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Resveratrol-Drug Trial Halted

Here's an example of more pharmaceutical games that block prevention of disease for the public. Big Pharma can't make money in cheap, easy cures for people. There is also no profit when the public strays healthy.

The article below is a recent example — in a long list of examples — where Big Pharma will block natural health initiatives or new drugs from entering the pipeline if it threatens the company's bottom line.  

Resveratrol based medicines could prevent or treat almost every disease and theoretically decrease sales of most every pharmaceutical in the market. Glaxo Smith Kline bought Sirtris Pharmaceuticals for $720 million so it could take over control and block the drug from hitting the market. It was cheaper for them to do this then to allow them to make it to market competing against their drug pipeline. Read the article to understand more:

Resveratrol-Drug Trial Halted Over Undisclosed Safety Concerns; Lack Of Transparency In Clinical Trials Arises Once Again; Little Concern For Resveratrol Supplement Users.

Las Vegas, NV (USA May 4, 2010) - News agencies aired a report today that a human study was suddenly halted due to safety concerns over the combined use of a resveratrol-based drug with a toxic chemotherapy cancer drug among patients with myeloma (bone marrow cancer).  The announcement can be found here.  No reason has been given why the drug-combo trial was stopped.  The listing of the human clinical trial with the National Institutes of Health can be accessed here.

There should be little or no concern of toxicity among the many thousands of resveratrol dietary supplement users says Bill Sardi, formulator of resveratrol pills, but he cautions that patients taking any medication should take them at a different time of day than their resveratrol pills.  Separation should be at least two hours.

Resveratrol dietary supplements were first marketed heavily beginning in early 2004 after Harvard researchers reported that this red wine molecule may be responsible for the French Paradox – that the French live longer, leaner and healthier than North Americans despite their high-fat diet.   Despite concerns over labeled dosage and stability of commercially available resveratrol pills, including unsubstantiated advertising claims, no major recalls or reports of side effects among resveratrol-pill users have been issued in the past 7 years.

Potential for drug interactions

Resveratrol (pronounced rez-vair-ah-trawl) works like molecules found in grapefruit juice, known to enhance or dull the effect of many medications.  Resveratrol can transiently make a medicine too powerful, such as when combined with a blood-pressure lowering pill.  For example, a person taking blood pressure medications at the same time as resveratrol may experience temporary dizziness from a drop in blood pressure until the resveratrol is fully metabolized in the intestines or liver a few minutes after consumption, says Sardi.  However, he notes that many consumers unsuspectingly take resveratrol pills with medications with no reported side effects.

Some drug compounds are not carcinogenic (cancer causing) until they have been metabolized in the body by cytochrome P450 enzymes in the liver.  Resveratrol’s abilty to inhibit detoxification enzymes produced in the liver could in fact help avert tumors by limiting exposure to these drug activated carcinogens.

Any potential toxic effects of resveratrol are self limiting, says Sardi, because this molecule rapidly attaches to larger detoxification molecules (glucuronate and sulfate) in the intestines and liver and resveratrol is not biologically available till it is freed via the glucuronidase enzyme from its carrier molecule at sites of inflammation, infection or malignancy.  It is nature’s drug delivery system, says Sardi.

The drug trial

The drug trial was designed for some patients to take a resveratrol-based drug alone (SRT501 Sirtris Pharmaceuticals) and other patients in combination with bortezomib (Velcade), a toxic cancer drug.  Without greater transparency as to the suspected cause of the safety problem, consumers are left to guess whether it was the drug, resveratrol, or their combination that prompted the study to be closed down.

The combination of drugs like bortezomib and resveratrol was suggested by researchers in 2006.  Resveratrol and bortezomib had undergone successful testing in prior lab dish studies and had been shown to enhance the cancer-toxic effects of this drug.

Myeloma drug enhancement

The manufacturer of bortezomib, with 2008 sales exceeding $1 billion worldwide, may be searching for ways to enhance this drug since a competing drug has recently been found to be superior to bortezomib in a recent clinical study.

The study calls into question the idea of making toxic cancer drugs even more toxic.  While the side effects in the above mentioned study are unknown, resveratrol works to inhibit detoxification enzymes (cytochrome P450 enzymes) in the liver, which can make anti-cancer drugs work even better, though more toxically.  

Resveratrol dosage

Dosage may also have something to do with resveratrol safety.  Based upon animal studies, it appears resveratrol exhibits a better margin of safety in lower doses ranging from 70-100 milligrams per day, compared to 270+ milligrams per day.  While some resveratrol pill makers have engaged in competitive battles to offer higher dose pills, researchers have shown that relatively low doses of resveratrol mimic a limited calorie diet and even activates more longevity genes.

Animal studies suggest mega-dose resveratrol (1750-3500 mg/day) may be appropriate for cancer therapy, inducing cancer cell death.  The human drug trial in question specifies 5 grams (5000 milligrams) of resveratrol be consumed by myeloma patients daily, a mega-dose that could induce toxic reactions.

Resveratrol as sole cancer therapy

Resveratrol alone has been proposed for treatment of myeloma because it exhibits multiple ways to block this form of cancer, including inhibition new undesirable new blood vessels (angiogenesis), inhibition of tumor cell invasion, and works synergistically in bone tissue with vitamin D.

Resveratrol alone is known to exhibit profound anti-cancer properties. For example it inhibits cancer at all three stages of development (initiation, growth and spread), something no existing anti-cancer drug does.

“It’s even possible resveratrol by itself was shown to be superior to the toxic cancer drug, that drug toxicity solely caused the study to be halted, and the drug company is hiding the results to protect a billion-dollar product,” says Sardi.  The lack of immediate transparency in this study is of concern given the recent mandate that sponsors of drug trials report all their data in a timely manner.  For more information about safe use of resveratrol pills, visit Resveratrol Consumer.   end