Kohl Targets Kopelow (and the ACCME)

This time the target is Murry Kopelow, MD, chief executive of the Accreditation Council for Continuing Medical Education (ACCME), the organization that bestows accreditation on MECCs, medical societies, and universities to deliver certified CME. Senator Herb Kohl (D-WI), chairman of the Senate Special Committee on Aging, sent a letter June 20 (link courtesy of Pharmalot) as part of an ongoing investigation to determine the influence that pharma has on CME. The contents of the letter indicate that Senator Kohl and the Committee have much to learn.

As the Committee continues its examination of the relationship between physicians and pharmaceutical companies, we have become concerned with reports that pharmaceutical companies are increasingly [emphases added] using continuing medical education (CME) events as a vehicle to increase the market for their products.

The opposite is true. Thanks largely to heavy fines exacted by the Office of the Inspector General (OIG) for off-label promotion,* pharma has become decreasingly involved in the development of content for industry-sponsored CME. In my MECC experience during the last several years, pharma has continued to play a decidedly hands-off role in the development of CME programs for which they provide financial support. Some companies have even gone so far as to recuse themselves entirely of reviewing the content (even for medical-legal purposes) before the program is released publicly.

According to the [ACCME] 2006 annual report, commercial support for CME activities accounted for $1.2 million, or half of the budget for CME courses in the United States.

For what it's worth, the most recent number may actually be a little higher, accounting for 60% of the US CME budget.

Of particular concern are instances where drug companies use CME courses to encourage physicians to use their products for potentially controversial medical practice. For example, it has come to the Committee's attention that one pharmaceutical company, which produces an anti-herpes drug, sponsors CME events which promote testing all pregnant women for herpes.

Senator Kohl may consider this nitpicking, but how does a CME program on pregnancy concern senior care? Couldn't the Senator or the Committee's investigators find a more relevant and objectionable CME program?

In any event, it appears that Senator Kohl is referring to GlaxoSmithKline's support of at least one Medscape-produced CME program ("Genital Herpes and Pregnancy"), which expired more than a year ago. GSK is the maker of valacyclovir (Valtrex), which is indicated for "the treatment or suppression of genital herpes [HSV] in immunocompetent individuals and for the suppression of recurrent genital herpes in HIV-infected individuals."

The Medscape program was delivered by Zane Brown, MD, Professor of OB-GYN at the University of Washington, and Serdar Ural, MD, then of U Penn, who (along with the accredited bodies of Medscape and the Medical Education Collaborative) are responsible for the program's content. Brown, in particular, urged HSV testing of all women during early pregnancy, which is based on (according to the program) his data published in the NEJM in 1997, JAMA in 2003, the American Journal of Obstetrics and Gynecology in 2004, and Obstetrics and Gynecology in 2005. Also Brown's experience with a newborn's death caused by congenital herpes (shown in the program) is probably enough for any doctor to mandate HSV testing for all pregnant women in his/her practice.

However, routine testing for herpes in pregnancy is not recommended by any scientific evidence or any national expert panel. In fact, the American College of Obstetricians and Gynecologists, the Centers for Disease Control and Prevention, and the United States Preventive Services Task Force all reject prenatal herpes testing due to the dearth of evidence that exists to recommend routine screening and the potential harm to many low-risk women and fetuses from the side effects of antiviral therapy.

Drs. Brown and Ural may disagree with the Committee (and again, shouldn't we be talking about conditions that affect the aging?) that "routine testing...is not recommended by any scientific evidence." And while it is true that the ACOG, the CDC, and the US Preventive Services Task Force do not recommend routine HSV testing for all pregnant women, this may be a point on which obstetricians reasonably disagree. For instance, in the Medscape program, the majority of program participants (64%) said that they do offer HSV testing to all of their pregnant patients. Dr. Brown also offers the following explanation about ACOG's recommendations to not routinely screen for HSV: "A reason that ACOG is reluctant to issue a new bulletin is because they are concerned about the medical-legal ramifications of widespread screening. On the other hand, I would just ask you to consider a woman whose baby develops a case of neonatal herpes..."

I am troubled by any attempt to persuade physicians to use a drug treatment for any reason other than the patient's condition and the drug's effectiveness in treating it.

Senator Kohl, at least as far as the Medscape program is concerned, appears to be missing its point. The program (as far as I read it) stresses the detection of subclinical HSV during pregnancy to reduce the risk of congenital HSV (which, at the risk of repeating myself, isn't relevant to the aging). Senator Kohl is also probably out of his league here and out of line when it comes to questioning the diagnostic and therapeutic recommendations of physicians (particularly academic physicians)—even if recommended treatment is off-label (which is any physician's prerogative, even duty). I certainly wouldn't want to get into a debate with Dr. Brown on this particular issue.

Therefore, it was with great interest that the Committee took note of the ACCME's credentialing standards and practices for CME courses.

In an effort to better understand the ACCME's credentialing standards and practices for CME courses, please provide us with the following documentation and information.

1.) a copy and written description of the accreditation process for CME courses;

2.) any criteria the ACCME uses, as part of the accreditation process, regarding the scientific validity of course content;

3.) any mechanisms that ACCME has in place to ensure that no undue influence by any industry is being exerted through CME courses; and

4.) any further plans the ACCME may have in place to develop such mechanisms.

Senator Kohl appears to be making a common error here, confusing accreditation with certification. Organizations are accredited by the ACCME to deliver certified CME. An accredited organization (eg, Medscape) certifies the CME programs it produces (and can do so, because it is accredited). Therefore, the ACCME does not oversee the production of individual CME programs and would not have direct oversight of an individual program's scientific validity (nor would the ACCME have the wide expertise that is necessary to oversee the scientific validity of the myriad CME programs). The duty is left largely to the faculty who participate in the content development and delivery of CME programs, as well as the employees of the accredited organization (which are often CME experts and/or health care professionals). The mechanisms that the ACCME has in place to mitigate undue industry influence are contained in the ACCME Standards for Commercial Support. The Committee can find "further plans...to develop such mechanisms" in the ACCME's recent Policy Announcements, a document I absolutely adore. 

MECCs = medical education communications companies.

* For example, see Harris G. Pfizer to pay $430 million over promoting drug to doctors. NYT. May 14, 2004.