On February 22, 2016, the US Senate will hold a cloture vote for the Senate confirmation of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA).
The Quinolone Vigilance Foundation sent the following letter to US. Senator Richard Burr, who is on the HELP Committee.
As you may recall, QVF met with Senator Burr’s office in Washington, DC on February 3. One of many things QVF brought up was fluoroquinolones, failure on the part of the FDA, patient safety and preventable medical harm, and the possible confirmation of Dr. Califf.
February 11, 2016
Senator Richard Burr
217 Russell Senate Office Building
Washington, DC 20510
Dear Senator Richard Burr,
As a patient who has been irrevocably harmed by a dangerous fluoroquinolone antibiotic, and as the Executive Director of the Quinolone Vigilance Foundation, I am writing to express deep concerns over the impending cloture vote on February 22, 2016 for the Senate confirmation of Dr. Robert Califf as Commissioner of the Food and Drug Administration (FDA).
Three United States Senators have placed a hold on the Senate confirmation of Dr. Califf. Despite that, the Senators who have said they will block such a vote have done so, not out of political contentiousness, but rather from grave concerns over Dr. Califf’s ability to provide the kind of leadership that the FDA needs to protect the health and safety of the American people.
The New York Times recently stated, “Califf has ‘deeper ties to the pharmaceutical industry than any F.D.A. commissioner in recent memory.’ The threats to patient safety are enormous and alarming.
A Xarelto study led by Dr. Califf came under sharp criticism by the FDA as having a built-in bias in favor of this new, more expensive blood thinner. Although eventually approved, Xarelto is now the subject of mass litigation for causing untold injury and death.
Dr. Califf has said that he will not lower FDA standards. Yet a recent New York Times editorial states that “In 2014, Dr. Califf gave a speech to researchers, lawyers and industry experts in which he described regulation as a 'barrier' to biomedical innovation. He also helped author a series of papers which were critical of the FDA, and had his name removed from those papers in close proximity to when he was nominated for the Commissioner position. Dr. Califf has recently come under scrutiny for providing the Senate HELP Committee members with questionable answers.
If Dr. Califf is confirmed, there is grave concern that he will jeopardize patient safety and further lower the integrity of the FDA review process. Patients need a Commissioner who will provide reasonable assurance of the safety and efficacy of our drugs and devices through the gold standard of double-blind, human clinical studies. Therefore, I and other patients who have been harmed by toxic fluoroquinolone antibiotics, call on the Senate to prioritize patients above industry groups, to put the integrity of the scientific process above profits, and decline to confirm the nomination of Dr. Robert Califf as Commissioner of the FDA.
Rachel Brummert, Executive Director
Quinolone Vigilance Foundation
Charlotte, North Carolina 28213