##################################################################### DEATH BY REGULATION -- THE PRICE WE PAY FOR THE FDA By Dr. Mary J. Ruwart ##################################################################### A MATTER OF LIFE AND DEATH How would you feel if a member of your family had an incurable disease, but they were forbidden, by law, to import a medicine which might save them? If you think it can't happen here, think again. Until July of 1988, U.S. customs officials took dextran sulfate, a potential AIDS therapy, away from the AIDS victims who had travelled all the way to Japan to purchase it. By demonstrating how our Food and Drug laws are killing thousands of innocent Americans, the AIDS community convinced the Federal Food and Drug Administration (FDA) to allow limited importation of medications from other countries for personal use. These pharmaceuticals are not available here because of the "drug lag" our laws have created. In the United States, pharmaceutical firms are required to spend much more time and money demonstrating that their drugs are safe and effective. Afterwards, the FDA takes an average of two to six years to decide whether the manufacturer will be allowed to market them. Americans get new, life-saving drugs years later than citizens of other countries that are not so restrictive. Some drugs which take a long time to test, such as those that may retard aging, are not available to Americans at all. ABOUT THALIDOMIDE Sometimes this delay protects us from drugs which have side effects which are not readily predicted from animal studies. Thalidomide, for example, was marketed in Europe for several years as a sedative while awaiting approval for use in the United States. In the early 1960's, the sensitivity of an unborn child to the deforming effects of drugs was not widely appreciated, so doctors began prescribing thalidomide to pregnant women. Consequently, approximately 12,000 European children were born with deformed limbs. Few American babies were affected because only a few test samples had been distributed in this country. The FDA physician who had delayed its approval was given a Presidential Award. PAYING WITH OUR LIVES Encouraged by this feedback, the FDA began to require even more studies. Testing and approval took even longer, especially when compared with countries like Great Britain where there were no immediate changes in the way new drugs were processed. While the British continued to enjoy many new drugs to treat their illnesses, only half of these were available to Americans, and only after many more years of waiting. One of these new drugs denied to Americans was propranolol, the first Beta-blocker to be used extensively to treat angina and hypertension. Approximately 10,000 Americans died needlessly every year because it was against the law for their doctors to treat them with propranolol. Propranolol was finally approved here for minor uses in 1968, but was only approved in 1973 and 1976 for angina and hypertension respectively. The regulatory delay of this single drug may have been responsible for the death of more Americans than all other deaths from drugs in this century. Even so, the FDA came under severe criticism by Congress for "premature" approval of this valuable drug! Former F.D.A. Commissioner Alexander Schmidt noted that ". . . rarely, if ever, has Congress held a hearing to look into the failure of F.D.A. to approve a new entity; but it has held hundreds of hearings alleging that the F.D.A. has done something wrong by approving a drug . . ." The drug lag, he claimed, could only "be remedied by Congressional and public recognition that the failure to approve an important new drug can be as detrimental to the public health as the approval of a potentially bad drug." Just how detrimental is the drug lag to public health? Conservative estimates of needless deaths due to the "drug lag" are tens, perhaps hundreds of thousands of innocent Americans every year. Perhaps a loved one you’ve lost was among them. The saddest part of this story is that we gain very little by having a "drug lag". Countries which have a faster approval process sometimes withdraw a drug because it has side effects in humans that don't show up in animal testing, but usually the number of deaths is less than the number that die from aspirin each year. Aspirin causes malformations when given to most pregnant animals, and could not gain FDA approval if tested today. While any harm from drugs is undesirable, we must recognize that no drug is safe for everyone. People die every year from drug allergies or idiosyncratic reactions which cannot be predicted with state-of-the-art expertise. Whenever we take drugs, we must weigh the risks and the potential benefits, just as we weigh the substantial risks and benefits of driving an automobile. By demanding that the FDA protect us from drugs that have any side effects, we deprive ourselves of drugs that save hundreds of thousands of lives. Ironically, FDA regulations sometimes force people to take more toxic drugs. For example, one San Francisco physician encourages his AIDS patients to take DDC, an unapproved drug, instead of DDI, a legal drug that damages the pancreas. DDC is still in testing, but causes less pancreatic damage than DDI, which eventually it will replace. Until then, AIDS patients buy the safer substance from illegal buyers' clubs. Sick people are forced to purchase their medicine on the black market instead of from reputable pharmaceutical firms! At least the AIDS patients can purchase DDC somewhere. Many of the delays and extra testing demanded by the FDA often makes unpatentable products, such as vitamin and mineral regimens, too expensive to develop. Diseases that affect only a few are never researched, since the development costs cannot be recovered. All these factors restrict the areas in which we expand our knowledge. If common, everyday aspirin cannot meet the rigorous standards of today's regulatory agencies, other drugs, of equal or superior value, have undoubtedly been excluded from our drugstore shelves too. As a former head of the FDA, Donald Kennedy, noted, "the pattern of intervention into science from a combination of local, state, and federal sources has moved from reasonable control to something close to chaotic strangulation." THE EASY WAY OUT What do we do when even those affiliated with the FDA can see that drug regulation flunks its own criteria of being safe and effective? How do we stop our tax dollars from being spent on killing both ourselves and our loved ones? How do we insure that Americans get all the safe and effective drugs possible? Patients and their physicians legally should be able to buy whatever drugs they wish, regardless of the stage of testing. Each person needs to decide for themselves, in consultation with their physician or other specialists, which risks they are willing to take. Those who wish to wait for FDA approval or a "Seal of Approval" from a medical organization or a consumers group will have that option. Those who, like AIDS patients, can't wait a decade or two for a new drug to be tested and approved, should be able to buy pharmaceuticals direct from the manufacturer -- either here or abroad. Sometimes people may feel it's worth the risk to try something experimental or not fully tested for safety. It is their life, and it should be their choice. If your loved ones were dying, wouldn't you want access to every possible chance? WE'VE DONE IT BEFORE In the early 1900's, Americans could decide for themselves which drugs to take. Before the FDA came into being, American drug manufacturers usually gave their customers the best drugs that the state-of-the-art would allow. After all, killing the customer is bad business. Deaths due to inadequate testing were much less frequent than the deaths produced by today’s ``drug lag.’’ In evaluating our FDA regulations, Professor Peltzman at the University of Chicago concluded that "the penalties imposed by the marketplace on sellers of ineffective drugs before 1962 . . . have left little room for improvement by a regulatory agency." It is time to quit asking the impossible from the FDA. It's time to stop denying ourselves and our loved ones life-saving drugs. Dr. Mary Ruwart is a Senior Research Scientist for the Upjohn Co. in Kalamazoo, Michigan. Cited in "Who's Who of American Women" in 1989 and 1990 and in "American Men and Women of Science", she is the author of over 50 scientific publications and is intimately involved on a daily basis in pharmaceutical research and development. RECOMMENDED READING The Regulated Consumer (Mary B. Peterson) .................... $2.95 (With introduction by Milton Friedman) Life Extension (Durk Pearson & Sandy Shaw .................... $14.95 (Includes review on F.D.A.) Healing Our World (Dr. Mary Ruwart) .......................... $14.95 For these and other books and tapes write: Freedom’s Forum Books, 1800 Market Street, San Francisco, California 94102. Add $2.50 P & H for 1st book and $1.00 for each additional item. Additional (hard) copies of this attractive two-color pamphlet are available for 5 cents each (minimum order $1.00). Price includes shipping. This pamphlet is produced as a public service by the International Society for Individual Liberty. If you would like to receive free literature about ISIL's activities around the world, and receive a sample copy of the FREEDOM NETWORK NEWS newsletter and book catalog, please write: INTERNATIONAL SOCIETY FOR INDIVIDUAL LIBERTY 1800 Market Street, San Francisco, California 94102 USA Tel: (415) 864-0952 Fax: (415) 864-7506