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


Americans suffer and die even though effective drugs to treat their diseases are approved in other countries. The public is generally aware that novel drugs are sold in Europe and Japan, but intense lobbying by the pharmaceutical industry has blocked the wide-scale availability of these better medications.

Drug companies don’t want Americans to shop the world for more effective therapies. They prefer the current FDA-protected system where large companies enjoy a virtual monopoly over the American marketplace. This archaic system earns record profits for drug companies at the expense of U.S. citizens, who pay inflated prices for the medications the FDA does allow them to have.

The FDA deceives the public and Congress into believing that drugs approved in other countries are somehow “dangerous,” despite having no evidence to support this. What the FDA conveniently ignores is the fact that drugs they say are “safe” kill over 106,000 Americans every year.(1-3)

Thalidomide still kills


Proponents of today’s drug approval system have to go back 41 years to the thalidomide debacle to find an example of an offshore drug causing a serious side effect. Thalidomide still kills because the FDA is using this old issue as an excuse to embargo life-saving drugs that are approved by health ministries in other countries. Furthermore, these drugs have been used in other countries for years without serious side effects.

Few people remember that it was not the FDA who discovered the thalidomide problem. It was a German scientist who identified thalidomide’s dreadful power to halt limb development in the early stages of pregnancy. The FDA’s sole contribution to avoiding this problem in the United States was a delay by a junior FDA officer in reviewing the original application.

There is tragedy on the other side of the thalidomide ledger, too. Thalidomide has been shown to halt the proliferation of blood vessels, an effect that may help starve certain cancers and protect against blindness induced by wet macular degeneration. In 1998, the FDA finally approved thalidomide to treat a complication related to leprosy. That means that doctors can legally prescribe thalidomide to patients with other diseases. The FDA, however, has put up so many restrictions on its off-label use, that few physicians or patients are willing to fight the red-tape.(4)

The rare disease the FDA approved thalidomide to treat only occurs in about 50 Americans every year. The FDA, however, says the company that makes thalidomide cannot promote its use in treating cancer and macular degeneration. Recent First Amendment losses the FDA has suffered in the courts may enable thalidomide to be advertised,(5) but that would mean the company making the drug would incur the wrath of the FDA and be subjected to retaliation against other drugs it might want to get approved.

Fearing FDA retaliation

The FDA has taken science out of the practice of medicine and replaced it with an incompetent and biased bureaucracy. To win FDA approval of a new drug, it takes a lot of political influence.
The FDA has put up so many restrictions on its off-label use, that few physicians or patients are willing to fight the red-tape

The committees who advise the FDA whether or not to approve a new drug are largely comprised of individuals who are beholden to the pharmaceutical giants.(6) Small biotech companies who cannot afford to put their own people on these advisory committees are at a significant disadvantage. There are FDA-staffers who appear unusually friendly to large drug companies, but find every excuse imaginable to delay the approval of novel drugs from smaller companies.(7-12)

The FDA intentionally delayed the approval of ribavirin for decades while this anti-viral drug was saving lives in just about every civilized country on earth. The company who made ribavirin committed the terrible “sin” of holding a press conference to extol the virtues of this drug before the FDA approved it. Another victim of FDA retaliation was the immune-enhancing drug isoprinosine. While isoprinosine has been prescribed by doctors throughout the world for nearly two decades, the FDA will never approve it here because the manufacturer helped promote the fact that Americans could import it from other countries for their own personal use. The sad fact is that when effective drugs are not approved because of FDA retaliation, American citizens die.(13,14)

Life-saving offshore drugs

An example of a drug that may never be approved in the United States is thymosin alpha-1. In 1981, we wrote a headline article about the multiple benefits of this immune boosting agent produced in the thymus gland.(15) Unfortunately, the small company making the drug lacked the resources to win FDA approval. Thymosin alpha-1 did gain approval in Europe. Published studies show that when used in combination with cancer chemotherapy, it helps mitigate bone marrow toxicity.(16,17) When thymosin alpha-1 is combined with interleukin-2 or alpha interferon, it enhances immune response against cancer cells and the hepatitis C virus.(18-23) Thymosin alpha-1 should be available to Americans, but the FDA says no!

Another drug that could be of benefit to hepatitis C and certain cancer patients is polaprezinc. This ultra-safe Japanese drug has been shown to reduce viral load and induce complete response in Type 1b hepatitis C (when combined with interferon).(24) It may also be effective as an adjuvant therapy in cancer cells that up-regulate a growth factor called nuclear factor kappa beta. If you don’t live in Japan, it is very difficult to obtain polaprezinc, a unique compound of carnosine and zinc.

Neurodegenerative diseases such as Alzheimer’s have no effective treatment. A drug called memantine may delay the progression of Alzheimer’s and Parkinson’s disease. Memantine works by a different mechanism than current FDA-approved drugs such as Aricept and Tacrine. Memantine has been used in Germany for the last ten years, but it remains bogged down in FDA-mandated clinical trials. Four million American Alzheimer’s disease patients anxiously await.(25-33)

A prime example of a drug that should have been approved by the FDA years ago is a COX-2 inhibitor called nimesulid. Americans suffered from arthritis pain and cartilage degeneration while nimesulid was long-ago approved in other countries. Americans now pay outrageously high prices for FDA-approved COX-2 inhibitors and American cancer patients are dying because this class of drug is not yet approved to treat cancer. Nimesulid was patented way back in 1971, but Americans had to wait for another COX-2 inhibitor called Celebrex to be approved in December 1999. Some studies indicate that nimesulid is safer than Celebrex or Vioxx. Nimesulid may also be more effective in the adjuvant treatment of cancer than Celebrex or Vioxx. It costs about $125.00 a month for Celebrex or Vioxx, yet nimesulid can be obtained in Europe for only $22.00 per month. It is unconscionable that U.S. citizens were denied access to COX-2 inhibitors for so long and now have to pay an average of five times more for this class of medication.

It’s time to revolt

Today’s flawed system of drug approval needs a major overhaul or Americans will continue to perish while effective therapies exist in other countries.

As more Americans learn that they are not getting the best that science has to offer, we believe the citizenry will rebel against the medical establishment, who place their monopolistic profits ahead over the well-being of the patient.


1. Lazarou J, et al. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998 Apr 15;279(15):1200-5.

2. Bates DW. Drugs and adverse drug reactions: how worried should we be? JAMA 1998 Apr 15;279(15):1216-7.

3. Cimons M. “FDA Moves to Reduce Accidental Drug Deaths.” LA Times May 10, 1999. Home Edition Section: PART A Page: A-1.

4. Thalidomide Information. “FDA Announces Approval of Drug for Hansen’s Disease (Leprosy) Side Effect—Imposes Unprecedented Authority to Restrict Distribution”

5. Faloon W. “What’s Wrong with the FDA?—FDA Suffers Massive Defeats.” May 2001 issue Life Extension magazine.

6. Cauchon Dennis. “FDA advisers tied to industry.” USA Today; Arlington, Va.; Sep 25, 2000.

7. William David. “Scientists Who Judged Pill Safety Received Fees.” LA Times, October 29, 1999. PART A Section.

8. William David. “2nd NIH Researcher to Become Part of Conflict Probe.” LA Times, September 4, 1999. Home Edition PART A Section.

9. William David. “Researcher’s Fees Point to Other Potential Conflicts at NIH.”

10. “Deadly Medicine” by Thomas J. Moore.

11. A Letter from Roderic Dale, Ph.D. May 2000 issue Life Extension magazine.

12. Driscoll J.P. “PERSPECTIVE ON DRUG POLICY—FDA’s ‘Caution’ Is Killing People; Unnecessary delays in approval for vital drugs and medical devices are more dangerous than thalidomide.” LA Times, June 4, 1995. Home Edition Section: Opinion Piece Page: M-5.

13. FDA vs ICN Pharmaceuticals, Drug: Ribavirin.

14. FDA versus Newport Pharmaceuticals, Drug: Isoprinsoine.

15. Anti-Aging News Vol. 1 No. 11 November 1981 “Thymosin: The Immunity Hormone.”

16. Ohta Y, et al. Thymosin alpha 1 exerts protective effect against the 5-FU induced bone marrow toxicity. Int J Immunopharmacol 1985;7(5):761-8.

17. Ohta Y, et al. Immunomodulating activity of thymosin fraction 5 and thymosin alpha 1 in immunosuppressed mice. Cancer Immunol Immunother 1983;15(2):108-13.

18. Moscarella S, et al. Interferon and thymosin combination therapy in naive patients with chronic hepatitis C: preliminary results. Liver 1998 Oct;18(5):366-9.

19. Sherman KE, et al. Combination therapy with thymosin alpha1 and interferon for the treatment of chronic hepatitis C infection: a randomized, placebo-controlled double-blind trial. Hepatology 1998 Apr;27(4):1128-35.

20. Garaci E, et al. Thymosin alpha 1 in the treatment of cancer: from basic research to clinical application. Int J Immunopharmacol 2000 Dec;22(12):1067-76.

21. Beuth J, et al. Thymosin alpha(1) application augments immune response and down-regulates tumor weight and organ colonization in BALB/c-mice. Cancer Lett 2000 Oct 16;159(1):9-13.

22. Moody TW, et al. Thymosinalpha1 is chemopreventive for lung adenoma formation in A/J mice. Cancer Lett 2000 Jul 31;155(2):121-7.

23. Pica F, et al. High doses of Thymosin alpha 1 enhance the anti-tumor efficacy of combination chemo-immunotherapy for murine B16 melanoma. Anticancer Res 1998 Sep-Oct;18(5A):3571-8.

24. Nagamine T, et al. Preliminary study of combination therapy with interferon-alpha and zinc in chronic hepatitis C patients with genotype 1b. Biol Trace Elem Res 2000 Summer;75(1-3):53-63.

25. Winblad B, et al. Memantine in severe dementia: results of the 9M-Best Study (Benefit and efficacy in severely demented patients during treatment with memantine). Int J Geriatr Psychiatry 1999 Feb;14(2):135-46.

26. Schneider E, et al. [Effects of oral memantine administration on Parkinson symptoms. Results of a placebo-controlled multicenter study]. Dtsch Med Wochenschr 1984 Jun 22;109(25):987-90.

27. Fischer PA, et al. [Effects of intravenous administration of memantine in parkinsonian patients (author’s transl)]. Arzneimittelforschung 1977 Jul;27(7):1487-9.

28. Jain KK. Evaluation of memantine for neuroprotection in dementia. Expert Opin Investig Drugs 2000 Jun;9(6):1397-406.

29. Androsova LV, et al. [Akatinol memantin in Alzheimer’s disease: clinico-immunological correlates]. Zh Nevrol Psikhiatr Im S S Korsakova 2000;100(9):36-8.

30. Wenk GL, et al. No interaction of memantine with acetylcholinesterase inhibitors approved for clinical use. Life Sci 2000 Feb 11;66(12):1079-83.

31. Mobius HJ. Pharmacologic rationale for memantine in chronic cerebral hypoperfusion, especially vascular dementia. Alzheimer Dis Assoc Disord 1999 Oct-Dec;13 Suppl 3:S172-8.

32. Parsons CG, et al. Memantine is a clinically well tolerated N-methyl-D-aspartate (NMDA) receptor antagonist—a review of preclinical data. Neuropharmacology 1999 Jun;38(6):735-67.

33. Ditzler K. Efficacy and tolerability of memantine in patients with dementia syndrome. A double-blind, placebo controlled trial. Arzneimittelforschung 1991 Aug;41(8):773-80.

34. Faloon W. “What’s Wrong with the FDA?—Abuse, Neglect and Corruption,” May 2001 issue Life Extension magazine.

35. Huber Peter, “FDA Caution Can Be Deadly, Too.” The Wall Street Journal 07/24/1998 Page A14.