Our Challenge to Court Secrecy Ignites a Medical Ghostwriting Crackdown
Pharmaceutical companies often try to sell their drugs via television ads filled with sunny skies and happy, active people. Most people—especially doctors—take these advertisements with a grain of salt, knowing that these commercials are the result of a carefully-crafted marketing campaign. But drug companies discovered a more underhanded way to tout the safety and effectiveness of their drugs —by paying to have academic medical articles written praising the use of their drugs to treat health issues, and then recruiting doctors to present these articles as their own in respected medical journals. Understanding that physicians rely on medical literature when deciding which drugs to prescribe, it’s easy to see how this type of “ghostwriting,” as it’s called, puts patients in danger.
This is why we represented PLoS Medicine, a medical journal published by the non-profit Public Library of Science, in its efforts to obtain public access to thousands of discovery documents unearthed in the course of litigation against Wyeth Pharmaceuticals. These discovery documents demonstrated that Wyeth had created a massive ghostwriting campaign to sell its hormone replacement therapy drug, Prempro. The case, In re Prempro Products Liability Litigation, was brought against Wyeth by women who had suffered stroke, heart attack, blood clots, cardiovascular disease, and cancer after taking Prempro. A study by the National Institute of Health (NIH) had revealed that taking Prempro increased the likelihood of developing these deadly side effects, but prior to the NIH study, numerous other articles written about studies of the drug had assured doctors and patients alike that Prempro was perfectly safe. Those articles and the studies to support them were created by Wyeth ghostwriters who recruited doctors to then sign off as “authors” in order to hide the drug company’s role.
The Prempro case speaks to the inherent dangers of presenting biased articles as independent research. As PLOS Medicine Chief Editor Virginia Barbour stated in Public Justice’s motion to intervene in the Prempro case, ghostwriting “gives corporate research a veneer of independence and credibility” and may “substantially distort the scientific record”… “threaten[ing] the validity and credibility of medical knowledge.”
Because of our intervention in this case, led by Amy Radon and Leslie Brueckner, all of the materials detailing Wyeth’s ghostwriting campaign were made public. Publicly exposing these documents enabled medical journals to see firsthand how drug companies create ghostwritten articles, recruit doctors and academics to pass off these articles as their own, and then minimize or even erase any evidence of the drug company’s role when the article is submitted to a medical journal for publishing. PLoS Medicine used the documents to publish an investigative piece about the dangers of ghostwriting in medical publications, and to urge reform in this area. They also made the documents available in indexed, searchable form at the Drug Industry Documents Archive at the University of California, San Francisco.
The case also attracted the attention of The New York Times, which reported in 2009 that the Prempro ghostwriting documents have prompted many medical journals to institute procedures that are more effective at discovering incidences of ghostwriting and informing readers of the extent to which a drug company has been involved in creating a ghostwritten article. The Journal of the American Medical Association, for example, has instituted authorship forms that require contributors to detail their role in creating any article and to disclose conflicts of interest.
The Prempro case also led to U.S. Senator Charles Grassley of Iowa to begin an investigation into the practice of ghostwriting, and to publicly urge the NIH to take measures to crack down on the practice. The NIH in 2011 amended its regulations that govern financial conflict of interest disclosures for the first time since 1995 for all federally-funded medical research. NIH Director Dr. Francis S. Collins explained that “[s]trengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds.”
Our efforts to unseal the discovery documents in the Prempro litigation have brought the practice of medical ghostwriting into the public discourse, which has in turn served as a catalyst for new industry standards that will keep us all healthier and safer.