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Sunday, September 03, 2006

Tuskegee II? An Interview with Peter Lurie of Public Citizen

Peter Lurie, MD, MPH, is a Health Researcher with Public Citizen, a non-profit consumer advocacy organization founded by Ralph Nader in 1971. Public Citizen fights for safe foods, drugs and medical devices; greater consumer control over personal health decisions; and universal access to quality health care.
Currently Public Citizen is involved in speaking out against US funded HIV trials being conducted in developing countries which deny effective drug therapy to participants and are in violation of the Nuremberg Code. Dr. Lurie has played a central role in bringing this issue to the attention of the public. His findings have been published in the New England Journal of Medicine and presented to both President Clinton and Secretary Shalala. Public Citizen has joined with leading health experts including Wilbert Jordan, MD, MPH, Chairman of the Black Los Angeles AIDS Consortium; Michael Grodin, MD and George Annas, JD, MPH of Boston University’s Health Law Department; and George Silver, MD of Yale School of Medicine; to demand an investigation by the Department of Health and Human Services Office of the Inspector General. The group has also appealed to Secretary Shalala to order the researchers to provide participants immediate access to AZT in order to prevent further loss of life. Furthermore, Public Citizens recommends a referral to the National Bioethics Advisory Commission and is supported by Dr. Philip Lee, former Assistant Secretary for HHS; Dr Thomas Murray, a member of the NBAC and Director of the Center for Biomedical Ethics; Case Western Reserve University School of Medicine; Dr. Richard Humphrey, of the John Hopkins University Medical School and School of Public Health; and Dr. Author Caplan, Director of the Center for Bioethics, University of Pennsylvania.
Dr. Lurie spoke to me in his capacity as Health Researcher with Public Citizen on November 11, 1997 from his office in Michigan.

Interview
Perez: I’d like to start at the beginning--what lead you into the field of HIV research; specifically your interest in the socioeconomic and ethical issues surrounding HIV?
Lurie: I am originally from South Africa and was always interested in ethical and socioeconomic issues. In 1984, as a student, I began working with Pubic Citizen examining the double standards of the Pharmaceutical industry in developing countries. I went back to medical school and obtained my MD while continuing to pursue my interest in the socioeconomic implications of health. People are not generally interested in socioeconomic issues but if you look at all causes of morbidity and mortality, socioeconomic status is the strongest predictor. All causes of morbidity and mortality are very strongly correlated with socioeconomic status. In America we shrug this off, but it is a stronger association than many other things we obsess about. It’s one of those things that you start off with in Public Health but then forget about. The assumption is that it can’t change, but some of the biggest success stories in Public Health are due to these changes; for example, better housing conditions. I saw a big gap - especially on the international level. Also, if you are interested in HIV, you have to be interested in what is happening in developing countries. It is estimated that 90% of all HIV is in developing nations... economics and politics play a large role in the health of the citizens.
Perez: I couldn’t help but notice you are no stranger to controversy; you strongly support Needle Exchange Programs which are often an unpopular idea in this country; what is your opinion on the role of education and research in the prevention of HIV?
Lurie: Most public opinion polls show the public does support Needle Exchange Programs (NEP), the problem is not with the public but rather the politicians. They are seized by hysteria with the war on drugs...at which we are failing miserably. I saw a recent article that estimated over 57 Billion dollars of drugs were being brought into this country -- we only seize about 1/5 -- the problem is so large...but they can’t be seen as soft on drugs so it pollutes the ability to debate NEP’s because of the absolutist way NEP draws into ideologies such as giving away pure Heroine when in fact that is not the proposal. It is not radical to say in Public Health, “lets balance the risk vs the benefit”. NEP’s have been shown to reduce HIV transmission; we are not advocating giving away drugs but that is what gets drawn into the argument. So, while politicians are saying there can be absolutely no increase in drug use and demanding assurance of this...basically a zero tolerance on drugs... the ability to intervene with a demonstrated and effective way to reduce HIV transmission is being overlooked.
Perez: Speaking of controversy, you are in the midst of one at the moment. In affiliation with Public Citizen, you have openly charged the National Institute of Health and the Centers for Disease Control of funding and conducting unethical HIV trials in developing countries. How did you become involved in speaking out against these trials and why?
Lurie: In February I was presenting at a meeting exploring the relationship between research and journalism in South Africa. The CDC came in to present work being conducted on these trials and the audience objected. Much of the opposition centered on the medication regimen being used. I feel the use of shorter trials are a legitimate research question and highly dependent upon what drugs the shorter trials are being compared to. When I questioned the speaker as to what drugs they were comparing... in this case it was a placebo. I knew this was important right away but I had no idea of the total number involved until further investigation showed studies either being conducted or funded by the NIH and CDC in several developing countries. We went public with the information in April. Of course the trials have been in existence since 1994 and have gained momentum. I wish I had learned of them before.
I am not opposed to randomized controlled trials to determine the effectiveness of different interventions, but there are several problems associated with these trials. First of all, the use of a placebo denies women access to an effective HIV intervention which has already been shown to reduce the transmission of HIV from mother to baby. This is not tolerated in the US but is being supported for use abroad. Alternatives are available. We know that AZT can reduce HIV infection in babies by about two-thirds... of those which are infected, approximately 65% are transmitted during delivery and 95% of the remaining cases are transmitted in the first few months after birth. The NIH and CDC argue that the differences in duration and means of administering the drugs (oral or intravenous) justify the use of a placebo but this does not account for the availability of alternative means of drug therapy. For example, research on shorter drug regimens suggests they may be equally effective in reducing the transmission of HIV if given during critical risk periods. Also, the use of oral or intravenous administration has already demonstrated similar blood levels for each group. Given the availability of alternatives, it is difficult to justify the use of placebo controlled studies.
Perez: Why do you believe the general public should be concerned?
Lurie: For several reasons. Any time there is needless suffering and death there is a need for compassion. Also, as Americans, there is a concern for any such study with American money behind it. Morally, and as international policy, it is offensive to adhere to lower standards and ethics abroad than what is deemed appropriate for our own citizens.
Perez: According to a statement by the CDC and NIH, it is estimated that more than 1 million children (worldwide) are already infected and 5-10 million will become infected through perinatal transmission in the coming decade. Given these statistics it is obvious intervention is needed as soon as possible. The CDC and NIH claim these studies are warranted by the need to quickly identify a drug regimen available to poorer nations and the respective countries supported the use of placebos in the trials. How do you respond to this argument?
Lurie: It is a stupid argument. The charting is irrelevant and implies we don’t understand the problem. It’s nonsense. Obviously we would like to see fewer die - not more. The facts stipulate alternatives are available. It is simply not a winning argument. They say placebo trials are the best way to find a quick intervention, but it is not true that placebo trials are any faster than equivalency trials. The sample sizes are comparable and the small difference that does exist could be easily overcome by recruiting less than 20% more people in order to reach the needed sample size. It is not as if we are asking them to build a state of the art heart institute costing millions of dollars. The argument that researchers must comply with the standard of care in the sponsoring country is being distorted to create a double standard that permits a research design that is unacceptable in this country. It is for this reason, a single international standard of ethical research must be developed.
Finally, the trials are unnecessary because there is little guess that a shorter version of AZT is better than nothing-- we have a good working knowledge of when transmission occurs; most often during labor...and we can prevent 65% of those infections from occurring. No, there is no question that this is better than nothing, the data from 076 shows this. As for the support of the countries, there are several problems. First of all the ethic committees are young and often lack support. In fact, some do not even have ethicists on the board, only researchers who may be involved in the research. This is potentially a conflict of interest as funding for research is often difficult to obtain. It becomes difficult to screen out unethical research. Also, you must keep in mind that approval and informed consent is not the same as an ethical review. If the studies are unethical in the United States, you cannot make them ethical by review or informed consent in another country. In a way it is even more unethical.
{Note: 076 refers to a demonstration of the AIDS Clinical Trial Group (ACTG) to the World Health Organization in the summer of 1994 that showed positive results in the AZT drug regimen. The WHO called for the immediate use of the 076 regimen in the industrialized world where it is feasible...and the immediate exploration of alternative regimens to be used in developing countries where cost is a factor}.
Perez: In “1,000 Foreign Infants to Die...” and again in a letter you co-authored to Secretary Shalala, a comparison between the current HIV trials and Tuskagee was drawn. Do you feel the comparison is warranted?
Lurie: Yes. Although the analogy is not perfect, it is afterall an analogy, it is close enough to warrant the comparison. Both studies withheld effective therapy, both involved members of a minority group, and although there is informed consent in these studies where there was none in the Tuskegee experiments, the informed consent is terrible and problematic; countries often must decide between a placebo controlled trial or no trial at all. Interviews with the women reveal that many of the women believe that at least one of the pills they received would treat HIV or that they agreed to participate in the trial simply to obtain access to medical care in any form. In an environment where many cannot read or write and where poverty, sickness, hunger, and homelessness is rampant; where the powerful, the rich or the expatriate is a semi-god, how can you talk of informed consent? Also, both have attempted to argue that in the absence of the studies the subjects would not have been treated. But, there is opportunity for effective treatment, it does exist, but they are choosing to do this instead. They CHOOSE not to give treatment and it is death for these children. Part of what is going on is the slavish adherence to clinical trials....they have sacrificed to the Holy Grail of randomized trail by placebo rather than redesign the study to include treatment.
Perez: How would you respond to those who feel 1,000 infant deaths are a small price to pay in order to save millions?
Lurie: I believe it is the Neuremburg Code that states the interest of society does not take precedent over the rights of the individual. Research cannot justify theoretical and unproven future benefits of life savings in view of certain death. The choice these researchers have made will result in certain death for these children. The benefits are debatable; at this point they are just proving the obvious.
Perez: Dr. Lurie, you co-authored a letter to President Clinton in addition to that of Secretary Shalala...what official response, if any, have you received?
Lurie: Secretary Shalala, the NIH and CDC, and others have released public statements regarding these trials but at this time the debate is still on-going.
Perez: What can other concerned citizens do to help?
Lurie: People of color, especially African Americans, can play an extremely important role by becoming actively involved in taking a stand against this research...as should we all. I encourage anyone who is interested to begin a letter writing campaign, voicing their opposition to these trials, to Secretary Shalala with a copy of the letter sent to Public Citizen. The address is;
Secretary Shalala
Dept. HHS
200 Independence Ave SW
Washington DC, 20201
FAX: 202.690.7203

Public Citizen
1600 20th Street NW
Washington DC, 20009

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