>> now on book tv, harriet washington argues a growing corporate presence in the medical industry yields dire issue for patients a development of drugs i initiated on a for-profit basis. ... she was on a fellowship there.

we connected them and we have been friends ever sent. the last time she was at the university of georgia she was touring her first book medical apartheid which one a slew of awards, including the national book critics circle best nonfiction of the year award. we are so pleased to bring her back this year touring with her second book, and i want to thank all the people that had made her visit possible, the university of georgia office university, the graduate program at grady college, the professional in residence program for the journalism department and by owen graduate program in medical journalism. harriet is a journalist who morphed into an author who gained an international reputation as a medical emphasis. she is a moral thinker. she is a voice that we need to hear in the public dialogue and

on a practical level, she helps explain to us why medicine works the way it does and why at all costs so much. so let's welcome harriet washington. [applause] >> good afternoon. good afternoon. [laughter] alright. thank you so much, pat and i give my heartfelt thanks for bringing here again. it always feels like coming home and for that i am very very grateful. i have a lot to say here today and i'm not actually going to get to all of it. that's my pattern but i did want to caution you that if i should skip over a slide as i'm speaking at something you are fascinated by pressure to ask a question question about it in the q&a session. also i'm not in the habit of reading nice lives.

your academics and you can read them for yourselves. that said i want to talk to you about my most recent work, which is actually a critique of american medicine. it's a multilayered critique. what i am principally concerned about is the ethical and moral consequences of big corporations although they may or may not have been well intentioned the consequences seen or unforeseen have been disastrous for american medicine for all of us and i hope to eliminate -- illuminate exactly why. i liked it and i will try to eliminate why by showing you figures to show you why things in medicine may not be the exactly the way they appear either in the conventional media or in medical journalism itself

including previous medical journals. going back in time a little bit to think about what medicine once was and not pretend there was any healthy golden age of medicine but i'm going to say it looked very different in the corporate culture. there's probably no better illustration of that than the fight against polio which i'm actually old enough to remember. i remember the march of dimes and i remember as a student coming to school every fall and we had apprehension of who would not be there, what desk would be empty. there were always kids missing and those kids often had polio. and when i got a fever or a chill or stomachache my parents first thought was always, oh my god i hope it's not polio. polio in many ways occupy the area of culture that aids occupies today. it was a scourge government was mysterious and selectively

carrying out parts of the population we were hell-bent on trying to find an answer to it and we did. not one but two answers actually. he appeared on murrells show admiral asked him what he going to do now? everyone is going to want it in the demand is going to be incredible and someone is going to make a lot of money on the soap this so who holds the patents? and salk said the american people i think. could you patents the sun? this was not unusual. this was the overriding mentality in the research culture, feeling that groping after money, seeking profits, ceasing to maximize profits on patents on biologically active molecules and medicines was not really a local -- moral calling. research required a long arduous

course of study. it attracted very brilliant people and it was very competitive and very difficult and yet it did not pay very well. these people were not motivated by money. they were motivated by intellectual competition. they wanted to be seen as benefactors. that was important to them. they wanted to win prices. these were the motivations of drove the manager miniature them very well. under these modalities, we actually kept a lot of answers to our medical crises. penicillin was found to cure syphilis and other stds. streptomycin, i mean of course the polio vaccine many important medications were devised by researchers who were not concerned about money. they worked in universities and universities were very different. universities and corporations could not have looked more different. corporations sought to maximize their profits.

universities were actually centers of science. they were centers of research that was clearly focused on the ills of society feed a medical or social or whatever and it attracted people who are drawn to that role. the university had quite a unique role actually in pursuing the public interest and that was true of medical research as well. in fact there were laws and regulations that band universities from using the discoveries that were made with government subsidies. they could not license the corporation and they could not sell them to corporations in most cases so there was a very very clear and permeable membrane between corporations and universities. it's not there anymore and i'm going to talk about what happened when it dissolved. so, one of the consequences although maybe not the most important consequence, is the cost of medications. i think i noted here that when

medicare and medicaid were finally passed in the 60's it's interesting that there is no provision for the cost of medications. there's no provision for helping the elderly and the infirm and poor pay for their drugs. why? because drugs were so cheap. it wasn't needed. drugs were cheap because university researchers working in universities device them. they were then marketing and there was a real animus against profiting. in fact anat blackmon had a hard time when he sold his patent to university. he p. then bake it back because he was afraid of what people would think if they knew that he had sold his drug to a profit-making company. drugs were cheap. they are not cheap any more. there is also high innovation. if you look in the past at the figures he will find that depending on the year, there was a trend where hundreds of drugs were devised every single year. hundreds of new drugs and yet there is a mentality among

corporations and the legislators to whom they were whispering that was not enough because there were lots and lots of medically active molecules that were not being made into drugs, thousands of them as a matter fact. so there was an animus that we have all these patents on drugs. no one is doing anything with them. we need to have hospitals and medical centers partner with corporations so we can develop all these drugs that are lying fallow. a senator from indiana and birch buy was a senator who listened and he began complaining on the floor of congress that we have 28,000 patents made in universities that are not being developed. they are just lying there collecting dust. we spend $30 billion collecting, 30 billion so birch by sought to convince his fellow senators and congressmen that we need a law

to d's the universities and private corporations. he was successful on their a very extreme pattern because initially the law was voted down. initially congress wanted no part of it and more importantly a very powerful senator russell long was against it. following his lead the senators voted it down. but even though he lost birch by one on two lose the election and it was not a good year for him and jimmy carter was a lame-duck. at the end of the year there was an emergency congressional session called specific as to pass financial legislation and urge wanted to reinvigorate his law. he wanted another try at getting this act passed. bob dole was his partner. he worse worried about long. log was in opposition to him and long for his part doing beatty

was leaving commented to the people, urged by, think i'll give him a break. he is leaving office and he has been a good old boy so he called urge by and said do you know what, take that patent bill. you have earned it. blog tells him he's got the bill passed before there is a boat but long was right it is at the end of the year at the last hour of the last day of the congressional session the bill was indeed pass. the bay company act was passed and now they can sell to corporations. now. now we will have those 28,000 patents made into a big -- medications and we will all be better off. not exactly. what happened was universities and corporations did indeed partner and they did indeed make a lot of money by doing so, a lot of money. that did not translate into more and better agent -- medications

for you and me. parter it had to do with cultural changes in medicine. unfortunately medicine began to take on more and more of the coloration of corporate mentality. now researchers like corporations became jealous of their patents. this meant collaboration went down the tubes. we can work together with this other university researcher working on the same problem because we want to have the patent. only if we on the patent can we sell it to drug companies to make a great deal of profit so we cannot share information or intellectual property with them. any collaboration must be done internally, intra-merely and even then the problems were losses when researchers sought to collaborate. also when drugs were devised and assigned to corporations corporations were now on the drivers seat. corporations now paid researchers to do research. so that their research, many

medical schools began to look more and more at the department has a corporation. they received funds from them for research. there were research dollars paying the salaries of the researchers. where did the loyalties live now? for the loyalties with the american people or with the corporate maximizing hefty profits? also, what happened to love these new medications? did we end up having even thousands of drugs instead of hundreds every year? no comments that we have seen innovation declined. can anyone guess approximately how many new drugs were approved last year. there were hundreds of drugs approved in the years before 1980. you are in the ballpark. last year there were 21. the year before, 26. some years have been even lower because if you look here you can see in 2010 there were only 15.

15. innovation has dried up. so although this change, this sea change in medical research was sold to the mac and people on the basis of having access to new and better drugs and said we have access to fewer drugs in her of those drugs better? are they better? not exactly. one can generalize of course important drugs have been developed at a lot of drugs have been developed are either new nor are they better. there are many more copycat drugs. these are tracks that have already been devised, tested and approved for indication and the corporations seeing the patent, the 20 year patent is about to run out, doesn't want to lose its grip on its patent. they want to maximize their profits. what did they do? they take the smaller pill and they tweet it slightly. they change it with an electron. if it's a handed molecule they see as the right-handed version

will work or maybe a mixture of the left and right version might work. if so they have a new drug in a new patent. so this is not exact the new drug. this is a copycat drug. we have far fewer drugs for up device to be a most drugs tend to be for more trivial disorders that we will discuss a little bit later. debate dole act was not the only law passed in 1980. also there was the decision by the supreme court that found for the first time a product of nature can be patented. that means a living thing can be patented so now we can take the patent out on a genetic sequence, on a biologically important -- which is programmed to all you develop cancer. on a plant so the fact that something is living was no longer legal patenting.

this eliminated the legal challenge. i don't know if any of you have followed at that very recently the supreme court sent out the case of a breast cancer gene patent. these patents could be affected because of this law passed in 1980. than then there were other laws of the stephenson wire act which made it easier for universities to partner and john moore. patent was taken out on this human being, product of his body even though his doctor and never told him when he moved his 22 pounds lean he was doing it for research. he told them he was doing it to treat his hairy cell leukemia. and his on his doctor took notice wayne and isolated the active ingredient he took out a patent then he owned the patent on john moore's.he. a pretentious president i think. i love this quote and sums up

what has happened since 1980. he disappears to the detriment of the communitarian society of society. what do i mean when i say that drugs are expensive? eakes suspect you know that without me telling you that drugs are too expensive but even i was completely staggered to see how expensive some of them are. were talking about hundreds of thousands of dollars for one years treatment. how did this happen? drug companies interestingly they don't deny they are expensive and they say they are but they say they have to be expensive because they invest so much money to bring them to market. and i think 2001, do the massey released a report that was hardly endorsed by the pharmaceutical manufactures claiming that every new pill that came to the market cost

$802 million to bring to market and then it was revised upwards to $2 million. now the claim is we pay $2 billion for every new drug on the market. and that is why your medications are so expensive. economist merle cusa looked at this and said you know i think the figure you want is closer to $20 million. goosed or said that is not chump change but it's not $2 billion either. the tb alliance to their own analysis and they said no 150 to 240 million found it was even lower, 110 million. so why the white diversions? why do the pharmaceutical companies claim they are spending 2 billion why did these groups are devoted to providing low cost medications to people here in the developing world claim it's so much cheaper? because the pharmaceutical companies report that the report is deeply flawed. is simply not accurate. verse of all when it looks at

the cost of drugs they only looked at daree atypically expensive drugs. these are drugs that are brand-new with no president. they are not copycat drugs. they are new entity, totally different, totally new drug. those are expensive and those are also quite rare. most drugs do not fall in that category. they also look at a small subcategory of those drugs. those few drugs for which the government invested no money in its development. that is also quite rare because usually the government will invest money in research at a university and then when the researcher find something that is worth developing medically only then does the corporation step corporations step in as a partner. and it starts controlling the additional research needed for fda approval etc. so if you drugs relatively few drugs don't have that initial support so they looked at that small segment. also the tomas report did not correct the industry's dramatic

tax benefits and the tax benefits of the largest of any industry in this country and they are so high that for every dollar the industry spends they only lose 66 cents. so these are really big benefits and they did not figure into this report. also the charge in opportunity cost. this was an education to me. i had never heard of opportunity cost before. opportunity was devised by jon stewart mill. and a financial sense that you pay, that you surrender to pursue activities in one direction at the expense of another. the example i gave in the book is if i have $10 i decide i'm going to just go to the movies and i buy a movie ticket but if i had put it in my savings account i would have burned interest. that lost interest as my opportunity cost. if i left in the bank for long enough he enters would have doubled the $10 to $20 that is exactly what tomas he did in this report said well these drug companies spend all this money

on research. they could buy stock at starbucks without money or do both that money to global hunger relief and they would have an effect but they are are giving that up to devote their funds to drug development. well isn't that what they exist to do? i mean if these drug companies were to spend all their resources at starbucks or global hunger relief they would not be drug companies anymore and that is why the opportunity cost is not apply. actually what they receive its tax benefits and actually it's not an investment for them to do drug design. it's part of what they do. if the cost of business and the opportunity cost is not apply. this would cut the remaining figure in half. so we can see how easily you can fall from the 2 billion figure to something that is closer to 100 million that his wife their claim is baseless.

so what do these high drug prices mean? you all know what they mean. if we know somebody or are close to somebody who can buy the medications, who can't get care, who can't get health insurance or who have not had a test or treatment that they need. there's no mystery there. we know this is really significant but here it is quantified a bit. half of the people his country fall into one of those categories. even people who are employed and have health insurance are not immune because employers have consistently been making employees shouldered more and more of the cost of their research -- of their insurance and other medications. so now we have the background and we see what happened and we understand this in terms of drug costs but interestingly this law, this confluence of industry and research organizations

doesn't only affect patients but affects research as well and this is the thing that i found deeply deeply troubling and i'd wonder why people are not more aware of this. chris parrish is a researcher at australian national university and he has devoted his entire career, 20 years to a liver cancer drug, a promising liver cancer drug. it was in stage iii trials. it was doing extremely well. was called pia a eight and it looks promising. he acquired a corporate partner and he was happy about that because his corporate partner allowed him to finish work on the drug, have attested and funded its research. he didn't really care he said that when he parted with his group through his university, they told him luck, we have to license or sell the patent to this new health pharma, this new company so you no longer on the patent. he said i don't care, i just want them to devise a drug and

he did. at the end of the stage iii trials before was about to attain approval they shut it down. they ended the trial. we don't want it and we are not going to market it. why didn't they wanted? it's a liver cancer drug and although it's not a large problem in this country liver cancers the cancer is the number three killer globally and they're not that many good drugs for it, desperately needed drug but paul farmer said we we are not dentures at it and it any more. why? to other drug companies were devising cancer drugs that would compete with it in the marketplace. paul farmer said we don't want this truck unless it's going to be a blockbuster. it won't be a blockbuster because of the competition of other drugs and therefore we are going to do something else. it's not worth your time and money to see this to be in. what is a blog buster drug? a blockbuster drug is usually a drug that takes in at least $1 billion in profits a year. we are talking about a

310 billion-dollar industry. that is the watershed. if you're not taking in a billion dollars a year at paul at paul farmer you are not worth our time. and in the interest of the people like chris parrish whose life work is now at a standstill and the interest of the liver cancer patients around the globe don't factor into the corporate model. so what other things have we seen having to do with devising new and better drugs? are the drugs really better? that all depends on your point of view. the drug companies certainly think so, but looking globally it seems quite clear that they are not better drugs because if you look at the diseases that kill people in the greatest numbers across the love, these are diseases that the pharmaceutical companies are not interested in devising and the answer is simple. because malaria which is quite prevalent, affects people who are poor and can't afford the drugs and therefore they are not

making the assessment. there is has been one new malaria drug device lately about what drug do you think it is? is not to treat malaria. is for wealthy western travelers to help them avoid -- so even when drugs are devise for people in developing world they are not device for those people to use. they are devised to protect people like us, relatively wealthy westerners. so if you look at sleeping sickness i think that is a perfect unfortunate example because there are only a handful of drugs that are as bad as the disease. one of them is a compound of arsenic in antifreeze and you don't have to be a chemist to know that is bad news. what happens is if you are desperate and you have sleeping sickness in western africa you take it because you are desperate. sleeping sickness will definitely kill you. the drug will kill you. i think one in four people died from the treatment.

moreover, if your disease progresses to the point where you're going into it, this drug cannot bring you back. it can help people who go into the final stage of the disease. so this is a tragedy, an absolute tragedy. however drug was found that would not only treat people safely but it would bring those unconscious patients back to the brink. this is wonderful. the company and i'm not going to name it right now because i don't want to spend my life in -- but the company decided to -- -- and for a while the partnership with doctors with borders -- without borders was very good. in order to make sure people had have access to the drugs, but they only did that for a few years because after a while it was quite clear that no one in that part of the world could afford the drug. they were losing money on a consistently. i think it's one of that they were willing to do this, willing

to make sure people have the drug but the problem is, as is typical, they only did it for five years. they only did it for short period of time and it wasn't nearly enough to treat the real problem. there were only able to help a relatively handful of people. now the generic -- the fact that they withdrew it from the west african market doesn't mean that anyone of us can't get it. we can get it but there's no there is no sleeping sickness in this country so why would we need that? the florentine that is being marketed for women who have facial hair. the commercials come on tv sometimes. if you are embarrassed by your facial hair and you don't want to use a razor get beneath that, it's a cream you put on your face and it's $20 a month ago it will banish your facial hair. wealthy western women can buy this drug to banish their facial

hair but dying west africans cannot obtain it and that is what is wrong with medicine today. that is what is wrong with this court are -- corporate partnerships. these corporations i can criticize and heavily but i also want to know that they are not in business to promote health. no matter what their stirring ads say no matter what the heartwrenching commercials say. they are not in business to maintain them or store health. they are in business to maintain a profit. the government is involved here. it is our tax dollars that fund the initial research on these molecules transfer to corporations. we have an investment here. as marcia marshall points out we end up paying for drugs twice. we pay for this developments with our tax dollars and we goes on the market we pay the

inflated prices of the government should step in. in other countries governments have stepped in and said to companies your drugs are too expensive for you -- if you are not going to distribute this drug at a price that our people can afford we are going to take that patenting give it to somebody else. that could be done in this country and one is what is interesting is the government has done it in this country for radio receivers, for certain television technologies but not for medications. so there is a shared responsibility here. the government has a responsibility to do this and why don't they do with? in my opinion this is not being done because of the cozy relationship between these companies and legislators. the lobbying is completely out of control. pharmaceutical companies have the highest number of lobbyists and they pay them the most in a lot of these lobbyists are former legislator so that they are cutting a deal with their former colleagues to make sure that drug prices don't go down.

to make sure that we are locked into paying high prices and to make sure that they are permitted to sell their trip you'll medications and ignore critical health problems without any interference from the government. of course i always get to say a word about the fact that there are so few medications for today's killers but for dysfunction we have had 14 drugs since 1996 and it does not kill anybody, although almost 600 men have died from taking them. it says something sad about where our priority seem to live or where pharmaceuticals companies priority seem to life. so what effect has corporate control of research had in the developing world? the image on the left is familiar to anyone who is older than 45. these are children who

develop -- from thalidomide. it was distributed pretty widely. it was given to women as a sedative and to treat their sleeping problems. but when the children, after while even though it had been improved in europe children were warned that have these devastating birth defects. there were articles and pictures everywhere. even as a kid you could not avoid them and everyone said the same thing. they said this will never happen again. thalidomide will never again. why would american people be effective because there were only 11 children born in this country and thousands of -- because the fda. frances kelsey a pharmacist at the sca looked at the tests and said the tests were not on crack and i'm not convinced the drug is safe. the drugmaker said we are going to sue the fda. if you don't approve these drugs we could market them we are

going to sue you. the fda held firm and said no we are not going to gamble the lives of americans and of course the americans were saved by this tragedy. but what has happened today? the picture on the right is also a picture of a baby with folk amelia and he also has it he does his mother was given thalidomide. thalidomide is being tested only in the developing world, only in brazil, nigeria, cuba and other parts of africa. it's not being tested in the west and this is a horrible ethical misstep. it's not only that these people are being asked to assume all the risks and none of the benefits of the testing because the testing is for conditions like -- leprosy and what they have said to me when i asked about it is harriet, leprosy is rampant in places like urzua nigeria so we are doing them a favor. we are giving them a new drug. no no we are not because this

drug will never make its way to these people. they can't afford it and more to the point pharmaceutical companies do not devise drugs for people in developing world. for a long time researchers told me that there was unspoken tenet that you didn't test drugs for uses in the tropics or the developing world because people there could not afford and the company didn't want to have to explain why they were not using the drug there. but the data will also tell you economist michael cramer wrote that of the 12,333 drugs tested by pharmaceutical companies in a 25 year span guess how many were developed for the people in the developing world for people who live in the tropics? four. so these people are not it priority for pharmaceutical companies but they are a priority for testing of these drugs. so the testing is done by

european and american researchers. there are lots of social justice violations. for example the thalidomide, when it is prescribed to people in the west for a condition like leprosy and of course it's very were in the west or local myeloma they are warned that if you are a woman you have to take two forms of contraception. you cannot become pregnant on this drug and the caps are labeled with a picture of it deformed babies but unfortunately i don't think that labeling is a clear thing. if you don't already know you may wonder what it is you are looking at. there's a picture of a baby on this capsule and what does that mean? so these people are being warned however it's quite certain that in some trials people in the developing world are not worn. for example the packaging material and west africa until 1978 described thalidomide is completely harmless without side

effects. and many of these people are illiterate. they would not be a will to read the warning warnings in a purslane study revealed 67 children have been born to women with folk amelia and they were distinctly traced to women who took thalidomide. it's also a question about whether thalidomide -- which means men might take precautions to match. we have all of these violations. women might be told and if women were told to take contraceptives they can't buy them. in many countries contras had this are beyond their financial region also their acculturation's why they cannot obtain contraceptives. so these are people who were not able to protect themselves and this is where the research is being carried out in one might wonder why.

i think that wes would be a more logical place because he released women can protect themselves but why isn't research carried out in the developing world? as you can see the developing world is not the market for these companies. the problem is, not the problem is that the decision has been a financial one. and madison article showed pharmacies conduct one in every three trials in the developing world and that was more than a year ago. one in three trials. because they can conduct cheaper trials, faster trials, very important for fda approval and these trials are higher-quality in the developing world. they can get that her quality and more experienced practice researchers to work for less money. although a lot of our discourse providing drugs to the developing world has been well we can afford to do this because people are so poor and that is why they can't afford health

care. we can't afford to be the world's beneficiary and give them free drugs. companies make that claim. we wish we could give drugs to these people wouldn't when we can afford it. these countries are actually saving us a lot of money by allowing us to conduct cheaper trials, cheap fast trial so we are in their debt. morally we have an obligation to provide them minimally with free drugs to offset the excess risk they are taking on and as i mentioned in some cases we should not be conducting trials there because people cannot protect themselves. if you look at the disease burden around the world there's a consistent pattern. very very high in terms of infectious diseases and yet all these medications that are needed are missing. a lot of focuses on hiv, as it should be but there are other

things that are much easier and cheaper to administer and give. for example vaccines in the developing world. vaccines are easy because you don't have to make a diagnosis. you don't have to provide a lot of time or monitoring. it's a one-shot deal. every child gets a vaccine and it's very easy to administer and it's not very expensive necessarily because the bill gates foundation has partnered with the drug company among others to provide very cheap vaccines to the developing world. you have to keep in mind it's not just a matter of importing western vaccines. the special challenges include the fact that health care pack sisters are scarce. you don't want it to be an injectable. refrigeration is not always an option so these things have to be kept in mind and even so they were able to take a 70-dollar vaccine and distributed for 50 cents and the developing world.

is really important to me the pharmaceutical companies are part of that partnership. in my opinion this is where the future lies for them because as i talk about how this new model does not work for patience and it doesn't work for researchers really because researchers run the risk of having the plug pulled on them. think about what it means to them to have to drive the pipeline of new drugs. 15 drugs a year, 26 they drugs a year. that's not enough for them to make a profit. they are seeing their patents expire. blog buster drugs has fallen off with a rapidity and drug companies are something. they are still making a great deal of money but they have fallen from the number one spot to number three the number three spot in a few years. i think they should become aware of the fact that the developing world since a huge untapped market for them.

instead of thinking in terms of charging these prices and bankrupting people, hundred thousand dollars a year for drug they should think about for cheap drugs to many people in the developing world can prove lucrative if they have a good model. there people like the health impact fund out of yale. there are economists actively working on these models that pharmaceutical companies might consider adopting. and sn emphasis i'm deeply concerned about the effect of these corporations on research ethics. research ethics have been deformed by corporate control. even ethicists who are supposed to be the guardians, even they are engaging in what i consider troubling activities. more and more it ethicists are joining the ethical ports of pharmaceutical companies and i see this as a distinct problem.

if someone is doing things that are resulting in the deaths of people, resulting in people going bankrupt trying to pay for their drugs, i'm not going to be on their corporate board. i'm not going to advise them to get ethicists do advise them in the troubling thing to me is that many of these people don't think they are doing anything wrong. unfortunately there's a mentality among many ethicists that we know in our hearts that our motives are pure and clear doing god's work. yes i have this check from pfizer in my back pocket but it's not going to change the way i act as a champion for the underserved. well, it might. it might easily and so being able to cite the opinions of ethicists in defense of some other practice i think is a developing new trend. another disturbing new trend is

the fact that corporations have discovered that recruiting people for clinical trials takes a lot of time because we have to explain the trial. we have to obtain permission and informed consent in a nutshell and informed consent has been a basic tenet of american medical research since the mid-1940s at the nuremberg trials. in the principle tenet was the voluntary consent subject is absolutely essential but that is not chew today any more. beginning in 1990 there have been a series of changes to the code of federal regulations. they allowed researchers to conduct research on people who do not give consent. if you are unconscious and a trauma victim you can be enrolled. people like that up and enrolled in research without consent. they don't have to ask your consent for the research and they don't have to tell you about it afterwards and they don't have to obtain the family's consent. this law is very easy to look up if you look under code of

federal regulations 21, 504.3, 504.4. it has remained under our radar for too long. i wrote a few articles about it because i'm deeply concerned about this and the largest study that used this law ended in 2007. it included 720 people around this country and the artificial blood was tested turned out to be harmful. it turned out more people who received it have suffered heart attacks and deaths than people who got the standard of care. you would think this would lead to a moratorium on this research without consent but instead a new study was approved whose goal is to enroll 21,000 people. it went from 720 people to 21,000 people in 11 centers across the country and canada, the number one trauma centers and they are testing a wide variety of agents on people who

suffer traumas come anything from a gunshot went to a car crash to a heart attack. 21,000 people and yet when i spoke to the ethicists and said don't you find this disturbing, what i heard most often was yes but you have have to understand very rarely used. this is not something that affects most people. it's really rather he -- rarely used. i don't think 21,000 people are rare and i don't think that's an ethical defense. defense. if i kill somebody can go to court and say but i rarely care people -- very rarely kill people. wrong is wrong but yet this is being done and offended. informed consent is going the way of the dodo and one troubling aspect of this, if you look at these content forms a lot of them use the word consent that when but when you read their descriptions they are failing to provide consent. their failure to allow person to say yes or no to medical

search -- research. my concern is if we don't stop it now it's going to continue to escalate. i want to wind up soon because i do want to leave time for questions but again i want to summarize by saying that in my opinion pharmaceutical companies have been responsible for a lot of pain and suffering. a lot of unnecessary heartache and they have a chance to redeem themselves if they take the opportunity to embrace new schemes of research that will benefit people in the developing world, they will that will benefit people in this country. if they change their focus from maximizing patent profits to maximizing distribution of their medications at a lower profit, they might ultimately make more money and if they don't see things that way it's the responsibility of the government to do so. the government should exercise its power to horse these companies to do what is right if

they choose not to do the right thing. that is essentially what i have to say to you. thank you so much for listening to me. [applause] i was told if anyone has questions and i certainly hope a lot of you do, give time for the mic to get over to you. so we can pressure to record them properly. >> i see motivation is a big factor in one's motivation switch from the incentive for research and collegial competition to profit, what happened was profit went down. it's hard to take us out of that mentality. people would get angry at the government. i mean the incentive to get out more medicines is going to

increase your profit and were finding the same thing in the american economy now, today. corporations want to make our money but they can only do it if they recognize that we are a team working together and there is no middle class to buy products they are not going to make them any more. so is there any kind of program or understanding our push other than little groups like this to try and bring this awareness about? >> i think it's really important for people especially little groups like this, to try to make good legislators aware the fact that they're concerned about some of these developments and that has worked in california where xavier becerra after being approached by constituents draft of a law and david loken joined with him. it is a law that is being patented. but that is only part of what has to happen. this issue actually began in the law and it has to be ended in the law. the big hurdle is congress because right now we have

legislators who have not been paid -- it's more than i know actually but this legislators have been elected by us and get their behavior is squarely in line with the interests of pharmaceutical companies and against our medical interest. so we have to get rid of these lobbyists. we they have no place in health care design. they have no place in decisions about medical? care and get they are exerting a huge -- lecture legislator know you're concerned about this. i resell people to take action where they are. whatever group they are involved with that is the group you should try to sell your outreach about this. of course if they won't do it on their own but pelot will be where it ends. some companies aren't going to do the right thing of their own volition. if they have been the case they would have done it already. they do it occasionally and sporadically but not in in a consistent way that we need.

>> the fda came up with a statement that says that only drugs can cure illness and i was reading a book by kevin trudeau and open into a the statement that you made about lobbying and the congress and the pharmaceutical companies. but what do you think about the idea of revitalizing the option of natural supplements in this country, revising herbal options and that sort of thing to help with curing elements?

>> that is a very and just in question. i'm not aware of the fta report that you are alluding to but they question about complementary medications, earlier today we were discussing this very issue. my take on it is that alternative and complementary remedies are only alternative until they are shown to work and then they are sure by conventional medicine. this demarcation is actually artificial. to me, not to most people but i actually view it not as between alternative and complementary and conventional. i look at whatks andhat es not work. to me that is a key distinction and to know what works one has to test it ruthlessly. there is some sentiment that i don't agree with that alternative medications don't have to go through western-style testing in order to be thought of as efficacious. interestingly neither does germany. if you look at your many money have a long tradition of testing

alternative and supplemental medications and they have a really good body of evidence now that there are some things at work and some things that don't work. that is holy need to do. we need to do a vigorous testing. it is simply an does. people will say i have uses for 20 years and it's worked well and they sing its praises. it may not be accurate and it may be inaccurate on other people. everyone deserves medications -- [inaudible] and that is the only way we are going to get them no matter what the medication is. >> eye of the thalidomide question. if they are testing it in third world countries for diseases that primarily affect the third world like leprosy, the other examples you mentioned, where is the economic incentive for them

there and doing testimony with thalidomide? >> that's a good question and to into me what i ask is, is this actually the reason why it has been tested? is this actually the application they have in mind because in the figure i gave you about the four medications out of 12,300 odd that would indicate it is not being used for the application. when someone like me asks why are you doing this dangerous research in brazil and nigeria but not in connecticut so i wonder if that is the real issue. >> advertising prescription drugs -- i was wondering what you thought

about the efficacy about that and the second question i have is once the drug becomes extremely profitable what is the emphasis to have it become obsolete? if the disease were to be cured would we not know about it because the drug is profitable? >> the director consumer ads were pharmaceutical companies bypass the position a physician and go right to you, the television viewer and they sing the praises of their drug and then they do list of side effects from problems way too quick way for mortal man to read or hear. and then what happens? you go to your doctor. that is the way it works. no country except the u.s. and uzi landau loves this. other countries to not allow this because they understand that in bypassing the physician, e companies are not informing you correctly about

the drug. they also know they are capitalizing on and laypersons lack of information to sell it to them and they also understand that this exerts obscure but very subtle but very strong pressure on physicians. physicians will prescribe these drugs partly because they are human and they understand that if you don't get the drug through them you will get the drug through someone else so it's an enormous amount of resch on them and that is why countries did not permitted amway we should not permitted either in my opinion. and her question about, and are they really interested in curing disease? the disease -- quelled with that not dry up their revenue stream? quite frankly i don't only answer but i do know that -- to be honest with you and i think that is a question we need to answer because i don't think we were in much danger of these companies devising new drugs that are going to cure disease.

and much more directories and then that is these companies earn just in a quick returning a big return on the dollar and often doesn't mean finding cures which is rigorous and lengthy. that means finding things like tess, devising a test for a particular drug, the genetic ailment so you utilize a test for the genetic ailment and take a patent out on that and now nobody else needs that test. when tyrone device to test for hepatitis c the price of hepatitis c in great written skyrocketed six times as high. why? because they have been using a cheaper test by another company and chiron's lawyers with them and said cease and disist, you have to user test and that is what we did -- back that is what they did. that the sun cheaper revenues devising test, devising drugs for lifestyle disorders, the

gastric distress, the dtc ads never tell you if you have stop living on pizza and hamburgers. they don't say that. they say take our pill. they capitalize on people's insecurities. toenail fungus, dysfunction. they have half the men in america convinced that their normal occasional failure to function is the disease, which is very profitable for them. because of that focus i'm not sure we have to go to the point where we say is it worth it to find a cure because it is not worth their while to find a treatment for certain ailments. is worth their while to find cheaper easier ways to patent medication. >> so we are on the university

campus and technology transfer has been very good to universities and universities are always striving to make it better by transferring these two corporate entities. should we all be disbanding our technology transfer activities? can we go back? what i'm asking is can we go back to that time when researchers actually had to make a choice between academia and business and they couldn't actually do both. can we ever go back there? >> we could go back and i think it would be a good thing to go back. whether we will go back i don't know because it's true universities get a good deal of money. but unfortunately now that bonanza does not filter down to people. the people who don't need money but need effective treatments that they can afford. so we could repeal bayh-dole but

i'm pretty sanguine of the chance of that happening. i'm not thinking that is going to happen anytime soon and i realize it may not have been all but it will be a good step. sometimes were freight of not being progressive and not going forward. there is this nigerian proverb and it's called san kope and what it says is it's not wrong to go back for that which you have forgotten. in this case we have forgotten something. in their zeal to make money we have forgotten to put the patients at the center so i think it would be a very good idea to basically effect a divorce between corporations and universities. now, that may not happen and is probably not going to happen so what shall we do? i think the government should exert very serious pressure on pharmaceutical companies. i think they should exert pressure -- though i'm sorry, first get rid of the lobbyist.

it's like shakespeare, first let's kill all the lawyers. first let's get rid of the lobbyist. government should exert strong pressure on these companies to partner with groups like doctors without borders which they have a patiently successfully done it full-scale to adopt new marketing models like the health impact fund which says that instead of charging a lot of money for a drug you are going to be paid for your drug based on how many lives you have saved, based on how many people you helped. not only does it guarantee a windfall for a cure for an important disease but in that model every life is the same. saving the lives of 10 americans is the same as saving the lives of 10 african so that is a wonderful model.