This Ethics Guideline for Pharma CME Support is a Pile of Malarkey!

A news item from a small corner of the world (the Irish Times) caught my attention. "Doctors told not to accept trips from drug firms' is the headline.

"DOCTORS MAY no longer accept direct invitations from the pharmaceutical industry for trips to international medical meetings, funded by drug companies, following the clarification by the Medical Council of its ethics guidelines..." said the article. 

"While accepting that payment of travel and accommodation expenses for doctors to attend meetings, either as participants or speakers, supports the aim of continuing professional development, the updated guideline says 'these payments should go through unrestricted education and development funds made available by the sponsoring company to the institution which is hosting the meeting or the conference organiser'." 

"Unrestricted education and development funds are not linked to or controlled by the organisations that contribute to them and healthcare institutions can choose to spend the funds any way they see fit," the clarification says [my emphasis].

What a pile of malarkey!

Healthcare institutions theoretically can choose to spend the funds any way they see fit THE FIRST TIME AROUND. It's virtually a sure bet that if they choose NOT to pay speakers for travel, they

1. won't have any speakers and/or 
2. won't get funded again by the pharmaceutical sponsor.

This is what makes ethics so ineffective in the real world. If the goal -- as expressed by the "Council" -- is to ensure that doctors' "professional judgment is not affected by the hospitality" of pharma companies, then pharma-sponsored CME should be banned outright. Otherwise, stop putting lipstick on this pig!

Psychiatry "Suicide" by Pharma

British psychiatrist and "Big Pharma gadfly" David Healy argued that his profession is “committing professional suicide” by failing to address its dangerously close relationship with the pharmaceutical industry. He made his argument speaking at an annual meeting of the American Psychiatric Association during a "well-attended session on conflicts of interest" according to this article.

Dr. Paul Appelbaum, a past president of the APA and director of Columbia’s Division of Law, Ethics and Psychiatry cited a study that showed "only 34% psychiatrists believe that receiving food or gifts affects their own prescribing patterns, 53% believe that it influences that of their colleagues... Research shows that this type of thinking — 'Everyone else is prone to biases and social factors, but not me'” — is common and confounds attempts to address conflicts.'At least some of our colleagues are wrong,' Appelbaum said drily of the study."

Healy offered some advice for how his profession can put some distance between it and the pharmaceutical industry.“The key issue in the short term is access to data. We have to insist on that,” he said. “We let industry come to our meetings and let them talk in our programs. I don’t think it’s huge problem that they get paid. The big problem is that if you ask for data, they can’t give it to you. That’s not science, that’s marketing masquerading as science.”

Daniel Carlat, M.D., director of the Pew Prescription Project, organized the session. Carlat once characterized pharma-sponsored Continuing Medical education (CME) as "a new twist on that well-known instrument of corruption, money laundering." Listen to the following podcast interview of Dr. Carlat on that issue:

Listen to internet radio with Pharmaguy on Blog Talk Radio

Pharma Support of CME at Lowest Level Ever Recorded!

According to data maintained by the Accreditation Council for Continuing Medical Information (ACCME), in 2011 the percent of accredited CME revenue attributed to the pharmaceutical/medical device industry (i.e., grants, advertising, and exhibit fees) was 33.2% of total revenue received from all sources.

This is the lowest percentage attributed to commercial sources since ACCME began reporting these data in 1998 when the percent was 34.0%.

Refer to the infographic on left (find a full size view on my Pinterest page here).

These data refer to CME offered primarily to national or international audiences of physicians and other health care professionals by provider directly accredited by ACCME. It does not include data from state-accredited providers.

For the first time, the 2011 ACCME Annual Report Data features separate data sets about the CME delivered by ACCME-accredited providers and by state-accredited providers, offering an overview of the CME system at both the national and state levels.

Whereas the total commercial support for direct ACCME-accredited providers was $1.033 billion ($736 million in grants and $296 million in advertising and exhibit fees) in 2011, state-accredited providers received only $28.5 million from the drug industry ($16 million in grants and $12.6 million in advertising and exhibit fees).

As the last chart in the infographic shows, the trend in the percent of physicians opting for online CME continues to decrease. About the same number of physicians participated in ACCME-accredit CME programs in 2011 as in 2010 (approx. 11.4 million), but a lower percentage (37.8%) participated in online CME (not including live sessions and search learning). That compares to 40.1% in 2010 and a peak of 41.9% in 2009.

Why are fewer physicians participating in online CME activities? There were 25,000 online CME activities offered by ACCME-accredited providers in 2011 vs. 23,300 in 2012. The decline, therefore, cannot be attributed to fewer available activities.

UPDATE: Hat Tip to Mario Nacinovich (@nacinovich), Managing Partner, AXON, for pointing out to me that the CME numbers I quoted above should be bolstered after implementation of the FDA opioid safety plan (see "Drugmakers must pay for opioid continuing medical education programs for physicians").

The FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics (find it attached to above article) calls for "education for prescribers of these medications, which will be provided through accredited continuing education (CE) activities supported by independent educational grants from ER/LA opioid analgesic companies." Unfortunately, the training is voluntary and won't begin until March 2013. The grants may or may not impact the 2012 ACCME data and reverse some of the trends noted above.

Pharma Support of CME Infographic

Pharma support of CME continues to decline, but at a slower rate.

"Other" Sources of Revenue (eg, registration fees, grants from gov't or independent foundations) have taken up the slack and then some so that 2010 revenue actually increased compared to 2009!

The distribution of CME income by source as a percent of the total looks more like the "old" days around the turn of the century.

A big surprise is the drop in percent of physicians opting to participate in online CME programs.

Source of Data: ACCME Annual Reports

ACCME's Dirty Little Commercial Funding "Secret"

Having nothing better to do on a Saturday morning, I posted results of my latest analysis of sources of Continuing Medical Education (CME) funding reported by ACCME (Accreditation Council for Continuing Medical Education) in its 2010 annual report (see "Pharma Support for Accredited CME Continues to Decline"). I was tardy in doing this yearly task -- the report was made public last July. Better late than never.

The real reason why I posted my ACCME analysis over the weekend, however, is because I had in my hands a study of physician attitudes about commercial support of continuing medical education that was going to be published on Monday and the data was relevant to the post I made after the study was published (see "Physicians Are Concerned About Pharma Support of CME, But Are Unwilling to Pay Their Own Way!").

In the meantime, Derek Warnick (@CuratioCME), CME Director at Curatio, an ACCME accredited medical education company (MECC), posted a response to my analysis of the ACCME data (see "Response to CME Post on Pharma Marketing Blog"). Derek takes issues with many points I made in my analysis, but the most interesting comment he made was this:

"I’m going to let you in on a little secret (although, if you work for an accredited CME organization, you probably already know this): those numbers used by the ACCME to report Total Commercial Support? Yeah, they’re not as cut-and-dried as you might think. Sure, you can look at them and say, “Hmmm... looks like MECCs are getting a LOT less commercial support.” But here’s the thing: the Total Commercial Support numbers you see only reflect the amount of commercial support given directly to the accredited provider sponsoring the activity [Derek's emphasis].

"So, if there is an activity that is co-sponsored by two accredited organizations, the organization responsible for certifying the activity is the organization that receives the commercial support. They then re-distribute the money to the other organization for their role in the activity. Typically, the organization that directly receives the commercial support reports the entire amount to the ACCME; the other organization doesn’t report anything. This has been my experience. The ACCME does allow the option of each organization individually reporting their split amount of the grant, but that gets pretty confusing if you have a lot of activities and lots of partners. The ACCME is fine with it either way; [Derek's emphasis] they just don’t want the money 'double-reported'."

This raises a couple of interesting question. First, however, let me say that this may not be as big a secret as Derek thinks.

In July, 2008, Pfizer announced that it would no longer directly fund CME courses provided by for-profit, third-party companies (MECCs) although it would keep paying for courses offered by medical schools, teaching hospitals and medical societies. Shortly after that, I hosted a survey (see "What's the Best Way for Pharma to Support CME?") that asked respondents if they thought all pharmaceutical companies should follow Pfizer’s lead. The following chart shows the results:

An anonymous respondent clued me in on the "little secret" Derek referred to in his post:

"Med schools, teaching hospitals, and medical societies frequently use MECCs to create their CME anyway, and unless CME is funded by pooled grants (ie, from multiple pharma companies), the bias will be no less than it is in the MECCs, or not much less."

Derek claims that because of this kind of "subcontracting," MECCs may not be getting as small a piece of the CME funding pie as I estimated from the ACCME numbers. Fair enough. But I note that only a small fraction of MECC respondents to my survey thought it was a good idea for other pharma companies to follow Pfizer's lead. That's understandable, because MECCs would have new academic bosses to deal with who may nickel and dime them. It's much better to get your slice of the pie direct from the baker than to beg a piece of someone else's slice!

I think Derek agrees with my analogy. He said:

"How often does this happen? Well, I can’t really speak for other companies, but my guess is it hapens (sic) a lot more frequently then it did 5 years ago. As already mentioned, the Pfizer’s and OMJ’s of the world no longer provide commercial support to MECCs. That eliminates a pretty big chunk of money that MECCs used to report to the ACCME. The alternative now is to find another accredited partner, such as a medical school or physician society, to co-sponsor the activity. That medical school or physician society is the accredited provider and they receive the commercial support. So in the past, where a MECC would have directly received a $100,000 grant from Pfizer (and reported it all to the ACCME), now a co-sponsor receives the $100,000 grant, reports it all to the ACCME, and then sends $50,000 to the MECC (or whatever the split is) for their role. That’s a $200,000 swing in how the commercial support is reported to the ACCME, when in reality the actual difference is only half that. Again, the ACCME is OK with this."

So, Derek and I agree that MECCs are losing more than just crumbs from the pie, but we differ on exactly how big the pieces really are. The more important issue, however, concerns bias. Is there any less bias in commercially-supported CME if industry funding in channeled through medical schools and medical societies to for-profit MECCs than if the funding went directly to MECCs?

Further reading:

• "Waning Pharma Support of CME: The Plight of For-Profit MECCs"

Physicians Are Concerned About Pharma Support of CME, But Are Unwilling to Pay Their Own Way!

Talk about having your cake and eating it too! Commercial funding of continuing medical education (CME) and the potential for bias appear to concern many physicians, yet only a TINY MINORITY (7%) are willing to pay registration fees to eliminate or offset commercial funding sources, according to a report in the May 9 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

Maybe physicians would like ObamaCME; ie, government subsidy of their education?

No, not quite. But they are willing to give up certain things to reduce costs such as eliminating a printed syllabus. They are not, however, keen to give up the free coffee and snacks!

The authors surveyed attendees at live CME courses delivered by the International AIDS Society–USA (IAS-USA), a nonprofit organization that pools the support it receives from industry so that no one company funds any particular program. In total, 770 attendees (a 57% response rate) completed the 22-item survey, which focused on beliefs about commercial funding and potential for bias, willingness to offset the cost of commercial support, knowledge about the costs of producing CME programs, and demographic information.

Although the study surveyed nurses, nurse practitioners, physician assistants, and persons with Ph.D.s or other academic degrees as well as physicians, I'll just focus on the responses from physicians (N = 378).

Potential for Bias
Although he authors never specifically define what they mean by "bias," I think we all know they are referring to influence over the content of CME courses in such a way as to benefit the commercial supporter.

There are several opportunities for bias to creep into CME, all of which involve money from drug and device companies:

• Faculty members' research may be supported by grants from companies
• Faculty members may be paid members of company speaker bureaus
• Faculty members may be paid directly to speak at CME programs
• The CME program itself is supported to some degree by a grant from a single or multiple companies

Of course, some CME programs are not funded in any way by the drug industry and is paid for entirely  from registration fees paid by physicians (the Institute of Medicine estimates that physicians, on average, spent slightly more than $1400 per year for CME in 2007).

The survey asked physicians how they would rate the bias of CME programs under each of these scenarios. The results are presented in the chart below:

This chart shows the percentage of physician respondents who believe the listed CME funding options have a moderate or large potential for bias.

According to the respondents to this survey, the least potential for bias in CME is when the faculty is completely independent; ie, receives NO funding of any sort from the drug/device industry. However, that is an unlikely scenario given the fact that perhaps 80% of the CME faculty pool receives some form of funding from pharma/medical device companies.

"Speakers will continue to have relationships with industry in various ways, especially for research funding," noted authors of a commentary that was published in the same journal as the report. "Bias will always need to be addressed through speaker disclosures and direct monitoring for bias at CME events."

Given that so many physicians feel that pharma support of CME introduces bias, you would think they would want to eliminate that support. Actually, only 17% of physicians surveyed agreed strongly or somewhat that commercial support of CME should be eliminated entirely (see chart below) and 56% agree that "Pharmaceutical/medical device company support is essential for accredited CME and should not be eliminated" (data not included in following chart).

Physicians were asked what they would be willing to do to "eliminate the need for pharmaceutical/medical device company support" of CME activities they attended. The choices are shown in the list in the above chart.

Only 50% of physicians would give up free food or snacks to eliminate the need for commercial support of CME. BTW, these costs are substantial. Hotels -- where most live CME programs are held -- charge as much as $8.47 for a cup of coffee! "A $9 cup of coffee may not seem to be the most economical use of CME dollars," noted the authors of the study.

It's the Internet Age, Stupid!
Reducing the cost of CME seems to be the best way to eliminate the need for commercial support.

"Barring a substantial reduction in the cost of delivering CME, however, a rapid reduction or elimination of funding might be unacceptably disruptive, and some have postulated that such a change will result in the disappearance of live CME as we know it..." said the authors.

What better way to reduce costs than by delivering CME via the Internet? The survey did NOT ask if physicians would participate ONLY in online CME programs if that meant eliminating the need for commercial support. In fact, more and more physicians are receiving CME credit online (see "Pharma Support for Accredited CME Continues to Decline").

Yes, delivering CME via the Internet would "result in the disappearance of live CME as we know it," but that's a good thing, not a bad thing, given the exobitant costs and biases in the CME as we now know it, IMHO.



Summary of Survey Results

Pharma Support for Accredited CME Continues to Decline

Pharmaceutical industry support - ie,  direct sponsorship PLUS advertising - of physician continuing medical education (CME) declined 13.3% in 2009 compared to 2008. This is based on income data (see here) provided by the Accreditation Council for Continuing Medical Education (ACCME). This marks the second consecutive year of decline as shown in the following chart:

The following chart illustrates the trend in both types of CME income (direct commercial support AND advertising income) that CME providers receive from pharmaceutical companies:

The pharma industry supports CME by funding different types of ACCME-accredited CME providers. These include for-profit Medical Education Communications Companies (MECCs), medical schools, and physician societies. The following chart shows how this funding has changed over the years:

Physician societies and medical schools continue to take pharma CME money away from MECCs as shown in this graph:

Online CME Trends
Meanwhile, the percentage of physicians who receive CME credit online continues to increase, albeit at a slower rate -- at least for the time being -- as shown in the following chart:

The above chart includes physicians who participating in "Enduring" online CME activities, which ACCME defines as: an Internet that is "available when the physician participant chooses to complete it. It is 'enduring,' meaning that there is not just one time on one day to participate in it. Rather, the participant determines when he/she participates. (Examples: online interactive educational module, recorded presentation, podcast)"

The chart does NOT include physicians who participate in "Live" Internet CME; ie, "an online course available at a certain time on a certain date and is only available in real-time, just as if it were a course held in an auditorium. Once the event has taken place, learners may no longer participate in that activity. (Example: webcast)"

In 2009, only about 38,000 physicians participated in live Internet CME courses compared to 4.5 million physicians participating in enduring online CME.

NOTE: These numbers refer to the number of registered attendees of CME events. Some physicians may attend more than one course and thereby be counted more than once.

Internet Searching and Learning
A third type of Online CME defined by ACCME is "Internet Searching and Learning," in which about 116,000 physicians participated in 2009. This is a CME activity "in which a learner accesses the content of the activity directly from the internet. This is differentiated from a 'course' and an 'enduring material' because the provider does not create the content but rather the learner chooses content based on what (s)he feels meets their needs or answers their questions."

Wow! Physicians can get CME credits just by searching for medical information on the Internet. No wonder Wikipedia has become an important source of information for physicians!

For-profit MECCs were responsible for 99.5% of physicians (115,324) who received "Internet Searching and Learning" CME credits.

I suppose MECCs draw up a list of multiple-choice questions that physicians must answer after searching the Internet. Perhaps they are directed to search certain sites such as WebMD or Wikipedia. It's likely that nobody reviews this information to determine if it is "unbiased." It's possible, therefore, for pharma companies to publish non-peer-reviewed content on these sites and thereby "game" the process and not be held responsible for sponsoring "biased" CME content.

P.S. The 2010 ACCME annual report will be available sometime this July at which time I will update these charts.

New PhRMA Survey of Physicians: Are Sales Reps as "Useful" as PhRMA Wants Us to Believe?

"New Survey Emphasizes Value of Biopharmaceutical Company Engagement With Healthcare Providers" is the main point PhRMA (Pharmaceutical Research and Manufacturing Association - the industry trade association) emphasized in its press release (here) regarding a survey of physicians it sponsored. PhRMA also pointed out that nearly 9 out of 10 physicians considered company-sponsored peer education programs to be "up-to-date, useful and reliable."

That's good news for pharmaceutical marketers who spent $24 billion between October 2009 and September 2010 on physician-targeted promotional spending, not including nearly $1 billion on continuing medical education (more data on promotional spending will appear in a Pharma Marketing News article to be published later today). It's good news because the survey justifies devoting the bulk of that promotional spend to support physician detailing by sales reps.

Of course, it's always educational to go beyond the PR and the trade publication stories that merely rephrase the PR (eg, this story) to learn something new, even some things the drug industry may not want you to learn.

For instance, look at this survey result that PhRMA doesn't mention:

What I notice is that only 22% of physicians surveyed said that patient access to the care they need is "working best." There is some survey results interpretation issues here, but it seems that access to care may be a problem in the US according to physicians. And without access to care, everything else -- including the value of medicines, the quality of care in general, and the value of pharmaceutical sales reps -- means nothing. Of course, "access to care" is probably a physician buzz-phrase related to the shortcomings of "managed care" and even "Obamacare."

The very first sentence in PhRMA's press release emphasizes that "Nearly eight out of 10 physicians view pharmaceutical research companies and their sales representatives as useful sources of information on prescription medicines." What PhRMA does NOT say, however, is more telling. Take a look at this survey result:

What I notice is 38% of physicians find Web-based sources of medication information "very useful" versus 26% who find sales reps very useful for that information. Hmmm... either sales reps are not doing their job as well as the Web or maybe they are doing their jobs TOO well -- ie, providing company-sanctioned and biased information rather than information physicians think is useful. Or you could look it another way -- maybe docs are finding a lot more useful "off-label" information on the Web (and CME, which ranks #1?) -- information they technically cannot get from sales reps.

As with any survey, it is difficult to interpret the results of this survey, which allows for all sorts of spins. You can find the entire survey results attached to this Pharma Marketing Forums post.

Are Docs Being Banished from Pharma's Garden of Eden?

"It is a breathtaking sweep to squash something that is really important to us, the science going on in the private sector," said Francis Collins, director of the National Institutes of Health, at a meeting in Bethesda, Md. At issue is a decision by the American Heart Association (AHA) to ban pharmaceutical industry employees from making medical education presentations later this year at the AHA's annual scientific sessions (see "Drug firms banished from medical talks").

"The policy is blood-curdling," said Keith Yamamoto, executive vice dean of the University of California, San Francisco School of Medicine. "This is conflict-of-interest considerations run amok."

Wow! It's as if physicians were banished from an Eden where they enjoyed the fruits of the tree of knowledge made accessible by the pharmaceutical industry. To some, it's a development of biblical proportions that deserves an appropriate image:

Before the drug industry advocates get their panties in a bundle over this, let's see exactly what the AHA says about the policy (find it here):

"In compliance with ACCME requirements, employees of a commercial interest entity cannot be the presenting author of the abstract. A commercial interest is defined as any entity producing, marketing, re-selling, or distributing healthcare goods or services consumed by, or used on, patients. For our purposes, an employee is defined as someone who is directly working for the commercial interest as their primary employer and the commercial interest provides their primary source of income. A person acting as a contractor to a commercial interest, providing consultation, or other services secondary to their primary appointment at, for example, a university, would not be considered an employee."

"If the abstract is selected for presentation (oral or poster)," says AHA, "the employee of the commercial interest cannot present but must select another author."

What this means is that an abstract that is authored soley by a physician or physicians DIRECTLY employed full-time by a pharmaceutical company can be blocked. Otherwise, another, non-pharma employee author can make the presentation. There is almost always other non-pharma authors, including the physicians who ran the clinical studies being reported. Also, ghostwriters can make presentations, as indicated by this FAQ from AHA:

Q: I am the primary author of an abstract and designated as the presenter. I am currently employed by a home health agency. Can I still present my abstract?

A. Yes, the ACCME does not consider providers of clinical service directly to patients to be commercial interests.

IMHO, all the fuss over this AHA decision is unjustified as far as physician education is concerned. It may, however, be a blow to pharma research physicians who do all their clinical trials in-house without using independent physicians outside the firm. And that kind of "science" we can do without.