Monday, November 23, 2015

FDA, pharmaceuticals, chemo, heart surgery, and supplements

The FDA will not allow "snake oil" to be advertised as a cure for a disease. It's a great idea.  However, in order to meet the FDA's burden of proof, it is a very expensive process to prove a treatment can help a disease.  The same burden of proof is not required for any surgery because there is no way to give the surgery that many times, especially in multiple centers trying to use different techniques, or even have a placebo group.  This is how the cardiology field gets away with literally selling snake oil and killing people who could have lived.   Honest groups of cardiologists have even published the vast failure of heart surgeries that should have been putting in tubes instead (basically, if you are not in the wake of a recent heart attack, you should be skeptical of the need for open heart surgery over a stent, according to the medical field's own research). The oncology field commits the same crimes under the pretense of investigating new drugs (for the past 4 decades...with no improvements) that sell false hope.  It's not distinguishable from snake oil. The details are usually arguable, but in many specific cases it is  clear. You can't get doctors to testify against other doctors in most cases or they can get in deep systematic trouble with their peers, especially with the heads of medical boards that issue the licenses needed to testify.  Researchers face the same problem: be careful what truths or opinions you tell or your funding dries up. 
My point in the comparison is that heart surgeries and chemotherapies that are known to be harmful and not provide any benefit are being prescribed, and yet people who sell very safe inexpensive compounds are not allowed to tell you (by FDA regulations and severe penalties) that they stop Parkinson's in the test tube, in animals, and prevent PD in epidemiological studies.  Instead, supplements require the same level of proof as usually toxic and expensive pharmaceuticals. Even the majority of private and public funding go to the pharmaceuticals there is every reason to believe will not help (at least in cancer) as opposed to the safe and cheap supplements that already have supporting evidence. Where's the logic in this if it is not because of some sort of accidental or intentional conspiracy in our economics? 
Then there is advertising:  GM1 phase 3 trials were complete over 5 years ago. But almost no one here has heard about GM1.  See
It reverted and stopped the disease from progressing, which is not being said of nilotinib.  It was 77 patients instead of 12.  The data is published.  Nilotinib study is not.  It was a phase 3 trial.  Nilotinib is only a phase 1 trial that is supposed to be only looking at safety. I wonder if a lot of professionals are aghast that they are saying these things through the media before publishing, especially since it was supposed to look only at safety. On the other hand only 12 people and the researchers doing such an outlandish thing like going public could mean it really is that good.  I just hope it is not cold fusion all over again, if you remember that fiasco where they went public without the science to back it up. Getting back tot he point of advertising:  I came across GM1 accidentally because I was looking for the trial on nilotinib.
Two years after treatment stopped, they had progressed to where "standard care" patients had been 2 years earlier.  In other words, the benefits seemed to permanently reverse the condition by 2 years even after treatment was stopped. That's my reading of figure 2 in the link above.
It's not a conspiracy theory, but I think it's just how economics works.  We all seek profit.  Doctors, politicians, pharmaceuticals, and researchers should not be expected to act any different than we do. I assume everyone acts about like mechanics, plumbers, painters, and AC repairmen.  My experience with them does not usually fall under the heading of "honest" and "fair".  If the consumer is not knowledgeable, then he should expect to be taken to the cleaners.
I do not know of something better than GM1, but that does not mean there are not 5 other compounds out there with similar proof.  It's just one I accidentally saw.  Gallic acid might be just as good and it's super cheap, but it probably hasn't been tested in people, except for the benefits noted from black tea and grape seed.

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