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You were going to mention going bald headed out. And that was a doctor's warning which was just this moment well written well of progress here. However life like nothing to live my life. Here's the truth and I think you might as well be public with the past and now it's the drugs that we simply don't have and therefore find Marge in most cases. Judgment on the part of the doctor
went from going very well here. This drug aides talk about drug use what they are and how they affect modern man. Produced for radio by the American University broadcast center in collaboration with the National Institute of General Medical Sciences Unit of the National Institutes of Health. In our discussions with authorities on drugs and their use We'll explore where drugs come from how they are discovered the natural substances provided by nature and the synthetics invented by man. We'll examine why people take drugs of all kinds and the effect of drugs on 20th century society. We'll investigate the latest developments in pharmacological
research ways in which the federal government is concerned with the drugs and drug use. Drug laws why we have them and whether they are beneficial. These and other questions facing us only in this drug age. On today's program Patricia Wakeling discusses the physician and the distribution of drugs with Dr. Herschel Jacques director of the division of Clinical Pharmacology at let me know Shattuck Hospital in Boston and associate professor of clinical pharmacology at Tufts University Medical School. Dr. Jacques is an M.D. who specializes in research. He is now involved in a project designed to expand and increase the medical knowledge available to those who prescribe and dispense drugs to the public. The National Institute of General Medical Sciences has observed that the prescription of drugs tends to be based not on a firm foundation of
such knowledge but rather on the basis of general experiences with an average patient with his projected drug surveillance system. Dr. Jack hopes to make the process of drug prescription less susceptible to error. This Istomin employs automated techniques that will make it easier to get at the necessary data. A system of search and assembly procedures to deal with the vast masses of information facilitating a widespread surveys and eventually providing a sound specific basis of knowledge for the clinical use of drugs. Dr. Jack explains how the drug surveillance system works and what some of its benefits will be. The surveillance by carefully monitoring large numbers of patients we will begin to learn which patients are most likely to benefit from various drugs and which patients are most likely to develop harmful side effects.
It would obviously be extremely valuable if we could predict ahead of time which of these two categories patient would fall into and it does turn out that people who particularly people who develop certain problems with drugs tend to have certain characteristics. And if we can find these ahead of time we can provide some extremely important clues to the practicing doctor who is ministry's drugs which will alert him to the fact three types of individuals may have a larger chance of getting into trouble or a larger chance of benefit. The practice is there peace comes down to a matter of judgment on the part of the individual doctor and of course in at least in my judgment some do very well. And in my judgment some of them don't do terribly well. I think most people who study this field believe that there are too many doctors who have relatively poor judgment at times and I think it's a problem that we're going to
the medical profession is going to have to deal with along with the drug industry and the government there else who's involved what they use for such a short sale and their techniques for this cut down on the problem behind this. Well that's not the whole of course. There are two elements to this kind of problem one is the. In the final analysis the doctor is going to use his judgment based on his experience and what kind of individual he has and so on. The other thing is that he's got to take into account the knowledge that's available on which to base that judgement. Now we have a lot of knowledge in terms of basic pharmacology in terms of what drugs do in normal animals and perhaps even normal humans. We but we have relatively little knowledge about what drugs do in sick people simply because it's extremely difficult to study this. Do you really have a lot of knowledge about what drugs do in normal healing beings. Relatively speaking the answer is yes that most drugs which depending on the category most drugs which are given to man have been fairly
carefully fairly rigidly studied in normal so-called normal volunteers so that in those individuals depending on the particular measurements that you're making you can come up with an overall conclusions that are limited by valid once you get a very complicated and sick human being with many many things going on. Then a particular observation that was made of normals a young healthy volunteer may not be applicable to that elderly sick individual in fact something entirely different from what you are projecting from the person may act occurred in these verses. But this this is extremely difficult to study scientifically. We were attempting to approach this through and epidemiologic technique where we study very very large numbers of patients and we attempt to bring out certain phenomena that are current with a certain amount of frequency and we tend to describe the individuals that in which these phenomena are current. And by that he says that these techniques to
get a larger fund of knowledge so that when the doctor uses uses his judgement he can base its judgement on information. Now we have had a number of findings that have already come out of the study which are which appear to me hard facts which the doctor can use to base his judgment I think we already asked and others at least locally. This is this is occurring we have reported for example that certain types of bleeding tendencies on certain drugs tend to occur in elderly women for one reason or another and it's our impression. I haven't analyzed this in detail since we reported that in a medical journal that the amount of this drug has been given to only females has gone down and the people who were involved in this study can read the journal intend to know what's happening so they tend to have this information available and this information is also reported quite widely in other journals and it may very well be that the FDA may require that this goes into the packed package insert and if there is a companion someday this kind of information
may be the companion and we would hope that doctors all over the country would use this information and then make their judgment about whether to give this drug to patients. Now the day may come some day when if the doctor refuses Arns for some way and for some reason is any of this information go ahead go ahead and use a drug improperly and certain measures will be taken to let you know that he has essentially done the wrong thing and certain measures have to be taken to mention just repeat the stand that people suffer because it comes up against legal difficulties and now practice so much. At the moment this is about the only protection really that the patient has if the doctor does something that is generally considered to be the wrong thing. The patient can take legal action against that after the fact and that is how this occurs very frequently. But leo's doctors have no practice. Another thing that adds to the difficulty of finding out a drug's effect is that some
agents may lie don't lie dormant for weeks even years in curious contradiction to the body's tendency to rid itself of foreign substances. And then there's another spooky point what causes drug action to outlast the time the drug stays in your system. How do you deal in your dogs and system with these. Well at the moment we are studying patients who are. In the hospital and were as we are thinking about system to follow a patient on a long term basis. Our data currently deals with patients while they're in the hospital. Now after drugs were stopped if the patient remains in the hospital we continue to see what happens to him and I think as we continue to record the events that are occurring in this individual and by using certain happening your logic techniques and with the help of the computer we are able to find associations between the administration of the drug say this week and the occurrence of certain events perhaps weeks later.
If these in fact are current. It is extremely difficult to get correct information about the effects of drought on the human being because it is extremely difficult to get to know all the variables about the patient a human being. The surveillance program and the Doctor Dick and his colleagues have introduced him to five Boston hospitals allows for controlled drug trials. Explain to us how important this sort of testing is compared to the hit or miss results of the so-called out-of-control chemical killer round me with a controlled trial in as a comparison between two groups of patients who are the same presumably in every way except that the treatment age group is different. Now ideally the individual or the physician who is the one wearing this treatment is not sure which one of the two treatments any one given individual is taking as read.
The design is such a trial of the doctor's particular prejudices with regard to one drug or another are eliminated because he simply doesn't know which drug the patient is getting and neither the circumstances these kinds of observations can provide scientific information which you can rely upon. Now if the study is under control if there is only one group of patients and only one drug and the doctor knows which drug the patients getting in obviously his judgement as to what goes on is is tempered by his own particular experience of his own particular bias and the information one can get from that kind of experiment. This is extremely limited. Then you write a knowledge entails greater responsibility and we must not I'm going to mention the other side of the coin of modern pharmacology namely that the adverse effects of drugs the diseases of medical progress in American Medical Association now has a registry of adverse reactions and so does the Food and Drug Administration. There comes a time when the research Manal the condition of the drug company or the FDA has to ask whether. He
was justified in killing six people from a size six patients from a side effect of a drug that Dr. stanched 6000 and in the same context let me ask how the M.D. today reckons I was his martyr Primum non not yet a first do no harm with the use of drugs. It was the fact he doesn't really know. Obviously each M.D. who practices today has to make his own decisions with regards to the potential benefits and the potential harms that may be done to a given individual. And I might say that on experience as well as others have shown that there is a good deal of difference between the way various doctors practice their picks. At the moment this is purely a personal decision on the part of my margin for each individual doctor. Takes care of people I think most of us do take this risk we know that every drug we use will be harmful to a certain number of patients however we feel if
we can benefit many many more than we harm than obviously the odds are with us in any way given another disease or side effect of medical progress is the growth of resistance of some parasites build up to me and I called them killer drugs for example malaria parasites have built up defenses over the last 15 years. Bacteria is a susceptibility said to cells and then sometimes the second or last stage of the patient patient is worse than the original state. How do we deal with that one. I think in the case of this particular problem which is the more significant one chorus the answers are the official answers are most likely to come from the very most fundamental research from the research and biochemist biologists who are really going down to the very essence of. What life is and what it's made up of and what the fundamental elements are that control the way a given
organism. Oh I don't. I think this this problem of the way the game goes in life. It's not easy and we know that the environment we were living in is a terribly adaptive one. Things change an artist and makes things a lot more difficult but by no means hopeless and I think my guesses are proof that with regard to have x given all the problems of resistance of the problems that we have on Mars there is probably a bit more good than harm done with these agents although I do know some people with 300 clinical investigators tried a certain drug on 10000 patients and on the basis of 50 to 80 percent showing improvement the drug manufacturer claims that said drug was highly effective against such and such disease. I'd like you to comment on the thinking behind such claims made on the basis of such small uncontrolled experiments for the problem.
A difficult one and I also would prefer to believe that the drug manufacturers are neither cynical nor evil and I really don't have any evidence accusing them however then I think they see the fundamental problem here is that it's just extremely difficult to study 10000 patients with a very controlled scientific experiment and I'm told very recently the best that we really could do was to say that the drug was giving to some of the tens of thousands of patients and that so many of them seemed to get well. The difficulties with insured there are fairly obvious at least anybody who's studied this field first of all where these 10000 patients where their patients with a particular disease were extremely ill or their patients with a particular disease who were not terribly ill. This is extremely important in other words there is a selection factor with dealing with one type of patient are now the second thing we have to know what particular problem with drugs used to treat most of medicine of course most problems go away anyway. And therefore if you wait long enough the
patient will prove Well if you get a dr at the start when the patient gets better sometime thereafter Obviously it's extremely difficult to know. Dr. Levy do you permit and I think this kind of advertising this kind of reporting is becoming less and less acceptable I would assume. Years to come. This kind of thing that you just described will not be accepted on all advertising in that. Advertisers have to produce more scientific kind of information in order to make certain claims there is a school of thought that believes that drugs should not be publicized as a fine new drug should become known profession on the basis of its merit. I'm sure that that that particular argument could be defended very nicely on the other hand we do live in the kinds of Friday that we live in the kind of economic structure and the moment it doesn't seem realistic to. Refrain from any kind that ties in on my dad for whatever it's worth that a lot of the medical journals and journals dependable national company advertising. Yeah right.
So if we were to do away with that and if we want to continue having his journals we would either have to up the cost of the journal normally or else have some sort of. Today Nnamdi is much like the rest of us and he reads the ads and listens to the commercials much for the rest of us. So that's what it's all supposed to live the stated claims for efficacy of a drug and admitted running information. How is it possible for any reputable drug company to justify this sort of advertising this kind of advertising which we've we have seen in the past is becoming less and less prevalent and many journals have individuals who are clinical pharmacologist who are academically oriented someone who going to these ads prior to acceptance to the journal. And if there are any ads that make claims for which there are no justification then they will inform the general. I think that is not acceptable I think if you look over journals now most American Journal of the ten years ago you'll find a lot more responsible.
One other point I think is extremely important here and that is that by and large we don't have anywhere near the type of information that's necessary to serve and what for what a drug is indicated. And therefore when a drug company makes a claim over beyond what a paper set is that claim may be correct. Yes there's an article somewhere yes if the medium sat quiet you know. Question here is whether a company has to prove that what it says is correct or whether somebody else has to prove that what it says learn correct me usually to some of these claims on either type of knowledge. But isn't the FDA supposed to do this. Yes the DEA the FDA can only use the information that's available to the FDA Brian mark itself does not do any research on the history of this kind out lie on the other side of people there and there are as you know thousands of new drugs around and none of them have come anywhere near as far as I know having the type of total thorough well controlled scientific studies done. From that you can say aha this is exactly what the Dr does
work in and whom and this is exactly what doesn't work and someone. And again if you go up to if you go to competent physicians who are academically oriented and someone you will find enormous controversy over whether drugs should be used for this or that and you will find people who use drugs very frequently and other people who are equally educated and so on. Drive very infrequently you know the majority of diseases do go away after a time in any case you don't have to take drugs for anything. Well that would be. Yeah that would be my opinion. You have to differentiate as you did earlier between diseases and symptoms. Most of the drugs as you point out are used to treat symptoms headache cake various kinds of pain insomnia and so these are the kinds of symptoms that are notoriously variable one day that may be bad the next day may be good in such circumstances it's extremely difficult to evaluate whether Dr is really doing something. The vast majority of diseases as well are what we call self limiting In other words people get over the measles or you know the flu and so on. There are certain diseases which fairly many patients are
not self-limiting continue to get worse. And in those circumstances it may be a little easier to. Much easier a little bit easier to evaluate the effects of a drug on these. My own feeling is that the vast majority of doctors use drugs based on their own experience. If during their training they learned certain types of drugs for certain problems and they seemed to work fairly well they will continue to do so when the drug comes along with many areas for which it was developed that is relatively unsuccessfully treated then reason tend. Logical tendency. Part of a doctor to try that drug to see if it isn't proven over the previous therapy he used and what tends to happen with most drugs is that some doctors find this an improvement they will continue using drugs other doctors find that it's not me better perhaps even worse when they run the trouble with the drug and therefore they tend not to use it and this again if one explains this wide
variation in how doctors practice their kids if you study one doctor versus another you hardly recognize frequently that they were in the same fashion but this is the really the best Brian Lars a man practicing medicine can do he can try these drugs based on the information he initially gets and if they seem to work out well he can and if they don't he doesn't bother me now. I think studies have shown that to me that taking doctors as a whole across the country most of them get their preliminary information from a man and from material sent out by the drug companies. This information is generally available a lot earlier than say publications in medical journals. It will this many years usually before publications get medical journals on new drugs and it's very likely that the vast majority of busy practitioners will not read the journals in which those articles appear. So here is about you. He's
told about the advances from the drug company literature about a detail he tries it if he's if he feels that previous therapy in this area is and is not entirely satisfactory and if it works out well when he runs into trouble with it which case he answered and I'm afraid that's that's about the best we can do for most drugs that most new drugs come down on one of your colleagues has made the statement that doctors frequently use officially approved medicines that may be toxic and never have been that never have been established if Acacius So how can this be. Laws were passed by Congress at certain times. In the last 20 or 30 years at least some of these laws were retroactive for only so long and many of the drugs I think that people referred to here were marketed and approved for general use prior to the effectiveness of the various congressional laws and I think most of the drugs that that the
National Research Council found as being said it's active or whatever are Drs who've been on the market for many many years and did not have to pass these various standards are now required to some of them back in the 30s with the 56 key fob or act. He wasn't 56 I think with only retroactive for a few years of anything that came on the market prior to that. Every reason to stay off however things about the sea change now this group has gone over presumably virtually every compound that's been available from the start and is now available and now apparently the FDA is requiring that the company. Show that there is effectiveness and so on. This is not an easy problem however because it takes an awful long time to take any countdown and to really prove this fact innocent you get a little more sophisticated about it to prove in what group of patients it might be effective. And if a countdown has been around for 40 years the company will say Well doctors are still using it it must be good that courses of state can be
chance but nevertheless to suddenly go back to them and say OK well since this drug has been on the market for 40 years and we haven't had these studies on the last 40 years we want you now to prove that this drug really works. I think that's fine in terms of protecting the public health. Anyway I think one should realize that this does create enormous problems for a company who suddenly has to take a drug it's unseemly for 40 years and have to find somebody tested to see if the darn thing is really good. There are undoubtedly drugs being used many of them today many many people and side effects that they're using are not known. Let me do the best we can with the vast majority of drugs that come on the market to produce serious side effects with the techniques that we have in the past. Nice to think of New York Times for people suddenly discover. This is perhaps years and years. Yeah I think what I meant perhaps but that wrong and that is that the side effects be publicized with side effects in fact.
Besides I don't see any problem that I'm aware of was that. Again depending on what you mean by publicize the vast majority of advertisements now. Have a reproduction of the so called package insert packages or something. Bad Food and Drug Administration almost invariably with every side effect is something of the struggle. Whatever that's not terribly effective because perhaps a dozen or two dozen side effects are reported. So when you start looking at these things you see the same side effects as they're really driving the returns he said. You know every drop you thought on the side on so I think we can be a little more discriminating in terms of pointing out the most important and most common the most dangerous side effects for a specific drug and not sort of putting them into about 30 other side effects that might conceivably occur in this century. Well now these days we are going in the direction of
asking companies to prove that their drug is really worth something. This is something quite in the past I think they just have to provide evidence of safety. And. Perhaps some evidence of that sometime. Today. Whately talking with Dr. Mitchell object of. Lemuel Shattuck Hospital in Boston. About the drug surveillance system and how the medical profession keeps up with the ever changing ever growing demands of this drug. And the next program in this series Drugs and our society. A discussion of how to deal with the so called dangerous drugs and the mounting dilemma of drug abuse among the participants. Donald Miller of the Justice Department's Bureau of Narcotics and
rather mo Del pharmacology professor at Cornell University Medical College. This drug age is produced for radio in collaboration with the National Institute of general medical sciences a unit of the National Institutes of Health. This is the national educational radio network.
This drug age
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The Physician and the Prescription
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University of Maryland (College Park, Maryland)
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