Results tagged “ghostwriting” from Pathophilia
The reason to care about medical ghostwriting is that it may be used to convey drug-industry messages through credited academic authors. In other words, there is an attempt by industry to influence a physician-reader's prescribing practices under the guise of academic objectiveness (although nobody, to my knowledge, has demonstrated this outcome).
But I would argue that the issue of medical ghostwriting is irrelevant when pharma-employed scientists are among the credited authors of articles (which are usually reports of pharma-supported studies). In these cases, the potential for commercial influence in the published material is already obvious, regardless of who actually wrote the article.
Nevertheless, the possibility that there are situations in which medical ghostwriting is immaterial is evidently lost on some (nor will it get in the way of a mission to root out ghostwriting, no matter how immaterial). Case in point:
In a 2-part effort to impugn the marketing of the antidiabetes drug Avandia (rosiglitazone), the Senate Committee on Finance sent a letter to FDA Commissioner Margaret Hamburg on July 12, alleging that manufacturer GSK 1) failed to publish negative studies of the drug "in a timely manner" and 2) hired ghostwriters to pen medical articles that were favorable to Avandia. The former charge, the more serious of the two, has received considerable press attention—most notably in a recent NYT article by Gardiner Harris. However, the ghostwriting charge has not, by any means, been ignored.
In a confusing post at the generally anti-pharma (and often sensationalist, IMO) blog Pharmalot, Ed Silverman asked his readers last Thursday, "Did the American Heart Association's Circulation journal publish a ghostwritten article about Avandia?" Silverman's answer, yes, lies in an exchange of letters among the Senate Committee, the FDA Commissioner, and the AHA. But a closer examination of the letters and the published literature reveals a more nuanced answer than what Silverman concluded (and what his blog readers are likely to be receptive to). A closer examination also reveals how deftly and stubbornly the Committee maintained its ghostwriting allegations against the AHA while failing to acknowledge 1) its confusing and/or mistaken evidence and 2) when medical ghostwriting is an important issue.
In its July 12 letter, the Finance Committee provided 2 attachments to substantiate allegations of Avandia-related ghostwriting by GSK. The first attachment, H (pp 58-109 of 158), contained an e-mail from the Avandia Publication Strategy Manager, who presented a draft manuscript to his GSK colleagues. The manuscript, which reviewed 5 modifiable risk factors for cardiovascular disease, was to be credited to University of Texas cardiologist Steven M. Haffner, MD, and "targeted" to the American Journal of Cardiology, an independent peer-reviewed medical journal that is published by Elsevier. The journal is not affiliated with the AHA.
The text of the redacted and "VERY poorly written"* manuscript mentioned rosiglitazone exactly twice (at the end of the article), both times in conjunction with its chief competitor, pioglitazone (Actos). A notable, suggested edit was to use "Avandia references" in the construction of a table detailing the effects of thiazolidinediones on cardiovascular risks.
The Committee's follow-up attachment I (pp 110-158) contained Haffner's "reworked" and highly condensed manuscript, entitled, "Modifying cardiovascular risk in the type 2 diabetes patient." The title page of the review now indicated the authorship of Haffner and nurse Holly B. Cassells, PhD, who is on faculty at the University of the Incarnate Word [?!]. The title page also acknowledged that the paper was "[s]upported by an unrestricted, educational grant from GlaxoSmithKline" (thereby acknowledging the potential for commercial influence in the manuscript). The heavily redacted text in the attachment mentioned rosiglitazone 4 times (by my count) and highlighted a study of the cardiovascular effects of combined therapy with atorvastatin (Lipitor; Pfizer) and rosiglitazone (Cohen et al, 2001). A GSK e-mail suggested that the review article should now be targeted to another non-AHA journal, Clinical Cardiology (published by Wiley).
In its attachment I to Hamburg, the Committee chased the Haffner review paper with another Haffner-authored article, which was evidently accepted into the journal Circulation, a bona-fide AHA journal. This article, "Effect of rosiglitazone treatment on nontraditional markers of cardiovascular disease in patients with type 2 diabetes mellitus," described the results of an actual study; in other words, it was not a review article (and it was clearly not the review manuscript previously cited by the Committee in its attachments). The article, published in 2002, had 6 credited authors, 3 of whom (including Martin I. Freed, MD) were acknowledged employees of GSK, and the study's GSK funding was made clear.
On August 23, the AHA responded to the Committee's charges by sending a letter to Hamburg. Donna K. Arnett, PhD, the chair of the AHA's Scientific Publishing Committee, attempted to clarify the distinction between the 2 articles cited by the Committee in its attachments. Arnett noted correctly that the review article was never published in Circulation and was targeted to at least 2 non-AHA journals.** Arnett concluded,
Since Circulation has never published a review article by Haffner and Cassel[sic] entitled, "Modifying Cardiovascular Risk in the Type 2 Diabetes Patient," as claimed in the letter to you, the letter and its appendices are misleading. We have requested that [the Committee] provide a correction for the record.
But not to let details get in the way of a mission, Ranking Member of the Committee, Senator Chuck Grassley, responded to Hamburg with yet another letter, dated September 1. Grassley disingenuously wrote (or one of his staffers disingenuously ghostwrote),
At the time, it was unclear if the emails about ghostwriting concerned the article that appeared in Circulation, or if they were discussing a separate manuscript.
To which I say: Rubbish. The featured, originally ghostwritten review article by Haffner (and then Haffner and Cassells) was the clear subject of the GSK e-mails.
Then Grassley (or his staffer) added, while completely ignoring the cited review article,
Regardless, my staff has consulted with GSK, and the company confirmed that the manuscript which appeared in Circulation was written for GSK by a medical education company.
To which I say, more or less, to the Committee (and Pharmalot): So what? Given that 3 of the 6 authors of the Circulation article were acknowledged GSK employees and that the study was transparently funded by GSK, the potential for commercial influence is obvious to any physician-reader, regardless of who actually wrote the article.
Now as far as the originally ghostwritten review article is concerned, which Senator Grassley (or his ghostwriting staffer) failed to address in the September 1 rebuttal letter, a quick search of the literature reveals that Cassells and Haffner (credited in that order) finally published, “The metabolic syndrome: risk factors and management,” in the Journal of Cardiovascular Nursing in 2006. This journal is not an AHA journal. Because access to the article requires a subscription, I am (at this time) unable to assess the objectiveness of the article, how closely the article adheres to the attachment I text, or whether commercial support is acknowledged.
* As it was described by GSK's Julia Eastgate, Head of Diabetes Communications, Europe, in her e-mail.
** Silverman called Arnett's letter "sharply worded"; on the contrary, I find Arnett's wording moderate in tone and matter-of-fact.
No. 3: The Transparency Movement Takes a Vice-Like Hold
The push to uncover every potentially relevant tie between physicians and commercial interests, every medical writer behind a figurehead author continued with a vengeance in 2009.
In December, Northwestern University became the latest medical school to voluntarily disclose the financial relationships of its faculty with drug or device companies at its web site. The Chicago-based university joined Stanford, which provided similar online information in August, and the Cleveland Clinic, which boarded the disclosure train last year.
A handful of pharma companies, perhaps in an effort to avoid legislated disclosure,* also committed to posting some of their payments to physicians. This year, Eli Lilly, Merck, and GlaxoSmithKline began revealing various forms of compensation to healthcare professionals for a variety of services, like consulting or speaking. And Pfizer promised to disclose comprehensive data (for instance, meals exceeding $25) beginning in the new year.
Caught up in the spirit of transparency—the Accreditation Council for Continuing Medical Education (ACCME), the US organization that accredits other organizations to provide certified CME—released detailed data on 729 accredited providers in August. In an impressive data dump, the ACCME revealed each provider's accreditation status and whether they received commercial support or income from advertising or exhibits (without, however, disclosing dollar amounts). The vast majority (81%) received some type of commercial support.
Peer-reviewed medical journals published at least 2 press-worthy studies that outlined the prevalence of industry ties among academic physicians (53%) and the incomplete disclosure practices of orthopedic surgeons specifically (nearly 30% of payments, some of which exceeded $1 million). An example of the exhaustive transparency to be expected in medical journals today: the author disclosures in a highly publicized, company-sponsored study in Alzheimer disease consumed roughly 3 columns of small type in the journal Neurology.
In addition to flushing out the financial ties of physician authors, journal editors launched the age of "ghostbusting." The practice and that of honorary authorship (eg, adding the name of a laboratory head to lend cachet or credibility to an article) were found to be relatively common in the most prestigious medical journals, including The New England Journal of Medicine and the Journal of the American Medical Association, according to survey results presented publicly in September.** For offenders whose work is published in PLoS Medicine, the editors recommended immediate article retraction, lifetime banning of the named author, and a report to the author's institution for investigation. Ouch.
Recently Cochrane reviewers became concerned about the actual involvement of listed authors, the possibility of ghostwriting, and the quality of the data from a 2006 analysis of 10 Roche-sponsored trials of oseltamivir (Tamiflu). The drug company received a very public comeuppance from BMJ editor Fiona Godlee this month, for resisting unconditional access to the trial data (see BMJ Editor Bitch Slaps Roche). Godlee concluded that the joint investigation by the Cochrane reviewers, BMJ editors, and a British TV news station "cast doubt not only on the effectiveness and safety of [Tamiflu] but on the system by which drugs are evaluated, regulated, and promoted."
* Either through the proposed Physician Payments Sunshine Act or healthcare reform bills.
** Nosing in on the ghostbusting movement was Senator Chuck Grassley (IA-R), ranking minority member of the Senate Finance Committee. In November, Grassley sent a letter (personally written by the Senator?) to the deans of 10 medical schools, asking them to respond to 6 essay-type questions regarding their schools' policies on ghostwriting and plagiarism.
Investigating medical ghostwriting, Senator Chuck Grassley (IA-R), ranking minority member of the Senate Finance Committee, sent a letter to the deans of 10 medical schools, reported the NYT on Wednesday. The text of the 2-page, single-spaced letter was chosen carefully by one or more members of Grassley's staff and then signed by Grassley.
In the Grassley-signed letter (which can be found here), the medical deans are asked to respond to 6 essay-type questions regarding their schools' policies on ghostwriting and plagiarism. The deans will, no doubt, delegate the writing of the responses to administrative minions and then sign their names to the responses no later than December 8th, as requested.
Photo of Senator Grassley from grassley.senate.gov.
A movement by editors to eradicate ghostwritten articles in medical journals is featured in today's NYT. The perhaps-too-cute term for the movement, "ghostbusting," was coined by the editors of Blood in January.
The most draconian of proposed steps to thwart ghostwriting—which typically involves an unacknowledged medical writer who is employed (either directly or indirectly) by pharma—include immediate article retraction, lifetime banning of the named author, and a report to the author's institution for investigation. Editors at PLoS Medicine recently described these punishments and their disdain for ghostwriting in firm, albeit clumsy, terms.
Medical journal editors need to decide whether they want to roll over and just join the marketing departments of pharmaceutical companies. Authors who put their names to such papers need to consider whether doing so is more important than having a medical literature that can be believed in.
Ideally the Age of Ghostbusting heralds an era of the medical writer as a contributing author and not the avoidance of the medical writer by the physician author—who generally can't write his way out of a paper bag.
The president of the American Medical Writers Association (to which I belong) has written to its members (below) regarding the practice of medical ghostwriting, and AMWA's response to the NYT article about Merck's use of guest authoring and ghostwriting has been printed. I agree with AMWA's assessment.
Hello, AMWA colleagues,
As many of you have been discussing, the articles in this week's JAMA about alleged misuse of medical writing resources by Merck in publications about Vioxx garnered a lot of press coverage. As is often the case, the JAMA articles and the associated press coverage tend to blur the distinction between "guest authorship" (putting an author's name on an article he/she did not help to write) and the unacknowledged use of medical writers (ghostwriting, a term AMWA tries to avoid). A number of people have asked whether AMWA should do something.
Several of us saw this as an opportunity to assert AMWA's leadership in promoting ethical practices in medical writing. Accordingly, we have submitted letters to the editors of the NY Times, Philadelphia Inquirer, and Chronicle of Higher Education, all of which carried stories about the JAMA articles. All letters are signed by me as AMWA president.
Key points in all the letters:
- While ghostwriting (the undisclosed contribution of a medical writer) is unethical in scientific publications, the use of professional medical writers may be appropriate and ethical.
- Using their skills in communicating complex data, professional writers help researchers report their findings effectively, making contributions comparable to those of professional statisticians who analyze data or artists who create illustrations.
- The 5500-member American Medical Writers Association promotes ethical practices in scientific publication, including acknowledgment of medical writers' roles, adherence to applicable guidelines (eg, authorship rules of the International Committee of Medical Journal Editors), and full disclosure of potential conflicts of interest, including financial support.
- Transparent disclosure of the roles of all contributors avoids ghostwriting and allows readers to evaluate the credibility of research reports.
We're also drafting a response to JAMA. We'll keep you posted to let you know if these letters are published. In addition, Lori Alexander will include an editorial in the summer issue of the [AMWA] Journal, bringing these issues to members' attention.
Best regards,
Sue Hudson
