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Six years ago, a bioethicist came across a heavily-cited article in a prestigious health economics journal that pegged the estimated cost of developing new drugs at a far higher level than previous research.

The article, published in the Journal of Health Economics in 1991, had been widely publicized by the industry’s trade association to support claims that high prices were necessary to pay for the research and development that creates new drugs.

The authors estimated that the average cost per drug had increased to $231 million, more than four times the highest previous estimate. An update published in 2003 raised the estimated cost of a new drug to $802 million.

But concerned that rising drug prices would limit access to treatment, Donald W. Light, a professor at the University of Medicine and Dentistry of New Jersey, decided to take a closer look.

QUESTIONING METHODS, QUESTIONING MOTIVES

Light, a sociologist who is also a research fellow at University of Pennsylvania, and a colleague submitted a critique of the paper to the JHE in 2004, questioning the validity of the data and methodology used in the report, as well as raising possible conflicts of interest due to pharmaceutical funding.

A month later, Thomas McGuire, a health economics professor at Harvard Medical School and one of the journal’s editors, responded to the critique, asking for “major modifications” regarding claims of the industry influence on the study’s results. A back-and-forth exchange ensued, and Light soon hired a lawyer, Alan C. Milstein. [SEE CORRECTION BELOW]

The issue was settled in July 2005. The Journal published two revised versions of Light and his colleague’s critiques along with the authors’ responses. Milstein called it a “half-victory,” as he estimated that the JHE’s editors had cut 90 percent of Light’s final commentary.

“This case violates almost everything you would expect of fair editing,” Light said in a recent phone interview, stating that the authors were given more space and time to reply to the critique than he and his colleague.

“Health economics journals are a major conduit for legitimizing industry-supported studies to justify high prices for prescription drugs,” said Light, who published an article in the Harvard Health Policy Review earlier this year detailing his experience with the journal.

Guire, who was the editor handling the review, acceptance, and editing of the article, defended the editorial decisions, stating that the modifications were intended to take out the “personal attacks and innuendos” directed at the original authors.

“It is the first and only time in my experience an aggrieved author has threatened to sue over an editorial decision,” McGuire said. “In the end, they did manage to find an outlet in the Harvard Health Policy Review for their personal attacks, both on the authors, and now on the editors who handled their comment.”

COPING WITH THE PROBLEM

While both sides acknowledged the importance of minimizing conflicts of interest in academic research, they differed on whether all journals should be required to espouse a certain set of guidelines.

McGuire said that it’s not necessarily a problem that different journals have different review standards, but in his article in the health policy review, Light recommended that all health economics journals sign up to the Committee on Publication Ethics, a British body that developed a set of editorial procedures to ensure ethical practice.

Light said that “the traditional hands-off stance of publishers and academic societies towards the editors of journals they own is absolutely right, except when it comes to the ethics of editorial conduct.”

Journals based in Britain, including The Lancet and the British Medical Journal, are among those that have pledged to follow COPE’s standards.

Sabine Kleinert, COPE’s vice chair, said that the organization provides support and advice to editors, authors, and publishers in order to uphold the integrity of scientific journals. She noted that Elsevier, which publishes the JHE, signed up all its journals this year.

An Elsevier spokeswoman said that she could not comment on the specifics of Light’s case, but added that the publisher recently launched several measures to curb unethical practice.

Elsevier’s managing director of journal publishing, Martin Tanke, said that Elsevier also launched PERK, a publishing ethics toolkit for journal editors, and a reference tool to strengthen the peer review process.

The appeal process provided for under COPE could potentially help reduce conflicts, such as the one he has with the JHE editors, Light said.

“I don’t doubt that they were trying to be good editors, but by what standards and what pressures were they under? Why were they behaving this way?” Light said, adding that he and his colleague had “searched frantically” for an avenue of recourse. “Our problem was that there was no place to go.”

—Staff writer June Q. Wu can be reached at junewu@fas.harvard.edu.

For recent research, faculty profiles, and a look at the issues facing Harvard scientists, check out The Crimson's science page.


CORRECTION

The Oct. 10 story, "Journal Integrity Questioned," stated that one of the academics in question, Donald C. Light, hired an attorney, Alan C. Milstein. In fact, Milstein was not hired by Light, but volunteered to take the case and did not charge a fee.