Those of us who have followed the progress of the implementation of the Physician Payment Sunshine Act have been acutely aware of one potential loophole: drug companies might try to hide payments to doctors for industry-supported CME activities. That’s because these payments are not “direct” payments to doctors, but rather indirect payments.

In a 2007 op/ed piece for the New York Times, I referred to this arrangement as a money laundering scheme: “Essentially, this is a new twist on that well-known instrument of corruption, money laundering. Drug companies don’t directly pay doctors to teach courses. Instead, they pay someone else to cut the checks. Similarly, the drug companies don’t explicitly tell doctors to say good things about their products. Instead, they hire a company to write good things about their products and to pay doctors to deliver the messages.”

Nothing substantial has changed about this cloak and dagger payment process since 2007—other than the fact that the total amount of commercial support for CME has dropped substantially, from a high water mark of $1.2 billion in 2007 to $830 million in 2010—a decrease of  37%. But $830 million is still a chunk of change, and some unknown portion of that sum is paid directly to physicians by the CME provider.

Therefore, those of us in favor of transparency were able to breathe a sigh of relief when CMS recently unveiled its proposed regulations. Drug companies will, in fact, be required to report payments that flow through third party entities and end up in doctors’ pockets, as long as the company is aware of the identity of the doctor. And how could they not be aware? ACCME requires all CME programs to publically disclose the identities of both the industry supporter and the faculty—meaning that companies will eventually always know which doctors end up partaking of their “educational grants.”

In closing this loophole, CMS officials were hardly acting on their own—they were simply implementing the Sunshine Act as it was approved by Congress. In fact, if you look at the text of the Act, it is hard to imagine any reasonable interpretation other than CMS’s. Here’s the crucial opening paragraph of the law, which sets the context for the entire Act:

“On March 31, 2013, and on the 90th day of each calendar year beginning thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (or to an entity or individual at the request of or designated on behalf of a covered recipient), shall submit to the Secretary, in such electronic form as the Secretary shall require, the following information with respect to the preceding calendar year….” (my italics).

The language is technical, so let’s unpack it a bit. “Applicable manufacturer” means a drug or device company. “Transfer of value” means giving a doctor anything of value, including cash, meals, and gifts.  “Covered recipient” means a physician, dentist, podiatrist, optometrist, or chiropractor—all of which are professionals covered by the law. So far, the law is saying, in common parlance, “Any drug company that gives money or something else of value to a doctor…will have to report this to the government.”

But the framers of the Act went out of their way to acknowledge that sometimes these payments are indirect, and that such indirect payments should be reported as well. How else could you interpret all the language in parentheses: “ …Or to an entity or individual at the request of or designated on behalf of a covered recipient.”  To translate again: the Act is saying here that drug companies must report payments to any “entity” (eg., a MECC, a medical society, a non-profit organization) that takes payments from drug companies when those payments are actually “designated” for a “covered recipient”, ie., a doctor.

It seems quite clear, but of course both drug companies and those MECCs dependent on drug company grants are viewing this issue differently–see, for example, Tom Sullivan’s take in this article on his blog Policy and Medicine. So stay tuned. Hopefully CMS will stick to its guns and issue final regulations that will not allow drug companies to cast a shadow on a major source of physician payments. Let the sun shine in!

For those who have not yet heard, there is a new lobbying group in Washington, the CME Coalition. Their mission is to polish the tarnished image of industry-supported CME, in the hopes, apparently, of fending off any future legislation that would further regulate industry funding of CME.

Now, if you read the organization’s mission statement, you would get a different impression, since it mentions nothing about commercial CME, diplomatically framing their goals in terms of educating policy makers about CME in general. But the steering committee belies their true agenda—there are currently six member organizations: five are Medical Education Communication Companies (MECCs) and one is a pharmaceutical company, Cephalon.

I’m not saying they are trying to deceive anyone, this is just the way Washington works—you officially frame your special interest group in impartial and balanced terms, and then once you are in the halls of Congress, you push your agenda like a tiger with teeth bared. That’s what lobbyists are paid to do, and the coalition has hired two high powered lobbyists already—including Andrew Rosenberg, a former personal staff member of Senator Edward Kennedy and former head of health policy practice at Ogilvy, which describes itself as “arguably the largest direct marketing and interactive marketing network in the world.”

The CME Coalition isn’t fooling around.

Today, Thomas Sullivan, on his blog Policy and Medicine, announced that the CME Coalition has adopted a new “CME Code of Conduct”–a 10 commandments of ethical CME. Reading through them, I found nothing objectionable and much to agree with. Commandments 1 and 2 particularly warm the cockles of my heart:

1. Decisions concerning CME activity design and content, and decisions related to the support of CME, will always be made in the best interests of improving patient care and addressing public health needs.
2. CME content will always be evidence-based and free of inappropriate influence.

Of course, the devil is in the details. What percentage of industry-supported CME actually turns out to be “free of inappropriate influence”? I assume the CME Coalition would admit that there are some bad apples in their industry, but would argue that this is true of any industry and we don’t need new regulations, just better enforcement of existing regulations. My point of view is somewhat different. I believe, like the AMA and the Institute of Medicine, that industry support of CME should be discouraged, though not necessarily forbidden. If there are truly types of medical education that are so expensive that they require industry support, then so be it. Hopefully the CME Coalition will be able to work with policymakers in deciding which portion of medical education actually needs industry funding to survive. My sense is that we’re talking a tiny part of the CME pie.

At any rate, I’m happy to welcome the CME Coalition to the wild and wooly world of CME politics. Let the games begin!

I began my research on the Accreditation Council for Continuing Medical Education’s “Ask” section, “Credit” subsection, of their website. It seemed to be the proper place to begin as I had questions regarding credits. I was told to visit http://www.ama-assn.org/go/cme and found “Other Ways to Earn AMA PRA Category 1 Credit,” which led me to Recognizing physician’s participation in educational activities – What physicians should know about the AMA PRA credit system. I found that accredited CME providers (the Carlat CME Institute is ACCME-accredited) can, indeed, award credit to physician faculty for original presentations at their live activities. You may wonder if doctors can also get credit for writing CME articles—but oddly enough, they cannot. However, they can claim this as “category2 CME”. I also learned that doctors who teach mock board courses are not eligible for category 1 CME. ACCME’s rationale seems to be that you have to prepare and present original material to get CME, and that watching students interviewing patients does not qualify.

At any rate, the news is good for faculty who do qualify to earn CME—because they can actually earn two credits per one hour of teaching (but they cannot “double-dip” by claiming credit as both a presenter and a learner.)

Our partner was pleased to hear that we can now issue physician faculty CMEs – I began receiving many requests from faculty for these CMEs. But now we had to come up with a way to streamline these requests and maintain all of this new data according to ACCME’s policies. Accordingly, we helped our partner to create an online evaluation survey that includes all the data needed by ACCME.

But then we encountered another issue. Our partner had the data in their database, but we needed to retrieve that data for our own records. But how should we maintain the new data to be in compliance with ACCME’s regulations? I went back to ACCME’s website http://education.accme.org/faq126 and found a section called “Learning from Teaching” which told me what I needed to know. The bottom line is that I had to package the data in a certain way and submit it electronically to the all-powerful ACCME database known as “PARS” (Program and Activity Reporting System).

But I still wasn’t done. I’ve discovered that ACCME is fond of papers and binders. Therefore, I had to create a binder to contain the faculty’s requests for CME, copies of their CVs, and the names, dates, and locations of the courses they actually taught. This is basically the “proof” that ACCME may want to look at when they do our reaccreditation.

In conclusion, it took some time and research, but I found that we are allowed to issue physician faculty CME credit, and I figured out how to gather and store this information to make ACCME happy. Success!

An “expert panel” assembled by the National Lipid Association has recently published new recommendations on how to test patients for high lipids. At first glance, everything appeared legit. The authors are noted researchers in the field. The “Journal of Clinical Lipidology” is in medical libraries and is referenced on Medline. The organization sounds, well, official. But just below the surface are torrents of conflicts of interests. All the authors are paid by lipid companies or lipid testing companies. The actual editor of the journal (also one of the authors) has consulted for seven lipid companies. The article was apparently partially written by medical writers paid by companies. The entire enterprise—from organizing the expert panel to writing the article to getting it published—appears to have been completely underwritten by companies that stand to profit mightily from the article’s recommendations.

If this were 5 years ago, such a blatant display of industry manipulation of thought leaders would not surprise me. But over that time, major medical organizations have endorsed ethical regulations supposedly curbing such practices, most top academic medical centers have discouraged this kind of “promotional academia,” and national legislation has been passed to require full disclosure of the details of payments from drug companies to doctors. Mt. Sinai Hospital’s Jennifer Neuman, an expert on conflicts of interest in medical guideline creation, had this to say about the National Lipid Association’s spurious new guidelines: “The Institute of Medicine has made a number of recommendations on how to manage conflicts of interests on guideline panels in order to limit potential bias, and the NLA appears to have disregarded most of these recommendations. This flies in the face of national and international efforts to improve the credibility of the guideline development process.”

It looks like NLA is definitely kickin’ it old school. Let’s hope this is just a blast from the past and not the beginning of another era of medical corruption.

When I received an e-mail about this event, I clicked through right away to learn more.

As I read phrases such as “an interactive conversation about media, health research, science and public understanding of these issues” and “Leaders in science, health communications, journalism and social media” I sighed “Ooh, Baby! Gimme more!”

But then my building excitement and anticipation was doused by a real buzz kill in the middle of the sponsor logos…

Pfizer?! Sponsoring a gathering of the very journalists who are supposed to be independently examining the company’s products and pitches? In truth, I was not completely blind-sided: Pfizer also tosses money to the National Press Foundation to pay for workshops on cancer and Alzheimer’s aimed at journalists. (Gary Schwitzer & I wrote about one of those all-expenses-paid journalism workshops last fall.) —Also see a new blog post from Gary Schwitzer and a post in which an Italian journalist argues against pharma-sponsored press events.

Pharmaceutical companies are adapting some of their marketing efforts in response to growing concerns about how gifts and “educational” meetings for physicians alter their clinical decision-making and prescribing practices. A growing number of health care and medical education institutions are restricting or banning such goodies given out to the docs who are supposed to act in the interests of patients, not industry. Medical journals have substantially toughened disclosure requirements for authors. Changing standards and emerging regulations are shining more light on these ties between companies and doctors. (See the excellent reporting by ProPublica, “Dollars for Doctors”.)

Ah, but there are no regulations or reporting requirements when it comes to attempts to co-opt journalists. Seems to me there’s a natural opportunity there for companies to shape the messages reaching both consumers and policymakers.

Meeting organizers often respond that the corporate sponsors don’t dictate the program or panelists. But these events tend to cluster around diseases that the sponsors just happen to have products for. I’m sure that the sponsors are smart enough to realize that the media spotlight will spill over onto their drugs and devices. There is no need for them to be heavy-handed in order to shift the media agenda and ultimately get a marketing boost.

And on a broader level, these kinds of events and the stories that result tend to focus on diseases and medical interventions. I don’t see a similar level of attention to public health, how transportation and urban planning policies affect physical activity, how agricultural policies influence the foods we eat, how zoning and industrial policies affect disparities in neighborhood health, and so on. There aren’t any commercial products that are likely to get more sales based on enhancing public attention to these topics… so the media agenda is subtly redirected in a way that is consistent with commercial interests.

The Association of Health Care Journalists fundraising policy bars sponsorship or even advertising from companies that sell products or provide services in the health care field, though academic medical centers may be event sponsors. Pfizer would not be welcome at an AHCJ meeting.

As dear to my heart as the topic of journalism about science and medicine may be, I would not feel comfortable attending an event with the sort of corporate ties the “Let Me Be Clear” meeting displays.

This post was reprinted with kind permission from Andrew Holtz. It was originally posted on his blog at: http://thescriptdoctor.holtzreport.com

Please leave a comment below with your advice to earn the CME community’s undying gratitude.

But PhRMA’s pushing back, saying, essentially, “What’s cash got to do with it?” Kate Connors, a media liaison for PhRMA, argues in the blog that the public is not getting the full picture:

“Over the coming days and even weeks, there will be attention in the press to a database and series of articles called “Dollars for Docs,” which claims to promote transparency by compiling already-public information about company payments to physicians. Unfortunately, it does so without any context, clearly to raise questions about the propriety of these interactions.”

Connors links to another article that provides the context she believes is missing:

“Why do biopharmaceutical companies engage with healthcare professionals? Biopharmaceutical research companies are deeply committed to the discovery and development of innovative new medicines. However, it is also important that those medicines, once approved by the FDA, reach the patients who need them.

Companies work with physicians and other providers in a variety of ways, including consulting and research, programs in which physicians provide information to their colleagues through peer speaker programs, and meetings in which company representatives distribute FDA-approved information and clinical data.”

In other words, there’s nothing nefarious about the $760 million. It’s all about developing new medicines and disseminating this crucial information to doctors and the public.

If this is were actually true, I would have no problem with it. If I were a diabetic, for example, I would want companies to hire the smartest doctors and researchers to provide advice on how to create better diabetes drugs. And I would want these same experts to go to my primary care doctor’s office to discuss the data showing that the newly developed drugs are better than the old ones. These are the noble activities that PhRMA is claiming the $760 million buys.

The problem is that drug companies have resisted revealing any evidence that advisory boards and speakers bureaus actually work this way. If they really wanted to gain the public’s trust, they would provide evidence with the same level of specificity as ProPublica’s financial disclosures. For example, if advisory boards are such wonderful boons to medical science, they could post the agendas and minutes of these meetings—with proprietary information redacted.

But, to my knowledge, they have never done it. The closest I’ve found to such an agenda is this proposal for a 1993 Paxil Advisory Meeting that was supposed to have featured Dr. Charles Nemeroff. (Nobody seems to know if this meeting ever happened—another perplexing lack of transparency from PhRMA).

If you read the detailed agenda, it doesn’t look remotely like a scientific meeting to develop better treatments—it simply looks like a marketing summit.

For example, here’s the first part of the agenda:

This was not about teaching doctors about how to use best treatments for patients. It was about developing advertisement copy to convince doctors to prescribe more Paxil, when other equivalent medications (at that time, Prozac and Zoloft) already existed.

Granted, this was in 1993, and the tenor of such meetings may have changed since then—but maybe they haven’t. Unfortunately, PhRMA and their member companies have not seen fit to follow through with the “context transparency” that they are demanding of ProPublica.

Until they do, their defense of their $760 million in payments to doctors rings hollow.

So I’ll lay down the gauntlet for PhRMA. If you want to regain the goodwill of doctors and patients, post the following—I’m happy to put it on my website if it speeds things up for you.

For each pharma-funded advisory meeting or speaking engagement, post the following (with appropriate redactions as needed to hide trade secrets):

• The location of the meeting
• Meeting costs, including payments to key opinion leaders for travel, room, meals, and consulting or speaking services
• Meeting agendas
• Meeting minutes
• For “educational talks” to other health care providers, transcripts of the talks as well as the slides and handouts

PhRMA: It’s time for you to show us the money…behind the money.

We’ve been beefing up our Carlat CME Institute website. Our latest feature is the “CME Rogue’s Gallery” (you can view it on the bome page) in which we keep a running list of the most blatantly promotional CME programs that cross our path. Currently we are spotlighting a program funded by Mylan Pharmaceuticals to increase prescription of the MAOI EMSAM, and a program created by Stephen Stahl, funded by Avanir, to increase prescriptions of Nuedexta.

Please nominate your own entries to the CME Rogue’s Gallery. We’ll check them out, and if they appear to be simply drug ad disguised as CME, they will earn their own undistinguished place on our Rogue’s Gallery list.

Leave a comment below to submit your nomination. Please include all the information that you have so we can check it out.