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Full Disclosure: How Do We Fix the Problem of Pharma-Sponsored Ghostwriting?

Full Disclosure: How Do We Fix the Problem of Pharma-Sponsored Ghostwriting?

Picture of William Heisel

chemotherapy, cancer, william heisel, antidote, pharma, ghostwriting, reporting on health

People with leukemia and their families undoubtedly read with great interest this week the news that University of Pennsylvania researchers had found a new way to obliterate cancer cells.

Reuters illustrated its story about the discovery with a photo of a 3-year-old girl named Mari in Tbilisi, Georgia, looking up at the camera with a cherubic face as two stuffed animals dangled from an IV drip connected to her veins. Who does not want to help this child?

Helping her, and millions of others around the world, will require a lot of time and money. It also will require the know-how to transform the results from a three-person study into a clinical application for a broad range of people. One of the lead researchers on the study, Dr. Michael Kalos, director of translational and correlative studies at the University of Pennsylvania's Perelman School of Medicine, told Reuters' Deena Beasley, "We are looking for corporate partners as we head into Phase II trials."

In other words, Penn is looking for a pharmaceutical company to make a new drug to kill cancer. When those Phase II trial results are published, though, this will lead to a question that isn't as easy to answer: Who should be credited with authoring the study?

This question has a particular weight at Penn right now because of a simmering ghostwriting scandal.

Prameet Kumar at the Daily Pennsylvanian reported recently that the consumer watchdog Project on Government Oversight (POGO) has asked that President Obama remove Dr. Amy Gutmann, Penn's president, from his bioethics advisory panel. Gutmann is eminently qualified for the post and one of the most celebrated academics in the country.

But POGO thinks she should have taken a tougher stand against Penn professors found to have put their names on articles ghostwritten by the pharmaceutical industry. As Eric Campbell, a professor of medicine at Harvard Medical School put it to Kumar, "To claim you did something when you didn't is a fundamental violation of one of the tenets [of research]."

And POGO makes a great point in its letter to Obama. It quotes from an interview that Dr. Francis Collins, the head of the National Institutes of Health, gave to C-SPAN:

I was shocked by that revelation-that people would allow their names to be used on articles they did not write, that were written for them, particularly by companies that have something to gain by the way the data is presented .If we want to have the integrity of science preserved, that's not the way to do it.

This all started when Dr. Jay Amsterdam, a Penn psychiatry professor, accused the chairman of Penn's psychiatry department, Dr. Dwight Evans, another Penn psychiatry professor, and other academics of stealing his work and using ghostwriters hired by GlaxoSmithKline (GSK) to write an journal article that put the antidepressant Paxil in an overly flattering light. According to Naveen N. Srivatsa at The Harvard Crimson:

The psychiatrists allowed the medical communications company Scientific Therapeutics Information, hired by SmithKline Beecham, to draft a paper using their names, according to the complaint. The paper, according to Amsterdam, suggested that the antidepressant Paxil can help treat some cases of bipolar disorder. SmithKline Beecham, which has since merged into the pharmaceutical company GlaxoSmithKline, manufactured Paxil. The practice known as ghostwriting is widely condemned by scientific journals. The World Association of Medical Editors calls ghostwriting "dishonest and unacceptable."

As far as POGO is concerned, Gutmann should have recognized a pattern and taken action. Last year, POGO accused Evans and Dr. Dennis Charney, the dean of research at Mt. Sinai School of Medicine at New York University, of allowing their names to be used on an editorial ghostwritten with GSK's assistance and arguing "that there should never again be a valid reason for not aggressively seeking out and treating depression in medically ill patients." A cynic could argue that by calling out patients with cardiovascular disease, cancer, HIV/AIDS and neurologic disease in the editorial, Evans was helping create a whole new pool of customers for Paxil.

In that case, Penn decided that there was no wrongdoing. I don't know how thorough the school's investigation was, but officials there could have easily decided that Evans had followed the proper protocols because he acknowledged at the end of the article that he had been helped in writing the piece. "We acknowledge Sally K. Laden for editorial support," the article says. Laden worked for Scientific Therapeutics Information. (You may remember the name from an earlier Antidote post.)

That one-sentence acknowledgment is part of a much larger problem. In two recent pieces in PLoS Medicine, a pharmaceutical company consultant and a former ghostwriter argue for changes in the way the pharmaceutical industry is involved in research and is credited.

In a series of upcoming posts, I'm going to highlight some of their specific ideas and invite you to weigh in with your own ideas. How should presidents of universities navigate the tricky but necessary relationships between academia and industry? How far should individual researchers, especially those who have been granted significant public funds for their work, be allowed to become intertwined with companies that are trying, first and foremost, to please their shareholders? How might disclosure rules become more standardized and more transparent, allowing people to see all the hands in the process, including the skilled hands that work for drug companies? How should reporters document and disclose for their readers the way industry has been involved in a scientific discovery?

When you see a picture of an adorable child like Mari who has very steep odds of surviving leukemia, you can't fall back on the too-easy idea that pharmaceutical companies are evil. When you have gone through treatment for a serious illness or know a friend or family member who has survived with the aid of drugs, you can't argue with conviction that every interaction an academic researcher has with industry taints the scientific process.

But you also can't argue very well that simply listing a ghostwriter's name in the acknowledgments is going to insure that the science behind the piece is solid. What's publicly playing out at Penn also is going on in laboratories and academic centers across the globe, and now's as good a time as any to find new ways to change the culture that has made ghostwriting so common.

Have a comment or question? Write askantidote@gmail.com. Follow me on Twitter: www.twitter.com/wheisel

Related Posts:

Drug document archive puts Paxil in the spotlight

The Mittleman Files, Part 1: Deposition provides treasure map for ghostwriting stories

The Mittleman Files, Part 2: Just another day on the ghostwriting assembly line

Covering Pharma Ghostwriting: Five Tips from PLoS Medicine's "The Haunting of Medical Journals"

Emergency Exorcism, Part 1: Medical journal editors need to do more about pharma ghostwriting

Emergency Exorcism Part 2: Five ways to bust pharma ghostwriting in medical, science journals

Doctors Behaving Badly: "Nothing dishonest" about ghostwriting, says professor caught with faked article

Doctors Behaving Badly: Gynecologist has "excellent" adventure with pharma ghostwriter

Photo credit: Nicki Dugan via Flickr

Comments

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It's not just U of Penn. It's Hopkins and all the "big" places with 'big name' faculty who are on NIH advisory groups or have NIH funding and publish widely. Sometimes it's their articles in important journals. Sometimes it's smaller forums or 'teaching slide kits' or presentations that they make at satellite sessions associated with big conferences. They go to dinners sponsored by one and actually boast to each other how much they're getting from another pharm company at the next dinner or the last trip. Big amounts too; not just nominal honoraria. This has been 20+ years in the making; it's well developed and it's not going to be so easy to eliminate because the docs have grown accustomed to the income (not to mention that it's income without work so it can't just be replaced by another gig). And their juniors have watched and aspired or assumed it would be coming. It can easily be checked --just look at the handouts and publications and go to the big author name, then ask what part he or she actually wrote. And check out the writers/editors on the payroll of the companies used by the pharm companies OR the publishing companies of the journals, some are even peer-reviewed or claim to be.

Picture of William Heisel

You bring up some great points. Penn was just the latest example, of course, and this is the reason I have started down this path. Look for more pieces that explore the not "easy to eliminate" part in the weeks to come.

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