It’s Anything But at the FDA
By Victor M AdamusMy Oncology appointments last week left me wondering as to why our country is so slow in providing cures or helpful drug therapies for cancer patients when the same drugs are already on the street in Europe and Asia. My cure, for example, is being offered in Germany where Bayer developed it in 2006. It’s on the so called FAST TRACK here in the U.S. with an FDA release date of June, 2013. That may not be FAST enough for some colon cancer victims.
Obviously if you’re in good health like I am, you may live that long to get the cure here next year. But for those who have advanced colon cancer the odds are less they can wait, if they don’t have the wealth to travel to Germany, flight, hotel and pay for the 12 weeks' worth of infusions.
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| Timothy Leary |
Heroin, for example, derived from morphine was invented in 1874 by Alder Wright at St Mary’s Hospital in London and was used to treat respiratory ailments. It was legal here too for the same purpose but criminalized in 1924 under the Heroin Act. LSD, known as acid, to treat mental patients was developed by Albert Hofmann in Switzerland in 1938. After Harvard Professor Timothy Leary used it widely with his friends as a hullucinogenic drug, the U.S. government put it on Schedule 1 making it illegal. Another drug, Ectacy, was a popular tool to use in Psychiatry, enhanced by AlexanderShulgin in 1986, became a party drug of choice and soon banned under Schedule 1 as illegal. These drugs never cured a disease, certainly not cancer, but the history that at one time these drugs were legal to the medical community gives validity to their use as a treatment for different ills. The same with GHB produced naturally in the human body and synthesized in 1925 in France. Body builders and some boxing greats used it until the government found, in 1990, that mixed with alcohol it caused death. The FDA banned it under the Comprehensive Drug Abuse Prevention and Control Act.
This history hasn’t helped pharmaceutical companies in the U.S. Unlike European countries that initiate a common sense approach to medicine, the U.S. has established rules for clinical trials, even though they have been proved successful in other countries. They must stand the trials here before filing with the FDA which in turn takes two years for the FDA to study the results.
Pharmacology is a complex science. Finding the right atom mix for a cure is work intensive. But when the right combination comes together, regardless of which nation’s chemist found it, the U.S. government should act quickly to make the drug available to victims of various diseases as soon as possible. To me it’s a life and death situation. The FDA FAST TRACK is anything but FAST.
The death of Aldous Huxley comes to mind when riddled with cancer his wife injected him with 100 micrograms of LSD. He faced a 48 hours end of life scenario and went out smiling. Huxley died the day John F Kennedy was assassinated. His doctors agreed that the LSD would make dying for him more comfortable. Try getting a doctor to prescribe that today for a dying victim of cancer.
The fact that it takes longer for the FDA to respond supports the people fighting big government. If government made it legal for victims of diseases to import drugs administered by their doctors here and they made taking the potential cure their own risk, why not? The FDA could still have their five year FAST TRACK but the cancer victim would have options to accept the trial results in Europe and decide for themselves if it’s worth the risk.
3 comments:
Bravo! This is an excellent piece of writing and very informative, especially for some of us who have no reason to know about all of this.
I don't really care how big or little government is, it just needs to do something and get the job done, rather than relying on so much information from which they can finally make a decision.
They need to read BLINK.
What I find interesting, is that the FDA will approve drugs and vaccines, with little clinical trials, i.e. gardasil et al. BIG pharma promotes their drugs, and 5 years later they are pulled off the market because they kill people! It has nothing to do with the FDA guarding our safety, but everything to do with the corporations that now run this country. Up until a few years ago, doctors were loathe to even give a dying person morphine, because they might become addicted! We just happen to be the stupidest country on the face of the earth!
Well Terry, you're right! There are a lot, maybe too many, uneducated people who the government learned to lead by the nose. Agencies like the FDA should fight daily to save lives and not be bought off by Big Pharma.
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