Visions of the Future

Home > Other > Visions of the Future > Page 66
Visions of the Future Page 66

by Brin, David


  In 1981, AIDS was a disease of unknown origin.76 It is controllable today because of rapid scientific innovation. Pancreatic cancer, on the other hand, still kills virtually all its victims with the best hope for long-term survival being the Whipple Procedure first described in 1935.8

  So why were AIDS treatments discovered so quickly while effective cancer therapies languish?

  The difference was the aggressive way that experimental multi-modal therapies were implemented in HIV/AIDS patients compared to the suffocating bureaucracy that stymies cancer research.

  In the early days of AIDS treatment, any therapy that might work was tried immediately on dying patients and the results evaluated and documented. These treatments were often administered by those infected with HIV who faced pending death if a cure were not discovered quickly. The FDA was cast by the wayside as AIDS activists made certain that potentially effective treatments were not obstructed by bureaucratic red tape.77

  We at Life Extension are proud of the part we played in saving the lives of AIDS patients by defying FDA attempts to shut us down. An editorial published late last year in the New England Journal of Medicine revealed how HIV revolutionized the way global health is pursued, and how it resulted in accelerated delivery of innovative life-saving treatments.78

  New England Journal of Medicine Praises Work of Early AIDS Activists

  Allan Brandt, PhD, is a professor of medical history at Harvard Medical School. Dr. Brandt’s perspective titled “How AIDS Invented Global Health” was published in the June 6, 2013, edition of the New England Journal of Medicine.79 Here are some quotes from his perspective:

  “AIDS has reshaped conventional wisdoms in public health, research practice, cultural attitudes, and social behaviors.”

  “The rapid development of effective antiretroviral treatments, in turn, could not have occurred without new forms of disease advocacy and activism.”

  “But AIDS activists explicitly crossed a vast chasm of expertise. They went to FDA meetings and events steeped in often arcane science of HIV, prepared to offer concrete proposals to speed research, reformulate trials, and accelerate regulatory processes.”

  “This approach went well beyond the traditional bioethical formulations of autonomy and consent. As many clinicians and scientists acknowledged, AIDS activists, including many people with AIDS, served as collaborators and colleagues rather than constituents and subjects, changing the trajectory of research and treatment.”

  Omitted from Dr. Brandt’s complimentary statements were the harassment, persecution, and incarceration of AIDS activists by government agencies that sought to suppress burgeoning development of AIDS therapies.80,81

  We Were Jailed!

  The FDA did not like our aggressive stance when it came to accelerating medical research, particularly as it related to helping AIDS victims. The FDA did everything in its power to shut Life Extension down and imprison us for life.82 According to the FDA, we were ripping off dying AIDS patients by recommending unproven therapies.

  The Journal of the American Medical Association (Nov 27, 2013) featured an article describing a 54% reduction in the risk of progressing from HIV to full-blown AIDS using selenium and multi-vitamins.83 Life Extension first recommended these nutrients in the October 1985 edition of this publication (called at that time Anti-Aging News).

  While the study published in the Journal of the American Medical Association was conducted in a region of Africa where malnutrition is rampant, and the study had other flaws (like a 25% dropout rate in both groups), the delay in HIV-induced immune suppression in patients taking these nutrients was remarkable.

  A number of previous studies support the benefits of certain nutrients in delaying HIV progression79,84–86 Even FDA Consumer Magazine eventually acknowledged the value of AIDS patients using nutrient supplements.

  We also recommended a drug called isoprinosine to AIDS patients in the October 1985 issue of Anti-Aging News. This contributed to our being arrested by the FDA because isoprinosine was not an approved drug. In the June 21, 1990, edition of the New England Journal of Medicine, a study found that HIV-infected humans who took isoprinosine were eight times less likely to progress to AIDS compared to placebo.87 This was not enough, however, to keep us from being indicted in 1991.

  What helped save us was the continuing publication of research findings corroborating that isoprinosine and certain nutrients significantly delayed disease progression in HIV-infected patients, thus negating the FDA’s argument that we were “ripping off AIDS patients” by recommending “unproven” therapies.

  The FDA was on the wrong side when it sought to destroy us in the 1980–1990s. Regrettably, millions of Americans continue to perish from needless bureaucratic red tape from virtually all diseases except AIDS. The reason AIDS is the exception is that AIDS activists made it clear to the FDA that there would be no bureaucratic delays in delivering experimental therapies to HIV-infected patients. The FDA capitulated and this enabled rapid medical innovation to occur in a free market environment.

  Cancer patients, on the other hand, sit by like timid sheep, as the FDA decides which experimental therapy they are “allowed” to try and how far their disease must progress before the experimental therapy is made available on a so-called “compassionate-use” basis. FDA’s granting of “compassionate-use” sometimes occurs weeks after the patient dies, or is so close to death that it has no chance of working.

  “In conclusion, our data suggest the relevance of NK (natural killer) cells as primary effectors not only against high-risk leukemias, but also solid tumors.” 44

  Quote from study published in the April 2013 edition of the journal Oncoimmunology

  Not Fast Enough!

  In 2010, the Life Extension Foundation® pledged a substantial amount of money to a prestigious cancer research institute to evaluate many of the components contained in our published Pancreatic Cancer Treatment Protocol. The institution eagerly pushed this project forward, generating reams of paperwork in order to obtain Institutional Review Board approval.

  Here we are in 2014, and the total number of pancreatic patients enrolled in this study is zero.

  Bureaucratic delays like this are beyond rational understanding. These are human lives we are talking about!

  When we devised unique treatments for AIDS in the 1980s, they were provided to dying AIDS patients almost overnight. Not all of them worked, but the ones that did built on a foundation that has resulted in HIV patients living for decades, as opposed to pancreatic cancer patients who often die in a matter of months.

  Contrast the rapid development of AIDS therapies to most pancreatic cancer patients who die even after enduring the Whipple Procedure that was first described in 1935. It is clear that methods employed by AIDS activists are far superior to today’s regulatory quagmire that stymies cancer research.

  Citizens Should Revolt

  Cancer will likely kill over 570,000 Americans this year.88

  Already-approved treatments could be saving lives, such as administering moderate dose interleukin-2 early in the disease process. Yet even these simple treatment enhancements are ignored by the oncology mainstream that prefers to practice assembly line medicine.

  These kinds of delays would have never been tolerated by AIDS activists, who experimented with any potentially effective drug on large numbers of dying patients to quickly discover what worked and what didn’t.

  The New England Journal of Medicine credits the work of AIDS pioneers as revolutionizing the way medical research is conducted today. We at Life Extension disagree with this Pollyanna assessment, as cancer therapies we uncovered decades ago remain bogged down in FDA red tape. Many are not being pursued at all despite a continuous stream of favorable data flowing out of research facilities.

  The slogan “Act Up, Speak Out… Silence = Death!” was chanted by AIDS activists who surrounded FDA headquarters in 1988 and shut down the agency for one day:89,90

  Protest Now Rather Than Wait For F
unerals

  I do not know why every cancer patient and their family does not march on Washington to demand the same exemption from bureaucratic suffocation that enabled HIV to become a manageable disease in a relatively brief window of time.

  Perhaps cancer patients should write their family and friends and state something to the effect:

  “In lieu of attending my funeral, would you mind marching on the Capitol in Washington D.C. and insist that cancer patients have unfettered access to any therapy that might work.”

  ENDNOTES

  Specht G, Stinshoff K. Walther Kausch (1867–1928) and his significance in pancreatic surgery. Zentralbl Chir 2001 Jun; 126(6):479–81.

  http://www.grandroundsjournal.com/articles/gr07l0001/gr07l0001.pdf.

  Birkmeyer JD, Siewers AE, Finlayson EV, et al. Hospital volume and surgical mortality in the United States. N Engl J Med 2002 Apr 11; 346(15):1128–37.

  Ho CK , Kleeff J,Friess H, Büchler MW. Complications of pancreatic surgery. HPB (Oxford) 2005; 7(2):99–108.

  Shrikhande SV, D’Souza MA. Pancreatic fistula after pancreatectomy: evolving definitions, preventive strategies and modern management. World J Gastroenterol 2008 Oct 14; 14(38):5789–96.

  Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery 2007 Nov; 142(5):761–8.

  Ferrara MJ, Lohse C, Kudva YC, et al. Immediate post-resection diabetes mellitus after pancreaticoduodenectomy: incidence and risk factors. HPB (Oxford) 2013 Mar; 15(3):170–4.

  http://www.webmd.com/cancer/pancreatic-cancer/whipple-procedure.

  http://money.cnn.com/2008/03/02/news/companies/elkind_jobs.fortune/index.htm?postversion=2008030510.

  http://www.forbes.com/sites/erikkain/2011/10/05/steve-jobs-has-died-at-age-56/.

  http://abcnews.go.com/Health/CancerPreventionAndTreatment/steve-jobs-pancreatic-cancer-timeline/story?id=14681812.

  http://usatoday30.usatoday.com/news/health/medical/health/medical/cancer/story/2011-08-24/Apple-CEO-Steve-Jobs-resigns-after-battling-pancreatic-cancer/50127460/1.

  Weigent DA, Stanton GJ, Johnson HM. Interleukin 2 enhances natural killer cell activity through induction of gamma interferon. Infect Immun 1983 Sep; 41(3):992–7.

  Kehrl JH, Dukovich M, Whalen G, Katz P, Fauci AS, Greene WC. Novel interleukin 2 (IL-2) receptor appears to mediate IL-2-induced activation of natural killer cells. J Clin Invest 1988 Jan; 81(1):200–5.

  Yao HC, Liu SQ, Yu K, Zhou M, Wang LX. Interleukin-2 enhances the cytotoxic activity of circulating natural killer cells in patients with chronic heart failure. Heart Vessels 2009 Jul; 24(4):283–6.

  Yokoyama WM, Altfeld M, Hsu KC. Natural killer cells: tolerance to self and innate immunity to viral infection and malignancy. Biol Blood Marrow Transplant 2010 Jan; 16(1 Suppl):S97–S105.

  Hwang I, Scott JM, Kakarla T, et al. Activation mechanisms of natural killer cells during influenza virus infection. PLoS One 2012 7(12):e51858.

  Brandstadter JD, Yang Y. Natural killer cell responses to viral infection. J Innate Immun 2011; 3(3):274–9.

  Chisholm SE, Reyburn HT. Recognition of vaccinia virus-infected cells by human natural killer cells depends on natural cytotoxicity receptors. J Virol 2006 Mar; 80(5):2225–33.

  Viel S, Charrier E, Marçais A, et al. Monitoring NK cell activity in patients with hematological malignancies. Oncoimmunology 2013 Sep 1; 2(9):e26011.

  zur Hausen H. Immortalization of human cells and their malignant conversion by high risk human papillomavirus genotypes. Semin Cancer Biol 1999 Dec; 9(6):405–11.

  Rosenberg SA, Lotze MT, Muul LM, et al. Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer. N Engl J Med. 1985 Dec 5; 313(23):1485–92.

  Salup RR, Wiltrout RH. Adjuvant immunotherapy of established murine renal cancer by interleukin 2-stimulated cytotoxic lymphocytes. Cancer Res. 1986 Jul; 46(7):3358–63.

  Marumo K, Ueno M, Muraki J, Baba S, Tazaki H. Augmentation of cell-mediated cytotoxicity against renal carcinoma cells by recombinant interleukin 2. Urology 1987 Oct; 30(4):327–32.

  Wang J, Walle A, Gordon B, et al. Adoptive immunotherapy for stage IV renal cell carcinoma: a novel protocol utilizing periodate and interleukin-2-activated autologous leukocytes and continuous infusions of low-dose interleukin-2. Am J Med. 1987 Dec; 83(6):1016–23.

  Fisher RI, Coltman CA Jr, Doroshow JH, et al. Metastatic renal cancer treated with interleukin-2 and lymphokine-activated killer cells. A phase II clinical trial. Ann Intern Med. 1988 Apr; 108(4):518–23.

  Chu MB, Fesler MJ, Armbrecht ES, et al. High-dose interleukin-2 (HD IL-2) therapy should be considered for the treatment of patients with melanoma brain metastases. Chemother Res Pract. 2013:726925.

  Atkins MB, Kunkel L, Sznol M, Rosenberg SA. High-dose recombinant interleukin-2 therapy in patients with metastatic melanoma: long-term survival update. Cancer J Sci Am. 2000 Feb; 6 Suppl 1:S11–4.

  Keilholz U, Conradt C, Legha SS, et al. Results of interleukin-2-based treatment in advanced melanoma: a case record-based analysis of 631 patients. J Clin Oncol. 1998 Sep; 16(9):2921–9.

  Petrella T, Quirt I, Verma S, et al. Single-agent interleukin-2 in the treatment of metastatic melanoma. Curr Oncol 2007 Feb; 14(1):21–6.

  Acquavella N, Kluger H, Rhee J, et al. Toxicity and activity of a twice daily high-dose bolus interleukin 2 regimen in patients with metastatic melanoma and metastatic renal cell cancer. J Immunother 2008 Jul–Aug; 31(6):569–76.

  Schwartz RN, Stover L, Dutcher J. Managing toxicities of high-dose interleukin-2. Oncology 2002 Nov; 16(11 Suppl 13):11–20.

  Brivio F, Lissoni P, Rovelli F, et al. Effects of IL-2 preoperative immunotherapy on surgery-induced changes in angiogenic regulation and its prevention of VEGF increase and IL-12 decline. Hepatogastroenterology 2002 Mar–Apr; 49(44):385–7.

  Böhm M, Ittenson A, Klatte T, et al. Pretreatment with interleukin-2 modulates perioperative immunodysfunction in patients with renal cell carcinoma. Folia Biol (Praha) 2003 49(2):63–8.

  Nichols PH, Ramsden CW, Ward U, Sedman PC, Primrose JN. Perioperative immunotherapy with recombinant interleukin 2 in patients undergoing surgery for colorectal cancer. Cancer Res. 1992 Oct 15; 52(20):5765–9.

  Lissoni P, Brivio F, Fumagalli L, Di Fede G, Brera G. Enhancement of the efficacy of chemotherapy with oxaliplatin plus 5-fluorouracil by pretreatment with IL-2 subcutaneous immunotherapy in metastatic colorectal cancer patients with lymphocytopenia prior to therapy. In Vivo. 2005 Nov–Dec; 19(6):1077–80.

  Ades EW, McKemie CR 3rd, Wright S, Peacocke N, Pantazis C, Lockhart WL 3rd.Chemotherapy subsequent to recombinant interleukin-2 immunotherapy: protocol for enhanced tumoricidal activity. Nat Immun Cell Growth Regul. 1987 6(5):260–8.

  Da Costa ML, Redmond P, Bouchier-Hayes DJ. The effect of laparotomy and laparoscopy on the establishment of spontaneous tumor metastases. Surgery 1998 Sep; 124(3):516–25.

  Shakhar G, Blumenfeld B. Glucocorticoid involvement in suppression of NK activity following surgery in rats. J Neuroimmunol. 2003 May; 138(1–2):83–91.

  Rosenne E, Shakhar G, Melamed R, Schwartz Y, Erdreich-Epstein A, Ben-Eliyahu S. Inducing a mode of NK-resistance to suppression by stress and surgery: a potential approach based on low dose of poly I-C to reduce postoperative cancer metastasis. Brain Behav Immun. 2007 May; 21(4):395–408.

  Marik PE, Flemmer M. The immune response to surgery and trauma: Implications for treatment. J Trauma Acute Care Surg. 2012 Oct; 73(4):801–8.

  Yokoyama Y, Sakamoto K, Arai M, Akagi M. Radiation and surgical stress induce a significant impairment in cellular immunity in patients with esophageal cancer. Jpn J Surg. 1989 Sep; 19(5):535–43.

  Sano T, Morita S, Tominaga R, et al. Adaptive immunity is severely impaired by open-heart surgery. Jpn J Thorac Cardiovasc Surg. 2002 May; 50(5):201–5.

  Rasmussen L, A
rvin A. Chemotherapy-induced immunosuppression. Environ Health Perspect. 1982 Feb; 43:21–5.

  Zandvoort A, Lodewijk ME, Klok PA, et al. After chemotherapy, functional humoral response capacity is restored before complete restoration of lymphoid compartments. Clin Exp Immunol. 2003 Jan; 131(1):8–16.

  Angelini C, Bovo G, Muselli P, et al. Preoperative interleukin-2 immunotherapy in pancreatic cancer: preliminary results. Hepatogastroenterology 2006 Jan–Feb; 53(67):141–4.

  Hietanen T, Kellokumpu-Lehtinen P, Pitkänen M. Action of recombinant and interleukin 2 in modulating radiation effects on viability and cytotoxicity of large granular lymphocytes. Int J Radiat Biol. 1995 Feb; 67(2):119–26.

  Boise LH, Minn AJ, June CH, Lindsten T, Thompson CB. Growth factors can enhance lymphocyte survival without committing the cell to undergo cell division. Proc Natl Acad Sci USA 1995 Jun 6; 92(12):5491–5.

  Oberoi P, Wels WS. Arming NK cells with enhanced antitumor activity: CARs and beyond. Oncoimmunology 2013 Aug 1; 2(8):e25220.

  Sanchez-Correa B, Morgado S, Gayoso I, Bergua JM, Casado JG, Arcos MJ, Bengochea ML, Duran E, Solana R, Tarazona R. Human NK cells in acute myeloid leukaemia patients: analysis of NK cell-activating receptors and their ligands. Cancer Immunol Immunother 2011 Aug; 60(8):1195–205.

  Brunner S, Herndler-Brandstetter D, Weinberger B, Grubeck-Loebenstein B. Persistent viral infections and immune aging. Ageing Res Rev. 2011 Jul; 10(3):362–9.

  Kozlowski JM, Fidler IJ, Campbell D, Xu ZL, Kaighn ME, Hart IR. Metastatic behavior of human tumor cell lines grown in the nude mouse. Cancer Res. 1984 Aug; 44(8):3522–9.

  Kim S, Iizuka K, Aguila HL, Weissman IL, Yokoyama WM. In vivo natural killer cell activities revealed by natural killer cell-deficient mice. Proc Natl Acad Sci USA 2000 Mar 14; 97(6):2731–6.

  Smyth MJ, Swann J, Cretney E, Zerafa N, Yokoyama WM, Hayakawa Y. NKG2D function protects the host from tumor initiation. J Exp Med. 2005 Sep 5; 202(5):583–8.

 

‹ Prev