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Friday, June 23, 2017

Cancer and the FDA Gary North from Specific Answers

Cancer and the FDA

Gary North - June 21, 2017
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The gay lobby was able to overcome the Food and Drug Administration on anti-AIDS "cocktails." This was one of the few major triumphs of politics over bureaucracy in my lifetime.
Consider this report.
Hasini Jayatilaka was a sophomore at the Johns Hopkins University working in a lab studying cancer cells when she noticed that when the cells become too densely packed, some would break off and start spreading.She wasn't sure what to make of it, until she attended an academic conference and heard a speaker talking about bacterial cells behaving the same way. Yet when she went through the academic literature to see if anyone had written about similar behavior in cancer cells, she found nothing.

Seven years later, the theory Jayatilaka developed early in college is now a bona fide discovery that offers significant promise for cancer treatment.
Jayatilaka and a team at Johns Hopkins discovered the biochemical mechanism that tells cancer cells to break off from the primary tumor and spread throughout the body, a process called metastasis. Some 90 percent of cancer deaths are caused when cancer metastasizes. The team also found that two existing, FDA-approved drugs can slow metastasis significantly.
The article goes into detail about two already existing therapies that are used for treating other diseases and cancer. They can be combined to slow metastasis in cancer cells. There is hope that with another discovery, metastasis may be stopped completely. But, even today, at least in experiments on animals, the rate of metastasis can be significantly slowed. People may be able to get extra years by using these treatments.
But, of course, the FDA is not going to allow this. The FDA is cancer. It has spread throughout the medical field. It metastasized a long time ago.
Free-market economists for half a century have complained about the FDA. The FDA demands that a new drug go through extensive testing. Almost nobody can afford to conduct these tests. This is one of the great subsidies to big Pharma. Economists have known this for decades, but the general public is oblivious.
The FDA insists that any new drug must be safe and effective. This means the FDA can establish the criteria for both safety and effectiveness. Why should the FDA have any authority to say whether a drug is effective or not? Isn't that for sick people to decide? As for safety, courts have long-established liability. This can also be established by insurance companies. The FDA has no legitimate function in this area. Government should have no regulatory function in this area. But the public does not understand this. This goes back to Teddy Roosevelt. It was when the FDA was created.
The FDA wants to have rules that protect the FDA from criticism. The FDA wants to stop all possible criticism. There is no criticism from the dead people who did not get treatment from a drug that was never marketed. This is the fallacy described in 1850 by French pamphleteer and economist Frederic Bastiat. It is the fallacy of the thing not seen. In this case, it is the fallacy of the people not heard. Dead men tell no tales. Dead men do not write to their congressmen.
The gay community understood the threat to their members' lives posed by the FDA. So, beginning in 1988, they staged one of the great public relations campaigns in the history of American politics. They browbeat the FDA, and the FDA capitulated. You can read about it here. That successful public relations campaign saved a lot of lives. But the public forgets that it took political mobilization and political theater to break the resistance of the FDA, which sped up the bureaucratic process of authorizing new drugs to treat AIDS.
Here is what cancer victims face: delay. The report continues:
Though metastasis was not completely stopped, Jayatilaka said, the mice given the drug cocktail fared well and survived through the experiment. She said adding another, yet-to-be-determined drug or tweaking the dose might stop metastasis entirely.Contrary to the hair loss, nausea and other negative side effects patients undergoing chemotherapy suffer, Wirtz said the side effects from the drugs used in the study would be minimal.
Anirban Maitra, co-director of a pancreatic cancer research center at the MD Anderson Cancer Center at the University of Texas, cautioned that clinical trials in humans are needed to prove the theory.
"There's a risk that something that looks so great in an animal model won't pan out in a human," he said.
But Maitra said the study looked promising, in particular because the researchers had used drugs already on the market. It can take a decade to identify a drug that would perform similarly and get it approved, and many similar observations don't advance because of the time and expense it can take to get drug approval, he said.
How many people are going to die from cancer over the next decade? The FDA does not care. The FDA is not threatened by negative sanctions by Americans who will die because a particular drug was not introduced legally in the United States. It would face negative sanctions if it approved a drug, and then the drug proved dangerous. The function of every bureaucracy is to avoid making a mistake. Here is how every bureaucracy survives: (1) doing it by the book, (2) not making a mistake in public. The FDA will get no good publicity from not suppressing a drug that cures a million people. It will get devastating publicity for a drug that it approves, which then kills a hundred people . . . maybe.
The thalidomide disaster is what caused the FDA to metastasize. A low-level bureaucrat in the FDA would not approve thalidomide in 1960. In other countries, thalidomide led to deformed infants who were born without arms and sometimes legs. The FDA still takes credit for this blocking. From that point on, the FDA had carte blanche on suppressing any treatment that big Pharma could not patent. In 1962, the government passed new legislation increasing the power of the FDA to regulate drugs. That was the beginning of the metastasis.
Bureaucracy stifles innovation. This is a law of bureaucracy. It is rarely broken.
This is why alternative medicine exists in the shadows. It's illegal to advertise something that cures cancer or anything else that has not gone through the multimillion dollar meat grinder known as the FDA. Big Pharma can afford to go through it. Big Pharma gets a big payoff at the end of the process. Nevertheless, the Internet is spreading words of encouragement to afflicted people who get no help from big Pharma. It is much more difficult to control the spread of this information today than it was in 1995. Even in 1995 newsletters and alternative media had begun to loosen the stranglehold of the FDA. But until its budget is cut, nothing is going to stop the metastasis of the FDA. That is the one cure for this disease.
If it works on the FDA, it will work on all of them. I assure you, this drug will never be FDA-approved.
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