OK, first I have to admit I am totally ignorant of this process, so I had to look it up online. I don't always trust everything I read, but this sounds about right. I actually believe it's harder than this, as a disclaimer. This is from an eHow article.
"The pre-clinical phase is the "discovery" part of the approval process and consists of three and a half years of testing in the lab. After this time has passed, an application is sent to the FDA to begin human testing. This is called an Investigational New Drug Application. The FDA will rarely grant "Fast Track Designation" to certain companies who demonstrate that their drug or biologic compound clearly addresses an unmet medical issue. All other drugs go on to the regular human trial process."
Let's put this in terms of feasibility. If you find a cure for cancer, and determine that it's a vitamin deficiency, you have to test a FOOD (that's not able to be copy righted and is free to everyone) for 3 and a half years. That means you better either have government support or very wealthy backers. Who is going to give you money for research when there is no chance of a return monetarily? There is no drug to copy right and have exclusive rights to, it's natural and you can run down to the super market and get it.
"If the FDA approves the Investigational New Drug Application, then the drug moves into Phase 1 clinical trials, where 20-80 human subjects are tested. Researchers will look at how the drug affects the human subjects, what the side effects are, and how safe the drug is. Phase I trials usually last around 1 year."
So, now you have invested 4 and a half years into a cure that you can't get any money from. I wonder why such researches write books and don't give this information out for free? Maybe they're not independently wealthy? Besides, the only people willing to do such trials would be people who are using this as a last resort. In the case of cancer, it's probably people who have been told they have a limited time left so they turn to alternatives. It's like the author of the book said, someone can be shot, have the bullet removed and still die from the damage done.
"If the Phase I results are efficacious, then the drug moves on to Phase II. During Phase II, a larger number of human subjects (100-300) is tested to see how well the drug actually works. Researchers will again look at the drug's safety profile and also what the benefits are. Phase II trials normally last around 2 years."
So, if a good number of patients weren't too far along to save, and actually do well with changing their diet (again, it's food we're talking about so it can't be copy righted), then the researcher has to put in 2 more years (we're up to 6 and a half years now) and get even more people to do this (according to the medical community) hokey cure. I think at this point, they'll probably say that the benefits don't outweigh the profit margin, because it's a FOOD and diet change.
"If a drug is proven to be safe and efficacious, then it will move along to the largest of the clinical trials in Phase III, where 1000-3000 patients are tested. During this phase, researchers take a closer look at the safety and effectiveness. They also review the "contraindications," or situations in which taking the drug would be dangerous to the person's health. Phase 3 normally takes 3 years and is the most comprehensive and stringent of the 3 phases."
So, now we're up to 9 and a half years. Who can hang around that long with no funding? Unless he's doing the research totally by himself/herself without hiring assistants, they can't afford to. And now they have to get 1,000 to 3,000 people to participate? I think it would hard enough to find 80 people who were willing to throw away conventional medicine and change their diet. That's a big risk when we've been told all our lives to trust our doctors. If they do it along side conventional medicine, it is only poisoning the system and would not get accurate results.
"If the drug passes Phase III as safe and effective, then a New Drug Application is filed with the FDA, which can take over 2 years to review. This application details all previous clinical trials and can be tens of thousands of pages long."
So, with the review, we're up to 11 and a half years. And this application won't write itself, and it's tens of thousands of pages long? I know how much paper costs, as well as the ink cartridges. So now they're also investing money into something that will not produce a return. I'm beginning to see why the medical community and the pharmaceutical companies don't want a FOOD to be proven as a cure for cancer. All the money they put into research to push their cancer drugs would evaporate if someone could run down to the local grocery store and change their diet. Maybe that IS why they outlawed the sale of raw apricot kernels.
"Once the FDA reviews the New Drug Application and approves it, the drug is officially approved and can begin to be marketed to the general population."
So after a minimum of 11 and a half years, the researcher gets permission to tell everyone that a food (suppose it was B17) will cure cancer. He writes a book releasing that information. People would stop getting the expensive chemo therapy drugs, costing the big pharma lots of money. They would also cut down on trips to the doctor, as they would only need monthly visits for a follow up. According to Obamacare, follow ups are supposed to be free. That means the doctor loses money now. The surgeon loses money as the tumor goes away and he doesn't have to do surgery. All the staff in the hospital that would have been needed lose money. It's all about the money.
No comments:
Post a Comment