Harold Sox doesn't seem like a firebrand ethics cop.
But this 69-year-old medical journal editor believed that a message had to be sent to the drug industry about "seeding trials."
"It's an imperfect world and there are imperfect motivations," Sox, the editor of the 90,000-circulation Annals of Internal Medicine, said yesterday in his office lined with medical books and educational certificates.
On Monday, the Philadelphia-based journal - which is considered one of five major medical journals in the United States and Britain - published an article and scathing editorial on seeding trials. Critics say seeding trials are marketing programs masquerading as legitimate randomized trials of a drug's effectiveness, or side effects.
And the Annals of Internal Medicine, which typically keeps a low profile in its offices on Independence Mall, had in its sights the ethics of one of the world's largest and most influential drug companies, Merck & Co. Inc.
Researchers documented a Merck seeding trial of Vioxx by using court documents. Seeding trials had been an "open secret" in the drug industry, but there had been no hard proof to show they existed, Sox said. Some of the documents in the journal article had been previously cited in a New York Times article.
The article and editorial, titled "Seeding Trials: Just Say No" will help keep the twice-monthly Philadelphia medical journal on competitive footing with rivals the New England Journal of Medicine and Britain's Lancet.
About 30 employees in the American College of Physicians, a nonprofit educational charity focused on internal medicine doctors and health-care professionals, publish the journal. The group employs 300 in the city and engages in educational outreach. It has 126,000 member doctors and others. John Tooker, chief executive officer, said Sox and the journal's staff had complete editorial independence from the parent organization and articles were "free from commercial bias."
Sox, a lean and tall man who is the former chairman of medicine at the Dartmouth Medical School, takes his public-service mission seriously. He talks about the broader mission of health care and the power of medical journals to stir debate. He said seeding trials betrayed the trust patients had in doctors and drug companies.
Patients say they believe they are participating in a bona fide drug trial to determine health benefits of a drug. But drug companies have other goals: selling pharmaceuticals.
Merck has said the study in question answered important scientific questions.
Sox said he did not think so, detailing in the interview what he considered the small advance in medical science the study accomplished.
Sox felt some responsibility to the story, too.
Several years ago, the Annals of Internal Medicine published an article on a Vioxx drug trial. The journal later had to publish new information on the trial, Sox said, because the authors withheld information unfavorable to Vioxx.
According to the new research, that study was, in actuality, a seeding trial. "Sometimes you are going to get burned. That's what happens," Sox said.
Sox said he was aware of how easily a journal could be duped by scientific fraud. He described the process for publishing articles. Authors submit about 3,000 articles each year; only 300 make it to print.
Medical experts and number crunchers review the articles. In weekly manuscript meetings, editors and medical experts discuss article content. Secret ballots are conducted.
Authors have to answer detailed questions that can run into several single-spaced typed pages. "Getting it right is a painstaking and expensive process," the editor said.
Sox said he could be cynical, but "99 percent of what we do here is wonderful and only a little is not."
The real discussion of issues begins after articles are published. Sox said he believed the same would be true with seeding trials, which, he said, the journal "shined a bright light on."