Here comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety
Science by Barbara Loe Fisher | July 22, 2015
A 2015 Pharma-driven bill blessed by the FDA seriously compromises the integrity of the vaccine licensing process and is sailing through the U.S. Congress. Act to protect vaccine safety and join http://www.NVICadvocacy.org and learn more at http://www.NVIC.org.
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21st Century Cures Act Gets a Revision
By Randi Hernandez | PharmTech | July 7, 2015
The 21st Century Cures Act will see some revisions before the House votes on the bill later this week. On July 2, 2015, the House Committee on Energy and Commerce released a summary of major changes to the bill that reduce the funding to the National Institutes of Health (NIH) and Cures Innovation Fund to approximately $8.75 billion over the next five years instead of the $10 billion that was originally proposed. The funding amount was amended “to clarify the availability of a $9.3 billion advanced appropriation for FY2016–FY2020. $110 million is made available for FDA regulatory modernization activities annually from FY2016–FY2020.”
Other changes to the proposed bill include not requiring companies that receive NIH funding to report their data, and additional changes to how drugs are reimbursed, specifically, payment amounts for branded drugs and infused specialty drugs. … continue
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Is The 21st Century Cures Act Good Or Bad For The Biopharmaceutical Industry?
Forbes | June 8, 2015
… “An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients. More than two-thirds of new drugs are approved on the basis of studies lasting 6 months or less – a potential problem for medications designed to be for a lifetime. Once the FDA starts its review, it approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all drug applications within 6 to 10 months, an impressive turnaround for such complex assessments.” … Full article
Obama Administration Gives Priority to Bioweapons Research
By Sherwood Ross | BLACKLISTED NEWS | 05-01-2010
The priorities of the National Institutes of Health (NIH) in the area of bacteriology have been “catastrophically re-ordered” by emphasizing bioweapons research over non-bioweapons research, a prominent authority states.
Giving priority to bioweapons research at NIH, started under the Bush Administration and continuing under President Obama, “diverts resources from critical public-health and scientific objectives,” says Richard Ebright, Professor of Chemistry and Chemical Biology at Rutgers University, New Brunswick, N.J.
“The negative impact has been most severe in bacteriology, in which NIH research priorities have been catastrophically re-ordered—with research on bacterial bioweapons receiving more support than research on the top five bacterial causes of death combined—and in which non-bioweapons research has suffered catastrophic losses in resources and personnel,” Ebright said.
Ebright cited the examples of research into two bacterial pathogens: “Streptococcus pneumoniae and Staphylococcus aureus, which claim 40,000 and 20,000 U.S. lives each year, respectively. Each kills more Americans than HIV-AIDS (15,000 U.S. lives) “but neither of these bacterial pathogens is on the list of NIAID Priority Pathogens,” Ebright pointed out. (NIAID, the National Institute of Allergy and Infectious Diseases, is the subdivision of NIH responsible for infectious-disease research.)
“These two killer bacterial pathogens are not in NIAID’s ‘Category A’, with the anthrax bacterium and the smallpox virus, or even in NIAID’s ‘Category B’ or ‘Category C,’” Ebright says. “Something is wrong—very wrong—when NIAID fails to prioritize the top infectious cause of U.S. death,” he said in an email to this reporter.
Other top bacterial causes of U.S. deaths include Enterococcus faecium/faecalis, Clostridium difficile, Pseudomonas aeruginosa, and Mycobacterium tuberculosis. “Of these, only the last is on the NIAID Priority Pathogens list and this pathogen is only in Category C,” Ebright said.
Asked “What is the mood of the scientific life sciences community at this time toward the Administration?” Ebright responded, “Hopeful expectation” but “growing concern that, thus far, there has been more continuity [from the Bush Administration] than change.”
The scope of the government’s involvement in bioweapons research, may be gauged from its estimated expenditure of $70 billion since 9/11 and the fact that, according to Ebright, more than 400 U.S. institutions are engaged in such work.
Francis Boyle, professor of international law at the University of Illinois, Champaign, said that in constant dollars the $70 billion “is twice what they spent on the Manhattan Project to develop the A-bomb—ergo, this is a weapons program.”
Boyle, who drafted the Biological Weapons Anti-Terrorism Act of 1989 for the U.S., said President Bush “turned the NIH into a front organization for biowarfare work,” and “(President) Obama is simply continuing the Bush policies” and is “now even exporting biowarfare capabilities to Third World Countries.”
Asked about the scope of the nation’s biowarfare activities, Boyle estimated there are “about 13,000 death scientists involved…(so) Dr. (Josef) Mengele has arrived on American campuses all over and the universities’ Institutional Review Boards (to review biowarfare research programs) are a joke and a fraud, too.” (Mengele was a German SS officer and physician who, during WWII, performed diabolical experiments on prisoners at the Auschwitz-Birkenau concentration camp in Poland.)
Boyle said, “There is so much money involved that universities simply are not going to turn down these proposals no matter how reprehensible they might read…”
At his own University of Illinois, Boyle said, previous biowarfare research and development contracts with the Pentagon clearly stated: “We have selected pigs (to gas with biowarfare agents) because they have a circulatory system and a respiratory system similar to human beings.”
Boyle said, “I am sure similar type biowarfare contracts that are clearly anti-human, anti-ethical, illegal and criminal on their face alone have been approved all over (at) American universities by now. Money talks. Ethics walks.”
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Sherwood Ross formerly worked for the Chicago Daily News and contributed regular columns to Reuters and UPI. His articles on biowarfare have been published in The Humanist and other magazines. Reach him at sherwoodross10@gmail.com

