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IRA FLATOW, host:

You're listening to TALK OF THE NATION: SCIENCE FRIDAY. I'm Ira Flatow.

Up next, keeping prescription drugs safe and a new report that looks at whether the FDA is up to the task. The FDA commissioned the report from the National Academies after critics said the FDA failed to act quickly to deal with the safety issues surrounding Vioxx. You remember two years ago Merck pulled the blockbuster drug off the market after studies showed an increased risk of heart attacks for patients on the drug.

Last week the National Academy's Institute of Medicine released its report looking at the drug review, approval and regulation process at the FDA. The Institute found a host of problems. First, a lack of regulatory authority and chronic under-funding, organizational problems - all of which make it difficult for the agency to ensure the safety of prescription drugs. Especially the new ones. Especially after they have reached the mark of following them up and seeing whether they are as safe as we think they are - sort of what happened with Vioxx. The report recommends an overhaul of the agency, saying it needs to pay as much attention to monitoring drugs once they're on the market as it does to monitoring the approval process beforehand.

So for the rest of the hour we're going to talk about prescription drugs and the drug safety system. Does the FDA sacrifice safety to get a drug to market quicker? If you'd like to join our discussion give us a call. Our number: 1-800-989-8255. 1-800-989-TALK. Let me introduce my guests.

Sheila Burke is chair of the Committee on the Assessment of the U.S. Drug Safety System at the Institute of Medicine and the Deputy Secretary and Chief Operating Officer at the Smithsonian Institution in Washington. She joins us today from Washington. Welcome to the program, Ms. Burke.

Ms. SHEILA BURKE (Chair, Committee on the Assessment of the U.S. Drug Safety System at the Institute of Medicine): Thank you very much. I appreciate the opportunity to be with you.

FLATOW: You're welcome. Scott Lassman is a senior assistant general counsel at PhRMA, the Pharmaceutical Research and Manufacturers of America in Washington, and he's also joining us from his office there. Welcome back to the program, Mr. Lassman.

Mr. SCOTT LASSMAN (Senior Assistant General Counsel at PhRMA): Thanks for having me back.

FLATOW: You're welcome. Sheila Burke, I mentioned the Vioxx was really - was the Vioxx problem what prompted this report and this study?

Ms. BURKE: Well there's no question that that issue as well as really a number of events led to the questions being asked about the adequacy of post-marketing surveillance and led to the request being made by the FDA as well as a number of other organizations, including the Center for Medicare and Medicaid, and the VA participated as well.

FLATOW: And there was also the problems with using antidepressants in younger patients, right?

Ms. BURKE: That's correct.

FLATOW: In the drug approval process you've identified the period of time after a drug comes to market as the problematic period. Why is that?

Ms. BURKE: Well under the current system, extensive evaluation before approval, occurs, and extensive marketing, after the approval - so that the use of the drug that's been studied in a relatively narrow population expands very rapidly and very widely to patients that perhaps might not have been exactly the same as those that were studied prior to approval.

And so what essentially occurs is a broader use, which exposes us to greater risks - some of which we might not have anticipated because, in fact, we hadn't thought to look at those populations. So again, the resources today at the FDA are largely focused on the pre-approval process, and there is an imbalance between both the personnel as well as money available for post-approval activities.

FLATOW: So you're saying when - just to part this out a bit - you're saying that when we do these carefully-selected studies under controlled conditions to get to be drug approved, that might not reflect the real life use of the drug by many more people for a longer period of time after the drug is on the market?

Ms. BURKE: You've exactly pointed out the issue. Again, there's a great deal of study that takes place prior to approval. But once the drug is in use it often is in use in a much broader population that presents somewhat different issues. Perhaps they are on medications that weren't studied prior to approval in terms of combination. They might have different conditions, in fact, in combination with the condition they're being treated for. So greater use, in fact, sometimes presents a different set of issues.

FLATOW: Should we not tell patients the facts about this, that there is, you know, even though it has been tested out, maybe we haven't discovered all those side effects that might happen?

Ms. BURKE: Absolutely. This will always be the case. There has always been uncertainty and this is nothing new. The best source of information, obviously, for a patient is their physician. But we would hope as well that additional information more accessible, more transparent - the fact that we are suggesting that a new indication be put on the label of new drugs will heighten the concern and attention to the fact that this is a new drug that might well present different circumstances and you ought to be particularly alert to unusual events that might occur.

FLATOW: You're actually talking about putting a symbol or something on the label?

Ms. BURKE: That's exactly right. We're suggesting a system not dissimilar to that which is in place in the United Kingdom, which literally puts a new indication on the label noting that this is a new drug that should be given particular attention.

FLATOW: Scott Lassman, as someone who represents the drug makers, what's wrong with Sheila Burke's logic?

Mr. LASSMAN: Well, are you talking about specifically with respect to putting a symbol on or just generally?

FLATOW: We could start…

Mr. LASSMAN: You know, I think the IOM really ought to be commended. They did a very comprehensive job at looking at a very complex issue. And, you know, I think our industry does agree with a lot of what they have said. We disagree with some of it and we still are reviewing other aspects of it. But I do think that they ought to be commended for doing a great job by looking at this issue.

FLATOW: Do you agree that sometimes the tests done on the drugs may not reflect what happens in real life once the drugs get out there?

Mr. LASSMAN: Definitely, but I think that it's important to recognize that the drug safety system that we have today is a very robust. It's not broken and I would, despite some of the press reports that you may have seen, I think that would be a mistake to take that away from the IOM report. Clearly there are things that we can improve on, and I think FDA is looking to improve on that. The pharmaceutical industry is certainly looking to improve direct safety, but by and large the system is not broken.

Really if you look at drug products that are approved today, we do know a lot more about the safety of those drug products than drugs that may have been approved 10 or 15 years ago just because the science evolves and we're routinely looking for particular safety signals.

Just to give you an example, testing on QT(ph) - which will look at potential cardiovascular risks of a drug product, or liver toxicity - routinely is done now and it may not have been done 10 or 15 years ago.

FLATOW: Sheila Burke, you said before that there should be more attention paid to what happens in the aftermarket, but there is an imbalance in the money that the FDA allocates for the pre-approval and the post-approval period.

Ms. BURKE: That's exactly correct, both in terms of the funds that are available to the FDA for post-approval work, as well as the number of staff that are focused particularly on that period of time in the life cycle of a drug. There is currently an imbalance. Clearly the FDA, I believe, has been under-funded for a number of years. But in this particular instance, there is a particular need - with respect to the post-approval process; again, both with respect to resources available to the FDA, whether it's to conduct their own studies, whether it is to hire the appropriate staff, whether it is to engage in additional new technologies - to look at what is increasingly, as Scott pointed out, a complex environment in which a great many questions need to be asked that are far more complex than they used to be. We have greater tools available to us and the FDA needs to have the resources to be able to apply those tools.

FLATOW: Are their organizational problems at the FDA?

Ms. BURKE: The committee found, in fact, that there were, we believe, organizational problems. Certainly the absence of stable leadership at the FDA, we believe, is something that has caused concern. We believe there is a tension that exists between the staff that are largely assigned to the pre-approval processes compared to those that are involved largely in the post-approval safety surveillance process; that a greater collaboration between those two -what should be complimentary activities and engaged activities - needs to take place. Our thought is that, in fact, we ought to consider drugs as being a life cycle; that attention needs to be given to the entire period of time that the drug is on the market; and that life-cycle approach ought to evaluate the risks in the context of benefits; and that we ought to look at engaging those questions as early in the process as possible; and participation by the broad range of staff at the FDA throughout that process is very important.

FLATOW: Do you feel that, on the whole, the drugs are being tested or being given enough time to be tested pre-approval?

Ms. BURKE: Well, of course, there is no reason that speed and safety need to be at odds. We believe, in fact, as many have called for, rapid approval is in fact a priority and ought to be considered as such. Getting drugs to the market for individuals is very important. So under no circumstances do we want to cause any greater delay.

We do think that the opportunity to examine some of these questions post-approval will improve the process. It need not delay the process further. It will allow the FDA, essentially, to identify those questions that might not be able to be answered prior to approval because of the absence of greater use, but allow them to engage those questions after the fact, so that they continue to inform us going forward.

So there are really issues both pre- and post-approval, but they need not be at odds to the desire to get drugs to the market.

FLATOW: I also found an interesting recommendation your committee made and that was two things. Let me go through both of them. One was to ban or limit these commercials we see on television, direct advertising, during the period when that product carries that symbol denoting the newness of it.

Ms. BURKE: That's correct. As I indicated, in the case of a new drug - and this is very specific to a new drug - we believe that in fact there ought to be some caution in how we encourage broad use of that drug until we know more about its application and the results. And that an absence of advertising during that period of time, and there is discretion given to the FDA - it need not be for every drug, it need not be for a very specific period of time, but really at the judgment of the FDA, given the risk of the particular medication - that the absence of advertising will assist us in slowly gaining knowledge, allowing that drug to be used under limited circumstances, as it was directly intended to be while we gathered this further information.

FLATOW: Scott, how do you react to that? I know that the drug industry spends $13 billion, something like that, on marketing to the public and to doctors and things like that. This is a big industry. Would they be willing to agree to that?

Mr. LASSMAN: Well, we certainly agree that physicians ought to be educated before a drug is widely advertised to the general population. In fact, just last year, Pharma and the pharmaceutical industry adopted principles, voluntary principles, for DTC advertising. And that was one of the principles that we did adopt. We called for companies to impose a voluntary moratorium until the doctors could be educated so that when the patient went in to see them, they could have a better conversation.

I think when you're talking about, you know, imposing government moratoriums, that is something that we would oppose. We certainly believe that DTC advertising provides useful information. It does get patients in to see the doctor that might not otherwise have seen it. And, you know, I think in this country while some are worried about over-utilization - and I think that's certainly a concern - a much bigger problem is underutilization of pharmaceuticals.

You got a lot of conditions out there such as high cholesterol, high blood pressure, diabetes and depression where patients are going under-treated. And if DTC can help get those patients in to see the physician, I think that's a benefit.

FLATOW: DTC is direct-to-consumer ads. Those ask your doctor ads, things like that.

Mr. LASSMAN: That's right.

FLATOW: 1-800-989-8255 is the number. We're talking about drug prescriptions and the FDA on TALK OF THE NATION: SCIENCE FRIDAY from NPR News.

Talking with Sheila Burke and also talking with Scott Lassman. Let's see if we can go to the phones and get a couple of calls here. Let's go to Tim in Milwaukee. Hi, Tim.

TIM (Caller): Hi. Yes. My question is how objective can you expect the FDA to be concerning new drugs when the companies putting out the drugs are the ones paying the FDA to approve them? I mean that's where they get a significant amount of money from.

FLATOW: Do they not pay, Scott, something like $400 million each to a fund?

Mr. LASSMAN: That's a great question. Yes, there is a program called the Prescription Drug User Fee Act, whereby companies are required to pay fairly substantial fees when they submit a drug application. I think it's important to remember, though, that that fee is paid to allow FDA to hire more people so that they can review those applications faster. It's not a payment for an approval, it's really just to help them get the review time down.

The decision can be an approval, it can be a disapproval. So…

FLATOW: Is the money earmarked for that particular drug when they submit it?

Mr. LASSMAN: No. It goes into the general fund. Not for any particular drug product.

Ms. BURKE: If I might…

FLATOW: Sure.

Ms. BURKE: …state a comment there. Scott's exactly correct. The PDUFA or the user fee that is currently in place in fact does provide funds that have allowed for the hiring of additional staff. I would note that in the committee report, having acknowledged that, it is our view in fact that there is really the need for additional federal resources to essentially balance out the broad range of funding we think ought to be applicable for what is essentially a public good.

That in fact to the extent that necessary, perhaps relieving some of the restrictions under the current provisions of PDUFA, which essentially provide that that money be largely for the pre-approval process. That those be relaxed to allow the FDA to use those funds more broadly. But that also additional funds that are appropriated funds from the general fund of the government ought to be in place and not increasing dependence upon essentially industry user fees.

Mr. LASSMAN: And let me just add that we would completely agree that the FDA ought to be fully funded and do support more fees - not more fees, I'm sorry - more funds from general appropriations.

FLATOW: This administration has just, you know, it seemed to be very, treating the FDA like a second citizen in many ways. There was a commissioner - and didn't have a full commissioner for many years, for most of the term, of this administration.

Ms. BURKE: Well, I think that, I don't know that I would limit the concerns, specifically to the last four or five years. I think there is a long history of the FDA under prior administrations not being adequately funded. There's a long history of an absence of stability in terms of the length and period of time in which an FDA commissioner serves.

Over the last 30 years or so, the range of time has been anywhere from two months to six years. So I, again, I think it is an issue, both funding as well as stability of leadership. I think it is an issue that has been there for quite some period of time. And I think there are certainly - I'm not I'd suggest blame. But there's certainly enough responsibility to spread around over a long period of time.

This took a number of years to be in the position it's in, and I suspect it'll take some period of time to correct these issues as well.

FLATOW: All right. We're going to come back, talk lots more with Sheila Burke and Scott Lassman, take your phone calls. Stay with us. We'll be right back after this short break.

I'm Ira Flatow. This is TALK OF THE NATION: SCIENCE FRIDAY from NPR News.

(Soundbite of music)

FLATOW: You're listening to TALK OF THE NATION: SCIENCE FRIDAY. I'm Ira Flatow.

We're talking this hour about drug safety. My guests are Scott Lassman, senior assistant general counsel at Pharma, and Sheila Burke, chair of the committee of the assessment of the U.S. drug safety system at the Institute of Medicine. She's also deputy secretary of the Smithsonian Institute in Washington.

Our number: 1-800-989-8255.

Just a general question about the Vioxx-like case. You don't have to talk about the Vioxx case in specifics cause there are other cases like it. But I've had doctors tell me that, you know, drugs like Vioxx are the only drugs that will work on some people. I mean shouldn't we not make a class of drugs, even though they may be higher risk, to allow drugs that cure or treat some of the most crippling diseases that have no alternative drugs to them for patients to take those things, and having the patients know the risk?

Ms. BURKE: If I might, Ira. There is no question that there are circumstances under which a risk is greater than it might what we'd hoped for. But, in fact, these are the only medications that are available for a particular condition. Under the current system, essentially we try to balance those questions of risk and benefits.

They are different with every medication. There is sometimes and agreement made or a decision made to allow a drug to go on to the market because of the unique circumstances of the condition that it treats, and that there are not similar or comparable medications available to treat this condition.

And so we're willing to tolerate a greater risk in those circumstances. Every situation is a different one. There is no simple answer to what is increasingly a complex question, and I think Scott would agree.

Mr. LASSMAN: Yeah. I think that, you know, raises a very good point, which is the very difficult balancing act that FDA much engage in when it looks at, you know, safety and efficacy issues with drug products. There have been, you know, fairly recent situations where drugs have been taken from the market and a small subset of patients, or maybe even a large subset of patients, really demands that it be put back on.

You know, one of our concerns with some of the proposals that are made in the IOM reports, proposals for distribution restrictions and the like, is that there the potential that it will limit the availability of these drugs products to patients for whom those drug products would be useful. And I think that's something that we always have to be careful of when we're trying to make this very delicate risk benefit balance.

Ms. BURKE: I would agree with Scott that we do have to be careful. I would absolutely agree as with the committee that each decision has to be balanced very carefully. I would not agree that in fact the decisions that we've made or the suggestions that we've made will in fact lead to fewer drugs being available or restrictions unreasonably on the availability of these medications to patients.

Again, there is great discretion left to the FDA with respect to use, with respect to directions given to physicians. And, of course, the ultimate authority lies with the physician in his or her judge with respect to the care of their individual patient.

Again, the desire here is not to slow up or impede in any way the arrival of medications on the market. It is simply to provide for adequate resources to maintain a safety surveillance throughout the life cycle of the drug. And frankly, to continue to inform ourselves as we gain more information once the drug is in broader use.

FLATOW: What about the idea and the practice of new pharmaceuticals coming on the market that are basically no better - I'm using that word - no better than the ones that are on the market anymore, except the ones on the market have lost their patents or not being as profitable to the pharmaceutical companies as the older ones are - which are now generic or available?

Mr. LASSMAN: I think that is somewhat of a myth. You may be talking about what is often called the me too phenomenon. And in fact, you know, even if you had several drug products in a class, we know that different drug products can affect different patients differently. And so it's always better to have a choice. If one drug product doesn't work, you have the option of another one.

Ms. BURKE: I would also suggest that one of the reason that we in fact, believe that this post-marketing surveillance and resources is so important is that, frankly, ongoing evaluations of drugs that are on the market can, in fact, benefit all parties, including the industry. The lipid-lowering statin drugs are a good example, where a number of large, long-term clinical trials have provided high-quality evidence about health benefits of statins. I mean, they have continued to inform us.

So our goal here is not simply again, in the attention to the pre-approval process, but rather to continue to gather information once drugs have been on the market when additional medications come on the market that are similar -perhaps not exactly the same, not simply the generic, but rather similar in a class - that there may be some difference and that we ought to be alert to those circumstances and have the capacity in the FDA to, in fact, examine those and to continue to inform us throughout the period of time when those drugs are on the market.

FLATOW: Ed in Berkeley, California. Welcome to Science Friday. Hi, Ed.

ED (Caller): Hi. I don't mean to change the topic of this, but back to what you were originally proposing. So it seems to me as though the smaller allocation of funds for testing, results in the beta testing of these drugs by the American public.

FLATOW: So in other words, the public is the guinea pig on this?

ED: Well, there's always a gradual amount of release to a larger and larger population, but it seems as though money spent here would really be effective. It's a good place to spend money.

Ms. BURKE: Ed, if I might call you Ed…

ED: Yes, please.

Ms. BURKE: You're exactly right, that in fact, there is knowledge to be gained. There is no question that once a drug hits the market, its intended use may be much broader, and to be informed about that is important to us in terms of providing adequate information to physicians and patients about the risks and the benefits. And there is no question that new information is gained once that drug is in that broader market.

ED: How much more do you think? Twice as much money, three - five times as much money? What do you think would be a practical…?

Ms. BURKE: Ed, you've asked a question that we as a committee examined and don't, frankly, have the answer for, but believe what has to occur is a very careful analysis by both the FDA, as well as by Congress to look at exactly that question. We didn't presume to know the answer to exactly how many individuals or what resources, for example, in computer capacity or the ability to do data mining. We suggested in the study that there are areas where we believe there needs to be investment - the ability to do extramural as well as intramural research on the part of the FDA. But we did not put a number to those proposals because, frankly, we didn't have the ability to do the kind of detailed analysis necessary to give you a real answer to that question. I think it would be adequate to say from our perspective, more is better.

There's just no question there needs to be more. How much more, I think, is a question that has to be examined carefully.

Mr. LASSMAN: This is Scott. We would also agree that more needs to be done and that, you know, once a drug product is approved, you need to have a robust surveillance system to detect any issues that might arise after approval. I would disagree, though, with the implication that folks may be guinea pigs testing new drug products. As I said before, I think we know more than ever about the safety and effectiveness of a drug product these days, once it's approved. I think folks can be comforted that when FDA approves a drug product, it has a positive risk-benefit balance. But I do think folks need to understand that all drug products have risks. (Unintelligible) important to talk to their physician about whether a particular drug product is right for them; to make sure that the physician has read the drug label, understands the benefits of the drug, understands the risks and can make an informed decision for that particular patient's particular situation.

Ms. BURKE: Frankly, we need to do a much better job of making sure those labels and that material is transparent and understandable. Having looked at some of that information myself, it is at times incomprehensible. And I think it is incumbent upon us, the industry as well as the FDA, to do a much better job of providing that information to patients and physicians so that, in fact, it is understandable.

FLATOW: You think a patient can read that 5-point writing on a pull-out of a drug box?

(Soundbite of laughter)

Ms. BURKE: That's my point.

Mr. LASSMAN: Yeah, well, there's no question that drug information is complex. You know, I think there is somewhat of a dichotomy here, for people - on the one hand, they want to know every single risk out there, and on the other hand, they want it to be wrapped up in a nice summary. But actually, FDA has just implemented something that's pretty much along those lines. They've sent out a new regulation for drug labeling, which actually will provide - up front for physicians, a summary of the most important safety and efficacy information.

Ms. BURKE: Yeah, no questions…

Mr. LASSMAN: …long way to addressing some of the concerns that Sheila's raising.

Ms. BURKE: Scott's right. In fact, they are making some progress in that respect, and I think they ought to be noted and thanked for that. And I think they recognize we need to continue to improve that, going forward.

FLATOW: What about all the physicians who are using drugs off label? They're prescribing them for diseases that they are not intended for?

Mr. LASSMAN: You know, that is something that has always occurred, and that is pretty much recognized as well within the legitimate practice of medicine. I think it happens more in some specialties than others. For instance, I know in oncology, the treatment of cancer, off-label usage is something that often can be the standard of care. So I think it is something that is legitimate. I think physicians do need to know information about the latest uses. I will note that that is something that the pharmaceutical companies are prohibited by law from promoting. Companies cannot promote for off-label, but again doctors can and do prescribe, and it is an accepted and legitimate practice of medicine.

FLATOW: Chuck in Minneapolis. Welcome to Science Friday. Hi, go ahead.

CHUCK (Caller): Hi. I just wanted to represent the perspective of some of the end-users, I guess. It seems to me that there's a lot more advertising, and it's a lot more aggressive for a lot of drugs, especially like the anti-cholesterol. And also that a lot of the things that are prescribed for ADD and things like that - you go to the doctor and there's a big smorgasbord selection that you're given, and then you can sort of pick and choose by these little blurbs. And it's - the push for it is very quick. There's this - and then people get involved in Paxil that are difficult to get away from once they start using them. It seems like it's a lot more aggressive process than it used to be.

FLATOW: All right, thanks for calling.

Mr. LASSMAN: This is Scott. I'll jump in. You know, clearly DTC advertising has been, you know, one of the controversial issues we've been dealing with recently. About a year ago, the pharmaceutical company adopted principles for DTC advertising, and I believe 28 of our companies signed on to those. And they call for, I think, a lot of improvements in maybe the past practices. One of the things it calls for is for companies to submit TV advertisements to FDA ahead of time so they can get FDA's feedback before they put the ad out to the public. And I think that those principles, which we just implemented in January, have made a big difference. And I hope people have seen the difference the last couple of months.

FLATOW: Talking about prescription drugs this hour on TALK OF THE NATION Science Friday from NPR News. Talking with Scott Lassman and Sheila Burke. Do drug companies have a duty to report side effects that they see with the usage of their drugs, that were not detected beforehand?

Ms. BURKE: They do indeed. There were, I believe, least year - and Scott, please correct me if I'm wrong - I think there were somewhere in excess of 400,000 adverse events reported. A percentage of those were reported from the companies. They, in fact, are required to do so, and in fact do so. So there is, in fact, a system out there to begin to collect that information. But one of the challenges we face is isolating those that are unique and need to be followed up. Some are not as clear, because of the volume of information. And one of the tools that we would hope the FDA would have available with additional resources, is the ability to look at that adverse-event reporting system, the error system. Look at it, consider what kinds of changes might be made, how better to mine that information, how better to gather information over a period of time about the usage of a particular medication.

But again, to answer your specific question: Yes, the companies are, in fact, required to report adverse events. And information is gathered from consumers directly, from physicians and others. And the question is how best to use that information to inform us to make decision as quickly as possible.

Mr. LASSMAN: And just to add on to that, Sheila is definitely right. Companies are required by law to submit any adverse event that they learn about, directly to FDA. Often there are strict timeframes associated with that. So for instance, if they learn of an adverse event that's serious and unexpected -that is it's something that they haven't seen before - that has to get reported to FDA within 15 days.

There's also something called an annual report, whereby every year, companies are required to take all of the information that they have learned about that year - whether it be from adverse event reports or from clinical trials and report that information to FDA. And they also must tell FDA what they're going to do to address any problems that are noted, for instance, labeling changes and that kind of thing. But we also agree with Sheila that, you know, FDA needs to take a look at how it's doing things and do it better. They need more money, they need better tools. Right now they rely mostly on the adverse-event reporting system, and you know, if they can get better access to large health-care databases, rely more on epidemiological studies and get that kind of expertise in-house, it's only going to improve the system.

FLATOW: I want to thank you both for taking time to talk with us. I do want to mention that we did ask someone - the FDA to send someone to represent the FDA, and they refused to do so and didn't break their track record. Sheila Burke, chair of the Committee on the Assessment of the U.S. Drug Safety System at the Institute of Medicine and deputy secretary at the Smithsonian Institution in Washington; Scott Lassman, senior assistant general counsel at PhRMA, the Pharmaceutical Research and Manufacturers of America. Thank you both for taking time to be with us.

Ms. BURKE: Thank you, Ira.

FLATOW: You're welcome.

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