PACME: Session on External Environment Looked 360

I recently had the opportunity to moderate a panel at Pharmaceutical Alliance for Continuing Medical Education (PACME) discussing the external landscape of Continuing Medical Education (CME). The panelists speaking included:

Robert Popovian, PharmD, MS – Senior Director, Advocacy and Professional Relations, US Public Affairs, Pfizer, Inc.;

Hilary Schmidt – Associate Vice President of Medical Education at Sanofi-Aventis;

Steve Kawczak – Associate Director, Center for Continuing Education, Cleveland Clinic;

Rafael Fonseca, MD – Professor of Medicine, Mayo Clinic; and

John O’Brien – Executive Director, Responsible Health Institute

Robert Popovian – Politics and Provider Education

In his discussion, Dr. Popovian cited economists who found that the most important products are discovered by industry, often building on NIH funded enabling discoveries.  Specifically, he used a chart to show that for the development of 21 drugs with the “highest therapeutic value” introduced between 1965 and 1992, 80% of the funding enabling the discovery was public, and almost 90% of the funding for the synthesis of the compound came from private funding.

The average lag between the “key enabling discovery” and the introduction of the drug was 24 years.  This gap in time was significant because it represents an extremely difficult problem industry is facing when the Food and Drug Administration (FDA) is understaffed and severely lacking resources to the point where it takes a quarter of a century to approve a drug. In that time frame, thousands of patients die, and sometimes the original disease or condition a drug was created to treat changes.

The fact that the U.S. had more compounds in development than the rest of the world combined in 2007 makes this average lag between discovery and introduction even more troublesome. With thousands of patients waiting for treatment, this means that the FDA is probably overwhelmed with research and applications.

Moving along in his presentation, Dr. Popovian discussed the importance of interactions between physicians and industry by citing a 2009 Minnesota Physician Publishing survey, which found that only 35% total strongly agreed or agreed that “physician employers should place restrictions on who doctors can have contact with, such as pharmaceutical or device representatives.

Conversely, over 60% either disagreed or strongly disagreed with such restrictions. In other words, the majority of respondents felt that interaction between industry and physicians is good for their patients.

While these results show the positive attitudes towards physician-industry relationships, Dr. Popovian addressed critics as well. He noted how there is not enough published data on the interactions between industry and physicians, and those research “experts” in the field tend to be few and often cite each others’ work as corroboration of validity. He further added that most of the research occurs in academic medical center (AMC) settings, and that there is little research done in the medical community or outpatient settings.

As a result, he pointed out that there is no known research on the effects of COI on health outcomes or health care costs (as compared to pharmaceutical costs). However, he did address one often cited social science article expressing a behavioral philosophy that is favored by industry critics. This study ignores much of the recent research we have discussed over the past year, such as the Cleveland Clinic Study, which showed that a large, prospective analysis found no evidence that commercial support bias in CME activities, and that bias levels seem quite low for all types of CME activities and is not significantly higher when commercial support is present.”

Instead of believing that industry influences physician prescribing habits, Dr. Popvian cited Michael Gonzalez-Campoy’s article in Endocrine practice, in which he stated that”

“A more powerful influence on physician prescribing habits is that which originates from most formularies and health maintenance organizations, including those with state or federal sponsorship. Managed care dictates an algorithmic approach to medicine.

Strategically, Dr. Popvian also showed that the Hatch-Waxman legislation fueled a robust generic drug industry, which lowered medication costs while preserving innovation. Still, drugs only account for 10% of healthcare expenditures.

In concluding his presentation, Dr. Popvian noted that today politics dictate physician and industry relations, similar to comparative effectiveness research.  As a result, he called for better collaboration between public affairs, government relations, advocacy development and the medical education departments in pharmaceutical companies since most patient and provider advocates ask for, support and defend industry interaction.

Hillary Schmidt – Driving Value From the Inside Out

Ms. Schmidt focused on how health care providers and entities should get to know officials in government affairs, policy, communications group, sustainability groups etc., and should elicit their perceptions, identify misconceptions, and educate them about CME.

Her presentation also told participants to become a source of rapid information about and interpretation of new information about CME policies, guidances, meetings, articles, research etc. She mentioned providing resources such as Policy in Medicine, Healthcare Coalition, ACME website, leaders in the field.  Ms. Schmidt also noted that CME providers should share the outcomes of CME activities and demonstrate their impact.  In addition, she told participants to invite colleagues to Taskforce, ACME, PACME Summit, etc., and to keep a continuous, ongoing dialogue with officials.

In doing so, CME providers can set a strategy that is aligned with company goals, identify programs that decrease quality gaps consistent with educational areas of interest, and educate healthcare providers about innovations in healthcare with the goal to improve practices and outcomes.

Ms. Schmidt also noted that commercial support and bias exists in FDA committees, guidelines committees and research, not just CME.

Steven Kawczak – Industry Support of CME: Does it Create Commercial Bias?

Mr. Kawczak used his presentation to discuss major issues within the debates about industry involvement in CME, review the evidence related to the effect of industry support on CME, and identify methods to manage potential issues of bias when industry supports CME.

He also talked about following ACCME Standards for Commercial Support, and how doing so can ensure commercial funding does not create perceived bias.  Instead, he focused on how commercial funding support creates acceptable levels of bias.

In discussing the evidence related to the effect of industry support on CME, Mr. Kawczak described the results from his Cleveland Clinic study, and asserted how the presence of commercial support – in and of itself – does not correlate with an increase of bias.  He further noted how the evidence he found indicated no association between commercial funding and perceived bias.

As a result, he called for a shift in the debate regarding industry supported CME, which recognizes that industry funding is not the “problem.” Instead, the debate must focus on “Good CME,” which appropriately manages industry funds and leads to quality education & positively impacts patient care.  This shift is necessary and simple, since current accreditation guidelines are effective in preventing bias.

John Michael O’Brien – Health Care Reform and CME

In discussing the impact health care reform will have on CME, John O’Brien noted how more people with insurance and/or lower drug costs will mean more drug use. More drug use will mean more drug spending, which will pose budget challenges for states and the federal government.  The budget challenges will cause a change in payment methodology.  This change in methodology and a focus on quality will create new incentives for innovation. These new incentives, coupled with new marketing rules and a focus on comparative effectiveness will lead to outcomes-based marketing and purchasing.

Ultimately, this cause and effect chain of new drug provisions, new insurer provisions, and new quality provisions will lead to an entirely new practice and business models for companies.

In the end, more patients in our health care system will mean the need for more doctors, and more health care providers, all of which will need medical education and CME to remain certified, licensed and up to date on the newest life saving technologies.

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