Lucentis Study Warned by FDA Over Protocol Failures
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
By Kelda Doherty
The HARBOR study assessing the drug Lucentis, sold by manufacturer Genentech has received a warning from the Food and Drug Administration over numerous violations when it was found to have failed to follow correct protocol and failed to maintain accurate case history of the patients. The study which compares high and lose dose versions of Lucentis, a macular degeneration treatment, among patients with eye afflictions recently. As it turns out, the higher dosage didn't provide better visual acuity.
Violations included 5 out of 23 participants in the study not meeting the criteria required to be fulfilled in order to be included in the study and visual acuity tests being carried out by uncertified personnel. Worksheets which recorded who conducted the examinations failed to correspond with subject medical charts. In addition, proper informed consent was not obtained from two participants in the study, with one individual being unable to read the consent form as it was given after the subject's eyes were dilated! These failures put into question the validity and reliability of the data recovered from the study and also puts the integrity of the manufacturer Genentech in doubt.