Thursday, April 22, 2010

Medical Societies' New Ethics Code: Secret Q&A Document Revealed

The Council of Medical Specialty Societies just announced a new Code for Interactions with Companies. They have received good press so far. According to AP, “It's the most sweeping move ever taken by the Council of Medical Specialty Societies to curb conflict of interest…”

But The Carlat Psychiatry Blog has just obtained a disturbing highly classified Q&A document leaked by a mole within the Council. Or maybe we just made the thing up. Read the following excerpt, and you can decide.

Q: Are there any provisions here that are going to significantly decrease the income we receive from drug companies?

A: Not at all. You can still receive all the drug company money you want for educational programs, “charitable” contributions to doctors, and research grants. The only semi-meaningful restriction we’ve added here is on funding for practice guidelines committees, but we even developed a work-around for that, which we can explain later.

Q: That’s good news. But I’m still a little nervous. I mean, this new code is a 25 page document, with dozens of elaborately numbered rules. There must be something in there that will change business as usual. Please reassure me that I'm wrong.

A: Don’t worry, be happy! Yes, we know the Code looks long and serious, but we were simply following the advice of our PR consultants (on loan from one of our sponsoring drug companies), who taught us about the first rule of advertising: “The more you tell the more you sell.” We learned that if you want to sell a product that actually has very little added value, you can’t just say, “Here’s my product.” Instead, you have to add a whole bunch of other stuff along with your offer, stuff that doesn’t actually add information content, but that keeps your audience engaged and focused on your product. That’s why we created this 25 page document, even though all the actual new regulations could have fit into a single paragraph.

Q: Whew! I am feeling a little less panicky. But still, I’d appreciate it if you could walk me through the document and explain to me exactly how each “new” rule is actually meaningless.

A: Sure. We start with a 2 page preamble that just says the usual blather about ethical standards and proper relationships with industry. Basically, we copied and pasted most of this from the latest PhRMA code on relationships with doctors. After all, why reinvent the wheel?

Q: Oh yeah, I remember that code from 2 years ago. That was the "Tchotchke Code." No more logoed pens or mugs. That turned out to be no problem for us. They can still bring us lunch and take us to fine restaurants as long as they have paid one of our doctors to give an “educational” talk.

A: Exactly--it resulted in very little financial pain for us. Same idea for our Code. To continue our guided tour, after the Preamble there is a section called “About the Code” where we just say “We decided we needed to write a Code, so we wrote a Code.” But we were able to fill two pages saying it, giving the document a little more heft.

Q: But why, exactly, did we even need to write a Code?

A: PR stuff entirely. The drug companies had written an ethical code in June 2008 and it was becoming embarrassing that the doctors had not produced their own ethics code. Also, we were getting some flack about this article in the Journal of the AMA that recommended a bunch of changes (don't worry, we artfully ignored the most significant ones). But the kicker was that the Health Care Reform Act that recently passed Congress includes a required physician payment registry, so all payments to doctors and societies are going to be forced out in the open soon anyway [Note to reader: After we posted the original version of this Q&A, we learned that the Sunshine act will not, unfortunately, require disclosure of payments to medical societies. Oh well!]. We figured this will make it seem that we are ahead of the curve on this.

Q: Okay. Then there’s this huge section with “definitions” of things like “business transaction” and “company.” Am I missing something here? Are the people reading this that uneducated?

A: The official line? We needed to spell out the definitions to clarify often misunderstood terms. The real purpose? We needed to add those 4 pages to achieve our goal of a 25 page document.

Q: Okay, so far so good. But when I started to read the section labeled “independence” and I spotted the phrase “discontinue payments,” I started to get a little queasy. What’s going on here?

A: Patience, grasshopper. Not to worry. If you read it carefully, we are suggesting that a grand total of only five people in each medical society should “discontinue payments” from drug companies: the president, the president-elect, the immediate past president, the CEO of the society, and the editor-in-chief of the society’s journal. Everyone else can still rake it in.

Q: Hey, not so fast. I’m thinking of running for president of my society. Am I being left out in the cold?

A: Of course not. There are so many exceptions and provisos that you will do just fine. Here they are:

1. If you were taking cash before you were elected, you can keep getting paid for a “reasonable period” after the election. What’s a “reasonable” period? That’s up to you.
2. You can maintain your consulting relationships with all the companies during your tenure; you just can’t accept a “consulting fee.” But here’s our clever workaround. You can still get reimbursed for all “travel expenses,” meaning that you can accept cash for airplane tickets to exotic locations, for hotel bills, for fancy meals with company executives, etc… Just make sure to call it “travel expenses” on your tax forms.
3. You can still accept cash for industry research studies, as long as you are not foolish enough to deposit the cash into your personal bank account. It has to go into a different bucket, usually your academic department’s account.
4. Finally, once your tenure as president and past-president are over, you can resume your full fledged financial relationships with companies immediately.

Q: What about the transparency provision. That’s not going affect the bottom line, is it?

A: No, it should not affect your income. Remember, this just means disclosing the income, not giving it up.

Q: Then there’s this huge section on regulations about “charitable contributions.” Does this mean we are going to limit the charity cash that drug companies lavish on us?

A: No. This was another document padding exercise. It just says--in the space of five paragraphs--that you have to use charitable contributions responsibly.

Q: Same deal with corporate sponsorships?

A. Yes, you can still accept as many sponsorships as you want, as long as it is “aligned with the Society’s strategic plan and mission.” We do suggest that you try to seek multiple corporate sponsors for programs so it doesn’t seem too obvious that you are being used as an advertising vehicle for a single product.

Q: Actually, that could be a win-win—more sponsors, more cash.

A: Bingo!

Q: It says no more company logos on tote bags and such. That’s not so great—hey, we made a few thousand bucks at every meeting on that stuff.

A: Sorry guys. That couldn’t be helped. Companies have already promised not to distribute these things to doctors, so it would have been poor form if we tried to do it anyway.

Q: I'm seeing pages and pages about CME meetings. This makes me nervous.

A: Chillax, my friend. We simply copied and pasted all the existing ACCME regulations that we have been required to follow for years anyway.

Q: You mean there’s nothing new here at all? We can continue to take millions of dollars yearly from drug companies to put on accredited CME programs that are focused on drug categories that they market?

A: Absolutely. There are no new restrictions here at all.

Q: Okay, but let’s move on to something more ominous-sounding. Item 7.3 says: “Societies will not permit direct Company support of the development of Clinical Practice Guidelines or Guideline Updates.”

A: Yes, this was a genuine concession to the pharmascolds. But it’s not as bad as it seems. After the initial print run of your guidelines, drug companies are free to pay you mucho dinero for “repurposing” guidelines. That is, they can package them up into journal supplements, Internet education programs, whatever they want. They just can’t pay us to actually write the guidelines.

Q: Oh--that’s fine. Basically we still get drug company money to produce clinical guidelines, but the checks don’t actually get cut until after we write and print them.

A: Hey you’re smarter than you look!

Q: One last question. Are these guidelines mandatory?

A: No. Take ‘em or leave ‘em. If you adopt them we’ll throw your society’s name on our website. A little bit of free PR for you. There’s really no downside to adopting them. You’ll get good PR, and you’ll be able to maintain your existing extensive relationships with pharmaceutical companies at all levels of the organization.


Marilyn Mann said...

Clever. I was underwhelmed as well.

PsychEducation said...

Here's another twist, see what you think, Dr. C' --

Pharmaceutical company pays independent company to put together programs about diagnosis and treatment of Hepatitis C. Progams include doc's from all over, who can give their own talks (no company slides). Some present on diagnosis, others on treatment. Target is primary care doctors in rural areas, who presumably can't refer patients easily to specialists; indeed, the program explicitly states that the goal is to enable PCP's to treat Hep C. Obviously the sponsor companies are those that make interferon/ribavirin.

The question: is it ethical to take the money?($1500 plus travel to a semi-rural town in the next state over; I make the arrangements) The target audience is one I've been after for years; and I can use my own presentation about screening for bipolarity -- per the FDA recommendations, by the way -- before using antidepressants. My message, right target; I'm just using *them*.

Okay, surely the companies are also using me, to market their drugs to rural or semi-rural PCP's. If my goal is to see that they do it well (screen for bipolarity before using antidepressants), is there a conflict here?

Maybe I should give away all the money except that which I'd have made during the two days had I stayed home working? Uh, that's about $1500, I think.

Interested in your opinion --
Jim Phelps, M.D.

Daniel Carlat said...

Hi Jim,

For me, the key is always to ask whether you are taking money primarily to market a product or primarily to provide needed medical education. In this case, it sounds like you are providing a sorely needed educational service, and that the marketing needs of the company are coming along for the ride. Given that, sure, why not get paid for your time etc...?

So often, though, doctors get caught up in the trap of starting out believing they are providing legit med ed, but gradually get caught up in the fun of it and the money, and then start doing talks that are primarily promotional.

Anonymous said...

please direct the readers to the list of signatories.

Ethics said...

Maybe they should have looked at Josephson's suggestions for adding the Six Pillars to the ethics code?

Unknown said...

Pharmaceutical visitors pays independent visitors to take the money excluding that which I'd have made during the two being had I stayed home effective?

The issue: is it ethical to put together programs about test for time; and I can give their own talks (no band slides). If my own presentation about diagnosis and handling of Hepatitis C. Some portray on diagnosis, others on dealing. Target is to see that the goal is to allow PCP's to remedy Hep C. My meaning, right intention; I'm just with me, to bazaar their drugs to rural or semi-rural PCP's. Obviously the sponsor companies are also with *them*.

Okay, indeed the companies are those that make the arrangements) The foil listeners is one I've been after for bipolarity -- per the FDA recommendations, by the way -- before with antidepressants), is there a conflict here?

Maybe I should give away all the money?($1500 plus travel to a partially-rural city in rural areas, who can use my goal is first heed doctors in the next declare over; I make interferon/ribavirin. Uh, that's about $1500, I think. Progams compose doc's from all over, who presumably can't refer patients simply to specialists; indeed, the series explicitly states that they do it well (check for bipolarity before with antidepressants.
link exchange
university admission