Opportunities for Early Access to New Treatments

June 27, 2012

Rapid advances in the development of treatments for advanced prostate cancer are creating some unique opportunities for access to these treatments at no cost to patients under “Early/Expanded Access Programs.”

PHEN President, Thomas A. Farrington

These opportunities become available when phase 3 clinical trial results are proven effective and the trials are halted. However, there is still a Food and Drug Administration (FDA) process that companies must complete before these proven treatments can be “marketed” to the public. This process takes many months before it is completed.

I serve as a member of a committee called “The Early/Expanded Access Program for Prostate Cancer Patients.” This committee advocates for early access to those treatments that have completed the phase 3 clinical trial and awaits final FDA approval. This is information about the committee and its purpose.

We are pleased and excited that Astellas/Medivation has made MDV3100 (Enzalutamide), and Bayer has made Radium-223 Chloride (Alpharadin) available under the early access program. Both these treatments are for “advanced prostate cancer patients.” Information about each is included in the June Treatments and Clinical Trials e-newsletter.

These early access program opportunities are especially appealing to those patients that have urgent needs, and also for patients who may have difficulties in affording these treatments once they receive final FDA approval. I urge advanced prostate cancer patients to review the information on each of the treatments to determine if there could be a personal benefit.

PHEN Establishes Patient Advocacy at BIO International Convention 2012

June 26, 2012

PHEN emerged among fierce competition for life science advocacy by being part of the BIO International Convention, held from June 18 – 21 at the Boston Convention and Exhibition Center in Boston, MA. The convention is a global event that brings together different organizations to partner, explore, promote and discuss with more than 1,000 companies and institutions of the Biotechnology Industry Organization (BIO). BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.

PHEN took part in the exhibition center, with its mission, resources, and more on display for the thousands of attendees at the convention. While big pharmaceutical companies are the end-players in drug development, patient’s needs are the drivers for drug research, and PHEN established itself as a leader as it advocated and educated specifically for prostate cancer victims across the nation about personal diagnostics, treatments, and clinical trial opportunities.

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Faith and the Father’s Day Rally Against Prostate Cancer

May 7, 2012

I was diagnosed with prostate cancer in the year 2000 and still I remember vividly that day and my doctor’s words: “you have prostate cancer.” The shock and fear of facing a disease that had taken the lives of my father and both grandfathers was a heavy psychological burden to bear. Working with many other men who have faced prostate cancer, this burden seems universal and managing the emotional stress becomes an urgent need for men and their families.

PHEN President, Thomas A. Farrington

Summoning the inner strength to lift this pressing psychological burden and make decisions about treatment was a major challenge for me, as it is for most men. I turned to my Christian faith through prayer to find the strength to face prostate cancer, and throughout my twelve years as a survivor my faith has been the bedrock in meeting my survivorship challenges.

PHEN’s Father’s Day Rally Against Prostate Cancer in partnership with institutions of faith connects men and families who are facing prostate cancer, managing survivorship issues, or have lost a loved one to this disease. Through the power of prayer and spiritual fellowship their isolation is removed and replaced with open and supportive relationships. The Rally is based on the importance of faith in healing, and this Father’s Day ceremony is proving highly effective in helping to remove many heavy burdens.

The commitment and support of the hundreds of churches that have joined the Father’s Day Rally since its launching in 2009 has transformed the Rally into a dynamic national movement that is part of the healing process for many thousands across our country. I sincerely thank the leadership of these churches and I salute those survivors who are working within their churches to help facilitate the Father’s Day Rally. These survivors are true faith disciples for their courage to stand up and speak about their personal experiences to outreach and help others. There are many pastors of our partnering churches who are themselves survivors and while these faith leaders are very impactful within their own churches, some are assuming the added responsibility of recruiting other churches to our efforts.

While I am excited with our progress, there is much left for us to accomplish through our joining hands in prayer and action. Prostate cancer is a devastating disease, especially among Black men. The need for healing is tremendous and I know that faith has a great role in reducing suffering and saving lives. The Father’s Day Rally Against Prostate Cancer puts this into action.

A New Era in Prostate Cancer Treatment

April 2, 2012

Treatment for prostate cancer ends for those men who are blessed to be cured of the disease through their primary treatment which is usually some form of surgery, radiation or combination of both. However, those men who have a recurrence of the disease after their primary treatment are faced with added dimensions in their battle with the disease. Hormone therapy is usually the first course of treatment following the primary treatment but this course of treatment is not curative. Once hormone treatment is no longer effective for men they are then faced with what is termed “advanced prostate cancer.”

For years the primary, and often only treatment for advanced prostate cancer was chemotherapy until the Food and Drug Administration approved Provenge in April 2010. Provenge ushered in a new and novel treatment that seemed to have opened the gates for a rapid development of treatments for advanced prostate cancer.

Provenge is a pioneering immunotherapy treatment that has set the stage for what is hoped will be a series of new treatments leading to making prostate cancer a chronic disease where fewer and fewer men will die from it.

PHEN is focusing on immunotherapy treatments for prostate cancer during April on this 2nd anniversary of the approval of Provenge. Please tune into our webcast on April 11th at www.rapcancer.org .

Farrington Radio Interview with Dr. Luke Nordquist

February 20, 2012

Thomas A. Farrington, PHEN President and Founder, discusses the Impact of Prostate Cancer and PHEN’s efforts to increase knowledge about the disease, with Dr. Luke Nordquist, Urology Cancer Center, Omaha, NE, on the Radio Show “Cancer Opinions with Dr. Luke.”

               Prostate Cancer and the Impact on African American Men with Thomas A. Farrington

Dr. Luke Nordquist and Thomas A. Farrington - Click to Listen to Interview

An Update on the PSA Screening Issue

February 1, 2012

According to feedback from the U. S. Preventive Services Task Force (USPSTF) it is scheduled to make a final recommendation on the PSA test screening issue during the first six months of 2012. The USPSTF’s draft recommendation for a grade “D” level which it issued on October 7, 2011, if left standing, will dramatically change the fight against prostate cancer. The emphasis on early detection of the disease will be changed to an emphasis on not over-treating men. With an emphasis on early detection using the PSA test the overall prostate cancer mortality rate has declined by 40%. Is there scientific evidence to support a reversal in direction?

PHEN President, Thomas A. Farrington

For scientific evidence the USPSTF is relying heavily on the PLCO (Prostate, Lung, Colorectal and Ovarian) study which is the only randomized controlled trial in the United States for PSA screening. This study brings into question the benefits of PSA Screening, however, it is recognized by medical experts to be a severely flawed trial. Responding to recent revelations about the trial, members of the Prostate Cancer Roundtable sent a letter to Dr. Francis S. Collins, Director of the National Institutes of Health on January 24, 2012. The letter requests that NIH conduct a Quality review of the PSA screening data from the PLCO trial and to embargo its use until this review is completed; letter to Dr. Collins.

Another important issue related to the PLCO trial is the lack of a statistically significant number of high risk men included in the trial (African Americans and men with a family history). In a letter dated January 23rd, 2012, from Dr. Carolyn Clancy, Director of the Agency for Healthcare Research and Quality, this issue was addressed with this statement; “I recognize your concern that the Task Force may lack sufficient scientific evidence on the effects of PSA testing on African American men and other high risk groups … I have urged the Task Force, as it finalizes its recommendation, to explain the evidence underpinning the applicability of their recommendations to men at higher risk of prostate cancer, such as African American men.” Dr. Clancy’s letter is in response to a letter from members of the Prostate Cancer Roundtable.

Members of the U. S. Congressional Black Caucus, Representatives Donna Christensen (VI), Elijah Cummings (MD), Gregory Meeks (NY), Ed Towns (NY) sent letters to HHS Secretary Sebelius requesting that “the USPSTF, prior to the issuance of the final recommendation, provide the evidence and assumptions used to include men regardless of race and family history within its recommendation.” The request was that this evidence be made available in a public forum for comment.

It is critical that the final USPSTF recommendation be THE RIGHT DECISION for all men, and the level of scientific evidence used to make a decision regarding high risk men should be no less stringent than that used for other men; a randomized controlled trial. As we approach the time where the USPSTF makes its final recommendation on PSA screening, the prostate cancer community will continue to weigh in and keep the public updated on this high priority public health issue.

Information, Knowledge, and a Cure for Prostate Cancer in 2012

January 8, 2012

The pursuit of a “cure for cancer” is the objective of research efforts in many of the leading cancer research centers throughout the world today. However, how will we know when a cure for cancer has been found? Will cancer as a disease disappear completely because a “magic bullet” has been identified to eliminate all types of cancers? Will new treatments eliminate

deaths from certain types of cancers and be defined as cures? The answers to these and similar questions are important in shaping the public’s understanding about cures for cancer. However, based on what I understand about ongoing research efforts there will probably be multiple forms of cancer cures that will differ based on the type of cancer, the patient and the definition(s) of cure. 

What is the definition for a cure for prostate cancer, and do we have a cure entering 2012? 

There is no magic bullet cure today that I am aware of which will prevent a man from getting prostate cancer. There are promising research and study efforts underway to reduce a man’s risk for the disease which at some time in the future may approach a magic bullet cure for some. Also, there is an accelerating pace of new classes of prostate cancer treatments under development aimed at increasing survival and the quality of life for those men living with the disease; some have already been approved by the Federal Drug Administration,

If an accepted definition for a prostate cancer cure is survival after a diagnosis with minimal to no impact on a man’s quality of life then there are cures for the disease as we enter 2012. These cures may at times involve multiple combinations of treatments and therapies and differ from man to man. I consider my personal eleven year prostate cancer survival to be within this definition of cure. Conversely, I believe that the vast majority of prostate cancer deaths and sufferings today are due to a lack of information and knowledge about accessing the cures available in a timely manner. Information and knowledge about one’s risk level, early detection, treatment options, and managing survivorship issues are critically important to a cure for prostate cancer in 2012. For a man not to have this knowledge is to play Russian roulette with his prostate.

The journey for reaching a prostate cancer cure where there is no magic bullet available can be complex, but certainly navigable. As we enter 2012 PHEN continues to broaden its educational outreach to assist men and their families along this journey. We will augment our monthly live webcasts which began in January, 2011 with a monthly e-newsletter highlighting information about available treatments and clinical trials. Many of our sponsors and partners are at the forefront in providing new and innovative treatments, therapies and detection tools that will be part of the focus of our educational outreach efforts. 

Knowledge is the best defense against prostate cancer in 2012. PHEN and its partners are committed to reducing prostate cancer deaths and suffering by increasing the overall knowledge base about the disease and the approaches to cures and survivorship. Our information is aimed at men and their families as we emphasize the importance of wives, mothers, sisters and daughters becoming actively involved in the prostate health of the men in their lives. Prostate cancer is a disease that impacts the entire family and in many (perhaps most) cases family members are needed to support a man’s efforts to become knowledgeable and interface with his doctors. PHEN invites you to use our online resources available to you at your convenience, tune in to our monthly webcasts, and study the information presented in our e-newsletters to increase your knowledge. Join our efforts to help cure prostate cancer cases in 2012 with the health of your family as a primary goal.

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