Wednesday, December 16, 2009

Thoughts on Ghostwriting

There has been a lively and thoughtful discussion about ghostwriting in the comments section of my post on BlueSpark’s invitation to a doctor to write a review article on bupropion and depression. Here are some of the issues that have come up.

1. What’s in a name?

Michael Altus has been tenacious in his efforts to educate us in the still evolving vocabulary of this business.

“Ghostwriter”= A person who writes or otherwise assists in presenting the author's work without being acknowledged.

“Ghost author” = Identical to a ghostwriter.

“Guest author” = A person who is listed as an author without having made substantial contributions. This is what has also been called “identified author,” or “named author.”

Beyond this, there are acknowledged medical writers, usually listed at the end of an article, and typically described as providing “editorial assistance,” “assistance with data analysis,” etc…. These are not really ghostwriters, because they are visible. However, they are often spectral writers, or semi-ghost writers, because in some cases they have essentially done all the work, including the conception (in conjunction with the company’s marketing team), the outlining, the writing of the first draft, and the final editing. Anybody who does all that, or even part of that, should be listed as an official author. But it doesn’t look very legitimate to have a medical writer without an MD recorded as an author, and what the drug companies are looking for is legitimacy, whether genuine or fabricated.

2. So who should be listed as an “author”?

According to the web site of the International Committee of Medical Journal Editors (ICJME), in order to get your name up in lights as an author of a scientific paper, there are three specific criteria. To quote from their recommendations:

“Authorship credit should be based on 1) substantial contribution to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published.”

As you can see, there’s quite a bit of wiggle room here. For example, what should count as “substantial contribution to conception”? If an academic has a brief phone conversation or an email exchange with a pharma-funded medical writing firm in which the topic of the article is discussed, the firm might later argue that this counted as a “substantial contribution to conception.” In fact these criteria do not require that an author do any actual writing—as long as they do some “revising.” As an editor myself, I know that “revising” is an expandable term, and can include everything from reading a draft of an article and saying “that looks great, I have no changes for you,” all the way to performing major surgery on the very organization of a paper.

3. Isn’t ghostwriting acceptable in some circumstances?

This is really the crux of the controversy about ghostwriting. Many commenters have pointed out that making science understandable is difficult, specialized work. It is unrealistic to think that scientists have the time or expertise to do the wordsmithing needed.

I agree, which is why I draw a bright line between industry-funded medical writing and academia-funded medical writing. Both ghostwriting and acknowledged editorial assistance are perfectly acceptable when the assistance is not arranged by a company that has a stake in the topic of the article. Most academic departments hire research assistants and editors whose jobs are to help write the many articles that get churned out by the more productive members of the departments. There is no incentive for such editors to bias the articles in any way.

But when an editor is paid, either directly or indirectly, by a drug company to work on an article, readers should be concerned, because now there is a powerful incentive for the editor to manipulate the content of the article to promote the sponsor’s product. If the final published article is not promotional enough, the writer won’t get a future assignment from the funding company. It’s as simple as that.

4. What’s the solution?

I have two recommendations:

--Journals should not publish articles that are clearly written in order to promote the funder’s product. Generally speaking, this would exclude any articles involving medical writing companies, even when their involvement is acknowledged. After the many recent example of corrupted scientific literature by drug company/medical writing firm partnerships, we can no longer have any trust that such teamwork is anything other than marketing.

--Journals should continue to publish research funded by industry, as long as the researchers sign disclosure statements assuring editors that they had complete control and involvement in every aspect of the paper. This means essentially no contact with the drug company after having accepted the money. Obviously, such research can still be highly tainted by bias, but the degree of bias is likely to be less extreme. Furthermore, as the medical literature gate-keepers, editors will scrutinize such research with extra care in order to make sure they are not unwittingly publishing advertisements in guise of science.

Monday, December 7, 2009

Check Out Antidote: The Best Blog on Ghostwriting

Occasionally I admire the work of William Heisel, a journalist and blogger who writes the razor-sharp health blog Antidote, hosted by the University of Southern California and the Annenberg School for Communication. Lately, Heisel has been digging into UCSF's Drug Industry Document Archive (DIDA), specifically its huge collection of smoking gun documents about the medical writing company DesignWrite. There are reams of material here and there is nobody better than Heisel at making sense of it all, and revealing the bankrupt sense of morality that seemed to have permeated DesignWrite and everything it touched.

Currently, Heisel is blogging about Dr. David Archer, an ob/gyn and a key part of the Wyeth/DesignWrite team. Wyeth pharmaceuticals hired DesignWrite to ghostwrite dozens of articles to promote its various products, including birth control pills, antibiotics, and the hormone replacement pill Premarin. Heisel traces Dr. Archer's activities with DesignWrite with devastating tenacity, following the path of financial relationships through the drug company, bought-out "journals," medical writers, and so-called "authors." Each time, the punch line ends up being a glowing endorsement of a Wyeth product, authored by Dr. Archer, but written by...who knows?

At one point, Archer was the editor of a newsletter called "Menopausal Medicine," which is funded by Wyeth. As editor, he had accepted an article by Dr. James V. Fiorica (also a Wyeth-kept man) entitled "Mammographic breast density and hormone replacement therapy." Ghostwritten by DesignWrite, it was a carefully crafted argument that HRT does
not interfere with images on mammography (as has been charged by others academics). In a move reminiscent of the Nemeroff/VNS/Neuropsychopharmacology fiasco, Archer was playing on both sides of the field, each side chock-full of conflicts of interest.

Says Heisel: "[Archer] was supposed to be, as the journal editor, the ultimate arbiter of the strength of the submissions to Menopausal Medicine. But, as documents in the Drug Industry Document Archive show, he also was working directly with DesignWrite on tailoring the article."

Sunday, December 6, 2009

Subject: Invitation to Author a Review Article

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


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,

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.

Thursday, December 3, 2009

Canadian Medical Association Gets Dumb (and $780,000)

The Canadian Medical Association is getting plenty of flak about their $780,000 CME deal with Pfizer, and anyone with half a brain can see why. Pfizer is not in the business of altruism. When they spend lots of money, they do so in order to make their shareholders happy.

For example, when the company cut a
$12.3 million CME deal with a collaborative including the University of Wisconsin and the California Academy of Family Physicians, they did so in order to encourage doctors to talk to their patients about smoking cessation. Presumably, this increased sales of Pfizer's anti-smoking drug Chantix. While this CME program, called CS2 Day (Cease Smoking Today), does not have the blatant infomercial feel of most commercial CME, it treats Chantix with kid gloves. As covered in the Milwaukee Journal Sentinel, an online course for doctors fails to mention a small piece of the Chantix puzzle--the fact that its side effect profile includes serious psychiatric symptoms. Heck, they didn't mention any of their product's side effects in the presentation. You call that accredited CME?

So now the officials at the Canadian Medical Association are chugging the same kool-aid as UW's director of CME, George Mejicano, who had defended the Pfizer-funded courses with a pile of nonsense: "He said such courses are rarely comprehensive and are designed to meet selected learning objectives.” Now listen to his Canadian colleague:

“There's no connection between the funder and the people who are actually providing the content,” Dr. Sam Shortt, CMA's director of knowledge transfer, said. “We're confident that these two elements meet and exceed any expectations from any observer.”

In my experience with colleagues from Quebec and Ontario at American Psychiatric Association meetings, Canadians are generally far from naive--so why did Dr. Shortt and the CMA turn off their neurons? Hmmm. Let me count the reasons--all 780,000 (U.S.) of them.