Your supplements under attack by FDA

"Free of charge, free of advertising, and free of the A.M.A."

Written and copyright 2003 by Andrew Saul, PhD, of
http://www.doctoryourself.com, an online library of over 350 natural healing articles with nearly 4,000 scientific references. Commercial use of the website or the contents of this Newsletter is strictly prohibited.

A QUACK IS ANY PHYSICIAN WHO gives twelve separate courses of antibiotics to an infant under a year old. I know more than one doctor who does.

Ray, a health professional himself, brought his 11-month-old son Robbie to me. The child was very sick, and had been for over a week. No one, and I mean no one, in their family had had any sleep in a long time. They were up night after night with this child, who had a high fever, glazed watery eyes, tons of thick watery mucus, labored breathing, would not sleep, and did little else but cry. Day and night, night and day.

Robbie was under the care of a pediatrician, who had been prescribing serious antibiotics all along. Antibiotics were clearly not working. This was all too apparent to Ray. "Twelve rounds of antibiotics for a baby under a year old, and all the doctor wants to do is give more antibiotics?" he said. "That makes no sense at all."

"Ray, antibiotics are their knee-jerk answer to a lot of things. There is a saying: 'When the only tool you have is a hammer, you tend to see every problem as a nail.'"

"Well, we've thoroughly tried the medical route, and cooperated one hundred percent with the pediatrician. At this point," Ray said, "Robbie is worse, not better. We have got to do something ourselves, and we are going to. My wife is just as emphatic about that as I am."

She was home, taking care of the other children. I promptly acquainted Ray with some vitamin C research. "So the bottom line is to give Robbie as much vitamin C as he can hold without having loose bowels," Ray said. "Yes."

"We can do that," he said. And he did, too.

So now I have a new case history record to offer: 20,000 milligrams of vitamin C daily for an under-20-pound baby of 11 months of age. That's how much it took to cure Ray's baby of severe congestion, fever, and listlessness. That is over 1,000 milligrams of vitamin C per pound of baby per day; 2,200 mg "C" per kilogram body weight per day, nearly twice what Dr. Robert Klenner customarily ordered for patients. And even at that huge amount, the baby never had diarrhea!

You have to marvel at where it was all going. More marvelous is how quickly it worked. Ray kept in touch on the phone.

"Robbie was noticeably improved in under twelve hours, and slept through the first night." Ray told me two days later. "He was completely well in 48 hours. Symptoms free. Completely well!"

Even without considering the harmful side effects of massive antibiotic therapy, we can look at the futility of all those repeated doses. Antibiotics are either going to work with the first or second round, or they are not going to work at all, period. There is no point in emptying twelve water fire extinguishers on an electrical fire. More of the wrong thing is just more wrong. And in a baby, just plain stupid.

One simply must find the best, safest, and most effective way, especially with infants. The vitamin C quacks ( Linus Pauling, Frederick Robert Klenner, Emanuel Cheraskin, William J. McCormick, Irwin Stone, Robert F. Cathcart III, and, ah... me) will tell you that you have a genuine option: consider using vitamin C as your first choice antibiotic/antiviral.

http://www.doctoryourself.com/titration.html
http://www.doctoryourself.com/ortho_c.html
http://www.doctoryourself.com/klenner_table.html
http://www.doctoryourself.com/klennerpaper.html

Taking enough C results in the three C's: patient comfort, low cost, and parental control. Without necessitating the use of invasive technology nor the trauma of hospitalization, parents can regain confidence and mastery over illness to a degree that they might never have thought possible. We have now gone light years beyond the medical profession's customarily paternalistic, condescending attitude towards self-care.

For this reason, bowel-tolerance vitamin C therapy has periodically been decried and denounced as irresponsible quackery. It takes some real ego strength for a parent to stand firm and say, "This is what I am going to do: I am going to follow the Klenner/Cathcart vitamin C protocol." The vitamin C doctors' shared knowledge of how it is done is the buttress that makes such a stance possible.

When I was a kid, everybody got miracle drugs. From sulfa to Physohex, we followed the crowd from waiting room to prescription counter. Our parents gave us "safe" children's aspirin. Oops, not so safe for high fevers, it was discovered. So then it was children's Tylenol (acetaminophen) for everybody. Hmm: it turns out there's some liver and kidney side effects with that, too. And, as drugs go, acetaminophen is really safe. But drugs all carry side effects; you just choose your poison carefully. Vitamins are vastly safer than drugs.

LAW: The number one side effect of vitamins is failure to take enough of them.

"BUT ** THAT **  MUCH VITAMIN C?" said Marta, another client, aged 30, with a chronic viral illness. "Well," I said, "If you are going to do it, Marta, you might as well do it right. This means building up your C level to saturation. That's bowel tolerance. "And you mean that I might have to take much more than I'd expect to, right?" Marta added.

"Yes," I said. "You do not take the amount of vitamin C you think you should take; rather, you take the amount of vitamin C that the body responds to. When your symptoms leave, that's the right level for you at that time. As you get better, you will not be able to hold as much of the vitamin. The dose is self-adjusting, and you need no equipment to monitor it. Just take as much as you can comfortably hold, just enough to be symptom-free, but not so much as causes loose bowels."

Marta said, "How long will it be before I see any progress?"

"It depends on how much vitamin C you take, and how much vitamin C you need. A dry sponge holds a lot of water. The body seems to have an enormous capacity for vitamin C when infected with a virus. We'll all find out how much you need when we see how much you can comfortably hold. It is not a contest; just do what gets the healing." "What can I expect along the way?" she asked.

"Look at it this way," I responded. "Let's say you were in a plane taking off from Buffalo International Airport in the middle of winter. It is snowing, dark, gray, stormy and windy. Your jet takes off, and begins to climb. The wind rocks the plane, the snow and sleet and hail come down, and it's all dismally gray outside. The plane keeps climbing. All you can see out the window is snow, darkness and the wings shaking from the wind. The person next to you is turning a bit green. Up you go, still in the winter storm. Then, all of the sudden, the airplane breaks out on top of the clouds, and like magic, there's bright sunlight and blue sky everywhere. Look down: Far below you is the storm. It's like it never happened, like you were never in it.

"That is exactly what it is like when you reach saturation of vitamin C. At a certain altitude, higher than you expected, your symptoms go away. This characteristically occurs with such ease that it is hard to believe it until you experience it for yourself. Precious few medical professionals have learned this. The medical-dietetic industry has a real fear of flying if vitamin C is the aircraft. Too bad, when it is the safest and fastest plane in the air."

"OK," said Marta. "I guess I should get started." She did.

It was not that long afterward that I had a follow-up conversation with her. "All traces of the viral infection are gone," Marta said, "And have been gone since I got to saturation with the C. Do you want to know how much it took?"

"You bet I do." "44,000 milligrams a day!" she hooted. "Can you believe that? And at that much I hardly had any bowel signs at all. So I dropped it to about 35 to 40 thousand and stayed there. That's it!"

That Dr. Klenner fellow. I'd have liked to have met him.

Right now there are a whole lot of researchers searching for a new anti-viral wonder drug, or the ultimate six-pack of flu wonder shots.

They are the blind leading the blind. They already have an answer.

It would seem as if the pharmaceutical industry's mercenary scientists and their medical doctor clones will, in fact, try everything BUT megadoses of vitamin C. I think of them as birds that are willing to land on any branch except one. Too bad, because that one branch is the best in the entire forest.

CHRONICALLY SICK CHILD CURED WITH VITAMIN C MEGADOSES

http://www.doctoryourself.com/immune.html

INFLUENZA AND COLDS

http://www.doctoryourself.com/colds.html


MORE ON MEGADOSE VITAMIN C THERAPY:
SAFETY AND EFFECTIVENESS

 http://www.doctoryourself.com/mccormick.html
http://www.doctoryourself.com/mccormick1951.html

VITAMIN C MEGADOSE THERAPY book written by a medical doctor:

http://www.doctoryourself.com/levy.html

"Big Bro. Is At It Again"

NOW THE U.S. HOUSE OF REPRESENTATIVES WANTS FDA TO CONTROL YOUR ACCESS TO SUPPLEMENTS

A so-called "Dietary Supplement Information Act" (H. R. 724) has been introduced into the House of Representatives "to amend the Federal Food, Drug, and Cosmetic Act" and bring supplements under direct and absolute FDA control. (Read the full text of the House bill at http://thomas.loc.gov/, where you simply type "HR 724" into the search box to get a copy.)

While this particular bill commences primarily with "registration," it is well within the world's memory that dictatorial powers have often begun organized repression and extermination with just such a move.

The FDA's agenda is to control, and then eliminate, public access to high-dose vitamin preparations because they are direct competition for the Agency's pet customers: the pharmaceutical industry.

This is nothing new. FDA Deputy Commissioner for Policy David Adams, at the Drug Information Association Annual Meeting, July 12, 1993, said: "Pay careful attention to what is happening with dietary supplements in the legislative arena... If these efforts are successful, there could be created a class of products to compete with approved drugs. The establishment of a separate regulatory category for supplements could undercut exclusivity rights enjoyed by the holders of approved drug applications."

And the FDA Dietary Task Force Report, released June 15, 1993, said: "The task force considered many issues in its deliberations including to ensure that the existence of dietary supplements on the market does not act as a disincentive for drug development."

The most ominous parts of the House bill, H.R. 724, are these:

1) The Secretary of the FDA is given all the power to "conduct a clinical evaluation of each serious adverse experience reported." This means total FDA control, and do not let anyone tell you otherwise.

2) Even trivial experiences will be included, and indeed sought out: "With respect to the receipt of information on adverse experiences that are not serious, a manufacturer of the dietary supplement involved shall submit reports to the Secretary annually, or at such shorter intervals as the Secretary may require. Each such report shall meet such requirements as the Secretary may establish." FDA would be handed the power to dictate terms, no matter what those terms may be.

"In carrying out such program, the Secretary shall seek the cooperation of appropriate public and private entities, including entities that respond to medical emergencies." This means all medically-biased organizations nationwide will have a free-for-all feeding frenzy attacking high-dose vitamins, with the FDA cheering them on.

3) "The term 'adverse experience regarding a dietary supplement' means any adverse event associated with the use of such supplement in humans, whether or not such event is considered to be related to the supplement by a person referred to in paragraph (1) who obtains the information." Vitamins may be accused as culprits when innocent, and found guilty even if innocent, all by a single person: the Secretary of the Food and Drug Administration.

4) The idea that FDA wants, specifically, a "SURVEILLANCE PLAN" (their wording) for supplements reveals their orientation most clearly. FDA has already assumed that supplements are the problem, as they historically have done.

FDA intends to regulatory language exactly as if supplements were quack devices, namely:

"Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374
) is amended (in subsection (a)(1), in the third sentence,) by striking `or restricted devices' each place such term appears and inserting `restricted devices, or dietary supplements'; and (in the fourth sentence) by striking `and devices' and inserting `devices, and dietary supplements.'"

This is an outrage, and the worst form of political power grabs. Since FDA really means "Favors Drugs Always," I think this bill, and the Senate's equally misguided S. 722, present a very serious danger to your family's health.

Additionally, all supplements would have to have, printed on the label of every bottle, the FDA's toll-free "telephone number, and the address of the Internet site, maintained by the Secretary for purposes of the medical product reporting program (MedWatch or any successor program)." And, for a nice serio-comic touch: The FDA will be allowed to charge supplement companies for the costs of their registration.

This bill, if made into law, will complete the FDA's twin, underlying
purposes: to gain control over supplements, and to treat them as drugs. Sure, 2004 is twenty years after "1984." But Big Brother is patient, and George Orwell was looks to have been quite right.

Congress needs to receive your letters of objection right away. Be sure to ask for a response. (You can get your Congressman's address easily at http://www.congress.org/congressorg/home or with a Google search.

Here are a couple more congressional responses that readers have forwarded to me:

SENATOR PAT ROBERTS (R, Kansas)

"Consumers should have access to dietary supplements that meet quality standards, are free from contamination, and are accurately labeled. The proposed rule will not limit consumers' access to dietary supplements. It will give consumers greater confidence that the dietary supplement they use will have the identity, purity, quality, strength, and composition that is claimed on the label."

Sincerely,

Pat Roberts

Roberts@senate.gov

DOCTOR YOURSELF COMMENT:

I think the Senator is quite incorrect: the bill will most assuredly limit access to any supplement for which there is even one single adverse report, a report than does not even have to be true. I think your senator should read S. 722 before commenting on it.

CONGRESSMAN MARTIN OLAV SABO (D, Minnesota)

"I appreciate having been informed of your views and will keep your comments in mind as the House of Representatives considers legislation related to dietary supplements."

Sincerely,

Martin Olav Sabo

http://www.house.gov/sabo/

The Newsletter reader, and letter-writer, comments:

"I have no idea where he stands on the issue and how he plans to vote on S. 722 or H.R. 724. This is very unclear, frustrating and confusing for me."

Darn straight. Write again and ask him how he will vote. Or better yet, tell him how to vote. You pay his salary.

READERS SAY:

Gary Headley, of Fayetteville, AR writes:

"Love your stuff, as usual. Just wondering, though: do you think the vitamin industry should police itself? With more and more people taking nutritional supplements, it is a huge business. Isn't it likely that some people will get into the game and advertise that their product contains one thing but in reality, it will contain something else? Or not the right dosage? I think there should be some FDA regulation of the industry, just as there should be regulation of any food product. Big businesses will get away with whatever they can in order to cut corners and save a buck. As much as I'd like to think otherwise, I know that not everyone in the vitamin industry is looking after our health."

FDA has always had the authority to take any mislabeled or adulterated or fraudulent product off the market immediately. They have such authority today. The supplement industry knows this, and overall does a commendable job of self-regulating. Could they do it better? Probably. But the government knows that there is not even one death per year caused by vitamins. The real issue concerns dangerous pharmaceuticals that are unfairly marketed as "supplements." FDA has always had the power to instantly remove any harmful product from the shelves. They have this power today as well. No new legislation is needed.

THE "SAFETY" SMOKESCREEN

So far, most elected officials responding to readers' letters are saying pretty much the same thing: "I support access and I support safety."

You and I are also in favor of safety and access. This recent FDA-fed legislative call for "more safety" is bogus, in my view, and the worst kind of public deception. If the FDA and pharmaceutical lawyers have their way, by the time they are done manipulating any safety issue that involves supplements, access will be curtailed.

I am probably rather cynical about government regulation. This may be due to all the lobbying I did to help get congress to pass the DSHEA in 1994. Truly, that law (for the US at least) is all we need to ensure manufacturing safety. . . and that law is already in force and on the books, and it guarantees our freedoms as well.

Historically, this has all been tricky going. I think nearly every
governmental attempt to stop misleading products (potency pills and magic dieting aids, which I very much disapprove of, come to mind) has tarred vitamins and minerals with the same, very big legislative brush. I think we need to err on the side of liberty, or our government(s) will go the way of the European Union. EU demonstrates what I think G. B. Shaw said: "The road to hell is paved with good intentions." And lawmakers listen to the
pharmaceutical companies more than anyone, again as EU illustrates, resulting in completely foolish "upper limits" for, say, B-6 or niacin in Britain.

Most Americans (and their lawmakers) are unaware that FDA has always had, and still has, the power to remove any dangerous or fraudulent product at any time. An example of just how extreme this power can be was when FDA took L-tryptophan off the market (http://www.doctoryourself.com/prozac.html). Tryptophan is still unavailable in the US, and there is no recourse that I am aware of.

I think that the attack on supplement safety is actually an attack on supplement efficacy. It seems to me that practically all proposed legislation starts out in the name of safety and ends up as a medical pharmaceutical industry opportunity.

That opportunity is first restriction and then prescription. I do not think we should have to accept the ridiculousness of living in a nation where it is easier to buy a shotgun than to get a bottle of high-potency vitamin C tablets.

TELL IT TO THE FDA

In addition to writing to your Senators and Congressman, you can voice your opinion directly to the FDA regarding new supplement rulemaking at the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You can also submit your comments at

 http://www.fda.gov/oc/mcclellan/chbn.html.

DR. ABRAM HOFFER WRITES:
"Governments are not to be trusted too much. The message is, "Thou shalt not tamper with my right to buy these safe products as I wish, in the same way I do not want anyone to tell me what I can eat or not eat."

READERS (AND THEIR WEBSITES) SAY

http://www.geocities.com/miamimystic23/blog :

"I simply do not want to be on medications when I'm older. Believe it or not, there are some elderly people in good health who don't take any meds! If I'm fortunate enough to live a long life, I'd like to be one of these people. Now, I'm not a fanatic. If someone has a pressing need to be on meds, they should be on their meds. But people need to be more informed about alternatives. There are other ways to manage chronic conditions besides synthetic prescription drugs.

"I was on a lot of meds for a lot of years, trying to manage my blood pressure and sinus problems. The pills I was taking wound up causing other side effects. Phantom pains doctors couldn't give a reason for. Escalated depression. Fuzzy thinking. Vivid, frightening and morbidly sad dreams. Chronic fatigue. And on and on.

"I'm happy for websites like Dr. Saul's Doctor Yourself - a very handy site filled with commercial free information about how to take care of your own health concerns. I refer to this site a lot. Now, I don't happen to agree with everything on there - but that's okay. It's still got tons of great information. And, unlike a lot of health related sites that sell products, Dr. Saul isn't selling anything. He drops some hints about his books now and then - but he's not pushing any particular vitamin product or brand. In my eyes, this gives him a lot of credibility. There should be more nutritionists and alternative healthcare workers like this guy on line giving thoughtful, expert advice - without an agenda."

FREE VITAMINS FOR THE POOR

Our vitamin dispensary for the poor in Rochester, NY has stepped up operation as the cold weather and flu season come upon us. For some time now, our dispensary has enabled homeless and other poor people to receive a high-potency multivitamin along with their free lunch. There is no waste with this program: the vitamin is only given to those who want it, one per customer. Currently, around 50 or more people every day are benefiting from this all-volunteer, entirely free-of-charge service.

While sales of my book

 (http://www.doctoryourself.com/saulbooks.html) help fund this project, the effort needs donations.

DOCTOR YOURSELF ON THE AIR

My next radio interviews will be:

Tuesday, Dec 9, California: KSMA
(twice between 7 am and 9 am Pacific Time, AM 1240)

Tuesday, Dec 9, Tennessee: 8-9 am Eastern Time
on WWSR (105.7 FM)

Tuesday, Dec 9, Pittsburgh PA: 11 am - 12 pm
Eastern Time on WKHB (AM 620)

Wednesday, Dec 10, Rhode Island: 1:05 pm
Eastern Time, WOON (AM 1240) and
live on the Internet http://www.onworldwide.com

Friday, Dec 12, Illinois: 9:05 am Central Time,
WDDD (107.3 FM)

Tuesday, Dec 16, South Dakota: 8:35 am Central Time,
KORN (AM 1490)

Thursday, Dec 18, Alabama: 8 - 8:30 am Central Time,
WQLS (AM 1200)

Thursday, Dec 18, Texas: 9:30 - 10 am Central Time,
(AM 860). Networked by ABC and ESPN.

You  go to the links made available in this article

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