Ghostwriting in medicine.

[Guest guest]

One of the members posted this link this morning at the Stopped_Our_Statins

forum. It shows us that you just can't belive every thing you read.

http://tinyurl.com/2e96fd6

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There is a fascinating and important recent article in the Public Library of

Science (PLoS) medical journal that addresses the topic of ghostwriting in

medicine.

The " peer-reviewed " medical literature is nearly universally held up as the gold

standard for medical research. The end all, be all, for evidence based inquiry

into and reasoned discussion of medical diseases and health. How often does one

hear the rebuttal from non-skeptical adherents of the conventional wisdom, " show

me the peer-reviewed studies " (often times, strangely enough, even when the

overwhelming peer reviewed literature does in fact contradict their claptrap).

There is also however great unease on the part of those outside of medicine,

which if anything is less voiced but more strongly held by those in medicine,

that the medical literature is itself very often biased and compromised by many

competing interests, the greatest of these being large financial interests.

The Haunting of Medical Journals: How Ghostwriting Sold " HRT " by ne J

Fugh-Berman is the first article I have ever seen that delineates in detail what

the actual mechanics are for how the literature becomes compromised by outside

interests and also gives some idea of the scope of the problem. It is quite

disturbing. Ghost writing is the practice of contracting out the writing of

medical articles to commercial companies than requesting that physicians and

scientists in the relevant field sign their name to the work with the commercial

authors remaining undisclosed. Before going any further it is probably worth

noting at the outset that Dr. Fugh-Berman discloses that she is involved as an

expert witness in pending litigation against Wyeth. So as is brought up in the

comments to the article she also has her own biases and agenda, then again, this

was disclosed from the start and one can at least hope her article wasn't itself

ghostwritten

Hormone Replacement Therapy (HRT) was a medicine being given out like candy to

post menopausal women in the 1990s. Not to take too much of an unwarranted jab

at the " all natural " crowd, but HRT was often itself a very natural product as

it was extracted from pregnant mare urine (i.e. Premarin TM). When the

overriding interest is commercial, being natural is no guarantee of safety.

After having been prescribed to tens of millions of women, the evidence was

finally unavoidable that HRT greatly increased the rate of stroke, heart attack,

blood clots, pulmonary embolism and breast cancer, leading to tens of thousands

of unnecessary deaths. Dr. Fugh-Berman uses HRT as a case study to look at the

mechanics of ghostwriting and its influence on the prescribing practices of

physicians.

The article is quite lengthy and in-depth so we can only touch on a bit of the

material but I would greatly encourage anyone interested in the issue to read

over the article in full. In the section " Publication Planning " the author notes

that pharmaceutical companies working to promote a high revenue drug will often

hire medical education and communication companies, " Academic physicians are

invited by these MECCs to " author " prewritten articles. " It may seem strange why

academicians would be willing to do this, but it needs to be placed in context.

Peer-reviewed publications are generally the life blood of academic advancement,

what a great way earn clout, advance one's career and still have time for golf.

The author notes that one of the consulting companies Wyeth hired was

DesignWrite.

In its communications with Wyeth, DesignWrite noted that " Research shows high

clinician reliance on journal articles for credible product information. " In

addition to " full-length review articles, " DesignWrite recommended that the

publication plan for Premarin products should include mini-reviews, case

reports, editorials, letters, and comments [15]. These short pieces could be

published quickly, DesignWrite noted, so were an efficient " means of placing

important information about the therapeutic profile of an agent into the hands

of influential physicians … " [15]. DesignWrite also explained that it would help

Wyeth decide what data to present, recruit " authors, " choose journals, create

abstracts and posters for medical meetings, and " Position the product

appropriately to influence prescribers " [15]. ...

Between 1997 and 2003, DesignWrite's output for Wyeth on the Premarin family of

products included " over 50 peer-reviewed publications, more than 50 scientific

abstracts and posters, journal supplements, internal white papers, slide kits,

and symposia… " [17]. Primary publications (articles that report clinical trials)

ghostwritten by DesignWrite included four manuscripts on the HOPE trials of

low-dose Prempro [18],[19] for which DesignWrite was paid US$25,000 each [20].

Secondary publications (articles that follow clinical trial reports and contain

" subsequent analyses, and reviews of the drug and its field of use " [10])

included 20 review articles that DesignWrite was assigned to write in 1997 [21]

for $20,000 each [22], a price that later rose to $25,000 [23]. Abstract

production cost $4,000. [24] DesignWrite charged $10,000 for editing manuscripts

and $2,000 for editing abstracts " written by author or other agency " [24].

From the section on " Managing 'Authors' and Journals "

In general, authors' revisions were permitted if marketing messages were not

compromised. For example, at a 2002 Strategic Publications Development Meeting,

an author's request " to shorten the Early Bone Loss paper…and prepare it for a

practical audience… " was discussed [40]. The consensus was that this was

acceptable as long as the message remained that " HRT is the most cost-effective

therapy for preventing bone loss for women entering menopause due to its other

benefits and low cost " [40]. ...

The trivial role authors were expected to play is demonstrated by DesignWrite's

reference to planned reviews as " opinion leader–endorsed " [42]. Furthermore,

authors were considered interchangeable; one document states, " I moved Dr.

Creasman as an author to the patient ed piece (with Blackwood, Weiss, & Speroff)

and left Horwitz and Boman on the basic science manuscript " [43], although

Horwitz's name does not appear on the published article.

Finally, in response to a question about whether previously commissioned papers

could be reused, Gerald Burr of Wyeth wrote: " You can't just put another name on

the article, but you can plagiarize the way we did when we wrote papers in

college. ...

DesignWrite's ghostwriters also managed journals by responding to editor and

reviewer comments [46],[47]. Ghostwriters argued for retention of specific

marketing messages, sometimes scolding reviewers under the guise of defending

peer-review. Responses to one presumably unfavorable review included: " The

review of the current paper is not the appropriate place to criticize the

methodologic flaws of published papers " ; and " The reviewer's suggestion to

revise the statement on page 8 `…absence of a definitive causal relationship

between exogenous postmenopausal ERT [estrogen replacement therapy] and breast

cancer risk' is not justified. This interpretation is well documented " [46].

One of the more disturbing sections details the industry response to compromise

the emerging evidence which was finding a link between HRT and breast cancer.

Many ghostwritten articles dispute the link between HT and breast cancer, or

imply, falsely, that breast cancers associated with HT are less aggressive (see

Tables 1 and 2, and Box 2). Some articles were built around a single message,

including a 2003 paper by Eden [55]. Notes from a publication planning meeting

held in 2000 read: " … Eden was suggested as the author of a breast cancer

paper questioning the role of progestins as a causative factor " [56]. Discussion

points the ghostwriter was told to put in the paper included " why progestins may

not be responsible for the incidence of breast cancer in hormone replacement

therapy (HRT) users " [57]. The published article states, " …results from

epidemiologic studies are inconsistent and mechanistic studies have not provided

a physiologic foundation to implicate progestin in the pathogenesis of breast

cancer " [55].

There are a number of other quite eye-opening sections that there isn't space to

reproduce. Will just close with an example of how the industry propaganda also

became instituted into continuing medical education (CME) courses. Passing

periodic CME course is a necessary part of remaining licensed.

The CME test accompanying the supplement reinforced its marketing messages. For

example, based on the text, the answer to the test question, " One of the most

consistent findings from research on postmenopausal hormone therapy and breast

cancer risk is that: " is most likely to be " ERT/HRT use is associated with a

decrease in all-cause mortality " . The most likely answer to the question, " Use

of ERT/HRT has traditionally been avoided in breast cancer survivors because

of: " is " the unsubstantiated hypothesis that hormone therapy will activate

dormant malignant cells " [80]. The CME accreditor claims that it has no records

of the correct answers to this 2002 test [85].

Wyeth paid $413,140.60 for the meeting, supplement, and CME accreditation

Well, I am pretty certain at this point that there are a number of readers here

who have more direct experience with these sorts of issues than myself, I would

certainly be curious to hear your thoughts on all this.