Commercial support — how to get it, how to eliminate the perception of bias that it creates, and how to collaborate effectively when commercial supporter and CME provider policies collide — is always a hot topic at the Alliance for CME Annual Conference. But when “Health Industry Practices that Create Conflicts of Interest,” an article written by several prominent physicians, came out in the Journal of the American Medical Association on the opening day of the 2006 conference in San Francisco, the topic went from hot to scorching. To protect CME activities from industry influence, the article calls for drug companies to stop awarding grants to CME providers. Instead, the authors recommend that companies donate funds to a centralized repository, which would then disperse them to CME programs.
Much outrage about the article was expressed among the approximately 1,350 attendees at the conference, held January 25 to 28. Many expressed the belief that instead of overhauling the funding system, the CME community should focus on following the current guidelines. Overall, there was a renewed sense of purpose among the attendees to “get it right” in their own processes and procedures, and to make sure they are doing all they can to eliminate the perception — and reality — of bias in CME. The sessions on commercial support were packed with CME providers and pharmaceutical representatives discussing ways to work together and provide the most effective education possible without stirring up more negative attention and regulation.
Pharma's Risk, Pharma's Rules
In an intensive session called Understanding Commercial Support 2006, Lawrence Sherman, CEO of the Physicians Academy for Clinical and Management Excellence, New York, led a panel of pharmaceutical representatives who explained to CME providers the constraints they're under in today's environment. (In response to panelists' request, we are not attributing quotes to specific individuals; however, a list of panelists appears on page 31.) As one panelist said, “If we don't make compliance job No. 1, the funds for CME may just dry up.” But compliance means something different for pharma than it does for CME providers, who mainly focus on complying with the Accreditation Council for CME's rules. One of the pharma panelists stressed thatrules are just one piece of the compliance puzzle for pharma, “and not one on the top of pharma's mind.” One company requires that providers sign an agreement to follow all the rules the company follows, including the Pharmaceutical Research and Manufacturers of America's Code on Interactions with Healthcare Professionals, the Office of Inspector General's pharmaceutical guidance, corporate rules, and state laws. “The OIG views pharma as guilty until proven innocent. The inability to prove compliance can be as costly as noncompliance,” a panelist said.
Because the OIG wants to ensure that pharma companies monitor and audit CME arrangements to prevent conflicts of interest, “pharma may very well be [scrutinizing grant proposals] to ensure the line budget items are fair market value, and that any foundation listed as a partner really is a 5013C by checking with searchable databases of IRS-recognized nonprofit organizations, such as GuideStar.com,” said one panelist. “For medical education companies, pharma wants to know that the firewall [between educational and promotional arms] is truly heat-resistant,” another panelist said. “We're not allowing vendors to cross the line at all. If you have our promotional business, you won't get our CME business.”
The pharmaceutical industry's focus on compliance with the OIG also may underlie some of the problems CME providers have using the increasingly ubiquitous online grant-processing systems. In a Pharmaceutical Alliance for CME dialog session, one attendee pointed out that the ACCME Standards for Commercial Support require a physical signed, but the offered by some companies' electronic grant systems only provide an online version. “Is pharma working with ACCME on this?” the person asked. “The short answer is ‘no,’” said session leader Maureen Doyle-Scharff, director, professional services and medical education, Ross Products Division of Abbott Labs, Columbus, Ohio. Another participant from pharma added, “Keep in mind that these online systems were built based on compliance with OIG and PhRMA, not ACCME regs.” In other words, at present, anyway, pharma companies need to focus on their own compliance issues, not CME providers' concerns.
Tips on Topics
CME providers had numerous questions about what pharma can and cannot support, in terms of types of programs, topics, and even meeting locations. The Neurontin case, in which Warner-Lambert paid a $430 million fine to settle charges that it had promoted off-label uses of its epilepsy drug, appeared to still weigh heavily in some pharma companies' decisions. When asked by the audience about pharma's willingness to support off-label CME, one panelist at the intensive session said that company policy is not to support it unless the company has a clinical trial in progress or an indication for a new use moving toward Food and Drug Administration approval. While most seemed to disagree, saying CME that covers off-label uses is still worth supporting, especially in cases where off-label use is the standard of care, they did offer caveats. “We have to make sure we're not just talking about off-label use,” said one panelist. Another added, “The point is that [CME providers] can [talk about off-label use] — we can't. Prove independence and verify that there's no conflict of interest, and you're fine.”
Providers also had a lot of questions about pharma's willingness to support an activity, such as medical ethics, that doesn't focus on a specific disease state. Pharma representatives at the PACME dialog session said that some companies include a list of “other” topics they're willing to support on their Web sites. Others have money set aside for “charitable contributions,” which this type of CME could fall under. “But keep in mind that charitable contributions are only maybe 3 percent of our budget,” said a panelist in the intensive session. “The bulk of the money will always be for evidence-based CME related to our product areas.”
Another panelist pointed out that there are some broad interest areas they'd be willing to support, such as education about cultural disparities in healthcare. “What trips us up is topics related to practice management — we're uncomfortable going into that arena.” Panelists stressed that more primary research would be needed during the needs assessment phase for this type of activity than may be necessary for specific disease-state-related CME.
Even if a company produces drugs for a disease state addressed by your activity, you might be out of luck, panelists at the intensive session said. For example, if the company sells products for gastrointestinal problems, but not specifically for gastroesophageal reflux disease, chances are they won't be willing to support an activity focusing on GERD. “I know you can't tie the activity to a specific product, but it would be a good idea to be more targeted,” said a panelist. To which a CME provider replied, “We can't get too specific, but if we're too general, we won't get the grant. We're in a Catch-22.”
One suggestion from pharma was to look at the company Web sites to see what products they have within certain disease states to see if your topic might be a good fit. “If there's a match, submit it. But don't make up a match if one doesn't already exist based on your needs assessment,” said a pharma representative.
Another tip was to see where the product is in its life cycle because, as a product matures, the funding shifts from CME to promotion. However, even activities covering mature products can be good commercial-support prospects, one panelist said. “If a mature product gets a new indication, it's like it's new again.” He added that sometimes his company will support an activity “because we're the market leader and we have to be there.”
When the audience asked whether companies limit the amount of support available to a specific provider over the course of the year, or limit the amount earmarked for activities about specific disease state activities, panelists at the intensive session explained that every company handled it differently. One panelist said, “We do limit dollar amounts for each disease state, and spread [commercial support for related activities] around geographically.” Another said his company limited the funds given to a specific provider “to the [dollar figure] the lawyers have determined would amount to us having bought the organization.” While panelists insisted that they did not keep a list of preferred providers, one did say, “We do have a list of medical education companies that do promotional work for us, and another for those that do medical education. We don't let anyone do both.”
Resorts: A Red Flag
CME providers also wanted to know if the word “resort” in a grant proposal would get their activity kicked to the “thanks, but no thanks” file. “The tendency is to see ‘resort’ and ‘Florida Keys’ and turn it down,” said one pharma representative at the PACME dialog. While some pharma participants said you can justify using a resort by making sure the education was the main focus of the activity and that the accommodations were appropriate, another wasn't as optimistic. When asked if a nice resort would be acceptable if the activity took place in the off-season and the education lasted all day, every day, the pharma participant responded: “I don't care if you got a $59 room rate and the education went 24/7. All that would get printed in the newspaper is that it was at a resort. Some brand hotels are off-limits, period. Remember that it's about perception, not actual costs. That's why any application with ‘resort’ in it will be kicked out.”
Likewise, some commercial supporters don't want to deal with activities held in another country. One panelist's company only funds activities on U.S. soil. Offshore activities “are a pain in the gluteus maximus. We end up having to ship the proposal off to attorneys in that country, and there's also tax involvement. It's just a nightmare.”
While pharma is interested in supporting outcomes measurement for CME activities, there still is some hesitation. As one panelist at the intensive session said, “It's still fairly new, and there are no standards for statistically measuring the data yet.” Another added that, because outcomes measurement is expensive, “I need to know what I'm paying for, and why.” Panelists also said that it is important that outcomes measurements do not track prescriptions to the commercial supporter's products. Also, the outcomes being measured should align closely with the activity's objectives, and the level of outcome being measured should be in line with what you can expect from a particular program. For example, an activity to raise awareness of guidelines for a particular disease state should stick to measuring the awareness that was raised, not a change in overall public health. “That would be a reach,” said one panelist.
Panelists also said providers should include control groups in their outcomes-measurements methodology, though there wasn't much agreement on whether or not it would be proper to include a financial incentive for control group participation, such as a certificate for Amazon.com or a dollar bill.
The pharma representatives on the panel did agree, however, that it's up to the provider to decide whether or not to use a third party to do the outcomes measurement, and to hire the third party themselves. “We approve grants with this as a budget line item all the time,” said one. And, the panelists added, the methodology should be determined from the start, so the provider can't change it in midstream if the results aren't fulfilling expectations.
But what if the outcomes show the activity in a bad light? “It has to be what it is,” said one panelist. “Good, bad, or ugly.”
The pharma panelists participating in the session, Understanding Commercial Support 2006: Avoidance of the Pain, Perils, and Pitfalls While Staying Safe, at this year's Alliance for CME Annual Conference, did not want their quotes attributed; however, some of them did allow us to list their names. The panelists included:
LAWRENCE SHERMAN, CEO, The Physicians Academy for Clinical and Management Excellence, New York (moderator)
DAVID T. RYBAK, CPA, director, Compliance Assessments & Records Management, Ortho Biotech, Bridgewater, N.J.
JON A. UKROPEC, PhD, associate director, Medical Education, McNeil Consumer Healthcare, McNeil Specialty Pharmaceuticals, & Ortho Women's Health and Urology, Fort Washington, Pa.
WALTER W. WOLYNIEC, MS, director, Medical Education, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Conn.
WILLIAM H. OLIVERSON, senior manager, Professional Education Support, Wyeth Pharmaceuticals, Collegeville, Pa.
MARSHA STANTON, deputy executive director, American Academy of Pain Management, Sonora, Calif.
Getting a Green Light
What do pharma companies look for when reviewing grant proposals for CME? This question was addressed during several sessions at the Alliance for CME Annual Conference in San Francisco. “We expect to get between 10,000 and 24,000 proposals this year. Short is good,” said one pharma. In addition to a good needs assessment, pharma companies also want details on how the money will be spent. “The main reason we turn down grants is that the proposals just present a need for a lump sum and don't break it down into what will be spent” in each area, said a pharma participant. “Also, we don't give grants if meals are more than $100 per person.”
One panelist broke down what his company looks for in grant requests:
- A signed grant request letter on official CME provider letterhead
- Budget with line items
- Thorough, referenced, and valid needs assessment
- Outcomes-assessment tools
- The general topic to be covered (but not the specific content)
- Tactical plan for the activity
- Type of audience
- Number of AMA PRA Category 1 ™ credits to be offered
- Type of program(s) to be supported (i.e., seminar, monograph)
- Name of any medical education or communication company that will be assisting with the activity, so the pharma company can ensure that it doesn't have a separate relationship with the MECC that could prove problematic
PACME Says: Fight Back
The publication of the Journal of the American Medical Association article condemning CME/industry collaboration (see main story) and subsequent related coverage in most major newspapers sparked discussion at the Pharmaceutical Alliance for CME session about the media's misconceptions about physician education. Participants decided that they needed to take action to both ensure CME's independence and counter media and government criticism of the commercial support system. Among their suggestions:
Do not allow any commercial support to go to individual clinical departments; work only through CME offices.
Encourage multicompany funding of CME activities. “Being the sole supporter these days just adds to the perception of bias,” said one pharma representative.
Write letters to newspaper editors and congressional representatives explaining the benefits of CME/industry collaboration.
In addition, there were suggestions that CME professionals from industry should work with other well-respected CME leaders and possibly the Pharmaceutical Research and Manufacturers of America and/or the Society for Academic CME, to create a white paper that outlines the history of collaboration between industry and CME, and the safeguards that are already in place to prevent bias.
Fix e-Grant Glitches
When asked what they'd like to see in an online grant-proposal system, attendees at a Pharmaceutical Alliance for CME dialog session at the Alliance for CME Annual Conference had plenty of suggestions, mostly based on their frustrations with the current processes. Here are their main recommendations:
Provide a logical budget entry form.
Allow enough characters in each entry line for a full description.
Make the forms stable and savable. Ensure that the system cannot time out in the middle of an entry.
Allow providers to upload budget, agenda, needs assessment, and other items.
Save the basic information (organization's name and address, for example) in the template.
List the main areas open to funding at the current time.
A few of the other suggestions were dismissed immediately. For example, some providers asked for a phone number to call for troubleshooting. A pharma representative replied, “I didn't understand when I was a provider how much money it costs to give away money. I would have to hire five more people to answer all those calls if we installed an 800 number.” The sheer volume of requests also makes it impractical for pharma companies to explain why each grant was rejected, or where each grant currently is in the process.
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Click here for more articles on CME and commercial support. Some recommended articles include “Getting to Yes,” “Code Blue,” and “Navigating Rough Waters.”