Industry documents show that articles praising drugs the companies produce are written in advance and doctors are essentially recruited to attach their names to lend credence. Doctors "can be paid handsomely" for this, The Observer reports, but the true role of pharma industry flacks is always carefully concealed. Evidence indicates the industry uses binding confidentiality agreements to further ensure the truth is not revealed.
A former editorial assistant for the flack industry also reveals it is "standard procedure" to modify Word documents to "remove the names of the medical writing agency...or pharmaceutical company" from the file properties and replace them with those of the credited doctors and institutions, even they "may have had no actual input into the paper." When asked to comment further by The Observer, the email's author said she could not because "I signed a confidentiality agreement..."
Revealed: How Drug Firms 'Hoodwink' Medical Journals
Pharmaceutical giants hire ghostwriters to produce articles -- then put doctors' names on them
By Antony Barnett, public affairs editor [for The Observer]
Hundreds of articles in medical journals claiming to be written by academics or doctors have been penned by ghostwriters in the pay of drug companies, an Observer inquiry reveals.
The journals, bibles of the profession, have huge influence on which drugs doctors prescribe and the treatment hospitals provide. But The Observer has uncovered evidence that many articles written by so-called independent academics may have been penned by writers working for agencies which receive huge sums from drug companies to plug their products.
Estimates suggest that almost half of all articles published in journals are by ghostwriters. While doctors who have put their names to the papers can be paid handsomely for "lending" their reputations, the ghostwriters remain hidden. They, and the involvement of the pharmaceutical firms, are rarely revealed.
These papers endorsing certain drugs are paraded in front of GPs [General Practitioners] as independent research to persuade them to prescribe the drugs.
In February the New England Journal of Medicine was forced to retract an article published last year by doctors from Imperial College in London and the National Heart Institute on treating a type of heart problem. It emerged that several of the listed authors had little or nothing to do with the research. The deception was revealed only when German cardiologist Dr. Hubert Seggewiss, one of the eight listed authors, called the editor of the journal to say he had never seen any version of the paper.
An article published last February in the Journal of Alimentary Pharmacology, which specialises in stomach disorders, involved a medical writer working for drug giant AstraZeneca -- a fact that was not revealed by the author.
The article, by a German doctor, acknowledged the "contribution" of Dr. Madeline Frame, but did not admit that she was a senior medical writer for AstraZeneca. The article essentially supported the use of a drug called Omeprazole -- which is manufactured by AstraZeneca -- for gastric ulcers, despite suggestions that it gave rise to more adverse reactions than similar drugs.
Few within the industry are brave enough to break cover. However, Susanna Rees, an editorial assistant with a medical writing agency until 2002, was so concerned about what she witnessed that she posted a letter on the British Medical Journal website.
"Medical writing agencies go to great lengths to disguise the fact that the papers they ghostwrite and submit to journals and conferences are ghostwritten on behalf of pharmaceutical companies and not by the named authors," she wrote. "There is a relatively high success rate for ghostwritten submissions - not outstanding, but consistent."
Rees said part of her job had been to ensure that any article that was submitted electronically would give no clues as to the origin of the research.
"One standard procedure I have used states that before a paper is submitted to a journal electronically or on disc, the editorial assistant must open the file properties of the Word document manuscript and remove the names of the medical writing agency or agency ghostwriter or pharmaceutical company and replace these with the name and institution of the person who has been invited by the pharmaceutical drug company (or the agency acting on its behalf) to be named as lead author, but who may have had no actual input into the paper," she wrote.
When contacted, Rees declined to give any details. "I signed a confidentiality agreement and am unable to comment," she said.
A medical writer who has worked for a number of agencies did not want to be identified for fear he would not get any work again.
"It is true that sometimes a drug company will pay a medical writer to write a review article supporting a particular drug," he said. "This will mean using all published information to write an article explaining the benefits of a particular treatment.
"A recognised doctor will then be found to put his or her name to it and it will be submitted to a journal without anybody knowing that a ghostwriter or a drug company is behind it. I agree this is probably unethical, but all the firms are at it."
One field where ghostwriting is becoming an increasing problem is psychiatry.
Dr. David Healy, of the University of Wales, was doing research on the possible dangers of anti-depressants, when a drug manufacturer's representative emailed him with an offer of help.
The email, seen by The Observer, said: "In order to reduce your workload to a minimum, we have had our ghostwriter produce a first draft based on your published work. I attach it here."
The article was a 12-page review paper ready to be presented at an forthcoming conference. Healy's name appeared as the sole author, even though he had never seen a single word of it before. But he was unhappy with the glowing review of the drug in question, so he suggested some changes.
The company replied, saying he had missed some "commercially important" points. In the end, the ghostwritten paper appeared at the conference and in a psychiatric journal in its original form -- under another doctor's name.
Healy says such deception is becoming more frequent. "I believe 50 per cent of articles on drugs in the major medical journals are not written in a way that the average person would expect them to be... the evidence I have seen would suggest there are grounds to think a significant proportion of the articles in journals such as the New England Journal of Medicine, the British Medical Journal and the Lancet may be written with help from medical writing agencies," he said. "They are no more than infomercials paid for by drug firms."
In the United States a legal case brought against drug firm Pfizer turned up internal company documents showing that it employed a New York medical writing agency. One document analyses articles about the anti-depressant Zoloft. Some of the articles lacked only one thing: a doctor's name. In the margin the agency had put the initials TBD, which Healy assumes means "to be determined".
Dr. Richard Smith, editor of the British Journal of Medicine, admitted ghostwriting was a "very big problem" .
"We are being hoodwinked by the drug companies. The articles come in with doctors" names on them and we often find some of them have little or no idea about what they have written," he said.
"When we find out, we reject the paper, but it is very difficult. In a sense, we have brought it on ourselves by insisting that any involvement by a drug company should be made explicit. They have just found ways to get round this and go undercover."
Following is the complete text of the email to BMJ, referred to in the article above, in which the former editorial assistant for a medical writing agency reveals tactics used to disguise the true (ghost) writers of industry flack pieces.
Who actually wrote the research paper? How to find it out.
12 June 2003
[From:] Susanna T Rees,
Care Assistant
CH66 1QL
In reply to the BMJ theme issue of 31st May 2003 (Vol 326 issue 7400) "Time to untangle doctors from drug companies."
Until the end of 2002, I worked for a medical writing agency as an editorial assistant. I believe that the agency I worked for generally has standards of practice that are consistent with best practice within the industry. I write to you about the broader issues associated with general practices in the industry.
It is my perception that there is consistently a high turnover in staff throughout all branches of the pharmaceutical industry. It is also my perception that the effect of this is that there is often a lack of consistent follow-through on how the pharmaceutical industry acquires data, monitors it, processes it, validates it.
Medical writing agencies go to great lengths to disguise the fact that the papers and conference abstracts that they ghost-write and submit to journals and conferences are ghost-written on behalf of pharmaceutical companies and not by the named authors. There is a relatively high success rate for ghost-written submissions -- not outstanding, but consistent.
One standard operating procedure I have used states that before a paper is submitted to a journal electronically or on disk, the editorial assistant must open the File Properties of the Word document manuscript and remove the names of the medical writing agency or agency ghost-writer or pharmaceutical drug company, and replace these with the name and institution of the person who has been invited by the pharmaceutical drug company (or by the agency acting on its behalf) to be named as lead author, but who may have had no actual input into the paper.
Quality-assurance auditors vet the standard operating procedures of the agency I worked for. I am surprised that these auditors, presumably following government guidelines, do validate such a procedure, which is actually in place in order disguise the true authorship from the editorial boards of journals. This area seems very blurred. This practice is contrary to the principles of openness and transparency of the scientific method.
The full file history of every Word document may be retrieved, using a Texteditor or a Hexeditor. It is impossible to change that history or to disguise who actually created the Word document or the name of the organisation of origin. Office applications can reveal the full chronology of authors, file paths, file names, file amendments, and details of the computers used. Text, graphics or tables that have been inserted into a Word file will contain the full history of the document that they were extracted from. Technical effort is required to identify this information[1,2]. Such a check might be made prior to peer-review, using an original file, saved onto disk by the authors and included as part of the submission package to the journal. Even this check may not be exhaustive or conclusive: for example, where a file has been exported into .RTF format, much of the original file history may be lost. A Word document that has been exported into .RTF format and subsequently back into .DOC format, may possibly lose much of its original Word file history. RTF offers a "track changes" option, so it may be possible to view the entire text-editing history of a Word document that has been exported into .RTF format. A file that has been exported into .PDF format will have lost its entire history.
On-line submission of ghost-written papers and abstracts to journals and conferences is done from the agency computer or sometimes from the offices of the pharmaceutical company. Do journals and conference organisers always try to identify the organisation that actually submitted the electronic file?
An internet engine search on the authors of a paper will quickly reveal whether these names are closely linked to pharmaceutical drug companies, to their products or publicity materials.
The interests of the pharmaceutical industry lie at the heart of many current, urgent debates: GM food, anti-depressants and their side-effects, and others. We need to ask: Who wrote this paper? Who did this research? Are the objectives of this research genuinely impartial? Is this process fully transparent?
Independent authorship and impartiality are the cornerstones of scientific research. The pharmaceutical giants are using the tools of scientific research as a marketing tool. I believe that these marketing practices are damaging the authority and effectiveness of pharmaceutical research.
With thanks to Doro Mücke-Herzberg
References
(1) PC-Welt (German language publication) 1999(7):242-243. "Verborgene Infos" (trans: Hidden information) Springer T, Apfelböck H.
(2) c't (German language publication) 2002(3):172-175. "Dokumente durchleuchtet: Was Office-Dateien verraten können" (trans: Documents under the X-ray: what Office files can tell you) Rost M, Wallisch A.
Competing interests: None declared
COMMENTS