The Bulletin, Monday, July 9, 1979
Dr. Stephen L. DeFelice, M.D.
A change in thinking about drugs is quietly taking place among physicians that promises to restore natural substances to their rightful place in our eternal battle against disease.
After all, natural substances exist in our bodies for a reason. They cause our hearts to beat, our brains to think and our glands to perform. A mere warm handshake is a tremendously complex psychological and physical process, mediated through a multiplicity of natural substances and systems.
When a foreign substance invades our bodies, natural antibiotics arise to destroy the invaders. We now have reason to believe that the body fights pain by releasing its own opium, the recently discovered endorphins. Something in yogurt appears to lower blood-fat oil, and, charlatans or not, vitamins may be playing larger roles than we know in the treatment of various diseases.
Most of us are aware of two natural drugs that are among our most effective therapeutic weapons – digitalis, found in plants, is used in treatment of heart disease; insulin, found in the pancreas of various animals, including humans, keeps diabetic patients alive.
Natural substances were our first medicines. But as the world developed scientifically, we became enthralled with the miracle of synthesizing artificial but effective new chemical molecules that could reduce hypertension or cholesterol. And enthusiasm for natural substances waned.
Now their promise is once again bright. But unfortunately, the prognosis dims the promise. For a sad and simple reason. We are smothering the innovator.
The essence of innovation in medicine is an idea and its clinical evaluation in patients. Penicillin may behave wonderfully in a test tube, but its promise to the patient dying with bacterial pneumonia can only be tested if the penicillin is injected into the patient. If the patient lives, we have an innovative advance in medicine. If he dies, we must test other ideas in the sick.
Clinical research or human experimentation is the essence of innovation in therapeutic medicine. Any system that blocks the transition from the creative idea to its clinical testing must necessarily block the discovery of valuable therapies.
And that is precisely what teas happened. Congress, spurred by the new morality of the consumerist movement, has erected a multitude of barriers to clinical research. It is silently and effectively eliminating the Louis Pasteurs in our dynamic country.
There is now no economic incentive here to test and develop natural substances. More often than not, patent or other economic protection is not only difficult but impossible to obtain. Even waiving patent protection, the cost due to regulation and possible legal retribution is prohibitive. So if anyone or any group believes that a substance in a cow’s intestine might improve brain function in the elderly, there is little chance the idea would be tested clinically.
As an individual and physician, I have entered the fifth decade of my life. It is a period when loved ones and family suffer and die at a rate far greater than in life’s earlier years. I cannot help but wonder how unnecessary much of that pain was and is.
And after the wonder comes the anger-at those who sit in Washington and inhibit the genius of discovery; at the pharmaceutical industry which lacks the leaders and perhaps the will to take the issue directly to the public; and at my leaderless friends and colleagues, the physicians, who temporarily have forgotten that they truly represent the patient and should speak up for him and her.
What is needed is a giant first step. Let Congress begin by a bullish and positive act that will set the tone of freedom for physician and innovator to test natural substances clinically. Let’s not wait any longer to bring the promise of nature to the ailing patient.