Health Canada bans thermogenic supplements (ephedra/ephedrine)

[Guest guest]

from: http://www.drumlib.com/dp/000025.htm

 

Health Canada Bans Thermogenic Supplements

Under the guise of protecting the public, the ever-growing global nanny

state sacrifices science, truth and obese people.

 

Interestingly, the Health Canada advisory calls this action a " voluntary

recall " of products that are " marketed without approval. " But it sounds

about as " voluntary " as 'giving' your money to an armed robber:

 

" Health Canada is issuing letters to Canadian manufacturers,

distributors and importers requesting that they discontinue sale of

these products and that the products be recalled from all levels of the

market, including retail. A customs lookout has also been issued, to

ensure that these products are not imported into Canada . . . A random

market survey will be undertaken within 6 months of the requested recall

to determine whether these products have found their way back onto the

Canadian market. Non-compliant products will be removed from the shelves

" (1).

 

Voluntary? I guess politicians instinctively run from the truth in the

same manner as cockroaches instinctively run for cover when you turn the

lights on.

 

In a previous post, I detailed how the FDA uses scientifically worthless

MedWatch adverse event reports to attack supplements. The Ephedra

Education Council has correctly pointed out that the Canadian ban is

based on the same type of scientifically fraudulent data used by the FDA

to attack thermogenic supplements:

 

" Health Canada's voluntary recall is an over-reaction to unsubstantiated

and unscientific adverse event reports (AERs). This action mirrors the

mistakes that the U.S. Food and Drug Administration made five years ago

in its attempt to restrict Ephedra products in the United States. In

1999, an investigation by the U.S. General Accounting Office (GAO) found

the FDA at fault for using AERs as scientific data even though the

reports contained no evidence of any causal link between Ephedra and the

adverse reactions about which FDA said it was concerned. The GAOs

findings forced the FDA to withdraw its proposed regulations and admit

lack of scientific evidence " (4).

 

In startling contrast to the deceitful scare mongering of power hungry

regulatory agencies, obesity scientists consider ephedrine/caffeine to

be so safe that they have started to use it to treat obese adolescents!

I kid you not. This study was published in the International Journal of

Obesity and you can get the full text from Selma's Document Retrieval

Service. In addition to finding that ephedrine/caffeine " spectacularly

improves weight loss, " the scientists found that it is so safe that it

is well-tolerated by obese adolescents:

 

" The present study was performed to investigate the efficacy and safety

of a caffeine/ephedrine (CE) mixture and obese adolescents . . . Adverse

events were negligible and did not differ between the CE and PL

[placebo] groups. Withdrawal symptoms were mild, transient and their

frequency and severity were not different between the placebo and active

groups. According to the present pilot study CE [caffeine/ephedrine] can

be a safe and effective compound for the treatment of obesity in

adolescents " (5).

 

Perhaps the most shocking contrast between the scientific evidence and

the rubbish the regulators are feeding us concerns the effect of

ephedrine/caffeine on your heart. The obesity scientists tested the

adolescents and found that ephedrine/caffeine does NOT stress the heart.

In addition, blood tests indicate that ephedrine/caffeine makes you less

likely to have heart problems:

 

" Some of the well-known cardiovascular risk factors also improved in the

active [caffeine/ephedrine] group. The plasma triglyceride and

apolipoprotein B plasma concentrations in the active group were

significantly lower than that of the placebo group at the 20th week . .

.. The cardiopulmonary responses of the subjects to stress testing were

not affected by 20 weeks of treatment, supporting the observations of

Stich et al made in adults after 3 days of CE [caffeine/ephedrine]

treatment . . . Blood pressure and heart rate values showed no

significant changes... " (5).

 

One reason why obesity is bad for your heart is because the abnormally

low activity of the sympathetic nervous system causes a number of

problems that predispose us to heart disease, diabetes, ect. Although

many pay lip service to that notion that obesity is a real disease, this

fact is rarely mentioned when discussing " obesity related diseases. "

Thus, as the blood tests revealed, by helping to normalize the obese

person's biochemistry, ephedrine/caffeine makes you less likely to have

heart problems. Unless, of course, you actually think power hungry

regulators know more than research scientists.

 

At the end of this page, there is a box that lets you email a link to

this page. Why not contact reporters and see if they are willing to look

into this scandalous situation. Selma's Document Retrieval Service will

supply them with free copies of medical studies and I will answer

technical questions. Are there any reporters out there with the guts to

do an honest investigation?

 

Here is a A huge list of links to online newspapers!

Low Doses And Bogus Time Limits

Health Canada's limitations are very similar to those recommended by the

FDA. Thus, Health Canada's ban pertains to " Ephedra/ephedrine products

having a dose unit of more than 8 mg of ephedrine or with a label

recommending more than 8 mg/dose or 32 mg/day and/or are labelled or

implied for use exceeding seven days. "

 

So where does this seven day time limit come from? In 1997, the FDA

proposed rules very similar to the rules that were recently adopted by

Health Canada. The FDA's justification for their proposed rules was the

single most fraudulent use of science that I have ever seen. They

claimed that " ephedrine alkaloids, even at relatively low levels " can

cause cardiomyopathy and myocardial necrosis, but most of the references

they cited to support their claim didn't even have anything to do with

ephedrine -- they were references to articles on cocaine and

methamphetamine!

 

The FDA did, however, manage to dig up two medical articles and an

abstract that were actually about ephedrine. I present them here, with

quotes, so you can see for yourself that they have absolutely nothing to

do with obese people who take moderate doses of ephedrine/caffeine. Here

is the FDA's case against long-term use of ephedrine and the references

they used to support it:

 

 

--

 

FDA Proposed Rules: " The scientific literature establishes that use of

ephedrine alkaloids for a period of several months or years can result

in cardiomyopathy (Refs. 66 through 68). " [emphasis added]

 

66.) Van Mieghem W; Stevens E, and Cosemans J. " Ephedrine-induced

cardiopathy. " Br Med J, 1978 Apr 1; Vol: 1; Number: 6116; Page: 816;

PMID: 638463.

 

" He had exercise-induced and hyperventilation asthma since the age of

14. In 1958 he began to take a cough mixture containing ephedrine that

relieved his bronchial spasms. He progressively increased his ephedrine

intake, until he was drinking more than a bottle a day, each of which

contained 400 mg of ephedrine. He was also taking liberal doses of

prednisolone intermittently, depending on how he felt. In 1972 and 1973

he was treated in another hospital for cardiac failure but continued to

take the cough mixture. " [emphasis added]

 

67.) To LB; Sangster JF; Rampling D, and Cammens I. " Ephedrine-induced

cardiomyopathy. " Med J Aust, 1980 Jul 12; Vol: 2; Number: 1; Page: 35-6;

PMID: 7432264.

 

" Fourteen months after her initial presentation, she was referred for

psychiatric treatment by her general practitioner. Her husband had

overheard a telephone conversation during which his wife revealed the

financial burden imposed by her drug taking habits. His unexpected

support and acceptance enabled her to seek help. It emerged that she had

been taking large quantities of ephedrine-containing compounds for 10

years because these gain her energy and a feeling of well-being, and

counteracted chronic fatigue and depression. She had originally taken

Ephedrobarbital, but had changed to Tabasan, as this was more easily

available. She had ingested 10 to 30 tablets of Tabasan daily until the

time of her admission to hospital for cardiac failure. She had not

resumed taking after Tabasan after discharge, but, three months later,

she started taking increasing amounts of Phensedyl elixir. At the time

of psychiatric referral, she was consuming three bottles (375 mL)

daily. " [540 mg ephedrine daily!]

 

Ephedrobarbital: Each tablet contains ephedrine HCl 30 mg, phenobarbital

15 mg.

Tabasan: Each tablet contains ephedrine HCl 15 mg, theobromine 30 mg,

and salicylamide 60 mg.

Phensedyl Elixir: Each 125-mL bottle contains promethazine HCl 90 mg,

codeine phosphate 225 mg, and ephedrine HCL 180 mg.

 

68.) Gaultieri J, and Harris C. " Dilated Cardiomyopathy in a Heavy

Ephedrine Abuser. " Journal of Toxicology, Clinical Toxicology, 1996;

Vol: 34; Page: 581-2 [Abstract - not on PubMed].

 

" We report a case of dilated cardiomyopathy in a heavy ephedrine abuser.

Case: a 28 y [year old] 143 kg female presented with a 3 week history of

progressing dyspnea, dry cough, fatigue, and orthopnea. She admitted to

taking 25 mg ephedrine tablets for 8 y to lose weight but denied any

other chronic drug or alcohol use except tobacco (1 ppd x 12 y) [1 pack

per day x 12 years] . . . One week after the onset of her symptoms she

reduced or daily intake from 80 tablets to three tablets. " [emphasis

added]

 

 

--

 

I fail to see how these examples of extremely reckless behavior can

legitimately be used to establish an 8 mg dose limit and a seven day

time limit. It is outrageous and morally criminal that government

regulators would use science in such a fraudulent manner in an attempt

to deny medicine to obese people. The FDA's propaganda about ephedrine

causing heart damage is so ridiculous that it even drew fire from the

U.S. Small Business Administration:

 

" The agency [FDA] states that its data shows that " long-term use of . .

.. ephedrine alkaloids, even at relatively low levels, is related to

serious adverse events, including cardiomyopathy and myocardial

necrosis. However, the presence of ephedrine alkaloids in the body is

not dispositive of the fact that cardiomyopathy was the result. Reliance

on AERs [Adverse Event Reports] to prove cardiomyopathy is inappropriate

because of the prevalence of the disease in the general population.

According to the Montgomery Heart Foundation for Cardiomyopathy,

approximately one in 500 people carry an altered gene that can cause

certain forms of the disease. Therefore, many who suffer or die from

this disease, contracted it genetically. Others contract it through

infection, endocrine disorders, metabolic disorders or other unknown

causes. The agency has not identified any test or assay to prove

dispositively that any reported incidents of cardiomyopathy truly are

due to long-term use of ephedrine alkaloids. In fact, literature on the

subject suggests that no such test exists " (9).

 

The mainstream media won't touch this with a ten foot pole, but one of

the world's foremost obesity scientists, Arne Astrup, actually came out

and publicly accused the FDA of misrepresenting his data in their quest

to demonize ephedrine:

 

" Dr. Astrup also pointed to an FDA report on the published literature as

misrepresenting data in his study on the safety of the two ingredients

to instead support FDA's allegations concerning Ephedra. " I think our

data and results are mischaracterized and the presentation is flawed and

distorted, " said Dr. Astrup. " It's giving a very negative picture of the

safety profile of the combination of ephedrine/caffeine, which is not

supported by our research " (10).

 

I challenge Health Canada to either produce some real science -- not

this type of fraudulent propaganda -- or put an end to this ridiculous

" voluntary recall " of thermogenic supplements.

 

 

Dennis Jones, Ph.D., of Bariatrix International provided additional

insight into why Health Canada says ephedrine products should only be

used for seven days:

 

" Jones pointed out that the Canadian label requirement cautioning users

not to take ephedra products for more than seven days is often

misunderstood. The caution does not imply that the products are unsafe

if taken for more than seven days, but rather expressed the attitude of

the Canadian government toward self-medication, according to Jones. He

explained that this statement means that if an individual uses a

self-treatment for seven days and sees no improvement, the individual

should go to the doctor " (6).

 

So there it is. Isn't it, like, totally ridiculous to apply this time

limit nonsense to a chronic condition like obesity? By the way, the 12

week limit that you currently see in the ephedrine warnings appears to

be a compromise between the FDA's original seven-day limit and the

supplement industry. I'm not aware of any real science to support any of

this political BS. It's no wonder people are confused.

 

Personally, I am sick to death of the government's " attitude " toward

self-medication. I get email from people who are scared and confused by

these time limits. What can I say? I'm not a doctor and I can't tell

anyone what they should do, but personally I believe the obesity

scientists. In my opinion, the evidence indisputably proves that the

bureaucrats cannot be trusted.

 

No Caffeine Allowed In Ephedrine Products

Health Canada is clearly aiming to exterminate effective obesity

products. If ephedra/ephedrine products contain caffeine, they will be

taken off the market: " All combination products containing

Ephedra/ephedrine together with stimulants (e.g. caffeine) and other

ingredients which might increase the effect of Ephedra/ephedrine in the

body " (1).

 

Scientists add caffeine to ephedrine because this combination is capable

of normalizing thermogenesis in obese people at low doses. Scientists

have called this phenomenon a " supra-additive thermogenic synergism "

(2). The addition of caffeine increases the thermogenic effect far more

than it increases the stimulant effect. This remarkable discovery made

it possible to normalize the thermogenic defect with low,

minimally-stimulating doses -- and it is for exactly this reason that

obesity scientists recommend the ephedrine/caffeine combination.

 

Only this combination -- not ephedrine by itself, or any other weight

loss medicine -- is capable of fully correcting the thermogenic defect

without excessive stimulation. Thus, ironically, the safety and

effectiveness of the ephedrine/caffeine combination is the reason why

obesity scientists recommend it:

 

" the ephedrine/caffeine combination is effective, while caffeine and

ephedrine separately are ineffective for the treatment of human obesity "

(3).

 

Removing caffeine from these products shows either a complete ignorance

of the biochemistry of obesity, or a deliberate attempt to eliminate

supplements that would compete with the upcoming prescription

thermogenic drugs. Obese people should contact their political

representatives and demand a formal investigation of this scandalous

situation.

 

If you've read my Thermogenic FAQ, you know that there are literally

decades of research supporting the use of thermogenic supplements for

weight loss. Indeed, the evidence is so strong that in 1992 research

scientists from all over the world held an international symposium to

try to get the medical industry to use ephedrine/caffeine to help obese

people. However, if Canadian companies want to sell the pathetically

weak ephedrine supplements that are still allowed, Health Canada says

they have to lie (by omission) and neglect to tell obese people that

this could save their lives. If the companies tell you the truth, Health

Canada will ban the product. Here are some things that can get a product

banned:

 

" Ephedra/ephedrine products with labeled or implied claims for appetite

suppression, weight loss promotion, metabolic enhancement, increased

exercise tolerance, body-building effects, euphoria, increased energy or

wakefulness, or other stimulant effects " (1).

 

So why would government regulators commit scientific fraud, force

companies to lie, and scare obese people away from the one treatment

that is actually proven to be safe and effective? The answer is simple:

to protect the profits of the Beta-3 prescription thermogenic drugs that

will be coming on the market. (See my Thermogenic FAQ for more

information.) An FDA Dietary Task Force Report (June 15, 1993) was

candid about the agency's motivation:

 

" The task force considered many issues in its deliberations including to

ensure that the existence of dietary supplements on the market does not

act as a disincentive for drug development. "

 

Government regulators know what side of the bread gets the butter --

regulators enjoy revolving-door employment with the pharmaceutical

companies. Is it any wonder why dietary supplements are treated as the

enemy?

 

Public Citizen Is Pushing The Same Agenda

Now here's where it gets funny. (Well, if it weren't for hundreds of

thousands of obese people dying every year it would be funny.)

Apparently, Public Citizen, the " consumer advocacy " organization founded

by Ralph Nader, is unaware of the decades of research and the

international symposium on ephedrine/caffeine. Why do I say that?

Because they are trying to rally the troops (the AMA and other storm

troopers) to get the FDA to ban thermogenic supplements. And Public

Citizen is parroting the most blatant lie of the anti-ephedrine camp:

" Ephedrine alkaloid dietary supplements clearly pose a grave danger to

their consumers, without providing any scientifically proven benefit "

(7).

 

Can you believe that? Ephedrine/caffeine is the most researched obesity

medication on the planet Earth and Public Citizen is saying it has no

" scientifically proven benefit. " Geez. They actually think banning

thermogenic supplements will help obese people: " ...we hope the you are

capable of adopting more pro-patient rather than pro-industry views on

this important issue " (7).

 

Pro-industry? Gimme a break from the Karl Marx stuff, OK? Thermogenics

supplements sell because they work! We're not stupid. We're not mindless

victims in need of your 'protection.' Perhaps Public Citizen should read

the medical journals or try to borrow a clue before running their mouths

trying to ban thermogenic supplements. And you, dear reader, if you are

tired of big government running roughshod over your life, perhaps you

should join the Libertarian Party. They are the only political party

that sincerely wants to get the government out of your private life. We

do not have to live in fear of power hungry bureaucrats that want to

take our supplements off the market. The solution is just a click away.

 

 

Concluding Remarks

The smallest and most vulnerable minority in every country is the

individual. Health Canada could have protected the public by simply

providing accurate information so people could make educated decisions.

Instead, Health Canada chose a heavy-handed method of " protecting the

public " -- and they were undeterred by the fact that it would hurt obese

people. Their idea of " protecting the public " even includes lying to

" the public " about the health benefits of ephedrine/caffeine.

 

A tree is known by the fruit it produces. History teaches us to be wary

of those whose grandiose 'good deeds' involve dishonesty and hurting

vulnerable individuals. It is hard to think of anything more evil than

denying medicine to people who need it. But in light of Health Canada's

demented collectivist altruism, I cannot help but wonder just where they

would draw the line:

 

If Health Canada thought underpopulation was a problem, would they

consider rape an altruistic act?

 

Is that not what they have done to obese people? Who will be chosen as

the next sacrificial lamb by those who would use brute force instead of

persuasion to make the world a better place?