This scam-which makes a mockery of the idea that medicine is 'scientific'-came to light after drug manufacturer Wyeth had to release secret documents to lawyers representing around 14,000 women who developed breast cancer after taking Wyeth's HRT (hormone replacement therapy) drug Prempro.
The practice is widespread-and has been for years-and has infected every prestigious medical journal currently published. Marketing and PR agencies, who have found academics prepared to put their names to papers they haven't written, have created the majority of the contents of these journals.
This strikes at the very heart of medicine, which prides itself on being an evidence-based discipline. It's clear that most studies-which are presented as independent and impartial-are, in fact, 'spin' that has been paid for by drug companies and concocted by their marketing arms.
The 1500 papers that Wyeth was forced to disclose revealed that the company had hired a PR/marketing company-known in the industry as a 'medical education and communication company' (MECC)-to prepare 'scientific papers' for publication in medical journals suggesting that its HRT drug was safe, even though the genuinely independent research had warned that the entire HRT family of drugs can endanger women's lives.
Wyeth had initially used several MECCs, from 1996 onwards, to promote Prempro, and sales of the drug and its other HRT, Premarin, reached $2 billion in 2001. However, everything changed a year later, when the Women's Health Initiative (WHI) study discover-ed that HRT drugs increase the risks of breast cancer and stroke (JAMA, 2002; 288: 321-33). Indeed, the risks were so great that the researchers stopped the HRT trial prematurely to avoid further exposure of the participating women to the drugs' potential dangers.
Wyeth's damage-limitation exercise was primarily headed by Princeton-based MECC DesignWrite. The firm prepared 'clinical trials' and recruited leading academics to put their names to papers they hadn't written. Altogether, the articles were published in 18 journals, such as the American Journal of Obstetrics & Gynecology and the International Journal of Cardiology.
Virtually all of the published trials were meta-analyses and, as such, were reexaminations of previously published papers, but given a special spin or slant. In general, they down-played the health risks of Prempro and Premarin, and promoted their benefits, even making the unfounded claim that HRT was good for the heart. Other ghostwritten articles prepared by DesignWrite attacked the genuinely independent studies that questioned this supposed benefit.
A PR pandemic
The Wyeth documents are but the tip of the iceberg of a practice carried out by most drug companies. According to its website, DesignWrite has written 500 'clinical papers' for drug companies in 12 years. As there are some 180 MECCs operating in the US alone, more than 90,000 marketing papers purporting to be independent, scientific trials may have been published between 1997 and 2009.
Indeed, as much as 75 per cent of every medical journal could comprise such 'ghosted' manuscripts, claims the Scientific-Ethical Committees for Copenhagen and Frederiksberg, which carried out a review between 1994 and 1995 (PLoS Med, 2007; 4: e19. doi: 10.1371/ journal.pmed.0040019).
Adriane Fugh-Berman, at George-town University Medical Center in Washington, DC, who did a complete analysis of the Wyeth disclosure papers, says that every medical journal has been "infested" by industry-funded marketing messages. "Although the prevalence of proffered or accepted invitations to sign ghostwritten articles is unknown, the practice may be common" (PLoS Med, 2010; 7: e1000335; doi:10.1371/journal.pmed.1000335).
As she says in her commentary, the drip-drip of spin and misinformation dressed up as science creates a mindset in doctors that even truly independent and 'clean' research cannot alter. "Despite scientific data to the contrary, many gynaecologists still believe that the benefits of HRT outweigh the risks in asymptomatic women. This non-evidence-based perception may be the result of decades of carefully orchestrated corporate influence on medical literature."
The constant stream of deliberate misinformation goes way beyond HRT, of course. It is likely that doctors are unwittingly prescribing drugs that may be dangerous or even lethal, as a result of being unable to distinguish between fact and spin. The medical journals that publish these articles appear to be equally duped by the practice.
Although clinical trials and studies are peer-reviewed-the manuscript's contents are assessed by independent experts-prior to publication, the spin that masquerades as science manages to get through almost every time. This may be because the interpretation given by MECC writers is subtle, but significant, and because the papers appear to be authored by leading academics in the field.
Publishing papers is a key way to improve professional status, but it's often arduous and time-consuming. The entire process can take two years from setting up the study and finally having it published. Yet, as one blogger, William Heisel (University of Southern California's Reporting on Health; see www.reportingonhealth.org/blogs), notes, one academic has apparently published more than 200 papers in the past few years alone-an impossible feat without the help of an MECC.
Just sign here
One academic invited to rubber-stamp a paper he hadn't written was rheumatologist Jeffrey Lisse, at the University of Arizona, and lead author of an 'independent' trial of Merck's painkiller Vioxx, published in the Annals of Internal Medicine. The reported results omitted a number of deaths that had occurred during the trial, and Lisse later admitted that "Merck designed the trial, paid for the trial, ran the trial . . . [then] came to me after the study was completed and said, 'We want your help to work on the paper'" (The New York Times, 22 August 2007). Vioxx was later cited as causing 60,000 deaths from cardiac arrest, and Merck was involved in the largest civil-action lawsuit in history, eventually paying out $4.85 billion to bereaved relatives.
Dr Gloria Bachmann, a professor at the Robert Wood Johnson Medical School in New Brunswick, NJ, was sent a 14-page outline of an article on menopausal hot flushes and night sweats. In e-mails to DesignWrite, Bachmann said the article was "excellent", and a near-verbatim copy of the draft appeared in the Journal of Reproductive Medicine in 2005 under her name (The New York Times, 5 August 2009).
The extent of the practice became clear to David Healy and Dinah Cattell during their involvement in a lawsuit against Pfizer for its SSRI antidepress-ant Zoloft (sertraline). Documents revealed that Pfizer had recruited an MECC, Current Medical Directions, to coordinate 85 documents related to the drug but, in many instances, an author had not yet been ascribed to the paper, suggesting that professional writers had prepared them. Healy and Cattell noted that all the reports were positive about sertraline, and downplayed side-effects (Br J Psychiatry, 2003; 183: 22-7).
Ghosts in the machine
Wyeth started employing MECCs to promote Prempro in 1997, but the strategy changed in 2002 following the WHI findings. As DesignWrite explained to Wyeth in one of the documents released under the disclosure process, "Research shows high clinician reliance on journal articles for credible product information". In other words, doctors rely on medical publications to help them decide which drugs to prescribe.
For this reason, between 1997 and 2003, DesignWrite prepared "over 50 peer-reviewed publications, more than 50 scientific abstracts and posters, journal supplements, internal white papers, slide kits and symposia".
The MECC wrote the reports of four clinical trials on low-dose Prempro, and was paid $25,000 for each. Many of the articles disputed the WHI's results and implied that the breast cancers caused by HRT were somehow less aggressive. Overall, the manuscripts minimized the risks, cast doubt on competing products and even promoted the drugs for off-label use-using a drug for an indication for which it is not licensed-which is illegal. DesignWrite produced numerous ghostwritten reviews and commentaries that promoted the use of Prempro for preventing Alzheimer's disease, Parkinson's disease, age-related macular degeneration and wrinkles.
A crucial element of the strategy was finding leading academics prepared to put their names to DesignWrite's words, thus giving the papers authority and guaranteeing their publication.
Back to school
Wyeth's damage-limitation exercise went beyond ghostwriting. In 2002-shortly after publication of the WHI study-Wyeth helped the University of Wisconsin-Madison's School of Medicine and Public Health start a medical education programme for doctors. The programme promoted HRT in an online course, and thousands of doctors participated. It was entirely funded by a $12 million grant from Wyeth, and the university received $1.5 million of the money for its own use.
The university, Wyeth and Design-Write-which prepared much of the course material-formed the Council on Hormone Education, which served as a 'front' for the online programme. The council was made up of 40 physicians and consultants, 34 of whom had financial ties to Wyeth.
Even after the course had finished, the materials were freely available on the Internet for doctors and patients to download. However, the site suddenly disappeared on 15 January 2009, but only after a local newspaper, the Milwaukee Journal Sentinel, started to question the propriety of the pro-gramme (Milwaukee Journal Sentinel, 25 January, 2009).
WDDTY VOL. 21 ISSUE 08