A few days before the FDA Advisory Committee hearing March 29 on Provenge (sipuleucal-T), Thomas Farrington, a leading African-American prostate cancer survivor advocate, wrote an urgent plea. Farrington, who is President and Founder of Prostate Health Education Network (PHEN), wrote:
With a death rate 140% higher than for other men, coupled with a comparable level of suffering and quality of life loss, our need for new and innovative treatments is desperate and unparalleled relative to any other type of cancer in terms of the death rate disparity.
Last September — a month celebrated annually as Prostate Cancer Awareness Month — Farrington’s group PHEN helped organize a 2-day, Washington, D.C. African American Prostate Cancer Disparity Summit. This event was sponsored by Dana-Farber Cancer Center, TAP Pharmaceuticals, and Dendreon Corp. and a fourth sponsor, The Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country’s leading pharmaceutical research and biotechnology companies.
This event brought together a range and depth of physicians, scientists, lawmakers, religious leaders, industry representatives and professional and volunteer prostate cancer patient advocates. Yet its agenda ended up focused rather narrowly on prostate cancer vaccines as a solution to disparities. The 2-day event was structured around four main topics:
- Why the African American Prostate Cancer Disparity?
- Outreach for Education, Awareness and Advocacy…What Works?
- Early Detection Screening: The Benefits, Risks and Debate
- Prostate Cancer Vaccines: Immunotherapy…the Promise of a Cure?
The session on prostate cancer vaccines aimed “to bring into focus the status and progress of immunotherapy as a prostate cancer treatment option.” At that time vaccines for prostate cancer were not a treatment option, they were in clinical trials. Panelists were invited to explore “how success in this area could impact the elimination of the racial disparity and how this treatment compares to others that are currently available.” Lead speaker for this session was Mitchell H. Gold, MD, President and CEO, Dendreon Corporation.
Is the company taking steps beyond sponsoring patient advocacy activities to assure equal access to the vaccine if and when it is approved? Well, yes, but whether these are solid steps must be examined.
Dr. Andrew von Eschenbach, M.D., Director of the FDA, who is an oncologist, surgeon and cancer survivor, often uses the metaphor of a building a bridge between the promise of science and technology and the delivery of drugs, or “interventions,” that can “eradicate” diseases including cancer, diabetes and Alzheimer’s disease. “Together we can build that bridge,” he said in 2006. “We can build a bridge that links discovery and development of new drugs and biologics and medicine with their delivery to all people.” Dr. von Eschenbach envisions a transformation of the FDA into a science-based and science-led institution:
we must envision an FDA that will not only be a science-based regulatory agency, but that will be a science-led facilitating agency, which helps new products come across that bridge of development more rapidly, in much larger volumes, ready to be delivered to patients.
But as Bob Samuels brought up at the FDA Advisory panel hearing March 29th, African-American prostate cancer patients were under-represented in the clinical trials for Provenge. While Dendreon’s role in the Summit encouraged African American men to believe that a vaccine may help resolve some of their direst cancer care access problems, the company has not even tested this product on a fair representation of African American patients.
Dendreon’s representative om the 2006 African American Prostate Cancer Disparity Summit’s advisory board was Christopher Lockett, who by then was the company’s Director of Government Relations. LAst month Lockett was promoted to the position of a senior director of government affairs. Locket will be “responsible for managing Dendreon’s relationships with local, state and federal government officials.” Primarily he will be responsible for “Dendreon’s interactions with the Centers of Medicare and Medicaid Services (CMS) regarding potential future coverage of Provenge, and provide counsel and direction on coding and reimbursement for the product.”
If Provenge is approved Medicare and Medicaid coverage of the vaccine will be vital for men with advanced prostate cancer who lack private health insurance. The current estimated price for Provenge is around $30,000. Before and after receiving Provenge, most patients will be expected to remain on androgen ablation drugs like Lupron or Zoladex; some will take bisphosphonates to counteract osteoporotic effects of the androgen loss induced by Lupron and Zoladex, and some will go on to take chemotherapy as soon as Provenge fails to control the cancer or ceases doing so, which may happen within weeks.
So Medicare and Medicaid coverage is absolutely essential and will follow if the FDA approves the vaccine. A second accessibility factor of concern for advanced prostate cancer patients is convenient access to a clinic or hospital qualified to administer powerful anti-cancer drugs. This is especially an issue with chemotherapy. For patients in rural areas or distant suburbs, a weekly or 3-weekly trip to anything approaching a “center of excellence” for chemotherapy may entail arduous, heroic efforts or may be foreclosed by lack of a driver, extreme distance or impassible weather conditions.
A third factor to consider with regard to Dendreon’s preparations for dealing with Medicare and Medicaid is the company’s natural desire for rapid market penetration.
Is Mr. Lockett’s role at Dendreon part of this highway to the future? Do his qualifications for the job make him a bridge toward overcoming of entrenched, systemic disparities in our health care system? Mr. Lockett joined Dendreon from TAP Pharmaceutical Products Inc., where, Dendreon says, “he most recently served as director of government affairs. He spent the majority of his 17-year career at TAP providing strategic counsel to the company on the impact of state and federal programs, including Medicare and Medicaid, as well as legislative issues on TAP’s two leading products.”
One of TAP’s leading products is Lupron, an androgen-blockade, or therapeutic castration, drug of a class that has dominated treatment for men with advanced prostate cancer since the late 1980s.
During Mr. Lockett’s 17-year stint at TAP in the ’90′s, TAP was charged with health care crimes against Medicare. In 2001 the company agreed to pay $875 million to settle charges. “As part of a condition for doing business in the future with providers who are members of the Medicare and Medicaid programs, TAP agreed to enter into an extensive Corporate Integrity Agreement. That agreement provides for significant training of TAP’s sales and marketing employees and changes in supervision and controls.”
“Chris is an expert in health care policy issues management,” said James Caggiano, Dendreon’s vice president of sales and marketing, to whom Lockett will report, “particularly with respect to prostate cancer medicines, and will play an important role in ensuring that our commercialization strategy is aligned with current and evolving policies that could affect PROVENGE.”
The day Norm Fotheringham got his diagnosis he knew only one thing about prostate cancer: that it was deadly.
