Pharmageddon (16 page)

Eastell, who was the dean of medical research at Sheffield, meanwhile had authored several papers on the same research, one of which required him to declare he had access to the data. He said he had had access. In September 2009, Britain's General Medical Council (GMC), were asked to rule on whether Eastell's behavior was appropriate or whether he should be debarred from medical practice. At the heart of the issue was the question of what are data. After two days of legal argument, the GMC came up with a formulation that most readers of this book have likely already come to—that access to the data means access to the raw medical records. Summary tables of events or results are not data. (Eastell, as one might expect, pleaded that this had not been his understanding of what the term “data” meant at the time of his declaration.
⁶
)

If the key data are the raw medical records, who owns these data? In point of fact, no one knows. When it comes to legal cases, companies regularly keep any paperwork they have stemming from “their” trials and other data off the US mainland just in case a court should request access. If in responding to an article presenting a company's drug trial results, I were to request access to the raw data I would be told to get lost. But this is an exercise of
force majeure
rather than a position that has scientific, legal, ethical, or moral support. Companies may be practicing their version of evidence-based medicine, but they are not practicing data-based medicine, which is the soul of scientific medicine, and they are actively stopping anyone else from practicing data-based medicine.

Compared to the days in which purveyors of proprietary medicine flourished, one of the protections we now have is that someone like me cannot simply stand up at a major medical meeting and claim I have a new treatment for some condition without making the data available. I would be jeered off the podium. Practitioners of alternative or complementary therapies never get asked to medical meetings precisely because their claims are not based on data that can be examined.

Yet standing up and making claims while refusing to make the raw data available is exactly what pharmaceutical companies, and academics speaking on their behalf, do time after time. At first this wasn't much of an issue as there were only occasional reports of company-sponsored drug trials scattered among other articles in peripheral journals and occasional presentations on the program of academic meetings. Initially many people assumed that the trial data was available just as it was in other studies: the academic presenters of the material must have had access to it. When it became clear that the presenters hadn't seen it, academics took refuge in the thought that at least the regulator would have seen all the data. But now, the majority of treatment trials reported in leading journals, as well as large chunks of academic conference programs, feature company material without data access and even if regulators request all the data, they do not get all the studies and certainly do not get the data in accessible form—although few doctors know this.
⁷
At academic meetings and in scientific journals everyone welcomes the velvet glove of scientific appearances while ignoring the iron fist of refusal to part with data.

Access to the data of experiments is at the heart of what makes science. Right from the very first scientific meetings in seventeenth- century England in Oxford and London, there was a consensus that what made these meetings scientific and different from all previous meetings was a focus on observable evidence. Whether the subject was physics, chemistry, or biology, participants ran experiments in front of their peers. Whether by virtue of a novel technique or a new method, the experimental art aimed at generating data that revealed a formerly hidden aspect of the world. Where others talked, scientists generated data and made both the data and the method to generate it publicly available. It is inconceivable that Louis Pasteur, Robert Koch, Richard Cabot, or other medical people who came after them would have refused access to the data underpinning any scientific claims they made. Refusal to share key information, however, was precisely what characterized the purveyors of proprietary medicines.

GHOSTS IN THE MACHINE

Just as many drug companies began outsourcing clinical trials in the 1970s, they began to do the same with medical writing, giving rise to a huge increase in ghostwriting and, in a further twist, ghost-presenting. This went on quietly for more than twenty years before the issue began to surface in the academic media and later more generally.

The first companies in the medical ghostwriting business emerged in the 1970s but many more entered the market in the 1980s and 1990s; there are now fifty or so medical writing companies in the United States and Britain.
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These specialized companies compete for drug company contracts for a series of articles on the basis not only of price per article and article quality, but also on the stature of the academic “authors” the outfit is able to recruit and the ability of the ghosts to get an article speedily placed in a prestigious medical journal. Many of these writing agencies have since become subsidiaries of public relations companies, who are in turn branches of global advertising companies such as WPP,
⁹
Omnicon, and Interpublic, some of whom have now taken up the clinical trial business themselves.

Axis Healthcare Communications, one such company, offers to help pharmaceutical companies “brand the science.” Envision Pharma announces that “data generated from clinical trials are the most powerful marketing tools available to a pharmaceutical company.” GYMR boasts that they “know how to take the language of science and medicine and transform it into the more understandable language of health. We advise clients of the best dissemination strategy for their news and make sure that the message they deliver is compelling, documented and contributes to other national dialogues in a real and meaningful way.”
¹⁰
Meanwhile, Current Medical Directions offers to deliver scientifically accurate information that has been strategically developed for specific target audiences. To do this, they “write up studies, review articles, abstracts, journal supplements, product monographs, expert commentaries and textbook chapters, conduct meta-analyses, organize journal supplements, satellite symposia, and consensus conferences as well as advisory boards for clients.”
¹¹

Who are the ghostwriters in these endeavors? They are predominantly women, with PhDs or other science qualifications. The work may offer them an opportunity to work from home, possibly on a different continent than that of either the notional lead investigator or the study site. The job requires no familiarity with what actually happened; indeed it can probably best proceed without firsthand knowledge of the trial— that's not the writer's department, as Tom Lehrer might have sung.

Most of the medical writing companies and independent writers working on contract have put in place protocols or business plans specifying what they do and do not do, and they see themselves as adhering to these specifications and standards. The protocols may, for instance, mention that they will ensure that any submission to a particular journal takes account of that journal's requirement for conflict-of-interest statements and authorship declarations. And in fact, these requirements are much more likely to be met in articles written by medical writers than in articles written by academics.
¹²

The ghosts see themselves as occupying a position midway between marketing and the practice of science. They are sure that the marketers, left to their own devices, would not be able to resist overt promotion and the resulting product would be rejected at peer review for not meeting the standards of scientific presentation. Left to the academics, the articles would not be ready in even draft form in time for a drug's launch and inadvertently might put the trial's results in less than the best light. The writers see themselves as producing an acceptable compromise.

The editorial staffs of leading journals such as the
British Medical Journal (BMJ), New English Journal of Medicine (NEJM)
, and others regularly attend the meetings of medical writers. They encourage writers to contact them early in a manuscript's development so that the extent of mutual interest can be gauged. If I am a ghost, I can contact the editorial desk and find out if the topic on which I'm writing would be of interest—if the journal has several articles on this already in press, for instance, they may not want more. But if they indicate interest, I am half way to having the article accepted as it is more likely to be sent out to sympathetic reviewers if this is an article the editor wants.

It is not so surprising that journals have drifted into a position of collaboration with industry. They have vested interests in getting an option on publication of the latest studies. Today, reports of randomized controlled trials stand at the top of the evidence hierarchy and the leading journals realize that their own influence and the perception of how seriously their journals are taken depend on getting access to these trials. Given that industry runs the great bulk of such trials and medical writers produce articles that tick all the quality boxes, avoid the excesses of the marketers, and turn around a product in a timely fashion, with a paper trail that makes for accountability, what's not in it for journal editors to cooperate?

When the matter of ghostwriting comes up, the medical journals seem mostly concerned with whether or not the role of the ghost should be acknowledged. Article writers, journal editors, and pharmaceutical companies all believe that prescribing doctors would find the articles less persuasive if they knew they were ghostwritten—that this would convey the message that these were commercial product placements rather than scientific articles. The implication is that if the authorship issues were managed in a better way, the system could be salvaged, ignoring the larger issues of scientific and medical integrity.

Faced, for instance, with evidence that Merck had employed Scientific Therapeutics Information (STI) to write up a series of studies on the drug Vioxx and that critical data on the hazards of Vioxx had been concealed,
¹³
Catherine DeAngelis, the editor of
Journal of the American Medical Association (JAMA)
, in a 2008 editorial deplored the deception.
¹⁴
But she did not deplore the ghostwriting per se. She was in fact concerned for the medical writers who had actually authored the piece but had not been included on the authorship line and so had not received due acknowledgement.

The next slip down the slope from the presentation of science by scientists to our current world of scientific appearances has been from ghostwriting into ghost-presenting. There is an increasing chance that the named authors on articles in journals such as
JAMA, New English Journal of Medicine
, or the
Lancet
will know relatively little about the study they have apparently authored. Having written the article, the medical writer will often be the person best placed to answer questions arising from any publication. As a result it is not uncommon in major meetings to find poster presentations of a study's results tended by attractive, confident women whom the passing doctors will assume are postdoctoral researchers linked to the study. Far better have this kind of arrangement than some academic stumbling unconvincingly through the study design and results, drifting perhaps off message.

It is difficult to think of any other domain of professional life where this would be possible—except in the entertainment industry. A lawyer would not be able to bring in someone who “looked good” to sway a jury. If asked thirty years ago which professions could be body-snatched in this way, academic medicine would have seemed an unlikely candidate.

Until relatively recently in the biomedical sciences the most distinguished scientists in the field, Nobelists or aspiring Nobelists, might have four to five hundred articles on their curriculum vitae when they reached their sixties. The great men would often joke that if they hadn't gotten a Nobel Prize for science, they would have been in line for one for fiction. Many of today's ghostwriters in their thirties or forties will have more articles published in major journals than any of these Nobelists. But the most interesting figures are the academics still in their forties that the pharmaceutical industry has made into opinion leaders and who may as a result appear as an author on eight hundred to a thousand articles. Sometimes the marketing copy slips and such an academic figure may be described as someone whose views you can trust because they have over eight hundred articles to their name.

When it comes to choosing names to go on a paper's authorship line, the marketing department of the parent company has the key input. Companies will pay some heed to the contribution an individual may have made to study design, execution, or review of the manuscript, but they put greatest store on the profile of the academics and their ability to serve as spokespersons for the study among their peers.

When choosing a journal, companies review their portfolio of articles and decide on the mix they need for marketing purposes—some for the
New England Journal of Medicine
, some for the
Lancet
, and some for more specialized outlets. Factors such as the journal editor and the likely speed of acceptance and publication of the article make a difference too. In the case of Vioxx, Merck was interested in
JAMA
, for example, because it offers a fast-track option for “important” papers.

How many articles are now ghostwritten? In the late 1990s a document developed by Current Medical Directions, a medical writing company that was at the time coordinating a portfolio of relentlessly positive articles on Zoloft for Pfizer, surfaced that helped answer this question. Along with colleagues, I had a chance to analyze the papers being written and this made it clear that even by the late 1990s well over 50 percent of all articles on a drug such as Zoloft were likely to have been written by medical writers and over 90 percent of those appeared in major journals.