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Life Extension Magazine

Life Extension Magazine December 2011
Report

Outrageous FDA Delay Endangers Melanoma Victims

By Aimee Dingwell

Dangerous $30,000-Per-Dose-Drug Approved in Record Time

Meanwhile, in March 2011, the FDA's Center for Biologics Evaluation and Research approved a drug called Yervoy™ (ipilimumab) to treat advanced melanoma, based on data that the drug extended survival by about four months.

Yet it has potentially life-threatening side effects that are so severe that the FDA required manufacturer Bristol-Myers Squibb to place a boxed warning on its prescribing information and documentation.

The side effects relate to immune-mediated adverse reactions due to T-cell activation and proliferation, including enterocolitis, hepatitis, dermatitis, neuropathy, and endocrinopathy.

Dangerous $30,000-Per-Dose-Drug Approved in Record Time

Still, Yervoy™ was approved in record time under priority review in just seven months. "I'm a huge fan of anything that can help patients," said Gulfo. "But the data are that, while there were some great responders, overall ipilimumab (Yervoy™) added just four months of life. Four months of the least productive, lowest quality, and most expensive life." Yervoy™ costs about $120,000 for four doses. That equates to $30,000 dollars a month of life riddled with horrific side effects, though use of Yervoy™ in earlier-stage melanoma patients might eventually prove to be more cost effective

"Detect melanoma at the earliest, most curable stage," noted Gulfo, "and you'll have forty years of high quality life! One of the massive ironies here is there is a tremendous disconnect between the FDA's laudable goals and what is happening as they stymie innovation that could save lives," Gulfo said. "It's almost as if the FDA didn't get the memo."

Bureaucratic Resistance Exports Innovation Overseas

Gulfo blames the delay on what he calls "innovation inertia," fostered in part by the FDA's long history of turnover and unstable leadership. In the last nine years, the beleaguered agency has had four commissioners, dotted by excessive periods of no leadership in between posts. "Yes, continuity is a big problem at the FDA," said Gulfo, "and it is worse on the device side." In February, FDA's Center for Devices and Radiologic Health (CDRH) Director Dr. Jeffrey Shuren testified before the Subcommittee on Health of the Committee on Energy and Commerce that high rates of turnover were affecting the center's ability to efficiently approve product applications.4 The result is stymied innovation and unnecessary delays in the availability of life-saving products for the public.

Just weeks before, FDA and CRDH launched the "Innovation Pathway" program, "a priority review program for new, breakthrough medical devices designed to encourage cutting-edge technologies among medical device manufacturers," according to an FDA press release.5 The program is meant to "accelerate the development and regulatory evaluation of innovative medical devices."

"So here you have another irony," said Gulfo. "We have just what the innovative program is stated to be looking for and it is right in front of them."

While the FDA appears to want to fuel innovation, the reality is that it is more comfortable approving a toxic, late-stage cancer drug—a familiar model in drug development—than approving a safe, non-invasive diagnostic device because it is novel. "Yervoy™ is a pretty common story in cancer drug approval," said Gulfo. "Drug developed for late-stage disease shows some reasonable benefit. In fact, that is every story in cancer drug approval. But we are a breakthrough."

It is this apparent aversion to progress and bureaucratic nitpicking that is causing patient groups, industry groups, and investment groups to sound the alarms that FDA's policies and procedures are burdensome, unclear, and threatening medical innovation itself. "Venture capitalists are openly saying they won't invest in companies if trials are done in the United States because they don't want their returns to be based on an FDA decision," said Gulfo. "So innovation is leaving America. Not even the big companies are doing their innovative work here."

Earlier this year, a report by investment house PriceWaterhouseCoopers showed that medical technology innovation, long centered in the United States, is moving offshore and that US consumers could eventually be the last to have access to innovative medical technology.6

A second survey of more than 350 medical device development experts sponsored by the Institute for Health Technology Studies at Northwestern University found that two-thirds of small medical device and diagnostic firms look to Europe for their first regulatory clearances.7

Not surprisingly, MelaFind® has already been approved for use in the European Union. (See Sidebar.)

Europeans Benefit As Americans Die
Europeans Benefit As Americans Die

In September 2011, MelaFind® was approved for use by dermatologists throughout the European Union, with initial introduction into the German healthcare system.

Incidence of melanoma has doubled in Germany over the past 10 years, where melanoma mortality rates are the highest in Europe. Approximately 20,000 Germans will be diagnosed with melanoma by 2016.2

Compare that to the US, where melanoma rates have risen steadily over the past 30 years, with an expected 70,2303 new cases in 2011 alone.

Thanks to the European Union's enlightened approval process, driven by hard science and public interest rather than profiteering and industry bias, Germans will now benefit from a technology that may eliminate skin cancer deaths.

American melanoma victims in the meantime run a higher risk of missed diagnoses and death as the 98% accurate MelaFind® technology languishes in the limbo of the FDA's irrational and irresponsible approval process.

"We are a test case. Everybody is watching this. We hit every endpoint and we hit every part of the innovation program. If FDA doesn't approve this—we say innovation is leaving, investment is drying up—it's all gone," said Gulfo. "If this doesn't get approved, it's the death knell. This case is much bigger than just MelaFind®. I believe a whole industry is at stake."

Summary

One American dies of melanoma every hour, yet it is virtually 100% curable if detected in time. Owing to flawed methodology, dermatologists may be missing up to 30% of curable melanomas.

An application was filed in June 2009 for MelaFind®, a completely safe, advanced optical diagnostic device that can help diagnose early melanoma with 98% accuracy. Citing concerns over "safety," the FDA is still reviewing the application for this lifesaving technology, while fast-tracking approval for ipilimumab (Yervoy™), a $30,000-per-dose, largely ineffective melanoma drug with potentially lethal side effects.

MelaFind® was approved by the European Union in September 2011, while the technology languishes here in the US thanks to the FDA. Numerous reports show that FDA bureaucracy and bias are sending other lifesaving medical innovations like MelaFind® overseas and out of reach for most Americans.

If you have any questions on the scientific content of this article, please call a Life Extension® Health Advisor at 1-866-864-3027.

BREAKING NEWS AS WE GO TO PRESS: FDA Succumbs to Pressure, MelaFind® Now "Approvable"

The FDA's seven-year war against common sense and logic in the case of MELA Sciences Inc.'s MelaFind® device may be finally coming to an end. After nearly a decade of ignorance and obstruction, the FDA is reversing an earlier decision that flatly rejected the MelaFind® device, costing untold lives in the process. In a Wall Street Journal article that appeared on September 27th, 2011, written by Thomas M. Burton, it was revealed that the FDA sent a letter to MELA Sciences Inc. stating its intention to review the device for approval. Inherent in this reversal is the acknowledgement by Dr. Jeffrey Shuren, the FDA's top regulator, that his staff "made the wrong call" when they decided to reject the device before ever holding a meeting of its advisors to discuss it.10

The government ineptitude on display should come as no shock to readers of this magazine. The original decision carried with it lethal consequences for sufferers of cancerous lesions that may have been detected earlier with the advanced technology offered by MelaFind®. Thankfully, the company filed a citizen's petition that forced the FDA to review the case and acknowledge its error. As we wait for the government to move at its normal excruciatingly slow pace to get this device in the hands of dermatologists, MelaFind® has already won approval for marketing in 27 European nations.


What is Melanoma?
What Is Melanoma?

Melanoma is the deadliest form of skin cancer, and if not caught early, it is one of the deadliest of all cancers, as there is no effective treatment for late-stage disease.

What's more troubling is melanoma is on the rise. Over the last 25 years, the incidence of melanoma in the US has nearly quadrupled, according to the National Cancer Institute. Last year, 68,130 Americans were diagnosed with melanoma, and 8,700 lost their lives to this deadly skin cancer. Its main risk factors? Sun exposure and family history.8

So what is melanoma? We all have freckles and moles. Melanomas are atypical moles. Excessive sun exposure can cause the uncontrolled growth of skin pigment cells called melanocytes, leading to lesions that may look like harmless, slightly irregular moles, when, in fact, a serious cancer is growing just under the skin. And while melanomas typically appear on the shoulders, legs and hips, they can show up anywhere on the body, including the scalp, between the toes, and rarely, internally.

The hallmark characteristics of a melanoma mole have been labeled the ABCDEs of melanoma:9

A – Asymmetry (one half of the mole is different than the other half)

B – Border irregularity (mole has uneven, fuzzy, notched or scalloped edges)

C – Color changes or multiple colors (usually blue, black, or dark brown)

D – Diameter greater than 6 mm (larger than the width of a pencil eraser)

E – Evolving (a change in ABC or D within weeks or months)

If caught early, however, melanoma is almost 100% curable. But the line between life and death is very thin, literally. According to Dr. Darrell Rigel, a professor of clinical dermatology at New York University's Langone Medical Center, the most important prognostic factor for survival in melanoma is the thickness of the mole, or how far down the melanoma has penetrated into the skin.

Most people will survive having a melanoma if it is removed when it is 1/32nd of an inch, or .75 mm deep. However, less than 50% of people will survive a melanoma that is 1/8th of an inch deep.

You are at an increased risk for melanoma if you have fair skin, many irregular moles, a personal or family history of melanoma or other skin cancers, or a history of excessive sun exposure, severe sunburns, or frequent use of tanning beds. However, studies have shown that about 50% of people who develop melanoma have no risk factors.

For these reasons, taking preventive measures, like wearing SPF clothing and adequate sunscreen whenever you plan to be in the sun, eating right, exercising, and being vigilant about early detection, are essential to defending against melanoma and saving your life.


References

1. Available at: www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/

MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM233831.pdf. Accessed September 15, 2011.

2. Available at: http://www.marketwire.com/press-release/mela-sciences-receives-european-union-approval-for-melafindr-nasdaq-mela-1557630.htm. Accessed September 15, 2011.

3. Available at: http://www.cancer.org/Cancer/SkinCancer-Melanoma/DetailedGuide/melanoma-skin-cancer-key-statistics. Accessed September 13, 2011.

4. Available at: http://www.fda.gov/NewsEvents/Testimony/ucm243716.htm. Accessed September 15, 2011.

5. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm242629.htm. Accessed September 15, 2011.

6. Available at: http://www.pwc.com/us/en/health-industries/health-research-institute/innovation-scorecard. Accessed September 15, 2011.

7. Available at: http://www.inhealth.org/wtn/Page.asp?PageID=WTN004937. Accessed September 15, 2011.

8. Available at: http://seer.cancer.gov/statfacts/html/melan.html. Accessed September 12, 2011.

9. Available at: http://www.skincancer.org/melanoma/Warning-Signs.html. Accessed September 12, 2011.

10. 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.