[Health&Healing] FDA Proganda Spin Attack

[Guest guest]

This is hard to take this seriously and believe the FDA is remotely

sincere when regular medical care is the 3rd leading cause of death

in the US, documented by JAMA!! I think it is much more obvious

they are concerned about the health of their wallets!

Misty

http://www..com

 

FDA Propaganda Spin Attack

 

 

The Pharmaceutical Industry Mafia prepares for a hostile takeover

of non-prescription vitamins, minerals, herbs and suppplements

(18 billion US$ annual market), due to the declining 'popularity'

of FDA-approved (but NEVER guaranteed safe) prescription drugs :

 

 

http://www.newscientist.com/news/news.jsp?id=ns99994853

 

 

Special report: A health fad that's hard to swallow

 

Exclusive from New Scientist Print Edition

10:30 12 April 04

 

One in four people in the US regularly pops a magic pill in the

hope it will improve their health, well-being and longevity.

Different people swear by different ingredients, but there is

one constant: the assumption that such pills, broadly known as

dietary supplements, are safe.

 

Most people assume that the vitamin A, B, C or D, or iron,

selenium, manganese or cod liver oil, or ginseng, Ginkgo biloba

or St John's wort they swallow has been rigorously tested by

government and declared harmless. It has not. And evidence is

mounting that many of these products contain ingredients that

can kill, especially if taken alongside certain prescription

drugs.

 

Last week, the US Food and Drug Administration (FDA) received a

report detailing the results of the first major investigation

into how the dietary supplements market should be regulated.

And the conclusions, from the Institute of Medicine (IoM), are

stark.

 

There are almost no figures on the efficacy or toxicity of the

29,000 dietary supplements sold in the US in a market worth $18

billion a year. Many supplements, including traditional

remedies, have been reformulated so often, and put to such a

wide variety of uses, that no one knows for sure if they are

still safe.

 

And unless the law governing supplements is changed, the FDA

will not be able to adequately protect the health of the

American people.

 

 

Adverse reactions

 

Calls for the regulation of dietary supplements have been

growing louder over the past two or three years, and 30 months

ago the FDA responded by commissioning the IoM to formulate a

strategy for identifying potentially dangerous supplements.

 

The timing was prescient. Since then, concerns have continued

to grow about the safety of one supplement in particular -

ephedra, a herbal extract also known as ma huang, that was

touted as an energy-giving, weight-reducing panacea.

 

In January this year, the FDA finally banned the product after

it had been linked to 155 deaths and was implicated in 16,000

adverse reactions, including raised heart rates and blood

pressure, which can spark a stroke or heart attack (New

Scientist, 10 January, p 6).

 

The FDA wants to stop people popping pills that contain

dangerous ingredients. But there is a problem, says the IoM

report, namely the 1994 Dietary Supplement Health and Education

Act. This enshrined in US legislation the assumption that all

such supplements are safe until proved otherwise.

 

This differs markedly from the regulations governing

conventional pharmaceuticals and food ingredients, for which

the FDA demands stringent safety tests before approving for

sale or consumption.

 

 

Whistle blowing

 

That is unacceptable, says the IoM. It wants the law changed to

compel supplement manufacturers to notify the FDA whenever

there is an adverse reaction to one of their products. And to

help force the issue, the IoM is encouraging consumers to act

as whistleblowers, telling the FDA of any problems. It

recommends that a freephone number to call be clearly displayed

on all product labels.

 

The IoM also wants the act changed to force manufacturers who

reformulate supplements - essentially creating a new product -

to submit safety data to the FDA before putting them on sale.

 

But even these steps may not be enough, say commentators. " It

looks like they are taking some interim steps that may help,

but they will not solve many of the problems, " says Stephen

Bent of the University of California in San Francisco. " It

would be much better to make the companies prove [all] their

products are safe to the FDA, in other words, pre-market

approval. "

 

With his colleague Richard Ko of the California Department of

Health Services, Bent has conducted a major review of the known

hazards posed by some of the most popular dietary supplements

(The American Journal of Medicine, vol 116, p 478). Published

this month, it lists the toxic contaminants in supplements and

toxic effects of herbs such as ephedra, allergic reactions, and

dangerous interactions with mainstream drugs.

 

 

Liver failure

 

Examples include fatal liver failure suffered by consumers of

kava kava, and kidney damage in women taking the herb

Aristolochia fangchi. In a survey of 260 traditional Asian

medicines, researchers found a quarter contained high levels of

toxic metals such as lead and mercury, and seven per cent had

been spiked with undeclared pharmaceuticals to increase their

efficacy.

 

Herbs such as Ginkgo biloba and ginseng may increase the risk

of bleeding during surgery, and intensify the effects of

anti-clotting drugs such as warfarin.

 

Many of these dangers are acknowledged by the IoM. But the

institute says it would be almost impossible to conduct

clinical trials to gauge the safety of dietary supplements.

Unlike medical drugs, supplements are not taken according to a

prescribed regime, and may be taken occasionally or for

decades, so the effects are unclear and difficult to study.

 

The products may come from plants that vary in quality, with

fluctuating amounts of active ingredient, both between plants

and between different parts of a herb such as its roots or

leaves. One analysis, says Bent, shows that some ginseng

products contain up to 200 times as much active ingredient as

others. Similar variations have been found in products

containing St John's wort.

 

The IoM report says that such complications contradict one of

the basic tenets of the 1994 act - dietary products do not need

testing because they are natural, traditional and have a

" history of safe use " . " The fact a substance was consumed over

a number of years does not indicate that it was consumed

without adverse effects, " the report says.

 

 

Lost knowledge

 

For example, past communities may have known that a particular

herb could damage a fetus, yet that knowledge may have since

been lost, leaving pregnant women to unwittingly consume

extracts of the plant.

 

The IoM is calling for a surveillance programme to help the FDA

identify such risks, though it accepts that it may be

impossible to make definitive statements based on scientific

evidence about a product's safety. But it says that it should

not be incumbent on the FDA to prove that a supplement is

unsafe. Identifying a significant or unreasonable risk should

be enough to have the product recalled.

 

Data from laboratory studies and comparisons with related

substances should be collated, it says. And attention should be

paid to human and animal tests of supplement ingredients. Even

in the absence of information on adverse effects in humans,

evidence of harm from laboratory animal studies should indicate

that a supplement may be dangerous.

 

The notification of adverse reactions, both in lab studies and

among consumers, should also help the FDA to spot a problem

before it is too late; it took the FDA seven years to collate

enough evidence to ban ephedra. The agency should even be

encouraged to conduct its own pre-emptive investigations into

suspect supplements.

 

For critics of the unregulated supplements industry, the IoM

report is long overdue. The industry is booming, with sales

rising by 25 per cent each year, fuelled by the belief that

" natural " products are by definition safe, says Bent.

 

Yet, six out of 10 people asked in a survey cited by Bent's

review mistakenly think that food supplements carry a seal of

approval from the FDA. A similar irony can perhaps be found

within another study published earlier in 2004.

 

According to the research, supplement use tends to be higher

among older, educated people who are neither obese, nor smoke.

Many engage in exercise, eat low fat diets and consume healthy

amounts of fruit and vegetables (Journal of the American

Dietetic Association, vol 104, p 27). In short, people who are

likely to be most concerned about their health and critical of

what they put in their bodies.