~ September 2007 - Life-Saving Cancer Drugs Rejected by the FDA
Contents . . .
- Life-Saving Cancer Drugs Rejected by the FDA
By William Faloon and Donna Pogliano
For the past 27 years, Life Extension has identified life-saving medications that languished too long in the FDA's archaic approval process.
When effective new drugs are delayed, the inevitable consequence is needless human suffering and death. An equally insidious problem is the chilling effect bureaucratic roadblocks have on the development of better drugs that might actually cure the disease.
Just imagine the difficulty of raising the tens of millions of dollars needed to get a new cancer drug into the approval pipeline when prospective investors see the FDA deny a drug with documented efficacy, as was done recently with Provenge.
Another problem with the FDA's unpredictable approval pattern is the outrageous cost of the cancer drugs that actually make it to market. Classes of cancer drugs (like anti-angiogenesis agents) that Life Extension long ago advocated are finally approved. The problem is that the out-of-pocket cost of these new drugs can exceed $12,000 per month. The media has reported on heart-wrenching stories of cancer patients who choose to die rather than send their families into bankruptcy from paying these costs.
It's easy to point fingers at drug companies for charging such extortionist prices, but the harsh reality is that getting these medications approved by the FDA is so costly and risky that the high prices can arguably be justified by the hideously inefficient drug approval process that now exists.
In this article, we review a few of many drugs that have been shown to be effective against cancer, but are not yet approved by the FDA. While there are dozens of anti-cancer drugs in various stages of the approval process, the sad truth is that thousands of compounds with anti-cancer activity will never be submitted for FDA approval due to lack of patentability, lack of investor funding, or just plain unwillingness to deal with today's cancer bureaucracy.
It has become brutally apparent that the system of drug approval needs a radical overhaul. We have some specific proposals at the end of this eye-opening article.
Read more . . .
- Vitamin D's Crucial Role in Cardiovascular Protection
By William Davis, MD
Health-conscious adults regularly monitor their cardiovascular risk factors--such as cholesterol, glucose, and homocysteine--in order to reduce their risk of debilitating cardiovascular disease. Now, intriguing new research suggests that vitamin D may play an essential yet overlooked role in staving off heart disease. Vitamin D deficiency may eventually be added to the list of causative factors that contribute to cardiovascular disorders.
A growing body of research indicates that vitamin D deficiency contributes to a broad spectrum of conditions such as high blood pressure, poor insulin sensitivity, inflammation, and other fundamental processes that underlie heart disease.
Alarmingly, vitamin D deficiency is extremely common throughout the population--affecting more than half of adults and the majority of the elderly.1
In this article, we'll explore the epidemic of vitamin D deficiency, its detrimental effects on cardiovascular and whole-body health, and how you can protect yourself by maintaining healthy blood levels of vitamin D.
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- Protecting Cardiovascular Health with Whole Grape Extract
By Julius G. Goepp, MD
Scientists continue to uncover a wealth of impressive nutrients contained in the red grape. The latest findings indicate that full spectrum grape extract can help support cardiac health by maintaining youthful endothelial function, regulating platelet aggregation, and reducing inflammation.
An ever growing body of evidence shows that components of red grapes can have powerful effects on vascular health, reducing platelet aggregation and lipid peroxidation while improving endothelial function. The ability of red grape constituents to fight inflammation is opening new doors in treatment of chronic age-related disorders, including both the prevention and treatment of cancer.
Nowhere are the "blessings of the grape" so evident as in prevention of cardiovascular disease. While many factorsranging from vitamin K deficiency to elevated glucose levelscontribute to cardiovascular risk, perhaps one of the most insidious triggers is inflammation.
When inflammation is present, oxidant stress damages blood vessel walls and oxidizes low-density lipoproteins (LDL). These processes cause immune system cells to release inflammatory mediators called cytokines, which in their own turn produce changes in the walls of blood vessels, eventually resulting in accumulation of diseased tissue known as plaques. The same cascade causes platelets, the tiny cell-like fragments responsible for blood clotting, to cluster together (aggregate) excessively, increasing the risk of clot formation that can produce ischemic heart attacks and strokes.
In just the past decade, striking new findings have been made on how components of red grapes (including both skin and seeds) affect vascular health, ranging from increasing vital nitric oxide (critical in maintaining endothelial function) to protecting against heart muscle damage.
This article explores how whole grape constituents can have a profound impact on your longevity.
Read more . . .
- Unknown Health Risks of Inhaled Insulin
By T.R. Shantha, MD, PhD, FACA
Fear of needles and the inconvenience of administering insulin injections have created a burgeoning demand for alternative methods of treating diabetes. An apparent breakthrough arrived with the development of an insulin preparation that required no needles, but instead could simply be inhaled.
While the FDA has deemed this novel insulin preparation safe and effective, many questions regarding its long-term health effects remain unresolved. Here, we discuss the use, safety, and potential risks of insulin inhalation preparations.
Read more . . .
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Unlike other products that contain only proanthocyanidins, this blend also provides standardized resveratrol and a new whole red wine polyphenol extract.
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