Saturday, February 16, 2013

Cancer Researchers Could Teach the Aviation Industry a Thing or Two

In an article in the British Medical Journal, researchers G. Smith and J. Pell have undertaken to analyze the effectiveness of parachutes in "gravitationally challenging" situations on the basis of randomized, double blind clinical trials. This methodology has been so engrained into the mindset of cancer researchers world wide as to become accepted as the only way by which scientifically valid results can be viewed as having any value. They were surprised to find that out of an enormous, world wide data base these researchers were unable to find a single randomized, controlled trial to measure the efficacy of parachute intervention in gravitationally challenging situations. This is appalling in view of the billions of dollars worth of scientific studies that have gone into developing this methodology as the gold standard for research involving human life.
While the use of parachutes is often limited to purely volunteer activities, as with posting the colors by dropping from the sky onto the field of an athletic event, there are far more serious applications that beg to be addressed. For decades, brave paratroopers have been mandated to risk their lives by using these unproven devices. One interesting result is that commercial airlines have refused to issue parachutes to their passengers and for good reason. One aviation expert, speaking on condition of anonymity, has stated flat out that his company will not assume the liability inherent in recommending the use of such untested devices for passengers.
There is obviously an immediate and urgent need to correct this deficiency in this major field of human endeavor. The perception that parachutes are of value is based strictly on anecdotal evidence. It is a universally accepted axiom that evidence based conclusions, not supported by randomized clinical trials is sorely wanting. It does not seem at all unreasonable to proceed immediately to correct this sore deficiency that is so pervasive throughout the aviation industry.
An effective clinical trial that would put this controversy to rest immediately does not seem to be beyond the bounds of reason and practicality. Roughly speaking, it could be carried out from a readily available test vehicle such as the old reliable C-130 aircraft. This craft has proven a workhorse the world over and its credentials are impeccable. The entire sequence of events relating to the trial could be carried out in a matter of minutes, seconds if the need be. It need only involve a number of test subjects (patients, if need be to keep the terminology continuous), say 100, each of which would wear a parachute and jump out at the signal of the principal investigator (jump master in the vernacular). It should be noted that a certain number of these candidates would be wearing normal parachutes while a certain number, say 5 for example, would be wearing what appeared by all accounts to be normal parachutes but would, in fact, be packed with ordinary bed sheets. Neither the jumper, the jump master nor the airplane pilot would know which were the dummy packs. For the moment it is not necessary to prescribe just what this number would be. This is better left to a committee of mathematicians from the National Cancer Institute to determine what number of "paracebos" would give the most conclusive data.
The opportunity for excellence in data reduction is manifold. For example, beyond the mere morbidity statistics, we could envision varying degrees of injury, and even predict survival estimates for those who did not suffer the inconvenience of death at impact with the earth. This could easily provide gainful employment for hundreds of research technicians. Of course there would be necessary and proper expenses. Surely the pilot and co-pilot should be rewarded handsomely for their participation, not to mention the principal investigator (jump master). Perhaps the biggest expense of all would be the media blitz to recruit volunteers. It is to be expected that intense pressure must be exerted to raise awareness on the need for such testing and finally get these brave heroes to volunteer. A strong call to their obligation to fellow air travelers world wide and their role as courageous scientists in a brave new venture should be sufficient. As a note on expenses, it should not be necessary to pay these brave souls anything as their participation in such a noble cause should, itself, be reward enough. After all, they did get a free ride on the airplane with complimentary light refreshments, free use of the parachute, free instruction from the jump master and a memorable descent to Mother Earth. What more could a reasonable participant ask? Financial support should be easily forthcoming from the likes of Boeing, Lockheed and the commercial airlines who stand to benefit greatly from the results.
Now of course the above is nonsense - or is it? Even as this is being written, thousands of Americans are being subjected to trials of all sorts, many of which have little or no merit other than the fact that funds needed to be allocated if funding renewal for next years projects is to be maintained. One simply does not return unspent money to Federal Grantors. Over the years, even the terminology has changed. Recent papers have referred to patients not as fellow human beings but as "units" and patient death is now being reported as a "survival event". One of the good things that came out of the holocaust was the Helsinki Accord on the Experimentation With Human Subjects. This noble document has many good clauses, perhaps the best of which was the one requiring the advised consent of the subject. How many times, a thoughtful person might wonder, has this been buried from sight in a pile of forms and mundane paperwork. Money is available in copious quantities but not without the consenting patient. To paraphrase the movie line, "No Buck Rogers, No bucks!".
As one who has enjoyed a rewarding career in the physical sciences, I am all for good research. Its that other kind that I object to - the kind that proceeds blindly down an unproductive path for a half a century and will not yield to introspective examination of its true effectiveness. The criticism that comes flying at anyone who dares to question runs along the lines of how can anything for which we have spent billions upon billions of dollars, the expenditure of thousands of human lives and the efforts thousands of researchers possibly be flawed? There is no discussion allowed on the fact that the per capita cancer death rate in the country has decreased only slightly in the last century despite all of the above.
The first question I would ask is whose point of view is being served? Our present system, adorned as it is in holy writ, is the darling of the NCI and the hundreds of centers and thousands of researchers that feed off of it. A recent expose on CBS "Sixty Minutes" caught Duke University with their hands in the cookie jar whereby they were fudging their numbers to make their drug look good. Perhaps the misplacing of a single decimal point in a particular direction could mean millions of dollars. In this case concern for the well being of patients clearly fell second to making money. A reasonable person might well wonder if this is not the norm in this day of greed and avarice. The point of view of researchers will doubtless be to continue the course regardless of results or the number of poor souls who will die from cancer. I would not go so far as to call this "fiddling while Rome burns" but I think that comes dangerously close to the truth.
Surely the American people are entitled to know just how many of their fellow citizens have died in these trials both in total and on a yearly basis. It seems to me that this is every bit as important as the budgets in dollars. Beyond that, I would personally like to know how many of those in the placebo arms of the trials, those who received only sterilized water, actually had positive responses. This is not as silly as it sounds. There is a recognized phenomena of human behavior that is known as the Hawthorne Effect. This was first recognized in evaluations at the Westinghouse Hawthorne plant in Chicago. Results there showed beyond doubt that humans are capable of unexpectedly positive response from the very fact that attention was being paid to them. Speaking for the hundreds of us who have beaten cancer death sentences using mind/body healing techniques, I should not be at all surprised if this number was higher that anyone might imagine. The resilience of the human spirit is a marvelous thing that is difficult for researchers to quantify.
As one coming from a successful career in the physical sciences where experimentation was a way of life, I am in no way implying that research is necessarily bad. I merely wish to point out that after a half century of far too many disappointing results it might be worthwhile to at least consider the possibility of another approach, drawn from the patient's point of view that appears to have exciting possibilities. As a patient, I am not the least bit concerned with either the politics of cancer research or in peeling back the foreskin of science. I SIMPLY WANT TO GET WELL and anything that can be shown to be promising represents a topic worthy of discussion. Let us therefore look at clinical trials as a purely binary proposition. Think of this as an either/or or black/white proposition. A treatment is administered to a number of patients with only two results possible - a positive response or no response.
Patients receiving this are encouraged to expect a good outcome, not kept in the dark by this statistical nonsense. Quite the contrary, the placebo effect is encouraged to work its wonders in addition to the efficacy of the drug. A 30% placebo effect, added to a 30% drug effect should yield a 60% favorable outcome. The Lord only knows how may good drugs have been passed over because they were not allowed this freedom of expression of all that is good and powerful in the human constitution. Before long this thing we call preponderance of evidence will provide the overwhelming proof that is required for oncologists on the front line of treatment to proceed with cautious optimism. Lives will be saved that would otherwise be lost in the statistically and politically correct clinical trials so pervasive in the country. Of course, this will be greeted with condemnation everywhere, despite the fact that our present system has had such minimal return from the money and lives expended over the last half century.
As for me, I will err on the side of caution. I will not jump out of any airplanes, with or without a parachute and I sure as the world will not submit myself into anybody's clinical trial.
Back in 1993 Gerald White survived a 20 pound kidney tumor that subsequently went metastatic to distant organs. After all medical treatments had failed and the dreadful "only three more months" death sentence had been delivered. He worked out a self- directed program of guided imagery that induced a remission in three months. He has served a three year term as a Director of the National Kidney Cancer Association. Through his webpage he maintains an active world wide mentoring program that has yielded many similar remissions of cases thought to be hopeless. His book has been translated into Chinese and Hungarian. A credible Scientist, in his career before cancer, he achieved some 20 technology patents in 9 countries.

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