Bureaucratic Assault On New Cancer Therapies
By William Faloon
By William Faloon
Life Extension Magazine
By William Faloon
The Real Issue…
The way this country tolerates FDA behavior, it is as if only large pharmaceutical companies are capable of discovering effective new drugs. Those without deep pockets are often shut out of today's Byzantine approval process, where it can cost over $100 million to have a new compound "approved" for sale.
Most troubling is what this is doing to medical innovation across the entire spectrum. We at Life Extension know of pioneering physicians who have discovered and are utilizing novel therapeutic protocols to treat the diseases of aging. Yet these inventions have virtually no chance of making it out of these private practices because of FDA overregulation.
To see how much more efficient an unregulated environment functions, look no further than the breakthroughs that have been made in the treatment of AIDS. This disease appeared in America around 1980. It took several years just to identify the HIV virus as the cause. In the first half of the 1980s, virtually everyone who contracted AIDS died within 1-2 years.
The difference was that AIDS activists were acutely aware that FDA-mandated randomized clinical trials were the roadblock to the discovery of effective therapies. Unlike cancer support groups who too often capitulate to FDA suppression, AIDS activists rebelled and forced the FDA to back down from restricting any therapy that might be effective.
Removed from the artificial constraints of controlled trials designed by uncaring and incompetent bureaucrats, front-line doctors and researchers were able to collect data from actual medical practice on AIDS patients and had the flexibility of trying whatever therapy might work. Life Extension® partnered with these groups early on and witnessed the miraculous results that occurred when doctors could prescribe therapies without regard to FDA dictates.
When Life Extension attempted to introduce this same strategy to dying cancer patients, the FDA stood in the way and said absolutely not!
Look at the Difference between AIDS and Cancer
Those afflicted with AIDS today are prescribed an armamentarium of medications and take huge quantities of dietary supplements to keep their infections under control. What used to be a near-certain death sentence has turned into a manageable chronic disease for most people. That happened more than a decade ago!
Contrast this with cancer, where a melanoma drug that gives patients an extra 108 days of life (that costs $120, 00010) is hailed as a breakthrough in 2011. Americans have been dying of melanoma for hundreds of years.
The FDA's approval of expensive and mediocre drugs like Yervoy™ and suppression of common-sense approaches (like MelaFind® and pixantrone) are stark examples of the FDA's bureaucratic assault on novel cancer therapies.
At the June 2011 conference of the American Society of Clinical Oncology (ASCO), the results from several human studies were announced about new compounds that prolong the lives of advanced melanoma patients.26 Despite an unusual amount of enthusiasm shown by oncology researchers, it may take years before the FDA will allow combinations of these compounds to be used in desperately ill melanoma patients… who are dying at the rate of one each hour.
One of the new targeted melanoma drugs featured at the June ASCO meeting is called vemurafenib and is being developed by Roche Holding AG and Daiichi Sankyo's Plexxikon unit.27 It inhibits a mutated form of a gene called BRAF found in more than half of patients with advanced melanoma.27 It has virtually no benefit on patients with a normal version of the gene.
Results from a 675-patient trial showed that those taking vemurafenib were 63% less likely to die over a six-month period compared to those taking chemotherapy called dacarbazine.28 The median time before the disease progressed for patients on vemurafenib was 5.3 months compared with 1.6 months on dacarbazine chemotherapy.
Based on this trial, we believe that melanoma patients with a mutated BRAF gene should have been allowed immediate access to vemurafenib if they were willing to sign a disclaimer acknowledging that it is not yet FDA-approved. Instead, thousands of melanoma patients are dying prematurely in the FDA's waiting room.
My Grandmother's Funeral
At age 13, I stood over the casket of my grandmother, who had died a horrific death from melanoma. She was only 54 and suffered terribly as metastatic lesions invaded every part of her body.
Her death was preventable, as she ignored a melanoma lesion on her leg for many years.
At that funeral in 1968, no one would have predicted that more Americans than ever would be dying of melanoma in 2011—43 years later! Like others back then, our family believed that medicine would advance and find a cure for cancer, just like antibiotics wiped out most bacterial infections.
While major technological advances are routine in virtually all disciplines, clinical medicine is the exception. It has devolved into a bureaucratic monstrosity that suffocates innovation while rewarding the politically well-connected.
How much longer will Americans tolerate a system that is a proven failure?
As a member of the Life Extension Foundation®, you help support our ongoing campaign to educate the public that most deaths today could be avoided if it were not for the bureaucratic assault on novel therapies erected by our own government.
For longer life,
1. Available at: http://www.melanomafoundation.org/facts/statistics.htm. Accessed May 18, 2011.
2. Available at: http://www.projectmelanoma.com/a-national-challenge.php. Accessed May 18, 2011.
3. Monheit G, Cognetta AB, Ferris L, et al. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. 2011 Feb;147(2):188-94.
4. Available at: http://www.marketwire.com/press-release/MELA-Sciences-Announces-FDA-Panel-Review-MelaFind-PMA-
5. Available at: http://www.thestreet.com/story/10944267/3/biotech-calendar-fda-drug-approvals-in-2011.html. Accessed May 18, 2011.
6. Available at: http://www.medpagetoday.com/Dermatology/SkinCancer/23448. Accessed May 19, 2011.
7. Available at: http://www.modernmedicine.com/modernmedicine/Modern+Medicine+Now/MelaFind-device-raises-
8. Available at: http://online.wsj.com/article/SB10001424052748704559904576230562290013904.html. Accessed May 20, 2011.
9. Available at: http://seer.cancer.gov/statfacts/html/melan.html. Accessed May 20, 2011.
10. Available at: http://www.bloomberg.com/news/2011-03-25/bristol-myers-squibb-wins-u-s-fda-approval-for-new-
11. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010 Aug 19;363(8):711-23.
12. Available at: http://www.mmm-online.com/fda-approves-bms-skin-cancer-biologic-yervoy/article/199258/. Accessed May 21, 2011.
13. Available at: http://www.non-hodgkins-lymphoma-cancer.org/news/non-hodgkins-news0026.htm. Accessed May 20, 2011.
14. Available at: http://seer.cancer.gov/statfacts/html/nhl.html. Accessed May 23, 2011.
15. Available at: http://www.nytimes.com/learning/general/onthisday/bday/0728.html Accessed May 23, 2011.
16. Available at: http://www.lls.org/diseaseinformation/getinformationsupport/factsstatistics/nonhodgkinlymphoma/. Accessed May 23, 2011.
17. Available at: http://www.drugs.com/health-guide/non-hodgkin-lymphoma.html. Accessed May 24, 2011.
18. Available at: http://www.drugs.com/clinical_trials/cell-therapeutics-pixantrone-phase-iii-extend-pivotal-trial-successful-achieving-
19. Available at: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/
20. Available at: http://online.wsj.com/article/SB10001424052748703766704576009512990553104.html. Accessed May 26, 2011.
21. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/
22. Available at: http://www.pharmalot.com/2010/02/the-fda-and-special-protocal-assessments/. Accessed May 26, 2011.
23. Available at: http://www.bloomberg.com/news/2011-03-25/bristol-myers-squibb-wins-u-s-fda-approval-for-new-
24. Available at: http://seekingalpha.com/article/198401-fda-s-early-verdict-on-cell-therapeutics-pixuvri-comes-as-no-surprise. Accessed May 30, 2011.
25. Available at: http://www.ipdatadepot.com/archives/ipp070402.pdf. (pg. 13/45). Accessed May 30, 2011.
26. Available at: http://online.wsj.com/article/SB10001424052702304432304576367802580935000.html?
27. Available at: http://www.bloomberg.com/news/2011-05-25/roche-leads-deadly-skin-cancer-turnaround-as-dozen-
28. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011 Jun 10 30;364(26);2507-16.
29. Rusciani L, Proietti I, Rusciani A, et al. Low plasma coenzyme Q10 levels as an independent prognostic factor for melanoma progression. J Am Acad Dermatol. Feb 2006;54(2):234-41.
30. Burton TJ. New tool in skin-cancer fight. FDA reversal clears path for a device that helps doctors diagnose melanoma. Wall Street Journal. September 26, 2011.