Exorcise the ghosts that have been haunting research journals

The New York Times and the medical journal PloS Medicine won an incredible victory for patients and for health writers last week. They persuaded a judge in a lawsuit against drug makers to release 1,500 previously sealed documents that tell the story of how drug companies like Wyeth have been acting as ghost writers in medical journals.

Some of the documents now have been posted on the New York Times site. They show how drug makers distorted the process of independent analysis and vetting of research by hiding behind well known researchers with established publication records and creating a mask of scientific independence and integrity for their marketing.

The fact that drug companies, particularly Wyeth, have ghostwritten articles is nothing new. In 1999, Charles Ornstein, then at the Dallas Morning News and now at ProPublica, wrote about how Wyeth had written stories that encouraged the use of fen-phen, a diet-drug combo that proved so dangerous for patients that it was pulled from the shelves. What's new here is the scale of the effort. As the Times notes:

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known. The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients.

Now, many of those patients are suing. Perhaps the most frightening piece of news is this: Wyeth's defense has been that everything it was doing was common practice.

If these papers were simply incremental pieces of research, small improvements on a previous study or evidence that seemed to counter an earlier body of work, they might be slightly less offensive. But most of these ghostwritten papers were sweeping review articles that appeared to analyze everything known about a topic to recommend a "best practice." Nowhere did the writers disclose that the research was funded by Wyeth, let alone that the reviews were being written by Wyeth employees or consultants. The reviews appeared in some of the best-read journals in the country, the leading publications in certain medical specialties, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.

Dr. Adriane Fugh-Berman, a professor at the Georgetown University School of Medicine writing for the PloS blog Speaking of Medicine, summed things up nicely:

While ghostwriters for celebrity autobiographies may do readers a service by rendering a non-writer's story readable, the ghostwriters who haunt medical journals represent the views of product manufacturers rather than the academic "authors" whose names decorate the articles. The newly exposed documents include correspondence among academic faculty, freelance writers, 'medical education' companies and Wyeth, and include records of payment to ghostwriters and ghostwriting firms. This treasure trove details the blow-by-blow process by which marketing messages were inserted into articles in the medical literature to promote unproven benefits of Premarin and Prempro while trivializing the risk of breast cancer.

The drug makers are the ones who are feeling all the heat on this. But there needs to be an equal amount of scrutiny given to the researchers who were allowing themselves to be tools for the drug makers. Duff Wilson and Barry Meier at the New York Times have been writing about Medtronic consultants who failed to disclose their ties to the company, even when testifying before Congress. Luke Timmerman, now at Xconomy, wrote a great investigative piece, Selling Drug Secrets, while at the Seattle Times with David Heath about how drug researchers leak secrets to investment banks to guide insider trading. Other writers need to do something similar with the researchers who allowed their articles to be ghostwritten.

A good starting point for understanding the topic, with links to the judge's order from July 25, 2009, and the PloS brief arguing for the unsealing of the documents, can be found here.

If you will allow me to mix monster metaphors here, we need to exorcise the ghosts from the medical literature and expose the zombies they have created to do their bidding.