No Strings Attached

“I was doing cartwheels — I was so happy,” says Gretchen Keefer, director of program development, Medical Education Collaborative. “We were able to do it right.”

Keefer's excitement bubbles over continually as she describes her experience developing educational programming about the management of respiratory tract infections. The project, which involved 19 programs held nationwide for groups ranging from 35 to 500 attendees, was funded by Aventis Pharmaceuticals, and accredited by MEC, a nonprofit education company with offices in Freehold, N.J. and Golden, Colo. So what's so unusual about the partnership?

According to all the players we interviewed — the faculty chair, the people from Aventis, MEC, and Aventis' advertising agency — everyone involved was committed to protecting the integrity and independence of the CME programs. Although interviewed separately, each participant echoed certain phrases when describing the project: clear boundaries, never felt compromised, hands-off, trust, communication, confidence. In other words, the partnership adhered not just to the letter of the law — the Accreditation Council for CME's Standards for Commercial Support — but also to the spirit of those regulations.

At a time when relationships between pharmaceutical firms and CME providers are under fire, with some charging that unbiased CME funded by pharma is an oxymoron, it's important to remember that positive interactions are possible, says Robert F. Orsetti, MEC vice president. A 30-year CME veteran who has worked on both sides of the fence — for CME providers and for pharmaceutical firms — Orsetti has seen plenty of permutations of CME provider/industry relations. “Sometimes you have to fight the commercial supporter every step of the way. But this was an example of how things can be done well, with the commercial supporter funding the project and then staying out of it. Aventis was acutely aware of the ACCME guidelines and committed to doing things correctly. We were not restricted in any way in the use of the grant. We were free to meet with potential faculty and set objectives without any restraints. They gave us access to materials, but never told us how to use them. It's nice to see that they appreciate that education and promotion are two different things, and that they allow the provider run the education.”

Independence Day

Right from the beginning, the roles of Aventis and MEC were clearly demarcated, says Keefer. “Sometimes a pharmaceutical company says, ‘We have this program ready to go; all we need is the accreditation.’ Yeah, right.” In this case, Stephen J. Glenski, PharmD, senior manager, national professional education, U.S. medical and regulatory affairs, Aventis Pharmaceuticals, Bridgewater, N.J., asked Keefer how she would develop education about the treatment of respiratory tract infections and the growing problem of antibiotic resistance. Aventis had a new antibiotic, Telithromycin, in the pipeline. “This was a new type of product for our company, so we didn't have a preconceived idea,” says Glenski. “We were all starting from scratch together.”

In more ways than one. Not only was Aventis a new company, formed in 1999 when Hoechst Marion Roussel and Rhone Poulenc Rorer merged, but Glenski had never worked with a CME provider before. He was impressed with MEC's professionalism, as well as its track record in the anti-infective area. Like Keefer, he had no concerns going into the project. “I felt a comfort level right off the bat,” he says. “I have a sense with people.”

But before Aventis would release the unrestricted grant, MEC had to sign a letter of independence in addition to the usual LOA (letter of agreement). “It says: We're giving you this grant, yes, but you understand that you are developing the educational content without our telling you what to do,” says Glenski. “We must have that signed and returned before we issue a grant.”

Orsetti has never encountered such a letter before. “It shows a real understanding and commitment to the guidelines,” he says.

The Good, the Bad, and the Ugly

Keefer spent about two months developing a plan and decided that the best approach was to design satellite symposia for annual meetings of medical societies, such as the American Society of Health-Systems Pharmacists, the American Geriatric Society, and the Infectious Disease Society of America. She also outlined target audiences, including physicians, pharmacists, nurses and nurse practitioners, research scientists, and managed-care specialists.

But first she wanted to learn all she could about the area. She asked Glenski if she could attend Aventis advisory boards and education sessions about Telithromycin. Glenski gave her carte blanche to meet with all the thought leaders in the area. “This is the first time I've been involved at such an intimate level,” Keefer says. “I got to hear the good, the bad, and the ugly. I got to talk very candidly with all the thought leaders.”

Because of her thorough research and preparation, Keefer was able to make decisions without consulting Aventis, which helped to ensure the programs were free of bias. “Steve gave me the necessary tools to make my own decisions. I didn't have to ask Aventis for faculty suggestions.”

Some providers do include commercial supporter representatives in their planning committees, but Keefer didn't in this case because she thought that would compromise the project's integrity. “I understood enough about the scientific issues that I felt like I could represent them well enough,” she says.

Keefer's “knowledge is power” approach was productive from Glenski's perspective as well. “Don't get me wrong. Gretchen and I had conversations about what directions she wanted to take with the courses,” he says. “I gave my two cents worth.” But he was able to take a hands-off approach, he says, because of his confidence in her grasp of the topic.

While some CME providers ask to be paid to attend advisory board meetings, Keefer did not. “She really wanted to know what external physicians, pharmacists, and nurses thought, so she could mold and create educational ventures and agendas that met everybody's needs,” he says.

Operative words: everybody's needs. No one in the partnership pretends Aventis's funding was for purely altruistic purposes. “They were preparing the market,” Keefer acknowledges. Adds Glenski, “Drug companies have ultimate goals of relaying how their products fit into a disease state.”

Nevertheless, Keefer stresses, the goal of the programs was strictly educational. “We were not making a commercial for Aventis,” she says. “We used straight scientific data. We were very careful not to discuss any information that had not been published and peer-reviewed. We covered every antibiotic on the market — the pros and cons — for respiratory tract infections. The fit was that Aventis had a new compound. Period.”

Finding Faculty

In addition to learning everything she could about respiratory tract infections at advisory board meetings, Keefer used the opportunity to scout for potential faculty. And one of the advisory board members did become faculty chair. David Nicolau, PharmD, coordinator for research, departments of medicine, divisions of infectious diseases and pharmacy, Hartford Hospital, Hartford, Conn.

Wait a minute. Nicolau was paid by Aventis while serving on their advisory board. Isn't that a potential conflict of interest? No, says Orsetti. “The ACCME rules apply no matter where somebody comes from. Many faculty people serve in other capacities. As long as [their relationships] are disclosed, I don't think it's an issue.” In looking over a sampling of the program brochures, one sees a range of faculty — some with financial ties to Aventis, some with ties to other pharma firms, some with no ties at all.

While it is acceptable for commercial supporters to suggest speakers, as long as the accredited provider makes the final decision, in this case Aventis did not even recommend faculty. “We partnered with faculty of our own choosing,” says Keefer, “and it was the faculty and MEC who had input into the program design — definitely not Aventis.”

Nicolau has worked on educational programs funded by a variety of pharmaceutical firms. “There are always those that perhaps want to be a bit more influential than they should be,” he says. “The provider acts as a buffer zone for the speakers or program chair. That hasn't been necessary in Aventis programs.”

Aventis was involved in talking to faculty when needed, Glenski says. For instance, right before one of the symposia, he participated in a conference call to apprise faculty on an FDA action Aventis was taking that related to Telithromycin, so they would be prepared in case they got questions from the audience.

But speakers were not pressured to bend content, says Nicolau. “We'd say, ‘Dr., this is the topic we'd like you to do a presentation about. You know what the important issues are — you develop the lecture.’ We did not corral speakers into using a certain set of slides.”

Keefer and Nicolau selected about 75 speakers. “We didn't want to do 19 programs with three speakers,” says Nicolau. Instead, speakers were chosen to meet the needs of the particular audience. That meant a lot more work for MEC. But it had positive results.

“Even if a program is fair, balanced, and meets all the requirements, it's easy to criticize it if you are parading the same people all over the country,” says Orsetti. However, a variety of programs and faculty shows “attention to needs in a particular area or region and shows that good programs can survive with different content and different faculty.”

Double Protection

Scheduling programs in conjunction with association conferences gave the project even more bias insurance, says Keefer, because associations enforce strict regulations regarding satellite symposia. In some cases, the associations interviewed faculty themselves. “It's another piece of the partnership. Everyone is protecting their ethics, accreditation, and reputation. [You've got] two accredited providers making sure one pharmaceutical company isn't being too hands-on.” There is a downside. “It made for a lot of paperwork. I'm working on my fourth filing cabinet right now.” Keefer quips, “We use a lot of trees.”

Communication, Not Coercion

Keefer kept Glenski informed about the project's progress, sending him packets of materials, including schedules, and copies of brochures and syllabi — after they were printed in final form. “They were done, so no suggestions could be made, nor were they made, regarding specific aspects of each program,” says Keefer. From Glenski's point of view, he didn't need to review materials before they were printed, because everything MEC did “was top notch. I trusted what they did.”

Aventis professional education research specialists did attend symposia, so if a question on the FDA status of the drug came up, the facilitator could tell attendees a representative from Aventis could answer their questions after the meeting.

Whether or not pharma reps in the audience should be allowed to answer questions has been a hot topic of debate at CME provider meetings. Glenski's opinion is that “commercial supporters should not be standing up and answering questions or providing comments about anything. It is not appropriate.”

No Back-Door Messages

Another potential problem area for CME providers is the relationship between the education and marketing campaigns. In this case, the relationship based on mutual trust and respect for boundaries extended to Aventis's advertising agency, KPR, in New York.

“We would work together as necessary,” says Keefer, “but everyone knew what the roles were from the beginning, so there was no overlap or controversy. I never sat in on marketing meetings. I never understood the [market] position of Telithromycin. There was no back-door message coming to me via the product manager — and we all know that stuff goes on.” Keefer credits Jennifer Boehmer, KPR vice president and account group supervisor, for her understanding of CME.

Because of the clear separation of roles, Keefer and Boehmer were able to share resources such as slides or artwork, which benefited both parties and Aventis. “You never want to reinvent the wheel or spend a client's money for no reason” says Boehmer. “But at no time were either of us pressured to use anything.”

High Marks

The programs were highly successful, says Keefer, with 60 percent of programs filling up before registration closed. Most sessions were standing room only. Evaluations showed that upwards of 90 percent of attendees felt that the programs met the objectives. Attendees were asked if they perceived commercial bias in the programs — none said they did, reports Keefer. The programs were so well-received, says Nicolau, because the agenda was based on the needs of participants, not the needs of the commercial supporter. “That's perhaps the important differentiating point,” he says.

But What About ROI?

The issue of how to demonstrate ROI from CME is a another hotly contested topic in the CME world. The people in pharma firms who allocate grants for CME are under increasing pressure to demonstrate to their superiors the measurable worth of CME, such as increased prescription rates, while CME providers believe that providing such data to commercial supporters is a violation of CME guidelines.

“We never measure prescribing behavior,” declares Orsetti. “A CME provider is not in the business of feeding back to the commercial supporter any [physician] change in prescribing behavior.”

In this case, the drug was in the pre-approval stage, so prescribing rates weren't an issue, but Glenski didn't ask for any proof of the education's benefit for Aventis.

“We were never asked to demonstrate ROI,” says Keefer. “Steve never commented on the symposia. The most probing question he asked was how many people attended.” MEC supplied Glenski with final attendance figures and summaries of evaluations.

“I don't track prescribing [behavior],” says Glenski. “I believe that the value of CME is that a large portion of the prescribing audiences get their educational information from live programs and printed materials. We know from advisory boards that people like to do things live. We know that if 450 people attended, at least half of those people learned something.” Looking at the bigger picture, Glenski says, “The bottom line is that people believe that it is the responsibility of the pharmaceutical community to provide support for education.”

The value of CME, says Orsetti, is greatest when the programs are truly independent. “I always tell commercial supporters that it pays dividends if you do it right,” he says. “Doctors have brains in their heads. They can see when [a program] is overtly commercial or biased. If you do it clean, you do a great service for physicians, and you get dividends because they recognize the value of what they are learning.”

Partnerships Are Work, Not Magic

Building a positive partnership between a commercial supporter and a CME provider is not magic, say the players in the Aventis Pharmaceuticals/Medical Education Collaborative initiative. Here are their tips:

• Up-Front Understanding From the very beginning, make it clear that the provider is in full control of content development, faculty selection, and needs assessment,” says Robert F. Orsetti, vice president, MEC, Freehold, N.J. “If the commercial supporter can't agree to that up front, then it's no deal.”

• No Strings The commercial supporter should not apportion dollars for elements of the program, such as content development or faculty, says Orsetti. “The use of funds should not be manipulated in any way.”

• Educate It's the responsibility of the provider to educate the commercial supporter about the Accreditation Council for CME's Standards for Commercial Support, says Orsetti. “Give them examples of what is appropriate and what is not appropriate. Tell them they can have some involvement, but the final decision is the provider's.”

• Respect Roles “It's critical that all team members respect each other's roles,” says Jennifer Boehmer, vice president and account group supervisor, with KPR, the New York — based advertising firm that handles Aventis. “The reason this team works so well is that no one ever crosses the line and puts anyone in a precarious position.”

• Understand Pharma's POV “It's very important that the CME vendor really understand the clinical needs, the product, the disease state, and what the pharmaceutical company believes about its product,” says Stephen J. Glenski, PharmD, senior manager, national professional education, U.S. medical and regulatory affairs, Aventis Pharmaceuticals, Bridgewater, N.J.

• Make Decisions The CME provider should not ask the commercial supporter for an OK on minor changes, says Glenski. “I honestly don't have time to baby-sit. I know a lot of vendors want you to approve everything. I don't really need to do that. I like to work with somebody who knows what to do.”

• Create Continuity “With some CME vendors, the turnover rate is so high, every time you turn around you are working with a different project manager,” says Glenski. “Gretchen [Keefer, MEC, director of program development] has been our contact from the first time we met her. That creates part of your comfort level.”

• Just Say No When commercial supporters do try to push the boundaries, “You can't say, ‘I'll take your money. Thanks very much. I'll do anything you want,’” says Orsetti. “If you're a properly functioning accredited provider, you have to make tough decisions when necessary. One of my strongest feelings is that if a company is doing something that is totally inappropriate, it is the provider's obligation to demand that it be changed, and if that isn't possible, then it's no deal. That's the bottom line.”