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ROBERT MacNEIL [voice-over]: While the nation is still reeling from the scare over poisoned Tylenol, the government is warning parents about the possible risks in an even more popular household remedy, ordinary aspirin.
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MacNEIL: Good evening. A lot of weather forecasters are predicting that this is going to be a severe winter, and that's likely to mean another heavy flu season ahead. But now the government is warning parents not to give children one of the most common drugs for alleviating the symptoms of flu -- aspirin. That's because several recent studies have suggested a link between aspirin and a rare, often fatal childrens' disease called Reye's syndrome. The Food and Drug Administration is planning to order manufacturers to put warning labels on products containing aspirin. They would caution against giving the drug to children under 16 who are suffering from flu or chicken pox. That idea is strongly opposed by some noted pediatricians and aspirin manufacturers. They say the warning label is misguided because it's based on flawed studies. They say it will undermine consumer confidence in a drug that has had a proven track record of nearly a century of use. Tonight, can aspirin be dangerous to your child's health? Jim?
JIM LEHRER: Robin, Reye's syndrome takes its name from the man who first identified it in 1963, an Australian doctor named R.D.K. Reye. It's not a common disease, striking only between 600 and 1,200 children in the United States each year. But when it does strike it's tragic. Up to 40% of its victims die; many of the others are left with permanent brain damage. The exact cause is still a mystery, but it usually appears after a child has suffered a viral illness, the flu or chicken pox being two of themost common. Early symptoms are lethargy, persistent vomiting, servere headaches and delirium. In its advanced stages there can be swelling of the brain, liver failure, and finally a coma. Some medical researchers have entertained suspicions of a link between Reye's syndrome and aspirin for nearly 10 years, but it was only this spring that the federal government became convinced a formal warning label on aspirin containers was warranted. That decision was made by the Department of Health and Human Services where Dr. Edward Brandt, Jr. is an assistant secretary and head of the U.S. Public Health Service. He came to that job in 1981 after being dean of the University of Texas Medical School at Galveston. Dr. Brandt, did your department determine that there is a definite link between aspirin and Reye's syndrome or a possible link?
Dr. EDWARD BRANDT: Well, it is our view that the link that is there is strong enought to warrant advising parents about the possibility. I would hate to say that it is absolutely definite at this stage of the game, but I think there is enough evidence to certainly warrant informing parents and informing physicians of this risk.
LEHRER: You say the evidence is strong. What is the evidence that adds up to strong to you?
Dr. BRANDT: Well, as you pointed out, a number of researchers have suggested this possible link for some period of time. Indeed, the first article was written in 1962, even before the description, the formal description of Reye's syndrome in 1963. More recently there have been four case-control studies studies in Michigan, Ohio, and in Arizona. All of these studies have shown that a preponderance of the patients who develop Reye's syndrome had been given salicylides by their parents --
LEHRER: Meaning aspirin?
Dr. BRANDT: Meaning aspirin -- while that was not true in the children who did not develop Reye's syndrome. We feel that with the consistency of these studies, with the continued association that's there, that the evidence is now strong enough that an educational campaign is certainly indicated.
LEHRER: You used the word "association." Are you of the opinion that it is possible that aspirin actually causes Reye's syndrome in these children?
Dr. BRANDT: I do not personally believe that aspirin is the sole cause of Reye's syndrome. I think it must play some sort of a role in the development of it, but I certainly don't think it's the cause. We certainly know that there are people who develop Reye's syndrome who apparently have never taken any aspirin, so I'm sure that it is not the cause, but that it does put the patient at additional risk.
LEHRER: Critics of your position, as you know, Doctor, suggest that children have been taking aspirin for 100 years, and Reye's syndrome, as you said, wasn't even really identified until '62, '63. Then how can you make that leap?
Dr. BRANDT: Well, of course, the first -- the first assumption that that physician has to make is that Reye's syndrome did not exist prior to 1963, and I suspect that that is true with almost all medical situations, that it probably had existed for some time and just had not been recognized by the profession, at least not characterized well enough to be absolutely sure. Secondly, I think that the use of aspirin in children may actually be somewhat greater than in the past. After all, Reye's syndrome is a rare disease, and as a rare disease, clearly you've got to have a lot of children exposed to the cause before you would see the disease show up.
LEHRER: Finally, Dr. Brandt, the question about putting a label on. What is the evidence that people actually read labels and act based on what they read on a label of an aspirin bottle or any other kind of bottle?
Dr. BRANDT: Well, our view of labeling of any product is that it is part of a total educational effort. It is part of the education of the consumer. We attempt to tell consumers to read labels. I think there is evidence that labels are read.For example, in the cigarette labeling we know very well that people are familiar with the labels, that they have read the label and know what it says. Now, the issue of whether or not they act is, of course, another issue altogether.
LEHRER: You are, of course, a physician in addition to now being a government official. If you were advising parents of children under 16, would you say don't take aspirin at all -- or don't give aspirin at all to your children who have flu and chicken pox?
Dr. BRANDT: Well, I think that -- our view about it, and the suggested warning that we are proposing be put on is that they should not do so unless directed to do so by their physician. We think that every physician --
LEHRER: But as a physician would you direct them not to?
Dr. BRANDT: If they were a patient of mine and there was some other way to manage them, the answer is, yes, I would advise them not to give aspirin if there were other alternatives available.
LEHRER: Thank you. Robin?
MacNEIL: As we said, companies that make aspirin see it very differently from Dr. Brandt and the administration. The Aspirin Foundation is a trade group representing manufacturers. Its chairman and president is Dr. Joseph White. Dr. White, what's your reaction to the warning decision?
Dr. JOSEPH WHITE: Good evening, Robin.
MacNEIL: Good evening.
Dr. WHITE: I think it's premature; I think it is misdirected, and I think that there is something that we do know and something that we do understand, and that is that early detection, immediate treatment in a facility that is well-equipped to deal with the complexities of this disease, will cut down the mortality and will cut down the results of the disease in those who survive. And I would suggest that that is where the government effort should be directed. That's where everybody's effort should be directed. I think it is always wrong to promulgate something that you're not certain about and may not be true at all. And I believe also that it is unfortunate in making this kind of a proclamation because you are involving the parents of children who perhaps have died of Reye's syndrome, and telling them that perhaps it was their fault because they may have given aspirin.
MacNEIL: You say it's not certain. Does that mean that in your view there could be a link between aspirin and Reye's syndrome?
Dr. WHITE: Well, there's no proof of it if there is such.
MacNEIL: Well, are you certain that there is no link? Are you, as a doctor yourself, certain there is no link?
Dr. WHITE: Well, I'm certain enough that I haven't picked up the phone to call my son to suggest that he not give aspirin to my grandson. MacNEIL: What do you think of the quality of the studies that Dr. Brandt just referred to that found this link?
Dr. WHITE: Well, they're unbelievably poor, and I'd like to see somebody get the money back that was assigned to the people who carried out these studies. They're flawed in many, many ways.
MacNEIL: Give us a couple of examples.
Dr. WHITE: Well, they're not even sure of the diagnosis in many cases. It's generally recognized you have to do a liver biopsy. Now, this was done in very few of the cases. Many of the cases did not have the traditional hiatus between the original infection and the development of the symptoms of Reye's syndrome. Without that it is very difficult to know whether or not the aspirin was given before Rise or after Rise. And we all understand the logic of that, that if it were given afterwards it can hardly be a cause.
MacNEIL: So you just don't think these surveys are reliable or carried out according to good scientific method? Is that what you mean?
Dr. WHITE: One of the best analyses were done by the Food and Drug Administration themselves in which they listed the problems, and the problems are manifold. For one example, they didn't see the packages. Well, parents can make mistakes in recall. We know that there are trademark mixups and so on. We also know that in cases where a trademark was written down, there were adult forms that had aspirin, adult forms that contained no antipyretic, and there are childrens' forms that were liquid that contained acetaminophen; and the assumption was made in these studies that that was aspirin, and it could well have been the childrens' dosage form because you would assume that that would be what you would give to a child.
MacNEIL: Well, given all those uncertainties and doubts, what is wrong with erring, as the administration seems to be doing, on the side of caution with the labels even if it later turns out to be a false alarm? What's wrong with that?
Dr. WHITE: Because it's misdirecting the effort. There is something we could be doing, even at this stage, and that is educating the parents that they should get immediate help, and that they should be in touch with their doctor, and that it is his responsibility. Once you confuse the environment with misinformation -- well, the doctor has a whole problem with, is it malpractice now to insist upon a child receiving aspirin, let's say, in juvenile arthritis and in conditions in which aspirin absolutely has to be given to the child? And he's going to have to fight the parents' resistance to treating the child the way the child ought to be treated.
MacNEIL: I see. Well, thank you. Jim?
LEHRER: In June the American Academy of Pediatrics, the pediatricians' professional group, took a position on aspirin and Reye's syndrome that was similar to the government's. It advised its 24,000 members not to prescribe aspirin for any child suffering from the flu or chicken pox. This followed a review of the situation by an Academy committee chaired by Dr. Vincent Fulginiti, chairman of the pediatrics department at the University of Arizona Medical School. He is with us tonight from the studios of public station KUAT in Tucson. Doctor. what in the studies convinced you that such strong advice was warranted?
Dr. VINCENT FULGINITI: Well, the sequential nature of studies from three separate areas of the country. And in fact there really were five studies -- two years in Michigan, two separate studies in Ohio, and the one in Arizona. So the concordance of those three studies by three separate groups of investigators and the strength of the association in the initial data review was very convincing. In addition, as criticism of the studies both by the panels that reviewed it -- the impartial panels that reviewed it -- came about, the association still held up, even if those criticisms were taken into account. And, finally, the reverse association with acetaminophen, that is, the fact that the cases did not take acetaminophen and controls did, indicate that the bias that might havebeen operating could not have been there. That basically is why we were convinced that the association was real.We did not know whether it was a causable association or not, but we felt it was real enough that we should caution our membership, which consists of pediatricians.
LEHRER: Well, you heard what Dr. White just said. He said those studies were flawed and they were unbelievably poor.
Dr. FULGINITI: Well, I believe that Dr. White and others that have spoken to this overstate the case. In fact, a working panel commissioned by the CDC and the FDA --
LEHRER: The CDC, that's the Center for Disease Control, right?
Dr. FULGINITI: The Center for Disease Control, right -- and the FDA panel itself both agreed after extensive reviews and considering every conceivable objection that had been raised by the aspirin manufacturers and by others who were independent of the aspirin manufacturers who also had problems with the studies -- after all of that review and after all of recalculation of the data, the association still held up.
LEHRER: What is your position -- you said a moment ago that the studies did not determine cause in terms of a connection between aspirin and Reye's syndrome, but what do you read into those studies?Do you think that that's possible, that taking aspirin actually causes Reye's syndrome?
Dr. FULGINITI: Well, I have to answer that in a little bit of a complicated fashion. First of all, many things in medicine have come about because of what we call epidemiologic studies; that is, the study of a situation in which a disease takes place, and to look at all possible factors. In the Michigan study, for example, they looked at environmental factors as well as drugs.
LEHRER: And was aspirin the only connection?
Dr. FULGINITI: Aspirin was the only connection. That's the other -- another reason for believing the results. In that context, what you're doing is getting a clue, a possible clue to the cause of a disease. This clue can now serve for laboratory studies, for field studies to extend from that clue. So that just because two things are associated does not always mean that they're connected, but if it's a strong association and a consistent association, then you could move on and study it.
LEHRER: What about Dr. White's point when Robin asked him what the harm would be in doing what the government has done and also what you all have done now -- warning your colleagues not to give aspirin. He says it could open up doctors -- all doctors to the possibility of malpractice suits if they should go ahead and prescribe aspirin to a child, and also there is -- well, you heard what he said. First of all, let's take that one, just in terms of malpractice.
Dr. FULGINITI: Well, there are two elements to that. One is, in the report that we issued we indicated the difficulty in attempting to identify every single child with influenza and every single child with chicken pox before the rash comes out. We know that some children will get aspirin. It's unavoidable. Secondly, physicians are responsible. They do not practice medicine by rote. They think about their decisions. They balance risks. And therefore I don't really think the malpractice issue enters this at all.
LEHRER: What about the question about rheumatoid arthritis?
Dr. FULGINITI: There again, the balance of risks. These are children that are taking massive doses of aspirin, and Reye's syndrome has occurred in some of those children. The therapeutic value of aspirin in those children far outweighs, in the opinion of many rheumatologists -- that is, doctors that care for these children -- far outweighs the smaller risk from Reye's syndrome. Therefore, those children should continue to receive it because their disease would flare.
LEHRER: Thank you. Robin?
MacNEIL: A number of other noted pediatricians think the government has acted too hastily in calling for a warning.One of them is Dr. Heinz Eichenwald, a professor of pediatrics at the University of Texas, Southwestern Medical School. Dr. Eichenwald was also part of a group assembled by a leading aspirin manufacturer to review the test data linking the drug to Reye's syndrome. Dr. Eichenwald, you examined the studies. You've heard what the others have said. What conclusion did you come to?
Dr. HEINZ EICHENWALD: Well, the conclusion that the group came to -- there were six pediatricians in this group -- was that there was no statistical association between the use of aspirin and the development of Reye's syndrome.
MacNEIL: Now, why would you come to that conclusion, reading the data, when the American Association of Pediatrics, represented by Dr. Fulginiti, came to just the opposite conclusion?
Dr. EICHENWALD: Because we had requested that we be provided with the raw data, which were the case report forms, of the studies. Now, perhaps I can backtrack for a few moments. There were several earlier studies mentioned by Dr. Fulginiti and by Mr. Lehrer. The FDA had decided in a memorandum of May 18th, 1982 -- it was an internal memorandum -- that those studies were uninterpretable because it was -- it could not be decided at what point in the child's illness the aspirin had been given. In other words, the aspirin may have been given for the signs of Reye's syndrome, and thus the aspirin could not be responsible for that syndrome because the disease had already occurred. Well, that left the Ohio study, which is referred to now always as the second Ohio study. And, again using the FDA criteria, there were only 42 cases that were interpretable, where one could say that the aspirin had in all probability been given prior to the onset of the Reye's syndrome. In other words, a rather small group of children. Now, when one examined the raw data, which we were able to do, and I've reviewed every case form of every child in every control, it was completely evident that there were many mistakes in the case form. For example, as Dr. White already mentioned, it was written that the child had received Dristan. Well, there are three forms of Dristan. One contains aspirin, one contains acetaminophen, one contains none of these two compounds. And it was always assumed by the investigators that if a drug like that was listed the child indeed received aspirin. Now, we don't know, since we can't look at the report forms and say there was aspirin in this one, there was aspirin not in this one, we cannot know for certain what the child received. But it's logical that a child under four or three years of age received a liquid. And the liquid preparations do not contain aspirin. They contain acetaminophen. When those corrections were applied, then there were no statistical differences.
MacNEIL: Well, how do you explain then the higher incidence, which we've heard, the higher incidence of Reye's disease among children who used aspirin and lower incidence among children who used substitutes for aspirin like Tylenol or something -- the reversal effect?
Dr. EICHENWALD: Well, the point is, in this particular study, if one made these assumptions that one could not tell whether a product contained aspirin or not, there were no differences. In other words, there was just as much disease in the acetaminophen group or in the untreated group as there were in children who received aspirin.
MacNEIL: If there's uncertainty about this, let me ask the question I asked Dr. White. What's wrong with erring on the side of caution -- putting the warning labels on -- until a link can be proved or disproved?
Dr. EICHENWALD: I think there are several problems related to that. In the first place, I think it causes confusion. Now, this may be unimportant. In the second place, and Dr. Fulginiti touched on this, we have the problem that aspirin is being used for a number of diseases where it has absolutely unique and safe properties -- rheumatoid arthritis is one of them; there are several others. What has already happened, and this was testified to in a recent congressional hearing by several rheumatologists, that parents are refusing to give their children aspirin and are asking for the rheumatologists to provide some other drug. Well, the so-called non-steroid substances which can be used in adults are quite unsafe in children because of toxicity and are also considerably more expensive. There is much less experience with them. Now, there are over a quarter of a million children with rheumatoid arthritis in the United States, and it's estimated that nearly all of them are receiving aspirin at the present moment.
MacNEIL: And you think their treatment would suffer because the parents would be frightened off it?
Dr. EICHENWALD: Well, we know that already. Another thing that I think one has to consider, and it's perhaps a touchy issue to bring up, but the last time I heard an undersecretary of the Department of Health and Human Resources say, well, we're doing the safe thing, was when the influenza vaccine was being argued about during the swine flu incident. And of course it was not the safe thing; it turned out to be a very unsafe thing. And I don't like that type of argument. We don't know what we are creating by removing aspirin from the scene.
MacNEIL: Thank you. Jim?
LEHRER: Dr. Brandt, how do you respond to Dr. Eichenwald on that?
Dr. BRANDT: Well, I think in the first place, we have made -- we are not going to remove aspirin from the scene, nor are we going to make aspirin any more unavailable. What we are trying to do, as Dr. White pointed out, we really need to have a total educational program, and we have already started that educational program. Labeling is only one component of that, and that's, I think, probably attracted more attention, but we have, for example, had articles already in the professional -- in journals going to the professionals to alert them. The American Academy of Pediatrics has begun their own educational program. We have now issued a Surgeon General's advisory. We have just released an article by the Surgeon General on aspirin that's going out to some 8,000 --
LEHRER: What does it say about rheumatoid arthritis, the concern that Dr. Eichenwald just mentioned?
Dr. BRANDT: Well, I think there's always going to be concern among parents when they think that they're putting their child at an additional risk. I really feel that that's a problem that clearly needs to be dealt with, and I don't -- I don't belittle it in the least. However, at the same time, it seems to me that mothers of children with rheumatoid arthritis need to be aware of the risk, just like mothers of children without.
LEHRER: Dr. White, let me ask you. Since all this -- well, since last spring when this really surfaced inthe public eye, and then the June announcement from the Academy, has there been a noticeable drop-off in the sale and giving of aspirin to children in this country that your industry has been able to pinpoint in any way?
Dr. WHITE: That's really an area that I pay very little attention to, and I don't have any real numbers. But I think one has to presume that it does have an affect. But I would like to comment on the educational program. I have been privileged to see the copy that's going on the radio by the Surgeon General of the United States, Dr. Koop, and there's very little emphasis on early diagnosis, early recognition by the parents and the parents getting to a hospital for treatment for their child.
LEHRER: Well, let me go to Dr. Fulginiti, and I want to go back to Dr. Eichenwald's point also about these studies. You heard what he said; I won't repeat it. How do you -- he looks at the same things and he said he got the raw data, you obviously didn't look at the raw data; so as a consequence he reads it differently than you do.
Dr. FULGINITI: Well, Heinz and I are used to disagreeing. I think much of the criticism that has occurred from that group -- Heinz's group -- and from the aspirin manufacturers is overstated.Let me give you examples. He says that an FDA committee on May 18th issued a statement saying that the studies were inaccurate. That's inaccurate itself. May 18th a preliminary group, preparatory to a May 24th meeting, which was an open meeting which a number of people including aspirin manufacturers and opponents to this idea attended -- that 18th meeting was to prepare the preliminary data which would be considered. When they analyzed that data, they raised a number of questions, and the questions are being quoted as if they were conclusions of that panel. It's not true; they weren't conclusions. Dr. Eichenwald said, well, that leaves only Ohio, thereby dismissing all previous data, which is ridiculous. It's a very cavalier statement. The fact is you cannot dismiss all of the previous data.
LEHRER: Is that -- excuse me. Dr. Eichenwald, is that what you're doing, is just that you only believe in the Ohio study, and it is so slim it doesn't mean anything to you?
Dr. EICHENWALD: No, that's not correct, and I think Dr. Fulginiti is overstating what I said. I said that the FDA has this in a memorandum which they wrote. I also know that if you look at the other studies and you try to find out the time at which aspirin was given during the course of the disease, you cannot find it. It is not there. All we know is that the child received aspirin, period.
LEHRER: But you don't know when and --
Dr. EICHENWALD: We do not know when. It is not in the data because the data were not collected that way.
LEHRER: I'm sorry, Doctor. I'm very sorry, but we have to leave it there.
Dr. EICHENWALD: Oh, okay.
LEHRER: Robin?
MacNEIL: Yes, Dr. Fulginiti, thank you for joining us from Tucson tonight; Dr. Brandt, Dr. White, in Washington; Dr. Eichenwald, in New York. That's all for tonight. Good night, Jim.
LEHRER: Good night, Rogin.
MacNEIL: We will be back tomorrow night. I'm Robert MacNeil. Good night.
Series
The MacNeil/Lehrer Report
Episode
Aspirin Warning
Producing Organization
NewsHour Productions
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National Records and Archives Administration (Washington, District of Columbia)
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cpb-aacip/507-hd7np1x849
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Description
Episode Description
This episode's headline: Aspirin Warning. The guests include Dr. HEINZ EICHENWALD, University of Texas; Dr. EDWARD BRANDT, Department of Health and Human Services; Dr. JOSEPH WHITE, Aspirin Foundation; In Tucson (Facilities: KUAT-TV): Dr. VINCENT FULGINITI, American Academy of Pediatrics. Byline: In New York: ROBERT MacNEIL, Executive Editor; In Washington: JIM LEHRER, Associate Editor; LEWIS SILVERMAN, Producer; MAURA LERNER, Reporter
Created Date
1982-10-12
Topics
Economics
Education
Environment
Health
Consumer Affairs and Advocacy
Science
Weather
Food and Cooking
Politics and Government
Rights
Copyright NewsHour Productions, LLC. Licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International Public License (https://creativecommons.org/licenses/by-nc-nd/4.0/legalcode)
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00:31:04
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Producing Organization: NewsHour Productions
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National Records and Archives Administration
Identifier: 97036 (NARA catalog identifier)
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Citations
Chicago: “The MacNeil/Lehrer Report; Aspirin Warning,” 1982-10-12, National Records and Archives Administration, American Archive of Public Broadcasting (GBH and the Library of Congress), Boston, MA and Washington, DC, accessed January 15, 2025, http://americanarchive.org/catalog/cpb-aacip-507-hd7np1x849.
MLA: “The MacNeil/Lehrer Report; Aspirin Warning.” 1982-10-12. National Records and Archives Administration, American Archive of Public Broadcasting (GBH and the Library of Congress), Boston, MA and Washington, DC. Web. January 15, 2025. <http://americanarchive.org/catalog/cpb-aacip-507-hd7np1x849>.
APA: The MacNeil/Lehrer Report; Aspirin Warning. Boston, MA: National Records and Archives Administration, American Archive of Public Broadcasting (GBH and the Library of Congress), Boston, MA and Washington, DC. Retrieved from http://americanarchive.org/catalog/cpb-aacip-507-hd7np1x849