- BIOETHICS FORUM ESSAY
Drug Company Leader Says, End Industry Support of CME
Remarks submitted anonymously by a pharmaceutical executive
Despite limits placed recently on industry funding of continuing medical education – and the requirement in the health reform law’s physician payment sunshine provisions that drug and medical device makers, beginning in 2013, publicly report payments to doctors and public hospitals for medical education – the practice continues to be controversial. The controversies are the subject of a conference being hosted today by PharmedOut, a Georgetown-based research and education project that focuses on inappropriate pharmaceutical company influence on prescribing. The conference, “Prescription for Conflict: Should Industry Fund CME?” includes speakers who are leaders in government, research, and industry. In remarks prepared for the meeting, a high-ranking pharmaceutical company executive condemns industry support of CME. The remarks were given to Bioethics Forum by PharmedOut’s director, Adriane Fugh-Berman.
The executive asked to remain anonymous, as do most critics within the drug industry, says Fugh-Berman. “Our presentations and other materials have changed clinicians’ minds about relationships with industry because we expose what industry says and does behind closed doors in its efforts to manipulate the prescribing habits of clinicians,” she says. “Our information about industry-wide practices comes from our unique network of former and current industry insiders. Only a few people who have worked in industry are willing to publicly criticize marketing practices.”
In this statement the executive says that drug companies try to create the impression that CME programs are unbiased while still making them “fit the profile of specific company products.” Fugh-Berman says, “This powerful perspective of an experienced industry professional should be heeded.” – The editors
There is substantial merit to both continuing medical education (CME) and continuing promotional education (CPE) regarding diagnostic and therapeutic practices and products. However, the two are distinct types of education and should be viewed and presented as such by the involved professional communities – academia and industry.
As an industry professional, I propose that however transparent commercial support may be, CME has the potential for inappropriate promotional messaging and influence. I believe that although industry support of public and academic institutions is critical and mutually beneficial, CME investment by the private sector is not the appropriate vehicle.
The Business Model
Both the public and private sectors seek to enhance public health, encourage the application of best practices and products, and support institutional viability and sustainability.
But the private sector necessarily relies upon a business model as a measure of success: Health care product companies succeed by selling their products and realizing profit and growth. Success is measured in absolute terms and in relation to competing therapeutic options.
Sales depend on access, perception of value, appropriate reimbursement, prescribing behavior, and end-user adherence. Clinician-prescribers are only one of several influential entities affecting a decision to use a given product; other influences include other caregivers, patients, insurers, benefits managers, formulary committees, department chairs, and so-called key opinion leaders (KOLs).
Typically, companies make CME investment decisions at annual budget meetings. The sales and marketing divisions dominate the deliberations, and expected return on investment is the bottom line for determining the distribution of CME cash.
In deciding which CME programs to support, companies profile and evaluate institutions and individual presenters. Large volume, influential institutions are not likely to be rejected. Institutions approaching formulary negotiations are similarly going to get attention. Friendly institutions, as defined by access and volume, are more likely to receive grants than those that favor another company’s products.
Grants may also be made in support of programs including particular KOLs whose opinions resonate with the promotional plan. That is not to say that there is inappropriate influence on these excellent academicians. Rather, a proposal may be more likely supported when particular KOLs are included in a program. Similarly, those known for positions antithetical to the company’s promotional plan are less likely to be supported.
The participation of respected teachers, as well as the presentation of nonbranded patient-management approaches that nonetheless fit the profile of specific company products, contribute to the audience’s impression that the CME programming is unbiased. More egregious violations of CME objectivity are more easily spotted and condemned by both academia and industry than these more subtle influences. But it is CPE – with the requisite transparency and regulatory compliance — that is the place for directing the attention of an audience to the benefits of a company product.
For example, satellite symposia at major meetings are common vehicles for CPE. They are often formulaic. A respected KOL – one whose name will help draw an audience – chairs the symposium. A KOL educator gives an overview of the clinical condition or issue. An epidemiologist then describes the magnitude of the problem – what is called the burning platform. (Burning platform is a common marketing phrase referring to the reason someone ought to pay attention to an issue that was previously unknown, misunderstood or underappreciated. For example: such-and-such side effect [of a competing therapy] may not seem like a big deal to you but a gazillion people stop their critical therapy because you, the clinician, did not focus on this when choosing a medicine.)
An investigator/academician describes new and existing therapies with a focus on the new approach of interest and product features. A panel then takes questions. These events are constructed to support a market position, and sometimes to yield durable materials – for example, a journal supplement – for distribution. Speakers’ bureaus and dinner meetings are variants of CPE.
Both Sides from Both Sides
Within both industry and academia there remains a spectrum of support for industry-funded CME. On the business side, there are some who truly believe that contributing to CME contributes to quality education and the public health; others see the need to even the playing field, to counter the messages of rivals who fund CME programs.
Some argue that the audience is sophisticated enough to judge the data on its own merits, independent of any motive of speaker or sponsor. And there are those who believe that a balanced discussion of off-label use is a responsibility, not something that one slips by the regulators. Finally, there is a survival driver: Jobs may depend on moving market share and size. As access to meaningful detailing diminishes in the community, CME is viewed as an attractive marketing option.
Some in academia and the public sector believe in the institutional capacity to identify and expose promotional distortion. They believe that institutional processes will protect CME from inappropriate influences and that cash does not sway institutional and educational leadership but, rather, allows for excellent programming at affordable cost. Without it, they reason, the intended audience and the best speakers may opt for those subsidized programs that are available, especially in difficult economic times.
On the other hand, industry-funded CME is losing its appeal for both business and academia. Companies are becoming disenchanted with increasingly restrictive CME-funding policies and regulatory scrutiny, as well as with what they see as a lack of meaningful return on investment. We have better ways to invest, they argue: Sales force, research and development, license and acquisition, advocacy donations, marketing, advertising, coupons, and samples, are just a few examples of options competing for investment dollars.
Reservations abound in the public sector as well. Some hold that industry-funded CME is a corruption of the educational mission, whether real or perceived, and that academia can provide educational excellence at a cost the professional community will support. They reject gifts that might call into question their negotiations for products and services, and they do not want to appear to demand pay for play.
And in My Opinion
In summary, CME contributions are commercial decisions. Commercial does not equal unethical or lacking in value, but it does represent a focus on a particular business objective. The nature of the return may be subtle, nonbranded, or indirect.
CME is generally regarded as a way to fulfill an educational mission, a commercial event, and a boon to the public health. Public attitudes and expectations are important in this debate because pharmaceutical companies know that the public depends on the independent assurance that objective education is thought to provide. CME is a typical state requirement for maintaining medical licensure – one of the means by which the states help protect citizens from practitioners whose knowledge base may not be contemporary.
CME is a public safeguard, not a guild decision. As such it is in a category different from other educational efforts. CME ought to represent the gold standard of objective evaluation of the literature. Scientific data, medical literature, promotion, and opinion should be analyzed in an unbiased fashion, addressing issues deemed most important by evenhanded educators in the best interests of patients. Even indirect interference with that expectation is an unacceptable corruption.
There are legitimate and necessary private-public commercial relationships, such as discovery, development, and business and scientific consultation. But CME is diminished by dependence on funds deriving from commercial interests. CME should represent what is most critical to health care, not that which is also likely to be funded. CME is not compatible with commercial intervention.