Life Extension Magazine September 2007
As We See It
FDA Rejects Promising Prostate Cancer Drug
By William Faloon
By William Faloon
How Provenge® Was Derailed
Provenge® was sabotaged by a minority of the FDA Advisory Panel who voted against it. The campaign to discredit Provenge® by those in the cancer establishment was “unprecedented,” according to Mark Thornton, MD, a former medical officer in the FDA Office of Oncology Products and volunteer president of the Sarcoma Foundation of America. Dr. Thornton authored an editorial titled “Black Day at the FDA” that opened by stating:
“Within an eight-hour period that day, the FDA succeeded in killing not one but two safe, promising therapies designed and developed to act by stimulating a patient’s immune system against cancer.” 30
—Wall Street Journal, May 14, 2007.
The other drug Dr. Thornton described is called Junovan™, which was shown to extend the lives of children afflicted with osteosarcoma.30,31 Despite clear survival advantages, the FDA denied approval of Junovan™ the same black day it denied Provenge®. (We discuss Junovan™ in detail in an article that appears later in this issue of Life Extension magazine.)
How Many Needless Deaths?
It is difficult to calculate exactly how many American men perished because the federal government would not allow them to risk trying Provenge®, even though they faced probable death from their advanced prostate cancer.
One way of measuring the number of human life years lost is to look at one of the Provenge® studies showing how many months of average life were added to Provenge® recipients compared with placebo. Based on this analysis, for each year Provenge® was delayed, 11,250 human life years have been lost. Since the delay has been almost five years, the total loss caused by this bureaucratic delay in approving this one drug amounts to a startling 56,000 years of human life.
Even more appalling, the efficacy of Provenge® was shown in men who had already failed all conventional therapies. These advanced stages of cancer are difficult to treat, because the cancer cells have already developed survival mechanisms that make them extremely difficult to eradicate. The fact that Provenge® demonstrated such impressive survival benefits in men with these advanced forms of prostate cancer hints that it could be even more effective if administered in earlier stages of the disease—perhaps at the first sign of metastasis or in those men with highly adverse risk factors associated with short survival times.
Life Extension versus Federal Government
For the past three decades, Life Extension has sought to expose an insidious drug approval process that causes human beings to die, even though effective therapies to treat their diseases already exist. We have revealed many medications that the FDA dragged its feet in approving, resulting in a severe magnitude of needless suffering and death.4
There are no federal prohibitions against Americans engaging in all kinds of risky behaviors that provide no benefit to society or opportunity of extending human life.
That the government pretends it has to protect citizens against drugs that it has not approved, yet has no restrictions against people engaging in dangerous activities, is somewhat hypocritical. What it all boils down to, however, is defining the term “risk.”
We at Life Extension have long contended that any person with a serious illness should have the individual right to choose any therapy that they think may work. Therapies not FDA-approved should have a large warning label stating “not approved by the FDA for safety or effectiveness.” This would let each individual determine what “risk” they are willing to assume in order to be given a chance to continue enjoying the very basic right to life.
The article in this issue titled “Lifesaving Cancer Drugs Not Approved by the FDA” reveals additional effective medications that are being denied to seriously ill Americans by our own government.
On page 13 we describe the specific action that each one of you should take to encourage Congress to change the law, so that no American with a serious disease is ever again denied a promising therapy.
For the benefit of yourself and your loved ones, please use the convenient system we have developed to contact your Congressional members about the critical need to amend the law, so that those with serious disease can take full advantage of the latest medical technologies.
For longer life,
Note: To review a chart of all the human clinical studies using Provenge®, refer to the next page.
1. Available at: http://www.newwest.net/index.php/city/article/hard_lessons_learned_from_oregon_deaths/C509/L509/. Accessed April 7, 2007.
2. Available at: www.prostatecancer foundation.org/site/c.itIWK2OSG/b.97763/k.3BA8/PR_June_18_2004.htm. Accessed April 10, 2007.
3. Available at: www.fayettetribune.com/local/local_story_296115637html?keyword=topstory. Accessed April 6, 2007.
4. Available at: http://www.lef.org/magazine/mag2004/jun2004_awsi_01.htm. Accessed April 7, 2007.
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7. Available at: http://www.asco.org/portal/site/ASCO/enuitem.34d60f5624ba07fd506fe310ee37a01d/vgnextoid=
8. New cancer drugs. Wall Street Journal. January 26, 2004.
9. Small EJ, Schellhammer PF, Higano CS, et al. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015)
10. Available at: www.investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=152362&Header=News. Accessed April 7, 2007.
11. Available at: www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/10-31-2005/0004203756&EDATE=. Accessed May 21, 2007.
12. Available at: www.marketwatch.com/news/story/dendreon-shares-skyrocket-fda-panels/story.px?guid=
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14. Available at: www.investor.dendreon.com/ReleaseDetail.cfm?ReleaseID=156146&Header=News. Accessed April 10, 2007.
15. Basler M, Groettrup M. Advances in prostate cancer immunotherapies. Drugs Aging. 2007;24(3):197-221.
16. Brand TC, Tolcher AW. Management of high risk metastatic prostate cancer: the case for novel therapies. J Urol. 2006 Dec;176(6 Pt 2):S76-S80.
17. So-Rosillo R, Small EJ. Sipuleucel-T (APC8015) for prostate cancer. Expert Rev Anticancer Ther. 2006 Sep;6(9):1163-7.
18. Lin AM, Hershberg RM, Small EJ. Immunotherapy for prostate cancer using prostatic acid phosphatase loaded antigen presenting cells. Urol Oncol. 2006 Sep;24(5):434-41.
19. Dawson NA. New molecular targets in advanced prostate cancer. Expert Rev Anticancer Ther. 2006 Jul;6(7):993-1002.
20. Anon. Sipuleucel-T: APC 8015, APC-8015, prostate cancer vaccine—Dendreon. Drugs RD. 2006;7(3):197-201.
21. Rini BI, Weinberg V, Fong L, et al. Combination immunotherapy with prostatic acid phosphatase pulsed antigen-presenting
22. Beinart G, Rini BI, Weinberg V, Small EJ. Antigen-presenting cells 8015 (Provenge) in patients with androgen-dependent, biochemically relapsed prostate cancer.
23. Kantoff P. Recent progress in management of advanced prostate cancer. Oncology (Williston.Park). 2005 Apr;19(5):631-6.
24. Schellhammer PF, Hershberg RM. Immunotherapy with autologous antigen presenting cells for the treatment of androgen independent prostate cancer. World J Urol. 2005 Feb;23(1):47-9.
25. Burch PA, Croghan GA, Gastineau DA, et al. Immunotherapy (APC8015, Provenge) targeting prostatic acid phosphatase can induce durable remission of
26. Eymard JC, Bernard J. Cell therapy and prostate cancer. Bull Cancer. 2003 Aug;90(8-9):734-43.
27. Rini BI. Technology evaluation: APC-8015, Dendreon. Curr Opin Mol Ther. 2002 Feb;4(1):76-9.
28. Valone FH, Small E, MacKenzie M, et al. Dendritic cell-based treatment of cancer: closing in on a cellular therapy. Cancer J. 2001 Nov;7 Suppl 2S53-S61.
29. Small EJ, Fratesi P, Reese DM, et al. Immunotherapy of hormone-refractory prostate cancer with antigen-loaded dendritic cells. J Clin Oncol. 2000 Dec 1;18(23):3894-903.
30. Available at: http://online.wsj.com/article/SB117911315709601659.html. Accessed June 21, 2007.
31. Available at: http://www.drugs.com/nda/junovan_070509.html. Accessed June 21, 2007.
32. Available at: www.hemonctoday.com/200503/frameset.asp?article=autologous.asp. Accessed June 25, 2007.
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34. Burch PA, Breen JK, Buckner JC, et al. Priming tissue-specific cellular immunity in a phase I trial of autologous dendritic cells for prostate cancer. Clin Cancer Res. 2000 Jun;6(6):2175-82.
35. Available at: www.hemonctoday.com/scorecards/APC8015.asp. Accessed June 22, 2007.
36. Available at: http://professional.cancerconsultants.com/oncology_main_news.aspx?id=38681. Accessed June 22, 2007.
37. Higano C, Burch PA, Small EJ, et al. Immunotherapy (APC8015) for androgen independent prostate cancer (AIPC): final progression and survival data from a secon(+) Phase 111 trial. ECCO 13th European Conference, Oct 2005.