Help stop law to make herbal supplements a prescription drug

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THIS IS REALLY IMPORTANT IF WE WANT TO BE ABLE TO GET NATURAL SUPPLEMENTS. IF THE MEDICS EVER GET THIS CONTROL, ALL THE SMALL, NATURAL- MINDED COMPANIES WOULD GO OUT OF BUSINESS AND WE WOULD BE AT THE MERCY OF THE PHARMACEUETICAL INDUSTRY.

TAKE TIME TO READ AND ACT ON THIS. Dr. John

--------- Forwarded message ---------- From: The Arthritis Trust Of America Mon, 01 Jan 2001 16:39:48 -0600 Subject: Laws Message-ID: <3.0.1.32.20010101163948.007a9d20@mail.telalink.net>

Dear Friend: (From my friend Perry Chapdelain, head of the Rheumatoid Disease Foundation)

AN OMINOUS SCHEME IS AFOOT

Will all those who feel powerless to change things please signify by maintaining their usual silence.

A bill is being drawn up which will be appended to a complicated HMO bill which will not be controversial. Both sides of the aisle want to reign in some of the abuses of the HMOs. So far, so good. If this bill slips through the F.D.A. will be empowered to regulate natural (herbal) products. Yep, you will need a prescription to get your echinacea, etc. It would devastate the health food industry while lining the pockets of physicians.

We have the email addresses of all of the Senators and Congressmen. We wrote some unique software which can send an email to each legislator. The email appears to have come from you. It is tempting to just do it but, without your permission, that would be deceptive and downright unethical.

With our large subscriber base we can probably stop this outrage in its tracks. Imagine a legislator receiving 30+ thousand emails demanding that this nefarious appendage be removed from what is otherwise a good bill.

WILL YOU SPEND 30 SECONDS TO HAVE YOUR VOICE HEARD?

If you share our conviction that herbs remain unregulated then all you must do is

1. Send and E-Mail to Jon5454@yahoo.com

2. Type "Herbs - A prescription item? in the Subject Box

3. Type OK in the text box (The OK will give Jon your permission for him to send an e-mail to all senators and congressmen asking them to remove the clause in the new bill that will require us to have a prescription to buy herbs.)

If you will take a few minutes and forward this to your friends, or post on a news/discussion group we will gain thousands of new voices.

If you choose not to respond then perhaps you have no problem with paying your physician $50.00 for a prescription for your favourite herbal remedy.

Perry A. Chapdelaine, Sr. Cordially, Perry A. Chapdelaine, Sr., Ex. Dir./Sec.

The Arthritis Trust of America, 7111 Sweetgum Road, Suite A, Fairview, TN 37062-9384; http://www.arthritistrust.org; E-Mail: administration@arthritistrust.org; non-profit, 501(c)(3) IRS Tax Exempt; The Arthritis Trust of Canada, 4th Floor, 300 March Road, Kanata, Ontario K2K 2E2 non-profit status; The Rheumatoid Disease Foundation, PO Box 10237, Ashwood, 3605, KZN, Republic of South Africa; tax exempt charity; The Arthritis and Rheumatism Natural Therapy Research Association; Cracoe House Cottage, Cracoe, Nr. Skipton, North Yorkshire BD23 6LB, England Your donation appreciated by each of us!!

-- Lisa Richards (lisarichards@jerusalemail.com), January 04, 2001

Answers

Lisa:

I don't have a great deal of problems if the intent of bringing herbal supplements under FDA approval is the suppliers have to prove they work as advertised. If the suppliers of, say, St. John's Wart, said helped alievate joint pains, they had would have to provide scientifically verifiable document which proves it does. Yes, it may drive some out of business for selling something which is falsely advertised as a beneficial health product.

Just because they would under FDA supervision, doesn't mean they would require a prescription. Many over-the-counter products are under FDA supervision now.

-- Ken S. in WC TN (scharabo@aol.com), January 04, 2001.


WELL I HAVE A BIG PROBLEM WITH IT! It is none of the business of the government how I choose to treat myself. The FDA needs to stay out of herbal medicine. Its bad enough that if you want to keep some antibiotics on hand for an emergency you have to go to mexico to buy it. if the FDA gets involved in this they will make herbs illegal, because of the deep pockets of the drug companies. Herbs are our only protection from the drug companies we have left. The FDA has been trying to stop the herbal industry for years and the reason isn't public safety. The reason is, money money money! The government certainly doesn't want us to be able to treat ourselves, because then we aren't slaves to the medical establishment.

Little Bit Farm

-- Little bit Farm (littlebit@calinet.com), January 04, 2001.


I agree with Little Bit, we don't want government in this. Being approved by the FDA means nothing to me, they approved Phen/Fen & other drugs then had to pull them from the market after ruining people's lives. I'd rather rely on my own research & intuition, I care more about my health than the government does.

-- Lenore (archambo@winco.net), January 04, 2001.

Don't have a problem supporting this but....

what's the bill(s) that will allow this to happen?

Seems the post is a little short on hard facts.

Not trying to be a 'downer' but full disclosure is important.

j

-- j (jw_hsv@yahoo.com), January 04, 2001.


Ken, with all due respect, I hope you'll rethink your position on this very important matter. Yes, there are those that are unethical in the herb industry just as in all others. There's a few different ways to approach this, but I'll take it from my health point of view. Herbs and other natural remedies are the only medicines that I can take. My husband works very hard for our money, and I don't want any more of it to go to the pharmacists/pharmaceutical company/doctors.

It's synthetic chemical/vaccinations etc. that got me in this condition, but they can't get me out of it.

Also, the government took L-tryptophan off the market after a lot of people got sick from it. The government "found out later" that it was the Japanese company that screwed it up. Years later you can buy it, but only with a perscription. I really doubt you can get it for under $20 a bottle through a dr.

We can grow many of our own herbs, but not all. Will the government forbid the selling of empty capsules? It's a possibility.

I don't think we need any more government interference, "IT" already thinks it's God, and that the people don't have enough sense to take care of themselves. Why should we let them go on believing that?

-- Cindy (atilrthehony_1@yahoo.com), January 04, 2001.



How do you "forward this to your friends" is there a way other than typing it all out? thanks

-- Cindy (atilrthehony_1@yahoo.com), January 04, 2001.

To forward -- highlight everything you want to copy as if you were going to delete it. When it is highlighted, hit 'Edit', then 'copy'. Go to a fresh 'new mail' section that you will e mail your friends with, put the cursor on the space as if you were going to type it in, go back to 'edit', open it, now hit 'paste'. That should put it there and you can e mail it to your heart's delight.

-- Julie Froelich (firefly1@nnex.net), January 04, 2001.

Just as an aside, most memebers of congress ignore e-mails, especially those that come en-mass with virtually the same text. A letter or phone call to their office is much more effective.

As for the issue, I have little trouble with herbal supplements being marketed as long as no health claims are made on the packaging or accompanying literature. If companies wish to market things they claim will cure what ails ya, they should be willing to back it with scientific evidence and have little or no fear of the FDA. Patent medicines were once prevalent and though well of by many, but most had little positive effect and many caused bad things to happen. Caveat emptor.

-- ray s. (mmoetc@yahoo.com), January 04, 2001.


Ray and Ken, I'm sorry to say that from my years of involvement in the herbal healing field, the idea that the FDA cares about 'scientific evidence' and the public good is far and away a fallacy. The FDA has shown itself consistently to exist primarily as a protective agency of corporate America, period. The 'studies' necessary to get a product approved are almost invariably funded by the companies who benefit from said approval. The phamaceutical industry builds complex infrastructures into the land grant educational institutions, medical schools, public schools,and so on, to brainwash the public into believing that the crap they make and push on the populace through their physician-pushers is safe and effective. Well its not true.All pharmaceuticals have side effects, and the myriad combinations of drugs that are commonly prescribed today, particularly to elderly people, are NEVER TESTED TOGETHER. The government hasnt a clue how safe they are, but that does not stop them from not only approving their widespread use, but encouraging it,and also trying to bad mouth natural herbal remedies.

Way to go LIL bit!!

-- Earthmama (earthmama48@yahoo.com), January 04, 2001.


Whoa, this is BIG!!! Earthmama, we are in complete agreement! The only thing to add to the other pro people, anti bureaucrat position is that the FDA gets an average of 2 million for each "drug" it approves. I admit that i don't know the dispensation of the funds, but they don't care about your health at all....please check out all the FDA previously approved drugs in the Bad medicine post I'm about to put up.

-- Doreen (animalwaitress@excite.com), January 04, 2001.


I would like to add that I have never heard anyone claim that St. John's Wort cures joint pains...I have heard it used in place of Prozac, which can cause LIVER FAILURE, but is approved by the FDA. The only thing I have heard St. John's Wort doing was causing some instances of increased photosensitivity, and increased risk of sunburn.

I am forgetting what specific year it was, but I want to say 1998, in which there was ONE case of fatal ingestion of an herbal supplement (Ephedra -- taken by a teenager who wanted to get high and exceeded the dosage by several dozen times), and in the same year there were in excess of 10,000 deaths directly attributable to FDA approved drugs. Tylenol, available off the grocery shelf to anyone, is also responsible for liver damage, and if you take it without reading the directions and drink alcohol, you can be a candidate for a liver transplant.

I also recall the wise FDA banning Cyclamate sweeteners in soft drinks because they caused cancer, and approving the continued use of 'harmless' saccharine. The saccharine tasted like ****, so I refused to drink it -- lucky me!!! Turns out that the saccharine producers got the FDA in their pocket to approve their product and squeeze out the cyclamate producers...and it turns out that cyclamates didn't cause cancer, but the saccharine did.

So much for the FDA being able to find their butts with both hands. And I certainly would NOT trust the quack....er, medical doctor that I have been forced to see to make a correct prescription of herbal supplements. He prescribed three different antibiotics for me after seeing me a total of MAYBE 10 minutes in three visits and never doing a single culture -- turns out I didn't HAVE anything an antibiotic would cure!

Sorry for the frothing at the mouth, but the FDA and 'conventional' medicine hasn't done me a lot of good.

-- Julie Froelich (firefly1@nnex.net), January 05, 2001.


Apparently the FDA is already involved somewhat with herbal remedies. This out of today's paper:

Chinese herbs recalled

WASHINGTON - Two California companies are recalling eight brands of Chinese herbs after federal testing found some bottles contaiminated with a chemical that can destroy the kidneys.

Lotus Herbs of La Puente, Calif. and FineMost Corp./QualiHerb of Cerritos, Calif., recalled the produces after the Food and Drug Administration detected aristolochin acid comtamination.

The chemical is highly toxic to the kidneys and can cause cancer.

Recalled Lotus products are: Mu Tong and Fang Ji. Recalled QualiHerb products include Ba Zheng San, Fang Ji Huang Qi Tang, Chuan Mu Tong, Wei Ling Xian, Han Fang Ji and Ma Dou Ling.

Consumers can call Lotus at 877-665-6884 or QualiHerb at 800-533-5907.

-- Ken S. in WC TN (scharabo@aol.com), January 05, 2001.


P.S. Remember there is about a 50/50 chance the doctor treating you won't live to see 60.

-- Ken S. in WC TN (scharabo@aol.com), January 05, 2001.

To clarify, my answer was in no way a defense of the FDA or all of its practices. However, until the herbal "remedy" industry is willing to undego the same scrutiny in product labeling and product purity constraints as major drug co.s, someone has to make the call on public safety. I am all for an informed populous making its own decisions on drugs. I take nothing from my doctor until I have read and had explained to me all available warnings about side effects and drug interactions. Anyone who doesn't probably deserves what they get. What bothers me is herbal supplements making medical claims without regard to dosages, or product purity and ,in some cases, facts. Who ensures that I am indeed getting what is claimed? Yes, there are some very good companies out there and they should not be punished for doing good. Neither should they be exempt from the rules just because they claim to be pure of heart.

-- ray s. (mmoetc@yahoo.com), January 05, 2001.

I have worked with the FDA and the clinical trials establishment for several years, so here's my insiders take on the situation.

1)The process to bring a drug from initial concept to final FDA approval can take 10-15 years and cost millions of dollars. The drug companies are willing to foot the bill because they know that they'll have exclusive patent protection for the new drug and can get a good return on their investment. Similar patent protections do not exist for herbal remedies, so there is no financial incentive to do the studies and nobody works for free.

2) One of the first things required by the FDA in the approval process is the complete chemical structure of all of the active components of the drug. For example, the active component of the drug Prozac is a chemical called fluoexetine hydrochloride. Eli Lilly Co. created this chemical using computer modeling, then spent many years figuring out how to actually make it. An herb is not an isolated chemical, it is a complex mixture of substances working together to produce the desired effect. Even in well-studied herbs such as St. John's Wort there is not complete agreement as to what all the active components are.

3) Each drug submitted for FDA approval must undergo extensive testing to prove safety and efficacy. The FDA will not accept the hundreds of years of evidence that a particular herb is safe and works as claimed because these are not "controlled studies". Each active component must be tested individually for the study to be considered controlled. With drugs this is fairly simple. The active components in herbs tend to work synergistically, which means when you test each component individually you lose the desired effect. In fact, some herbs have components which are toxic on their own, but are moderated by other components in the plant. Many herb companies are now marketing what they call "standardized extracts", but even these are added to a whole-herb base so that the moderating components are not lost.

There would need to be a complete overhaul of the mindset of the FDA before we see herbs going through their approval process. The drug companies have the FDA in their pocket, IMO they will only allow it to happen if they can figure out a way to make a buck out of it. I would much rather have my "untested and unsafe", inexpensive, whole herbs rather than some industrialized, expensive, processed herb component with all of nature's energy sucked out of it!

BTW, St. John's Wort infused in oil is used externally for muscle and joint pain. The media hype about it's antidepressant effects has largely overshadowed this use. I make a lip balm from oil infused with it and thyme (an antiviral) which works great on cold sores.

Winter's Blessings, Sherri in IN

-- Sherri C (CeltiaSkye@aol.com), January 05, 2001.



I agree with you Ray, but only because we're talking about two different things. The FDA requlations are huge and very convoluted (like anything else in our government!). What you are talking about falls under the sections dealing with "misbranded and adulterated products". These regulations apply to food, both prescription and OTC drugs, and cosmetics. Simply stated, they require that whatever is in the product be listed on the label, and whatever is on the label be in the product. The Chinese herbal suppliments being recalled in California contained an ingredient that was not listed on the label, that's why they're being recalled. I agree that these regulations should apply to herbs; when I buy a bottle of ecchinacea capsules the capsules should have ecchinacea in them!

What I was talking about in my other post was the process in which it is "scientifically proven" to the FDA that a drug works as it is claimed and is more "clinically benificial" than anything else currently available. I just don't see herbs making it through this process as it currently stands.

Sherri in IN

-- Sherri C (CeltiaSkye@aol.com), January 05, 2001.


Julie, actually I quote I've often read about the deaths due to prescription drugs is closer to 40,000 a year!

-- Earthmama (earthmama48@yahoo.com), January 05, 2001.

Sherri- I think we agree. I would add this: If you're going to attribute medical benefits to your product, you should be willing to prove them in some other way than anecdotal evidence. If you cannot prove that it works in "scientific" studies how can you claim it works? My key objection is the claiming of benefits that cannot be proven.

Earthmomma- Please do not take this as a contentious answer, but how many lives are saved or extended through the use of prescription drugs? Not all things work the same for all people.

-- rays. (mmoetc@yahoo.com), January 05, 2001.


St. John's Wort is great for sciatic pain. I started taking it for depression, can't say it did much for that, but what I did get was amazing relief for sciatic pain and brown spots on my arms from the sun that will never go away. I stopped taking it and went back to exercising for the sciatic pain. A friend did some research on the internet and found that St. John's Wort was used for sciatic pain long before anyone ever dreamed of the FDA.

I'll take my chances with herbal remedies that the FDA hasn't approved, I try them, if they work, great, if not then I toss them. I, for one, am a firm believer in vitamin, herbal and homeopathic remedies. Blessings

-- judymurray (nomifyle@yahoo.com), January 05, 2001.


Ray, I encourage friendly contention! I am one of those weirdos who have no faith in the medical establishment whatsoever, so my response is questionable and biased.....however, to me, the answer to your quesion is "almost none". Although I would never assume to tell anyone else how to manage their own personal health care, I do heartily believe there is a natural remedy, preventative, and cure for virtually every malady that we might encounter. I do not believe in drugs for high blood pressure, high cholesterol, depression, PMS, sexual dysfunction, morning sickness, cancer, etc etc, that are handed out like so much candy in this country. I believe that antibiotics have a small role to play serious illness (there are natural antibiotics that work just fine for minor infections), but beyond that, I personally would have nothing to do with pharmaeuticals. Doctors are good at diagnosis and trauma, and do some amazing things with surgery, but that's the extent of their potentional involvement in my and my family's life. But I reiterate, this is just my peculiarity, and it has served us well so far.

Blessings,

-- Earthmama (earthmama48@yahoo.com), January 05, 2001.


Thank you earthmomma for the reasoned response. I ,too, have a healthy skepticism for much of modern medicine but not quite the dim view of yours. I do agree that it is our differences that make us great and enjoyable to be around. How boring it would be if all were like me.

-- ray s. (mmoetc@yahoo.com), January 05, 2001.

Everybody note the date...I agree with all who posted against the FDA regulating herbal remedies....egad. As a board-certified member of the medical establishment for longer than some of you have been alive, it is very apparent that the drug companies do not give the proverbial rodents posterior about your health, only your wallet, and the FDA only cares about the drug companies. The AMA does not know diddly about herbal remedies and therefore condemns them. Ah, but if so many millions of Americans are buying them, then...hmmmmmm...maybe we need to get in on this market after all....I have always practiced that less medicine is best medicine. Can't count the number of angry moms and dads who threatened to sue me becuae I would not prescribe antibiotics for a little one's cold...More than half of the folks taking regular medicine do not need it, but try to tell them that. On the other hand, i have seen many folks become seriously ill because they chose to treat themselves with herbs rather than check out symptoms with a physician or nurse practitioner..had an Amish teen die from a ruptured appendix because his parents were giving him herbal cold water enemas for three days. Just as prescription meds are overused (or ill used), so are herbs..be knowledgeable and be careful, and DO NOT allow the FDA to regulate a single herb. God bless.

-- Lesley (martchas@bellsouth.net), January 05, 2001.

Well, I'm happy to be in agreement on something with all my rabidly anti-government friends. Start now to learn about the herbs you can gather and grow and compound. I know that advice is not for everyone, but if enough of us become "herb doctors", others will have someone to turn to. This may bring to your mind a picture of a return to very "primitive" medicine, - but it's not a step backward. This is 2001, and our knowledge of herbal medicine and alternative therapies is far from primitive. It was inevitable that if herbal medicines cut too much into the profits of the medical establishment, they would come under attack. Though a scientist by training and occupation, I don't share Ray's faith in the scientific approach. Most of what we know is based on experience (anecdotal evidence) - ours and others.

-- Sam in W.Va. (turnip55a@yahoo.com), January 07, 2001.

I would need to see a bill number and have more information before I could write a letter. I've seen this posted on some natural health lists I belong to and many have said it is a hoax (due to lack of specific information). While I'm against all regulation of herbal medicine, I also am relieved I can make my own medicines and grow my own herbs. Nobody can stop me from doing that.

-- Amy (acook@in4web.com), January 07, 2001.

Count me among those who distrust the medical community since money is their god. I, too, believe it is wrong for the government to regulate this since it's only for money and NOT for health. It's like the "certified" or the "qualified" anything. As long as the dues are paid, you can get the "certificate." It actually (rarely) means squat! Forget what the bottle "claims" the herb is for. LEARN for yourself and then buy what you need. There are countless herbal books/guides out there. Grow or wildcraft what you can. That's what we do, Countrysiders! I've got wild St. Johns Wort, mullein, plaintain, rosehips, etc.. here and have started my own echinacea, calendula, comphrey... I know there are somethings we will always have to purchase, but learning what works for what and the dosage and the form, etc.. means I can go and buy it without ever looking at what the latest claims are. I would put money on those claims over those of the pharmecutical companies any day. Just look at their record! Scary. Psalm 104:14

-- Nancy in CA (sonflower35@icqmail.com), January 08, 2001.

There has been a bit on this in the paper recently.

Article said the estimate of those in the U.S. annual from an adverse drug reaction may be as high as 100,000 - twice the number of deaths from traffic accidents. Many cases may go undetected. You are sick, you die and the link is hard to prove.

Other factors:

FDA being pushed to get new drugs on the market quicker. At one time FDA looked to Europe. Drugs could be introduced far easier there and adverse reactions generally showed up prior to introduction in the U.S.

FDA cannot test for the reaction of a drug to every other possible drug. While it might work great by itself, most patients have other problems for which other drugs (or herbs) are being taken. Two of my sisters had/have heart conditions. Their doctors were/are constantly having to adjust doses between several medications.

As soon as a new 'wonder drug' is approved, it is heavily advertised with the advice to talk to your doctor about it. Thus, doctors can feel pressured from patients to try a new drug.

One cannot expect a doctor to be a walking "The Physician's Desk Reference to Drugs" or whatever the title is.

On statements, I bought a resupply of one-a-day multi-vitamin/multi- mineral. Says "with Lutein - Helps Maintain Healthy Eyes**" In small script at the bottom, "**This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."

I agree with the one posting about this perhaps being a hoax. Literally thousands of bills are submitted to Congress each year. Only a very small fraction become law.

-- Ken S. in WC TN (scharabo@aol.com), January 10, 2001.


Actually, I would welcome this. I pay a copay of $7. for any prescription I get and then go and pay $30.-$40. for some herbal remedies. If you don't have insurance, than I'm sure the price of the herbals will go up when they are "regulated." But, then if you can afford to buy them as they are priced now "unregulated", then I guess it won't effect you....possibly, the prices may come down on many of these since they are not regulated and pricing is totally based on supply and demand.

Truthfully, I can tell you, you aren't getting what you think when you buy some of these herbs. Think about this, if Chinese Ginseng can bring $100 a pound, how is it you can go to a healthfood store and pay anywhere from $6./60 caps to $24/30 caps for the same "Chinese Ginseng?" Something is wrong somewhere. Nothing wrong with some regulation of these products. Right now, you just have to trust the manufacturers...I can tell you as a chemist, that it takes a crackerjack chemist to run mass specs on these herbs and give you an accurate "standardized" analysis of what is actually in that cap...only the larger manufacturers can afford to pay a staff of PhD chemists to do this type accurate analysis....I only buy big name brands.

Think hard before you get all gung-ho about fighting the government on this...not everything they do is wrong.

-- jimR (jymcyn@earthlink.net), January 10, 2001.


Perhaps we need to take a look at the way we go about this. I grow herbs for my own use. I order through a few discount places, the items i can't resonably grow. I will not pay 30-40 dollars for a bottle of herb with no herb in it. These mircle herbs are a joke and the companies that sell them know it. The best way to stop a bad product is to quit buying it. However the government should not be involved in this. I understand that some companies sell bad products. It is up to us as consumers to be aware of what we buy. I agree the government isn't all bad, maybe only 95%.

-- Shau Marie Miller (shau@centurytel.net), January 10, 2001.

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