Melissa Healy

LA TIMES    July 11, 2009

 

From: Bill Sardi, Resveratrol Partners LLC, dba LONGEVINEX

 

Yes, yes, yes, Melissa, those dietary supplements are not proven to be safe,

but then again, do you really require a safety study before you take vitamin E,

garlic or ginger pills?  They have been in use for decades with relative safety.

By the way, drugs only undergo conclusive safety evaluation AFTER they

are on the market. 

 

Furthermore, supplements are far safer than table salt, aspirin (kills a few

thousand people every year), tylenol (primary cause of liver transplants),
vaccines and most Rx medications.  Product liability suggests bad products
will be eliminated over time.  Just where are all the dead bodies from those
resveratrol pills, or any dietary supplement for that matter?

 

New dietary ingredients (anything introduced after 1994) require safety studies,

though we see Acai berry and Hoodia come onto the market and the FDA did

nothing to demand safety and toxicity studies.  In fact, it took the FDA over

a decade to come up with Good Manufacturing Practices (GMP) for dietary

supplements.  Over that time, supplement makers had to endure unfair

criticism.  GMPs are in place now. 

 

Resveratrol has a unique status as a drug (Sirtris Pharmaceuticals) and

as a dietary supplement.  No manufacturer has conducted toxicity and safety

studies, but an agency of the US government did, so none were needed.

Short-term mega-dose safety studies appear to give resveratrol a go-ahead,

but the long-term effects are of greater concern. 

 

Resveratrol is a copper chelator and can induce anemia over time.

Achilles heel soreness is reported by users and this may emanate from

the lack of copper for collagen synthesis.  (Cipro, a mineral-chelating

antibiotic produces similar side effects.)  Resveratrol should not be used

during pregnancy nor by growing children.  Resveratrol does not have

GRAS status and should not be added in large amounts to foods.

 

High-dose resveratrol may produce adverse symptoms among

anemic individuals, more commonly headaches, fatigue, sleepiness, and

less commonly skin rashes, joint stiffness, anxiety reactions or flu-like symptoms
which could mean the immune system is being impaired (excessive TNF

inhibition). 

 

More troublesome is a study which showed mega-dose

resveratrol (360 and 1565 mg) actually shortened the lives of lab animals.

Mega-dose resveratrol appeared to impair the immune system
(animals succumbed to lymphoma).  Resveratrol is alleged to prolong life,
so this is a bit of a shocker.

 

An irresponsible Harvard professor, who touts a resveratrol-like drug,

tried to dissuade consumers from resveratrol supplements by saying

a few thousand mgs (equal to 1000 bottles of wine) would be required to

produce the same effects demonstrated in the laboratory.  This spawned

neophyte manufacturers to produce mega-dose 500 mg and 1000 mg

resveratrol pills, which should go on the red-light caution list.

 

University of Connecticut researchers showed that 175 mg and 350 mg

resveratrol protects the heart from damage should a heart attack occur,

but that 1750 mg and 3500 mg would weaken the heart and result in

greater damage should a heart attack occur.  (animal study)

 

Another recent study shows that lower-concentrations of resveratrol

slow the cell cycle and allows more time for DNA to be repaired, making

lower doses appropriate to achieve longevity, but higher concentrations
speed up the cell cycle, lead to cell death (apoptosis) and would be more

appropriate to treat cancer.

 

The above-named drug company seeks to make a pill that works better

than resveratrol by greater activation of the Sirtuin1 gene, but more

than about 8-fold greater Sirtuin1 protein produced heart failure in an

animal study.  So I wouldn't hold my breath for super-Sirtuin1 gene

activating drugs.

 

So is there really hope for an anti-aging pill?  Yes, the French happen

to use a liquid one called red wine.  Consumption of 3-5 five-ounce

glasses produces profound longevity (the wine-drinking French have

far more centenarians per capita than any other developed nation)

and lower coronary heart disease mortality rates (91 per 100,000

for the French, 240 per 100,000 for North Americans).

 

Take away the alcohol and you have all of red wine's polyphenolic

molecules (resveratrol, quercetin, catechin, ferulic acid, gallic acid,

kaempferol, malvidin), about 60 mg of polyphenols per glass of

aged dark red wine.  So 3-5 glasses would provide 180-300 mg

of these polyphenols.  This would be the safe and effective range.

 

Our company produces a red wine pill, LONGEVINEX, which

attempts to mimic the effects of red wine without the alcohol,

calories or sulfite preservatives.  It provides 250 mg of

red wine molecules (quercetin, resveratrol, ferulic acid) and

red-wine-like molecules (rice bran phytate), equivalent to

what is provided in 4 glasses of red wine.  This would appear

to be a more prudent dose for adults.

 

In an animal study, LONGEVINEX was found to exert a

9-fold greater genomic effect (gene array study) than plain

resveratrol or a calorie restricted diet, at a dose 17-320 times

lower than prior studies (Experimental Gerontology Sept 2008).

The news media and scientific community have chosen to

ignore this science. 

 

As for clinical trials, yes, where are they?  Resveratrol is one of the

most promising molecules on the planet.  It has been demonstrated to

be exhibit anti-depressant, anti-bacterial, anti-fungal, anti-viral, anti-inflammatory,

anti-cholesterol, anti-diabetic, anti-hypertensive action and inhibits cancer

at all three stages of development (initiation, growth and metastasis), something

no cancer drug can claim.  Where are the studies sponsored by the National

Institutes of Health?  One NIH study attempted to examine whether resveratrol

prevents cancer, but they selected young adults as subjects and young

adults generally don't get cancer.  It would take 30-40 years for this study

to prove anything.  So the NIH buried resveratrol.

 

The NIH was going to sponsor a study involving Longevinex for Alzheimer's

disease, but a pharmaceutical company interfered and lured a university to

study their drugs instead. 

 

Yes, there are hucksters who sell resveratrol pills, falsely claim their products

were shown on CBS' 60 Minutes, or on Oprah, or endorsed by Barbara Walters

or Dr. Oz, and that their products cure wrinkles, Alzheimer's, cancer and

obesity.  The public didn't elect to consume resveratrol pills en masse till these

bogus advertising claims were made and free trials of these pills were offered for

the cost of shipping only.  Then consumers suddenly found their credit cards

being billed $87 a month for a monthly supply of resveratrol pills they never

ordered.  Good science will always be trumped by exaggerated advertising claims. 

The FDA and FTC have yet to sanction irresponsible sellers of these

pills.  Buyer beware.

 

 

http://www.latimes.com/features/health/la-he-resveratrol-safety13-2009jul13,0,4292239.story

Is resveratrol safe to take?

By Melissa Healy

July 13, 2009

Like aspirin and the heart medicine digitalis, resveratrol is a plant extract -- one with seemingly powerful and broad effects on living organisms. It acts as a phytoestrogen, mimicking many of the hormone estrogen's effects. In the cells of rodents as well as humans, it disrupts the genetic machinery that gives rise to inflammation and to cancerous tumors. In cell cultures of brain tissue, it even cleans up the tangled amyloid deposits that are the hallmark of Alzheimer's disease.

It is, potentially, a powerful drug.

But unlike aspirin and digitalis, resveratrol qualifies as a dietary supplement, produced and marketed by an industry that operates under far less stringent government oversight than companies producing prescription drugs.

Supplement manufacturers are forbidden to make direct claims that their products will treat or cure diseases in humans. But they are permitted to cite animal research suggesting a product's curative powers, and to claim that their products improve or support the function of healthy bodily processes.

They are under no obligation to demonstrate the safety of their products before they are offered to the public for sale.

Supplement supporters maintain that, if a substance seems to have only positive effects -- as resveratrol seems to -- there's little need to wait for the glacial pace of clinical trials to determine whether resveratrol supplementation is safe. Similarly, a fine-tuning of the precise dose can seem unnecessary as well.

Traditional health experts disagree. "Taking it as a supplement without long-range safety and toxicity studies is foolish," says Dr. Gerald Weissmann, director of New York University's biotechnology study center. Besides, he adds, "you might get terrible pimples, infections or worse" because the touted "antioxidant" agents that resveratrol sets loose in the body to scavenge toxins also function to dampen our defenses against some dangerous bacteria.

Dr. Arthur Grollman, a microbiologist at New York State University at Stony Brook, says people are taking resveratrol -- often in very large doses -- "on faith" that compounds will have the same effects in humans that they do in the lab and in experiments with animals.

On complex biological issues such as aging and the human diseases that come with it, says Grollman, "they rarely do."

Studies now underway will show whether that faith is well founded or illusory. But it will take several years. Among 12 human clinical trials currently underway or recently completed on resveratrol, just two are Phase 3, or advanced human trials, which are designed to establish the safety and effectiveness of a potential medicine against specific diseases (both will test its effectiveness against Alzheimer's disease). The rest are in earlier stages of research, focusing on the safety of a potential medicine in a range of patients.

melissa.healy@...