Skirting CME Regulations in Real Time: Watch it Here!

Because the Senate Finance Committee concluded that the commercially-funded CME system is broken, the ACCME issued new policies intended to create thicker firewalls between industry and medical education. In a prior post, I "translated" these new policies into language mere mortals can understand. Now, in a new article in Medical Marketing and Media, we can see how commercial sponsors are already finding ways to avoid real changes.

The article profiles Bruce Bellande, Ph.D., president of CME Enterprise. Dr. Bellande bemoans that he and his parent organization, Deborah Wood Associates, have to demonstrate that they are meaningfully "separate." Deborah Wood Associates began as a medical education communication company, but has expanded into a 100-employee strong marketing consultation firm for the pharmaceutical industry. In order to show ACCME that CME Enterprise is now separate from Deborah Wood Associates, Bellande moved his staff into "new quarters" (read: Time for everyone to pick up your laptops and move down the hall!) and he had to create a trail of paperwork proving that a firewall exists. This included an organizational chart, some disclosure forms, and a few other documents that he likely had on his computer because ACCME has always required these for accreditation. He fired it off to Murray Kopelow, CEO of ACCME, and received this letter back, saying, essentially, that the firewall requirements were satisfied.

If you go right now to the Deborah Wood Associates website, you can see just how strict ACCME's new firewall policies are. This site is geared toward pharmaceutical companies wanting to sell their products, and their techniques couldn't be clearer: "See how we achieve optimal results through two dedicated groups: CME Enterprise and Avant Healthcare Marketing."

This rice paper firewall makes a mockery of ACCME's new policies. It's astonishing that Kopelow has signed off on CME Enterprise.

What's Wrong with DTC Ads?

According to the Wall St. Journal's Health Blog, John Edwards is calling for a two year post-approval ban on direct-to-consumer drug ads. Having stayed up for the past several nights watching my team win the World Series, I have certainly received an excessive dose of DTC ads for the likes of Cialis, Flomax, and Lipitor (is anybody else creeped out by Jarvik as he cocks his head and bats his baby blue eyes?) And, yes, I get that DTC's encourage consumers to ask their doctors to prescribe the newest and most expensive meds.

But banning them doesn't make sense. Why? For one, it's one of the only arenas where drug companies advertise their products with full disclosure. Everybody knows it's an expensive ad paid for by the company. There's no pseudo-legitimate journal or medical education company pretending to be a scientific article, when in reality it's a paid advertisement.

Second, they do serve an educational function for consumers, if biased. There are a lot of guys out there urinating very frequently who would not consider this a potentially treatable issue if they hadn't seen those irksome Flomax commercials, the ones featuring the sports-crazed baby boomers who get to hang out in their kayaks longer without having to run into the woods--all because they're taking their Flomax. Sure, viewers are going to run to their doctors and ask for Flomax my name, but it's up to the docs to decide which drug is best. And meanwhile, some men will find out they have early prostate cancer (rather than benign prostatic hyperplasia) and might get their lives saved in the bargain.

I say let the companies have their DTC ads, and use the extra money they gain from increased sales to fund a government-administered pool of money to pay for unsponsored continuing medical education. This will save the health care system much more money in the long run.

Takeda's Clinical Symposia: It's all about Rozerem

Today's New York Times has a nice piece by Stephanie Saul on sleeping pills, entitled "Sleep Drugs Found only Mildly Effective, but Wildly Popular." She covers a recent NIH-funded report which concludes that sleeping pills "reduced the average time to go to sleep 12.8 minutes compared with fake pills, and increased total sleep time 11.4 minutes." Saul focuses particularly on Rozerem, which has been heavily promoted in direct-to-consumer ads, and yet was found by NIH to be one of the less effective pills. To quote Saul: "Consider that it costs about $3.50 a pill; gets you to sleep 7 to 16 minutes faster than a placebo, or fake pill; and increases total sleep time 11 to 19 minutes."

I am not anti-sleeping pill by any means. I prescribe plenty of them, and sometimes take them myself. They certainly work. But I am not convinced that the brand-name pills are worth their higher prices. I prescribe plenty of trazodone, temazepam, and diazepam for sleep, as well as generic Ambien (zolpidem). Occasionally I'll go to pricey Ambien CR for patients who like Ambien but who wake too early in the morning.

I have had a grand total of one patient respond to Takeda's Rozerem. Nonetheless. The journal Clinical Symposia, in a recent edition sent free to all physicians, likes Rozerem so much that it highlights the melotonin receptors on the picture of the brain on the cover (see above). That seemed odd to me, since this was an issue on insomnia for primary care physicians, and Rozerem is hardly the drug that PCPs would or should turn to first when treating insomnia. Once I flipped it over, the mystery was solved, as this entire issue was sponsored by Takeda. In addition, the first author, Gary Richardson, M.D., is a prominent Takeda speaker. See, for example, this website, "SleepJournalClub.org," chaired by Richardson, funded by Takeda, and providing CME credit for reading journal articles on insomnia. I suggest you click on "archived events" and scan through the 11 articles posted thus far. I went through this exercise in an effort to determine whether the articles chosen were biased either in favor of Rozerem or against its competitors. Here's what I found:

1. Effects of NG2-73 On Sleep Onset, Quality and Next Day Function In a Transient Insomnia Study. A clinical study of a new compound, NG2-73, manufactured by Neurogen, which acts as a partial GABA agonist. Does not promote Rozerem.

2. A Review of the Evidence for the Efficacy and Safety of Trazodone in Insomnia. A review of trazodone concluding that it has little supporting evidence as a hypnotic and that is has significant side effects. Promotes Rozerem by trashing its main generic competitor.

3. Highlights from APSS (a sleep conference) 2007. Reviews a study showing that Ambien causes the elderly to be shaky on their feet, and refers to Takeda-funded studies (read abstracts here) showing that Rozerem does not have this liability. Promotes Rozerem.

4. The Brain’s Master Circadian Clock: Implications and Opportunities for Therapy of Sleep Disorders. Emphasizes the importance of the melatonin system in insomnia. Promotes Rozerem.

5. Safety of Ramelteon in Individuals With Mild to Moderate Obstructive Sleep Apnea. Need I say more? Promotes Rozerem.

6. Combined Therapeutics for Insomnia: Should our First Approach be Behavioral or Pharmacological? Unsponsored paper on therapy vs. meds for insomnia. Does not promote Rozerem.

7. Tiagabine Enhances Slow Wave Sleep and Sleep Maintenance in Primary Insomnia. Promotes Tiagabine.

8. Influence of Pharmacokinetic Profiles on Safety and Efficacy of Hypnotic Medications. Funded by Sanofi, maker of Ambien CR, this article is strongly and cleverly promotional of Ambien CR.

9. The Management of Insomnia: From Herbals to Hypnotics. While this is a review of all sleeping pills, it ends with several extraordinarily positive statements about Rozerem (eg., "The selective melatonin receptor agonist ramelteon represents the first major advance in the treatment of insomniain more than 40 years.") Promotes Rozerem.

10. Insomnia and Hypnotic Use, Recorded in the Minimum Data Set, as Predictors of Falls and Hip Fractures in Michigan Nursing Homes. Study showing that hypnotics do not increase the risk of nursing home fractures; rather, insomnia does. While this is not specifically promotional of Rozerem, this fits in well with Takeda's promotion of Rozerem as being safer than Ambien for the elderly. Promotes Rozerem.

11. Relative Abuse Liability of Hypnotic Drugs: A Conceptual Framework and Algorithm for Differentiating Among Compounds. This article, sponsored by Takeda, is essentially a prolonged advertisement for Rozerem, highlighting its main advantage: lack of abuse liability. Promotes Rozerem.

Conclusion? In my analysis (certainly biased by my heightened sensitivity to underlying promotional agendas), 7 out of 11 articles in this Takeda-sponsored CME program are promotional of Rozerem.

Mais bien sur, you say. Why else would Takeda pay Richardson and colleagues to chair this journal club? If they didn't choose articles that made Takeda happy, these physicians would be "missing their dreams" of fat honoraria checks!

A Pharma Mule Show and Tell

Clin psych just dropped me a note requesting that I scan in the documents that I described yesterday. These were the industry-funded CME activities that poor Primary Psychiatry has to schlep around like the abused but well-paid mule that it is.

I tried scanning them right into this blog but Blogger gave me too much technical grief. So I have posted them all at Google Docs. Just click on the relevant links to go directly to the artwork.


1. Here's the DVD funded by i3CME and Bristol-Myers Squibb in which they paid three of the foremost experts in schizophrenia to say nothing about Abilify's propensity to cause akathisia/activation.

2. Here is Stephen Stahl's Cephalon-sponsored newsletter, "Wake up!", which awards 1.25 hours of CME credit to encourage you to detect more patients with "excessive sleepiness" and to prescribe Provigil.

3. Here is a larger version of the actual journal (also pictured above) with its Eli Lilly overwrap advertising a nonsense telesession about bipolar disorder.

4. Finally, here is the first page of the Michael Clark "Cymbalta Synergy" article including the erroneous financial disclosure.

Good old show and tell. I haven't had this much fun since kindergarten!

Primary Psychiatry: Pharma's New Mule

Granted, everyone’s entitled to make a buck, medical publishers included. This almost always involves doing some advertising for drug companies. There’s nothing inherently wrong with this, as long as the advertising doesn’t infiltrate the content of the articles. This firewall between marketing and editorial content is crucial, and some journals are very good at maintaining this separation—journals such as Lancet and New England Journal of Medicine come to mind.

And then, on the other hand, there is Primary Psychiatry.

The September issue of Primary Psychiatry is the encapsulation of the worst of the worst of what might be called "greed journalism." Rather than serving as a medical journal, Primary Psychiatry has become a mule for various sponsoring pharmaceutical companies, heaving promotional CME programs into our offices. An almost exquisite example of journal as marketing vehicle, the September issue is the very Mona Lisa of CME corruption.

It arrived in my office “polybagged” with three industry-funded educational activities. Polybagging entails wrapping the journal in plastic wrap and throwing in stuff that drug companies want you to see. The September issue contains:

1. A DVD funded by Bristol-Myers Squibb, coyly entitled, Akathisia: Problem of History and Concern of Today. BMS markets Abilify, widely acknowledged as the atypical most likely to cause akathisia—an inconvenient truth for BMS, because this drives down Abilify’s market share. Thus, BMS paid i3CME (you remember them--the producers of the great Lindsey DeVane fiasco) to find speakers who would play down this liability, and they got exactly what they paid for in these Three CME-usketeers: Prakash Masand, Naveed Iqbal, and Tim Lambert. Abilfy’s association with akathisia is conveniently not mentioned by any of these key opinion leaders. Instead, we hear that Risperidal, Zyprexa, Clozapine, and even Seroquel (!) can cause it. If you can stomach watching this biased presentation, you'll quickly discover that its promotional message is: (1) Akathisia is more common with first generation antipsychotics; (2) There’s no real difference between the atypicals; (3) It’s often caused by SSRIs rather than atypicals; (4) Don't worry, prescribe Abilify.

2. The second prize is a newsletter called “Wake up!”, produced by Steven Stahl and funded by Cephalon. An 8-page advertisement for Provigil, it contains articles written by a Who’s Who panel of industry-funded psychiatrists, including Wallace Mendelson, famous for his ghost-written trazodone-bashing article in the Journal of Clinical Psychiatry (2005;66:469-476; see my New York Times op-ed on his work for Sepracor here). For those who don’t know, Stephen Stahl, founder of the company Neuroscience Education Institute, is one of the more industry-conflicted psychiatrists in the profession, right up there with Charles Nemeroff. The “wake up!” newsletter oozes Cephalon and Provigil, with exhortations to diagnose more people with "excessive sleepiness" and to treat them with Provigil and other meds. Cephalon pays Stahl tens of thousands to say good things about Provigil, and then pays Primary Psychiatry even more to mule the newsletter to 60,000 physicians.

3. Finally, the actual journal is covered with an overwrap advertisement for an Eli Lilly-sponsored educational event on bipolar disorder. No, I didn't spend any more of my precious time enduring that telesession. I'm assuming it will argue that patients with bipolar disorder are at a higher risk for diabetes regardless of which medication they use, so don't worry about slamming them with Zyprexa.

The "Pharmatorial" content doesn’t end with the plastic goody bag. Inside the journal, synergizing nicely with a three-page ad for Lilly’s Cymbalta, is an entire section on pain in psychiatry, including an article on "Psychopharmacology of Chronic Pain." The author, Michael R. Clark of Johns Hopkins, is listed as having “no affiliation with or financial interest in any organization that may pose a conflict of interest.” This fib can be checked out by going to Google and typing in “Michael Clark, M.D. and disclosures.” The first page of results shows that Dr. Clark has been the course director of two CME conferences on pain management this year, supported by educational grants from Lilly, King Pharmaceuticals, and Cephalon.

It isn't easy being a mule. But the money helps.

The AMA, Pharma Gifts, and the Power of 8

This Thursday I will be joining several colleagues in testifying at the Massachusetts State House in support of a bill to tame the cost of medical care in the state (read a fact sheet from Health Care For All here). One portion of the bill will ban most drug company gifts to doctors. The thinking here is that when we receive gifts from reps, such as textbooks or free dinners or lunches, we inevitably feel that we owe the rep something in return. That's just human nature.

What we give the rep in return varies widely. Sometimes, it's just increased access--more frequent visits with us, an extra few minutes of shmoozing, etc.... This works for the rep, since more access equals more time to sell their product.

More insidiously, the pay-back is choosing to prescribe their product over an alternative drug that may be much cheaper. This happens to us all, even to an industry skeptic such as myself. For example, not too long ago, my Ambien CR rep gave me a pamphlet with a selection of free books, and against my better judgment I took her up on it. It was a book on the brain by John Ratey.

Several days after her visit, one of my patients came in complaining of insomnia which had not responded to several hypnotics. He had tried Ambien, Sonata, and Benadryl, but was unable to sleep through the night. Usually, in these situations, I would offer trazodone, which has a long enough half life to last most patients all night long. But something in me made me think about my Ambien CR rep, who had left the office saying, "I hope you'll give Ambien CR a try." I prescribed Ambien CR. As it turned out, this worked no better than regular Ambien, and he ended up on trazodone.

The fact is that pharmaceutical gifting is an effective marketing technique, as much as physicians deny that their medical opinions can be swayed by such small dispensations.

Our increasingly embarrassing American Medical Association (AMA) touts its policy on the ethics of accepting pharmaceutical gifts. Recently, they accepted over $600,000 in pharmaceutical money in order to help advertise their guidelines to doctors. In a nutshell, the policy is: no gift over $100 in value, and any gift must be related to medical care or medical education. Here, as in most of AMA's policies, the emphasis is on making no waves and maintaining the status quo, since this allows docs to get their textbooks, stethoscopes, and nice dinner programs, as long as the dinners are modest. (By the way, the AMA defines "modest" dinners as those meals that physicians would ordinarily pay for themselves, which leaves plenty of room for largesse).

The AMA guidelines become farcical at times. For example, not only is it acceptable to accept a nice dinner out by industry, but it is also acceptable to be offered an array of $100 gifts as an inducement to attend the dinner. But here's where AMA draws the line: physicians can be offered no more than eight different gifts to choose from. Here, verbatim, is the relevant section:

"(i) May companies invite physicians to a dinner with a speaker and offer them a large number of gifts from which to choose one?
In general, the greater the freedom of choice given to the physician, the more the offer seems like cash. A large number of gifts presented to physicians who attend a dinner would therefore be inappropriate.
There is no precise way of deciding an appropriate upper limit on the amount of choice that is acceptable. However, it is important that a specific limit be chosen to ensure clarity in the guidelines. A limit of eight has been chosen because it permits flexibility but prevents undue freedom of choice. Each of the choices must have a value to the physicians of no more than $100."

We don't need gifts from drug reps, nor do we need the biased "education" they provide during their visits. Let's stop pretending that gifts are anything other than influence-peddling.