Life Extension Magazine®

Issue: Aug 2013

When “Rules” Are Broken

Cancer patients are often treated with technologies developed during the first part of last century. Innovative treatments remain bogged down in regulatory quagmire. Those who dare to bring them to the surface risk financial ruin and incarceration by regulators protecting pharmaceutical interests. Life Extension® has long sought to persuade Congress to allow individuals to try drugs shown to be safe but not yet approved. In a free-market environment, lethal diseases will succumb to less expensive cures and greater competition will eliminate today’s health care cost crisis.

By William Faloon.

  When “Rules” Are Broken
Former Vice-President Nelson
Rockefeller
died at age 70 from
a heart attack. Former President
Gerald Ford
died at age 93 from
arteriosclerotic cerebrovascular
disease and diffuse arteriosclerosis.
Former Speaker of the House Carl
Albert
died at age 91 probably of
vascular disease based on his history
of multiple heart attacks and triple
bypass surgery. Photo courtesy
Gerald R. Ford Presidential Library.

The people you see throughout this article were the most powerful group in the world.

They now share one common problem…they’re all dead.

These individuals are partially responsible for their demise because they inadvertently created and maintained rules that interfere with medical progress.

The catastrophic result has been needless suffering and deaths of tens of millions of Americans.

This article describes the development of what was considered a technological impossibility. The only reason this breakthrough happened was the willingness of an individual to break the rules, which put his personal liberty in jeopardy.

This rule breaker is now a hero and is credited for saving lives.

The dilemma is that most brilliant individuals today lack the confidence to risk prison and lose everything they have. They instead adhere to rules that strangle the kind of advances humans need to reverse age-related disease.

We will send this article to every member of Congress. Our objective is to persuade Representatives/Senators to recognize their power to amend archaic rules that impede scientists from curing old age disease.

Jet Engine Controversy

When World War II broke out, nations rushed to develop weapons that would give them a tactical advantage. When a group of British scientists proposed expending research funds to develop a jet engine for aircraft, the consensus of their opposition was that this was impossible and would be a waste of scarce wartime resources.1

What the British did not know was that the Germans were already pursuing jet engine technology. Fortunately, it came to fruition too late in the war to produce a Nazi victory.

As you’ll read next, narrow-minded limitations on this kind of technology are not limited to the 1930s.

The Battle to Build Iron Dome

   Senator Arlen Specter
Senator Arlen Specter died at age 82
from complications of non-Hodgkin’s
lymphoma. © gettyimages.com

Israel is a tiny country surrounded by enemies that routinely fire rockets and missiles into it. Israel responds to these attacks with its own bombs and missiles, along with land invasions that cost many lives.

In late 2012, thousands of missiles and rockets were fired into Israeli population centers from the Gaza strip. While not particularly accurate, the volume of this weaponry would normally inflict many Israeli injuries and deaths.2

  Senator Daniel Inouye
Senator Daniel Inouye died at age
88 of respiratory complications.
© gettyimages.com

This time around something unexpected happened. A new technology called Iron Dome resulted in 84% of these deadly projectiles destined to hit Israeli population centers being destroyed in mid-air.1

If you are not impressed by what Iron Dome accomplished, what you read in this article will enlighten you to a scientific achievement the world has never witnessed.

Perhaps the most fascinating aspect of Iron Dome is that it would have never been developed had an Israeli general and defense minister not broken bureaucratic rules.2

We at Life Extension contend these same kinds of advances would occur in the medical arena if Congress would abolish rules restricting the development of lifesaving medical therapies.

Bureaucratic Opposition to Iron Dome

The Israeli military establishment did not believe Iron Dome had a chance of working and was vehemently opposed to it. So-called “experts” at the US Pentagon voiced similar opposition and dismissed Iron Dome as doomed to fail.

Despite these bureaucratic obstacles, a lone Israeli general pushed the project through, breaking laws and rules in the process that could have landed him and others in serious personal trouble.2

Technical Challenges

Senator Warren Rudman
Senator Warren Rudman
died at age 82 from cancer.
© gettyimages.com

The pessimism of the military bureaucrats was nothing compared to the technological difficulties faced by the Iron Dome creators.

Rockets and missiles of all types are fired into Israel from only a few miles away. They fly erratically and can hit Israeli communities within seconds. Most are just a few feet long and a few inches wide. In some years thousands rain down (over 4,000 in the year 2008 alone).2

To counter this armada of rockets, a system had to be developed that could continuously scan enemy territory, detect a rocket the instant it was fired no matter how big or small, pinpoint its likely strike location and calculate if it was likely to hit a population center, and finally, if it was going to hit a city, blast it out of the sky with a missile. The system needed to do all that within about 15
seconds
.

Additionally, interceptor missiles would need to cost about one-tenth of an average air-to-air missile, or else Israel’s rocket-flinging foes would be able to bankrupt Israel. And instead of taking 10 years or more to develop, typical for new weapons systems, Iron Dome needed to deploy in half that.

These daunting challenges deterred most from even considering this project, but not General Daniel Gold, who was director of Israel’s new weapon’s research department. General Gold has a PhD in mathematics and took up the rocket’s challenge with enthusiasm seen in very few individuals.

Bypassing the Establishment

Senator Ted Kennedy
Senator Ted Kennedy died
at age 77 from glioblastoma
multiforme (brain tumor).
© gettyimages.com

Almost none of Israel’s military experts believed this kind of rocket defense could work. Enemy rockets of varying sizes fly erratically and rapidly hit nearby Israeli communities.

Drawing inspiration from other types of weapons defense systems, General Gold and his team in March 2005 agreed on a patched-together concept for what would become the Iron Dome.2

General Gold called up an Israeli weapons maker to head the project, bypassing required approvals from the military’s general staff, the defense minister, and the Israeli government. An audit by the Israeli state comptroller criticized this step, which led to years of heated condemnation of the project. If regulatory or criminal actions had been taken against General Gold, the highly controversial Iron Dome missile defense system would have likely never happened.

Senator Jesse Helms
Senator Jesse Helms died at
age 86 of vascular dementia.
© gettyimages.com

General Gold disputed allegations that he broke rules, saying he simply sidestepped red tape. Said the General, “ I just canceled all the unnecessary bureaucracy…I left only the most crucial bureaucracy needed for success.”2

Another problem was that no one in government agreed to pay for the project. That left General Gold once again having to think outside the box. By using funds from his research budget and others in the private sector, he secured enough monies to cover early stage development costs.

Even after war with Hezbollah broke out in Lebanon, resulting in thousands of rockets being fired into northern Israel, the military establishment and Israel’s prime minister refused to divert government funds for Iron Dome.2

General Gold Breaks More Rules

Senator William Proxmire
Senator William Proxmire died
at age 90 from Alzheimer’s
disease. © gettyimages.com

Without government funding, it is difficult to imagine a military project continuing. Instead of scaling back, General Gold directed a private Israeli defense contractor to begin full-scale development of the Iron Dome project when there was no order or appropriation to do so. According to the Israeli comptroller’s audit report, “ The directive was not under his (Dr. Gold’s) authority.”2

The defense contractor agreed that there was no legal basis to advance this system’s development and was quoted, “ But if you want to achieve something in a very short time…you have sometimes to bypass the bureaucracy.”2

The risk taken by General Gold and a handful of others paid off. The Ministry of Defense finally committed some funding to keep Iron Dome alive. (Government auditors later found the Ministry of Defense violated regulations by committing these funds without military or government approval for the project.)

Despite engineering miracles in the developmental process, Israel did not have the funding to quickly move Iron Dome forward. Israel sought out aid from the United States. After US military experts thoroughly reviewed the project, the American team concluded that, “This is something that cannot be done.”2,3

Finally, the Israeli government became convinced enough to provide the first large cash infusion to Iron Dome with more funds likely to be appropriated later. This event, however, set off another attack against General Gold, mainly by rivals who feared losing out to the improved technology General Gold had expeditiously pushed through.

General Gold Investigated Again by Israeli Authorities

   President Ronald Reagan
Former President Ronald
Reagan
died at age 93 from
pneumonia after suffering systemic
degenerationbrought on by Alzheimer’s
disease. © gettyimages.com

In response to increasing recognition that General Gold had pioneered a breakthrough technology, Israel’s government auditors initiated a new investigation of the project and issued a report accusing General Gold of launching a billion-dollar project without the necessary approvals. According to the auditor’s report:

Brigadier General Gold decided on the development of Iron Dome, determined the timetables and ordered predevelopment and full development before the relevant authorities had approved the project.”2

Fortunately for General Gold, Iron Dome was making rapid progress. A team of engineers assembled from across Israeli defense companies worked around the clock. Even pensioners were called out of retirement. In 2009, during the first field test, an Iron Dome prototype successfully intercepted an incoming rocket.2

Iron Dome Revolutionizes Military Defense…But Still No Cancer Cure Breakthrough

Intercepting supersonic projectiles in midflight was once considered science fiction. Engineers pulled off the feat by combining cutting-edge tracking radar with electro-optic sensors and mounting them on highly mobile, all-weather air defense systems. Iron Dome can hit multiple types of rockets and missiles at ranges up to 43 miles.4 It can be relocated quickly to new sites with totally different terrain. Iron Dome determines within split seconds whether an incoming rocket will land in an open field or a population center.

From drawing board to deployment, Iron Dome was completed in a few brief years. If you wonder why these kinds of breakthroughs aren’t happening in the medical field, look no further than an archaic regulatory system that suffocates innovation. That’s unfortunate for about 577,000 Americans who die from cancer alone each year.5

Israel’s Missile Defense, How Iron Dome system works

United States Finally Recognized Iron Dome

The Pentagon sent a team of experts to Israel in late 2009 to reevaluate Iron Dome—a concept they earlier deemed as something “that cannot be done.3

In its final report, the Pentagon team declared Iron Dome a success. Field tests showed it was hitting 80% of the targets, up from the low teens in the earlier US assessment. This prompted the United States to provide roughly $200 million in Iron Dome funding.2

Lives Saved

Iron Dome went operational in March 2011. It shot down its first Palestinian rocket on April 7. Within three days it shot down eight more rockets. It wasn’t until the Gaza flare-up in late 2012 that Iron Dome made its mark on the public consciousness.2

The result was a quick ending to this conflict, where Iron Dome knocked down 421 rockets launched from Gaza and bound for Israeli cities, an 84% success rate, according to the Israeli military.2

Iron Dome limited Israeli casualties to six during the seven days of intense bombardment. As a result, there was markedly less political pressure on Israel’s decision makers to invade, and a cease fire was implemented.2

There would be no Iron Dome had General Gold not broken rules that enabled him to push the system’s development forward.

Regrettably, there are few heroes in the medical arena today willing to risk their personal liberty to bring these kinds of technological breakthroughs to those dying of chronic degenerative diseases.

Missiles That Shoot Down Missiles… But No Cure for Cancer

   Senator Daniel Patrick Moynihan
Senator Daniel Patrick Moynihan
died at age 76 after complications
(infection) suffered from an emergency
appendectomy.(This is an example of
hospital incompetence that is likely to
worsen under the Affordable Care
Act.)6-9 © gettyimages.com

Every day in America, more than 1,500 people perish from cancer.5 Many of these patients are treated with surgery and radiation, technologies developed during the first half of last century. Others receive toxic chemotherapy drugs approved in the 1970s, ‘80s, or ‘90s.

While more Americans are being cured of cancer, they often are left with horrific side effects, and the survival rate for certain cancers has not appreciably improved since the 1950s.13-18

We have today, advanced imaging techniques (e.g., PET/CT scans) that can detect exactly where tumors are throughout a patient’s body. Genetic testing of tumor cells enables us to know what enables them to uncontrollably proliferate and how they may be evading therapeutic eradication. Yet about 577,000 of these patients die each year surrounded by oncology experts.5

Effective treatments remain bogged down in regulatory quagmire.19,20 Those who risk bringing them to the surface prematurely risk financial decimation and incarceration by regulators determined to protect gigantic pharmaceutical interests.

The corrupt influence of pharmaceutical behemoths is so widespread that innovators fear the only way to get new therapy approved is to meticulously follow regulatory channels that were long ago proven inefficient. In this process that can take a decade and countless millions of dollars, potentially effective therapies are lost forever in a bureaucratic labyrinth.

Real-World Solutions

  Congressman John Murtha
Congressman John Murtha died
at age 77 due to complications from
gallbladder surgery. This egregious
act of hospital incompetence
occurred because the surgeon nicked
Murtha’s intestine during the surgery,
resulting in death from peritonitis.
This occurred in one of the federal
government’s top military hospitals,
and Murtha was one of the military’s
best friends from an appropriations
standpoint.10-12 © gettyimages.com

This article has been laced with depictions of former members of Congress and presidents who share a common tragedy of all dying before technology could evolve to prevent their death.

Life Extension has long sought to persuade Congress to amend the Food, Drug and Cosmetic Act to allow individuals to “opt-out” of FDA’s regulatory stranglehold and allow companies to provide innovative products that are clearly marked, “Not approved by the FDA—Use at your own risk.”

This approach will allow companies to offer drugs that have demonstrated safety and a reasonable likelihood of effectiveness, which are labeled “Not Approved by the FDA.” Patients who wish can still use only FDA-approved drugs, while those willing to take a risk, in consultation with their doctors, will be allowed to try drugs shown to be safe that are still not approved.

We believe that this initiative will result in a renaissance in the practice of medicine similar to the computer technology revolution of the past four decades. In the liberated environment we envision, lethal diseases will succumb to cures that are less expensive than is presently the case. And greater competition will help eliminate the health care cost crisis that exists today.

      Senators Ted Kennedy, Mike Mansfield, 
and Robert Byrd
Senators Ted Kennedy, Mike
Mansfield
, and Robert Byrd all died
of natural causes that could have been
prevented or treated if medical research had
been unshackled from bureaucratic over-
regulation. These men had long-serving
careers with plenty of plenty of opportunities
to change laws that constrain scientific
progress before they personally became
victims of the regulatory stranglehold this
country’s healthcare system has suffered
since the early 1960s. © gettyimages.com

Today’s broken system results in terminally ill people learning of scientific discoveries that might well cure their disease, but sadly hearing their newscaster say the therapy is years away from FDA approval. We think that seriously ill people, in consultation with their doctors, should be able to make up their own minds about what drugs they are willing to try.

Outside-the-box thinkers like General Gold are repressed in today’s hostile regulatory environment because Congress has failed to amend the law.

Americans should not face prison for accelerating medical progress, yet that is how the law is written and the reason why so few cures for lethal diseases have been found over the past 60+ years.

We at Life Extension have long contended that any person with a serious illness should have the individual right to choose therapies that have not yet received official approval.

Under this personal choice initiative, the marketplace, rather than government regulators, would determine which medical technologies are safe, efficacious, and cost effective.

The result will be the rapid emergence of medical therapies analogous to the Iron Dome missile defense system that came into existence because of General Gold’s willingness to break rules that made no sense.

For longer life,

For Longer Life

William Faloon

References

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  3. Available at: http://www.foxnews.com/world/2012/12/02/behind-iron-dome-key-engineer-tells-how-israeli-defense-system-saved-lives. Accessed March 11, 2013.
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  14. Kelly PJ. Gliomas: Survival, origin and early detection. Surg Neurol Int. 2010 Dec 25;1:96.
  15. Available at: http://seer.cancer.gov/csr/1975_2004/results_single/sect_01_table.03.pdf. Accessed May 6, 2013.
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