I want to add another perspective as to why the ACCESS ACT would be a great start in reforming the FDA, bringing about much needed transparency and accountability, and most importantly putting lifesaving treatments in the hands of patients who need them, NOW.

Our fight encompasses FDA reform, transparency, and accountability, especially as it relates to Provenge. Provenge and prostate cancer are important to me because my grandfather died of prostate cancer. I have organized three rallies, one in Chicago, one in Rockville, MD at the FDA headquarters, and most recently one in Madison, WI which was part of nationwide protests in ten U.S. cities to express our dissatisfaction with the FDA's decision to delay Provenge. Growing up in rural Alabama, I was quiet and shy. Never in my wildest dream would I have imagined myself an activist; but here I am on a path I firmly believe was chosen for me by God.

When beginning this fight, I wondered where was the huge outcry. Where were all the prostate cancer survivors and their families? Then after reaching out to the prostate cancer community, I realized that most survivors are too weak to fight. Those that can have never done anything like this before, so they do not know how to fight this injustice. Who knew there would come a day when one would have to fight to live. Lack of outrage can also be attributed to lack of awareness. Some prostate cancer survivors who attended the rally at the FDA headquarters had no idea Provenge was not approved. I have to admit I had never considered the FDA drug approval process before. I have had some limited experience with clinical trials. However, when the clinical trials are over, the next time the public hears about the drug is when it hits the market and/or news regarding serious or deadly side effects related to the drug. My, like most people's, interest in Provenge was piqued because my family has been affected directly. My grandfather may have been able to enroll in a Provenge clinical trial, only if I had known. He refused chemotherapy, radiation, and surgery. He said he had lived a good life and was resigned to the fact that this was his fate.

Prostate cancer affects African American men more than any other ethnic group. According to the CDC, one in five will be diagnosed with prostate cancer and one in 20 will die from the disease. Aside from this statistic, African American men tend to have less doctor visits. I can't even get the men in my family to go to the doctor. When they do, it is usually too late. The irreversible damage has already been done. In addition, there is still a lack of access to quality health care in the African American community. Many African American still have a distrust of the medical community. They are most likely not going to be included in clinical trials and even less likely to seek out clinical trials. So, for all practical purposes, new innovative treatments are unavailable to this population, until they are on the market.

One of my best friends may have benefited from enrolling in a Neuvenge clinical trial; she died of breast cancer at age 37 leaving an 18-month-old daughter behind. In the end, she was grasping for any possible lifeline she could, even wanting to travel to Mexico for treatment, but she was too weak. Now in hindsight, I should have been more aggressive in finding clinical trials early on. The type of breast cancer she had was very aggressive. African American women tend to have the more aggressive type of breast cancer and are diagnosed later than their counterparts are.

On March 29, 2007, an FDA advisory panel of immunology experts and other invitees had reviewed Provenge, and decided overwhelmingly that it was both safe and effective. Unfortunately, the Provenge data was apparently not extensive enough to satisfy the strict "science driven" statistics of the FDA. Why the strict statistics approach with potentially lifesaving medicines for dying patients, who have run out of options? One of the FDA's smokescreen is they are a science driven agency. Well, the FDA's own panel of experts voted 17-0 that Provenge was safe and 13-4 that Provenge worked. How much science do they need for dying patients?

Another FDA smokescreen is the compassionate use program. As a registered nurse and patient advocate, I have cared for and lost far too many patients to prostate cancer, breast cancer, and other types of cancer. One of my patients is a 48 year old who has run out of options and is now seeking Provenge through the compassionate use program. If advanced prostate cancer does not kill him, jumping through all the bureaucratic compassionate use program hoops surely will. Another friend I met thru this fight was waiting for access to Provenge. Sadly, he passed away on May 30, 2008 without ever given the opportunity to choose Provenge. The compassionate use program is a cruel joke on dying patients.

Americans have seen far too many deaths because of cancer. We live in the greatest country in the world. We have made great advances in science, medicine, and technology. Yet, in the last 45 years, the only advancement in the treatment for late stage prostate cancer is Taxotere. A chemotherapy that half of all men with prostate cancer refuse because it is so marginally effective and wrought with devastating (sometimes lethal) side effects. No one should have to endure the type of pain and suffering related to cancer and the side effects of current treatment options. We live in the land of the free. Yet, the FDA runs its organization like a dictatorship, which lacks transparency and accountability. The time is long overdue for some FDA accountability.

I am by no means saying that Provenge is the miracle cure for prostate cancer; but unless dying prostate cancer patients are given the opportunity to try it, they and families like mine will never know.

Detailed Summary

Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.

Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act.

Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.

Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.

Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.

Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.

Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.

Status of the Legislation

Latest Major Action: 6/17/2008: Referred to House subcommittee. Status: Referred to the Subcommittee on Health.

Points in Favor

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Points Against

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