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It seems that almost every day now in the news there is a story that one way or another has to do with prescription drugs. Now the cost of prescription medications make up a big part of the health care cost in this country. And one of the things that we're reminded of every day is that he we here in the United States pay more for our medicines than people in any other country. In addition there are stories about medicines that are approved and that are put out there for use and people take them and then sometime later we find out that they had bad side effects. We are greeted almost every day on advertising in magazines on television with ads for prescription medications and the idea is at least the idea that the drug companies have is that we will go to our physicians and say please prescribe this drug for me. These are all very very big questions. Any one of them is certainly worthy of an entire hour of conversation but this morning will try at least to touch on some of the big issues and of course people who are listening are welcome to call.
We have a guest who spent a lot of time thinking about this subject and has authored a book that's titled Powerful Medicines the benefits risks and costs of prescription drugs. The book has been out now for a few months it's published by Knopf. And our guest is Dr. Jerry Avorn. He's professor of medicine at the Harvard Medical School. He's also chief of the division of pharmaco epidemiology and pharmaco economics at Brigham and Women's Hospital that's in Boston. His research centers on issues that include medication use with particular reference to elderly patients and chronic disease. And he's interested in things like how would his physicians make the decisions on which drugs they will prescribe how it is that we decide that certain medicines actually work. What we know about how compliant. Patients are. That is whether people are taking the medicines the way they're supposed to and many other issues as well. He's joining us this morning by telephone. And as we talk questions comments from people
who are listening are welcome. We just ask callers to be brief in their column and their comments and their calls so that we can keep the program moving. Get as many people in as possible in Champaign-Urbana if you'd like to call the number to use 3 3 3 9 4 5 5. We do also have a toll free line. That was a good anywhere that you can hear us around Illinois and Indiana if it would be a long distance call for you. Use the toll free line in fact if you're listening on the Internet if you're in the United States you may also use the toll free line that's 800 to 2 2 9 4 5 5. Dr. Evelyn Hello. Hi thanks for talking with us. Thanks for having me. Well as I said that you cover a lot of territory in this book and any of these things that I have mentioned I'm sure that we could spend an entire hour on. Will try to hit some of the high points and and I'll ask you some of the basic questions and then of course people who are listening they can ask their own. Maybe let's start with the one that seems to be on the top of a lot of people's agenda agendas when it comes to prescription medications and that is
cost and why it is that drugs are so expensive and related to that why it is that in the United States we are paying more for our medicines then I think anybody else anywhere in the world. Well we are the only industrialized country that does not have some kind of negotiation with the drug makers about what they're going to charge for their medicines. And as a result we do have prices that are sometimes as high as double what they are in other similar kinds of economies like Canada England Japan Australia France Germany Sweden and so forth. And we also ironically are the only industrialized country that does not have some kind of provision to make sure that everybody in the country has drug coverage so that if they need some medicine they can be assured that they're going to be able to pay for it. Why let me ask you this. Again this is sort of related because I think that one of the criticisms that has sometimes been made of the drug companies has to do with the extent of their profits and that there are
some people who would say something like Well we don't begrudge the drug companies profit we understand that they have to make money to stay in business. But if you take a look at the level of profit in the pharmaceutical sector and compare that with a lot of other sectors one might argue that it's excessive. Now on the other hand of course the drug companies say their response is Well look we need to make profit because it's expensive to develop new medicines and if you expect us to continue that and develop more new medicines we've got to have the money to cover those costs. So it seems that they're saying to the consumer hey you can have your choice either you can have affordable medicine or you can have new fantastic cutting edge drugs but you can't have both. What can you say about these two points One is you know is it actually possible to say whether or not drug companies make too much money. And then this issue of the relationship between profit and. The amount of money that pharmaceutical companies put into research.
Well as you mentioned it what I call in the book the research ultimatum essentially says you know you can either have affordable drugs or and we make a lot of profit or we're not going to discover any new medicines and you're all going to get sick and die. And the problem basically is that we don't really have affordable drugs or a very rich pipeline of new products coming out on the market. One of the things that that industry analysts have looked at in relation to the drug companies is how really lame their research pipeline has been over the last 10 years. At the very time that they've had these unprecedented dollars. And part of the reason is that an awful lot of those dollars go into promotion and those direct consumer ads that everybody sees on television at night. Those are very expensive. And if you actually break down where the dollars go in fact about 30 some odd percent goes for promotion marketing and administration. And then about another 20 percent goes for profits for the shareholders which is OK if they are producing a lot of new products which they're not and only
about 11 to 13 percent actually gets ploughed back into research and development and all of that a lot of it is to discover ways of changing around the molecule so that it can be patented again when its patent expires and at only a small fraction of that 11 ur 13 percent actually goes to the discovery of important new medicines and so it's a GR. It argument that they that they have to make you know let us have all your money and then are or you're not going to have any new drugs but in fact that has not been borne out they have gotten all of our money but we have not been getting the new drugs. Let me ask you a quick another question then I have a couple of callers so we'll get to you and that you touch on the issue I mentioned advertising you touched on that and that is one of the big changes that we have seen within the last not all how many years a great increase in advertising of prescription medicines to consumers and as I said the hope of the drug companies is that we will see these ads and we will decide gee that sounds good and I've got that problem and I need that. So I will go down to my doctor
and say look I know I need this thing where you prescribe this for me and apparently that works and doctors are writing prescriptions for them. I wonder what you think about drug advertising to consumers and whether that's either good or bad or maybe not really one of the other. Well somehow every other country on earth manages to run its health care system without allowing direct advertising of prescription drugs to consumers except for New Zealand. No other country allows it and I hear New Zealand is thinking about changing its mind. We never allowed it until 1997 when the companies decided that this would be a great way to increase their market share. And yes it does work as you said it. There's a lot of good data that a patient will often come in to a doctor waving a you know an ad they've seen in the magazine or talking about a commercial they've seen on the news the night before and saying I want that. And while doctors are not going to be giving people cholesterol pills if they don't have high cholesterol they certainly are going to be giving them the more expensive cholesterol pill that there is an ad for as opposed to an older one that will this perhaps generic and will be much much less expensive and work every bit as well so it is
money well invested from the company's point of view because it does change around prescribing but it drives up the cost of prescribing because no one is advertising good old cheap drugs that have been around for years that work perfectly fine. The only drugs that get advertised are the ones that are very very expensive. And that's helping to make our drugs more affordable. We're given the the lack of enthusiasm. It seems that we have in this country for regulation do you think. How likely do you think it might be that that one day we would decide to go back to what we had before and say no to the drug companies no you can't do this anymore. Well the companies have got some of the biggest lobbying clout in Washington and they are very good friends of Certainly the current administration but also they spread around their money to both parties and they have been very successful in fighting any kinds of. Regulatory pressure of any kind including advertising and will probably continue to do succeed in that way and so I don't look for that to change very much in the future I think. All that we can hope for is that patients and doctors might be a little bit more skeptical and might say hey wait a
minute I'm not going to be taken in by this. That's how millions of people ended up on Vioxx who then some of them went on to have heart attacks and stroke so maybe to be more skeptical is the best hope we can offer. I have a couple of callers here we'll get right to them. Let me just to quickly introduce our guest again we're speaking with Dr. Jerry Avorn. He's associate professor of medicine at Harvard Med School author of the book Powerful Medicines the benefits risks and costs of prescription drugs is published by Knopf. First caller here in line is listening in Indiana this morning. Ally number four. We will go there alone. You've talked about the one thing I was going to ask about in regards to replacement of monies from the profits at the 11 percent level for a new research. I wonder if you could throughout the program more or less attack the physicians or at least explain them that the drug companies have and what I'm going to ask about is that drugs are not safe from other countries. We have the FDA to make sure everything is safe things from Canada you can't
trust which is unusual I know a lot of the drugs we kid are made in the other countries. What if you could talk about that. That part of it also. Sure that's a real important issue because I think the FDA has not done the public a big service by essentially throwing sand in people's eyes on this issue over the last couple of years. Many of us know Canadians they tend to be rather civilized intelligent healthy people and they're not dropping dead on the streets of Toronto because of all these rogue medicines. What the companies don't mention and what FDA unfortunately doesn't mention is that the drugs that are sold in Canada are generally the same drugs made by the same companies in the same factories that the drugs that we buy here in the U.S. are the only difference is that if a bottle if they all of a vi Agora that Pfizer makes tend to get made in Ireland. So when they ship the VI agora to Canada they sell it at a given price. And when they ship it to the U.S. they just double the price from the same factory so the idea that somehow Canadians are using this bathtub remedies that are made in a vat somewhere in the third world is simply not true. The FDA could definitely regulate
the importers of drugs from Canada just as they regulate Pfizer's ability to bring in drugs from plants that it has in other parts of the world. And the idea that this somehow can't be controlled is simply bogus. There is though is there not concern about some about some of the medicines that people might be buying particularly over the Internet it's one thing to say to two if you could go across the border into Canada and go into a Canadian pharmacy and present them with a prescription and get the drugs or even I suppose you could. There are people here in the United States I'm sure that are getting their medicines from Canadian pharmacies that way and there's no problem. But if you're ordering from somebody that you don't actually know is is there not some possibility that you could be getting a drug that was counterfeit or that was not what it says it is on the label and might be a problem of course. And there's a fairly straightforward solution to that possible problem which is that there would be certified sources whether they be Canadian
pharmacies or Internet so that all internet services that are certified by FDA as only using drugs from reputable manufacturers that are made in approved plants and again we we do that for the drug companies when they want to import products from plants in other countries. That is certainly a role that if you could take on as it already is doing in many sectors it just has chosen not to it has chosen instead to say we could never figure this out and it would be a real hassle for us. And so you're on your own. Of course once they take that position it does open up the possibility that somebody could get some rogue Internet provider that is actually shipping bad stuff but a lot of states in fact in Illinois I believe is one of them. I have been looking into going through the proper channels and working with countries like Canada or it could be England or Germany or Japan and working with their regulatory authorities to make sure that these Internet services are only getting drugs from reputable sources and that can definitely be arranged if the government wants to make it happen.
Let's talk with someone here in champagne. Someone on a cell phone line number one. I'd make a suggestion that you might comment on it based upon the discussion earlier as to what companies were saying in terms of why they charged so much for the drug. It seems that what we have in this country is is a culture of dishonesty and POC withy. In real life but the drug companies should say is we're business and we're going to maximize our profits and because we have to maximize our profit because we have shareholders and we have our own salaries and that that's what we do. And then the government should be equally honest and they should say we recognize that you're a businessman it's your job to maximize your profit. But what we do for you is we have an organization called the FDA which does or at least supposed to look checked at the medicine that you supply to the
public. Quite safe. And by doing that provide you with a service we protect you or we should from lawsuits for side effects that you can't be held responsible for in the HEU knowingly that those side effects and exchange for are doing that providing you with that service as well as service to the community of course we want you to put more money into developing new drugs. It seems to me that we should just lay all the cards right out there and the government should say you know it's fine you have business you also have a monopoly which we help enforce and therefore we're going to insist that you did. And maybe you can comment if you have any say thank you. OK thank you very much I think you've laid out some very important and very perceptive issues and you're exactly right. There is sometimes a tendency and frankly the companies are the ones who really bring us this image the most that they somehow are not really corporations like
General Motors or IBM or Enron but rather they are somehow in the healing profession a much as one you know doctor might be and that somehow they have a different standard of behavior. And in fact the caller is absolutely right. And it's not an evil thing they're businesses and that's OK they're allowed to be businesses. But let's say exactly as the caller proposes we should take them for what they are which is companies that are there primarily to maximize profit and if they stop. Doing things that their shareholders are going to feel is bad for business they're going to sell their shares and that we need to understand and also raise a real important point. It's not just the service that FDA provides in evaluating the drugs it is something you mentioned a little bit later which is the monopoly power that the government essentially will say to a company when you patent a drug we the government will enforce your right to not allow anyone else to make or sell that drug. While your patent is in effect and that's a pretty great deal and in exchange for that the companies ought to be expected to do something not because they're they're
good folks but rather because that's part of what is running a responsible business ought to be about. And we've bought a little bit too much into this television commercial image of they're just out there and their only concern is is having the American people get the cures of tomorrow. If that were their only concern they would go out of business in a hurry and we just need to know if that's the case. One other point about where these cures of tomorrow come from. There's a lot of the news this morning about a vast in one of the cancer drugs and how it's being shown to be effective for different kinds of cancers and that's wonderful. But what people tend to forget is the discoveries themselves are often the result of research that is performed with government grants often in university settings. In the case of a vast and it relates directly to some research that was done with funding here in Boston by Harvard from the National Institutes of Health and that the companies are then able to really capitalize on those discoveries and then patent the product kind of in the the last tail end of its development and get to keep all the marbles. And we sometimes forget that it's really the tax payer in the citizens who have paid for a lot of
that research not the companies. The number here in Champaign-Urbana for people who are listening if you'd like to call in with questions or comments. 3 3 3 9 4 5 5 we do also have the toll free line that's 800 to 2 2 9 4 5 5 Our guest is Dr. Jerry a board He's associate professor of medicine at Harvard Medical School and is author of the book titled Powerful Medicines the benefits risks and costs of prescription drugs. It's published by Knopf last year a different quest. And yet another question. One of the things that we know is that this goes back to the drug companies and their interest in making profit is that they are continually introducing new drugs because they are allowed to profit exclusively from a particular medicine for a while but then that runs out. So what they want to do is produce something new and in many cases what they're doing is they're taking existing medicines and changing them just enough so that they can claim that they are new. I suppose there are some cases where they're bringing out medicines that are completely new
but of course they're also doing the other thing so that they can then have something again that they can patent have exclusive rights to and make some money on. And they. Are continually making the pitch to consumers and also to physicians offering these new medicines and saying here look this is something we have for you that's new. It's much better than anything we've had before it's going to be great. So do you consumers ask your doctor and your doctors Here's a great thing you can offer to your patients and so that brings us to the question are new drugs necessarily better than older ones that had been prescribed to to do the same thing. Well not only are they not necessarily better they can sometimes actually be worse because they don't have the track record of safety and performance that a lot of the older drugs that we know about have and we've seen this with drugs like Vioxx in recent months that it turns out that it probably was not only not better than what we had before but maybe was worse in terms of its capacity to cause heart attacks and strokes. And you're absolutely right this is the
so-called innovation that we hear about on the and the massive commitment to developing the drugs often turns out to be this rather cynical. Let's change one atom on the molecule. We know it's not going to make this into a meaningfully different product. But lo and behold we can get a new patent on it because it is a new molecule and the patent office. It's kind of obliged to go along with that. And so there are some examples that I cite in powerful medicine that a lot of the listeners no doubt will have encountered like Nexium which is you know advertised copiously on television and it is simply a mirror image of what the older drug trial effect which has been around for ages and as parlous X Patton was winding down the company simply took the molecular mirror image of the drug and told the patent office it's a new product because it's a mirror image of the old product. There's never been any evidence that it's meaningfully better for patients heartburn than the older product was. The other example that a lot of people have seen commercials for is Clarinex. It is the cousin more than that of the twin of Claritin the
anti-histamine allergy medicine Claritin patent was running out and not content with saying we've made billions of dollars on the struggle over the years and now let's move on to discover something new. The company that makes it took the molecule that your own liver turns Claritin into once it's being metabolized in the body and itching to do something which is actually Clarinex and they said oh we've discovered a new molecule. In fact everyone who takes the Claritin pill within a couple of minutes has made it into Clarinex. But now we have all these Clarinex ads as if this is a breakthrough product and in the book I kind of call that the triumph of marketing over science and instead of coming up with important new discoveries. These are rather self-serving little molecular manipulations that don't do good for anybody except you can then have a new patent and a brand new ad campaign. Well this is something that at least has not escaped the notice of HMO those who prescribe has have some kind of prescription benefit for their their patients and for example in with the case of Nexium and prolific that
what a lot of them have done is that when Prozac went over-the-counter they said to their patients OK if you were taking this before a subscription medicine will continue to cover this for you. We will pay for you to use the over-the-counter version. Knowing I'm sure knowing that while it still was going to cost them money that if suddenly all their patients decided they wanted to take Nexium it would be extremely expensive. So obviously they have they have caught on. Do do managed care organizations is it possible that they might sort of undercut this strategy the drug companies have about saying that we have this new medicine it's new it's great it's different the old stuff. Forget that it it's not as good as it was. And prescribe this new thing and take this new thing even though it's a lot more expensive obviously the most in managed care. People say no not all. We think the old medicine is just fine and we're going to continue to provide that to our patients and maybe even if if you use if you release it as an
over-the-counter medication. You know the HMO have certainly taken a lot of heat in recent years but one of the things they are pretty good at doing is cutting through a lot of the smoke and mirrors and looking at these brand new improved products and saying we're not convinced then they can bring to bear teams of doctors and pharmacists and pharmacologists and economists to really look at these things very carefully and come up with a reasonably good decision much easier than a given loan. Doctor in solo practice can do and yeah. They definitely in the case of the prozac Nexium switch are going in a very reasonable direction in that regard of course the drug companies are always one step ahead of everybody. They responded by having an unexpected shortfall in the availability of private sector over-the-counter and there was an article in the paper just a week or so ago saying if you go to an awful lot of drug stores you can't find the Prozac. It turns out it's made by the same company that makes Nexium. And so at some point they said let's not cut our own throat if all these people are switching to our over-the-counter
product. Let's make it scarce. And while we don't have evidence yet that that's been going on. It sure is surprising that the company somehow cannot make enough profit to keep the over-the-counter shelves stocked. So there it's this kind of cat and mouse game that goes on but. But yes often the age of most can can make a useful dent in the problem. Well you know that's an interesting point of interest that you raise that because I read the same story and I think that for their part the drug companies the the company that thinks AstraZeneca that makes it says Now whether this is true or not they. They perhaps should have realized because what they started to do was aggressively promote the over-the-counter version which now of course anybody can go out and buy aggressively promote that to consumers. And there apparently are a lot of people with heartburn in this country and people just went and went out in Indeed and bought it so that perhaps in combination with the fact that in HMO that they were switching their patients they were saying OK we'll continue to cover your problem and you can have the over-the-counter that there was
there was an at least what the drug company says is there was an unexpected level of demand and they were surprised that they couldn't meet. So they're obviously they've they've got a position on it. Other people have said what you said they said well maybe the drug company actually did this on purpose because they knew that they would make more a lot more money selling the Nexium than the problem would. It sounds like you're saying well we really don't know which of these actually is true. We don't have the facts at least I sure don't know which is true but it's a little surprising to me that a company that's been making this drug for so many years and I've got factories churning it out have a marketing plan that they somehow are surprised that it's working and suddenly run out of the drug at the very same moment that they are making the competing drug that they make a lot more money on so I think everybody will come to their own conclusion I'm pretty suspicious. All right let's talk. Some other people here in the next caller is in loving one. Number one I harbor and we have pretty much the same dia going on with a pesticide
where you can live. It's a good example you know the market is round where you can go to any other country in the world and get the stuff at a fraction of the cost. And I just wonder is this just common with I guess all is this is part of the chemical industry away operators. I think it's perhaps the U.S. government and the way it operates probably more than any other country. We have got lobbyists and industry representatives sitting in in Congress and making the rules and regs and often their voices get heard a lot louder than the average patient or farmer or citizens need to get get heard about. And that's one of the ways that every other country manages to contain costs is by setting up a level playing field where there is some kind of constraint on what can get charged. We don't have that here in in large part that's because we have the industries whether it's the chemical industry a pesticide industry writing the laws.
Hope that gets at the question the call is good to back here locally to a caller on line number two. This is someone in our band. Well yeah you briefly talked about the possibility of foreign pharmaceutical and pharmaceuticals getting into the this market and you know taking up this huge vacuum. Where are our pharmacies. We want to do the high profit. Chronic stuff and a lot of a lot of a lot of companies I understand like in Europe have a different approach and they're willing to produce drugs that have low profit margins and and actually cure something instead of just treating symptoms of such etc.. And I was wondering if
if. Apparently there's some sort of there's some some pulp recently. One of our patents was thrown out by the European Patent Office on drug on the fungus side derived from name. And it's a tree that grows in India and it's traditional knowledge that that the name church seed had this particular effect in the U.S. tried to get in there and say we're going to patent it. And the Europeans are saying no. I hope that the fine of some ability of the drugs and the attitude and from Europe infiltrating. Or maybe the WTO I don't know. I don't know could you talk a little bit more about the possibility
of drugs from Europe say or maybe even Asia coming in year in and filling up these areas where our drug companies seem to refuse to get into and eyeing up banks. OK. Yeah this whole issue of globalization is a really interesting one in relation to drugs because on the one hand we keep hearing that globalization is good for everybody and that it enables people to buy. Products in the cheapest possible way and that keeps prices down. And certainly the drug companies are awfully good at playing the globalization game where if they find out that they can have a factory in Europe or in the developing world where they can make a drug cheaply they will certainly go ahead and do that. They're even running clinical trials now in Eastern Europe because then and China because it's cheaper to do clinical research there. But when customers or patients want to go ahead and say OK I want to make globalization work for me also I want to buy
my supplies i.e. drugs as cheaply as I can the companies come along and say oh no no globalization is not for you. You can do what we're doing. And I suspect that over time that's not going to be a very defensible argument if globalization is supposed to be available to everybody and we ought to be able to as patients buy our drugs overseas just like they can make their drugs and do their clinical studies overseas and over time that that may end up having a good impact on the price of drugs in the US. Let's go to another band. This is line number one. Hello. Yes would you comment on the recently passed half a billion dollar Medicare bill that was passed without a funding mechanism and with no provision for a more active economical purchase because of a volume buyer namely the U.S. government. Great question and boy if I got something to say about that you know the whole section in Powerful Medicines about how that is one of the bigger ripoff of the decade. You're absolutely
right that the bill was passed remarkably quickly there's only one day of debate in the Senate about this which is bad form for any bill whether you like it or you don't. And there is the there there the fingerprints of the drug companies and the insurance industry all over that bill because it is a windfall for the industry. And what the caller's referring to is that unlike as we were saying before every other country that has a drug plan all the other countries or all of Western Europe Canada Australia Japan have a provision saying we will make drugs available for everybody in our country. But in doing so we are going to negotiate as a buyer with the drug companies to make sure that the prices are affordable and by the way the companies still manage to make very handsome profits in those countries. Half of all drug sales are outside the US and they're doing fine they're not losing their shirts otherwise they wouldn't be selling drugs in those countries. But we actually went the exact opposite direction in the US. Again thanks to a lot of input from the drug industry when the Medicare law the Medicare drug bill was passed in December of 0 3
it had a strict provision in it that said that the government was not allowed to negotiate better prices with the drug companies. They had to just take it at whatever price the companies wanted to charge. And ironically even Tommy Thompson who was the recently left as secretary of Health and Human Services and kind of His last week on the job said yeah I guess it would have been better if they had given me authority to negotiate drug prices because everyone is now realizing that this Medicare drug benefit is going to be unaffordable for the government that the caller mentioned half of a billion dollars. It's now looking like it's going to be close to seven or nine hundred billion dollars over the next 10 years once it once it goes forth. And I. Suspect that's going to be a low ball estimate too and we're going to end up thanks to that provision with an unenforceable and an affordable kind of benefit that we may even need to back off on because a lot of folks who are conservative Republicans say hey wait a minute that's not the scale that I find on for for those government spending and it's more expensive than we were told. Maybe we shouldn't have this benefit at all so it's going to be a mess in January of 0 6 when it
starts. Could you speculate too on the provision recently shot down that disallows the terminal patients to use marijuana for to ease their pain and stimulate their appetite. I feel that possibly it's because of the drug companies cannot make any money off of marijuana because people can home grow it and therefore they don't want it that's why John Waters came to the Illinois legislature and preached against it. Do you have any feelings on that. Yeah I think that may be part. But I think an even bigger part is the kind of puritanical nature of our country which is that this is a substance that some people get high on and therefore we're just going to not let anyone use it even if it's got a good purpose. And I guess we make exceptions for alcohol but for other substances and clearly marijuana is not addictive it's a pretty benign substance. A lot of cancer patients claim that they get great benefit from it. So it's a it's sort of a mixture of our puritanical nature and
also the fact that it would be something that would be kind of hard to have a monopoly on the way we do for oxycontin for example. Thank you. Thank you other questions are welcome. 3 3 3 9 4 5 5 here in Champaign Urbana toll free 800 to 2 2 9 4 5 5 our guest for this hour focus 580 is Dr. Jerry Avorn He's professor of medicine at Harvard Medical School. He's chief of the division of pharmaco epidemiology and pharmaco economics at Brigham and Women's Hospital in Boston and is author of the book Powerful Medicines the benefits risks and costs of prescription drugs. It's published by can often it deals with all of these issues and questions that we're discussing here this morning so if you'd like to read more on the subject you can look for the book and we can and we also by the way got a website which is doubly guilty w powerful medicines with an S on it. Dot org. And people can take a look at some of what's in the book there aren't very good to come back to. The question one of the questions we're talking about a little earlier the fact that the drug companies continue to develop new medicines that they promote but they say these are new and these are
better they would be coming to a doctor and saying to to him or to her. These are new in these are better than what you were prescribing before. And you're I think one of the questions that you raise is well do doctors know enough about the drugs or are they too dependent on the information that's being provided to them by the drug companies when they decide if indeed the new drug is better than the older. Right. Big issue and it is not just what we doctors can and can't remember or learn about. If the data don't exist then nobody can know about them. And what I'm referring to here is the fact that there is no requirement that anybody needs to test a new drug against the older drug that you might have used instead of it. The FDA says favorite comparison when they are looking at approving a drug is a sugar pill and unless there's a major ethical reason like you know with an AIDS drug or a cancer drug where you can't put people on placebo whenever possible the FDA prefers. And of course. The companies love this that all you have to do is show that your drug is better than a sugar pill and if it is you can
market the product and that does nothing for me when I think about which drug is best for a given patient because patients never come in and say Dr. Avery can you please give me a pill that's better than nothing. They want to pill that's better than what they're taking now or better than what I would have prescribe them or better than their sister in law's taking and knowing that it works better than a sugar pill doesn't do me or them a whole lot of good. And yet that is the standard that FDA uses to decide about drug approvals and nobody does any follow up studies because they are expensive studies and we don't have a mechanism. Aside from the studies the companies choose to do for testing drugs in this country. Well another yet another one of these really big questions is Is this well how is it that drugs are approved for use and physicians are prescribing them in some number. People take them for in some cases for perhaps for years and then one day we realize that the drugs have harmful side effects and perhaps either they shouldn't have been approved or that at least when physicians prescribe them and people take them there they need to be better informed about
the potential problems and there are lots of examples just one recent example was the problems that seem to have come up with the Cox 2 inhibitors medicines like Vioxx and Celebrex right. How is it that we approved drugs and then later decide that they have problems. Yeah it's pretty scary stuff and I think the American public has gotten a real rude awakening in the last six months to issues that a lot of us who study these things for a living have been worried about for a long time. It all has to do with the fact that the studies that get done or the studies that the companies choose to do and if they don't choose to do a study and if FDA is being. Kind of passive in its regulatory role which it has been for the last four or eight years. Then the study simply never come to the surface and the only way we found out that Vioxx doubles as a patient's risk of heart attack or stroke was that Merck was conducting a study not to find out about that but to find out about whether they could sell even more Vioxx by having people take it to prevent the growth of Pul polyps in the
colon. And they inadvertently stumbled upon the fact that people were in that study as well having double the risk of heart attacks and strokes and that point they really couldn't keep the drug on the market although interestingly last month they're now coming back and saying we want to market it again. But the way we got into this fix and it's not holy cow how can these things you know happen it made must be some inscrutable problem. It's very clear what happened in the first studies of Vioxx. Going back to the late 90s there was in a study that was published in The New England Journal of Medicine of the year 2000 a four fold increase in the number of people having heart attacks in the Vioxx group compared to the comparison group. Now it wasn't a huge number of people and it wasn't significant statistically but it sure as hell was a scary signal at that point. What would have made sense would have been for Merck to say Gee I wonder if we have a problem on our hands let's do a study to follow up on this. Or FDA should have said this is worrisome. It may not be a clear enough signal to allow you to not market the drug. But we want you to follow up. Neither
of those happened. In fact Merck planned a study to look at whether Vioxx increases the risk of heart disease and then canceled it at the last minute. So we then have five years go by articles in the medical literature we published one of them Dr. Solomon and I and in one of the major cardiology journals in 2000 and three others published them even earlier saying there's a worrisome problem here about Vioxx and heart attacks. But the studies to follow up on it never got done and that's why we had to wait for five years of the drug on the market and tens of millions of patients before the answer inadvertently came out in a study of peoples colons and we could have known about this much earlier and the amount that Merck was spending on all those direct consumer ads with Dorothy Hamill skidding around on the ice telling everyone how great she feels a fraction of those dollars would have paid for the clinical study in 2000 would have the answer by 2001. Another caller here in Urbana Let's talk with. Them line Well you know you gave some statistics early on and I tried to stop and write them down but I don't think I did a very good job.
I was wondering if you could give Cisco a rundown I think you said something like 30 percent was spent on advertising marketing a ministration. Right. And maybe about 12 percent on R&D. But I think you said that part of that was was what I would call and you might want to save this term redesign or drugs or and not design a drug. Yes you absolutely got those numbers right. And that and those are not my calculations those are numbers from the Securities and Exchange Commission in Washington which the companies have to report their financial details to annually and they've got to say where their revenues went and so these are federal data that the companies themselves submitted and that's exactly the ratio. One is the old and new are and the split about half and half what I be wrong to say they were each about 6 percent. It's even worse than that if you look at again other people of have looked at this carefully and there's a couple of websites that you can go to that are there in the back of the book. When you look at what is the fraction of kind of useful R&D of breakthrough important products versus
Mitsu R&D is actually a small fraction is the me too it's well under a quarter and some people have said it's more like 15 percent of the new drugs are drugs that we really could have live without. So it's even worse than 50/50 on the R&D side. Now when you say 15 50 percent we could live without but that benefit I understand we we need it in the other 85 percent we could live without a 15 percent that we mean. Exactly right. But now that could include fail drugs drugs didn't do any good as I don't know if these are these are drugs that have made it past FDA approval and again the the source of that is the FDA itself that FDA as a new drug is is approved is proposed by a company. I think you missed my question. I'm sorry. I meant as opposed to saying drugs that didn't make any money did didn't do us any good ones that were redesigned. To go out to change one of the molecules or the color of something as opposed to whether they failed FDA. Right. I'm thinking only of the drugs that have passed FDA review. OK and of the drugs of the past
FDA review according to FDA zone designation only best 15 percent of those new ones are really important breakthroughs and the other 85 are like what we already had. OK. It would now see I could see something would have similar results but not be a somewhat similar chemical. I guess maybe that's what I'm driving at. Whether they're with it actually a new drug that just didn't do anything really awesome or whether they're a reengineered version of Like you said I think you compared PRI La Perla second Nexium or something. Right and they they lumped together the sort of new drugs that are. Molecularly different but no great shakes versus the trivial differences they put all those in the home category. OK and you said 20 percent to return on stockholders. Yeah and do you have anything that that adds up to what 62 percent or something. Do you have anything on the rest. Well the rest is things like their raw materials to buy to make the drugs and their cost of manufacturing and all the other stuff they need to get actual numbers to go with us.
No it's just everything is left out every day and he doesn't the website that I give him powerful medicines has got all those numbers I don't have them and I had started by the about that now no problem at all as they call it. To another color this is also someone listening in Urbana online too. Hello. You stay on long enough you get your questions answered by the previous question about profit. What are the solutions. I guess you know we know what the problem is in terms of Congress and the amount of money. You know what are the solutions here. OK that's a really good question because we're clearly not going to nationalize the drug industry nor should we. So you know what do we do now I guess is your question and it's a real important issue. I think it's a lot that we can do both as patients and as doctors and as a society. One thing is I think from from a patient perspective it's useful whenever a doctor prescribes something for you to ask you know is there a generic version of this available.
How long has this drug been out there. If it's something which is really no better than what else we've already got. On the doctor side of things I think we need as prescribers to be more skeptical and to not quite be as willing to go along with the flashy sales prevent patients and free meals and other goodies that we get. We put together a program of the what I called academic detailing in which detailing is the the sales rep activity that is so ubiquitous in this country from the drug companies and what I've been doing for maybe two decades now is doing that not from a commercial base but from a medical school base and saying you know he's got a pretty good at changing our behavior and getting us to think about new information. They're doing a survey can get a bigger commission and increase product sales but what if we were to go out and try and get that same approach to be used to just teach doctors how to prescribe good old fashioned plain vanilla drugs whenever they are the best ones to use. And we've been doing that for a while we we trained pharmacists to go out and be sort of an sales reps and they visit doctors and the
program turns out to save twice what it costs because you can save the pay or whether it's Medicaid or the Veterans Administration or the HMO. A lot more money than it costs to put on this program. And we put together some an advertisement for them to use and there are there's some examples of those on the on the website Powerful Medicines dot org where. They look like drug ads but they basically say doctor you don't need to use this crap because it's really not very good. And we're going to be doing that on a larger scale on the national level. We need to have a way of having growth and testing not the private property just of the drug companies. If we are going to be spending billions of dollars a year as one of the earlier caller said on a Medicare drug benefit and we're already spending billions of dollars of public taxpayer money from the vetted Veterans Administration and Medicaid in a lot of other programs we need to have some way that we can get the answers to questions we need about which drugs work better which drugs are more cost effective which drugs are safer and not simply hope that the drug committee is going to do studies to
Vili studies they're going to do quite understandably are the ones that are going to help their own sales. And Senator Grassley who is certainly not a flaming liberal said that he was holding his hearings about the FDA a couple months ago because as chair of the Senate Finance Committee he found that the federal program spent a billion dollars a year on Vioxx last year and that money we now know could have been much better spent. So it's not a matter of more federal dollars it's about. Trying to spend the federal dollars that were already going to spend more sensibly and almost certainly if we have those kinds of studies we would have known back in 2000 that Vioxx is potentially hazardous. We we would have known more clearly that it's no better than most of the drugs that are out there that people already can get over-the-counter like molten for example. And we would have a source of information that is beyond what the drug companies want to know and we would actually reduce federal expenditures by doing these studies instead of increasing it. And I'm hoping that that idea will catch on in the coming year especially once we see what the Medicare drug benefits going to cost. Thank you very much.
Thanks for the call. One of the questions I want to ask you was this it has to do with the way that we develop and then test new medicines and I'm assuming that it goes something like this. You first do your laboratory work and then you do experimental work on animals and then eventually at some point you start giving the medicine to small groups of people to see what it does in human beings and then at. Point after you've done that then they become widely available and I guess I'm I'm wondering do you. Can you really know what the effect of a medicine is going to be until you truly have large numbers of people taking it over a period of years and then fact in the first few years that a new medicine is available. Do we. Should we truly think of that as being actually an extension of the testing phase. That's a good point and I think yes that's a good way to think of it. There are going to be problems that are despite the best efforts of everybody involved. Not going to crop up right away so for example if you have a side effect that occurs one in every thousand people and you have
only fifteen hundred people in your study you may or may not see it. By the luck of the draw. And yet if I drug then it's taken as the Vioxx type drugs were by tens of millions of people you could have a real problem on your hands. And so one logical way of doing that would be to say not let's have every study last for 20 years before the drug is marketed because we do want to get useful drugs out there. But they have a very active program of surveillance once a new drug is on the market so that we have ways of finding out about these problems through epidemiological studies of the kind that we do in our group at Harvard or clinical trials that might need to be done to follow up on problems out because we know that they're going to be some rude surprises. The problem is that at the moment FDA is really understaffed and underfunded in that part of FDA all the money has been going to let's approve the drugs quickly. And the Office of FDA that's in charge of drug safety wants drugs are marketed has really been been strangled for funding and for and for morale as a matter of fact. We definitely need to do a better job on that and there's a number of proposals
Focus 580
Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs
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WILL Illinois Public Media
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WILL Illinois Public Media (Urbana, Illinois)
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With Jerry Avorn, M.D. (Professor of Medicine at Harvard University School of Medicine)
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pharmaceuticals; Consumer issues; Health; medicine; community; Drugs
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Guest: Avorn, Jerry
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Chicago: “Focus 580; Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs,” 2005-03-15, WILL Illinois Public Media, American Archive of Public Broadcasting (GBH and the Library of Congress), Boston, MA and Washington, DC, accessed August 12, 2022,
MLA: “Focus 580; Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs.” 2005-03-15. WILL Illinois Public Media, American Archive of Public Broadcasting (GBH and the Library of Congress), Boston, MA and Washington, DC. Web. August 12, 2022. <>.
APA: Focus 580; Powerful Medicines: the Benefits, Risks, and Costs of Prescription Drugs. Boston, MA: WILL Illinois Public Media, American Archive of Public Broadcasting (GBH and the Library of Congress), Boston, MA and Washington, DC. Retrieved from