Tag Archives: financial conflict of interest

by | November 29, 2015 · 4:41 PM

Party Pooper?

The Annual Education Conference (AEC) of the National Society of Genetic Counselors offers a balanced mix of the academic, the clinical, the professional, and, perhaps most importantly, the social. Some of my most cherished professional relationships were formed at the AEC after I struck up a conversation with a genetic counselor who I had not previously known but who wound up sitting next to me in the audience, joined me on a panel presentation, came up and asked me a question after a talk I gave, or perhaps most commonly, unwinding at a bar after a marathon of lectures and workshops. Professional demeanors discarded, guard down, shoes off at day’s end, sipping an interesting beer or a fine single malt Scotch, you can easily become BGCCF (Best Genetic Counseling Comrades Forever). Sometimes I can’t remember a blessed thing I heard all day at the AEC but that post-plenary bar conversation often opened my mind to new and exciting ideas and warm companionship.

Capitalizing on the social networking aspect of the AEC, some corporate sponsors have taken to hosting evening parties and dinners. Maybe it is just my imagination, but the number of these soirees seem to have increased over the last few years. Free food, a generous open bar, genetic counselors eager to socialize and compare notes – what a great way to live it up on our meager travel budgets, freed from the worry of trying to justify several glasses of wine when you submit your receipts for reimbursement. So who can complain?

Well, me, for one.

Okay, so I admit to being an ethical stick in the mud who can suck all the fun out of the dance hall. But now that we have acknowledged yet another of my social failings, let me pose this question for discussion – Is it appropriate for genetic counselors to accept free fare provided by corporate sponsors at the AEC, particularly at non-educational activities?

Stick In The Mud Bobby

Stick In The Mud Bobby

To be clear – I am not taking the corporate sponsors to task. They are businesses, and doing business is what businesses do. With so many labs competing for our samples, they should and will do whatever ethical actions it takes to keep their genetic counselor customers happy. If we told them they would be more likely to get and keep our accounts if they donated that money to Action Against Hunger instead of catering to slightly hungry genetic counselors who want to party a little, I am sure they would do that (not to split hairs too finely, but, all else being equal, selecting a lab in part because it participates in what you consider to be ethical practices such as donating to charitable organizations based on the company’s ethos is different than using a lab because it donates money to feeding clinicians at a conference). The ethical burden is on us, not the sponsors, who are responding to a demand that we have – silently? – created and fostered.

I can already hear the complaints of “Oh Jeez, Bob, can’t you just let us have a good time? I mean it’s just a few drinks and some good food. I give that lab a lot of business. Why can’t I get an occasional treat out of it? So I am nibbling on shrimp atop a round of fried polenta topped with basil pesto while sipping a glass of Nebbiolo. Enough with your puritanical ethics already. Really, what harm is gonna’ result?”

Puritan Bobby

Puritan Bobby (not my real wife)

Perhaps none. But is a practice ethical until harm results? What would patients think if they knew that the very labs that were analyzing their specimens were also providing us with food and spirits? Maybe many of our patients would not care, and might even be slightly envious. But other patients might be surprised if they learned that the lab where you sent their specimens to be analyzed was also wining and dining you. Or what if one day a lab became embroiled in some financial funny business or God forbid a scandal from sub-standard laboratory practices and word leaked out that the lab was in the practice of courting counselors with culinary baksheesh? We would feel awfully awkward and might appear to be guilty by association.

One could legitimately ask whether an occasional gift of food and wine really affects our decisions about which labs we use. Probably many practitioners would deny it or suggest that it does not affect their decisions but may sometimes affect their colleagues’ choices (“I’m very ethical and would never let a glass of wine stand between me and my patients’ best interests. But maybe that is not so true for a few other genetic counselors.”). On the other hand, it is hard to believe that labs would spend valuable cash on activities that resulted in a loss of business. This stuff must be successful on some level or else they wouldn’t do it. TANSTAAFL. We may not be consciously aware of how these influences work. Vide Blind Spots. Which leads me to pose more uncomfortable questions – Should we include attending a corporate-sponsored after-hours bash in our conflict of interest statements when we publish articles or make professional presentations? Many hospitals and other employers of genetic counselors ban vendor sponsored lunches in our offices, so how is this any different? If the free food and drink is not directly connected to an educational activity, would this be a violation of the Stark Law on the part of the vendor, since  just about all labs receive Medicare and Medicaid reimbursement?

By the way, yes, you can call me Mr. Guilty. I have attended my share of these events, but, after a long discussion with my conscience (who I also met at the bar), over the last few years I have decided to avoid them.

But enough of my thoughts. This is about all of us, not just me. What do the Good Readers of The DNA Exchange think about this? Are there better ways to foster collegial and professional relationships with labs that are transparent and ethical, and that allow labs to maintain and grow their volumes? Complete the admittedly unscientific poll below and also share your thoughts in the Comments.

Voodoo Bobby Doll

Voodoo Bobby Doll

And please, be gentle with your Bob Resta voodoo dolls.

 

Thanks to Emily Singh for realizing the graphics and to Maureen Flynn for a thoughtful discussion that sparked and helped shape this posting.

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by | July 1, 2012 · 5:19 PM

The NSGC Financial Conflict of Interest Policy for The Development of Practice Guidelines: Good But Not Good Enough

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.

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by | January 15, 2012 · 1:04 PM

Blind Spot: Genetic Counselors and Financial Conflict of Interest

Many people don’t know that the human eye has a blind spot in its field of vision. There is a part of the world that we are literally blind to. The problem is, sometimes our blind spots shield us from things that really shouldn’t be ignored. Sometimes our blind spots keep our lives bright and shiny.
– Meredith Grey, character from ABC TV Series Grey’s Anatomy

It’s safe to say that genetic counselors are not in it for the money. I prefer to believe that our practice is guided by what we perceive to be our patients’ best clinical and psychosocial interests, with no concern for fiscal gain for ourselves. But however bright and shiny we may be, we are only human and subject to the same economic pressures, character flaws, and temptations as everybody else. I am not claiming that there is wide scale greed and corruption in the profession. What worries me more is that our blind spot can prevent us from detecting or admitting the possibility of a conflict of interest.

This topic has not been openly discussed among genetic counselors, so it’s about time the subject was broached. I suspect this discussion will evoke discomfort, defensiveness, and not a little denial.  Financial conflicts of interest might arise in many areas of genetic counseling but I will explore just three: when genetic counselors work for laboratories as expert advisors on genetic testing, when we need to justify our clinical positions to hospital administrators, and at our  annual education conference.

 Medical laboratories and their employees are driven by a genuine desire to help referring physicians and their patients. I have been uniformly impressed by the help I receive from lab counselors who have walked me through the testing maze in complicated clinical situations. But let’s face it – labs are profit-driven corporate entities. If an insufficient number of tests are ordered, the laboratory and its investors lose money. Hopefully laboratory directors do not set monthly test quotas (“Resta, I better see 150 TRFs for our new autism screen next month or you are out of a job.”). But if the number of tests drops below a certain threshold, some manager somewhere is going to notice. Labs may choose to discontinue that particular test, but more likely they will try to boost test uptake.
The need to make a profit, with the attendant job security for us, is a powerful motivator that can subconsciously influence conversations between lab counselors and healthcare providers. Think of those gray situations where multiple tests can be ordered but it is unclear just how likely they are to be positive or clinically useful (“Well, this doctor does not want to leave any stone unturned  in working up this family so maybe I should suggest Test X that she hadn’t thought of, even if is very unlikely to be positive and will not change clinical management.”).
Or consider labs that offer SNP testing for risk assessment for common disorders like diabetes or cardiovascular disease, tests that do not yet have proven clinical value. One might justify such testing under the rubric of “Patients Have A Right To Know.” But patients also assume that because a test is available and yields a precise sounding risk estimate, it must have some clinical value, and therefore patients think they have a right to know. Is offering such tests motivated by an altruistic desire to ensure that patients’ rights are not denied, by profit-seeking, or by misguided clinical judgment? The answer is murky.

Genetic counselors who work in medical centers are just as liable to conflicts of interest as their laboratory counterparts. In these tough economic times, we are being called upon to justify our jobs to administrators who face dwindling budgets and might have less of an appreciation for clinical and psychosocial issues. In response, we might look to increase our patient volumes, and one way to do that is to expand the indications for referral to genetic counseling beyond what might be considered “medically necessary.” You might then tell your boss that broadened guidelines will increase downstream revenue through more extensive screening and increased rates of prophylactic surgery. Surely we are not talking our patients into salpingo-oophorectomies or breast MRIs to enrich the hospital’s coffers or to secure our jobs, but that is the  message we are communicating to hospital administration (for the moment, ignoring the fact that we have little data to prove that assertion).

Or think about fetal diagnostic testing through maternal serum, which will presumably reduce the need for amniocentesis and CVS. Even if maternal serum testing proves to be not quite  diagnostic and still require invasive testing for verification, First Positive rates will be much lower than with traditional serum/ultrasound screening. This in turn might lower departmental revenue by reducing the number of counseling referrals,  invasive procedures, and karyotypes. Just how will those economic considerations affect our job security, how we evaluate these new tests, how we present them to our patients, and how we integrate them into our clinics?

The National Society of Genetic Counselors (NSGC), our collective face that we present to the public, has expanded its financial relationship with private laboratories. For example, in 2011, about 25% of the revenue from the Annual Education Conference came from corporate exhibitors and sponsors (contributing ~$216,000 of the total conference revenue of ~$820,000). Our professional relationships with labs are critical on many levels. But  accepting money  from them tacitly – if not officially – condones their services. NSGC would probably not accept certain labs as exhibitors or sponsors if those labs offered questionable  services, like using genetic testing to find the perfect mate or to improve your sex life through nutrigenomics. Excluding some labs lends a certain amount of legitimacy to those labs  from whom we do accept funds.

And let’s not forget those breakfasts and evening debaucheries that some private labs sponsor at every Annual Education Conference, or those  exhibitor booths where we fill our corporate-logo imprinted conference tote bags with giveaway geegaws and doodads (“Oh, I’m just bringing these home for my kids. I am certainly not going to use this lab just because they gave me a glow in the dark double helix pen and a piece of chocolate. Even if it is a Dove dark chocolate.”).

You are deluding yourself if you think these drinks and trifles do not subtly affect your selection of  a lab to run your tests. Just about every research study on this topic has concluded that those not-so-freebies do influence healthcare providers. Besides, if those giveaways didn’t help a business’s bottom line, do you think they would waste money giving them away? And when we go home and take those tote bags to the grocery like responsible Green Citizens, we become walking billboards that announce to the world that NSGC and Lab X are awfully cozy with each other.

I am not saying that genetic counselors should be unconcerned about their institutions’ bottom lines, or that the NSGC should abandon relationships with corporate sponsors. I have no idea of the magnitude of the problem because it has not been systematically studied. It is almost impossible to study it ourselves; those of us in the middle of are likely to have a hard time seeing it. Somebody outside of our profession needs to study this.

What the profession can do for itself is to clearly define financial conflicts of interest and develop guidelines to help genetic counselors navigate the treacherous waters of the Great Sea of Conflicts of Interest.

Am I being overly worried? Are there other aspects of genetic counseling that are vulnerable to these concerns? Share your thoughts and comments and air out this dusty old closet that we have avoided opening.

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