Another Wheel Already Invented (in 1988) - the WHO Ethical Criteria for Medicinal Drug Promotion

At the 2010 Gezonde Scepsis (Healthy Skepticism) "Selling Sickness" conference, I was made aware of another wheel invented a long time ago, the 1988 WHO Ethical Criteria for Medicinal Drug Promotion, a document about which few now seem to be aware.  Were this code to have been widely followed, it might have prevented some of the problems afflicting the pharmaceutical industry today.

Some relevant quotes follow:

Drug Promotion

6. In this context, 'promotion' refers to all informational and persuasive activities by manufacturers and distributors, the effect of which is to induce the prescription, supply, purchase and/or use of medicinal drugs.

7. Active promotion within a country should take place only with respect to drugs legally available in the country. Promotion should be in keeping with national health policies and in compliance with national regulations, as well as with voluntary standards where they exist. All promotion-making claims concerning medicinal drugs should be reliable, accurate, truthful, informative, balanced, up-to-date, capable of substantiation and in good taste. They should not contain misleading or unverifiable statements or omissions likely to induce medically unjustifiable drug use or to give rise to undue risks. The word 'safe' should only be used if properly qualified. Comparison of products should be factual, fair and capable of substantiation. Promotional material should not be designed so as to disguise its real nature.

8. Scientific data in the public domain should be made available to prescribers and any other person entitled to receive it, on request, as appropriate to their requirements. Promotion in the form of financial or material benefits should not be offered to or sought by health care practitioners to influence them in the prescription of drugs.

9. Scientific and educational activities should not be deliberately used for promotional purposes.

Note that these provisions would seem to prohibit promotional efforts begun before a drug is legally approved (e.g., ghost-writing as in this case), the use of "key opinion leaders" without full disclosure of their role as marketers of drugs, suppression of clinical research sponsored by pharmaceutical companies whose results did not support these companies' marketing interests, e.g. studies which failed to show efficacy of their products, nearly all kinds of payments to physicians, and nearly all pharmaceutical sponsored continuing medical education.

Medical Representatives

17. Medical representatives should have an appropriate educational background. They should be adequately trained. They should possess sufficient medical and technical knowledge and integrity to present information on products and carry out other promotional activities in an accurate and responsible manner. Employers are responsible for the basic and continuing training of their representatives. Such training should include instruction regarding appropriate ethical conduct taking into consideration the WHO criteria. In this context, exposure of medical representatives and trainees to feed-back from the medical and allied professions and from independent members of the public, particularly regarding risks, can be salutary.

18. Medical representatives should make available to prescribers and dispensers complete and unbiased information for each product discussed, such as an approved scientific data sheet or other source of information with similar content.

19. Employers should be responsible for the statements and activities of their medical representatives. Medical representatives should not offer inducements to prescribers and dispensers. Prescribers and dispensers should not solicit such inducements. In order to avoid over-promotion, the main part of the remuneration of medical representatives should not be directly related to the volume of sales they generate.

Note that these provisions appear to prohibit the current cheer leader/ ex-athlete model of the drug representative, and to prohibit many of the current activities of such representative, including providing gifts, meals, travel to meetings, honoraria, etc  (e.g., see posts here and here).

If only these standards had gotten some traction, think of the trouble that could have been averted.  On the other hand, it is obvious that such traction would have threatened some peoples' lucrative incomes and power, who may have worked hard to make sure it did not happen.

That Wheel Was Already Invented: the UN Special Rapporteur's Guidelines for Pharmaceutical Companies

For five years now, we have been writing about concentration and abuse of power in health care, and on specific tactics used predominantly by large health care organizations that threaten the values that physicians and other health care professionals once swore to uphold.

Pharmaceutical companies may not have been the worst offenders when it came to threatening these values, but they have not been laggards.  Specific issues we have discussed included (in a peculiar order that I will explain in a minute): failure of the companies' boards of directors to be accountable for misbehavior by its management, sometimes associated with conflicts of interest affecting these board members (e.g., this recent case); outright crime and corruption (e.g., this case); use of key opinion leaders paid by the company to market products cloaked in the mantle of academia; payments made by the companies to patient advocacy groups (e.g., this one), medical societies, and academic institutions that induce institutional conflicts of interest, and enlist these well-reputed organizations as stealth marketers; ridiculously high prices charged for particular medicines, often to particularly vulnerable patients (e.g., this case); suppression and manipulation of clinical research evaluating the companies' products; and deceptive drug marketing practices.

Many other bloggers have written about these issues.  Some of them have been widely taken up in the mainstream media.  A few have even made it into the medical and health care literature. 

But those of us who bring them up have been attacked as a tiny group of pharmascolds (e.g., here), who get in the way of the needed innovation and scientific advances that the pharmaceutical industry generously brings to the public.  Despite such attacks, it may be that our concerns are somewhat more universal, although those with vested interests in maintaining the status quo might not want that publicized too much.

A new issue of PLoS Medicine included several articles on drug companies' responsibilities for human rights.  One was by a former United Nations Special Rapporteur on the right to the highest attainable standard of health.  I, and I suspect most of even our Health Care Renewal readers were not familiar with that office.  I also confess to being unaware that he had published a report to the UN General Assembly entitled Human Rights Guidelines for Pharmaceutical Companies in Relation to Access to Medicines, which included 47 specific guidelines. 

Amazingly enough, it turns out that some of these guidelines seemed to directly address the issues raised above, to wit:

Board of Directors' Accountability

11. The company should have a governance system that includes direct board level responsibility and accountability for its access to medicines policy.

Anti-Corruption

15. A company should publicly adopt effective anti-corruption policies and measures, and comply with relevant national law implementing the United Nations Convention against Corruption.

Disclosure of Financial Support

18. The company should annually disclose its financial and other support to key opinion leaders, patient associations, political parties and candidates, trade associations, academic departments, research centres and others, through which it seeks to influence public policy and national, regional and international law and practice. The disclosure should extend to amounts, beneficiaries and channels by which the support is provided.

19. When providing any financial or other support, the company should require all recipients to publicly disclose such support on all appropriate occasions.

Drug Pricing

33. When formulating and implementing its access to medicines policy, the company should consider all the arrangements at its disposal with a view to ensuring that its medicines are affordable to as many people as possible. In keeping with Guideline 5, the company should give particular attention to ensuring its medicines are accessible to disadvantaged individuals, communities and populations, including those living in poverty and the very poorest in all markets. The arrangements should include, for example, differential pricing between countries, differential pricing within countries, commercial voluntary licences, not-for-profit voluntary licences, donation programmes, and public private partnerships.

34. The arrangements should take into account a country’s stage of economic development, as well as the differential purchasing power of populations within a country. The same medicine, for example, may be priced and packaged differently for the private and public sectors within the same country.

35. The arrangements should extend to all medicines manufactured by the company, including those for non-communicable conditions, such as heart disease and diabetes.

Suppression and Manipulation of Clinical Research

39. The company should take effective measures to ensure that all information bearing upon the safety, efficacy and possible side effects of a medicine are easily accessible to individuals so they can make informed decisions about its possible use.

Deceptive Drug Marketing

41. The company should publicly disclose its promotional and marketing policies and activities, including costs.

Needless to say, I can see no evidence that any big pharmaceutical companies are trying to adhere to any of these guidelines.  Somehow I suspect that those who are supporting the vested interests of big pharmaceutical corporations may not all have that much respect for the United Nations.  However, I think that the Special Rapporteur's guidelines lend more credibility to the argument that we need better leadership of health care organizations, and specifically that such organizations should follow clear ethical precepts, and their leadership should be held accountable when they do not.

So the next time someone calls you a "pharmascold," you can say, "yeah, yeah, so is the UN Special Rapporteur."

New CMS Chief Donald Berwick: a Trojan Horse for Quackery?

On July 7, President Obama appointed Dr. Donald Berwick as Administrator of the Centers for Medicare and Medicaid Services (CMS). Dr. Berwick, a pediatrician, is well known as the CEO of the non-profit Institute for Healthcare Improvement (IHI), which "exists to close the enormous gap between the health care we have and the health care we should have — a gap so large in the US that the Institute of Medicine (IOM) in 2001 called it a 'quality chasm'.” Dr. Berwick was one of the authors of that IOM report. His IHI has been a major player in the patient safety movement, most notably with its "100,000 Lives Campaign" and, more recently, its "5 Million Lives Campaign."

Berwick's CMS gig is a "recess appointment": it was made during the Senate's July 4th recess period, without a formal confirmation hearing---although such a hearing must take place before the end of this Senate term, if he is to remain in the position. A recent story suggested that Obama made the recess appointment in order to avoid a reprise of "last year's divisive health care debate." The president had originally nominated Berwick for the position in April, and Republicans have opposed "Berwick's views on rationing of care," claiming that he "would deny needed care based on cost."

A "Patient-Centered Extremist"

If there is a problem with the appointment, it is likely to be roughly the opposite of what Republicans might suppose: Dr. Berwick is a self-described "Patient-Centered Extremist." He favors letting patients have the last word in decisions about their care even if that means, for example, choosing to have unnecessary and expensive hi-tech studies. In an article for Health Affairs published about a year ago, he explicitly argued against the "professionally dominant view of quality of health care":

I think it wrong for the profession of medicine—or any other health care profession, for that matter—to “reserve to itself the authority to judge the quality of its work.” I eschew compromise words like “partnership.” For better or worse, I have come to believe that we—patients, families, clinicians, and the health care system as a whole—would all be far better off if we professionals recalibrated our work such that we behaved with patients and families not as hosts in the care system, but as guests in their lives. I suggest that we should without equivocation make patient-centeredness a primary quality dimension all its own, even when it does not contribute to the technical safety and effectiveness of care.

A new definition. My proposed definition of “patient-centered care” is this: The experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity, and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care.

Does this mean that Dr. Berwick would also eschew professional, i.e., expert, judgment in favor of patients' wishes? In a word, yes:

Evidence-based medicine sometimes must take a back seat. First, leaving choice ultimately up to the patient and family means that evidence-based medicine may sometimes take a back seat. One e-mail correspondent asked me, “Should patient ‘wants’ override professional judgment about whether an MRI is needed?” My answer is, basically, “Yes.” On the whole, I prefer that we take the risk of overuse along with the burden of giving real meaning to the phrase “a fully informed patient.”

Dr. Berwick is not so naive as this opinion might suggest. He envisions a "mature dialogue" in such a case, and argues that "if, over time, a pattern emerges of scientifically unwise or unsubstantiated choices...then we should seek to improve our messages..." He also admits that there might be an occasional patient whose demands are so unreasonable that "it is time to say, 'No'." That exception, he argues, should not dictate the rule.

There are situations in which most civilized people would agree with Dr. Berwick's view of 'patient-centeredness'. In both the Health Affairs article and in his recent address to the 2010 graduating class of the Yale School of Medicine, he offered real examples of petty, arbitrary hospital rules causing unnecessary sorrow for patients and their loved ones. It is in such contexts that he makes a convincing case that health professionals ought to behave "as guests in their lives." In an interview for the New York Times, he argued:

We don’t have a standard of services or processes that are comfortable for patients. We have built a technocratic castle, and when people come into it, they are intimidated.

Nothing to disagree with there. To create that standard, moreover, would not undermine settled medical practice ethics---it would celebrate them, even as it rightly embarrasses the profession for having taken so long to do so.


Enter the Woo

Eschewing the scientific basis for modern medical practice, however, is another matter. In February of 2009, Dr. Berwick gave a 'keynote' address at the IOM and Bravewell Collaborative-sponsored Summit on Integrative Medicine and the Health of the Public. He shared the podium with Mehmet Oz, Dean Ornish, Senator Tom Harkin, and other advocates of pseudoscientific health claims. I wrote about the conference at the time, mainly to call attention to its misleading use of the term "integrative medicine": literature emanating from the Summit characterized it as "preventive" and "patient-centered," whereas the only characteristic that distinguishes it from modern medicine is an inclusion of various forms of pseudomedicine.


I noticed that Dr. Berwick was on the speaker roster, which I found disappointing: I imagined that he had either gone over to the Dark Side or, perhaps, was sufficiently naive about the topic to have been duped; or, more likely, that he had cynically accepted the offer to further his ambitions. I didn't bother to listen to his speech until the CMS appointment was announced a few days ago.

It is troubling, to say the least. Dr. Berwick did not argue, as he had in the NYT piece, that "If we doctors feel a person is going to make unwise choices, we have to take on the responsibility of being teachers, educators and informers." Rather, he praised his fellow speakers, most of whom were spouting nonsense, for their "reach" and "eloquence." He praised the IOM for its "glorious record...in pursuit of better designs in health care...traditional, allopathic curative care and now migrating into this distinguished and important new arena." He mentioned homeopathy and acupuncture, not to wonder why they should be promoted as effective, but merely to warn that they will fail---presumably in some economic sense---if they try to compete with each other for reimbursement.

Such language, and Dr. Berwick's very presence at the Summit, were a far cry from advocating "patient-centeredness." What they amounted to was a generous endorsement of pseudoscientific practices and of the socio-political movement that promotes them. Even granting some naivete on his part (he called himself "an amateur at this topic"), he must have known this. Such an endorsement, unlike tearing down the "technocratic castle," has ethical implications at least as profound as those that Dr. Berwick tacitly or explicitly relies upon to support his arguments for patient-centeredness.

"Physicians have no Immunity to Moral or Ethical Constraints"

The relevant medical ethics treatises (reviewed here) are in substantial agreement that it is unethical for physicians to prescribe scientifically implausible methods or to refer patients to other practitioners for the same purpose. They are also in agreement that it is unethical to prescribe a placebo to a patient while claiming that the treatment has specific biologic activity---a point that has been vigorously argued in the UK this year, with regard to homeopathy. These ethical tenets are not mere odes to nerdy, sciency thinking; they are matters of honesty and integrity---fundamental bases for ethical interactions between physicians and patients.

In 1983, philosophers Clark Glymour and Douglas Stalker published an article in the New England Journal of Medicine titled “Engineers, cranks, physicians, magicians.” They framed modern medicine as follows, comparing it to what was then called "holistic medicine" (the article is quoted extensively here):

Medicine in industrialized nations is scientific medicine. The claim tacitly made by American or European physicians, and tacitly relied on by their patients, is that their palliatives and procedures have been shown by science to be effective. Although the physician’s medical practice is not itself science, it is based on science and on training that is supposed to teach physicians to apply scientific knowledge to people in a rational way.

The practice of medicine in the United States and in other industrialized nations is a form of consultant engineering...

That statement is just as accurate now---even more so, in this era of Evidence-Based Medicine---as it was nearly 30 years ago, even if some might find the likening of medicine to engineering displeasing. Nor is it at odds with almost any definition of "patient-centeredness," other than one that presumes that the patient's desires trump the physician's ethics:

A physician engineer can act as consoler; nothing in either logic or social psychology forbids it. But certain combinations are impossible or extraordinarily unlikely. A physician engineer cannot honestly claim powers of magic or occult knowledge. The principles governing scientific reasoning and belief are negative as well as positive, and they imply that occult doctrines are not worthy of belief. Moreover, physician engineers have no immunity to moral or ethical constraints. On the contrary, they are by training and by culture enmeshed in a tradition of rational thought about
the obligations and responsibilities of their profession.

Dr. Berwick---if he really believes what his presence and words at the "Integrative Medicine" Summit imply---is playing with ethical fire. (If, as I hope, he doesn't really believe those things, he's playing with ethics of another kind). Will we begin to see pseudomedicine "integrated" into Medicare and Medicaid? That is certainly the expectation of those who observed Dr. Berwick's performance at the Summit, and who appear intent to hold him to his word.

KA

Two other blogs that have addressed this issue are:

Dr. RW: Not only evidence based medicine but science based medicine may take a back seat in Donald Berwick's vision for patient centered care

Dr. David Gorski: Dr. Donald Berwick and “patient-centered” medicine: Letting the woo into the new health care law?

BLOGSCAN: CMSS New Ethics Code Analyzed

The Council of Medical Specialty Societies got some good press for its new code of ethics regarding medical associations' interaction with industry.  Two of the best skeptical bloggers about health care dissected the code, suggesting it will not be as tough as it was cracked up to be.  See these posts by Dr Daniel Carlat on the Carlat Psychiatry Blog and by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the Health Care Renewal mill since 2005.  For example, see these posts:

- here about ghost-writing of a Vioxx research publication;
- here, and here about allegations that Merck executives tried to intimidate Vioxx critics;
- here about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case;
- here about how an apparently major clinical trial of Vioxx turned out to be a "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and
- here about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs. 

Thus, the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case).

Merck just announced just the latest settlement of Vioxx related legal actions, as reported by Business Week:

Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees.

Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well 'honest communication' with doctors.

'In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,' according to the amended code. 'We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.'

Also,

The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.

Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party.

The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories.

Note that this settlement is only of one type of lawsuit, as described in a Wall Street Journal article,

The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx.

Merck had already settled thousands of lawsuits,

Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.

Merck has lots of other legal actions to go through,

The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.

So the parade of legal actions and settlements thereof continues.  We believe that the scope of this parade provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis.

One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research. 

On Health Care Renewal we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of manipulation and suppression of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an organizational ethics policy, which in turn may have the potential to actually improve behavior. 

On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

Why Are Health Care Organizations' Ethics Codes News?

This just in from the Orlando Sentinel,

The head of Central Florida's largest blood bank told Florida senators Wednesday that she has completely overhauled the operation — from the boardroom to the bloodmobile.

'Believe me, I get it,' an apologetic Anne Chinoda told members of a committee investigating the business ways of Florida's Blood Centers and other blood banks across the state.

Chinoda said FBC now prohibits board members from doing business with the agency, has instituted nine-year term limits for board members and has put together a group to review executive compensation. She also unveiled a blood-donor bill of rights she promised to publicize.

Sen. Don Gaetz, chairman of the health regulation committee that asked Chinoda to appear, said he was pleased by her testimony. 'What we saw today was an admission of inappropriate practices in the past and a promise they will be fixed,' he said.

These new ethical standards were a response to a past controversy,

Gaetz's committee has been investigating FBC, which generates $100 million in revenues annually, and the statewide industry since the summer.

The inquiry was triggered in part by a series of stories in the Orlando Sentinel that showed FBC board members have sold millions of dollars in goods and services to the agency each year; that board members had no term limits; and that Chinoda was compensated nearly $600,000 annually. Her salary was not discussed at the hearing.

Like others in the industry, FBC gets its blood for free from donors, tests and repackages it. FBC then sells the blood to 70 hospitals and medical facilities in 21 counties in Central and South Florida.

How often do you hear pleas from local blood banks about urgent shortages?  How often do you donate blood, or feel bad because you did not or could not donate?  Many people who selflessly donate blood were likely unpleasantly surprised to find out that blood banks sell (at a high price) the blood they donated, and used the proceeds to pay their executives generous salaries, and pay vendors run by their board members.

Here was another example of a previously revered local, not-for-profit health care institution run apparently for the personal benefit of its top insider leaders.

Why was it news when the organization in question adopted a code of conduct that limited self-dealing by board members, limited board members to only(?) nine-year terms, and put in place some sort or organized process to set the CEO's compensation?  Do those not seem like they ought to be standard, and not  newsworthy practices?

Similarly, an article in the Newark Star-Ledger back in November recounted how  Hackensack University Medical Center in New Jersey, whose board members had been accused of self-dealing (see this post), and to which a New Jersey state legislator had been convicted of selling his services (see this post), had instituted "tightened ethics rules," including a provision that "board members will no longer be allowed to do business with the hospital."  Again, why should a rule like this be news?  One of the duties of board members of all not-for-profit organizations is the duty of loyalty, "a standard of faithfulness; a board member must give undivided allegiance when making decisions affecting the organization."  Overpaying crony executives and authorizing business dealings with one's own business seem to obviously violate this duty.

We have noted how the business culture of health care organizations has increasingly come to resemble the larger business culture in an era of laissez-faire capitalism and the rise of new oligarchs and robber barons.  So it is telling that it was also news when UBS, a large international bank enacted a code of ethics for its employees that required them to actually comply with "foreign tax reporting rules," (per Bloomberg.)

One would have once thought that health care organizations, given their responsibilities for human life and health, and their formerly sterling reputations, would have clear, comprehensive codes of ethics that are actually enforced.   But it is news when a health care organization develops such a code (and it still may be news when such a code is enforced.) 

This post summarized some current thinking on organizational ethics policies.  In conclusion, I asked readers to think about whether their own health care organization had anything resembling such a policy.  I suspect few could identify such policies. 

Health care professionals need to inquire why health care organizations, including drug, device, biotechnology and health care information technology companies,  health care insurers, to hospitals, academic medical centers, and medical schools, etc, almost never have real organizational ethics policies.  Of course, the suspicion is that lack of such policies makes it easier for insiders to direct the organization for their personal benefit.  At least if we could make such policies the norm, we could remind organizational leaders that they are supposed to be upholding the mission, not lining their pockets. 

"Organisational Ethics Policies; A Primer"

I regret that it took me so long to find an essay on "Organisational Ethics Policies" by Howard Whitton, available from the European U4 Anti-Corruption Resource Center. While it was written with international non-governmental organisations (NGOs) who "administer aid programs" in mind, it seems applicable to all kinds of NGOs and not-for-profit organizations, including those in health care. In the US, most medical schools and their parent universities, most hospitals and academic medical centers, essentially all medical societies and disease advocacy groups, and some insurance companies and managed care organizations are not-for-profit.

The main points of the paper are its summaries of the basic elements of "effective ethics policies."

First, such a policy

- must first have unequivocal authority and the endorsement of boards and senior management, and must be:
o founded on the organisation’s core values, mandate, and ethical principle
o developed in consultation with those affected by it
o realistically achievable
o written in plain language, coherent with other policies, and easily available
o clearly understood by staff, and by other stakeholders
o consistent with the organisation’s policies on rewards and sanctions
o regularly reviewed and evaluated with all stakeholders
o universally applied, and transparently enforced.

The main content areas might include such "major areas of ethical risk" as:

o financial management and accountability standards
o internal and external audit processes
o professional ethics, conduct, and conflict of interest standards
o fair treatment rules for staff and clients
o processes for the prevention of fraud and other abuse of trust
o integrity mechanisms governing proper decision-making
o provision of transparent information to stakeholders
o complaints and whistleblower disclosure processes
o principled policy dispute processes
o transparent and objective evaluation mechanisms.

So, specific policies should include the following functional elements:

o a code of conduct/ethics based on the organisation’s core values
o professional practice standards interpreting the code’s principles
o procedures for managing conflict of interest situations (including the registration of relevant interests and assets of decision makers)
o procedures for offering and accepting gifts and business courtesies
o criteria for the proper use of organisational assets and authority
o prohibition of harassment and discrimination in the workplace
o criteria for protected reporting of unethical or illegal behaviour
o rights of clients to obtain service, including complaint procedures for failure to meet standards
o obligations for accountability and transparency,and information provision
o standards for dealing with confidential and privileged information
o constraints on ancillary and post-separation employment
o standards for providing reasons for administrative decisions.

Also the policies should include:

• A commitment to training staff in the full range of ethics-related activities. Training will improve personal awareness and strengthen the ability to define and manage improper conduct, whether by co-workers, managers, or external stakeholders.
The range of training themes should include the organisation’s integrity system, specific anticorruption measures, harassment-free workplaces, non-discrimination principles, financial management and audit, integrity in procurement practices, donor relations, personal and institutional conflict of interest, accountability, responsibility, procedural fairness, and strategic problem-solving.

• Policies and procedures for regular management reporting to boards and executives, in particular to enable monitoring of matters which may be of particular concern from time to time.

• Independent, external scrutiny of policies provide an important resource for boards and executives for ensuring that espoused core values and actual behaviours are aligned, and to identify areas of policy and management practice requiring
improvement.

• Policies and procedures for protected reporting of improper conduct, both to enhance worker and stakeholder confidence in the integrity of an organisation, and to provide avenues for early detection of inappropriate behaviour. Genuine
whistleblowing must be effectively endorsed, and effectively protected, to ensure the organisation’s credibility.

• Procedures for the sanctioning of improper conduct and failure to meet relevant standards by staff, structured so as to enhance management’s capacity to deal effectively with ethical issues in the workplace.

Such policies cannot be considered ethical panaceas, but in my humble opinion (and based, I believe, on at least a little cognitive psychology), visible, reasonable, clear ethics policies could reduce the sort of bad behavior that Health Care Renewal often discusses on the part of leaders of major health care not-for-profit organizations and NGOs.

So, those of you who work for or are otherwise affiliated with a not-for-profit university, medical school, hospital, academic medical center, medical organization, disease advocacy organization, or insurance company/ managed care organization might want to go through the exercise of answering these questions:
1 - Does your organization have anything that resembles an ethics policy?
2 - If so, which of the characteristics listed above does it have?
3 - Which of the content areas listed above does it include?
4 - Which of the functional and additional elements listed above does it include?

If much is missing, is there an obvious reason for what was omitted? If the policy seems poorly characterized or incomplete, why should it not be improved? Would you feel comfortable suggesting improvements? If not, why not, and what does that say about the organization?

Dodging Stones Thrown From Glass Houses: the JAMA Article on Conflicts of Interest

This week's JAMA featured a major article about addressing conflicts of interest that face physicians. (Brennan TA et al. Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA 2006; 295: 429-433.) The article has already attracted a lot of media attention (e.g., see the New York Times, Washington Post, and Los Angeles Times).

Unfortunately, I believe that this article is much more notable for what it omits than what it says.

I will summarize its main points, and then comment.

Main Points

Conflicts of Interest Are Important-

Physicians' commitment to altruism, putting the interests of the patients first, scientific integrity, and an absence of bias in medical decision making now regularly come up against financial conflicts of interest.

The Most Important are Conflicts of Interest Involving Pharmaceutical Corporations and Device Manufacturers and Affecting Physicians -

Arguably, the most challenging and extensive of these conflicts emanate from relationships between physicians and pharmaceutical companies and medical device manufacturers

Academic Medical Centers (AMCs) Shall Police Such Conflicts-

To remedy the situation and prevent future compromises to professional integrity, academic medical centers (AMCs) must more strongly regulate, and in some cases prohibit, many common practices that constitute conflicts of interest with drug and medical device companies.

Specific Interactions Between Physicians and Pharmaceutical and Device Corporations Must Be Addressed -

The following list, while not exhaustive, indicates the interactions with industry that must be addressed: gifts, even of relatively small items, including meals; payment for attendance at lectures and conferences, including online activities; CME for which physicians pay no fee; payment for time while attending meetings; payment for travel to meetings or scholarships to attend meetings; payment for participation in speakers bureaus; the provision of ghostwriting services; provision of pharmaceutical samples; grants for research projects; and payment for consulting relationships.

Physicians Shall Not Receive Any Gifts from these Corporations -

All gifts (zero dollar limit), free meals, payment for time for travel to or time at meetings, and payment for participation in online CME from drug and medical device companies to physicians should be prohibited. A complete ban on these activities by eliminating potential gray areas greatly eases the burden of compliance.

Physicians Shall Not Get Pharmaceutical Samples -

he direct provision of pharmaceutical samples to physicians should be prohibited and replaced by a system of vouchers for low-income patients or other arrangements that distance the company and its products from the physician.

Hospital Formulary Committees Shall Exclude Those Health Professionals with Financial Ties to Drug Companies -

Hospital and medical group formulary committees and committees overseeing purchases of medical devices should exclude physicians (and all health care professionals) with financial relationships with drug manufacturers, including those who receive any gift, inducement, grant, or contract.

Corporations Shall Not Support Continuing Medical Education (CME) Directly, but Shall Give Money to a Central Repository at the AMC -

Drug and Device Manufacturers should not be permitted to provide support directly or indirectly through a subsidiary agency to any ACCME-accredited program. Manufacturers wishing to support education for medical students, residents, and/or practicing physicians should contribute to a central repository (eg, a designated office at an AMC), which, in turn, would disburse funds to ACCME-approved programs.

Drug and Device Manufacturers Shall Only Support Trainees' Travel by Giving Money to the Central Repository -

Pharmaceutical and device manufacturers interested in having faculty or fellows attend meetings should provide grants to a central office at the AMC. That office could then disburse funds to faculty and training program directors.

Physician Faculty Shall Not Serve on Industry Speakers Panels -

Faculty at AMCs should not serve as members of speakers bureaus for pharmaceutical or device manufacturers.

Physician Faculty Shall Not Publish Ghost-Written Articles -

Faculty should be prohibited from publishing articles and editorials that are ghostwritten by industry employees.

To Consult for Industry, Physicians Shall Have Explicit Contracts with Deliverables -

Because the process of discovery and development of new drugs and devices often depends on input from academic medicine, consulting with or accepting research support from industry should not be prohibited. However, to ensure scientific integrity, far greater transparency and more open communication are necessary. Accordingly, consulting or honoraria for speaking should always take place with an explicit contract with specific deliverables, and the deliverables should be restricted to scientific issues, not marketing efforts.

Industry Shall Give Research Grants and Contracts to AMCs -

To promote scientific progress, AMCs should be able to accept grants for general support of research (no specific deliverable products) from pharmaceutical and device companies, provided that the grants are not designated for use by specific individuals.

AMCs Shall Post Grants and Contracts on the Web -

To better ensure independence, scientific integrity, and full transparency, consulting agreements and unconditional grants should be posted on a publicly available Internet site, ideally at the academic institution.

My Comments

The paper starts out well, by highlighting the importance of conflicts of interest in health care.

Conflicts Involving Other Health Care Organizations

It first goes seriously wrong by limiting its concern to only conflicts of interest involving pharmaceutical and device manufacturers, and only conflicts of interest affecting physicians. Health Care Renewal, and other related sources have documented conflicts of interest involving nearly all kinds of health care organizations.

Most particularly, although they don't often make news any more, most physicians are acutely aware of the strong conflicts of interest posed by their relationships with managed care organizations. Much was written about this in the 1980s and 1990s when managed care became ascendent as a way to control health care spending. To summarize, I wrote this in 2003,[1]

Physicians, especially primary care physicians, are often exposed to incentives that conflict with professional values. 'Market driven health care creates conflicts that threaten medical professionalism.'[2] Managed care organizations, in particular, provided strong incentives to do less for patients, but at the risk of making physicians into 'double agents,' whose financial incentives are no longer clearly aligned with providing services, but may turn on holding services to some minimum level.'[3] Most primary care physicians feel pressure from managed care to limit referrals and see more patients,[4] and thus are concerned about conflicts of interest and failure to regard the patient’s interests as paramount.[5] Managed care organizations may employ a 'strategy of giving with one hand while taking away with the other, of offering consumers comprehensive benefits while restricting access through utilization review, [which] obfuscates the workings of the system, undermines trust between patients and physicians, and has infuriated everyone involved.'[6]

Conflicts Affecting People Other Than Physicians

Conflicts of interest affect not only physicians, but also others involved in health care, particularly the leaders of health care organizations. Again, my "Cautionary Tale" article, and the contents of Health Care Renewal provide many examples. Some recent ones include the cases at Roger Williams Medical Center, the University of California, and the University of Medicine and Dentistry of New Jersey (UMDNJ).

Furthermore, there have been many examples of leaders of health care organizations being willing to sacrifice physicians' core values at the alter of increasing the organizations' bottom lines. A recent one would seem to be at the University of Sheffield, where research leaders cautioned Dr Aubrey Blumsohn not to demand the data from his own research project, lest he offend the pharmaceutical company that was sponsoring that research. More systematic evidence was provided by the Mello study[7], (see post here), which showed that AMC leaders were willing to sign research contracts with commercial sponsors that allowed the sponsors, rather thant than the AMC faculty, to control how the research was done, and how and even whether its results were presented.

I agree that physicians should be held to high ethical standards that strictly limit their conflicts of interest. But these standards should restrict all conflicts of interest that could threaten physicians' professionalism. If payments from a drug company that could make physicians more favorably disposed to its products are bad, financial incentives from a managed care organization that tempt physicians to withhold care that could benefit patients are equally bad.

Furthermore, leaders of health care organizations, including executives and trustees of AMCs, should be held to equally strict standards.

The Commandments

The article sets forth what amount to a set of commandments. I actually agree with many of them, even though some are harsh. However, I disagree with those that forbid individual physicians from specific intereactions with drug and device companies but allow AMCS to have such interactions. As noted above, corporate money can sway leaders of AMCs away from their institutions' missions, just like such money can sway physicians from their professional values. Also, as implied above, lacking are any commandments dealing with conflicts involving organizations other than pharmaceutical and device manufacturers. In particular, there are no commandments relevant to conflicts involving managed care organizations or insurance companies. Furthermore, again as implied above, lacking are any commandments for anyone other than physicians.

Enforcement of the Commandments

Why are AMC managers better qualified than are physicians to enforce these ethical standards? Physicians already are held to strict ethical standards incorporated in their training, the oaths they swear, and the requirements for licensure they must maintain to practice. AMC executives, aside from the decreasing minority who are also physicians, are not held to any standards of training or licensure, or any particular code of ethics. Chervenak and McCullough found "there has been to date no ethical framework offered that academic leaders can use to identify, prevent, and responsibly manage the ethical conflicts that are inherent, but sometimes hidden, in being an academic leader." Also, "ethics is an essential but largely neglected tool in the AHC (i.e., AMC) leader's 'toolbox'...."[8]

This blog is full of cases of bad, conflicted, and sometimes frankly corrupt leadership of AMCs and teaching hospitals. Again, the most recent examples include Roger Williams Medical Center (the entire organization was indicted, its CEO was indicted and just fired), UMDNJ (the entire organization admitted to commiting crimes, and is now operating under federal deferred prosecution agreement, while its President was just fired). In the past year, we have also seen the CEO of Fletcher Allen Health Care convicted of federal conspiracy (see post here), ongoing stories of mismanagement at University of California-Irvine (see post here), King/Drew Medical Center (see post here) and at Westchester Medical Center (see post here), etc, etc, etc.

Yet, the JAMA article's policies would put AMC managers in charge of policing physicians' compliance with conflicts of interest policies. These policies would condemn a physician for accepting a $1 pen from a drug company because such a gift might affect his or her practice. However, the policies would tolerate a drug company sending millions of dollars to an AMC. How could one deny the possibility that receiving large amounts of money would affect the organization's decision making?

Instead, I suggest developing a broad set of principles about conflicts of interest, and generally about business ethics in health care, focused on all transactions with outside organizations with their own vested interests or agendas. These principles should apply to all who make decisions in health care, physicians, other health care professionals, and leaders of health care organizations. The details of the implementation of these principles could vary, so as to apply to the setting and role of each individual.

A Final Irony

Finally, it is ironic that the first author of an article on conflicts of interest apparently had an important, relevant conflict of interest that was not disclosed in this article. Dr Troyen Brennan, who is listed as a Professor at Harvard Medical School, just accepted a position as Medical Director of Aetna, Inc, the large, for-profit health insurance and managed care company (see Jan 19, 2006 articles in the Boston Globe and Hartford Courant). Brennan must have been in negotiation with Aetna during some phase of the writing of this article, yet his relationship to the company is not indicated in the JAMA article.

Notes
1. Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Int Med 2003; 14 (2003) 123–130.
2. Kassirer JP. Managed care and the morality of the marketplace. N Engl J Med 1995; 333: 50-52.
3. Shortell SM et al. Physicians as double agents: maintaining trust in an era of multiple accountabilities. JAMA 1998; 280: 1102-1108.
4. Grumbach K et al. Primary care physicians’ experience of financial incentives in managed-care systems. N Engl J Med 1998; 339: 1516-1521.
5. Feldman DS et al. Effects of managed care on physician-patient relationships, quality of care, and the ethical practice of medicine. Arch Intern Med 1998; 158: 1626-1632.
6. Robinson JC. The end of managed care. JAMA 2001; 285: 2622-2628.
7. Mello MM et al. Academic medical centers' standards for clinical-trial agreements with industry. N Engl J Med 2005; 352: 21.
8. Chervenak FA, McCullough LB. An ethical framework for identifying, preventing, and managing conflicts confronting leaders of academic medical centers. Acad Med 2004; 79: 1056-1061.

Update (1/31/2006) - For a take on this in the inimitable manner of PharmaGossip, go here.

Reinventing the Wheel (Doh!) : The Organizational Justice / Fairness Literature

I just managed to stumble across an entire literature/ area of inquiry in psychology, sociology and management science that is very relevant to the issues discussed on Health Care Renewal, but which so far has hardly been applied to health care.
The area is called organizational justice or organizational fairness.
It is usually divided into three parts:
Distributive Justice- "the fairness of what one receives as the result of an allocation decision."
Procedural Justice- " the perceived fairness of formal decision-making processses," that can be broken down into dimensions such as consistency, bias suppression, representativeness, correctability, accuracy, and ethicality.
Interactional Justice- "the fairness of interpersonal treatment that one receives from a decision maker"
( Definitions come from Schminke M et al. The effect of organizational structure on perceptions of procedural fairness. J Appl Psychol 2000; 85: 294-304. See abstract here.)
There are widely used survey instruments designed to assess these different aspects. For example, the Moorman scale for procedural justice asks whether decision making procedures are meant to:
1. collect accurate information necessary for decision-making
2. provide opportunities to appeal or challenge decisions
3. have all sides affected by the decision represented
4. generate standards so decisions are made consistently
5. hear the concerns of those affected by the decisions
6. provide useful feedback regarding the decision and its implementation
7. allow requests for clarification or additional information
And the scale for interactional justice asks whether the leader:
1. considered your viewpoint
2. could suppress personal bias
3. provided timely feedback about decision and its implications
4. treated you with respect and kindness
5. showed concern for your rights
6. dealt with you truthfully.
Workers who perceive that such organizational justice is lacking have been shown to have less job satisfaction, organizational commitment, cooperation, and citizenship behavior, lower job performance, and are more likely to leave, steal, file a grievance, engage in conflict, and experience stress. (See summary in Schminke above.)
There are over 350 related publications in the PsychLit database on organizational justice or fairness. However, I could find only two articles on organizational justice or fairness in health care organizations.
One study in Finland assessed the cross-sectional relationship between organizational fairness and physicians psychological distress. Both procedural and interactional fairness were strongly negatively correlated with psychological stress in male, but not female physicians. (Sutinen R et al. Organizational fairness and psychological distress in hospital physicians. Scand J Pub Health 2002; 30: 209-215. Abstract available here.)
One study in Canada assessed the relationship between organizational fairness and hospital nurses' perceptions of respect. Interactional fairness was strongly related to respect. It is notable that less than half the nurses gave a positive response to each component of the fairness scale (e.g., my manager treats me with respect, my manager discusses implications of decisions, etc.) (Laschinger HKS. Hospital nurses' perceptions of respect and organizational justice. JONA 2004; 34: 354-364. See abstract here.)
Amazingly, when one staggers briefly out of the world of health care, and blinks one's eyes, there is another world where people actually worry about concepts like organizational justice.
Based on the anecdotes we have reported in Health Care Renewal, I suspect that if someone were to do the studies, they would find that many health care professionals perceive a lack of organizational justice, and that their perceptions will correlate with their dissatisfaction and demoralization (and likely poor quality of care, decreased access, and increased costs.)
It would be nice if health care managers got the idea that they should make open, honest fair decisions, and treat their employees fairly and with respect.

Finally, An Ethical Framework for the Relationship Between Medical Schools and Teaching Hospitals

The excellent team of Frank A. Chervenak and Laurence B. McCullough have produced another pioneering article (unfortunately, available by subscription only. The full citation is Chervenak FA, McCullough LB. Responsibly managing the medical school - teaching hospital power relationship. Acad Med 2005; 80: 690.) They had previously written the first article to propose an ethical framework for the leaders of academic medical centers (see our post here.) The fact that this 2004 article was the first to ever discuss the need for such a framework was, of course, disturbing.
The new article is the first ever to propose an ethical framework for the relationship between medical schools and their teaching hospitals. From the introduction,

• "Finances are an increasingly contentious aspect of the relationship between medical schools and their teaching hospitals. Joint budget negotiations can be shaped by incomplete information and sometimes even misinformation, failure to consider enhancements to other services, strategic procrastination and strategic ambiguity in the process and substance of the negotiations, unfunded mandates for matters vital to the hospital, such as quality, and attempts by each party to shift costs toward and reimbursements away from the other party. Both parties are under mounting and relentless fiscal pressure, creating an environment in which each party increasingly tends to focus on protecting its organizational self-interest, especially its bottom line. As a result, both parties are at risk of acting solely on self-interest, thus losing sight of and failing to be guided by their co-fiduciary responsibility for excelllence in patient care, education, and research. This could result in ethically unacceptable organizational cultures and practices that could adversely affect the parties' ability to fulfill that responsbility."

Sound familiar to those in medical education? Their solution first is transparency:

• "Transparency means that both parties must be forthcoming about revenues, including collateral revenues, and actual and assigned costs."
• "Sharing this information routinely will allow a factually based, informed allocation of revenues and costs as they relate to the mission of excellence in clinical care, education, and research."
• "The justification of transparency in business ethics ultimately involves an appeal to rational self-interest in avoiding (mutual) exploitation in market exchanges."

Furthermore, the reason for transparency is not just based on business ethics:

• "An explicit appeal to the medical ethical concept of co-fiduciary responsibility provides a crucial, additional basis for such responsible management, because fulfilling co-fiduciary responsibility makes transparency obligatory, not just a matter of rational self-interest."

The article is worth reading in its entirety. I only hope that a few leaders of medical schools and teaching hospitals will take it to heart.