Go Back   AnandTech Forums > Social > Off Topic

Forums
· Hardware and Technology
· CPUs and Overclocking
· Motherboards
· Video Cards and Graphics
· Memory and Storage
· Power Supplies
· Cases & Cooling
· SFF, Notebooks, Pre-Built/Barebones PCs
· Networking
· Peripherals
· General Hardware
· Highly Technical
· Computer Help
· Home Theater PCs
· Consumer Electronics
· Digital and Video Cameras
· Mobile Devices & Gadgets
· Audio/Video & Home Theater
· Software
· Software for Windows
· All Things Apple
· *nix Software
· Operating Systems
· Programming
· PC Gaming
· Console Gaming
· Distributed Computing
· Security
· Social
· Off Topic
· Politics and News
· Discussion Club
· Love and Relationships
· The Garage
· Health and Fitness
· Merchandise and Shopping
· For Sale/Trade
· Hot Deals
· Free Stuff
· Contests and Sweepstakes
· Black Friday 2013
· Forum Issues
· Technical Forum Issues
· Personal Forum Issues
· Suggestion Box
· Moderator Resources
· Moderator Discussions
   

Reply
 
Thread Tools
Old 03-01-2003, 06:47 PM   #1
Yossarian451
Senior Member
 
Join Date: Apr 2002
Posts: 886
Default Ephedra Question about AdvoCare

My girlfriend has been trying to lose weight and just recently she gave up my good advice of just healthy workout and eating right; so she has been taking some "diet" pill called advocare the PLatinum or something version, not sure. I was a bit skeptic of these things so I googled it, and I wasn't able to get a difenitive result for what was in it, but I did see a post on some site whre the question was asked and soemone said that it contained ephedra. What worries me is the large ephedra recall and warnings. Since she won't listen to me or reason becasue she is a dumbass, I want to know if anyone knows definitively if it does in fact contain ephedra. and if so I can prove to her and make her stop using it. Thanks in advance for any help.
Yossarian451 is offline   Reply With Quote
Old 03-01-2003, 07:34 PM   #2
tcsenter
Lifer
 
tcsenter's Avatar
 
Join Date: Sep 2001
Location: Central California
Posts: 16,952
Default Ephedra Question about AdvoCare

Quote:
What worries me is the large ephedra recall and warnings.
From what I can gather Advocare Platinum contains no ephedra. It would indicate on the label if you're buying the product in the USA.

Despite the hysterical fear-mongering over ephedra, the FDA has thus far refused to ban it because the FDA has a problem; other commonly available OTC preparations "deemed safe" by the FDA cause more deaths annually than ephedra. Aspirin being just one example.

Ephedra has been proven over and over to be safe if taken according to the labeling and precautions. There are like 20 million people who regularly take ephedra and only few dozens of deaths have been associated with ephedra. Of those deaths, the majority were related to misuse and abuse, people taking ephedra in clear violation of the labeling and contraindications. MJB pitcher Bechler had abnormal liver function and borderline high blood pressure, pick up any product containing ephedra and guess what it says about liver abnormalities and high blood pressure. Yup, don't take it.
tcsenter is offline   Reply With Quote
Old 03-01-2003, 07:48 PM   #3
911paramedic
Diamond Member
 
911paramedic's Avatar
 
Join Date: Jan 2002
Location: Sonoma County, CA
Posts: 9,451
Default Ephedra Question about AdvoCare

Quote:
Originally posted by: tcsenter
Quote:
What worries me is the large ephedra recall and warnings.
From what I can gather Advocare Platinum contains no ephedra. It would indicate on the label if you're buying the product in the USA.

Despite the hysterical fear-mongering over ephedra, the FDA has thus far refused to ban it because the FDA has a problem; other commonly available OTC preparations "deemed safe" by the FDA cause more deaths annually than ephedra. Aspirin being just one example.

Ephedra has been proven over and over to be safe if taken according to the labeling and precautions. There are like 20 million people who regularly take ephedra and only few dozens of deaths have been associated with ephedra. Of those deaths, the majority were related to misuse and abuse, people taking ephedra in clear violation of the labeling and contraindications. MJB pitcher Bechler had abnormal liver function and borderline high blood pressure, pick up any product containing ephedra and guess what it says about liver abnormalities and high blood pressure. Yup, don't take it.
Ephedra is dangerous, and if you think it's not, you are kidding yourself. It is the same as speed, as far as harming your body.

I personally treated many 20-something people with heart failure/problems when phen phen came out back in the 90's.

There are no shortcuts, eat right and exercise, that is the only safe way to lose weight.

__________________
911paramedic is offline   Reply With Quote
Old 03-01-2003, 08:06 PM   #4
tcsenter
Lifer
 
tcsenter's Avatar
 
Join Date: Sep 2001
Location: Central California
Posts: 16,952
Default Ephedra Question about AdvoCare

Quote:
Ephedra is dangerous, and if you think it's not, you are kidding yourself. It is the same as speed, as far as harming your body.
I agree, so is aspirin, ibuprofen, acetaminophen, psuedoephedrine, and 100 other common OTC preparations deemed "safe" for public consumption, with warnings and caveat, which are documented to contribute to the deaths of a few hundred people annually.

Ephedra is not the same as speed, if by speed you mean amphetamine or methamphetamine. They share very little in common.
Quote:
I personally treated many 20-something people with heart failure/problems when phen phen came out back in the 90's.
I'm sure you did, lots of people abuse and misuse the drug. That doesn't make the drug 'unsafe', it means there are a lot of stupid people out there.
tcsenter is offline   Reply With Quote
Old 03-01-2003, 08:11 PM   #5
Dznuts007
Senior Member
 
Join Date: Apr 2000
Posts: 629
Default Ephedra Question about AdvoCare

No such thing as a safe drug. Why? Because people are stupid. That makes all drugs dangerous regardless how safe it may be. I've been getting alot of questions from patients, asking me, "is it ok if I swallowed 10 of my pills?" I asked them why? They replied "because I wasn't feeling well so I took 10 of them..."

As mean as this may sound...it might be a good thing for her to o/d on that so that she doesn't pass on her stupid genes...
Dznuts007 is offline   Reply With Quote
Old 03-01-2003, 08:28 PM   #6
BD231
Diamond Member
 
BD231's Avatar
 
Join Date: Feb 2001
Posts: 9,516
Default Ephedra Question about AdvoCare

Quote:
Originally posted by: 911paramedic
Quote:
Originally posted by: tcsenter
Quote:
What worries me is the large ephedra recall and warnings.
From what I can gather Advocare Platinum contains no ephedra. It would indicate on the label if you're buying the product in the USA.

Despite the hysterical fear-mongering over ephedra, the FDA has thus far refused to ban it because the FDA has a problem; other commonly available OTC preparations "deemed safe" by the FDA cause more deaths annually than ephedra. Aspirin being just one example.

Ephedra has been proven over and over to be safe if taken according to the labeling and precautions. There are like 20 million people who regularly take ephedra and only few dozens of deaths have been associated with ephedra. Of those deaths, the majority were related to misuse and abuse, people taking ephedra in clear violation of the labeling and contraindications. MJB pitcher Bechler had abnormal liver function and borderline high blood pressure, pick up any product containing ephedra and guess what it says about liver abnormalities and high blood pressure. Yup, don't take it.
Ephedra is dangerous, and if you think it's not, you are kidding yourself. It is the same as speed, as far as harming your body.

I personally treated many 20-something people with heart failure/problems when phen phen came out back in the 90's.

There are no shortcuts, eat right and exercise, that is the only safe way to lose weight.
Phen-Phen was made in a lab, it is far stronger than real ephedra. True ephedra has been used by the chinese for hundreds of years for colds, asthma and immune system strengthening. It's completely safe for a healthy person if 100mg is not exceded, personally I wouldn't recomend anybody go past 40 to 60 in any given day, it's still very strong. Ephedra containing supplements have become as common as coffee.
__________________
2550k @ 4.7 - Gene-Z ROG - 7970 - 8gb @ 2133

DEATH TO GANGSTALKERS. MAY YOU ALL DIE A SLOW AND PAINFUL DEATH.
BD231 is offline   Reply With Quote
Old 03-01-2003, 08:58 PM   #7
911paramedic
Diamond Member
 
911paramedic's Avatar
 
Join Date: Jan 2002
Location: Sonoma County, CA
Posts: 9,451
Default Ephedra Question about AdvoCare

Ephedra is being used (misused) by people thinking it is something it is not. Most of the deaths are in younger patients that think it will give them some sort of athletic edge. They take it and go practice sports and end up killing themselves. It is a stimulant, plain and simple. It will put stresses on the body that it is not meant to take and can (I stress can, not will) kill you.

It needs more information with it, and since it is not technically a drug in the eyes of the FDA it does not have to include these warnings. Now it does, take it at your own risk.
__________________
911paramedic is offline   Reply With Quote
Old 03-01-2003, 09:02 PM   #8
LeeTJ
Diamond Member
 
Join Date: Jan 2003
Posts: 4,899
Default Ephedra Question about AdvoCare

Quote:
Originally posted by: tcsenter
Quote:
What worries me is the large ephedra recall and warnings.
From what I can gather Advocare Platinum contains no ephedra. It would indicate on the label if you're buying the product in the USA.

Despite the hysterical fear-mongering over ephedra, the FDA has thus far refused to ban it because the FDA has a problem; other commonly available OTC preparations "deemed safe" by the FDA cause more deaths annually than ephedra. Aspirin being just one example.

Ephedra has been proven over and over to be safe if taken according to the labeling and precautions. There are like 20 million people who regularly take ephedra and only few dozens of deaths have been associated with ephedra. Of those deaths, the majority were related to misuse and abuse, people taking ephedra in clear violation of the labeling and contraindications. MJB pitcher Bechler had abnormal liver function and borderline high blood pressure, pick up any product containing ephedra and guess what it says about liver abnormalities and high blood pressure. Yup, don't take it.
i thought Shay (sp) legislation made it EXTREMELY difficult for the FDA to ban this. not that they deem it safe but that their hands are tied.

ephedra is dangerous taken in large quantities (as most substances are) BUT it should be taken w/ care and a doctors advice.
LeeTJ is offline   Reply With Quote
Old 03-01-2003, 11:52 PM   #9
Dznuts007
Senior Member
 
Join Date: Apr 2000
Posts: 629
Default Ephedra Question about AdvoCare

DSHEA ?
Dznuts007 is offline   Reply With Quote
Old 03-02-2003, 01:24 AM   #10
tcsenter
Lifer
 
tcsenter's Avatar
 
Join Date: Sep 2001
Location: Central California
Posts: 16,952
Default Ephedra Question about AdvoCare

Quote:
I thought Shay (sp) legislation made it EXTREMELY difficult for the FDA to ban this. not that they deem it safe but that their hands are tied.
Not at all. The Dietary Supplement Health and Education Act (DSHEA) simply shifts the burden onto the FDA to prove a supplement or food poses a "significant or unreasonable risk of illness or injury", rather than requiring the manufacturer or marketer of the product to prove the product is safe as drug companies must. The FDA can restrict or ban any food, dietary product, or supplement at any time, but it must be able to prove the product is unsafe. The FDA hasn't because it can't. Other reasons under which the FDA can take action are a dietary supplement that is 'adulterated', 'misbranded', or makes an unauthorized claim to heal, treat, remedy, or cure any ailment or illness.

The FDA was poised at one time to severely restrict ephedra but it took the US General Accounting Office to point out that the FDA's information was unreliable and scientifically unsound, which the FDA admitted but decided to press forward with the restrictions, anyway, until pressure from Congress and the dietary supplement industry forced the FDA to back away and settle for product labeling requirements.

The August 1999 GAO report etitled "Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids." found that of the numerous Adverse Event Reports (AER's) cited by the FDA in its proposals to restrict ephedra, many could not possibly have been caused by ephedra or were only superficially 'associated' with ephedra use, and described the bulk of evidence cited by the FDA as "informationally worthless".
tcsenter is offline   Reply With Quote
Old 03-02-2003, 02:54 AM   #11
Buffdaddy34
Senior Member
 
Join Date: Sep 2000
Posts: 503
Default Ephedra Question about AdvoCare

studying supplements over the years, and being a nutrition major, and a nutritionist, not that it means anything, but yes, I' ve been studying supplements for quite some time now.

There are few things that people should remember when they take these supplements, or for most people they are called weight loss pills. Take them in moderation. Drastic changes to your body will make your body change. May it be in your diet or in your supplements, or vitamin intake. However, these supplements that people are scared of, like ephedrine, they are probably taken in large large dosages if it leads to death. I've taken ephedrine products for years, cycling them, and testing new diets for some articles I write.

Ephedrine is not like speed. lol. I have never hallucinated, or thought I was stronger than a bull, but maybe taht's due to my lack of physical size. but anyhow, it's not like speed. When you take supplements, PLEASE PLEASE PLEASE read the label. This is what I find ironic about the people that take these supplements. They probably read the caloric, fat intake of food products, and other things, but when they take supplements, it seems like they go right past the label. READ THE LABEL. If it tells you to take 4 pills MAX per day, don't take 6 or 8. Seriously, it will only harm you. Cycle your supplements. don't take ephedrine products for a year, cycle it for six weeks. And if you have health problems, TALK TO YOUR PHYSICIAN. seriously, I hate people who bash the industry. Yes, some companies make shady products, but they usually go out of business pretty quickly.

read up on your products. don't be foolish about it, and buy from a reputable company. I swear, those last few people that died from ephedrine related deaths, I believe took more than the daily dosage. Even with the daily dosage, I can barely hang in there. This stuff is powerful. I guess people dont' think it is because it's "HERBAL." What a joke. Marijuana is herbal, powerful medicine and high. Just uneducated and foolish mistakes that could have been prevented if and only if the bottle was ready correctly. It frustrates me and it's tragic that people die because of simple error, and also some force pressure from peers.

Sorry, I love talking nutrition and supplements. And as for your gf, make sure she has no health problems. Make sure she takes in moderation. I like to cycle my supplements in for 6 weeks. From there, your body should see some drastic change. Your metabolism will be higher naturally from the work out that you will be doing with the product. Don't take over the recommended dosages. ppllllleasee... don't!!! If you need any more suggestions, you can e-mail me at mikekim@manfood.com or pm me.

Sorry for the long post. hehehehe
Buffdaddy34 is offline   Reply With Quote
Old 03-02-2003, 07:45 AM   #12
C'DaleRider
Diamond Member
 
C'DaleRider's Avatar
 
Join Date: Jan 2000
Posts: 3,048
Default Ephedra Question about AdvoCare

Long controversial, ephedrine is a central ingredient in the illegal drug methamphetamine or speed.

Interestingly, you do not see ephedrine products promoted any longer, just ephedra products. That is one way the herbal manufacturers are skirting the edicts the FDA passed in '94-'98 clamping down on how much ephedrine is in products. The herbals moved from the now-regulated drug ephedrine, to using just the "natural herbal" source, ephedra or ma huang, which is unregulated.

You will also notice there has been a distinct lack of pills with such names as Herbal Ecstacy and Ultimate Xphoria promised a "natural high," as ephedra was marketed in the mid-'90's. You also no longer see adverts promoting ephedra as a performance enhancing supplement, or being marketed as an "herbal phen-fen" as Nutri/Systems used to do.


And as of late 1997, at least 17 deaths and 800 illnesses linked to ephedrine-laced dietary supplements. Now, since that point, ephedrine has disappeared and been replaced with ephedra and ma huang listings. And the linking process had to start over. While you may belittle 17 deaths, over 800 injuries/illnesses is significant for a dietary supplement supposed to be completely safe.

And despite the cries of "Read the label", an FDA survey last year uncovered some supplements that called for users to ingest up to 109 milligrams in a single sitting.
C'DaleRider is offline   Reply With Quote
Old 03-02-2003, 08:00 AM   #13
StageLeft
No Lifer
 
StageLeft's Avatar
 
Join Date: Sep 2000
Location: Sydney
Posts: 70,214
Default Ephedra Question about AdvoCare

Quote:
MJB pitcher Bechler had abnormal liver function and borderline high blood pressure, pick up any product containing ephedra and guess what it says about liver abnormalities and high blood pressure.
Thing is how many people are taking ephedra related products and have similar things and don't know about it?

In reality all the different views here have some truth to them. Millions of people have taken ephedra products, myself included. Millions haven't died, myself included.

But it is a stimulant and although the hype over how bad it is for you is almost certainly overblown (especially with a famous guy dying of it recently) it's not _good_ for your body. It's just not "that bad".

The truth of the matter is all this argument aside I'll bet my balls on the fact that if your gf relies on this as her primary means of losing weight she will, the second she stops taking it, start piling the weight on again. When a person loses weight, be it through excercise or calorie restriction or a combination of the two, once they've lost the weight if they then revert back to what they originally did the weight will come back. That is why, even if ephedra is safe, most people have no business using it because they become reliant on it. Unable to lose weight through conventional means of excercise/nutrition they find that they can't do anything without the supplement. And how healthy do you think it is to take it years on end? Not very! These things are called supplements because they supplement you - you can't rely on them as the primary means to your goal because you're setting yourself up for failure.

Even if this stuff is perfectly healthy if using it as her primary means of weight loss she's setting herself up for failure. That's simply a fact.
__________________
It is accomplished.
StageLeft is offline   Reply With Quote
Old 03-02-2003, 02:12 PM   #14
Yossarian451
Senior Member
 
Join Date: Apr 2002
Posts: 886
Default Ephedra Question about AdvoCare

Quote:
Originally posted by: Buffdaddy34
studying supplements over the years, and being a nutrition major, and a nutritionist, not that it means anything, but yes, I' ve been studying supplements for quite some time now.

There are few things that people should remember when they take these supplements, or for most people they are called weight loss pills. Take them in moderation. Drastic changes to your body will make your body change. May it be in your diet or in your supplements, or vitamin intake. However, these supplements that people are scared of, like ephedrine, they are probably taken in large large dosages if it leads to death. I've taken ephedrine products for years, cycling them, and testing new diets for some articles I write.

Ephedrine is not like speed. lol. I have never hallucinated, or thought I was stronger than a bull, but maybe taht's due to my lack of physical size. but anyhow, it's not like speed. When you take supplements, PLEASE PLEASE PLEASE read the label. This is what I find ironic about the people that take these supplements. They probably read the caloric, fat intake of food products, and other things, but when they take supplements, it seems like they go right past the label. READ THE LABEL. If it tells you to take 4 pills MAX per day, don't take 6 or 8. Seriously, it will only harm you. Cycle your supplements. don't take ephedrine products for a year, cycle it for six weeks. And if you have health problems, TALK TO YOUR PHYSICIAN. seriously, I hate people who bash the industry. Yes, some companies make shady products, but they usually go out of business pretty quickly.

read up on your products. don't be foolish about it, and buy from a reputable company. I swear, those last few people that died from ephedrine related deaths, I believe took more than the daily dosage. Even with the daily dosage, I can barely hang in there. This stuff is powerful. I guess people dont' think it is because it's "HERBAL." What a joke. Marijuana is herbal, powerful medicine and high. Just uneducated and foolish mistakes that could have been prevented if and only if the bottle was ready correctly. It frustrates me and it's tragic that people die because of simple error, and also some force pressure from peers.

Sorry, I love talking nutrition and supplements. And as for your gf, make sure she has no health problems. Make sure she takes in moderation. I like to cycle my supplements in for 6 weeks. From there, your body should see some drastic change. Your metabolism will be higher naturally from the work out that you will be doing with the product. Don't take over the recommended dosages. ppllllleasee... don't!!! If you need any more suggestions, you can e-mail me at mikekim@manfood.com or pm me.

Sorry for the long post. hehehehe
Thanks for that information, and since you seem to have knowledge of the supplements so again , do you know if the Advocare supllements have it? I ask becaus e she has been having stomach pains and I believe they are causing it but she doesn't believe me. I don't want her to have prologed problems from it, but I think she is giong to quit after she finishes this box.
Yossarian451 is offline   Reply With Quote
Old 03-02-2003, 02:26 PM   #15
Mani
Diamond Member
 
Mani's Avatar
 
Join Date: Aug 2001
Location: Texas & Philly
Posts: 4,785
Default Ephedra Question about AdvoCare

Just out of curiosity, how effective is this stuff? I mean, why are people risking their health taking these, do they have some drastic weight loss effects?
Mani is offline   Reply With Quote
Old 03-02-2003, 02:56 PM   #16
SludgeFactory
Platinum Member
 
Join Date: Sep 2001
Posts: 2,969
Default Ephedra Question about AdvoCare

If she's taking ephedra, tell your gf that ephedra when used as a thermogenic (i.e. 80-100 mg per day, every day, with the appropriate ratio of caffeine) is good for about a 2-3% increase in metabolism. That's on the order of 50-100 calories a day. So she can continue to spend $$$, take the health risks (although I agree they're very much overblown by the media), develop a bitchin' caffeine addiction, and have a really nice rebound of weight gain when she finally quits -- or she can get the same metabolic effect by figuring out how to cut 50-100 calories out of her diet (one less cookie, half can of coke, etc). Her choice.

Taking ephedra w/o addressing diet and energy expenditure issues is like pouring money down the drain IMO. If she wants to take weight off at a decent clip and keep it off, then diet/exercise/permanentlifestyle change, blah blah blah.

Ephedra isn't the magic pill. When the magic pill comes out, everyone will know about it, it will be expensive as hell, a nation of fatasses will rejoice, and I hope I have stock in the company that gets it to market first.
__________________
My Rig
SludgeFactory is offline   Reply With Quote
Old 03-02-2003, 03:00 PM   #17
SludgeFactory
Platinum Member
 
Join Date: Sep 2001
Posts: 2,969
Default Ephedra Question about AdvoCare

Quote:
Originally posted by: Mani
Just out of curiosity, how effective is this stuff? I mean, why are people risking their health taking these, do they have some drastic weight loss effects?
If you take it 3-4 times a day, every day, besides the thermogenic quality, ephedrine/caffeine can have an appetite-supressing effect in many people. If you don't use it for weight loss (take it only occasionally and don't build up a tolerance), there's a substantial energy boost, which is what a lot of athletes use it for, until one of them fvcks up and ruins it for everybody else in their sport.

It's also effective at making certain people jittery, anxious, pissed off, angry, etc.
__________________
My Rig
SludgeFactory is offline   Reply With Quote
Old 03-02-2003, 03:07 PM   #18
Mill
Lifer
 
Join Date: Oct 1999
Posts: 28,561
Default Ephedra Question about AdvoCare

I don't think it is fair to compare Ephedrine to Methamphetamine. Yes, Ephedrine is synthesized during a chemical process to create meth but they are not one and the same.
Mill is offline   Reply With Quote
Old 03-02-2003, 09:14 PM   #19
tcsenter
Lifer
 
tcsenter's Avatar
 
Join Date: Sep 2001
Location: Central California
Posts: 16,952
Default Ephedra Question about AdvoCare

Quote:
And as of late 1997, at least 17 deaths and 800 illnesses linked to ephedrine-laced dietary supplements. Now, since that point, ephedrine has disappeared and been replaced with ephedra and ma huang listings. And the linking process had to start over. While you may belittle 17 deaths, over 800 injuries/illnesses is significant for a dietary supplement supposed to be completely safe.
Yup, and a "link" is all that existed, sorta like the "link" between obesity and owning refrigerators. All obese people own refrigerators.

---------------------------

FDA?s proposal was based primarily on the more than 800 adverse event reports that the agency had received between 1993 and June 1997. FDA stated that it had purposefully not considered the long record of safety for the more potent over-the-counter ephedrine drug products for asthma because, according to FDA, asthmatics are less sensitive to ephedrine. However, FDA cited no scientific evidence for this assertion, and subsequent review of the medical literature has revealed no basis for rejecting this wealth of safety data. FDA also asserted that clinical studies on ephedrine for use in the treatment of obesity were also not relevant to the safety of Ephedra because obese individuals may be less sensitive to ephedrine, but again FDA cited no studies to support this theory.

In the end, careful examination of FDA?s very lengthy proposed rule showed that the proposed limits were based almost entirely on the adverse event reports, reports that FDA had historically found to be unreliable and therefore not useful for determining product risk. Therefore, the scientific validity of FDA?s proposal rose or fell depending on the quality of the adverse event reports and their relationship to Ephedra consumption.

Surprisingly, congressional inquiry into FDA?s proposed rule revealed that FDA never examined the adverse event reports on which it relied to determine if there was any relationship between the event and the consumption of Ephedra. Indeed, a number of the reports related to products that did not even contain Ephedra, but were nonetheless counted by FDA as Ephedra-related events.

As a direct result of FDA?s failure to perform even the most simple quality review of its reports, FDA?s record for the proposed rule included absurd reports such as the following:

a report of a woman whose blood alcohol was twice the legal limit and who died of a fractured skull after driving her truck into a tree at 90 mph;

a report of a man who shot himself;

a report of a suicide from a gunshot wound;

a report of a man who died of environmental hyperthermia;

a report stating "Shot and killed store clerk";

a report of a woman who "got pregnant though using Norplant"; and

reports of excessive hairiness, a 75-year old woman menstruating, a possible diagnosis of multiple sclerosis, a case of impotence and a case of constant erection.

Careful analysis of the record that FDA had compiled showed that at least 85 percent of the reports on which FDA had relied were so lacking in information essential to a scientific assessment of their relationship to the consumption of Ephedra that they were informationally worthless. Further, FDA had relied on just 13 of the reports as a basis for the proposed dose limits, even though the agency never reviewed these few reports to determine if they were causally related to the consumption of Ephedra. These immediate problems with FDA?s proposed rule led to more thorough review of the rule by Congress, a critical review by the General Accounting Office (GAO), and to the eventual and unprecedented withdrawal of the key portions of the proposed rule.

WHY HAS FDA WITHDRAWN PORTIONS OF ITS PROPOSED RULE?

A number of companies that marketed ephedra products were legitimately concerned about the safety issues that FDA raised in its June 1997 proposal to prohibit most uses of ephedra products. These companies had sold thousands and in some cases millions of servings of ephedra products, but had either received no reports, or only isolated reports, of problems with their products. Several of these companies decided to hire qualified independent experts to review the scientific basis for FDA?s proposed rule.

Although there were several separate efforts to review FDA?s basis for the proposed rule, the conclusions of these efforts were essentially the same; FDA did not have a valid scientific basis for the proposed rule.

The vast majority of the adverse event reports, approximately 85 percent, were informationally worthless because they lacked essential information such as how much Ephedra was consumed and for how long, the identity of the product at issue, and medical records including prior medical history.

The proposed serving limits were based on just 13 out of more than 900 reports, and FDA admitted in the proposed rule that it did not attempt to determine whether any of the 13 reports were causally related to the consumption of Ephedra. Independent expert review revealed that the 13 reports could not be scientifically attributed to Ephedra.

There was no scientific basis for either FDA?s duration limit (no more than seven days of use), which led FDA to prohibit use for weight loss and other uses that would encourage longer-term use, or for the agency?s prohibition on combining Ephedra with caffeine.

Over 20,000 comments to the proposed rule, the vast majority opposing the rule, were filed with FDA.

One set of comments, filed by the Small Business Administration (SBA), deserves special mention. SBA was highly critical of FDA?s proposed rule as a result of FDA?s serious underestimation of the number of small businesses that would be impacted. However, the SBA also raised serious questions about the lack of any apparent scientific basis for the proposed rule, and about FDA?s cost/benefit analysis.

The SBA comments were instrumental in activating congressional involvement with FDA?s Ephedra proposal. After review of the relevant information, including the SBA comments, the House Committee on Science, by letter dated May 12, 1998, requested the GAO to conduct an audit of FDA?s scientific basis for the proposed serving limits (less than 8 mg ephedrine alkaloids per serving, less than 24 mg per day) and duration limit (no more than 7 days). The Committee on Science also requested that GAO examine the quality of the cost/benefit analysis FDA had included to justify the need for a regulation.

The GAO made its completed audit public in early August, 1999. The GAO concluded that FDA did not have a sufficient scientific basis for the serving and duration limits that the agency proposed, and also concluded that the cost/benefit analysis was deficient in several important ways.

With respect to FDA?s reliance on just 13 adverse event reports (AERs) to establish a serving limit, the GAO stated

While FDA used these 13 AERs to set a dosing level, the agency did not perform a causal analysis to determine whether the reported events were, in fact, caused by the ingestion of dietary supplements containing ephedrine alkaloids. Our review of these 13 AERs found numerous problems that raise questions about the causal relationship between ingestion of the implicated product and the adverse events observed. For example,

? three AERS included physician reports that stated the cause of the event was not related to a dietary supplement;

? one consumer-related sample was obtained and tested 2 years after the initial event, and possible reformulations of the product might have resulted in different levels of ephedrine than the product implicated in the reported adverse event;

? three individuals reporting adverse events had experienced similar problems prior to or well after using the dietary supplement;

? one individual who experienced the event was eating only one meal a day; and one AER contained no medical records.

Some of the 13 AERs had more than one of these problems. As a result, there are uncertainties in FDA?s conclusions in setting a specific dosing limit since this limit was based on a small number of adverse events?events which may or may not have been a result of ingestion of dietary supplements containing ephedrine alkaloids.

GAO Report, pages 13-14.

With respect to FDA?s proposed duration limit, the GAO concluded that

FDA did not present scientific evidence specifically pointing to an increase in adverse events beginning at 7 days and under normal use conditions. Rather, the scientific information FDA used to support a 7-day limit outlined problems associated with extended use (months and years) of ephedrine alkaloids. The agency also cited support for its 7-day limit from studies involving other sympathomimetic agents, such as cocaine and methamphetamines, but these studies also involved long-term use of the drug.

GAO report, page 14. As a result of these and other problems, the GAO found that "there are uncertainties in the agency?s analysis of the relationship between duration of use of dietary supplements containing ephedrine alkaloids and the occurrence of adverse events." GAO report, page 14.

GAO also found numerous serious problems with FDA?s cost/benefit analysis, including the following:

FDA failed to consider whether state regulations being developed or already in place were sufficient to address FDA?s concerns, and therefore did not establish that there was (or is) any need for the regulation. GAO report, pages 43-44.

FDA did not establish a base-line level of risk for the adverse events at issue, and as a consequence FDA never considered whether the proposed rule would provide any benefit compared to taking no action. GAO report, pages 45-46.

FDA?s estimates of yearly averages of serious events, in addition to being based on an undocumented set of AERs, were also based on the unsupported and unscientific assumption that 80 percent of the AERs were in fact caused by ephedra products. GAO report, pages 48-50. In fact, the GAO found that FDA had never reviewed the AERs used as a basis for the proposed rule and the cost-benefit analysis to determine if any of the AERs were actually a result of the products at issue. GAO report, pages 11, 14, and 49-50.

The GAO found that, when FDA established its assumed percentages of events caused by ephedra products, FDA chose a high estimate within a large range of possible estimates, again without explanation. The GAO concluded that FDA?s use of inflated numbers "drove up the estimated number of actual adverse events and, as a direct consequence, the estimated benefits of the proposed rule." GAO report, page 49.

Finally, the GAO found that FDA also failed to conduct a "sensitivity analysis" or to consider the implications of "alternative assumptions," GAO report, page 51-55. As the GAO noted, "[c]hanges in any of [FDA?s assumptions] could have dramatically changed FDA?s estimates of the proposed rule?s benefits. GAO report, page 19.

FDA made errors that tended to inflate the benefits of the proposal. The GAO found that not even FDA could repeat the analysis. The GAO?s findings, when combined with the criticisms of the Small Business Administration (SBA) that FDA has seriously underestimated the costs of the proposed limits on small businesses, made it impossible to rely on FDA?s claim that there was any public health benefit to the proposed rule, or that any such benefit would be greater than the costs of the regulation.

The simple answer to the question of why FDA has had to withdraw its proposed ban on Ephedra is that the GAO exposed FDA?s lack of science in a way that it was impossible for FDA to ignore. The message that FDA could not go forward without real science to support any future proposal was included in GAO recommendations to the Department of Health and Human Services and to FDA:

Given the uncertainties in the information upon which FDA based its proposed rule, we recommend that the Secretary of Health and Human Services direct the Commissioner of FDA to obtain additional information to support conclusions regarding the specific requirements in the proposed rule for dietary supplements containing ephedrine alkaloids before proceeding to final rulemaking. Specifically, FDA needs to provide stronger evidence on the relationship between the intake of dietary supplements containing ephedrine alkaloids and the occurrence of adverse reactions that support the proposed dosing levels and duration of use limits. GAO report, pages 24-25.
tcsenter is offline   Reply With Quote
Old 03-03-2003, 04:54 AM   #20
Buffdaddy34
Senior Member
 
Join Date: Sep 2000
Posts: 503
Default Ephedra Question about AdvoCare

Quote:
Originally posted by: Millennium
I don't think it is fair to compare Ephedrine to Methamphetamine. Yes, Ephedrine is synthesized during a chemical process to create meth but they are not one and the same.
thank you. I needed someone else to restate that, lol.

If your GF is serious about losing weight, I would change the diet first. Either increase your meals, and spread out the caloric intake throughout the day.

I've tested several diets during the years for kicks and for my own research. Sitting at home and taking less than a 1000 calories a day, you don't lose weight. Your metabolism is just shot to hell.

I don't know if those 2-3% stats are true for increasing metabolism, but I do know, if you take ephedrine products like hydroxcut, xenadrine ( the latest popular athlete killer ), you can't help but get out of your damn chair and work out. It just gives you that much energy.

Yes the "READ THE LABEL." If you have health problems, consult a physician. I mean, these people must have had health problems before. And yes even if YOU think that the dosages are high, these aren't meant for people with health problems. Simply put, if you have health problems dont' take it. The athletes that died, they had some serious health problems. Stringer = heart problem, should have cut his diet first. The pitcher, probably had health problems, was drinking NO liquids, and died of dehydration. As tragic as it is, it could have been prevented if they contacted their physicians. Maybe it was partially mental as well, but i do'nt deal with those problems. Tell your GF to go and talk to her physician. I suggest changing her diet, spread the caloric intake through out the day, its' a bit of a hassle, but it will naturally boost your metabolism. Cut the processed sugars out of your diet, run, and if you need a little energy boost, sure knock yourself out with supplements, but don't use them unless you really need that edge.

Buffdaddy34 is offline   Reply With Quote
Old 03-03-2003, 04:57 AM   #21
Xionide
Diamond Member
 
Join Date: Apr 2002
Posts: 8,678
Default Ephedra Question about AdvoCare

i say do you own a nissan maxima
__________________
Heat
Xionide is offline   Reply With Quote
Reply

Thread Tools

Posting Rules
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Jump


All times are GMT -5. The time now is 12:41 PM.


Powered by vBulletin® Version 3.8.7
Copyright ©2000 - 2014, vBulletin Solutions, Inc.