Alliance day4: Commercial support marathon

That's right, this morning was a three-hour, 45-minute, no-break marathon on everything you wanted to know about commercial support, but never had the opportunity to ask. Led by moderator Lawrence Sherman, who I just learned today has left Jobson to be the CEO of The Physicians Academy for Clinical and Management Excellence in New York, the session consisted partly of presentations from a panel of pharma folks (and one ex-pharma person), and partly of lots and lots of Q&A from the audience. I don't know if I have the stamina left to post everything they talked about (look for more in the next issue of Medical Meetings), but here are some of the highlights.

But first, my favorite quote from the session. An audience member who had attended this session for the past couple of years said at the outset, "I've found the Pain, Perils, and Pitfalls sessions gave me more pain than pleasure. Can we have a better balance this year?" Alas, since the situation remains painful, that person probably left looking for an aspirin once again.

Supporting off-label CME: When asked by the audience what the situation looks like nowadays for getting support for off-label CME, one panelist said, "Our policy follows the Neurontin case. If we don't have a trial in place or an indication moving forward, we won't support it." Another said, "The label is irrelevant to CME as long as what you've done represents the true and complete story." The echo from another panelist: "If the grant request is based on appropriate science, the label doesn't matter to me." One panelist said that most CME contains some discussion of off-label use. "We just have to make sure we're not just talking about off-label use." Another added, "We would not support an activity that just talks about off-label use and nothing else. While the OIG isn't focusing on CME, they will get to it." But if the off-label use is the standard of practice and you don't teach it, that wouldn't be right. "The point is that you can do it—we can't. Prove independence and verify that there's no conflict of interest, and you're done," said a panelist. Sherman added, "Keep in mind the confluence of the needs of the learners, commercial supporters, and providers when justifying the use of off-label discussion. You have to figure out where the point is where all these needs meet."

Supporting non-specific-disease-state CME

Another burning question from the audience was about the chances of getting commercial support for CME that doesn't focus on a specific disease state. One panelist said his company does a few of these a year, but most of what they support is disease-state-specific.

Meeting outside the U.S.

One audience member who works for a U.S.-based organization that will be holding a meeting in Canada. Whose rules rule? The panelists agreed that it should be U.S. rules. One whose company's headquarters is based outside the U.S. said enterprising MECCs where getting to know marketing managers in other countries in the effort to gain a foothold with them. "We trained the other offices to kick anything that mentions ACCME back to the U.S." to stop that from happening, he said. Another panelist said that any grants they provide must take place on U.S. soil. "The others are a pain in the gluteus maximus. We end up having to ship the proposal off to attorneys in that country. There's also tax involvement—it's just a nightmare."

Compliance is job #1

This came through loud and clear from the pharma panelists. One even started her presentation by quoting the Ford motto, adding, "if we don't make compliance job #1, the funds for CME just may dry up." She reminded the audience that ACCME rules are just one piece of the puzzle, and not one on the top of pharma's mind. "We have providers sign an agreement to follow all the rules, including corporate and state rules. We can work together as long as we make sure it's done ethically." She added that the Office of the Inspector general views pharma as "guilty until proven innocent," adding that "the inability to prove compliance can be as costly as noncompliance."

Compliance also means ensuring that there are no conflicts of interest of any kind, including being able to verify and document all due diligence. The OIG is looking for policies and procedures, monitoring and auditing, ensuring that there's a compliance officer, and training and education in following the rules. This means pharma may very well be double-checking providers on things like ensuring the line budget items are fair market value, and that any foundation listed as a partner really is a 5013C by checking with GuideStar. For medical education companies, pharma wants to know the firewall is heat resistant, this panelist said. "This is critical. We're not allowing vendors to cross the line at all. If you have our promotional business, you won't get our CME business."

A smaller pharma company person from the audience asked if her company had to do everything that big pharma does. The panelists were a little mixed on the answer. One said that OIG won't expect them to do everything the big companies do, but to document your processes and the intent of your compliance program. Another said, "I disagree. If you don't have enough people to do all the screening and monitoring, you need to go to management and plead your case. OIG doesn't care if you're big pharma, small pharma, or a MECC. If you don't audit, monitor, and correct, all you have are words on a paper." Another added, "You need to have and follow defined processes. FDA and OIG are tracking all the dollars."

Support for disease-state topics that may not cover a specific product category within that disease state

An audience member spoke of a dilemma: "We recently had a grant turned down under general GI disease because it didn't meeting their guidelines for a sub-topic under GI: GERD. One panelist said that if it doesn't cover that company's interests, don't submit it. "Keep in mind that we're restricted," another panelist said. "I know you can't tie it to a specific product, but it would be a good idea to be more targeted. It's a fine line." To which a provider replied, "You can't get too specific, but if you're too general, you won't get the grant. We're in a Catch-22."

Panelists suggested looking at the Web sites to find topics they would be willing to support within that disease state. "We offer some of the top-level learning objectives we're interested in to help guide requestors, and our lawyers are comfortable with that." Another suggested scoping out the company's Web site to see what they're doing in that topic area. "If there's a match, submit it. But don't make up a match if one doesn't exist already from your needs assessment."

What pharma wants

One panelist outlined what his company was looking for in some areas. For a grant request, that means: a signed grant request letter on official provider letterhead; budget with line items; thorough, referenced, and valid needs assessment; outcomes assessment tools; general topic (not the content); tactical p lan of the activity; type of audience; number of credits; type of program(s) to be supported (monograph, seminar); name of any company that will be assisting with the activity so the company can ensure that it doesn't have a separate relationship that could prove problematic.

Can we meet face to face?

Providers really want the chance to plead their case to a live human, and not rely on an impersonal Web site that doesn't let them explain the nuances. Not going to happen, said the panelists. "Submit a request and if we're interested, we'll get in touch with you" to find out more about who you are and what your activity is all about.

How do pharma companies decide how much to spend on what? Does marketing have a say?

The question: "When you do your budget, do you h ave a strategy for the types of grants you want t o fund and wait for them to come in, or do you just evaluate the ones that come in based on your disease states of interest?" The answer: "Yes." Another panelist said his company does its own needs assessment to determine the relevant audience and what type of education is most likely to affect that audience. "We do this with compliance, medical affairs, finance, and sales and marketing." But should sales and marketing be involved in this type of decision? "The OIG says sales and marketing shouldn't be involved in granting functions, but our money comes from the sale of our products, bottom line. During our budget planning season, we ask them for general directions, but not specific guidance. After all, the money comes from them."

Another pointed out that every company is set up differently, and some medical affairs departments actually compete with sales for the dollars. Others get the money straight from corporate. "Sales might see our budgets and line items, but not our grant requests. After a grant is approved, we can share."

Providers also wanted to know if there are limits on the number of grants, or on the dollar amount, they give to a particular provider over the course of the year. "We do limit dollar amounts for each disease state, and spread them around geographically. But this really refers mainly to grand rounds," said one panelist. Another said his company limited the dollar amount given to a specific provider to "the amount the lawyers have determined would amount to us have bought the organization." Another added that the senator investigation by Grassley et al is looking closely at this area.

Do pharma companies have a list of preferred providers that they use? If so, would they be willing to share it with third parties who also want to work with providers supporters like to work with?

Most of the panelists said they didn't keep a list like this. "We work with the same people more than once, sure, but we don't keep a list." Another said, "You as providers need to qualify your own MECCs, do your own due diligence." Sherman added that sharing such a list, even if they had one, would entail a huge potential legal liability. A panelist added, "We have to be careful not to be a perceived agent of record." Another said, "We do have a list of med ed companies that do promotional work for us, and another of those that do med ed. We don't let anyone do both."

What about three-way contracts?

Well, it varies from company to company. "We only sign letters of agreement with the provider, and the provider works with their providers. We steer clear of three-way contracts," one panelist said. Another said, "We want a contract with all the providers." Yet another said, "We want them all listed in the LOA, but it has to be signed by the provider." Another added that they insist on including a line in the LOA that the MECC isn't involved in anything on the promotional side.

If it's a joint or co-sponsorship, one panelist said he would want signed letters from both partners; another said one letter is OK, but it has to be signed by both.

Any spinoffs from the conference, such as monographs or CDs based on the main event, also should be determined ahead of time, including who is going to produce them.

Why support a didactic dinner lecture that you know isn't going to change behavior?

One panelist said that, while the lecture might not be the best vehicle for learning, its effectiveness in large part depends on where the product is in its life cycle. "If it's new, that big association dinner meeting is the perfect place for that product. And if a mature product gets a new indication, it's like it's new again."

"It's not wrong to support a large, didactic activity," said another panelist. "We have a brand in a mature market, and there's no need to do a lecture. But we're the market leader, so we have to be there. We'll do it for goodwill and public relations, support whatever the provider thinks would be important for people to learn."

More on product lifecycles

One panelist pointed out that, as a product matures, the funding shifts from CME to promotion. "Keep the lifecycle of the product in mind when making a grant request." Another added that patent expirations, which are public records, also can be a way of seeing when a product is nearing maturity.

All about outcomes measurement

Pharma says its interested in supporting outcomes measurement, but it's not without its challenges. For example, outcomes measurement is still fairly new, and there are no standard was of statistically measuring to get the data as of yet. Also, since the data providers give to supporters may go beyond the medical affairs office, it needs to be in a format that's easily understandable to people who aren't well-versed in CME. And the methods need to be spelled out: "Outcomes are expensive, so I need to know what I'm paying for, and why."

There also are limitations on outcomes measurement when a commercial supporter is involved. For example, the architecture and methodology could pose a problem for funding if it appears to be specific to prescriptions to that company's drugs. While scrip data of a drug class is not forbidden, one has to be careful not to get too specific. Also, the outcomes being measured should align very closely with the objectives of the activity. The level of outcome being measured also should be aligned with what you could expect from that program. An activity to raise awareness of the guidelines for a particular disease state, for example, shouldn't measure level five gains in overall public health statistics. "That'd be a reach," said one panelist.

One area of non-agreement among panelists was if a financial incentive were involved in recruiting a control group (which most said was a must-have for any credible outcome measure). "If they were going to give an certificate to incentivize the control group to participate, we'd have a problem with that," said one panelist. Another added that they couldn't support a study that included an exchange of money or gifts, while yet another panelist said "we don't mind a small payment to those who participate in the control group for outcomes measurement. It's not our relationship with the physician; it's the provider's." To be safe, another said she'd run it by her lawyer if she saw that as a line item. "I'd find the $100 dinner more problematic that $5 sent with a survey," a panelist retorted.

As to whether a third party should be funded separately by the supporter to do the outcomes measurement on another provider's activity, well, some perceived that to be too close for comfort. While an outside pair of eyes can find things the provider may not, there could be all kinds of problems with things like getting a detailed list of participants, understanding the content well enough to measure outcomes, and the potential for it being seen as attaching a string or condition to the grant. A panelist said, "The provider should do the outcomes." An audience member agreed, saying, "It's part of the educational process and should be the provider's job to do." Another added, "If a third party is going to do it, the provider should hire that third party." The panelists said that they approve grants with this as a budget line item all the time. And the methodology should be laid out from the start so the provider can't change it in mid-stream if the results aren't looking too good.

But what if the outcomes don't turn out so great? "It has to be what it is, good, bad, or ugly," replied a panelist.

There also was some discussion of what seems to be a highly theoretical potential problem with outcomes measurement, i.e., what to do if an adverse drug reaction is uncovered during the outcomes measurement. This only would happen with chart audits and, as one panelist said, "If I know enough about an individual patient's adverse event to report it, I'm getting information I shouldn't get. We're getting into HIPPA territory." This would be much more likely to come up at a promotional event, another added, where someone might stand up and say the drug didn't work.

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