he U.S. Food and Drug Administration (FDA) today announced that it has approved a new manufacturing facility used to produce influenza virus vaccines. The facility is approved for seasonal influenza vaccine production and could be used for the production of vaccine against the new 2009 H1N1 influenza strain. As part of its overall pandemic influenza preparedness efforts, the FDA meets with vaccine manufacturers to guide the efficient establishment of influenza vaccine facilities that comply with agency requirements. The agency promptly reviews applications and manufacturing supplements that could increase both the number of manufacturers and the overall supply of vaccine.
JayaJan Pharmaceutical Research in India was one of the companies with which Merck had a contract to test Gardasil. Like most of the industry, Merck increasingly outsources its clinical trials to Contract Research Organizations (CROs) in areas of the world where trial subjects are plentiful, operating costs are low, and regulations lax. These CROs are a booming $15 billion industry whose revenues are rising at 15 percent a year. Critics point out that CROs can come with built-in problems. Conflicts of interest can arise when CROs are paid royalties only after a drug is approved rather than being paid a set fee that is independent of how safe or effective the drug turns out to be.
At least three US federal laws should concern all Americans and suggest what may be coming – mandatory vaccinations for hyped, non-existant threats, like H1N1 (Swine Flu). Vaccines and drugs like Tamiflu endanger human health but are hugely profitable to drug company manufacturers.
Between now and October FDA needs to deliver a draft plan on how to spend a $364-million IT budget to modernizing its IT systems. The GAO expects, “A comprehensive IT strategic plan, including results-oriented goals and performance measures, is vital for guiding and coordinating the agency’s numerous ongoing modernization projects and activities.”
From drug safety snafus dating as far back as Vioxx to last year’s heparin scandal, from melamine in dog food to salmonella in peanut butter, the FDA has spent beaucoups hours fighting fires. Meanwhile, dispassionate observers such as the Government Accountability Office have advised big-time changes for the agency, and its own Science Board said it was so seriously understaffed and underfunded that it couldn’t ensure the safety of food or drugs in the U.S.
the Obama administration wants to hike the FDA’s budget by 19 percent to $3.2 billion for fiscal 2010. That’s a whopping increase: In dollar terms, it amounts to about half a billion, Reuters reports. A good billion or so of the total comes from industry via user fees.
For the past seven months, the popular talk show has focused on the dangers of Gardasil, Childhood Immunizations and the Anthrax vaccine that has been linked to the Gulf War syndrome. The hosts have interviewed parents, and medical experts as they strive to share information about the dangerous and toxic adjuvants that are used in the vaccine serums as preservatives and additives. After months of research and combing FDA, CDC and myriads of pharmaceutical documents, Janak and Botha discussed the link between vaccines with toxic compounds, and neurological damage.
Perhaps the most impressive site to date is Gardasil’s “Take a step against cervical cancer” profile on Facebook—with more than 100,000 fans. (For comparison, American Idol’s Facebook page has about 430,000 fans.) But the big difference between the two is that “Take a step” is a one-way communicator: no comments allowed.
The following is a transcript from the Public Television series, FRONTLINE. The program, Politics, Profits and Pharma was aired on November 13, 2003. I’ve kept in my files for years as a source reference document. This past week, while working on a paper with my writing partner, Leslie C. Botha, and I opened my FRONTLINE [...]
What Exactly Is Cervical Cancer? Cancer begins in cells, the building blocks of tissue which make up the organs. Normally, cells grow and divide to form new cells as the body needs them. When cells grow old, they die and are replaced with new cells. The problem comes in when abnormal cells “appear” and start [...]
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