Your Trusted Brand for Over 35 Years

Life Extension Magazine

<< Back to September 2014

How To Turn 8 Pennies Into $600

September 2014

By William Faloon

Example Of How Medical Progress Occurs

Life Extension ’s discovery of ribavirin’s multi-benefits was somewhat serendipitous.

Scientists supported by Life Extension faced a viral epidemic in their animal colony. They went to Mexico in 1983 to purchase ribavirin, hoping it would save their research project. The ribavirin cured the animals. When the scientists contracted viral infections themselves, the ribavirin cured the scientists.21 So Life Extension knew ribavirin was effective from studies that had been published in the scientific literature, by the fact it had been approved by drug regulators in most other countries, and because it worked on animals and humans infected with a wide array of viruses.36-40

Ribavirin by itself is not a cure for hepatitis C. It has to be combined with the FDA-approved drug interferon-alpha to achieve viral eradication.41-45 Many hepatitis C patients do achieve viral eradication with interferon alone, but it is a grueling therapy.46-48

So first there was interferon-alpha that cured some hepatitis C patients.49-50 In those it failed to cure, it still reduced future risk of liver cancer.51-55 When ribavirin was added to interferon-alpha, eradication rates doubled, according to some research.33,35 This was a major advance, but the FDA still required hepatitis C patients to undergo six-month treatment using interferon, which inflicts horrific side effects.

With the approval of Sovaldi®, 90% of hepatitis C patients will be cured19 and most of them should be able to avoid interferon-alpha therapy. But for Sovaldi® to optimally work, it needs ribavirin.

I hope you see the stair-step approach often required for real medical breakthroughs to occur. If it were not for a Herculean battle waged in the 1980s-1990s to get ribavirin approved, Sovaldi® may never have made it past initial clinical testing. It needed co-administering of ribavirin to achieve its curative effect.

The FDA now states that Sovaldi® should not be used without ribavirin.56 Yet before 1998, the FDA initiated criminal investigations against those who promoted ribavirin’s antiviral benefits.21

The problem is that there are precious few resources available to identify which of the thousands of compounds in the developmental stage should be fast-tracked to save lives today. It’s in the interest of some drug companies to delay expending billions to get a better drug approved if that superior drug would compete with existing, already approved patented drugs.

Life Extension ’s mission is not to incite revolts against bureaucrats who refuse to recognize good science. Yet we have been put in that position as the pharmaceutical establishment cowers to governmental whim and edict when it comes to obtaining official drug approval.

The frightening aspect of this is that no one really knows how many cures are being suppressed by pharmaceutical companies that don’t want their valuable patents diminished by bringing out more effective treatments. There is also the risk that the FDA might overlook good science and reject an effective therapy after billions have been spent.

We need to tear down bureaucratic barriers that stifle medical progress. Huge numbers of hepatitis C patients could have been saved had the FDA not blocked the approval of ribavirin. Even today, many health insurance companies are refusing to pay for Sovaldi (the $84,000 drug) until after hepatitis C patients succumb to liver failure.

Our 30-Year War Against Extortionist Drug Prices

Life Extension has members worldwide. This is one reason why we are able to discover novel approaches to disease prevention and treatment before they become accepted by the medical mainstream.

A consistent comment we hear from members in other countries is how low priced their drugs are compared to the US. We’ve used this information to expose the incestuous relationship that exists between pharmaceutical companies, government bureaucrats, and elected politicians that cause American drugs to be so outlandishly priced.

To put this in context, Life Extension compiled the chart on the previous page nearly 12 years ago to expose the outlandish markups of prescription drugs.57 This chart was blown up and used on the floor of the House of Representatives to push through a bill that would allow Americans to import lower-cost medications from other countries. Aggressive consumer activism enabled this bill to be signed into law.

The FDA nixed the law on technical grounds that it (the FDA) did not have the resources to ensure the safety of imported drugs. This single act by the FDA provided the pharmaceutical industry with a financial windfall as Americans struggle to pay increasing health insurance premiums, co-pays, deductibles, and higher taxes to subsidize government-mandated insurance programs like the Affordable Care Act.

I relate this history to let new members know that we are no strangers to drug price gouging. The markup on acyclovir ointment where consumers pay close to $7003 for an ingredient that costs 8 pennies exceeds anything we’ve seen in the past.

These irrational prices are being forced on consumers who need pharmaceuticals often to stay alive. These outrageous markups would never survive in a free-market environment.

This blatant price gouging exists because of government-imposed regulations under the guise of consumer protection. These regulations stifle innovation, strangle creation of new treatments, and cost the public their money and longevity.

The obvious solution is to open up the market so that any reputable company could produce something as simple as acyclovir ointment and the many other generics that don’t require specialized manufacturing expertise.

For longer life,

For Longer Life

William Faloon

References

  1. Bader MS. Herpes zoster: diagnostic, therapeutic, and preventive approaches. Postgrad Med. 2013 Sep;125(5):78-91.
  2. Levin MJ, Zaia JA, Hershey BJ, Davis LG, Robinson GV, Segreti AC. Topical acyclovir treatment of herpes zoster in immunocompromised patients. J Am Acad Dermatol. 1985 Oct;13(4):590-6.
  3. Available at: http://www.healthwarehouse.com/acyclovir-5-ointment-30g-tube.html.Accessed March 2014.
  4. Bartlett JG. Recent developments in the management of herpes simplex virus infection in HIV-infected persons. Clin Infect Dis. 2004 Nov 1;39 Suppl 5:S237-9.
  5. Wald A, Ericsson M, Krantz E, Selke S, Corey L. Oral shedding of herpes simplex virus type 2. Sex Transm Infect. 2004 Aug;80(4):272-6. Erratum in: Sex Transm Infect. 2004 Dec;80(6):546.
  6. Arvin AM. Varicella-zoster virus: overview and clinical manifestations. Semin Dermatol. 1996 Jun;15(2 Suppl 1):4-7.
  7. Modi S, Van L, Gewirtzman A, et al. Single-day treatment for orolabial and genital herpes: a brief review of pathogenesis and pharmacology. Ther Clin Risk Manag. 2008 Apr;4(2):409-17.
  8. Wald A, Zeh J, Barnum G, Davis LG, Corey L. Suppression of subclinical shedding of herpes simplex virus type 2 with acyclovir. Ann Intern Med. 1996 Jan 1;124(1 Pt 1):8-15.
  9. Sheffield JS, Hollier LM, Hill JB, Stuart GS, Wendel GD. Acyclovir prophylaxis to prevent herpes simplex virus recurrence at delivery: a systematic review. Obstet Gynecol. 2003 Dec;102(6):1396-403.
  10. Available at: http://www.drugs.com/sfx/zovirax-ointment-side-effects.html. Accessed March 2014.
  11. Available at: http://www.nlm.nih.gov/medlineplus/druginfo/meds/a606001.html. Accessed June 2, 2014.
  12. McKeough MB, Spruance SL. Comparison of new topical treatments for herpes labialis: efficacy of penciclovir cream, acyclovir cream, and n-docosanol cream against experimental cutaneous herpes simplex virus type 1 infection. Arch Dermatol. 2001 Sep;137(9):1153-8.
  13. Kleymann G. Agents and strategies in development for improved management of herpes simplex virus infection and disease. Expert Opin Investig Drugs . 2005 Feb;14(2):135-61.
  14. Available at: http://www.prweb.com/releases/herpes_simplex/virus_treatment_HSV/prweb8257847.htm . Accessed June 17, 2014.
  15. Bacon TH, Levin MJ, Leary JJ, Sarisky RT, Sutton D. Herpes simplex virus resistance to acyclovir and penciclovir after two decades of antiviral therapy. Clin Microbiol Rev. 2003 Jan;16(1):114-28.
  16. Available at: http://www.cdc.gov/hepatitis/hcv/pdfs/hepcgeneralfactsheet.pdf. Accessed June 17, 2014.
  17. Available at: http://www.forbes.com/sites/natesadeghi/2014/03/27/breaking-the-bank-the-innovation-cost-paradox-of-us-healthcare/ . Accessed March 28, 2014.
  18. Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87.
  19. Available at: http://www.npr.org/blogs/health/2013/12/30/256885858/-1-000-pill-for-hepatitis-c-spurs-debate-over-drug-prices . Accessed March 28, 2014.
  20. Available at: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm . Accessed May 23, 2014.
  21. Available at: http://www.lef.org/magazine/mag98/sep98_wws.html?source=search&key=ribavirin . Accessed March 28, 2014.
  22. Reichard O, Norkrans G, Frydén A, Braconier JH, Sönnerborg A, Weiland O. Randomised, double-blind, placebo-controlled trial of interferon alpha-2b with and without ribavirin for chronic hepatitis C. Lancet. 1998 Jan 10;351(9096):83-7.
  23. de Lédinghen V, Trimoulet P, Winnock M, et al. Daily or three times per week interferon alpha-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis C not responding to previous interferon alone. J Hepatol. 2002 Jun;36(6):819-26.
  24. Ali S, Nazir G, Khan SA, Iram S, Fatima F. Comparative therapeutic response to pegylated interferon plus ribavirin versus interferon alpha-2b in chronic hepatitis C patients. J Ayub Med Coll Abbottabad. 2010 Oct-Dec;22(4):127-30.
  25. Available at: http://www.hepatitiscentral.com/hcv/ribavirin/combo.html. Accessed May 31, 2014.
  26. Available at: http://www.webmd.com/hepatitis/hepc-guide/hepatitis-c-and-liver-cancer . Accessed March 31, 2014.
  27. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006 Oct;45(4):529-38.
  28. Omland LH, Farkas DK, Jepsen P, Obel N, Pedersen L. Hepatitis C virus infection and risk of cancer: a population-based cohort study. Clin Epidemiol. 2010 Aug 9;2:179-86.
  29. Bruno S, Crosignani A, Maisonneuve P, Rossi S, Silini E, Mondelli MU. Hepatitis C virus genotype 1b as a major risk factor associated with hepatocellular carcinoma in patients with cirrhosis: a seventeen-year prospective cohort study. Hepatology. 2007 Nov;46(5):1350-6.
  30. Available at http://www.liverfoundation.org/patients/organdonor/about/.Accessed May 31, 2014.
  31. Schalm SW, Hansen BE, Chemello L, et al. Ribavirin enhances the efficacy but not the adverse effects of interferon in chronic hepatitis C. Meta-analysis of individual patient data from European centers. J Hepatol. 1997 May;26(5):961-6.
  32. Chuang WL, Dai CY, Chang WY, Lee LP, Lin ZY, Chen SC, Hsieh MY, Wang LY, YuML. Viral interaction and responses in chronic hepatitis C and B coinfected patients with interferon-alpha plus ribavirin combination therapy. Antivir Ther. 2005; 10(1):125-33.
  33. Hézode C, Forestier N, Dusheiko G, et al. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50.
  34. Martinot-Peignoux M, Maylin S, Moucari R, et al. Virological response at 4 weeks to predict outcome of hepatitis C treatment with pegylated interferon and ribavirin. Antivir Ther. 2009;14(4):501-11.
  35. Lai MY, Kao JH, Yang PM, et al. Long-term efficacy of ribavirin plus interferon alfa in the treatment of chronic hepatitis C. Gastroenterology. 1996 Nov;111(5):1307-12.
  36. Durr FE, Lindh HF, Forbes M. Efficacy of 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide against influenza virus infections in mice. Antimicrob Agents Chemother. 1975 May;7(5):582-6.
  37. Sidwell RW, Khare GP, Allen LB, et al. In vitro and in vivo effect of 1-beta-D-ribofuranosyl-1,2,4-triazole-3-carboxamide (ribavirin) on types 1 and 3 parainfulenza virus infections. Chemotherapy. 1975;21(3-4):205-20.
  38. Stephen EL, Dominik JW, Moe JB, Walker JS. Therapeutic effects of ribavirin given by the intraperitoneal or aerosol route against influenza virus infections in mice. Antimicrob Agents Chemother. 1976 Sep;10(3):549-54.
  39. Tanikawa K. Recent advances in antiviral agents: antiviral drug discovery for hepatitis viruses. Curr Pharm Des. 2006;12(11):1371-7.
  40. Trembling PM, Tanwar S, Dusheiko GM. Boceprevir: an oral protease inhibitor for the treatment of chronic HCV infection. Expert Rev Anti Infect Ther. 2012 Mar;10(3):269-79.
  41. Poynard T, Marcellin P, Lee SS, et al. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. Lancet. 1998 Oct 31;352(9138):1426-32.
  42. McHutchison JG, Gordon SC, Schiff ER, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. N Engl J Med. 1998 Nov 19;339(21):1485-92.
  43. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65.
  44. Cornberg M, Wedemeyer H, Manns MP. Treatment of chronic hepatitis C with PEGylated interferon and ribavirin. Curr Gastroenterol Rep. 2002 Feb;4(1):23-30.
  45. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82.
  46. Jaeckel E, Cornberg M, Wedemeyer H, et al. German Acute Hepatitis C Therapy Group. Treatment of acute hepatitis C with interferon alfa-2b. N Engl J Med. 2001 Nov 15;345(20):1452-7.
  47. Santantonio T, Fasano M, Sinisi E, et al. Efficacy of a 24-week course of PEG-interferon alpha-2b monotherapy in patients with acute hepatitis C after failure of spontaneous clearance. J Hepatol. 2005 Mar;42(3):329-33.
  48. Wiegand J, Buggisch P, Boecher W, et al. Early monotherapy with pegylated interferon alpha-2b for acute hepatitis C infection: the HEP-NET acute-HCV-II study. Hepatology. 2006 Feb;43(2):250-6.
  49. Davis GL, Balart LA, Schiff ER, et al. Treatment of chronic hepatitis C with recombinant interferon alfa. A multicenter randomized, controlled trial. Hepatitis Interventional Therapy Group. N Engl J Med. 1989 Nov 30;321(22):1501-6.
  50. Hoofnagle JH, Mullen KD, Jones DB, et al. Treatment of chronic non-A, non-B hepatitis with recombinant human alpha interferon. A preliminary report. N Engl J Med. 1986 Dec 18;315(25):1575-8.
  51. Akuta N, Suzuki F, Suzuki Y, et al. Long-term follow-up of interferon monotherapy in 454 consecutive naive patients infected with hepatitis C virus: multi-course interferon therapy may reduce the risk of hepatocellular carcinoma and increase survival. Scand J Gastroenterol. 2005 Jun;40(6):688-96.
  52. Hino K, Okita K. Interferon therapy as chemoprevention of hepatocarcinogenesis in patients with chronic hepatitis C. J Antimicrob Chemother. 2004 Jan;53(1):19-22.
  53. Moriyama M, Matsumura H, Aoki H, et al. Decreased risk of hepatocellular carcinoma in patients with chronic hepatitis C whose serum alanine aminotransferase levels became less than twice the upper limit of normal following interferon therapy. Liver Int. 2005 Feb;25(1):85-90.
  54. Shiratori Y, Ito Y, Yokosuka O, et al. Antiviral therapy for cirrhotic hepatitis C: association with reduced hepatocellular carcinoma development and improved survival. Ann Intern Med. 2005 Jan 18;142(2):105-14.
  55. Mazzella G, Accogli E, Sottili S, et al. Alpha interferon treatment may prevent hepatocellular carcinoma in HCV-related liver cirrhosis. J Hepatol . 1996 Feb;24(2):141-7.
  56. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm . Accessed April 2, 2014.
  57. Available at: http://www.lef.org/magazine/mag2002/oct2002_awsi_01.html. Accessed April 2, 2014.