Dr. Sidney M. Wolfe speaking at a symposium held at the University of Minnesota College of Pharmacy. Wolfe’s topic was on the conflict of interest between industries and professionals in the medical services fields, the availability of information from the medical industry and medical services fields, and the exclusion of consumers from information in the medical delivery field (drug industry especially).
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I'd like to describe. Some of the problems that we see in this country now in the area of Health the way people are being adversely affected by poor health conditions by 1/2 and poor Healthcare System. And I think Sid in describing it. I'd like to focus on a crisis of decision-making that I think underlies many of the problems that that we see in Washington and that are seen elsewhere in the country. People who are making the decisions, whether they be doctors with respect to Patient therapy owners of factories with respect to the exposure of workers to dangerous chemicals or the exposure of citizens around the factory to the same dangerous chemicals and smaller concentrations. Weatherby dentist or pharmacist the groups that are doing the decision-making are pretty much isolated in most cases from any public input. So that many of the decisions are made up by people on behalf of their own self-interest much more than behalf of the public self-interest parallel to what one might call a conflict of interest in decision-making not that the decision should be made exclusively by the public with the public should at least have a role in deciding if a new toxic chemical is going to be used in a factory exposing people in the community and workers to it people should be involved somewhat in the decision as to whether or not an operation they're going to have that is beneficial to them more than it is harmful. We think the coupling with this apparent conflict of interest in excluding consumers for major decisions having to do with health is a very markedly curtailed accessed information of all sorts. One of the current activities of many groups in Washington has to do with Federal Freedom of Information Act. This is an act which says that by and large decisions made by federal agencies and the information upon which the decisions are made are to be made available to the public. One of the greatest of uses of this Freedom of Information is in the area Pharmaceuticals where the drug industry tries to impose the notion that all this information is a trade secret and thereby keep people who honestly want to see the results of drug testing and so forth from from seeing it. So the decision making has two unfortunate components. The decisions are largely made by perpetrators owners operators rather than by the victims of these decisions and the victims have very limited access to information that they should have in order to make a better decision. The tour are tied up on a very closely because the number one argument that is always raised against consumers being involved in decision-making is how did they know, you know, they didn't go to medical school or they don't know how to do an operation. They aren't a biochemist and so forth and with respect to technical condiments Some of these criticisms are are correct. But at the same time as cruel as consumers are being criticized for not being capable of a participate in decision-making are being prevented from getting any kind of information that could make them more capable so that that sort of vicious circle and he needs to end and in many ways is beginning to end. With respect to health Weatherby Healthcare or adverse effects on people's health. To break down people who are making decisions into two major groups Industries those run Industries and the professional group The Industries produce Goods. Which in the case of the chemical industry have very adverse effects on people's Health in the plant and outside. the drug industry the same and thus the people who offer or deliver or sell Services where they be dentist doctors pharmacist and like If you look at the way the industries are run in the industry with which we are most familiar is the chemical industry, including the pharmaceutical industry, but a lot of work that our group has done has been helping workers and local unions particular in the chemical industry. Be able to gain enough information so they can do something about very adverse working conditions. They are excluded from the decision-making process. I'd like to give a couple of very specific recent examples of the gross levels to which this exclusion goes. A local Chemical Company a union of a local Chemical Company about a year-and-a-half ago which makes Pharmaceuticals but this particular plant happened to be in agricultural products division making pesticides and other cultural camel chemicals fertilizers many of whom had suffered on the lineated disease out of proportion to their age and numbers became became concerned with the passage of a federal law in 1971 that occupational safety and health act big became concerned about the fact that they didn't have any means of getting a handle on their exposure on the job until they ask the company. For a list of the chemicals that they're working with. And the company said you don't have a right to have this information. And they contested this and finally just got to Louisville Federal arbitration check for the soul issue was doesn't work or have a right to know the names of chemicals in the workplace seems like a ridiculously simple kind of issue and anyone who even remotely believes in human rights worker rights would think that would be automatically grab it was granted and it had to be taken through level after level of arbitration and grievance and so forth and finally after probably thousands of hours of expenditure of a large number of people time. The issue was one in favor of the workers in the decision was that yes workers do have a right to know the name of chemicals that they work with. A right, which is obviously very prerequisite to finding out whether or not any of the chemicals are harmful. Another example of the indifference on the part of Industries for workers and we've seen other evidences in the past of the indifference in the part of industry in terms of of environmental issues. Another Chemical Company workers exposed to benzene. Benzene is very commonly used as a solvent as a starting material for number of other processes and Benzene is been very well-documented to cause bone marrow depression manifested by low white count by anemia in some cases by pancytopenia and there are a large number of cases in the medical literature of acute leukemia 5 or 10 times higher incidence in workers and implants for their first of NC. Well this year in this plant was not whether or not the workers had a right to their names of chemicals are working with although the company sort of thought. They didn't put the workers have gotten ahold of the information. I'll be issue was does the worker have the right to have a doctor of his or her choosing look at the medical records that the company is accumulated that show whether or not being exposed to Benzene is have any adverse effects on a person's health and the answer by the company was no the workers does not have the right to choose a doctor visit her choice and have the medical records forwarded from the company doctor in the company to this other doctor is a right which is considered part of medical practice for most people in this country, but apparently workers are not looked upon as as first-class human beings and they were excluded this right same series of grievances arguments when about and It just two weeks ago in Pittsburgh. We were involved with again and arbitration before federal judge and what are the workers have a right to see whether or not they become anemic how a name if they become and so forth. Have a doctor see it. We've been involved with a number of Union Saint similar kinds of issues having to do with an industrial lead poisoning and the crippled almond for the workers even beginning to do anything about being poison. The workplace is finding out what chemicals are there, seeing or getting someone of their choosing to see the medical records and then using the contract is a weapon using striking his weapon trying to negotiate changes. In the process of doing this at we work with two unions that were involved with industrial lead poisoning where significant proportion the workers were anemic and as a result of the workers being given report for a group of how many were getting lead poisoning. They were able to change significantly the working conditions in the plant. So that in this case workers in the plant exposed to chemicals are excluded from decision-making often as to whether the chemical is having an adverse effect or even more basically whether a new chemical known to be toxic should be used even though it cost a penny less than another non toxic chemical. These decisions are made 1 2 3 blocks or Miles Away by the executives of the corporation who themselves make every effort not to be exposed to these chemicals by distance in addition to ventilation of precautions. The same is true in another sense. About decision-making on the part of people who receive Professional Health Services. We have raised repeatedly the issue of unnecessary surgery overprescribing of drugs and so forth and human experimentation, but critical to all these issues again, the fact that the person who is victimized in many cases or who is the least intended recipient of the Professional Services or Goods in the case of drugs as a consequence of the social services. People are not given what one call informed consent in focusaid is something that is more traditionally thought of in connection with a surgical procedure. But in a sense informed consent to be a part of any kind of therapeutic decision by anyone who's involved in in health or in law for that matter patients really have any idea what their diagnosis is. They don't feel it's the right to ask. What is the name of the disease that you would decide I have let alone what basis did you use to arrive at? It medical records are kept in abysmal a sloppy and illegible and non-scientific fashion. You're having made a decision as to what the diagnosis is does the patient have any notion as to what the benefits and risks and possible consequences of some of the therapies are at we have recently been very much involved in in efforts to improve the informed consent of women with respect to sterilization. This all generated from the unfortunate case of to I believe 11 and 13 year old children in the South were sterilized. One of them probably turns out not to be retarded. All of that was the justification for doing it. No informed consent. No one knew what was going. Well, there are small number of people in this country who are underage and mentally retarded for whom extra precautions need to be used for 4% But most people getting sterilized in this country are neither under age normally retarded, but with respect to the information that they should have in order to make the Des. They are certainly retarded from getting information. People in many University centers estimate that as many as 1/4 third of all hysterectomies are done without any justification at all. And the usual trick is the doctor telling a woman that well, you probably don't want to have any more kids and addition to that. You have a little medical problem. Might as well take care of that at the same time the Obscure a non-therapeutic reason for sterilization Emily to stop having children with a contrived are often contrived medical reason, which may not be contrived in terms of its existence but is often contrived in terms of whether its existence really indicates the need for doing a hysterectomy or other form of sterilization so that again the decision-making processes is totally taken out of the hands of people who are affected by it. And again, we're not advocating that women learn how to do hysterectomies or that women go to medical school. But what is being advocated that women ask as they are in many places more and more questions when people say Hey, we think you should have a hysterectomy a recent appalling example of how Cavalier Obstetricians and gynecologists are that took place at the National Convention of the American College of Obstetrics & Gynecology two years ago. And at that time so called elective sterilization for non-medical reasons was beginning to increase more and more so that in one major teaching center UCLA. There was a Sevenfold increase in hysterectomies over the last two years prior to that time. What was going on with the doctors who previously hid behind medical reasons were coming out and saying we don't need to pretend that we're doing it for medical reasons. We'll just do it because we think that should be population control and so far the Sun in order to give publicity to this issue and allegedly resolved it the American College of Surgeons guy called you decide to have a debate and was called the great debate and they tape this debate in and I got a copy of the debate and when something like this there were three people speaking in favor of elective sterle's at history of hysterectomy was the specific topic hysterectomy. buy Electric Sterling as a means of elective hysterectomy is mean to sterilization the three people spoke in favor of it and one of the Maine remarks most notable marks in favor of it was by someone from the nearby Mayo Clinic who said that I hope that obstetricians-gynecologists have become mature enough so that when they're their patients have reached the age of 40 and have decided that they don't want anymore children that they can call up there friendly obstetrician-gynecologist and schedule their birthday hysterectomy. This Groove this true Great Golf pause and laughter from the audience there, but at the when all was said and done they carted out an Applause meter, which is a very professional way of deciding issues and rejected the two sides of the debate to an Applause meter and both in terms of this actually happened today both in terms of intensity and duration of applause. Although there were a few selected people who could be heard over the tape recorder plotting particular long and lat the side Pro one. Well, I don't I think I'm all in favor of democracy even in the American College of obstetrics Gynecology. If I were the only reason I mention this is it really be speaks a very casual and Cavalier attitude that obstetricians-gynecologists have about sterilizing other people in a recent article just appeared about 3 months ago on the sterilization or family control practices are patricians and gynecologist in themselves, and although they are recommending with increasing order and frequency sterilization surgical sterilization for other people their own wives. Don't use it quite as frequently as they prescribe it so that there's a bit of a contradiction in that. What can you do about all of this? the two levels of action for anyting I suppose whether it's in in the health area or not in the health Darien and these are individual action and action by the government and neither has a soul means work despite the assertions to the contrary by respectively Anarchist or centralized socialist depending on whether you believe in individual action or total government action. but I think that a combination of both approaches has someone characterize at least the efforts that we have made weather being Occupational Health where we work with local unions at the same time as we've tried to strengthen the federal occupational safety and health act whether it be in the area of healthcare delivery where we have work with local citizens groups at the same time as we have tried to improve h e w is regulation of healthcare limited as though it may be or in the case of pesticides drugs consumer products the same thing people at an individual level need to be equipped with a certain amount of information so they can make an intelligent decision to buy something or not to buy which one to buy or not at all in the case of being a patient whether or not there is adequate justification for certain decisions that have been heaped upon them. Certain questions can be asked such as I suggested before having to do with what's wrong with me. Why you giving me this shit draugr or operation? So we work with local groups. We do local pilot projects such as a recent the doctors directory which we just finished a month or so ago, but we also believe in in a federal kind of effort. Why is there any need for a federal effort? Why is there Washington why are there regulatory agencies in Washington that are trying to improve things in Pharmaceuticals in household products and doctors and so forth for the reason is getting back to original state in the reason is that the decision making love to his own devices weather at an industrial level in the case of Plants factories chemical companies drug companies in the case of professional groups just hasn't worked out. These groups have not been accountable and I needn't recite all the disasters that have resulted from the lack of accountability. But refer any of you to state laws regarding Pharmacy medicine Dentistry, they are pure unadulterated self-interest laws and to the practices of the industries, which have much more concerned about short-term goals such as there a prophets and so forth than they do about the long-term societal impact of there a blowing stuff out into the air and killing off workers. Does chemical company up in Buffalo was there a hundred workers who got bladder cancer hundred workers have got bladder cancer from exposure to Benzene on me and the company really did a little bit about it as a result of state inspections, but only by virtue of a lawsuit that we in some chemical workers brought last year are companies starting to clean up cancer-causing chemicals, which are you know, what caused the death of styles of workers in this country. So that left to their own devices. The industry doesn't seem to be terribly interested in is more important things Walker doesn't get bladder cancer until 20 years after they start working with the chemical by then. They may not even be working in the company anymore. So there's even less reason for the company to be Be concerned so that the the abdication of responsibility or the lack of accountability put in more modern terms of all professional groups or industry is really the cause of there being an increasing amount of effort at a federal or state or local level to bring into some kind of control what's going on in that another obvious reason is in the case of a Pharmaceuticals or Health Services. The government is paying much larger share than it used to with the bill and for that reason alone so-called cost reason so they become they become interested. Who is the girl in one sense of what we are doing in Washington with our group and what many other public interest groups are doing at a state level in health or in other than other areas to increase the role of the individual consumer in decision-making. That's just not a Marketplace decision-making have a long time to buy that are good. But also a long time to live in it cleaner place or or work in a cleaner place. What is the role of Pharmacy in in in this whole process? I'll just spend a few minutes talking about that and I really be interested in staying the rest of the time listen to what you have to say answering questions that you may have. There's a thing called preventive medicine which is a fairly new Department in some universities and preventive medicine or would most of its Origins as the public health to cleaning up infectious diseases. And so they got in his nation's going and start studying at the demyx and so forth and so on. Is there such a thing as preventative Pharmacy? well Dr. Weaver said at the beginning of the role of Pharmacy pharmacist pharmacies schools of Pharmacy has changed significantly in the last while from a product orientation which implies dispensing of goods and services to the beginnings of a patient orientation. Which has to do with the implications of the goods and services that are dispensed. The idea of academic Pharmacy has become very popular. So the people are talking about making rounds in hospitals with doctors and and looking at drug interactions and so forth and I'm glad to see this happen. I hopefully will happen if fully aware of all the lessons to be learned from how this happened some time ago in medicine and what went wrong with it happening what went wrong in medicine in a few sentences from my humble perspective is that VMA which at one time was a much better organization and it is now with the Advent of academic. Medicine pretty much divided in its ranks and many of the ACT emissions left in May either actually or function like and became involved with teaching medical students and so-called academic medicine and left the m a sort of the crippled by the absence of their Progressive thoughts and I certainly hope that that as academic Pharmacy becomes more and more a part of his teaching a pharmacy in The Pacifier and see that the same thing doesn't happen that that the less Progressive elements in Pharmacy or not left to their own devices to go on saying and doing whatever they want which may or may not be in the public interest a recent. Example of this would we had this discussion up about it before I start talking to do with the government's recently enough policy with respect to purchasing generic drugs. App for 2 years and memo has been lying and floating around h e w that says that federally financed for h e w Finance Healthcare program should not be buying the most expensive drugs as they frequently are but should be buying the lowest price quality drugs and at long last it when forced to it by a number of groups and individuals when no for the delay could have been in common secretary Weinberger and lasted December 19th. I believe that they would Implement such a policy. The phone to the manufacturers Association which represents the large drug manufacturer has been trying every way they could to get people on the bandwagon against it because of course there are drugs the highest quality brand name drugs are much better than generic drugs. Did they seem to have forgotten that in the last few years they themselves because I've become one of the major dispensers of generic drugs often made by some of the same small companies that they attack when they sell the same generic drugs under their own label when they sell them under the label of the Pfizer and Merck that they are the good part of the day. They all met that kind of argument for they've been running to page ads in the medical journals in last 6 months or so. We're an increasing list of organizations that opposes this concept of government purchasing generic drugs have been listed the American Medical Association Board of Trustees and a whole host of other organization including a retail drug. And like I was very disturbed to see that a recent tropical meeting in the last month or so January 10th. I believe the American Association of colleges of Pharmacy join the ranks in voted with a resolution that attacked the concept of the government find the lowest price quality drugs. As students of Pharmacy you really should demand some kind of explanation for this. Although I'm told that that the decision was not exactly made in the most informed consent way that's in it was a hoodie decision that many people who went to the meeting didn't know that it was going to come up as an issue with nevertheless. Your trade Association your professional association has voted with the industry essentially on an issue. That's critical because it involves shaving of an extraordinary amount of tax money what you were paying for. It involves putting to rest all day and a Creative Concepts that that are completely reputed. If only because the the major manufacturers who keep bad-mouthing the generic themselves are doing it accepted as I said before it's good when they when they do it even though it's someone else's drug that they're selling. I mentioned as simply as an example of Preventive Pharmacy whatever that is. This is preventing people from wasting extraordinary amount of money into this case is preventing everyone from wasting a lot of money on unnecessarily expensive drugs when much better or much less expensive equal effective drugs are available. I think that. It goes beyond just taking stands on federal issue such as this or taking the wrong stand for what I would consider the wrong state and federal issue. Like this goes beyond making rounds in the hospital. It goes to one of the most serious consequences of the product which pharmacist have always delivered and focused on the Drug's adverse drug reactions. There been excellent articles on adverse drug reactions in the journal American pharmaceutical Association to a lesser extent a lesser extent in the medical literature. But I was drug reactions. Are something that prevented Pharmacy could could cut down on significantly there's a recent experiment conducted on the west coast were in a pharmacist started reviewing the purchasing practices prescribing practices and so forth of patients in a nursing home and found that they were able to save something like 80% of the class of drugs if you included now in the purchase cost but also the cost of hospitalizations due to adverse drug reactions and so forth. So here you have a pharmacist not dishing out product but intervening in what is a terrible your rational process called prescribing drugs, which doctors do ignorant of many of the important principles, which shouldn't underlie prescribing, but very aware of the most recent message by the latest detail man that to visit them. I think that to the extent that adverse reactions. Are attributable in many ways to drugs that should never have been given in the first place to say nothing of Miss prescribing and overdosing and Miss dosing and drug interactions for drugs. That should have been prescribed in the first place. There's a very significant role for the pharmacist to play at this point in time very clearly to act as a countervailing force to the doctor. in recent the testimony before the Senate hearings on truck. We recommended that all promotion of prescription drugs should be stopped entirely to doctors. The only information that should be given off by the company's information having to do with price of drugs, which doctors are almost totally unaware of now and published studies having to do with the safety and efficacy of a drug is difficult to imagine why a doctor should be concerned about anything other than what a drug cost the patient to they sent it to drugs of equal efficacy and safety difference different by 5 cost. And what is the drug works or not? And if it's safe or how safe it is worth the adverse reactions are what interactions it had. Well, these are the last factors that are considered by many doctors in prescribing drugs too with the extraordinary overuse of antibiotics for conditions that never have been shown to respond to antibiotics tranquilizers for conditions. That has more to do with normal stress than to do with any serious kind of mental impairment in the light. What role is is Pharmacy going to take in in becoming preventive Pharmacy in preventing over-prescription of drugs and all the other? Disastrous doctor originated things with the help of the drug industry Dr. Originated things which kill off a large number of people. I don't know the answer and I'd certainly like to hear from some of you what your thoughts are about this and the way in which some of these things are Incorporated now only it's your academic practice as you are learning in school, but into into what you do after school, how are there people who don't work in drugstores don't work in hospitals who are working in the area of educating eye doctors. There are two such an experiment going on at the Virginia Commonwealth pharmacy school. I believe now, they've been sending some students out the doctors offices to replace the drug detail, man, are they they want to say to replace it because that's too strong line. What do they say to augment the drug detail man? We have argued that the idea of a drug detail man whose income is directly proportional in many ways to the amount of drugs are cells that the idea of such a person giving a purely objective information is just absolutely impossible. However, what was learned from the drug detail men experience I think is that is very helpful to have people going in doctors offices and I think that in the future more and more efforts will be made toward providing teams of pharmacist and doctors to go into doctors offices and talk with them about what's the best drug to use for someone that has an upset stomach and so forth rather than having them listen to 10 messages about antibiotics that probably should never be used in 9 out of 10 cases in which are five times more expensive one use than something that is equally effective. But as I said be quiet in here in your reaction to these kinds of these kinds of thoughts and as I mentioned in correspondence with people at the school week for the first time, we're going to have a phone to student the summer. I'm working with us. We have not yet selected the student not any of you undergraduate or graduate are interested in working in what we can call for Venice Pharmacy be glad to talk with you afterwards or have you write to us is a health research group 2000 P Street in Washington. to summarize then I think there's a great role for pharmacists in the future in the other than product orientation as is already been alluded to I think that Rose and become an adversary to the doctor was just what people say when you say well shouldn't what why don't you why don't pharmacists. Get empowered with looking at what is being diagnosed not just what's been prescribed so they can look at a prescription and then decide whether or not the the prescription has been written has anything to do with the disease that allegedly exist and when it when you mention this to say why we don't want to get we don't want to have to get on the outs with the doctors and we don't want to antagonize the doctors and we don't have become adversaries the doctors and whereas in the long run nobody hosted the adversarial relationship is all that exists right now. We are really in a serious crisis having to do with too much pushing of Medicine by doctors under the influence of of a tremendous amount of promotion does the billion-dollar your figure is really never been refuted except that it's getting slightly larger now billion dollar spent per year in various forms of promotion of prescription drugs. Headed for the president may be necessary to become an adversary to the pharmaceutical manufacturers and certainly to become an adversary to some doctors who think that it's that is necessary to give pills out to everyone regardless of what's of what's wrong with them another area where pharmacists can become involved work which has nothing to do with at least a practicing physician has to do with over the counter drugs on this is one thing we're considering having student work on the summer. As you know is been a massive initiation of reviewing over the counter drugs something that hasn't really ever been done before to look up such basic questions as do they work or not it which is supposedly a legal requirement under the 1962 Drug law and and are they safe for relative to the benefits that accrue on people from using them? I think there's a tremendous role of pharmacist Here video the literature that I read in the trade magazines that asked a question a pharmacist. What would you prescribe someone came into and said hey I have an upset stomach. Presents a in many ways a far more rational set of decisions being made then in some cases are made by doctors and certainly more rational than the decisions of consumers make as a result of the television promotion of over the counter drugs that we've been very much involved with Alka-Seltzer for the last year-and-a-half trying to end its use as an antacid as I hope most of you know, an Alka-Seltzer has a large slug of of aspirin in it. And if there's any group of people who should not be taking aspirin if people with gastrointestinal symptoms and yet that's been the main reason that Alka-Seltzer has been used and we've been involved in a whole series of of struggles with the Food and Drug Administration and with Miles Laboratories because they they have somehow wanted to keep it on the market as an antacid somehow suspecting that if that if it's used only as a painkiller that it won't be as popular at 20 times the cost of aspirin as as as it is right now and the compromise position that was involved by the CNS advisory committee was It's not rational to prescribe Alka-Seltzer as an antacid alone because people who take it for gas intestines symptoms might have an ulcer and so forth in my geography. But if you have a headache then it's all right, and if you look at the recent change in Alka-Seltzer add you see that reflected is a if you have a headache and symptoms of gastrointestinal then it's all right to take Alka-Seltzer will on the basis of logic without knowing anything about medicine or Pharmacy that does not seem to make too much sense and we will surely be involved in a in a lawsuit. Possibly it is if our position which is not to allowed to be used in an acid is not adopted. We we were involved in a formal hearing before the Food and Drug commissioner over over this issue the Maine attorney for the Food and Drug Administration the General Consulate of the Food and Drug Administration who had significant input into changing what was initially a decision by the Committee not to allowed to be used by an F as an antacid changing his decision to the present irrational one. This attorney used to be the lawyer for Miles Laboratories. Such is the conflict of interest in Washington and elsewhere. So I think in addition to prescription drugs that there is a major role that can be played more more by pharmacist in in again countervailing. The very Insidious forces of of Television promotion is that promote many cases the worst and most expensive frogs rather than the ones that are the most benefit is something like 30 or more million dollars a year promoting office. Dr. Larson television. Well, I'll close now. Going back to the original theme that if you think the patient should be involved more in decision-making, since you were all patients in addition to being pharmacist would be interested in having you work with us to be interested in helping out local programs here going to meet this afternoon with the Minnesota public interest research Group, which I understand is already initiated some programs with people in the school Pharmacy. This is very very critical more so than almost any area many things having to do with Health Care delivery need to be regulated need to have accountability at a local level on were certainly glad to help develop local projects work with them in addition to doing things in Washington. Thank you.