OVERMEDICATION Conclution

Some Straightforwad proposals to make drugs more trustworthy

SIDNEY KATZ January 26 1963
OVERMEDICATION Conclution

Some Straightforwad proposals to make drugs more trustworthy

SIDNEY KATZ January 26 1963

Some Straightforwad proposals to make drugs more trustworthy

OVERMEDICATION Conclution

SIDNEY KATZ

AFTER NINE MONTHS of searching study, a committee of three prominent Canadian physicians will soon complete a thick report for the federal government. The contents of this report, are of intimate and personal concern to all of us. For among the thousands of words of technical data, graphs and charts will be found an answer to the crucial question: "How can the public be best protected from possible harmful effects of new drugs?"

The drug review committee consisted ol Dr. Frank Brien of the University of Western Ontario, Dr. F. A. Sellers of the University of Toronto and Dr. Roger Dufresne of the University of Montreal. It was hastily convened last spring at the government's request, by the Royal College of Physicians and Surgeons of Canada, in the wake of the chilling news that several thousand deformed babies were born after their mothers took thalidomide, a “harmless" tranquilizer. One result of the thalidomide tragedy is that it is apparently revolutionizing our procedures for testing and marketing new drugs. The United States government has already given its Food and Drug Agency tough new regulatory powers. The British Medical Association has put forth a rigid seven-point control plan to prevent a repetition of such tragedies of the past. The World Health Organization is drawing up a blueprint for a co-ordinated, global "safety watch" on all new medical drugs.

Such developments are long overdue. During the past thirty years, there has been a spectacular "drug explosion." There are now at least 7.776 prescription drugs on sale in Canada. Collectively, these new potent agents — antibiotics, tranquilizers, psychic energizers, hormonal compounds, anticoagulants, antispasmodics, diuretics — have been a boon to mankind. Syphilis and gonorrhea are now curable. Tuberculosis, typhoid, scarlet fever and bacterial pneumonia are no longer dreaded diseases. The mortality rate of pernicious anemia has dropped by sixty-five percent. Some cancers can be partially controlled. Thousands of mental patients have been at least partially rehabilitated and spared the devastation often associated with life in a mental hospital. The pressure for beds in such institutions is also being lessened, as a result.

But this age of therapeutic plenty has proven to be a mixed blessing — a fact honestly and fully discussed in public only since the thalidomide tragedy. Each year, the many new kinds of drugs cause an indeterminate number of cases of illness and death. The reasons for these tragedies are numerous and complex. Some drugs have been rushed to the market before their toxicity has been fully explored. Confused by a vast and unfamiliar array of new' agents, some doctors prescribe drugs when the patient's condition doesn't really warrant them: at times, these prescriptions have called

for an overdose of a potent, quick-acting drug. "There are so many new drugs that very few doctors can possibly know a great deal about them." says Dr. E. A. Sellars, professor of pharmacology. University of Toronto. Pressure on the doctor from patients encourages overmedication. "Many people think that there's a specific drug for every malady and demand it." says Dr. John O. Ciodden. associate editor of the Canadian Medical Association Journal. The per capita consumption ot prescribed drugs has increased two and a half times in Canada during the past twenty years. Drug manufacturers also sell as hard as they can to the doctors. They mail hundreds of pieces of promotional literature and free samples a year, advertise heavily in medical journals. despatch salesmen or "detail men" to doctors' offices to extol I the virtues of their latest product.

"The drug commercials today are so loud, incessant and brash that they jam the channels of communication," say s Dr. Harry F. Dowling of the University of Illinois. "The bewildered physician prescribes by suggestion and not from information."

Hopefully, the physicians' drug review committee, as well as a parliamentary special committee appointed in December, will suggest changes in our Food and Drug Act to eliminate present dangers and correct present abuses. At this writing, the recommendations of" these two groups have not been made public. However, what can be listed are the recommendations made by the several leading physicians, hospital clinicians, pharmacologists

and research scientists whom 1 have interviewed.

New drugs should be more thoroughly tested on animals before they are given to human beings. At present, the manufacturer first subjects a new drug to "pre-clinical" tests on animals. If the drug proves to he safe, he distributes it to a number of doctors, referred to as clinical investigators, who prescribe it for a limited number of patients.

Collectively, the leading drug firms spend millions of dollars annually on animal research. However, in the opinion of observers of the calibre of Dr. k. 1. Melville, professor of pharmacology at McGill University. "Much of the preclinical testing is inadequate. It doesn't tell us enough. "

Testing a drug on an animal is much more complex than it sounds. Unfortunately, no animal reacts exactly like man. Man. for example, is fifteen times more sensitive to atropine than are rabbits. On the other hand, man can safely take a dose of strychnine that would kill more than his weight in rabbits. Monkeys, baboons and other primates are the most reliable experimental animals because they ressemble man most closely. Next come dogs, and least reliable are rodents — mice, rats and guinea pigs.

For convenience and economy , the bulk of preclinical testing by drug firms today is carried on with mice and rats. Ideally, a new agent should be tested first on small animals, then on many large animals such as dogs. Tests should be extensive and describe, in detail, the effect the drug has on the various organs

and tissues in the body. 1 he rate anil degree ol absorption and excretion of the drug and the duration of its action should be noted. To screen out genetic effects, animals should be followed through two or three generations. Fetal tests should be made. But this kind of research is expensive and can keep a product off the market for two or three years. I lie result is that some drug firms, under pressure to be practical and maintain their profit levels, often hold preclinical testing at a minimum. ‘The period between the start of preclinical testing and the time the drug moves to market is becoming shorter and shorter, says Dr. Maurice Murnaghan. professor of pharmacology. University of Ottawa.

It is true, as was recently pointed out by Dr. (i. D. W. Cameron, federal deputy minister of health, that "no amount of drug testing on animals will reveal, for certain, how a new drug will act on humans." But it's also true that more complete animal testing might have avoided some of the drug tragedies of the past. For example, after the first disquieting news about thalidomide reached England from Germany, scientists there administered the drug to pregnant rabbits. The animals gave birth to badly deformed litters. Thalidomide, in Germany, was not thoroughly tested with a wide variety of experimental animals for possible congenital malformations.

Some drug firms have pleaded that it would be unprofitable if they had to subject each drug to lengthy studies involving a variety of animal species. If this is the case, then perhaps the new product CONTINUED ON IVAGF. 31

A BLUEPRINT FOR OFFICIAL DRUG CONTROLS THAT WILL WORK

CANADA'S FOOD AND DRUG Act — and the Food and Drug Directorate which administers it — are no longer geared to cope with what ha:; been referred to as "the therapeutic age of plenty."

There are too few people doing too many jobs. Some three hundred and twenty-seven civil servants, operating on an annual budget of two million dollars, each year handle two hundred applications from manufacturers to market new drugs; review five thousand drug labels and fifty-five hundred radio and TV commercials. In addition, they test thousands of drugs for purity and check on the sales practices of five thousand drugstores. But this is only a fraction of their job. They are also charged with policing the cosmetic and food industries, an immense and complex operation. In this excess of work, it’s inevitable that effective control of drugs is difficult and sometimes impossible. There are only ten professional men in the FDD assigned to reviewing new drugs, and they work only part time on this job.

Because of this n. inpower shortage, the FDD is unable to keep abreast of what’s going on. Thalidomide was banned in Germany in

November 1961, and frequent reports of its dangers were published in the medical and lay press. Yet it wasn't until March 1962 that the tranquilizer was removed from the Canadian market. FDD is also often slow' to learn about drug warnings from foreign countries.

The present regulations dealing with the introduction of new drugs need tightening. The FDD should have the power to insist on more animal studies, more clinical trials and on deciding who is and who is not a "qualified clinical investigator." At present, even the most inexperienced and uninformed general practitioner, using the most unscientific procedures, can test a new drug.

A present weakness is that the FDD does no drug testing on its own. It is completely dependent on the reports made by the manufacturer on his own product. Understandably, these reports are sometimes biased. To do a competent job of drug evaluation, the FDD needs at its disposai an independent testing agency, staffed by our ablest physicians and medical scientists. With no pecuniary interest at stake, such an agency could give complete reports on the efficacy ami toxicity of the drugs they EXAMINE.--SK

CONTINUED ON PAGE 31

continued from pupe 21

Methods used by physicians who test new drugs are sometimes crude, says a pharmacologist

should he tested by an independent, research agency, jointly supported by drug manufacturers. This suggestion will be dealt with at greater length later on in this article.

The initial testing of new drugs on human beings should be made more scientific. Ideally, the clinical testing of new products should take place at a university-affiliated hospital, clinic or research centre. This is the likeliest place to find a large number of patients and trained clinical investigators. The new drug should be subject to a “controlled, double-blind' trial. This approach involves working with three groups of patients whose illnesses have been carefully diagnosed. The experimental group receives the pill to be tested: the placebo group receives a placebo or harmless sugar pill: the control group is retained only for observation and comparison. The placebo group is essential because it's been found that, for psychological reasons, a high proportion of patients wall react to any pill given them by a doctor. During the trial, the investigators must be perceptive enough to measure improvement or toxic effects in the patients. And finally, the results of the test must he accurately and objectively analysed and reported.

Unfortunately, because there are so many new' drugs and so few adequate testing facilities and qualified clinical investigators, these high standards of testing are seldom met. A more usual practice is for the drug manufacturer to turn over a quantity of the new product to a group of doctors chosen by the manufacturer. Many of these doctors are general practitioners with no special knowledge of pharmacology. They work with limited numbers of patients. They seldom use control or placebo groups. “ T heir methods are sometimes crude." says Dr. K 1. Melville. professor of pharmacology. McGill University.

In some tests, the manufacturer supplies a blank form for each patient and the doctor supplies answers to the list ot simple questions it carries. He records the patient’s reaction in such vague terms as "unimproved” or “much improved." Dr. F. G. Rhodes C halke. head of the department of psychiatry at the University of Ottawa, says. "The manufacturer often gets reports which are completely unscientific. They sound more like testimonials.”

Dr. Graham A. Foulds critically examined some six hundred and twenty-three reports, many of them dealing with drugs, which were published in American and British medical journals. "Only thirty-three could be considered scientifically designed to answer the questions posed.” he said in an article in Lancet, the authoritative British medical journal.

When it comes to the evaluation of drugs, it may be inferred ti.at the average C anadian doctor is too busy, too disinterested or too uninformed. In 1956 the federal government's Food and Drug Directorate, asked six-

icen thousand Canadian doctors by mail to describe the side effects they had observed from drugs. Only thirtythree replies were received. When this mailing was repeated in June, 1962. after the thalidomide tragedy, only twenty doctors replied.

A glaring weakness in the present system of drug testing is that the drug manufacturer alone decides on who is a “qualified clinical investigator." This sometimes leads to situations as ludicrous as they are dangerous. Consider, for example, the case of Dr. Robert E. Licfmann. 42. of Montreal. In February. 1962. l.iefmann informed the Food and Drug Directorate that he had manufactured l.iefcort. a hormonal treatment for arthritis. He and twenty Quebec doctors, he said, were going to try it out on patients. During the nine months that followed, l.iefmann and the twenty doctors administered l.iefcort to an unknown number of Canadians and Americans at various prices, while the Food and Drug Directorate vainly tried to secure more detailed information about the new product. Finally, on October 4, 1962. the drug was banned both in the United States and Canada.

A woman taking l.iefcort had died of complications following uterine bleeding — attributable, in all probability, to the fact that l.iefcort contained at least ten times the sale dosage of a sex hormone.

It is appropriate to ask why Dr. l.iefmann rated as a "qualified clinical investigator" in view of his curious background. Following his graduation from McCiill University. Licfmann was prosecuted several times for practising medicine without a license. Later, he was suspended from the staff of the Royal Victoria Hospital in Montreal for implanting the pituitary glands of calves in the thighs of arthritic patients. We next hear of Licfmann in 1957. when he was peddling a hormonal cure for baldness in the United States. Officials of the Foot! and Drug Administration were horrified to discover that his product contained thirty-five times the amount of estradiol, a female sex hormone, listed on the label. This is a highly dangerous dose. When a warrant was issued for his arrest, l.iefmann skipped back to Canada, where he continued to sell his baldness nostrum until 1959 when the Food and Drug Directorate ordered him to cease and desist.

Licfmann is. of course, a special case; but his case raises questions that apply more widely. Why was he entrusted with the testing of a new drug? And why did it take nine months to ban the drug, which was clearly risky if not obviously a killer? A Food and Drug Directorate official says that his department didn't want to appear to be abusing governmental powers. Was the health of many people the price paid for this piece of political nicety?

In the testing of new drugs increasing attention must he paid to the possible damaging effects on pregnant women and young children. The thalidomide incident brought attention to the fact that other drugs too are clearly teratogenic — they deform babies. This is a matter of considerable concern in an age when women olten take a great many drugs during pregnancy and delivery. 1 he twelfth to sixteenth weeks of pregnancy are the

most dangerous; next comes the period just beiforc and at the completion of the ninth month when drugs taken by the mcithcr may concentrate in fetal blood. /And there is still no proof that some'' drugs may not be harmful throughout the whole course of gestation. Dr. David H. Woollam of Cambridge University suggests that the woman who suffers with morning sickness, and is therefore more likely to seek medication, may be the very one whose fetus is most suspectible to baby-damaging drugs.

Certain hormonal compounds, given to women to prevent abortion, arc definitely known to be teratogenic. There are at least a hundred cases on record of female babies born with male genitalia which have had to be removed by surgery. If the mother takes thiouracil during pregnancy to control an over-active goiter, there’s a chance that the baby will be born with congenital goiter. The tranquilizer, reserpine, may cause the newborn infant to have a nasal discharge which can fatally interfere with its breathing.

Each month the list of suspected baby-damaging drugs grows. Only a few weeks ago. Health Minister J. Waldo Monteith announced in Ottawa that Swedish authorities have reason to suspect that meclizine, an antinausea drug, is teratogenic. Canadian doctors have been informed, said Mr. Monteith. and henceforth meclizine will he sold only by prescription. Until then meclizine, under the brand names of Antivert. Bitah 707, Bitab 70S. Bonadettes, Bonadoxin. Bonamine and Promesis. had been freely available in drugstores. An English

physician claims that podophyllum, derived from the root of the mandrake plant and used in laxatives and slimming preparations, has led to cases of congenital malformation. Preludin, used for several years as an appetite depressor, is now also suspected. One or more drugs may be responsible for the alarming increase in the rate of leukemia among children.

Recent studies of the thalidomide births lend weight to the opinion of many medical authorities that pregnant women are probably still taking drugs whose teratogenic qualities have not, as yet, been identified. German doctors are puzzling over the fact that in about twenty-five percent of the "seal limb" births, thalidomide was not involved. The same is true of three out of the ten cases carefully reviewed in Alberta.

Dr. Charles Roux of the University of Paris, believes that all drugs that could conceivably be used by a woman of child-bearing age should be subject to exhaustive study. "A woman shouldn't have to be a heroine every time she has a prescription filled," says Dr. Ira W. Gabrielson of Yale University. Dr. David H. Woollam of Cambridge University wants the testing "carried out in state-controlled laboratories by approved workers at hospitals or universities." He urges long-term follow-up studies of apparently normal babies born to mothers who had taken thalidomide, for possible delayed physical or mental defects. Woollam also suggests the establishment of a central registry to record the drugs taken by any mother before the birth of a defective child. Dr. F. C. Fraser, a McGill University

geneticist, has suggested a method of testing baby-damaging agents. “In certain areas of the world," he says, "women may have legal abortions. If a woman is going to have a legal abortion anyway and she has no objection to it. why not give her an experimental drug, under carefully controlled conditions, to see w'hat it does to the embryo?"

There is also an immediate need to begin paying special attention to the way drugs react on very young children. Dr. A. L. Chute of the Hospital for Sick Children in Toronto complains that the testing of many drugs is done exclusively on adults. The usual procedure is to give a reduced dose to the youngster, based on his weight and the surface of the body skin. “In practice, it doesn’t work that simply.” says Dr. Chute. An immature body cannot be equated with a mature body. The child, for example, does not even tolerate some household pain relievers as well as the adult. The antibiotic chloramphenicol, even in proportionately smaller doses can lead to death. “Drugs for children should be tested for children," says Dr. Chute.

A way must be found to bring doctors the most accurate and most recent information about drugs. It’s no secret that many — if not most — of our doctors have been unable to keep abreast of all the new developments in pharmaceutical therapeutics. Working long hours at his practice, the doctor finds it almost impossible to keep up with the proliferation of new pills, capsules, elixirs and mixtures.

A physician who is determined and has time to spare is able to consult some authoritative sources of drug information. Medical journals publish thousands of reports on drug trials each year. But to take advantage of this material the doctor would have to read through scores of journals. He would also require some sophistication in the reading of clinical pharmacology and in the scientific method since, in the opinion of authorities like Dr. Lawson Wilkins, president of the American Pediatric Society, many of the drug reports in the journals are "uncritical." There is also available the British Pharmacopoeia but it is published only once every five years. Another reliable source is the Medical Letter on Drups and Therapeutics, New York. Unfortunately, only a small number of Canadian physicians subscribe to it.

What happens, in effect, is that many doctors receive a good deal of their postgraduate drug education from the promotional material of the drug firms. This material is too often incomplete, slanted and misleading. According to a study published by Dr. Solomon Garb, associate professor of pharmacology at the Albany Medical College of Union University, New York, eight out of ten pieces of literature mailed to the doctor by the manufacturer made exaggerated claims for the product and minimized the undesirable qualities. Dr. Garb also sharply criticized the ads of the drug firms appearing in medical journals. "Some journals seem to accept advertising with little question of the merits of the product." he wrote. Another physician, Dr. Harry F Dowling of

the University of Illinois, says. "False advertising to the public is no longer the major issue. It has shifted to false advertising to the doctor." This view is shared by health officials in Ottawa.

Obviously, if matters are to improve, a good place to start would be to insist, in the words of Dr. Lawson Wilkins, that "medical journals have stricter standards for acceptance of drug advertisements.” Dr. Harry Beckman, formerly of the Marquette University School of Medicine, urges that medical and pharmacological associations raise funds for "the education of practitioners in the choice, use and/or rejection of a drug. Let the medical schools (in penance for past remissness?) provide the necessary courses in instruction.” Beckman advocates the use of traveling clinical teachers and closed-circuit TV. Many Canadian medical societies are now taking the initiative in bringing postgraduate courses in therapeutics to practising physicians.

Finally, in the opinion of Dr. Sheppard Siegal of New York's Mount Sinai Hospital, there is a need for a new type of publication mailed every week or two to every physician in the country. The editorial board of this publication might include a dozen or so of our ablest physicians, clinical pharmacologists and other specialists. It would set forth in direct, easy-toread form, the latest authoritative information about the use and possible abuse of drugs, both old and new.

Modern organizational and administrative skills must he applied to the evaluation of drugs and to the dissemination of the information gathered. The new' drugs arc so numerous and so complex that our present methods of handling them have become archaic.

There is no lack of suggestions as to how the present situation can be streamlined. At a recent meeting, the British Medical Association advocated the establishment of an independent drug agency. "It should be independent of the finances of the drug houses or other vested interests," says Dr. H. W. Rodgers, professor of surgery at Queen’s University in Belfast.

"It should be a publ.c service.” says Dr. Rodgers. "It would be expensive but no more expensive than looking after the six hundred thalidomide babies born in the United Kingdom." The Hinchclilfe Committee, w'hich reported to the British Minister of Health in 1959, proposed a similar kind of agency with one notable exception: the costs of operating the agency should be .jointly met by the drug industry.

While American proposals for reform are not as far-reaching, the need for some kind of co-ordination is repeatedly mentioned. Dr. Sheppard Siegal. of the Mount Sinai Hospital in New York, calls for a "nationwide drug clearing-house." Its function would be to issue bulletins to doctors throughout the country concerning the toxic effects of drugs now being used.

There's an obvious need for an international clearing house as well. Happily, the World Health Organization is now studying methods whereby nations can quickly exchange drug information when human health is endangered. They are also devising testing and reporting procedures.

Perhaps the clearest and easiest-toimplemcnt proposal that has been put forth is for "drug reaction committees” in all the larger hospitals. Sometimes, the toxic effect of a drug remains unknown because the machinery is lacking to observe, report and collect such occurrences. "At present, only a small percentage of all drug reactions are ever recorded," says Dr. Dale Ci. Friend of the Harvard Medical School. Dr. Friend has a drug reaction committee functioning in the Peter Bent Brigham Hospital in Boston. The life-saving possibilities of such committees have already been demonstrated. "In a short time,” says Dr. Friend, "a surprising amount of data was accumulated. Members of the staff become more alert in recognizing and reporting drug reactions.” No such committees exist in Canada.

Before approving a new compound for the market, the drug directorate should insist on sound evidence that the new agent is a clear medical advance over drugs already in use. The machine gun rate with which drug products are placed on the market is the principal cause of the bewilderment and confusion of many doctors. This proliferation would be justified if the fresh products represented a real advantage to the patient. Unfortunately, this is all too rarely the case. Many of the new pills are “me too" orugs — products the same or almost the same as existing products. By a miniscule amount of "molecule juggling" the manufacturer has a new brand name to promote. “Instead of energy being directed towards research and the discovery of new drugs, it is frittered away on dozens of unimportant modifications, designed to compete with drugs that are already available,” says Dr. Harry F. Dowling of the University of Illinois. It should be said that, occasionally, molecule juggling is effective. Prednisone and Prednisilone. variants of cortisone. are improvements over the original drug. Several tranquilizers have also been rendered more effective.

The greatest single health hazard to the patient today is the proliferation of the “mixtures" — pills containing two or more active ingredients. About two out of three new drugs are mixtures. Some mixtures contain as many

as five antibiotics, each one, in its own right, capable of producing sensitization and side effects. In one study. Dr. Dowling examined sixty-one antibiotic mixtures on the market and concluded, "There's no good reason for using any one of them." Dr. Maxwell Finland, associate professor of Medicine at the Harvard Medical School, says, "1 know', in practice, only three diseases in which combined antibiotics have proved really useful." Dowling fears that if the present enthusiasm of the drug manufacturer for mixtures continues unabated we'll approach the state of chaos which exists in Germany. "One German manufacturer has put twenty-two different substances in a single tablet,” he says.

Manufacturers usually justify mixtures on two grounds: first, that the price of two drugs in combination is lower than their price separately. And second, that one ingredient offsets the side effects of another. Dr. Isaac Starr of Philadelphia, chairman of the American Medical Association Council on Drugs, says that he only knows of one mixture where this effect is actually achieved. For the rest, he believes drug mixtures lead to overmedication, "a serious matter in this era of active and toxic remedies. When two active drugs are needed they should be given separately so their dosages can be manipulated separately in accordance with the needs of the patient."

A more orderly and systematicapproach to the naming of drugs would also be helpful in reducing confusion. Both generic and trade names should immediately give the doctor an idea of the kind of drug he's handling. At present, too many drugs beat names which are inappropriate, unwieldy, difficult to pronounce and which yield a paucity of information.

The Food and Drug Act should he drastically revised and the Food and Drug Directorate, which administers it, should he strengthened. A first need, as is explained in the box on page 21, is for more people in the FDD. With more people, the FDD should be able to improve its channels of communication as well as answering the needs described in that box. All too often in the past, the directorate has not seemed to know'

what was going on in the drug field. As is reported on page 21, thalidomide was outlawed in Germany in November. 1961. In December. January and February, medical journals and the lay press carried reports about the “seal limb“ babies. Yet it was not until March, 1962, that thalidomide was banned in Canada. In the opinion of this writer, this delay has not yet been satisfactorily explained.

The FDD should also develop faster, more effective ways to communicate with doctors, druggists and hospitals. Six weeks after it was recalled. thalidomide was still on sale in many parts of Canada. Improved communications with other countries might spare lives by alerting us to unknown dangers. Although eight out of ten new drugs originate in the United States, no regular channel of communication exists between the FDD and the Food and Drug Administration, its counterpart in Washington. Phenacetin, found in several overthe-counter headache pills sold in this country, has been held responsible for fifty-three deaths in Australia; Sweden placed this drug on the restricted prescription list two years ago. Either the directorate is unaware of this, and charges against other drugs in other countries, or it is undisturbed by the knowledge.

The present regulations for the introduction of new drug products need tightening. The directorate should have the power to insist on more animal studies, more and better clinical testing. The "qualified clinical investigators" conducting the trials should be named along with their education and qualifications to do the job. Actually, it would be better still if we insisted that all early clinical trials take place in hospitals, clinics or research centres affiliated with universities. The directorate needs the power, which it now lacks, to halt clinical trials or to pull a drug off the market promptly if it's proving to be too toxic.

A major weakness in our present system of drug evaluation is that the Food and Drug Directorate does no drug testing. Testing is left to the individual manufacturer who submits an account of his tests along with his application to market a new product. Much of the present confusion and doubt could be eliminated by the establishment of an independent drug evaluation agency. Staffed and governed by outstanding physicians and scientists, this body could serve as the FDD “brain” in handling new drug applications. The independent agency could conduct preclinical trials, supervise clinical tests. It could turn down both toxic drugs and drugs which merely duplicate products already on the market. The agency might also publish a weekly or monthly report on drug findings, mailed to every physician in the country. There is no longer a place for the leisurely method of reporting toxic effects first in a medical journal, perhaps months af-

ter they're observed. The existence of an independent agency would do away with the pressure which some manufacturers now exert on the FDD. “At times, I’ve had to snap back at them." says Dr. C. A. Morrell, the director of FDD.

The independent agency could serve as a training ground for clinical pharmacologists— a variety of specialist now in short supply. The agency could be entrusted with the job of revising and modernizing the pharma-

cology courses now given to university medical students. The students should be taught how to distinguish between a bona fide medical report and a paper full of omissions, distortions and departures from the scientific method.

Few industries are more useful to society than the drug industry. Its imagination, ingenuity and energy have given us products which have assuaged pain and also prolonged and saved countless lives. It is to our advantage that we continue to have a

vigorous, competitive group of pharmaceutical manufacturers. Nothing should impede the wise and safe development of genuinely new and useful medicaments. At the same time a new set of rules is required to protect the public against the dangers of overmedication. The introduction of such rules with as little delay as possible is certainly the legitimate demand of the ordinary citizen who hopes to be helped, but is too often harmed, by drugs. ★