AIDS Vaccine Activist Luis Santiago Speaks with HIV InSite

by Joe Wright, HIV InSite Guest Editor. This is the second in a series of interviews with AIDS vaccine experts.

Luis Santiago is also on the board of the AIDS Vaccine Advocacy Coalition, on the Community Advisory Board for New York’s Project Acheive (an HIV prevention and vaccine research site), a member of ACT-UP New York and a founder of ACT-UP New York’s committee ACT-UP Americas. And writes articles about vaccines for a Gay Men’s Health Crisis newsletter and web site. And–I’m sure I’m forgetting something.

There aren’t many people like Luis in the HIV vaccine world. Struggles over AIDS treatment produced a gaggle of activists who worked two jobs–day jobs and unpaid jobs, taking at least as much time, as AIDS activists. But AIDS has become increasingly professionalized; lots of those activists ended up getting day jobs in AIDS, while others died or fell away from AIDS politics for other reasons. And of the few activists in this mold who remain, fewer than a handful work on vaccine issues. Perhaps this is because the traditional base of this driven, focused and highly skilled kind of activism comes from the ACT-UP tradition, which has been mainly focused on AIDS treatments.

Luis Santiago also emerges from ACT-UP, but in this interview discusses his long involvement as an activist working on vaccine issues.

We begin with a discussion of a fateful meeting in 1994, when a National Institutes of Health panel decided not to go forward with a government-funded large-scale efficacy trial of that year’s versions of the gp120 vaccine. The meeting has particular resonance, because Don Francis and two other Genentech employees ended up spinning off Genentech’s gp120 effort into a company called VaxGen, and they are now beginning a privately funded efficacy trial of an updated version of their gp120 vaccine. At the time, Francis made no secret of his disdain for the 1994 decision, and some media accounts of the story made it seem as if the meeting had been “The activists versus the vaccine.” But as Santiago makes clear, the issues were rather more subtle than that. (Interestingly, he is also skeptical about the extent to which his comments and those of other activists who were concerned about that trial really influenced the final decision.)

Looking forward, Santiago discusses the advocacy issues for community activists looking at VaxGen‘s new trial. Incidentally, he ends the interview by giving praise to VaxGen for going forward with their trial; he is not an “either/or” kind of activist, as this interview makes clear. He notes the necessity for both effective risk reduction within the VaxGen trial; and effective recruitment of high-risk participants. Both, he suggests, are important issues for community advocates at local VaxGen sites. He also feels it’s important for VaxGen trial participants to know about the history of controversies over gp120–his own article on the topic (link) might be a good text for participants to use as a starting point.

Santiago also explains the history of ACT-UP Americas, a unique collaboration between New York-based Latino AIDS activists and Latin American groups. The group is one precedent for a set of relationships which will doubtlessly be essential to effective AIDS activism in the coming years. I find it interesting that ACT-UP Paris has also been increasingly focused on building relationships with advocates from countries in the South. Though much of this network-building has focused on issues of access to treatment, it could become valuable to community vaccine advocates as large vaccine trials become increasingly international.

At one point, Santiago suggests that there may need to be “an ACT-UP for vaccines.” At the same time, AVAC, the only current group exclusively focused on AIDS vaccine advocacy, has used a different model–a Board of Directors, no membership, and professional staff. The closest analogy is San Francisco’s former VACT-UP, Vaccine Advocates Committed to Universal Prevention, which has since folded its pioneering web site into AVAC’s site, while most of its members have moved on to other AIDS advocacy work. It seems to me that AIDS vaccine activism probably needs its own styles, its own ways of working–informed by the history of ACT-UP, but also taking its own path. But if that’s true, Luis Santiago–an activist and writer who is active locally, nationally and internationally–may just be one model of that new style.

“Mental health care is preventive health care.”

Making the Grades

Healthline: What will these report cards look like?

Zingale: We’re still developing the format. The goal is to present them in a format that is easy to use and will cross language, linguistic, and cultural barriers.

Healthline: Are we talking about report cards like in school, with actual grades on how plans are doing in different areas?

Zingale: We’re looking at various formats in use around the country.

Healthline: Industry and medical officials often complain that such efforts gloss over complexities in delivering care and penalize providers on the cutting edge of tertiary medicine. Are you getting cooperation from plans and providers?

Zingale: The early signs are that the managed health care plans will be very cooperative with the report card process and the medical survey process we are getting underway.

Healthline: There have been a number of reports lately about how poorly California fares both in the health status of its citizens and access to insurance. One way to close the insurance gap is California’s Healthy Families program for indigent children, but enrollment levels have been disappointing. It may be too early in your tenure to get into such details, or do you favor a removal of the ban on direct marketing by HMOs for Healthy Families clients?

Zingale: This governor has made remarkable progress in bringing more children into the Healthy Families program. At the same time, he has told me directly that he is not completely satisfied with the progress that has been made. He has asked me and others in the administration to look for ways to continue to expand access to coverage for California’s children. I take this charge seriously.

Healthline: You have a long association with Governor Davis and with Sacramento. I understand you were born and reared in Sacramento. Is it fun to be home?

Zingale: Very much so. I had strong personal reasons for wanting to come home. My parents are getting older and they live here. My five-year-old son needed to be closer to his grandparents.

Healthline: Good luck and enjoy your honeymoon period for as long as it lasts. Thank you for joining us.

Zingale: You’re welcome.

“I have been very direct about the fact that I am most interested in preventive health care and preventive regulation. . . Economists who argue that preventive care is not cost effective are wrong.”

Making Prevention Universal

Healthline: Sometimes HMOs decide to go find healthier enrollees.

Zingale: That is a slightly different problem involving adverse selection or what is sometimes called “cherry picking.”

The answer to your first question is to make access to preventive services universal. Even though most health plans are doing a good job with preventive health, where there are holes, you fall into the problem you’ve just articulated. If 90 percent of the plans are providing good diabetes screening and prevention, but 10 percent are not, all of the plans know that that 10 percent of risk might add up on their account books at the end of the day.

That is why I think Governor Davis and the Legislature acted wisely when they mandated prevention services in the area of diabetes, cancer, and mental health in the package of bills that created this department.

Healthline: You’ve been a big champion of mental health parity. What is in the new package of bills addressing this?

Zingale: Mental health was one of the preventive health interventions included in the package of mandated benefits. I believe this reflects the understanding that mental health care is preventive health care. The fact remains, as I said earlier, modest investments could prevent huge expenditures and suffering down the road. This is as true about mental health as any other area of health care.

Healthline: What about care that is not preventive? There are tensions inherent in the HMO concept葉he drive to keep costs down and ration care can be at odds with what individual patients want or need. What about patients’ rights to sue or have recourse to obtain independent reviews when HMO decisions don’t go their way?

Zingale: I have been very direct about the fact that I am most interested in preventive health care and preventive regulation. In other words, I think we need to begin with what can be done to prevent harm to patients in the first place用reventive regulation.

We can spend the next hundred years fighting over resources and damages for harm that was done today. Or, we can invest those same dollars early and avoid spending all those precious health care dollars on litigation and advertising wars and the other things that health care dollars are wasted on. I’m interested in seeing how we can stimulate those investments to keep people healthier, to prevent damage from being done, and to prevent care from being denied.

Healthline: But the battles are already going on. Whatever screening and prevention is in place, people will still be fighting over denials of care. Your predecessor body [the Department of Corporations] went out with the parting shot of a million-dollar fine against Kaiser for the delay of care in a case involving a ruptured aortic aneurysm.

Is this the kind of thing your agency will be tracking? Governor Davis, for example, was accused of trying to gut the right-to-sue provisions of the HMO bill package by making sure that all external review processes are exhausted before patients are ever allowed near a courtroom. Is the ability of patients to have independent review of their claims about denial of care important to your department, or is this only the horse being out the barn door and down the road apiece in terms of your prevention initiatives?

Zingale: The independent medical review included in the HMO reform package is at the heart of the advances for the State of California. That is the mechanism by which medical experts will have the final say as to what kind of care is or should have been available. That is an enormous gain for consumers.

The department is responsible for building the infrastructure that will provide medical review for consumers and facilitating the implementation of that system. We’re now looking at criteria for who should be providing such a review to make it absolutely certain there is no conflict of interest. We will also facilitate consumer inquiries.

Healthline: What about helping consumers navigate the maze of information about providers and plans and options in general?

Zingale: We talk about the principle of shared responsibility. Government will not solve every problem. The new department wasn’t created to be a giant bureaucracy micro-managing the health care system in California. The department has a clear set of responsibilities, but so do the health plans, providers, and consumers themselves. This experiment will only work if everyone takes responsibility for it. Consumers have the responsibility to learn more and to take some responsibility for their own health.

The department will publish the first report card on managed health care, which I hope and expect will provide user-friendly data on how well health plans are serving California.

Fighting Over the Shrinking Pie

Zingale: Unfortunately, we’ve been spending a lot of time and resources fighting over how we divide a shrinking pie in the health care delivery system. I am interested in moving beyond this and returning to the root principle of managed health care, which I believe offers the key. Managed care was founded on the principle of early investment in preventive health to keep more people healthy for a longer period of time, thereby preserving our precious health care dollars for people when they are really sick. Under that model there is no excuse for not providing optimal care when people really need it. We’ve strayed from this in a number of troubling and complex ways, and I believe that only by returning to that principle will we be able to raise ourselves out of this bickering over who pays how much for what.
Healthline: Does this assume that preventive care is actually going to save money, and not merely allow for patients to develop more expensive diseases down the road, as some health care economists have argued?
Zingale: Economists who argue that preventive care is not cost effective are wrong. There is a mountain of evidence proving that relatively low-cost, early preventive interventions save health care dollars, save lives, and prevent human suffering. Anyone who quarrels with that is at odds with the goals of this new department. I believe there is enough agreement and understanding among the principle players用roviders, consumers, and plans葉o move ahead on this.
Healthline: It certainly makes sense to take advantage of the “managed” part of managed care: the ability of HMOs to track patients, remind them what to do to take care of themselves. But how can you do this in an environment with such turnover用atients being dropped and switched and not knowing what is going to happen with their plan from one year to the next?
Zingale: You’ve identified one of the current obstacles to prevention playing the role in managed care that it shoulda: the transitory nature of today’s enrollees. From a purely economic point of view, a health plan can make a decision that it isn’t worth the investment in keeping an enrollee healthy in the long term because that enrollee is likely to have moved on and the cost savings won’t be realized.

“Only by returning to first principles will we be able to raise ourselves out of this bickering over who pays how much for what.”

On July 1, 2000, the newly created California Department of Managed Health Care began operation, assuming from the Department of Corporations the job of regulating HMOs and protecting consumers. Governor Davis gave the reins of the new agency to an old friend and ally, Daniel Zingale, who had been deputy controller and chief of staff during Gray Davis’s tenure as state controller.

A Sacramento native, Mr. Zingale most recently served as executive director of the Washington, D.C.-based AIDS Action Council, a lobbying group. A graduate of the University of California at Berkeley with a master’s degree in public administration from Harvard, Mr. Zingale has also worked as public policy director of the Human Rights Campaign, a gay civil rights lobbying organization. He has also served as managing director of government relations of the American Psychological Association. California Healthline’s Jeff Stryker talked to Daniel Zingale about his first month on the job.

Healthline: How many patients are covered in the plans you regulate?

Zingale: There are more than 20 million Californians enrolled in managed care in one form or another.

Healthline: A poll recently showed that fewer than ten percent of Californians know which state agency regulates HMOs.

Zingale: I saw that survey and welcomed it. It will fuel our campaign to raise the awareness of consumers’ rights and responsibilities and the role this new department plays in improving the situation for managed care.

Healthline: In overseeing managed care, is it possible to attend to both the health of the managed care industry and the interests of consumers?

Zingale: The department was created by more than 20 pieces of legislation with many specifics about how we must proceed. I believe it all comes down to two fundamental roles. The first is to improve the managed health care system for consumers for a healthier California. Alongside that is to help insure the financial stability of the managed health care system. I believe these two goals can be complementary.

Healthline: Why don’t we start with the second part, the solvency and viability of the plans themselves. There seems to be a lot of turmoil in the field. The latest is United HealthCare’s decision to foist off a quarter million patients on Blue Cross. There is also, especially in California (even if your regulatory arm doesn’t reach this far) concern about the solvency of physician groups.

Editorial Note

Editorial Note: This report demonstrates that M. tuberculosis can spread rapidly among HIV-infected inmates in congregate living situations and to their visitors; disease developing in a visitor and a parolee may have led to secondary transmission in their household contacts. Containment required efforts of correctional and health department staff at the state and local levels to address the unique medical, custody, public health, and fiscal challenges posed by the outbreaks.

Updated policies and procedures for managing possible TB cases and their contacts are under development and implementation in correctional facilities and the community. The changes are to ensure that HIV-infected inmates with new radiographic abnormalities consistent with TB are placed in respiratory isolation, reported to the local health department and the central public health system of the prisons as having suspected TB, and started on multidrug therapy for TB even when another pulmonary process is diagnosed. These procedures will minimize the likelihood that HIV-infected persons with undiagnosed infectious TB (such as the index case-patient in the prison B outbreak) are transferred from jails, hospitals, or the community into prisons. The clinical course of the index case-patient in the prison A outbreak illustrates the challenge of detecting TB disease that develops in HIV-infected inmates after they have been cleared of having TB disease at entry to prison but develop it later. A TB evaluation should be initiated for HIV-infected inmates with respiratory symptoms who are diagnosed initially with conditions other than TB (1), even if TB has been excluded recently.

A prompt response to infectious TB cases is critical to minimize the transmission of TB and the development of disease among infected persons. All persons suspected to have infectious TB, including any person with a respiratory specimen that is smear-positive for AFB, must be placed immediately in respiratory isolation. A contact investigation must be initiated promptly. All HIV-infected contacts, regardless of TST status, should receive preventive therapy once TB disease is excluded (2,3).

Prevention of community spread (and reintroduction of undiagnosed infectious TB patients into correctional facilities) requires the rapid investigation of contacts in the facility. Inmate contacts should be evaluated and begun on treatment or preventive therapy before release from any facility, including hospitals or high-risk housing units. Joint efforts are under way in California to clarify roles and ensure that the infrastructure of prisons and health departments is adequate to track TB cases and suspected cases and to elicit, notify, and evaluate community contacts promptly (4,5).

The use of preventive therapy may need to be expanded beyond TST-positive inmates to certain HIV-infected persons with a negative TST. HIV-infected persons with a history of untreated or inadequately treated TB that healed should receive TB preventive treatment regardless of their age or results of TSTs (2). Primary prophylaxis for TST-negative HIV-infected persons with an ongoing and unavoidable high risk of exposure to M. tuberculosis should be considered (2,6,7). Following the TB outbreaks described in this report, the California Department of Corrections has recommended routine use of INH preventive therapy for all HIV-infected inmates with CD4 counts less than 100 cells/uL, provided that such therapy is not contraindicated (7). The risks and benefits associated with primary prophylaxis in these settings need to be evaluated.

References

  1. CDC. Guidelines for preventing the transmission of Mycobacterium tuberculosis in health care facilities, 1994. MMWR 1994:43(no. RR-13).
  2. CDC. Prevention and treatment of tuberculosis among patients infected with human immunodeficiency virus: principles of therapy and revised recommendations. MMWR 1998:47(no. RR-20).
  3. CDC. 1997 USPHS/IDSA guidelines for the prevention of opportunistic infections in persons infected with human immunodeficiency virus. MMWR 1997;46(no. RR-12).
  4. CDC. Prevention and control of tuberculosis in correctional facilities: recommendations of the Advisory Council for the Elimination of Tuberculosis. MMWR 1996;45(no. RR-8).
  5. California Department of Health Services, California Tuberculosis Controllers Association, and the California Conference of Local Health Officers. Guidelines for coordination of TB prevention and control by local and state health departments and California Department of Corrections. Berkeley, California: California Department of Health Services, 1998.
  6. CDC. Anergy skin testing and preventive therapy for HIV-infected persons: revised recommendations. MMWR 1997;46(no. RR-15).
  7. California Department of Corrections, Public Health Infectious Disease Advisory Committee. Tuberculosis protocols for human immunodeficiency virus infected inmates. Sacramento, California: California Department of Corrections, 1998.

Tuberculosis Outbreaks in Prison Housing Units for HIV-Infected Inmates — California, 1995-1996

During 1995-1996, staff from the California departments of corrections and health services and local health departments investigated two outbreaks of drug-susceptible tuberculosis (TB). The outbreaks occurred in two state correctional institutions with dedicated HIV housing units. In each outbreak, all cases were linked by IS6110-based DNA fingerprinting of Mycobacterium tuberculosis isolates. This report describes the investigations of both outbreaks; the findings indicated that M. tuberculosis can spread rapidly among HIV-infected inmates and be transmitted to their visitors and prison employees, with secondary spread to the community.

In both of the investigations, a positive tuberculin skin test (TST) was defined as an induration of greater than or equal to 5 mm in contacts and/or HIV-infected persons. A TST conversion in a contact was defined as an increase of greater than or equal to 5 mm from a documented negative to a positive TST within the previous 2 years. Only culture-positive pulmonary cases were considered infectious, and the infectious period was considered to begin 6 weeks before the date the culture-positive specimen was obtained (if the patient was asymptomatic) or the date of onset of symptoms consistent with TB.

Prison A

On entry to the 500-person prison HIV housing unit in May 1995, the index case-patient was asymptomatic and anergic with a negative TST, and had a CD4 count of 6 cells/uL, and a 1-cm calcified nodule on chest radiograph. Three sputum specimens, routinely collected on entry of all inmates into the housing unit, were smear- and culture-negative. Isoniazid (INH) was not prescribed because of baseline liver function test abnormalities. During the next 3 months he was treated with several courses of antibiotics, initially for laboratory-confirmed Pneumocystis carinii pneumonia (PCP) and then for episodic fever and cough. Each time his symptoms decreased, and one chest radiograph showed a new infiltrate that resolved with antibiotic treatment. In late August 1995, a chest radiograph revealed a new infiltrate, and sputum specimens were smear-positive for acid-fast bacillus (AFB). The patient was isolated and started on multidrug therapy for TB.

During September 1995-April 1996, drug-susceptible TB was diagnosed in 14 other inmates (including three parolees) and the HIV-infected wife of the index case-patient. Their M. tuberculosis isolates matched the isolate from the index case-patient by DNA fingerprint analysis. All inmates with TB resided on the same wing when one or more persons with TB with the outbreak strain had infectious cases. Of the 312 inmates who resided at least 1 day on the same wing as case-patients, 185 were available for screening in December; three had TST conversions but no disease. Inmates with TB disease were isolated and treated, and the proportion of the approximately 150 contacts in the wing receiving directly observed INH preventive therapy was increased from 14% in October 1995 to 60% in January 1996.

Prison B

In January 1995, the index case-patient had a positive TST and received 6 months of preventive therapy while in a state prison. In December 1995, he was sent from the prison to a community hospital with cough, fever, a chest radiograph with infiltrate on the right, AFB smear-negative sputum specimens, and a newly diagnosed immuno-deficiency (i.e., low CD4 count). He was empirically treated for PCP with trimethoprim/sulfamethoxazole, but his fever persisted. After the addition of prednisone, his fever resolved. On January 6, 1996, he was transferred from the hospital into an 180-person HIV housing unit in a different prison (prison B). The community hospital staff indicated that no respiratory isolation was necessary. A chest radiograph on January 11, was normal. By January 19, cultures from sputum specimens and bone marrow aspirate obtained while he was at the community hospital (December 23, 1995) grew M. tuberculosis; he was placed in respiratory isolation, had a chest radiograph with a diffuse infiltrates bilaterally, and was started on multidrug therapy for TB. He died from miliary TB on January 20. None of his sputum specimens obtained on January 8, January 10, and January 11 were AFB smear-positive.

During January-August 1996, drug-susceptible TB was diagnosed in 15 other inmates (including six parolees). The DNA fingerprints of M. tuberculosis isolates from all 15 matched the fingerprint of the isolate of the index case-patient. Analysis of sputum specimens from all 140 inmate contacts in the facility at the time of the investigation identified seven secondary case-patients whose chest radiographs were normal at the time of screening; five were asymptomatic. Screening of inmate contacts also detected 25 (18%) asymptomatic TST convertors who did not have TB disease. These 25 received preventive therapy.

Contact Investigations

In both prisons, during the 4-month intervals between identification of the index case-patients and chest radiograph screening of all the contacts remaining in the housing unit, 190 inmates had been released. Of 56 (29%) who were reincarcerated in prisons or jails before they had had health evaluations in the community, follow-up information was available for the eight who were reincarcerated in jails; none had TB disease, and six accepted preventive therapy. The remaining 134 were referred to 22 local health jurisdictions. Of these 134, 76 (57%) were assessed; nine (12%) had culture-positive TB (three from prison A and six from prison B), each with the same outbreak strain of M. tuberculosis as found in the originating prison.

Secondary transmission may have occurred from both prison outbreaks to the community. The HIV-infected wife of the index case-patient in Prison A visited her husband for 4 hours per day on the 3 days before his placement in AFB isolation. Two months later, she developed smear- and culture-positive pulmonary TB with the outbreak strain. Her daughter, whose TST result was 0 mm on school entry in 1994, had a 28-mm reaction; she had not visited her father during his infectious period. An adult and two children aged less than 5 years who lived with a parolee from prison B while he was symptomatic all had TST results greater than 10 mm but had no prior baseline.

Among prison employees who had contact with case-patients, TST conversions occurred in nine (2.8%) of 319 in prison A and 11 (4.9%) of 223 in prison B. All 20 had had two documented negative TSTs during the previous 2 years, 19 had a baseline TST result of 0 mm, and 18 had a positive TST result of greater than 10 mm. No employees had TB attributable to either outbreak strain.

Reported by: T Prendergast, MD, B Hwang, MD, R Alexander, San Bernardino County Health Dept, San Bernardino; T Charron, MD, E Lopez, MD, Solano County Health Dept, Vallejo; J Culton, MD, J Bick, MD, M Shalaby, MD, D Dewsnup, DO, H Meyer, MD, E Horowitz, MD, N Khoury, MD, California Dept of Corrections; J Mohle-Boetani, MD, S Royce, MD, D Chin, MD, S Petrillo, V Miguelino, E Desmond, PhD, R Harrison, MD, J Cone, MD, C Greene, M Joseph, S Waterman, MD, State Epidemiologist, California Dept of Health Svcs. Div of Tuberculosis Elimination, National Center for HIV, STD, and TB Prevention, CDC.