mr. kyl: mr. president? the presiding officer: the senator from arizona. mr. kyl: mr. president, i ask unanimous consent that further proceedings of the quorum call be dispensed with. the presiding officer: without objection. mr. kyl: thank you.

mr. president, today i'd like to talk about a bill which today senator mcconnell and i introduced and i think a companion bill will be introduced by some of the leadership in the house of representatives. the number of the bill is 1259. and this bill is called the patients act. patient as in doctor and patient. and the idea is to focus on health care as it relates to patients. the health care reform should be patient centered. that nothing should come between the physician and the patient. and we're concerned that there is something that is being done that we need to stop because it could, in fact, insert government bureaucrats in between the patient and the physician. what's happened is that in the stimulus bill, the congress appropriated $1.1 billion for something called comparative effectiveness research. now, comparative effectiveness

research has been used for years by physicians and hospitals, medical schools do research and they determine what kind of treatments are best. for example, if you have two different drugs for the same condition, they'll do testing to see which one seems to work the best. and it's called clinical trial. they do clinical research and physicians in hospitals frequently use the result of that research as recommended for the -- for the best way to treat a particular condition. it's not manned trivment obviously -- mandatory. what is good for most patients may not be good for all patients. it's not something forced upon people. but it provides good information. the problem is that too many people now who are proposing health care reform want to use comparative effectiveness research to end up rationing care. to have a federal entity or even a state entity or i should say a private entity, use that research in ways that would end up rationing care.

to say that some care is too expensive for you to have and since the government is paying for it, the government isn't going to give it to you. what our bill would do is to make it clear that comparative effectiveness research cannot be used to deny coverage of either a health care service or treatment by the secretary of h.h.s. and we say the secretary of health and human services because all of the various enterries that might do that in the federal government are part of h.h.s. so we simply prohibit the secretary of h.h.s. from using this comparative effectiveness research to deny a health care service or treatment. now, you would think that that would be uncouldn'controversial. and i'm hoping at the end of the day that it is not controversial. nobody wants their health care rationed by somebody here in washington, d.c. it would also require that comparative effectiveness research account for differences in the preference of patients and their treatment response to

personalized medicine and something called gee nomics. geonomics is the break down of the body that makes us unique as individuals. what geonomics focuses on is what is in your human genome that might be different than someone else's. that is a personalized treatment might work for you and it might not work for someone else. they're finding that they can tailor specific drugs to treat specific genes in such a way that if they know your human composition, they can find a way it treat your condition, say a cancer, potentially slightly differently than they would someone else's cancer. whether it is in the dosage of the medicine or specific kind of medicine. however it might be. the point being is that not

everyone is the name. in fact, we're all different. we're all unique. one of the things that medicine must recognize is our uniqueness as individuals and not get into the habit of saying, well, there's a sort of size that fits all year and we're going to say that if doctors will treat everybody with this particular medical device or drug or treatment, then we'll pay for it, but we're not going to pay for it if they do anything else. that would not be a good medicine. that inserts the government in between the patient and the physician. we're saying that can't be done by using the comparative effectiveness research. the bill also makes clear that nothing prohibits the f.d.a. commissioner from responding to drug safety concerns under his authority obviously if a drug is not safe, the f.d.a. needs to say the drug is not safe and the federal government isn't going to pay for it. that's obvious. but the point here is that this comparative effectiveness research should not be use bid the government to deny, delay or ration care. the reason for it is, obviously,

we all want to be in charge of our own health care with our doctor we want a choice. if the doctor says we think you need this kind of treatment, and we can get coverage for that from our insurance, we want to be able to get that care. if we can't, we want to find insurance that will provide that coverage. at a minimum, we want to be able to pay for the treatment, if nothing else. what we don't want is for the federal government to say it doesn't matter whether you're covered, you can't get it because the federal government says so. this is especially important if we have a government-run insurance company, which is what many on the other side of the aisle are talking about. the president has said that he wants a so-called public option so that there will be a government insurance company that will be a place where everybody could go for coverage if they don't have it. i happen to think there are better ways of getting everybody covered. to the extent we have some people who need help in getting coverage, the government can

provide that help without changing the coverage the rest of us have. surveys show 2-1 everybody believes we should help people get insurance who don't have it. by the same rough numbers, everybody says, however, you don't need to affect my coverage in order to do that. in other words, i have insurance, i like it, i want to keep it. i don't want to change and i don't want to have to pay through my insurance or through having care rationed in order to make sure somebody else gets care. the bottom line is we all want that sacred patient-doctor relationship maintained. you might say why would we be worried that this comparative effectiveness research might be used to ration care? is there anything in the legislation that suggests that this is going to happen? and as it turns out, in both the bill that came from the "help" committee and the legislation pending -- that will be drafted in the finance committee, there are organizations that are going to do this research that could

in fact ration care. in the "help" committee bill, there is a specific provision that a government entity is going to be created to conduct this research, and nothing whatsoever prohibits that entity from denying care based upon the application by rationing. and the same thing is true under the plan that is being talked about in the finance committee. there, a private entity is organized. but, again, there is nothing that would prevent the -- prevent the federal government from rationing the care that's researched by the private entity. the "help" committee creates what it calls the agency for health care research and quality in the department of health and human services. it is a private research entity. but in neither case is the federal government prohibited from using this comparative effectiveness research in rationing care. and in addition to that, the "help" committee bill establishes what's called a

medical advisory council. the medical advisory council is specifically given the authority, very broad authority to make recommendations on health benefits coverage. in other words, what is covered by the federal government. and obviously when the federal government sets rules, insurance companies frequently apply those same kind of rules. you don't want the government rather than patients and doctors making decisions about how much health care or what health care you would have. another point that i've tried to make to folks is that if they think that the federal government isn't considering this, think about what some people have said in the federal government about allocating treatment based upon cost. no less than the acting director of the national institutes of health announced that the n.i.h. could use this stimulus money, the money in the so-called

stimulus bill that pays for the comparative effectiveness research to ration care just as it's done in other countries. i'll quote what he said, that the n.i.h. released a list of research topics and called for -- and i'm quoting now, the inclusion of rigorous cost effectiveness analysis because cost effectiveness research will provide accurate and objective information to guide future policies that support the allocation of health resources, or the treatment of acute and chronic diseases. end quote. allocation of resources is a euphemism for rationing of health care. similar statements have been made by larry summers, frankly, the president himself has talked about this not in those specific terms, but in a recent interview with the "new york times" he said what i think the government can do effectively is to be an honest broker in assessing and

evaluating treatment options. if the government is going to be a broker in treatment options i think that is a euphemism in what it's going to pay for and what it isn't going to pay for. what you get and what you can't. when former u.s. senator and at one point candidate for h.h.s. secretary talked about this, he acknowledged in a book that he wrote that doctors and patients might resent any encroachment on their ability to use certain treatments. but he called for the same kind of body in his book that would in effect allocate treatments based upon this kind of cost research. there are many others who have spoken about it as well. we know from experience that this hasn't worked out so well in countries that have tried it, like great britain and canada. but -- in fact i'll quote one other individual who has talked about this, a professor at the harvard business school, regina

hertslinger said the stimulus, the comparative effectiveness research in the stimulus bill could easily morph into what he wha* she called an instrument of rationing by the federal government. there are comparisons of what is being done in great britain and canada, ironically at a time when those countries are actually turning away from the federal monoply or the national monoply because of the fact that it has provided -- it has resulted in rationing of care that the citizens of those countries don't like at all. former head. american medical association, which incidentally, has endorsed our legislation, the legislation senator mcconnell and i are introducing here said this in an op-ed in the in "the chicago tr" today. he's talk about the british agency which ironically the acronym is "nice," the national institute for comparative -- i'll get it in just a moment. he says -- quote -- "for example, the agency that makes

these decisions in the united kingdom determined that we are all worth $22,750 for six months of life or $125 a day. i'm sorry, $125 is the cost of a nice date with my wife not the value of my life. what he's talking about are something called quality-adjusted life years, which is the british definition of the value that they're going to place on a life for the purpose of comparing the cost done by this cost-effectiveness research to see whether the cost of the treatment outweighs the value of the life. just think about that. let me quote from the nice web site. i told you i would tell you what it stands for. national institute for health and clinical excellence, nice. here's what it says on its web site in britain. with the rapid advances in modern medicine, most people

accept no public clip funded health care system, including the n.h.s., can possibly pay for every new medical treatment which becomes available. well, that's right. if the federal government has a monopoly, it probably doesn't have enough money to pay for every treatment that becomes available. the enormous rationing involves means choices have to be made. the qaly, the quality method helps us measure these factors so we can compare different treatments for the same and different conditions. the idea of how many extra months or years of life, of a reasonable person a -- quality a person might gain. each drug is considered on a case-by-case basis. generally, however, if a treatment costs more than 20,000 to 30,000 pounds per quality adjusted life year then it would

not be cut, considered cost effective. and they don't give it to you. we have many, many examples of peach in great britain that are denied care because the government has decided that the cost of the treatment is more than your quality-adjusted life year. and this is adjusted for age, so that the older you get the more the treatment -- or even though the treatment may cost less, you're less likely to get it because of your age. well, think about that for a moment. if something costs $20,000 in the united states and you're 65 years of age, and they decide they can't afford to pay for it. is that what the united states of america is all about? is that what our government should be telling us? should the government have the right to say based on this research we've done, you can't have that treatment. if you want to say that can't happen in the united states, i think it can. it's happened in great britain and canada, our legislation says

it can't. what is the harm in tkoplgt our legislation. that is the question of anyone who comes here and asks, well it's not necessary. i want to put the question, what harm does it do to say this research can't be used by the federal government to deny or delay treatment? i hope that my colleagues will appreciate that health care is the most important thing to all of us for our families. whatever else we may think needs to be done to reform health care in this country, i think the one thing we can agree on is taxpayer shouldn't result in a rationing of health care for americans. our legislation is one step in that process. it doesn't preclude rationing of health care in other ways, but at least it says you can't use comparative effectiveness research in order to ration care. so i think that -- i hope that our colleagues would view this legislation as an important step that we can take. let me just give you a couple of the examples that i said i could provide. there's a fellow by the name of

rocky fernandez, a kidney cancer patient in britain. he was given two tphopbgts live when the cancer spread to his lungs. his doctor wanted to spraoeub a drug, a new drug for advanced kidney cancer but the british government said no. he and thousands of other cancer patients protested the british government's decision. this is what you'd have to do, i gather. the government ultimately reversed its decision and, fortunately, he was able to begin taking the drug. but the british health authorities knew this wasn't the end. more costly life-extending drugs would become available, patients would demand access to the drugs, and the government would be faced with increasingly difficult decisions. so faced with a finite pot of resources, the british health authorities decided expensive drugs would only be approved under very specific conditions. they must, for example, extend life by at least three months and must be used for illnesses

that affect fewer than 7,000 patients a year. stop and just ask yourself, is that what we want here in the united states? before you can get a drug that would give you better quality life or extend your life, the government is going to run through tests like this? and if it doesn't meet the test, you don't get the drug? this is the danger of a government-run system. in effect the bureaucrats and government become health care cops. we don't want that in america. so in the reform legislation that we end up acting on here, i think we all agree one of the things we can do is to at least say we're going to do no harm. we're not going to allow this comparative effectiveness research that's going to be done to be used by the federal government to deny our care. mr. president, i'll ask unanimous consent to put the record -- in the record a lengthier statement and also the op-ed in "the chicago tribune"

by dr. paul masano which i quoted from earlier. the presiding officer: without objection. mr. kyl: thank you. mr. president, i wanted to conclude by just mentioning a couple of things. first of all, we have actually seen the danger in using this kind of research for rationing of care in another context. when we created the medicare part-d, which provides drugs to seniors, we saw the danger of rationing of drugs. and so we specifically provided in the medicare modernization act which provided for the part-d drug benefit an explicit provision that says you can't use cost-effective analysis to allocate the drugs. it's prohibited there. what we should do is take that same policy and apply it to the

rest of our health care, to seniors who are on medicare and to the rest of the population to the extent the federal government will be able to dictate its care. we have not provided that same protection for any other care in the country, and that's what our legislation, the patients' act, would do. mr. president, the final thing that i'd like to discuss here is the notion that we can have a government-run insurance plan and that somehow that will be healthy for americans. stop and think for a moment. a government-run option, a government option, as it's called, would be the federal government making decisions about care. so while you may decide that it's a lot cheaper because the federal government can subsidize the insurance plan, the government will actually be deciding what kind of coverage you get. this is one of the areas that we're concerned about in using this comparati