Last week, AstraZeneca received some bad news from an FDA advisory committee, which voted 14 to 3 not to approve a respiratory syncytial virus (RSV) drug called Rezield, or motavizumab, for high-risk infants due to side effect and risk-benefit concerns. The drug is a planned successor to Synagis, a $1 billion-a-year blockbuster that loses patent protection in 2015. And if Peter Roelvink is to be believed, public health officials may breathe easier over the panel's decision.
Here's why: Roelvink joined AstraZeneca as a director in its Infectious Disease department shortly before the drugmaker, which purchased both drugs as part of its 2007 acquisition of MedImmune, received a complete response letter from the FDA. He had been assigned to speed the biologics license application and, later, review RSV nasal wash samples that were obtained from patient studies and had to be analyzed in response to the FDA's request for more info.
However, Roelvink soon learned of a discrepancy between samples tested in different locations and, after investigating further, he discovered that inappropriate filters had been used by a technician to distinguish viruses from 111 patient samples. Yet his supervisor allegedly did not intend to submit the conflicting data to the FDA, according to a lawsuit filed by Roelvink, who claims he was terminated wrongfully for objecting to the decision to include incorrect results. As the lawsuit describes it, he suffered retaliation because he refused to "sweep problems under the rug," and blame the test-kit manufacturer.
"For reasons not made known to Roelvink, (his supervisor) said that not all differing results would be reported to the FDA. Roelvink knew or reasonably believed that the failure to report all test discrepancies would constitute false reporting in violation of FDA law, and indicated this" to his supervisor, according to the lawsuit, which suggests "serious concerns" over the data in the original BLA. Roelvink's staff, by the way, later found 58 percent and 65 percent of the samples from two different sample groups were incorrect.
By August 2009, he was fired for "the flimsiest reasons," according to the suit, which states his supervisor alleged he was not up to being a department director. Only five months earlier, he received a $19,000 bonus. And so he is seeking $5 million in compensatory damages and $5 million in punitive damages. We are awaiting a reply from AstraZeneca (see below for the reply).
UPDATE: On Tuesday, June 8, at about 10:30 am, AstraZeneca conveyed this response: "Bahija Jallal, MedImmune’s Senior VP of Research and Development, provided (this statement) at last week’s advisory committee meeting: MedImmune is confident that the data submitted to the FDA and presented to the Advisory Committee are accurate. The pending lawsuit contains unsubstantiated allegations by a former employee. MedImmune is confident that all data submitted for review for this application are true and accurate."