For Sale

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Commentaries
Physicians for Sale: How Medical Professional Organizations Exploit Their Members


Lawrence Grouse, MD, PhD

Medscape J Med. 2008;10(7):169. ©2008 Medscape
Posted 07/21/2008

Introduction
Scenario 1: You are a medical specialist -- say a pulmonologist -- walking to the intensive care unit to see one of your patients, and you pass a roomful of your colleagues in the hospital auditorium crowding around tables piled with food and drink. Outside in the hall you see a sign on a stand that says, "MEGA Pharma welcomes the attending staff to a Pizza and Pasta Lunch brought to you by GALE FORCE, the new fixed-combination medication for asthma and COPD!" An attractive young woman stands in front of you, asks you to join the luncheon, and hands you a flyer with the program for the talk that will be given.

"Free CME," it says. The other pulmonologist at the hospital is giving a talk that is based on a study in which he had been an investigator. The talk is "The Use of a New, Improved Fixed-Combination Medication as First-Line Therapy for COPD."

Scenario 2: You are attending the annual lung society convention in San Francisco, California, and the conventioneers are walking around with convention bags, pens, programs, inhalers, packages, and even neckties emblazoned with pharmaceutical product names and logos. You notice that these same names and logos are on the placards and signs in rooms and hallways, in the programs, and even on the convention buses.

Prior to the convention, you received letters and postcards for the nightly gala dinners and CME symposia sponsored by pharmaceutical companies with the best-known pulmonology experts as speakers. You notice that there are 3 speakers at each symposium; two of the speakers are giving interesting scientific talks, and one is giving the talk "The Use of a New, Improved Fixed-Combination Medication as First-Line Therapy for COPD." The lung society is providing CME accreditation. You find that many of your clinical colleagues from other countries have been given "grants" from pharmaceutical and other commercial medical and device companies (referred to in this essay as Pharma) to attend the meeting as "consultants."

Scenario 3: A Pharma representative buttonholes you as you enter your office and hands you a free copy of the latest single-sponsored practice guideline from the lung society, and with it an ad slick for GALE FORCE along with free drug samples, peak flow meters, and pens with the GALE FORCE colors and logo. She hands you 3 published, state-of-the-art, randomized controlled trials from the lung society journal written by the top experts in the field and funded by the makers of GALE FORCE that explicitly state the point of view that GALE FORCE is a better choice than the 3 drugs that you currently prescribe.

When I find myself in such ethically questionable situations as those portrayed above, it is natural to wonder what led to their occurrence. A common response to the problems with the US healthcare system is to blame Pharma and their excessive marketing zeal. Several authors have written their perspectives about the events and policies that have crippled US medicine during the past several decades.[1-8] They discuss cutthroat competition within medical coverage providers, the ascension of medicine as a business, predatory marketing practices by Pharma, and the effects of inhumane government policies in damaging US healthcare. Their descriptions of the effects of "corporate medicine" and the inappropriate commercialization of medical practice provide a chilling perspective on some of the problems.

However, except for Dr. Kassirer's article,[9] these works have not emphasized the damaging role of medical professional organizations (MPOs) and their leaders on US healthcare. I believe that it is in large part the dependence of these organizations on Pharma funding that has led them to compromise their professional ethics. Although this influence is also exercised by medical device, biotech, publishing, and diagnostics companies, for simplicity I will include all of these medical commercial organizations in aggregate as "Pharma" because they act in similar ways on MPOs, and the giant multinational pharmaceutical companies wield the greatest influence.

Pharma operates in the realm of business and in accordance with national laws. They are conducting legal businesses regulated by business ethics, whereas physicians and their MPOs are bound by medical ethics. When physicians violate these principles of medical ethics, they lose their professional identity and authority. Although I do not wish to ignore the positive medical and scientific activities of MPOs, in this commentary I lay much of the blame for unduly expensive and inappropriate medical care in the United States at the doors of MPOs. As the above scenarios imply, practicing physicians are constantly bombarded by MPO-abetted promotion from Pharma.

This thesis concerns only those MPOs in which inappropriate Pharma influence can be documented or inferred. In my experience, these tend to be the MPOs that serve the higher-income specialty organizations and are active in governmental lobbying. Their members are prescribers of specific pharmaceutical products relevant to the Pharma that support them. Some MPOs in the United States are not very dependent on Pharma support. Most are, as judged by the listings of the categories of their revenue. I suggest that the largely hidden relationship between MPOs and Pharma enhances the ability of MPOs to promote their specialties' services inappropriately, and it fosters the excessive prescription of expensive, highly-promoted medications. These results would be important factors in the spiraling costs of US healthcare.



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Reader Comments on: Physicians for Sale: How Medical Professional Organizations Exploit Their Members
See reader comments on this article and provide your own.

Readers are encouraged to respond to the author at lgrouse@u.washington.edu or to George Lundberg, MD, Editor in Chief of The Medscape Journal of Medicine, for the editor's eyes only or for possible publication as an actual Letter in the Medscape Journal via email: glundberg@medscape.net

Who and What Are for Sale?

The MPOs that have become so dependent on Pharma funding that these funders exert control over MPO policies and cause them to violate precepts of medical ethics;
The MPOs that are fundamentally trade organizations and use their resources to inappropriately increase their specialties' financial status with little regard for the welfare of patients or the public health;
The MPOs (and their foundations) that receive advertising, grants, convention and meeting support, project support, payments in kind for MPO support, and other tangible benefits from Pharma in which the funding from Pharma represents a substantial percentage of their earnings;
The MPOs whose actions violate medical ethics to benefit their Pharma funders and their own members;
The MPO leaders to whom I refer as key opinion leaders (KOLs) who control the policies of their MPOs for their own benefit and the benefit of their Pharma funders;
The KOLs who profit from projects, prestige, honoraria, and connections with Pharma, and reap perquisites, prestige, and influence from the MPOs;
KOLs whose yearly total of Pharma funding represents a substantial percentage of their earnings as practicing physicians or physician educators; and
All physicians whose actions violate medical ethics to benefit their Pharma funders and to generate payments for themselves.



MPOs in the United States
The most relevant history of the dealings of MPOs with Pharma in the United States began in 1905 when the American Medical Association (AMA) urged physicians not to prescribe drugs that were advertised directly to consumers by Pharma, which in those days took the form of smaller patent medicine-formulating companies. Preventing these communications by Pharma put power in the hands of the AMA. The AMA established a Council on Pharmacy and Chemistry that played a similar role to that of the US Food and Drug Administration (FDA) today with respect to drugs. The AMA Council would not approve any drug that was directly advertised to the public. This regulatory authority enabled the AMA to stand between Pharma and their customers.

Revenues for AMA journal advertisements rapidly became the principal source of funds for the Association. The relationship of AMA and Pharma paved the way for the current economic structure of medical professional organizations in the United States.[10] What has changed in recent times is that with the rise of specialty MPOs and the collapse of power of the AMA, the control of professional communication to patients in the United States is predominantly wielded by the specialty MPOs rather than the AMA. The MPOs have simply replicated the initial AMA strategy.

What Do MPOs Do?
Most MPOs in the United States have followed the pattern of the AMA in that they operate as trade organizations, advocating for the financial benefit of the organization and its members. The MPOs' major roles, which they do not emphasize publicly, appear to be fund-raising, lobbying for their specialty, and applying political influence on healthcare payers and providers. Although they publicly emphasize their role in postgraduate education and publishing, I believe that these activities are undertaken in large part to generate funds from Pharma.

Who Are the Specialists, and How Many of Them Are in the United States?
Prior to 1950, about 75% of physicians in the United States were general practitioners (GPs) and did not consider themselves to be specialists; that is, they took a year of internship after medical school and then began to practice general medicine.

In contrast, today almost all physicians in the United States consider themselves specialists, even those in primary care practices. Only about 13% of US physicians are GPs or family doctors.[2,11] Today, after their medical school graduation, almost all physicians take a residency training program in a specialty and sometimes further fellowship training for subspecialty education.

There are approximately 850,000 physicians in the United States; there are about 550,000 physicians who practice what used to be considered specialist care. Most of the rest, such as family physicians, pediatricians, and general internists, practice primary care and are generalists, but many consider themselves specialists as well to help market their practices.

There are very few GPs in the United States; they were driven out of business by specialists in the 1960s, and to defend their practices they restructured themselves as specialists in family practice. These family physicians now have a 3-year residency and consider themselves specialists, as do many pediatricians and general internists. Thus they are specialists in general medicine, a somewhat paradoxical designation. It would be economic suicide not to be a specialist in the United States. Medicine in the United States is an entrepreneurial activity and not a part of an organized healthcare system, and without a specialty a physician cannot easily participate in the marketing and marketplace of medicine.

Although specialty certification is usually awarded by specialty medical boards that are separate from the MPOs, most physicians join the MPO for their practice specialty. These MPOs become the focus of their postgraduate education and their advocates on behalf of the specialty. They become the key groups to provide professional identity for each specialty.

One of the most lucrative powers that the US MPOs have achieved for their members is the ability of patients in the United States to consult directly with a specialist rather than going through a primary care "gatekeeper." Most countries strictly limit access to expensive specialist care, and they limit the number of specialists that are allowed to be trained and practice. The privileged position of specialists in the United States greatly increases their revenue, and it increases the number of physicians who become specialists and subspecialists. It also dramatically increases healthcare costs.[10] This situation has led to confusion about the differences described above between primary care, generalist care, and specialty care in the United States.

It is apparent that the terms generalist and specialist are not used in a consistent way in the United States. However, for the purposes of this essay, it is not important what these groups call themselves; what is of interest is how their MPOs interact with Pharma and influence US healthcare costs. Although my focus in this commentary is on the United States, I point out similarities in the relationship of Pharma with MPOs internationally.

How Much Money Do MPOs Receive From Pharma?
In the entrepreneurial US healthcare marketplace, the MPOs' power derives from their symbiotic relationship with Pharma. Without Pharma funding, the MPOs would be unable to support their advocacy and institutional costs. With Pharma funding they can influence the healthcare system and their own members, and establish a favored financial reimbursement status, but in the bargain I believe that they also become the tools of Pharma. It is my contention that with the power of the purse, Pharma exerts subtle control on the communications of the MPOs and the practice of their specialists.

Pharma control limits consideration of practice approaches apart from expensive drug therapy. Pharma control of the KOLs of the specialty further increases its influence on MPOs. This control minimizes the use of prevention and public health measures in medical practice, except for those that rely on pharmaceuticals. I elaborate on my reasons for believing this.

Pharma provides an enormous amount of funding for MPOs, and as a result they have considerable input into the policy and educational programs of these organizations. A large percentage of Pharma marketing budgets is specifically allocated for MPOs whose members are the prescribers of their products. It is understandable that they would advertise to their likely customers, but it is significant that they do not target all of their advertising to the physicians directly. MPOs have considerable control of Pharma communications to their members, just as the AMA had more than 100 years ago. Pharma must support the MPOs to influence their members.

If you review the financial statements that are publicly available from the AMA and other MPOs, you will find that the reporting of revenue is particularly vague. When you calculate the amount derived from membership fees, you will find that it usually only accounts for about 15% to 25% of the MPO's revenues. Much larger are the revenues from journal advertising, the national conventions, grants for educational projects, and grants to the associations' foundations, which theoretically are independent, nonprofit charitable organizations. All too often, the only charity that is benefited is the specialty itself.

Specific sources of these revenues are not revealed by the MPOs, nor are they supplied when requested, but in informal discussions during meetings with leaders of MPOs, you will learn that Pharma is the real source of most of the MPOs' revenue. The same conclusion can be reached by an analysis of the major categories of revenue and the likely funders of these activities. Some MPOs, such as those of public health physicians, do not receive much Pharma revenue because few of their members are high prescribers of drugs.

In the spirit of disclosure, and to cite the experience on which my current thinking is based, please note that I have worked closely with the executive directors, directors of education, and scientific directors of many MPOs both in the United States and internationally for more than 30 years. During that time, I did fundraising for US National Heart, Lung, and Blood Institute (NHLBI) projects with US Pharma companies and did fundraising with international Pharma companies for nonprofit organizations founded by the NHLBI and the World Health Organization (WHO). The perspectives expressed here concerning the relationship of MPOs and Pharma both in the United States and globally came from these activities.

It became clear to me that the MPO leaders' major day-to-day efforts were related to their contacts, projects, meetings, and fundraising with Pharma, and to politics relating to finance; they spent very little time on member activities. I had learned over the years that when I attended medical conventions of MPOs, if I sat in the entry area of the main convention hotel, I would soon see key people at the meeting from the MPO and from Pharma come through the door separately and leave together. As I attended conventions of our collaborating organizations and watched in the hotel lobbies, I observed the parade of meetings between delegations of the MPOs' top leaders with marketers and decision makers of the Pharma companies that marketed their drugs to the specialty.

The practicing physician members of the MPO were off in the convention centers attending scientific lectures that would expand the medicines, procedures, and costs of their practices and wandering through the exhibit halls collecting free presents and drug promotion at the Pharma booths, whereas the specialty society leaders were meeting in plush Pharma hospitality suites to trade the loyalty of their members for Pharma money.

Because MPOs conceal the sources of their funding, in many cases I can only use the information, behavior, and activities of MPOs that can be publicly inspected to assess their dependence on Pharma. On the basis of my personal observations of MPO activities and policies as well as information gathered from many of the major US MPOs, most of those I have studied appear to receive the majority of their funds from Pharma.

Follow the Money
Using the established journalistic procedure of following the money that MPOs receive, we can learn about the dependency and control that run through the Pharma/MPO relationship. As I mentioned, MPOs do not provide any detailed public financial statements that document the specifics of Pharma support, nor can I obtain them upon request. Even the filings for the Internal Revenue Service (IRS) that can be obtained publicly only contain general descriptions of revenue sources, and even members of the specialty organizations are given the runaround if they inquire about such specifics. They are told that such information is confidential.

As an example, a typical subspecialty MPO of about 13,500 members might report yearly revenue of about $18 million.[12] Let's take a look at how the lion's share of that funding travels from Pharma to the MPO.

The annual meeting of such an MPO would be its biggest funding source at about $8.5 million, and judging from the extensive commercial presence, the vast majority of that revenue would come from Pharma. Meeting registration and educational session fees would account for about $0.8 million, but of the approximately 14,000 people who would attend the MPO's annual meeting, only about 6000 would be practicing specialists. The rest would be Pharma industry attendees and their vendors, so most of this registration revenue would also be from industry. In addition, Pharma might pay about $2 million in "nonconference" grants for after-hours activities at the annual conference.

An undisclosed way of funneling Pharma money to MPOs in Europe and Asia is the common practice of Pharma paying for specialists to attend their MPO's annual meeting. A pharmaceutical company pays the physicians who, in turn, pay the MPO meeting registration and expenses. A leading physician marketer from an international company recently told me he estimates that 80% of the attendees are funded in some way by Pharma at many MPO meetings. In the United States, Pharma no longer pays physicians to attend CME conferences; however, it is unknown how many physicians from outside the United States are paid to attend, and the percentage of non-US attendees at medical conferences has grown greatly over the past 2 decades.

Other ways that Pharma funds MPOs include nondisclosed grants-in-aid, project grants, funding for educational programs, directed donations to the specialty organization's foundation, and payments in kind, such as convention and professional services and payments to physician attendees and consultants.

Most MPOs publish 1 or more journals. Pharma ads in the organization's journals might account for about $2 million a year in a typical MPO, and many also receive about $0.5 million in royalty payments from commercial sources, usually Pharma.

The revenue from membership fees for this typical MPO would only be about $2.5 million. We can see from the estimates above that about $12-$14 million of the $18 million of such a typical MPO's revenue could come from Pharma. Although these payments to the MPOs are essential for their survival, they are small change for Pharma budgets. Most big international Pharma have revenues of $4-$8 billion, of which about half comes from the United States.

So a typical specialty MPO could receive $14 million a year from Pharma out of a total of $18 million total revenue: almost 80% of the revenue, not an insignificant contribution. This level of Pharma revenue would qualify an MPO as a "physicians for sale" organization. In practical terms, Pharma is their exclusive customer. Do you think Pharma wants anything in return? In colonial times Benjamin Franklin wrote, "Never make your physician your heir!" A contemporary Franklin might write, "Never let Pharma finance your physician!" A consequence of this massive conflict of interest that involves physicians and MPOs, leading to their dependency on Pharma funding, will be the destruction of the credibility of the medical profession.

Although specialty societies appropriate the largest share of Pharma funding, the AMA is also in the market for Pharma funding. Even though their membership has fallen to a small percentage of US physicians, the AMA still has annual revenues of about $280 million a year. According to Dr. George Lundberg, "the AMA has too much money and too little purpose.[13]"

To bolster its finances, the AMA has pioneered a new source of Pharma revenue. A review of the AMA's financial statement shows that the AMA's new funding source is licensing its AMA Physician Masterfile, which contains information about virtually all US physicians, to Pharma. This revenue is even larger than the revenue from Pharma ads in their journals that historically have been its major revenue source.

With today's new information technology, the AMA Masterfile is very valuable. Medical information services, such as Integrated Medical Services (IMS) (operating revenue in 1995, $1.75 billion[13]), which track the prescriptions written in the United States and in most other countries worldwide, are able to match physician data and demographics with prescriptions tracked to individual regions and drug stores. In many cases their data can provide Pharma representatives with information about what drugs are and are not prescribed by individual physicians throughout the United States. These data allow drug detail representatives to provide negative information about competitors to specific physicians to promote their own products, knowing exactly what these physicians currently prescribe, and it allows them to punish and reward physicians for their prescribing decisions. More than a dozen states are considering laws to shield physicians' prescription pads from Pharma.[14]

This exploitation by MPOs of their members is really just a variation of the AMA's initial policy in 1905 concerning Pharma communications with their members. However, rather than having the MPO be a conduit of authorized information from Pharma, the current program of selling physician contact information appears to have aspects of a conspiracy of MPOs with Pharma to allow them to unwittingly influence physicians -- including their own members. There are suggestions that other MPOs are now imitating AMA's creative funding program by selling their members' and former members' personal information to Pharma so that they can be more effectively detailed. Physicians in all specialties should be asking their MPOs whether they are selling their members' information.

Consequences of Pharma Influence on MPOs
One has only to attend an MPO's convention or read an MPO's journal to see the powerful impact of Pharma funding. The MPOs endorse Pharma educational products; they put their society logos on communications alongside Pharma logos; and they place banners and signs thanking Pharma for matters large and small throughout their convention halls and journals. They encourage their members to visit the exhibit area where Pharma promotes commercial products. Exhibit areas are better than an amusement park: They have high-tech, luxurious booths with films, magicians, and game shows as well as free food, drink, and presents for the physicians and florid promotions of the drugs.

MPOs cover Pharma products and initiatives in their publications, publish Pharma drug studies in their journals, and recommend Pharma products in their practice guidelines. Coverage of public health issues and alternative approaches to healthcare is rarely seen.

The need to serve Pharma is an important source of the antipathy of practicing clinicians toward physicians working in public health, and toward other healthcare professionals -- such as chiropractors, acupuncturists, and other alternative healthcare givers. For example, while scanning a program for the American College of Cardiology's annual scientific session,[15] I found a prominent listing of more than 350 Pharma and other medical companies that would be exhibiting at the convention. In the list of more than 250 scientific sessions that are enumerated, there were:


No sessions whose title indicates any coverage of public health issues of cardiology;
No session that appeared to cover other healthcare professionals or alternative healthcare givers' role in cardiology;
No sessions on cost issues or socioeconomic or epidemiologic issues in delivering cardiology care;
No sessions on lack of access or minority issues in cardiology care; and
Only 2 sessions on prevention of cardiovascular disease.



Because most cardiovascular disease in the United States is the result of preventable problems (poor diet, lack of exercise, lack of screening for and treatment of risk factors) that may be best addressed using public health approaches on a population basis, isn't it surprising that these topics receive such limited coverage at a cardiology convention?

It goes without saying that most of the talks listed in the program are about the use of pills, devices, and procedures to diagnose and treat heart disease. It is almost as if the MPO was employed by Pharma to encourage physicians to prescribe pills, devices, and procedures. Preventing illness, providing fair and universal care, and caring about the patient do not appear in the program. It is difficult to identify the commitment of the major MPOs to US public health except for lip service and public relations efforts. It seems to me that most of them follow the long tradition of the AMA in securing the welfare of their members and lining their own pockets.

Pharma Control of Postgraduate Education
Pharma, through its funding, has assumed extensive control of postgraduate physician medical education (aka continuing medical education [CME]) in the United States. It would be of interest to see whether the education that they provide results in improved and appropriate patient management. Recent data indicate that appropriate treatment for patients is given in only 50% of physician visits. In fact, longer clinical experience, and hence more postgraduate education, are correlated with inferior quality of care.[16] By this measure the value of current forms of postgraduate education must be questioned.

At many MPO conventions and in many CME activities put on by medical education companies hired by Pharma, the programs include promotional material about the sponsor's products. In the United States more than 30,000 people are employed in the Pharma-funded CME industry.[17] Until recently, they were reputedly crafting drug promotion disguised as education that focused on the advantages of the sponsor's product and minimizing discussion of dangerous side effects.[18] The US Senate Committee on Finance recently wrote to the organization -- Accreditation Council for Continuing Medical Education (ACCME) -- that supervises US postgraduate education to express its concern about the conflict of interest when Pharma spends more than $1 billion a year for education about topics that highlight the use of their products. Who pays the piper calls the tune, they imply. ACCME replied that their policies and procedures for developing educational materials are sufficient for ensuring their objectivity. However, the Senate Committee pointed out that although ACCME surveyors review accredited organizations' procedures for ensuring the independence of certified CME, they do not analyze the actual content that is presented.[19]

I've observed hundreds of CME-certified presentations sponsored by Pharma during my professional career, and in those content areas that I knew well enough to judge, it was clear to me that in the vast majority of instances, a bias was introduced in the communications in favor of the product produced by the sponsor of the CME. In some cases it was not so much that the information presented was false, but that the fair balance and clinical perspective that should have been present were predictably distorted by the proprietary interest. ACCME has recently introduced new procedures designed to eliminate some of the conflict of interest that has occurred in many CME activities. It may improve the education that is provided if it is implemented. However, if there is no mechanism to analyze the resulting content of the medical education activities, the Pharma-funded medical educators who actually conduct the activities have many opportunities to introduce undetected Pharma promotion.

Because of the increasing visibility of these problems with Pharma-funded medical education, the US Institute of Medicine and the Association of American Medical Colleges (AAMC) are conducting inquiries into conflicts of interest in medical education. Because of the increased vigilance of regulatory agencies, such as the FDA and the US Department of Health & Human Services (HHS), millions of dollars in fines and penalties have already been imposed on Pharma, and many of the most egregious activities have now been stopped. In Europe, laws enacted in France and Italy are similarly limiting Pharma promotion in medical education.

Acquiring the KOLs
The close relationship of Pharma with the MPO leads to close relationships with the MPO's leaders. These physician leaders are very important to Pharma, and they are recruited as lecturers on the Pharma speakers' bureaus, investigators for their clinical trials, consultants on their advisory boards, and experts for their medical education symposia. These leaders are referred to by Pharma as KOLs -- key opinion leaders -- and I have used this term as well. It is important for Pharma that the cooperation of KOLs is acquired. Their activities with Pharma provide the MPO leaders with substantial revenue and prestige. These activities provide Pharma with access to the decisions of the MPO. Some of these physician leaders, who are generally academics, are soon making more money from Pharma than from their academic day jobs and easily qualify as "physicians for sale." The lucrative Pharma advisory groups, lectures, research grants, symposia, and other payoffs for the MPO's physician officers encourage their cooperation. They begin to work for Pharma, perhaps without realizing it. Full disclosures of such payments to KOLs are rare.

This issue of Pharma influence on the KOLs goes well beyond revealing that these leaders may receive a lot of money from companies for their services and advocacy. The KOLs, through their leadership positions, also participate in the control of the MPOs and their pro-Pharma policies. The MPOs may have the appearance of being democratic, but in most instances the membership is simply given a choice of electing various KOLs who have already been acquired by Pharma to be their representatives. The membership gets little meaningful information about the beliefs, activities, or conflicts of interest of the candidates. For most MPOs the succession of presidents of the organization is decided years in advance. The decisions of the MPOs are made by small executive boards; they are made in secret; there is no free medical press to critique or question their decisions. The MPO house organs trumpet the wise decisions of the board and their benefits to membership. The ethical problems with the activities of the organization are not often discussed. MPO management usually lacks the quality of transparency that is a keystone of good governance.

As a result of the conflicts of interest on the part of the MPOs and their leaders, there have been increasingly vigorous demands by government and by critics of MPOs for disclaimers of payments they receive from proprietary interests. However, the usual disclaimers filed by KOLs, even those disclaimers required by the WHO, provide little information. They simply note the companies that have provided payments and not the specific amounts or services provided. A typical specialist leader will have payments from 5-10 Pharma companies in a given year, with no way for the public to know if they received $5 or $50,000. In addition, very little is known about the nature of the arrangements that led to the payments. Further, because MPOs refuse to provide information about their revenue sources, it is even more difficult to identify specific conflicts of interest.

Pharma involves KOLs in leading clinical trials of medications that are required for FDA approval, and they provide premiere showcasing of the KOLs' educational skills before their peers in symposia organized by Pharma. As a result, the KOLs become recognized as experts if they were not already so recognized. They become the peer reviewers of important articles in their specialty in the peer-reviewed medical literature in which their Pharma-created biases can prevent publication of results or ideas that are opposed to their proprietary interests.

Equally destructive is the fact the KOLs are chosen to be consultants to governments. They serve on FDA and European Medicines Agency (EMEA) advisory panels to give advice on which drugs should be licensed and which rejected. They serve on National Institutes of Health (NIH) advisory panels to review grant applications. With this power, the KOLs can influence the entire direction of new research -- competing ideas, directions, and the products that will or will not be used. These obvious conflicts of interest are finally beginning to be discovered. Experts are now often required to file disclosures about payments that they receive that could represent conflicts of interest. However, in most instances, these experts' opinions are still accepted regardless of their conflicts of interest. They should not be.

Implications of KOL Acquisition for Peer Review
The pervasive funding system that Pharma has established for the KOLs, and which is now coming into wider view, has other important implications for the peer review system that is at the heart of the NIH basic and clinical research enterprise as well as the medical literature. The thesis has always been that science is self-correcting; if an unethical researcher fakes data then there would be other, more ethical researchers who would do the experiment correctly and right the wrong. However, what if the key researchers in a particular area are on the payroll of the companies that have a vested interest in a certain result? What if the companies designed the studies to get the result they wanted and only the studies funded by the companies and managed by their KOLs would ever be conducted? What if the experts who do the peer review of the studies for the medical journals are KOLs for the companies that funded the studies? Why does it seem to happen so often that all of the published studies funded by company A show that the products of company A are better than those of company B, whereas those of company B show the reverse? I believe that the peer review system, before which US scientists genuflect, often fails.

The interpretation of medical research is by no means straightforward and uncontroversial. Different groups of respected scientists study the same question and get diametrically opposed results all of the time. Study exclusion criteria and other technical features of studies can affect their general applicability. Studies of a therapy that are conducted in clinical research facilities staffed with experienced investigators and staff may not give the same results as those seen in a busy primary care setting. Also, if the arbiters of these studies -- the expert peer reviewers -- have conflicts of interest in judging the results, how can we be sure what to believe? The situation can easily develop in which large randomized controlled trials can show significant benefits of drug therapy, whereas the use of the drug in actual clinical practice will introduce large costs but no benefit for patients. Improvement that results from therapy in surrogate clinical variables, such as glycemic control, may not result in improvements in mortality or public health benefit (as data concerning rosiglitazone have suggested[22]).

Do MPOs Benefit the Public Health?
As I saw the effectiveness of global public health approaches to deal with major diseases in work that I did with WHO and NHLBI, and then when I compared them with the US medical model, which involves providers treating individual patients, I often wondered whether the MPOs that advocated the use of the medical model involving expensive and high-tech care were improving public health or whether they were diverting resources from population-based approaches and simply enriching their organizations and member physicians at the expense of public health.

This comparison illustrates a fundamental question about MPOs: Do they serve the public interest or serve to increase elitism in medicine? They promote the training of more physicians of their own specialty; they lobby for monopoly rights to perform expensive procedures; and they demand more and higher payments for their services. These efforts drive up healthcare costs, and ultimately they limit access to care. Certainly high-tech medical care can be lifesaving, but the data that many specialty services in the United States are provided at a rate that is more than twice that in other developed countries -- without any evidence that it improves US public health -- cause concern about the overuse of specialist care in the United States.[8,20]

It seems that MPOs view their members as individual entrepreneurs in a capitalist model, focused mainly on their own profitability. Medical professional issues are infrequently discussed. The MPOs seldom take positions on national health policy, only on policies relating to their reimbursement. It sometimes appears that they are not interested in the public's health, only their own economic health. When MPOs do not act in support of ensuring fair and appropriate care, they are in violation of the most fundamental principles of medical ethics.

The dependence of US MPOs on Pharma revenue represents a conflict of interest in MPOs' role in defining the practice of medicine, and this is not a medically or ethically responsible position for them. What other group of professionals is so dependent on the vendors that solicit their favor? Lawyers have detailed rules about conflicts of interest in their practices. Why do many MPOs try to pretend that their conflicts of interest are unimportant?

Adding It All Up
The control that Pharma has established over the MPOs and their members is exerted through many mechanisms. The first is by making MPOs dependent on Pharma revenue. The second is through Pharma supervision of postgraduate education. A third results from Pharma use of physician advertising, public relations, and communications. The fourth mechanism involves the Pharma representatives, known as the detail force or sales reps. Then there are the Pharma lobbyists in Washington, DC, and the Pharma direct-to-consumer (DTC) commercials that mold the thinking of the public.

Because marketing expenses are usually intermixed with other Pharma expenses, such as research and development, it is difficult to identify specific Pharma budget lines to quantify what they pay to influence physicians in the United States. Reports have suggested that the actual amount is about $20 billion per year.[21] Nearly 95% of US physicians receive gifts from Pharma sales representatives.[22] If these funds went instead to provide more healthcare, they could substantially benefit public health.

The United States currently spends more than 15% of its gross domestic product (GDP) on healthcare. Estimates are that this will increase to 20% within the next few years. Most other developed countries spend from 5% to 10% of their GDP on healthcare. A major part of the increased cost in the United States relates to increases resulting from expensive diagnostic and therapeutic procedures and increased specialist physician costs in the United States.

Why is it then that when we look at various measures of health in the United States we find that they show that the health of the US population is worse than these other countries that pay on a GDP basis one third of what we pay for healthcare? Clearly, the extra amount that we pay does not yield incremental benefits to US health.

A conclusion that must be considered is that with the free market approach to healthcare financing and delivery in the United States, Americans must pay 3 times as much as the citizens of many other developed countries so that healthcare businesses can make high profits, even if they deliver worse healthcare. In the harsh US medical marketplace that the MPOs, the insurance companies, the hospitals, Pharma, and the government have established, we pay much more and are worse off.

How to Regain Our Profession
Dr. Marcia Angell, former editor of The New England Journal of Medicine, has a simple solution to MPO hypocrisy and conflicts of interest. She believes that MPOs should be self-supporting.[6] They should not take money from proprietary interests that can corrupt their policies and actions. I agree with Dr. Angell's position. I believe that it is important that physicians and the public assess and eliminate the conflicts of interest of MPOs and their leaders. Because of the issues related to "physicians for sale" providing input into government recommendations for practice and drug approval, I suggest that such official recommendations be developed by independent international experts without such conflicts of interest and that "physicians for sale" be excluded from these health policy decisions.

Physicians should fight for additional steps to be taken that could improve healthcare and lead to ethical self-sufficiency of MPOs:

MPOs should not accept funding from Pharma and other groups whose payments create a conflict of interest for them.
If such payments are made to MPOs (and KOLs, the leaders of MPOs) from proprietary groups whose payments may create a conflict of interest, they should be publicly revealed, including the precise amounts and conditions of such payments.
MPOs and KOLs with conflicts of interest should not be allowed to offer judgments about medical or scientific matters in governmental or scholarly regulatory groups that may affect the sources of the conflicts of interest.
Postgraduate CME should not be funded by Pharma or other groups whose payments may create a conflict of interest. Physicians should take responsibility for funding their own CME.
Physicians should refrain from accepting all gifts and services for themselves from Pharma.
Physicians and MPOs should put considerations of their patients' welfare and the public health above those that relate to their own income, and they should be able to demonstrate how they have sought to accomplish this goal.
Patients deserve their own personal physician who can act as counselor and advocate for their health needs. Insurance payments for specialist care should be limited to those specialist referrals made by the patient's primary care physician.



The antidote to overcommercialized specialty care is good primary care. I urge consideration of efforts by the WHO and the World Organization of Family Doctors, such as the "15 by 2015" initiative (http://www.globalfamilydoctor.com/index.asp?PageID=7802&ContType=15By2015), to strengthen the primary healthcare system worldwide.

Physician members of US MPOs should formally demand that their organizations demonstrate transparency concerning their funding and relationships with proprietary interests as well as complete disclosure of conflicts of interest among all of their leaders. They should demand that practice guidelines and recommendations of their MPOs be developed and reviewed by independent public health experts to ensure that they are consistent with the overall public health. They need to demand that MPOs implement programs that will seek to provide proper healthcare to all US residents. Physicians should seek to implement the points listed above and to resign from organizations that oppose these actions; they should support organizations that take action to implement MPO reform.

There is a bigger task that all US physicians need to undertake if they are to improve the state of US healthcare: They need to rethink what their profession is and identify what they need to do to regain their professional integrity. They must separate this professional identity from the procedures that they do and the economic rewards that they receive as a result. The professional identity and its medical ethical precepts should define what the physician does.

American medicine today, in my opinion, has been made a slave of economics. It is controlled by economic managers who regard medicine simply as a business and who ignore human needs and responsibilities. Medicine is too greatly influenced by insurance companies, Pharma, and MPOs that constrain the concept of healthcare along commercial lines and ignore human factors. They ignore physicians' responsibilities. We need to return to the traditional road that is patient-centered, where free care is freely given to the needy, where expensive and invasive procedures are avoided unless they are clearly cost-effective and substantially benefit the patient, where physician reimbursement is fair but not exorbitant or opportunistic, and where ethical precepts trump the profit margin. I believe that the control of insurance companies, Pharma, and MPOs over medical practice must be limited. A greater degree of oversight by government is needed to defend the public health. All of these parties need to focus on standards of public health that must be achieved.

In my opinion, a proper balance of medical care should be established in the United States with an eye to the need for both universal care and cost containment. This may require substantial changes in the organization and reimbursement of care. Financial conflicts of interest by physicians should be minimized. There should be a concern for improving US public health that leads to action focused on this goal. Patient needs and not the financial needs of medical practitioners and organizations should be the regulating force in the practice of medicine in the United States. There needs to be a return to the physician's role as a humane counselor and health advocate for their patients. Healthcare services that do not benefit public health should not be funded.

The health systems of other developed countries have not been damaged as much by the power of insurance companies, Pharma and the MPOs as the US healthcare system because their governments have not permitted the abuses of pricing that occur in the free market US economy. These countries are already addressing the permissible relationship between Pharma and physicians.

I believe that conflicts of interest in US medicine are just a subset of conflicts of interest throughout US culture. Politicians cannot be elected without taking money from special interests that obligate them to support policies that reward the special interests but destroy US interests. Developers bribe politicians so that they can grow wealthy by despoiling the land and environment. MPOs seek money and influence from Pharma and politicians to promote the wealth of their specialty while damaging the country's public health. Such conflicts of interest must be prevented, or at least ameliorated, if the United States is to survive in its current form.

This essay has focused on the abuses of the US MPOs, their damaging emphasis on increasing the financial welfare of their specialties without regard to public health, and their collaboration with proprietary interests to accomplish this goal. Journalists have also revealed abuses among US specialist practitioners who increase their revenue with expensive therapies and procedures that do not benefit their patients.[8] Although these examples are true, I believe that the driving forces of such inappropriate medical specialty practice are the MPOs that make financial conflicts of interest and overzealous application of expensive and unproven technologies the standard of care.

This is a time of upheaval in both the US healthcare system and the relationship of Pharma and physicians. The destructive system that I have described in this commentary is starting to collapse. The Massachusetts State Senate has voted to ban all gifts to physicians from Pharma. The AAMC has taken the position that medical schools and teaching hospitals should ban gifts to physicians, faculty, staff, students, and trainees. I urge my colleagues to become personally involved in these issues so that we can regain our profession. We can start by remembering the words that many of us spoke from the Oath of Maimonides when we graduated:


Thy eternal providence has appointed me to watch over the life and health of my fellow human beings. May the love for my art actuate me at all times; may neither avarice nor miserliness, nor thirst for glory, or for great reputation engage my mind; for the enemies of truth and philanthropy could easily deceive me and make me forgetful of my lofty aim of doing good to my patients.

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Wolinsky H, Brune T. The Serpent on the Staff: The Unhealthy Politics of the American Medical Association. New York: Tarcher/Putnam; 1994.
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Bodenheimer T, Grumbach K. Understanding Health Policy. New York: Lange Medical Books/McGraw-Hill; 2005.
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Lawrence Grouse, MD, PhD, Clinical Assistant Professor, University of Washington School of Medicine, Seattle, Washington
Author's email: lgrouse@u.washington.edu


Disclosure: Lawrence Grouse, MD, PhD, has disclosed that he did fund-raising for US National Heart, Lung, and Blood Institute (NHLBI) projects with many US Pharma companies and with multiple international Pharma companies for nonprofit organizations founded by NHLBI and the World Health Organization.

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