Consumers Against High Drug Prices
Exposing The FDA's Regulatory Quagmire
CoQ10 Wars
Assembly Line Medicine
Collapsing Within Itself
Intolerable Delays!
"Unsustainable" Cancer Drug Prices
How Government Treated Those For Whom We Now Celebrate Holidays
Horrific Conditions Inside Drug Factories
When "Rules" Are Broken
Federal Death Panels
Science by Ambush
The Looming Doctor Shortage
Former FDA Commissioner Admits Risk of Bureaucratic Delay
FDA Says Walnuts Are Illegal Drugs
The FDA's Most Heinous Drug Approval
No Real Healthcare Cost Crisis
FDA Delay of One Drug Causes 82,000 Lost Life-Years
Deadly FDA Neglect
How Much More FDA Abuse Can Americans Tolerate?
Drug Company Pleads Guilty to Health Fraud
Why American Healthcare is Headed for Collapse
The Generic Drug Rip-off
Ending the Atrocities
Millions of Needless Deaths
Would You Tolerate This Abuse?
The FDA Indicts Itself
The FDA's Cruel Hoax
Fish Oil Now Available by Prescription!
FDA Threatens to Raid Cherry Orchards
Inside the FDA's Brain
FDA Fails to Protect Domestic Drug Supply
FDA Permits New Fish Oil Health Claim
FDA Approves Deadly Drugs, Delays Lifesaving Therapies
The $50.00 Toll Bridge
Dangerous Medicine
Cardiologists Overlook Lifesaving Discovery
What You Don’t Know About Blood Sugar
Jerry Falwell Attacks Life Extension Foundation
Life Extension Achieves "Impossible" Victory in the U.S. House of Representatives
Fighting the FDA
Patient Advocates Sue FDA Over Drug Access
FDA's Lethal Impediment
Don't Blame the Doctors
One Man's Ten-Year Ordeal With Prostate Cancer
A New Day At FDA?
The FDA Versus the American Consumer
Supreme Court Roundup
The Lethal Information Gap
Consumer Rape
Dying From Deficiency
Are Offshore Drugs Dangerous?
Drugs the FDA Says You Can't Have
Does Cholesterol Cause Artery Disease?
What's Wrong with the FDA
FDA Suffers Second Massive Legal Defeat in Pearson v. Shalala
FDA Loses Case Against Compounding Pharmacies on First Amendment Grounds
Ending The Cancer Bureaucracy
Victory in the House and Senate
Life Extension Wins in the House and Senate
Congress Recognizes The Prescription Drug Problem
Americans are getting Healthier... But the FDA Remains a Major Impediment
Are We to Become Serfs of the Drug Monopoly?
A Glorious Victory Over FDA Tyranny
The Great American Rip-Off
The Plague Of FDA Regulation
Health Costs to Double Is there a free-market solution?
The FDA versus Folic Acid
They Want You Brain Dead
Life Extension vs. the FDA a Hollow Victory: Why the Agency's Approval of Ribavirin is Inadequate
FDA Approves Deadly Drugs, Delays Lifesaving Therapies

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

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