Ben Goldacre, The Guardian, Saturday 18 September 2010

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: this time, we get a new insight into the strange phenomenon of medical ghost-writing.

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 a programme of academic papers that can be rolled out in academic journals to build a brand message. After copywriters produce the articles, in collaboration with the drug company, to their specifications, the ghostwriting company finds some academics who are willing to put their names to them, perhaps after a few modest changes.

The latest documents come from a court case brought against Wyeth by around 14,000 patients who developed breast cancer while taking their hormone replacement therapy, Prempro. The open access journal PLoS Medicine, acting with the New York Times, argued successfully in court that 1500 documents from the case which detailed the ghostwriting should be placed in the public domain, because they represent important 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, we should remember, has had a rocky history. Initially the panacea to all ills, by 1998 the HERS trial showed it didn’t prevent cardiovascular events after all, and by 2002 the Womens Health Initiative trial showed it also 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 continue to have beliefs about the efficacy of HRT that are in excess of the evidence. Reading how the literature was engineered, it’s not hard to see why.

The 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 programs, over 200 satellite symposia, 60 international programs, dozens of websites, and a broad array of ancillary printed and electronic materials”. They proposed a “planned publication program” to Wyeth, consisting 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 then advised on the creation of a second draft. Only then did the paper get sent to the academic who would appear as the “author”. Review articles cost Wyeth $20,000. Abstracts are $4,000. The academics weren’t 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 helpfully 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. The analysis in PLoS (by an academic who appeared as a paid witness against the company in court) found that these publications variously promoted unproven and unlicensed benefits of Wyeth’s HRT drug, undermined its competitors, and downplayed its harms.

You might imagine there are rules against this. There are not: there are traditions, good faith, and leaky regulations. It’s illegal, for example, for a pharmaceutical company to promote its drug for “off label” use, which means selling it to treat a medical problem for which that drug has no license. In the case of Wyeth’s HRT drug, that meant they couldn’t market it for preventing Alzheimer’s, Parkinson’s, and wrinkles, to name but a few. The PLoS analysis finds that many articles produced by DesignWrite for Wyeth 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, and in very large numbers. There is no possible way they could persuade themselves that what they were doing was correct. “Research shows high clinician reliance on journal articles for credible product information,” said DesignWrite, in their initial pitch. They’re right, and that’s for a reason: when you read an academic paper, you trust it was written by the person whose name is on it.

There are very simple solutions. If a commercial writer employed by a pharmaceutical company has the idea for a paper, and writes it, then their name and their company’s name should be on the paper. If the first, last, and corresponding authors on a paper didn’t write or lead on it, they should say so, loudly and clearly. Universities, which are currently inconsistent on ghost writing, could take a lead, but they don’t, and so these serious problems in academia will persist, because they are slightly 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. Our only hope is the power of shame.