Medical Journal Editors Issue No Registration-No Publication Rules

The world's leading medical journals today issued new rules for the public registration of clinical trials. The guidelines stripped away some trade secrets loopholes that companies have used in the past when registering clinical trials. But they left at least one major exception that ought to be reversed.

Last September, the editors of the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet and ten other leading journals declared that any trial started after July 1, 2005 must be registered in a publicly available database before the trial begins. If it wasn't registered, the editors said, the final results wouldn't get published no matter how significant the findings.

Why the crackdown? There have been a number of high profile incidents where companies hid critical clinical trial data from the public and regulators. The issue came to a head during last year's debate over anti-depressants and suicidality in children, which led New York Attorney General Eliot Spitzer to file suit against Pfizer for hiding data about Paxil.

Under the new rules (for a copy, click here), companies, academic institutions and the government will have to pre-register a trial's funding sources, the names of all the researchers, its ethical board seal of approval, as well as the details of the trial, from who will be enrolled to what will be measured. The joint editorial accompanying the guidelines pointed out that some trials registered recently in the government database have masked the drug's name or left out key points -- like what the researchers were hoping to find.

"The purpose of a clinical trials registry is to promote the public good by ensuring that everyone can find key information about every clnical trial whose principal aim is to shape medical decision-making," the editorial stated. "We will do what we can to help reach this goal."

Unfortunately, the guidelines gave industry a pass on registering first stage clinical trials -- where investigational new drugs are tested for safety. Te rules also gave a pass to some second-stage trials, where the drugs are tested for initial clinical effectiveness. Editors will judge publication of such trials on a case by case basis.

Why the exception? The editors bought into industry's defense for its secretive behavior in these early trials by suggesting that public notification "might slow the forces that drive innovation."

I can think of two reasons why this isn't so. First, good science requires collaboration and the sharing of information. If early stage trials that fail are made public, other scientists will learn what paths are not worth pursuing. Failed safety trials have a lot to teach other researchers about the possible pitfalls in a new drug class. Getting this information out early-on will save the collective biomedical research enterprise -- whether industry or government-funded -- time and money in the long run.

Moreover, while it is true that early public notification will tip a company's hand to other players in the field, is that something to be afraid of? If it spurs on competition, won't we get to those miracle cures even faster? Or are the editors suggesting that competition is bad for innovation? Only a monopolist thinks like that.

Posted by gooznews at May 23, 2005 09:06 PM