“A Misery of Choices”, is how an author in JAMA: A Historical Perspective of Pharmaceutical Promotion and Physician Education described the dilemma of so many therapeutic options available to physicians in the late 1950’s. Is this a dilemma or a blessing to most living at the time it was a blessing.
- The article discusses how contrary to popular believe that the debate over commercial support of CME has been with us at least since the explosion of modern medicine in the late 1950’s.
- That there have been congressional hearings on commercial support of CME every ten to twenty years starting in the early 60’s.
- That doctors at that time and since struggled with the shear amount of information they needed to know, given all the new medications. The argument against support of CME is that all these therapeutic choices are bad.
- This article represents more of the apocalyptical whining by professional scolds about the perils of commercial intrusion into medicine and the unsustainability of medical expenditure. These claims have been incessant, yet medicine has become more effective, longevity has increased, quality of life has improved in the USA and in countries with nationalized health systems and product price controls that freeload off of US innovation.
- The only difference between the Chicken Littles of then versus now is that nearly all parties responsible for the perceived problems — specialists, hospital administrators, journal editors, and insurance companies have managed to deflect all the blame on the medical products industry.
- There arguments ignore 50 years of incredible advances in medicine and science if commercial support of CME was a true problem in the 1950’s then how did we advance so far with such a deep level of cooperation between industry and academia.
I have outlined much of the article and some key excerpts, the writer comments are in italics and my comments are in red:
THE MEDICAL PROFESSION (Interpretation: medical professionals who don’t do research, treat patients or publish real research) HAS RECENTLY AWAKENED (because JAMA and other editors have worked overtime to ensure this) to a crisis over industrial influence in medical education (a debate on an issue does not constitute a crisis, is but I am sure the editors added this one for effect – all made up problems are a crisis of equal proportion to Hurricane Katrina).
In recent years, the problem of industrial funding of continuing medical education (CME) (Are we to think that industrial funding of CME is a problem, actually the lack of funding would create a problem) has been the subject of stern warnings from academic medicine, prominent congressional hearings, and strict revisions of the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support. Commercial support for CME continues to increase and now comprises more than half of all CME income (So why is this a problem? Support for other industries is around that same number and no one is calling those industries a crisis. Remember for effect all things are equal to Hurricane Katrina … shh people are living longer and it is costing the healthcare system more now … that is a crisis). These clear indicators of dependence have raised widespread concerns (by the editors of JAMA) of bias in the ongoing education of practicing physicians regarding new drugs (Yes, everyone is concerned about bias, but let’s not leave out all the other bias’s that exist like let’s say –goverments and managed care bias to save money. I don’t know about you, but this line that all things new are bad, goes back to the beginning of time) and failure of the medical profession to assume responsibility for educating physicians (The medical profession is responsible for educating physicians. It is exactly the opposite of what the writer implies, medical professionals are involved in every aspect, from program design to instruction and implementation, to evaluation, to say they are absent is to ignore the work of thousands of medical professionals involved in CME activities, to allude to such nonsense that they have failed to assume responsibility is foolishness).
How did this come to be?
Critics of the role of pharmaceutical promotion in medical education have claimed that policy changes in the 1980s altered relations between the medical profession and the pharmaceutical industry. (Wait a second tell me this is not true, of course we are fighting the same inquisition we have fought for thousands of years.)
However, in the late 1950s and early 1960s, divisions over the role of pharmaceutical marketing in physician education had already surfaced in the medical literature and in Congress.
On closer analysis, the history of industry involvement in medical education involved tensions between promotion and education dating back to the origins of the wonder drugs, from antibiotics to antipsychotics. (It dates back longer than that, but starting in the 50’s and 60’s is fine for this analysis)
The Therapeutic Jungle
Between 1951 and 1961, 4562 new prescription products were brought to market, and analysts estimated that 70 cents of every dollar spent on drugs in 1961 went toward the purchase of drugs not available 10 years earlier. This deluge of new pharmaceutical products in the postwar era visibly strained the ability of US physicians to remain current with newly available therapeutics. (Such a problem; people living longer, surviving illnesses they died from just a decade earlier. A doctor’s life was much simpler if the patients simply died and he didn’t have to bother to keep up with all that information) At the same time, increasing competitiveness in the pharmaceutical marketplace placed stronger emphasis on pharmaceuticals as brands, to be introduced to physicians through media ranging from journal advertising to direct mail to individual visits by pharmaceutical representatives. (Those brands, those bothersome visits, that pesky direct mail.)
By 1960, Goodman and Gilman's classic textbook referred to this overflow of innovative compounds and promotional materials as the "therapeutic jungle." (I don’t know about you but in the jungle of the 1960’s people lived longer, and were healthier than just ten years before in the 50’s. During that time my mother’s older brother died of appendicitis. I would not call that a jungle I would call that a paradise. Have we lost the love for living? I want to know my grand children. How about you?)
Following studies in the 1950s documenting that physicians consistently rated pharmaceutical sales representatives as the most important source in learning about new drugs, the role of commercial sources in physician education became a subject of research to market researchers, sociologists, psychologists, and the medical profession. These studies challenged the image of physicians as autonomous professionals insulated from the influence of marketing, and cataloged the nonrational bases of many prescribing decisions. (Why was it then and now irrational to learn about a new drug and prescribe them?)
As Ernst Dichter explained in a 1955 report to the Pharmaceutical Advertising Club of New York:
The physician expects himself to make up his own mind on the basis of objective evidence. And yet he finds himself confronted, like a housewife in a supermarket aisle, with a misery of choice which he tends generally to resolve by irrational and emotional factors. (A misery of choice is a great example of how these people invert reality. To those of you old enough – go back to remember how little choices you had at the local store in the 30’s and 40’s. Again, I thought choice is good not bad, am I missing something – let’s make a jungle out of paradise.)
Reformers and Apologists
As evidence of the influence of pharmaceutical marketing over prescribing decisions mounted by the late 1950s, a cadre of academically based clinical investigators and educators began to clamor for corrective action. (Chicken Little the sky is falling) In a widely cited 1957 address, Harry Dowling (an active member of the American Medical Association's [AMA’s] Council on Drugs) argued that the increasing influence of pharmaceutical promotion on bewildered physicians prescribing worthless or redundant drugs constituted a moral crisis (These guys make up crisis’s about every ten years or so) and a failure of the profession to uphold its duties of self-regulation of knowledge. (What the heck is self regulation of knowledge – does this mean I shouldn’t learn from others?) Dowling's critique was joined by other prominent figures in the fields of infectious disease (who linked the problem of antibiotic misuse to exuberant pharmaceutical promotion) and clinical pharmacology (who sought to distinguish rational from irrational use of prescription drugs) (I find it interesting that antibiotic misuse has been around since they were first developed yet, people live longer and we have yet to die of the super bug, predicted by these same naysayers. The more things change, the more they stay the same).
The response from industry was swift. Arthur Sackler, a psychiatrist and partner in the most prominent pharmaceutical advertising agency in the country, replied that physicians were fully able to read pharmaceutical marketing critically. "Pharmaceutical advertising," he wrote, "has made one of the major contributions in the rapid dissemination of new therapeutic information."
The danger he portrayed (and correctly) was not deception or bias but a far more perilous communication gap; to Sackler, the corrective action was thus not for the pharmaceutical industry and its advertisers to tone down their rhetoric, but for the medical profession to keep pace in attracting the attention of its constituents. (Here, here, this guy is my new hero.)
The AMA's inability to address this problem (A misery of choices, wasn’t it better when our lives were simpler and there was less to learn) during this period stemmed from internal schisms between those interested in strengthening the ties between organized medicine and the pharmaceutical industry, and those interested in promoting rational therapeutics. (Why is not learning about new therapies considered rational therapeutics, I encourage you to look at the sheer irrational basis of this argument.)
The Kefauver Hearings, 1959-1962
Although the Kefauver Hearings are often remembered for their outcome—the Kefauver-Harris Amendments of 1962, which mandated proof of efficacy prior to drug approval—Sen Estes Kefauver's (D, Tennessee) high-profile investigation of
"Administered Prices in the Pharmaceutical Industry" (1959-1962) also focused attention on the form and content of general pharmaceutical marketing and the postgraduate pharmaceutical education of the nation's physicians.
Over the course of the hearings, therapeutic libertarians such as Austin Smith (president of the Pharmaceutical Manufacturers Association and former editor-in-chief of JAMA) argued for "competitive education" between the pharmaceutical industry and academia (what a rational idea), while therapeutic reformers in academia (what made them reformers? This is more like the proletariat, in academia the “we know better” crowd has always been against the innovators) warned that such an arrangement would result in the inevitable "brainwashing" of physicians. (This is a very simpleton view of a physician as an irrational prescriber, unable to sort out choices.) As the editor of Pediatrics, Charles D. May, warned in 1961:
A vicious cycle is created by a mad scramble for a share of the market: the doctor is made to feel he needs more "education" because of the prolific outpouring of strange brands but not really new drugs, produced for profit rather than to fill an essential purpose; and then the promoter offers to rescue him from confusion by a corresponding brand of "education." (We could cut and paste this argument today, but the truth is patients have greatly benefited from new therapies, and the adverse effects have been quite small when you look at them in totality; even failed therapies bring us one step closer to a cure.)
Amidst such dissension, AMA representatives proposed a pragmatic compromise: so long as advertising standards were carefully guarded and physician education improved, promotion and education could exist as clearly separate spheres, each serving its own distinct purpose. This position would emerge from the Kefauver hearings as the prevailing descriptive and normative model to guide future action—and would ultimately come to be tested with respect to physician education. (Just for the record, the author could not hide the fact that greater minds prevailed then.)
CME and Commercial Interest Since Kefauver
In the aftermath of the Kefauver hearings, leaders in the AMA and academic medicine worked to establish formal CME as a professional control over physician education regarding pharmaceuticals, and CME requirements rapidly became tied to state licensing bodies.
The increasing use of CME, however, also was accompanied by an increased interest in CME by the pharmaceutical industry. In 1963, a JAMA editorial declared of CME: "The principal source of financial support must come from within the medical profession. Financing often determines control, and control must remain in the hands of the profession." (I still have not heard a rational case why the principle support for CME must come from within the medical profession).
However, investing in CME required funds that could not be borne out by tuition fees alone (same holds true today), and the pharmaceutical industry soon proved a willing partner in providing the ever-increasing budget for high-technology communications solutions to information transfer in CME. (Sounds like a good thing not a bad one.)
Modern physicians, faced with the modern problem of information oversupply (those pesky choices), demanded modern communications solutions, from radio to audiocassette to interactive telesymposia. Yet each new medium came with a significant price tag and found its most enthusiastic support among communications and public relations departments of pharmaceutical companies, at the same time that a growing market of medical education and communication companies emerged to produce CME content for pharmaceutical clients. (Technology requires expertise, so this support is a good thing?)
Where the logic of separate spheres implied a firewall between the business and editorial functions of CME, ample evidence of the porousness of these firewalls existed as early as 1976, sufficient to prompt a series of hearings into the subject led by Sen Gaylord Nelson (D, Wisconsin). (De Ja Vue)
Despite such hearings, the influence of medical education and communication companies continued to increase throughout the 1970s and 1980s. By the early 1990s, the subject emerged again in another set of hearings—now chaired by Sen Edward Kennedy (D, Massachusetts)—provoked by increasing reports of extravagant marketing practices by the pharmaceutical industry. The Kennedy hearings prompted a set of self-regulatory responses by the pharmaceutical industry and the medical profession under threat of governmental regulation. (I am sure Senator Kennedy now is grateful for the stride medicine has made in brain cancer research, and at his recent Democratic National Convention speech he is a poster child for improvements in medical care and those working to create them.)
The Accreditation Council for Continuing Medical Education, meanwhile, was prompted to issue Standards for Commercial Support on the limited and proper role of commercial interest in CME, which placed formal emphasis on firewalls to separate the business divisions of medical education and communication companies from their editorial divisions. (This has been successfully undertaken.)
Nonetheless, the standardization movement of the 1990s did little to stem the growth of the medical education and communication industry, and instead may have helped to legitimize and create a legal defense for the industry, which has increased steadily since that time. (Again why is this a bad thing?)
In the end:
Arguments from academia, industry, and organized medicine articulated in 1958 persist in almost untouched form in 2008
My Closing Comments
History repeats itself; let’s not ignore the medical gains of the last 50 years, just to pursue a crusade of moral purity (elimination of commercial support of CME) which is not based on evidence or logic. The logic behind these proposals then and now are equivalent of saying we should discontinue all support of training for engineers who work on the space shuttle because they could be unduly influenced by those paying for the education.
Industry support of CME has helped improved the quality of life patients and saved millions of lives. To say this was a problem then and a problem now is to ignore undeniably the best 50 years of medical breakthroughs. Those who say “medical marketing” is evil need to consider that without education new therapies could have been ignored and those millions of saved lives lost. Try to remember the issue is not purity it is lives we are dealing with. If 50 years ago they were wise enough not to throw out support from industry, it appears they made the right choice.