LONDON - The British Medical Journal (BMJ) has admitted it was wrong to publish data indicating that Scotia Pharmaceutical plc's photodynamic therapy drug Foscan caused serious burns, without allowing the company to comment.
"We [the BMJ] did not do as well as we would have liked in publishing this drug point," writes Richard Smith, the editor.
Two of the four authors of the paper, which reported that six of 14 volunteers in a safety study of Foscan had developed serious burns at the site of the injection, also acknowledged their mistake. "We are not suggesting that the true incidence of burns with Foscan is 43 percent - this was just the incidence in the group referred to us." The two authors said they agree with Scotia that the correct figure is "probably around 2 percent," and that the high incidence of complications "may well have been due to a problem during the administration of the drug."
The clarification, on Friday, boosted Scotia's shares by 9 pence to #1.23. The company lost more than a quarter of its value, falling from #1.53 to #1.13, when the original report was published at the beginning of May.
The two authors, Shehan Hettiaratchy and John Clarke, said that irrespective of whether the cause was a problem with administration, the medical community needed to be aware of the potential for serious burns, which behave differently from conventional thermal injuries.
In his comments, Smith also questions whether the two other authors, Jorg Taubel and Chola Besa, who work for a clinical research organization, have competing interests they should have declared. "If the adverse reactions resulted from how the drug was given, rather than the drug itself, then questions might be raised about their suitability to work in the center."
Scotia, based in Stirling, Scotland, was in need of some consolation, having announced earlier last week that the FDA has extended its review period for Foscan from July to October. This is to give the FDA time to review new data it requested from the company on its pivotal Phase III trial.
Scotia is hopeful that the new data will result in wider labeling. The update of patients in the trial shows that the complete tumor response rate has improved from 11 percent in the original submission to 16 percent.
"The goals of obtaining approval for Foscan and achieving an optimal label for the product post-approval were best served by a submission of the updated database," said Rob Dow, CEO. "It is pleasing to see that the update has shown a meaningful improvement in the complete tumor response rate."