, you have to consider who is taking the biggest risks to make genomic medicine a reality. It is not people working 9-5s and writing blog articles, it is people who are leaving their jobs to do startups, often in the face of entrenched opposition from the old guard. Genetic counselors are better than that, we are not part of the old guard, we must be part of the future of genomic medicine, and we must realize that means something different from the very expensive status quo.
Pingback: New York Times Weighs in on GC Conflict of Interest | The DNA Exchange