Register | Sign In


Understanding through Discussion


EvC Forum active members: 65 (9162 total)
6 online now:
Newest Member: popoi
Post Volume: Total: 915,817 Year: 3,074/9,624 Month: 919/1,588 Week: 102/223 Day: 13/17 Hour: 1/1


Thread  Details

Email This Thread
Newer Topic | Older Topic
  
Author Topic:   Childhood Vaccinations – Necessary or Overkill?
Wounded King
Member
Posts: 4149
From: Cincinnati, Ohio, USA
Joined: 04-09-2003


Message 226 of 327 (370027)
12-15-2006 7:26 PM
Reply to: Message 223 by Buzsaw
12-15-2006 6:30 PM


Re: Testing Avoidance
A bag of jelly beans or double bubble gum has more potential for serious illness than 98% of the herbals.
Do you have some evidence to back that up?
The point isn't that the safety of the supplements is in question but rather the efficacy of their health claims. The safety issue is a minor one in terms of why the industry doesn't want to be regulated. Their concern is not for being held to a too stingent standard of safety of consumption but of being held to a too stringent standard with regards to the health claims they make, the same standard to which food is held.
What you are addressing is the sort of strawman spectre the industry used to push through the original DSHEA legislation, that of supplements being driven out of the market place by ludicrous safety standards equivalent to an experimental new drug therapy.
As I pointed out previously that wasn't the standard they were going to be held to, it is a wholly specious argument.
TTFN,
WK

This message is a reply to:
 Message 223 by Buzsaw, posted 12-15-2006 6:30 PM Buzsaw has not replied

purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 227 of 327 (370172)
12-16-2006 9:21 AM
Reply to: Message 222 by Wounded King
12-15-2006 6:03 PM


Re: Testing Avoidance
You're trying to create an argument where there wasn't one.
As I said before, I asked a simple question concerning basis for a statement. Message 184
quote:
So why you still act as if these manufacturers are a model of concern for the wellbeing and informed status of their consumers, I mean apart from the way they lie about the implications of proposed legislation which obviously just confirms their good character.
I've never implied any industry is a model of concern for the wellbeing and informed status of their consumers.
Drug, Food, and Supplement industries are out to make money. Period. Businesses are out to make money. The people in the government are out to make money. Their "concern" for our wellbeing is based on what benefits them and keeps them in business.
Given that the following excerpt might give you an idea of their concern.
The FDA took a position in response to the NLEA, which many, including some in Congress, took to reflect an overeagerness to place undue restrictions upon claims made from dietary supplements.
Apparently the standard was unclear. Was significant scientific agreement a dozen published articles that agree with the claim or agreement by the National Institute of Health concensus panel?
So the supplement industry apparently didn't like the FDA's interpretation of the standard.
quote:
Your last couple of posts just seem to be agreeing with the points Schraf and I have been making all along, that these companies want to avoid complying with the same standards of evidence for efficacy that every other type of product making similar health claims does.
I feel we have a different idea of what they may be avoiding.
Since natural substances supposedly can't be patented, the supplement industry would not benefit financially from the level of testing done for drugs, which IMO is why they don't want to be deemed drugs. They want to be responsible for maintaining safety standards.
As shown above concerning health claims, they had difficulty with the lack of clarity in the NLEA standard and FDA's interpretation.

"Peshat is what I say and derash is what you say." --Nehama Leibowitz

This message is a reply to:
 Message 222 by Wounded King, posted 12-15-2006 6:03 PM Wounded King has replied

Replies to this message:
 Message 232 by nator, posted 12-16-2006 3:43 PM purpledawn has replied
 Message 233 by Wounded King, posted 12-16-2006 4:47 PM purpledawn has replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 228 of 327 (370217)
12-16-2006 3:17 PM
Reply to: Message 220 by purpledawn
12-15-2006 4:29 PM


Re: Testing Avoidance
quote:
For example: The supplement industries want the FDA to prove before a court that a supplement is unsafe etc.
Shouldn't the producers of the product have to show that it is safe BEFORE they are allowed to sell it?
Why should the taxpayers have to pay for research that the manufaturers should have to do?
I've asked this question before in this thread, and it was never addressed.
It's not rhetorical, by the way.
Edited by schrafinator, : No reason given.
Edited by schrafinator, : No reason given.

This message is a reply to:
 Message 220 by purpledawn, posted 12-15-2006 4:29 PM purpledawn has replied

Replies to this message:
 Message 237 by purpledawn, posted 12-18-2006 8:20 AM nator has replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 229 of 327 (370218)
12-16-2006 3:21 PM
Reply to: Message 223 by Buzsaw
12-15-2006 6:30 PM


Re: Testing Avoidance
quote:
A bag of jelly beans or double bubble gum has more potential for serious illness than 98% of the herbals.
Buzsaw, when are you going to address the case studies I posted where people were seriously injured by the liver poisons in comfrey?

This message is a reply to:
 Message 223 by Buzsaw, posted 12-15-2006 6:30 PM Buzsaw has not replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 230 of 327 (370220)
12-16-2006 3:26 PM
Reply to: Message 224 by Buzsaw
12-15-2006 6:45 PM


Re: autism-sorry, long
quote:
For example if one uses perfumes, fumigators, hair and arm sprays, tanning/sunburn lotions, hair dyes, lipsticks, et al, et al, their cancer risk rises significantly.
Reference, please.

This message is a reply to:
 Message 224 by Buzsaw, posted 12-15-2006 6:45 PM Buzsaw has not replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 231 of 327 (370221)
12-16-2006 3:28 PM
Reply to: Message 225 by Buzsaw
12-15-2006 6:55 PM


quote:
It is about as addictive to children as tobacco is to adults
Evidence, please.
quote:
and many times more of a health threat than 98% of herbal and other health suppliments found on the natural health suppliment shelves.
Evidence, please.

This message is a reply to:
 Message 225 by Buzsaw, posted 12-15-2006 6:55 PM Buzsaw has not replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 232 of 327 (370225)
12-16-2006 3:43 PM
Reply to: Message 227 by purpledawn
12-16-2006 9:21 AM


Re: Testing Avoidance
quote:
The FDA took a position in response to the NLEA, which many, including some in Congress, took to reflect an overeagerness to place undue restrictions upon claims made from dietary supplements.
This is a quote from a consultant to the supplement industry who shares your opinion.
What is that supposed to prove?
Given the industry's willingness to lie to consumers about their products and also about the proposed regulation doesn't give me much confidence in their analysis of the situation.
quote:
Since natural substances supposedly can't be patented, the supplement industry would not benefit financially from the level of testing done for drugs, which IMO is why they don't want to be deemed drugs.
OK, PD.
Please explain to me why a manufacturer who claims that their product "supports liver function" or "tetoxifies the blood" shouldn't have to actually demonstrate that their product does, in fact, support the function of the liver or detoxify the blood, before they are allowed to sell it?
Would it also be acceptable for a manufacturer and seller of an automobile to claim that it gets good gas mileage without actually having to demonstrate that the car actually gets good mileage?
quote:
They want to be responsible for maintaining safety standards.
What safety standards?
Seriously, what safety standards exist for herbal supplements?

This message is a reply to:
 Message 227 by purpledawn, posted 12-16-2006 9:21 AM purpledawn has replied

Replies to this message:
 Message 235 by purpledawn, posted 12-17-2006 8:20 AM nator has not replied

Wounded King
Member
Posts: 4149
From: Cincinnati, Ohio, USA
Joined: 04-09-2003


Message 233 of 327 (370234)
12-16-2006 4:47 PM
Reply to: Message 227 by purpledawn
12-16-2006 9:21 AM


Re: Testing Avoidance
Since natural substances supposedly can't be patented, the supplement industry would not benefit financially from the level of testing done for drugs, which IMO is why they don't want to be deemed drugs.
Read what I have actually posted previously and then reply. If you can still make this ludicrous claim then you obviously have missed about 3 of my posts which quite clearly point out that the standards they were to be held to were those for food not those for drugs. How can you still not understand this?
Can you show me what source you have that says they were to be regulated as drugs rather than food?
TTFN,
WK

This message is a reply to:
 Message 227 by purpledawn, posted 12-16-2006 9:21 AM purpledawn has replied

Replies to this message:
 Message 234 by purpledawn, posted 12-17-2006 6:58 AM Wounded King has not replied

purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 234 of 327 (370346)
12-17-2006 6:58 AM
Reply to: Message 233 by Wounded King
12-16-2006 4:47 PM


Re: Testing Avoidance
This comment by me in Message 227 is not the point of my post: Since natural substances supposedly can't be patented, the supplement industry would not benefit financially from the level of testing done for drugs, which IMO is why they don't want to be deemed drugs. It refers more to the original statement by Schraf that started this chain. Message 184
This was the point of my post and referenced my response to your health claim issues.
purpledawn writes:
As shown above concerning health claims, they had difficulty with the lack of clarity in the NLEA standard and FDA's interpretation.
As I've said before, it is a political game. A lot of wordsmithing on both sides. Each side protecting their assets.

"Peshat is what I say and derash is what you say." --Nehama Leibowitz

This message is a reply to:
 Message 233 by Wounded King, posted 12-16-2006 4:47 PM Wounded King has not replied

Replies to this message:
 Message 236 by nator, posted 12-17-2006 5:42 PM purpledawn has not replied

purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 235 of 327 (370352)
12-17-2006 8:20 AM
Reply to: Message 232 by nator
12-16-2006 3:43 PM


Re: Testing Avoidance
quote:
This is a quote from a consultant to the supplement industry who shares your opinion.
What is that supposed to prove?
Which brings us back to Message 201.
purpledawn writes:
You can find MD/scientists that support your view with complaints against mine and I can find MD/scientists that support my view with complaints against yours. They are out to support/protect their interests.
quote:
Please explain to me why a manufacturer who claims that their product "supports liver function" or "tetoxifies the blood" shouldn't have to actually demonstrate that their product does, in fact, support the function of the liver or detoxify the blood, before they are allowed to sell it?
Statements of Nutritional Support (DSHEA)
(6) For purposes of paragraph (r)(1)(B), a statement for a dietary supplement may be made if -...
(B) the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading...
As I said in Message 160: We are going through a change in the way we deal with healing and it takes time to get all the ducks in a row, just like it took time for allopathy to get to where it is today. As with any system there are people who take advantage of loop holes to make money. Nothing new there. As those holes are found they are dealt with.
As shown in the letter from the American Chinese Medicine Association (ACMA) to Congress, safety and efficacy of medicinal herbs are based on thousands of years of clinical practice.
Personally I agree with the ACMA and feel that medicinal herbs should have a slot of their own with appropriate regulations. They are not for the general public or unlearned practioners. Not all manufacturers of medicinal herbs sell to the general public.
quote:
What safety standards?
Seriously, what safety standards exist for herbal supplements?
Adverse Event Reports Bill passes. Message 195
(b) Reporting Requirement-
(1) IN GENERAL- The manufacturer, packer, or distributor of a dietary supplement whose name (pursuant to section 403(e)(1)) appears on the label of a dietary supplement marketed in the United States (referred to in this section as the `responsible person') shall submit to the Secretary any report received of a serious adverse event associated with such dietary supplement when used in the United States, accompanied by a copy of the label on or within the retail packaging of such dietary supplement.
(2) RETAILER- A retailer whose name appears on the label described in paragraph (1) as a distributor may, by agreement, authorize the manufacturer or packer of the dietary supplement to submit the required reports for such dietary supplements to the Secretary so long as the retailer directs to the manufacturer or packer all adverse events associated with such dietary supplement that are reported to the retailer through the address or telephone number described in section 403(y).
DSHEA Congressional Findings:
(14) dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare

"Peshat is what I say and derash is what you say." --Nehama Leibowitz

This message is a reply to:
 Message 232 by nator, posted 12-16-2006 3:43 PM nator has not replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 236 of 327 (370447)
12-17-2006 5:42 PM
Reply to: Message 234 by purpledawn
12-17-2006 6:58 AM


Re: Testing Avoidance
Mostly, I'd like a reply to message #228 in this thread.
Thanks.

This message is a reply to:
 Message 234 by purpledawn, posted 12-17-2006 6:58 AM purpledawn has not replied

purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 237 of 327 (370599)
12-18-2006 8:20 AM
Reply to: Message 228 by nator
12-16-2006 3:17 PM


Safety
quote:
Shouldn't the producers of the product have to show that it is safe BEFORE they are allowed to sell it?
I feel I have provided information that addresses your questions, but I don't feel you have read the information provided.
In the world of FDA, safe for dietary supplements means that the ingredient does not present a significant or unreasonable risk of illness or injury under conditions of use recommended in the product's labeling. (FDA Guide to Dietary Supplements)
For drugs it means that the benefits of the drug outweigh the risks for the population the drug is intended to treat and for its intended use. (Why Drugs Get Pulled Off the Market)
Safe does not necessarily mean harmless.
When supplement manufacturers plan to market a new dietary ingredient (a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.) they must provide the FDA with information showing that the new ingredient is reasonably safe.
From what I have read and mentioned before; vitamins, minerals and herbs have a history of use and already considered safe. New drugs do not.
I also showed you in Message 235 that manufacturers of dietary supplements provide substantiation that their labeling is truthful and not misleading.
I also showed in Message 235 that Congress found that dietary supplements are already considered safe within a broad range of intake, and safety problems with the supplements are relatively rare.
As any other product made for human consumption, they are required to follow good manufacturing procedures.
Excerpt from An FDA Guide to Dietary Supplements.
"The majority of supplement manufacturers are responsible and careful," FDA's Yetley says. "But, as with all products on the market, consumers need to be discriminating. FDA and industry have important roles to play, but consumers must take responsibility, too."
Consumer's being discriminating also applies to prescription drugs since there are drugs marketed in the United States that do not have required FDA approval.
However, for a variety of historical reasons, some drugs, mostly older products, continue to be marketed illegally in the United States without required FDA approval. Many healthcare providers are unaware of the unapproved status of some drugs and have continued to unknowingly prescribe unapproved drugs because the drugs’ labels do not disclose that they lack FDA approval. Often these drugs are advertised in reputable medical journals or are included in widely used pharmaceutical references such as the Physicians’ Desk Reference (PDR).
quote:
Why should the taxpayers have to pay for research that the manufaturers should have to do?
What research have you found that taxpayers are paying for?
Edited by purpledawn, : No reason given.

"Peshat is what I say and derash is what you say." --Nehama Leibowitz

This message is a reply to:
 Message 228 by nator, posted 12-16-2006 3:17 PM nator has replied

Replies to this message:
 Message 238 by nator, posted 12-18-2006 9:54 AM purpledawn has replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 238 of 327 (370605)
12-18-2006 9:54 AM
Reply to: Message 237 by purpledawn
12-18-2006 8:20 AM


Re: Safety
You are using the definition of "dietary supplement" to encompass herbal drugs when they shouldn't.
I mean, come on.
Many, many things sold as "dietary supplements" (a term invented in 1994 to be a loophole for the manufacturers and retailers) have no "dietary" value.
They are taken as, and intended to be, medicine. Remedies. Theraputic.
In other words, drugs.
I mean, what nutrition does Comfrey provide? Black Cohosh? Willow bark? Ephedra? Kava Kava? Ginko Biloba? Echinacia?
To expect me to agree that people ingest these and probably hundreds of other substances because they are trying to improve their nutrition is insulting.
They are clearly marketed with that loophole in mind.
quote:
What research have you found that taxpayers are paying for?
When you said that the FDA should have to prove that an herbal drug is unsafe, it is the same as saying that the American taxpayers should pay to prove that a product sold by a private company isn't safe, since the taxpayers fund the FDA.
To me, this is backwards.
The company that wishes to sell anything should have to prove that it is safe BEFORE being allowed to sell it, not require the taxpayers to do the research the company should have been required to do in the first place.
This would include determining what a safe dosage is, what the side effects in the short or long term are, if there are interactions with other drugs or foods, if there are certain subgroups that are affected differently, etc.
Currently, herbal manufacturers are not required to do any of this, and, AFAIK, none of them do it voluntarily.
Can you explain why you believe they shouldn't be required to do so?
Edited by schrafinator, : No reason given.
Edited by schrafinator, : No reason given.

This message is a reply to:
 Message 237 by purpledawn, posted 12-18-2006 8:20 AM purpledawn has replied

Replies to this message:
 Message 239 by purpledawn, posted 12-18-2006 12:29 PM nator has replied
 Message 243 by Coragyps, posted 12-19-2006 9:40 AM nator has replied

purpledawn
Member (Idle past 3457 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 239 of 327 (370636)
12-18-2006 12:29 PM
Reply to: Message 238 by nator
12-18-2006 9:54 AM


Re: Safety
quote:
You are using the definition of "dietary supplement" to encompass herbal drugs when they shouldn't.
As does the FDA.
quote:
I mean, what nutrition does Comfrey provide? Black Cohosh? Willow bark? Ephedra? Kava Kava? Ginko Biloba? Echinacia?
To expect me to agree that people ingest these and probably hundreds of other substances because they are trying to improve their nutrition is insulting.
Which brings me back to my comment in Message 235 where I stated: Personally I agree with the ACMA and feel that medicinal herbs should have a slot of their own with appropriate regulations. They are not for the general public or unlearned practioners.
and Message 160 where I stated: We are going through a change in the way we deal with healing and it takes time to get all the ducks in a row, just like it took time for allopathy to get to where it is today. As with any system there are people who take advantage of loop holes to make money. Nothing new there. As those holes are found they are dealt with.
quote:
When you said that the FDA should have to prove that an herbal drug is unsafe, it is the same as saying that the American taxpayers should pay to prove that a product sold by a private company isn't safe, since the taxpayers fund the FDA.
I don't recall expressing that I felt the FDA should have to prove anything.
In Message 106 I said: If a supplement is hazardous, it is the job of the FDA to take action. Which it is.
In Message 220 I said: From what I have read, the supplement industry feels that the FDA is in the pocket of the drug and food industries. They claim that these industries feel that the supplement industry threatens their profits. The respectable supplement industries seem to be working towards legal intervention instead of the FDA having the power. For example: The supplement industries want the FDA to prove before a court that a supplement is unsafe etc.
According to the DSHEA the United States shall bear the burden of proof before a court of law. It doesn't specify what that is. It doesn't automatically mean a full blown scientific study funded by the government. If you feel otherwise give me an example.
DSHEA
In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.
Wouldn't taxpayers have to foot the bill for any legal action that the FDA takes against any company? Even if it concerns removing unapproved drugs or drugs considered to be unsafe after approval.
In the United States, doesn't the burden of proof lie with the accuser?

"Peshat is what I say and derash is what you say." --Nehama Leibowitz

This message is a reply to:
 Message 238 by nator, posted 12-18-2006 9:54 AM nator has replied

Replies to this message:
 Message 240 by nator, posted 12-18-2006 1:16 PM purpledawn has replied

nator
Member (Idle past 2170 days)
Posts: 12961
From: Ann Arbor
Joined: 12-09-2001


Message 240 of 327 (370643)
12-18-2006 1:16 PM
Reply to: Message 239 by purpledawn
12-18-2006 12:29 PM


Re: Safety
You are using the definition of "dietary supplement" to encompass herbal drugs when they shouldn't.
quote:
As does the FDA.
And it shouldn't have to, PD, that's the whole frigging point.
It was forced to when that travesty of a law was passed instead of the one that should have been.
The FDA was forced to adopt that definition because of the law that was passed that was, in large part, influenced by the false PR and lobbying campaign put on by the herbal manufacturers and retailers.
quote:
Personally I agree with the ACMA and feel that medicinal herbs should have a slot of their own with appropriate regulations. They are not for the general public or unlearned practioners.
So, what do you think appropriate regulations should consist of?
quote:
In the United States, doesn't the burden of proof lie with the accuser?
No, not when somebody is SELLING something.
Shouldn't a product that claims on its label that it "supports liver function" have to show that it actually does, in fact, "support liver function" before it is allowed to sell such a product?
IOW, should a company be allowed to sell a product that it doesn't actually know if it works or not?
Why or why not?
ABE: Basically, what you are suggesting is that, instead of Honda and Ford and BMW having to pay for the safety testing they do for their automobiles as a cost of doing business, it should be the taxpayers who pay for all of that testing only after some of their new models are shown to be dangerous.
Edited by schrafinator, : No reason given.

This message is a reply to:
 Message 239 by purpledawn, posted 12-18-2006 12:29 PM purpledawn has replied

Replies to this message:
 Message 241 by purpledawn, posted 12-18-2006 6:58 PM nator has replied

Newer Topic | Older Topic
Jump to:


Copyright 2001-2023 by EvC Forum, All Rights Reserved

™ Version 4.2
Innovative software from Qwixotic © 2024