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Bridgeport, CT
Correspondence to: Kathleen McCauley, PhD, RN, School of Nursing, University of Pennsylvania, Claire M. Fagin Hall, 418 Curie Blvd, Philadelphia, PA 19104; e-mail: kmccaule{at}nursing.upenn.edu
In this edition of CHEST (see page 664), Tonelli reviews conflicts of interest (COI) affecting clinical practice. His scholarly approach is gentle and diplomatic. Others have been much less kind. For example, The New York Times has published a series of articles that paint a very unflattering portrait of us. Rather than discount this as liberal demagoguery, consider, instead, a moment of introspection. In each of the following areas, I ask myself whether I am guilty of similar COI and am therefore contributing to the problem. I encourage you to do the same.
Pharmaceutical Companies and Physicians
With global sales of approximately $4.2 billion last year, Zyprexa is Lilly’s largest-selling drug and a major contributor to company profits.1
At > $300 for a monthly prescription, Zyprexa, which is used to treat schizophrenia and bipolar disorder, is the single biggest drug cost for state Medicaid budgets.2
Marketing documents given to The New York Times by a lawyer representing mentally ill patients detail a multiyear promotional campaign that Lilly began in Orlando, FL, in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.3
Documents provided to The New York Times last month by a lawyer who represents mentally ill patients show that Lilly played-down the risks of Zyprexa to doctors as sales of the drug soared after its introduction in 1996. Internal documents show that in Lilly’s clinical trials, 16% of people receiving Zyprexa gained > 66 lb after a year of receiving the drug, a far-higher figure than the company disclosed to doctors.1
Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who said they were injured by the drug. At least 1,200 suits are still pending, the company said. Approximately 20 million people worldwide have received Zyprexa since its introduction in 1996.1
These quotes from articles imply that pharmaceutical companies think that practicing physicians are important targets and that they can be easily manipulated. Why would the lay press perceive this? Well, new drugs create large profits. It often takes years to detect prevalent and potentially serious toxicity of new medications. And in some notable cases, pharmaceutical companies have concealed serious complications, gambling that extra revenues generated in the interim will dwarf fines and legal fees.
To What Degree Might We Be Guilty of Individual COI?
While "drug lunches" have been a regular fixture in most hospitals in which I have practiced, I generally do not know which company is providing which drug. I believe, like most doctors do, that patients are not being affected by the transaction. Yet, I know that cannot be true because pharmaceutical companies would not invest without evidence of returns. Nonetheless, my residents’ immediate and long-term behaviors are certainly impacted by the lunches and drug detailing. While I have not acted to limit or regulate this practice, I will (see below).
Pharmaceutical Companies and Academia
In an article published yesterday in The New England Journal of Medicine, the doctors wrote that Lilly—the sixth-largest drug maker in the nation—had manipulated treatment guidelines for sepsis patients to promote Xigris at the expense of older, cheaper, and equally effective treatments. To promote Xigris, Lilly used "marketing strategies masquerading as evidence-based medicine... " Two recent clinical trials of Xigris have been discontinued because the drug increased the risk of severe bleeding and—at best—did not reduce the overall death rate in patients who received it.4
The Surviving Sepsis Campaign,5 an international effort to increase awareness and improve outcome in severe sepsis, recommended "use of recombinant activated protein C in patients with severe sepsis and high risk for death." The campaign will certainly do good, raising awareness of evidence-based methods to improve outcomes of patients. But was the recommendation for activated protein C evidence based on the natural response of human beings to a gift (ie, pharmaceutical company underwriting the campaign)? Other specialties are suffering from the same malady.
The following was noted in the New York Times article regarding6 a president-elect of the National Kidney Foundation. In the year he was chosen as president-elect, the pharmaceutical company Amgen, which makes the most expensive drugs used in the treatment of kidney disease, underwrote more than $1.9 million worth of research and education programs for this physician. The next year, Amgen paid this physician at least $25,800, mostly in consulting and speaking fees, the records show. Most doctors believe that these payments have no effect on their care of patients. "When honest human beings have a vested stake in seeing the world in a particular way, they’re incapable of objectivity and independence," quotes Max H. Bazerman, a professor at Harvard Business School for the New York Times article. Amgen’s financial connections to individuals at the National Kidney Foundation caused one physician quoted by the paper to view the foundation’s anemia guidelines—and subsequent revisions with great skepticism.6
These articles suggest that there are those in medical academia who suffer from misguided hubris and that pharmaceutical companies can find them. Since their credibility is at stake,78 professional societies are grappling with this problem.
To What Degree Might We Be Contributing to Academic COI?
Since I am not a world expert on anything, I am innocent of academic COI. But I recall sitting on a panel in which one jurist seemed very committed to a particular product, and it took eight or nine of us to subdue him. We did not know whether he was intellectually or financially conflicted. Irrespective, the confrontation was uncomfortable but necessary to protect the legitimacy of the final society-sanctioned document and the patients it might affect.
Doctors vs Hospitals
The episode occurred at a small hospital that is owned and run by doctors: 1 of approximately 140 such hospitals around the country, with nearly 24 more under development, that are set up to specialize in certain types of procedures such as heart surgery, back operations, and hip replacements. These hospitals have been assailed for "cherry picking" the most profitable procedures from the 4,500 or so full-service hospitals in the nation.9
Even though the majority of hospitals are not-for-profit, philanthropic institutions,10 this article exemplifies the feeling of the public that there are physicians and health-care organizations that are money focused rather than patient focused. In many communities, physicians and hospitals compete for health-care dollars. While laws prohibit hospitals from engaging in predatory practices (eg, paying physicians to admit insured patients), physician-entrepreneurs are less restricted and have absorbed some of the more profitable services. Some not-for-profit hospitals are left with an abundance of underinsured patients and poorly reimbursed procedures. Public health is not necessarily the beneficiary,11 especially if essential services to the needy suffer as a result.
To What Degree Might We Have Contributed to Conflicts of Doctors and Hospitals?
Since I am a full-time employee of a hospital, I have a financial COI in this area. Nonetheless, I have always advocated a team approach to critical care, believing strongly that patients are best co-managed by intensivists and their primary care doctors. Many disagree with this viewpoint. I have been a self-righteous, evidence-based zealot who, for many years, did not fully appreciate that the quality of primary care practice is predicated on life-long doctor/patient relationships. As an educator of internists, I now realize that to divorce primary care doctor and patient at the time of greatest need is neither in the patients’ nor the doctors’ best interests. I am a better steward of the doctor/hospital relationship but still have a way to go. At the same time, I believe that we should all agree to discourage some particularly problematic behaviors (see below).
The subtext of Harold Sox’s definitive tome12 on the development of American medical professionalism is that society has historically trusted doctors to manage themselves and do what is "right" for their patients and community. It is the very facet of the American medical system (ie, independence) that has attracted many to medicine. But the public’s faith in our "guild" is predicated on honoring that social contract. Is The New York Times describing the actions of a few bad apples? If so, have we failed our guild obligation to discipline those who erode the public’s trust? Or is The New York Times describing a more prevalent malaise that threatens the integrity of medicine?
To do our part, we must "manage" our COI by preventing any potential selfish needs from undermining what is best for our patients. We must also urge like-minded colleagues to join in defending our profession. Consider embracing the following with me:
1. Individual COI: We respond to congeniality and kindness with favor. Therefore, we will consider whether a prescription is the best medicine for our patient (and society) or the natural response to a free meal or smile from a pretty sales representative. In fact, we will consider buying our own lunch because we would be embarrassed to post in the waiting area how many free sandwiches we have consumed. And, we would be even more embarrassed if a patient recognized that he/she was paying a higher co-pay for a more expensive medicine when an equally effective, less-costly choice would have sufficed. We have an obligation to explore whether pharmaceutical company-sponsored lunches should be eliminated entirely or tightly regulated (eg, prohibition of detailing) for our resident trainees. As new examples of individual COI are exposed in the lay press and our medical journals, we should examine whether we too are affected and respond accordingly.
2. Professional Society Guideline Panels: The American College of Chest Physicians has been a leader in creating high-quality, evidence-based guidelines and has an excellent COI policy for its panelists.7 Taking this lead, I have supported the following personal standard. If I receive direct payments, research underwriting, or own financial shares of a company, I will recuse myself from drafting or voting on "official" society practice guidelines that pertain to my COI. While I might provide expert testimony regarding science, I cannot exclude the possibility that my COI might affect my vote. The public’s health and the integrity of the professional societies I serve are too important to risk.
3. Doctors vs Hospitals: As hospital employees, we will work to make this hospital as safe and efficient as possible for patients of our outpatient-based colleagues. We will urge colleagues to discourage business practices that hamstring not-for-profit hospitals and, simultaneously, work to strengthen relationships with our colleagues to best serve their patients (everyone can win).
4. Education: As educators, we should share the The New York Times and JAMA descriptions of COI with our trainees. We should openly discuss how and why these reports constitute COI. We should encourage high standards of ethical conduct and discourage, through policies of low tolerance, unprofessional conduct. If trainees witness COI, we should not "look the other way." We should name it, explicitly, and discuss potential effects on the quality of patient care. Trainees learn professionalism by our examples; if we attend to items 1 to 3 above, we will be modeling behavior worth emulating.
These are the types of steps1314 we must take, collectively and in full public view, to fulfill our social contract and regain fully the trust of our patients. If enough of us choose to manage ethically our COI and discourage the "few bad apples" from unethical conduct, then we can retrieve the high ground and The New York Times can turn its searing focus to other issues.
Footnotes
Dr. Manthous is Associate Clinical Professor of Medicine, Yale University School of Medicine.
Other than consuming thousands of dollars worth of "drug lunches" since medical school (1986), Dr. Manthous has no financial or intellectual conflicts of interest relevant to this article.
References
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