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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VISA and colchicine: maybe the banks and Pharma really ARE in it for the money!

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This is a guest posting by R. Stephen Griffith, MD, Chair of the Department of Family and Community Medicine at the University of Missouri-Kansas City.

A recent article explains in some detail one of the devious ways the banking industry, and the recently spun-off companies of VISA and MasterCard, make the money it takes to support the executive salaries and bonuses. (“How Visa, Using Card Fees, Dominates a Market”, Andrew Martin, NY Times, Jan 4, 2010)

Each time one of us swipes a debit card at a retail outlet, the retail outlet pays a banking institution a fee. That seems like an honest way to make a living, but the plot thickens. If we punch in the secret code associated with the card, the bank gets a few cents. If instead of using the code we sign the receipt the bank gets a bigger fee. Apparently there is no more expense associated with the latter method, but the fees negotiated by VISA et. al with the retailers provides for the higher fees. The individual banks then receive the fees, which encourages them to “push” more of the VISA’s (or which ever company is offering them the best deal). The credit card companies expand their reach, the banks make more money, and everyone involved in the deal is happy. In fact, the higher the cost per transaction the credit card company can negotiate makes more money for the bank, and so a bidding war develops in which the higher the fee, the more the banks gravitate to that company. The fee can be up to 75 cents per transactions—many multiples of the fee for a swipe and use of the code. This is transparent to the consumer, who willingly signs or puts in his/her code as requested by the retail outlet. Of course, the unwitting consumer eventually pays the extra expense (passed on from the retailer as part of the cost of doing business). Just another way for the banks to make a living.

There are those of us who would suggest that this is “gouging” the customer and there should be some repercussion to the perpetrators. I was among the inflamed and insulted when I read the article. But then this horrible thought crossed my mind: as a well meaning and cost conscious family physician, how many times have I committed the same offense?

The relationship between physicians and Pharma has been a topic of discussion since I was in medical school, although until relatively recently I have seen very little response from the medical community. The representatives of Pharma host our meetings and visit our offices, give us food, pens, pads, tickets to games, sometimes even trips to nice places. Associated with the gifts is also free “education” about why the product about which they are educating the physician is better than generic or “me, too” drugs made by another company. The docs are given samples which they can provide their patients to try the new drug out and “help save money for the patients.” Of course, if the medication works, a prescription for the drug will be given. The extra expense (sometimes an extraordinary amount of extra expense!) of the newer drug is borne by the patient or the patient’s insurance after a co-pay (which results in higher premiums the patient pays.)

So the medical community’s “scam” is we get lots of benefits and the expense of those benefits is borne by someone else—our patients.

To be fair, not all physicians accept gifts from Pharma. And in the last few years or so, the value of the gifts has been more restrained. And a growing number of physicians are refusing to even meet with representatives from Pharma, refusing the samples and the false economy of providing them, refusing the gifts and “education”. Creating distance from Pharma is a good thing—they are as fun to hate as the banking industry. And if you doubt the amount of greed in Pharma, please read this: “An Old Gout Drug Gets New Life and a New Price, Riling Patients”, Jonathan D. Rockoff, Wall St. Journal (and below, as it may not be completely available on the WSJ site.)

The article is about colchicine, a drug for the treatment of acute gout (and a few other things) that has been around for more than a century—long before the advent of the FDA. The FDA has encouraged pharmaceutical companies to study some of the older drugs for true effectiveness, and the company can then apply for a three year patent on the medication. URL Pharma, Inc. did the clinical trials on less than 1,000 patients, and proved that a drug everyone already knew worked, worked. Amazing! They received a three year patent, and now a pill that was $4 per month long before the $4 per month plans existed, is $5 per pill! Since it is usually given twice a day, the drug will now cost patients $10 per day when it formerly cost about a quarter.

Stories like this and the one about banks makes it easy to feel distaste for the banking industry and Pharma. Where is the justice in banking executives making millions and then being bailed out by taxpayers? Where is the justice of Pharma making huge (I would argue inappropriately huge) profits from the ills of our patients? I just wish the profession of medicine (and I) hadn’t played a part.


(From the Wall St. Journal),
An Old Gout Drug Gets New Life and a New Price, Riling Patients
By JONATHAN D. ROCKOFF
A centuries-old drug used to treat excruciating gout pain had cost just pennies a tablet—until last year. Now, the retail price has skyrocketed to more than $5 and some of the manufacturers have ceased production amid a battle over marketing rights.
The tale of how this common gout drug, colchicine, became the costlier branded drug Colcrys offers a window into the Byzantine world of drug pricing. The price rise is a consequence of a Food and Drug Administration effort to improve the safety of long-used but unapproved drugs, with a trade-off often made between drug affordability and safety.
In July 2009, a Philadelphia drug maker received FDA approval to exclusively market colchicine for gout attacks for three years. The company, URL Pharma Inc., was taking advantage of a push to bring medicines predating the FDA, like colchicine, under the agency's regulatory umbrella. The FDA offers exclusive marketing rights if a drug maker conducts clinical trials.
URL Pharma had commissioned studies that confirmed its colchicine product's safety and efficacy, while demonstrating it should be taken at a lower dose than typical and not used with certain other medicines. The company is marketing its drug as Colcrys—and the retail cost averages $5 per pill, according to DestinationRx, a health-care data provider.
URL is also suing longtime manufacturers of unapproved colchicine, saying the companies are now illegally marketing their products. Some of the companies are fighting the lawsuits. Some themselves have raised prices—including one increase of just under a dollar per tablet to $1.17, according to DestinationRx. The higher price for Colcrys was first reported by Kaiser Health News.
There were 3.5 million prescriptions and $6.4 million in sales in 2008, according to the most recent data available from IMS Health, a drug-data firm.
"It's not a new product. It's been out for hundreds of years. To all of a sudden have to pay $125 or $150 a month, after it only cost $5 or $10 a month, is a real problem," said Stanley Cohen, a Dallas doctor who is the president of the American College of Rheumatology. He met with the FDA to express concern about the price increase.
The chief executive of URL Pharma, Richard Roberts, said that it priced Colcrys in line with other approved, branded drugs used to treat gout pain. To help patients afford Colcrys, Dr. Roberts said, the company is offering to pay a portion of co-pays, and it is providing a three-months' supply to low-income patients for $15.
Eileen Wood, vice president of pharmacy and health-quality programs at CDPHP, an insurer in New York state, said insurers will have to absorb much of the added expense. URL's contribution was "not any new therapeutic tool, not new science; they just added cost," she said.
Nancy Sparks Morrison, a retired schoolteacher who suffers from familial Mediterranean fever, an inflammatory disorder that's treated with colchicine, said she is buying colchicine from Canada because she can't afford Colcrys. Ms. Morrison said she plans to get help from URL Pharma to pay for Colcrys because the company has just expanded its assistance program. "I'm retired on Social Security, and I have a small pension," said Ms. Morrison, 71 years old, who lives outside Charleston, W.Va.
The price increase is an unintended consequence of the FDA's nearly four-year-old initiative to regulate unapproved drugs. These medicines were sold before the FDA was established, and therefore weren't required to undergo approval. After decades of use, the medicines are considered safe by doctors, but haven't been proven to satisfy the agency's standards. Colchicine's use has been traced back to the sixth century, according to the FDA.
Seventy drugs that were grandfathered have been approved since the FDA began its initiative, most notably pain reliever Vicodin, from Amneal Pharmaceuticals LLC, the FDA said.
The FDA had hoped a significant price increase wouldn't follow Colcrys's approval and regrets the increase, said Janet Woodcock, director of the agency's Center for Drug Evaluation and Research. Dr. Woodcock encouraged more competition, saying another company could seek approval for colchicine's regular use in gout, rather than the acute use that URL Pharma received approval for.
There had been no standard for dosage before FDA approval. Colchicine's excessive use can cause side-effects, such as severe diarrhea that is potentially fatal. The FDA said it receives reports of five deaths a year, on average, involving patients who took colchicine tablets.
"We took bad guidance, even guesswork, and made this evidence-based medicine," Dr. Roberts said.
Closely held URL Pharma, which is owned by a hedge fund, a private investor and employees, is a longtime seller of generic drugs, including colchicine. When the FDA launched its push, the company began searching for those with safety risks whose patients could benefit from clinical testing, Dr. Roberts said.
URL Pharma said its 17 clinical trials of colchicine involved a total of 988 patients. The trials showed that gout patients need take two tablets after an attack and one more an hour later, the FDA said. Trials also demonstrated side-effects from use with certain other medicines, including some antibiotics and antihypertensive medicines. Those are now flagged on the label of Colcrys.
After obtaining FDA approval of Colcrys, URL Pharma went to federal court to sue manufacturers of colchicine, including Excellium Pharmaceutical Inc., Vision Pharma LLC, Watson Pharmaceuticals Inc. and West-Ward Pharmaceutical Corp., saying they have been illegally marketing their colchicine products since Colcrys's approval. A fifth company, Qualitest Pharmaceuticals, settled and stopped production. The four companies are fighting the lawsuits.
"You have this product out for at least a hundred years and all of a sudden it's no good?" said Lou Dretchen, who oversees sales and marketing at Excellium of Fairfield, N.J. Mr. Dretchen said the small, closely held generic drug maker stopped colchicine production after URL Pharma sued. The other companies declined to comment.
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Harvard Medical School limits outside income: a good start

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Partners Health Care, the physicians group comprising the clinical faculty of the Harvard Medical School at Massachusetts General Hospital and Brigham and Women’s Hospital, has recently set “strict” limits on the compensation that about “two dozen senior officials” (including department chairs, vice presidents and others) can receive from serving on the corporate boards of biotechnology and pharmaceutical companies, according to Duff Wilson in the New York Times, January 3, 2010 , Harvard Teaching Hospitals Cap Outside Pay. These physicians will also be prohibited from receiving any speaking fees from drug companies. The article indicates that many medical schools have put limits on such outside income, but that Harvard’s are the strictest yet. And consequential, because Harvard has so many leaders who sit on such boards. Apparently, the ban on speaking fees was decided first by the policy committee, and then the board income was limited so as not to limit outside income for junior faculty (who may speak for drug companies) but not senior leaders (who are more likely to be on the boards). There is no indication of limits on the participation of anyone on boards of other types of corporations, although biotechnology and pharmaceutical, along with medical device companies, are the most likely to create a conflict of interest.

Many do not see these restrictions as enough. The chair of the Partners’ policy committee, that wrote the rules, distinguished cardiologist Eugene Braunwald, is quoted as saying “We’re the first to go in this deep, and we’re still into it only up to our knees.” Former New England Journal of Medicine editor and Harvard professor emeritus Arnold Relman definitely thinks that they are too weak: “I think that’s a gross conflict for an official of an academic medical center to be on the board of a pharmaceutical company...It’s happening more and more around the country…If it isn’t stopped, I think the academic institutions are going to lose the confidence of the country and the government and they will no longer deserve the tax exemption or anything else. They will be part of industry itself.” Regular people may not see the restrictions, to $5,000 a day (based on $500 an hour for a 10-hour day of actual work on the board) as too severe, but they are not moving in the world of corporate boards. Dennis Ausiello MD, chair of medicine at Mass General, has received over $200,000 since 2006 from sitting on the board of the pharmaceutical giant Pfizer. “I certainly think I should be compensated fairly and symmetrically with my fellow board members,” he says. However, he will abide by the rules. “I’m not there to make money… if my institutions rule otherwise [i.e., against being compensated as are his fellow board members], as they have, I will continue to serve on the board.”

Clearly, Ausiello has a different perspective than Relman, because he believes that he makes a positive contribution being on the board: “I’m very proud of my board work,” while Relman thinks the very presence of medical school faculty on boards is corrupting its mission. Interestingly, both the committees seeking to restrict the participation and corporate pay experts agree that paying board members based on corporate performance and profit ties them to the profitability of the corporation. The Times notes that “Thomas Donaldson, a professor of business ethics at the Wharton School of the University of Pennsylvania…who advises large companies on corporate governance, said dual roles in a hospital and at a drug maker were ‘dicey at best’ because a director’s duty is to look out for the corporation’s financial interests.” He said: “It strikes me as a breath of fresh air in a room that’s getting progressively more stale. I hope this will set a standard for others — hospitals, medical schools.” The Harvard rules specifically prohibit this, believing that pay for work (@ $500/hr) at least has the chance of allowing its faculty to maintain some scientific integrity.

The issue can be complicated for insiders. Deborah Powell MD, former dean of the medical school at the University of Minnesota and an advocate for policies that encourage restraint, herself accepted a paid position on the board of Pepsico. Many believe that her subsequent firing was due, in part, to negative publicity from this action. (U of M medical school reorganizes; dean out by summer, Tim Post, Minnesota Public Radio, January 29, 2009). The American Academy of Family Physicians (AAFP) has recently developed a “corporate partnership” with Coca-Cola that has received a great deal of criticism both within and outside the family medicine community – criticism that has not resulted in the AAFP ending the relationship. Which is a greater conflict of interest for physicians and medical school faculty members – alliances with companies, such as Coke and Pepsi, whose products are clearly detrimental to health, or sitting on the boards of corporations that make medical and pharmaceutical products? I leave the call to you; to me they are both rotten. Corporations want them to get the imprimatur of science and health that these relationships provide. Organizations like AAFP want them for the money. Presumably the individuals on the faculty of Harvard and other medical schools also like the money, but also may, like Drs. Ausiello and Powell, think that they can make significant positive contributions to health through their roles on the boards. And, if these people are full-time employees at their main job, who should get the money that it engenders? Harvard is, as noted, limiting the income, but is allowing corporations to use the rest of the money that the board member would have gotten paid as a charitable donation to any charity not linked to Harvard, Partners, or the hospitals. That deals with the money issue, but still leaves the questions about the ethics of participation, even for free, that are raised by Dr. Relman and others.

Interestingly, the Times article cites the Partners’ decision as, in part, due to the fact that “Harvard, in particular, has come under scrutiny from Senator Charles E. Grassley of Iowa, a leader of Congressional inquiries into the influence of money in medicine.” I say “interestingly” because Grassley, the Finance Committee's ranking Republican, received more than $2 million from the health and insurance sectors since 2003 (Industry Cash Flowed To Drafters of Reform, Washington Post, July 21, 2009). Of course, like the medical school faculty who believe that they are doing important work and are not influenced by the pay (which Sen. Grassley doubts), Grassley himself says the campaign contributions have no effect on his positions (Grassley: Campaign Contributions Hold No Sway, Press Center from the Des Moines Register, August 31, 2009). Double standard? Of course. Ironically, Grassley uses his investigations into the policies of places like Harvard as evidence that he is not “bought” by those interests!

Harvard is taking the right first steps and those principles should guide other medical schools in the future to take even stronger action. And the same should be done for contributions to members of Congress.
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Cancer Care and Hospital Advertising

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The December 19, 2009 issue of the New York Times contains an article entitled Cancer Center Ads Use Emotion More Than Fact. The piece, by Natasha Singer, documents the extensive use of advertising by hospitals to attract cancer patients, and decries the appeal to people’s emotions at a time of great vulnerability, after they have received a cancer diagnosis. These appeals contain testimonials from people who were “cured” or had a good outcome (or at least think, at the time of the testimonials, that they had a good outcome), and imply – sometimes frankly state – that their cancer care is better than their competitors’. Those competitors may be other hospitals in the same metropolitan area, or, in the case of centers that have received special National Cancer Institute (NCI) “cancer center” designation, or in the case of the “top” centers (e.g., MD Anderson in Houston, Dana-Farber in Boston, in New York ) each other.

The issue is that this advertising does not have to be based on fact. This is not to say that the actual people in the testimonials are lying, but that there is no requirement for data on statistical outcomes from these hospitals before they produce their advertising. The individual patient may have had a good outcome, but has no way of knowing if the outcome would have been as good (or better) somewhere else. The article documents assertions of superlatives, such as a doctor having the “highest cure rates” and “lowest risk”, which a reasonable person might infer was based on data comparing that doctor’s, or that hospital’s, results to others. However it turns out that they are based on anecdotes, something that would be completely unacceptable in the reporting of scientific results. One expert noted that “There seems to be a disconnect between the business end of the cancer treatment industrial complex and the physicians on the front lines treating patients,” a dramatic understatement. “This isn’t retail advertising,” said the president of a Manhattan agency that developed ads for Mount Sinai hospital, “This is reputation advertising. There is a very big difference.”

Why hospitals want to advertise their cancer care (or their care for any other profitable “service line” such as, the article notes, cardiovascular disease or cosmetic surgery) is obvious – to make money. Though most of them are “not-for-profit”, all that means is that the “profits” don’t go to shareholders, but they can certainly be used by the hospital for expansion or creations of new and better service lines. And higher salaries and bonuses for executives (and physicians). Does it improve people’s health? Well, to a certain degree competition between hospitals does; like competition in any industry it operates against complacency, against “doing what we’ve always done”, against being satisfied with less than “the best”, because if it is possible to do better, there is the chance that your competitor will do better, and take away your business. It is also reasonable to advertise, so that people know how well you are doing. However, when the advertising is not based on real outcomes data, but purports to be, that is, it indicates – possibly not knowingly untruthfully but without evidence to back it up – that is at best misleading, and possibly unethical.

From a health perspective, a community needs a certain capacity for care of cancer patients – or any patients. That community may be a part of a city, or a city, or a metropolitan area, or in the case of rarer cancers, a region or even the nation. Excess capacity is extremely costly – if hospital A gets most of the cancer “business” in town, so hospital B chooses to invest heavily in building a new cancer-treatment facility (including, by the way, with public funds, since because they are not-for-profit, donations are philanthropy and tax-deductible), we now have excess capacity in the community, and a great deal of extra cost. To the extent that this represents a competition that results in better care, as discussed above, it may be a good thing – but the hospitals should have to document that there is actually better care provided, something almost never done. And, if it is going to spend a lot of money to create excess capacity in the community, the hospital should have to use the traditional method of raising capital and not be able to use tax-deductible contributions for this purpose (but, of course, they do).

There is another problem, which I mentioned briefly above. Hospitals do not heavily (and possibly deceptively) advertise all their services; like other businesses they advertise the profitable services. In general, services (“product lines”) are profitable because the current payment system reimburses for these services far more than the cost of delivering them. Cancer is in this category, because of the enormous markups for providing chemotherapy drugs (this is in addition to the enormous markups charged by the manufacturers). So are cardiovascular procedures, neurosurgical procedures, and of course cosmetic surgery. Hospitals do not heavily advertise the care that they provide (even if it is in fact excellent and better than others’ based on real data) if they don’t make as much, or even lose, money. This includes “regular” medical diseases, as well as very costly special services including much trauma and burn care. Pediatrics is a special case; in general (other than, of course, pediatric cancer care, for the same reasons as adult cancer care, and neonatal intensive care) does not make money, so general hospitals don’t heavily advertise it. “Children’s Hospitals”, however, are often among the greatest recipients of philanthropy in a community, and this is their main source of revenue, so advertising what they do makes sense for them in order to keep their name in front of donors.

We have become used to hearing (including from me) cautions about the greed and influence of the health insurance and the pharmaceutical and device manufacturers on health care, on health legislation and on politicians. These companies are for-profit and interested in their bottom lines, not on the impact that they have on health itself. Much of this is discussed in the New York Times article Health Lobby takes fight to the states on December 29, 2009, but as I have noted, it is the health care industry lobby, not the health lobby. We would have hoped that our communities’ hospitals would see themselves as more interested in our health, but this sort of advertising makes it clear that, non-profit though they may be, they are the health care industry.

Where does this leave us? It leaves us with the need to develop, and publicly report, good measures of outcomes for physicians and hospitals, as called for by many experts, notably Institute for Healthcare Improvement director Don Berwick, MD[1]. Otherwise people will continue to choose hospitals and doctors based on reputation and the quality of their “hotel facilities” rather than on the quality of their care. Pending that, we need to remember to see all health care advertising, including that from doctors and hospitals, as precisely that, advertising, and not confuse those claims with the scientific evidence that we hope will guide our care.

[1] Berwick, D., “Measuring physicians’ quality and performance: adrift on Lake Wobegon”, JAMA Dec9,2009;301:2485-6
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