One Infant Dies from Whooping Cough; Unvaccinated and Political Officials Responsible

A 2-month-old infant died from whooping cough (pertussis) yesterday in New Mexico. It’s unclear how the child was exposed to the disease. It had been vaccinated with its first dose of vaccine, usually given at 2, 4, and 6 months, and then later in childhood several times as well. Recently the Advisory Committee on Immunization Practices has recommended that adults be re-vaccinated for pertussis when they get their tetanus and diphtheria booster shots as well.

Pertussis vaccine is very effective, but immunity wanes after 4-20 years (depending on age of the individual, number of booster shots, etc.). Herd immunity for pertussis requires a high vaccination rate – in the 92-94% range. Since vaccine efficacy is somewhere between 85% and 95% (depending on the study you read), if herd immunity is not reached even those vaccinated (but not with effective immunity) are vulnerable.

Before vaccines were available, for example “from 1926 to 1930, there were 36,013 pertussis-related deaths in the United States. The average death rates from 1940 to 1948 per 100,000 population per year were 64 in children less than 1 year old, 6.4 in those 1–4 years of age, and 0.2 in those 5–14 years of age. More than 90% of the reported pertussis cases occurred in children less than 10 years of age, with about 10% of those in children less than 1 year of age.” (Cherry, 2007) Since vaccination has become available, death rates have dropped to less than 1 per 100,000 population.

The tragedy here is not solely the one New Mexico infant’s life (which I don’t mean to minimize with this commentary). The tragedy is that these deaths are preventable. Now, I’m not one to attribute blame for many things – I find it doesn’t do much good to concentrate on who did something, but more to look at why it happened and how we can correct the situation, including preventing deaths in the future. But in this case it seems clear to me that we have blame to apportion in two arenas: 1. those who don’t vaccinate their children or get their own vaccinations, and 2. our politicians who skimp on public health resources.

1. The unvaccinated are responsible for the death of this infant.
Parents who are irrationally fearful of getting their children vaccinated reduce the population vaccination rates and therefore herd immunity is not obtained. Similarly, adults who don’t get their booster shots are as culpable.

Because immunity is not 100% obtained by 100% of the population being vaccinated, some individuals will be vulnerable to getting pertusis. The only way to prevent those vaccine failures from getting the disease is for the population to reach its herd immunity, requiring at least 94% of the population being vaccinated. Those who don’t get vaccinated (aside from those who have justifiable medical reasons like compromised immune systems from cancer or immune deficiencies) are reducing the probability of herd immunity. They are, in essence, freeloaders – thinking they can avoid the disease while abdicating their responsibility to prevent it for themselves or others.

2. Our state and local politicians (and federal to some extent) are responsible for the death of this infant.
Local and state health departments have been devastated with the reduction in financing during this recession. They have lost 15-25% of their personnel, had to reduce or eliminate 33% of their programs, and have had significant morale problems. They are asked to perform almost all of the functions they were doing before 2008 with many fewer resources. This impacts vaccination rates and surveillance capabilities.

It’s always difficult to point the finger at one fiscal cut and say “that caused this infant’s death.” That’s because people don’t attribute the same kind of cause and effect from indistinct dollars (even if guided to certain programs) and unidentified lives in the community. But there are plenty of philosophical reasons to claim that there is no difference between identified and unidentified lives when it comes to health care expenditures. (Harvard’s Program in Ethics and Health had a 2-day conference on this topic last month.)

But politicians who self-righteously defend program cuts while simultaneously decrying the ineffectiveness of our health care system or public health system are as culpable as freeloading parents who don’t get their children vaccinated, or adults who aren’t re-vaccinated. And now they want to do it again: cutting the Prevention and Public Health Trust Fund to reduce interest rates on college loans.

What about you – are you up-to-date on your booster shot for tetanus, diphtheria, and pertusis? If you are over 60 have you gotten your shingles and pneumococcal vaccines?

Addendum

:
A couple of days after I first posted this item it came to light that the state of Washington declared a pertussis epidemic on April 3rd. Over 1280 cases have been reported as of May 11. The governor of WA “announced the state is putting $90,000 into a public awareness campaign and diverting some federal money to pay for 27,000 doses of vaccine.” Where was the governor in preventing the epidemic in the first place? This gets back to the old question: “Prevention vs. Treatment: What’s the right balance?” Unfortunately, this is another example of prevention not getting its due when it could have been more effective – before the epidemic occurred.

Second addendum:
See the NY Times article today about this outbreak. Here’s the particularly relevant paragraph:

Here in Skagit County, about an hour’s drive north of Seattle — the hardest-hit corner of the state, based on pertussis cases per capita — the local Public Health Department has half the staff it did in 2008. Preventive care programs, intended to keep people healthy, are mostly gone.

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In this case Scott Gottlieb has it wrong

A couple of weeks ago Scott Gottlieb wrote an op-ed rant in the Wall Street Journal entitled, “Meet the ObamaCare Mandate Committee.” I usually enjoy Gottlieb’s op-eds, though often don’t agree with him. He is usually thoughtful, even if he has a really negative view of the FDA, for example. I don’t share this view, but find his arguments thought-provoking. [I’ve told Peggy Hamburg in the past that I think the FDA does good work given its mandate and available resources. This is from many years and a number of companies in my venture capital portfolio that have had to get FDA clearance for devices or drugs. The FDA has an important population medicine role and it fulfills it very well.]

In Gottlieb’s current case, though, I can’t say I can even appreciate his viewpoint. It isn’t thought-provoking as much as significantly misleading and even poorly argued. Gottlieb, who seems to think that any cost considerations in medical decision-making is the equivalent of the Devil doing her dirty work, argues that the US Preventive Services Task Force (USPSTF) has been given too much power within the context of the Accountable Care Act, AKA ObamaCare.

The USPSTF has been in business since the mid-1980s. It was the first significant federal body to use carefully reasoned data analysis and literature searches to make recommendations related to screening for disease, or risk factor reduction. After thorough analysis of existing data about a screening test, preventive medication, or prevention counseling technique, the
USPSTF issues a letter grade on any particular item as follows:

Grade A The USPSTF recommends the service. There is high certainty that the net benefit is substantial.
Grade B The USPSTF recommends the service. There is high certainty that the net benefit is moderate, or there is moderate certainty that the net benefit is moderate to substantial.
Grade C Note: The following statement is undergoing revision.
Clinicians may provide this service to selected patients depending on individual circumstances. However, for most individuals without signs or symptoms there is likely to be only a small benefit from this service.
Grade D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.
I Statement The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits & harms of the service.

The USPSTF uses very high criteria for determining these letter grades. ObamaCare determined (in my view appropriately – I’ll elaborate in a moment) that a recommendation of “A” or “B” would automatically qualify for full coverage in the federal mandate for benefits coverage. Thus Gottlieb is correct when he states that this committee “is empowered to evaluate preventive health services and decide which will be covered by health-insurance plans.” But he implies that this committee exists solely to do such a thing, and that its forward-going tour de force will be to wield power to force costs on the health care system by covering what it likes, and also reduce costs by downgrading items it doesn’t like.

[I say in my view appropriately because when I was Medical Director at Aetna in 1988 I helped develop a prevention rider that was based on the USPSTF’s recommendations – it was the only unbiased, evidence-based screening and prevention group in the nation at the time. Subsequently the American College of Preventive Medicine’s board of regents recommended that the Clinton Health Care Reform plan include the USPSTF’s recommendations also. I chaired the policy committee of the ACPM at that time.]

Back to Gottlieb. He also slams the USPSTF because of its change in screening recommendation for mammography in 2009. Many advocacy groups didn’t like the change because it reduced the frequency and starting age of screening for breast cancer (see chapter 5 of Prevention vs. Treatment by Dianna Petitti, vice-Chair of the USPSTF at the time). So, Gottlieb doesn’t like (a) the power the USPSTF possesses, (b) the fact that its recommendations may increase some costs, (c) the fact that some of its recommendations may decrease some costs if recommendations are not A or B, and (d) the fact that advocacy groups may have less clout than they have in the past.

You can’t have it both ways, Scott. Do you want evidence-based medicine? Do you want effective medicine? Or do you want only unbridled freedom for anyone to do anything they want, causing the out-of-control spiral of health care costs already burdening the system?

Let’s look at each of the complaints Gottlieb poses:

1. The USPSTF has some power. Yes, it does. Why is this a problem? He doesn’t say. He tries to argue that it is because it has made decisions in the past that he doesn’t like. But no one can argue that the USPSTF has been arbitrary and capricious in its decisions. It has looked at the evidence, modeled the harms and benefits (where information is available), and dispassionately made recommendations. Is that wrong? Would we rather have politicians making coverage decisions that usually have been arbitrary and capricious, mostly because of the politicians’ personal experiences only, or pressures from advocacy groups that then get resources that are far disproportionate to the diseases for which they advocate? I don’t think so. One way to get that arbitrary and capricious decision out of the hands of those who are (as Kahnemann would say) fast thinkers without using their slow thinking is to put it into the hands of those who can think slowly and methodically.

We know that advocacy groups and individuals don’t necessarily care about the evidence, they care about their advocacy mission. The USPSTF is scrupulous about avoiding conflicts of interest (financial) and conflicts of commitment (advocacy). Most medical specialty societies and advocacy groups can’t avoid these conflicts by definition.

Gottlieb is further worried that “the task force will surely recommend against many services that patients now take for granted, while mandating full insurance coverage for things that they’d be just as happy paying for.” As medicine advances we learn that some things don’t work which we thought did, and some things do work which we may not have thought did. Why shouldn’t coverages be shifted appropriately once we have this new information? Are we stuck in using arsenicals for syphilis and not antibiotics because patients (and physicians) are now “taken for granted?”

2. A or B recommendations will increase costs. Yes, they might. As Louise Russell points out in chapter 3 of Prevention vs. Treatment: What’s the Right Balance? (Oxford University Press, 2011), not all prevention is cost-saving. Some is merely cost-effective. Until now the USPSTF has not considered costs in its evaluation and recommendations. It can start doing so given the mandate from the ACA. But will it? It’s not clear. However, Scott complains that it is allowed to. Wait a minute. He also complains that prevention might cost money. Wait a minute. He also complains that some prevention might be dropped because it isn’t cost-effective. Wait a minute. I’m confused. Do costs matter or not? Does effectiveness matter or not? Gottlieb needs to tell us – is he for or against effectiveness as a criterion for coverage? Is effectiveness more important in prevention than treatment, or less so (or equal)?

3. C, D, or I recommendations may decrease costs. See #2 above. Plus: insurers still have the option to cover them. But why would they consider covering a D or I recommendation? A D recommendation says that the screening method creates more harms than benefits. This is a good reason to avoid its use. If an individual wants to pay for it to expose himself/herself to the harms then one can ask why an insurer should get involved. Further, one could even ask why an insurer should be on the hook to cover the treatment that likely will be required for the harms once this poorly informed and evaluated decision is made by the patient and provided by his/her physician.

For an “I” recommendation there isn’t enough information to know if screening or treatment is of any value. In essence this makes it like an “experimental” decision, except it is not being done in a controlled clinical trial, but simply out of ignorance by patient and provider. By what right does a patient have to get this paid for by the commons?

That leaves “C” recommendations, for which the evidence is not solid and the patient and physician need to have a lengthy discussion of its value and risks. Leaving aside the problem that most physicians don’t have the time to provide full information and explanation/discussion of these issues with patients, (and indeed don’t – see the February American Journal of Preventive Medicine article about this), the C category is one for legitimate discussion and disagreement perhaps. In this case insurers can decide based on the marketplace whether coverage is appropriate or not. Here is where advocacy groups and conflicted treatment specialists can weigh in with some clout.

4. Per #1 above, advocacy groups may have less clout than in the past because they have less influence on the USPSTF. But they still can argue their cases in responding to proposed recommendations – the recommendations are provided as drafts for a defined time period for comment before issued. They also can still advocate for increased research funding for their causes. The research is (and should be) outside of insurance coverage. First prove something works. Then let it be covered. Otherwise we’d be covering a lot of nonsense simply because one party or another claims it works.

I do agree that the process should be transparent. I doubt if the Task Force members would feel significantly different. Except they should be able to go about their work initially undisturbed by advocacy groups. If the task force misses a key study, the advocacy group has the option of pointing it out to them when the draft recommendation is released for comment. The recommendations are released usually about the same time as the evidence base review is released, usually in a peer reviewed journal.

And to go to Gottlieb’s introductory and concluding paragraphs about contraception. The actual coverage decision for that was not made by the USPSTF, but by a different body. The Obama administration could have rejected that recommendation for political reasons, and is modifying it now (like with the allowance of over-the-counter sales to minors of emergency contraception). How can Gottlieb imply or fault the USPSTF for that decision?

Whose Bait and Switch? We all need fair play in health care.

When I was a resident my “mentors” did what most physicians do:  they taught me how to write-up preventive screening procedures as diagnostic or therapeutic ones so that they (and the patients) could get reimbursed by insurers.  So, a screening mammogram to detect early breast cancer, which wasn’t covered in the 1970s and 1980s in most insurance contracts, was written as “mass, rule-out cancer” or a screening resting EKG (which we now know is of little value) was recorded as “chest pain, rule-out ischemic heart disease.”

Surveys of physicians done by reputable researchers in the late 1980s and repeated in the late 1990s/early 2000s showed many physicians knowingly coded screening procedures fraudulently (see for example JAMA 1989;261(20):2980-85; JAMA 2000;283(14):1858-1865).  In the 1989 survey the researchers found that,

The majority [of physicians] indicated a willingness to misrepresent a screening test as a diagnostic test to secure an insurance payment…Most physicians indicated a willingness to engage in deception in some circumstances, justifying their decisions in terms of the consequences and placing a higher value on patient welfare and keeping confidences than on truth telling.

In the 2000 article, Wynia, et. al. concluded that:

A sizable minority of physicians report manipulating reimbursement rules so patients can receive care that physicians perceive is necessary.

Now the tables have turned.  The health reform act (known as the Accountable Care Act, or ObamaCare) has a provision that requires prevention procedures to be covered at 100% without a co-pay or deductible.

Secondary prevention is the use of screening procedures like colonoscopy to detect existing disease before it has signs or symptoms (see Prevention vs. Treatment:  What’s the Right Balance? pages 12-13 for more details). This preventive screening procedure means that something is being done without a suspicion of existing irregularity –  cholesterol is being checked to see if it is abnormal (not because it’s been abnormal and the patient wants to see if treatment has brought it down), or a colonoscopy is being done when there are no symptoms or signs that would suspect colon cancer (not because of an already established positive blood stool test, or presence of previous polyps, or prior diagnosis of colon cancer).

So physicians can get rid of their deceptive practices of old and request the procedure for what it is.  Let’s hear it for the system now encouraging moral integrity for physicians!  At least given old practices.

Covering new benefits, of course, costs more money for insurance plans, which will have to raise premiums to cover these new benefits.  If the actuaries for insurers haven’t already raised the premiums (or requested raises, which the state insurance commissioners may have nixed or reduced), then no pity on them – they had fair warning.  But presumably they have factored these newly covered benefits into their premiums, so now, as reported by the AP (see here), they are simply gaming the system the way physicians have for years.

In my experience in the health insurance industry in the 1980s and early 1990s we found many physicians gaming the system in many ways – up-coding procedures, mis-coding procedures, splitting (unbundling) what should have been bundled procedures, mis-dating follow-ups so they didn’t look as if they were for bundled payments, etc.  At the same time, reputable insurers tried to administer health insurance contracts quickly and fairly.  At Aetna, where I was medical director of the claims department, we prided ourselves on clearing claims very rapidly.  Where there were questions, we attempted to review and adjudicate the claim as soon as information was received to clarify the questions.  98-99% of all claims were paid without question.  But on a claims base of millions a day, 1-2% would still kick out >1500/ day.  Not all of these were medical issues, sometimes they were contractual benefits or eligibility ones which were handled by other departments.

Certainly we heard of irreputable insurers in the business, looking for ways not to pay claims.  But that wasn’t our culture.  I’ve been out of the health insurance business for 21 years, so things may have changed.  (OK, please don’t write in about your individual claim problem.  We’ve all had disappointments with one or more claims if we’ve lived long enough and submitted enough claims to health insurers.)

I’m not trying to be an apologist for insurers – I know they can be frustrating and difficult to deal with sometimes.  And certainly what they are doing now – changing the definition of a screening procedure to a diagnostic one because of findings from a screening procedure – seems deceitful.

My advice to individuals who experience this is to be sure that (a) your physician writes clearly that the requested procedure is for screening, (b) the screening requested is clearly within the guidelines of the US Preventive Services Task Force A or B recommendations, (c) you be vocal and proactive in talking with the insurer and provider in advance, and (d) if you get a billing surprise, appeal the decision as many times and layers as necessary.

So while the patient is asking for fair play from the insurer, at the same time the insurer is asking for fair play from the doctor and patient – don’t misrepresent the purpose of the test as screening if indeed it is diagnostic because of pre-existing symptoms or signs.  In that case the bait and switch isn’t the insurer’s fault, but the patient’s and doctor’s.  We all need fair play – honesty, not manipulation – in health care.

Does Prevention Save Money?

There is a significant difference between something saving money (net reduction in total expenditure) and being cost-effective (requiring less cost per outcome than something else). Sarah Kliff from the Washington Post takes on this question by discussing Louise Russell’s chapter 3 in Menzel’s and my edited text, Prevention vs. Treatment: What’s the Right Balance? Doug Kamerow also addresses this question in more layman’s terms in his new text, Dissecting American Health Care, Commentaries on Health, Policy, and Politics (RTI Press, p. 29).

The argument Kliff looks most at is related to the table Russell shows (figure 3.1) by Joshua Cohen, et. al. that appeared in the New England Journal of Medicine in 2008. According to Google Scholar this article has been cited 195 times since its publication.

It seems to me there is one problem with Cohen, et. al.’s article: it lumps together apples and oranges in its comparison. To compare all well-defined studies of prevention with all well-defined studies of treatment ends up comparing such disparate items as genetic screening for inborn errors of metabolism and surgery for elderly men with prostate cancer. On a macro basis this may be the best we can do when asking the economic question of prevention vs. treatment. But such comparisons seem besides the point when mixed together. I’d rather see comparisons of like-minded prevention and treatment. For example, how does preventive statin use compare with coronary artery bypass surgery? Or more broadly, how does screening and reduction of risk factors for heart disease compare with treatment of preventable heart disease?

A discerning eye can see that prevention cannot impact all types of heart disease, e.g., already established unexplainable congenital heart defects, or right heart failure due to hereditary chronic lung disease. Many (perhaps most) diseases we find in medical textbooks do not have easily defined causes which can be short-circuited by prevention maneuvers. Just as we cannot prevent a disease in a non-at-risk population (i.e., a population that cannot get the disease in the first place – men don’t get ovarian cancer; women who’ve had total hysterectomies cannot get uterine cancer), we cannot prevent a disease for which we do not know predisposing risk factors or causative agents.

[Let me be clear that this doesn’t mean we can’t prevent disease without knowing its proximate cause. Scurvy was prevented in sailors without knowing about vitamin C per se; it was prevented by an observation of the relationship of the lack of citrus fruits and the profound spread of scurvy among sailors. In this case citrus fruits were a surrogate for the active vitamin C ingredient. There are many other such examples in the history of preventive medicine. See, for example. Burt Gerstman’s Epidemiology Kept Simple, 2003, p 290]

One other problem with the cost-effectiveness analyses typically done: they discount the value of future lives. This almost automatically puts prevention at a disadvantage because by definition the effects of prevention are in the future, while the effects of treatment are usually gained in the short-term. So for every life saved in treatment this year, we would need two or more lives saved in the future through prevention if we discount lives. This has interesting ethical implications, the most obvious of which is: why is a life in the future worth less than a life right now? Menzel explores this issue in detail in chapter 11 of Prevention vs. Treatment and I won’t recount his discussion here other than to say that the economic rationale of discounting monetary value most likely doesn’t hold for the value of life, especially when an ethical analysis is done. Because we make health policy including not just dollars but also values, this may hold a very telling modification of the policy implications of Russell’s analysis.

Medical Management and Executive Leadership

In 1983 I became medical director of a staff model health maintenance organization in Lexington, KY. I practiced half-time in the clinic, while spending the other half-time re-organizing the health care system and hiring/replacing personnel. The HMO had been founded as a non-profit for poorer residents of the area.

One of my first challenges was to encourage staff that their key concern had to be the patients. Many of the employees were more interested in their own concerns. In other words, they were not customer focused. They had come to see our patients as a problem (non-adherent, poor health habits, less important than their own priorities), not their service client. Over the first year we changed that by instituting intensive training programs, customer satisfaction surveys, and performance evaluations. Employees who couldn’t make the switch were asked to leave. 50 of the 55 of them did.

Also we had to train the physicians to understand the concept of comprehensive, coordinated, integrated care. This was not just our primary care physicians who worked in the clinic, but also our specialists to whom we referred patients. We needed to train the specialists that we weren’t just referral sources; we were partners in the health care of our patients. We wanted to maximize convenience and quality care for patients, which often meant providing service to patients at one visit in the location they knew – the primary care clinics. And we wanted all non-emergency decisions to be made in partnership between the primary care physicians and the specialists.

Changing physician practice patterns is not easy. It takes daily review of practice habits by questioning medical leadership. It needs to be done collaboratively, and at the same time with a firm managerial hand. It requires training physicians to think differently from the way they are trained in residency. It requires a bit of humility on the part of physicians – they need to understand that they can continue to learn new competencies while they are practicing; they need to rely on their colleagues who may have complementary skills; and they need to broaden their creativity skills.

At the same time we needed to provide the physicians and staff with a feeling of personal control. While we implemented strong and strict performance standards for patient satisfaction (and quality control), we also provided the physician staff with greater control over their workday patterns – providing schedule flexibility and teamwork models to increase workflow efficiency.

All of this is in saying that the November 2 Atlantic Monthly article, “The Quiet Health Care Revolution” was a pleasure to read. Finally there are some places getting it right.

The danger is, of course, that once the larger insurer, Wellpoint, gets its hands on it it might be corporatized without the ability for continuing intrapreneurship. I say this with some experience. For several years in the late 1980s and 90s I was medical director at Aetna, where I also headed a strategic investment unit. We looked at acquiring certain companies that might have let us do this same kind of work but without the medical ownership. My supervisor at the time was a wise man who had been with Aetna for a long time. He nixed more than one potential acquisition of an innovative and creative company of entrepreneurs because of his fear that “Aetna will destroy this” by requiring bureaucratic policies to be implemented that would stifle competitiveness and innovation in efficiency and effectiveness of care.

Alan Hoops is a smart fellow. I hope he’ll be able to avoid too much corporatization of CareMore, and will recognize that the essence of improvement in the health care system requires strong and close physician management and creativity.

PSA Screening and Prostate Cancer

Making health policy involves many different aspects of life:  scientific evidence of a highly predictive diagnostic test, reasonable price, competing resource demands, comfort and convenience of a test, seriousness of the disease being detected, impact of the disease on the individual and the population, etc.

Anyone who’s been involved in health policy debates will recognize that, except for predictive value of the test and actual cost of the test, both of which can be determined somewhat objectively, all of the rest of the items listed above are laden with values (and one can argue even arriving at the predictive value involved significant calls on various values in doing the studies).   Evidence-based medicine only provides information, it doesn’t provide a support of values and how they will be applied in society.

Rather than reproduce some of the less-than-obvious arguments about screening for prostate cancer here, those interested can find more information in Paul Menzel’s and my recent posting on the Oxford University Press blog website.

Wealth and Conflicts of Interest

Carl Bialik’s column in the Wall Street Journal this past weekend (Nov. 12, 2011) discusses the “Income Ladder’s Sticky Steps.”  He tackles the difficult question of assessing mobility, showing how defining the strata may change the conclusions that can be reached, including issues such as (1) What age groups should be included? (2) How do you handle natural progress of careers; older employed folks usually make more than they did when they were younger because their careers progress? (3) Would we be better tracking longterm earnings, as there can be natural fluctuations from year-to-year?

These have important implications when trying to look at economic progress.  For example, the Occupy Wall Street folks claim they are the 99% who are below the chasm of the 1% highest earners.  Of course they are – the 99 out of 100 people will be in the 99% by definition.  Except for celebrity guests of the Occupiers (who likely are in the 1%), those with the time on their hands to protest will be in the 99%.

Bialik states, without making further comments, “And none of the income measures explicitly includes wealth, which is distributed more unequally than income.”  This is an important statement.  Bialik is not the only one who recognizes but does not deal with the issue of wealth.  In Conflicts of Interest in medicine and health care wealth is at least partially ignored.  How?

Most conflict of interest disclosure requirements for authors in journals or speakers in continuing medical education events include provisions to disclose relationships with companies or other interests.

The International Committee of Medical Journal Editors states:  “Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties).”

The American Council on Continuing Medical Education (ACCME) states:

2.1 The provider must be able to show that everyone who is in a position to control the content of an education activity has disclosed all relevant financial relationships with any commercial interest to the provider. The ACCME defines “‟relevant‟ financial relationships” as financial relationships in any amount occurring within the past 12 months that create a conflict of interest.

In the ACCME’s case financial relationships are defined as “…those relationships in which the individual benefits by receiving a salary, royalty, intellectual property rights, consulting fee, honoraria, ownership interest (e.g., stocks, stock options or other ownership interest, excluding diversified mutual funds), or other financial benefit.”

How does this normally exhibit itself in CME speaking activities?  In my experience the moderator of a session will state “so-and-so discloses that (s)he owns stock in [Drug] Company” or “so-and-so discloses that she has been paid an honorarium by [Device] Company” and it is left at that.  As we know, disclosure doesn’t fix the conflict, it merely reveals it.   Loewenstein notes related to the physician-patient relationship,

Disclosure may give the adviser a “moral license” for strategic exaggeration in the adviser’s best interest. (“I told her I had a conflict—now, I can recommend the surgery.”) Having disclosed a conflict of interest, moreover, advisors may feel compelled to give advice in an extra-forceful fashion.

This may be similar for the speaker-audience relationship, “I [the speaker] have disclosed my conflict, now I needn’t worry about it, or I may feel free to discuss it even more than if it were hidden.”

However, the key question that needs disclosure is “What does this relationship mean to the speaker and how has it influenced his/her presentation of information?”  Simply knowing that someone has been paid an honorarium or owns stock in an enterprise doesn’t tell the audience if such ownership is meaningful.  More importantly, what does that represent in terms of one’s income or wealth?  If the speaker has net worth of $100 million, owning $10,000 of stock likely is relatively meaningless.  On the other hand, if the speaker’s net worth is only $200,000, that $10,000 of stock may be critical for how she wants to please either the commercial interest (to get more stock or honoraria) or the audience (to purchase more of the product offered by the commercial interest).

(As an aside, at a recent Harvard University Program in Ethics and Health conference conditional cash transfer payments to encourage health promoting activities in second world countries was discussed.  As I recall, levels of payments had to approach 20-30% of annual income to get behaviors to change substantially.  This, of course, differs from findings related to physician behavior, which is influenced by small pharmaceutical company gestures.)

So, while ignoring wealth as the denominator of disclosure is usually done, we should consider the issue as a much more important measure.  Further there likely is some interactive relationship between meaningful financial ownership (wealth) and income.  Income fluctuations may have little meaning if the amounts are small, or if one has equilibrium with a lifestyle that is fully supported by drawdowns on existing wealth (not requiring additional annual wealth through income or increases in, for example, stock value).

Because of the complexity of the interaction of wealth, income, and meaningful bias/influence the leading medically-related institutions are moving to requiring disclosure of any financial relationship between an author/speaker/influencer and a commercial interest.  This makes sense, in that research indicates that we often don’t let data get in the way of our biases, which can easily come from financial self-interest, and that even small conflicts can result in unconscious bias.   Until we have more reliable data on the relationship between wealth and income this is probably prudent, but also recognizably excessive.

How to find the right balance?  More easily done when more research is completed.