Dark Times for Public Health and Healthcare: Will the insurance industry fix itself?

It’s an exciting time for both health care and public health! Anything goes, and almost anything is, or will in the near future! On the public health front, we have the nomination by President-elect Trump of Robert Kennedy, Jr. to the post of Secretary of Health and Human Services. Kennedy has long been what is generously called a “vaccine skeptic” and his lawyer, Aaron Siri, has sued the Food and Drug Administration to revoke the approval of the polio vaccine. Although the NY Times article says ‘Like Mr. Kennedy, Mr. Siri insists he does not want to take vaccines away from anyone who wants them. “You want to get the vaccine — it’s America, a free country." This is disingenuous. If the FDA approval is revoked, nobody will be able to get it.

I have written recently about the importance of vaccines, especially polio and measles, in preventing disease and death (Raw milk, vaccines, and RFK, Jr: Some dates worth remembering, Nov 15, 2024). A series of letters to the Times in response to the Siri article make clear the risk. Read them; they address the science, the controlled trials of polio vaccine, the experience of those who were doctors and children during previous polio epidemics, and touchingly, the experience of dancer Tanaquil LeClerq, wife of choreographer George Balanchine (short answer: no vaccine, polio, and paralysis). In regard to other vaccines, we can read in the Times ‘Tiny Coffins: Measles Is Killing Thousands of Children in Congo’ and imagine it happening in the US as a result of Kennedy’s anti-vaccine actions. Kennedy calls his movement “health freedom” and says that he will give infectious diseases a “break” (whatever that means), but in fact, as described by Gregg Gonsalves in The Nation, RFK Jr. Is Giving Infectious Diseases a Promotional Tour.

I posted on Facebook that I have heard people say “kids get too many shots”, and asked “then which preventable disease do you want your child to die of?” One comment I got from a colleague was that the problem was not that kids get too many shots, but that too many kids get shot! The most recent killings, in a Christian school in Madison, WI (15-Year-Old Girl Identified as the Shooter in a Wisconsin School) were at least the 323^rd this year in the US! THIS is an epidemic, the extent of which people in most other countries cannot imagine, and, like many of us, wonder what will be done about it. Sadly, the answer is going to be very little, if anything; we may be closing out the statistics for deaths from school shootings in 2024, but nothing suggests that 2025 will be any better.

On the healthcare front, things are not getting better. The anger at the health insurance industry exposed by the shooting of UnitedHealthcare CEO Brian Thompson was deep, broad and well-justified, as I wrote in Murder of a Health Insurance CEO: People HATE the companies and the people who run them (Dec 8, 2024). Study after study continues to appear providing evidence that more and more people have inadequate, unaffordable, or no health insurance. The Commonwealth Fund recently published a report that shows Hispanic/Latino Adults Lack Adequate, Affordable Health Insurance Coverage,

and that this led to their having real trouble accessing health care. The breadth of this lack goes far beyond Latinos.

Maybe we can come up with a solution! I think I have already indicated several – mainly instituting a single-payer universal national health insurance program. Or, until we do, capping the amount of out-of-pocket costs a person can have to a reasonable number ($1000?). And limiting the profits of health insurers, or the ways in which health care providers (e.g., hospitals mainly, but also nursing homes, doctors, etc.) act to make money, whether technically profit or “non-profit”, at the expense of people’s health.

Others have entered this discussion. In a remarkable Op-Ed essay in the NY Times on Dec 13, UnitedHealth Group’s CEO Andrew Witty (Brian Thompson’s boss, who makes more than $20M a year) wrote The Health Care System Is Flawed. Let’s Fix It. Unfortunately, what is remarkable about this article is that the Times chose to run it at all, since it makes no significant suggestion on how to “fix” it, certainly none that would threaten UnitedHealth’s profits. It mostly displays the Times’ complicity in an effort to focus away from the righteous fury of the American people with the health insurance industry.

USA Today reports on Seven reasons why Americans pay more for health care than any other nation, and it gets most of them right. (Reason 1: Lack of price limits, Reason 2: Hospitals and doctors get paid for services, not outcomes, Reason 3: Specialists get paid much more ‒ and want to keep it that way, Reason 4: Administrative costs inflate health spending, Reason 5: Health care pricing is a mystery, Reason 6: Americans pay far more for prescription drugs than people in other wealthy nations, Reason 7: Private Equity.) There are a few others, but it is a good list. Despite that, however, it doesn’t come up with a meaningful, comprehensive solution to them, or any of them. Indeed, it ends up quoting the Witty piece referenced above, "We know the health system does not work as well as it should, and we understand people’s frustrations with it,” rather than having any kind of answer. Like, say, universal non-profit health insurance, limits on hospital system (and physician) incomes, and banning private equity and other for-profit players from the health system!

Maybe it is asking a lot for insurance companies, largely the perpetrators of this massive scam that is bleeding the entire US economy, to come up with a “solution”. But USA Today, Commonwealth Fund, and others that do such a good job of identifying the problem should be able to take the simple next step to recommending the fix. In what is to me an amazingly open (if entirely disgusting and reprehensible) acknowledgment of their agenda, CNBC reported back in April 2018 that Goldman Sachs, the huge investment bank (Jamie Dimon, CEO) raised the question (discussing biotech research) ‘Is curing patients a sustainable business model?’.

!!??

Actually, it’s a good question. Maybe the answer is “no”. Most ethical physicians I know (and it is the vast majority who are ethical) have always said something like “I look forward to the day when we can put ourselves out of business”. Investment banks and other forms of private equity, and the insurance companies like UnitedHealth and the providers that they control, do not see this as a positive. Maybe it is refreshing to see such a stark portrayal of the problem? Or not.

But I, and I believe most Americans, would rather see diseases and the people who have them cured, and would be happy to see the profits of any of these profiteers, privateers, just plain ganevem, and the salaries of their C-suite execs and Boards, disappear.

COVID-19 and protecting healthcare workers

The world, and the US, have entered unchartered waters in recent history as a result of the COVID-19 epidemic. Obviously, the deaths of people who would not otherwise have died is the most important. The real economy (forget the stock market) is a disaster; in this country 3.3 million people applied for unemployment insurance benefits one week only to have it double to 6.6 million the next – the previous high was less than 700,000. The responses of governments – national, state, local – to the epidemic, and the degree to which they rely on actual science, is another huge issue.  Here I seek to address one part of the crisis, one tension, the protection of health care workers, including doctors and nurses.

For starters, we have the issue of the actual health of these individuals. The reason for placing special emphasis on the protection of them is not because they are better or more important people than others, but because we need them to care for the sickest of us, those whose illness means that they cannot safely “shelter in place”, and need to come to urgent care centers, doctors’ offices, emergency rooms, and hospitals. Health care workers, particularly in hospitals, are personally more vulnerable because they have ongoing, repeated exposures to the virus. Greater levels of virus, from one or multiple exposures, increase the risk that a person will not only become sick, but become sicker, as discussed in ‘These Coronavirus exposures might be the most dangerous’ by Joshua Rabinowitz and Caroline Bartman in the NY Times April 1, 2020, and healthcare workers in hospitals have repeated exposures.

In addition, of course, we need these people to care for the sick, because they are the ones with the skills and training to do so. Thus, they need to be protected as much as possible. The news has been full of stories of this not happening, of hospitals not providing necessary Personal Protective Equipment (PPE) to its providers, and even punishing those who bring their own (with the bizarre idea that it is not fair to the other workers who do not have it). Our healthcare providers need to be protected, not punished for identifying flaws in the system (Nicholas Kristof, April 2, 2020, ‘”I Do Fear for My Staff,” a Doctor Said. He Lost His Job.’). Doctors, nurses, and other healthcare workers have often been lauded by the public (the practice of applauding out the window, begun in Italy, is especially touching), but punished by their employers. (Others, such as Capt. Brett E. Crozier of the aircraft carrier USS Theodore Roosevelt, are also being punished by their bosses for doing the right thing.) And these people are, although health professionals, also people, with families and with risk (Sandeep Jauhar, ‘In a Pandemic, Do Doctors Still Have a Duty to Treat?’. Heroes are great, but dead heroes are still dead, fired heroes are still fired, and dead or sick healthcare workers cannot provide care to others.

One of the most elementary pieces of PPE is in great shortage: the effective N-95 masks that every healthcare worker, certainly those in the hospital, should have on all the time. Some of this is because our overall national response has been anemic, and production has not ramped up quickly enough, and some is because hospitals have adopted the “just in time” approach to acquiring equipment popularized by corporations like Toyota and Ford. It may work for cars, and it may be profitable and efficient for hospitals in normal times, but like so much of our “normal” capitalist system it is fatally (quite literally) flawed when stressed by a real crisis. This fault has been augmented by individual profiteering -- well over a month ago the staff in my local Home Depot laughed when I asked about them; they told me they had all been bought up when COVID-19 began in China, by “entrepreneurs” who sold them to Chinese on eBay. True? I can’t know, but there sure were none available. One thing that the rest of us can do is to ensure that essentially ALL new N-95 masks should be available for healthcare workers, especially those in hospitals. Other people should not be wearing, not to mention hoarding or scalping them. Don’t get some to wear when you go out. Stay home. Especially if you’re symptomatic. Stay away from others. Social distancing is something we can practice, and healthcare workers cannot. What about other masks, “surgical masks”? They won’t protect you much if at all from acquiring the virus, but may help (if you can find them, or else use a bandana) protect other people from getting the virus from you if you are infected but asymptomatic. Of course, if you are symptomatic, you should not be going out at all -- unless you are so sick and short of breath that you urgently need to go to the hospital, in which case, wear a mask.

Sometimes this balance between our own self-interest (I need to go out and an N-95 mask protects me) and society’s interest (healthcare workers need the N-95 masks) is difficult, but it is decision that should not be hard. You, me, or our family members, may be the ones who would have been cared for by that doctor or nurse if they weren’t lying in the next bed because they didn’t have the mask we wore to the grocery store.

But some other decisions are harder, like deciding who should get access to a ventilator when there are far too few for everyone who needs one. In their generally good opinion piece (April 1, 2020), Protect the Doctors and Nurses Who Are Protecting Us: They need immunity from lawsuits and prosecution for triage decisions, Cohen, Crespo, and White argue for laws to protect doctors making difficult decisions protection from lawsuits or criminal charges for making them. This is a very good idea. They make two very important points. The first is that there need to be formal criteria established for triaging access to scarce resources so that we do not just have individual doctors making individual decisions, but rather following well-thought-out guidelines. The other is that those decisions need to be legally protected. They cite   

A Maryland statute [that] makes health care providers “immune from civil or criminal liability” for actions they take “in good faith” during a declared “catastrophic health emergency.” According to the Maryland Attorney General’s Office, this statute immunizes clinicians who follow state-approved ventilator allocation protocols, “regardless of the negative consequences arising from the withdrawal of a patient’s ventilator.”

This is a good idea, and one that should be adopted by all states.

But these writers also note that “Denying some patients short-term ventilation, against their wishes, will probably cause them to die when they might have gone on to live long and healthy lives with the treatment. But it will also make limited numbers of ventilators available to other patients who are more likely to survive.” Fortunately, this is not yet really the situation we are in, having to decide which “people who might have gone on to live long and healthy lives with treatment” should be left to die. But we will be, and are in places like New York, in a situation in which decisions will have to be made that deny some patients who would NOT have gone on to lead long and healthy lives ventilation to allow their use for other patients who are more likely to survive.

People who have pre-existing terminal diseases from which they would have died anyway, or those with dementia who are never going to have normal healthy lives (and cannot make their own decisions) will be, and should be, the last people to receive ventilator treatment. Hopefully, this will not be “against their wishes” (or those of their family, if their dementia makes it impossible for them to express those wishes), because they recognize the sense of this. When people have a terminal disease, and/or are suffering from dementia, coming to grips with dying and when it is time to say “enough” even if there WERE sufficient ventilators, is something that should have been addressed already, by the patient, family, and physicians. Of course, none of this argument should suggest that criteria other than pre-existing health status and the likelihood of a full recovery should be considered in allocating resources; certainly not income, wealth, insurance status, race, disability of any kind that is not associated with an expectation of dying soon, or even age in and of itself.

COVID-19 has affected, or will affect, (as the southern hemisphere enters winter) the whole world. We are all in it together. In fact, of course, we are always all in it together, but the pandemic has exposed the flaws in individualistic arguments. I am not going to write that we can “beat this” because I don’t know, but we can behave in wise and responsible ways to keep the terrible consequences a little less terrible.

Baselga, graft and corruption in medical research: why should we tolerate it?

On September 8, 2018, the NY Times reported that José Baselga, MD, Chief Medical Officer at the prestigious Memorial Sloan-Kettering Cancer Center in New York, and a world-renowned cancer researcher, had received at least hundreds of thousands of dollars in payments from drug companies and manufacturers of radiation equipment bought by his hospital. The number of companies from which Dr. Baselga was receiving payments turned out to be in the dozens. The emphasis in this article was not so much that he had received the money, for him personally, but that he had not reported this conflict of interest (COI) to the many journals that had published articles he had written. These articles were often studies of drugs produced by the companies that had paid him money.

 ‘Dr. Baselga did not dispute his relationships with at least a dozen companies. In an interview, he said the disclosure lapses were unintentional. He stressed that much of his industry work was publicly known although he declined to provide payment figures from his involvement with some biotech startups. “I acknowledge that there have been inconsistencies, but that’s what it is,” he said. “It’s not that I do not appreciate the importance.”’

He in fact DID let it affect his science, as the article reports:

‘At a conference this year and before analysts in 2017, he put a positive spin on the results of two Roche-sponsored clinical trials that many others considered disappointments, without disclosing his relationship to the company. Since 2014, he has received more than $3 million from Roche in consulting fees and for his stake in a company it acquired.’

This is important stuff. He took bribes from drug companies and spun the data to make their drugs look good. This is corruption. It is important to separate this from conflict of interest. COI, as I discussed on August 20, 2010 (“The AAFP, Coca Cola, and Ethics: Serving the public interest?”), exists when you have – surprise – conflicting interests! As when you receive money from your employer, and also money from some other company, thus creating a conflict. As medical ethicist Howard Brody, MD, pointed out in his article on the AAFP:

‘imagine that a judge who is sitting on a case involving a contract dispute between two companies is discovered to own $100,000 worth of stock in one of the companies. The judge cannot divert criticism of this conflict of interest by saying, ‘But you haven’t waited until I delivered my verdict—how do you know that I won’t rule against the company in which I own stock?“

He has a conflict of interest. You don’t have to actually do anything to the detriment of one of your funders to be in COI; most journal policies require reporting it so that readers can be aware of the COI, but it does not necessarily mean that if impacts your work. In Baselga’s case, however, it obviously did.

I guess he realized it. On September 13, 2018, the Times reported Baselga’s resignation from Memorial Sloan-Kettering. You can just imagine the Sloan-Kettering board of directors holding their breath to see if this would just blow over, and I am sure mostly that it would not affect donations from rich people. On that same day, the Times also published several letters from readers about the topic, all of them critical of Baselga, but emphasizing different issues. Charles Fried, a law professor from Harvard, notes that Baselga received $1.5 million in income from his employer, Sloan-Kettering, and wondered “Why isn’t $1.5 million enough?” Of course, for some people, nothing is ever enough. But the important point here is that Baselga was scarcely a penniless medical researcher barely scraping by and thus in need of this graft to pay a mortgage on a modest home, or buy a second bass boat. He was just really greedy.

Other letters emphasize other aspects of this practice, noting that Baselga may be a famous and particularly corrupt example, but that he is far from the only one receiving payoffs. Daniel J. Brauner, MD, a geriatrician and ethicist from the University of Chicago, notes that revealing COI is insufficient, observing that ‘The sad fact is that the current system of medical research and care conducted by physician-scientists like Dr. Baselga is fundamentally flawed and does an extreme disservice to patients, who deserve an unbiased accounting about the true worth of potential treatments.’  Frances M. Visco, president of the National Breast Cancer Coalition, bemoans the fact that ‘Breast cancer patients are tired of “breakthrough” therapies that do not extend life for even a day but do bring millions of dollars to industry, medical institutions and the doctors who care for us,’ and demands that researchers and journals ‘Just stop circling the wagons, focusing on financial gain and fame.’

On September 16, 2018, the Times published a full-column editorial on the issue in its widely-read Sunday Review. It notes how common the practice of paying corporate money to doctors and researchers is, observing that ‘A 2015 study in The BMJ found that a “substantial number” of academic leaders hold directorships that pay as much as or more than their clinical salaries.’ In addition, it report that ‘nearly 70 percent of oncologists who speak at national meetings, nearly 70 percent of psychiatrists on the task force that ultimately decides what treatments should be recommended for what mental illnesses, and a significant number of doctors on Food and Drug Administration advisory committees have financial ties to the drug and medical device industries.’ In its analysis of the problem, the editorial leaves out one major issue: much, or most, of the basic research that is done and leads to the production of these hugely-profitable drugs is funded by the federal government through the National Institutes of Health (NIH); that is to say, you and me. The drug companies pick up the work later when they think that the drug may represent a big financial boon for them.

The Times calls for greater safeguards to protect the public, with several suggestions including: 1. Ban paid appointments to outside boards, 2. Create uniform reporting standards, 3. Establish real consequences for violations, and 4. Build a culture of transparency. These are good suggestions, and should be implemented, although how one does #4 is not entirely clear, and the likelihood of #1 happening is low. But the real issue is the degree to which we, the American people, are willing to tolerate graft and corruption. We may – or may not -- dislike it when it occurs in the private sector (certainly President Trump was a major practitioner in his pre-Presidential years). We condemn it when it involves politicians, though it is rampant in federal, state, and local government (although what is illegal graft for state legislators is legal, if sometimes embarrassing, for Congressmen), but we expect it when it comes in the form of “campaign contributions”. And we should not be surprised when it infects medical researchers and physicians, who we hope have our health interests, not their own financial interests, at heart in what they do.

Corruption and graft is corruption and graft. It happens, and shouldn’t, and won’t stop until we demand it. And it won’t stop in health care until we get the profit incentive out of it.

Medical futility and the responsibility of physicians...and patients

Ethics is a difficult area. Medical decision making is a difficult area. Both are fraught with ambiguities, conflicting priorities, differing values. Priorities shift with time, as our moral compass tacks back and forth, seeking to compensate for current problems and deficiencies, and sometimes overreaching, require new future shifts in direction. We will probably never get it exactly right, but need to keep working in the right direction.

Barron Lerner makes an excellent start in his NY Times  Op-Ed from September 18, 2014,”When Medicine is Futile”.  He talks about his father, who was a physician leader in “The medical futility movement, which argued that doctors should be able to withhold interventions that they believed would merely prolong the dying process...”. The father was an infectious disease specialist, whose early career was marked by the miracle of penicillin and drugs to treat tuberculosis. However, later his practice, as that of most infectious disease physicians in the US, was being called to consult on infections occurring in hospitalized patients who were otherwise severely ill, often in intensive care units, with terminal diseases and frequently advanced dementia, “…connected to machines and tubes he knew would not help them.”

The younger Dr. Lerner, author of this piece and a professor of medicine at a major medical school, notes that his father “..placed some of the blame for the situation at the feet of bioethics and patients’ rights, two movements that I, as a young physician, had fiercely advocated,” which put them in conflict. And yet, from a longer perspective, he can see a great deal of his father’s concerns. As he point out, the patient’s rights movement and to a lesser extent bioethics

…did not account for one thing: Patients often demanded interventions that had little or no chance of succeeding. And physicians, with ethicists and lawyers looking over their shoulders, and, at times, with substantial money to be made, provided them.

The stimulus for this article is a recent report by the Institute of Medicine (IOM) of the National Academy of Sciences, “Dying in America,” “…that argues that we subject dying patients to too many treatments, denying them a peaceful death.” This report begins the process of reconciling the physician’s responsibility to at least provide accurate information on treatments and the likelihood of their success with the autonomy of patients to make their own decisions about the treatment that they want. This is a welcome effort at reconciliation of these two apparently or potentially conflicted ethical principles, especially given, as Dr. Lerner points out, that “Physicians declaring things to be ‘futile’ sounded too much like the old system of medical paternalism, in which doctors had made life-and-death decisions for patients by themselves.” But any meaningful discussion of this  requires consideration of four powerful issues that always impact upon it.

First, there is trust. Can patients and their families trust the doctors to be advising them in their best interests? This is particularly true for many disenfranchised people who are not like the majority of doctors in background, ethnicity, and certainly income. For the poor and members of minority groups that have in fact in the past been victims of outrageous abuses, there may remain a suspicion of any effort to suggest that further interventions would be futile. People may think “you are only saying this because I (or my family member) is …” and would recommend intervention for a member of your own family, or someone more like you.

Second is the issue touched on above about the “likelihood of success”. Success at what? For patients and/or their families to make intelligent decisions, the parameters of success, or similar words like “help”, “improve”, “make better”, need to be clearly defined in words and concepts that lay people can understand and that physicians are willing to use. I have written in the past about a woman whose daughter worked with me who was dying in the intensive care unit (ICU) of the hospital I worked at. I came to visit and met her 5 children trying to decide whether to approve the use of an intervention in their unconscious, uncomprehending, and terminally ill mother that they were told “would help”. As I was not the treating physician, I went to the ICU doctor and inquired, on their behalf, what the intervention was and how it was expected that it might help. I then cautiously returned to the family to feel them out regarding their understanding of “help”. They thought it meant it would make her “better”. What, I asked, did “better” mean to them? When they appeared confused, I went further, asking if it meant that she would wake up, be able to talk to them, be able to go home, perhaps be able to say goodbye? Yes, they said, that is what it meant to them. I tried to gently say that this would not happen, that this intervention would, perhaps, correct a laboratory value, but would not have any of the outcomes they hoped for. They opted to not have it.

These are not easy discussions, and lead to the third issue. Most people do not have the training and background to understand the ramifications of the decisions that they are asked to make under the rubric of “patient autonomy”. I feel that I am knowledgeable about many areas, particularly medical ones, but it would be ridiculous to ask me how a bridge should be built. You wouldn’t want to drive over it, and I wouldn’t either. Simply citing “patient autonomy” and presenting incomprehensible data and decisions about whether to do something that even the words for make no sense to a regular person is not ethical; it is equivalent to abandonment. Sometimes a doctor or nurse or other health professional with patience can spend the time and effort necessary to help a patient or their family really understand what is going on, what likely outcomes of any intervention or –equally validly – non-interventions might be, so that they can make an informed decision based upon that information and on their own values and priorities. Most of the time the healthcare providers are too busy, and do not have the time and may not have the inclination, and are not paid well, or at all, for that time.

Which leads to the final issue, money. In a quote from Dr. Lerner above regarding procedures that will not be effective, I include “the substantial money to be made from them”. The money to be made by providing them is a profoundly important issue, potentially corrupting any discussion of ethic versus futility. Dr. Lerner notes that the IOM report “…advocates that Medicare and other insurers pay physicians to talk to their patients about end-of-life care”. This is a great idea, but it doesn’t currently happen often, and even the proposal that physicians do it (not to mention be paid for it) was grossly misrepresented as “death panels” when included in the Affordable Care Act (ACA). Even if this time is paid for, it would never approach the amount of money that would come from doing the procedure, or certainly not the money a busy surgeon, for example, might make from operating on someone else.

All people know, intellectually, that everyone dies. What may be harder for many to accept is that they must die, particularly when their time comes. It may be even harder for family members, who are not the actual patient, to accept, and to demand that “everything” be done. For Dr. Barron the elder, as described by his son, “Infections were the way that such frail individuals were supposed to die, the ‘final straw’ in the deterioration of so many of the body’s vital organs and functions.” Yet somehow they had become things that needed to be treated.” 

Everyone dies; what we can only hope for is a death unaccompanied by pain and unpleasantness. Infections like pneumonia which should be treated in an otherwise healthy person in whom a return to health is likely probably should not be in a person who is terminally ill, bed bound, demented. They are nature’s exit door. The same could be said for starvation, a relatively benign way to go, and almost always better than the alternatives of feeding tubes or intravenous nutrition, which carry high risks of complications of aspiration and infection and discomfort.

There must be a real understanding that patient autonomy does not include the right to demand any treatment. We would not assume a person could request a Corvette or a lifetime pension, and yet the latter would probably do more to improve health than any medical intervention, and the former would cost less than many.

Dealing with and overcoming the barriers presented by the first three issues will be difficult but can be done. To really do so means eliminating the fourth issue, the perverse economic conflict of interest that can cloud judgment, decrease trust, and pollute the entire process.

Rationing, Waste, and Useless Interventions

Most people, when they or those they love are sick, want things done for them that might be of benefit. Cost is a secondary factor, especially when it is not directly being borne by them because they have health insurance coverage (but if it is going to be costly, that insurance better be good). In general, the order of preference would be for: 1) things that will definitely help; 2) things that might help; 3) things that almost certainly won’t help-but-you-never-know and don’t cause serious harm; and 4) things that won’t help and may very well cause serious harm.

It might seem superficially as if most people wouldn’t want #4 interventions, but surprisingly people opt for them. This is particularly true when the expected outcome is death; if you’re going to die anyway, what harm could be greater? Besides, maybe a miracle will occur. Of course, there can be greater harm than simply dying – death preceded by increased suffering caused by futile attempts at treatment – but when confronting death, many people look at the positives and ignore the negatives. In addition, the decision may be different when made by the person actually facing death (provided s/he is conscious and competent – or has advance directives -- and isn’t doing what the family, not s/he wants, because s/he is used to caring for them) or by his/her loved ones.

This leads into a discussion about rationing of health care resources, which is, appropriately, achieving a lot of attention. Two “Perspective” pieces in the New England Journal of Medicine May 24, 2012, and a “Viewpoint” from JAMA, May 23/30, 2012, address these issues from slightly different, well, perspectives/viewpoints. Howard Brody, MD PhD, in “From an ethics of rationing to an ethics of waste avoidance[1], as a bioethicist, begins with providing the ethics of rationing: “First, rationing occurs simply because resources are finite and someone must decide who gets what. Second, rationing is therefore inevitable; if we avoid explicit rationing, we will resort to implicit and perhaps unfair rationing methods.” I’d say “certainly unfair”; while Brody is talking in the abstract, we need only look around at what is actually occurring in the world to know that we have rationing that is unfair. He adds “The main ethical objection to rationing is that physicians owe an absolute duty of fidelity to each individual patient, regardless of cost. This objection fails, however, because when resources are exhausted, the patients who are deprived of care are real people and not statistics. Physicians collectively owe loyalty to those patients too.”

Brody addresses the current importance of this discussion given recent studies that show that as much of 30% of health care expenditures are “waste”, as opposed to less than 10% that might be attributed to “deliberate fraud.” Eliminating fraud is important, but it is a “one-time” saving, whereas eliminating waste not only represents a bigger number, but, because doing more and more tests is a major driver of rising health costs, may represent a way to “bend the cost curve.” Of course, as I noted, what is “waste” can depend upon ones perspective, values, and even degree of selfishness. Certainly because, as Brody notes, one person’s health expense (even if it is “waste”) is another person’s income, this is not going to be an easy discussion.

Brody cites the case of treatment of advanced metastatic breast cancer with high-dose chemotherapy followed by autologous bone marrow transplantation, which was “…initially thought to offer perhaps a 10% chance of a significant extension of life for patients who would otherwise be fated to die very soon. Insurers’ refusal to pay the high costs of this last-chance treatment did much to torpedo public trust in managed care during the 1990s. Data now suggest that the actual chance of meaningful benefit from this treatment is zero and that the only effect of the treatment was to make patients’ remaining months of life miserable.” However, it could have gone the other way; maybe longer experience would have shown it to be more effective. The “torpedoing of public trust” was surely enhanced by protests from advocacy groups as well as from physicians and hospitals that benefited financially from these procedures. Another result, noted by Volpp et al., in JAMA “Assessing value in health care programs”^[2], is that “Many insurers, including Medicare, are continuing to cover bevacizumab for metastatic breast cancer, despite the unanimous recommendation by a US Food and Drug Administration panel that it not be covered because it is not helping patients to live longer, does not control their tumors, and exposes them to serious adverse effects, and despite an average annual cost of $99,000.”

Volpp and his colleagues  argue that, in health care, return-on-investment (ROI) cannot always be measured directly as positive in dollar terms, and is less so as the pool (everyone, a big company, a small company, an individual) is reduced:

“What would happen if the rule were applied to every health care decision that is made? Besides childhood vaccination and flu shots for the elderly, few health care services save money. The positive return-on-investment criterion is not applied to most health care services because almost nothing satisfies it. Medicare is prohibited by law from considering cost in coverage decisions, and other insurers tend to follow suit, even if the benefits are small and the costs very large. Would anyone ever ask, ‘What is the return on investment in treatment of this patient’s cancer?’ This is not a meaningless question, but almost certainly one that most people would think inappropriate to ask.”

They add “It certainly does not make sense to use one criterion—Are there clinical benefits?—for coverage decisions for treatments and a different criterion—Are health care savings greater than program costs?—for preventive services or for delivery system innovations designed to improve health;” however, we certainly do.

The third article, “Beyond the ‘R Word’? Medicine’s New Frugality”[3] by M. Gregg Bloche MD JD, takes a more policy, political, and law-oriented approach toward understanding what might happen in limiting health care expenditures. He discusses the medical “luxury tax” (on “Cadillac plans”) and notes that while this is not having a big impact now, with the threshold at $23,000 a year, it will in the future because costs of medical care (and insurance) rise faster (at least 2% and often more) than the consumer price index (CPI), while the threshold for the tax is 1% above CPI. He suggests that “Employers

will pay the tax, but workers will bear its burden as firms shrink salaries to cover the cost.”

This is really important, and it is another strong argument for a single-payer health insurance program that will cover everyone. Costs do – and will continue to need to be – controlled, and this will result in continued rationing. But that rationing is only ethical when it is explicit and based on medical need, not the character of one’s insurance or socioeconomic status.

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[1 Brody H,”From an ethics of rationing to an ethics of waste avoidance”, NEJM 24May2012;366(21):1949-51

[2] Volpp  KG, G Loewenstein, DA Asch, “Assessing value in health care programs”, JAMA 2012May23/30; 307(20):2153-4.

[3] Bloche MG, “Beyond the ‘R word’: medicine’s new frugality”, NEJM 24May2012;366(21):1951-3.

"Eggs Benedict" and "Choosing Wisely": often the best thing to do is nothing

Years ago (OK, decades ago), when Woody Allen was a standup comic, he did a short, famous bit called “Eggs Benedict”. The narrator (let’s say “Woody”) is having pain in the chestal area (a great formulation which has long been popular in my house). He is pretty sure it is heartburn, but is worried and doesn’t want to pay the $25 to see a doctor (I told you it was a long time ago). Luckily his friend, Eggs Benedict, is having the same kind of pain. He figures if he can get Eggs to go to the doctor, he can find out what it is and save money. It works, and Eggs finds out it is heartburn. Two days later, he discovers Eggs is dead. He immediately checks into the hospital, has all kinds of tests, and discovered he has – heartburn. The bill is $110 (it was a really long time ago!) He goes to see Eggs’ mother and asks if his friend suffered much. “No,” she says, “the car hit him and that was it!”

I was thinking about this story when I was asked to call into a local radio talk show to comment on “Choosing Wisely”, an initiative of the American Board of Internal Medicine (ABIM), which calls on medical specialty societies to list 5 tests or treatments frequently performed in their specialty that they recommend not be done, or not be done on most patients. In the recently released report, 9 medical specialty societies are represented, for a total of 45 recommendations, which can be found here. The 5 for my own specialty, Family Medicine, listed by the American Academy of Family Physicians’ (AAFP), were:

1.  Don’t do imaging for low back pain within the first six weeks, unless red flags are present.

2. Don’t routinely prescribe antibiotics for acute mild-to-moderate sinusitis unless symptoms last for seven or more days, or symptoms worsen after initial clinical improvement.

3.  Don’t use dual-energy x-ray absorptiometry (DEXA) screening for osteoporosis in women younger than 65 or men younger than 70 with no risk factors.

4.  Don’t order annual electrocardiograms (EKGs) or any other cardiac screening for low-risk patients without symptoms.

5. Don’t perform Pap smears on women younger than 21 or who have had a hysterectomy for non-cancer disease.

Each is backed by the evidence, and is accompanied by a summary of the reasons. For example, for #2: “Most sinusitis in the ambulatory setting is due to a viral infection that will resolve on its own. Despite consistent recommendations to the contrary, antibiotics are prescribed in more than 80 % of outpatient visits for acute sinusitis. Sinusitis accounts for 16 million office visits and $5.8 billion in annual health care costs.” Big money for a treatment that doesn’t work, and can cause bad side effects (allergies to the antibiotics and increased resistance of bacteria to antibiotics, for two).

The talk radio hosts had questions, especially about treatment of cancer. One of the American Society of Clinical Oncologists’ (ASCO) recommendations is “Don’t use cancer-directed therapy for solid tumor patients with the following characteristics: low performance status (3 or 4), no benefit from prior evidence-based interventions, not eligible for a clinical trial, and no strong evidence supporting the clinical value of further anticancer treatment.”  That seems like a no-brainer to me, but they wanted to know “What if a patient wants treatment for cancer anyway?” I said I thought it was the responsibility of the doctor to point out that the treatment would not help, and would not only cost money but would have a lot of toxic side effects; I said that I thought most people, if they knew they were going to die from their cancer and the treatment would not help, would not wish to spend their last days and weeks nauseated, losing their hair, and being unable to interact comfortably with their loved ones.

The radio hosts also said “We are always told patients should be self-advocates. What if advocating for ourselves we say we want antibiotics for our sinusitis?” I said that self-advocacy was really important, because no one but the patient and their family could really identify what their health goals were. But this was different from deciding what treatment you wanted; going to the doctor is not going to the grocery store with your shopping list that may include both healthful and bad-for-you foods. It is critical that you identify where you want to go and work with the doctor, or other provider, to come up with a plan that is mostly likely to get you there safely and effectively.

Coincidentally, the same week I facilitated the discussion about futile treatment at the end of life for a group of third-year medical students in their medical ethics course. They had just received a lecture from a distinguished medical oncologist, who presented the four core principles of medical ethics: Autonomy, Beneficence (do good), Non-maleficence (do no harm), and Justice. They also read several articles documenting cases in which end of life decision-making did not go smoothly or well, and the article “How Doctors Die” by Ken Murray, that I have previously discussed (How people die, and how should we?, April 7, 2012). One of the cases involved a patient with terminal cancer who had already failed treatment, and for whom further treatment would be futile (although not without adverse effects). He had agreed to hospice, and to comfort care, until a relative (a physician!) came to town and demanded additional treatment for him, and convinced him to as well.

The medical students, who had  all been through clinical experiences and most of whom had been part of teams that confronted dealing effectively with dying patients, were in agreement with the physician in the article, and with each other, that the treatment was futile and would be a bad idea. However, several felt that, if the patient demanded it, the principle of Autonomy required that it be given. Others noted that this might violate the principle of Non-maleficence. I pointed out that that there were many areas in which we do not allow the patient to pick his/her treatment of choice. For example, we do not allow people to walk into a pharmacy and buy narcotic pain relievers without a prescription, no matter how much they might want them. Certainly the effects of chemotherapy poisons were at least as great.

These are not always easy decisions, but it is one of the reasons being a doctor is hard, respected, and well-paid. If everything were a simple algorithm and one could just memorize the right answer as these medical students were expected to do so often on their multiple-choice tests, it could be done by someone with much less training. Sure, it is possible that someone getting antibiotics for viral sinusitis to get better – indeed they usually do, with our without the antibiotics. Temporal association is not cause. Thus, even when you do the right thing, based on the evidence, and do not get a test or treatment, it is still possible that you will end up worse.

As Eggs and Woody discovered.

What is the ethical role for physicians in the "business" of health care?

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Health care is a complex business. “Business” in the sense of “a human endeavor”, but also as “an organization seeking to make a profit.” Over the last several decades we have seen increases in the portion of health care delivery services that are formally organized as “for profit”. Hospitals, especially, have undergone such changes, joining the ranks of long-term care facilities, pharmaceutical companies, device makers, home health agencies, and insurance companies that have always been primarily “for profit”. Indeed, most physician practices, whether solo, small-group, or large group, are for-profit, organized into “professional” or “limited liability” corporations.

“For profit”, however, means that these organizations pay taxes, but because an organization is “not-for-profit” does not mean it behaves significantly differently. Not-for-profits are granted this status because a significant part of their activity is providing a public good, and their income-over-expenses (profit, which we can call “margin” to be less confusing) is not owned by shareholders but is rather intended to be re-invested to further enhance that public good. But not-for-profit hospitals generally follow very similar business practices to for-profit. They have to “compete for market share”. While they may have a mission, they often cite the mantra “no margin, no mission” as they invest in high-margin product lines (heart disease, cancer, neurosurgery) to attract more paying customers. Rather than, say, spending that money providing their wonderful care for free or at great discounts to the poor and uninsured. Or expanding their provision of high-need but low-margin services (primary care, obstetrics, pediatrics, psychiatry). The salaries paid to management of not-for-profit hospitals and professional personnel are often as high as those paid by for-profits (who, after all, have to maximize profit to please their shareholders, so want to keep costs, largely salaries, down).

So what is reasonable profit in health care, for companies that are for-profit? Should there be any? Does competition with for-profits distort the behavior of non-profits or would they act in the same ways if they had to compete only with other non-profits? Is competition good or bad? And what about doctors? Do they behave differently in their practice if they are salaried or have an incentive to make profit? Is this a good thing or a bad thing? So many questions!

In their commentary “Physician stewardship of health care in an era of finite resources” (JAMA 27Jul2011; 306(4):430-1), David B. Reuben and Christine K. Cassel address some of these issues. They start by noting that “Although there are varying opinions about the quality of health care in the United States, there is consensus that it costs too much.” I would guess that this is probably true, but may be as far as it goes. I suspect that each individual player or industry dependent upon health care dollars is unlikely to think it is their part that costs too much. It’s those other guys!

Reuben and Cassel focus on physicians. Not on how much physicians earn (salary or profit), but how they choose to spend health care dollars, because “Health care costs are directly related to decisions made in clinical practice”.  They go on to say that “These decisions are difficult to influence because they are made in the context of individuals who are often sick and vulnerable, with little understanding of the potential benefits and risks of diagnostic and therapeutic options. Patients seek help from physicians and physicians chose careers to provide this help, or at least the hope of it. Because of this relationship, it is futile to expect that changing physicians' behavior through evidence and shared decision making alone will solve the problem of high health care costs. Alternative approaches will be necessary.”

Cassel, the President and CEO of the American Board of Internal Medicine (ABIM, the organization that certifies internists; not to be confused with the American College of Physicians, ACP, the internal medicine professional organization), is both a geriatrician and a medical ethicist. I have heard her discuss physician stewardship in individual cases, arguing that the use of resources ordered by an individual physician for an individual patient should not be based on issues other than the benefit and risk for that patient, since the physician and patient have no control over what money “saved” might be used for. (My patient and I cannot decide to not do expensive interventions and instead use the money for housing the homeless or feeding the hungry – unless s/he is that rare person paying all the costs out of pocket --  all we can decide is whether to do those interventions or not.) Savings have to be looked at on a more global level, with a shared understanding of what those “saved” dollars will be used for.

The contribution that Reuben and Cassel make in this piece is to provide something of a taxonomy of physician stewardship, examining the various levels at which it can occur beyond that of individual patient decisions. These include the “highest” level, of national and state policy where spending decisions (initially, one presumes, via Medicare and Medicaid) should be based on evidence of benefit and consistency with national policy objectives (such as, I imagine, Healthy People 2020). The second level is that of payers (insurers) who would choose to pay for interventions that are shown to be beneficial (and presumably cost effective) rather than those that are ineffective or marginal. They suggest that rather than charging high deductibles and co-pays for services that are known to be beneficial and cost-effective, they simply do not pay for those that are not. This makes sense; why should insurers pay even a significant portion of procedures that are of little or no benefit while excluding such things as hearing aids that are of great benefit and (relatively) inexpensive?

The third level that they address is the practice level, where groups of physicians can use evidence to guide their group decision making and decrease inappropriate variation in physician practice. An example of this would be the use of a limited drug formulary emphasizing generic medications (this could also occur at the insurer level). Finally, there is the individual patient level; while making cost-effective decisions at this level can be more complex, it can certainly be done. While it is certainly unfair to ask a sick person to decide upon the choice of having, or not having, a medical intervention that they can scarcely understand so that saved dollars may possibly benefit some unnamed person more, it is quite a different thing to educate people about the impact of their health decisions, especially before they become critically ill. Advance directives, such as living wills, are one method, but there are many others.

What is clearly unethical and unacceptable is for physicians to encourage patients, sick or well, to undergo a diagnostic or therapeutic intervention because the physician stands to gain financially from doing it. Unfortunately, this happens. Sometimes it is done consciously, but often it is because the physician who does the procedure (and will happen, coincidentally, to benefit financially from doing it) truly believes it is of benefit. To not believe it would, in fact, be cognitive dissonance. Although there are increasing numbers of procedures being called into question for everyone, there are far more that are of benefit to some people but not to others. It is the ability of physicians to distinguish between these people and present recommendations honestly and free of financial bias that will make the biggest difference. The fact that there are still many physician-owned for-profit hospital and “surgi-centers” in which the doctors benefit financially not only as the providers but as owners of the facility from more procedures being done argues that we have a long way to go. (See also my commentary in an earlier post,  Greed, corruption and medical procedures: ignoring or suppressing the evidence?, August 12, 2011.)

The greed of human beings is not going to be wished away, whether they are physicians or lay corporate executives; whether of for-profit or not-for-profit companies. The taxonomy of Reuben and Cassel is useful for thinking about these issues, but it is only comprehensive – and thoughtful and balanced – regulation that can be sufficient impetus to make these changes happen.

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Conflict of interest reporting

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looks like using Google Chrome instead of IE8 solves the problem. Hmm.

This is the first of a two-part series on conflict of interest, medical ethics, and whether we can trust recommendations.

In several posts last year (Harvard Medical School limits outside income: a good start January 10, 2010, Statins and scientific integrity July 6,2010 and especially The AAFP, Coca-Cola, and Ethics: Serving the public interest? August 20, 2010), I discussed the question of conflict of interest, citing the work of ethicists such as Howard Brody, along with common sense, to demonstrate that a “conflict of interest” is simply that; a conflict between one set of a person or organization’s interests and another. In the case of the American Academy of Family Physicians (AAFP) and its relationship with the Coca-Cola Company or that between the American Dietetic Association (ADA) and Hershey’s Chocolate, the conflict is between what is in the best interests of the health of the patients that the AAFP’s member physicians or ADA’s member dieticians serve and what is in the best interests of Coke or Hershey (making money). The latter is only important to the professional organization because those companies share some of the money they make with them. In defending themselves against what appears to many people, both within and outside the organizations, to be corruption, the leaders who made these deals (such as then AAFP-President Lori Heim, MD) make the argument that only by looking at whether the information presented on the AAFP’s http://www.familydoctor.org/ website (for which Coke provided support) is biased (presumably toward Coke) can the presence of a conflict be determined.

This is patently absurd; the conflict is there, and along with it the suspicion that information may be skewed. This is particularly true when dealing with a site such as http://www.familydoctor.org/, on which the information is intended for the general public, not for professionals. Its value depends entirely upon the trust of the members of the public who use it, and such conflicts of interest undermine that trust. “How can I trust information provided on a medical site with ads from a company that my doctor says makes stuff that is bad for me – heck, that everyone knows is bad for them?” is a reasonable question, a reasonable suspicion, and a legitimate reason for concern by the public. “Hey, take our word for it; taking Coke’s money (or Hershey’s, in the case of the ADA) didn’t influence the content of the information on our website,” is a pretty weak defense, not one that is likely to engender trust of the organization or, of greater concern, of its member professionals.

The issue of conflict of interest has been a significant focus in the medical literature. Most major journals now require the authors of original research studies, particularly those that evaluate the effectiveness of drugs, to indicate if they have conflicts of interest; that is to say, financial connections with the manufacturer of the drug (or any other drug manufacturer or potential conflict of interest). This is in addition to identifying the source of funding for the study – mainly whether it was funded by a drug (or device) manufacturer as opposed to funded by the federal government (through NIH or another agency) or, much less common for such studies, a not-for-profit foundation. Again, the reason is obvious: if the author has a conflict of interest (gets money for speaking for a drug company, say, that manufactures the drug being examined, we all have reason to be more guarded in our interpretation of the results, or at least the confidence that we have that the study was done completely without bias. One problem is that bias can creep in unconsciously, even if there is not intentional fraud. Another problem is selective publication: we may only see the papers that report on studies where the drug had a positive benefit, because negative studies are suppressed; this is further complicated by the general preference of journals for positive results, regardless of who is funding the research. If the authors do not disclose their conflicts of interest, we have no way of knowing about them, and may not be sufficiently skeptical in interpreting the findings.

Am I saying we need to be skeptical? Is it not possible to be paid for speaking by a drug company and still do unbiased scientific research on their drugs? Is it not possible even when the drug company is funding the research? Of course it is possible, but unfortunately the data show that it is less likely. In the Introduction to their recent article in JAMA, Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments[1], Michelle Roseman and colleagues note that “Results from positive trials and from favorable analyses are more likely to be published than results unfavorable to sponsors. Compared with nonindustry-funded trials, pharmaceutical industry–funded studies more often yield results or conclusions in support of the sponsor's drug, and authors' relationships with drug manufacturers have been linked to favorable assessments of drug efficacy and safety,” with numerous references for each of these assertions. The actual focus of their study is to look at meta-analyses to see whether they report conflicts of interest (COIs) in the original studies that they are analyzing. Meta-analyses can be the most potent source of information about a question, as they analyze the results of many studies (ideally, all randomized controlled trials) on a particular topic, and if well done can help to resolve the question of conflicting results from different studies. Of course, if the studies that are included are in themselves biased (either intentionally or not) it will of course impact the results of the meta-analysis. Roseman and her colleagues found that, while the authors of the meta-analyses reveal their own conflicts of interest (if any), consistent with the policies of the journals they publish in, they rarely indicate whether the many studies that they are re-analyzing had such conflicts.

This can be important. For example, if the different studies examined by the meta-analysis tend to show differences in the benefit of a drug treatment, it would be good to know if the ones that showed greater benefit were sponsored by a drug company, or if the authors were on that drug company’s speaker’s bureau. It just might make a difference. Wealth makes a difference because it can buy loyalty, buy favors. The old saw “It is as easy to love a rich man as a poor one” can be modified to “it is as easy to use a product made by someone who pays you as by someone who doesn’t”. Or even “it is as easy to believe an idea supported by the rich and the powerful as one supported by only the poor and disenfranchised”. The problem is that the connections are not random – the ideas of the rich and powerful are too frequently self-serving, and “just so happen” to favor them over the poor and disenfranchised. An excellent example, featuring Ayn Rand and her disciple Alan Greenspan, is provided to us by Matt Taibbi in chapter 2 of his book “Griftopia”[2].

Then it isn’t as easy. Then it is corrupt. Then it is immoral. Then it is selling your soul.

[1] Roseman M et al, Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments, JAMA. 2011;305(10):1008-1017

[2} Taibbi M. “Griftopia: Bubble machines, vampire squids and the long con that is breaking America“. Speigel and Grau. New York. 2010. Ch. 2, “The biggest asshole in the universe”

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Compromised public health ethics across the pond: Britain too!

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Not long ago, I wrote of the “consumer alliance” between the American Academy of Family Physicians (AAFP) and the Coca-Cola company (The AAFP, Coca-Cola, and Ethics: Serving the public interest?, August 20, 2010). In that piece, I also noted the close relationship between the American Dietetic Association (ADA) and Hershey’s. For the record, I did not believe that these were, um, healthful, for the American people. I cited the work of Howard Brody, who looked at the ethics of the conflict of interest specifically in the Coca-Cola/AAFP case (and yes, there is definitely a conflict of interest whether or not that conflict results in prejudicial outcomes).

It turns out that this kind of arrangement is not limited to the United States. Indeed, Dr Alex Scott-Samuel, Director of EQUAL (Equity in Health Research and Development Unit) in the Division of Public Health at theUniversity of Liverpool, brings our attention to an article in the British newspaper the Guardian. It reports that in the United Kingdom, the “…Department of Health is putting the fast food companies McDonald's and KFC and processed food and drink manufacturers such as PepsiCo, Kellogg's, Unilever, Mars and Diageo at the heart of writing government policy on obesity, alcohol and diet-related disease”, an apparently far more malignant development.

The potential advantage of a government-run national health system is that it can insure that health care is provided for everyone, as I have often lauded. The public health role, however, is one that is even more commonly a public one, even in the United States, but in the UK the influence of the Department of Health over public health policy is even greater than in the US because they do not have independent state governments with their own health departments and health policies. We are, of course, familiar with the “fox guarding the henhouse” method of making public policy, which seemed to have reached its apex in the GW Bush administration with the big oil companies writing energy policy. Or maybe not; recently we discovered from a recent NPR investigative report (we need more of those) that the noxious Arizona immigration law was actually written by the private, for-profit prison industry as a way to increase business! (“They even named it. They called it the 'Support Our Law Enforcement and Safe Neighborhoods Act.’")

Is, then, the public’s health just another example of this type of “consumer alliance” (I really love this term!) – the British call them “responsibility deals”, more enigmatic, perhaps, but not more accurate – or is it another matter? Clearly, as demonstrated by the BP oil spill in the Gulf of Mexico, energy policy is critically related to health. And a law that makes it illegal for a person, a US citizen, to stop an offer humanitarian life-saving help to someone they find wandering and half-dead in the Arizona desert, not to mention imprisons and deports those who are not legally here, impacts on their health. Certainly these policies impact the rest of their lives.

Maybe it is because this is happening in the UK that makes it stand out. Maybe because some of us, myself included, have seen the UK and other European countries (and certainly there are many differences between European countries) as more focused on the health of their citizens. I know that there have been any number of problems with and criticisms of British health and social policy, including those of Julian Tudor Hart (“the inverse care law”[1], Medical Student Selection, December 14, 2008) and Sir Michael Marmot (the “Whitehall studies”, Health Outcomes: The interaction of class and health behaviors, May 9, 2010), and continued by current public health experts and scholars. I guess that the presence of the British National Health Service and its universal access have been so overwhelmingly positive in this regard that I have regarded such criticisms as those of people who “don’t know how good they have it”. Let me be clear: I never doubted that the concerns were valid, but rather that they may minimize the good things present in the system; in the same way I know that those in US cities with public hospitals are correct when they point to the underfunding, second class care, and inequities that they suffer, but at least, unlike where I live, they have public hospitals.

This initiative is, clearly, malignant. It is unquestionable “conflict of interest” for those whose interest is in selling more of their products, however unwholesome they may be, to be involved in the writing of public health policy around the use of, and advertisement of, those products. And, moreover, they will certainly ensure the insertion of policies that benefit themselves at the same time as they harm the public’s health. Note that it goes beyond food (and junk food); not only does the “food network to tackle diet and health problems includes processed food manufacturers, fast food companies,”, but “The alcohol responsibility deal network is chaired by the head of the lobby group the Wine and Spirit Trade Association.” Wow. One consumer advocate noted "This is the equivalent of putting the tobacco industry in charge of smoke-free spaces." It’s quite an achievement. Even Philip Morris couldn’t get to chair the cigarette control board!

Obviously, that this is occurring shortly after the Conservative Party has taken control of the British government is not a coincidence. It is part of a very successful strategy to transfer not all most, but virtually all, wealth and power to those who are already most wealthy and powerful. In the US, despite the control of the White House and both houses of Congress by the supposedly more progressive Democratic party, this consolidation is proceeding apace, clearly helped by Supreme Court decisions such as Citizens United that essentially removed all limits on corporate contributions to political campaigns.

Having input from corporations that stand to benefit from legislation or policy is one thing, as long as it is balanced by input from consumer groups – and the welfare of the people is the final criterion for making a decision, not maximizing corporate profit. In this case, the case of the public’s health, the decision should be clear cut.

[1] Tudor Hart, Julian, “Three decades of the inverse care law”, Br Med J, 2000 Jan 1;320(7226):15-8.
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The AAFP, Coca-Cola, and Ethics: Serving the public interest?

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Last fall, the American Academy of Family Physicians (AAFP) (full disclosure: the organization of family physicians, to which I belong) entered into a partnership agreement with the Coca-Cola Company for support of its patient information website, FamilyDoctor.org. The amount of the funding is uncertain, but it is reputed to be in the “mid-six-figures”. The arrangement came in for a great deal of criticism, both within and outside of the family medicine community, and several members of the organization resigned in protest. I addressed this as a small part of a larger blog, Harvard Medical School limits outside income: a good start, on January 21, 2010.

The debate has not gone away, and has been highlighted by two articles in the recent (July-August 2010) issue of Annals of Family Medicine, the research journal sponsored by all the family medicine organizations in the US and Canada. The first is by Howard Brody, the family physician and medical ethicist from the University of Texas Medical Branch at Galveston, “Professional Medical Organizations and Commercial Conflicts of Interest: Ethical Issues”, and the second is response by Lori Heim, President of the AAFP, “Identifying and Addressing Potential Conflict of Interest: A Professional Medical Organization’s Code of Ethics.” Brody’s essay is a clearly written review of the ethics of conflict of interest, addressing both whether the relationship between AAFP and Coke is a conflict of interest (COI) and whether it is ethically worrisome, and an analysis of the reasons and defenses put up by AAFP and Coke. In the first, he notes that a conflict of interest can, and often does, exist even when no “bad” outcome can be identified; it is simply a conflict between the primary set of responsibilities (in this case, of physicians and their organizations’ social responsibility for looking out for the best interests of their patients’ health; in other settings it might be awarding of government contracts or foundation grants) and a second, usually financially motivated set of interest.

Brody distinguishes between two strategies for addressing COI, a Management Strategy in which COIs are divulged so that others (presumably in this case, patients and the public) can take them into account, and the Divestment Strategy, in which organizations rid themselves of COI relationships. He dispenses with the conflation of COI with intellectual conflicts (that an investigator might want to show that his/her “pet hypothesis” is correct and put it in the best light) because readers will always be aware of the latter, but will not know of commercial relationships unless they are divulged. He notes that the Divestment Strategy is favored in most recent ethical literature (and in increasing numbers of medical schools, as per my January 21 blog), although not by the AAFP.

He then addresses the counterarguments and justifications that the AAFP has put forward in this case. These include:

· “Premature Accusation”, in which the AAFP says “you can’t know that we have a conflict until you see the content. He notes the conflict exists regardless, and offers this “crude” analogy: “imagine that a judge who is sitting on a case involving a contract dispute between two companies is discovered to own $100,000 worth of stock in one of the companies. The judge cannot divert criticism of this conflict of interest by saying, ‘But you haven’t waited until I delivered my verdict—how do you know that I won’t rule against the company in which I own stock?’ In the AAFP case, if the final educational material includes a strong statement against sugary soft drinks, we will never know whether, absent the Coca-Cola funding, the statement would have been even stronger. That such questions will inevitably be raised shows the conflict of interest is both present and serious, quite apart from the eventual contents of the educational materials."

· “Other Party not Evil”, in this case Coca-Cola. The issue, of course, is not whether they are evil, but whether their interests may lie in opposition to the interests of the health of doctors’ patients; “The physician has a duty to prescribe medications or make dietary recommendations based on scientific evidence. The companies have an interest in selling more beverages, or more drugs, regardless of the evidence.”

· “Wrong not to Engage” with organizations such as Coca-Cola. “Schafer[1] noted the propensity for engagement with industry, in such discussions, magically to convert itself into accepting large sums of money from industry.…No one is suggesting that the AAFP not engage Coca-Cola if the engagement avoids conflicts of interest and the result of the engagement would be improved public health.” [my bold]

Brody also addresses the similarities and difference between this and the 1997 relationship in which the American Medical Association (AMA) actually endorsed products made by Sunbeam. He notes that the relationship is called a “Consumer Alliance”, when it is more properly a corporate alliance. (I had missed this Newspeak usage in my January 21 blog, where I mistakenly called it a “corporate partnership”!)

Heim’s response states that Brody misses the point, and goes on to make the same arguments that AAFP has made before, that Brody has addressed and debunked, offering nothing new to the discussion. It refers to the AAFP Code of Ethics, and creates the disturbing sense that “we want the money, we don’t think we are doing anything unethical with the money, and so stop criticizing us.” In other words, it purposely and deliberately misses the point.

Does the AAFP’s relationship with Coke go beyond a conflict of interest (which it clearly is) to actually providing unhealthful material? Some authors believe so; public health attorney Michelle Simon, in her blog Appetite for Profit, addresses the issue on July 22, 2010. She notes that FamilyDoctor.org contains the disclaimer “This content was developed with general underwriting support from The Coca-Cola Company,” and comments “That makes it sound as if the Coca-Cola is just paying someone else to do the writing. But it appears the company is directing the substance of the content as well, since the verbiage is pretty similar to that found on Coca-Cola's own website on these very topics. (See for example, the company's page on sweetener ‘facts and myths’.)”

Simon quotes Dr. Heim’s article, “To gauge an individual or organization’s ethics, one must view its behavior over time, define the goal of that behavior and compare the outcome with the mission and values. Within this context, one can determine whether the assumption or appearance of conflict of interest or ethical lapse was, in fact, correct.” And comments: “What? She lost me somewhere between outcome and values. Taking money from Coca-Cola is not a science experiment that you watch over time, gather data, and then publish the analyzed results. But if one were to approach the issue that way, there's no shortage of evidence of Coca-Cola's 'ethical lapses.' Whether your concern is marketing to children, labor abuses, or contaminating water supplies in developing nations, Coca-Cola would be the one company you'd not choose as a partner. Journalist Michael Blanding has written an entire book called The Coke Machine: The Dirty Truth Behind the World's Favorite Soft Drink, due out in September, which chronicles these misdeeds and more.”

Certainly, the AAFP is not the only organization that has potentially undermined its public trust. For another big one, the American Dietetic Association (ADA) has a partnership (I don’t know if they’ve dared to call it a “consumer alliance”) with – Hershey! (see ADA’s press release at its own website; also see the Fooducate blog).

Maybe the ADA’s partnership is more outrageous, but as a family doctor and educator, I take the AAFP’s relationship with Coke more personally because it undermines me. At the time of this deal, several of the other family medicine organizations, including the Association of Departments of Family Medicine (ADFM, academic department chairs, to which I also belong) expressed serious concerns about this relationship to the AAFP leadership. These concerns related particularly to the fact that, to the public, family medicine is family medicine, and when the largest family medicine organization, AAFP, does something the entire discipline is affected; for example, medical students, or faculty in other departments, who may be distressed by the relationship express that concern to the faculty of family medicine. AAFP, the big dog on the block, listened. It didn’t change its policy, though. Money talks, of course, but if AAFP’s 55,000 active members (not including students, residents, and retirees) each sent in $10, it would be about the same amount as they received from Coke. Are we that cheap? As far as the content on FamilyDoctor.org is concerned, check it out for yourself. You can start by clicking on the benign (but somehow familiar) logo at the top of its web page.

Brody concludes his essay with: “Family physicians are widely trusted by their patients and communities. Merely by having chosen our specialty, family physicians have demonstrated a commendable commitment to putting the health needs of their patients ahead of personal financial gain. They deserve to be represented nationally by an organization that fully reflects those high ethical commitments and standards.” I couldn’t agree more.

[1] Schafer A. Biomedical conflicts of interest: a defence of the sequestration thesis—learning from the cases of Nancy Olivieri and David Healy. J Med Ethics. 2004; 30(1):8–24

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