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My Bad

2016-07-09

Here is the transcript of further communications that I received from Ivan Oransky:

Hi Conrad

Thanks for the response. While it is true that there are nearly 2,800 unapproved comments, that figure neglects the fact that there are far in excess of 20,000 approved comments. The latter either did not make any factual claims, or supported those claims with evidence. The former were reviewed but remained unapproved.
We are in agreement that we will not “go to the trouble to look up everything that is said in the comments section.” But that’s not what I mean by verifying claims in comments. What I mean is that it is the responsibility of the commenter to provide the evidence for his or her claims. Generally that’s done with links, pointing out where facts came from. We may differ on whether we should require such evidence, and many blogs don’t, but we feel strongly that we should not allow any unsupported claims anywhere on the blog, given the nature of what we cover. You don’t have to agree with our approach, but if you want to comment on our site, those are the rules. On your own site, you can have whatever rules you want.
It is not controversial that antipsychotics have bad side effects. But you made some very specific claims in this particular instance: That “acute akathisia is far more common than Janssen claims,” and, seemingly based on that, that “Janssen tries to downplay side effects.” It is certainly possible that both of those statements are true.
However, what is required to demonstrate that they are true is to show the real rate of acute akathisia, and the claims that Janssen makes about the rate of acute akithisia. I appreciate that you sent some data on akathisia rates in your last email, and these are the sort of data and links that would have made it trivial to verify your claims. That being said, if you are not sure whether the 10% figure comes from Janssen, you haven’t provided evidence that akathisia — assuming all of the data refer to acute cases — is more common than Janssen claims, because you haven’t provided any evidence of what Janssen actually claims.
I am sorry if you feel slighted by the requirement to provide evidence for your claims, but I can only say that we hold all commenters to the same standard.
I also see that you have quoted my emails on your blog, which you are welcome to do. I would ask, however, that you redact my email address and cell phone number. Neither of those is listed publicly, and I can’t think of a situation in which I would publish that kind of information as a journalist without requesting permission — which I will not grant. Thanks in advance for taking care of that.
Best,
Ivan
Dear Ivan,

I redacted your email address and phone number at 4:35 PM PDT.  I didn’t even realize they were there.  I don’t think they will fall into the wrong hands as it appears that the post was only viewed a couple of times (probably by you).

Your chain of reasoning about evidence is certainly rigorous and admirable, and I have no concerns there.
 As to akathisia as a side effect of Risperdal, the 10% figure comes from drugs.com, not directly from Janssen.  Janssen’s  “highlights” (the full prescriber’s information isn’t on line) show tables that specify rates of adverse reactions in their studies.  The rate for adults with schizophrenia of akathisia is shown as 10%  (table 8).  For pediatric patients, the rate of akathisia is given as 9% (table 9), and for bipolar patients with adjunctive therapy it is 8%, with monotherapy 9% (tables 11 and 10) .
In table 9, the rate of sedation is said to be 10%.  Since drugs.com gives the rate of sedation as “up to 63%”, their source of information about side effects must be somewhat different.  There are also differences in dosage between different side effect rates; lower-dose risperidone used in combination with olanzapine has a lower rate of akathisia.
The article in “Current Opinions in Psychiatry” that I quoted states that a Cochrane review found that about a third of patients developed extra-pyramidal side effects on either olanzapine or risperidone, but  “25% of patients receiving risperidone required medication to alleviate the akathisia, which was significantly higher than those receiving olanzapine during a 12-week to 12-month trial period.”  This statement suggests that the total rate of akathisia may have been greater than 25%, but that only that 1/4 needed medication.
Therefore, I think it is incontrovertible that Janssen is trying to minimize the rate of akathisia.  Whether you find that satisfactory as a chain of evidence is entirely up to you.
The only change in your comments section that I would definitely advocate (off the top of my head) is what the NYT does with comments: they send an email when the comment is reviewed and approved if the comment is acceptable (or disapproved if not.)  This may or may not be possible in your particular environment.
The only reason I felt slighted is because there was no feedback as to approval/disapproval of a comment.
Thank you for your detailed and thoughtful response.  Keep up the good work.
Sincerely, Conrad.
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