"More Marketing Than Science" - An Anonymous Confession About Deceptive Marketing Published in the British Medical Journal

The British Medical Journal just published an anonymous article by a pharmaceutical company insider that explained once again how pharmaceutical companies turn research studies, apparently scholarly articles, and medical education into stealth marketing efforts.  (See Anonymous.  Post-marketing observational studies: my experience in the drug industry.  Brit Med J 2012; 344: 28.  Link here.)

We have previously discussed examples of health care corporate insiders confessing their individual efforts to turn medical research and education into marketing.  For example, peruse this.  We have also discussed how documents made public through litigation have revealed marketing plans for specific drugs that used apparently academic, educational, or scholarly publications and venues to market without revealing this transformation.  For example, see the Neurontin marketing plan (see post here), and the Lexapro marketing plan (see post here).  We have also discussed numerous examples of manipulation of particular research studies by those with vested interests, and outright suppression of studies whose results did not favor such vested interests.

Yet I suspect majorities of health care academics and professionals, health care policy makers, and the public at large do not realize, or would not admit that the evidence base for making health care decisions, and the general academic and professional discourse has been so corrupted.  So it is worthwhile to review once again how an insider summarized this corruption.

Research Studies Designed Primarily as Marketing Vehicles

In general, the anonymous author suggested that at least some studies were done for marketing, not scientific purposes:

some of the studies I worked on were not designed to determine the overall risk:benefit balance of the drug in the general population. They were designed to support and disseminate a marketing message.

Whether it was to highlight a questionable advantage over a 'me-too' competitor drug or to increase disease awareness among the medical community (particularly in so called invented diseases) and in turn increase product penetration in the market, the truth is that these studies had more marketing than science behind them.

Furthermore, the studies were supervised not by physicians or scientists, but by marketers in the marketing department,

Although the medical department developed the publication plans, designed the study, performed the statistical analysis, and wrote the final paper (which when published was passed on to marketing and sales to be used as marketing material), the marketing team responsible for that product were directly involved in all stages. They also closely supervised the content of other educational 'scientific' materials produced in the medical department and intended for potential prescribers. Instructions from marketing to the medical staff involved were clear: to ensure that the benefits of the drug were emphasised and the disadvantages were minimised where possible.

Manipulation of Research Design, Implementation, or Analysis

The author described how the marketers manipulated research studies so they would produce the results desired from a marketing perspective, regardless of their underlying truth,

Since marketing claims needed to be backed-up scientifically, we occasionally resorted to 'playing' with the data that had originally failed to show the expected result. This was done by altering the statistical method until any statistical significance was found. Such a result might not have supported the marketing claim, but it was always worth giving it a go to see what results you could produce. And it was possible because the protocols of post-marketing studies were lax, and it was not a requirement to specify any statistical methodology in detail. On the other hand, the studies were hypothesis testing (such as cohort studies, case-control studies) rather than hypothesis generating (such as case reports or adverse events reports), so playing with the data felt uncomfortable.

Other practices to ensure the marketing message was clear in the final publication included omission of negative results, usually in secondary outcome measures that had not been specified in the protocol, or inflating the importance of secondary outcome measures if they were positive when the primary measure was not.

So to summarize, the marketers would control the statistical analyses, promoting multiple analyses to attempt to come up with the "right" result that would support the marketing message (although the more kinds of analyses one tries, the more likely one is likely to come up with false results by chance alone). Presumably the marketers did not care whether or not the results were really true, which is perhaps why even they felt "uncomfortable" in some circumstances.

They would also foster the suppression of negative results, and the dredging of data for extra outcome measures when analysis showed no advantage in terms of the real primary outcomes. Suppression of negative results could be viewed as plain lying. Deliberate analysis of multiple end-points again risks identifying random error as true results.

The Role of Key Opinion Leaders

The author described how key opinion leaders, that is, health care professionals thought to be especially influential on practice or policy, were hired to become marketers presumably without revealing this intention.

Every big international observational study had a large advisory board. This was critical since the success of a newly launched drug in the market would depend on how many key opinion leaders were part of the study. Not only would they add credibility to the results, but they would also be key in influencing decision makers and other prescribers. In regional studies with thousands of patients, the study’s advisory board was formed by at least one key opinion leader from each country in that region, ensuring that areas important in terms of possible sales were covered. The contributions of the key opinion leaders to the study were always positive, but in my experience more directed towards designing new studies to answer their specific clinical questions rather than critically appraising our results and conclusions. In general, the relationship was amicable. We took them to the best hotels and restaurants during our advisory board meetings, and they appeared as authors in our research. Later, they would act as the company’s 'ambassadors,' giving conferences, teaching doctors, or talking to the media about the benefits of the drug.

Note that even the anonymous author could not bring him or herself to call the key opinion leaders salespeople, or marketers, but used the ambiguous wterm "ambassadors." Nonetheless, the role of key opinion leaders described would clearly be that of marketers or salespeople. However, it is extremely doubtful that any of these KOLs felt they had to declare that they were paid salespeople when presenting at conferences, teaching doctors, or talking about the media.

I would suggest that their actions would therefore fit Transparency International's definition of ethical corruption, "abuse of entrusted power for private gain." The KOLs are entrusted to be professional, and in many cases, scholarly. Using a professional or scholarly guise to act as a salesperson appears to be abuse of that entrusted power, in my humble opinion. In nearly every case, KOLs are paid, often handsomely, by the companies whose products they are selling. Thus, key opinion leaders acting as described by the anonymous author appear to be ethically corrupt.

Summary

The evidence of unethical marketing practices by commercial health care firms is mounting. Although I am most familiar with evidence from the US, there is mounting evidence that these practices are global, often done by companies that are not US based, and meant to influence practice and policy world-wide.

As the evidence mounts, it becomes increasingly clear that many such marketing practices are corrupt, at least in an ethical sense. Whether they may break laws in particular countries is a question for someone else.

The latest BMJ article is a reminder how skeptical the shrinking group of health care professionals who do not have conflicts of interest, are not biased in favor of particular products, and who put patients' interests first must be about ALL published research, scholarly publications, and apparently educational activities. Advocates of true evidence-based medicine must be extremely careful to try to use the least biased and manipulated parts of the evidence-base.

The mounting evidence suggests that at a minimum, all research reports, scholarly articles, media reports, conferences, and educational programs should provide full, detailed disclosure of all conflicts of interest. Perhaps having to make a declaration like "I am paid 50,000 Euros a year by the marketing department of company X to help market drug Y" before a supposedly educational talk would make some health care professionals think twice about such relationships.

However, even such detailed disclosure may not be sufficient to hamper marketing practices that now appear overtly corrupt. In my humble opinion, it is time to consider a global ban on the funding or influencing of human research by companies and other organizations which stand to gain financially according to the results of the research, or whose products and services are subject of such research. It is also time to consider a global ban on the funding or influencing of health care education by such organizations.

However, so many people are making so much money from the current practices that I doubt such proposals would get much support, or even public notice beyond this humble blog.

Pseudo-Evidence Based Medicine Should be a Global Health Concern

We have frequently advocated for evidence-based medicine (EBM) , that is, medicine based on judicious use of the best available evidence from clinical research, critically reviewed and derived from systematic search, combined with biomedical knowledge and understanding of patients' values and preferences.  However, EBM risks being turned into pseudo-evidence based medicine due to systematic manipulation and distortion of the clinical research evidence base.  Dr Wally Smith wrote about pseudo-evidence based medicine, which he defined as "the practice of medicine based on falsehoods that are disseminated as truth," in the British journal Clinical Governance (Smith WR. Pseudoevidence-based medicine: what it is, and what to do about it. Clinical Governance 2007; 12: 42-52. Also see this post).  

Now it appears that this issue is causing concern in the Cochrane Collaboration, the main voluntary international group promoting EBM.  An article from December, 2011 in the Indian Journal of Medical Ethics outlined why we need to question the trustworthiness of the global clinical evidence base.  (See Tharyan P. Evidence-based medicine: can the evidence be trusted.  Ind J Med Ethics 2011; 8: 201-207.  Link here.)  It merits further review.

The Role of Vested Interests

Dr Tharyan, its author, emphasized that a major threat to the integrity of the clinical research data base is the influence on clinical research of those with vested interests in marketing particular products, e.g., drugs, devices, etc.

The motives for conducting research are often determined by considerations other than the advancement of science or the promotion of better health outcomes. Many research studies are driven by the pressure to obtain post-graduate qualifications, earn promotions, obtain tenured positions, or additional research funding; many others are conducted for financial motives that benefit shareholders, or lead to lucrative patents.

The Importance of Pervasive Conflicts of Interest

Early on, the author discussed how the distortion of the clinical research data base arises from the pervasive web of conflicts of interest in medicine and health care:

This hijacked research agenda perpetuates further research of a similar nature that draws more researchers into its lucrative embrace, entrenching the academic direction and position statements of scientific societies and academic associations. Funders and researchers are also deterred from pursuing more relevant research, since the enmeshed relationship between academic institutions and industry determines what research is funded (mostly drugs at the expense of other interventions), and even how research is reported; thus hijacking the research agenda even further away from the interests of science and society.

The article then goes on to show how the influence of vested interests may distort the design, implementation, analysis, and dissemination of research.

Distortion of Research Design and Implementation

The Research Question

Dr Tharyan noted

The majority of clinical trials conducted world-wide are done to obtain regulatory approval and a marketing licence for new drugs. These regulations often require only the demonstration of the superiority of a new drug over placebo and not over other active interventions in use. It is easier and cheaper to conduct these trials in countries with lower wages, lax regulatory requirements, and less than optimal capacity for ethical oversight. It is therefore not surprising that the focus of research does not reflect the actual burden of disease borne by people in the countries that contribute research participants, nor address the leading causes of the global burden of disease. Some 'seeding' trials, conducted purportedly for the purpose of surveillance for adverse effects, are often only a ploy to ensure brand loyalty among participating clinician-researchers.

Insufficient Sample Size

The article stated,

Many trials do not report calculations on which the sample size was estimated, often leading to sample sizes insufficient to detect even important differences between interventions (for primary, let alone secondary outcomes)

I would add that such small trials are particularly bad at detecting important adverse effects of the interventions being promoted.

Excessively Stringent Enrollment Criteria

As Dr Tharyan wrote,

Most RCTs funded by industry and academia are designed to demonstrate if a new drug works, for licensing and marketing purposes. In order to maximise the potential to demonstrate a 'true' drug effect, homogenous patient populations; placebo controls; very tight control over experimental variables such as monitoring, drug doses, and compliance; outcomes addressing short term efficacy and safety; and methods to minimise bias required by regulatory agencies are used to demonstrate if, and how, the drug works under ideal conditions.

The problem is that very few patients in clinical practice resemble those enrolled in such trials, so the generalizability of the trials' results is actually dubious. Ideally, clinicians practicing evidence-based medicine could refer to trials that include patients similar to those for whom they care.

Practical or pragmatic clinical trials are designed to provide evidence for clinicians to treat patients seen in day-to day clinical practice, and evaluate their effectiveness under 'real-world' conditions. These trials use few exclusion criteria and include people with co-morbid conditions, and all grades of severity. They compare active interventions that are standard practice, and in the flexible doses and levels of compliance seen in usual practice. They utilise outcomes that clinicians, patients, and their families consider important, such as satisfaction, adverse events, return to work, and quality of life). Recommendations exist on their design and reporting , but such trials are rare.

Comparisons to Placebo, not the Other Interventions Clinicians Might Realistically Consider

Per the article,

Industry sponsored trials rarely involve head-to head comparisons of active interventions, particularly those from other drug companies, thus limiting our ability to understand the relative merits of different interventions for the same condition.

The result may thus be a number of studies showing particular interventions appear to be better than nothing, but few if any studies that would help clinicians decide which intervention would be best for a particular patient.

Inappropriate Comparators

However,when studies are done comparing the intervention of interest to other active interventions, the details of the choice of comparators are often managed so that the comparators are likely to appear to be worse.

Even if active interventions are compared in industry-sponsored trials, the research agenda has devised ways in which the design of such trials is manipulated to ensure superiority of the sponsor’s drug. If one wants to prove better efficacy, then the comparator drug is a drug that is known to be less effective, or used in doses that are too low, or used in non-standard schedules or duration of treatment. If one wants to show greater safety, then the comparator is a drug with more adverse effects, or one that is used in toxic doses. Follow up, also, is typically too short to judge effectiveness over longer periods of time.

Meaningless Outcomes

A favorite tactic used in the design of trials influenced by vested interests is to choose outcomes that are likely to show results favorable to the product being promoted, but have no meaning for patients or clinicians. There are three ways this is commonly done.

The first is to use rating scales that are very sensitive to small perturbations, but not meaningful in terms of how patients feel or function:

The choice of outcome measures used often ensures statistically significant results in advance, at the expense of clinically relevant or clinically important results. Outcomes likely to yield clinically meaningless results include the use of rating scales (depression, pain, etc.). These scales yield continuous measures usually summarised by means and standard deviations, rather than the dichotomous measures clinicians use such as: clinically improved versus not improved. These rating scales, however extensively validated, are hardly ever used in routine clinical practice. A difference of a few points on these scales results in statistically significant differences (low p values), that have little clinical significance to patients.

Another is to use surrogate outcomes,

Other outcomes commonly used are surrogate outcomes; outcomes that are easy to assess but serve only as proxy indicators of what ought to be assessed, since the real outcome of interest may take a long time to develop. These are mostly continuous measures that require smaller sample sizes (blood sugar levels, blood pressure, lipid levels, CD4 counts, etc.). These measures easily achieve statistical significance but do not result in meaningful improvements (reduction in mortality, reduction in complications, improved quality of life) in patients’ lives, when the interventions are used (often extensively) in clinical practice.

Finally, there are composite outcomes,

The use of composite outcomes, where many outcomes (primary, secondary and surrogate outcomes) are clubbed together (e.g.: mortality, non-fatal stroke, fatal stroke, blood pressure, creatinine values, rates of revascularisation) as a single primary outcome, can also mislead. Such trials also require smaller sample sizes, and increase the likelihood of statistically significant results. However, if the composite outcome includes those of little clinical importance (lowered blood pressure, or creatinine values), the likelihood of real benefit (reduction in mortality, or strokes, or hospitalisation) and the potential for harm (increase in non-fatal strokes or all-cause mortality) are masked.

Distortion of Analysis

Relative Instead of Absolute Risks

A favorite trick is to emphasize relative risks rather than absolute risks. For example if a trial reduces the risk of a bad outcome from 2 of 10,000 patients (0.02%) to 1 of 10,000 patients (0.01%), the relative risk reduction is 50%, but only 1 of 10,000 patients experienced a benefit.

The use of estimates of relative effects of interventions, such as relative risks (RR) and odds ratios (OR) with their 95% confidence intervals, provides estimates of relative magnitudes of the differences and whether these exclude chance, as well as if these differences were nominal or likely to be clinically important.

However, even relative risks can be misleading since they ignore the baseline risk of developing the event without the intervention. The absolute risk reduction (ARR) is the difference in risk of the event in the intervention group and the control group, and is more informative since it provides an estimate of the magnitude of the risk reduction, as well the baseline risk (the risk without the intervention, or the risk in the control group). Systematic enquiry demonstrates that on average, people perceive risk reductions to be larger and are more persuaded to adopt a health intervention when its effect is presented as relative risks and relative risk reduction (a proportional reduction) rather than as absolute risk reduction; though this may be misleading.

Sub-Group Analysis

Another statistical trick used to present favourable outcomes for interventions is the use of spurious subgroup analyses, where observed treatment effects are evaluated for differences across baseline characteristics ( such as sex, or age, or in other subpopulations). While they are useful, if limited to a few biologically plausible subgroups, specified in advance, and reported as a hypothesis for confirmation in future trials; they are often used in industry-sponsored trials to present favourable outcomes, when the primary outcome(s) are not statistically significant.

A major statistical point is that the more ways one subdivides the study population, the more likely it is to find a difference between those receiving different interventions by chance alone.

Distortion of Dissemination

Poor Exposition

As noted by Dr Tharyan,

Evidence also shows that the published reports are not always consistent with their protocols, in terms of outcomes, as well as the analysis plan, and this again is determined by the significance of the results. Harms are very poorly reported in trials compared to results for efficacy; and are also often suppressed or minimised.

Ghost-Writing

Also, those with vested interests may try to ensure maximally favorable dissemination by employing ghost-writers,

Other tactics used to influence evidence-informed decision making include ghost-writing, where pharmaceutical companies hire public-relations firms who 'ghost-write' articles, editorials, and commentaries under the names of eminent clinicians; a strategy that was detected by one survey in 75% of industry-sponsored trials, where the ghost author was not named at all, and in 91% when the ghost author was only mentioned in the acknowledgement section. Detecting such conflicts of interest is difficult, since they are rarely acknowledged due to the secrecy that shrouds the nexus between academia and industry in clinical trials.

Industry-sponsored trials often place various constraints on clinical investigators on publication of their results; these publication arrangements are common, allow sponsors control of how, when, and what is published; and are frequently not mentioned in published articles.

Ghost-writers under the direct control of those with vested interests could more efficiently bias their writing in favor of their sponsors than could even academics constrained by contractual obligations to sponsors.

Suppression of Research

When all else fails, the most crude example of distorted dissemination is suppression of studies that despite all the manipulations noted above fail to produce favorable results for the product being promoted:

A considerable body of work provides direct empirical evidence that studies that report positive or significant results are more likely to be published; and outcomes that are statistically significant have higher odds of being fully reported, particularly in industry funded trials.

By the way, the latest demonstration of suppression of research was a study by Turner et al (Turner EH, Knoepflmacher D, Shapley L. Publication bias in antipsychotic trials: an analysis of efficacy comparing the published literature to the US Food and Drug Administration database. PLoS Medicine 2012; 9(3): e1001189. Link here) It showed that of 24 trials of atypical antipsychotics registered in the US FDA database, 15/20 (75%) of the published trials were positive, that is, had results in favor of the sponsors' drugs according to the FDA review, but only 1/4 (25%) of the unpublished trials were positive. In other words, 15/16 of positive trials were published, but only 5/8 non-positive ones were.

Summary

Thus, Dr Tharyan provided a nice summary of many of the ways that the clinical research data base can be manipulated or distorted to serve vested interests. Such distortions risk the transformation of evidence-based medicine into pseudo-evidence based medicine.

We have repeatedly discussed (see links above) most of these issues. Because we are located in the US, and speak mainly English, this blog may have given the impression that the lack of trustworthiness of the clinical research evidence base is primarily a US problem. The article by Tharyan emphasizes, however, that it is a global problem.

While this problem now seems to have the attention of the Cochrane Collaboration, it seems to be relatively anechoic in global health circles. It appears to be no more prominent on the agendas of global health organizations than is health care corruption (look here.) Yet the two issues are highly related. Most of the distortions in the global clinical evidence database may be driven by conflicts of interest. Conflicts of interest are risk factors for corruption. Distortions of the global clinical research data base that lead to use of expensive, but ineffective or dangerous interventions when other options would work as well or better leads to needless suffering and death, and by unnecessarily raising the costs of care, decreases access, especially for the poor.

Also note that conflicts of interest may be one reason that all these problems remain so anechoic (look here).

True global health care reform requires addressing health care corruption, but also conflicts of interest and their role in the distortion and manipulation of the clinical research data base. I still live in hope that that some academic health care institutions, professional societies, health care charities and donors, and patient advocacy groups will gain enough fortitude to stand up for accountability, integrity, transparency, and honesty in health care.

Two Steps Back: International Council on Human Rights Policy Closes, Dutch Healthy Skepticism Ends Domestic Focus

We have noted the paucity of organized efforts to combat health care corruption and related phenomena.  What efforts exist tend to focus on corruption elsewhere, as if no one is willing to admit it can occur in their back yard.  Now one organization that has made some efforts in this sphere is closing, and another will explicitly focus its efforts on problems elsewhere.

International Council on Human Rights Policy Closes

The ICHRP was located in Geneva.  It had a wide focus, but was willing to consider how corruption could affect human rights.  Its publication, Corruption and Human Rights: Making the Connection, explicitly noted the threat of corruption to the right to health.  (Note that in international policy, this right is not considered to be to unlimited health care, but to "attainment of the highest available standard of physical and mental health.")  It went on to list a variety of ways in which government corruption, or corruption of health care leaders or organizations outside of government could harm health.  (Full disclosure: I participated in a meeting the IHCRP convened to review a draft of this publication.)

Now, as announced in the IHCRP blog, the IHCRP will close at the end of this month:

The decision to close was taken by the Executive Board primarily due to continued financial difficulties, largely a result of the difficult funding climate, especially for human rights and even more so for human rights policy research. It is especially regrettable because for more than a decade the ICHRP stimulated co-operation and exchange across the non-governmental, governmental and inter-governmental sectors, and strove to mediate between competing perspectives.

Healthy Skepticism in the Netherland to Only Focus on Problems "Abroad"

Today I got a press release (as of 21 February available here) from the Dutch Institute for Rational Use of Medicine (IVM), that stated:

The Dutch Institute for Rational Use of Medicine (IVM) is changing the course of its renowned Healthy Skepticism programme, which has critically monitored the pharmaceutical industry’s impact on the use of medication over the past ten years. Healthy Skepticism will be shifting attention away from its activities in the Netherlands, choosing to focus instead on supporting initiatives abroad.

The immediate reason seemed to be lack of funding, like the reason advanced for the closing of the ICHRP:

The change is prompted by the fact that the Dutch Ministry of Health, Welfare and Sport has eliminated funding for the programme....

The announcement first suggested that the change of focus came about because the initiative had attained its original goals:

another factor is the radical change that has occurred in the pharmaceutical industry’s attitude and conduct over the past decade.

Commenting on the change, IVM director Ruud Coolen van Brakel stated: 'Although there are still some problem areas, overall the industry has become more mature and more responsible’.

However, later in the announcement the implication was stronger that this lack of funding may have resulted from how the program challenged the powers that be, perhaps those who were personally profiting the most from the status quo:

The impact of Healthy Skepticism’s initiatives has not been unequivocally positive. IVM met with considerable resistance, which at times even became personal, and, because of its critical attitude, often became the target of aggressive attacks that also compromised its funders, the Ministry of Health, Education and Sport and the Healthcare Inspectorate.

Summary

We noted most recently (here, December, 2011) most of the organizations one might have expected would have provided some response to health care corruption instead have largely treated it as at best a nuisance. Specifically, there is almost no teaching or research on corruption in health care academics (including medical and public health schools, and programs in health care research and policy.)  There is almost no mention of corruption by health care professional associations.  There are almost no initiatives to fight corruption on the part of health care charities and donors.  There is almost no interest in corruption among patient advocacy organizations.  (See previous discussion here.)

Furthermore, I also postulated that at least in the US context, this lack of interest in corruption may partially be explained by these organizations' institutional conflicts of interest and the individual conflicts of interest affecting their leaders. It may be further explained by the exposure of some leaders to the irresponsible, if not amoral culture that now currently pervades finance, which may have in turn been one cause of the great recession, or global financial collapse.

The ICHRP and the Dutch Healthy Skepticism program seemed to be happy exceptions.  However, both of them depended on outside government or non-profit organizations for funding.  In both cases, these outside funders seem to have lost enthusiasm, maybe for reasons discussed above.

At least the ICHRP archives remain available, and Dutch Healthy Skepticism may be able to make some useful contribution outside the Netherlands.

There is increasing evidence that health care corruption may end up killing people.   I still hope that the courage of those who have tried to increase awareness of health care corruption, the conflicts of interest that can increase its likelihood, and surrounding phenomena, will not be in vain.  I still hope that some academic health care institutions, professional societies, health care charities and donors, and patient advocacy groups will gain enough fortitude to stand up for accountability, integrity, transparency, and honesty in health care.

Will the Freeze of the Global Fund Finally Put Health Care Corruption on the Agenda?

In February, 2011, we posted about problems with corruption affecting the Global Fund to Fight AIDS, Tuberculosis and Malaria. At the time, the Fund promised to better detect fraud and corruption affecting its grants programs. We later posted about how after an internal debate, the Fund promised to make more information public about any losses to fraud and corruption.

Now it has made more such information public, but it also appears that further problems with corruption have lead to the freezing of the Fund.

The New Findings of Corruption

First, as reported by Bloomberg on 1 November,

A $22 billion disease-fighting fund backed by Microsoft Corp. (MSFT) founder Bill Gates found that money intended for people with life-threatening illnesses was used for home renovations in India and diverted to a person linked with money laundering and so-called blood diamonds in Nigeria.

The Global Fund to Fight AIDS, Tuberculosis and Malaria is seeking to recover as much as $19.2 million from grants in eight countries, the Geneva-based organization said in a set of reports today. As much as $1.3 million was misused by the head of a non-governmental AIDS organization in India to buy a car and renovate his apartment, one report said. In Nigeria, money was siphoned to a person arrested in 2003 for money-laundering and smuggling diamonds that are mined and sold to support war.

This amount was in addition to previous amounts disclosed before:

The organization said last year it was seeking the recovery of $44.2 million in four nations for 'grave misuse of funds.'

It is not clear how much money the Fund has lost to corruption in total. According to an AP report, via CBS News,

Earlier probes by the fund's internal watchdog, the inspector general's office, had detected about $53 million in losses, according to fund documents, some unpublished, provided by senior officials.

The fund's board chairman Simon Bland told The Associated Press it has now reviewed about one-seventh of $14 billion in grants disbursed.

Whether similar amounts of corruption affected the other six sevenths of grants is unclear.

The Freeze on Grants

This week, several reports that the Fund would stop funding new grants appeared in the media. As reported by BusinessWeek,

The world’s biggest disease-fighting fund canceled its next round of grants as the global financial crisis crimps donations and threatens its ability to curb the spread of the world’s deadliest infections.

The Global Fund to Fight AIDS, Tuberculosis and Malaria, which has spent or committed to spending $22 billion since 2002 on preventing and treating disease, will only have enough money to pay for essential services for existing programs through the end of 2013, the Geneva-based fund said in a statement today. It will not make new grants until 2014,...

The reason for this freeze on grant making was,

The fund faces 'accelerating deterioration' in its finances for the next three years because of economic distress in donor nations, combined with corruption in some of the poor countries it helps,...

A NY Times article implied that one reason for the financial shortfall was that some donor nations withheld money due to their concerns about corruption:

Several countries, including Djibouti, Mali, Mauritania and Zambia, lost their grants or had new safeguards put in place after officials were accused of stealing. The Global Fund’s own inspector general exposed the fraud and earlier this month was trying to recover about $20 million that had been stolen; that amount is less than 1 percent of the $13 billion that has been disbursed.

There have been reports of friction between Dr. Kazatchkine and the inspector general, John Parsons. They each report separately to the board.

Some major donors, including Germany and Sweden, expressed their dismay by freezing their donations.

Also, CBS News reported,

Germany, the European Commission and Denmark withheld hundreds of millions of euros in funding pending reviews of the fund's internal controls. Germany — the fund's fourth-largest donor- has since restored its funding.

Summary and Comment
In summary, the uncovering of specific instances of corruption that wasted the assets of the Global Fund, and the concerns of international donors about the effects of corruption on the Fund have been some of the causes of a freeze in funding that will preclude new initiatives at least until 2014. This is a dramatic illustration of how corruption can undermine health care.

We wondered previously whether the realization that corruption was subverting the Fund's activities would lead the Fund to actively address corruption.  In fact, the Fund seems to have investigated previous corruption affecting its work more aggressively than have many other health care organizations.  However, the Fund did not appear to have instituted any initiatives to prevent, forestall, or challenge corruption.  In that, it is typical of nearly every health care organization in the world.

Transparency International defines corruption as "abuse of entrusted power for private gain."  By that definition, many of the cases discussed on Health Care Renewal are about corruption.  For example, if a pharmaceutical company pays physicians as part of a deceptive marketing campaign that exaggerates the benefits or minimizes the harms of a drug, and that campaign increases sales and hence executive compensation, one could argue that the case involves corruption of both of physicians and of company management.  We have discussed many such cases on Health Care Renewal.  One striking example was the stealth marketing campaign for Neurontin as described in posts here, here, here and here.

Thus, there are many examples of corruption affecting health care professionals and academics, and all sorts of health care organizations, hospitals, health care insurers, pharmaceutical and device companies, health care information technology companies, medical education and communication companies, contract research organizations, etc, etc, etc  In 2006, Transparency International's Global Corruption Report asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  As we summarized here, the report discussed the scale and diversity of health care corruption, and the severity of its adverse effects.

However, at least for a generation, there has been almost no opposition to such corruption.  In fact, as we have noted, health care corruption, and the problems and leadership and governance that lead to it, have been nearly anechoic.  Specifically, there is almost no teaching or research on corruption in health care academics (including medical and public health schools, and programs in health care research and policy.)  There is almost no mention of corruption by health care professional associations.  There are almost no initiatives to fight corruption on the part of health care charities and donors.  There is almost no interest in corruption among patient advocacy organizations.  (See previous discussion here.)

Why do they all ignore such a huge problem?  Most likely it is because of institutional and individual conflicts of interests.  Most of the these organizations are substantially funded by health care corporations, including corporations most involved in corruption, (and parenthetically, by financial firms whose corruption was likely a major cause of the global financial collapse / great recession, the other ostensible cause of the freeze of Global Fund grants.)  Many prominent health professionals and academics, and health care organizational leaders themselves have individual financial relationships with such companies.  For example, a majority of US medical school department chairs have significant financial relationships with health care corporations (see post here).  We have shown how top medical school leaders may simultaneously serve on the boards of directors of health care corporations (see post here).  People who are personally profiting from relationships with health care corporations are unlikely to question such relationships.  The leaders of organizations which depend on funding from such corporations are unlikely to question whether conflicts of interest might lead to corruption.  People whose colleagues, friends, family members, or supervisors are personally benefiting from conflicts of interest may hesitate to challenge such relationships.

So will the freeze of new grants at the Global Fund at least get health care corruption on the agenda?  One can only hope.  I personally hope that there are enough honest and unconflicted people remaining who will raise their voices above a murmur, even if that might discomfit those around them.

Of course, one reason we started Health Care Renewal was to make these issues less anechoic. So hear we go again.


PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information.

Enabled by the Revolving Door, Corporatistic US Trade Policy Seems to Put US Drug Companies Ahead of Global Public Health

We just discussed how leaders of big health care corporations with histories of ethical and legal missteps want to export our supposedly "wonderful technology, wonderful approaches" to the rest of the world.  A story on the Huffington Post showed how big health care corporations, partnering with the US government, have already been doing that with not very pretty results.  The article discussed two cases, connected by a single person who transited the revolving door from government to the pharmaceutical industry and then back to government.

The US Dispute with Brazil, on Behalf of Merck and Pfizer, About HIV Drugs

When [William] Daley was commerce secretary in the later years of the Clinton administration, Brazil rankled U.S. drug companies by opting to provide its citizens with a generic version of another HIV drug. Like Thailand, Brazil declared a public health emergency in an effort to lower the cost of treating roughly a half-million HIV infections. The U.S. government responded by sending Daley to Brazil with executives from U.S. pharmaceutical giants Merck & Co. and Pfizer to try to pressure the Brazilian government into reversing its decision.

Thus the US government appeared to be putting the revenues of US corporations ahead of the public health, at least in Brazil.
Daley soon made the transition to the private sector:

In a speech at Johns Hopkins University before leaving for Brazil, Daley encouraged students to enter the revolving door between big business and public policy-making. 'Let me say this: As one of the only members of the president's Cabinet to come from business, it's good when you mix both government and business in your careers,' he said. 'It makes better public servants, and it makes better businesspeople.'

It has certainly been good for Daley's career. His effort to twist arms in Brazil failed, but drug companies apparently took note. It was after leaving the Clinton administration that Daley was hired by Abbott, where he raked in more than $1.3 million as a board member from 2004 to 2010, according to Securities and Exchange Commission filings. Over the same period, he served on Boeing's board and was a top lobbyist for JPMorgan Chase.

Abbot's Dispute, Supported by the US Government, with Thailand About Kaletra

Soon Abbot was involved in a similar dispute.

The background is:

[HIV drug] Kaletra costs more than $10,000 a year for a patient living in the United States, a price that is reflective of the highly protective American patent system. The U.S. is the only country that grants long-term monopolies on life-saving medicine without regulating the price of monopolized drugs.

In addition

In countries that negotiate with companies on drug prices, the cost of medicine is often far lower. But though American pharmaceutical companies do supply drugs to developing nations at rates below those charged in the U.S., those discounted prices are still too high for many poor or hard-hit nations to afford.

'In many developing countries, it's a death sentence,'said Nobel Prize-winning economist Joseph Stiglitz, referring to high drug prices.

The core of the dispute:

In 2007 negotiations with the Thai government, Abbott Labs wouldn't budge below a price of $2,200 per person, per year for Kaletra. At the time, Thailand was classified as a 'lower-middle income' country by the World Bank -- the second lowest of four categories. With more than a half-million citizens living with HIV, Thailand considered that price beyond its budgetary capacity. So it declared a public health emergency and began importing a vastly cheaper generic version of Kaletra from India.

And then, by international trade standards, all hell broke loose.

'When countries declare the health emergency, they face a huge backlash, particularly from the USTR [US Trade Representative] and the drug companies,'said Tim Boyd, policy research coordinator with the AIDS Healthcare Foundation, a U.S. nonprofit dedicated to eradicating HIV.

Abbott responded by withdrawing pending applications to register drugs in Thailand, cutting its citizens off from other medications. The move was unprecedented: Never before had an American drug company attempted to punish a country during drug price negotiations by cutting off the supply of other medicines.

At the time, Brook Baker, a law professor at Northeastern University and a member of the board at the Health Global Access Project, called the move a 'ruly appalling example of corporate hubris'that 'irectly violates any conceivable norm of corporate responsibility.'

At that time, the US government went along with Abbott:

As for the USTR, it seemed to support the company, placing Thailand on its 'Priority Watch List 'of nations that do not respect U.S. intellectual property rights. 'In late 2006 and early 2007, there were further indications of a weakening of respect for patents, as the Thai Government announced decisions to issue compulsory licenses for several patented pharmaceutical products,' wrote the agency in its report announcing that Thailand had been added to the priority list.

Although the USTR blacklist is little known domestically, it is a major economic indicator abroad and can affect a country's ability to import everything from software to DVDs to automobiles. Thailand's new status as an international rogue sparked concern among the country's economic policy officials and corporate leaders. And 35 members of Congress wrote to the USTR to protest Thailand's blacklisting, noting, 'The move is being interpreted in the public health community as a warning and a threat to other countries.'

Note that:

Abbott Labs declined to detail Daley's involvement in the Thailand episode, but as a member of the board, he should have been well informed about the strategy.

US Government Pressure to Protect Drug Companies' Patents

William Daley has transitioned the revolving door again in the other direction:

As commerce secretary under Bill Clinton, William Daley worked with U.S. pharmaceutical giants to curb the use of cheaper generic drugs abroad. As a board member for Abbott Laboratories, he had a front-row seat on a brutal clash between a major drug company and a developing nation over access to life-saving medication. And as White House chief of staff today, Daley has President Barack Obama’s ear.

In his new government job,

Add up Daley’s power and experience, and experts who follow public health policy suspect his influence in the U.S. stance in negotiations over a major international trade deal -- a stance with hugely profitable implications for giant American drugmakers.

The United States is in talks with eight other Pacific nations to establish the Trans-Pacific Partnership, which the administration hopes will serve as a template for other trade pacts. According to leaked documents from the negotiations, the Obama administration is using the deal to push hard-line intellectual property standards that could drive up medicine prices overseas, boosting the bottom line for U.S. drugmakers like Abbott Labs at the expense of public health.

Public health advocates are worried. 'If the point of the trade policy is not just to protect the interests of our companies, but the public health benefit and burden of research, then [the United States] is doing this all wrong,' said James Love, director of Knowledge Ecology International, a nonprofit that focuses on how patent laws affect the poor.

A White House spokesman said only that the negotiations -- which are being conducted behind closed doors with input from corporate lobbyists -- are being 'ably led' by the United States Trade Representative (USTR) and that Daley is 'not directing or participating in those negotiations.'

Note that the USTR leadership includes other travelers through the revolving door:

Daley's personal history with drug access is not unique among top-tier government officials with trade responsibilities. McCoy lobbied on intellectual property issues at the influential D.C. law firm Covington & Burling before moving to the USTR in 2006. His top deputy, Kira Alvarez, was a lobbyist for drugmaker Eli Lilly before joining the agency.

Summary

Per Zach Carter, the author of the Huffington Post article:

Daley, who previously lobbied for JPMorgan Chase, is a prominent examplar of a bipartisan phenomenon in American government in which corporate insiders, and the profit-driven perspective of the boardroom, have come to dominate formal and informal debate over public policy.

Another way to describe this is corporatism. The corporatism in this case is partly enabled by the continuation of the revolving door, the free transit of individuals from leadership positions in top corporations and in government. The government and big corporations have teamed up to produce solutions that may seem beneficial to the people making the decisions, and may benefit their long term career strategies, but may not be good for the US public, for patients' and the public's health in this case, and for the ability of the country to conduct foreign policy based on some ethical and moral principles.

By the way, note that combined with other cases we have discussed, this shows that the revolving door pheonomenon, and other aspects corporatism affecting health care are not linked with any one political party.

So,

There is no evidence that any of these players, including Daley, have done anything illegal or explicitly corrupt during the Trans-Pacific trade negotiations. But public health doesn’t seem to be their first priority.

'The real concern is that the U.S. is using its international power and prestige to force poor countries to enforce our intellectual property standards, and the result of that is that access to medicine is denied and people are dying,' said Joseph Stiglitz.

Until we dispel the fog of corporatism that has spread over the government that was once supposed to be of the people, by the people, and for the people, expect no real health care reform, and expect continuing rising costs, declining access, and worsening patient care. Obviously, true health care reform would start with the government and its officials putting patients' and the public's health first, way ahead of the financial comfort of corporate leaders.
xx

"Running Away from the Problem" of Health Care Corruption

Despite its likely importance, the very concept of health care corruption remains highly anechoic. 

Last week's Lancet, however, actually mentioned it, albeit indirectly and ironically.(1)  The context was Richard Horton's discussion of a press conference on the final report of the UN Secretary-General's Commission on Information and Accountability for Women's and Children's Health. It appears that accountability, which we consistently advocate, was central to the report:

The big conclusion is that a huge accountability gap exists - we have incredibly weak mechanisms to make sure that the billions spent on women's and children's health are delivering the results we expect.

The report listed "ten commandments of women's and children's health, [which] aim to fill that accountability gap."

While the press conference went on, something unusual happened, as Richard Horton discussed somewhat ironically:

In truth, meetings such as these may not always produce the most exciting moments in the history of health (but this one did). Yet they can produce episodes of raw undiplomatic honesty which make the long waits and dull protocol worthwhile. [Secretary General of the International Telecommunication Union Hamadoun] Toure has a reputation for being blunt and outspoken. He surpassed himself last week. At the end of the first day, he suddenly began a riff of denunciation that left us all speechless. 'There is more corruption in the G8 countries than in the whole of Africa,' he declared with conviction. 'We are just running away from the problem.'

There you have it, one of the few mentions of health care corruption in the medical and health care literature, and one of the very few mentions of health care corruption afflicting developed, not just developing countries.

Interestingly, Horton then documented an immediate attempt by some very important people in global health care to paper over the unpleasantness raised by Toure's honest assessment:

President [Jakaya] Kidwete [of Tanzania] and Margaret Chan, WHO's Director-General, did well to pull their colleague back from the brink of professional suicide. 'This is a partnership effort,' affirmed Kikwete. He wanted no one think the generosity of international donors did not count. 'They are critical for development,' he said. Dr Chan stepped in to assert that 'development money works.'

So there you have it again. Stating that health care corruption is an important problem in developed countries is "professional suicide," even for the Secretary General of the International Telecommunications Union.

Yet Dr Horton, was willing to go a little further, maybe risking his own "professional suicide,"

The President and DG are right. But Toure had a point too. And most of us in the room knew it.

We have noted before that health care corruption is the great unmentionable.  The corruption that is mentioned is that afflicting developing countries.  Hardly anyone seems willing to say that health care corruption is just as big a problem in developed countries, including those that provide most of the funding for health care development in the developing countries.  As we see above, we now have an acknowledgement in one of the most influential medical journals that mentioning health care corruption in the developed world is "professional suicide." 

That is the anechoic effect writ large.  Left unsaid is why this is so.  Presumably, the reason is that corruption is wide-spread.  The corrupt have made a lot of money and become very powerful.  So it is very unwise to offend them.  That, of course, just lets corruption flourish, and so health care gets increasingly expensive, inaccessible, and bad for patients and the public.

If we really want to improve health care in our own countries, and to improve global health, we will all have to be as brave as Mr Toure.

See below for a repeat of our previous summary of the issue of health care corruption.

+++

Many people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, Transparency International's Global Corruption Report asserted in its executive summary, "the scale of corruption is vast in both rich and poor countries." It also noted how diverse is health care corruption:

In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.

It further stated how serious the consequences of corruption may be:

Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly....


The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services.


Corruption affects health policy and spending priorities.

On this blog, our limited resources make us focus mainly on the US, and sometimes other English-speaking countries. Yet we now have in our archives some amazing stories that document various forms of corruption, including numerous allegations of corporate misbehavior ending in legal settlements, and examples of outright fraud, bribery, kickbacks and other crimes. Also, as we have noted before, the US Institute of Medicine has defined conflicts of interest

Conflicts of interest are defined as circumstances that create a risk that professional judgments or actions regarding a primary interest will be unduly influenced by a secondary interest.

Given that Transparency International's definition of corruption is

abuse of entrusted power for private gain

One can easily argue that in health care, conflicts of interest defined as above create risks of abuse of power by health care professionals influenced by the private gains provided by their secondary interests. On Health Care Renewal, we have provided a massive set of examples of individual and institutional conflicts of interest. There is evidence that about two-thirds of medical academics(2) and academic leaders(3) have significant conflicts of interest. The huge prevalence of conflicts suggests the enormous risk of major corruption.


So what we all should be shocked, shocked about is how little has been done to fight health care corruption, whether in Mozambique or the US.


However, one can find very few significant efforts to discuss, teach about, or research ways to fight corruption, or to promote accountability, integrity, transparency, honesty and ethics by academic health care institutions. (See this post for how difficult it was to find academic institutions' initiatives to resist conflicts of interest.) One can count the conferences, meetings, symposia, and courses on such topics on one's fingers. When I last looked, I could count only a single course on fighting corruption at any US medical or public health school (at Boston University, by Prof Taryn Vian).


Given the scope of corruption, we should be shocked, shocked at how anechoic it is, and how our respected health care institutions, particularly academic institutions and health care charities have ignored the problem.


Given the scope of corruption, we should be shocked, shocked at how anechoic it is, and how our respected health care institutions, particularly academic institutions and health care charities have ignored the problem.


Of course, one reason we started Health Care Renewal was to make these issues less anechoic. So hear we go again.


PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information.


References


1.  Horton R. Offline: ten commandments, G8 corruption, and OBL. Lancet 2011; 377: 1638.  Link here.
2. Campbell EG, Gruen RL, Mountford J et al. A national survey of physician–industry relationships. N Engl J Med 2007; 356:1742-1750. Link here.
3. Campbell EG, Weissman JS, Ehringhaus S et al. Institutional academic-industry relationships. JAMA 2007; 298: 1779-1786. Link here.

Global Fund Will Not Suppress Discussion of Health Care Corruption

Some good news to discuss, for a change....

We previously discussed losses from corruption reported by the Global Fund to Fight AIDS, Tuberculosis, and Malaria, and by the Health Alliance International here.  At the time, we noted that some experts in health care corruption praised the Global Fund for being transparent about the effects of corruption.

However, last week there was concern that some elements within the Global Fund thought that the best response to losses due to corruption would be hiding them.  As reported by the AP (via CBS): 

A global health fund championed by celebrities and world leaders is considering scaling back its groundbreaking philosophy of full transparency about how it spends billions of dollars in health care in poor countries. Its decision could have broad consequences for the ways international aid groups operate.

Revelations this year by The Associated Press about misspent funds and corruption among recipients of the money — and the donor backlash that has followed — have prompted leaders of the Global Fund to Fight AIDS, Tuberculosis and Malaria to propose scaling back on the investigations that uncovered the problems, and revealing less about them to donors and the public.

But hardly everyone within Fund leadership wanted to abandon transparency:

The Global Fund's internal watchdog fiercely opposes the proposed changes. In its latest progress report, obtained by the AP, Inspector General John Parsons warns the board that a move toward less transparency 'could be interpreted negatively and as a purposeful effort to suppress material information.'

Also,

The president of the board, Ethiopian Health Minister Tedros Adhanom Ghebreyesus, opposes any changes.


'Even the mere appearance of suppression of information is unacceptable. Scaling back, or the perception that we are retreating from, this commitment is something we simply cannot allow,' Tedros said. If anything, he added, 'we should increase our level of transparency.'

Now, it looks like the transparency advocates won, at least in part. As again reported by the AP (via CBS):

A multibillion-dollar fund that fights three killer diseases said Friday that it will make public more detailed information about money it has lost to corruption and mismanagement, but won't release other information critics have sought.

The board of the $22 billion Global Fund to Fight AIDS, Tuberculosis and Malaria met this week to address a backlash among major donors over revelations by The Associated Press that the fund's internal watchdog was turning up losses of tens of millions of dollars of grant money.

Board members decided to publish detailed accounting of losses and money recovered, the fund said, in an effort to distinguish between fraud and other problems such as poor accounting.

However,

The fund will not, however, provide other details from internal investigations and audits that might have made it possible to calculate how much of the money investigated is lost to corruption, or what percentage of the fund's overall disbursements are misspent.

Also,

The fund also is not making public an internal chart obtained by AP showing that in 12 nations where internal audits and investigations reviewed almost $576 million in spending, an average of 8 percent was lost to fraud, undocumented or unauthorized spending.

Still, it is very good news that transparency won out in this case. Maybe the Global Fund leaders' decision will encourage more discussion of the severity of global health care corruption and its negative effects.

On the other hand, it is bad news that even discussion of health care corruption remains controversial. In 2006, Transparency International's Global Corruption Report asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  As we summarized here, the report discussed the scale and diversity of health care corruption, and the severity of its adverse effects.  Yet the very subject of global health care corruption remains as anechoic as many of the specific topics we discuss on Health Care Renewal.

Also, as we have noted before, recently here, there are very few if any meetings about global health care corruption, very few courses on it in medical or public health schools, no institutions specifically designed to address it, and no programs at the foundations and NGOs which are losing money to global health corruption to combat it.  Similarly, there are few efforts to promote accountability, integrity, transparency, honesty, and ethics in health care (aside from this blog and a few other similarly informal initiatives.) 

What is wrong with that picture?

We hope that the willingness of the Global Fund to discuss and admit it has a problem with health care corruption will make health care corruption a little less anechoic, and lead us closer to concrete steps to address it.

PS - If anyone in our vast audience does know about any additional anti-corruption or conflict of interest, or pro-accountability, integrity, transparency, honesty and ethics initiatives, courses, meetings relevant to health care, please let me know and I will do my best to disseminate the information.

[Posted on Health Care Renewal by Roy M. Poses MD]

Khadafy's Academic Mercenaries' Health Care Connections

We just discussed Henry Kissinger as an early example of the intellectual mercenary, and recent striking examples of academic mercenaries,particularly the Harvard University-derived Monitor Group's academically disguised public relations work for Libyan tyrant Moammar Khadafy.

We concluded that academic mercenaries help foster the corporate culture in which health care is now immersed.  However, it also appears they may have direct influence on health care. 

Monitor Group Leadership

Consider for example the main figure in the Monitor Group - Khadafy scandal.  According to a Boston Globe article, Michael Porter developed the Monitor-Khadafy connection:

Monitor’s work in Libya began when Michael Porter, a Harvard Business School professor who is among the country’s top theorists on management strategies, received a call from Saif Khadafy around 2001, according to Porter. Saif, a Western-leaning doctoral student who US officials hoped would become the next leader of Libya, asked for his expertise to help change Libya’s battered, Soviet-style economy.

(Saif, of course, later sided with his father in brutally putting down anti-government protesters.)

According to his official Harvard biography, Michael Porter also has a big interest in health care:

Since 2001, Professor Porter has devoted considerable attention to competition in the health care system, with a focus on improving health care delivery. His work with Professor Elizabeth Teisberg, including the book Redefining Health Care: Creating Value-Based Competition on Results (Harvard Business School Press, 2006), is influencing thinking and practice not only in the United States but numerous other countries.

In fact, the New England Journal of Medicine published his four-page commentary on "value-based" health care reform in 2009 [Porter ME. A strategy for health care reform - toward a value-based system. N Engl J Med 2009; 361: 109-112. Link here.]

The journal required that he disclose financial relationships with other health care organizations, including

receiving lecture fees from the American Surgical Association, the American Medical Group Association, the World Health Care Congress, Hoag Hospital, and the Children's Hospital of Philadelphia, receiving director's fees from Thermo Fisher Scientific, and having an equity interest in Thermo Fisher Scientific, Genzyme, Zoll Medical, Merck, and Pfizer.

The Boston Globe article identified two more Monitor leaders who helped develop the Libyan connection:

Porter brought in Monitor, a firm he had helped found, along with other associates including former Harvard professors Mark Fuller, who is now the firm’s chairman, and Joseph Fuller, who works at Monitor and also collaborates on research with some Harvard professors.

Mark Fuller, the current CEO of the Monitor Group, who wrote to the Libyan government proposing to counter its "deficit of positive public relations" as described by Mother Jones, per the New Profit Inc web-site is:

a Member of Harvard University's Major Gifts Steering Committee, a Member of the [Harvard] Board of Overseers' Committee on University Resources,...

Joseph Fuller was an unsuccesful candidate for the Harvard Board of Overseers in 2010. His biography for that candidacy also stated:

He and his wife, Ruthanne Schwartz Fuller, MBA ’83, served on the HBS Board of Dean’s Advisors and Joe on the Harvard College Fund and the FAS Undergraduate Education Planning Committee.

So of the three Monitor Group leaders who developed the stealth public relations campaign for Khadafy, the leader who set up the relationship with Libya has a professed interest in health care, published on health policy in a prominent journal, and has financial ties to multiple health care organizations. The two others have leadership roles within their own university which are likely to affect its medical and health care spheres

Monitor's Hired Academics

Furthermore, of the seven outside academics the Monitor Group paid to help promote the Khadafy regime per the Mother Jones article, three had health care connections. 

Richard Perle is on the board of directors of New Health Sciences Inc, a biotechnology company.

In 2008, Francis Fukuyama was elected a member of the Board of Trustees of the Rand Corporation, which does substantial health care research.

Benjamin Barber's own biography claims he has been on the National Advisory Board of American Health Decision Inc since 1992.

Summary

As we noted before, severe problems with the leadership and governance of health care seem not to be only due to specific deficiencies within health care, but may also be influenced by larger societal problems.  The leadership of many organizations seems to have been given over to self-serving opportunists with no fixed values or loyalties. David Halberstam described Henry Kissinger as a prototype of these "wildly ambitious agents of opportunity," also as:

the free agent—the professional political player who brilliantly manipulated the press, played both sides of issues, and put his own agenda ahead of all others.

We discussed examples of such free agents who cloaked themselves in the mantles of two formerly prestigious academic institutions, Columbia and Harvard Universities. Both universities have medical schools, teaching hospitals, and considerable influence within medicine and health care. So it seems likely that the free agency of faculty outside of medicine and health care could influence how things are done within medicine and health care. Furthermore, we have demonstrated that many free agents whose focus may not primarily be on health care and medicine may have wide-ranging activities including some that directly affect medicine and health care.

The pervasive nature of free agents, or agents of opportunity within academia, government, and the rest of society shows why it has been so hard to challenge the threats to core values created by conflicts of interest in medicine and health care. The conflicted already hold much of the power within the larger society in which medicine and health care operate. They are unlikely to favor restrictions on their brother and sister free agents within the medical and health care sector.

So our effort to address concentration and abuse of power in health care, and promote accountability, integrity, honesty, and ethics in health care leadership and governance must necessarily take into account these issues in society at large. The bad news is that the problems are much bigger than we first imagined. The good news is that we have potential allies facing similar problems throughout the world.

But it is now really clear that to truly reform health care, we must improve the accountability, integrity, honesty and ethics of not only health care leadership and governance, but of all organizational leadership and governance. That should keep us busy for a while.

"The 'Third Rail' that No One Wishes to Analyze" - Conflicts of Interest Affecting Health Care Foundations

On Health Care Renewal we discuss what we think are important issues affecting health care that seem to be rarely mentioned in the medical and health care literature and the "main-stream media."  In particular, we focus on problems in health care leadership and governance, how they threatened the core values of health care professionals, and how these threats contribute to rising costs, and declining access and quality. 

One of our preoccupations has been why these problems remain so anechoic.  A new article in PLoS Medicine [Stuckler D, Basu S, McKee M. Global health philanthropy and institutional relationships: how should conflicts of interest be addressed? PLoS Med 8(4): e1001020. doi:10.1371/journal.pmed.1001020.  Link here. ] seems to have uncovered another missing link to the anechoic effect. 

Private Foundations and Their Influence on Global Health

The article noted the importance of the influence of private foundations on global health:

While corporate involvement in and government aid for health has been extensively analyzed and critiqued in the public health literature, less attention has been paid to the impact of private donors on public health. Over the past decade, the bulk of new health aid designed to reach the Millennium Development Goals has come from individuals and corporations. The influence of this private philanthropy on global health is profound and transformative.

So,

Private foundations operate outside the typical boundaries of democracy; unlike government ministries, private foundations cannot be influenced in the same way by the communities affected by the foundations' actions. In the interests of public health, and particularly because poor communities affected by foundations do not automatically have a feedback mechanism to influence the decisions of private funders, we argue that it is appropriate to subject private foundations to the same scrutiny received by public institutions.

In this paper, we examine the scope of potential conflicts of interests that exist among the private foundations that are major funders of global health.

I would add that private foundations may have an outsize influence not only on global public health policy, but also on health care policy within particular countries, including the US.   This may arise because of the perception that they are more independent and nearer the cutting edge than are government and industry sources of funding. For example, here in the US, the Kellogg and Robert Wood Johnson Foundations have been widely perceived by health care, services and policy researchers as especially influential and respectable sources of funding, possibly partially because of the perception that they have less self-serving agendas than do government agencies and for-profit health care corporations.

The Possibility of Conflicts of Interest

The authors noted increasing concern about conflicts of interest affecting the activities of for-profit corporations involved in public health and health care:

because tensions can arise between the profit motives of corporations and the promotion of public health. Whereas corporations make products that can improve health (such as pharmaceuticals and vaccines) and relationships between public health institutions and for-profit corporations can be seen as positive opportunities for corporations to improve public health, corporations also make products that damage health (such as tobacco or unhealthy foods). And because some corporations have a vested interest in the activities of public health bodies, there have been documented attempts to influence the public health agenda by establishing associations with health care institutions

Thus the authors thought it also made sense to address conflicts of interest affecting private foundations operating in the global health space. They performed a case-study of the largest global health foundation, the Bill & Melinda Gates Foundation, while also briefly discussing four other large global health foundations, the Ford Foundation, W. K. Kellogg Foundation, Robert Wood Johnson Foundation, and Rockefeller Foundation.

Stock Holdings

The article noted that the Gates Foundation had substantial investments in food and pharmaceutical companies:

The Bill & Melinda Gates Foundation's corporate stock endowment is heavily invested in food and pharmaceutical companies, directly and indirectly .... The Foundation holds significant shares in McDonald's (9.4 million shares representing about 5% of the Gates' portfolio), and Coca-Cola (>15 million shares, over 7% of the Foundation's portfolio, not counting Berkshire Hathaway holdings). In 2009 the Bill & Melinda Gates Foundation sold extensive pharmaceutical holdings in Johnson & Johnson (2.5 million shares), Schering-Plough Corporation (14.9 million shares), Eli Lilly and Company (about 1 million shares), Merck & Co. (8.1 million shares), and Wyeth (3.7 million shares).

Also, the Foundation indirectly invests in food and pharmaceutical companies through its holdings of Berkshire Hathaway:

Berkshire Hathaway's largest investment is in Coca-Cola. It owns an additional 8.7% of Coca-Cola (Warren Buffett's firm is the largest shareholder in Coca-Cola, having stock worth >$10 billion dollars) and 6.3% of Kraft (Buffett is also the largest shareholder of Kraft). Berkshire Hathaway also has significant ownership in GlaxoSmithKline, Sanofi-Aventis, Johnson & Johnson, and Procter & Gamble, and is one of the main global investors in the latter two pharmaceutical companies.

The article also noted that the Ford, Rockefeller, Kellogg and Robert Wood Johnson Foundation had significant holdings in Coca-Cola, Kellogg, PepsiCo, Pfizer, GlaxoSmithKline, McDonalds, Nestle, NovoNordisk, YumBrands, Pizza Hut, KFC, Johnson & Johnson, and Sanofi-Aventis, and that the Ford Foundation held shares in a tobacco company, Lorillard, and the Kellogg and Rockefeller Foundations "were indirectly invested in tobacco corporations through conglomerate equity funds...."

This admittedly case-based data suggested that the major private foundations active in global health may have financial holdings that could possibly influence their actions in favor of the vested interests of food, pharmaceutical, and even tobacco companies.

Conflicts Affecting Foundation Leadership

The article noted that:

Several of the [Gates] Foundation's members of the management committee, leadership teams, affiliates, and major funders are currently or were previously members of the boards or executive branches of several major food and pharmaceutical companies ... including Coca-Cola, Merck, Novartis, General Mills, Kraft, and Unilever....

In addition,

Further overlaps between Bill & Melinda Gates Foundation leadership, other private foundations, and circular flows of personnel with food and pharmaceutical companies were observed .... Such patterns of interlinked board directorships, common among corporations and nonprofit organizations, were similarly found in the other private foundations studied.

Examples provided in an appendix were:

Anne Fudge, the chairman of the Gates Foundation’s US Program Advisory Panel is also on the board of directors of Rockefeller Foundation (in addition to General Electric, Novartis, Unilever, and Harvard University, among others).

Furthermore,

Members of personnel also move between the Foundation and pharmaceutical companies. For example, in April 2010, a former Merck senior vice president, Richard Henriques, became the chief financial officer of the Gates Foundation. At least two other members of the Gates Foundation leadership have transferred from the leadership of GlaxoSmithKline to sit on the Foundation’s board of directors, including Kate James, the chief communications officer, and Tachi Yamada, until February 2011, the head of the Foundation’s global health program. Similar patterns were observed with the other foundations studied.

Again, this admittedly case-based data suggested that the major private foundations active in global health may have leaders who have financial relationships that could possibly influence their actions in favor of the vested interests of food and pharmaceutical companies.

Program Initiatives Possibly Related to Conflicts

The article asserted:

The bulk of the Bill & Melinda Gates Foundation's financial transfers in global health have been to programs developing medical technologies....

In particular,

Overall, about 42% of all funding was spent on health care delivery or increasing access to drugs, vaccines, and medical commodities, while an additional one-third was allocated to technology development (mainly for vaccines and microbicides) or basic science research.

Specific programs were related to companies in which the the Gates Foundation or its leaders had financial interests:

The Foundation has established partnerships with the Coca-Cola Company, which, in the words of the Foundation, are intended to 'create new market opportunities for local farmers whose fruit will be used for Coca-Cola's locally-produced and sold fruit juices'.

Also,

many of the Foundation's pharmaceutical development grants may benefit leading pharmaceutical companies such as Merck and GlaxoSmithKline....

and

Johnson & Johnson has entered a clinical partnership to develop new HIV-prevention technology, noting 'the work between Johnson & Johnson and the Gates Foundation is a strong, strategic, comprehensive relationship'.

While there are many needs in global health, and many approaches to addressing these needs, this limited case-based data suggested that a strong focus of the Gates Foundation was on approaches that revolve around drugs, devices and biotechnology, again which would tend to favor the vested interests of the pharmaceutical companies which the Foundation holds in its investment portfolio and with which some of its leaders have or had financial relationships.

Discussion

While the data from this case-study were limited, they do suggest that major private foundations that support global health, and by extension, health care, services, and policy research may have institutional conflicts of interest, and their leaders may have personal conflicts of interest. It is possible that these conflicts have steered global health policy to favor vested interests, particularly towards approaches that depend on drugs and devices, perhaps instead of more effective ones using less technology.

Furthermore, it is possible that that these conflicts of interest have helped create the anechoic effect.  Conflicts of interest could have pushed the foundations in directions that favored specific vested interests, and away from others that may threaten such interests.  Many of the issues we discuss on Health Care Renewal may threaten such interests.  Private health foundations have been notably uninterested in addressing how problems in leadership and governance of health care organizations can threaten core values, They have been particularly uninterested in addressing specific tactics used when leadership is ill-informed, incompetent, self-interested, conflicted, or even corrupt, e.g., deceptive practices used to promote products and services, and promote policies favorable to vested interests, including, of course, deliberate creation of conflicts of interest (such as the cultivation of key opinion leaders).

In fact, a particular version of the anechoic effect surrounds the private foundations themselves, as described by Stuckler et al:

Although the philanthropic activities of wealthy individuals and corporations have attracted controversy in the past (Text S1), their charitable mission often means that they face less scrutiny than governments; critical analysis of foundations can be seen as 'biting the hand that feeds us.' As a result, within the global health community, private donors are sometimes viewed as the 'third rail' that no one wishes to analyze.

We have often commented on the pervasiveness of conflicts of interest in health care. Now we see them affecting even the most respected private health care foundations which were previously regarded as independent. The web of conflicts of interest may benefit those personally involved, but to the detriment of patients' and the public's health. Unfortunately, as the web has gotten more complex, it stifles awareness of the problem by the unconflicted, much less their ability to respond.

At a minimum, I urge that private health care foundations fully disclose their institutional conflicts of interest, and the conflicts of interest of their leaders. If they wish to maintain their previously sterling reputations, they ought to consider divesting themselves of financial holdings that generate institutional conflicts, and of leaders who have financial relationships that generate personal conflicts.

Hat tip: to Ed Silverman on the PharmaLot blog.