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Healthy Skepticism Library item: 16889

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Electronic Source

Carlat D
Subject: Invitation to Author a Review Article
The Carlat Psychiatry Blog 2009 Dec 6
http://carlatpsychiatry.blogspot.com/2009/12/subject-invitation-to-author-review.html


Full text:

Here is an email sent to one of my psychiatrist colleagues by BlueSpark, a medical communications company working under contract for the drug company sanofi-aventis. Read it, and decide whether you think this is a solicitation to become a ghost author.

Subject: Invitation to Author a Review Article
Date: Dec 2009

Dear Dr. XXXXXXX,

I hope this note finds you well. My name is Jonathan Wert, MD, and I am a medical director at BlueSpark Healthcare Communications, a medical communications company located in northern New Jersey. I was given your contact information by Dr. YYYYYYY , who spoke very highly of you.

I am writing to you on behalf of sanofi-aventis, which has authorized us to facilitate publication of an MDD/Bupropion-focused review article. We feel that your input on a multitude of topics including the following would be extremely valuable:

  • Your views on MDD, including the variability in response to treatment.
  • How MDD is currently being treated and how successful these treatments are at inducing remission and preventing relapse.
  • What are the other benefits of available therapies?
  • What are the unmet needs/drawbacks of these medications?
  • What attributes novel antidepressants should have.

sanofi-aventis and BlueSpark would be pleased to have you serve as the author of this article, and we will work closely with you in its development. Initially we will help develop a draft outline. Once you have reviewed and approved this outline, we will proceed to development of a draft paper. We will then revise the manuscript according to your direction and assure that it is styled appropriately for submission to your proposed journal.

As I am sure you are very busy, our team would like to arrange a brief conference call to discuss the content to be included in the manuscript/outline. I look forward to hearing from you at your earliest convenience.

Best regards,
Jon

Jonathan M. Wert, MD, MAAP

Here’s the way I interpreted the letter.

Sanofi-aventis just introduced a “new” antidepressant called Aplenzin. Aplenzin is not really new at all, being simply a reformulated version of bupropion extended release. Its advantage is that it offers once a day dosing in all three of the usual doses prescribed (150 mg, 300 mg, and 450 mg), whereas generic bupropion ER offers once daily dosing for 150 mg and 300 mg only. The unusual patient who needs 450 mg dose has to combine 150 mg with 300 mg. So from a clinical standpoint, Aplenzin represents an “advance” in the most minutely incremental sense.

The disadvantage of Aplenzin is not so subtle. It is a health care budget-buster, costing 20 times more than generic bupropion ER. Where do I get this figure? Vermont’s Pharmaceutical Marketer Price Disclosure Law requires that drug companies disclose their drug’s wholesale price along with the prices of drugs in the same class. It turns out that the starting dose of Aplenzin costs $5.58, while the same dose of generic Bupropion ER costs only 28 cents. I’m sure Obama would be pleased to hear about this!

Obviously, selling Aplenzin is going to be an uphill battle, so along with the usual journal ads and drug rep visits, sanofi-aventis has added a publication plan to their marketing strategy. Here’s where Dr. Wert and BlueSpark come in. BlueSpark is looking for doctors to write, as they put it, an “MDD/Bupropion-focused review article.”

Although the letter is artfully crafted to make it appear that they are simply seeking the good doctor’s “input” on some issues, the flavor of input they are after is clear if you read between their lines. I’ve taken the liberty of deciphering the coded language used by BlueSpark, in order to further clarify the nature of their solicitation.

  • “Your views on MDD, including the variability in response to treatment.”
    [You should say that lots of patients don’t respond to SSRIs or to the usual doses of bupropion, in order to set up the conclusion that Aplenzin is useful.]
  • “How MDD is currently being treated and how successful these treatments are at inducing remission and preventing relapse.”
    [Here, your focus will be on how SSRIs are often not successful at achieving remission, so you better try Aplenzin.]
  • “What are the other benefits of available therapies?”
    [Similar to the point above, namely, say that available therapies suck, so hurray for Aplenzin].
  • “What are the unmet needs/drawbacks of these medications?”
    [The main drawback: nobody is prescribing Aplenzin yet]
  • “What attributes novel antidepressants should have.”
    [Best attribute: be a once a day version of bupropion like Aplenzin].

Playing fair, I emailed Dr. Wert, telling him that this looked to me like a solicitation for a ghost author, which is contrary to the policies of the International Committee of Medical Journal Editors, and asking him if he wanted to comment.

I got a response from Michael Weems, BlueSpark’s COO, who disagreed with my assessment, saying that I had “misunderstood” his invitation: To quote from his response: “Any development of a draft manuscript would take place only after the author has developed a formal outline that would include tables, figures, and references. Following this, the author would review the draft manuscript and have total control of the content (ie., change, add, remove, or edit as he or she sees fit to meet the manuscript objectives). Our role would be to facilitate the development of the article by helping the author publish the article in a timely fashion. Additionally, our support is always acknowledged and can also lead to co-authorship if it meets the guidelines defined by the ICJME.”

As I read Mr. Weems’ letter, my built-in BS detector went as wild as a Geiger counter in Iran. Because let’s face it. No psychiatrist is going to wake up in the morning and say, “I think today is the day I’ll work on a review article on bupropion and depression and how awful it is that the tiny number of patients who require the maximum dose have to take two pills in the morning instead of one. Yes-this will be a significant contribution to the medical literature.”

This would never happen, because there’s nothing new or interesting in this topic. We know that bupropion works well for depression, and we’ve known it even since it was approved by the FDA in 1985.

No, the only reason a psychiatrist would get motivated to write such an article is if a cold-call email solicitation from BlueSpark gets past the spam filter. I’m guessing that BlueSpark hopes that eventually they will find an uncreative, mid-level academic who is treading water professionally, and who will jump at the chance to pocket a little extra money while simultaneously padding the resume with a publication that will require essentially no work to produce. (Dr. Wert’s line at the end of his solicitation, “As I am sure you are very busy…” seems a nudge-nudge wink-wink assurance that the company will take care of everything.)

Whether or not this meets the formal definition of ghost-writing, it is clearly a manipulation of the medical literature, a kind of plastic surgery of science. The articles may look impressive, and they may look real, but in fact they will be phony.

The most telling part of BlueSpark’s response to me came at the end of the COO’s letter:
“Based on your misunderstanding of our invitation, we are requesting that you do not post this letter on your blog. If you have any additional questions or would like to discuss this topic further, please e-mail me or call me directly at the number below.”

Does this mean that if I had understood the invitation, they would have been happy to see it posted? I doubt that. Or was this simply BlueSpark’s effort to bully me into keeping this embarrassing letter out of the public eye? If so, I guess it didn’t work.

Abe Lincoln put it well: “You can fool some of the people all of the time, and all of the people some of the time, but you cannot fool all of the people all the time.” For all of our sake, let’s hope this holds as true in the 21st century as it did in the 19th.

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963