Homeopathy is everywhere!

Steve,

You would be in favor of large scale clinical trials of homeopathic "remedies", wouldn't you? And if they fail, they'd be illeagel to sell, like apricot pits for cancer.
 
Ed said:
If there were anything to homeopathy, anything at all, the loons that practice it would be all over the FDA to have their "remedies" tested and approved. They don't cuz they know better.

Sniff test.

Homeopathy=BS

If you disagree, then why the low profile with the FDA?

Incidentially, Steve, not one thing you posted addressed this.
 
Ed: You would be in favor of large scale clinical trials of homeopathic "remedies", wouldn't you? And if they fail, they'd be illeagel to sell, like apricot pits for cancer.



Absolutely! The companies who make these should conduct phased trials just like other companies do for allopathic drugs.
I dont know what you call large scale but I have seen studies for new sleeping pills involve only a hundred or so people. Each person has ten sleep studies, each sleep study is 1000 pages long so this is a million pages of data. (100X10X1000) so the
paperwork adds up quickly. Today we can put this much data on
60 or 70 DVD or Optical Disks but sometimes such studies are still done on paper and shipped to the FDA via a number of tractor trailers.

Since such firms are not going to risk putting themselves out of business and pay for the privilege the FDA shoud mandate such studies if they wish to continue selling in the U.S. market. If not, good bye. Nice knowing you.

But you and Pyrrho said it wasnt so simple due to something about being grand fathered in. So all the FDA has to play with are the same pro and con and "maybe its placebo effect" studies that we have looked at here. Not enough for them to grant the petitions over the years they have received to ban homeopathic drugs.

Anyone figure out how to determine the placebo effect in a dog?
A horse? Or a human infant?
 
Ed: Incidentially, Steve, not one thing you posted addressed this.

Reply: Because they do not have a low profile with the FDA. In fact they probably have a very high profile with them. The FDA has been petitoned twice to ban them and rejected the petitions. The FDA regulates them, I posted the regs:

1. They regulate the manufacture of homeopathic drugs
2. They regulate/inspect the location of their mfg
3. They regulate/specify labeling
4. They regulate/specify packaging
5. They differentiate between OTC homeopathic drugs and
homeopathic drugs and potencies which must be prescribed
by a licensed physician
6. in their regs they caution against fraudulent claims
7. they regulate/license who prepares homeopathic drugs, their qualifications, etc.

As to why homeopathic manufacturers dont cough up the millions to do large scale clinical trials, I think the answer is obvious: they don't have to and why take the risk. (see below-I agree the FDA
should mandate them to do this or clear out of the US market).
 
SteveGrenard said:

Anyone figure out how to determine the placebo effect in a dog?


As James Carvel said "That dog don't hunt."

This is completely irrelevant, I just love the expression. Sorry:D
 
SteveGrenard said:
Ed: You would be in favor of large scale clinical trials of homeopathic "remedies", wouldn't you? And if they fail, they'd be illeagel to sell, like apricot pits for cancer.

Absolutely! The companies who make these should conduct phased trials just like other companies do for allopathic drugs.
I dont know what you call large scale but I have seen studies for new sleeping pills involve only a hundred or so people. Each person has ten sleep studies, each sleep study is 1000 pages long so this is a million pages of data. (100X10X1000) so the
paperwork adds up quickly. Today we can put this much data on
60 or 70 DVD or Optical Disks but sometimes such studies are still done on paper and shipped to the FDA via a number of tractor trailers.

Since such firms are not going to risk putting themselves out of business and pay for the privilege the FDA shoud mandate such studies if they wish to continue selling in the U.S. market. If not, good bye. Nice knowing you.
I agree, the FDA should mandate such studies. Any manufacturer of a drug, homeopathic or otherwise, should have to play by the same rules as all other such manufacturers.

But you and Pyrrho said it wasnt so simple due to something about being grand fathered in. So all the FDA has to play with are the same pro and con and "maybe its placebo effect" studies that we have looked at here. Not enough for them to grant the petitions over the years they have received to ban homeopathic drugs.

Anyone figure out how to determine the placebo effect in a dog?
A horse? Or a human infant?
See, that's the problem. The FDA isn't fully doing its job as regard homeopathic preparations.
 
You can petition the FDA to investigate a claim/drug. It requires a bit of backup and the FDA MUST respond, by law within a certain time frame. I had suggested here that this would be a good class project for us but the idea went over like a turd in a punchbowl.

We, the folks on this board, petition the FDA.
 
Ed said:
You can petition the FDA to investigate a claim/drug. It requires a bit of backup and the FDA MUST respond, by law within a certain time frame. I had suggested here that this would be a good class project for us but the idea went over like a turd in a punchbowl.

We, the folks on this board, petition the FDA.

What does it require? Write me an article and let's start a landslide... :)
 
CFLarsen said:


What does it require? Write me an article and let's start a landslide... :)

Here is what they say on their web site. Do you think that it is worth following up on?

Petitions
Another way to influence the way FDA does business is to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly.

Petitions require careful preparation by the submitter. FDA spends considerable time and staff resources processing petitions. Individuals sometimes submit petitions, but most come from regulated industry or consumer groups. For example, a drug company might request a change in labeling for one of its products; a food company might ask that its product be exempted from some provision of a regulation; or a consumer group might petition FDA to tighten regulation of a certain product.

Petitions submitted to FDA must contain:

Action requested--What rule, order, or other administrative action does the petitioner want FDA to issue, amend or revoke?
Statement of grounds--The factual and legal grounds for the petition, including all supporting material, as well as information known to the petitioner that may be unfavorable to the petitioner's position.
Environmental impact--This information is generally required if the petition requests approval of food or color additives, drugs, biological products, animal drugs, or certain medical devices, or for a food to be categorized as GRAS (generally recognized as safe). Procedures for preparing environmental impact statements can be found in Title 21 of the Code of Federal Regulations, Sections 25.24 and 25.31. If an environmental impact statement is not required, petitions should include a statement to that effect.
The following official certification statement --The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition.
Identifying information-- The petition must be signed and include the petitioner's address and phone number.
In addition, some petitions may require information on:

Economic impact--This information is required only if FDA requests it after review of the petition.
Petitions should be mailed or delivered to: Dockets Management Branch, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.

Ultimately, FDA management decides whether to grant a petition. But first, agency staffers evaluate it, a process that may take several weeks to more than a year, depending on the issue's complexity. After FDA grants or denies the petition, the agency will notify the petitioner directly. If not satisfied, the petitioner can take the matter to court.

For more information on submitting petitions, consult Title 21 of the Code of Federal Regulations, Sections 10.30, 10.33, and 10.35.

Besides accepting public comments and petitions, FDA also schedules public meetings and hearings to discuss and explain its proposals. These usually are held with industry representatives or consumer groups, but anyone interested may attend and, with advance notice, may comment on a proposal. Meetings often are held in the Washington, D.C., area, but sometimes are set in other areas across the country. Meetings for the public to present views are announced in the Federal Register.
 
1994 Petition in re homeopathy signed by Randi, Kurtz + 40 Others

Petition Regarding Homeopathic Drugs

Docket # 94P-0316/CP 1

Dockets Management Branch,
Food and Drug Administration
Room 1-23
12420 Parklawn
Rockville, MD 20857

The undersigned, as agent for 42 individuals, hereby submits this petition pursuant to FDA laws and regulations that require all commercially available drugs to be proven safe and effective and be adequately labeled for their intended uses.

Action Requested

The FDA Commissioner should initiate a rulemaking procedure, similar to the OTC Review, to require that all OTC homeopathic drugs meet the same standards of safety and effectiveness as nonhomeopathic OTC drugs. In the interim, the Commissioner should issue a public warning that although the FDA has permitted homeopathic remedies to be sold, it does not recognize them as effective.

Statement of Grounds

Although homeopathic products are not recognized as effective by the scientific community, the FDA has tolerated their marketing because a provision of the 1938 Food, Drug, and Cosmetic Act recognized substances listed in the Homeopathic Pharmacopeia as drugs. However, nothing in the law prohibits the FDA from requiring homeopathic remedies to be proven effective to remain on the market.

FDA Compliance Policy Guide 7132.15, issued in 1988, states that "nonprescription homeopathics may be sold only for self-limiting conditions recognizable by consumers . . . [Their] labeling must adequately instruct consumers in the product's safe use." However, the guide warns that compliance with its requirements "does not establish that [a product] has been shown by appropriate means to be safe, effective, and not misbranded for its intended use."

The FDA's laissez-fair regulatory policy has enabled dozens of companies to market hundreds of products with claims (often simply in the name of the product) that are unsubstantiated. All of these products are misbranded because they do not indicate on their label that they can remedy nothing. Nor do they state how much of any ingredient the product contains in a way that the average consumer can understand. Nor can adequate directions for use be written for products that don't work. Because the FDA permits their sale, consumers are being misled into thinking that the remedies are effective, not only for symptomatic relief but for the treatment of serious diseases.

Products designated as 24X, 12C, or higher, should contain no molecules of the original substance from which they are prepared. Yet they are being marketed as though they are potent remedies.

One homeopathic manufacturer even advertises that "unlike most over the counter medicines, Medicine from Nature works in harmony with the body's natural defenses and gets to the cause of your illness or discomfort." [See Exhibit A] Many other manufacturers have made similar claims.

Exhibit B provides an overview of the homeopathic marketplace.

Exhibit C is the National Council Against Health Fraud's position paper.

Environmental Impact

None

Certification

We certify that this petition includes all data, information, and views upon which this petition relies, and that we know of no reliable scientific data or other information that are unfavorable to this petition.

Agent for Petitioners

Stephen Barrett, M.D.
P.O. Box 1747
Allentown, PA 18105



FDA Homeopathy Petition

List of Signers, August 1994

(Titles for Identification Only)


Seth Asser, M.D., pediatrician, Assistant Professor of Pediatrics, University of California; Coordinator, NCAHF Task Force on Children's Health Threats
Robert Baratz, D.D.S., M.D., Ph.D., Assistant Clinical Professor of Medicine, Boston University School of Medicine
Stephen Barrett, M.D., author, editor, consumer advocate. Recipient, FDA Commissioner's Special Citation Award for Public Service.
Paula Benedict, M.P.H., R.D., Public Health Nutritionist, San Bernadino County Dept. of Public Health
Wayne Bidlack, Ph.D., Professor, Food and Human Human Nutrition, Iowa State University
John Bolton, M.D., Assistant Clinical Professor of Pediatrics, University of California Medical School (San Francisco)
Michael Botts, Esq., former Assistant Attorney General of Iowa, specializing in health-fraud cases
Bruce Brown, former FDA public information officer
Paul E. Brown, M.D., internal medicine specialist, Lakeview Clinic, Waconia, Minnesota
John E. Dodes, D.D.S., President, New York Council Against Health Fraud; Lecturer, School of Dentistry, State University of New York/Stony Brook
Donald Driscoll, Esq., public interest attorney, Oakland, California
John H. Ellis, Ph.D., Emeritus Professor of History, Lehigh University
Daniel B. Futch, D.C., M.P.S., vice president, National Association for Chiropractic Medicine; vice president, Orthopractic Manipulation Society, U.S.A.
Martin Gardner, science writer, former staff member, Scientific American
Saul Green, Ph.D., research biochemist, former researcher, Memorial Sloan-Kettering Cancer Center
Victor Herbert, M.D., J.D., Professor of Medicine, Mt. Sinai School of Medicine; Recipient, FDA Commissioner's Special Citation Award for Public Service
Wallace Janssen, FDA Historian; former director of public information for the FDA
Leon Jaroff, contributor to and former senior editor (science) of Time magazine; founder and former managing editor, Discover magazine
William T. Jarvis, Ph.D., Professor of Preventive Medicine, Loma Linda University; and President, National Council Against Health Fraud
Manfred Kroger, Ph.D., Professor of Food Science, The Pennsylvania State University
Paul Kurtz, Ph.D., Chairman, Committee for the Scientific Investigation of Claims of the Paranormal
Marvin Lipman, M.D., Clinical Professor of Medicine, New York Medical College; chief medical advisor, Consumers Union; former member of two FDA advisory committees
William London, Ed.D., Associate Professor of Health Education, Kent State University
James A. Lowell, Ph.D., Professor of Molecular Biology, Pima Community College
Paul MacCready, Ph.D., engineer, inventor, board chairman, Aerovironment, Inc.
Gabe Mirkin, M.D., Associate Clinical Professor of Pediatrics, Georgetown Medical School
Grace P. Monaco, J.D., specialist in health law; former member of FDA advisory committee
Merlin Nelson, Pharm.D., M.D., former Assistant Professor of Pharmacy Practice, Wayne State University School of Pharmacy
Robert L. Park, Ph.D., Executive Director, The American Physical Society; former chairman, Physics Dept., University of Maryland
James Randi, author, lecturer, investigator of psychic/paranormal claims
Jack Raso, M.S., R.D., editor/publisher, Nutrition Forum newsletter
John H. Renner, M.D., President, Consumer Health Information and Research Institute
David B. Roll, Ph.D., Acting Dean and Professor of Medicinal Chemistry, University of Utah College of Pharmacy
Paul Saltman, Ph.D., Professor of Nutrition, University of California, San Diego
Wallace Sampson, M.D., F.A.C.P., Clinical Professor of Medicine, Stanford University School of Medicine; member, Cancer Advisory Council for the State of California; Board Chairman, National Council Against Health Fraud.
Marvin J. Schissel, D.D.S., dentist, private practice, Woodhaven, New York
Elie Schneour, Ph.D., Sc.D., Director, Biosystems Research Institute, San Diego, California
Varro E. Tyler, Ph.D., Professor of Pharmacognosy, Purdue University College of Pharmacy
Lewis Vaughn, author and magazine editor
Mahlon W. Wagner, Ph.D., Professor of Psychology, State University of New York/Oswego
Elizabeth M. Whelan, Sc.D., M.P.H., President, American Council on Science and Health
James Harvey Young, Ph.D., Professor of History, Emory University; former member of FDA National Advisory Food and Drug Council.
 
I had a suspicion that homeopathy has been petitioned to the FDA. I'm sure the lobbyists stopped the tests from occuring. Homeopathy and alternative meds are a billion-dollar industry after all. A billion dollars of profit with little to no overhead since tap-water is very cheap.
 
I think the big question for anyone thinking of re-petitioning on this is to learn how the FDA interpreted this petition which it obviously failed to enact. Some questions such as:

1. do they accept the clinical trials extant as sufficient evidence to
meet their criteria?

2. do they interpret the 1938 enactment as sufficient legal
justification not to act on this petition

3. does FDA lawyers think they can be successfully challeneged
(in court) on either 1 or 2 above?

Or any other factors that may've gone into their decision and then find a rationale and basis to overcome them.
 

1. do they accept the clinical trials extant as sufficient evidence to
meet their criteria?


I doubt it has anything to do with clinical trials, since there aren't any credible studies that support the effectiveness of homeopathy.


2. do they interpret the 1938 enactment as sufficient legal
justification not to act on this petition


I also doubt this, as the real motivations are political and not medical.


3. does FDA lawyers think they can be successfully challeneged
(in court) on either 1 or 2 above?


Probably not, especially since they ARE the governing body.


Or any other factors that may've gone into their decision and then find a rationale and basis to overcome them.


Money and voters is the main reason. The skeptics of society are the minority and most people believe in some form of "alternative" medicine.
 
thaiboxerken said:

Bull! Just like you, he is defending homeopathy while not stating that he believes in it. You both are dishonest trolls.

No bull. :)

From what I can tell, Steve (and feel free to correct me if I'm wrong Steve) is impartial like myself on the effective/ineffective-ness of homeopathy. And that he simply studies the papers that are out there, whether significant or non-significant, and judges accordingly to the database of evidence. That is, he obviously admits that many studies cannot differentiate homeopathy from placebo, but also admits that there are a some significant studies that warrant further study.

That, in my opinon, is very far from dishonest.

As for myself, I've also stated numerous times to you Ken that I do not personally believe in homeopathy. However, I can detach myself emotionally from that and study the significant papers in addition to the non-significant ones.
 
Ed said:
My take is that a woo-woo put the fix in some time ago and now this junk is grandfathered in some obscure way. I suspect that homeopathic lobbyests are in there some where. Is the a homeo lobby? Bet there is. I also bet that they would be against any testing and bringing homeo products up to the level of acceptance as real ..

Bring on the conspiracy theories.
 
SteveGrenard said:
Anyone figure out how to determine the placebo effect in a dog? A horse?

I was staying out, here, because it's all boring and repetitive. However, this is something I know about.

It's remarkably easy to persuade the OWNER of the dog or the horse that the animal is better, even when it isn't. For some reason homoeopaths seem to be particularly good at this. This is why it's extremely important to blind the person who is responsible for assessing the animals' condition - especially if subjective assessments are being relied on, as they often are with homoeopathy.

Another point to consider with some of the animal homoeopathy claims I've seen is the accuracy of the original diagnosis. If you simply assert that the dog has condition x, which is serious, then give it the homoeopathy and it recovers, hey, bully for the homoeopathy. But if condition x is something which needs to be confirmed say by laboratory tests, and these tests were never done, how do we know the animal actually had that condition in the first place?

There are very few properly controlled trials of homoeopathic remedies in animals. NONE of them, I repeat none, none, none, has ever shown an effect.

Rolfe.
 
Boring. Repetitive. 16 pages going round in circles. :mad:

Homoeopathy is political, both in the States and the UK, and just about everywhere else. It's the sort of Sympathetic Magic which appeals to unsophisticated people, and its proponents seem especially skilled in putting out warm fuzzy messages about the general niceness of the so-called "natural" method.

Because of support in political high places and a lot of vested interests which are making a great deal of money out of it, the "grandfathering" of homoeopathic remedies (which means that they can be marketed without any proof of efficacy) is difficult-to-impossible to assail. Even though there's nothing or next to nothing in any of them.

In human medicine, there are a few studies which have come up with apparently statistically-significant effects of homoeopathic remedies. A couple of poorly discriminating meta-analyses have given these studies more weight than they actually warrant.

Against this, there is a wealth of literature both demonstrating null effect of homoeopathic remedies and/or methods, and pointing out the serious statistical and methodological flaws in the above papers.

On top of that, any reproducible evidence that there is any way at all to differentiate a homoeopathic preparation from a sham, and the Million Dollars is in the bag. Nobody has gone for it. Even the easy bit, showing that the "provings" are valid by showing that a healthy person actually does feel something out of the ordinary when taking a remedy, hasn't been touched.

But SG and T'ai Chi just keep repeating the fact that there are some positive studies out there, while ignoring all the contrary evidence they're shown. And claiming that the only reason nobody has gone for the challenge is that everybody involved in homoeopathy is so unworldly and so rigorously scientific that they'd scorn such an unorthodox test. They then dress this up as impartial assessment of the evidence.

I've given up hoping that either of you will actually look sensibly at the references people keep posting here, and I for one don't intend to post them all again.

Come on. If you can't move on with the discussion, but just intend to keep plugging away with the same inane assertions, why not just drop it?

Rolfe.
 
When you deal with true believers it is pretty much always the same. The interesting question is how do true believers get that way?
 

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