Wednesday, December 10, 2008

It’s Not About Goodwin. It’s About Disclosure.

The Frederick Goodwin/Infinite Mind case has become one of the defining controversies for a crucially important health policy issue. Some of us have become hot-headed in our comments, largely because this is something we feel so passionately about. So, in this post, I’ll be keeping my cool, and will pluck some of the significant issues from the morass of accusations into which this debate has degenerated.

1. This is a debate about disclosure of potential conflicts of interest, and not a debate about Dr. Goodwin’s scientific views or his academic integrity.

Let’s not get sidetracked into a discussion of whether antidepressants do or do not cause suicidality. On "Prozac Nation Revisited," it was clear that Dr. Goodwin and his guests believed that this danger has been exaggerated. I happen to agree. But that’s not the issue here.

Nor is this about Dr. Goodwin’s scientific work over the years, which has been excellent. His writings have always struck me as scientifically fair and balanced, including his industry-sponsored CME articles, which is a tall order, given how difficult it is to keep MECCs from sweetening CME with pro-sponsor messages.

No, this debate is specifically about how, when, and where academics should disclose potential conflicts of interest with the pharmaceutical industry. And I believe that "The Infinite Mind" should have disclosed to the listeners, at the beginning of each program, all potential conflicts of interests relevant to the topic of that program.

2. I do not believe that the mere disclosure of conflicts of interest is an admission of “guilt” or “bias,” but audience-members need to be informed so they can judge for themselves.

If an academic takes money from the drug industry and then educates physicians or the public about drugs, this is, inherently, a potential conflict of interest. Here is the conflict: on one hand, the speaker has an interest in providing accurate, useful, and unbiased information to the audience. But on the other hand, the speaker has an interest in maintaining the flow of money from the company, and companies are paying out the money to improve sales.

Speakers with such conflicts may do one of three things. First, they may knowingly bias the talk in favor of the sponsor’s drug. Second, they may unconsciously bias the presentation. Or third, they may not bias the talk in any way at all.

The audience has no way of knowing what goes on in the mind of the speaker, so they have no way of knowing whether they can trust what he or she has to say. In my opinion, the best way to resolve this problem is for doctors to stop accepting money from drug companies for promotional activities. However, at a minimum, listeners needs to know what the potential conflicts are, so they can be on the alert for potential bias.

3. Many have pointed out that “we all have biases,” so why focus on those related to drug company payments?

Yes, many forces and experiences influence our opinions. As a psychiatrist, for example, I might choose drug X over drug Y because:

--A relative did well on drug X.
--A relative did poorly on drug Y.
--I don’t like company Y’s marketing practices.
--I publish a newsletter, and my readers enjoy hearing me criticize drug Y.
--I’ve made $1 million doing promotional talks for drug X, and I’d like to make another million (I haven’t!).
--I’ve done 10 years of research on drug X’s mechanism of action, and if I get one more paper into New England Journal of Medicine I’ll be promoted to full professor.

And so on. There are innumerable sources of potential bias, and we should disclose those that are most clearly identifiable. In my opinion, financial conflicts are the easiest to identify, and also the easiest to resolve. I can choose not to take the money, but I cannot choose to change the fact that a relative did poorly on drug Y, or that I have staked my career on drug X, etc….

This is why we focus on financial conflicts of interest.

4. Finally, this is not about whether Senator Grassley, Senator Kohl, or the New York Times are trying to destroy psychiatry as a profession.

Most of the targets of Grassley’s investigation have been psychiatrists. Some have been cardiologists, and some have been orthopedists.

Psychiatrists have been particularly targeted because, at least in two of the states where drug companies are compelled to disclose payments to physicians, psychiatrists have topped the list. As a profession, I believe psychiatrists are the most vulnerable to the blandishments of the pharmaceutical industry, for various reasons.

First, we psychiatrists make less money than most other medical specialties, and want to supplement our income with drug company money. Second, psychiatrists, by abandoning psychotherapy to those “lower” on the pecking order, such as social workers and psychologists, have painted ourselves into a corner in which all we do is prescribe drugs. Thus, we are exquisitely dependent on information on pharmaceuticals, information which is usually funded by drug companies. Finally, we have a chip on our shoulders in relation to the rest of medicine. Are we “real” doctors? Are we as “good” or as “scientific” as our colleagues in other specialties? Psychiatrists obsess about such questions. Working closely with the pharmaceutical industry makes us feel valued, scientific, and powerful.

Let’s keep the focus where it belongs.



7 comments:

Anonymous said...

Dr. Carlat, I do think that the issue is less about disclore and more about Goodwin and the facts. Regardless of whether he declared his conflicts or not, the show had blatantly false statements that no one, neither NPR or Goodwin, has done anything to correct. If it had been a straight news show, a retraction would be in order. No doubt the issue of the link between the SSRIs and suicide is complex, but his show did not present both sides of the debate.
-Jon Leo

Anonymous said...

The Carlat Psychiatry Blog, Wednesday, December 10, 2008:
It’s Not About Goodwin. It’s About Disclosure.
...audience-members need to be informed so they can judge for themselves...

Judge how, Danny?

The Carlat Psychiatry Blog, Wednesday, March 19, 2008:
Full Disclosure = MORE Bias?
It may well be that disclosing COI [conflict of interest] has the unintended effect of encouraging people to give worse advice than they otherwise would.

Daniel Carlat said...

Jon, There's no doubt that the show presented one side of the debate, and your article (http://chemicalimbalance.org/?p=113) did a great job of dissecting statements made on the show. I've chosen to focus on the disclosure issue, which has wider applicability across all fields of medicine.

Michael, I knew someone was going to call me out on this! How can I say that disclosure is crucial while at the same time citing research showing that disclosure can backfire? Hopefully, as we all become more aware of the effects of conflict of interest, disclosure of COI will become more productive. But ultimately, as I mentioned in this post, the best solution is to stop taking pharma money for promotional activities altogether.

Anonymous said...

I guess the question I have to ask here is does the work done in this "blogosphere" have applicability out in the rest of the world, or just make for more spin for this medium alone?

That is what I find mostly frustrating, as I would like to take the info I read at sites like this and share it with colleagues and patients, but many who do accept what I offer in the beginning respond with more skepticism than appreciation when they learn it is blog-generated.

Let's face it folks, this is a medium that is opinion generated first, so viability and reliability is going to be challenged if it is not supported or based on strong data and documentation from media/sources outside the internet. And, I personally agree with this viewpoint. I could start a blog and make statements that I believe are fact and truth, but in the end, responsible people are going to ask, "where do you derive these conclusions/hypotheses"? If I say, "well, I read it on the internet", or "came to the conclusion based on what I alone know", is it going to be respected and valued? Doubtful.

Not that this is what Dr Carlat does here, but at the end of the day, it comes down to basically "that's your opinion, and it is wrong, in my opinion." When you publish it on hard copy, it takes on a different meaning and value.

The points above in Dr C's posting are on the mark for me. But, said here alone, will it have meaningful weight? Only time and widespread response will tell.

In the end, let's be brutally honest here as clinicians: so many of us have sold out, can respectability and credibility be restored for the profession as a whole? Not if we reject these disgusting influences that have profit as the driving force, not patient care first.

Until then, we are screwed. And when I say we, I speak for the doctors who embrace the Hippocratic Oath and all its intents with passion and consistency. Without the masses saying in unison, "the Biedermans, Goodwins, Schatzbergs, and other greedy, insensitive bastards out just for themselves can go to hell", we are labeled by this pathetic minority.

By the way, I believe one act of wrong can erase multiple acts of right. That is what I see with Dr Goodwin's example, because he defends what is so obviously wrong even when a thoughtful doctor would conclude, "I screwed up."

Just my opinion.

therapyfirst

Steven Reidbord MD said...

Dan, Thanks for another fine post. Disclosure of potential COI is the minimum, not the maximum, a speaker should offer. Far better is to avoid potential COI whenever possible.

This is like the difference, in a scientific paper, of describing the possible influence of confounding variables in the discussion, versus controlling for them in the methodology. The latter is clearly preferable.

Of all sources of potential COI, financial sources such as company sponsorship are rightly paid the most attention. Drug and device manufacturers are in the business of creating bias in favor of their products.

Anonymous said...

We can pin this headline on a copyeditor, not Harris.

Very parsimonious wrap-up, Daniel. I do respect your sticking to your principles.

But do you really think, with a headline like this, it's only about failure to disclose?

It might as well say Dr. X Still Beats His Wife

----------
Radio Host Has Drug Company Ties


By GARDINER HARRIS
Published: November 21, 2008

Anonymous said...

I greatly respect what you are trying to do here on the blog, Dr. Carlat, but I would like to voice my support for Jonathan Leo's comment. Although I'm angered by the conflicts of interest and think it's a problem, the real problem for me was what Goodwin and his guests presented on the radio show and how they did it. Goodwin clearly had an agenda, a very strong bias, going into the show and whether it was because of his conflicts or really his whole belief system is not entirely clear. He presented his case using assertions, misrepresentations of facts, poor references to evidence, and patronizing and arrogant language, dismissive of both the media and victims and survivors, like myself, of antidepressant-induced harm. They acted as if even mentioning that a school shooter was on an antidepressant was an affront to their profession. They seemed to think that if an individual was troubled then ergo medication could not be in any way responsible for the violent act which followed and this is simply a non sequitur. They presented trend lines in prescription rates and suicide rates as if they were some holy grail of proof about causation between them. They tried to portray suicidal ideation and suicide as two distinct and perhaps opposing phenomena which is frankly absurd. They spoke of great fears of undertreatment without pointing out that we currently have well over 25 million people already taking antidepressants! And finally they asserted great efficacy with nothing to back it up other than their own anecdotal observations. This is all rubbish. These guys were trying to protect their territory, not shed any new light on the relationship between antidepressants, suicide and violence. And they should be ashamed of how they did it.