Medical news story bends the truth about drug safety   (January 3, 2008)

This website (and others) recently trumpeted a Reuters news story "New drug seen helpful in elderly type 2 diabetics ... according to a report in the journal Diabetes Care."

Reading the "news story", which was allegedly written by a physician, it seems more likely that it was a press release planted by the drug company. For instance, there's a direct quote from a company spokesman and none from the researchers.

But of greater concern is misleading lack of information about possible drug safety issues.

The story correctly indicates that the drug "has not yet been approved by the US Food and Drug Administration. The FDA issued an approvable letter for the drug in February 2007." What is not explained in the story is why the FDA held up approval of the drug: because of drug side effects seen in preclinical trials in monkeys way back in 2006.

I'm also shocked by the claim in the news story that "there were no serious adverse events attributed to vildagliptin therapy." First, let's clarify: SAEs are a specific type of side effect -- they are, by definition, adverse events that resulted in death, or were life-threatening, or resulted in hospitalization or congenital anomaly, or which was considered medically significant by the investigator or the company; and "attributable" means either the investigator or the company thought the side effect was possibly related to the use of the drug.

Enrolling 1469 patients in a study (or studies, as it turns out: this publication actually was an analysis of 5 studies) and not finding a single attributable SAE surprised me, so I went back and read the original article in Diabetes Care, where I read a different statement, that "None of the SAEs in vildagliptin-treated elderly patients was suspected to be drug related." Ah, ha! There were only 238 elderly patients (65 years of age or older), and 1231 less-than-elderly (less-than-65) patients. And among those younger patients, indeed an SAE had occurred. And one in an elderly patient taking another drug. (There were a total of 24 patients with SAEs in the report, so 21 were considered unlikely to be related to the use of the drug; for example, if a patient was hospitalized following an auto accident when they were a passenger in a car struck by another car, most physicians would state that the hospitalization was not related to the use of the study drug.)

Re-reading the news story, the entire sentence about side effects reads as follows: "Adverse events, including hypoglycemia (low blood sugar), occurred no more often among elderly patients than among younger patients, the investigators say, and there were no serious adverse events attributed to vildagliptin therapy." This misrepresentation of the fact that there was indeed an attributable SAE is a clear attempt to fudge the truth.

My conclusion: the author of this news story was willing to bend the truth about drug safety. And it's attitudes like his that makes us all worried about the safety of our pharmaceuticals. Utter and total honesty is needed by medical writers as well as the researchers who presented their findings; after all, it's not everyone who can have access to the full-text of the scientific publication and check the accuracy of the story.

And my comment to the author, whether physician or drug company flack: Shame on you!