The circumstance of science; Episode 6 of 13

We could all agree on a good ultimate purpose of advertising much of the discussion and criticism of the pharmaceutical ever does in my opinion would be obviated. I would almost think at the moment that the controversy between the government in the form of FDA and the scientific community is much more of volatile and much more stringent and much more on aggressive than any controversy in the research area that exists between the government and the industry. As long as there are human illnesses to be relieved efforts to discover new remedies and better drugs. Not only should but will continue. Modern drug use the risks and the benefits. One program in the series the circumstance of science exploring the forces of contemporary science and technology and their possible effects on society. Two hundred years ago all voluntary defined medical treatment as the art of pouring drugs of which one knew nothing into a patient of whom one knew less.

Over the years the medical profession has continuously refined the art of treatment to the point where 90 percent of all prescriptions written today could not have been filled 15 years ago. Forty five percent of our drugs were not even available five years ago. With so many new drugs available to the practicing physician many important questions have become fundamental. When has a new drug been proven safe enough for use. How does the doctor keep up with the constant changes. And how is the manufacturer advertising and sale of prescription drugs regulated in this discussion will present the views of the director of the Bureau of Medicine of the Food and Drug Administration the director of drugs of the American Medical Association and the president of the Pharmaceutical Manufacturers Association. About 1 in 1 1/2 billion dollars annually is spent for medical research in this country. Yet most medical people agree that this effort is in adequate when measured against the risk implicit in the use of

contemporary drugs. And a report of the Commission on drug safety of the Pharmaceutical Manufacturers Association notes that the average American is not sufficiently aware of the fact that progress in the development of drugs cannot be achieved without adverse drug effects. What is an adverse reaction a reaction that was not planned or contemplated not a positive advantage or a therapeutic effect in the minds of the discoverer or the manufacturer of the product. SEE Joseph Statler president of the Pharmaceutical Manufacturers Association. Dr. Thomas Hayes is the director of drugs of the American Medical Association. He also illustrates the adverse reaction then British reaction to a drug is the appearance of any unexpected or an end to supported unusual very action which would

include the extension of the pharmacologic action of the drug when it is administered in a therapeutic dose in the treatment of disease. Can these reactions be foreseen or anticipated accurately in most situations. Not necessarily. In some instances similar chemical motifs may be responsible for similar side effects but it is not possible to predict the occurrence of a particular adverse reaction or side effect to any to any given drug. Then can we assume that some adverse effects are often considered normal in drug development. Well I wouldn't say that the variance of adverse effects are considered to be normal. I would say that. Break equally every drug that is developed

will cause in some people an adverse reaction or untoward effect. The responsibility for a drug you is finally resides with the practicing physician. The drug is new. The onus is severe. There is a possibility of an adverse reaction to the risk and the benefits must be considered. How does the doctor decide. Dr Hayes the balance between risk and benefit depends upon the disease being treated and the magnitude of the reaction in relation to the expected outcome. For example a drug which will show promise in the treatment of malignant disease particularly terminal malignant disease it could be used even though the reaction might be relatively severe. In this particular situation. The end would justify

the means and I'm certain the patients in this particular category would undoubtedly make the same choice. If there was hope of effecting some improvement on the other hand if the drug was used to modify or ameliorate some minor symptom and there was a possibility of undue hazard from the use of the drug way obviously way the drug could not be considered safe for its intended use. So it depends upon upon the drug and the condition for which it's intended. Dr. Herbert Les the director of the Bureau of Medicine of the Food and Drug Administration cites a specific example. If the disease is serious with no alternative treatment. The risk of even a side effect a serious side effect may have to be accepted. For example some of the drugs now under trying to modify the course of cancer they

depress the bone marrow and deplete the number of white blood cells needed to protect the patient against infection. The advertisements for new drugs that appear in medical journals are often of real value to the physician. As another way of keeping him informed. But some persons have been critical of medical advertising in some journals it's been claimed that in many cases these advertisements do not receive adequate scrutiny and review efforts have been made by both the FDA and the FEMA to prevent deceptive claims. Frankly there is wide variation in the quality of medical advertising. Dr. Levy of the Food and Drug Administration in general. Current FDA regulations have resulted in definite upgrading of this information. And the. Details conveyed by the advertisement to physician. Requirements are simple and reasonable. Accuracy of claims based on substantial evidence and a fair balance. In brief

a mention of all possible ill effects as well as the good effects of the particular drug. Dr. Hayes first of all I think you have to take into account the way advertising really does every time using it will call attention to new products. We'll call attention to specific points of interest in the products whether they're new or old that will provide leads to pertinent literature. Sometimes the end ever ties NG will generate interest in a specific drug or a class of drugs. However scientific data or information persay should not be sought for an advertisement of variable quality. Medical literature should discourage anyone from accepting at face value the data or conclusions that may be reported in a in a drug you had a great deal of

criticism has been heaped on advertising. And to be sure there is room for for criticism this criticism resolves itself into the question of the relative value of a drug advertisement as a valid instrument of drug information rather than accuracy persay. You know there have been charges that there were ties mincer not accurately scrutinized here at the A.M.A. and the ads are very carefully evaluated to serve a particular purpose and that purpose has become controversial. Some believe that advertisements are educational. Here DA may we believe that the average Thais mits primarily are a useful form of communication. If we could all

agree on a and ultimate purpose of advertising much of the discussion and criticism of pharmaceutical everydays in my opinion would be obviated Das advertising appears to play an important role in the dissemination of new drug information. Still some feel that the pharmaceutical industry spends too much of its money on advertising to promote widespread early acceptance of new products. I'm perfectly familiar with the charge and I think it's it's wrong. So you just stop there. President of the Pharmaceutical Manufacturers Association definitely the more responsible elements of the drug industry do an effective job of promoting and distributing their products. I think it would be rather rather foolish for anybody any company to spend the millions of dollars that our firms do on research and given the low number of successful products that result from the

thousands of compounds that are tested. If after coming up with a successful product they were to keep it a secret from the public or from the profession. Also as a patient I think I would have a rather dim reaction to that sort of a procedure if a product is available if I have a disease I want it. I want to vailable to my doctor. I wanted available to my pharmacist and I wanted available to myself and I want the information on that product widely disseminated and quickly. I don't want to get it three years after I have suffered with a disease I wanted as soon as the drug is available so the manufacturer in widely disseminating his product making it available at 50000 drug stores not just in one small geographic area and making the information about its effectiveness and also its contraindications available to the medical profession and pharmacists. Does a real service to the public. Also it's this mass

distribution and mass production that results from widespread promotion that permits. They need a drug to be produced in large volumes and therefore at a price which makes the product more accessible to the general public. It is this heavy promotional activity by the industry that has permitted drug prices contrary to other consumer commodity items to go down in the last 10 years. I'd say it's a very healthy activity and one which should definitely be continued. Other common criticisms of the manufacturers of prescription drugs concern research and development. It's been charged that actual research on drugs of major value is hindered by the manufacturers insistence on trivial repetition. The situation arises when several companies attempt to compete by all perfecting the same drug. We asked Dr. Hays of the A.M.A. for his comments. So-called me too drugs reach the market cannot be ignored

as a result there of somewhat of an extra burden is placed upon the physician to sort out their various claims and place these claims in their proper perspective. You know I might say that this is one of the continuing efforts of the Council on Drugs and its drug information program. However when several competing manufacturers are actively working in the same pharmaco therapeutic area I think that a desirable pharmaceutical and pharmacologic advances are often achieved as a result of this activity. Mr step lower the pharmaceutical manufacturers the drug industry is accused of a lot of things by some people these days. On the one hand you find the charge that there's a good deal of duplication that by virtue of molecular

manipulation the manufacturer puts out a drug which is very similar if not identical to a drug of another producer and that this is a way he introduces himself into the market. On the other hand you find a strong challenge levelled at the industry that. We have a monopoly situation that there's a lack of effective competition within the drug industry. It's pretty hard to satisfy both of these charges. There is a there is a duplication of drug product and it's a very healthy thing because that doesn't mean competition. It means that the patient has more than one drug available to him. It means that his physician has more than one drug to prescribe. And it's that multiple availability that does result in proper pricing as far as the ultimate consumer is concerned and that's the economic situation as far as the drugs themselves are concerned. Much of the research that has been done on closely related products

and some of the the changes that look rather small and insignificant to the non-scientists has really resulted in the most dramatic breakthroughs in drug therapy. I understand from our research people that some of the most effective products that have come out to challenge the entire new disease entities have been the result of the so-called molecular manipulation that is decried in some circles I think not only the industry but the scientific community would make a very strong protest if anyone were to suggest seriously that there be any prohibition against this close scrutiny of apparently identical or or similar products. It's from this type of research that we've had our most startling ineffective results in new drug discoveries.

The relationship among the three major forces in drug development and use the American Medical Association the Pharmaceutical Manufacturers Association and the Food and Drug Administration provide a very interesting basis for discussion. Generally the report appears to be one of co-existence but at times the situation becomes strained. We ask to see Joseph stop LURD the pharmaceutical manufacturers to describe the relationship among the industry and the government and the drug industry has relationships with all sorts of elements in the federal government from the United States Congress to executive agencies of the government the federal and state. You read more on doubted Lee about the difficulties which the industry has with the government than you do about the very constructive affective relationships that exist. Answering that question just as it's asked I would say that the relationship between the industry and government is good. Now that doesn't mean there are not some isolated instances and some problems which are extremely important to us and to the public

problems which get a lot of attention I just mention two or three areas very quickly without any details. The Food and Drug Administration by virtue of having the assignment of enforcing the control regulations at fact in the industry is our major point of contact in the executive branch of the government. And since some of these regulations are very stringent and restrictive we find ourselves in contests with the Food and Drug Administration. We also find ourselves in many areas of constructive cooperative relationships with the FDA. Another branch of the government of course is the United States Congress. We have very effective constructive relationships with most of the committees. Dr. Thomas Hayes of The Department of drugs of the AI May was ask if government regulations get in the way in drug research and development. I would have to answer the question with a yes and qualify it

in this way that I believe that the present thoughtful. Clinical investigators are of the opinion that the present FDA regulations that govern patient consent in drug trials are somewhat restrictive and have resulted in the certain investigators restricting their research to more laboratory rather than clinical studies. Dr. Herbert light director Bureau of Medicine Food and Drug Administration regulations governing drug research apply for the most part to the human phases of such research. They are intended to protect the human

subjects to receive the drug. And to provide as much information as possible about drug action. And interaction. Before a drug is permitted in the marketplace. This research is expensive by its very nature. And unsafe drugs would be costlier still in terms of injury. To the consumer both in terms of physical and mental health. Good careful drug research is not only possible under existing regulations it is actually promoted by these regulations whether carefree. Restrictions on research. Are self imposed by an investigator or imposed by the Food and Drug Administration. The end result is the same. A well studied the action of which is predictable by the physician who eventually prescribes it to a patient.

Research and Development. I would not identify as our principal area of difficulty with the Food and Drug Administration. Mr. stop the FDA by virtue of amendments passed in 1962 does have the authority to monitor and to have continuing surveillance over research conducted by the industry. They can stop that research or they can re direct it at any time. This means of course that we have a very close relationship with FDA on research but at least up to this time their activities in this regard have not been what I would term too restrictive. There is no doubt that by virtue of these new regulations and these new controls that the time required to develop new products has increased materially and the cost involved in developing new products has

increased substantially. The introduction of new products onto the market in the last five or six years has gone down steadily to the point where it's reaching some rather disturbing proportions. But this is a result of a whole series of administrative regulations of the FDA only part of which deal with research. And as I say I think there are others that are probably more difficult than this as far as research is concerned. Within the last couple of months there have been. Some very strenuous objections raised by the scientific community to the activities of the FDA in the field of research and clinical investigation. I would almost think at the moment that the controversy between the government in the form of FDA and the scientific community is much more of vulnerable and much more stringent and much more on aggressive than any controversy in the research area that exists between the government and the industry.

In 163 speaking before the annual meeting of the Division of Medical Sciences of the National Academy of Sciences Dr Ltd Congress or chairman of the Commission on Drug Safety commented without impairment of the public's dependence on the Food and Drug Administration's policing and enforcement responsibilities. The agency must itself become part of the scientific community if it is to meet the sophisticated demands of this era. Dr Cogswell further noted there was an urgency in making the Food and Drug Administration an adequate scientific evaluating as well as enforcing agency. And I'm hundred sixty one report of a citizen's Advisory Committee called for a reorientation of the FDA philosophy beyond its primary police duties. These comments seem to suggest that the FDA serves a primarily as a law enforcement agency with secondary emphasis on scientific activities. Is there a need for more research from the Food and Drug Administration.

Dr. Hayes That would depend upon the kind of research that would best help the medical profession and the public in relation to drug development. I believe that the agency could perform a very useful service if it would for example carefully and objectively evaluate experimental designs of clinical drug experiments and work toward the development of newer and perhaps more effective experimental design. But to present some of its activities and various other aspects of drug development have sometimes been rather awkward and rather unproductive.

The authority or the mandate given to the Food and Drug Administration. By law is both regulatory and scientific in nature. Mr. stock lower. They have a very heavy requirement in terms of their monitoring of drug research as I just mentioned. And in their perusal of new drug applications and having the decision as to whether new drugs are safe and or effective which is scientific in nature so they have a very heavy responsibility and in both areas I would say that their capabilities for performing the regulatory function under the present administrative set up is greater than their capabilities for doing a scientific job. And it's a very simple proposition. There is in this country a shortie scientists. The job that the FDA has is a tremendous one. They have not been able to attract a sufficient number of doctors or other scientific types to perform these jobs that Congress passed on to them. I have a personal

doubt that they will ever be able to attract enough scientific personnel to do the job. There for some time and soon I think there will have to be a re-examination of the structuring not necessarily of the responsibilities but the structuring of FDI and whether or not they can or should be given the scientific responsibility. Or possibly whether that should be put into a more scientifically identified agency such as NIH or something of that type. Or whether or not they're going to have to follow a course like the Veterans Administration did some 10 15 years ago when they really went back to the scientific community and to the educators and to the doctors and delegated back some of their scientific responsibility not to some extent. The FDA did that this past year when they signed a contract with the drug research board of the National Academy of Sciences to perform the effectiveness review of drugs that were marketed prior to

1962 and after 938. We think this was a very wise decision as a result they have gotten the benefit of the real expertise in the field of pharmacology in the United States and this junk job will be done in a in a very effective way. This is the sort of developments that I think the government and the Congress and the Department of H.E. double are going to have to look to and terms of long range ability of FDA to do this John. I might say that right now you may or may not know 80 Debby is in the throes of some planned reorganization. And I think some of these things are definitely in their minds a scientific level of the FDA activities. And the scientific competence of its professional personnel should not be under rated. Doctor like the staff include well qualified physicians many of whom are certified in specialists in various fields.

And in addition pharmacologist promises chemists and statisticians. By contract with Georgetown University School of Medicine only Food and Drug Administration has shared in the development of a department of Clinical Pharmacology available to us for the performance of scientific studies and in which members of our staff can proceed to supply aid in research activity. The FDA supports by contract research on drugs and other medical centers as well. Through consultants and advisory committees. The FDA has access to the very highest level of professional judgement in the country. Dr. Dickinson Richards professor of medicine at Columbia University has asked how far should we go or try to go in compound in more and more drugs for our society. Are we indeed trying to work with nature or are we trying to work against it and control it. There's one is diseases exists for which there is no thorough He says finding

or says factory treatment. We will need more specific and better drugs as far as working again. Against Nature I disappoint time I can't conceive of that situation developing as more specific drugs are developed and as our understanding of drug effects improves I think we can look forward to a time when the orderly processes of drug development will have evolved to a point where drugs having dangerous and potentially far reaching effects will have been eliminated before they are introduced for general use. As long as there are human services to be relieved efforts to discover new remedies and better drugs not only

should but will continue. Human ingenuity and race sourced from us almost every press of modern drugs the risks and the benefits. This has been one program in the series the circumstance of science exploring the forces of contemporary science and technology and their possible effects on society. A transcript of this program is available without charge from WKRN Michigan State University East Lansing. This series is prepared under a grant from the Louis W. in Mott Hill Family Foundation of St. Paul Minnesota produced by Steve Miller Shea for Michigan State University Radio. This is NE are the national educational radio network.