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Don’t Read This: An email exchange (of sorts) with Ivan Oransky, MD, of “Retraction Watch”

2016-07-08

I tried to have an email exchange with Dr Oransky but I couldn’t seem to get my thoughts in a succinct fashion.  I don’t want to send him a long email that he’s not going to really read because it sounds like a rant from some old fart who’s got a bug in his beard.  So I’ll publish it here where no-one will even see it.  Like sending a message in a bottle.

Here is what I wrote, but didn’t send, with his note to me:  (you can see that it’s way too long to read easily.  I got burned by writing too long of a paper in college and I’ve never forgotten it.  That’s why this blog.  I can spout all I want without ever worrying about who’s going to have to take the time to read it.)

My comment, on his blog about Retractions, to a post about a controversy over whether the manufacturer of Risperdal tried to tailor a research paper to hide side effects:

In my opinion, Risperdal’s side effects are intolerable in all but the worst cases of acute psychosis. Prescribing it to children or adolescents is unwise, especially for long periods. I say this having had professional experience with this drug: acute akathisia is far more common than Janssen claims, and long term side effects are also prominent and troublesome (to use common psychiatric euphemisms). Elevated prolactin, weight gain, apathy, dystonias, etc. I have tried this drug (experimentally, not clinically) and you would not wish to have this experience. I am not surprised that Janssen tries to downplay side effects, with good reason; if psychiatrists knew what their patients were experiencing, they wouldn’t prescribe it.

The letter I didn’t send and Oransky’s letter:

You say that my comment contained “verifiable claims and facts that we’d need to verify.”  You never informed me of your disapproval, at least to my knowledge… did I miss something?
How are you going to “verify” my personal experience?

I said that the side effects I had noted in my practice were my personal experience and my opinion.  There’s no way you can verify that unless you prescribe it or take it yourself.  Or take a close look at the literature.

Here is what drugs.com says about risperidone side effects:
“Very common (10% or more): Sedation (up to 63%), parkinsonism (up to 28%), akathisia (up to 10%), dizziness, (up to 14%), tremor (up to 11%), drooling (up to 12%), headache (up to 12%)”
Would you take risperidone unless you were suffering from acute psychosis where the condition is worse than the side effects?
Respectfully, I feel neglected.  I’m interested in publishing my opinion, and if you’re not interested, I can publish it on my own blog under my own responsibility.  I felt that my comments were highly relevant to the issue: that the manufacturer is dissembling about risperidone’s side effects by getting articles published that omit them.
If you don’t think it’s relevant or that I’m wrong, you should tell me.  I only found out by accident that ALL of my comments, even the anodyne ones, are going into your “pending approval” file.  I’m not going to comment at all unless there’s some chance of my comments appearing… meaning there’s less chance of my reading your blog in the first place.
It’s unclear to me whether my comments are appearing with the “awaiting moderation” tag, or not appearing at all.
If you don’t have time to approve the comments, which I see you don’t (“Currently 2,797 comments are waiting for approval.”)
then maybe you should announce a change in policy.

 

On Fri, Jul 8, 2016 at 7:54 AM, Ivan Oransky <ivansciam@gmail.com> wrote:

Hi Conrad, your comment was not approved because it contains verifiable claims and facts that we’d need to verify. Please review our comments policy: http://retractionwatch.com/the-retraction-watch-faq/

 

Ivan Oransky, MD
Vice President and Global Editorial Director, MedPage Today http://medpagetoday.com
Distinguished Writer in Residence, New York University’s Arthur Carter Journalism Institute
Co-Founder, Retraction Watch http://retractionwatch.com
Vice President, Association of Health Care Journalists
Clinical Assistant Professor of Medicine, New York University School of Medicine
 

———- Forwarded message ———-
From: WordPress<wordpress@retractionwatch.com>
Date: Fri, Jul 8, 2016 at 9:43 AM
Subject: [Retraction Watch] Please moderate: “Drugmaker accused of omitting side effect data from 2003 Risperdal paper”
To: ivansciam@gmail.comA new comment on the post “Drugmaker accused of omitting side effect data from 2003 Risperdal paper” is waiting for your approval
http://retractionwatch.com/2015/08/12/drugmaker-accused-of-omitting-side-effect-data-from-2003-risperdal-paper/Author: Conrad Seitz MD (IP: 70.211.70.120, 120.sub-70-211-70.myvzw.com)
Email: conradseitz@gmail.com
URL: http://conradseitz.com
Comment:
Wondering why my comment is still “awaiting moderation” after nearly a year?Approve it: http://retractionwatch.com/wp-admin/comment.php?action=approve&c=1067622#wpbody-content
Trash it: http://retractionwatch.com/wp-admin/comment.php?action=trash&c=1067622#wpbody-content
Spam it: http://retractionwatch.com/wp-admin/comment.php?action=spam&c=1067622#wpbody-content
Currently 2,797 comments are waiting for approval. Please visit the moderation panel:
http://retractionwatch.com/wp-admin/edit-comments.php?comment_status=moderated#wpbody-content

The letter I DID send:

Respectfully, I have two problems:
1) I never got an email saying that my comment wasn’t approved.  I don’t know what the tag “awaiting moderation”  really means: does it mean the comment is invisible to everyone but me, or is it just a tag to tell others that you don’t approve it?  Or that you haven’t yet approved it?
2) If you don’t want to hear about my personal experience even when I’m sure it’s true and it’s highly relevant to the subject at hand (the manufacturer’s dissembling about side effects) then I can publish it in my own blog under my own responsibility.
It’s not clear whether you think I’m wrong or just can’t prove I’m right.
Here is the response I received from Ivan:

Hi Conrad

Thanks for responding. To answer your questions:
— We don’t email everyone to let them know comments haven’t been approved. There just isn’t time. As we note in our comments policy, readers are welcome to email us about why a comment wasn’t approved, or, as you did here, leave another comment asking that, which we will respond to as time permits. Comments that are awaiting moderation are only visible to RW staff and to the people who left them.
— You are of course free to publish your comments on your own blog. We need to verify everything that appears on the site, even in comments, so if you want to send evidence for all the claims, we can review that and consider approving the comment. We have no opinion on whether you’re right or wrong; we just can’t prove that you’re right without evidence.
Thanks.
And here is my response to his response:
Dear Ivan,

It appears to me that your staff is overwhelmed by the volume of comments, because there is a line at the end of the email that you sent me that states “Currently 2,797 comments are waiting for approval. Please visit the moderation panel:”

Based on this information, I can see that there is no point in making substantive comments on your blog because you won’t have time to “moderate” them.  I will, in future, restrict my comments to my own blog, where I alone can take responsibility for what is said.
Sincerely, Conrad.
And here’s what else I wrote, after reflection:

Dear Ivan,

I’m sorry that I can’t get off this subject, and I apologize in advance for the length of this email.  I feel slighted by your statement that “if you want to send evidence for all the claims” — what kind of evidence do you want, copies of my progress notes?  I don’t claim to have special knowledge or to have conducted any formal trials.  I just noticed something that happened in my practice which seems to me should be glaringly obvious based on all the information that has been presented in public; and I stated at the beginning that it was my opinion.
I thought that there should be plenty of evidence out there for what I said, so I googled “Risperdal side effects” and in five minutes, found the following:
Here is what drugs.com (one of the biggest web sites; they feature patient reports about their drug experiences) had to say about Risperdal side effects:
“Very common (10% or more): Sedation (up to 63%), parkinsonism (up to 28%), akathisia (up to 10%), dizziness, (up to 14%), tremor (up to 11%), drooling (up to 12%), headache (up to 12%)”
Then there are the 127 patient experience reports on drugs.com, most of which state that weight gain, akathisia, confusion, and elevated prolactin were troublesome side effects.  Most of them also say that Risperdal was effective for their mania or auditory hallucinations, so it’s not like it doesn’t work.
Drugwatch also has a long piece about Risperdal’s side effects and mentions a study that found a very high incidence of pituitary tumors due to risperidone.
Here is a quote from an article in Medpage Today [http://www.medpagetoday.com/neurology/autism/53288 ]
” most clinicians prescribe risperidone only when the benefits outweigh the risks, says Edwin Cook, MD, professor of psychiatry at the University of Illinois at Chicago”
(“when the benefits outweigh the risks” is a euphemism for “last resort.”)
That article also mentions that Janssen settled with the FDA for $2.2 bn on charges that it “aggressively marketed Risperdal for unapproved indications.”
Here is a quote from an article about second-generation antipsychotics and akathisia:[http://www.medscape.com/viewarticle/703492_4]
“However, 25% of patients receiving risperidone required medication to alleviate the akathisia,”
(25% is more than 10%, is it  not?  I think the 10% figure comes from Janssen’s own research results.)
Further on in the same article:
” It has also been noted that akathisia occurring early in treatment or after increases in doses may be more troublesome and distressing for the patents.[42] Chronic akathisia from risperidone has been reported recently as a reason for a patient to become extremely irritable, easily agitated, and sometimes violent.”
(Reference 42 is a paper entitled, “Akathisia as a risk factor for suicide”, which suggests just how distressing akathisia can be.)
Then there are my own experiences:
I personally experienced akathisia, along with orofacial dsykinesias, accidentally after a single dose of risperidone, and only the fact that I knew it was a side effect made it even remotely tolerable.  If a quarter of patients taking risperidone have these side effects, then prescribing it seems to be a last resort.
Then there were the drug reps who pushed Risperdal to me, all of whom minimized the side effects and insisted that they were tolerable.
Then there were all the patients I treated who developed diabetes after large weight gains from chronic administration of risperidone.
This is what I wrote:
In my opinion, Risperdal’s side effects are intolerable in all but the worst cases of acute psychosis. Prescribing it to children or adolescents is unwise, especially for long periods. I say this having had professional experience with this drug: acute akathisia is far more common than Janssen claims, and long term side effects are also prominent and troublesome (to use common psychiatric euphemisms). Elevated prolactin, weight gain, apathy, dystonias, etc. I have tried this drug (experimentally, not clinically) and you would not wish to have this experience. I am not surprised that Janssen tries to downplay side effects, with good reason; if psychiatrists knew what their patients were experiencing, they wouldn’t prescribe it.
My statements are on the extreme end of the spectrum as to risperidone side effects and indications, but they are not off the wall, and they are supported by abundant literature.  I don’t expect you to go to the trouble to look up everything that is said in the comments section, but apparently you feel the need to do so.  Yet you are unable to rise to that level due to the volume of comments.  I think that you should consider changing your comments policy, but that’s just my opinion, and I’m just an old fart.
Sincerely, Conrad.
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