LOVE POTION? May 7, 1998 The NewsHour with Jim Lehrer Transcript

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Viagra, the new sex pill for men, has been in great demand since its approval by the Federal & Drug Administration five weeks ago. The small blue pill has been found effective at enabling erections for men who have some form of impotence. The NewsHour has the report and Elizabeth Farnsworth leads a discussion on the new wonder drug.

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A RealAudio version of this segment is available. NEWSHOUR LINKS: May 15, 1998 Participate in an Online Forum on the new drug Viagra. May 5, 1998 HMOs are sued for failing to cover treatment originally in their insurance policy. December 23, 1997 Is there a cure for baldness in a bottle? September 15, 1997 Two diet drugs are taken off the market. March 25, 1997: How are middle aged people making the most of their golden years? Browse the NewsHour's coverage of health. OUTSIDE LINKS: A report on Viagra from its developer, Pfizer Inc. American Urological Association International Impotence Education Month

KWAME HOLMAN: It's being hailed as the new best friend to thousands of men. Viagra, a drug developed by Pfizer, Incorporated, has proven effective at reversing male sexual impotence with few side effects. Generically known as Sildenafil, Viagra was approved five weeks ago by the Food & Drug Administration. Since then, doctors have written thousands of prescriptions and pharmacists have struggled to keep the small blue pills in stock.

Some 30 million American men have some form of impotence.

A urologists' group estimates 30 million American men have some form of impotence. They are unable to achieve or maintain an erection for physical and/or psychological reasons. Dr. James Regan is a urologist at Georgetown University Medical Center in Washington, D.C..

DR. JAMES REGAN, Urologist: Viagra is designed to increase the blood flow into the penis. And that, after all, is what an erection is. So, very simply, it enhances the blood flow down into the penis, resulting in an erection.

KWAME HOLMAN: Most current treatments for impotence are painful or intrusive. They include: penile implants and direct injections of drugs. Viagra goes to work one hour after being taken orally, and Pfizer is working on a faster acting form of the drug.

DR. JAMES REGAN: Patients have really come to the office in unprecedented numbers looking for a prescription for the medication.

KWAME HOLMAN: Drug maker Pfizer reports more than 30,000 prescriptions for Viagra were written the first week the pill became available, 110,000 in the second week, and now, after a month, some 350,000 prescriptions for Viagra have been filled. The cost is about $10 per pill. So far, Viagra is not covered by most health plans. Dr. Regan warns Viagra has shown some mild side effects.

DR. JAMES REGAN: In the clinical trials that were done for the Food & Drug Administration roughly15--10 to 15 percent of patients reported a flush feeling in their face, maybe a headache, sometimes stuffiness in their nose, or a little bit of indigestion. Curiously, 3 percent of the patients in the Food & Drug Administration reported difficulty distinguishing blue and green colors for about twenty or thirty minutes after they took the pill.

KWAME HOLMAN: That last finding prompted the American Academy of Ophthalmologists this week to recommend that men with severe vision problems not use Viagra. The group also called on the Food & Drug Administration to conduct further testing.

Lingering questions.

Researchers say Viagra has not been shown to improve the sexual performance of men not suffering from medical impotence. The question of Viagra's effect on women currently is being examined in clinical trials in England. The huge stir caused by the new drug has been fueled by late night talk shows, magazines, and newspapers around the country. On Wall Street the value of Pfizer's stock shot up to $106 a share from $70 a share two months ago. Analysts predict Viagra sales will top $5 billion in the next year.

JIM LEHRER: And to Elizabeth Farnsworth in San Francisco.

ELIZABETH FARNSWORTH: And now a discussion of the Viagra phenomenon. Dr. Ira Sharlip is Assistant Clinical Professor of Urology at the University of California, San Francisco, School of Medicine. Eileen Palace is a clinical psychologist at Tulane University Medical Center, where she will also direct the Center for Sexual Health, which will open in July. Paul Wolpe is a sociologist and bioethicist at the University of Pennsylvania School of Medicine's Center of Bioethics. And Chip Kahn is the chief operating officer and president-designate of the Health Insurance Association of America, representing 250 health insurance carriers. Thank you all for being with us. Dr. Sharlip, how strong is the demand in your practice right now?

"There's been a pent-up demand of men who have had this problem...."

DR. IRA SHARLIP, University of California, San Francisco: It's very strong, Elizabeth. There's been a pent-up demand of men who have had this problem, who have known that the drug is coming for at least six months. And so there's been a tremendous response of patients who want to take the drug.

ELIZABETH FARNSWORTH: What kind of stories do they tell you? What are they telling you after they take it?

DR. IRA SHARLIP: Patients typically say that they feel like they did twenty or thirty years ago. They're having a great improvement in their sexual pleasure and performance and a great improvement in self confidence. I've had one patient who was injured in an automobile accident over 30 years ago and had been impotent since then, he's now having sex again with his wife.

ELIZABETH FARNSWORTH: Eileen Palace, let's talk a little bit about the problem this is aimed at solving. How important is male erectile dysfunction for a relationship, for example? What do you find in your practice?

EILEEN PALACE, Tulane University Medical Center: A sexual response is made out of two components: the physiological, such as blood flow, which is what Viagra is targeting, but also the cognitive, that is, the thoughts, the feelings, and the expectations you have about yourself, your body, and your ability to get sexually aroused. What I found in my research is that changing expectations increase blood flow within 30 seconds. So that's how quickly your mind can affect your body. And I think that you need to take both of those components into account in any treatment program. If you look at just physiological treatment, without taking the other component into account, that is, the thoughts that may either have caused the problem or that maintain the problem, then I think you have a less effective treatment. Really, the treatment for sexual difficulties is the marriage between mind and body, the cognitive and the physiological, which gives us our greatest potential for sexual health.

ELIZABETH FARNSWORTH: But, Ms. Palace, this will help in many cases, will it not? You're not saying this is not a really useful treatment?

A wonderful treatment?

EILEEN PALACE: I think it's a wonderful treatment. And it certainly will be helpful, but, again, I think it's important to recognize the thoughts and their effect on physiology, that we can't just take a physiological treatment because even if it's a purely physiological problem, such as diabetes, that has an impact on how you feel about yourself, how--your self confidence, your self esteem, and your relationships. So really working the two together, which we know these other problems, such as depression, is the most effective for whole mind/body health.

ELIZABETH FARNSWORTH: And Dr. Sharlip, just so we have this clear, this is not an aphrodisiac. You still have to experience desire to have this work, right?

DR. IRA SHARLIP: Yes. This drug does not work unless a man has the interest and then initiates sexual activity. If he takes the drug and then doesn't become sexually involved, nothing will happen. He'll waste $9, which is the cost of the pill.

ELIZABETH FARNSWORTH: Mr. Wolpe, let's expand this a little bit. This whole question of male sexual function is something that goes back to the very beginning of time. It's been very important in human life for a long time, hasn't it?

PAUL WOLPE, University of Pennsylvania: Yes. In fact, if you look back, many ancient artifacts show pictures and sculptures of men with erections, many neolithic carvings show powerful men with strong erections. The Sern Abyss giant, which is this large figure cut into the hillside of a countryside in England, is a large figure holding a club with an erection. Even the word "potency," if you think about it, shows that connection has always been made between male ability to perform sexually and some sense of male strength.

ELIZABETH FARNSWORTH: And, Mr. Wolpe, there have also long been potions that have enhanced male sexuality, isn't that right?

"Love potions" throughout history.

PAUL WOLPE: Well, there have long been potions that have claimed that they enhanced male sexuality, but men have always been looking for these things. Aphrodisiacs for men that promised stronger and longer lasting erections have been used almost as long as aphrodisiacs for women that were supposed to make women susceptible to men's seductions. So the idea that a man is measured in some degree by his ability to perform sexually is a very ancient idea. And it's no different today.

ELIZABETH FARNSWORTH: So, Mr. Wolpe, are you surprised by the popularity of Viagra? Has this phenomenon taken you by surprise?

PAUL WOLPE: Not at all. I think that any--virtually everyone expected this to be a fast-selling drug and a drug that had an enormous capacity for proper and improper use. And I think we're seeing that happening with Web sites that are offering the drug with the most cursory of examinations and black markets already beginning.

ELIZABETH FARNSWORTH: Eileen Palace, how important is the discussion that's been launched by this drug? People are talking about things that used to be taboo, aren't they?

Talking about former taboos.

EILEEN PALACE: Yes. I'm glad you raised that. I think that's the silver lining in all of this, is that it certainly is a wonderful and a helpful drug but in addition I think, as you can see from your newscast and others around the country, that this is now raising the acceptability of talking about sexual behavior. And I think in our culture that people are very willing to talk about it sort of friend to friend, or clinical lore, but fact-based, knowledge-based discussion of sexuality is not nearly common enough in our culture. And I'm very pleased to see that. And I hope that it helps the--Pfizer quoted 140 million men worldwide with erectile difficulties; 23.5 million women with orgasm disorders; and 15 million women in this country with desire disorders--to know that they're not alone, that there's many people experiencing sexual difficulties, and that we do have some very effective treatments available to them, that they feel comfortable seeking that help.

ELIZABETH FARNSWORTH: Do you agree with that, Dr. Sharlip?

DR. IRA SHARLIP: I certainly do, Elizabeth. And I think that's been one of the really good side benefits of this drug. What my observation is, is that it has decreased the stigma of impotence, and it has de-sensitized the embarrassment that men feel from having erectile dysfunction. And many, many more are presenting to their doctors for diagnosis and treatment. And that can only be good.

ELIZABETH FARNSWORTH: Paul Wolpe, do you agree with that? Do you think just the discussion is important, or are you worried there's too much hype here?

PAUL WOLPE: Well, I think there is too much hype here. The discussion is certainly important, but I do think that there is a problem with this enormous market for people who are looking for sexual enhancement, rather than people with impotence. And I think a lot of the potential problems have not been discussed. For example, men who use this drug in order to achieve erection to impregnate their mates, we really don't have any data on what kind of effect a drug like this could have on male semen. We tend to only think drugs affect female pregnancy problems, like Thalidomide and DES. But we really have no idea what Viagra might do for male reproductive health. And we have no idea what it might do for male reproductive fluids.

ELIZABETH FARNSWORTH: Okay. Let's start with the first of those issues. How many men want to just improve their sexual performance, they don't really have a big problem with sexuality?

"This drug will not make a superman out of a normal man."

DR. IRA SHARLIP: I think there are many men who would like to perform at the maximum of their capacity. But this drug will not make a superman out of a normal man. And those men who are able to get the drug on the black market or by some other means, but who have normal erections to begin with, will find that it doesn't do them any good. And I think that they will quickly stop using it. There is certainly potential for abuse of this drug. But I think that organizations such as the American Urological Association and other professional organizations, working in conjunction with responsible physicians, will see to it that this drug is only prescribed in a responsible way to men who have a problem with erectile dysfunction.

ELIZABETH FARNSWORTH: And what about the second part of what Mr. Wolpe raised, the problem of side effects? Already, the ophthalmologists are concerned about the effect on eyes. Could there be really negative side effects down the line that we just won't know about until it's too late?

DR. IRA SHARLIP: This drug was very thoroughly studied. The investigations that were submitted to the FDA involved over 4,000 men. Certainly it's possible that there are complications and side effects that could occur in the future that did not appear in the early studies, but it does seem to be a safe drug and a very effective one too.

ELIZABETH FARNSWORTH: Okay. Chip Kahn, let's bring you into this. Who should pay for this? So far, many insurance companies are only paying for it in a limited way, isn't that right?

Paying for the pill.

CHIP KAHN, Health Insurance Association of America: That's correct. Right now, insurance companies are taking a very cautious attitude towards this drug. And the reason is because insurance companies are providing coverage that they want to keep affordable. Consumers want affordable health care coverage, and a drug like this has a potential for abuse and a potential for overuse and a potential for leading to significant increases in premiums for consumers.

ELIZABETH FARNSWORTH: Who do you think should pay for the drug?

DR. IRA SHARLIP: I don't know the answer to that question. That's a difficult question. But I don't think there are any underlying ethical issues in this. I think it's strictly an economic issue. Do I want to pay a higher insurance premium to pay for someone else's sexual activity? Well, I might when I reach that point.

ELIZABETH FARNSWORTH: Who's paying for it so far among your patients?

DR. IRA SHARLIP: For the most part it's the patients who are paying, but some of the insurance companies are paying for part of the cost or for a certain number of pills per month.

ELIZABETH FARNSWORTH: Eileen Palace, how important do you think this is and the problem that Viagra is supposed to solve is in people's lives, and should insurance companies pay for it just like they do for other medications, some other medications?

EILEEN PALACE: I think that they should. There has been an issue with other medications, such as Prozac and birth control pills, but I think that it's important that the insurance companies begin to understand, again, the mind-body link, and that we know that mental health inherently affects physical health. For example, we know that stress and the way people function in the workplace has long-term impacts on immunological functioning, on the likelihood of susceptibility to disease, and even to the length of people's lives and to mortality rates. So sexuality is a very critical part of our lives and our lifestyle and our overall physical health. And the more and the sooner that people recognize that you can't separate that false dichotomy between mind and body, but that sexuality is part of our physical, as well as our psychological health, the more I think they'll understand that funding this may, in fact, help other kinds of physical problems.

ELIZABETH FARNSWORTH: Chip Kahn, how do you respond to that?

CHIP KAHN: Well, there are many things right now that improve health that are not paid for. Basically, insurance pays for what's medically necessary, not everything medicine can do. Plastic--certain plastic surgeries, in vitro fertilization, there are many things that are very useful, but the decision's been made to keep premiums down. Insurance shouldn't include that in the packages. Over time, it will be consumers that make the decision about whether they want this to be included in the package and what effect it would have on affordability and how they balance affordability versus offering these new kinds of opportunities to consumers.

ELIZABETH FARNSWORTH: Paul Wolpe, do you think that this drug is part of a larger trend in American life where problems that used to be seen as psychological or just part of aging are now being dealt with medically, and is this a good thing?

The medicalization of social problems.

PAUL WOLPE: Well, the medicalization of social problems, the medicalization of diseases like alcoholism, which used to be in the realm of the judiciary--it was drunk and disorderly; now it's a disease. We are medicalizing a lot of social behaviors and then using pharmacological solutions to them. And this is certainly an example of that. And as was said earlier, if you have a couple with a dysfunctional relationship and you add Viagra, you now have a couple with a dysfunctional relationship and an erection. And nothing has really changed. You know, many men think that they had relationship problems because of their lack of erection and don't understand that they have a lack of erection because of relationship problems. So I think the idea of pharmacological problem--solutions to social problems is a difficult one. This, of course, doesn't apply to those men with organic dysfunction, but I think that is going to end up being a fairly small section of the Viagra market.

ELIZABETH FARNSWORTH: Well, before I go to Dr. Sharlip on this, where does leave you, Mr. Wolpe, on the question of who should pay for this drug?

PAUL WOLPE: Well, I think it was interesting that Mr. Kahn said that this is not an ethical problem but an economic one and then asked the profoundly ethical question to illustrate it, which is: Do I want to pay for someone else's sexual health, which is an ethical not just an economic question. I think he's right, though, that consumers are going to make this decision. And what consumers are going to do is demand that their insurance companies pay for Viagra. But that's when the interesting question comes. What is a reasonable dose of Viagra for a week or a month? I understand that in California Blue Cross/Blue Shield is talking about six pills a month. Is that the amount of sex that impotent men are going to be allowed to have, according to their insurance companies? These are profound questions that we're not even nearly ready to answer yet, I think.

ELIZABETH FARNSWORTH: Dr. Sharlip, you had a couple of points to make, I think.

DR. IRA SHARLIP: The insurance company is not legislating the number of times per month that its insureds can have sex; it's saying this is what we can afford to pay for; you can buy as many of these as you'd like, have sex as often as you want, but this is the amount that we can afford to pay for this. I have to disagree with Mr. Wolpe about one thing. Let's not forget that there are approximately 20 million men in the United States between the ages of 40 and 70, who have organic erectile dysfunction; they have mild, moderate, or severely decreased erections, and it's on a physical, not a psychological basis. There's a very large portion of the population, particularly men over the age of 50, who have a real organic problem.

ELIZABETH FARNSWORTH: Now, Dr. Sharlip, what about the hype and disappointment question, has there been so much hype through no fault of yours and the other urologists perhaps, maybe just the journalists, on this question that it will inevitably lead to disappointment, as I believe has happened with other drugs?

DR. IRA SHARLIP: I've been very surprised at how well the drug has performed in the general population. The history of drug trials is that the drug performs better in the trials because the drug is applied to a very limited number of patients with specific indications. And then when drugs get applied to a larger population, it doesn't perform as well. My experience with this drug is that it has exceeded the performance that I expected of it.

ELIZABETH FARNSWORTH: Well, thank you all very much for being with us.

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