How about YOUR question here?
Read below or choose another question.
The question is, "Why does the FDA do what it does?"
More generally, many people who are enthusiastic about the vitamin world, and natural remedies, etc., see the FDA as the terrible villain.
They are really bad, but not as bad as you may think.
I'll be posting more of the actual laws which govern the FDA here in due course, but, generally, here's the law as they operate.
The law that governs the FDA says, simply, that the FDA is charged with making sure that any substance for which a claim is made that it will cure or prevent a disease, or alter a bodily function, IS a substance for which the FDA must have received acceptable scientific evidence that, first, it is safe, and second it is effective.
If you make a claim, for instance, that "Vitamin C can prevent or cure a cold," it is obviously a violation of the law. No one has "registered" vitamin C with the FDA. No one has done the appropriate scientific studies to show that, at the recommended doses Vitamin C is safe. No one has done the required studies to show that, at those doses, Vitamin C actually prevents or cures a "cold."
Why?
Simply because it costs millions of dollars to do these studies and once they were done, and Vitamin C was "proven" (to the satisfaction of the FDA) that it was safe, ANYONE who sold that Vitamin C could make that claim.
Once Vitamin C was "proven" to be effective, then ANYONE who sold it could make that claim.
The drug companies spend those millions of dollars to prove some drug is safe and effective ONLY when they have a patent, or some monopoly, on that drug.
It would be foolish to do otherwise.
So, drug companies can find some vitamin, like Vitamin C, and figure out FIRST how to change it in some way so that they can get a patent on the "changed Vitamin C." Eastman (Kodak) has done that in reference to Vitamin E. They have a new name for it. Their "Vitamin E" is called NuTriene Tocotrienols! Since they fiddled around with the original Vitamin E, changing the molecule in several ways, they could get a patent on this new product, called "NuTriene." You'll be seeing more and more about this stuff.
Now that they have a patent on it, they can afford to do the research on it. Let's say that Vitamin E has been "proven" (but not to FDA standards) to reduce the risk of heart disease (it has). But, you sure can't advertise that claim because you would be violating the laws that govern drugs. But, if you "invent" NuTriene, and do studies on THAT substance, AND then show that NuTriene reduces the risk of heart disease, you can get FDA approval on that claim and THEN you'll see big ads in the Wall Street Journal, etc., by Eastman, telling you that your chances of dieing of heart disease are reduced by 45.6% (or whatever) if you take 800 IU of NuTriene per day.
They will pull in a bundle of money!
It's not evil, either. It's just the way the game is played here, at this time.
After this information had been published a while, someone from the company that makes this material wrote to me. I have no reason to dispute his information, and therefore include his entire eMail to me:
July 22, 1999
The President
Vibrant Life
1831 N. Bel Aire Drive
Burbank, CA 91504
Dear Sir/Madam:
I am Dr. Andreas Papas, senior technical associate at Eastman Chemical Company. I am writing in response to an editorial on your web site entitled "Why Does the FDA do What it Does?". We would like to clarify a few inaccuracies in this editorial pertaining to Eastman's NuTriene tocotrienols.
1. NuTriene tocotrienols are manufactured by Eastman Chemical Company, which is independently owned with stock (EMN) traded on the NYSE. It has not been a part of Eastman Kodak Company since it was spun off in 1994.
2. You reference NuTriene tocotrienols as "vitamin E that has been fiddled with or changed in several ways." This is not actually correct. Vitamin E found in plants naturally occurs in 8 different forms that have very slight structural differences but which all have some biological functions. Four of these forms are called tocopherols and four are called tocotrienols. Historically science has focused on a single tocopherol compound (alpha-tocopherol). Over time alpha-tocopherol has become synonymous with the term vitamin E. Alpha-tocopherol can be extracted from plant sources or synthetically manufactured. Synthetic alpha-tocopherol, or stabilized forms of this single molecule, are by far the most predominant source of vitamin E on the market. Eastman has never marketed synthetic vitamin E.
NuTriene tocotrienols, on the other hand, are an extraction of all 8 of the naturally occurring compounds in the vitamin E family. The tocopherols and tocotrienols in NuTriene are extracted and concentrated from rice bran oil in their original, naturally occurring form. The molecular structure of the tocopherols and tocotrienols are not changed in any way. The difference between NuTriene and most vitamin E products is that NuTriene is a combination of all 8 of the members of the vitamin E family. Typically, vitamin E products contain only alpha-tocopherol, In most natural source vitamin E products, the other 7 compounds are removed; synthetic vitamin E products never had them to start with.
Eastman chose to market NuTriene tocotrienols as a dietary supplement because we believe in the validity of the growing body of evidence that indicates the other 7 compounds in the vitamin E family, in particular gamma-tocopherol and alpha- and gamma-tocotrienols, have significant biological value. We do try to support research studies on these compounds, however the vast majority of the research to date (and in all probability most future research) will be conducted independently of Eastman funding or influence. No single nutritional supplement company has the resources to support the type of research trials required to obtain FDA approval for specific health claims, patent or no patent.
I hope this information has been helpful and feel free to contact me if you have any questions.
Sincerely,
Andreas M. Papas, Ph.D.
Eastman Chemical Company
P.O. Box 1974
Kingsport, TN USA 37662
Tel: (1)-423-229-8747
Fax: (1)-423-224-0414
E-mail: apapas@eastman.com
So, you WILL find some people claiming that Vitamin C, or Vitamin E, will prevent or cure some disease, but you will not find the LARGE companies making those claims. The small companies that make those claims are taking a risk of being put out of business.
So, Vitamin C has been "shown" to prevent and reverse cancer! That's the fact!
That doesn't mean it is either legal or safe to say that!
If you claim that Vitamin C will prevent or cure a "cold" you are very safe. This would be an illegal claim, but it is a claim which the FDA would ignore.
Why?
Because, first, Vitamin C is safe. Also, it is well known to prevent or cure the cold. But, more importantly, that claim is usually made by small companies only, and because so many people know about it that even if the claim were discontinued, people would buy Vitamin C for that purpose.
But, if you claim that Vitamin C will prevent or cure cancer --- AH!!
You are in big-time trouble.
The FDA does NOT want claims for cancer cures to be floating around. Why? Because people who have cancer are desperate. They are already swallowing hundreds of strange herbs and other substances, sold by small companies, and because these people are so desperate the FDA doesn't want them to be taken advantage of by promoters who have strange herbs to sell.
So, it is MUCH more dangerous to claim that Vitamin C will prevent or cure cancer than it is to claim that Vitamin C will prevent or cure a cold.
What do companies do to get around this problem.
They don't make the claim, themselves. Instead, they find some scientific study that says the same thing and then they point you toward that study.
That can get the company into trouble with the FDA too! Believe it or not!
If a company selling Vitamin C itself makes no claims for cancer cure, but sends you a reprint of a scientific study (done by some person independent to them) showing that Vitamin C cures cancer, the company is still guilty.
So, you understand why, when you ask some company the question, "Does your product prevent or cure cancer?" you get a worried mumble on the other end.
So, Vibrant Life does NOT claim that Vitamin C, or any product, CURES or PREVENTS cancer. We have found some legal advice that what we DO say is safe.
We speak with care, and as boldly as we feel we can do.
You need to understand WHY the FDA does what it does. Then you can help yourself more by asking questions which do not appear to be "entrapment" type questions.
Here is a story about a dear friend of mine, whose name I will not show here. He had a clinic in Mexico where he "cured" cancer. One of my viewers wrote me the following testimonial, and allowed me to use it only taking out the name of his wife.
Hello, Karl!
You wrote:
Thanks, Keith.
xxxx is (or was) in jail for violating his parole. I haven’t heard for
> several weeks.
How unfortunate. Is the charge valid?
Karl: My own wife and dying step father were at Jimmy’s on the Saturday, before
the Monday when he was abducted.
They may well have met my wife.
I’d be glad to hear as much more as you would like to write.
At another’s request, I once wrote it up. Following is a cut-and-paste of that text, which you may find of interest. You may feel free to use this information if you desire. Please omit my name and my wife’s if you choose to post this information publicly; but I will gladly vouch for the facts if there’s any need.
Quote...
My wife xxx had fully-metastised ovarian cancer which had spread throughout her abdomen. She had large and growing tumor masses basically everywhere below the diaphragm when we brought her to xxx’s clinic in March of 1991. She was unable to walk fully erect, had hard masses in her stomach area, was very weak and suffering abdominal pains and digestive distress because of the growths.
She had been earlier mis-diagnosed (rather reprehensibly so in my opinion) with fibroid tumors of the uterus. Her cancer was discovered in a surgery (intended to remove her uterus and ovaries) on 5 February 1991, immediately upon opening her abdomen with a huge T-shaped incision. A biopsy was taken and she was stapled-up immediately. The surgeon returned his fee within hours, and we were left with a dismal prognosis.
A longtime acquaintance who had experienced a near-miraculous and seemingly permanent recovery from an apparent brain tumor, recommended us to the xxx clinic. We spoke to Jimmy and several others by phone and decided to attempt his treatment.
Mr. xxx interviewed us upon our arrival at the Tijuana clinic, and detailed what we could expect. He was guardedly optimistic, explaining that the surgery would have caused the cancer to spread aggressively (it had, in spades). He said the fact xxx had not undergone chemotherapy, and that she was young and basically healthy meant her chances were good of making dramatic progress. He said the daily treatments would make her very tired and she must sleep long hours. He said she would almost certainly experience "pulling" sensations in the areas of the tumors as the masses shrank. He told us the process of recovery would involve a stringent diet which must be maintained indefinitely, as well as the treatments, and would require many months and repeated visits to the clinic.
The daily therapy consisted of a grab-bag of alternative approaches; Mr.xxxx seemed to use every therapy he knew which had any chance of success. xxx was given everything from pancreatic enzymes to Laetrile, in a constantly-varying daily routine.
But it consisted of two very essential items which were never omitted:
an IV drip of saline solution containing a very large dose of Vitamin C; and an intravenous serum, normally added to the same saline solution, which we were told consisted of amino acids and polypeptides.
This last serum was the one totally unique aspect of their treatment, and it was to that which they attributed the lion’s share of their success. And success it was. I will not detail their stories here, but we were surrounded with people whose tales of recovery were consistently heartening, and sometimes bordered on the incredible.
A typical day at the clinic consisted of arrival at 9AM; an interview with Mr. xxxx in which he used a technique (which I had never before seen) of body-response to his questions which led him to prescribe the day’s mix of therapies. Items and proportions changed daily. Laetrile some days, not others. More serum one day, less another. All based, apparently, in a method of physical feedback where he pressed downwards upon the patient’s extended arm as he asked questions or named medicines. The arm’s resistance to pressure seemed to vary and provided xxxx his response. xxxx also seemed to examine his patients’ outward appearance very closely, and asked searching questions about diet, sleep, how they felt, and so forth. An assistant noted his comments on the day’s therapy for each patient.
We then sat upon chairs, arranged throughout the several rooms and hallways of the small clinic, and with about 40 to 60 other patients, were provided with the IVs, injections and tablets. I assisted with some aspects of my wife’s treatment, including needle "sticks" and IV "pushes." Usually we were done by noon or so, then went "home," xxxx usually to bed-rest.
As to cost, the various medicines involved specific charges for each; generally, as I recall, a day’s treatment would cost anywhere from $150 to $250.
I remained there with my wife for about a week, and attended all her visits to the clinic. We set her up in a kitchenette -equipped motel room near the border. We bought her all the elements of the very strictly organic and vegetable-laden diet xxxx had prescribed.
I then returned to my work in Seattle, but stayed in constant contact with xxxx by phone. As she had done from the beginning, she reported the "pulling" sensations predicted by Mr. xxxx, and slept a large proportion of every day. She was not very descriptive of her progress during this time; I later learned it was because she wanted to surprise me.
The initial surprise, though, was not a happy one, when xxxx called to report the incident of xxxx’s abduction. She had been there for about three weeks. She was slated for just a few more days’ treatment, then to be sent home for about a month before another stint at the clinic. Mr. xxxx had no more told her this than he was assaulted and taken by force from the clinic by three armed men. My wife physically fought one of them, and was threatened with a gun for her trouble.
Upon her return, I was flabbergasted at what I saw. She was utterly transformed to a state of emphatic *health*. It was nothing less than amazing. xxxx walked fully upright. Except for a few small hard masses in the lower abdomen, all evidence of her tumors was gone. She was more energetic and alert than I had *ever* seen her. She had the complexion of a robust child, peaches and cream, rosy cheeks! Never before had she had such an appearance.
Though this triumph was overshadowed by the knowledge that the clinic was closed and no more treatment would be available, xxxx’s wonderful condition persisted for months. She woke early and slept light. She practically bounced out of bed, something she’d never done before. Her energy was remarkable. It required about four months before she began to experience the symptoms of digestive distress again, and several more before the growths became as strongly evident as before.
Our tale from there is much like those of many another sufferer of that cancer. Other efforts to duplicate xxxx’s treatment, on which we spent thousands, were unsuccessful. We were finally left with nothing but surgery (a colostomy, finally necessary to keep xxxx alive) and the usual spiral of chemotherapy.
xxxx died, a remarkable three years after her diagnosis, of liver failure. But for an almost-successful attempt at killing her with Taxol (which weakened her terribly and after which her doctor recommended euthanasia to our horror), xxxx would probably have lived many months longer. I am convinced xxxx would have lived a fraction of that time without xxx’s amazing treatment.
Unquote.
I wish you well, Karl, and all success.
Keith
I am trying to find some very basic information on FDA approval. It's
not jumping out at me on the website. I don't know where to begin.
I just want to know what the general process is for getting FDA approval from
a layman's perspective.
Even though I'm involved in clinical
research I am not directly involved in this aspect of it.
My main reason for this interest is this.
My mother is currently involved with a company called NuSkin. In my opinion, they use all sorts of sleaze ball tactics to make their company appear to be more founded in scientific research than it is (amongst other sleaze ball tactics).
My mother seems to have adapted the idea from this company that the FDA is bad. She believes that companies pay the FDA to get the FDA approval & that this is responsible for driving up the prices of FDA approved drugs. I told her that this was not the case & the reason why much of the NuSkin products she pushes (and she does push them) do not have FDA approval because they are not required to (yet), not because they choose not to.
I think they have portrayed the image
that they do not have FDA approval because they are above the FDA ethically
(yes, I'm serious).
Please let me know how I can provide her with some accurate, straight forward information on what the FDA does and does not do. I believe NuSkin is brain washing her and many other people and misleading them to misunderstand the whole process of scientific research. I would like to provide her with some information that is not from me or NuSkin so she will believe it.
xxxx
Dear XXX
|
I promise to answer your message -- click here to send me a personal message
|
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