Prostate Cancer Advocates Support The Access Act

To:  U.S. Congress and Senate

Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (S.3046 H.R.6270).

Congress now has an opportunity to help save and extend the lives of cancer patients and others with serious life-threatening illnesses, thanks to the recently introduced Access, Compassion, Care, and Ethics for Seriously Ill Patients Act.

The Access Act creates a new approval mechanism called Compassionate Investigational Access (CIA) for patients who cannot wait. Patients receiving a CIA drug must suffer from a serious or life-threatening disease, be out of approved options and unable to gain access to a clinical trial. Patients must also provide informed consent, and allow the collection of clinical data from their experience with the drug, so we will all know more about the safety and efficacy of new therapies before they are approved for wider use.

House initiating sponsor Representative Dianne Watson (D-CA): "The activism of the AIDS community in the 1990s expedited the marketing to the general public of promising antiretroviral drugs. Sadly, the expedited approval of promising new drugs for cancer patients and patients with other life-threatening diseases does not receive the same attention or expedited approval."

A clear example and one of the poster children of “decelerated” approval at the FDA is Provenge, an immunotherapy for dying men with prostate cancer. Over 30,000 men have died since the FDA decision last May to delay Provenge, citing the need for more data. Provenge has shown activity and efficacy in every one of the six trials where it has been studied including three phase three trials. The FDA looked at the phase three trial that showed the median (midpoint) survival benefit was 4.5 months but the mean (average) survival benefit was much better: 34 percent of all men receiving Provenge were alive after three years compared to 11 percent of those who did not. In the last 45 years, chemotherapy is the only medicine approved to treat terminal prostate cancer.

I urge Congress to support and pass the ACCESS Act (S.3046 H.R.6270).

Sincerely,

The Undersigned

The Prostate Cancer Advocates Support The Access Act Petition to U.S. Congress and Senate was created by and written by Melody Davis (dnursemelody@charter.net).  This petition is hosted here at www.PetitionOnline.com as a public service. There is no endorsement of this petition, express or implied, by Artifice, Inc. or our sponsors. For technical support please use our simple Petition Help form.