Where did Cong. Rosa DeLauro get her ban the Reagan Udall idea from?...And where did she get the idea that biomarkers are somehow a source of inferior science? this from Kaisernet...
" FDA seems to be moving "with unusual speed" to organize a private-public foundation to help support the agency, and some critics are saying the initiative might be "little more than a front for the industries it regulates," CQ Today reports. The group, known as the Reagan-Udall Foundation, was established in the FDA reauthorization legislation, which President Bush signed into law Sept. 27.
The 14-member board of the foundation must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." While five of the nominees will be chosen by FDA, some critics are concerned the at-large seats will be filled by industry representatives (Adams, CQ Today, 10/2). FDA began taking nominations on Wednesday (Edney, CongressDaily, 10/3).
The foundation largely will be financed through private donations, including those from food, pharmaceutical and medical device companies, according to CQ Today (CQ Today, 10/2). It is meant to help fund research to modernize the agency, according to CongressDaily.
Critics are concerned that if drug makers gain too much influence on the foundation, the resulting criteria established for evaluating products could be excessively industry-friendly. Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said, "The last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn't been proven." Diana Zuckerman, president of the National Research Center for Women & Families, said, "You have a situation where most of the money will be from (industry groups) -- they're going to control the board and therefore they're going to control the executive director, staff and the research."
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47990
Shame on Goozner and the rest for deliberately misleading Del Lauro and the media on what biomarkers do and can offer people in terms of safer drugs. I was there at Critical Path conference he blogged on when Janet Woodwock patiently explained the difference between a surrogate endpoint (cholesterol levels) and genetic markers that are predictive of disease progression or drug response. He is either dumb or manipulative. Or both. Here's what the FDA recently said in a guidance on drug-induced liver toxicity regarding biomarkers:
"As part of the Critical Path Initiative, 3 the FDA is working with industry, academia, and other experts to broaden our understanding of the biochemical and genetic bases of DILI. In June 2006, the FDA co-sponsored a scientific workshop to determine the feasibility of developing a mathematical (in-silico) model for DILI from which other predictive experimental models can be derived to characterize potential hepatotoxicity. The long-term goal is to develop a model, or models, that can help researchers identify criteria for determining when early clinical intervention (i.e., stopping the drug) is appropriate. It is also hoped that predictive bioassays and biomarkers can be identified that will help determine which patients most likely will suffer liver toxicity from specific compounds.
This urgently needed research is not a regulatory requirement, but is an important opportunity. At present, we are able only to search among patients with drug-induced injury to predict what might happen to others. Ideally, we should seek to identify individuals at increased risk before administering a drug that they cannot tolerate. The goal is to be able to identify persons who should never be exposed to a given drug because they are idiosyncratically hypersusceptible to, or unable to recover from, DILI caused by it. If tests that screen for people susceptible to severe DILI can be developed, a hepatotoxic drug could remain available to people who are not susceptible to severe DILI, instead of having to withdraw the drug from the market, allowing no one to benefit from it.
* In addition, identification of common genotypic characteristics among patients experiencing DILI in response to one or more class-related hepatotoxic agents might permit the development of in vitro or ex vivo tests or genetically altered animal strains that can be used to better predict serious hepatotoxic potential, or the lack thereof, of new drugs belonging to the same or closely related classes. "
Yeah, I guess a foundation that will develop tools designed to screen drugs for safety and effectiveness based on genetic markers and standardize that approach for evaluation is a bad thing. Even worse to have the companies themselves foot the bill.
I give DeLauro a pass for not knowing enough in this instance. (Note to the FDA: Hie thee to Rosa's office for a briefing on what's what. ) Not so Goozner and Zuckerman. Anyone can be wrong. Only idiots persist in their errors. Or miscreants.
" FDA seems to be moving "with unusual speed" to organize a private-public foundation to help support the agency, and some critics are saying the initiative might be "little more than a front for the industries it regulates," CQ Today reports. The group, known as the Reagan-Udall Foundation, was established in the FDA reauthorization legislation, which President Bush signed into law Sept. 27.
The 14-member board of the foundation must include three academics, two consumer advocates, one health care provider, four industry representatives and four "at-large" members with "experience relevant to the purpose of the foundation." While five of the nominees will be chosen by FDA, some critics are concerned the at-large seats will be filled by industry representatives (Adams, CQ Today, 10/2). FDA began taking nominations on Wednesday (Edney, CongressDaily, 10/3).
The foundation largely will be financed through private donations, including those from food, pharmaceutical and medical device companies, according to CQ Today (CQ Today, 10/2). It is meant to help fund research to modernize the agency, according to CongressDaily.
Critics are concerned that if drug makers gain too much influence on the foundation, the resulting criteria established for evaluating products could be excessively industry-friendly. Merrill Goozner, head of the Center for Science in the Public Interest's Integrity in Science Project, said, "The last thing you want is an industry-run board in which they create a science-sounding rationale before they put the FDA rubber stamp of approval on something that hasn't been proven." Diana Zuckerman, president of the National Research Center for Women & Families, said, "You have a situation where most of the money will be from (industry groups) -- they're going to control the board and therefore they're going to control the executive director, staff and the research."
http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=47990
Shame on Goozner and the rest for deliberately misleading Del Lauro and the media on what biomarkers do and can offer people in terms of safer drugs. I was there at Critical Path conference he blogged on when Janet Woodwock patiently explained the difference between a surrogate endpoint (cholesterol levels) and genetic markers that are predictive of disease progression or drug response. He is either dumb or manipulative. Or both. Here's what the FDA recently said in a guidance on drug-induced liver toxicity regarding biomarkers:
"As part of the Critical Path Initiative, 3 the FDA is working with industry, academia, and other experts to broaden our understanding of the biochemical and genetic bases of DILI. In June 2006, the FDA co-sponsored a scientific workshop to determine the feasibility of developing a mathematical (in-silico) model for DILI from which other predictive experimental models can be derived to characterize potential hepatotoxicity. The long-term goal is to develop a model, or models, that can help researchers identify criteria for determining when early clinical intervention (i.e., stopping the drug) is appropriate. It is also hoped that predictive bioassays and biomarkers can be identified that will help determine which patients most likely will suffer liver toxicity from specific compounds.
This urgently needed research is not a regulatory requirement, but is an important opportunity. At present, we are able only to search among patients with drug-induced injury to predict what might happen to others. Ideally, we should seek to identify individuals at increased risk before administering a drug that they cannot tolerate. The goal is to be able to identify persons who should never be exposed to a given drug because they are idiosyncratically hypersusceptible to, or unable to recover from, DILI caused by it. If tests that screen for people susceptible to severe DILI can be developed, a hepatotoxic drug could remain available to people who are not susceptible to severe DILI, instead of having to withdraw the drug from the market, allowing no one to benefit from it.
* In addition, identification of common genotypic characteristics among patients experiencing DILI in response to one or more class-related hepatotoxic agents might permit the development of in vitro or ex vivo tests or genetically altered animal strains that can be used to better predict serious hepatotoxic potential, or the lack thereof, of new drugs belonging to the same or closely related classes. "
Yeah, I guess a foundation that will develop tools designed to screen drugs for safety and effectiveness based on genetic markers and standardize that approach for evaluation is a bad thing. Even worse to have the companies themselves foot the bill.
I give DeLauro a pass for not knowing enough in this instance. (Note to the FDA: Hie thee to Rosa's office for a briefing on what's what. ) Not so Goozner and Zuckerman. Anyone can be wrong. Only idiots persist in their errors. Or miscreants.
