[Advocate] During a signing ceremony for the Ryan White HIV/AIDS Treatment Extension Act, President Barack Obama announced Friday that the federal government would end its ban on travel and immigration to the U.S. by people who are HIV-positive, as first reported by The Advocate. Obama made the announcement in the Diplomatic Room of the White House, where he told attendees that that policy was instituted 22 years ago “in a decision rooted in fear rather than fact.”

“We are one of only a dozen countries that still bar people with HIV from entering our own country,” he said. “If we want to be the global leader in HIV, we need to act like it.”

The ban, first implemented in 1987 and codified into law by Congress in 1993, prevented non-U.S. citizens who were HIV-positive from traveling or immigrating to the United States unless the Department of Homeland Security granted them a waiver.

Congress passed the policy reversal last summer under the leadership of Sen. John Kerry, then-senator Gordon Smith, and Congresswoman Barbara Lee; President George W. Bush signed it into law, but the administration was unable to finalize the change before his term ended. President Obama thanked the former president for approving the initial steps to repealing the ban.

The new regulation, which is now on display here and will be officially published in the federal register on Monday, eliminates any travel and immigration restrictions that are tied to a person’s HIV status. The Department of Health and Human Services put the wheels of change in motion in late June by publishing the proposed regulation to the federal register, which triggered a 45-day public comment period before HHS sent the rule back to the Office of Management and Budget for final approval.

Obama said the new rule would go into effect “just after the new year.” Since January 1 is a federal holiday, the rule is expected to officially take effect January 4.

In the intervening months, U.S. Citizenship and Immigration Services has directed its officers to place holds on any decisions regarding green card applications that are based solely on an individual’s HIV status pending full implementation of the new rule.

Rachel B. Tiven, executive director of the LGBT lobby group Immigration Equality, welcomed the announcement.

“At long last, people living with HIV will no longer be pointlessly barred from this country,” Tiven said. “Every day, Immigration Equality hears from individuals and families who have been separated because of the ban, with no benefit to the public health. Now those families can be reunited.”

Enactment of the Ryan White HIV/AIDS Treatment Extension Act will fund critical HIV/AIDS treatment and some prevention programs through 2013 at about $2.5 billion annually, representing a 5% increase for all sections of the act. The program helps about 500,000 mostly low-income and uninsured people living with AIDS/HIV per year, according to the Government Accountability Office.

“We can’t give Ryan White back to Jeanne, back to his mom,” Obama said, speaking of Jeanne White-Ginder, who was in attendance. “But what we can do — what the legislation that I’m about to sign has done for nearly 20 years — is honor the courage that he and his family showed.”

The Ryan White CARE Act, named after an Indiana teenager who contracted HIV through a blood transfusion and was diagnosed with AIDS in 1984, was originally passed in 1990 and has since been extended three times.

REMARKS BY THE PRESIDENT
AT SIGNING OF THE RYAN WHITE HIV/AIDS
TREATMENT EXTENSION ACT OF 2009

Diplomatic Reception Room  11:58 A.M. EDT

THE PRESIDENT: Good morning, everybody.

AUDIENCE: Good morning.

THE PRESIDENT: We often speak about AIDS as if it’s going on somewhere else. And for good reason — this is a virus that has touched lives and decimated communities around the world, particularly in Africa. But often overlooked is the fact that we face a serious HIV/AIDS epidemic of our own — right here in Washington, D.C., and right here in the United States of America. And today, we are taking two important steps forward in the fight that we face here at home.

It has been nearly three decades since this virus first became known. But for years, we refused to recognize it for what it was. It was coined a “gay disease.” Those who had it were viewed with suspicion. There was a sense among some that people afflicted by AIDS somehow deserved their fate and that it was acceptable for our nation to look the other way.

A number of events and advances over the years have broadened our understanding of this cruel illness. One of them came in 1984, when a 13-year-old boy from central Indiana contracted HIV/AIDS from a transfusion. Doctors assured people that Ryan White posed no risk to his classmates or his community. But ignorance was still widespread. People didn’t yet understand or believe that the virus couldn’t be spread by casual contact. Parents protested Ryan’s attendance in class. Some even pulled their kids out of school. Things got so bad that the White family had to ultimately move to another town.

It would have been easy for Ryan and his family to stay quiet and to fight the illness in private. But what Ryan showed was the same courage and strength that so many HIV-positive activists have shown over the years and shown around — show around the world today. And because he did, we didn’t just become more informed about HIV/AIDS, we began to take action to fight it.

In 1990, the year Ryan passed away, two great friends and unlikely political allies, Ted Kennedy and Orrin Hatch, came together and introduced the Comprehensive AIDS Resources Emergency Act — the CARE Act — which was later named after Ryan.

In a few minutes, I’m going to sign the fourth reauthorization of the Ryan White CARE Act. Now, in the past, policy differences have made reauthorizations of this program divisive and controversial. But that didn’t happen this year. And for that, the members of Congress that are here today deserve extraordinary credit for passing this bill in the bipartisan manner that it deserves: Tom Harkin and Mike Enzi in the Senate, we are grateful to you for your extraordinary work; Speaker Pelosi, who’s always leading the charge on so many issues; Frank Pallone, Jr., Joe Barton, Barbara Lee and Donna Christensen in the House, thank you for your extraordinary work — oh don’t worry, I’m getting to Henry. (Laughter.) Nancy is always looking out for members, but we’ve got a special section for Henry.

And Chairman Henry Waxman, who began holding hearings on AIDS in 1982, before there was even a name for AIDS, was leading here in Washington to make sure that this got the informed attention that it deserved and who led the House in passing the original Ryan White legislation in 1990.

I also want to acknowledge the HIV community for crafting a consensus document that did so much to help move this process forward. Some of the advocates so important to this legislation are with us here today: Ernest Hopkins from Cities Advocating for Emergency AIDS Relief; Frank Oldham, Jr., President and CEO of the National Association of People with AIDS; and Julie Scofield, Executive Director of the National Alliance of State and Territorial AIDS Directors.

And I’m especially honored that Ryan’s mother, Jeanne White-Ginder, is here today. For 25 years, Jeanne had an immeasurable impact in helping ramp up America’s response to this epidemic. While we lost Ryan at too young an age, Jeanne’s efforts have extended the lives and saved the lives of so many others. We are so appreciative to you. Thank you. (Applause.)

You know, over the past 19 years this legislation has evolved from an emergency response into a comprehensive national program for the care and support of Americans living with HIV/AIDS. It helps communities that are most severely affected by this epidemic and often least served by our health care system, including minority communities, the LGBT community, rural communities, and the homeless. It’s often the only option for the uninsured and the underinsured. And it provides life-saving medical services to more than half a million Americans every year, in every corner of the country.

It’s helped us to open a critical front on the ongoing battle against HIV/AIDS. But let me be clear: This is a battle that’s far from over, and it’s a battle that all of us need to do our part to join. AIDS may no longer be the leading killer of Americans ages 25 to 44, as it once was. But there are still 1.1 million people living with HIV/AIDS in the United States, and more than 56,000 new infections occur every single year.

Some communities still experience unacceptably high rates of infection. Gay men make up 2 or 3 percent of the population, but more than half of all new cases. African Americans make up roughly half of all new cases. Nearly half of all new cases now occur in the South. And a staggering 7 percent of Washington, D.C.’s residents between the ages of 40 and 49 live with HIV/AIDS — and the epidemic here isn’t as severe as it is in several other U.S. cities.

So tackling this epidemic will take far more aggressive approaches than we’ve seen in the past — not only from our federal government, but also state and local governments, from local community organizations, and from places of worship.

But it will also take an effort to end the stigma that has stopped people from getting tested; that has stopped people from facing their own illness; and that has sped the spread of this disease for far too long. A couple of years ago Michelle and I were in Africa and we tried to combat the stigma when we were in Kenya by taking a public HIV/AIDS test. And I’m proud to announce today we’re about to take another step towards ending that stigma.

Twenty-two years ago, in a decision rooted in fear rather than fact, the United States instituted a travel ban on entry into the country for people living with HIV/AIDS. Now, we talk about reducing the stigma of this disease — yet we’ve treated a visitor living with it as a threat. We lead the world when it comes to helping stem the AIDS pandemic — yet we are one of only a dozen countries that still bar people from HIV from entering our own country.

If we want to be the global leader in combating HIV/AIDS, we need to act like it. And that’s why, on Monday my administration will publish a final rule that eliminates the travel ban effective just after the New Year. Congress and President Bush began this process last year, and they ought to be commended for it. We are finishing the job. It’s a step that will encourage people to get tested and get treatment, it’s a step that will keep families together, and it’s a step that will save lives. (Applause.)

We are continuing the work of crafting a coordinated, measurable national HIV/AIDS strategy to stem and suppress this epidemic. I’m pleased to report that the Office of National AIDS Policy, led by Jeffrey Crowley, has already held eight in a series of 14 community discussions in cities across the country. They’ve brought together faith-based organizations and businesses, schools and research institutions, people living with HIV and concerned citizens, gathering ideas on how to target a national response that effectively reduces HIV infections, improves access to treatment, and eliminates health disparities. And we are encouraged by the energy, the enthusiasm, and great ideas that we’ve collected so far.

We can’t give Ryan White back to Jeanne, back to his mom. But what we can do — what the legislation that I’m about to sign has done for nearly 20 years — is honor the courage that he and his family showed. What we can do is to take more action and educate more people. What we can do is keep fighting each and every day until we eliminate this disease from the face of the Earth.

So with that, let me sign this bill. (Applause.)

1.  whether receipt of posttrial services constitutes a fair benefit or an undue inducement to research participants,[1-4]
2. whether providing posttrial services unfairly prioritizes research participants over other community members,[5-7] and 
3. whether an obligation to provide such services creates an excessive burden for trial sponsors, thus reducing their incentive to conduct research.[5,6]

In addition, particularly for trials conducted in resource-limited settings, it has been suggested that local governments and nongovernmental organizations may be better suited than trial sponsors to provide posttrial services.^[7-9]

Limited survey data suggest that patients may have strong desires and expectations to receive posttrial services.

• 98% of participants in an international HIV trial stated that an efficacious study drug should be provided after trial conclusion to, at minimum, trial participants;
• 81% of these participants stated that the medication should be provided to all HIV-infected patients in the world.^[1]

In a second study, patients also felt that trial participants should receive lifelong medical care for both trial-related and -unrelated conditions.^[10] There is little published literature on expectations regarding posttrial services, or receipt of such services, for patients with conditions other than HIV infection.

Accurate expectations regarding posttrial services by research participants, investigators, and human subjects committee members may be particularly important for trials of antiretroviral drugs (ARVs) for HIV infection, given recent evidence of clinical risks following treatment interruption.^[11-13] However, providing long-term ARVs requires infrastructure, personnel, and clinical and laboratory monitoring that add substantial costs to the expense of ARVs alone and may not be available after trials conclude in resource-poor locations.^[6]

Despite the importance of posttrial services, international research guidelines offer few specific recommendations regarding these services.^[14-21] The Declaration of Helsinki asserts that posttrial access to interventions studied in trials should be “assured” to trial participants and that plans for posttrial services should be explicitly described in trial protocols.^[14] However, other widely cited research guidelines, including those of the US National Institutes of Health (NIH) Division of AIDS,^[15] state only that post-trial access to medications and medical care should be “considered” in the trial planning process.^[16-21]

Protocols and informed consent forms (ICFs) comprise important sources of information regarding trial procedures and trial-related benefits to participants, investigators, and human subjects committee members. Our objective was to characterize the ways in which posttrial services are described in protocols and ICFs of ARV clinical trials. We conducted a systematic review of trial protocols and template ICFs, and we report on the frequency with which these documents explicitly mention and/or offer to provide posttrial medications and medical care to trial participants.

Method

Clinical Trials Included

We identified all eligible Phase 3 and Phase 4 ARV trials in adults, sponsored by either the pharmaceutical industry or the NIH. Phase 3 trials were included to capture investigational medications with a high probability of demonstrating efficacy but not yet commercially available, thereby creating a situation in which they would be desired by participants after trial completion. Phase 4 trials were included to evaluate situations in which patients might be expected to have another means of obtaining the study medication after trial completion, for example by prescription through their usual means of obtaining medical care.^[22]

We used different methods to identify three types of trials. Industry-sponsored Phase 3 trials were identified from US Food and Drug Administration (FDA) drug approval documentation records.^[23] Industry-sponsored Phase 4 trials were identified from the international Clinicaltrials.gov registry maintained by the NIH.^[24] NIH-sponsored trials were limited to those administered through the adult AIDS Clinical Trials Group (ACTG), the largest NIH-sponsored HIV trials network, and were identified from the ACTG protocol-specific Web pages.^[25] Trials were selected according to the following inclusion and exclusion criteria ( Table 1 ).

All Trials. For all categories of trials, we included stand-alone studies of ARV trials in adults (≥12 years old) conducted during or after 1987 (the year in which zidovudine was approved for treatment of HIV). The analysis was limited to trials completed by December 13, 2006 to improve the willingness of pharmaceutical companies to share confidential trial documents.

Phase 3 Trials. Industry-sponsored Phase 3 trials were limited to all trials identified as the “pivotal” trials leading to FDA approval of single-formulation HIV medications for adults. The FDA Center for Drug Evaluation and Research (CDER) documents the licensing process for all approved HIV medications and designates specific Phase 3 trials as the “pivotal” sources of data used for approval.^[23] Pivotal trials were chosen to create a reasonably sized sample of industry-sponsored trials that spanned nearly 20 years, both before and after introduction of highly active antiretroviral therapy. In addition, all ACTG-administered Phase 3 trials were included.^[25]

Phase 4 Trials. All industry-sponsored Phase 4 ARV trials registered on Clinicaltrials.gov were included.^[24] All ACTG-administered Phase 4 trials were included.

Document Procurement and Data Extraction

We attempted to obtain the protocols and ICFs of all eligible trials. Protocols and ICFs for industry-sponsored trials were obtained by direct request from the sponsoring pharmaceutical companies. Confidentiality agreements were executed between the investigators and all pharmaceutical companies requesting such documentation, ensuring that drugs and trials would be de-identified in all reports. Although we attempted to obtain documents for all remaining trials from the FDA via the Freedom of Information Act, these documents are proprietary and are not subject to this Act (CDER, e-mail communication, Nov. 2, 2006). ACTG protocols and template ICFs were provided by ACTG staff. This research was approved by the Human Subjects Committee of the Massachusetts General Hospital.

Only trials for which complete protocols and ICFs were available by July 1, 2008 (18 months after study initiation) were included. All protocols, appendices, amendments, and template ICFs were reviewed in full by the first author. Missing data were obtained from the ACTG Website and Clinicaltrials.gov when available.

Trial Characteristics and Services Provided to Participants During Trial Periods

Data were collected regarding the date and version number of the last available protocol/amendment, location of trial sites (United States, other developed setting, or resource-limited setting), sponsorship (industry or NIH [ACTG]), anticipated number of participants, age and gender inclusion criteria, and trial duration. Data were also collected regarding additional services offered to participants during the trial period. These included on-study provision of the study drug itself, other required ARVs (”background regimen”), and substitute drugs (as needed for drug toxicity or virologic failure). We also recorded mention or offer of payment for study participation (worded as “payment,” “compensation,” or “reimbursement,” including offers to compensate subjects for time, transportation costs, or child care costs), and mention or offer of payment for care for trial-related injury. These variables were recorded as comparators for services offered after trial conclusion and in order to test a priori hypotheses regarding trial characteristics associated with the primary and secondary outcomes.

Outcomes

The clinical trial was the unit of analysis. The primary outcome was any mention of posttrial services, defined as any text regarding medications or medical care following trial conclusion. Amendments extending the duration of previously enrolled trials met this definition only if they referred to services to be provided after the conclusion of the last described trial phase.

Associations between trial characteristics and the primary outcome were examined using chi-square exact tests with an alpha level of 0.05 (SAS 9.1; SAS Institute, Cary, North Carolina, USA). Multivariate analyses were planned but were precluded by the small sample size. We hypothesized that posttrial services would more frequently be mentioned in the documents of (a) trials with protocols written after 2000 (compared to those written before 2000), reflecting increased awareness of international research ethics guidelines; (b) Phase 3 trials (compared to Phase 4 trials), reflecting a finite period of anticipated need for medications between trial completion and drug licensure; (c) pharmaceutical industry-sponsored trials (compared to NIH/ ACTG-sponsored trials), reflecting greater financial resources for provision of posttrial services and 2005 NIH guidelines stating that posttrial medications would not be supplied;^[15] (d) trials conducted in developed settings (compared to those conducted in resource-limited settings), reflecting lower levels of anticipated need for posttrial services due to private or public insurance; and (e) trials offering to provide payment for participation or care for trial-related injury during the trial periods (compared to trials not offering such services), reflecting a greater overall willingness to provide services to participants.

For trial documents in which posttrial services were mentioned, secondary outcomes included whether trial documents offered to provide medications or offered to provide medical care to participants after trial completion. If posttrial medications or medical care were offered, information was extracted regarding (a) the type of medications or care offered, (b) which participants were eligible to receive these services, (c) the duration for which these services were offered, and (d) who was to pay for medications or care.

Results

Trial Characteristics and Services Provided to Participants During Trial Periods

Sixty-five trials met criteria for inclusion; documents from 31 of the 65 eligible trials were obtained. Reasons for lack of availability of the remaining documents are detailed in Table 2 . Trials ranged widely in number of participants (range, 30-3236; median = 325) and in duration (range, 16-416 weeks; median = 103 weeks) ( Table 3 ). On average, ACTG-administered trials occurred earlier (1987-2004) than industry-sponsored trials (1996-2005). Fifty-eight percent of trials were conducted entirely within the United States, and only two trials (6%) were conducted entirely in resource-limited settings (one each in South Africa and Brazil).

Provision of Antiretroviral Drugs. During the trial periods, all but one trial offered all necessary study drugs to participants ( Table 4 ). In 16 trials (52%), additional “background” ARVs were required; 6 trials (19%) required participants to obtain these medications from sources outside of the study, 9 trials (29%) provided background ARVs completely or partially, and 1 trial (3%) did not specify whether background ARVs would be provided. In the event of virologic failure or toxicity requiring substitutions in study drug or background ARVs, three trials (10%) provided any needed substitute ARV; eight trials (26%) provided selected substitute ARVs only; and four trials (13%) stated that substitute ARVs were permitted but not provided. In 15 trials (48%), no substitute ARVs were available, primarily because a need for substitution necessitated study discontinuation.

Mention of Payment for Study Participation. Documents from 23 trials (74%) explicitly mentioned whether participants would be paid for trial participation ( Table 4 ). Eight trials (26% of total trials) specified that participants would be paid, and trials (48% of total trials) stated that participants would not be paid.

Mention of Payment for Care for Trial-related Injury. Documents from 29 trials (94%) explicitly mentioned whether participants would receive reimbursement for care for any trial-related injury ( Table 4 ). Seventeen of these (55% of total trials) stated that injury care would be reimbursed, and trials (39% of total trials) stated that such care would not be reimbursed.

Mention and Offer of Posttrial Services

Mention of Posttrial Services. Posttrial services of any type were mentioned in the documents of 14 trials (45% of trials, 54% participants; Table 5 ). Documents from 12 trials (39% of trials, 44% of participants) mentioned posttrial medications. Documents from five trials (16% of trials, 28% of participants) mentioned posttrial medical care. Not mentioning or providing payment to participants, as well as anticipated enrollment greater than the median, were significantly associated with mentioning any posttrial service and with mentioning posttrial medications ( Table 6 ). Enrollment greater than the median, trial sponsor (NIH/ACTG), and not offering payment for injury care (a characteristic of all ACTG trials) were significant correlates of mentioning posttrial medical care.

Offer to Provide Posttrial Medications. Of the 12 trials mentioning posttrial medications, 10 offered to provide medications after trial conclusion (32% of trials, 34% of participants), and 2 stated that posttrial medications would not be provided (6% of trials, 9% of participants). Not mentioning or providing payment to participants, anticipated enrollment greater than the median, and inclusion of at least one trial site in a resource-limited setting were significantly associated with offering to provide posttrial medications. Of the 10 trials offering to provide posttrial medications, 7 were industry-sponsored trials. Seven offered study drug, and one offered study drug with background ARVs. Six trials offered posttrial medications to all study completers; two offered posttrial medications only to participants completing the study drug arm. Two additional trials offered the “best available alternative treatment” after trial conclusion (one of these at participant expense), although this was limited to participants failing zidovudine in the late 1980s, when few alternative HIV therapies were available. Six trials offered posttrial medications until commercial availability or for a defined period thereafter, one until a rollover protocol enrolled, and three for an unspecified duration. Posttrial medications were offered at sponsor expense in eight trials, at participant expense in one trial, and without specified payer in one trial.

Offer to Provide Posttrial Medical Care. Of the five trials mentioning posttrial care, one (3% of trials, 2% of participants) offered to provide posttrial medical care. This was further explained as the “best available care” for participants failing zidovudine in the late 1980s, offered at participant expense. In the remaining four trials (13% of trials, 26% of participants), documents stated that post-trial care would not be provided.

Trial Characteristics Not Associated with Primary Outcomes

Calendar year of trial documents was not associated with mention of any posttrial service or offer of posttrial medications; 42% of documents from trial documents written before 2000 and 47% of trial documents written after 2000 mentioned any posttrial service (p = 1.0). In addition, trial phase (Phase 3 compared to 4), trial duration, age inclusion criteria, and provision of background or substitute ARVs were not associated with mentioning any posttrial service or with offering posttrial care. Because only one trial offered posttrial medical care, bivariate analysis was not performed for this outcome. The small number of trials reviewed precluded multivariate analysis of the associations between trial characteristics and mention or offer of posttrial services.

Discussion

Accurate expectations regarding access to medications and medical care after clinical trial conclusion are crucial to informed decision making by research participants, investigators, and human subjects committee members. This may be particularly true in the case of trials of antiretroviral drugs for HIV infection, after which participants who lack access to effective, combination ARVs may experience clinical deterioration.^[11-13] To our knowledge, this study represents the first published review of descriptions of posttrial services in clinical trial documents.

In this sample of major Phase 3 and 4 ARV trials, posttrial medications and medical care were mentioned in the protocols or ICFs of fewer than half (45%) of all trials. Plans regarding payment for trial participation (74%) and payment for care for trial-related injury (94%) were explicitly mentioned more often than were posttrial services, suggesting that authors and reviewers of trial documents are more aware of the importance of describing services offered during trial periods than of the need to outline plans for posttrial services. Post-trial services were mentioned in documents from 12 trials, and 10 (70%) of these offered to provide posttrial medications. Of these 10 trials, 70% were industry-sponsored trials, 60% offered medications until they became commercially available, and 80% offered medications at sponsor expense, reflecting current diversity of recommendations and interpretations about posttrial services.

Decisions about whether posttrial services should be provided are complex, because they include discrete and heavily debated questions about what services should be provided (study medications, other medications, or medical care),^[1,10] to whom they should be provided (all study completers, or other community members),^[1,26,27] and for how long they should be provided (until medications become commercially available, or indefinitely).^[10] Several authors have suggested that trial sponsors should assume at least some responsibility for providing posttrial services.^[5,6,16,28] Important roles for investigators, local organizations, and national governments have also been proposed,^[6,7,15,28] with or without sponsor financial support to create enduring local health care capacity.^[9] The extent of sponsor obligation may depend on whether the sponsor is a government agency or a for-profit entity, which might be expected to have greater financial capacity to provide posttrial services.^[27] In support of this concept, the NIH Division of AIDS states that “the NIH’s authority to ‘encourage and support research’ does not extend to providing treatment following the completion of that research.”^[15]

We found no association between mention or offer of posttrial services and the year in which trial documents were written (before or after 2000), although our study had limited power to detect such effects. Although research guidelines began to mention posttrial services in the 1990s,^[16,21,27] the Declaration of Helsinki (2000, revised 2004) was the first such guideline to clearly recommend that posttrial services be mentioned in trial protocols.^[14] Many of the trials included in this review predate these recommendations; however, our limited data suggest that the proportion of trials in which documents mention posttrial services does not appear to have substantially increased after the year 2000. In 2005, the NIH issued guidelines (quoted above) for trials conducted in resource-limited settings, asserting that NIH would not provide posttrial medications and recommending instead that “investigators engage in a dialogue with host countries’ authorities . . . in order to facilitate the inclusion of [ARV trial participants] in available in-country antiretroviral treatment programs.” These guidelines may have increased mention of post-trial services in trial documents; but, by insisting that NIH not provide posttrial medications, they may also have reduced offers of posttrial medications. Documents for the ACTG trials meeting our inclusion criteria were written in 2004 or earlier, and only one was conducted in a resource-limited setting, so these studies were not subject to the 2005 NIH guidelines.

Because of the small numbers of ACTG trials meeting our inclusion criteria, the low proportion of trials provided by pharmaceutical sponsors, and the large number of statistical comparisons made, our conclusions regarding the associations between trial characteristics and mention or offer of posttrial services must be interpreted only as hypothesis-generating. The direction of several statistically significant associations was contrary to what had been hypothesized, for example, mentioning or offering posttrial services was associated with “not mentioning” or “not providing” payment for trial participation, whereas we hypothesized that mentioning or providing payment would suggest a greater overall level of services provided and would be associated with these outcomes. This suggests that other trial factors may explain this association. Similarly, the observed association between not providing injury-related care and mentioning posttrial medical care is explained by a statement common to more recent ACTG trials (1997-2004), specifying that pediatric and pregnancy-related care would not be provided if participants became pregnant during the studies. Numbers of included trials were too small to permit multivariate analysis to further explore these relationships.

Major international research ethics guidelines do not provide specific guidance to researchers regarding posttrial services.^{[14,16,17,19-21]} It is likely that no single recommendation about posttrial services will be appropriate to all research situations, because the specific risks to participants and needs of the communities in which research is conducted will differ between trials.^[2] Instead, it may be helpful to outline a process by which posttrial services can be included among the other risks and benefits considered in the standardized evaluation of all proposed trials.^[2] For example, education regarding posttrial services could be a component of the training required for a Federal-Wide Assurance (FWA) number for human subjects committees.^[29] Additionally, a description of “planned post-trial services” could be added as a required component of trial protocols and ICFs. This might involve a requirement similar to that currently in place for trials that are subject to FDA requirements and that involve at least minimal risk to subjects: ICFs for such trials must include clear descriptions of plans regarding payment for care for trial-related injury, regardless of whether or not such payment will be provided.^[9,14,30]

During the protocol development process, sponsors may be appropriately reluctant to commit to a future obligation to provide posttrial services, due to uncertainty about drug efficacy or about future financial circumstances.^[18,19,31] However, given the very high expectations of some surveyed trial participants,^[1,10] a statement about posttrial services, even one that makes explicit that posttrial services are not guaranteed, may help to ensure that unreasonable expectations do not play a role in decisions about trial participation.

This study has several important limitations. First, documents other than protocols and ICFs (including internal memoranda, sponsor/investigator contracts, and local ICFs) may contain information about posttrial services and were not reviewed in this study. However, with the exception of local ICFs, these additional documents are likely to be less readily available to participants, investigators, and site human subjects committee members than the protocols and template ICFs. Second, we reviewed all available versions of protocols and ICFs, and the definition of “mention of post-trial services” was fulfilled only if such mention referred to the time after the trial period described in that document version was to conclude. Although this definition may incompletely capture the practice in which trial sponsors provide posttrial services through amendments that extend trials until drugs become commercially available, it is consistent with the goal of making planned posttrial services explicit at the time of participant recruitment.

Finally, the eligible sample of 65 ARV trials included only pivotal industry-sponsored Phase 3 trials leading to medication licensure, rather than a complete sample of Phase 3 ARV trials, and included only ACTG-administered trials, rather than all NIH-sponsored trials. Furthermore, the obtained sample included fewer than half of the eligible trials (93% of ACTG trials, but only 34% of industry-sponsored trials).

This sample of reviewed trials may be biased for two reasons. First, the inclusion of only “pivotal” Phase 3 industry-sponsored trials (those leading to medication approval) resulted in a sample of trials of efficacious medications, after which sponsors may be more likely to offer medications than after trials of inefficacious medications. Second, sponsors may have been less willing to share eligible trial documents in which posttrial services were not mentioned. If documents from all 34 unavailable trials did not mention posttrial services, then the total proportion of trials mentioning post services could be as low as 14 of 65 (22%) overall: 47% (7/15) of ACTG studies and 14% (7/50) of industry studies. Both sources of bias would be expected to lead to results indicating that posttrial services are mentioned or offered more frequently than is really the case. Although clearly important limitations of our study, these factors may suggest that the low frequencies of the outcomes that we observed are even more worthy of consideration.

We are aware of no reports of actual rates of receipt of posttrial services by trial participants with HIV infection or other medical conditions. Efforts to characterize trial participants’ expectations regarding posttrial services and their actual rates of receipt of such services remain important directions for future research. In the meantime, trial sponsors should explicitly communicate their plans about posttrial services to trial participants, investigators, and human subjects committees at the time of protocol approval and participant recruitment, whether or not they intend to provide such services. This could be accomplished by including clear descriptions of plans for posttrial services in trial protocols and informed consent forms. This review suggests that such explicit statements are not yet the standard practice in major HIV clinical trials.

“Women represent the fastest growing population of persons infected with HIV in this country, and heterosexual transmission has become a much bigger factor,” according to Denise J. Jamieson, MD, MPH, chair of ACOG’s Committee on Gynecologic Practice. “There are two basic messages for patients: Every woman should know her HIV status, and it’s a simple test.”

Because approximately 25% of all Americans with HIV are unaware of their infected status (with women representing a growing proportion of the infections), the ACOG states that testing is critical for awareness purposes but also to “improve women’s chances of survival, reduce associated illnesses, help them take steps to avoid unintended pregnancy, protect their sexual partners, and reduce the likelihood of mother-to-child transmission should pregnancy occur.”

He mentioned the six core values as people sensitivity, professionalism, teamwork, discipline, innovation and integrity.

Dr. Amofa gave the advice when he launched a magazine by the Ghana Health Service (GHS), in Accra on Wednesday.

The 36-page quarterly magazine touches on real issues that affect the health of people such as ethics, practice, faith and health, finance and investment. It also dedicates a page for students, which is aimed at fostering good relationship between GMA and the medical students.
Dr. Amofa advised that all articles should be based on scientific evidence so that when they are challenged, empirical evidence could be provided. He also urged them to work as a team for the sustainability of the magazine.

Professor Agyeman Badu Akosa, former Director-General of GHS who chaired the function, said the magazine was a platform for all who wanted an in-depth knowledge of the profession and its related issues.

He stressed the need for medical practitioners to write and educate the public and not only to stick to the consulting room and drug prescriptions.

Prof. Akosa urged them to advocate for safer roads, good drinking water and good hygiene, among other things, saying when these were put in place the disease burden of the country would be minimised.

The President of the Ghana Journalists Association, Mr Ransford Tetteh, commended the GMA and noted that writing was not easy and if the magazine was sustained it could be a major reference point for the media.

He said it was unfortunate that 51 years after independence people still lived in unsanitary conditions increasing the disease burden. However, he said, people were becoming conscious of healthy lifestyles.

Dr. Sodzi Sodzi-Tetteh, General Secretary of the GMA and Editor, said the Focus Magazine was driven by three passions – public health education, advocacy and the need to appreciate the unrecognized work of the medical practice. The magazine would also provide a platform for holding creative conservation.

He said it was the expectation of the GMA leadership to connect and reconnect better with each other and with the ever-present world beyond the hospital. http://www.myjoyonline.com/health/200804/15186.asp 

The researchers looked at the experience in Oregon and the Netherlands, where people can receive help from a physician to die. They focused on 10 populations, including those with disabilities, low socioeconomic status, HIV/AIDS, low education levels or psychiatric issues — all factors believed by many to make one more vulnerable. Only in the case of AIDS did they see evidence of more deaths, Battin said. In the other nine categories, rates were actually lower.

The study was released Wednesday and is published in the October issue of the Journal of Medical Ethics.

In the nine years since the law took effect in Oregon, where a doctor can prescribe lethal drugs to patients diagnosed by two doctors as having a terminal illness and less than six months to live, 456 patients received lethal prescriptions and 292 used the drugs to kill themselves. That’s 0.15 percent of all deaths in Oregon during that time.

In the Netherlands, a physician can either administer a life-ending medication or prescribe one a patient can take himself. The law requires “intolerable suffering,” but not terminal illness. Of 136,000 deaths each year in the Netherlands, about 1.7 percent are by voluntary active euthanasia, 0.1 percent by physician-assisted suicide and 0.5 percent are “extralegal” because they involve patients with no current explicit request to die, but who made one before becoming incompetent or are perceived to be suffering intolerably, researchers said. The study centered on cases in the Netherlands between 1985 and 2005, while the Oregon data covers 1998-2006.

In both places, those most likely to choose a physician-assisted death had an average age of 70, and 80 percent of them had cancer. Slightly more men than women chose physician-assisted suicide.

During the nine years in Oregon, only six AIDS patients died with a physician’s assistance, 2 percent of all deaths under the law. But the researchers said that “persons with AIDS were 20 times more likely to use assisted dying” than a comparable group of patients without the disease who died of chronic respiratory disorders. In the Netherlands, of a group of 131 gay men in Amsterdam diagnosed with AIDS from 1985-1992 and who died by 1995, 22 percent chose physician-assisted suicide or euthanasia. The researchers said that rate might be lower now because of medicines that let many patients live with AIDS as a chronic illness.

“There’s no case in Oregon where someone with a disability but not also with a terminal illness chose this,” Battin said.

The analysis included data that was clear and some from which inferences were made, she said. For instance, data clearly provided gender, age and terminal diagnosis for Oregon. But for the Netherlands, socioeconomic status was inferred from a postal code. “Such data is recognized to be less strong,” Battin said, “but it is still informative.

“We recognized considerable differences in the strength of the data, but we did see a common picture in these two jurisdictions. This should put to rest some of the more florid concerns.”

The experience with physician-assisted suicide is important because other jurisdictions, including several U.S. states, are considering such laws, and the “slippery slope” argument is a regular in the debates, she said.

“This practice is reported everywhere, and it’s a heavily debated issue, particularly in countries with advanced health-care systems, where the average life expectancy is quite long and diseases with downhill courses are frequent,” Battin said.

The other researchers were Dr. Agnes van der Heide of Erasmus Medical Center, Rotterdam; psychiatrist Dr. Linda Agenizing at Oregon Health & Science University, Portland; and Dr. Gerrit van der Wal and health scientist Bregje Onwuteaka-Philipsen, of the VU University Medical Center, Amsterdam. Van der Wal is inspector general of The Netherlands Health Care Inspectorate, which advises that nation’s health minister.

By Lois Collins http://deseretnews.com/dn/view/0,5143,695213548,00.html

The comments triggered anger among HIV-AIDS workers, who accused Howard of xenophobia and of blaming sufferers for their illness.

Asked in a radio interview whether people with the virus that causes AIDS should be allowed into Australia as migrants or refugees, Howard said he would like to take “more counsel” on the issue, but added, “My initial reaction is no.”

He said that there may be “humanitarian considerations” in certain cases.

“I think we should have the most stringent possible conditions in relation to that nationwide, and I know the health minister is concerned about that and is examining ways of tightening things up,” Howard said.

Howard was asked about the issue during a visit to Melbourne, the capital of Victoria state, where the state health minister said this week that 70 of the 334 new HIV infection cases reported in Victoria in 2006 were among immigrants who had arrived in the country with the virus.

Don Baxter of the nongovernment group the Australian Federation of AIDS Organizations said HIV tests were already among health checks prospective immigrants were given, and most HIV-positive applicants were rejected on the grounds that they could pose an unfair burden on the public health system.

“It’s very tight already,” Baxter told Australian Broadcasting Corp. radio.

Chris Lemoh, an infectious disease specialist who is researching HIV-AIDS among African immigrants in Victoria, said excluding people with HIV should be condemned.

“It’s a hysterical overreaction, it mixes racism with a phobia about infectious disease,” he said. “To not allow people to come on the basis of any health condition is immoral, it’s unethical and it’s impractical to enforce.”

Many countries, including the United States, impose restrictions on immigration and visa approvals for people with HIV, though there are often exceptions in special cases.

Copyright © 2007 The Associated Press. All rights reserved.

Read more: The dilemma of a deadly disease: patients may be forcibly detained