Oslo, Norway and New York, NY - Possibly fraudulent data submitted to prominent medical journals is in the news again this week.

A Norwegian hospital has confirmed that one of its scientists fabricated data that appeared in the Lancet recently—a study of nonsteroidal anti-inflammatory drugs (NSAIDs) on the risk of oral cancer [1].

Meanwhile, an editorial in the Wall Street Journal [2] comes down hard on the New England Journal of Medicine over its attack last month on Merck & Co and the "missing data" from the VIGOR trial with rofecoxib (Vioxx) [3].

The Norwegian daily newspaper Dagbladet reports that a number of statistical improbabilities were found in the data set of the cancer trial, published in the Lancet in October last year. The lead author, oncologist Dr Jon Sudbø (Radium Hospital, Oslo), is the one in the center of the storm. The study found that NSAIDs halve the risk of oral cancer but double the cardiovascular risk, with hazard ratios ranging from 1.7 for naproxen to 2.86 for ibuprofen. The Radium Hospital says it first became aware of a problem last week when an external scientist questioned the data.

One example of the "improbabilities" is the fact that of the 908 people in the trial, 250 shared the same birthday. The hospital reports that other anomalies in patient profiles and case histories went undetected by the coauthors and the hospital.

The trial is believed to have had an effect on decision making with regard to NSAIDs in oral cancer and, more important, has played a key role in the entire NSAID debate. Preliminary findings of the study were discussed at the FDA coxib hearings last year and were pivotal in the decision-making process there. 

Lancet editor Dr Richard Horton told the BBChe would be speaking to the coauthors of the study to seek their permission to retract the paper [4]. He described the fabrication of data as "a terrible personal tragedy" for Sudbø, but he denied there is anything wrong with the process of peer-reviewing scientific contributions to journals. The process "is good at picking up poorly designed studies, but it is not designed to pick up fabricated research," he said.

Sudbø is on sick leave but has agreed to the hospital accessing all of his data, which will be examined by an external investigating committee.

At the same time, the Wall Street Journal has turned its attentions to the attempts of the New England Journal of Medicine to get Merck to correct "key" Vioxx trial data, as reported by heartwire last month. In an editorial this week entitled "The New England Journal of Politics," the WSJ says the NEJM is "joining the ranks of the academic publications risking their reputations as nonpartisan arbiters of good science in order to rumble in the political tar pits."

The newspaper covers in detail the early-release editorial by the journal just before Christmas, which called on Merck to rectify important "inaccuracies and deletions" of cardiovascular data. The row centers on three MIs in the rofecoxib group that were omitted from the VIGOR publication—which the authors say happened after the cutoff date for the study, the reason they were not included. This resulted in an understatement of the risk of MI with rofecoxib, the NEJM editors said.

The WSJ says the "not-so-subtle accusation is that Merck manipulated the data," but, it adds, "as prominent scientists have attested, the authors were simply following the rules of science." It quotes an epidemiologist, Dr Brian Strom (University of Pennsylvania, Philadelphia): "If the outcomes truly occurred after the close of the study, then they don't belong in the study."

For its part, Merck publicly released the information about the additional MIs and included it in marketing materials that contained the published VIGOR study, the newspaper says.

"The NEJM clearly knew all this and as an esteemed professional body presumably understood the scientific rationale behind the omission. Yet it nonetheless chose to use the Vioxx trial as an opportunity to join in the latest political and legal tarring of big pharma as greedy profiteers," it continues.

Executive editor of the NEJM Dr Gregory Curfman declined to comment to the WSJ but issued a statement: "The editors of the NEJM expect that a manuscript submitted for publication will provide a complete and accurate description of the study that was done and that certain data will not be withheld."