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Just one example of delays in approval for a drug for treatment of prostate cancer. Provenge demonstrated substantial benefits for treating less aggressive forms of prostate cancer back in 2002 but the FDA refused to recognize these findings and approve the drug. A second study in 2005 showed even more effectiveness than the first but again the FDA refused to approve. It took until this year for the FDA to finally approve Provenge. The Life Extension Foundation has documented this process and estimate the life years that might have been saved if the FDA had approved the drug in 2002. This amounts to 82,000 human life-years.
There is an even more serious result of those delays. The cost of the additional studies adds significantly to the cost of the drug. In the case of Provenge, the therapy will cost $93,000 per patient without adding any significant knowledge about he drug’s effectiveness. In addition, because the treatment requires specialized laboratories to produce the individualized vaccines for the treatment, only 2,000 patients will have access to the treatment over the next year. This is a small percent of the estimated 27,000 men who will die from prostate cancer in that year. These articles provide more details about the long process to approve Provenge.
Currently, patients are not allowed access to drugs not approved by the FDA, even if they are willing to take the risk. One such person was Abigail Burroughs who died without having access to a drug her doctor believed might save her life. Her father created the Abigail Alliance to fight for access to promising drugs caught in the FDA quagmire.
The FDA is nothing more than a government bureaucracy which has lost its way. It is a menace. Like all bureaucracies it is more concerned with process than with its mission to provide timely access to proven treatments.
There is legislation to amend the FDA Act to allow access to medications pending final approval (H.R. 4732). You can get more information about this act and how to encourage its passage at the Abigail Alliance. If saving lives and money is important to you then I urge you to learn more.
The malfeasance…yes, malfeasance…at the FDA goes far beyond drug approval delays. It’s bureaucratic bullshit also interferes in our right to make personal nutrition choices.
Growth hormones used in beef cattle? Yep…just fine with the FDA WITHOUT appropriate labeling so we can make our own decisions.
Raw dairy on their bad list? Yep, despite studies that show raw dairy to be very effective in asthma and allergy relief, not to mention that unpasteurized milk is well tolerated by folks formerly thought to be lactose intolerant. The condition would be more accurately called pasteurization intolerant.
Many studies show vaccinations to increase dramatically the incidence of autism. Autism occurred in 1 out of 250 children in 1970. With vaccination rates going up dramatically since then autism is now present in 1 out of 120 births, 1 out of 100 males, and 1 out of 80 for children of military personnel, the group of Americans with the highest rate of vaccination.
The FDA regularly approves dangerous drugs. Avandia was touted as a wonder drug for diabetics…but it also caused heart attacks, including one of mine.
Anyone old enough to remember Thalomide babies? Google it…all over a drug of convenience.
Hell…I’ll stop now or I’ll be typing all night, but remember one thing…
When the government controls your health care, be it FDA drug approval or Obamacare, and when the government controls your food, through the FDA and/or USDA rules, THEY OWN YOU.
Once your health care and food choices are out of your control, you become a slave to whoever has that control.
Enjoying the plantation?
Bob,
I do realize that I just scratched the surface with the FDA. I hesitate to ask how you feel about compact fluorescent light bulbs.