Court Case: Medical Ghostwriting a ‘threat to public health’ *
Medical ghostwriters who build a brand
There are no rules against this, just traditions, good faith, and leaky regulations
If I tell you that Katie Price did not, necessarily, write her own book, this is not a revelation. From academics I have slightly higher expectations, but now the legal system has spat out another skip full of documents: we get a new insight into the strange phenomenon of medical ghostwriting.
Attributed authorial assistance is one thing. This is different, and more cynical. A commercial medical writing company is employed by a drug company to produce papers that can be rolled out in academic journals to build a brand message. After copywriters write the articles, in collaboration with the drug company, to their specifications, the ghostwriting company finds some academics willing to put their names to them, perhaps after modest changes.
The latest documents come from a court case brought against Wyeth by around 14,000 patients who developed breast cancer while taking Prempro, the hormone replacement therapy (HRT).
The open access journal PLoS Medicine, acting with the New York Times, argued successfully in court that 1,500 documents which detailed the ghostwriting should be placed in the public domain, because they represent information on a potential threat to public health.
Now, PLoS has published the first academic analysis of these documents, which is free to access online.
HRT has a rocky history. Initially the panacea to all ills, by 1998 the HERS trial showed it did not prevent cardiovascular events and by 2002 the Women’s Health Initiative showed it increased the risk of breast cancer and stroke. We now know it increases the risk of dementia and incontinence.
Survey data shows that even today many gynaecologists have beliefs about the efficacy of HRT that are in excess of the evidence. Reading how the literature was engineered, it is not hard to see why.
The medical communications company DesignWrite boasts that over 12 years they have “planned, created, and/or managed hundreds of advisory boards, a thousand abstracts and posters, 500 clinical papers, over 10,000 speakers’ bureau programmes, over 200 satellite symposia, 60 international programmes, dozens of websites, and a broad array of ancillary printed and electronic materials”.
They proposed a “planned publication programme” to Wyeth, of review articles, case reports, letters, editorials, commentaries and more, using the medical literature as a marketing tool.
DesignWrite wrote the first drafts, and sent them to Wyeth, who advised on the creation of a second draft. Only then was the paper sent to the academic who would appear as the “author”.
The academics were not paid cash, but they did get an easy publication in an academic journal for their CV. And once the publication process was in train, the chap from Wyeth’s marketing department provided comments and suggestions for the authors to use in response to peer reviewers’ comments.
The PLoS documents show DesignWrite sold Wyeth more than 50 peer reviewed journal articles for HRT, and a similar number of conference posters, slide kits, symposia, and journal supplements. Adriane Fugh-Berman, associate professor in the department of physiology at Georgetown University Medical Centre in Washington DC, who analysed the documents (who appeared against Wyeth in the class action) found that these publications variously promoted unproven and unlicensed benefits of Wyeth’s HRT drug, undermined its competitors, and downplayed its harms.
There are no rules against this. There are traditions, good faith, and leaky regulations. It’s illegal, for example, to promote a drug for “off label” use, which means selling it to treat a medical problem for which it has no licence.
In the case of Wyeth’s HRT drug, they could not market it for preventing Alzheimer’s, Parkinson’s, and wrinkles, to name but a few. Fugh-Berman’s analysis found that many articles promoted the drug’s use for exactly these conditions: but academic journal publications are not regarded as promotional activity, so this was all legal.
Worst of all is the complicity of the academics. There is no possible way they could persuade themselves what they were doing was correct. “Research shows high clinician reliance on journal articles for credible product information,” said DesignWrite. They’re right: when you read an academic paper, you trust it was written by the person whose name is on it.
There are simple solutions. If a commercial writer employed by a pharmaceutical company writes a paper, their name and their company’s name should be on it. If the authors on a paper did not write or lead on it, they should say so. Universities could take a lead, but do not, and so these problems will persist, because they are complicated, and hidden from public scrutiny. That’s why you should read about them in PLoS, talk about them, crane your neck over, scratch your chin, and mutter in astonishment. Nobody in a regulatory role is interested.