New York Times, Saturday, July 19, 1975
By Dr. Stephen L. DeFelice, M.D.
To all our other troubles, add one more-a crisis in the discovery of valuable and needed new drugs.
Drugs are by far the most effective weapons in the treatment of patients. Imagine life today without polio vaccine, penicillin, digitalis, insulin, diuretics, anesthetics, tranquilizers and all the other drugs that keep us alive and free of pain.
Today, few valuable new drugs are being discovered in the United States. Little or no experimentation is being done to discover them. Our system of drug discovery offers little hope of a cure for our four million diabetic patients, our 23 million hypertensive patients, or the millions who suffer from such devastating diseases as multiple sclerosis, schizophrenia, rheumatoid arthritis or heart disease.
The principal blame for this lies with Congress, which has evidently accepted consumerism’s false ideal of a completely no-risk existence and has forced upon the Food and Drug Administration such restrictive regulations as to discourage drug investigation and thus effectively cut down new drug discovery.
This country has the brain power, the technology and the money to restore us to world leadership in drug discovery. What we lack is an environment conducive to and supportive of a more productive discovery system.
There are two phases in drug discovery. One is preclinical-pharmacology, chemistry, toxicology and other types of nonhuman research. The other, however, the clinical phase, is the critical one. Every hypothesis or observation made preclinically must be tested in humans before a potential discovery becomes a reality.
This is where our hang-up is. The consumerists will not let us forget the horror of thalidomide or the immorality of the untreated syphilitic patients at Tuskegee, although the lessons of both have been long since absorbed.
“Our ethic in this country,” a former F.D.A. commissioner has observed, “does not permit-at least not in present-day context-a needless surrender of one life.”
But we know this to be false. Everything we do in living our lives today involves some risk, and most of us add to that from time to time.
The fact is that human experimentation under controlled conditions carries with it no risk greater than we take every day in our travels, our work, our athletic pursuits.
Surgical procedure labors under no such restrictions as do drugs. In the last decade, surgery has achieved miracles. Drug discovery, on the other hand, has fallen precipitously. Yet surgery affects far fewer people than does drug therapy.
It is obvious that we need a new system of drug discovery and a movement Is being organized to educate the public and the Congress in this need and its solution.
There are five positive actions that should be taken. We should
– Reduce Federal control over innovative clinical drug research and return responsibility for supervision to the experts, the academic community.
– Return the role of the F.D.A. to Its proper competence-supervision of drugs already on the market or scheduled to go there. Most adverse effects come from old but indispensable drugs, like digitalis and insulin, because their use is not closely monitored as are new drugs under clinical study.
– Provide insurance-probably Government insurance-against damage suits to institutions, drug research committees and clinical investigators.
– Initiate a new specialty in medical schools, the clinical drug developer -a generalist able to guide new drugs through the complexity of scientific judgments and social barriers.
– Make a national effort to assemble groups of volunteers from among all parts of the population-the healthy, the sick, the rich, the poor-who would be available to help evaluate new drug ideas.
The amount of physical and mental suffering that exists today, despite all our modern therapy, is vast. In scientific, social and moral terms, it Is certainly acceptable and even desirable for some of us to take small risks, even big ones, to diminish this vastness.