Catherine D. DeANGELIS

Effectiveness of an antihistamine-decongestant combination for young children with the common cold: a randomized, controlled clinical trial.

We tested the hypothesis that antihistamine-decongestant combinations cause no clinically significant relief of the symptoms of upper respiratory tract infections in young children by randomly assigning 96 children to one of three treatment groups: antihistamine-decongestant, placebo, and no treatment. There were no differences among the three study groups in the proportion of children considered better overall by the parent 48 hours after the initial assessment (drug, 67%; placebo, 71%; no treatment, 57%; p = 0.53). There were no differences among groups in individual or composite symptom score changes. Two thirds of parents whose children were eligible for the drug trial believed that their child needed medicine for cold symptoms. In the proportion of parents believing that their child needed medicine, there was no difference between those who consented to participate and those who refused. Parents who wanted medicine at the initial visit reported more improvement at follow-up, regardless of whether the child received drug, placebo, or no treatment. We conclude that there is no clinically significant improvement in symptoms of upper respiratory tract infection, including no significant placebo effect, in young children for whom an antihistamine-decongestant is prescribed.

Intravenous immunoglobulin in minimal change nephrotic syndrome: a crossover trial

To determine whether intravenous immunoglobulin (IVGG) would be an efficacious adjunct in the treatment of childhood minimal change nephrotic syndrome (MCNS), we enrolled ten patients with frequently relapsing or steroid-dependent MCNS in a double-blind crossover clinical trial. At the time of relapse of the nephrotic syndrome, patients were assigned to treatment with a single outpatient infusion of IVGG (800 mg/kg) or intravenous albumin as a control. The relapse was treated concurrently with standard doses of oral prednisone. At the time of the next relapse, patients who had first received IVGG were treated with albumin, and vice versa. There were no significant differences in the length of remission between the IVGG and albumin treatments. The study had a power of 0.72 to detect a true difference of 45 days between the two therapies. We conclude that in the dose of drug used in this trial, administered at the time of relapse in conjunction with prednisone therapy to children with frequently relapsing or steroid-dependent MCNS, IVGG does not lead to a clinically important extension of the period of remission.

The Importance of Physicians’ Financial Disclosure for the Public's Health

You might ask why it is important for the public’s health that physicians and other authors disclose their financial relationships with pharmaceutical and medical device companies when they publish in biomedical, health science, and policy journals. And why is it important that the public have access to payments made to physicians by pharmaceutical and medical device companies? The short answer is that while there is no ironclad guarantee, these critical disclosures help ensure that the authors whose articles are published in peer-reviewed journals are open and honest about the funders, connections, institutions or companies, and associations related to their studies. Equally important, these disclosures give some assurance that the prescribed medications, therapies, or devices recommended in these articles provide the best options for patients and, hence, the public’s health.

Peer Review and the Public’s Health

Essentially all clinical practice, public health administration, and health policy should be based on research published in peer-reviewed biomedical, health science, and policy journals. The textbooks our students read and our colleagues consult also are based on what has been published in those journals. Thus, it is critical that all peer-reviewed published articles are based on valid data, good science, and sound reasoning.

Women's Contribution to the Health of the American Population

Women have always made a significant contribution to the health of the American public, in both nursing and medicine. But it is only over the past several decades that more and more women have become physicians, thus entering a medical profession that for many years had been primarily a mans world. n nEvery medical student knows, or should know, that Elizabeth Blackwell became the first woman physician in the United States, after graduating from Geneva Medical College in 1849. She also was the first woman to be listed in the United Kingdoms medical register. Interestingly, her sister, Emily, was the third woman to graduate from a US medical school. n nTo put this in perspective, Elizabeth Blackwell graduated 84 years after the University of Pennsylvania School of Medicine, the first medical school in the United States, was established in 1765. The University of Pennsylvania, however, admitted only male students to its medical school, as was the case for most American medical schools in all of the 18th, and most of the 19th, century. In 1850, 85 years after the founding of Penns medical school, the Womens Medical College of Pennsylvania was founded as the first medical school exclusively for women. n nWomen physicians fared only slightly better with the American Medical Association, which was established in 1847 but did not accept its first woman member until 1876. It took 113 more years for Nancy Dickey to become the first woman board member in 1989. n nThis tendency for women to be accepted as members but not as leaders in medicine has continued to the present day. According to the American Association of Medical Colleges (AAMC), in 1905 only 4% of medical school graduates were women; by 1965, this had increased only slightly, to 8%; in 1985, the number was 31%; and since 2003, about 48% of graduates of US medical schools have been women.1 So it essentially has been only for the past decade that women and men have been graduating from medical school at about the same rate. n nIn contrast, according to the AAMC, while women comprised 35% of the faculty in the 141 US medical schools in 2012, only 13 were deans, and women accounted for 21% of division and section chiefs, 19% of professors, 31% of associate professors, and 42% of assistant professors. The goal, of course, is that these iniquities will lessen as more women assume senior professorial and leadership positions. n nIt is also important to note that the specialty fields chosen by women, as compared with men, are quite different. According to the AAMC, 30.4% of all actively practicing physicians in the United States in 2010 (the latest data available) were women. However, 48% of pediatricians, 47% of obstetricians/gynecologists, 34% of general internists, and 32% of family physicians were women. Clearly, these specialties had a higher proportion of practicing women physicians than all other medical fields in 2012. In contrast, only 6% of urologists and 4% of orthopedic surgeons were women, representing the specialties least frequently chosen by women.2 n nThese career choices made by women physicians have substantial financial consequences. The current median annual salary for a pediatrician is about

Conflicts of Interest in Medical Practice and Their Costs to the Nation’s Health and Health Care System

177,000; for an obstetrician/gynecologist, about

The Electronic Health Record: Boon or Bust for Good Patient Care?

256,000; for a urologist, about

Volunteering for Clinical Research Studies and Public Health

338,000; and for an orthopedist, roughly

Where Have All the Primary Care Doctors Gone

432,000 (http://www.salary.com). The specialty choices made by women contribute, at least to some degree, to the generally 20% to 30% smaller salaries for female than for male physicians. Another reason for this disparity is the relative disproportion of women in leadership positions, which also command higher salaries. In any case, men simply are not choosing the primary care (ie, lower-paying) specialties at the same rate that women are. n nSo what effect do these specialty choices made by women have on the health of the population? It is hardly a secret that there is a substantial need for primary care physicians in this country. Considering the aging population and the expansion of health insurance coverage because of the passage of the Affordable Care Act of 2010, we will need 35,000 to 50,000 more primary care physicians over the next decade. Who will fill this need? If you have been reading this column carefully, you already know the answer. Since 1996, according to the AAMC, there has been a 40% increase in women choosing primary care specialties versus a 16% decrease for men.1 n nLooking to the future, women comprise 81% of obstetrics/gynecology residents and fellows, the highest percentage for any field, and 72% of pediatric residents and fellows, the second highest percentage. But only 13% of urologists and 9% of orthopedic residents and fellows are women.1 So the trend of more women in the primary care fields should continue in the near future. n nPediatrics is a primary care specialty and the only one in which the number of generalists versus specialists is balanced. And even though obstetrics/gynecology is not a primary care specialty per se, the majority of women will need the care of an obstetrician/gynecologist at some point in their life, usually for routine gynecological care. n nI recently learned from my obstetrician/gynecologist colleagues that many of their patients refuse to allow male medical students or residents to care for them or even allow them in the room to observe the care provided by a woman physician. This bodes ill for men interested in that specialty and has great implications for the future of womens health. I found this decision by women patients to be a very interesting twist, especially considering how few women are urologists, and yet female patients do not appear reluctant to be seen by male urologists or male medical students in those situations. n nSome argue that because women physicians work fewer hours than men and take off months or years for child bearing and caring, their contributions to patient care is diminished. But it is also important to note that men have more significant health problems in later life, when they tend to be at the peak of their earning capacity, and live, on average, 2 to 3 fewer years than women. So might this total practice effort even out over a lifetime? In any case, until the unlikely event in which men are able to bear children, true equality will never be accomplished. We can aim only for equity. n nIn addition, it can be argued that women in general are naturally more nurturing than men. Surely a nurturing personality is what patients seek in a physician, but how important is that for physicians caring for patients? I know of no good study that has answered that question. Its time for someone to do it. Will women physicians work as hard and for as many hours over their lifetime as men do? This question, too, needs to be studied and can be answered only over the next few decades, as we now have a better balance of the sexes in medicine and as many men are now contributing more to the care of their children. n nWhatever the answers to these questions turn out to be, it is clear that while women were late in being allowed into the medical profession of medicine, most have chosen the primary care specialties and thus are contributing disproportionately more to the primary care medical needs of Americans, not to mention the populations overall health. More to the point, Americans should be grateful that women physicians have made these choices.

A Comprehensive School Health Initiative

Virtually all American physicians take some form of the Hippocratic oath when they graduate from medical school. And I would bet that all these newly minted doctors truly believe they will maintain the ethical conduct professed in that “oath” throughout their professional careers. Almost every medical school has modernized and changed the oaths wording from its origins on the island of Kos so many centuries ago. Nevertheless, these declarations all adhere to the essence of what the original oath assured would be the foundation of the doctor-patient relationship, that the physician would always strive to act in the patients best interest.1 n nOnly the rare physician admits to having deviated from this promise and when one does, it usually is after being caught doing something illegal, immoral, or both. Sadly, the reality is that today far too many physicians have violated or ignored the true meaning of the Hippocratic oath. Specifically, many, if not most, physicians practicing today have, or have had, conflicts of interest that clearly do not result in their patients’ best interest. n nThe term “conflict of interest” refers to a conflict between the private interests and the official responsibilities of an individual in a position of trust. Surely physicians function in positions of trust; in fact, the very foundation of the doctor-patient relationship rests on trust. So when and where do conflicts of interest occur most often with todays medical profession? n nLets begin with the free black bags, instruments, or books given to medical students by a pharmaceutical company, or even the doughnuts, coffee, soft drinks, and free lunches provided at teaching conferences. Does accepting those gifts lead to acting in the best interest of patients? n nNow lets up the ante to include the free food, tickets to sporting and other events, sponsored trips to resort locales, and the shower of other gifts given to physicians by the pharmaceutical representatives assigned to them. Some people maintain that such gifts do not influence physicians’ prescribing practices. But if that were so, why would pharmaceutical companies spend billions of dollars on these items, and why would they partially reimburse their marketing representatives according to the number of prescriptions written by the physicians to whom they are assigned? n nAnd what about the free drug samples provided to physicians for their patients? It has been argued that these free samples help patients who cannot afford them. But then why are the vast majority of these free samples for new (meaning those still under patent protection) and expensive drugs that are almost exclusively for illnesses that require the drugs frequent or continued use? Although the first prescription is free, the patient then must pay much more for future prescriptions instead of using an equally effective generic, or less expensive, drug. This manipulation works well for the direct-to-consumer advertising of drugs (look at almost any magazine), so why not use it, as Big Pharma reasons, on the men and women who control the prescription pads? n nWhat about academic physicians who do research or write practice guidelines or review papers funded by Big Pharma? Here the association between research sponsorship by pharmaceutical and medical device companies and pro-industry conclusions is clear. Most Americans are surprised to learn that the clinical research funded by Big Pharma dwarfs the annual investment by the National Institutes of Health. Moreover, much of this industry-sponsored research is tainted by bias that is not always clearly stated.2,3 Of course, this unsavory practice can proceed only with the cooperation of the authors and the editors who publish the studies. The same cooperation is necessary for physicians who write and publish practice guidelines and review papers that are buttressed by industry-funded work and professional medical associations that are heavily involved in continuing medical education.4 n nAnd then there is the problem of physicians and biomedical and health care researchers who work for a pharmaceutical companys marketing division, rather than its scientific division. An obvious example occurs when “expert physicians” serve as industry-sponsored speakers and use the slides and data provided by the pharmaceutical company. Invariably, such “chaperoned” presentations accentuate the positive and downplay the negative (including price differentiation) aspects of the drug being promoted. These “expert presentations” help sell the drug in question, and few in the audience may be aware that the manufacturer of the drug, medical device, or technology being extolled is also handsomely rewarding its presenter. n nFinally, there is the promotion of a drug for off-label use. Imagine the following and, unfortunately, common scenario: At a major clinical or health-related lecture, a physician paid by the pharmaceutical company is “planted” in the audience. The “plant” raises his or her hand and supposedly innocently asks the presenter if he or she has ever used the drug for an illness for which the drug has not been approved by the US Food and Drug Administration (FDA). The presenter then discusses off-label uses of the drug for this or that illness or symptom. Remember that physicians in the United States can write prescriptions for any drug, whether or not it has been approved by the FDA for that illness. So why not add a few more uses, which can translate into multiple sales and millions of dollars in unexpected revenue? n nAs I discovered by doing a search of PubMed while I was editor-in-chief of JAMA, since the late 1980s the number of articles in the medical and population health literature on conflicts of interest has risen substantially. From 1975 to about 1990, there were no or very few such articles cited in PubMed. But by 2007, the number had risen to 600 and has remained at that level every year since. Not surprisingly, this rise in number corresponds all too neatly to a period when many pharmaceutical companies merged their scientific and marketing divisions. n nSo what does all this tell us about how physicians are maintaining their promise to act in their patients’ best interest? Dont all these examples represent conflicts between the private, for-profit interests and the professional responsibilities of individuals (physicians) in a position of trust? And dont such practices have huge (and frequently negative) implications for the publics health and the cost of health care? n nWe can only guess what effect the Physician Payment (Open Payment Program) Sunshine Act might have on such actions. This federal act, which is part of the original Sunshine Act, requires that all manufacturers of drugs, medical devices, and biologicals participating in US federal health care programs report certain payments and items of value given to physicians and teaching hospitals. Since August 1, 2013, manufacturers also have been required to collect and track payment, transfer, and ownership information. In 2014, most of the information contained in these reports will be available on a public, searchable website.5 n nMight the embarrassment of having their name and remuneration from pharmaceutical or medical device companies exposed to the public and on the Internet persuade physicians to uphold their professional promise to act in the best interest of their patients? We can only hope.