Wellbeing
The Prostate Cancer Foundation (PCF) supports the Food and Drug Administration (FDA) Transparency Initiative launched by Commissioner Dr. Margaret Hamburg to develop recommendations for making useful and understandable information about FDA activities and decision-making more readily available to the public, in a timely manner and in a user-friendly format.
FDA’s valuable efforts to prioritize enhanced transparency in its activities and decision-making will spur clinical and biomedical innovation and improve public health. PCF also supports the task force’s recommendations to disclose more information about the drug development process including when an application for a new drug or device has been submitted or withdrawn by the sponsor, whether there was a significant safety concern that caused a sponsor to withdraw an application, and why the agency did not approve an application.
The Initiative’s efforts offer deeper conversation between oncologists, physicians, patients and the biomedical field. As more cancer patients develop into advocates for their own lives and treatment plans, they seek online data, research and clinical trial information.
“For these patients, it’s not a question of creating hope; it’s a question of having more information accessible to make the best decisions,” said Dr. Jonathan Simons, President and CEO of PCF. “In addition, transparency in FDA regulations would trigger innovative thinking, dialect, a stronger knowledge exchange between parties, and a fair brokerage of new facts.”
With innovative thinking comes trial and error. When version 1.0 antibiotics for drug resistant TB were discovered in laboratories, patient blood levels were not high enough to penetrate lung tissue and most patients died. This class of antibiotic required a version 2.0 and 3.0 until it proved successful. If researchers, patients and investors weren’t interested in supplementary versions of clinical trials and never tested a faulty drug again, hundreds of thousands of cancer patients wouldn’t be alive. For example, penicillin at first looked like a marginal drug – as many initial patients were not cured and died. PCF encourages clinical trial designs to ask the question, “What went wrong with the experiment, not what was the problem with the drug.”
The initiative to increase transparency at the FDA coincides with a moment when the multiple and different forms of prostate cancer are becoming "transparent" to physician-scientists, patients, and their families. For the first time in PCF’s 17 year-history as a biomedical funding foundation, we have a game-changing understanding of the molecular fundamentals of prostate cancer biology. A PCF and NCI funded University of Michigan team—led by Drs. Arul Chinnaiyan and Kenneth Pienta—developed new chromosome fusion biotechnology to identify gene fusions that correspond to all 24 clinical and molecular subtypes of human prostate cancer.
These partnerships matter more and more for the field of medical and cancer research. The FDA is an essential partner, along with biotech and pharmaceutical industries, NIH, etc., in providing patients a better chance to be informed of earlier science. Not all medicines will make it to the market, but PCF-funded researchers and investors will continue working toward cures, while remaining innovative and transparent by following the standards of the FDA Transparency Initiative.
FDA’s valuable efforts to prioritize enhanced transparency in its activities and decision-making will spur clinical and biomedical innovation and improve public health. PCF also supports the task force’s recommendations to disclose more information about the drug development process including when an application for a new drug or device has been submitted or withdrawn by the sponsor, whether there was a significant safety concern that caused a sponsor to withdraw an application, and why the agency did not approve an application.
The Initiative’s efforts offer deeper conversation between oncologists, physicians, patients and the biomedical field. As more cancer patients develop into advocates for their own lives and treatment plans, they seek online data, research and clinical trial information.
“For these patients, it’s not a question of creating hope; it’s a question of having more information accessible to make the best decisions,” said Dr. Jonathan Simons, President and CEO of PCF. “In addition, transparency in FDA regulations would trigger innovative thinking, dialect, a stronger knowledge exchange between parties, and a fair brokerage of new facts.”
With innovative thinking comes trial and error. When version 1.0 antibiotics for drug resistant TB were discovered in laboratories, patient blood levels were not high enough to penetrate lung tissue and most patients died. This class of antibiotic required a version 2.0 and 3.0 until it proved successful. If researchers, patients and investors weren’t interested in supplementary versions of clinical trials and never tested a faulty drug again, hundreds of thousands of cancer patients wouldn’t be alive. For example, penicillin at first looked like a marginal drug – as many initial patients were not cured and died. PCF encourages clinical trial designs to ask the question, “What went wrong with the experiment, not what was the problem with the drug.”
The initiative to increase transparency at the FDA coincides with a moment when the multiple and different forms of prostate cancer are becoming "transparent" to physician-scientists, patients, and their families. For the first time in PCF’s 17 year-history as a biomedical funding foundation, we have a game-changing understanding of the molecular fundamentals of prostate cancer biology. A PCF and NCI funded University of Michigan team—led by Drs. Arul Chinnaiyan and Kenneth Pienta—developed new chromosome fusion biotechnology to identify gene fusions that correspond to all 24 clinical and molecular subtypes of human prostate cancer.
These partnerships matter more and more for the field of medical and cancer research. The FDA is an essential partner, along with biotech and pharmaceutical industries, NIH, etc., in providing patients a better chance to be informed of earlier science. Not all medicines will make it to the market, but PCF-funded researchers and investors will continue working toward cures, while remaining innovative and transparent by following the standards of the FDA Transparency Initiative.