Focus 580; The Truth About the Drug Companies: How They Deceive US and What to Do About It

Good morning this is Focus 580 our morning telephone talk show. My name is Jack Brighton. Glad you could listen today. Americans now spend something like 200 billion dollars a year on prescription drugs and prices for pharmaceuticals continue to rise much faster than the general rate of inflation. Some of us spend thousands of dollars every year on medications and millions of people have turned to buying drugs from Canada where prices are dramatically lower than in the United States Congress recently passed passed and the president signed a new Medicare prescription drug benefit for senior citizens. But now we're learning that the price tag could exceed half a trillion dollars. And the new law forbids negotiations between the federal government and the drug companies for lower prices. How did it get this way and what to do about it. During this hour focus 580 we'll get the perspective of someone who has had a front row seat from which to observe changes in the pharmaceutical industry and the impact on health care. For the past two decades Dr. Marshall Angell MARCIA ANGELL pardon me is a former editor in chief of The New England Journal of Medicine. She's the author of a book that must be driving the industry nuts. It isn't titled The Truth about drug companies how they deceive us and what to do about it.

Recently published by Random House in the book Dr. Angell examines the state of the pharmaceutical industry which he says has spun dangerously out of control. We'll talk with Dr. Angell about her analysis and direct recommendations for reform. During this hour as we do so we invite you into the conversation. All you have to do is pick up the telephone and call us around Champaign-Urbana the number 3 3 3 9 4 5 5. We also have a toll free line anywhere you hear us around the Midwest or if you're listening online anywhere in the continental U.S. 800 to 2 2 9 4 5 5 your question. You are welcome. A bit more about our guest Dr. Marcia Angell is a board certified pathologist having trained in both internal medicine and path ology at the Boston University School of Medicine. She writes frequently in professional journals and the general press on a wide range of topics including medical ethics health policy the nature of medical evidence the relations between industry and academic medicine among other things. She's the author of a previous critically acclaimed book science on trial the clash

between medical evidence and the law in the breast implant case. And Dr. Angell is currently a senior lecturer in the department of social medicine at Harvard Medical School and she joins us this morning by telephone. Dr. Angel Good morning. Good morning Jack. Thanks so much for your time. It's good to be with you. Now you were at the New England Journal of Medicine for about two decades. Twenty one years OK. And you say you observe major changes in the pharmaceutical industry during that time. What what did you observe. Well as it grew wealthier and more powerful it began to exercise. Lot of influence over the way research was done on its own products. It also began to exercise more influence over what doctors learned about the use of prescription drugs. I felt that this was really dangerous. Now you see there was a major pro-business shift in government policy beginning around 900 A.D. that brought profound changes to the pharmaceutical industry to talk about what happened.

Well part of it was just the atmosphere. You may remember that when Reagan became president. Suddenly there was a very strong pro-business culture in society as a whole and this extended to the pharmaceutical industry. And it took the form of very concrete laws that were passed by Congress that were quite friendly to this industry in 1980 for example Congress passed the by DOE act and that essentially enabled the pharmaceutical industry to live off of government funded research done at university and government labs. Later Hatch Waxman was passed that enabled the drug companies to manipulate their exclusive marketing rights in such a way that they could extend it for many years. Sometimes in 1987 at the industry's

behest Congress passed a law that prohibited anyone except the manufacturers from importing drugs from other countries that made it so that Americans for a long time were ignorant of the great price disparities between this country and Europe and Canada. In 1997 Congress passed laws that did many things to favor industry. It gave them six months longer patent laws as they tested their drugs and children something that they should have been doing anyway. In many cases. But they were bribed to do it. It lowered the standards for review of direct to consumer advertising and that began to the flood of TV advertising direct to consumer that we now see. It lowered the FDA standards for approving a new drug. It could be drugs could be approved with less

trenchant research. So in many ways this industry has enjoyed all kinds of favors from Congress since 1980. Let's talk in some detail about a number of those things and I'll try to I'll try to make the questions clear that you know maybe the best way to start would be with the claim of the pharmaceutical industry that prices have to be this high to support the research that you know that yes the costs of drugs are very high. But that goes back into developing all these new wonderful drugs that are that they're making available on the market. What's wrong with that claim. It was not true. What's wrong with that claim. In fact what the claim imply is that these companies are spending most of their money on research and development and that afterwards they have only enough left over for a modest profit. Both of those implications are simply not true. The major drug

companies spend relatively little on research and development. In 2002 for example the top 10 American companies that were listed on the Fortune 500 spent 14 percent of their sales on research and development. But that same year they spent over twice that 31 percent on marketing and administration. The lion's share of that was for marketing and even after all these expenditures they were left with 17 percent of sales as profits more than they had spent on research and development. That's a tremendous profit margin. And that year and the other Fortune 500 companies are all of the Fortune 500 companies had median profits of only 3 percent. So you can see that the pharmaceutical industry was doing almost six times as well as other Fortune 500 companies. Yes.

And that wasn't let me say that was your usual until last year year after year after year for over two decades. The pharmaceutical industry was the most profitable in the United States so it wasn't a matter of boom or bust. It was consistent. Last year for the first time the industry fell slightly from first place to third place but still well ahead of the media and there were some special circumstances for that slight dip. Now the claim about the costs of research as you've given some percentages to it in relation to the marketing expenses which in the profit margins in the pharmaceutical industry. But looking closer at the actual research this is something that your book covers in great detail. If it's turns out that the pharmaceutical industry actually does very little research on its own. Where where where is the research conducted. Well it does a certain kind of research. It spends most of its R&D money on the late stages of development that is clinical trials. But about a quarter

of those trials are what are called safe for studies. These are trials of drugs already on the market and many of those are little more than gimmicks to pay doctors to prescribe drugs. But that's where most of the R&D dollars go. The clinical trials which happen after a drug has gone through the early research and the preclinical phase of development. OK that's that's certainly want to follow up on that. Prior to that there maybe we could talk about the phases of research that you know how drugs actually how do they actually make it to the market from from scratch. Well the first thing you have to know is what. Causes the disease or the medical condition that you're trying to treat and that can take decades to find out you may never find that out. But decades of very basic research almost all of which is funded by the government by the NIH and only after

you understand the sequence of events that leads to the medical condition usually at a molecular level. Can you come up with a target a possible target that a drug could. It could target to break that chain. And then you have to find the molecules that correspond to the target and then you get into the later stages of development where you look at how they work in tissue cultures and in animals and so forth and then eventually you bring it to human studies beginning with what are called phase one studies in which you test it in a small number of patients to a volunteers too. Try to learn something about the drugs. Main mechanisms of action. It's a way of being excoriated its side effects its dosage ranges.

Safe dosage ranges. Then it would move on to save two studies where you would use it in a larger number of people who actually have a condition that you want to treat. Phase 1 studies are often done in normal people. So then then used use in somebody and people who have a condition sometimes comparing it with another drug or a placebo. But often not. That gives you a better feel for the way the drug is handled in patients who really have the condition and best dosage to use. Often in these two studies different doses are tried and then the phase 3 studies are the big stuff. Some times tens of thousands of patients who have a condition and they usually compare the new drug with the placebo. Sometimes with an older treatment for

the same condition. These are the studies that are submitted by the companies All these All these are sponsored by the companies. These are the studies that are submitted by the companies to the FDA the FDA doesn't do its own research. It simply reviews these studies that are submitted to it by the companies and if they find that in the phase three studies the drug is reasonably safe and reasonably effective then it's approved only after a drug has FDA approval. Can it be sold. Can it actually go on the market. Okay that's very helpful now. Now stepping back to the earlier stages of this research the basic research into the causes of the disease and trying to find a site that can be addressed by a molecule that is typically done at research universities and National Institutes of Health is actually that. Yes all mixes almost exclusively the drug companies are not innovative anymore. Their major product

is drugs that are very similar to drugs already being sold. Minor variations These are called copycat or meet to drug. And that's what the drug companies turn out. They are trying to cash in on an already established lucrative market or sometimes a company may maken me to drug to get a new patent and extend exclusive marketing rights in that way. A good example of that is Nexium Nexium is virtually identical to privacy but private sec was going off the market. It's a big seller for the British firm AstraZeneca. It was going off the market in 2001. It would have left AstraZeneca are not going off the market going off patent. It would have left AstraZeneca high and dry. So what the company did was to patent the virtually identical drug call it Nexium.

And then get exclusive marketing rights for Nexium and it put the company put about a half a billion dollars in the first year to convert private stick users. To Nexium through marketing through constant marketing I think Nexium is still the the most heavily marketed drug. Now this this kind of gets to the heart of where the profits from the industry come from. The issue of monopoly rights how how does this work there are how are the rights to drugs own and essentially well drug companies patent. They did in fact they obtain many many patents on each drug all the way along the line of research and development. When they get approval from the FDA they also get exclusive marketing rights from the FDA that's a little bit different from a

patent but they're back up for each other in the sense and the patent less on a drug of for 20 years from the time the patent is filed so that's 20 years. But the time it takes to test the drug in clinical trials is taken away from that patent life. The drug companies want to patent it before the trials because at that point it becomes well known what the drug is and they want to have they want to own the drug. But they can't sell the drugs and tell the clinical trials are done and the drug has gotten FDA approval. So you have to subtract from the 20 years the time for that and that is roughly six years. So they have about 14 years on their primary patent. The FDA needs and gives exclusive marketing rights after they have approved a drug depending on the kind of

drug for orphan drugs. Seven years for a new chemical compound usually 5 4 new formulations are new indications for a drug maybe three. And that operates in parallel to the path. OK so another example of the way this has played out in certain cases you were mentioning I forget that. The drug you mention before there's so many drugs I can't remember the names but one that people will know right away is a claritin that recently just maybe three years ago the patent expired on Claritin it became you know essentially in the public domain and then there were generic versions of Claritin on the market over the counter. And the response of the company that own Claritin was to develop a as you call it a meat to drug that they could then market in place of Claritin

and essentially make us think that this was the replacement for Harrison. Right. The Schering-Plough which is the company that made clear Acton was faced with exactly the same sort of situation that AstraZeneca was faced with with private sec. And they tried to do pretty much the same thing. They patented a metabolite of Claritin which is just for clarity and turns into when you smile and name that Clarinex tried to do what AstraZeneca did with successfully. Converting patients and doctors from private sec to Nexium Schering-Plough tried to convert patients from Claritin to Clarinex but they were a little slow off the mark. They were having some problems with the FDA in their menu fracturing standards. They had to clean up some of their plants that slowed them down. And so they didn't catch the crest of the wave in the same way that

AstraZeneca did. And they've been much less successful at converting doctors and patients from Claritin to Clarinex. I suspect that the similarity in the names has been a problem too. People could imagine that Nexium was a different drug from promise because the name was different. It's harder to make that case. Well even sounds like it's the next drug. Got next in it you know. Right yeah right right. I didn't even think of that that's a good point. But it's really just a form of yeah we have a couple calls to talk with let's include them in a conversation let me just briefly read to Duce our guest We're talking this morning with Dr. Marcia Angell. Her last name by the way is a N G E L L two L's. She's the author of the book The Truth about drug companies how they deceive us and what to do about it. Dr. Angell spent two decades with the New England Journal of Medicine. And we're talking with her this morning about her book. We do have a couple callers and time for others if you'd like to join us the number around Champaign-Urbana 3 3 3 9 4 5

5. Toll free elsewhere. 800 to 2 2 9 4 5 5. Have a listen on a cell phone on line number 1. Good morning unfocussed 580. I'd like you to extend your. Sort of conspiracy approach to what's happened in this town under Carl care I was in the private sector when it was still experimental and they were giving warnings about mice getting cancers and then it was accepted and then the HMO said no we don't want to cover private sector we're going to cover a mock result. Well I'm not sure which one that's actually called and then they said that's the same drug. OK I didn't hear them cover and then we're going to cover a trial effect ot see. But you could only buy the little containers that older people and I'll include myself in that can even get those pills out of there and they don't have bottles of them anymore you know they're the single tabs in half the time Rush. The tap

before you get it out and then it took Nexium which they would cover and they turned it into a two or three which means it costs $25 instead of $5. There's a lot of manipulation going on by the HMO and I want to know are they doing it for themselves or are they doing it in collusion with the drug companies. What I do know is that basically the consumers are getting a really bad deal out of all of these changes and everyone just basically I think much like airlines they try to keep you so totally confused that you have no idea where to go to find out what you should be taking and whether you should be paying more for the next tier. Is that a difference. Again why don't you get the generic and I mean. So that's I'd like to just talk a little bit. Who are all the people who are involved in basically screwing with the medical care. Well that's a very good question. It is a very confusing

situation out there in part because the industry tries to keep secret exactly what they are charging which payers for the same drugs the price is a very a lot more complicated systems of rebates and discounts. So it is very hard to wrap your mind around it. Yes there is often a form of collusion between the HMO goes and hospitals and the drug companies. And let me give you an example of that in Boston. Two of the teaching hospitals of Harvard Medical School have Nexium on their formulary despite the fact that it would be cheaper to buy over-the-counter private sec. I don't know how hard it is to get into the package I haven't tried it but. The reason the hospitals have Nexium is much more expensive brand name drug on their formulary is. That

the company practically gives the drug to the hospital so the hospitals are are worried about their own bottom line. And they are essentially being bribed to use Nexium. But what happens is when the patient is discharged from the hospital he usually is discharged charged with a prescription for Nexium and then someone else has to pay those high prices. So I think that's the kind of thing that you're talking about. Yeah our lines are awful I want to get to to as many calls as a camp which is a quick follow up. You describe in the book what can only be termed you know an assault a marketing assault on doctors in hospitals by the by the pharmaceutical industry. That is really that's you know that's one of the strategies essentially to get doctors to prescribe their drugs. That's right. That's right. We are all aware of the direct to consumer advertising and there certainly is a lot of it on television but that is small potatoes

compared with the marketing that targets doctors doctors have to write the prescriptions and the drug companies are all over doctors. They pay for most continuing medical education. They pay for most medical conferences most meetings of professional societies. They send legions of sales representatives to doctors offices all the time. They bring with them free samples but those free samples are not for generic drugs they are for the very newest most expensive brand name drugs with long patent a lot ahead of them so that when the free samples run out you and your doctor will be hooked on these drugs. But wherever there are doctors there are drug companies and they have to a large extent taken over the education of doctors about prescription drugs. We have four winds here let's go on and talk with more callers who next to us call the listener on

line number four. Good morning. I had to come away so I'm not sure if you went on to talk about the research cost supposedly that drug companies have. It's my understanding and please correct this that most of the basic research on drugs is probably done in Langridge at universities by using university facilities University graduate students and university faculties. So I'm sort of feeling like the public really pays for most research into pharmaceuticals. And my other question is about doctors complicity because during the Nixon administration when they tried to do nutrition guidelines they and they was all over them saying that yelling about biochemical individuality but now I see doctors prescribing a small group of brand name drugs to every body regardless of the biochemical individuality and and I'm having a problem with that not having a problem with it with doctors not having enough time to really talk with the patient to see if this drug

is really good for this person or if the side effects would not be. So those are my two questions. Let me start with the first question because you're quite right about that. The most research and development at the early stages and certainly most innovation is funded by taxpayers mainly through the NIH and carried out at universities and at the NIH itself. Q Let me go back to the me too drugs for a second because I mentioned that these drugs are the major product now of the drug companies. If you look at the last six years and all of the drugs that came on the market in those six years and there were about 400 87 of them that is approved by the FDA in this time. You find that 70 80 percent of

them. We're classified by the FDA as unlikely to be better than drugs already being sold. And Sixty eight percent didn't even consist of new chemical compounds they were simply old drugs and new combinations and slightly different formulations. So that shows you the size of the meat to market is huge. What about the innovative drugs in those six years. There were really just out of the four hundred eighty seven drugs only 67 or innovative in the sense that's only 14 percent incidentally were innovative in the sense that they contain new chemical compounds and were classified as likely to be improvements over old drugs already being sold. Those drugs were based primarily on publicly funded research. And then at some point that the big drug companies acquire or use this research

to do the later development of drugs they now also license about a third of their drugs often now from small biotech companies sometimes from universities and from the NIH so they really do for for the little bit of innovative innovation that they do. They count publicly funded research now. Even the me too drugs. This is an important point. You take Lipitor or Lipitor or is a top selling drug in the world but it's a me too drug. It's the fourth of the six. Very similar cholesterol lowering drugs of the same type. If you look at these families and the two drugs you often find that the first one was based on publicly funded research in universities and then the drug companies spin out variations on the same theme over many years.

In the case of these cholesterol lowering drugs the first one was call Mevacor. It came on the market in 1997 and it was based on university work primarily after that it was an easy matter to turn up the other me tooth Mevacor is now available as a generic as call over Statten but it can't compete with with the tour because there's no marketing muscle behind it. Now the second issue you raise doctors. Yeah there are two issues in your comment. It's hard for doctors to individualize drug treatment because you know you rarely know enough to do that about drugs when when you study drugs even the most honest research has got to take a group of similar patients. If you can't do it one at a time. So the doctors can do some trial and error but that's a difficult thing. I

think what you're also pointing to is the extent to which the doctors are now in the thrall of the pharmaceutical industry the medical profession has largely abdicated its responsibility to teach doctors about the use of prescription drugs. So by default they learn from drug companies and what they learn from drug companies is a highly drug intensive style of medicine. Doctors come to believe just as patients do that the newer drugs must be better than the older drugs. I think that's kind of an American belief anyway. Newer is always better. And they come to accept the propaganda that new brand name drugs should be used if possible so they really to some extent are manipulated by the drug companies because the profession is not doing the job it should be doing.

I hope it is the caller's question we have a lot of people weighing in I want to run into them with a recall. Will things that also you know might be relevant to the question that was posed by the Chicago listener. One of the things that you said in fact relating to the kinds of research service that is being done is it in fact the case that new formulations of drugs are not compared to old ones but merely to placebos. Well new drugs are not compared with all once the FDA will approve a new drug if it's compared in clinical trials to a placebo. And that's a sugar pill and that's a very low standard. All it requires is that the new drug be better than nothing. But that isn't what doctors and patients want to know. They want to know whether the new drug is better than what they're already using. The drug companies don't compare their new drugs with older drugs for the same condition at equivalent doses. They don't want to know the answer to that. It

is. If sometimes they do compare a new drug with an old drug to low it. So then the new drug looks better but they seldom compare a new drug with an old drug at equivalent dose as if they had to do that to get FDA approval. Then that would pull the rug out of the ME to market. Because probably most new drugs would not be better than the old ones a comparable busses and it's even possible that that with successive me 2 drugs they're getting worse and not better. There's just no way to know unless they're tested. But they're not what they do is compare the new drugs with placebo. Get FDA approval and then rely on marketing to try to convince doctors and patients that one is better than another when there is no scientific evidence whatsoever. OK and also going back to the issue of research being conducted at language University for example you don't know what language you

know OK well that's like the University of Illinois. There was a well I think no no there done it had all of the major research universities not the Land Grant in particular but it's funded by the NIH. OK well I guess the question I was was trying to get to is the the nature of the companies. Often make contractual arrangements with the research that is being conducted in these places this is something that was enabled in encouraged essentially by the by Dole Act that said that these research institutions could share in the the profits from from from the research that they were they were conducting and I guess I want to ask you to comment on you know what effect that has had on the objectivity of the research or maybe the kinds of research that is being done. There are two issues there. One is by Dole and what by Dole was that universities could have publicly funded the

fruits of publicly funded research and then give exclusive licenses licenses to drug companies before that publicly funded research was in the public domain. This is essentially made partners out of the universities and the drug companies because when they would license the fruits of their research to drug companies they would get a royalty. The drugs that were sold afterwards. So that changes the the atmosphere in the academic medical centers. They began to think of themselves as handmaidens of industry and began to behave that way. The other thing you're talking about is the increasing influence over of the way the clinical research is done at academic medical centers. The drug companies have always paid for the research have

paid for the clinical trials on their own drugs and usually have given grants to universities to perform that research. But they used to do it at arm's length. They used to say here's a grant if you're interested would you study our new drug. And then they would stand back and cross their fingers and hope the drug looked good. The faculty researchers would actually design how the study was going to be done and they would analyze the data. They would write the paper they would decide where to submit it whether it would be reported and so forth. That changed over the two decades I was at the New England Journal of Medicine. I saw the drug companies begin to exercise influence over every detail of the research. They began to design the studies to keep the data to write the papers and to decide whether the papers would ever be published and if so what they would say that was not an arm's length anymore. And it introduced bias

into clinical research which I believe has distorted in recent years the medical literature. Seriously they would design studies that incorporated bias for example. They might design a study of a drug that's meant to be used in all people but designed it so that it was studied and young people who were less likely to have side effects or and this is very common. They would design a study comparing a new drug with placebos not just to get FDA approval but because the people who read the medical journal would think that the drug. It was better just because it was better than placebo. And the researchers would know that that wasn't the right question that the question was is a better than what we're already using. But they wouldn't they wouldn't force a company to redesign the study. The faculty researchers were increasingly working as hired hands for the companies and the companies

were biasing the research. And of course we've heard recently that some of the unfavorable results they simply suppressed altogether. They would publish the favorable results sometimes many times and not publish the unfavorable results at all. And of course the returns to the research institution can be very very large. It is in there right I mean I think you saw in a couple cases where it is an MIT that generally you know we're talking hundreds of millions of dollars in you know oil to oil teas exactly yet from the research. Yes. So that certainly is an incentive to to work with. With This is absolutely absolutely. It turned it turned medical schools and teaching hospitals into entrepreneurial businesses in the sense we are getting a hand in glove with the drug companies. We have several callers weighing on sort of make them wait for so long but it will go on next to a listener in Champaign on line number two. Good morning.

Hi Dr. Angel. Yeah a quick question before my cell battery runs out. I have a good friend with a ls and with all the money that's raised with MDA research there there seems to be no progress. Is it political is it money or is it just too hard to see to figure out if it's a tragic disease. It's the worst interviews I've ever heard of and I just wonder why more people aren't. I mean we're bob of great minds in this world. There's one thing I think I I think people are probably working as hard as they can at the NIH which is where most innovative work is done I would not look to the drug companies for a cure for this I would look to the NIH although the drug companies would end up selling it. But it's it's just a devastating disease and we don't have an answer yet. Is there any political pressure that would help or it's not really a politics thing. I just think like AIDS gets a lot of right a LSS is smaller but much more

devastating. Right. Well I think there is there are AOS advocacy groups I don't know for sure but it's a very tricky thing because you don't necessarily find the answers from targeted research often you find the answers to diseases from basic research that seems to be in a quite separate area and suddenly it shines a light on something quite different. So I would be aware of be be wary of research that is too targeted to a specific disease. Paul this question will go next to someone on a cell phone line number three. Good morning Guy good morning. I have a very brief comment and I had a very brief question. The comment is can the source of basic research I seem to recall that during the space age the the Halcyon decades of the space age that we thought it a good thing that publicly funded research

leading to new materials and techniques etc. etc. was a good thing for the nation I'd be interested in your guest's comments on that. The question concerns the publication publication obviously is very important to the success of drugs and I understand that the journals JAMA and the New England are going to begin doing something different next year I heard the editor of The Journal interviewed on this I think last week wiring more extensive reporting of research etc. and I'll take my answer off the air. Okay thanks. Both very good points. The first is I think what you're saying is why is it a bad thing if it is the NIH funds. The early research and then transfers it to the drug companies. They do the late stage of development and sell the drugs. Isn't this what Bydel intended to do to transfer the

fruits of basic research into practical products that could be used at the bedside. And I would say that that's fine except that the drug companies by claiming that they are the source of innovation justify prohibitive prices is. If they were willing to acknowledge their much more modest role in this process then there would be more pressure for them to curtail their their price increases so they disclaim more than that and that is true. Also it's allowed them to get away with concentrating all their efforts on me too drugs and just relying on others for the basic research they now license about a third of their drugs often from a small biotech companies. So that's that's the first comment the second is about. You're talking about

the recent statement by the International Committee of medical journal editors. They said that from now on they will consider papers submitted about drug company sponsored research. Only if those companies had registered the clinical trials before the study was done on a publicly available and publicly administered website. This is an important step because what it speaks to is the fact that the drug companies don't publish and don't make available. There are clinical trials that have unfavorable results. They just published the favorable ones and that's distorting the whole medical literature. It's making doctors and the public believe that drugs are a lot better than they are and that they have fewer side effects. So this is an

attempt to get at that it's as if you want us to consider your papers for publication. You will have registered this study somewhere on that registry. You will tell us what the study is what patients you're going to to study the drug and how long the study will last what end point you're going to monitor. Just all of the factors about that trial. And then when the trial is finished you'll list on the website the salient results. That way every single trial ends up being submitted to a journal will be somewhere and people can say if it's not published what happened to that. Here's this trial we've never seen any results of it. So that's very important to try to stop the companies from suppressing unfavorable results. But the problem is is that that it would apply I the journalist can only make

it apply to studies that are actually submitted to them it doesn't apply to all studies that are never even submitted to journals. I think that that I would go further and say that there should be a publicly administered registry of all clinical trials period because a clinical trial is using human subjects and it seems to me that as soon as a drug company and rolls a human subject in the experiment they acquire some public accountability. They ought to say what happened in that trial. So I would go even further than the journals. But it is an important step. You know there is a website clinical trials dot gov. It was created to to essentially put a registry of trials before the public and I guess it's sort of a you know part way to that goal it's mostly voluntary at this point that is your problem. You know that's the problem. And the companies are now quickly saying oh well we'll put we'll put our trials on our own website. But if you look there are always weasel words we'll put our important trials there

are meaningful trials. No I think all trials should be on the website. OK. We know the caller talked with someone in Marshall Illinois. Line number one. Good morning good morning. Thank you so much Dr. Angel for writing that book. I think you know I did psychiatric nursing and of course that so pharmacy intensive. And I try to keep my students consciousness raised about these pharmaceutical companies and a lot of the information I do get from NPR. And I wonder if you would just comment on any of the psycho topics like the assess our eyes would they all be considered to drugs after Prozac is that yes generalization. Yeah. That's a very good example of a me too family Prozac was an innovative drug came on the market in 1987 and since then other companies have spun out me to variants. They too do not test their new drugs against older ones at comparable doses so there is no particular reason to believe that one is any better than another.

Also there's some reason to be much much more. Reticent about using them anyway. We've heard recently about the fact that some of the companies have buried evidence that they that these drugs produce suicidal thoughts in children and adolescents. But what we haven't heard published is nearly as much is the fact that if you look at all the clinical trials that have been done of the antidepressants and not just those that are published there was a study of all of the trials that were submitted to the FDA to get approval for six antidepressants. The authors got all these studies through the Freedom of Information Act and what you find when you look at all the studies and not just the positive ones is that these drugs are not all

that good. They they are compared with placebo. The placebo was responsible for 80 percent of the effect and the effect itself amounted to all those statistically significant amounted to I think it was just two points on the sixty two point Hamilton depression test which is clinically nothing. Yes just two out of sixty two points. So and it was true for all six of them about equally they were the four SSRI and effect 4 and what was the other one. I don't remember if I don't remember but it does I think and and and they were all roughly the same that is statistically slightly effective but probably not clinically and no way to tell if anyone

was any better or one of them you know they they compare they were all placebo controlled so there weren't a direct comparison for Lizzie but they looked at the effects and found that they all had about the same effect. What about the new generation of anti-psychotics. Pretty much of a sense causes pain or is causing pain by itself which is to say I haven't followed that that research is much I know there's a lot of concern about side effects but I just haven't followed it. And also about off label use Neurontin for I heard about that company getting in trouble for off label marketing for that one that's right but also label marketing as fairly standard. Thank you so much. You're quite welcome. We have just about maybe two minutes. Left I'm sorry there's a lot we won't be able to cover obviously in one hour. It's a great book. One of the things you talk about near the end of the book is The Power of the industry in Congress in the regulatory process and and also you know what it would take to reform the situation that you describe

throughout the book and maybe you know I can ask you spent a couple minutes talking about passings right now. Well this industry has an iron grip on both Congress and the White House and largely writes its own ticket in Washington. It has the largest lobby in Washington and 2002 it had six hundred seventy five lobbyists. That's more than one for every member of Congress. It gives generously to political campaigns and it gets what it pays for. A good example is the recent Medicare prescription drug benefit that contains a specific provision that states that Medicare will not negotiate with drug companies for lower prices. Now that's a startling provision. It makes drugs exempt from the general regulation that goes on in Medicare in general. Medicare regulates doctors sees it regulates in the hospital payments. But prescription drugs were held to be off limits.

No regulation of prices. And what that means is that the prices can continue to rise three times faster than inflation and the benefit which was inadequate to begin with will shortly be wiped out by rising prices. What the Medicare will then try to do is to take that out of seniors Hyde's and other ways by increasing premiums are increasing deductibles and we've seen that just this month to try to pay for the drug benefit or maybe even decreasing other services. I suspect that will happen to this drug benefit just gets an affordable but that shows you how much clout this industry have. One thing citizens can do is pay some attention to these these prescription drug friendly laws in Congress and let their representatives know that you know you may like the money you get from this industry. But you know lose my vote if you keep doing that. I think if

members of Congress had to decide between the campaign contributions and the votes they would take the vote. OK. We're going to stop there since we're out of time but I can suggest for folks if you like to learn more about the topic the book is The Truth about drug companies and the author MARCIA ANGELL A N G E L L M.D. and the publisher's Random House. And I'm sure you can find it in bookstores and libraries. And to you Dr. Angel thank you so much for your time appreciate very much. It was my pleasure.