Life Extension Magazine®

Issue: May 2004

FDA Approves Deadly Drugs, Delays Lifesaving Therapies

Acetaminophen kills 100 Americans and causes 56,000 emergency room visits each year. Acetaminophen exemplifies the FDA’s failure to protect consumers against lethal drug side effects, even while it brutally suppresses information about lifesaving therapies and supplements.

By William Faloon

LE Magazine May 2004

FDA Approves Deadly Drugs, Delays Lifesaving Therapies
 
William Faloon

What if a dietary supplement was shown to kill 100 Americans and cause 56,000 emergency room visits each year?1 Without a doubt, the supplement would be banned immediately and those who knowingly marketed such a lethal product would be subject to severe criminal penalties.

On January 22, 2004, the FDA confirmed what Life Extension members have long known—that acetaminophen is extremely dangerous.2 Acetaminophen is sold under the brand name Tylenol® and is contained in 600 other drug products. Life Extension revealed the toxicity of acetaminophen more than 12 years ago. We harshly criticized the FDA for not mandating that the label of acetaminophen products warn those with liver or kidney problems to avoid the drug.

In 2002, an FDA scientific advisory committee urged that warnings be put on the labels of acetaminophen drugs.3,4 Despite overwhelming documentation confirming acetaminophen’s toxicity,5-28 the FDA said no to its own scientific advisors. Instead, the agency has budgeted a mere $20,00029,30 to develop material that it hopes will be run in major magazines and distributed by pharmacy chains for free! This is the bureaucratic equivalent of doing nothing.

We at Life Extension are incensed about the FDA’s multi-decade failure to mandate warnings on deadly acetaminophen products. The agency spends tens of millions of dollars a year attacking companies selling natural health products that have harmed no one. Yet the FDA is making virtually no effort to prevent the 100 deaths and 56,000 emergency room visits that the agency itself admits are caused by acetaminophen drugs every year!31

Acetaminophen Risks Understated
Back in 1992, we warned that many more people are dying because of acetaminophen than the number indicated by the official statistics. While the FDA was pre-occupied with acetaminophen-induced liver failure, it overlooked studies showing that regular users of acetaminophen may be doubling their risk of kidney cancer.11,13,32

What does that translate to in actual numbers of victims? Each year, almost 12,000 Americans die of kidney cancer.33 The incidence of kidney cancer in the US has risen 126% since the 1950s,34 a jump that may be tied to the growing use of drugs containing phenacetin or acetaminophen.

Phenacetin is a painkiller that was banned because it causes severe kidney toxicity.35-40 Acetaminophen is the major metabolite of phenacetin, which means that some of the destructive properties exhibited by phenacetin could have been caused by its breakdown to acetaminophen in the body. So while phenacetin was withdrawn because too many people’s kidneys were shutting down, the FDA had no problem letting the major metabolite of phenacetin (acetaminophen) be freely marketed without any consumer warning whatsoever.

If acetaminophen is responsible for even a small percentage of the overall kidney cancer cases, this drug may have already killed tens of thousands of Americans—and the FDA has done nothing to stop this carnage!

Because acetaminophen generates damaging free radicals throughout the body, it may very well increase the risk of many age-related diseases. In fact, scientists can consistently induce cataracts in the eyes of laboratory animals by giving them acetaminophen. They consider acetaminophen a “cataratogenic agent.” Interestingly, if antioxidants are provided to the animals, the cataract-inducing effects of acetaminophen are often completely neutralized.41-46

One of Life Extension’s medical advisors long ago advocated that acetaminophen products include the antioxidant N-acetylcysteine to help neutralize destructive free radicals. When a person acutely overdoses on acetaminophen, the standard medical therapy is to administer N-acetylcysteine over a period of weeks. Unfortunately, the FDA bans the combination of an over-the-counter drug (acetaminophen) with a dietary supplement (N-acetylcysteine), so it is “illegal” to make a safe acetaminophen drug.

To alert as many people as possible to the risks of acetaminophen poisoning and its antidotes, we have included a chapter on this topic in all four editions of our Disease Prevention and Treatment book. Despite the overwhelming evidence that acetaminophen use should be strictly limited, the FDA capitulates to pharmaceutical companies that earn billions of dollars a year selling this lethal class of analgesic drug.

By failing to mandate a warning on the label of acetaminophen products, the FDA once again demonstrates its propensity for protecting the pharmaceutical industry’s economic interests at the expense of the American public’s health.

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,
image

William Faloon.

References

1. Available at: http://www.kvue.com/shared content/nationworld/nation/012204cccanat painkillers.40e6c221.html. Accessed February 27, 2004.

2. Available at: http://www.fda.gov/bbs/topics/ NEWS/2004/NEW01008.htm. Accessed February 27, 2004.

3. Available at: http://www.fda.gov/ohrms/ dockets/ac/02/agenda/3882A_Draft.doc. Accessed February 27, 2004.

4. Available at: http://www.fdanews.com/ 1_1/dailynews/7334-1.html. Accessed February 27, 2004.

5. Anand BS, Romero JJ, Sanduja SK, Lichtenberger LM. Phospholipid association reduces the gastric mucosal toxicity of aspirin in human subjects. Am J Gastroenterol. 1999 Jul; 94(7):1818-22.

6. Blakely P, McDonald BR. Acute renal failure due to acetaminophen ingestion: a case report and review of the literature. J Am Soc Nephrol. 1995 Jul;6(1):48-53.

7. Bonkovsky HL, Kane RE, Jones DP, Galinsky RE, Banner B. Acute hepatic and renal toxicity from low doses of acetamino- phen in the absence of alcohol abuse or malnutrition: evidence for increased suscep- tibility to drug toxicity due to cardiopul- monary and renal insufficiency. Hepatology. 1994 May;19(5):1141-8.

8. Clemmesen JO, Ott P, Dalhoff KP, Astrup LB, Tage-Jensen U, Poulsen HE.Recommendations for treatment of paracetamol poisoning. Ugeskr Laegr. 1996 Nov 25; 158(48):6892-5.

9. Conti M, Malandrino S, Magistretti MJ. Protective activity of silipide on liver damage in rodents. Jpn J Pharmacol. 1992 Dec;60(4):315-21.

10. DeLeve LD, Kaplowitz N. Glutathione metabolism and its role in hepatotoxicity.Pharmacol Ther. 1991 Dec;52(3):287-305.

11. Derby LE, Jick H. Acetaminophen and renal and bladder cancer. Epidemiology. 1996 Jul;7(4):358-62.

12. Dunjic BS, Axelson J, Ar’Rajab A, Larsson K, Bengmark S. Gastroprotective capability of exogenous phosphatidylcholine in experi- mentally induced chronic gastric ulcers in rats. Scand J Gastroenterol. 1993 Jan;28(1):89-94.

13. Gago-Dominguez M., Yuan JM, Castelao JE, Ross RK, Yu MC. Regular use of anal- gesics is a risk factor for renal cell carcino- ma. Br J Cancer. 1999 Oct;81(3):542-8.

14. Graudins A, Aaron CK, Linden CH. Overdose of extended-release acetamino- phen. N Engl J Med. 1995 Jul 20;333(3):196.

15. Jaeschke H, Werner C, Wendel A. Disposition and hepatoprotection by phos- phatidyl choline liposomes in mouse liver. Chem Biol Interact. 1987;64(1-2):127-37.

16. Jones AL. Mechanism of action and value of N-acetylcysteine in the treatmentof early and late acetaminophen poisoning: a critical review. J Toxicol Clin Toxicol. 1998;36(4):277-85.

17. Kaye JA, Myers MW, Jick H. Acetaminophen and the risk of renal and bladder cancer in the general practice research database. Epidemiology. 2001 Nov;12(6):690-4.

18. Kind B, Krahenbuhl S, Wyss PA, Meier-Abt PJ. Clinical-toxicological case (1). Dosage of N-acetylcysteine in acute paracetamol poisoning. Schweiz Rundsch Med Prax. 1996 Aug 2; 85(31-32):935-8.

19. Lieber CS. Role of oxidative stress and antioxidant therapy in alcoholic andnon-alcoholic liver diseases. Adv Pharmacol. 1997;38:601-28.

20. Lieber CS. Alcohol: its metabolism and interaction with nutrients. Annu Rev Nutr. 2000;20:395-430.

21. McLaughlin JK, Blot WJ, Mehl ES, Fraumeni JF Jr. Relation of analgesic use to renal cancer: population-based findings. Natl Cancer Inst Monogr. 1985 Dec;69:217-22.

22. Mitchell T, Needham A. Over-the-counter drug is treatment for Alzheimer's. Life Extension. November 2000:50-5.

23. Price LM, Poklis A, Johnson DE. Fatal acetaminophen poisoning with evidence ofsubendocardial necrosis of the heart. J Forensic Sci. 1991 May;36(3):930-5.

24. Richie JP Jr, Lang CA, Chen TS. Acetaminophen-induced depletion of glu- tathione and cysteine in the aging mouse kidney. Biochem. Pharmacol. 1992 Jul 7;44(1):129-35.

25. Siegers CP, Moller-Hartmann W. Cholestyramine as an antidote against paracetamol-induced hepato- and nephro- toxicity in the rat. Toxicol Lett. 1989 May;47(2):179-84.

26. Uhlig S, Wendel A. Glutathione enhance- ment in various mouse organs and protec- tion by glutathione isopropyl ester against liver injury. Biochem Pharmacol. 1990 Jun 15;39(12):1877-81.

27. Werner C, Wendel A. Hepatic uptake and antihepatotoxic properties of vitamin E and liposomes in the mouse. Chem Biol Interact. 1990;75(1):83-92.

28. Zhao J, Agarwal R. Tissue distribution of silibinin, the major active constituent of sily- marin, in mice and its association with enhancement of phase II enzymes: implica- tions in cancer chemoprevention. Carcinogenesis. 1999 Nov;20(11):2101-8.

29. Available at: http://www.fda.gov/cder/drug/ analgesics/letter.htm. Accessed February 27, 2004.

30. Available at: http://www.fda.gov/cder/drug/ analgesics/SciencePaper.htm. Accessed February 27, 2004.

31. Available at: http://www.fda.gov/ohrms/ dockets/ac/02/transcripts/3882T1.htm. Accessed February 27, 2004.

32. Kaye JA, Myers MW, Jick H. Acetaminophen and the risk of renal and bladder cancer in the general practice research database. Epidemiology. 2001 Nov;12(6):690-4.

33. Available at: http://www.kidney-cancer- symptoms.com. Accessed February 27, 2004.

34. Available at: http://www.kidney-cancer symptoms.com. Accessed February 27, 2004.

35. Piper JM, Tonascia J, Matanoski GM. Heavy phenacetin use and bladder cancer in women aged 20 to 49 years. N Engl J Med. 1985 Aug 1;313(5):292-5.

36. Linet MS, Chow WH, McLaughlin JK, et al. Analgesics and cancers of the renal pelvis and ureter. Int J Cancer. 1995 Jul 4;62(1):15-8.

37. McCredie M, Stewart JH, Day NE. Different roles for phenacetin and parac- etamol in cancer of the kidney and renal pelvis. Int J Cancer. 1993 Jan 21;53(2):245-9.

38. Brunner FP, Selwood NH. End-stage renal failure due to analgesic nephropathy, its changing pattern and cardiovascular mortal- ity. EDTA-ERA Registry Committee. Nephrol Dial Transplant. 1994;9(10):1371-6.

39. Stewart JH, Hobbs JB, McCredie MR. Morphologic evidence that analgesic- induced kidney pathology contributes to the progression of tumors of the renal pelvis. Cancer. 1999 Oct 15;86(8):1576-82.

40. Dubach UC, Rosner B, Pfister E. Epidemiologic study of abuse of analgesics containing phenacetin. Renal morbidity and mortality (1968-1979). N Engl J Med. 1983 Feb 17;308(7):357-62.

41. Rathbun WB, Killen CE, Holleschau AM, Nagasawa HT. Maintenance of hepatic glu- tathione homeostasis and prevention of acetaminophen-induced cataract in mice by L-cysteine prodrugs. Biochem Pharmacol. 1996 May 3;51(9):1111-6.

42. Rathbun WB, Holleschau AM, Cohen JF, Nagasawa HT. Prevention of acetamino- phen- and naphthalene-induced cataract and glutathione loss by CySSME. Invest Ophthalmol Vis Sci. 1996 Apr;37(5):923-9.

43. Nagasawa HT, Shoeman DW, Cohen JF, Rathbun WB. Protection against acetamin- ophen-induced hepatotoxicity by L- CySSME and its N-acetyl and ethyl ester derivatives. J Biochem Toxicol. 1996;11(6):289-95.

44. Zhao C, Shichi H. Prevention of acetamino- phen-induced cataract by a combination of diallyl disulfide and N-acetylcysteine. J Ocul Pharmacol Ther. 1998 Aug;14(4):345-55.

45. Qian W, Shichi H. Cataract formation by a semiquinone metabolite of acetaminophen in mice: possible involvement of Ca(2+)and calpain activation. Exp Eye Res. 2000 Dec;71(6):567-74.

46. Qian W, Shichi H. Acetaminophen pro- duces cataract in DBA2 mice by Ah recep- tor-independent induction of CYP1A2. J Ocul Pharmacol Ther. 2000 Aug;16(4):337-44.

47. Available at: http://www.alz.org/AboutAD/ Statistics.asp. Accessed February 27, 2004.

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

49. Available at: http://www.lifeextension.com/magazine/ mag2001/july2001_awsi.html. Accessed February 27, 2004.

50. Ambrozi L, Danielczyk W. Treatment of impaired cerebral function in psychogeri- atric patients with memantine—results of a phase II double-blind study. Pharmacopsychiatry. 1988 May;21(3):144-6.

51. Wilcock G, Mobius HJ, Stoffler A; MMM 500 group. A double-blind, placebo-con- trolled multicentre study of memantine in mild to moderate vascular dementia (MMM500). Int Clin Psychopharmacol. 2002 Nov;17(6):297-305.

52. Ferris SH. Evaluation of memantine for the treatment of Alzheimer's disease. Expert Opin Pharmacother. 2003 Dec;4(12):2305-13.

53. Tariot PN, Farlow MR, Grossberg GT, et al. Memantine treatment in patients with mod- erate to severe Alzheimer disease already receiving donepezil: a randomized con- trolled trial. JAMA. 2004 Jan 21;291(3):317-24.

54. Available at: http://www.lifeextension.com/magazine/ mag2001/july2001_report_brain_01.html. Accessed February 27, 2004.

55. Available at: http://www.fda.gov/cder/ogd/ RLD/rld_labeling_approved_June_2001.html. Accessed February 27, 2004.

56. Available at: http://www.fda.gov/cder/foi/ appletter/2001/20690s16ltr.pdf. Accessed February 27, 2004.

57. Available at: http://www.pbs.org/wgbh/ pages/frontline/shows/prescription/. Accessed February 27, 2004.

58. Available at: http://www.commondreams.org/ pressreleases/Dec98/120298c.htm. Accessed February 27, 2004.

59. Available at: http: //www.cato.org/dailys/1- 29-97.html. Accessed February 27, 2004.

60. Available at: http://www.pbs.org/wgbh/ pages/frontline/shows/prescription/hazard/. Accessed February 27, 2004.

61. Available at: http://www.lifeextension.com/magazine/ mag2001/june2001_report_fda.html. Accessed February 27, 2004.

62. Available at: http://www.lifeextension.com/magazine/ mag2000/sep2000_report_rezulin.html. Accessed February 27, 2004.

63. Available at: http://www.life-enhancement.com/ article_template.asp?ID=206. Accessed February 27, 2004.

64. Available at: http://www.lifeextension.com/magazine/ mag2002/jul2002_awsi_01.html. Accessed February 27, 2004.

65. Available at: http://www.lifeextension.com/magazine/ mag2003/mar2003_cover_effects_02.html. Accessed February 27, 2004.

66. Available at: http://www.lifeextension.com/magazine/ mag2000/dec2000_awsi.html. Accessed February 27, 2004.

67. Available at: http://www.newmediaexplorer.org/ chris/2003/07/22/access_to_medical_treatment_act_amta.htm. Accessed February 27, 2004.

68. Available at: http://www.newmediaexplorer.org/ chris/control_tactics.htm. Accessed February 27, 2004.

69. Available at: http://www.lifeextension.com/magazine/ mag2001/sep2001_awsi.html. Accessed February 27, 2004.

70. Available at: http://www.lifeextension.com/magazine/ mag2001/july2001_awsi.html. Accessed February 27, 2004.

71. Available at: http://www.lifeextension.com/featured-articles/track2.html. Accessed February 27, 2004.

72. Available at: http://www.lifeextension.com/magazine/ mag2001/feb2001_awsi.html. Accessed February 27, 2004.

73. Available at: http://www.lifeextension.com/magazine/ mag99/may99-cover.html. Accessed February 27, 2004.

74. Available at: http://tobaccodocuments.org/ pm/2046936740-6743.html. Accessed February 27, 2004.

Subscribe to Life Extension Magazine®

Subscribe Now

Advertise in Life Extension Magazine®

Learn More