Big Pharma is drooling over the prospect of getting it all to themselves.
Resveratrol, a substance found in the skin of red grapes as well as in pomegranates and Japanese knotweed, has been a popular dietary supplement for many years. It has anti-inflammatory and antiviral properties, possibly the potential to extend life, prevent several different cancers, protect the heart, ameliorate common diabetes symptoms, and control plaque in the brain and otherwise help with Alzheimer’s disease. And that isn’t even a complete list. It’s clear why drug companies are excited.
Resveratrol is widely available as a dietary supplement—but may not be for long if we are not vigilant. A new study has thrown the excitement over resveratrol into high gear. Results from ten years of research have just been published by David Sinclair, a Harvard Medical School genetics professor and the study’s senior author. The research validated earlier findings that resveratrol may protect against age-related diseases because it turns on the SIRT1 gene that recharges mitochondria.
Sinclair’s earlier research was partly discounted by other scientists in 2009 and 2010. They suspected that resveratrol might only seem to activate the SIRT1 gene because studies used a synthetic fluorescent chemical to track the effect. Since these synthetic chemicals are not found in nature, they reasoned, the experiment is not reproducible in humans. In this study, however, Sinclair used naturally occurring amino acids to track the benefits, which affirmed the compound’s benefits.
Sinclair is not a disinterested party. He is the founder of Sirtris Pharmaceuticals, which focuses on developing resveratrol drugs, that is drugs that will mimic resveratrol’s effects with new and thus patentable molecules. Pharmaceutical giant GlaxoSmithKline (GSK) acquired Sirtris in 2008 for $720 million. GSK subsequently abandoned its work on resveratrol-based drug SRT501 because the drug didn’t appear to work on cancer patients and worsened kidney damage. It’s likely, however, that the new findings will prompt GSK to restart its work on a resveratrol-based drug; resveratrol is already the subject of at least two dozen clinical trials.
Because Resveratrol is also the subject of an investigational new drug (IND) application, GSK could petition FDA to ban natural resveratrol. Yes, that’ s how warped the law is. Apply for FDA approval for something synthetic, new-to-nature, and thus potentially much more dangerous, and you can then try to ban the natural substance on which your product was based.
This is governed by a provision in the law, as we explained last year. There is an absolute prohibition against banning the natural substance if it is grandfathered (that is, marketed before 1994) or if the FDA has accepted a New Dietary Ingredient (NDI) notification from supplement manufacturers.
Supplement companies have tried to file NDIs for resveratrol, but the FDA has rejected them all, stating that an IND had already been filed, so they won’t accept an NDI. Despite resveratrol being a natural component of food and a constant part of the food supply, it may be hard to prove that it was marketed before 1994. This, of course, merely reveals the illogic of the grandfathering process: it was put in place as a means of proving the safety of an ingredient, but instead it’s being used to protect the pharmaceutical industry.
New drug applications (INDs) are confidential, but we can make an educated guess that Sirtris Pharmaceuticals is one of the companies that filed an IND since they have already started clinical drug trials (an IND is required before clinical drug trials). If they are successful, resveratrol will then be available in an expensive, synthetic drug form, likely requiring a prescription at a very high cost and a disease condition for access. It will be tempting for the drug company to then try to have the FDA ban the natural form of resveratrol. It is our job to prevent that by making it painful for both the company and the FDA.
In this context, let’s remember what happened to pyridoxamine, one of the three primary natural forms of vitamin B6. Biostratum, the North Carolina-based manufacturer of a planned pyridoxamine-based drug called Pyridorin, petitioned the FDA for market exclusivity, and FDA kowtowed, effectively prevented any substance containing pyridoxamine from being marketed as a dietary supplement. To date no drug has even appeared, so we have neither natural B vitamin nor drug, an outcome that is all too typical of FDA illogic and misuse of power. A similar petition has been filed regarding P5P, the natural form of B6 that is most bio-available. All other forms of B6 must be converted by the body to this form to be used, and without it we would all die. Is this really something to ban and make into an exclusive, prescription-only drug? (If you have not already done so, please send your message to FDA and Congress to make sure P5P remains available as a supplement.)
If the dietary supplement version of resveratrol becomes threatened, rest assured that ANH-USA will be with you on the front lines, fighting to maintain your access to this amazing nutritional ingredient.
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So this is yet another example of the incredible greed that exists throughout our ‘health care’ system. The FDA would’t give the supplement industry NDIs for reservatrol but they will quickly allow GlaxoSmithKline to aply for patents and approval.. The FDA or Glaxo will not have to do any research or testing because they will just use those already done (at great expense) by the supplement industry. All of a sudden that research is extremely important and deserves its attention. Worse, now we are all in danger of not being allowed to order reservatrol at will as it will not longer be available to the public but only by prescription. Good God!!
Get a petition going!!
FDA and the drug lords of creation, keep your filfhty hands off of trying to quite possibly
over regulate safe and effective NATURAL revesterol off the market and in it’s place put synthetic so called revesterol in it’s place and only with prescription$$$ mind you.
Dear Sirs: There are more poisonings and deaths each year from FDA approved drugs than all supplements put together. Why are we subjected to continued assaults upon our freedoms to use supplements? I have had diabetes for about 35 years and have a blood profile that most young people would love to possess. I am 75 years old and other than some slight arthritis from a youthful accident, I am healthy. I have become more resistant to disease each succeeding year. My blood pressure is 106/65. Each of these successes were achieved through supplements I do NOT get flu shots nor take any medications except Metformin and Insulin for my diabetes and an occasional aspirin for my arthritis. But I do take over 20 different vitamin and mineral supplements tailored to my diabetes. It is well known that diabetics have difficulties absorbing these from foods, and to absorb enough sunlight in northern Ohio to provide even the most minimal vitamin D needs is nearly impossible. Supplements are NECESSARY for health!
I do not want Resveratrol to be available in an expensive, synthetic drug form, likely requiring a prescriiption at a very high cost. I do not want P5P to be banned, and made into an exclusive prescription-only drug. I want P5P to remain as a supplement. Stop trying to sensor these beneficial, healthful supplements.
when is the fda big pharma going to be exposed for what it is an extension of our disease maintaining system not health promoting one. The people are/ave been shortchanged and don’t know any better because they are not being informed in the public airwaves like tv, movies, radio. We need an army of whistle blowers to wake the american public to the realities of what is going on in their standard american diet (SAD) food delivery system as well as their health preventing medical-pharmaceutical systems.
Healthy food not drugs promote health. When will every american be exposed to this truth that they are being ripped off to perpetuate an unsustainable agricultural system that’s contributing to a disease maintenace medical-drug delivery system. If a trial were held and the truth came out the FDA along with monsanto, and government officials would be indicted for promoting destroying our health and planet because of GREED. Don’t think i’ll see it in my lifetime but i’ll keep my fingers crossed.
You should make it easy to sign a petition. No one has time to phone or write a letter.
Time or ambition?
So crazy insane. I want to keep access to natural. Today now there talking about Z Pac has the ability to kill some people. These FDA approved drugs are harmful but they still want to take Natural away from us. I think the FDA is just Greedy.
Not only greedy but preventing cures, a cured person is a lost customer.
I can’t take it anymore!
Since God’s existence is not provable, SOMEBODY please save us from the greedy depredations of profiteering industrialists!
grape seed extract including Resveratrol, has been marketed since the mid 1980 to my own personal knowledge. It was the first health food supplement I ever used!
We need to pry the clutching claws of the FDA completely off of anything naturally occurring and leave them in the land of the synthetic, patented and poisons and rename them the DA.
There are a lot of what are called essential nutrients that we must have to live a normal life and some of them we must have to live. Here are three of those, a deficiency of B1 can lead to the disease Beriberi which is deadly, a B3 deficiency can lead to Pellagra and of course C can lead to Scurvy. All of these nutrient deficiency diseases are deadly and their are many more.
And all of them at a deficiency level can cause disease symptoms like depression, anxiety, insomnia, schizophrenia, irregular heart beat, asthma and on and on.
Signs of a Nutrient Deficiency?
Fatigue, Cracked Lips at corners, Headaches, Allergies, Mood Swings, Insomnia, Paranoia, Weakness, Irregular Heartbeat, Poor Balance, Cramps, Bruising, Irritability, Infertility, Premenstrual Syndrome, Inflamed Tongue, Facial Oiliness, Dizziness, Joint Pains, Sensitive Teeth.
The FDA is encroaching into a very dangerous area that threatens the lives of everyone, they need to be stopped!!!
“If people let government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as are the souls of those who live under tyranny.” Thomas Jefferson
Happy Healthy Trails
Doc Blake
The insane drive of greed and power never ceases to amaze me.
Re resveratrol: I thought that 60 MINUTES did a program on this and the researcher who did most of the research. I believe the conclusion was that he invented or misrepresented the positive results he obtained for the health effects of resveratrol. And the whole hype about resveratrol was a scam, which I believe they said on the air. This was of course after the sale. Is this not correct?
Help! Senator Clinton; you protected us from Big PharMa trying to ban Vitamin C (so they could add it to their drugs) now we need you again! Please help us, Senator, with a ban on Big PharMa’s attempt to ban naturally-occurring substances! Imagine if Big PharMa could re-label WINE as a Medicine (sorry for posting an all-caps word; needs emphasis).
I think the petition idea is a good one, unless you know otherwise. I also think the FDA doesn’t give a damn about the average citizen. They only care about power and money (like everyone else).
Its time to get rid of the corrupt influences of the FDA, who are in bed with big pharma. There are too many people who are aware of whats going on now, and we have just begun to scream about it! Its obvious they want us to get sick and keep us sick, but too many of us are suffering at their hands, and are wising up about it. The dam is finally breaking, and they wont be able to hold back the tide of awareness and outrage.
No, people, the point is that FDA WANTS YOU dead! Don’t you know that yet??
Another comment is not needed but I want to add my thanks to anh-usa.org for alerting us to challenges to our ability to acquire supplements. I am a healthy 88 years old, have been taking a variety of supplements for most of my life. My grandfather was one of first natropaths in U.S. A.and helped all his family to a natural life style. Taking supplements under guidance of a naturopath is important.
Here’s the problem with Resveratrol. Its usually bundled up in some garbage product with a ton of other stuff that isn’t so great for you. That’s why you gotta make sure you’re buying things from a solid company. Buying a resveratrol specific herbal bottle from a high quality herbal company is great. Buying one that is marketed as a fad weight loss tool is probably not going to be very good for you. Big difference between the 2.
Can’t grape seed extract, which contains resveratrol, be considered a form of resveratrol that was marketed before 1994? I also heard from an FDA representative that if a substance is shown to help patients, they are a separate population from the normal population and thus the substance will remain protected for the normal population. Can you address this point?
The law can really be warped. FDA banning the natural resveratrol is rather ludicorous especially the benefits that are evident in the studies.