MONDAY, Sept. 10, 2001 (HealthDayNews) -- Some of the world's most respected medical journals will launch a new editorial policy designed to help researchers fight the growing influence of the drug companies that fund most clinical studies.
In a joint editorial that appears this month in 12 journals, including the Annals of Internal Medicine, the Journal of the American Medical Association (JAMA) and The New England Journal of Medicine, the editors say increasing economic pressures have changed the face of drug research, and they worry about being unwitting partners in the possible publication of misleading information.
The decision follows some embarrassing episodes in medical research. The editorial cites recent problems where publication of a controversial study was delayed or blocked, where lead researchers did not have control over the design of the study or access to all the data, or where researchers had limited say in how data was analyzed.
The new policy will require researchers to sign a statement that verifies they had access to all the data in their study, that they decided if and when to publish the study, and that they take full responsibility for the conduct of the study.
The pharmaceutical industry says it supports the new policy and the right of the editors to make it.
Dr. Harold Sox, editor of the Annals of Internal Medicine, says, "We think it will make a difference, and by that we mean we think it will give clinical researchers some leverage in negotiating with pharmaceutical firms and other corporate sponsors to specify the rights of the clinical investigator."
"In some senses, scientific results don't exist until they appear in a medical journal," and doctors often will change treatments to reflect the results of clinical trials, Sox says. And that is powerful sway, indeed, when dealing with drug companies.
Sox says a recent JAMA survey asked 1,800 researchers across the country whether they had ever been involved in a situation where publication of a study was delayed because the results ran counter to the sponsor's interest. As it turns out, 120 said yes.
"That's the best information we have about the prevalence of the problem," says Sox.
"Quite often, people are making judgment calls based on how it affects their sales, not how it will affect human health," says Jeffrey Drazen, editor of The New England Journal of Medicine. "We hope to tip the balance. It'll help academic researchers in negotiating with pharmaceutical companies when they get into these tough situations."
The heads of research at some universities welcome the support.
"I think the policy overall is an excellent one," says Dr. Theodore Cicero, vice chancellor of research at the University Of Washington in St. Louis. Over the last few years, he says drug companies have been trying to exert more influence over studies. For example, he says a company may offer "professional writers" to help the researcher write the critical first draft of a study.
"I think this will be enormously helpful to be able to point to [standards] outside our [research] contracts. I was rather pleased to see the journals step up and take the lead. It makes our job easier," Cicero says.
Dr. Alan G. Robinson, vice provost of medical sciences at the University of California, Los Angeles (UCLA), says most large universities have policies regarding the research contracts they negotiate with drug companies. They usually include the right to publish, regardless of outcome, and a comment period for the sponsor before publication that does not include veto power.
But he says the extra backing from the medical journals will make a difference.
"Sometimes we do have to fight with pharmaceutical companies to get the language we want," Robinson says. "I think it strengthens the position we've wanted to have all along. In fairness to pharmaceutical companies, we don't usually have this problem, but occasionally it [happens], and I think this approach is helpful to us. Pharmaceutical companies want to have their research in the most prestigious journals. I don't think that's going to go away."
But one Food and Drug Administration (FDA) official says the problem goes deeper.
Robert J. Temple, director of medical policy at the FDA's Center for Drug Evaluation and Research, says, unlike medical journal editors, his agency gets all the raw data from clinical trials.
Temple says, "What I would want, if I were reviewing the studies, would be to have all the data shown, away from a point of view. But I think they're calling attention to a problem. That helps."
Temple says the federal government sponsors only a few clinical trials in this country; drug companies fund almost all the rest.
"No drug study happens by itself. That's the system," Temple says.
Dr. Bert Spilker, a spokesman for PhRMA, an organization representing more than 60 leading pharmaceutical firms around the world, says in a statement that, "In the interests of scientific integrity and patient safety, it is essential that academic researchers who participate in clinical trials have complete freedom to participate in and approve all aspects of a trial, including any publication that may result from such a trial. We agree that the editors and their publishers have every right to establish these policies for their journals. We respect their rights and encourage all authors to abide by their rules regardless of their affiliation."
Sox says he is optimistic about the new policy.
"The best outcome would be that, consistently, the identified author of a study had the freedom that researchers need to have to design a study and analyze the data. These are the absolute fundamental rights of the scientific process," he says.
What To Do
For more on the committee of editors that came up with the new policy, go here.
For the industry perspective, visit PhRMA.
