Politics Polarizing Issues In Needle-Exchange Study

POINTED ASSERTION: Dennis Fisher contends that his clinical trial examining methods of obtaining clean syringes is both ethical and valid. Though a federally appointed panel of scientists and ethicists in December okayed the continuation of a controversial needle-exchange clinical trial at the University of Alaska, Anchorage, questions still linger over the ethical and scientific nature of the study. At the same time, the project offers a view of how science can be politicized. Despite surveys showing the public would support clean-needle programs, which researchers say are effective in reducing disease, offering needles-through needle exchange or at pharmacies-is still perceived as encouraging drug use. Study after study shows that needle-exchange programs (NEPs), in which drug users trade used syringes for clean ones, reduce the spread of blood-borne disease among injecting drug addicts. Several European countries, including France, Great Britain, and the Netherlands, as well as Australia and Canada, have had effective NEPs for at least a decade, making such programs a standard public-health measure against HIV infection. Yet the United States government continues to ban federal spending on NEPs, citing a lack of definitive proof that needle exchange not only cuts the incidence of disease, but also does not promote drug use. The trial, supported by the National Institute on Drug Abuse (NIDA), is being led by Dennis G. Fisher, a professor of psychology at Alaska. The three-year, $2.4 million study will compare the incidence of hepatitis B virus (HBV) among participants who obtain clean syringes through NEPs and among those who purchase them at pharmacies. It will attempt to determine if one method of needle distribution is more effective than the other at stopping the spread of disease. It also will attempt to determine if access to clean needles encourages drug use. While the study is funded by government money, because of the federal ban the actual needle exchange is supported separately by the nonprofit Alaska Science and Technology Foundation. Congress in 1988 banned federally funded NEPs until the Surgeon General declared that they are effective without promoting drug use. Health and Human Services (HHS) Secretary Donna Shalala has the authority to lift the ban but has not done so. SLEIGHT OF HAND: Arthur Caplan thinks the Alaska study was funded because Congress wanted to delay dealing with a politically sensitive topic. University of Pennsylvania bioethicist Arthur Caplan calls the Alaska study the "quintessential example of how scientific research is politicized." OUTRAGED: Peter Lurie argues that the Alaska study puts participants at unnecessary risk of contracting hepatitis B. The study became a cause célèbre in October, when consumer advocates from Washington, D.C.-based watchdog group Public Citizen complained that some participants were being denied access to clean syringes and all were being unnecessarily put at risk for a potentially deadly disease. In letters to NIH director Harold Varmus that called for a halt to the study, Sidney Wolfe, the director of Public Citizen's Health Research Group, and Peter Lurie, an assistant professor of family and community medicine at the University of California, San Francisco, who also is research associate for the group, called the study "dangerous, unethical, and exploitative." The pair also sent letters to the Associated Press and National Public Radio. Subsequent media attention set off a firestorm of debate. Varmus commissioned a 10-member expert panel to study the objections further. The study had already received approval from the university institutional review board and from the federal Office of Protection from Research Risks. Fisher contends that the study is an effective and ethical way to compare two practices that have been shown to prevent disease to determine which works best. He thinks that Lurie and Wolfe, as well as the media, have distorted the details of the study. He states that participants, who are already being recruited, will be informed of their opportunities to purchase inexpensive needles at local pharmacies. "We're not denying access to syringes or withholding them," he says. SATISFIED: Panel chairman Robert Levine thinks the study may show a better way to reduce disease among intravenous drug users. The Varmus advisory panel agreed. "We found no scientific or ethical flaw that would preclude funding the study," says NIH panel chairman Robert J. Levine, a professor of medicine at Yale University School of Medicine. He contends that the study may show a better way to reduce disease among intravenous drug users. Participants are neither denied access to clean syringes nor put at unnecessary risk for hepatitis B, he maintains. Under Varmus's direction, the study will provide vouchers for participants who wish to be vaccinated against HBV. Providing vouchers for HBV vaccines is beyond the normal standard of care required in a clinical trial. Many scientists believe that more studies are needed to understand the best methods of providing drug users clean syringes. Yet they are frustrated about the role of politics in the funding of the scientific process. POLITICAL REALITY: Robert Heimer cites a "lack of political will from Washington" in continuing to ban federal funding of needle-exchange programs. Robert Heimer, an associate research scientist at Yale's medical school, says the ban on federal support for NEPs represents a "blatant example of science not being able to change policy and of policy made without consideration of science. "The debate has been removed from the sphere of science, but it is being thwarted by legal considerations and a lack of political will from Washington," says Heimer, who studies NEPs. CONCERNED: Don Des Jarlais worries that excessive federal oversight will discourage scientists from studying controversial areas. "The fundamental problem is that [public] policies aren't always in agreement with scientific data," says Don Des Jarlais, director of the Chemical Dependency Institute at Beth Israel Medical Center in New York. Des Jarlais recently published a study in Lancet (D.C. Des Jarlais et al., 348:987-91, 1996) that supported the efficacy of NEPs in preventing disease spread. Several earlier reports, notably a 1995 federal study (National Research Council and Institute of Medicine, Preventing HIV Transmission, National Academy Press), and a number of field trials that show a reduction in disease spread, have also endorsed NEPs. Des Jarlais says that "any time two politically sensitive areas of medicine-needle exchange and [infectious diseases such as HBV and] AIDS-are involved, politics can be nasty." David Metzger, director of the Opiate and AIDS Research Division at the Center for Studies of Addiction at the University of Pennsylvania, contends that enough data have been collected to show that NEPs work. "Studies that have examined the spread of HIV have shown a decrease in spread [using NEPs] without a rise in drug abuse," he points out. He doubts that the Alaska study, even if it demonstrates the superiority of one method in reducing disease spread, will change public policy and result in lifting the ban on federal funding for NEPs. Others contend that the Alaska study is a stall tactic. It could be a way of "putting off NEP advocates by saying, 'We're doing research in the field, but have yet to get results,'" says UC-San Francisco's Lurie. At last year's 11th International Conference on AIDS in Vancouver, Lurie reported that NEPs could have prevented nearly 10,000 HIV infections among injecting drug users, their sex partners, and their children since 1987. He calls the lack of federal response to proven studies "discouraging to scientists." Caplan, director of the Center for Bioethics at Penn's medical center, agrees with Lurie. "Rather than deal with the issue, Congress can tell its constituencies it is studying the issue further. The only question is whether we [as a nation] have the political will to confront this issue as a public health concern." He calls the Alaska study "a $2.4 million waste." Many criticized the fact that an extra NIH review of the Fisher study was done, although the project had passed through the normal institutional and federal reviews. "This may set a precedent," Des Jarlais says, adding that highly politicized science and excessive reviews discourage scientists from studying such areas. Yet Kenneth D. Pimple, a research associate at the Poynter Center for the Study of Ethics and American Institutions at Indiana University, makes the case that rarely is science not politicized. "It's how [funding sources, such as the federal government] choose what to study and fund," he points out. "Clearly some science need not be done, but we can't depoliticize all of science-it's how priorities are set." Pimple agrees that the extra NIH review "no doubt could have a chilling effect." Referring to Public Citizen's complaints, he adds, "it's appalling that science could be held hostage by any group." Yet he notes that such consumer groups are important public watchdogs, and the "reputable ones play important roles in ensuring public safety." Photo: Lynn Gambale HELPING OUT: Volunteers at Prevention Point Philadelphia provide assistance during a needle-exchange session. Many scientists and others are troubled by the details of the study's design. Specifically, it divides 600 current drug users into two groups, one of which will exchange dirty needles for clean. The other will purchase needles in pharmacies. The researchers will also study 500 former drug users to see if the availability of clean needles influences drug relapse. Critics point out that while the needle-exchange group can also obtain syringes from a pharmacy, the reverse is not true, which puts those participants at risk. It also compromises the study's validity, they say. This part of the study particularly bothers Des Jarlais. He contends that some participants may not always be able to get needles from pharmacies, whether because of difficulties getting to the pharmacy, or being turned away because of appearance, or perhaps arguing with the pharmacist. The Anchorage drug paraphernalia law permits pharmacies to deny a needle to those without a prescription if the individual appears to want the syringe to inject illicit drugs. (Anchorage, however, was an attractive site for the study because Alaska is one of only four states in the union that do not require prescriptions to purchase syringes.) Fisher counters that "many of these drug users have been buying needles for the past year or so. They know where they can go [among the 25 Anchorage pharmacies that sell syringes]." He argues that his protocol could settle the issue of whether one method is better than the other because a randomized trial is "scientifically valid." Previous studies have mostly compared disease rates between addicts who voluntarily used an NEP and addicts who did not. This "self-selected bias," he says, might affect the outcome because the group who decided to use NEPs might include many who were going to quit drugs anyway, and are more likely to practice healthy habits. Yale's Heimer calls the study a "good first step" because it will help chronicle the behavior of drug users at NEPs and at pharmacies. "We don't know which [method] will prove better; it's an open question." But he finds fault with a number of factors, and agrees with Des Jarlais's concerns that the lack of an effective way of preventing NEP participants from purchasing needles at a pharmacy could potentially compromise the results. Still, some argue that the choice of how to obtain clean needles should be left to the individual. Julie Parr, executive director of Prevention Point Philadelphia, an NEP that does about 20,000 exchanges annually, is also worried about the Alaska study design. "People should be given the choice [of NEP or pharmacy purchase]," she says, "since both these programs have been shown effective in preventing disease." UNETHICAL: George Annas believes the Alaska study violates the spirit of the Nuremberg Code. Others see the study as blatantly unethical. Bioethicist George Annas, a professor of health law at the Boston University School of Public Health, contends that the study end point, which is the incidence of hepatitis B, violates the spirit of the 1947 Nuremberg Code, under which no human experiment is to be conducted that could induce life-threatening-and preventable-harm. Annas calls such a study unconscionable, and says that a different end point needs to be established. "Using a dangerous disease [such as hepatitis] as a marker when the disease can be prevented is unethical." Annas compares the Alaska study to the Tuskegee syphilis study begun in the 1930s, in which researchers withheld penicillin from a group of African American men infected with syphilis to study the course of the disease. In this case, however, the HBV vaccine is not being withheld from participants and they are not all from one racial group. He argues that it's not enough that vaccine vouchers are supplied; the vaccines themselves should be given to participants. BEYOND THE CALL: Ezekiel Emanuel argues that clinical trials usually aren't responsible for providing health care to study participants. There is disagreement on this point, however. "It's not the responsibility of the nation's health care system to provide everyone with a vaccine," says panel member Ezekiel Emanuel, an associate professor of medicine and social medicine at Dana Farber Cancer Institute in Boston. "In a clinical trial, a standard method is being compared to another arm to find which is better for getting individuals clean needles. They [the researchers] provide information for obtaining an HBV vaccine. Varmus also has provided vaccine vouchers-that goes beyond a required standard of care [for clinical trials]." Many in the AIDS community oppose the Alaska study. Mike Shriver, director of public policy for the National Association of People with AIDS, a Washington, D.C.-based advocacy group, says he was surprised that the study was approved by the panel. "The study asks a first-generation question" that has already been answered, he says. "We know that these programs work. Why not offer both [NEPs and pharmacy purchase]? We need to get at these other next-generation problems-how to get people to come to NEPs and how they use them, for example. We need to look at a range of issues-not only treating drug users, but ways to change behavior, and how to educate them about drugs and avoiding them." He argues that the panel ignores the "class bias" against injecting drug users, who tend to be on the lower end of the socioeconomic scale and may not always have access to pharmacies. He notes that "the issues in this study that raised concerns involve the daily reality of many living with AIDS, such as a lack of money and access to medicine." Penn's Metzger calls for more studies on needle exchange effectiveness to answer "second-generation questions." Fisher's study is "not a one-time study-we need more information on needle exchange. We need to focus on who they work for, the best methods of setting them up in the community. We need to make an opportunity to use both sources [of clean needles] and do a qualitative study and find out why drug users use one rather than the other." Heimer concurs. "Do NEPs and those who coordinate them, for example, provide educational benefits and provide health resources? Are NEPs good vehicles for health promotion in neighborhoods?" "We need a new generation of studies that examine the benefits of needle-exchange programs," he says. Scientists should be discouraged by the politics involved, Annas believes. He says that they should take a lesson from this public review of the Alaska study; namely, that they "should take the ethics of human experimentation more seriously. Just because it's scientifically valid doesn't mean it's ethically so."

Politics Polarizing Issues In Needle-Exchange Study

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