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Life Extension Magazine

Life Extension Magazine December 2011
As We See It

Bureaucratic Assault On New Cancer Therapies

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!

Low CoQ10 Levels Associated with 790% Increased Risk of Melanoma Metastasis
Dermatologist removing mole
Dermatologist removing mole

In a study published in the Journal of the American Academy of Dermatology, plasma coenzyme Q10 levels were measured in 117 consecutive melanoma patients upon enrollment. One hundred twenty five matched volunteers without any clinically suspected pigmented lesions were utilized as the control group.

Researchers found that CoQ10 levels were significantly lower in melanoma patients compared to control subjects. Further, it was noted that for melanoma patients with CoQ10 blood levels of less than 0.6 mg per liter, the risk of developing metastatic disease increased by 790%, compared to those melanoma patients with blood levels of 0.6 mg per liter or higher. In addition, melanoma patients with higher blood levels had a metastasis-free interval that was almost double compared to patients with lower levels.29

Of the 82 patients with low CoQ10 levels, 17 died during the study, compared to none of the 35 patients with higher CoQ10. CoQ10 levels did not vary by sex.29

Levels of CoQ10 correlated well with tumor thickness, which is currently the best indicator of melanoma progression. Specifically, lower CoQ10 levels correlated with increased tumor thickness and poorer prognosis.29

The study notes that abnormally low plasma levels of CoQ10 previously have been known in patients with cancer of the breast, lung, and pancreas. This study may be the first to indicate that lower blood levels of CoQ10 can have an extremely adverse effect. The lead author of the study concluded that analysis of their findings suggested baseline CoQ10 levels are a powerful and independent prognostic factor that can be used to estimate risk for melanoma progression.

Statin drugs are known to lower CoQ10 levels. Will we find that melanoma progression is another side effect of statins? If so, this side effect can be readily overcome with CoQ10 supplements.

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,

For Longer Life

William Faloon

As this article was being finalized… FDA Partially Capitulates on MelaFind®

In response to intense legal and political pressure put on the FDA, a limited conditional approval has just been granted for the MelaFind® skin cancer detection device.30

This pending approval comes after a seven-year battle between the company that makes MelaFind® and the FDA.

After FDA rejected MelaFind® last year, the company filed a citizen's petition with FDA Commissioner Margaret Hamburg seeking to overturn the denial.

The House of Representatives held a hearing in the summer of 2011 where the FDA's top device regulator acknowledged the agency mishandled the MelaFind® application. The error occurred when the FDA denied approval of MelaFind® before it held a meeting of its own scientific advisors—talk about bureaucratic mix-up!

Pharmocracy

This does not mean that MelaFind® will definitely become available, but the FDA is at least moving off its refusal to approve it at all. MelaFind® did win approval in early September in 27 European nations.

In order for MelaFind® to be approved in the US, the FDA needs to agree on the device's final labeling, a user guide, details of a training program for doctors, and the design of a post-approval clinical trial.

The CEO of the company that makes MelaFind® was uncertain about when the FDA would approve MelaFind® and was careful to downplay if and when the company can begin selling the device. He acknowledged that discussions with the FDA were still going "back and forth" and therefore not complete.

Before MelaFind® can be sold in the US, the FDA wants additional "beta tests" with doctors to be conducted to make technical and usability improvements to the device. The FDA insists that MelaFind®'s label be longer and more complicated than the company ever envisioned.

Until these issues are resolved, MelaFind® will not be allowed on the American market.

There are examples of other products in the past that received this kind of conditional FDA approval but never made it to the market, though it seems the political heat has forced the FDA in a direction regarding MelaFind® that it previously refused to consider.

If you ever wonder why medical advances take so long and then cost so much, the expense and delay in pushing MelaFind® through the FDA's cumbersome bureaucracy provides a stark example.


References

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-
Application-on-August-26-2010-NASDAQ-MELA-1266362.htm. Accessed May 18, 2011.

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-
concerns-among-some-dermato/ArticleStandard/Article/detail/706390. Accessed May 19, 2011.

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-
melanoma-medicine.html. Accessed May 20, 2011.

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-
primary-endpoint-6168.html. Accessed May 24, 2011.

19. Available at: http://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/
oncologicdrugsadvisorycommittee/ucm199560.pdf. Accessed May 25, 2011.

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/
OncologicDrugsAdvisoryCommittee/UCM204335.pdf. Accessed May 26, 2011.

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-
melanoma-medicine.html. Accessed May 30, 2011.

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?
mod=WSJ_hp_MIDDLENexttoWhatsNewsTop. Accessed May 31, 2011.

27. Available at: http://www.bloomberg.com/news/2011-05-25/roche-leads-deadly-skin-cancer-turnaround-as-dozen-
drugs-coming.html. Accessed May 31, 2011.

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.