By Dan Abshear

Terminal patients are those who are not expected to live, usually due to an illness such as advanced cancer. Typically, a cancer patient is considered terminally ill if it appears he or she has 6 months or less to live. Cancer patients who are terminally ill, without cure or tolerable treatment, with the expectation that they will die soon, may seek and desire even unproven treatment options.

Understandably, for patients at a severe stage of illness, such as advanced prostate cancer, possible extension of life with comfort is worthwhile regardless of lack of evidence of proof that the treatment will indeed provide those benefits.

The FDA claims authority over the treatment options of such patients. Yet in recent years the FDA, with its frequent drug recalls and black box warnings –usually imposed only under pressure from the public — has proven itself to be rather inadequate. The FDA may not be an ideal judge of treatment options for very sick patients.

Individuals should be the deciding factor in selecting their treatment course along with their health care provider, and not an unreliable FDA.

Prostate cancer is the second most common cause of cancer death in men, with between 10 to 20 percent of men predicted to acquire the disease during their lifespan, resulting in the USA in about 30,000 deaths a year from this disease. The more aggressive and advanced prostate cancer becomes, as determined by measures such as Gleason score and methods such as bone scan, the harder it is to treat the patient.

Yet innovation still exists in medicine. A few years ago, a small biotechnology company called Dendreon was working on a conceptually new treatment for prostate cancer. They called it Provenge.

In submitting Provenge vaccine for the treatment of advanced prostate cancer for fast-tracked FDA approval despite aborting one clinical trial due to failure to meet the primary endpoint, Dendreon relied on meta-analysis of combined data from two parts of a phase III study, D9901. In fact, after the trials failed to meet their primary endpoint, time to progression, they were analysed twice over. Dr. Eric Small presented meta-analyses of impact on overall survival and prostate cancer specific survival and Dr. Daniel Petrylak presented a further analysis or suvival focused on a subset of patients who, when they progressed on Provenge, took Taxotere.

A link to a 5 hour video recording of the FDA Advisory Committee hearing held March 29 on sipuleucel-T (Provenge) for advanced, androgen independent prostate cancer. The video does not include the vote.

A full written transcript in .pdf including the voting is online at FDA, click here.

A crowd of about 70 people led by prostate cancer advocates marched and rallied in Washington, D.C. on June 4 to call on the FDA to Approve Provenge Now.

Thomas Farrington of Prostate Health Education Network addressed the group.

Raise a Voice organizer Jan Manarite introduced speakers including Tom Farrington and Dr. Mark Moyad.

The petition campaign was organized by malecare.com.

Visit Joel Nowak’s advancedprostatecancer.net blog,
Provenge Advocacy Hits the News

Organizer Jan Manarite receives a hug

from her son, who carried the message

"Help My Dad Live"

On June 5, campaigners met with FDA director Andrew von Eschenbach.

View ABC-TV video here. See photos of the rally (by brad.wick) and video of Mark Moyad’s speech.

Oncologist Dr. Howard I. Scher has received a death threat for opposing immediate FDA approval of Dendreon’s Provenge therapeutic vaccine for prostate cancer. Another oncologist who opposes approval of Provenge without completion of an ongoing clinical trial, Dr. Maha Hussain, has received unspecified threats.

Data presented today from an ongoing study designed to explore the biologic and clinical activity of cancer immunotherapy sipuleucel-T, or Provenge, in patients with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic disease are not all that impressive. The study showed that sipuleucel-T did not significantly delay the time it took for a patient’s PSA to reach a value of 3 ng/ml, the primary endpoint of the study, but it did show a prolongation in prostate-specific antigen doubling time (PSADT). An “early trend” toward slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo “did not reach statistical significance.”

Read the full story

Jan Manarite of Raise a Voice Campaign writes:

Prostate cancer patients have been watching for the prostate cancer/Provenge story on ABC World News with Charles Gibson. I just got a call from Dr Moyad that ABC called the prostate cancer patient who was interviewed for that story, and informed him that it would air Monday night, June 4th. This appears to be a commitment. Did ABC wait for our June 4th DC rally?

Dendreon announced today that the FDA will accept “either a positive interim or final analysis of survival” from its ongoing Phase III randomized clinical trial of Provenge immunotherapy for androgen independent prostate cancer.

In a press release, the company said it “has received confirmation that the U.S. Food and Drug Administration (FDA) will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to supplement the Biologics License Application (BLA) for PROVENGE (sipuleucel-T). This information was obtained in a recent follow up meeting with the FDA to discuss the additional clinical data required to support the licensure of PROVENGE requested by the FDA in the Complete Response Letter the Company received on May 8, 2007.”

Jim Kiefert, chair of the executive committee of US Too International prostate cancer support group, interviewed yesterday at the American Urological Association (AUA)’s annual meeting by CNBC’s pharmaceuticals reporter Mike Huckman, said some members of his support group wept when they heard FDA had delayed approval of Dendreon’s vaccine for advanced prostate cancer, Provenge. The interview with Kiefert is part of the video at this CNBC link. Meanwhile advocates are signing a petition and plan to demonstrate in Washington D.C. and hope to meet with the head of the FDA.

FoxNews (”Fair and Balanced”) aired Killer Bureaucracy: Why the FDA is Keeping Lifesaving Drugs from Cancer Patients May 19, 2007. Paul Gigot interviewed Dr. Scott Gottlieb. Scott Gottlieb MD, a stock analyst appointed to a top FDA job by President Bush in 2005, returned to Wall Street where he promotes Dendreon’s Provenge in his Forbes/Gottlieb Medical Technology Investor newsletter.