FDA's Pazdur in the middle of intense debate

Dr. Pazdur did indeed reach out to an organization, but referring to the National Coalition for Cancer Survivorship (NCCS) as a "patient" advocacy group is a stretch. NCCS receives much (if not most) of its funding from the American Society of Clinical Oncologists (ASCO) a professional trade group that represents mainly academic oncologists who conduct clinical trials for a living, and several pharmceutical companies (this info is on their web page). Dr. Pazdur has been known to show up at their closed-door meetings attended by those companies and high-ranking members of ASCO. His attendance at these meetings is not announced anywhere by the way, and the press is not invited to the meetings. A lot of drug company people attend these meetings and the one I attended was moderated by ASCO docs. NCCS and ASCO are both legally represented (and have been for a very long time) by the same attorney, Sam Turner, who has worked as a drug company lobbyist throughout his career. He also serves as a high ranking official of ASCO. NCCS has a long history of almost exclusively lobbying for increased coverage of cancer drugs by Medicare, Medicaid and private insurance companies (of interest to its pharma funders) and increased coverage for clinical trials (of interest to its ASCO friends). NCCS has also opposed patient access to new cancer drugs outside clinical trials (because the two resources most needed for clinical trials are money and dying cancer patients who have no other options but to risk getting a placebo in a clinical trial). NCCS only recently moderated its position on access to one encouraging maintenance of the FDA's current failing policies by submitting a request to FDA to cement them into promulgated regulation. NCCS elected to encourage this non-action in the face of pressure on FDA from real patient advocates and real cancer patients to put policies in place that will actually work to the benefit of patients who have cancer. NCCS through Dr. Pazdur, has wielded immense power over cancer drug development and approvals at FDA. They have supported and worked hard to engineer Dr. Pazdur's ascent at FDA, including the pushing for the creation of the cancer czar job and his being appointed to the position. At one point they lobbied for Dr. Pazdur to be appointed FDA commissioner. It is also curious that given Dr. Pazdur's complete control over the membership of his supposedly outside and independent Oncologic Drugs Advisory Committee (ODAC), a fact you won't find on the FDA's advisory committee webpage, virtually all of its members under his leadershiphave been and remain academic oncologists from large clinical trialing institutions, every one a member of ASCO and many of them high-ranking officials at ASCO. ASCO does many things, but its core mission is to serve the best professional and financial interests of its members - oncologists who conduct clinical trials. Finally, Dr. Pazdur and his staff have been anything but friendly or compassionate to cancer patients. Dr. Pazdur has substantially slowed approvals of new cancer drugs, delaying and even killing some new therapies that should have received accelerated approval, and made access to those therapies prior to his delayed approvals an impossibility for both sponsors and patients. He also has functioned as one of the strongest barriers to change at FDA, insisting on rigid enforcement of archaic, narrow-minded, statistical approaches to drug development and approval, resulting in a string of incredibly barbaric, unnecessary clinical trials that put dying cancer patients on nothing but placebos under blinded conditions, and allow them to die on those placebos, never getting a chance to try the active drug that should have already been approved based on compelling earlier trial data. Why? Because if they are allowed the new drug after their disease progresses, some will respond and live longer, thus statistically confounding (reducing) the overall survival difference between the two arms of the trial. His is a regulatory world where a meaningless statistical metric called a p-value is more important than human life itself, and his approach has delayed the availability of numerous good cancer drugs by 1.5 to 2 years, with associated premature deaths caused by those delays that number in the hundreds of thousands. So has Dr. Pazdur been the right person to run FDA oncology during a time of exploding biomedical knowledge? I think not. Does Dr. Pazdur value the views and needs of patient advocates and cancer patients? The answer is resoundingly no, notwithstanding his too-close association with NCCS.