Medscape Psychiatry Review, Part One: The Good...

Medscape is the number one website for American physicians--a 2010 survey found that 57% of doctors read the site. I'll wager that proportion is higher in 2015.

I have not always been Medscape's number one fan. I've called the site out for pushing Cymbalta in a Lilly-funded "Pain TV" program and for touting Invega in a CME-accredited infomercial that was so blatant that Business Week ran a story about it.

But I have found that the site has improved over the past few years. For example, gone are the notorious sponsored resource centers, in which a single company would underwrite all coverage of a disorder (eg., Shire bought the ADHD section, and GlaxoSmithKline bought bipolar disorder.) There are plenty of ads, but Medscape appears to have understood the separation between church and state, and has stopped merging ads with articles...at least in their main pages.

So if you are a psychiatrist browsing for some reliable, free information, can you rely on Medscape? I'll give a qualified "yes."

Where Medscape really excels is in bringing up-to-date news written in an unbiased journalistic style.

For example, above is the psychiatry homepage from April 7, 2015. Yes, there is a big positive feature on a heavily promoted antipsychotic agent, Latuda. But there’s also an article praising lithium as an effective and underused generic drug. And there's a piece about how antidepressants can cause seizures even at normal doses. So at least on the homepage, Medscape is no longer the shill for drug companies that it once was.

If you drill into specific topics, you’ll also find that Medscape becomes a gigantic encyclopedia of medical knowledge. It covers all specialties, and in the psychiatry section alone there are over 100 articles. The articles have multiple sections and are comprehensive. They remind me of the truck-sized psychiatry textbooks that most of us felt we needed to buy earlier in our careers but which we have rarely cracked open. Like those textbook chapters, Medscape’s educational articles are quite dry – even, at times excruciatingly boring. But, nonetheless, the information is out there for you to read and it is scot-free.

Unfortunately, there are still a few dark sides to Medscape. A 2013 article in JAMA authored by Sheila Rothman and colleagues alerted all physicians to the fact that Medscape, along with other similar medical communication companies, is in the business of sharing all of your personal data with drug and device companies. You can read Medscape’s privacy policy here. It's a long document but I will give them credit for using pretty plain language as they disclose the myriad ways in which they are sharing your information. One of the creepiest technologies is called a "web beacon." This is a hidden drone of the Internet that tracks every click you make, every page you seek, and every breath you take. Your mental processes are then sold to "third parties". It's absolutely creepy.

Some will object that this is business as usual on the web. Google does it, which is why I see ads popping up in my gmail for an obscure car rack that I searched for last month. Tracking my car rack searching behavior is one thing--tracking how I'm thinking about saving patients' lives...well, I think there's a qualitative difference. 

In part two of my Medscape post I will cover their continued addiction with industry funded CME. I guess that pays their bills. But the crassness of these infomercials is pretty astonishing, particularly in the era of the Physician Payment Sunshine Act. To be continued…

Medscape's CME Corruption

As debate over the American Medical Association's upcoming vote on industry funding of CME builds up to a fever pitch (see here and here), the popular physician website Medscape is being unmasked as nothing more than a CME industry voicebox. Of even more concern for the company, some of its CME offerings have become blatantly corrupted by their sponsors' marketing goals.

I cover their corrupt CME below. First, note that Medscape has conducted this poll asking doctors if they would support the AMA proposal to ban industry funding of CME. The results are being used as ammunition by industry stakeholders. But this is a sham poll. Here is how Medscape introduces their survey:

"At its June 14-18 annual meeting, the AMA will consider its ethical council’s call for a ban on industry support of CME for physicians, medical schools, teaching hospitals, and societies. Critics say the ban would reduce the availability and quality of CME and increase its cost. Do you favor or oppose such a ban on industry support of CME?"

This would be analoguous to the Gallop organization introducing a poll by saying, "John McCain is running against Barack Obama in the upcoming presidential election. Critics of Obama say that he will increase our taxes, damage our economy, and will pull our troops out of Iraq, leading to civil war and instability in the Middle East. Do you favor or oppose Barack Obama?"

And here are the unsurprising results of Medscape's "poll":

In favor of banning industry funding:
19% (464)


Opposed:
80% (1907)

Medscape is a medical education communication company entirely dependent on drug company advertising and CME funding for its existence. Many doctors have noticed recently that the company has dropped even the pretense of objectivity. Yesterday, I received a letter from Medscape in my office; inside was a brochure from Forest Laboratories advertising Lexapro, and nothing else. It was creepy, like Invasion of the Body Snatchers.

If you want to judge for yourself whether Medscape is capable of producing unbiased CME, go to their main CME page. You'll find dozens of CME articles, almost all of which are sponsored by different companies.

Here's one that can serve as a poster child for all that is wrong with industry-funded CME. Entitled "Managing Schizophrenia in a Patient With Alcohol Abuse and Hepatic Impairment", it is sponsored by Janssen, maker of Invega, a "new" antipsychotic which is simply the active metabolite of their now off-patent drug, Risperidone. As I've written here in The Carlat Psychiatry Report, Invega is simply a patent extender, with no real benefit other than the fact that it is not metabolized in the liver, and therefore is easier to dose in patients with hepatic impairment. In the grand tradition of promotional CME, Janssen commissioned Medscape to come up with a case-based program focussing on the single clinical situation in which Invega has an advantage.

For Janssen, the key promotional message is found in a section where readers are prompted to check off which treatment option would be most appropriate for the hepatically impaired patient who is profiled. Here is how it is worded:

"Selecting Treatment in a Dual Diagnosis Patient

How would you treat this patient now?

Don't make any changes to his current medication regimen

Switch him from olanzapine to clozapine

Switch him from olanzapine to quetiapine

Switch him from olanzapine to paliperidone"

The right answer, of course, is to switch him to paliperidone, Janssen's product! Here is the CME-arketing copy that follows this question, just in case you haven't yet been convinced to start prescribing Invega:

"A retrospective chart review of psychiatric inpatients found patients receiving either clozapine or olanzapine had a higher likelihood of having at least one condition associated with metabolic symptom.[8] Further, both agents have been associated with weight gain.[10] The adverse effects associated with use of olanzapine indicates the need to change this patient's medication regimen to one with fewer metabolic and hepatic side effects. Some of the newer typical treatments and delivery routes are associated with fewer adverse metabolic effects while affording a means of achieving improved adherence -- particularly among patients with metabolic disturbances.[28]
Research suggests quetiapine is less strongly associated with adverse metabolic effects and weight gain than olanzapine[10]; nevertheless, the potential adverse effects profile of quetiapine makes it a less-than-ideal option. Aripiprazole and ziprasidone are reasonable choices for patients who have experienced weight gain and metabolic adverse effects, but both drugs are metabolized in the liver.
In contrast to the majority of available antipsychotic agents, paliperidone is not metabolized by the liver, minimizing the risk of hepatic adverse effects and other hepatic drug-drug or drug-disease interactions.[21] Clinical trials have shown paliperidone extended-release tablets to be safe and effective in improving the symptoms of schizophrenia, including personal and social functioning.[21] The patented OROS technology allows for once-daily dosing and minimizes the variations in peak-to-trough plasma levels, thereby reducing the occurrence of adverse effects. Clinical trials have demonstrated the high efficacy and tolerability of paliperidone ER in patients with acute schizophrenia, with a rapid onset of action, as well as in maintenance treatment.[21,29] Early studies indicate few metabolic side effects, including only small increases in body weight. These advantages facilitate its use for this patient."

Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No. But is this blatantly promotional of the sponsor's product? Of course. If Medscape had followed ACCME's Standards for Commercial Support, they would have had an independent expert read the article to determine three things: 1. Is the article sponsored by a company that produces a product relevant to the topic? (The answer is yes.) 2. If so, does the article appear to be commercially biased in favor of that product? (Yes). 3. How do you propose to alter the content of this article to eliminate this bias?

Medscape may have done numbers 1 and 2, but they forgot about number 3, the management of commercial bias, which is the most important thing about the ACCME standards.

I intend to lodge a formal complaint regarding this activity with ACCME, and I will also forward this information to various members of the AMA as they are deliberating in Chicago this weekend.

Corruption is a bad thing. It's time to root it out of Medscape, and the rest of medicine.

Medscape Presents: The Brintellix Show

As I wrote in part one of my Medscape review, the website gets high marks for up-to-the-minute coverage of psychiatric news, and it deserves kudos for posting a ton of textbook-like content on disorders and drugs. I wasn’t so thrilled with its "un-privacy" policy, which results in your personal info and browsing history being sold to third parties. 

Today we get into the dark side of Medscape Psychiatry, which is their industry-funded CME. 

Medscape Psychiatry CME Overview

Medscape offers four different categories of CME on its “CME and Education” page.  "Clinical Briefs" and "Journal Articles" are mostly not industry funded, whereas "Patient Cases" and "Knowledge and Practice" are generally industry products.  

Brintellix (vortioxetine) Background

To give you a little context, Brintellix is the latest antidepressant to be FDA approved. It is being marketed as a "multimodal" antidepressant because it has effects on several different receptor sites. The company has produced some interesting data showing that Brintellix may cause fewer sexual side effects than other antidepressants, and that it may help improve the slowed-down thinking that is common with depression. But it is not FDA approved for either of these potential advantages, because thus far, the data are far from definitive.

Medscape and Takeda/Lundbeck

Medscape is the largest single recipient of pharmaceutical CME grants among all U.S. medical communications companies. According to an article in JAMA, it received $20,315,730 in 2010, the last year for which such data were aggregated. I don't know how much the company is receiving from Takeda/Lundbeck for producing CME programs, but it's probably a lot. If you click through Medscape's most technologically sophisticated online courses, a high proportion are funded by this duo.

Here are some of the titles of the courses:

• Strategies for Effective Communication With Patients With Major Depression
• Strategies for Improving Symptoms in Patients With Major Depression 
• Engaging Patients as Partners in Care: The National Quality Strategy in Practice
• Cognition in Major Depressive Disorder: Improving Quality of Life
• Updates and Perspectives in Major Depressive Disorder: Highlights From 2014 
• The Pharmacology of MDD Treatment: Building a Foundation With a Focus on 5-HT

Commercial Bias in One of the Courses

All of the courses listed above are likely biased in favor of Brintellix--there wouldn't be much point in paying Medscape to produce them otherwise. Since blogging is not my day job, I chose only one of them to watch: The Pharmacology of MDD Treatment: Building a Foundation With a Focus on 5-HT.

This course begins with four multiple choice questions, which are supposed to test your knowledge before you learn. Here's one of them:

Which of the following antidepressants manipulates the most serotonin receptors at once?

vilazodone

selegiline

quetiapine

vortioxetine

The correct answer? Vortioxetine. 

This is a clever way to prime the pump, to get the audience thinking about the promoted drug.

Next, we get a slide purporting to give an overview of the history of antidepressant drug development.

The big red bubble labeled MMD refers to "multimodal drug", ie., vortioxetine. That's the latest one. The implication is that it's the most technically advanced. 

Later in the program, there are a few slides highlighting "new antidepressants." Only one antidepressant gets prominently featured on two slides:

The more crucial question is not "how many ways can one drug manipulate 5-HT" (even the manufacturer states the "clinical relevance" of the drug's many serotonin actions is "unknown") but rather "how many ways can one communication company manipulate doctors's prescribing practices?"

To make their point crystal clear, one of the experts in the video glowingly endorses Brintellix, saying that its multimodal mechanism is like packing a bunch of great medicines into one:

"Vortioxetine is a great example of this multimodal thing we were talking about. It is a serotonin reuptake inhibitor, but it also is a very strong agonist at 5-HT_1A, which we said you want to have an agonist there. It also is a powerful antagonist at 5-HT₃ which and a powerful antagonist at 5-HT₇. On paper, here is a drug that has some of these qualities we have been talking about that could make it possibly a multimodal agent almost like a built in augmentation strategy in 1 pill, which certainly would be, just practically, a little easier for patients than having to take more than 1 medicine, which we often have to do.^[3-6]"

A bit later, he goes even further, implying that Brintellix uniquely targets three common symptoms of depression:

"Again, right now, the data clearly show the 3 most common residual symptoms, even with people who have a response to an antidepressant are insomnia, cognitive impairment, and fatigue. I think those are things that are not well addressed by an SSRI alone. Thinking more sophisticated, multimodal actions whether it is 1 pill that has that built in augmentation. I think that is where the field is going."

Summing up Medscape

Since the last time I reviewed a psychiatric website, I assigned a letter grade, I'll give Medscape one as well: a B-. 

Why? It gets an A for delivering bite-sized psychiatric news clips on its non-CME page, an A- for providing free but dry drug and disorders info, and an F for failing to comply with Standard 5 of ACCME's Standards for Commercial Support in its CME courses. Among other things, Standard 5 forbids a CME program from promoting a "specific proprietatry business interest of a commercial interest", and it requires that presentations "must give a balanced view of therapeutic options." 

I'm surprised that Medscape is still resorting to these shenanigans, but I guess that's what butters their bread. 

Can CME be both Biased and Accurate? Of Course!

I enjoy reading Notes from RW, the blog of Robert W. Donnell, MD, a hospitalist in Arkansas who writes frequently for Medscape. While the two of us disagree robustly about the propriety of industry-funded CME, he argues his points rationally. In his current blog entry, he takes me to task for my recent comments slamming Medscape's CME offerings. His main point is that I haven't demonstrated that the industry-funded CME articles in Medscape are inaccurate. To quote Dr. Donnell:

Concerning the Invega article, cited in his post on Medscape’s “CME corruption”, Carlat wrote "Has Janssen--I mean, Medscape--said anything inaccurate in this puff piece? No." That, we are to believe, is not important. In Carlat’s way of thinking the fact that the CME article is favorable to a product of the sponsor is damning enough without regard to the accuracy of the piece.

It's not that I believe accuracy is "not important." In fact, I believe accuracy is vitally important for CME. Unfortunately, however, accuracy does not protect CME articles from commercial bias.
The clearest argument is to compare drug advertisements with CME. The FDA regulates all industry advertisements for accuracy. Drug ads are required to make accurate claims about both the efficacy and the side effects of the sponsors' products. When ads are inaccurate, the drug companies can count on receiving nasty letters from the FDA such as this one, which scolded Pfizer last year for presenting inaccurate information about their antipsychotic Geodon.

Medscape's CME article on Invega is accurate, but is nonetheless promotional and commercially biased, because it focuses on the one clinical situation in which Invega offers an advantage over its competitors. It does not discuss advantages of other antipsychotics, nor does it discuss the many potential disadvantages of using Invega.

Likewise, Janssen produces advertisements for Invega which are accurate, but commercially biased. For example, here is a link to an advertisement for Invega .

It reads, in part:

"Powerful Efficacy for Many Patients Experiencing Symptoms of Schizophrenia

Including:

Patients who may benefit from a change in therapy

Powerful symptom control
In all 3 pivotal studies, INVEGA demonstrated significant improvements in PANSS total scores at all doses (3 mg, 6 mg, 9 mg, 12 mg ) versus placebo (P<0.001)."

There is nothing inaccurate here. Invega, like all FDA-approved antipsychotics, is efficacious for symptoms of schizophrenia. It does, indeed, demonstrate improvement in PANSS vs. placebo in all 3 pivotal studies. Nonetheless, this accurate medical information is commercially biased, because it is organized around the advantages of the sponsor's product and does not discuss the features of its competitors. For example, the ad does not mention that Invega performed poorly relative to Zyprexa in some of its FDA trials.

This advertisement could not possibly qualify as a CME article, because it breaks the two content rules of the ACCME's Standards for Commercial Support. Rule 5.1 states:
"The content or format of a CME activity or its related materials must promote improvements
or quality in healthcare and not a specific proprietary business interest of a commercial interest." By contrast, advertisements are crafted specifically to serve a company's business interest.

Rule 5.2 states:
"Presentations must give a balanced view of therapeutic options." Again, Janssen's drug ads are accurate but they do not give a balanced view of therapeutic options for schizophrenia. Nobody would expect such a balance--after all, these are ads.

However, the Janssen-funded CME article is supposed to give a balanced view, but it does not. Not only is the entire article organized around Invega's clinical advantages, but it ignores its two most conspicuous disadvantages: hyperprolactinemia and extrapyramidal symptoms (EPS). Instead, the article highlights weight gain and diabetes--side effects of great relevance to Invega's competitor Zyprexa.

(As an aside, Dr. Donnell defends another Medscape CME article which I criticized for an exceedingly gentle description of Zyprexa's side effects. That one, of course, was sponsored by Zyprexa's manufacturer, Eli Lilly. In Janssen's Invega article, by contrast, Zyprexa's side effects are described with vigor: The recent CATIE [study] highlighted the increased risk and incidence of metabolic consequences in patients with schizophrenia, which was associated with the use of a variety of atypical antipsychotic medications as well as specific modifiable risk factors.[10] In particular, the study noted the effects of specific antipsychotic medications on weight gain/obesity and metabolic endpoints. For example, the superior efficacy of olanzapine was tempered by its propensity to cause metabolic problems and greater weight gain than the other treatments, with an average increase of 2 pounds per month, as well as an increased risk for other metabolic effects vs the other agents.[17] In fact, the American Diabetes Association (ADA), American Psychiatric Association (APA), American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity together issued a consensus statement highlighting the relationship between specific atypical antipsychotics and the development of weight gain, diabetes, and hyperlipidemia.)

The bottom line is that accuracy is a minimum requirement of both CME articles and drug ads. In my experience, it is rare for industry-sponsored CME to be blatantly inaccurate. Instead, accurate statements are strung together strategically in order to encourage the use of the sponsor's product--and to discourage use of the competitor's.

Medscape News: Diseases for Sale

If you're a physician, you know Medscape. A division of that internet health care behemoth, WebMD, Medscape pounds our inboxes daily with offers of free CME. Much of the CME is industry-sponsored, which is not exactly a news item for most of us. But what you may not be aware of is that Medscape sells its disease-specific "resource centers" to the highest bidder. For example, the ADHD Resource Center is purchased by Shire, the Bipolar Disorder Resource Center is owned by GlaxoSmithKline, and the Pharmacological Management of Pain Resource Center is now the property of Cephalon.

How much do companies pay in order to take control of what doctors learn? Good luck extracting this information from Medscape, but rumor has it that about $500,000 gets you a sort of "base package" which includes four articles. The sponsoring company gets to specify the topics and the authors, of course. There is a menu of extras, so if you really want to saturate the medical mind with your marketing message, you can presumably part with well over a million. And this doesn't include income from the advertising banners that appear to populate each and every web page on the site.

Yes, doctors know Medscape. And Medscape knows money.

Dinosaurs Roam the Earth Once More

The AMA House of Delegates had a chance to make history, but they flinched. Faced with their own ethics council’s recommendation to declare industry funded CME unethical, they had three choices: approve, reject, or delay. They chose to delay, referring the proposal back to committee.

While MECC websites crowed victory, in fact, this is not really their victory at all. The proposal will return. It will be tweaked to become less objectionable to some, and will be resubmitted in November or next June.

Yes, the medical dinosaurs are prowling the earth once more, and that crashing sound through the jungle is heard nowhere louder than in the editorial offices of Medscape, where George Lundberg, their editor in chief, released one of the more bizarre performances in recent memory. In this videotorial, Lundberg declares that CME is “under siege.” Consumer warning: if you watch this, be prepared to cringe.

Like a cornered animal, Lundberg widly lashes out at all progressive forces in medicine, including, in no logical order: Jerome Kassirer, the American Association of Medical Colleges, Jordan Cohen, the American Medical Students Association, the AMA’s Ethics Council, the Josiah Macy Foundation, Senator Charles Grassley, and even JAMA, the journal which Dr. Lundberg once edited. All of these individuals and institutions are part of the vast conspiracy to destroy continuing medical education. What irked me, though (aside from his failure to mention me in his Rogue’s Gallery) were his parting comments: “What does all this mean for Medscape and eMedicine, the largest single source of CE for health professionals? We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”

Good? Clean? Transparent? Are we still talking about Medscape, the discredited purveyor of drug company ads, disguised as CME?

In a prior post, I deconstructed this offering funded by Janssen in which good, clean, and transparent Medscape editors scoured the ends of the earth for the single case study that might make Invega look good—and then created a CME article out of it.

Lundberg’s preposterous opinion piece prompted me to dig a little more deeply into their CME, and it gets worse. Let’s go down the list of their industry-supported CME (there are a few token non-industry funded articles sprinkled in here too). We’ll start with New Data in the Recognition and Management of Bipolar Disorder, an article funded by Lilly, which mentions their Symbyax (a combination of Prozac and Zyprexa) over and over again. When Lilly funds a CME, the editors know exactly what they are paid to do: discuss Zyprexa in a way that downplays its infamous metabolic dangers. True to form, here is the only discussion of weight issues in this article:

“Dr. Thase: Well, the good news on both OFC [Symbyax] and quetiapine is that they do not cause switching, do not induce cycling, and the primary metabolic consequence is weight gain, which is very reliably, accurately measured sequentially and you see it coming. No one will gain 5 kg without first gaining 2 kg, and particularly when they're warned ahead of time. So I would say 1 thing for the interest of primary care prescriber would be to gain some comfort with at least these 2 members of the atypical antipsychotic class, engage the patient in collaborative care and follow-up, watch weight gain closely.
The diabetes risk independent of weight gain is rare. It does happen, but you will need to treat well more 100 patients before you actually see someone who develops new-onset diabetes out of the blue, so it is a real consequence, but a rare one and the dyslipidemia is almost entirely weight dependent. So if there is no weight gain, there will be no dyslipidemia.”

This is the gentlest discussion of Zyprexa’s side effects that I’ve ever seen. The activity is ostensibly a discussion between luminaries in psychiatry, and I’m sure that’s how it began. But the editors can cut and paste interviews to achieve a variety of results--I should know, because I do this every month for my own CME newsletter. When I edit my interviews, I do so for clarity and conciseness—but when Medscape edits, they do so to push the sponsor’s product.

Lundberg: “We are good. We are clean. We are transparent.”

Next up: “The Evolving Management Paradigms for Pediatric ADHD.” There isn’t even an effort to provide the illusion of balance in this CME article. It quite simply a parade of praise for Shire products. After the introduction, ten of the first ten slides on treatment are advertisements for Shire products, in this order: Vyvanse (two slides), Focalin (two), Daytrana (three), and Guanfacine XR (three). How will Medscape defend the integrity of this article to ACCME? They will say that the article’s focus is on new ADHD treatments, and it just so happens that Shire has produced them all. It’s a beautifully-honed method of turning CME into promotion while skirting regulations. “It’s not biased—we just chose a topic that inevitably makes our sponsor’s products shine.”

If you keep going down the list, you’ll see the same pattern. Each CME article is biased in favor of the sponsor’s product.

Note to Dr. Lundberg and Medscape: what you are doing is not clean, not good, and most definitely not transparent.

BusinessWeek Covers Medscape Corruption Story

This week's edition of BusinessWeek features an article entitled, "Teaching Doctors--or Selling to Them?" Written by Arlene Weintraub, the article focuses squarely on the commercially-funded CME racket, and its cornerstone example of bias is none other than Medscape's ridiculous CME article promoting Janssen's Invega (paliperidone) for the treatment of schizophrenia. This was the story I initially broke on this blog here and here.

Weintraub does a great job of explaining to a lay audience exactly how continuing medical education has become an auxiliary marketing arm of the pharmaceutical industry. After leading with Pfizer's decision to stop funding MECCs and Zimmer's (maker of orthopedics devices) new policy to stop funding any CME at all, Weintraub points out that:

These moves are a blow to the marketing firms but by no means the end of their lucrative, multifaceted role. There are hundreds of such firms in the U.S. that design ad campaigns, hire doctors to educate colleagues about devices and medications, and produce conferences. Over the past decade, CME has become one of their most profitable businesses, as manufacturers have increasingly paid for the courses. Industry support for CME has quadrupled since 1998, to $1.2 billion a year, according to the Accreditation Council for Continuing Medical Education (ACCME), an organization in Chicago that approves CME providers. More than half of that is funneled to marketers, with the rest going to hospitals, medical associations, and other nonprofit entities.

The article goes on to describe my experience with Medscape's blatantly promotional Invega course. Particularly precious is Johnson and Johnson's response to Weintraub's request for a comment:

A spokeswoman for J&J's Janssen unit says in an e-mail that the company has no influence over its CME providers' selection of course content or faculty. "The accredited provider is solely responsible," she says.

Talk about turfing the blame to someone else! I imagine that Medscape is none too happy with this quote. Meanwhile, Medscape comes across as fairly lame, because its CEO, Steven Zatz, defended the article by saying that they had recently "updated" it, but then refused to specify what changes were made. The answer, as far as I can see: none.

Finally, the story ends with what is becoming a fascinating case study of how one company, Vox Medica, is pretending to comply with ACCME's new policy forbidding marketing companies from producing CME. Vox Medica is a multi-national pharmaceutical advertising firm with headquarters in Philadelphia. Promotional CME has always been an integral part of its business. Last year, in response to ACCME's call for firewalls between marketing and education, they "separated" their CME unit, "The Institute for Continuing Healthcare Education" from the main company.

Is this separation real or simply a ruse to make ACCME happy? Decide for yourself. Here is Vox Medica's website. At the top of the page is their rather unfortunate slogan: "At Vox Medica, we are healthcare thinkers for hire." To the right of the slogan are links to their three major divisions. The top link is...that's right, The Institute for Continuing Healthcare Education. The message is clear to the pharmaceutical executives who log on to the website: Vox Medica is in charge of producing CME that will enhance product sales.

There's a bit more here. In the new corporate shell game of "My CME division is unrelated to my marketing division," physical addresses matter. Here is Vox Medica's contact information. They say they are located in the "Curtis Building," suite 250-S, but they do not mention their street address. Here is The Institute for Continuing Healthcare Education's contact information. They say they are located on 601 Walnut Street, Suite 275-W, but they do not mention the name of their building, which is, of course, the Curtis Building.

The entertainment becomes even more rich when you look at the comments section for this article. Stephen Lewis, who is quoted by Weintraub and who is referred to as "Vox Medica's medical education chief" takes great exception to her error:

Arlene, the BW reporter, got the facts wrong in this piece in two areas: first, "marketing firms" can not be accredited providers of continuing medical education. The editorial she writes here states that I am with Vox Medica, even though I have been employed by the Institute for Continuing Healthcare, an independent corporation accredited by ACCME. Second, and more important, she misses the fact that all organization types -- medical education companies, universities, hospitals, and professional societies -- are paid by pharma via education grants to conduct unbiased education. Disappointing.

Since Vox Medica owns your company, Weintraub assumed that your employer is Vox Medica. Thanks for clarifying, Stephen. We'll file this one under "False sanctimony."

Medscape--Brought to you by Lexapro

It's sad to watch a company selling its soul. Medscape used to be a source of reasonably trustworthy medical information with a few drug company ads thrown in to help pay the bills. Gradually, however, the promise of ever increasing riches became too alluring. It began selling disease-specific "resource centers" to the highest bidder (see my prior post here), earning millions from companies keen to control which articles are fed to doctors believing they are receiving medical education. At least these resource centers have a pretense of legitimacy, and if you dig around you can usually find something of value.

How things have changed. Today when I opened my email's inbox I received an email from Medscape. On the subject line: "Reasons to Choose Lexapro First." Eloquent in its simplicity. When I opened the email, I received nothing more than an advertisement for Lexapro (pasted above).

Yes, it appears that Medscape has found a new buyer for its Depression Resource Center. Kaching.

Using ACCME's New Rules for Bias and Profit

In bmartin’s pro-industry-CME blog Pathophilia, there is an interesting post about the newly proposed ACCME rules intended to stamp out commercial bias while still allowing commercial support. Bmartin parses out the wording of ACCME’s proposal in order to try to divine the organization’s actual intentions, and finds much to ridicule.

You can detect a heavy dose of financial anxiety in this post. It’s an attempt to read the tea leaves in ACCME’s new policy, in the hopes that it will not actually mean any significant changes in the current system. But bmartin ends on a decidedly pessimistic note, predicting that the regulations will lead to less industry funding, and ultimately, to the disappearance of ACCME itself.

While I wish I could agree with bmartin, unfortunately I see this as very good news for industry support. Anybody who owns a CME company and has undergone accreditation and reaccreditation (as I have) knows that there is really nothing new in this “new” guidance. Any company will be able to demonstrate compliance with each of these and yet still produce promotional and biased CME. Let’s take each of these elements point by point and apply it to a recent promotional CME article produced by Medscape (see here for more details, and see Bernard Carroll's excellent investigative journalism on Medscape here and here).

1. Needs assessment will have to be identified by neutral organizations. Not a problem! You want to keep the flow of money coming from Janssen to help it promote Invega? Many non-industry funded organizations will report that practitioners have a need to learn more about the appropriate use of antipsychotics. Bingo—you’ve just done your needs assessment.

2. Practice gaps will have to be identified by neutral organizations. Same non-issue as number one. Any reasonable organization will identify adequate treatment of schizophrenia as a “practice gap.” For example, the AHRQ produced this document which can be cited to support the need for education about how to use atypical antipsychotics. Medscape will argue that focusing an article on treating a schizophrenic patient with liver disease (which just happens to be the specialty of Invega, its sponsor’s medication) fills an identified “practice gap,” and ACCME won’t argue with them.

3. The curriculum must be specified by a bona fide organization. This is a hard one…let me see…okay, how about psychiatry’s specialty board, the American Board of Psychiatry and Neurology, Inc., which publishes these “core competencies” in psychiatry. Go to the “Somatic treatment” section and you’ll find the following recommended curriculum for psychiatrists:

“Somatic treatments, including:
a) Pharmacotherapy, including the antidepressants, antipsychotics, anxiolytics, mood-stabilizers, hypnotics, and stimulants, including their:
i) Pharmacological actions
ii) Clinical indications
iii) Side effects
iv) Drug interactions including over-the- counter, herbal, and alternative medications
v) Toxicities
vi) Appropriate prescribing practices including age, gender, and ethnocultural variations
vii) Cost-effectiveness”

I think this is broad enough to support any CME activity, no matter how blatantly promotional, as long as it relates to some aspect of pharmacotherapy.

4. It must be verified as “free of commercial bias.”

This is a redundancy, since this is already a centerpiece of ACCME Standards for Commercial Support. The organization will never have the resources to monitor the thousands of industry-supported CME activities hatched yearly.

So don’t fret, bmartin—in fact, I would argue that this is a cause for great joy. ACCME is handing you the perfect mechanism for a commercial CME whitewash. Use some of that industry money to celebrate.

Eli Lilly's "Pain TV": Are they serious?

Sometimes in the CME field you come across something that seems so embarrassing for everybody involved that you just have to shake your head and wonder what they were thinking. So here is the link to Medscape's ACCME Accredited Category 1 CME activity called "Pain TV", supported by an "unrestricted educational grant" from Eli Lilly, manufacturer of Cymbalta, which recently won the FDA indication for chronic musculoskeletal pain--in addition to its indications for depression, generalized anxiety disorder, diabetic neuropathic pain, and fibromylagia. According to Pharma Marketing Blog, each new indication means another $500 million in the bank for the company.

To ensure that it will gain its windfall, Lilly has teamed up with Medscape, several academics on speakers bureaus for multiple companies, and lord knows what other ancillary production and medical writing companies, to produce a lavish 12 part series called "Pain TV" in which they will "educate" doctors about how to diagnose lots of patients with chronic pain, and how important it is to treat it. Will they blatantly push Cymbalta as the very best treatment? Of course not, since that would reveal the promotional intent of this CME program. Instead, they will teach us about the horrors of pain, the dangers of opiates, and about a new non-addictive treatment with a recent FDA approval for the condition that Lilly is paying millions to educate doctors about.

Maybe Cymbalta is, indeed, a miracle drug for chronic pain. Maybe all pain patients would benefit enormously from it. I'm not a pain specialist, and therefore I am in no position to judge the relative advantages or disadvantages of Cymbalta for pain. I'm certain there are thousands of complicated studies in the medical literature that have some bearing on whether Cymbalta is the go-to medication for this condition--and I am also certain that reasonable doctors would disagree about the relative merits of these studies. Accredited CME is supposed to be a way for doctors to learn about best medical practices from unbiased and credible colleagues. Unfortunately, I'm assuming that doctors who are paid by Lilly (indirectly via Medscape in this case) will have an overwhelming financial incentive to emphasize the strengths of Cymbalta and the weaknesses of its competitors--which is the very definition of commercial bias. It doesn't mean that Pain TV isn't of some educational value--many promotional activities can be quite educational. Just don't pretend that it meets ACCME's criteria for accredited CME.

I am certain that this is not the kind of CME that the AMA's new ethics guideline condones: "For the most part, accepting support from a company or permitting participation by an individual when there is an irreducible financial interest would not be ethically acceptable."

But then again, maybe I'm misreading the intent of these guidelines. Perhaps the AMA would be all for a CME activity in which Lilly funds a 12 part TV show highlighting a disease state for which it happens to have a treatment all dressed up and raring to go.

"Performance Improvement" CME, Brought To You By Medscape and Eli Lilly

Performance Improvement CME has become all the rage in the world of continuing medical education. Otherwise known as PI CME, it is being touted by the AMA as the next big thing in medical education. You can read an AMA white paper about it here.

Not all medical specialty organizations actually require that physicians complete PI CME, but they are moving toward this. The American Board of Psychiatry and Neurology now requires something similar, which they call "self-assessment" CME, and it requires a robust program of medical learning to doctors, along with a minimum of 100 CME questions. There's more to it than that--I had to learn about it in order to get Carlat Publishing approved for it.

It's fine with me, thought it is another annoying hurdle for CME providers and for doctors, but maybe in the end it will force doctors to keep their knowledge more up to date. The problem is that there are no regulations regarding who can support these new and elaborate programs. Obviously, as you can see from the screen shot above, or by following this link, Medscape is already exploiting commercial funding. This is a PI CME program called "Diagnosis and Treatment of Major Depression: Performance Improvement." It is funded by Eli Lilly, maker of the antidepressant Cymbalta. I haven't gone through the program yet, but I'm willing to bet that there will be a lot talk about pain in depression. 


I hope someone out there can investigate this Lilly/Medscape joint endeavor to see whether it is biased or unbiased. Let me know your thoughts!

A Review of QuantiaMD: Good Content, Murky Firewalls, and Hypo-Disclosure

There are a number of new and rapidly growing physician social networking sites, and two of the largest are Sermo and QuantiaMD. They both offer tempting packages of free information to doctors, including CME. When stuff is free to you, someone else is paying for it. That "someone" has a stake in the content, and the art of operating an ethical educational website hinges on creating a good firewall between product promotion and educational content.

In the spirit of full disclosure, I have an iron in this fire, since I own a for-profit publishing company (called, amazingly enough, Carlat Publishing LLC) and I have chosen a business model relying exclusively on users paying for content. That way, my readers know that there is no hidden promotional agenda. I don't have to deal with firewalls, because there is nothing to wall off. I hope  that this leads to high quality, trustworthy content; I know for a fact that it is a hard way to make money. After 8 years in business, my company's gross annual income from two newsletters and some joint sponsorship arrangements is slightly over $500,000--which is probably what Medscape charges for a single sponsored web-page. Am I bitter? You bet.

At any rate, when a new medical education website comes on the scene, I give it a close look, both to check on the competition and to provide fodder for this blog.

QuantiaMD was founded in 2003, and describes itself as "an online physician-to-physician learning collaborative where 1 in 6 U.S. physicians engage, share, and learn from experts and each other, free of charge."

The site specializes in short video powerpoint presentations--some are CME accredited, others are not. The quality is usually good. They get top academics as well as just very good doctors to give  mini-talks. There's plenty to learn on QuantiaMD.

Since there are no drug company ads on the site, at first I couldn't figure out how they were able to fund a site with so many bells and whistles. On their FAQ page, they explain their income like this:

"QuantiaMD generates revenue through sponsored content that is delivered to physicians as short, interactive, educational presentations narrated by medical experts. This content is always accompanied by sponsors’ logos, and the decision to view is at the physician’s discretion, with no associated penalties or rewards. QuantiaMD proprietary technology ensures that physicians will only be offered sponsored content that aligns with their specialty. Sponsors do not, in any way, influence the non-sponsored content that QuantiaMD members experience."

Okay, so they charge drug companies for a portion of its content, which should be clearly labeled as sponsored, and this money allows them to create unbiased content in the rest of the site. Sort of like Medscape without the ads.

But when you get on the site, it's far from clear where the sponsored content begins and ends. Navigating to the psychiatry section, the first thing you see is the "Expert Practice Series in Enhancing Psychiatric Care," and the featured presentations are on bipolar disorder. I watched some of them, and they were useful, by and large, and not clearly biased in favor of any particular bipolar medication. But I was perplexed that there were no industry disclosures listed in this section, although virtually all their featured experts have extensive industry relationships (Dr. Charles Nemeroff, for example, is one of the presenters).

In an email to QuantaMD's communication manager, Ross Homer, I asked him about this omission. He promptly responded:

"Thank you for your message. In terms of industry disclosures, I was aware that these need to accompany accredited content for CMEs, but I was not familiar with the need for these with unaccredited content. However, if this is an issue, I’d be grateful to hear more about your thoughts on this (and please excuse my naiveté) to direct how we incorporate industry disclosures moving forward. In terms of this TRD program, neither the Program nor the series had any direction or influence from a commercial entity. Both were conceived from our Primary Mental Health Interest Group, which was itself created to help address the problem that a great many of our PCP members told us they were struggling with: whether, how and when to diagnose, treat or refer their patients with mental health disorders.  In general, all commercial content on QuantiaMD is clearly marked and opt out. All non-commercial content, like the TRD series, is developed by independent subject matter experts with the support of our internal editorial team. This content is developed in response to the measured needs and suggestions of our clinician community."

Ross was right. There is no need for disclosure if by "need" you mean a regulatory mandate. But I encouraged him to go the extra mile:

"Ross, I agree with everything you have to say below. But if I were you I would put that very same explanation on your Interest Group page (or a link to an explanation, like "Where are the industry disclosures?"). The mental health experts on your site are well known in the psychiatric community for their close ties to the pharmaceutical industry, so I'm sure I'm not the only doctor with the same question. You might also explain how these doctors are getting paid (presumably directly by QuantiaMD, out of funds obtained via pharma ads and CME sponsorship), because in these days of cynicism every doctor realizes that no high quality information is free, and if they are not paying for it someone else is. Inquiring minds might be eased by Quantia's acknowledgment that it's important to follow the money trail if we want to trust the objectivity of your education."

Ross responded diplomatically: "Thank you for this insight. As we grow as a physician community and begin to do more promotion of our programs to the outside world, input like this is very helpful. We truly believe in the value of our content and don’t feel that we have anything to hide in terms of our business model, but it is important that we provide as much information as necessary so that everyone else we speak with about what we are doing feels comfortable as well."

This email exchange was on March 9, and since then there was been no discernible "QuantiaMD Spring" of increased transparency. There are still no industry disclosures in the Expert Practice Series, nor does the site print an explanation of why. 

Meanwhile, as I dug a bit deeper into the other sections of the site, I was disheartened to find that the CME activities I sampled were biased in favor of the commercial interests of the sponsors, if subtly so. For instance, PriCara, a Division of Ortho-McNeil-Janssen Pharmaceuticals, supports QuantiaMD's CME lectures on the management of chronic pain. PriCara markets the Fentanyl patch. One of the presentations, "Managing Chronic Pain with Opioids in a Primary Care Setting," reassures doctors that a positive opiate screen "does not diagnose drug addiction, physical dependence, or impairment." And on the final slide, one of the four "Take Home Messages" was that "the prevalence of 'true' addiction in patients treated long-term with opioids is unknown but appears low in a community sample." I'm certain that this is a debatable assertion among chronic pain experts, and that a "fair balanced" program would have better covered the range of views. Overall, the program portrays chronic opioid use as something that can be easily managed and for  which the dangers of addiction are low. That's music to the ears of the Fentanyl Patch people who paid for this "CM-Ad."

Eventually, I found Quantia's explicitly "sponsored content". Within psychiatry, they seem to have worked out a lucrative deal with Pfizer, with Geodon pushed by both Charles Bowden: 

 

and by Prakash Masand:

Dr. Bowden may want to review UT Health Sciences Center's policy on relationships with industry, which states that "Clinicians should not deliver talks that support a drug or device manufactured or marketed by the sponsoring company." I don't know if this Quantia gig runs afoul of that guidance, but it's certainly treading the line. Dr. Masand's employer Duke also frowns on promotional speaking, but its policy reads less strict than UT's.

To sum up, QuantiaMD is a mixed bag of great unbiased content mixed with promotional brand messaging. Figuring out where the honest education ends and the promotion begins is a challenge. The cynic in me suspects that this opacity is purposeful, and is done to ramp up sponsorship fees. Drug companies love promotion that does not look like promotion, and are willing to pay a premium for it.

I give QuantiaMD kudos for trying to create a useful website with minimal commercial content, and they succeed much better than some of their competitors, such as Medscape. But there's still that familiar sneaky hidden agenda feel to their site. Is it possible to create a large, robust, technologically sophisticated medical education site paid for exclusively by physician users? I pray that the answer is yes.

Jurassic CME Park comes to Capitol Hill

Look out, congressmen and senators. The dinosaurs are stampeding the Hill.

That reactionary unthink tank, Center for Medicine in the Public Interest (CMPI), is sponsoring what they are calling an "Evidence-Based Evaluation" of industry support of continuing medical eduation. You can view their invitation here.

For those who have not yet learned about CMPI, go to Sourcewatch for as much information about them as you can stomach. Essentially, they are a front group for the pharmaceutical industry, the CME industry, and whatever other stakeholding company is willing to fund them according to this menu of donating options. For example, $10,000 buys you a "corporate sponsorship" and up to four meals with "CMPI research scholars," $25,000 nets you a seat in the "Chairman's Circle" and an invitation to a "summit," and big spenders can go whole hog with a $100,000 membership in the "President's Club," and a "personal briefing."

Joining with this den of integrity will be none other than George Lundberg, M.D., editor-in-chief of Medscape. Dr. Lundberg embarrassed Medscape and the entire medical community recently with this video editorial in which he responded to the CME concerns of the nation's top medical organizations by saying: "We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”

Other participants, all of whom will examine the issue from a balanced and "evidence-based" perspective, are:

--Peter Pitts, who bills himself on the invitation as the "President of the Center for Medicine in the Public Interest," neglecting to mention his day job, which is Senior Vice President for Health Affairs at the global public relations firm, Manning, Selvage & Lee.

--Michael Weber, MD, listed as "Professor of Medicine, Downstate Medical Center, Brooklyn, NY." Apparently a printing error omitted the fact that he is the co-chairman of the "National Campaign to Control Hypertension," a group of hired gun physicians funded by Novartis to make sure your doctor and my doctor hear good things about Exforge, Novartis' new blood pressure pill.

--Roger Meyer, MD, listed on the brochure as "Clinical Professor of Psychiatry at Georgetown University and Adjunct Professor of Psychiatry at the University of Pennsylvania." Unfortunately, there just wasn't room to disclose the fact that he is actually the CEO of a company called Best Practice, which helps companies market their drugs via CME and provides a roster of "key opinion leaders" for hire.

I've only scratched the surface here, folks. There are many more speakers scheduled, all of whom are similarly dispassionate observers of the CME scene, and are equally scrupulous in their disclosures.

The event will occur on Monday, September 22, 8:00 – 12:30 pm, at 121 Cannon House Office Building, Washington, DC. You can RSVP with Mario Coluccio at 212.417.9169, or email her at mcoluccio@cmpi.org.

If you do go, I have a word of advice. Be careful around the speakers. Dinosaurs bite.

The Latest Conflict of Interest Poster Child: Dr. Zachary Stowe

The latest casualty of Charles Grassley’s investigations of conflict on interest is Zachary Stowe of Emory University.

Dr. Stowe is probably the most well known researcher in the risks of breastfeeding while taking antidepressants, and it is sad to see his reputation taking a nose-dive with these revelations.

The news originally broke in this article in the Wall Street Journal , but if you can’t stand the idea of actually paying for content you can find some of the same information for free on this post on the WSJ blog.

The bottom line is that Stowe has run into the same ethical problem as his boss Dr. Nemeroff—he was taking public NIH money to conduct research, while at the same time giving dozens of promotional talks for a company that stood to benefit from the results of that research.

Specifically, GlaxoSmithKline (makers of Paxil and Lamictal) paid Stowe $154,400 in 2007 and $99,300 during the first 10 months of 2008.

When I first saw this story I was rather unfazed and wasn’t even sure it was worth blogging about. Another academic using his NIH-supercharged credibility to make a bundle by hiring himself out to the highest bidders? Yawn, right?

But when I started to look through the publicly available documents, I realized there’s a bit more to this story than meets the eye.

For one thing, Stowe appears to have been deceptive during a recent deposition, when he claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for pharmaceutical companies. But wait a minute--if he made $154,400 from GSK alone in 2007, by my calculation this is already 66% more salary than he got from Emory. And Stowe did work for lots of other companies as well. Here is his disclosure from a Medscape CME gig he did in March 2007:

Disclosure: Zachary N. Stowe, MD, has disclosed that he has received grants for clinical research, grants for educational activities, and has served as an advisor or consultant to GlaxoSmithKline, Wyeth, and Pfizer. Dr. Stowe has also disclosed that he has served as an advisor or consultant for Bristol-Myers Squibb. Dr. Stowe has also disclosed that he has served on the speaker's bureau for GlaxoSmithKline, Wyeth, Pfizer, and Eli Lilly.

Who knows how much money he was also getting from Wyeth, Pfizer, Bristol-Myers Squibb and Eli Lilly? He may very well have doubled his Emory salary, or more.

Furthermore, the $154,400 disclosed by GSK does not include all the cash they paid Stowe through laundered CME money. For example, here is a CME program Stowe did for Medscape that was funded by GSK. The program is entitled “Long-term health risks of antiepileptic drugs in women” and is essentially a commercial for using Lamictal in pregnant women with bipolar disorder. In it, Stowe begins by saying nasty things about Lamictal’s competitors, Depakote and Tegretol, and then minimizes a large study showing that Lamictal causes cleft palate. I’m sure he got paid a lot for this, and that he did plenty of other similar CME programs that are scattered somewhere throughout the internet.

But wait! There’s more!

We learn from a remarkable series of emails furnished by GSK to Grassley that Stowe gets pretty agitated when he doesn't get enough promotional money. Look at Attachment C of Grassley’s letter if you’d like to follow along here.

First, sometime in August of 2003, a GSK rep emails Stowe that he is “sincerely sorry” but that they have to cancel two scheduled talks (that would have been $2500 a pop, his usual rate) in Wisconsin because attendance was too low.

On 8/19/09, Stowe responds politely, but says that this late cancellation presents "two problems." As it turns out, Stowe schedules only 4 days per month to give talks for drug companies, and the cancellation meant that “others are denied speaking engagements.” He then asks, “What provisions do you propose for my compensation for my lost time?”.

Stowe's second problem is that he had apparently been coordinating this GSK gig with a meeting at the American College of Obstetrics and Gynecology and he would now have to arrange a new flight at the last minute. He believes, therefore, that GSK owes him: “Given the circumstances I think GSK should book and cover the costs of the trip up as well…”

I guess I can understand Stowe’s being upset about a last minute cancellation of a lucrative speaking gig. If he had already paid for a plane ticket for that, then of course GSK would owe him that money. But that’s not the case here. Stowe was apparently planning to mooch off some aspect of the GSK travel to defray some costs associated with a meeting he was planning to go to anyway. Without the GSK money, he now has to pay his own way entirely, and so he wants GSK to fund those costs, even though it has nothing to do with GSK!

You can imagine that whoever got this email was not very happy, and didn’t respond as quickly as Stowe wanted. So Stowe sends off another email on 8/27/03, again pretty polite, admitting that he had once rescheduled these talks, and that since maybe his recheduling affected the attendance, he would settle for getting paid only $2500 for a talk he never gave, rather than insisting on $5000 for two talks he never gave.

But still no reponse from GSK. Stowe fires off another missive on 9/13 saying he was sorry the programs “didn’t work out” and wants to make sure they have his address for a check.

Again, utter email silence from GSK—what lousy handlers they are! So on 9/18, Stowe lets it rip. Warning that he is “no longer in a compromising mood,” he is now demanding $4500, not just $2500, and points out that “you are still getting a $500 discount” because he usually gets $5000 for two talks.

On the same day, he emails a colleague, apparently someone higher up in his department (a wild guess: Nemeroff?) to complain about the issue:

“REP NO RESPONSE – need your input or direction where to take this….I emailed the rep 3 times now with no response, because I had originally rescheduled this from an earlier date I told the rep that I would be okay with the 2,500 instead of the full 5,000 for the last minute cancellations (which I thought was very nice of me). She has failed to respond to 3 emails and I am getting slightly agitated, in fact to the point that she can just find the full 5,000 since my compromise has been ignored. I know that this has no business on your radar screen, but need a name of who to go to. Thanks for your help- talk to you soon. Any feedback on the Miami gig yet?”

I don’t know what the “Miami gig” meant, but I hope he got $5000 out of it!

Finally, on 9/19, somebody from the company responds, saying they will “take care of it.” According to Grassley, eventually Stowe received some compensation, but we don’t know exactly how much.

What to make of all this? It's a creepy insider's look at how entitled our key opinion leaders became at the height of the drug company gravy train in the early to mid 2000's. The only good news is that it is all coming to a screeching halt. According to the WSJ, Stowe has been formally reprimanded by Emory and ordered to cease his promotional talks. Of course, Emory recently announced a new policy that bans such practices anyway, so this may be a bit of overkill.

Industry-funded CME: Is Commercial Content Ever Appropriate?

Dr. Robert Donnell (the writer of Notes from RW ) and I have been debating some key topics related to commercial funding of CME.

In his latest post on the issue, he focuses on a core issue. When an industry-funded program highlights the sponsor's product, does this inherently imply bias? What if the sponsor's product actually is the best treatment for the condition under discussion? To quote from his post:

What if a clinical problem under discussion has only one commercially available treatment, or one drug which is clearly superior to the alternatives? Many topics come to mind in my own areas of interest: Thromboembolism prophylaxis and the risk of heparin induced thrombocytopenia in a post cardiac surgery patient. (Arixtra, the only available anticoagulant with a clear advantage, would be featured). Improving outcome in a patient with severe sepsis: modulating the inflammatory and coagulation cascades. (Gotta be Xigris). Or how about Options for basal insulin coverage in a brittle type 1 diabetic. (Lantus and Levemir would be the clear choices). While Carlat might not think these topics worthy of CME they are common clinically important issues. I just made them up but they are typical of offerings we are likely to see more of given the recent clamor among some academics for more focused, case based CME.

There are definitely a few situations in medicine in which there is one and only one reasonable treatment, and in those cases a sponsored and an unsponsored program would have essentially the same content. But these are exceedingly rare. In psychiatry, I can think of no examples at all. In most of medicine, there are multiple competing treatments, none with any clear advantage for most patients (which is a good thing for medical choice and progress). I suppose that one policy implication of Dr. Donnell's argument is that we might create a list of those few one-best-treatment topics, and allow industry funding for these topics only. It sounds unworkable to me, given the pace of medical progress and the disagreements among academics regarding treatments of choice.

Another point from Dr. Donnell's post:

Dr. Carlat raises another point. Some of Medscape’s offerings my not be in compliance with ACCME standards. Section 5.1 reads:

The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

On the surface that is so obviously true it’s a cliché, but a literal reading of the words would restrict comments on benefits of drug treatment to coverage of generics and orphan drugs! That’s not what the ACCME intended, so there has to be room for interpretation.

I disagree. This section does not prevent industry from funding discussions of both branded and generic drugs, as long as the discussion is not slanted toward one particular agent. If there is no slant, then the CME activity does not promote a “specific proprietary business interest.” The problem is that medical education companies have become specialists in the techniques of subtly slanting programs in the direction of the sponsor’s product. Such programs, indeed, are non-compliant with ACCME standards.

While we all agree on the importance of quality educational offerings the debate over CME will go on. My take? Medscape CME may have quality problems. I differ from Dr. Carlat in that I think its offerings should be adjudicated case by case.

By “quality problems,” does he actually mean “bias problems?” The problem with the idea that the solution is to “adjudicate case by case” is that the ACCME will never have the resources to even begin to do this. Working as a volunteer, it takes me hours to unravel the mechanisms of commercial bias in a single psychiatry CME program, and I can do this only because I have a very good familiarity with the literature in the field. How can ACCME hope to monitor these programs in all the different specialties of medicine with a staff of 12, most of who are not physicians? There are literally thousands of commercially-sponsored programs per year.

As an example of how ACCME is doing, I lodged a formal complaint about a course on drug interactions in psychiatry well over a year ago, a case involving such blatant manipulation of content that one of the authors called it a “piece of commercial crap.” ACCME is apparently still examining the issue, and will not respond to emails requesting an update. They have no formal process for complaint resolution.

Case by case adjudication is, I fear, a way of ensuring that there will be no reform.

Finally, I would be remiss if I didn’t point out that identification of the payer source is not a litmus test for the quality of a CME offering. No one has demonstrated a general correlation based on high level data. Dr. Carlat offers a few interesting anecdotes. I can easily counter with some of my own. Recently I attended a prestigious accredited course with no support from device companies in which a speaker promoted numerous non evidence based uses for inferior vena cava filters. I’ve seen similar clean, pharmfree and unbalanced promotions of coronary artery bypass surgery and angioplasty. More concerning examples (all ACCME accredited) can be found here, here and here. I could trot out many others. You get the idea.

Yes, it’s true that lack of industry funding does not guarantee unbiased presentations. However, presence of such funding almost guarantees a lack of balance. Interestingly, the three activities he cites as “concerning” are programs that would never receive industry funding. They are all courses on integrative or complementary medicine, offered by UCLA, Yale, and NIH. Each covers the clinical evidence for these treatments using evidence-based teaching, but because these techniques have little commercial potential, doctors are poorly informed about them. As an example, few physicians are aware that an NIH consensus statement declared acupuncture to be effective for both post-operative nausea and post-dental procedure pain.