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FDA Approves Deadly Drugs, Delays Lifesaving Therapies

May 2004

By William Faloon

FDA Denies Alzheimer’s Drug for 14 Years
At any given time, 4 million Americans suffer the devastating consequences of Alzheimer’s disease.47 Alzheimer’s has no cure, and all victims suffer a progressive neurodegenerative process that results in total disability and death.

In 1990, a drug used in Germany was found to slow the progression of the disease.48 The drug’s generic name is memantine, and Life Extension has long recommended it to family members of Alzheimer’s victims.49

Memantine does not offer miraculous benefits. The studies show that some patients experience improvements in memory and cognitive skills.50 For the vast majority, however, memantine merely slows the pace of deterioration, enabling patients to perform certain functions a little longer than would otherwise be possible.51,52 For example, the drug enabled some patients to go to the bathroom independently for an additional six months, a benefit caregivers called very important.53

The July 2001 issue of Life Extension featured an in-depth report on the clinical value of memantine in treating a wide range of disorders, including Parkinson’s disease, glaucoma, and diabetic neuropathy.54 We were highly critical of the FDA’s attempts to deny Alzheimer’s patients residing in the US access to this safe and partially effective medication.

Starting this year, Americans can now purchase memantine sold under the brand name Namenda® at American pharmacies. One reason memantine is available now is the intense pressure put on the FDA by family members of Alzheimer’s victims who had to order the drug from Europe and risk FDA seizure.

Americans had to wait 14 years to gain legal access to a drug proven to work in Europe. This is not the first time FDA bureaucrats have needlessly delayed approval of an effective drug for a terminal disease. In 1991, the Life Extension Foundation sued the FDA on behalf of Alzheimer’s patients in the US who were being denied access to the drug tacrine. Tacrine’s mechanism of action inhibits the acetylcholinesterase enzyme, thus making more of the neurotransmitter acetylcholine available to brain cells.

A judge tossed out our lawsuit on the grounds that the federal courts are not the proper forum in which to determine which drugs the FDA should approve. Six months after our lawsuit was dismissed, the FDA approved tacrine.55 (A few years later, the FDA approved a safer drug called Aricept® that shares some of tacrine’s same mechanisms of action but is less toxic.56)

Memantine works by a different mechanism than tacrine or Aricept®. Memantine blocks a reaction known as “excitotoxicity,” a pathological process in which too much glutamate is released in the brain, severely damaging the neurons. Those seeking to protect their healthy neurons against the damaging effects of excitotoxicity use dietary supplements such as methylcobalamin and vinpocetine. That it took litigation, harsh media criticism, and a citizens’ uprising to motivate the FDA to approve these Alzheimer’s drugs is a testament to the agency’s inability to differentiate between safe, effective medications that should be approved and lethal drugs that should be removed.57

Who Will Protect Us from the FDA?
The FDA pretends to protect Americans from dangerous and ineffective products, yet even a cursory review of the agency’s track record reveals the opposite to be true. Dangerous and ineffective drugs are approved, while novel lifesaving therapies and natural approaches to disease prevention are brutally suppressed.58-69

The FDA’s failure to mandate a warning on the label of acetaminophen products is just one example of its failure to protect consumers against lethal drug side effects. The agency’s inexcusable delay in approving drugs to alleviate the miseries of Alzheimer’s disease reveals its lack of compassion for human beings who have lost the cognitive ability to take care of themselves.

Since 1980, the Life Extension Foundation has recommended to its members drugs that the FDA has not yet approved.70-73 In many cases, what we recommended was eventually approved, which means that our scientific analysis—as opposed to the FDA’s politically motivated decision-making process—was medically correct.

Regrettably, some non-patentable therapies will never receive FDA approval because of the high cost of navigating the agency’s bureaucratic labyrinth. When it comes to disease prevention, the FDA has made extraordinary efforts to censor information about proper diet and supplements that would provide guidance to consumers who want to adopt healthier lifestyles.74

The Life Extension Foundation is dedicated to breaking down the governmental barriers that cause Americans to needlessly suffer and die while proven methods may already exist to alleviate or eradicate their health problems.

The health choices of most Americans continue to be constrained by FDA politics and bureaucracy. Life Extension members, on the other hand, are an elite group that often gains access to lifesaving information five to 10 years before it is accepted by conventional medicine or “approved” by the FDA.

For longer life,

William Faloon.