Saturday, December 20, 2008

Dr. Joseph Goldberg Responds to our Critique of Current Psychiatry CME Supplement

Note: I just received this e-mail from Dr. Joseph Goldberg, in response to our recent critique of this AstraZeneca funded supplement of the journal Current Psychiatry. With Dr. Goldberg's permission, I am printing his letter below in its entirety. I'll comment on it when I get a chance, most likely early next week.

Dear Dr. Carlat,

Your distillation of our comments in the case presentations of our recent Current Psychiatry supplement implies that the authors' goal was to motivate clinicians to diagnose more bipolar disorder and then use a medication manufactured by the sponsor of the CME. For the sake of fair balance to your readers, you might mention our findings published elsewhere that community practitioners fail to utilize DSM-IV criteria when diagnosing bipolar disorder, and consequently over-diagnose it in as many as 2 of 3 patients with mood instability and substance abuse (Goldberg et al., J Clin Psychiatry 69: 1751-1757, 2008); in such over-diagnosed patients, mood stabilizers appear far over-used to the exclusion of rigorous substance abuse treatment. But in patients WITH DSM-IV bipolar disorder, suicide risk is significantly higher, and use of unstudied drugs or medications with negative data may lead to disastrous outcomes.

Part of our goal in these case discussions was to review the differential diagnosis of bipolar disorder. Psychiatric medications work better when the diagnosis is correct, but often fail when it is not. Your comments fail to discuss the importance of correct diagnosis, differential diagnosis, and evidence-based (i.e., well-studied) therapeutics, as expressed in our supplement.

When a diagnosis of bipolar disorder IS correct, unfortunately, few medications have robust effects. In the case of bipolar depression, for example, the controlled trial literature has far more negative than positive studies (e.g., antidepressants + mood stabilizers are no better than mood stabilizers alone [Sachs et al., NEJM 2007; 356: 1711-1722); aripiprazole is no better than placebo (Thase et al., J Clin Psychopharm 2008; 28: 13-20); lamotrigine has 4 negative placebo-controlled studies (Calabrese et al., Bipolar Disord 2008; 10: 3; 10: 323-333)). For better or worse, quetiapine and Symbiax are the only psychotropics that have demonstrated efficacy for acute bipolar depression. The academic community would greatly welcome CME-sponsorship by more organizations, but most studied agents are now either off-patent (e.g., lithium, divalproex, lamotrigine), lack FDA indications due to negative findings (e.g., divalproex for maintenance; oxcarbazepine for acute mania (Wagner et al., Am J Psychiatry 163: 1179-1186, 2006); topiramate for acute mania (Kushner et al., Bipolar Disord 8: 15-27, 2006); or lack any data (e.g., ziprasidone or risperidone for bipolar maintenance). Our case discussion reflects this literature, but yours does not. Readers deserve a more fair-balanced critique of our summary than the one you provide.

-- Joseph Goldberg MD,
Assoc. Clin. Professor of Psychiatry, Mount Sinai School of Medicine;
Deputy Editor, Current Psychiatry

4 comments:

Anonymous said...

I respect your practices of posting responses from the individuals that you mention in your blog. I wish that you would go a step farther and use peer reviewed forums to debate the critical issues on which you focus. Your letter to JCP in June 2008 was a great example of elevating this type of exchange. In a blog, it is too easy to get caught up in the inflammatory nature of quick and public venting. The Blog mechanism lends itself to an attack mode. Academic publication, on the other hand, permits cooler heads to prevail, in its slower time course and peer review. It requires patience, but ultimately the debate is elevated, and may achieve your goals in a more meaningful way.

Anonymous said...

I think the point of the original posting was to show how the content and conclusions of this supplement betray its funding source. I went back and looked through the supplement in question and didn't see any mention of the overdiagnosis of bipolar disorder. In fact, there is a section on misdiagnosis that implies an underdiagnosis of bipolar disorder. I'm in favor of balance and would urge Dr. Goldberg to heed his own call. Doth he protest too much?

therapyfirst said...

Amen to the above two comments!

But, in the first opinion, just remember a good portion of publications are dependent on these pharma dollars, so who is going to speak negatively about their funding sources? Maybe a CME course like Directions in Psychiatry could take it on. Doesn't seem pharma tainted to me, that I can tell overall.

If physicians like Dr Goldberg truly expect us as fellow physicians to take their word as fair and unbiased, it is time for researchers who are published with regularity, or focus on one medication as a solo intervention, to report their yearly earnings with all pharmaceutical organizations, irregardless if the "funds" go to the university or research programs they more likely hide behind to minimize those monies being seen as going into their specific pockets.

I would be willing to make a $100 bet with anyone refuting my following claim, who would provide full transparency to a third party to insure validation, that Astra Zeneca has been involved in shady dealings to get the alleged indications for Seroquel, especially since they first got named the number 1 antipsychotic prescription in this country these past approximiate three years. Now for Unipolar depression, soon for anxiety; none of the literature supporting these indications is independently sponsored, I KNOW IT!

I will say this for Dr Goldberg, his comment about overdiagnosis of Bipolar with comorbid addiction issues is so on the mark for me, I just want to thank him for making such a statement in print. That is why I do not work in an addiction program anymore, as non-psychiatrists just want these people drugged, and that position is pathetic!

That said, the greed I hear from reps and see in the literature by these companies should interest Sen Grassley as much if not moreso than these Judas bastards who pocket the checks from said companies who are profit driven, not care driven.

Why don't we see the FBI raiding pharma offices? Because their (pharma) money is in the pockets of the politicians who should be representing their electorate, not special interests who are putting the public at risk with over-inflated indications.

I'm just glad to read that states aren't waiting for the feds to show responsibility by suing these companies like Lilly, Jannsen, and AZ now. I hope these individual suits expose pharma for their pervasive poor judgments these past 10 years regarding antipsychotics. Furious Seasons seems to be taking an interest in this direction, so hopefully 2009 will expose evil intentions and get them out of the market.

Change with Obama in 2009? With the congress still at large, hold your breath for those who think so, as those of us who are reality based would rather the clueless be unconscious. Reject greed, or you as physicians might as well wind up rejected as valued members of this society.

Nice post, especially for the weekend!

Steven Reidbord MD said...

In his last paragraph, Dr. Goldberg implies that only "organizations" that stand to profit from CME will sponsor it. This succinctly restates the problem. It's not that untruths are spread by biased CME -- maybe quetiapine is best in the cases presented -- but that truths are selectively offered in favor of the sponsoring company.