Dollars and Sense; 1; Over-the-counter Medicine. Part 1

... Almost one-third of all Americans, some 70 million persons work.

But all Americans, one hundred and ninety million persons, are consumers. And two-thirds of all spending, over four hundred billion dollars, is spent annually by consumers by all of us. Yet, as the late President Kennedy said, the consumer is the only important group in the American economy, which is not effectively organized. Tonight, national educational television begins a series of programs, designed to increase the knowledge of the consumer, dollars and cents. The first two programs deal with a dollars and cents issue that affects nearly every

home, every individual, every consumer. Over the counter-medicine. Good evening. I'm James Fleming. This program, dollars and cents, is an attempt in an era of energetic salesmanship to ask candid questions of all parties about some of the products most of us buy. Their price, their content, and their value to the consumer. Every year, more than two billion dollars is spent by American consumers on the over-the-counter remedies at the neighborhood drugstore. These are the products that can be bought over the counter by anyone without a doctor's prescription. They're designed for self-medication, they include aspirins, cold pills, cough medicines, motion sickness pills, and so on. And more than 5,000 brands made by over 4,500 different companies. And the bill is sizable. Is the money well spent? How can you and I get the most effective use of our buying dollars? Well, tonight, we're going to concentrate our attention on aspirin and cold remedies. In the next program, we shall take a look at the role of the Food and Drug Administration

in policing over the counter-remidies. What you're seeing now is a scene which I dare say is similar to some occurring daily and drugstores across the country. This one is in New York City, and the buyer is Miss C. G. Ware of the Dollars and Cent Stuff. Hi. I think I need some aspirin. Sure. What do you like? I don't know. What do you have? I don't know the difference. Well, we have bears aspirin. We have squibs aspirin. What would you suggest? What's the difference? Well, they're all aspirin. They're aspirin except that the bears aspirin is supposed to be faster dissolving aspirin. Oh, you know that. They're different in price? Yes. They're very impressive. Wow. What's the... The bears is the higher price. Bear is higher in price. Bear is higher in price. What's the lowest price? Well, you can have a cheap aspirin that has no names. Do you sell that here? No, I don't sell them here, but they could find with a very cheap price now. In scientific language, aspirin belongs to the family of drugs known as analgesics, pain

relievers, and as antipyretics, that is, as fever reducers. Now there's quite a variety of aspirin products, not just the difference in brand names, but in the ingredients of the pill itself. With the hard sell of the TV commercial and the massive print advertising running into millions of dollars, how does the consumer choose among products? For instance, are there differences in the pure aspirin itself and are there differences in the formulation of the aspirin pill? And if there are, how significant are they to the consumer? And finally, what about pricing? Recently, an NET researcher bought various kinds of aspirin products at a large discount store in New York. Each bottle of aspirin contained 100 pills, and this is how they were priced. The most expensive was Anneson, a dollar and 23 cents for 100 tablets. Anneson contains six grains of aspirin and a small amount of caffeine, somewhat less than the caffeine in a quarter of a cup of coffee.

The next highest price was Excedrin, 99 cents for the same number of tablets. Excedrin, which claims to be an extra-strength pain reliever, contains five grains of aspirin and two other analgesics plus one grain of caffeine, or somewhat less than the amount of caffeine you find in a whole cup of coffee. Buffrin was in the middle, priced at 75 cents. Anneson also contains five grains of aspirin and an acid that the manufacturer claims can settle the stomach and relieve the heartburn, which may be a side effect of aspirin. Bayer aspirin, also containing five grains of aspirin for tablet, was priced at 49 cents, 26 cents less than Buffrin, 50 cents less than Excedrin, and 84 cents less than Anneson. Now here's the real surprise. The discount store had an aspirin with a brand name of Corvelle. It also contained five grains of aspirin for tablet, and that incidentally was checked by an independent chemist's analysis.

It was priced at 13 cents for 100 tablets, far below any of the other brands. The prices, of course, may vary somewhat from store to store or city to city, but it's clear that there's a large difference in the pricing of aspirin products and that national brands sell at four times, in fact, sometimes almost ten times as much as local brands. 13 cents for 100 pills to $1.23 for 100. With several years ago, Consumers Union, a non-profit organization designed to provide information and advice on consumers goods and services, published a book entitled The Medicine Show, which discussed and evaluated a number of over-the-counter products. We asked Consumers Union Medical Consultant Dr. William O'Brien, an assistant professor of epidemiology at Yale University, to tell us if he thinks there is a significant difference between the various aspirin products. Well, the best studies, and the most carefully conducted ones, by the best studies, by the best scientists, have shown no significant difference between all of the various forms

of aspirin and their speed of absorption and their effectiveness. So I think it's safe to say that at the present time, the best evidence indicates that one form of aspirin is just as good as another. Dr. O'Brien, if all aspirins are more or less the same, why does one bottle of 300 cost less than sometimes than a bottle of 50 you'd get elsewhere? The actual chemical aspirin is produced by large chemical companies, such as Samo and Santo, and bought by the pharmaceutical houses. They're essentially buying exactly the same chemical from exactly the same supplier. They then compress this into capsules or tablets and sell it under their own name. Essentially, it's all the same stuff. The reason that there's this immense difference in price is the intense advertising campaigns and the expenses involved. There are three large producers of pure aspirin in this country, Dao Chemical Company, Monsanto Chemical Company, and Sterling Drugs.

Well together they turn out about 30 million pounds of pure aspirin, about 10 million a piece, almost 100 percent of the pure aspirin produced in the United States. Dao and Monsanto both sell their pure aspirin powder to the pharmaceutical houses, which form it into tablets, and in some cases they add other ingredients that go into the compound aspirins that we've been discussing. Well now Sterling Drugs, which is the parent company of Bayer aspirin, is the only organization that makes its own aspirin, forms it into tablets and markets it as a finished product. We ask Dr. Morris Tainter, a corporate vice president of Sterling Drugs, about his product. I suppose I have at this moment, and I confess I have a slight headache, but I suppose I had a very severe headache, and suppose that I had an option of going down to the cup raid drugstore and getting an aspirin that would cost half the price of Bayer aspirin. Are you suggesting that I would not be cured just as soon? I'm suggesting that if you use the Bayer aspirin you could depend on the result with greater certainty than if you took the fly-by-night sample that you bought at the lowest possible

price at the cheapest discount store in your area. The reason for this is that in the Bayer aspirin there goes a quality of aspirin powder, which is the very highest that we know how to make, or for that matter, as high as anybody knows how to make. Dr. Tainter, the public is the subject of much persuasion about the relative merits of these products. Isn't it true that among these compounds or aspirins the speed of action story doesn't really mean very much, isn't it just a matter of seconds or two, one acts just about as fast as the other? You can set up in a laboratory or in under-restricted conditions, all kinds of tests, which will give you results that can be modified by what you do. If you take aspirin, for example, when your stomach is full, you get a different speed of action than you get if your stomach is empty, and conditions like that can make a very great difference. And this has been tested, however, under exactly test conditions in the hospital, where everything

is just the same as near as they can be made the same from patient to patient. They find that the Bayer aspirin, more particularly, is just as good an analgesic as are any of the others. You don't need to pay the extra price to get a product to cost more, but doesn't give you any more, doesn't deliver any more to you in terms of relief of your pain and the cold or headache, whatever it is. Dr. Tainer then makes two points. First, that he believes his company's aspirin is more dependable than that of the discount house product price much lower. Second, that the pure aspirin of Bayer is at least as effective as the more expensive compounds on the market. Of course, Bayer's contensions are disputed by the makers of the compounds, and the cross claims are the subject of a pending court suit. He approached Bristol Myers, which makes both exedron and buffering, and Whitehall, the makers of Anison, for comment on Dr. O'Brien's statements, and both declined to appear. However, Bristol Myers spokesman pointed to a study they said indicated the superiority

in terms of relief and speed of absorption of buffered aspirin. This research was conducted at the University of Oklahoma and financed by the National Institute of General Medical Science and also Abbott Laboratories. The study concluded that buffered aspirin was superior, but a close study of the report shows that, again, as in other studies, though there may be a difference in speed of relief. It's a very slight one. Another research study was conducted by Dr. Lewis Lasagna, he's the chairman of the Department of Clinical Pharmacology at Johns Hopkins University, and Dr. Thomas Takornfeld of the University of Michigan, with Dr. Todd Frazier of the Baltimore City Health Department. This work was financed entirely by the federal government, and the results were published in the Journal of the American Medical Association in 1962. Five aspirins, plain, buffered, and compound were tested. They were Anison, Bears, Bufferin, Exedron, and St. Josephs. We asked Dr. Takornfeld to outline the work.

The purpose of this study was to compare five commercially available analgesic pain relieving drugs with each other and within the nerd substance we call a placebo. The study actually was divided into two parts. The first part tried to establish the rapidity of onset, the effectiveness, and the duration of action of these drugs, as far as the pain relieving properties is concerned. The second part of the study dealt primarily with the problem of gastric irritation and gastrointestinal upsets. The first part of the study was done in patients who very recently had a baby and who had some postpartum pain. The second part of the study was done in elderly patients at the so-called infirmary of the Baltimore City hospitals. This was a long-range six-week study dealing with gastric irritation. What were the results of the study, sir?

The results of this study, and when I said this, I must limit it to our patients at the time this study was done, seemed to indicate that there was no difference between the drug study as far as the rapidity of onset, peak effect, and duration of effect was concerned. So in effect, this study showed no important differences in terms of effectiveness or pain relief among the five aspirin products tested. Since that study was made, there have been some changes in the composition of anison and et cetera, but our medical consultants advise us that these changes do not materially affect the findings. Neither the DeCornfeld study nor any authoritative study that we know of compares the familiar brand name aspirins with the cut-rate brands. But all firms, manufacturing aspirin, have to meet minimum standards set by the United States' pharma capya and the Food and Drug Administration. And all drug firm production must be inspected under terms of the Kefover Harris Act of 1962. So the question, is the 13-cent aspirin as good as the 49-cent one, or as good as the

$1.23 compound, well, there's no proof that it's better or worse. So it would seem that the major difference is price, not effectiveness, and the evidence indicates that one may as well buy the least expensive aspirin available. Another big portion of that $2 billion a year that we spend on over the counter drugs goes for oral cold remedies. And here, too, as with aspirin, the consumers barrage with advertising, promising to help one safely and comfortably through that distressing symptom of a cold, promising all day, all night relief, and the like. The question, what can the consumer really expect from an oral cold pill? The common cold is a virus, perhaps several different ones, affecting the upper respiratory tract. Now, advertising doesn't claim that the oral cold remedy actually cures a cold. In fact, the law forbids such a claim.

But manufacturers do say, on the air, and in print, that their products can relieve symptoms. O-R-N-E-T researcher, Ms. Ware, also asked her drugist about it. What do you have for colds? Oh, we have glycidine. What does that mean? Well, contact, maybe. What's the difference with, of course, even contact, I don't know. Well, the difference is contact is good for 12 hours. glycidine is only good for four hours, every four hours, you've got to take a towel. These are the ones that explode in your back, and they should work every four hours. What do they do? Just relieve stuffing hours, and stuff like that? They're good for stuffing hours, hate views, and stuff like that. What would you recommend? Contact, of course, even, or what? Well, it's a matter of opinion. If you need something good that will last all day long, you're better off with a contact this way. You take just one in the morning and one at night, and this will give you relief for 24 hours. Continuous?

What do they do that I understand? Well, because they dissolve gradually, they disintegrate gradually in the stomach. Oh, a different time. Different time. Oh, I see. Does anyone else make contact this time? Well, I mean the same kind of, not the, yes, there are a few, most of them, either prescription or offline. Oh, well, I've seen this advertised a lot. This is very good. Right. In the old days, some doctors used to prescribe opium or dovus powder for cold. Others said, try a pinch of snuff or hot milk or rum or tea, and oddly enough, those remedies sometimes seem to work. They did relieve cold sufferers, perhaps mainly because people believe they would. The main effect was psychological, or what medical men call a placebo effect. Today, there are usually three chief ingredients in cold pills. First, there's an anti-histamine. It's a drug designed to counteract histamines, which are chemicals, the body releases and some allergies and inflammatory disorders. The cold pill manufacturers claim that anti-histamine will reduce thick mucus that keeps you

blowing your nose. Then there's a nasal decongestant, which you've taken by mouth may help to dry up the nasal passages. And finally, there's often an analgesic, quite often aspirin or finacetin, that reduces the aches and pains, which may be associated with the cold. In other words, the equivalent effect of an aspirin pill. We went back to consumer's union medical consultant, Dr. O'Brien, to ask him, what do you thought of the modern cold pill with its various chemical ingredients? Well, it perhaps helps a very small amount, but the main effect, of course, is psychological. You have a cold and you feel like you'd like to take a tablet, and perhaps after you take the tablet, you psychologically feel a little better, but the amount that this favorably influences your cold is probably slight. Some cold remedies are packaged as time capsules. Is that the same sort of thing you're describing? Yes. This is a sustained release capsule, and instead of being dissolved in the stomach and quickly going into the bloodstream, this type of compound is slowly released as it goes through the gastrointestinal tract.

Now, these capsules are much, much more expensive. You could get the same effect by taking several tablets over the same period of time. And these sustained release capsules have one further trouble, often the absorption is somewhat erratic. Some people will absorb them fairly quickly, others fairly slowly, so you don't get a uniform effect. And I think in terms of the cost and the benefit that one obtains, one is just as well off in taking a tablet every four hours or every six hours, as compared to taking one of these sustained release capsules every 12 hours. Well, Dr. O'Brien, you seem to suggest that these over-the-counter remedies aren't very effective. Now, are there any dangers in such remedies? Well, there are dangers in some over-the-counter medicines, particularly in that the individual may have symptoms, he may take some of these remedies, and he may delay and waste precious hours in getting attention for a potentially serious condition. For instance, a young child might have early pneumonia, and the parents might give one of these cold remedies and waste the first 12 or 14 hours of the child's illness.

By the time the child was brought to medical attention, the pneumonia might have spread and become a very serious condition, in fact, even life-threatening. Is there anything at all that's sold over the counter that helps a cold very much, or let me come right out with it? What will help a cold? What can I do, Dr? Well, I think the best thing is probably time, and that eventually the cold will go away. Some of these over-the-counter remedies may give you slight symptomatic relief. The old adage, of course, is that if a cold is treated properly, it will last seven days, but if you ignore it, it will go away in a week. So these are Dr. O'Brien's points in summary. First, although there may be some slight symptomatic relief, the main effect of a cold pill is psychological, and there's no real cure for a cold. Second, that 12-hour cold pills, such as contact, cannot guarantee a uniform release of the pill's ingredients, and third, that the long-acting pills can mask more serious symptoms.

We ask the manufacturers of contact, the Mendelian James Laboratories of Philadelphia, to respond. Their spokesman is Dr. Kenneth E. Hurley, he's the vice president and charge of research and development. We've just heard Dr. O'Brien saying that cold remedies are largely psychological and that a placebo, that is to say no remedy at all, just a pill that meant nothing, would be quite as good. I dare say that's not your conviction. That's very true. Actually, a placebo or a sugar pill, as most people know them, cannot give any effect in and of itself, but if we give sugar pills, a placebo, two patients, 40 or 50 percent of them might tell us that report to us that they get some degree of relief. Now in contrast, a product like contact, we know, gives about 80 percent relief to the same patients, so that there's a considerable difference between a placebo and a product such as contact.

Well, of course, Dr. O'Brien has said that a time capsule, and I suppose he means one such as contact, if it were taken when a serious illness was present, such as pneumonia, he mentions a child, that symptoms could then be concealed. This is really quite unlikely, so far as we're concerned, a serious disease, such as pneumonia, would have either high fever or severe coughing or pain associated with it, and the ingredients in a product like contact simply will not suppress any of these symptoms, so that the individual will be aware of it and will presumably contact his doctor to take care of it. Now the statement was made that this could be a problem in very young children. This is another thing, which is essentially not true because practically all cold products, capsules or tablets are not indicated for young children. In contact, for example, the label specifically says that it's not recommended for children under 12, so that this should not be a problem in young children since they shouldn't be taking the product.

We have been very conservative in the listing of contraindications, warnings, and so on, actually, I think almost more so than many other products, and we do not seriously believe that this is a problem that is masking the symptoms of pneumonia. Nor any other disease? Nor any other disease, no. Of course, the public doesn't always read the fine print. That is a real problem, and they should be warned always to read the label. And isn't it true, though, Dr. Hurley, that your greatest communication with the public is in these very attractive television commercials, which I have seen, where the capsule opens up in a little tiny delightful things, bouncing slow motion, and a very dulcet voice states a lot of things about contraindications, but it doesn't say any of these things under caution. Does it? No, it doesn't. Now, isn't that a rather incomplete communication to the public today? Perhaps it is, but in the time period that's available for television advertising, it's very difficult to include all of these things. Wouldn't you consider a good advice to your company to perhaps just include in those one-minute

commercials, note to the public, be sure to read the cautionary notice on the package of contact before you take it? That might be very good. Would you consider doing that? I'm not in the advertising department, and therefore I can only make it a recommendation to them. Of course, Dr. O'Brien did say that cold tablets, and these time capsules particularly, were quite expensive. Two expensive was the implication I got out of his statement. What have you to say to them? Well, if we take the leading cold medications and compare the price on the basis of a particular period of time, let's take 12 hours since that's the time that one time capsule will give relief for. We have a high of 29 cents, in the case of one product down to a low of 14 cents for 12 hour period, contact costs 15 cents for a 12 hour period of relief. Therefore, we feel that this is not an accurate statement that one is not paying a premium to take a time to release capsule, but actually is paying no more than he would for a comparable

tablet. Dr. Hurley, as you know, there's great concern about rate of absorption of time capsules. Now there's a third point that Dr. O'Brien makes, and he says in effect, as I get it, that human beings are different. Products tend to be the same, but people are different. And our rate of absorption is different, and I note that our research people have given me a note from a Dr. Gerhard Levy of the University of Buffalo writing in the Journal of the American Pharmaceutical Association in January 64, and he says rates of drug elimination can vary rather widely between individuals, yet the prolonged release dosage form can be designed only on the basis of an average elimination rate. In other words, you have to average out what goes into these tablets, and people are different. How do you cope with that? Well, first of all, Smith-Clyne and French, our parent company, has been dealing with this situation for 15 or 16 years and has marketed 20 prescription products in the sustained release form, which of course are used by physicians.

There are indeed differences in absorption rates between individuals, but we have designed these so that the average individual in this presumably means about 80 to 90 percent of the people taking it will get a very effective dose of drug over a 10 to 12-hour period. Despite manufacturers' assurances of the effectiveness of oral cold pills, they've been a subject of considerable dispute in the medical world, so let's look a little further into other opinion. The standard text for most medical schools is the pharmacological basis of therapeutics. This is the third edition published last year. It's written by Dr. Lewis Goodman of the University of Utah and Dr. Albert Gilman, Alfred Gilman of the Albert Einstein School of Medicine in New York. From the subject of antihistamines for tweeting colds, it says that antihistamines may afford some relief of symptoms, but it also cites a test in which antihistamines had no influence on volunteers inoculated with cold virus, even when the treatment was begun before the inoculations were given.

And a non-profit publication for doctors, this is the medical letter. It reported in 1959 that in some patients antihistamines reduce sneezing and mucus discharge, but that in many others, perhaps most they did not. The medical letters advisory board is made up of faculty members from seven medical colleges and universities. And a spokesman for this publication says that the 1959 report still is valid since the antihistamines and today's cold pills are the same. Now as to nasal decongestants, the pharmacological text book says there's no evidence, no convincing evidence that they'll help you decongest it all when they're taken orally in cold preparations. As to the third common ingredient, the analgesic or antipyretic, that is to say the aspirin type of remedy, this is really the effective element in reducing aches and pains. In other words, you could probably get as much relief from aspirin as from a cold pill and at less cost. Well, so much for aspirin and cold pills. In our next program, dollars and cents will look into the role of the Food and Drug Administration

in regulating over-the-counter remedies. This agency is the principal public guardian in this field and must approve all over-the-counter medicine. Only this month, the FDA, in fact, banned further manufacture of hundreds of antibiotic throat lozenges sold over the counter. This ruling was that in the face of 15 years' experience with these products, its apparent they didn't work. They were found not unsafe, only ineffective, although they often cost twice as much as ordinary cough drops. The FDA also has been concerned recently with motion sickness pills, and we'll be looking into that area and we'll be examining sleeping pills. Until then, this is James Fleming speaking for National Educational Television. Thank you. Bye. .

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