Pledge to the World - Part II

Part One: Puerto Rico can--should--undertake the clinical trials for developing dichloroacetate, known as DCA, as a cancer-fighting treatment. Call it "Our Space Mission," a national project to benefit the world.

Part Two: How?

Let's start with the key physical component: qualified laboratories. These would run from pharmaceutical-grade to clinical, from sheer equipment to patient-oriented. At present, Puerto Rico has around 18 world-class pharmaceutical laboratories (private and university-based). Although having one or more dedicated laboratories would speed up the clinical trials, We could "timeshare" these labs and use the overall proximity the Island's small size imposes to keep all the research teams "connected."

If you think face-to-face doesn't matter in these things, you're wrong. Human beings are very much social animals that thrive on personal contact. Scientific endeavors with millions of lives at stake must have the greatest possible contact levels to ensure the best results.

As for patient-oriented labs, at the clinical level, Puerto Rico has a second-tier hospital network (lacks world-class cancer treatment centers), but this is actually a plus because it keeps the DCA trial simple: Chemo- and radiotherapy are the methods most likely to reflect DCA effects.

With a population density of over 1,000 persons per square mile (the U.S. averages about 240), Puerto Rico can offer up--sadly--a wide range of cancer patients coming from a variety of backgrounds, from the controversial Vieques bombing area to the Agent Orange-strewn west central mountain region, not to mention other rural and heavily-populated urban centers.

And as hosts, We have three distinct university systems--two are private--that could jump at the opportunity, not to mention several teaching hospitals who could see this project as a way to make themselves an international beacon for students of oncology.

Now, the intangibles: Do We have the will?

Pardon the pun, but the answer is: Not now, but We will.

For one, hardly anyone on the Island knows about this idea. That will change.

Second, although We tend to wait for the government to step in and take the lead, in this case, the government is clearly in second position. Although they will provide some or even most of the $400-$600 million tab, once private industry, academia and the general public come together, the government will have no choice but to provide some level of support. The DCA Pledge to the World is exactly what the government has been trying to create locally for economic growth: a tripartite fusion led by industry and academia. Backing away from this DCA Project would be tantamount to slamming the door on future progress, but more importantly, would leave The Fools out of the white-hot limelight this Project would generate.

And if there's one thing Fools love almost as much as money, it's white-hot limelight.

And third: We have a clear-cut potential spokesman, leader and rallying point for The DCA Pledge to the World, a former Health Secretary with impeccable credentials, excellent presence and passionate vision. His name is Dr. Johnny Rullán. His integrity and drive would spearhead the effort to take The DCA Pledge from idea to conceptual plan to final reality. With Dr. Rullán and dozens, maybe even hundreds of Our best professionals behind The DCA Pledge, We can give the world a life-enhancing gift unlike any other ever given.

One that Dr. Rullán can personally appreciate better than most of Us as he continues his own battle against cancer.

And finally, for those of you who simply have to have some "Uncle Sam" connection, the former Surgeon General of the U.S., Dr. Richard Carmona, is Puerto Rican and has been very public about his opposition to cancer-inducing products. His inspiring and unique climb from poverty to Surgeon General along with his engaging public personna could add plenty of influence in the development of The DCA Pledge.

When Jack Kennedy challenged the U.S. to reach the Moon, the nation was barely a hundredth of the way there. For The DCA Pledge, We--Puerto Rico--are better prepared. And what We can achieve could surpass even the vaunted windfall of "One small step for Man."


The Jenius Has Spoken.

A Pledge to the World

It's called dichloroacetate, or DCA for short. It repairs the damage cancer cells do to their own mitochondria, which means that cancer cells can get their "engines" back on-line for other treatments to be effective. Cancer cells--those with inactive mitochondria--are essentially like zombies: there's no easy way to hurt them. With DCA, you can make them vulnerable and kill them off.

This isn't theory. Researchers at the University of Alberta have run extensive trials on animals and human tissue tumors and the results are not short of spectacular. The treatment is not only effective, it attacks almost all types of cancer cells, attacks only cancer cells (healthy cells don't need their mitochondria reactivated, so DCA leaves them intact) and a DCA treatment would be relatively easy to implement, inexpensive and significantly reduce the damage done by chemo- and radiotherapy.

So what's the catch? Dichloroacetate is not patentable: It's like salycilic acid, better known as aspirin. It's become a generic compound, used often to treat genetically-induced metabolic disorders in children. Because it cannot be patented, pharmaceutical companies will not invest the money to develop DCA in clinical trials. Without that development, the potential breakthrough in defeating cancer will remain experimental. Unless there's a megaprofit down the line, no drug company will do the work.

How much money are We talking about? From $400 to $600 million. Not exactly chump change, but compared to drug company profits, it's not even a mild stretch. The Alberta researchers are hoping for universities and other private entities to step forward and help finance the development, made prohibitively expensive by the numerous and laberynthian hoops the Food and Drug Administration throws at drug development. Doing it in Europe is an option, but there'd still be the hurdle of FDA approval for treatment in the U.S.

However, any disjointed effort would slow down the clinical trials and thus delay the development of the DCA tumor treatment, while cancer rages on. If you don't think this is important, then you don't have a loved one battling cancer.

So why am I bringing this up in The Jenius? Stop. Think about it. Pull the elements together...Clinical trials, drug development, FDA procedures, scientists, human test subjects, controlled conditions, U.S.-based to speed up approval, a central "organizing" entity, but above all, a funding entity that states unequivocally: We will do this and make the treatment available without regard to profit.


Here's where I'm going with this: Puerto Rico should pledge to sponsor, with monies and support resources, the clinical trials and development of DCA as a cancer treatment.

Puerto Rico has enough basic resources, both human and infrastructure, to begin organizing clinical trials. There's more than enough personnel for the millions of hours needed and whatever specialized knowledge is needed can be brought in. The government and private sector can pledge to put up $600 million over a 5-year period to make this happen.

But beyond those and other minor physical details (yes, We have more than $600 million floating around), the most significant factor in doing the DCA clinical trial is that it will unite Puerto Rico in a visible, measurable and globally-significant manner.

"We shall place, before the end of the decade, a man on the moon and bring him back safely." When President John Kennedy launched that challenge in 1960, the goal was beyond imagining: We had barely covered 100 miles of an almost 600,000 mile round trip into the pure unknown. The U.S. could and did pull that off. Puerto Rico can and should pull off the DCA clinical trial for development of a cancer treatment.

Think of the benefits. From medical "magic bullet" to "world center stage," Puerto Rico's pledge and activity in this project would set an example, one that would continue to shine if the treatment is then donated to the world as Puerto Rico's offering to develop a better world.

Would this unite Us? I believe so. Will there be detractors? Of course, but there are always naysayers both bright and dull against every idea. More importantly: Is it doable? Can Puerto Rico take a deep breath, stand up and get the job done? I believe it can. I believe it must.

The possible ramifications of this idea, of this pledge to the world, are too numerous to explore here, but I will mention one: Have you ever heard of a nation pledging its resources to help all of humanity? How would that nation be perceived by the rest of the globe's denizens? And finally, how would that nation feel about itself, during and after this pledge?


Puerto Rico should do this. No, more than that: We must.


The Jenius Has Spoken.

DCA On The Way

Thanks to My Special Friend, María, good news landed in My inbox: The clinical trials for dichloracetate (DCA) are beginning in Canada.

I wrote about this back in January, 2007, about how researchers at the University of Alberta discovered that DCA was extremely effective at "de-zombifying" the mitochondria of cancer cells, in effect, making them very vulnerable to radio- and chemotherapy. Basically, DCA makes cancer cells "live" so that treatment can kill them much more easily.

The repercussions are staggering on three levels:

1) Enhanced treatment of a wide range of cancers, including those cases where tumors are too close to delicate tissues for surgery.

2) Substantial decreases in medical costs and side-effects for patients.

3) DCA is so inexpensive it can be produced for as little as $2.00 a dose; it is a generic chemical that is very easy to manufacture to medical quality.

And as explained before, therein lies the rub: No pharmaceutical company would touch DCA because there's no true profit margin in developing it. I postulated that Puerto Rico could offer to put up the $600-$700 million needed to run the clinical trials, making of it Our version of the U.S.'s Lunar Landing project. A gift to the world, I called it.

A gift We never even bothered to consider giving.

My voice was too small, too insignificant to make this gift a reality. But think of this: The Canadian researchers are moving ahead although their entire budget so far is a little over $800,000. In other words, they are proceeding despite having barely 0.1% of the needed funding.

One-tenth of one percent.

Many people say scientists lack faith, but what other concept applies to this kind of effort? In their journey of a thousand miles, they have decidedly taken a first step. And there is no doubt--there can be no doubt--that they are doing so because they absolutely believe the DCA clinical trials are the right thing to do.

Conviction. Faith. Belief. Determination. Courage. Inspiration.

How I wish those words were about Us, rather than Canada. Maybe they still can be. I sure hope they can be.


The Jenius Has Spoken.


Postscript: I encountered this story on how private citizens in the Alberta area are giving money to help the funding of these clinical trials. Nothing We couldn't do if We chose to.

Pledge to the World - Part III

Part One: What We can do to help dichloroacetate (DCA) become a common anti-cancer treatment.

Part Two: A general direction for making the Pledge happen.

Part Three: Why?

I've partially answered this question already, but the fact remains that emotional appeals--no matter how grounded in rationality--will not work. For a nation (and I have no doubt We are a nation) to pledge the budgetary equivalent of one existing and necessary social program to back an experiment is asking a lot.

Or is it? Puerto Rico's internal budget hovers around $9.7 billion a year. It seems simple to take the ".7" out of the budget and We have the money for The DCA Pledge. But that $700 million represents about 7% of Our internal revenue, which according to almost every Fool, economist, analyst and statistical report, has long been badly over-strained. We need certainty, not risk, for any process as badly overmanaged and politically-laden as the FDA's is a risk, especially for outsiders trying to buck the fetid tide. So why would We take money We obviously need and place it in the hands of a risky process such as that of FDA treatment certification?

Because doing so will turn Puerto Rico around.

Guaranteed.

We are a nation without a goal, without enough unity to decide on goals and without a vision to help foster unity. We wave Our flags and sing Our anthem with the fervor of hubris when one of Our beauties comes in first or one of Our actors gets an award or one of Our athletes makes a name for himself or herself on a playing field. But aside from those moments of duly-earned pride, that's all We have: moments. We don't have--We refuse to have--an enduring process by which We define Ourselves. If We are defined at all it is by Our indifference to focus on anything other than Our smallness, Our physical smallness, using it as excuse, lament and--for those brief moments--as an "In your face" motivator .

We are so much more. We can be so much more. But We don't believe it. Like a teenager with a keen mind, a kind heart and a yearning desire to do more, We keep waiting for someone--anyone--to tell Us what We are, what to do and even how to do it. Lacking that "parent" or "uncle", We blaze around, all energy and passion, without direction, without a sense of proportion, without a point of view other than "Me." And just like teenagers, We make mountains out of Our molehills, see only the short term, get wrapped up in emotional webs and wake up every once in a while to the realization that "We are going nowhere and We don't know what to do about it."

One doesn't become an adult until one achieves what is considered "adult" things. Lacking a war, nations must rise to their levels of adulthood by taking on unique challenges. Puerto Rico's imposed transformation from economic rut to world-class prosperity ended some 25 years ago. We can now stand on Our own...if We only believed enough in Ourselves. And that belief cannot--will not--be built by winning beauty crowns, boxing belts, statuettes or rings. It will be built by creating something larger than an individual or a sports team, something larger than one institution, agency or company, something so large that other nations turn to Us and recognize that not only are We putting forth an admirable effort, We are capable of achieving such a worthy goal.

It will take money. We have it, for it will only require a tiny sacrifice on Our part to make it happen.

It will take knowledge. We have it, for We will not achieve this alone. No one achieves anything worthwhile alone, and trying to do so is not a sign of maturity, but of childish insecurity.

It will take persistence. No worthy goal comes from instant gratification. Being able to contribute a major step in curing cancer has been a challenge for decades. We can do Our part, even if takes longer than expected.

It will take pride. Not the jubilant vanity of "Me-ness", but the deep self-respect earned through conscious effort. It is this journey that The Pledge to the World sets Us on.

It will take a choice; OUR choice. For if not now...when?


The Jenius Has Spoken.

Orphan Cure Research Center

No, this isn't about sick orphans. But it could be.

Dichloroacetate. Bacteriophages. Copper. Scorpion venom. A list such as this could go on and on, with each element being a potentially world-altering treatment against disease. And the other factor that binds these elements together is that none--none--is being studied by pharmaceuticals because they cannot be patented.

I understand pharmaceutical companies are businesses and they need to make a profit. Let them. But to leave potential cures as orphans because the investment cannot be fenced for profitability is a chasm that business and industry may not bridge...but can be bridged, nonetheless.

I wrote several times about dichloroacetate, also known as DCA. I suggested We undertake the clinical trials of DCA's effects, of "switching on" cancer cells to make them extremely vulnerable to radiation and chemotherapy, here in Puerto Rico as a national project and make it a gift to the world. I now say We should do so for "orphan cures" of all types, cures that pharmaceutical companies will not touch because the ROI is too low for their stockholders.

Bacteriophages are microorganisms that eat bacteria. The eaters eat only specific bacteria, so if you need to eliminate Bacteria A, you get an A-Eating Bacteriophage and once the Bacteria A is gone, the A-Eater dies. Has done so for millions of years. And the bacteria have no defense...unlike antibiotics.

Phage therapy, as its called, is a big deal in Eastern Europe and the former Soviet Union. Has been for decades because antibiotic research was out of reach. To this day, you can take a sample of your infection to a local drug store, get it analyzed and you'll receive a phage blend specifically blended for you. Cost: about $3.00.

Although phage therapy is gaining adepts in the U.S. of part of A., most of the research is academic, i.e., not aimed at medical treatment of diseases in humans. The cost of shepherding a drug--or just one bacteriophage--through the near-endless hoops of the FDA easily exceeds a few hundred million dollars. Imagine trying to do that with thousands of bacteriophages.

Phage therapy works, but it won't become a powerful new weapon in medical centers unless it gets researched and proven. As antibiotics lose potency, phage therapy is the clear low-cost alternative. But low-cost also means low or no profit.

Copper reduces the potency of bacterias and viruses. Yes, viruses, particularly H1N1, known as "politician's flu." (Swine, hogs, pigs, politicians, same species.) Copper's myriad effects could revolutionize sanitation in hospitals and clinics, not to mention daily life. But it remains outside the realm of patents, so Big Pharma won't care.

Scorpion venom, a powerful neurotoxin, has been found to be very effective at reducing brain cancer tumors. But you can't patent scorpion venom unless you isolate the specific chemical and make that your wonder drug. (Digitalis, anyone?) But since anyone can get scorpion venom, Big Pharma won't dare.

There are other examples and more will emerge as researchers comb the Earth and its details with new eyes. But where can this research be supported, with government money so that the profit motive is sidestepped in favor of broader results?

I say Puerto Rico should be that Orphan Cure Research Center. As I wrote before: One doesn't become an adult until one achieves what is considered "adult" things. Lacking a war, nations must rise to their levels of adulthood by taking on unique challenges. Puerto Rico's imposed transformation from economic rut to world-class prosperity ended some 25 years ago. We can now stand on Our own...if We only believed enough in Ourselves. And that belief cannot--will not--be built by winning beauty crowns, boxing belts, statuettes or rings. It will be built by creating something larger than an individual or a sports team, something larger than one institution, agency or company, something so large that other nations turn to Us and recognize that not only are We putting forth an admirable effort, We are capable of achieving such a worthy goal.

LIke I said before, it will take money. But one of the irrefutable axioms of economics (one of the very few) is that goverment investment in research has invariably high ROIs, in the range of 50% to 150%. So altruism can also lead to pure profit in terms of economic growth. And the impact of Puerto Rico taking center stage in such an effort is inspiring, an affirmation, a step forward for a nation that too often has waited for the world to act in its favor.

It won't be easy; nothing truly worth doing ever is. We have to do something, We have to be something more than what We are now and unless We strive, We will shrivel, more and faster than We have up to now. And if not this, then something else, but it has to be a goal that stretches Us to reach Our potential and not a goal that has Us throwing away what's left in the mindlews pursuit of the unearned.

The Jenius Has Spoken.

Update: 17 August--We can add bug repellants, too...

Pledge to the World - Part IV

Several years earlier, the surgical-oncology department at U.C.L.A. had devised an experimental treatment for osteosarcoma, a cancerous growth, around the end of the femur, just above the knee. (It involved) a new chemotherapy drug called Adriamycin. Oncologists had nicknamed Adriamycin “the red death,” because of its cranberry color and its toxicity. Not only did it cause severe nausea, vomiting, mouth blisters, and reduced blood counts; repeated doses could injure cardiac muscle and lead to heart failure.

Imagine treating a patient--imagine having your loved one treated--by a drug called "the red death." A drug that kills you only slightly slower than it kills the cancer cells that will kill you, too. And all this comes about because cancer cells have a zombie-like immunity that dichloroacetate (DCA) can strip away. Once that happens, drugs far less lethal than "the red death" can wipe out cancer cells with fewer damage to the patient whose life is being saved.

The quote above is from a New Yorker article, by Jerome Groopman, about the way doctors make decisions. Time and again doctors must make quick judgments that can have a seriously beneficial or serously damaging effect on a patient's health. But when it comes to cancer, many of the decisions are made murkier by the simple fact that treating the disease is only slightly better--in terms of adverse health impact--than letting the problem continue unchecked.

The path of science has been the reduction of uncertainty, the clearing away of doubts and speculation in favor of certainty. Maybe not full certainty, but at least the reduction of ignorance and risk. When something as simple as DCA proves science is on the right path, anything that can be done to make its potential erupt is worth doing. Anybody who can step up to make the process reach fruition is doing the right thing. And for a nation to do so is not only the right thing to do, it is the only thing to do.

And there's no reason why that nation can't be Ours. It's Puerto Rico's choice to step up on a global stage and make its mark on--and for--the world.


The Jenius Has Spoken.