John Ashcroft

Mr. ASHCROFT

Mr. ASHCROFT. Madam President, the CDC claims it does not sponsor needle exchange conferences. Two times during the confirmation process, Dr. Satcher was given the opportunity to make his position on Federal funding for needle exchange programs known. Both times, in response to written questions, he wrote: I believe that, as a nation, we must remain open to the input of quality science. Secretary Shalala's 1997 report to Congress concluded that needle exchange programs ``can be an effective component of a comprehensive strategy to prevent HIV and other blood-borne infectious diseases in communities that choose to include them.'' At the same time, the administration's position on Federal funding of needle exchange programs is that we do not have adequate science to conclude that such programs do not encourage drug use in communities. Thus, we have not asked that the ban on Federal funding for these programs be lifted. Dr. Satcher was asked and given the opportunity to state clearly, in writing, what his position was, and it is pretty clear that this answer is consistent with the way they responded to my request for documents. Asked about his commitment to a clean-needle program, he said that he believed we must remain open to the input of quality science, and then he cited the administration's position. Well, quality science without values can be dangerous. The Surgeon General of the United States should reject such policies as an acceptance of defeat and an embrace of hopelessness. We should not decide we are going to accept drugs as a way of life in the United States. We should not spend resources providing clean needles to drug addicts or for conferences that promote the distribution of clean needles. In theory, there are those who really think clean needles would help. In practice it doesn't work that way. Let me just give you some information about needle exchange programs. First, needles are not always exchanged. Therefore, they do not keep dirty needles out of our communities. The New York Times' reporter went into a needle exchange center and received 20 syringes without exchanging any needles. His companion received 40 syringes. They serve them up by the dozen. According to the Associated Press, in Willimantic, CT, ``More than 350 discarded hypodermic needles were collected from the city's streets, lots and alleys'' in a single week. Now, there's a great environment for children in America--to have used hypodermic needles from drug addicts discarded under the guise of a ``clean-needle program,'' protecting the drug addicts, but exposing the children of America. It is obvious that we are teaching the wrong things to children when we teach them that we will provide them with clean needles so that they can involve themselves in drugs, but in one week in a small town in Connecticut, there were 350 discarded syringes. You know, of all the clean-needle studies I have heard about, they don't talk about the discarded syringes. Frankly, I suppose it is supposed to be laid at the feet of the Congress because we said it would cut down on HIV infections in drug users and would not increase drug use. Well, it doesn't ask about what happens to the children of the country. I think maybe we ought to think a little more carefully about what happens to the children. Here is an article from USA Today, September 17, 1997: Ms. Fiske says the exchange gets back one-third to one-half of the needles it gives out. That's not ideal, she says, but ``one-for-one exchange does not fit the reality of how injection drug users live. Some of them are homeless. What are they going to do--put the dirty needles in their pockets for a week? So the clean-needle advocates say, if we have 50 percent of the needles tossed on the road or available as sort of medical waste, contaminated with perhaps the deadly virus of HIV, that is a sacrifice we are willing to make in order to be able to accept drug use as a way of life. I don't think that is leadership or where we want to lead this country. That is not the kind of health to which we want the Surgeon General of the United States to summon us. We don't want to be summoned to an environment of drug use and dirty needles laying around. It goes on: It is 1:30 p.m., time for the exchange to close. Within minutes, the tables and leftover supplies are wedged back inside Acker's car. But she isn't done yet. Now she drives about a mile back to the neighborhood near the old exchange site and pulls up in front of a row house. Out comes Kellie Jones, a sometime drug user who has spent a rough 45 years on the streets. Acker gives her a garbage bag full of 900 boxed, sterile syringes. By 10 that night, Jones says, the bag will be empty and the clean needles will be in neighborhood shooting galleries. She distributes the needles, she says, because ``AIDS is such a horrible death,'' one she has seen. ``The public should know that this isn't about condoning drug use. This is about stopping the madness.'' I think if you are going to give out 900 needles in one night, 450 will come back and the rest will be found somewhere in the culture, it is about the madness. I think it injures the quality of life in our communities. From the Pittsburgh Post Gazette, a letter to the editor: . . . Aside from my personal aversion to the destruction needle exchange undeniably perpetuates in the life of the addicts, there are several other key issues that . . . are of concern to myself and my neighbors. Our community has worked hard to battle the drug problem that plagues our neighborhoods at many levels. But the needle exchange program gives dealers and users one more reason to stay here. In addition, drug users from outside our community now find reasons to frequent our neighborhood. Drug addiction is not a victimless crime. Not only does it kill the addict, but also, in the process, the addict preys on those around him. Prostitution, burglary, and now violence are an increasing problem in our community. So while the needle exchange people try to help addicts, they do so at the expense of our neighborhood. You wonder about taxpayers who establish neighborhoods, who own homes, pay their taxes, what they think of a Government that provides needles so that addicts will come to their neighborhoods and they help addicts at the expense of the neighborhood. The needle exchange people, who do not live in our community, have been allowed to operate openly for more than two years here, while the police and neighbors looked the other way. We have seen no noticeable changes of a positive nature. The drug problem only gets worse. Sadly, AIDS is a fact of drug addiction. But the truth is, nothing but recovery and abstinence can truly save the addict. Most addicts do not die from AIDS, but from a host of other tragic consequences directly related to a life of addiction . . . This citizen from Pittsburgh, PA, I think tells us something about needle exchange programs. Here is a letter from the editor of the New York Times: Ever since the Lower East Side Harm Reduction Center-- Remember the harm reduction group, the kind of group that sponsors these kinds of programs that have been subsidized by American tax dollars through the CDC. Ever since the Lower East Side Harm Reduction Center, a needle exchange program, began operating in a storefront in a residential population of working poor, our community has witnessed drug abuse not seen since Operation Pressure Point cleared the area of drugs in the 1980's. Needle exchange is a link in a chain called ``one-stop shopping.'' You can receive your Government-sponsored clean needles (there is no limit to the number), rob and steal to get money for drugs (or sell your clean needles), buy cocaine in store fronts, or heroin on any corner, then leave behind a pool of blood, dirty syringes, glycine bags, alcohol swabs, and bottle caps-- the debris of a depraved individual. The needle exchange program has legitimized drug use on the lower east side. ``The needle exchange program has legitimized drug use.'' That is the key. That is the problem. We don't want to make drug use legitimate. And by a tacit approval has invited a population of predators into our community. Statistics on the spread of AIDS cannot be the only criterion for measuring the success of the program. One of the inevitable consequences of needle exchange programs is that the police look the other way. I mean, after all, if you are going to give them the needle with which they are to use the illegal drug, you are not really in the position to go and ask them to stop using the illegal drug. So we compromise the integrity of the law enforcement community. We make them duplicitous individuals who say one thing but have to do another. We make the police house, a station house, a house divided. From South Tucson, the Arizona Daily Star News: When the unmarked police car pulled behind the Wagon Wheel Bar yesterday afternoon, a young woman in a black hat was squatting by the back wall with both hands on one ankle. ``She is shooting,'' said Gerald Brewer, South Tucson Police Chief. Brewer was checking areas frequented by intravenous drug users when he happened upon the woman who stood and walked over toward South 6th Avenue when the police car stopped. ``Police, stop,'' Brewer yelled, as he stepped from the car and walked after the woman. But she didn't stop, even as Brewer pulled a gun from his ankle holster and shouted at her several more times. She disappeared around the corner of the bar and Brewer didn't follow. She had shot the dope up and already she was rubbing her ankles. So there is no substance on her. ``She has discarded the syringe,'' Brewer said, explaining why he didn't chase her. After turning a trick, prostitutes go to drug houses near South 6th Avenue to buy heroin. Then they fire up in a vacant lot, or an alley, before heading back to 6th Avenue to repeat the cycle. The point here that is being made is since it is no longer illegal, since the government gave you the needle, once the drug is injected into you, and you are no longer carrying the substance-- at least outside your body and in your bloodstream --you are no longer subject to arrest, you end up demoralizing the police, and you end up making it impossible for individuals to enforce the law. This article is from the Vancouver Sun about Glasgow, Scotland which is called ``The drug injecting capital of the world.'' That is a title we don't want to wrest from their control. They have a massive needle exchange program there that makes it possible for individuals to be drug injectors very conveniently, theoretically, safely. The article from the Vancouver Sun says: Michelle is 20. She is soaked through, wearing all the clothes she owns. A thin, pretty, guarded girl in a sodden, flimsy top and light trousers. She has been on drugs for 5 years, and sleeps in an abandoned warehouse with her boyfriend, Michael, 26. Both had spent the equivalent of $800 Canadian on two days of heroin. Michelle isn't sure if she has 17 or 25 convictions for shoplifting. Michael has spent all but six months of the past 10 years in prison for two serious assaults. ``I was out of it, stoned, both times'', and has been on drugs for longer. Before Michael, Michelle lived with another junkie who repeatedly beat her up. She lost the baby she was carrying. ``I'd rather be dead than to live like this,'' she says. The unemotional delivery convinces you she means it. And, as she walks away in the rain, you realize that she is almost certainly moving toward it. Yes. ``The drug injection capital of the world,'' fueled by a clean needle program. As teen drug use continues to rise, as the use of heroin, cocaine, and marijuana continues to rise, the Federal Government should not be sending the message that drug use should be accepted. The Federal Government should not embrace drug use as a way of life. The Federal Government should not subsidize illegal drug use through clean needle programs. And the Centers for Disease Control should not advocate spending taxpayer dollars to provide clean needles which will find their way into the alleys and playgrounds and streets of American cities discarded by irresponsible IV drug users. And people who run the programs now that are privately funded or otherwise locally funded say that the 50 percent return is all you can expect. Teen drug use is up 105 percent from 1992 to 1995. The Office of the National Drug Control Policy, led by America's Drug Czar, General Barry McCaffrey, strongly opposes the needle exchange program. On August 20, the Office of National Drug Control Policy issued a statement: ``Federal treatment funds should not be diverted to short- term harm reduction efforts like needle exchange programs.'' We are told by those who keep statistics on drugs that more teenagers and young adults tried heroin for the first time in 1996 than ever before. Imagine what would be the case if it had the endorsement of the Federal Government. Speaking in front of a Harvard research conference, General McCaffrey called spending money on the needle exchange program a ``copout.'' He said, ``The problem isn't dirty needles. It is the injection of illegal drugs.'' His statement, I believe, is the policy that is appropriate. Here is a story from the Buffalo News, August 24, 1997 ``Accepting Defeat.'' The needle exchange is one of the few places where addicts aren't treated like losers, although that is how many view themselves. ``There is no more shame in me,'' said a 36-year old woman from the Buffalo who has been shooting up for 15 years. The woman, who asked not to be identified, has lived in heroin shooting galleries, and worked as a prostitute to support her addiction that costs more than $100 a day. She wears her terrible life on a racked, puffy face. To prevent three of her children from being placed in foster care, she sent them away years ago to live with a sister in North Carolina. But she can't stop thinking of them. She has attached to her blouse a section of an old rosary that belonged to her daughter's godmother. Next to it is a piece of jewelry she found, a gold heart surrounded by the words ``Perfect Mom.'' ``I pray a lot despite the life I lead,'' she said. ``I know it sounds farfetched. It helps me think that maybe there is a chance I can have my children back.'' The Buffalo News talked about the two sites which together have distributed 713,000 hypodermics in less than 4 years. They have also taken in about 600,000 needles, not in the exchange program necessarily, many of which would have littered the city neighborhoods in the exchange program. Needle exchange programs are not always as effective as their advocats suggest to the public. Connecticut has six needle exchange programs, and repealed its syringe prescription law in 1992. It has intravenous drug use related AIDS at 61 percent. This is almost double the national average. New York has 10 needle exchange programs, but has intravenous drug use related AIDS at 49 percent. It is also a lot higher than the national average of 33 percent. Italy and Spain have a 70-percent HIV rate among IV drug users, and have never had a restriction on the sale of needles. So they are freely available there. It is pretty clear, at least, I think from looking at the data, that there is no conclusive evidence that making needles available and providing them freely reduces the HIV infection rate. Embracing the harm reduction--defeatist--philosophy to any degree will lead to further tolerance of drug addiction. The so-called ``syringe experiment'' I think we have all heard about. First, they started a needle exchange program. Then they opened the needle park so that they could give addicts a place to shoot up. Obviously, it is a park in which they just allow drug use. Then, in order to cut down on crime, they began giving 1,000 addicts doses of heroin. And that will increase to 5,000 this year. This is an effort, a growing momentum, to legalize all drugs. It is a question of whether or not we as a culture want to say that we accept drug use as a way of life, or whether we want to say we want to correct this problem in America. I believe that we ought to stay with General McCaffrey; that the problem is not dirty needles. ``The problem is heroin addiction. The focus should be on bringing help to this suffering population--not to give them more effective means to continue their addiction. One doesn't want to facilitate this dreadful scourge on mankind.'' How does this relate to the nomination of Dr. David Satcher? Unfortunately it relates directly. Dr. Satcher has been less than candid with the U.S. Senate, and has been less than candid with Members of this Senate in providing his record on the needle exchange programs. The Centers for Disease Control, under his direction and authority, selectively has provided to the Senate materials which would indicate that he does not have a program supporting needle exchange when a more thorough review of the Record indicates that he has personally endorsed programs that would promote needle exchange opportunities. It is troublesome to me why this nominee would provide information on a selective basis. It is, second, troublesome to me that he would support a clean needles program. And, third, I would say that the single most important thing that must exist between the Nation and its family doctor is the idea of trust. I believe that the elements of that required trust are lacking in the way that the CDC has provided information, and its selective provision of information and its withholding of information that is important. The needle exchange program is just one of the reasons that I believe this nomination should not go forward. The needle exchange program flies in the face of the values of the American people whom I believe really endorse General Barry McCaffrey--understanding that the addiction is the problem, and for us to support that addiction with a clean needle program would make no sense. For these and the reasons relating to the AIDS studies, for the reasons related to the deployment of the resources of the Centers for Disease Control to limit the availability of or access of citizens to their second amendment rights, I believe we should reject this candidate. I was, I think, safely in the population of the Senate believing that there were no problems with an individual whose record is so replete with qualification and qualification at one time. It is true that Dr. Satcher is a remarkable person, and he has done great things. I thought that one of the Senators failed to mention that the Denver Broncos had won the Super Bowl for the first time under Dr. Satcher's direction of the CDC. But that is about the only good thing that hasn't flowed. But the truth of the matter is that there are other important considerations. David Keene came to my office late last year and began to alert me to the need for us to look more carefully at this candidacy, and to see the critical points of attention between the values of America and the willingness of this candidate to support things like the needle exchange, and to support things like research on other continents that could not be done here to support concepts like partial-birth abortion. While all of these things are related to science and can be undertaken by individuals of great intellect and may only be undertaken by individuals of great intellect and training, they are at odds with the values of America. There should be an understanding that Americans do not want to sponsor the criminal activity of intravenous drug use, that Americans do not want to treat people on the other side of the world as medical experiment subjects instead of as human beings. They don't want to give them sugar pills if giving sugar pills would be illegal in the United States. They don't want to pretend that we have been ethical by saying that we got the consent of all the people involved in the medical studies when those consents were not only seriously challenged--but had to be strengthened--on the advise of ethics boards because the consents were not appropriately obtained. This conflict of values is at the heart of this nomination. I believe the conflict is so substantial that we would be well served to ask the President to send us an individual whose commitment to the public health reflected the values of the American people. I take this opportunity to thank Mr. Keene who came to see me and who brought to my attention the need for this particular kind of investigation, which I believe demonstrates that this nomination should not be confirmed by the Senate.

Mr. ASHCROFT. The Senator from Missouri thanks the Chair. Madam President, I rise to oppose this nomination because this nominee has an approach to America's drug crisis which is an approach of tolerance--in many respects--rather than an approach of eradication. That is clear by the fact that this nominee has shown a clear willingness to encourage needle exchange programs and to groups of individuals that want to sponsor needle exchange programs and to embrace a concept waiving State laws in America that are against drug paraphernalia that accommodates the problem of drug abuse. This afternoon, I would like to take some time to review evidence that shows where we are in this debate in our culture. We can then juxtapose that with the views of the current nominees. To begin the discussion, we must understand that the Surgeon General of the United States has a very important responsibility, not only to the people of America--advising you and me and families across America on our health concerns--but also in advising the Secretary of Health and Human Services and advising the President of the United States in terms of health policy the Nation should be following. In that role, the Surgeon General--``America's Doctor''--should not only value life, but also should value the quality of life in this great land. Drugs in America impact not only the quality of life of those addicted to the illegal narcotics, but also the children in our schools and the citizens of our cities. If you look carefully, it is pretty clear that of the number of people in our prisons--the majority of them have been involved with some substance abuse in the commission of their crimes. The Nation's drug policy should be one of zero tolerance. It should not be a policy of accommodation. Drugs are turning our once vibrant cities into centers of despair and hopelessness. We need a Surgeon General who rejects and fights the drug culture--who has no tolerance for the drug culture. A Surgeon General who says that America can be called to a higher standard rather than accommodated in a culture of consuming drugs. Many special interest groups are calling on Congress and the administration to turn our drug policy into a policy of accommodation and tolerance. Let me just sort of try to help you understand what kind of an approach that would be. Rather than treating drug addiction as the problem-- understanding that it is a criminal act and that it should not be tolerated, many groups have increasingly called for a ``harm reduction'' policy. Harm reduction advocates policies to literally reduce the harm of injecting illegal drugs. These policies include providing clean needles to drug addicts and for some--legalization of drugs. This was the case with the former Surgeon General of the United States, Joycelyn Elders, who actually said that we ought to just legalize drugs, we should make them available on a broad basis so that more people could have easy access to them. I think that is the wrong approach. I think accommodating drug users, I think providing a greater accessibility to drugs, providing safe accessibility to drugs sends all the wrong messages. The ``harm reduction'' school of thought is the idea that if we provide people with either free drugs or clean needles, so that there will be less risk involved in using drugs, that we will have done the right thing. The Harm Reduction Coalition's Home Page provides that HRC ``supports individuals and communities in creating strategies and obtaining resources to encourage safer drug use. . . Rather than perpetuating the `all or nothing' approach to drug intervention, harm reduction--and here is the key phrase--``accepts drug use as a way of life.'' Once you come to the conclusion that you want to accept for this country drug use as a way of life, you really have embraced something that is--very troublesome as far as I am concerned. I think America wants to reject drug use as a way of life. We do not want to accommodate ourselves with the concept of more and more young people and more and more citizens of our culture who are involved in drug use. I think what we really want to be able to do is say we want fewer people to be involved in drug use, and that as a way of life it is something we want to reject rather than embrace. I see that my colleague from the State of New Mexico is here and has come to the floor. And I intend to speak for quite some time on this issue. I would be happy to ask for unanimous consent that he be able to make some remarks, and then that the Record would reflect that his remarks would be somewhere outside the confines of mine. I think he would probably prefer that.

Mr. ASHCROFT. Reserving the right to object, the proponents have been on the floor for quite some time. Does the Senator know how much time will be consumed for the two?

Mr. ASHCROFT. Madam President, may I ask how much time remains on each side?

Mr. ASHCROFT. Madam President, I yield myself as much time as I may consume in my opposition to this nomination.

Mr. ASHCROFT. If the Senator will yield, are you aware of the fact that after the new therapy was available and the Senate and the House began to debate this issue, even in the face of the new therapy and in the face of the informed consent laws, Dr. Satcher came to the Congress to lobby Members of the Congress against stopping the studies?

Mr. ASHCROFT. I would be very interested in seeing my signature on the document. More importantly, the point is this: There are times when it's appropriate to have a study and not provide notice. But when it becomes clear that there are therapies available and to persist in the studies without providing notice, that changes the whole dynamic. I think this is an essential and critical fact that hasn't appeared in your analysis and maybe hasn't appeared adequately in mine. So I will be pleased to discuss it, because the 1994 discovery of the AZT regimen, which cut by two-thirds the incidence of HIV virus cases that otherwise would occur, changes the dynamics. That brought the issue to the attention of the Congress, and the Congress forced the cessation of the studies on the part of Dr. Satcher. He lobbied against ceasing the studies even in light of that. I thank the Senator.

Mr. ASHCROFT. No objection.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I rise today in support of the proposed amendment to the United States Constitution to prevent desecration of our great national symbol. In 1995, I was an original co-sponsor of an amendment to the Constitution designed to protect the symbol of our nation and its ideals. When that resolution was defeated narrowly, we vowed that this issue would not go away and it has not. I stand here, again, today to declare the necessity of protecting the Flag of the United States of America and what it represents. Thoughout our history, the Flag has held a special place in the minds of Americans. As the appearance of the Flag changed with the addition of stars as the nation grew, its core meaning to the American people remained constant. It represents no particular perspective, political agenda, or religious belief. Instead, it symbolizes an ideal, not just for Americans, but for all those who honor the great American experiment. It represents a shared ideal of freedom. The Flag stands in this chamber and in our court rooms; it is draped over our honored dead; it flies at half-mast to mourn those we wish to respect; and it is the subject of our National Anthem, our National March and our Pledge of Allegiance. As the Chief Justice noted in his dissent in Texas v. Johnson (1989), ``[t]he American flag, then, throughout more than 200 years of our history, has come to be the visible symbol embodying our nation * * * Millions and millions of Americans regard it with an almost mystical reverence regardless of what sort of social, political, or philosophical beliefs they may have.'' There can be little doubt that the people of this country fully support preserving and protecting the American Flag. The people's elected representatives reflected that vast public support by enacting Flag protection statutes at both the State and Federal levels. Regrettably, the Supreme Court thwarted the people's will--and discarded the judgment of state legislatures and the Congress that protecting the Flag is fully consistent with our Constitution--by holding that the American flag is just another piece of cloth for which no minimum of respect may be demanded. As a consequence, that which represents the struggles of those who came before us; which symbolizes the sacrifice of hundreds; and for which many men and women have died cannot be recognized for what it truly is--a national treasure in need of protection. Further, the question must be asked, what is the legacy we are leaving our children? At a time when our nation's virtues are too rarely extolled by our national leaders, and national pride is dismissed by many as arrogance, America needs, more than ever, something to celebrate. At a time when our political leaders are embroiled in scandalous allegations, we need a national symbol that is beyond reproach. America needs its Flag untainted, representing more than some flawed agenda, but this extraordinary nation. The Flag, and the freedom for which it stands, has a unique ability to unite us as Americans. Whatever our disagreements, we are united in our respect for the Flag. We should not allow the healing and unifying power of the Flag to become a source of divisiveness. The protection that the people seek for the Flag does not threaten the sacred rights afforded by the First Amendment. I sincerely doubt that the Framers intended the First Amendment of the Constitution to prevent state legislatures and Congress from protecting the Flag of the nation for which they shed their blood. At the time of the Supreme Court's decision, the tradition of protecting the Flag was too firmly established to suggest that such laws are inconsistent with our constitutional traditions. Many of the state laws were based on the Uniform Flag Act of 1917. No one at that time, or for 70 years afterwards, felt that these laws ran afoul of the First Amendment. Indeed, the Supreme Court itself upheld a Nebraska statute preventing commercial use of the Flag in 1907 in Halter v. Nebraska. As the Chief Justice stated in his dissent, ``I cannot agree that the First Amendment invalidates the Act of Congress, and the laws of 48 of the 50 States which make criminal the public burning of the flag.'' Nor do I accept the notion that amending the Constitution to overrule the Supreme Court's decision in the specific context of desecration of the Flag will somehow undermine the First Amendment as it is applied in other contexts. This amendment does not create a slippery slope which will lead to the erosion of Americans' right to free speech. The Flag is wholly unique. It has no rightful comparison. An amendment protecting the Flag from desecration will provide no aid or comfort in any future campaigns to restrict speech. Moreover, an amendment banning the desecration of the Flag does not limit the content of any true speech. As Justice Stevens noted in his dissent in Johnson v. Texas, ``[t]he concept of `desecration' does not turn on the substance of the message the actor intends to convey, but rather on whether those who view the act will take serious offence.'' Likewise, the act of desecrating the Flag does not have any content in and of itself. The act takes meaning and expresses conduct only in the context of the true speech which accompanies the act. And that speech remains unregulated. As the Chief Justice noted, ``flag burning is the equivalent of an inarticulate grunt or roar that, it seems fair to say, is most likely to be indulged in not to express any particular idea, but to antagonize others.'' In sum there is no principle or fear that should stand as an obstacle to our protection of the Flag. It is my earnest hope that by Amending the Constitution to prohibit its desecration, this body will protect the heritage, sacrifice, ideals, freedom and honor that the Flag uniquely represents.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. ASHCROFT. Thank you, Mr. President. There have been a number of charges made and some pretty strong language suggested, as well as a lot of repetition and volume regarding some of the circumstances surrounding the conduct of Dr. Satcher in his role as an individual involved both in domestic health situations and international health situations. Let me begin by going through a number of these issues and referring to what notable authorities and investigators have indicated. When I raised the issue of the CDC, under the direction and in cooperation with Dr. Satcher, being involved with blind HIV testing for newborns--and while learning about the level of HIV present in the newborns not providing information to parents and sending newborns home without that kind of information--there was a pretty vociferous response, indicating that there were things in the studies that were worth learning. I don't challenge that. There are things that are worth learning that can be learned from medical research. As a matter of fact, it is sometimes easier to learn a lot of things more quickly if you don't really pay much attention to the ethics that are involved. You can learn the most, probably, with research that might be damaging to individuals. So the mere fact that there are items to be learned and that there is value in terms of statistical data that can be assembled from the study, doesn't justify the existence of a study. As a matter of fact, when you are running rats in a study, you can learn a lot of things very quickly. The reason we use animals in a lot of studies is because we accord to human beings a kind of standing that says the learning objective is not the end of all that we do: we also have to respect the dignity of the individuals involved. So I just wanted to mention a couple of the kinds of things that were said around the country and by authorities regarding these so-called blind HIV tests. Here is what was said in the New York Daily News on the 27th of June in 1995. They put it this way: Only politics, radical politics, explains the separate standard for AIDS. Meaning there is a separate approach: The Centers for Disease Control and Prevention carried this illogic to an absurd end by requiring testing of newborns, then keeping the results secret. That let officials track the epidemic but denied treatment. Fearful of the push to use the results for actual care, the CDC turned churlish and quit testing. It is kind of interesting to me that the New York Daily News, which doesn't have an ax to grind here, indicates that there was a set of circumstances that resulted in the CDC pursuing a logic to an absurd end, including testing newborns and keeping the results secret. And then when it was suggested that the CDC provide information to parents, instead of approaching the problem this way, the CDC just decided to quit the program altogether rather than provide information to parents. My view is that our objective in health, in confirming one who would be a health voice for all the people, should not be that one promotes controversial health measures by just keeping people from knowing about the situation. We should be informative and have a culture of information for people. If people have trouble accepting the information, we should work with them to help them get into a position where they digest the information appropriately and take steps to curtail the risks. The Washington Post made a pretty clear statement about this at the same time. I think it is important for us to understand that the Washington Post isn't some sort of organization that would be unfair in its assessment of this kind of situation: For the last 10 years, the Federal Government's Centers for Disease Control has urged doctors and hospitals to advise pregnant women at risk for AIDS to be tested for the disease. Now the CDC has recommended extending this effort to all pregnant women. The Washington Post goes on to say: This expansion is due primarily to completion of a study showing that administering the drug AZT to an infected mother during pregnancy and delivery and to her baby for a period after birth reduces incidence of transmission of the disease from 25 to 8 percent. If only those pregnant women known to be at risk are tested, others with the affliction will inevitably be missed and their babies won't receive the drug therapy that has proven to be so effective. Congress is now considering legislation that will make the AIDS testing of newborns mandatory. The congressional effort to include AIDS in this category deserves support. I think that's important: A positive test of a child is a sure indication that the mother has the disease. With this information, breastfeeding, which transmits this disease, could be avoided. I think it is very important to note that if you had provided information about the existence of the HIV virus to the parent, then they would know to avoid breastfeeding in certain situations. And because some of the babies, as Senator Kennedy has noted, first test positive for HIV and then later remit that indicator spontaneously, those babies shouldn't be breast fed by mothers with risk of additional contamination. The article makes another interesting point: And finally it is particularly important that the status of children who are placed in foster care be known. The CDC enumerates all these reasons supporting voluntary testing for all pregnant women. In fact, they are of sufficient weight to require the routine testing of all newborns for AIDS. The point is this, that testing newborns for AIDS should be attended by being able to take advantage of the appropriate therapies and the appropriate remedial action. Arthur J. Ammann, who is the professor of pediatrics at the University of California Medical Center in San Francisco and who was the man who discovered both pediatric AIDS and blood transfusion AIDS, really was distressed about a program of this kind testing blood samples from unidentified children and collecting the epidemiological data but not telling parents whether or not kids have AIDS. Dr. Ammann is a noted authority who, incidentally, was invited by the Labor committee to give a briefing just this week. And he put it this way. He indicated that the policies were a violation of the international Nuremberg code. ``The failure to inform the guardians of known HIV-infected infants, when treatment is available, violates both international and national codes of ethics.'' The quote comes from an August 3, 1995, Wall Street Journal article. I think it is important for us to note that there are very serious questions about the kind of testing and the information resulting from the tests and the ethics involved therein. And there may be ways in hindsight to come back and say, ``Well, there was value to what was learned and, therefore, it was appropriate for us to do what was done.'' But I do not think this adequately answers the questions. It does not really adequately address the question why, when we could have moved toward identification and notification, we simply acceded to the politics of the situation. The New York Daily News said that only radical politics explains the separate standard here, in referencing the fact that there are so many other diseases which, if you had that kind of information, would have been made available immediately. Another item which I raised earlier about Dr. Satcher was the idea of needle exchanges. The U.S. Congress has expressed itself on needle exchanges. And the American people are, I think, loathe to be participants in a program which would promote needle exchanges. A Member of this body came to the floor to say that Dr. Satcher had never supported the expenditure of any resources to provide clean needles at Government expense. I think that is technically true. Dr. Satcher and the CDC have, I think, not had a program. They have had studies in which clean needles were provided, and those have been funded. The Berkeley study in California was a study funded by the CDC which provided so-called ``clean needles'' to drug addicts. As a matter of fact, the group known as the Harm Reduction Group, which means trying to reduce the harm of IV drug use through needle exchanges, put on a conference called the Atlanta Harm Reduction Working Group Conference. It was a 2-day meeting designed to advance harm reduction in the Southeastern United States by providing government-sponsored or other privately sponsored needle exchange programs. The CDC was a sponsor or provided funding for this. So it is technically true, almost in a sort of lawyerspeak sense, that the CDC did not engage in a program of needle exchange. It has just had studies where the needle exchanges are used. And they have not exactly advanced the policy in some respect of needle exchanges, they have just undertaken to do it by sponsoring conferences for private groups, whose prime objective is to sponsor these so-called clean needle programs. We will have more to say about clean needle programs in the future because one of the things that is very difficult about clean needle programs is that they frequently provide clean needles to so-called drug addicts, and then the needles are not appropriately disposed of. And in a variety of settings those needles then are available in the culture because they are left laying around. It is dangerous to have those needles available. Let me move to the ethics of some of the studies that have been conducted. It is important to know that challenges have been made to the suggestion that the studies in Africa involved breaches of ethics. The study in Africa is said to involve a serious breach of ethics, as stated by the New England Journal of Medicine, a very important medical journal. The point was raised by supporters of the studies that two members of the board of directors resigned from the New England Journal of Medicine when the criticism of the studies was made. Let us look at what that means. According to one article, there are 25 members of the board of directors. There were two who agreed sufficiently with the nature of the studies to resign and 23 who thought that their resignations were inappropriate and apparently did not think they should resign. If we are to infer that the two who did resign supported the ethics of the way the study was conducted, we might infer that the 23 that did not resign opposed the ethics of the study. It is pretty clear that in our culture there are separate standards, in a lot of ways, for AIDS as a disease and for the HIV virus as a disease. I think some of that took place as a result of the early acquaintance of the culture with the HIV virus. Then people who had the disease could not get treatment and individuals would not get close to them, and there were elevated desires to have privacy. So HIV was treated in a different way than other viruses or deadly viruses would be treated. But the only individuals who resigned were individuals who were accustomed to the special ethical standing, if it is appropriate to say that, or the special rules for HIV. They were AIDS individuals. The people in the conventional medical community did not resign. Dr. Jerome Kassirer, the editor in chief of the New England Journal of Medicine--which is published by the Massachusetts Medical Society-- was asked about his response. He said he was surprised and dismayed at the resignations, but he said it was never policy to have editorial board members review editorials or other opinions before they were published. And these individuals who were interested in, I suppose, having the opportunity to screen what would be said about these kinds of studies simply had not been accorded that opportunity because the medical journal itself did not want to accord any special status or differential treatment here. A lot has been said about the ethics of the studies. Others indicated that maybe we should not have followed the ethical requirements because not much money is spent on individuals in Africa for health care on an annual basis. I think there was a statement made about $5.50 being spent per year in some of the countries. It varies in different countries in Africa. I believe the study that is most sharply in focus would have occurred in the Ivory Coast. The key is, some experts said we could not have used as a part of the study the 076 AZT regime which has been proven to be effective in reducing the number of HIV and AIDS cases among newborn children of HIV infected mothers. They said we could not use 076 because that treatment is a substantial regime and has substantial costs. They were trying to find a way for a lower-cost regime. And they were going to compare low doses of AZT to a placebo to find out whether low doses could be effective. However, that can be accomplished by comparing low doses to the standard, proven regime. As a matter of fact, the latter comparison is what ethics requires. According to the New England Journal of Medicine, published by the Massachusetts Medical Society, ``Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo.'' Again, the use of a placebo is ethical ``Only when there is no known effective treatment.'' We have had effective treatments substantiated and approved in the United States and internationally with the 076 AZT regime. Now, it would be possible to compare a lower level of AZT with this effective known treatment to find out whether the low levels were as efficacious as the 076 regime. But we chose instead--and I use the word advisedly, saying we ``chose'' instead--to use the unknown, low dosage with a placebo, with a sugar pill, which has a known consequence. We are not comparing two unknowns here. We are comparing a known consequence of no treatment, that is the placebo, with the unknown consequence of a treatment. But this is not the proven treatment. And the real approach we have to understand here is that the ethics of modern medicine in America, in a country that cares about individual patients as well as about scientific data can be generated, would not allow such research. Even though one can generate a lot of data in studies that are very dangerous to the people, our standards of ethics would not allow it. When there is a known treatment, we compare new treatments to the known treatment rather than comparing new potential treatments to something that we know will have no beneficial effect. And here is the way the editorial in the New England Journal of Medicine went forward. It said: Those requirements are made clear in the Declaration of Helsinki, of the World Health Organization, WHO, which is widely regarded as providing the fundamental guidelines of research involving human subjects. It states in research ``The interests of science and society should never take precedence over considerations relating to the well-being of the subject.'' And in any medical study every patient, including those of a control group, if any, should be assured of the best proven diagnostic and therapeutic method. Now, there was a proven diagnostic and therapeutic method. It was the 076 regiment which has been proven in the United States and internationally. Instead of comparing low dosages of AZT to the best proven therapy and diagnosis, they chose to compare low doses of AZT to a known placebo. And to say to individuals, ``Well, those of you that get the placebo are destined to have no therapy''--and we know what that means when it comes to the HIV virus. The New England Journal of Medicine noted, ``Further, the Declaration of Helsinki requires control groups to receive the best treatment, not the local one.'' Individuals have raised in the study the idea that ``Well, people wouldn't be getting good treatment over here anyhow, so we are eligible to disregard the treatment standards for them.'' They observe that these are poor people. These are African individuals. We can adopt a different standard there. We certainly could not do this in the United States, but we can do this over there because things are not what they ought to be over there. And here is what the New England Journal says: ``Acceptance of this ethical relativism''--this is important--``Acceptance of this ethical relativism could result in widespread exploitation of vulnerable Third World populations for research programs that could not be carried out in the sponsoring country.'' Now, additionally, it has been suggested that the reason researchers could not use the 076 regime, which is an expensive regime as in comparison to the low dose of AZT, is that there is not enough money in these African countries ever to give people the high-dose program. Therefore, we cannot experiment with any high-dose programs and find out, using them, whether or not the low-dose program would also work. The truth of the matter is, you can learn a great deal by comparing the low-dose program to the high-dose program. I submit that you have the opportunity to learn about as much, if not more, than you have by comparing the low-dose program to the placebo. But more importantly is that this is consistent with the ethical standards. It was suggested that the reason you could use the no-treatment program as part of the study--the placebo--is because there was a low, low amount of money to be spent per capita on health care in these countries. And it said you could not use an $800 program in the test because the people could not afford it. They only spend $5 a year on medicine. Why is it, then, that you could use the low-dose program, which is a $50 program? If one can't afford but $5, one is ineligible for $50 just like he would be for an $800 regime. I do understand that we are not talking about a regime for trying to give everybody the $800 program. Theirs was an effort to try and prove that a $50 program might work. So all they needed to do was to be able to compare the $50 program to subjects who were getting the full program. If the less expensive program it worked just as well, they would at least have the cost down to the $50 level. But the point being made by the proponents of the research as it was conducted was that it is ethical, because of the costs involved. My own view is that if you only have $5, you can't really buy a $50 treatment any more than an $800 treatment. To say $50 is close enough and $800 isn't misses the point. If you are trying to develop the availability of the $50 treatment, the tests themselves could be measured against a therapy which is more costly. The last point I make is that if none of the treatments would be used in the countries where the tests are being made, it is unethical to conduct tests there. It's clear from international standards, whether one is talking about the Nuremberg Code or other standards, you only conduct tests in countries where there is a chance that the therapy would be used. If the testimony of those who argue against the New England Journal of Medicine and these individuals is that you might have used the low dose, that is fine, we can conduct them there. However, you don't make laboratory rats out of people in the conduct of those tests merely because there is not a sufficient level of medical resources there to justify the more expensive program being used in the United States. The New England Journal of Medicine directly indicates that ``The test directly contradicted Department of Health and Human Services' own regulations governing U.S.-sponsored research in foreign countries, as well as joint guidelines for research in the Third World issued by the WHO and the Council for International Organizations of Medical Science, which require that human subjects receive protection at least equivalent to that in the sponsoring country.'' Now, here you have another standard. It is not that this fell short of the ethics of one part or another part, or one little fraction, or another little fraction. In the first instance, you never use a placebo when an effective treatment is known. Secondly, control groups are required to receive the best current treatment, not the local one. Thirdly, you don't do, in a Third World country, what you could not do in your own country. Now, it is pretty clear that there are a number of settings in which that idea of using other countries might be productive. But one might have trouble getting agreement to this, especially in the light of some of the controversy that has existed in the United States. Dr. Satcher testified at one time, ``What may not be readily apparent to all is how the CDC and the U.S. learned and benefited from international public health activities, including those related to HIV protection. It is clear that, in some instances, research relevant to both developing countries and the U.S. can be conducted more efficiently and expeditiously in developing countries because of the magnitude of the problem in those settings and, therefore, we have utilized that approach.'' Yes, it's more efficient and expeditious, if it is only because there is a bigger population. I think that justifies the potential if we follow the ethical guidelines. But if we say that we can do it more efficiently and effectively there because we don't have to provide real medicine, we say to the people of those countries that we don't care as much about your lives as we care about lives in our own country. If we say these things, we have then also embarked on a course of action that has very serious ethical complications. I would like to quote from Dr. Arthur Kaplan, the Director of the Center for Bioethics at the University of Pennsylvania: If you tried to do this study in the U.S., you would have to do it through a throng of demonstrators and a sea of reporters,'' he states. ``I would not do this study without a design that would let me run it without a placebo. I think you owe that to your subjects, even if they are not educated enough or savvy enough to demand it from you. Now, that is strong language. I have no doubt that Dr. Satcher is an individual of tremendous achievement and great scientific capacity. I have not sought to question that, and I certainly don't want to question his achievement, his capacity, his intellect, or the fact that he does represent the American dream. But I will question the ethics of the studies in which individuals were given placebos when it's clear that placebos are only ethical in comparisons when there is no known effective treatment. I will question the ethics of the studies when we owe treatment to our subjects and we fail to give it to them because they are in a culture where it's not normally expected. I think Dr. Arthur Kaplan is right. I wouldn't do this study without a design that would let me run it without a placebo. I think you owe that to the subjects. ``Subjects'' is a kind of interesting term there; it is really talking about the people who are in the medical study. ``. . .Even if they are not educated enough, savvy enough to demand it from you.'' Here is another article titled ``An Apology is Not Enough.'' This was printed in the Boston Globe on the 18th day of May, 1997: No research in developing countries is ethically justified, unless the treatment developed or proven effective will actually be made available to the population. We have had testimony here that the treatments could not be available, they would be too expensive. The low dosage treatment researchers were seeking to develop was estimated to cost $50. It might be possible to create a less costly regimen. But the components of the study should be performed ethically, regardless of what the ultimate objective is. Even though the objective was a $50 treatment, that doesn't mean that there could be no components greater than $50 in the study. Because ethics requires it you should be measuring the $50 treatment that is being experimented with and comparing it to the best known treatment. You don't compare it to a placebo. A lot of comment has been made about informed consent. I would just like to take a few minutes to talk about informed consent, because I think it is important for us to try dealing with this problem in the cold light of what the international ethical requirements are. All guidelines stress the importance of obtaining informed consent from individuals asked to participate in the studies. Informed consent isn't just signing a paper. I would indicate in a setting where you are giving individuals sugar pills and it is known that the individuals who get sugar pills are going to have no treatment, that the level of information in the consent should be more than a ``sign here,'' or a rush to consent. It should be an informed, considered, deliberate consent. Let's see what the international standards are on informed consent. The Declaration of Helsinki, which the New England Journal of Medicine cited, makes informed consent a sort of touchstone of ethics requirements. The Declaration says: In any research on human beings, the potential subject must be adequately informed of the aims, the methods, anticipated benefits, and potential hazards of the study and the discomfort it may entail. Guideline 10: When obtaining informed consent for the research project, the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. Certainly, in the African studies where these individuals are in a situation where the health care availability is not substantial, these people are in a dependent relationship to the physicians. In that case, the informed consent should be obtained by a physician who is not engaged in the investigation or is completely independent of this official relationship. Another guideline is from the Council of International Organizations of Medical Sciences--international ethical guidelines for biomedical research involving human subjects. We are not talking about running rats through a maze, or animal trials, taking the heart out of a pig and seeing if it will work in a variety of circumstances, but rather the international ethical guidelines for biomedical research involving human subjects. The Council of International Organizations of Medical Sciences, CIOMS, in collaboration with the World Health Organization make these statements regarding informed consent. Guideline 1: For all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject. Guideline 2: Before requesting an individual's consent to participate in research, the investigator must provide the individual with the following information, in language that he or she is capable of understanding: Each individual is invited to participate as a subject in research and the aims and methods of the research. So they have to be told that they are invited to participate as a subject and what the aims and methods are. The benefits reasonably to be expected to result to the subject, or to others, as outcome of the research, and any foreseeable risks for discomfort to the subject associated with participation in the research; any alternative procedures or courses of treatment that might be as advantageous to the subject as the procedure or treatment being tested. Guideline 3: Obligations of investigators regarding informed consent. The investigator has a duty to communicate to the prospective subject all the information necessary for adequately informed consent. All the information necessary. This is a technical area. All the information in a technical area like this might include being informed that there is a known therapy and that it is unethical to conduct a trial without providing the known therapy, according to the Helsinki Declaration and a variety of other ethics guidelines. Guideline 4: Subjects may be paid for inconvenience and time spent and should be reimbursed for expenses incurred in connection with their participation in the study, and may also receive free medical services. However, the payment should not be so large on the medical services, so extensive as to induce prospective subjects to consent to participate in the research against their better judgment. The idea here is, if you are going to offer a bunch of medical care free to a person, they might make a judgment about getting involved in your program and might look aside and not be aware of, or be sensitive to, the risks that would otherwise inure to them as an individual participant. There is a specific science guideline, No. 8, for research involving subjects in underdeveloped countries. Before undertaking research involving subjects in underdeveloping communities, whether in developed or developing countries, the investigator must be sure that every effort is made to ensure that the ethical imperative of consent of the individual subjects be followed. The first guideline of the Nuremberg code relates to informed consent. Here we are with another code. We have been through the Helsinki, through the CIOMS, which was the Council of International Organization of Medical Sciences, and now we go to the Nuremberg code. The voluntary consent of human subjects is absolutely essential. This means that the person involved should have the legal capacity to give consent. . . . should be so situated as to be able to exercise free power of choice without the intervention of any element of fraud, force, deceit, duress, overreaching, or other ulterior force, constraint, or coercion, and should have knowledge and comprehension of the elements of the subject matter involved to enable him to make understanding and enlightened decisions. I could go further. The truth of the matter is that Dr. Satcher claims that there was informed consent here. And there has been a lot of statements on the floor about the nature of informed consent. The facts of the matter, as I have come to understand them--it could be that I need to be corrected--is that the informed consent has not been as thorough as those who have joined in this debate would want to lead people to believe. Dr. Satcher, in an article that he wrote with Dr. Varmus states that there was informed consent in their studies. In the case of the NIH and CDC trial, there has been the same requirements for informed consent that would exist if the work were performed in the United States. Well, was there informed consent? It is kind of interesting. The New York Times sent a reporter to the area, and decided that there wasn't the level of informed consent that should exist in these cases. The New York Times article says: According to the CDC, before deciding about entering the studies, women who were potential study participants were provided information about HIV and AIDS and about the intended study, and the possible risks and benefits for their children. It was clearly intended that women involved, their children, and others receive a placebo, a capsule without active medication. There would be no way for them to tell which group they were in. Women must give informed consent before participation commences. That is what the CDC says. That is in a CDC study, to prevent HIV transmission in developing countries, and their report of April 30, 1997. So the CDC, in the case of everybody being given all of the information, and that there is an informed consent. Here is what happened when the New York Times sent a reporter, and the New York Times article brings into question whether many of these women truly gave ``informed consent.'' I indicate to you that I have blotted out the names of the actual individuals involved here respecting their privacy. Here is an excerpt of the article, along with the accompanying photograph of one of the women who participated in the study. According to the article--we will call this woman ``AB,''--a 23-year-old, illiterate, HIV-infected mother and patient in the study ``still does not grasp, even after repeated questioning, exactly what a placebo is, or why she might have been given that instead of real medicine.'' They gave me a bunch of pills to take and told me how to take them. Some were for malaria, some were for fever, and some were supposed to be for the virus. I knew there were different kinds. But I figured if one didn't work against AIDS then one of other ones would. This is a picture of AB. The reason to enroll in the study last year was clear. It offered her and her infant free health care and a hope to shield her baby from deadly infection. Unmarried and unemployed, this new mother, like many others, said the prospect of health as she brought her baby into the world made taking part in the experiment all but irresistible. Still the question of whether she and other pregnant women knew of the implications of consenting to a placebo test hangs over the subject. Let me give you what the New York Times said about this individual's circumstance, AB. This is CD? I have the initials on the individuals-- Minutes after she was informed for the first time that she carried the virus, one pregnant woman-- This is her picture, CD. still visibly shaken by the news, was quickly walked through the details of the test, as well as general advice about maintaining her health and protecting others from acquiring the disease, in less than 5 minutes. This is the eyewitness testimony of how this so-called ``informed consent'' was obtained ``in less than 5 minutes in which the previously unknown concept of a placebo was briefly mentioned.'' The session was over and DC.-- Unemployed, and illiterate-- had agreed to take part in the test. One of the most highly educated of the women who spoke to a reporter, a 31-year old single mother with a degree in law who gave her name only as X, said she had never been made to understand that the medicine being tested, ATZ, was already known to stop the transmission of the virus DURING pregnancy. So what we have here is a feint toward ``informed consent.'' We have people with formal training with a law degree not knowing about effective therapies, not knowing what the real options are, not knowing what the real facts are, and we have a situation where we are using a placebo knowing that the utilization of placebo in that setting is going to result in the absence of any treatment for a disease which is, understandably and acknowledged, to be fatal in virtually every situation. I think this New York Times article suggests to us that some of the so-called highly touted ``informed consent'' wasn't as informed as it should have been, and by just reading what the international conventions and the international declarations require you know that it is virtually impossible for a person even of great and substantial medical awareness to understand about ``informed consent'' in a 5- minute interval. This is obviously a difficult situation. I said when I started that America deserves better. I think Africa deserves better than this kind of treatment. I think people in Africa deserve to be treated with the same kind of dignity that the people America ought to be treated. I don't think we should say local conditions over there are different and that changes our ethics. I don't think our character is determined by the people we are dealing with. It is not OK to do things that are not ethical because you are dealing with people who are less well endowed than you are. I don't think it is OK to do things that are unethical or wouldn't meet the ethical standards here at home because the people are poorer than you are, or because they don't have the education. I think as Americans we understand that character is not a condition of circumstance. Circumstances may reveal character. But character is something on the inside that is determined by character itself--not by the circumstances outside. I really think these are very serious questions about the conduct of medical experimentation. No question in my mind that there is a lot to be gained from these studies. But the truth of the matter is time and time again people, because they have had a a lot to gain from studies who haven't been as sensitive to ethics as we have been, have done things that are inappropriate or ashamed of. There was something to be gained from the study. I am not saying this was Tuskegee. There was something to be gained by it. And the people who excused it said, ``Well, these are just poor individuals, and they are not very intelligent individuals. So we can treat them differently than we treat other individuals.'' And I think the Nation has a real tug in its heart. We realized we were wrong. It was inappropriate, and it was appropriate that there be an apology. And an apology obviously doesn't solve that situation. I think we have to ask ourselves whether or not we can excuse away the absence of the right ethical standards based on local conditions, based on local education, based on the individual's intelligence, based on any circumstances. I believe that we have a responsibility to adhere to the guidelines. And in the absence of our commitment to those guidelines there is a serious deficiency. I believe if we do not have a strong commitment to ethics in the office of Surgeon General that we will not have a strong commitment to serving the people of this country in the way that they should be served. Mr. KENNEDY addressed the Chair.

Mr. ASHCROFT. Madam President, may I inquire as to the state of the proceedings? What is the position of the Chamber?

Mr. ASHCROFT. Thank you, Madam President. I rise to continue my debate with respect to the nomination of Dr. David Satcher, a nomination for two positions, that of U.S. Surgeon General and Assistant Secretary for Health.

Mr. ASHCROFT. Thank you, very much. Madam President, there has been some considerable discussion today surrounding the ethics of the Centers for Disease Control and the studies that they have conducted regarding the transmission of AIDS from mothers to newborns--those studies having been conducted not here in the United States, but having been conducted in the underdeveloped countries of the world. These studies were conducted and have continued to be undertaken under the auspices of the Centers for Disease Control, under their authority and during the time which Dr. Satcher has had responsibility for the Centers for Disease Control. It is troublesome to me that a number of these studies have not really provided the same kind of guarantee in terms of the care which would be accorded to individuals if those individuals participating in the study were in the United States. Basically what I am saying is that the studies were conducted in such a way that they would probably be unacceptable in the United States of America. A disregard for individuals who participate in clinical trials or medical studies is, unfortunately, something that we have had problems with before. Not long ago, the United States apologized to a number of individuals who are part of what was called the Tuskegee experiment because the participants in the study had simply been left without treatment as doctors watched the progression of the disease. I think the Nation's conscience was shocked as a result of the fact those conducting the experiment were interested in scientific data that could be developed by watching people suffer and die. It was troublesome that we would somehow decide we could allow people to have been involved in that kind of experiment. When we discovered the nature of the Tuskegee experiment, the country was shocked and saddened by what had occurred. What was even perhaps more shocking is that after we had been through all the problems in assessing the difficulties of Tuskegee, there were revelations about these studies in Africa. The Boston Globe, on the 18th day of May of 1997, published an article entitled ``An apology is not enough.'' The article stated that ``Even as the President laments the Tuskegee experiment, the United States is conducting questionable research in Africa.'' This particular article--while it does not purport to say that the African research is similar in every respect to the Tuskegee situation, did point out that there are some real problems with what is being done in Africa. One of the problems is that in Africa individuals who are a part of the study are not given the best known medical help. They are not being accorded medical treatment which would be required by ethical standards. They were given, however, sugar pills or placebos in the face of a virtually always fatal virus. They were given capsules which had no real medicinal value. This was so shocking to the medical community and individuals who cared about medical ethics that it found its way into the editorial pages of the Massachusetts Medical Society's journal, the New England Journal of Medicine. The New England Journal of Medicine is the most widely respected medical journal in the world. Virtually no major announcements of medical import are made in the United States without appearing in the New England Journal of Medicine. The New England Journal of Medicine is prudent with regard to what it publishes. The Journal does not publish medical findings just because they have scientific value. It is alert to the dangers of science which would cause people to set aside ethics. For instance, in an editorial of the Journal's, the publication states clearly that reports of unethical research will not be published, regardless of their scientific merit. You could have reports that would be very valuable scientifically, but they could be unethical. You could probably learn some things by watching people die without treatment, and that data would be valuable scientifically. As a matter of fact, that is what happened in the Tuskegee setting. But it was clear that kind of experiment was wrong and improper. This medical journal takes a stand against that. It says it refuses to publish reports, even if they are scientifically meritorious, if those reports are the result of unethical research. Now, the research which was conducted in Africa was controversial for a couple of reasons. The first point of contention was the use of the placebo, or the sugar pill that doesn't have medicine, as part of the study. The New England Journal of Medicine indicates clearly, ``Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo.'' In other words, if you know that you can do absolutely nothing, there is no known way to cure something, no known way to impair or stop the progress of a disease, then you are allowed to try something and measure it against nothing--which is basically the placebo. But when you know, in fact, that there is something that works, it is unethical, according to the New England Journal of Medicine, to use a placebo against some other proposed remedy. I think that is the reason the New England Journal of Medicine took exception with the CDC studies, particularly as it related to the Ivory Coast. Prior to the time of these studies it was pretty clear that a regimen had been developed which had been effective in substantial measure in curtailing the transmission of the HIV virus from women to their children. As a matter of fact, the AZT treatment is called the AZT 076 regimen. That regimen has had pretty good results. Normally in newborns, 25 percent of those that are born to mothers with HIV carry the HIV virus themselves. But the studies indicated that if you followed the AZT regimen, the AZT 076 regimen, instead of having 25 percent, or 1 out of every 4 children emerge with the HIV virus, that you could cut it down to 8 percent. So from one-quarter of all the babies, 1 out of every 4 babies, to 1 out of every 12 babies. Now that is a substantial improvement. It is a clear demonstration, accepted by medical authorities, that it is a regimen of treatment that has promise, it is effective, and it is worth doing. So when you go to Africa to conduct a study, to do it ethically, according to the New England Journal of Medicine, it would require that individuals in the study compare proposed new treatments not with a placebo, but since there is a known effective treatment, new treatments would have to be compared against the known effective treatment. I quote from the New England Journal of Medicine: ``Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo.'' Now, what we have in the studies in Africa is the comparison of a known effective treatment with a placebo. This is not appropriate. Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo. In reaching this conclusion--this isn't just the opinion of the editorialists at the New England Journal of Medicine. They cite the Declaration of Helsinki of the World Health Organization as providing what is widely regarded as the fundamental guiding principles of research involving human subjects. In research on man, they say, ``The interests of science and society should never take precedence over considerations related to the well-being of the subject,'' and ``In any medical study, every patient, including those of the control group, if any, should be assured of the best proven diagnostic and therapeutic method.'' It is pretty clear that the best, proven diagnostic and therapeutic method is not the placebo, not the sugar pill. The best, proven therapeutic and diagnostic method is the 076 regimen, which cut the transmission rates from 1 out of every 4 to 1 out of every 12 infants infected with HIV. That is a substantial cut. I think it is always important for us to understand that we are talking about a nearly always fatal virus. We are not talking about a situation where maybe a few more people are threatened. The HIV virus, as it ultimately develops into a condition known as AIDS, is a final and fatal condition. So I don't think it behooves us to take it lightly. As a matter of fact, medical authorities have not taken it lightly. I will just point out that even those individuals who were involved in the very discovery of AIDS and the transmission of AIDS in the birth process do not take it lightly. As a matter of fact, studies of intensive treatment of AZT ended in 1994, just as soon as it was shown that the drug sharply reduced HIV transmission to infants. Four years ago, we made it clear that the use of the placebo was over. You would not be doing placebo-based tests any longer, because it had been demonstrated that the drug sharply reduced transmission of the virus from mothers to their babies. That is from the New York Times article, ``AIDS Research in Africa; Juggling Risks and Hopes.'' The Third World studies, however, were in progress in 1995. They continue to be in progress. Apparently, they were ongoing as of late January. Now, the CDC provided funding for the studies on the Ivory Coast. The study was simply designed to determine whether a new course of AZT--a short course, as opposed to the 076 regimen--whether that new short course would have an impact of curtailing the virus in the children born to HIV-infected mothers. As we indicated before, the 076 course cuts transmission of HIV from 25 percent of all infants down to 8 percent of all infants, or approximately a two-thirds reduction. The studies were designed to determine if a smaller dose of AZT would have any impact. CDC decided to use a technique known as the placebo controlled study, and it was their methodology of choice. Now it seems to me that we have a clear problem here, and that is that we have an ethical standard for a medical test and trial that says you don't use placebos when there are effective known treatments. You have had a clearly established treatment since 1994, recognized in the United States as a treatment that is effective in reducing the incidence of HIV in new-born infants by two-thirds. One of the reasons that the CDC chose to move forward with the placebo-based trials is that the trials are well understood to be very informative scientifically. Those who have come to the floor of the Senate on repeated occasions during the day have talked about how wonderful this was to get this information. I really don't want to get into a big argument about whether or not you can get good scientific data in trials where you let people die because you give them sugar water or sugar pills instead of real medicine. I think it is very likely that you can get good scientific data. I think it is very likely that the outcomes of your tests will be scientifically valid. You can prove that certain kinds of therapies are better than sugar and water. But we are not here just to find out what could be scientifically advantageous. I think it is important that we remind ourselves of that. There were scientists who thought they learned a lot from the Tuskegee studies. The mere existence of advantageous or helpful data at the end of a test or the mere facility with which scientific data can be collected doesn't really determine what the standard should be for us. The standard should be that we have our tests conducted in a way that is consistent with the ethical standards and with the requirements that have not only been developed for the United States, but are recognized in the international community. Among the guidelines in the international community for tests that are clinical and designed to inform our health care procedures is a guideline that says you should never test in a culture what the culture is totally unlikely to be able to implement. In other words, one culture is not allowed to go to another culture that isn't ever going to be able to use the therapy and say, ``We are going to use you as guinea pigs, we don't want to endure this on our own.'' There is another standard that is relevant, whether we are talking about Helsinki or a number of the other codes. We have the Helsinki Declaration; the Nuremberg Protocols; the WHO Guidelines developed in Geneva--a variety of guidelines. Another one of these ethical standards is that you should not test for a therapy in a country that can probably never use it. And you should not test where the cost of using a therapy will make it virtually inaccessible. That is one of the reasons that I think individuals want to support what was done by the Centers for Disease Control in this situation. They want to say, well, the 076 regimen is very expensive, therefore, it could not be part of a test to discover a less expensive regimen. It's important to understand that it is the expense of the outcome, the therapy that you are seeking to develop that should define whether or not a country or a society would be able to use it. It's not the expense of conducting the test that is the key issue, but the expense of using the therapy after the test is over. Unless the proponents of these tests want to argue that they were really hoping that sugar pills, which are very cheap, would be the ultimate therapy, they have to say that the ultimate therapy they were proposing is approximately the $50 therapy that CDC was experimenting with, which was the short course, or more confined schedule of administering AZT. That is a $50 dose. The 076 regimen, already proven effective, is an $800 dose. There is a big difference. The point I make is that what you are seeking to test in the country is not the $800 dose. That has already been established. That was established in the United States, and it was established in France. What you are seeking to test is not the placebo. We all know that is useless and worthless. You don't even have to be a medical practitioner. That is understood. What you are testing is the $50 dose. And so you have to ask yourself the question, is the $50 dose something that might someday be available and utilized there? If it is, that is the test. It doesn't change the need to treat people humanely in seeking to provide a basis for using that $50 test. So what we really have here is a question of whether or not the United States Centers for Disease Control treated individuals in Africa with the same kind of respect that they would have treated individuals in the United States. The real question is whether or not they followed the guidelines which require us to treat individuals as distinct and different from the way we would treat, say, laboratory animals where we might disregard their health and safety. Of course, the New England Journal of Medicine says when effective treatment exists a placebo may not be used, and it cites the Declaration of Helsinki saying that any medical study of patients, including those of a control group, should be assured of the best proven diagnostic and therapeutic method. I don't think there is any other way of saying it. No matter how thin you slice this, it is still baloney. It is clear that the placebo is not the best therapeutic method. It simply cannot be categorized as the best therapeutic method, which is the method, according to the New England Journal of Medicine, that participants in the study are required to have. This afternoon I took the time to go through the assurance of protection document entered into by the Ivory Coast and the CDC that lays out the guidelines, principles, and procedures that the parties agree to follow in the research. I believe that in the assurance of protection document mention was made of the Declaration of Helsinki. In biomedical research, involving human subjects and international ethical guidelines for them, the protection document states that research must be conducted in accordance with established international standards for protection of human subjects--for example, the Declaration of Helsinki, or CIOMS. Those are examples. But it says we must live in accordance with those established international standards. The signature page for the relevant officials says that the research will be conducted in accordance with the established international standards for the protection of human subjects. It is kind of interesting that the assurance of protection was not obtained until July of 1997, according to Dr. Satcher's written responses to questions from the Senate Labor and Human Resources Committee. We were dealing with these individuals in the Ivory Coast in a way which did not even provide them with a guarantee of the protections included in the Declaration of Helsinki and other relevant international guidelines. We did not see the guarantees until we had articles appearing in major newspapers in the United States that criticized the African studies--articles which compared them to the Tuskegee experiment. Dr. Satcher has claimed that the studies complied with all the rules. In the New England Journal of Medicine article with Dr. Harold Varmus of the National Institutes of Health, Dr. Satcher asserts that the NIH and CDC support trials have undergone a rigorous process of ethical review, including not only the participation of the public health and scientific communities in developing countries where the trials are being performed but also the application of the U.S. rules for the protection of human research subjects by relevant institutional review boards. Dr. Satcher also relies on World Health Organization guidelines developed in Geneva in 1994 as authority for the studies. He said that the CDC chose to use a placebo controlled study because such an approach has been recommended by a WHO conference of international experts, including those from many developing countries. This World Health Organization conference to which Dr. Satcher refers took place in Geneva in June of 1994. Marcia Angell and Michael Grodin of Boston University criticized the conference recommendation, saying that the CDC and the researchers involved developed the recommendations simply to justify their desire to conduct the AZT trials in Third World countries. I would like to review some of the international guidelines. It is pretty clear that people around the country and around the world understand that you shouldn't use placebos when there is an effective treatment, particularly if you are conducting a trial that includes victims of deadly viruses. Again, I mentioned that Dr. Marcia Angell said in the New England Journal of Medicine that only when there is no known effect or treatment is it applicable to compare a potential new treatment with a placebo. The director of Harvard's Human Subjects Committee has stated that use of placebos would be unethical in such cases. The New England Journal of Medicine reports that in 1994 a researcher at the Harvard School of Public Health applied for NIH funding for an equivalency study in Thailand in which three shorter AZT regimens were to be compared with the regimen similar to the 076 regimen. The journal indicates that the NIH study section pressured the researcher and his institution to conduct a placebo trial, which prompted the director of Harvard's Human Subjects Committee to reply in a letter. The conduct of a placebo controlled trial for AZT in pregnant women in Thailand would be unethical and unacceptable since an active controlled trial is feasible. So here we have medical authorities resisting efforts by our Government to accept and conduct a trial which is ethically substandard. You have them saying it is unethical; it is unacceptable because there are actively controlled trials that are feasible. Basically this is a reflection for which we can be grateful in the medical community. We don't use sugar pills when we have known capacity for treatment. I could go through the guidelines as I did this afternoon. I do not want to do this. The point is the simple ethics of the matter come down to this: If there is a known treatment which is a therapeutic treatment it can make a difference. It is unethical instead of giving patients that treatment to provide them with sugar pills, or with placebos. The known treatment is well established. It is well documented in the medical literature. Its availability makes impossible the use of placebo studies in the United States in this kind of setting, and to echo the statements of many experts, I think it should make it impossible in Africa as well. Some of those who have commended the unethical studies overseen by Dr. Satcher in the Centers for Disease Control have indicated that these are poor people and they will never be able to afford the 076 high-dosage, long-schedule regimen of AZT. The truth of the matter is this was a study to experiment with lower doses, shorter schedules, and could have been conducted in a manner consistent with medical ethics by using as a control group the 076 regimen. There are medical authorities that will provide testimony to that extent. The truth of the matter is that we would not do in the United States what we did in Africa. And I think that is an important point. Dr. George Annas, a bioethicist and professor of health law at Boston University, and health law professor Michael Grodin have criticized the AIDS work in Africa not only on the basis of the placebo but they said that these studies with lower ethical standards were imposed on a population that will never receive the fruits of the research. It seems to me that there are so many ethical questions surrounding this particular AZT trial that demand answers that we should look carefully at this study. One of the answers of individuals who have commended these tests is that ``The individuals knew what was happening''--that participants had given their informed consent. I will concede that there is virtually always an ironclad, high standard of informed consent that is required for medical trials and experimentation to take place, and virtually every one of the protocols--whether it is the Helsinki Declaration, the Council of International Organizations of Medical Sciences, the Nuremberg Code, or any number of other CDC or Federal regulatory items--they almost all require that participants give their informed consent. Those who would defend these AZT trials seem to want to emphasize that since there was informed consent, we can overlook breaches in the ethics that might have taken place in the design of the studies and in the implementation of the trials. First of all, the presence of informed consent does not authorize unethical activity. The mere fact that people would agree to engage in unethical activities and unethical trials with our Government or with agencies of our Government does not mean that our Government can or should do that. We have standards that require a certain respect for human beings and that do not allow our health organizations to treat them as experimental subjects. Whether or not there is consent does not obviate or does not alleviate or does not mitigate the demand of our ethical codes for treating people like human beings and not experimental subjects. But there still is a real question about the level of the so-called consent that was given. This afternoon I had the opportunity to refer to an article in the New York Times which talked about a woman who, 5 minutes after she was informed for the first time that she carried the HIV virus, still shaken by the news, was walked through the details of the so-called trials and tests, as well as given general advice about what she should do to help herself and her baby. In less than 5 minutes she was given a quick explanation of what a placebo was. The session was over and this unemployed, illiterate individual had agreed to take the test. Asked what had persuaded her to do so, she said, ``The medical care they're promising me.'' Here is a situation where this is a mockery of informed consent. People who don't even know what a placebo is agreeing to participate in a medical study where they have a 50-50 chance of getting the placebo, a sugar pill. The New York Times article talked about another individual. One of the most highly educated women in the test spoke to a reporter. She was a 31-year-old single mother with a degree in law who gave her name only as ``X.'' She said she had never been made to understand that the medicine being tested, AZT, was already known to stop transmission of the virus during pregnancies. One of the fundamentals of informed consent is helping people understand what kind of therapeutic, known cures or known treatments exist, and she wasn't even told about that. ``I am not sure that I understand all this so well,'' she said, ``but there were some medicines that they said might protect the child, and they wanted to follow the evolution of my pregnancy and the effectiveness of the treatment.'' People have talked about the situation of following the evolution of the pregnancy and the effectiveness of treatment. We have seen situations where we have followed the evolution of disease and the effectiveness of nontreatment and for half the people in this study we are talking about the effectiveness of nontreatment. There is no evidence in terms of this woman's testimony that she would have gotten real treatment rather than a sugar pill. ``Pressed further, X, like other mothers, said that she had not been told the results of the tests on her 1-year-old. Asked how she would feel if she learned tomorrow she received a placebo when proven treatment existed, X's tone changed abruptly,'' according to the New York times. ``I would say quite simply that that was an injustice,'' she said. Well, it appears to me she has a good understanding of ethics if she does not have a good understanding of medicine. She understands that to provide individuals with a placebo, with a fake pill, and not to tell them that there is a real treatment that is available, would be an injustice. I could not agree more. One of the important concepts about medical ethics is that you should only use treatments that host countries could reasonably be expected to use. As I mentioned earlier, those who support the studies say that we could not use the 076 regimen because it was too expensive. We could use the $50 treatments. However, that doesn't comport with their statistics which also state that the average expenditure for health care is $5. If the per capita spending in these countries is often less than $10 per person, as the CDC says, how can these countries afford even the $50 treatment. Dr. George Annas, whom I mentioned, from Boston University, was publicly critical of the AIDS studies on the grounds that ``they were being carried out with lower standards in a population who will never receive the fruits of the research.'' These same authors talk about the research being largely unrelated to the potential for treatment in these countries. ``No research in developing countries''--and I am quoting again from these same two authors, Dr. George Annas and Michael Grodin of Boston University--``No research in developing countries is ethically justified unless the treatment developed or proven effective will actually be made available to the population. And the best CDC can say about its new AZT regimens, if they work, is that they would be a far more feasible option for the developing world.'' More feasible, yes, but would they be attainable? No evidence of the fact they would be attainable. I resume quoting. ``This is a far cry from assuring that they will actually be made available.'' And then they say, ``In the absence of such assurance, the African women and their children are being used purely as guinea pigs. They will be subjected to the intrusions and risks of research without any hope, much less any expectation, that they or their communities can ever benefit from the studies.'' The problem of treating individuals as experimental subjects is a serious problem. It is an ethical problem. And it is one which was so problematic that it caused the New England Journal of Medicine and a variety of other scholars to say that this is unacceptable. As we are debating whether or not we have a nomination for a Surgeon General that should be the doctor for America's families, the leader in terms of what America should be and can be, I think the ethics of the research conducted at his specific direction and under his control are important and legitimate concerns. I am saddened that Dr. Satcher chose to get involved in experimentation in Africa which would have been unacceptable here, which medical ethicists have indicated could not have been done here, which would have occasioned an outcry from the public and from authorities here, but which he thought could be done in Africa because these individuals have a different standard of living and that local conditions are different than ours. The situation of ethics is not something that relates to the economic standing of people, and it should not be related to a capacity on the part of a nation to transfer experimentation which it would not allow in its own country to be undertaken in another country. I believe America deserves the highest and best when it comes to ethics. I believe we deserve a Surgeon General who would criticize rather than implement this kind of anemia in the ethical world. I believe we deserve a Surgeon General who understands that human beings, regardless of their wealth, social station, national origin or citizenship, deserve to be treated as human beings and not as laboratory experiments. I regret that too often in Washington we have come to the place of thinking that if we can get a big value, or if there is a lot of scientific knowledge to be gained, we can disregard ethics--that if the payoff is big enough, and particularly if the price to be paid is not in our own families, that we can look away from the ethics. I really don't think that ethics and integrity are divisible. Just like we should be one Nation, indivisible, I think we should have one ethical standard that is indivisible, and I think it should be a high one. I think America deserves better than a Surgeon General who is willing to adjust on a relative scale of values the ethics that relate to those in another setting as compared to individuals who would be here in the United States. It is time for us to demand a Surgeon General who will appeal to the better angels of our nature, not bow to our basest desires. As I conclude my remarks, I would indicate the African AZT trials and the ethical problems surrounding them are just one aspect of the serious difficulties I have with this nomination, difficulties that lead me to oppose this nomination. This nominee endorses the practice of partial-birth abortion. This nominee has indicated a willingness to fund studies for the distribution of clean needles to drug addicts. He has indicated a willingness to fund conferences to promote the distribution of clean needles to drug addicts, to put the Government in the business of facilitating the administration of illegal drugs. He has reserved, in a technical statement, that he had never provided funding for a Government program to provide clean needles to addicts. But he has provided funding for Government studies and he has provided funding for other programs to promote the distribution of such needles. He has indicated that if he could get the right result from the studies he would be willing to have a program that distributed clean needles. It may be true that clean needles might help some people avoid illness, but frankly I don't know that we should be in the business of assisting individuals in the administration of IV drugs merely because there would be some ``health benefit'' in a discrete situation where the Government provided a sterile instrument for the administration of illicit substances. Individuals have come to this floor also indicating that they don't believe firearms are a disease. As you know, and I think as Senator Craig of Idaho indicated pretty clearly, the Centers for Disease Control has sought to limit or otherwise conduct studies which might be used in seeking to limit the availability or eligibility of people to own firearms in this country because they say that firearms are dangerous to a person's health. Frankly, the provision that guarantees the right of individuals to bear arms in America is the second amendment to the Constitution of the United States and I don't believe that the Bill of Rights is a disease. I think if we have resources that need to be devoted in our culture to the abatement and mitigation of diseases, we ought to deploy those resources to fight diseases and not to try and build a case for depriving Americans of a right guaranteed them by the Bill of Rights. In all of these settings the cumulative effect of this candidate, this nominee of the President, shows us that we are not being offered the kind of Surgeon General to lead the American people in ways that I think are appropriate and consistent with the ambitions and aspirations of Americans. For these reasons--in addition to my focus today on the ethical deficiencies of the African AIDS studies--I think this nominee should be defeated. Madam President, I yield the floor.

Mr. ASHCROFT

Mr. ASHCROFT. I ask for its second reading, and I object to my own request on behalf of our side of the aisle.

Mr. ASHCROFT. In the absence of colleagues on the other side of the aisle, Mr. President, I understand that S. 1611, which was introduced earlier today by Senator Feinstein, is at the desk, and I ask for its first reading.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I ask unanimous consent of the Senate that several members of my staff be given floor privileges during the pendency of this debate: Don Trigg, Annie Billings, David Ayres, Lori Sharpe, and Sarah McElroy.

Mr. ASHCROFT. Thank you very much. Mr. President, as I explained earlier when the unanimous consent was sought by the leader to bring this matter to the floor of the Senate, there is an absence of some materials that are important and pertinent to an evaluation of this nominee as a result of the failure or lack of cooperation of this administration to provide to Senators information upon our request. So I indicate at this moment that there will be things that are reserved for debate at a later time when we have that material available to us. I am pleased to go forward now and take this opportunity to outline some of my reasons for opposing the nomination of Dr. David Satcher for U.S. Surgeon General and Assistant Secretary for Health. While a case against Dr. Satcher is a compelling one, I must confess from the outset to being a grudging participant in these struggles over political nominees. It is really not one of the more pleasant tasks in the Senate. It gives me no satisfaction to deny anyone an opportunity to serve his or her country. Nomination fights can be difficult, they can be abrasive, they can be partisan, and sometimes they work neither to educate nor to unify the Senate. Yet, after three years in Washington, I believe that America deserves better, America deserves higher quality, and America deserves higher standards of ethics than the standard that has been sent to this Senate by the administration for confirmation. A nation, like a person, rarely loses its integrity, or its capacity, or its ethics all at once. Instead, our values tend to be lost little by little. And I think we have seen that in this administration. I can remember a Surgeon General of this administration who wanted to legalize drugs. We have seen Cabinet Secretaries come forward to admit their infidelity. Then one day the Vice President goes out and endorses and embraces Hollywood and all of the values that Hollywood would propound to undermine the ethics and character of America. The next day the President vetoes a partial-birth abortion bill and basically defends what Patrick Moynihan, the Senator from New York, has labeled as ``infanticide.'' And so it goes. Finally, we wake up to find our President accused of a kind of conduct in the White House with employees that I wouldn't even want to try to describe here on the Senate floor. Frankly, I don't know what is more tragic: That the Office of the President has been so thoroughly debased in the debate and comments and accusations in the society, or that our values have been so demeaned, that it appears much of the public doesn't believe that we can expect any better. Frankly, if my time in government has taught me any one thing it is that we teach when we govern. We are assigning values to things when we govern. When we approve of something we say to the culture ``This is good,'' and when we disapprove of something we say ``This is bad.'' In assigning values in a culture, the values of which have been under serious attack, asking questions is an important one of our responsibilities. Government and its officials teach, and what we are teaching these days is wrong. Although Dr. Satcher is a person of incredibly strong medical credentials in terms of his expertise and his capacity, his effort has been devoted in an area and in a number of ways which call into serious question the values that we would be teaching and the kind of ethical standards we would be saying are OK, if we were to confirm him. While our Nation is challenged by the crisis of drugs, the tragedy of illegitimacy, and the breakdown of the family, our public officials have been too busy accommodating America in these things, rather than calling America to her highest and best. Piece by piece, our Nation's integrity has been sacrificed, and too often the Senate of the United States has participated in confirming nominations or ratifying proposals without looking carefully at the ethics involved or the values that are being challenged when a nomination is being confirmed. Dr. Satcher's elevation to the post of Surgeon General of the United States, Dr. Satcher's confirmation, would reject America at her highest and best and would simply say that we are willing to accept a series of values which are far beneath what the American people endorse. Dr. Satcher, for example, has embraced partial-birth abortion. He tolerates abortions for minor children without parents' consent. He supports free needle programs, so that drug addicts would be aided and assisted in the administration of their drugs by a Government program that provides free needles. I think this accommodates people where they are, at a low level, instead of challenging people to where we need to be, at a high level. I think America deserves that kind of challenge for quality and integrity and ethics. I question the value of a Government program and its ethics when it provides needles to drug addicts so they can administer drugs in a way which is more healthy--if you could say that. Why should the United States of America participate in that? Consider the following information. Dr. Satcher has promoted research on African women who were HIV positive. That research denied them known, lifesaving drugs and therapy. Our Nation's top medical journal is the New England Journal of Medicine. Virtually everything that you ever hear, in terms of something new, something at the cutting edge of improving medicine, is written of and announced in and discussed on the pages of the New England Journal of Medicine. The New England Journal of Medicine chastised Dr. Satcher, literally branding his research in these African HIV trials-- in which some African women bearing children were given sugar pills or placebos--as being unethical. I think America deserves better. America deserves a Surgeon General who repairs to the highest standard of ethics. America deserves better than a Surgeon General who would experiment on the most vulnerable members of the world's population. Dr. Satcher has championed blind tests that sent thousands of HIV positive infants home without parental notification. That happened in this country, not in Africa. Infants were tested for HIV. The tests were maintained as blind so that no parent would know if the child that was tested, their baby, was testing positive for HIV. This practice intentionally left moms and dads without an awareness or understanding of whether their child was infected with the HIV virus. It might be argued, ``Well, the moms and dads might be able to find this out because they realized they were living in risky lifestyles or were at high risk for HIV infection themselves.'' That might be true. It might not be true. But what happens if that mom or that family decides to give the child up for adoption? If there had been a test of the child's blood which indicated whether or not it was HIV positive, the adoptive parent might not be privy to that information, especially if the information isn't even available to the natural birth parent. I think America deserves better. I think this country deserves better than a Surgeon General who would have those kinds of tests conducted and not provide that kind of vital, potentially lifesaving information. I understand that people might want this kind of information for statistical purposes, so we could develop an awareness of the statistics about AIDS and which communities have the highest levels of AIDS. But I think Government too often views people as statistics. I think we need a Government that views people as human beings and understands the importance of individuals and parents and children. Ignoring the potential for an early diagnosis on the HIV virus is, I think, something that would raise serious questions. I would not want to be a parent who was not told if my child had HIV, in spite of the fact that the Government had conducted a test which would reveal it. Certainly, if I weren't the natural parent and I were in the shoes of someone adopting a child, I think I would want to know, not so that I might not adopt the child, but so that I might take whatever measures would be necessary. One might begin to take the steps which could curtail the incidence of the kinds of diseases that can attend and participate in the eventual collapse of an individual who is HIV positive. There is progress being made in the area of AIDS research. But it seems to me if you have some life extending knowledge, you would want to make that available because you might extend a life to the time when a cure would become available. America deserves better than a Surgeon General who is more concerned about the secrecy of experiments than he is about the lives of the specific patients involved. There are scientists and medical doctors who are more concerned about statistics. It may well be that they should be commended for their interest in statistics. But I think America's family doctor, the Surgeon General of the United States of America, should be one who reflects a concern about individual lives and about individual health conditions. He should call America to her highest and best as it relates to health and should never, never settle for America at her lowest and least. Maybe this is what America has come to expect from Washington. It may be what we expect, but it is less than we deserve. It is time for us to stand up and defend values--values like honesty, integrity and decency--and it's time for us to demand a Surgeon General who will appeal to the better angels of our nature, who will attend the health of the Nation, not one who would participate in the ``clean needles'' approach to the drug problem. These are issues that I intend to elevate in the Senate's consideration of this nomination: The African HIV studies overseen by Dr. Satcher during his supervision of the Centers for Disease Control and the ethical debate that swirls around these studies, including the indictment by the New England Journal of Medicine that these studies were unethical; the domestic AIDS detection programs that refused to identify the blood samples with the children so that the parents would never be told as a result of that test whether their children had AIDS, sending parents home with AIDS-infected children without giving them the benefit of what the studies could have shown; there are the clean needles programs which, frankly, don't appeal to us at our highest and best but accommodate the culture at its lowest and least and put the Government in the drug business. I think there are real reservations about the kind of signals that sends. What does it teach? What does it teach a young person if a junkie says to him or her, ``You ought to try this,'' and the young person says, ``Well, I don't know if I should.'' Then the junkie says, ``Well, look, the Government gives us these clean needles,'' rips open a pack, and says, ``so that you won't have any problem, so this will be a safe procedure for you.'' I have real reservations about that. I think the people of the United States of America deserve better than that. I think the United States of America deserves better than a Surgeon General who is willing to endorse the President's position on partial- birth abortion. It is clear to me that the people of this country understand the heinous terror, the horror, and the tragedy of partial- birth abortion. We do teach by what we endorse, when, by confirming something, we authorize and ratify it. I think we have real problems when we would purport to confirm an individual who is endorsing partial-birth abortion, especially when it is now well understood by medical authorities that it is not even a medically needed or indicated therapy. All of these things are interesting points. There are other matters which will be the subject of discussion. But America deserves better. We deserve a family doctor who will lead us to our highest and best, rather than accommodate us at our lowest and least. I mentioned in a colloquy, with the leader of this Senate, that we had sought information from the Centers for Disease Control and from the administration about this nominee and we had not been sent that information. Some of the information which we will be using in the debate has come as a result of Freedom of Information Act demands, which information hasn't been forthcoming without those kinds of inquiries. As a result, I think you can expect the debate to be more thorough as the information arrives. These are the broad outlines. America deserves better. America ought to have a Surgeon General who calls us to our highest and best, not one who accommodates us at our lowest and least. We should not have a Surgeon General who would participate in an assault on the values of America, opposing 80 percent of Americans who believe partial-birth abortion is wrong. We should not have a Surgeon General who believes that it would be OK to have clean needles programs that put the Government in the business of participating in the administration of illegal drugs. We should have real reservations about a Surgeon General whose regard for Third World populations allows him to use your tax dollars to have lower standards in conducting medical research on people overseas than the standards he would use in the United States of America. I think that has implications for who we are as a people and it has implications for the way other nations view us, if we are willing to do things with their population we wouldn't do with our own population. Obviously we would have reservations about the maintenance of a program which tests the blood of young children for HIV but does not provide their parents with the information that would allow them to make good judgments about their health care later on. With those things in mind, I would just signal that, as the information becomes available, I would expect additional Members of the Senate to come to the floor and participate in this debate. We will have a chance to examine each of those categories in detail with a view toward assessing whether or not this Senate should teach the kinds of things that would be taught to the American public if we were to confirm this nomination.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, tomorrow morning, the Senate will be in a period for the transaction of morning business from 10:30 a.m. until 11 a.m. At 11 a.m., the Senate, hopefully, will be able to begin consideration of S. 1601, the cloning bill. It is hoped that the Senate will be able to make good progress on that legislation throughout Thursday's session of the Senate. As a reminder to all Members of the Senate, we will not be in session on Friday.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I ask unanimous consent that the order for the quorum call be rescinded.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I rise today in support of the proposed amendment to the United States Constitution to prevent desecration of our great national symbol. In 1995, I was an original co-sponsor of an amendment to the Constitution designed to protect the symbol of our nation and its ideals. When that resolution was defeated narrowly, we vowed that this issue would not go away and it has not. I stand here, again, today to declare the necessity of protecting the Flag of the United States of America and what it represents. Thoughout our history, the Flag has held a special place in the minds of Americans. As the appearance of the Flag changed with the addition of stars as the nation grew, its core meaning to the American people remained constant. It represents no particular perspective, political agenda, or religious belief. Instead, it symbolizes an ideal, not just for Americans, but for all those who honor the great American experiment. It represents a shared ideal of freedom. The Flag stands in this chamber and in our court rooms; it is draped over our honored dead; it flies at half-mast to mourn those we wish to respect; and it is the subject of our National Anthem, our National March and our Pledge of Allegiance. As the Chief Justice noted in his dissent in Texas v. Johnson (1989), ``[t]he American flag, then, throughout more than 200 years of our history, has come to be the visible symbol embodying our nation * * * Millions and millions of Americans regard it with an almost mystical reverence regardless of what sort of social, political, or philosophical beliefs they may have.'' There can be little doubt that the people of this country fully support preserving and protecting the American Flag. The people's elected representatives reflected that vast public support by enacting Flag protection statutes at both the State and Federal levels. Regrettably, the Supreme Court thwarted the people's will--and discarded the judgment of state legislatures and the Congress that protecting the Flag is fully consistent with our Constitution--by holding that the American flag is just another piece of cloth for which no minimum of respect may be demanded. As a consequence, that which represents the struggles of those who came before us; which symbolizes the sacrifice of hundreds; and for which many men and women have died cannot be recognized for what it truly is--a national treasure in need of protection. Further, the question must be asked, what is the legacy we are leaving our children? At a time when our nation's virtues are too rarely extolled by our national leaders, and national pride is dismissed by many as arrogance, America needs, more than ever, something to celebrate. At a time when our political leaders are embroiled in scandalous allegations, we need a national symbol that is beyond reproach. America needs its Flag untainted, representing more than some flawed agenda, but this extraordinary nation. The Flag, and the freedom for which it stands, has a unique ability to unite us as Americans. Whatever our disagreements, we are united in our respect for the Flag. We should not allow the healing and unifying power of the Flag to become a source of divisiveness. The protection that the people seek for the Flag does not threaten the sacred rights afforded by the First Amendment. I sincerely doubt that the Framers intended the First Amendment of the Constitution to prevent state legislatures and Congress from protecting the Flag of the nation for which they shed their blood. At the time of the Supreme Court's decision, the tradition of protecting the Flag was too firmly established to suggest that such laws are inconsistent with our constitutional traditions. Many of the state laws were based on the Uniform Flag Act of 1917. No one at that time, or for 70 years afterwards, felt that these laws ran afoul of the First Amendment. Indeed, the Supreme Court itself upheld a Nebraska statute preventing commercial use of the Flag in 1907 in Halter v. Nebraska. As the Chief Justice stated in his dissent, ``I cannot agree that the First Amendment invalidates the Act of Congress, and the laws of 48 of the 50 States which make criminal the public burning of the flag.'' Nor do I accept the notion that amending the Constitution to overrule the Supreme Court's decision in the specific context of desecration of the Flag will somehow undermine the First Amendment as it is applied in other contexts. This amendment does not create a slippery slope which will lead to the erosion of Americans' right to free speech. The Flag is wholly unique. It has no rightful comparison. An amendment protecting the Flag from desecration will provide no aid or comfort in any future campaigns to restrict speech. Moreover, an amendment banning the desecration of the Flag does not limit the content of any true speech. As Justice Stevens noted in his dissent in Johnson v. Texas, ``[t]he concept of `desecration' does not turn on the substance of the message the actor intends to convey, but rather on whether those who view the act will take serious offence.'' Likewise, the act of desecrating the Flag does not have any content in and of itself. The act takes meaning and expresses conduct only in the context of the true speech which accompanies the act. And that speech remains unregulated. As the Chief Justice noted, ``flag burning is the equivalent of an inarticulate grunt or roar that, it seems fair to say, is most likely to be indulged in not to express any particular idea, but to antagonize others.'' In sum there is no principle or fear that should stand as an obstacle to our protection of the Flag. It is my earnest hope that by Amending the Constitution to prohibit its desecration, this body will protect the heritage, sacrifice, ideals, freedom and honor that the Flag uniquely represents.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, if there is no further business to come before the Senate, I now ask that the Senate stand in adjournment under the previous order.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I ask unanimous consent that passage of S. 1033 be vitiated and the bill be indefinitely postponed.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I ask unanimous consent that passage of S. 947 be vitiated.

Mr. ASHCROFT

Mr. ASHCROFT. Mr. President, I ask unanimous consent that when the Senate completes its business today, it stand in adjournment until 10:30 a.m. on Thursday, February 5, and immediately following the prayer, the routine requests through the morning hour be granted and the Senate immediately begin morning business, not to exceed 30 minutes, with Senators permitted to speak therein for up to 5 minutes each, with the following exceptions: Senator Gorton, 10 minutes; Senator Reid, 10 minutes; Senator Baucus, 10 minutes.