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Author Topic:   Childhood Vaccinations – Necessary or Overkill?
purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 206 of 327 (369479)
12-13-2006 6:09 AM
Reply to: Message 204 by Wounded King
12-13-2006 5:10 AM


Re: Testing Avoidance
Look at Message 201 again. Scraf doesn't seem to comprehend what I'm asking for. So I'm trying to explain.
purpledawn writes:
The problem is that you (Scraf) present QuackWatch as "gospel" (parden the expression) and you really have nothing that supports that his statements are true.
I found info that Barrett may not be as objective as he would lead his readers to believe. The example with Pauling is to show that Barrett is not just opposing unscientific quacks.
I end the post by rephrasing my question so that she might understand what I'm asking.
The post was not written to initiate a discussion on Pauling or his research.
So if you have information to support that the following statement is true, I'm listening.
Scraf writes:
...that the law that was passed that classifies all herbal drugs as "nutritional supplements" was lobbied heavily for in Washington by the manufacturers and retailers of these herbal drugs so they could continue to avoid having to test them for safety and efficacy.

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

This message is a reply to:
 Message 204 by Wounded King, posted 12-13-2006 5:10 AM Wounded King has replied

Replies to this message:
 Message 207 by Wounded King, posted 12-13-2006 6:29 AM purpledawn has not replied
 Message 212 by nator, posted 12-13-2006 10:30 PM purpledawn has not replied

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 208 of 327 (369484)
12-13-2006 7:15 AM
Reply to: Message 205 by Wounded King
12-13-2006 6:05 AM


Re: Testing Avoidance
Testing avoidance is the point not scare tactics.

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

This message is a reply to:
 Message 205 by Wounded King, posted 12-13-2006 6:05 AM Wounded King has replied

Replies to this message:
 Message 209 by Wounded King, posted 12-13-2006 7:44 AM purpledawn has replied
 Message 210 by nator, posted 12-13-2006 8:53 AM purpledawn has not replied

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 213 of 327 (369700)
12-14-2006 7:41 AM
Reply to: Message 209 by Wounded King
12-13-2006 7:44 AM


Re: Testing Avoidance
quote:
Why are you pissing and moaning about that specific reference if the claim that that reference supports is entirely irrelevant to your argument?
What is my argument? I asked a simple question in Message 184. I asked for some facts that lead Scraf to feel that manufacturers of herbal "drugs" want their products classified as dietary supplements to avoid having to test for safety and effectiveness?
As I stated in Message 189 concerning Quackwatch: I don't see how this supports that herbal manufacturers want to avoid proving their products are safe and effective.
quote:
If the Supplements industry doesn't want to avoid strict regulation then why does it lobby so fervently to do just that? Why weren't they perfectly happy for their 3 year exemption to lapse and to adhere to the same strictures as food manufacturers that in order to make a health claim, the FDA requires "significant scientific agreement."
Even though there are always groups trying scam the system, I don't feel that respectable supplement manufacturers want to avoid showing that their products are safe and effective. As shown below, some did not agree with the FDA interpretation of "significant scientific agreement".
FDA Regulation of Dietary Supplements
...still others did not object to NLEA's pre-market approval standard of "significant scientific agreement" in principle, but rather viewed FDA's interpretation of the NLEA as overly restrictive.

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

This message is a reply to:
 Message 209 by Wounded King, posted 12-13-2006 7:44 AM Wounded King has replied

Replies to this message:
 Message 214 by nator, posted 12-14-2006 8:15 AM purpledawn has replied
 Message 215 by Wounded King, posted 12-14-2006 9:43 AM purpledawn has not replied

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 216 of 327 (369738)
12-14-2006 1:19 PM
Reply to: Message 214 by nator
12-14-2006 8:15 AM


Re: Testing Avoidance
quote:
Do you or do you not agree that the PR campaign took place?
The campaign wasn't the issue. The links we read so far make it evident that the campaign was waged.
quote:
If you do, then what is your interpretation of WHY it took place and WHY the industry did it at that time?
It took place to prevent the FDA from finalizing regulations they had proposed in 1993. Some consumers and manufacturers apparently still had problems with the proposed regulations.

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

This message is a reply to:
 Message 214 by nator, posted 12-14-2006 8:15 AM nator has replied

Replies to this message:
 Message 217 by Wounded King, posted 12-14-2006 5:52 PM purpledawn has replied
 Message 218 by nator, posted 12-14-2006 8:00 PM purpledawn has replied

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 220 of 327 (369977)
12-15-2006 4:29 PM
Reply to: Message 217 by Wounded King
12-14-2006 5:52 PM


Re: Testing Avoidance
quote:
And would you agree that one of those problems was that they considered the FDA's standards of support for health claims too stringent?
They considered the FDA interpretation overly restrictive.
but rather viewed FDA's interpretation of the NLEA as overly restrictive
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.
I think it is a very big political game being played by all sides. We are on the fringe.

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

This message is a reply to:
 Message 217 by Wounded King, posted 12-14-2006 5:52 PM Wounded King has replied

Replies to this message:
 Message 222 by Wounded King, posted 12-15-2006 6:03 PM purpledawn has replied
 Message 228 by nator, posted 12-16-2006 3:17 PM purpledawn has replied

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 221 of 327 (369980)
12-15-2006 4:37 PM
Reply to: Message 218 by nator
12-14-2006 8:00 PM


Re: Testing Avoidance
quote:
And what problems do you think the industry had with the laws?
They supposedly didn't like the FDA interpretation. What they didn't like specifically about the interpretation, I don't know. From what I've read it sounds like they don't want the FDA to have all the power to decide.
quote:
And the PR campaign actually IS the issue, because if they had legitimate reasons for wanting to prevent the law, they would have used those instead of the false claims they made in the campaign.
Also, do you agree that the PR campaign was intentionally misleading to consumers when it depicted Mel Gibson being arrested for possession of vitamin C?
Could be. That is the American way! Incite the public! But, again, the campaign was not the point of my question.

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

This message is a reply to:
 Message 218 by nator, posted 12-14-2006 8:00 PM nator has not replied

purpledawn
Member (Idle past 3486 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

purpledawn
Member (Idle past 3486 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 3486 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

purpledawn
Member (Idle past 3486 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

purpledawn
Member (Idle past 3486 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

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 241 of 327 (370725)
12-18-2006 6:58 PM
Reply to: Message 240 by nator
12-18-2006 1:16 PM


Guess We're Done
So we're right back to square one and you haven't learned anything apparently. So I'm done.
Enjoy the season.

This message is a reply to:
 Message 240 by nator, posted 12-18-2006 1:16 PM nator has replied

Replies to this message:
 Message 242 by nator, posted 12-19-2006 7:18 AM purpledawn has not replied

purpledawn
Member (Idle past 3486 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 305 of 327 (427391)
10-11-2007 10:35 AM
Reply to: Message 290 by Kitsune
10-11-2007 9:45 AM


Screening
Obviously vaccines don't wreak havoc on everybody. Hopefully through more study there will be a way to tell before vaccinations if a child is genetically susceptible to an adverse reaction.
Autism: Lots of clues, but still no answers
There could be a whole host of chemicals that wreak havoc on the brains of genetically susceptible individuals, team member Isaac Pessah of the University of California, Davis, told the meeting. He points out that according to the US National Toxicology Report, between 60 and 80 per cent of the chemicals we are exposed to through pesticides, cosmetics and foods have not undergone adequate risk assessment.
You know as well as I do, or should, that we aren't carbon copies and we all don't react the same even to identical situations. It would be nice if a means to assess the individual's risks were available. Maybe someday there will be if there isn't any.
Maybe a practical approach for those concerned with possible risks of vaccinations is to make sure their child has less exposure to the other chemicals we come in contact with.
We can't really decide what is right for the majority. Since autism seems to be on the rise, the possible environmental factors will probably be addressed.
Complicating the story still further is the apparent rise in autism. The Autism Society of America estimates that there was an increase of 172 per cent in the US in the 1990s, though the population grew only 13 per cent. It is still not clear if the rise is due to some new, presumably environmental, factor or if doctors are simply becoming better at diagnosing the disorder.
Eventually maybe they'll be able to discern what may aggravate an already susceptible individual so they can act accordingly.

This message is a reply to:
 Message 290 by Kitsune, posted 10-11-2007 9:45 AM Kitsune has not replied

Replies to this message:
 Message 315 by molbiogirl, posted 10-11-2007 11:41 AM purpledawn has not replied
 Message 326 by nator, posted 10-11-2007 9:24 PM purpledawn has not replied

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