Navigation Links
Steven Zecola Files a Citizen's Petition with the FDA for a New Approach to Address Metastatic Cancer
Date:6/24/2013

Washington, DC (PRWEB) June 24, 2013

Cancer causes over 550,000 deaths in the United States each year 1_/, and 90% of those deaths derive from metastatic cancer. 2_/ Yet, only 8% of the federal funding for cancer goes toward metastatic cancer. 3_/

Additionally, under the FDA’s procedures for clinical trials, a new drug takes 12 years on average to make it through the FDA process 4_/ at an average cost of over $1 billion. 5_/

The burden imposed by the FDA’s rules is even greater for the compounds designed to treat metastatic cancer. First, the FDA’s rules require the compounds to reduce the primary tumor, but that is not the purpose of these compounds and they often do not pass this test. 6_/ Second, the objective of the compounds is to delay the recurrence of cancer, which by definition implies an even further elongated trial approval process and even more costs.

Nor does the FDA recognize the poor prognosis of metastatic cancer patients to establish distinct procedures for clinical trials with these participants. 7_/ Yet many of these patients have been told to get their affairs in order and many would be willing to take greater risks than others to participate in research. But the FDA applies its standard safety guidelines to the trials with these patients which cover six categories of safety including adverse events unrelated to the drug. 8_/

The Petition requests the FDA to adopt procedures specific to the circumstances surrounding metastatic cancer. For example, the trial design to ensure a compound’s efficacy would be limited to two phases. _9/

With the requested changes in place, the journey to finding a cure for metastatic cancer can begin in earnest.

The Petition can be read at: http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0695-0001

The FDA is now accepting online comments from the public on these matters at the above location.

1_/ See, e.g., the National Cancer Institute website at: http://seer.cancer.gov/statfacts/html/all.html.
2_/ See, e.g., “Molecular networks that regulate cancer metastasis”, Spano D, Heck C, De Antonellis P, Christofori G, Zollo M., Semin at Cancer Biol. (2012).
3_/ The National Cancer Institute reports an annual budget for cancer research of about $5 billion. See: http://www.cancer.gov/cancertopics/factsheet/NCI/research-funding/print. The category labeled “metastasis” receives about $400M per year, or about 8% of the total. See: http://fundedresearch.cancer.gov/nciportfolio/.
4_/ See, for example, California Biomedical Research Association, “Fact Sheet: New Drug Development Process”, http://ca-biomed.org/pdf/media-kit/fact-sheets/cbradrugdevelop.pdf (June 2008).
5_/ See, for example, Manhattan Institute for Policy Research, “Stifling New Cures: The True Cost of Lengthy Clinical Drug Trials”, Avik S. A. Roy, Senior Fellow (April 2012).
6_/ See, for example, Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).
7_/ See, FDA: “Guidance for Industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics”, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071590.pdf (May 2007).
8_/ See, FDA: “Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies” fda.gov/downloads/Drugs/.../Guidances/UCM227351.pdf
(December 2012).
9_/ For a discussion of the proper trial design, see Dr. Patricia S. Steeg, “Perspective: The Right Trials”, Nature 485, S58-59 (May 2012).

Read the full story at http://www.prweb.com/releases/2013/6/prweb10861402.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Director of Proteomics at the Broad Institute of MIT and Harvard, Steven Carr, to Deliver Pittcon 2014 Wallace H. Coulter Plenary Lecture
2. Representatives Betty McCollum (MN) and Steven LaTourette (OH) to Receive USGS Coalition Leadership Award
3. Ceres Expands Board of Directors with former BP Chief Scientist and Undersecretary of Energy Steven Koonin
4. Stevenage Bioscience Catalyst to Welcome Cambridge University Researchers
5. Stevenage Bioscience Catalyst Opens With Exciting Year Ahead
6. Cellular Dynamics International Files Registration Statement for Proposed Initial Public Offering
7. Dr. Rongxiang Xu, Patent Owner of Damaged Organ Regeneration, a Top Priority Addressed in the 2013 Presidential State of The Union, Files Lawsuit Against Dr. Yamanaka for Deception
8. Dr. Rongxiang Xu, Patent Owner of Damaged Organ Regeneration, a Top Priority Addressed in the 2013 Presidential State of The Union, Files Lawsuit Against 2012 Nobel Laureate Dr. Yamanaka for Deception
9. 3SBio Inc. Files Annual Report on Form 20-F for Fiscal Year 2012
10. Early Stage Drug Delivery Technologies: 62 Profiles of Start-ups and Emerging Companies
11. Regado Biosciences, Inc. Files Registration Statement for Proposed Initial Public Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... (PRWEB) , ... February 10, ... ... REGN) today announced that it has joined the Human Vaccines Project, a ... infectious diseases and cancer. , The Human Vaccines Project brings together ...
(Date:2/10/2016)... ... February 10, 2016 , ... Benchmark Research, a fully-integrated network ... two long-standing principal investigators (PI) to the roles of Chief Medical Officer, Clinical ... Dr. Laurence Chu, a Benchmark Research PI in the Austin office, will assume ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... registry built on the secure online PatientCrossroads platform, has exceeded both its one-year ... have joined the PROMPT study, which seeks to advance understanding of the hereditary ...
(Date:2/10/2016)... ... 09, 2016 , ... Creation Technologies, leading global provider of ... Customer Rating Award from Circuits Assembly , today announced its milestone achievement of ... Mexico and China. , The EMS provider, known in the EMS industry for ...
Breaking Biology Technology:
(Date:2/3/2016)... PUNE, India , February 3, 2016 ... to the new market research report "Automated Fingerprint Identification ... (Tenprint Search, Latent Search), Application (Banking & Finance, Government, ... 2020", published by MarketsandMarkets, the market is expected to ... estimated CAGR of 21.0% between 2015 and 2020. The ...
(Date:2/2/2016)... 2016 This BCC Research report provides ... reviewing the recent advances in high throughput ‘omic ... field forward. Includes forecast through 2019. ... and opportunities that exist in the bioinformatic market. ... as well as IT and bioinformatics service providers. ...
(Date:2/2/2016)... 2, 2016  Based on its recent analysis ... recognizes US-based Intelligent Retinal Imaging Systems (IRIS) with ... for New Product Innovation. IRIS, a prominent cloud-based ... America , is poised to set the ... retinopathy market. The IRIS technology presents superior price-performance ...
Breaking Biology News(10 mins):