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If Silence = Death,
Will Numbers = Answers?

Information Activism on the Net

December 1998

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

The project represents an unprecedented convergence of people with AIDS, activists, medical providers, researchers, and the computer industry. Many in the community have been waiting for years to see the Internet truly exploited as an AIDS research tool. The implications go farther than that. If successful, TDP could serve as a model for similar research on many other diseases.

Numbers have always haunted the AIDS community: skyrocketing numbers of people with HIV/AIDS, free-falling numbers of T-cells; inexorably rising viral load counts. Protease inhibitors have brought a measure of relief, and more numbers: thousands of experimental drug and dosage combinations being taken by hundreds of thousands of patients -- many with limited definitive information on safety or efficacy. More than one in four first combinations currently fail. Millions of lives remain at stake. Numbers as daunting as ever.

It is precisely these numbers the HIV Treatment Data Project (TDP) seeks to exploit, fighting fire with fire, or, in this case, statistics with statistics. Brainchild of acclaimed author and AIDS activist Larry Kramer, TDP hopes to soon recruit patients across the United States already participating in the vast untracked medical experiment that is current AIDS treatment to add their numbers to a large national observational database using the World Wide Web. "It's the next step in activism," Kramer contends, where "patients collect and record the scientific data that may save their lives."

The project represents an unprecedented convergence of people with AIDS, activists, medical providers, researchers, and the computer industry. Many in the community have been waiting for years to see the Internet truly exploited as an AIDS research tool. The implications go farther than that. If successful, TDP could serve as a model for similar research on many other diseases.

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Why TDP?

Traditional randomized clinical trials take years. New antiretroviral drugs may well render clinical strategies based on their outcomes obsolete. Physicians and patients often find themselves forced to change drug regimens due to resistance or side-effects which may limit conclusive assessment of the regimen's efficacy. The diversity of the AIDS-infected populace further complicates clinical trials. Physicians often are hard pressed for information on which to base optimal treatment strategies for antiviral-experienced patients. Addressing this information gap at the 12th World AIDS Conference in Geneva last summer, Wafaa El-Sadr, MD, chief of Harlem Hospital's infectious disease division, called on US health officials to start a program to monitor anti-HIV treatment in practice.

TDP will soon begin field testing on a Web site designed to do just that. Working in conjunction with biostatisticians and AIDS clinicians at New England Medical Center's Primary Care Outcomes Research Institute, the Lotus Development Corporation has constructed a site designed to collect data quickly on HIV treatments. Patients at test sights in California and New York (chosen to comprise a broadly representative sampling of people with AIDS and patterns of practice) will soon begin logging-on to the site, and, using TDP's computer administered questionnaire, pumping information into its database.

Participants will self-report data on a variety of clinical outcomes -- CD4 counts and viral loads, treatment regimen, and other clinical and quality of life information -- data that are important for researchers to identify effective disease management strategies. TDP will provide patients their own user-friendly home page where they can review their personal data or link to related Web sites. The site will also include a "chat" environment where participants can communicate and compare notes with others in the study.

During this phase of testing, the Web site's functionality will be examined, as will the reliability of patient-reported data. TDP's scientists face the major challenge of proving the validity of the data they gather, and whether they can extrapolate from it potentially life-saving information about effective HIV-treatment strategies. If they are successful -- and that is a big "if" -- TDP intends to roll out nationally. Here is the current plan: The study will be open to anyone who is HIV-positive and willing to complete a 15-to-20-minute questionnaire every three months and following every change in their HIV treatments. (Data will also be accepted via telephone, written questionnaire, etc.) When enough data are collected, researchers will aggregate and analyze the data. The aggregate data, along with any conclusions drawn from its analysis, will be posted and updated regularly, free of charge, for perusal by doctors and patients considering their treatment options. It is planned that the database will be able to answer treatment questions posed by users.

Whether or not TDP can pull all this off remains to be seen. Glaxo Wellcome has spent millions developing a somewhat similar database called CHORUS which has experienced unforeseen technical difficulties. CHORUS' coordinator, Ebere Igboko, thinks TDP's plan "sounds extremely ambitious." Still, Igboko maintains, "it would be really useful," a statement that seems to be the consensus opinion. While many questions remain, there appears to be widespread support for the project's mission. When Kramer approached National Institutes of Health's Anthony Fauci, MD, with the idea for TDP, Fauci, with whom Kramer has butted heads more than once over the years, encouraged him to "pursue the idea immediately."


Activism 3.0

For Kramer, co-founder of Gay Men's Health Crisis, and founder of ACT-UP, the tech-utilizing TDP might be thought of as Activism 3.0. Having successfully lobbied the US Food and Drug Administration for streamlining of its drug-approval process, the question for many activists became what to take. Kramer, HIV-positive himself, became frustrated that, while so many people desperate to fight off AIDS were playing "drug-combo roulette, no one was collecting the data on how they were doing." To Kramer, "it seemed an enormous waste, all this information going down the toilet. I thought there ought to be a way of collecting the data from the patients themselves, by having patients enter the data via the Internet."

So Kramer started talking to people. Fauci gave him the names of respected biostatisticians who led him to the project's principal investigator, Sherrie Kaplan, MD, of New England Medical Center and Tufts University. Kaplan's New England team has worked closely with research methodologists and AIDS clinicians at University of Washington's Center for AIDS and Sexually Transmitted Diseases on test questionnaires.

Kramer found unexpected support in an unlikely place when Mike Stocker, MD, president and CEO of Empire Blue Cross and Blue Shield, introduced him to Karen Ignagni, president of American Association of Health Plans (AAHP). A member of AAHP's board of directors, Stocker was intrigued by Kramer's idea and thought AAHP would be a good home for the project. Ignagni agreed: AAHP has provided more than a million dollars in funding to date.

Another pivotal partner came onboard when Bruce Brothers, a senior manager of Lotus Development Corporation and person with AIDS, read an article by Kramer in POZ magazine describing the project.1 Brothers had moved back home to Colorado to die of AIDS when one of the new three-drug combinations changed his plans. Back at work, Brothers was determined to do something meaningful. But as commonly happens, HIV mutated, and Brothers "realized this great ride and recovery was not a sure thing."

That is when he saw Kramer's POZ article and immediately called the publication, saying "I'm the person Larry is looking for." Brothers got in touch with Kramer, telling him he thought Lotus might be able to help with the project's technical development. And help they have, to the tune of more than $1.5 million in staff time and resources.


For the people

TDP's first allegiance is to consumers. To that end, TDP has installed longtime AIDS activist and patient advocate, Rodger McFarlane, as its director. The former head of GMHC and Broadway Cares/Equity Fights AIDS, McFarlane has much experience coordinating diverse groups and keeping them all moving forward while staying sensitive to the communities he is serving. TDP is doing so by consulting senior staff at Project Inform, AIDS Treatment News, and the National Minority AIDS Council, advocacy groups that would traditionally be left out of the loop on such a study. McFarlane considers input from such organizations vital to TDP's success, noting that "Project Inform's whole mission is to be critical of research." For that reason, research teams at UCSD, UCSF, and Harvard are also regular consultants to the project.


Challenges

No one seems more mindful of the possible analytical pitfalls facing TDP than its principal investigator Sherrie Kaplan, whose dictum, "beware the database in search of a question," became a mantra at early project meetings. All the information in the world does us no good if TDP can not ask the right questions in the right way to be able to draw viable conclusions. As Kaplan says, "the challenge is in the interpretation."

Kaplan is quick to point out that an observational study of this kind cannot establish a causal relation between outcomes. "TDP's conclusions will be descriptive," she cautions, TDP can only describe how patients do on different therapies rather then offer absolute proof. Still, Kaplan maintains, "the data may provide evidence of compelling trends which could lead us to better explore those trends. We may be able to build a set of findings for medications that has to do with side effects and quality of life." Kaplan warns against too-high hopes for the project. "TDP can't deliver everything," she asserts, adding that "one of TDP's major goals is education."

Jeannine Bookhardt-Murray, MD, agrees. She is medical director of HIV services at Morris Heights Health Center in the Bronx, one of TDP's test sites. Bookhardt-Murray believes educated patients make her job easier. "I'm just the one that gives them pills," she says, "I can't go home with them to see how they're taking care of themselves." Bookhardt-Murray believes TDP will help reinforce what she is telling her patients who "can zone out after listening to me harping on them for so long." She also thinks TDP could help improve communication between herself and patients who "won't tell me things because they think I'll scold them."

Lotus is setting up three terminals at the Morris Heights facility, which serves low-income patients. The current thinking is to make the computers available to all the center's clients, benefiting the entire community while keeping the terminals from becoming a red flag denoting a user's HIV status. While most of Bookhardt-Murray's patients have never used computers before, she believes they will be very enthusiastic. "Never underestimate individuals and their drive to get information," she admonishes. Her optimism belies one of TDP's major concerns: will people participate?

Bookhardt-Murray's former boss at Harlem Hospital, Wafaa El-Sadr, is concerned that "when people are sick, probably the last thing they want to do is enter data." She worries about the skewing that could result from only literate or healthier patients entering data.

Then there is the issue of bad information. The Internet is rife with it. What if users misinterpret or draw incorrect conclusions from TDP data? Bookhardt-Murray does not see that as a major problem, explaining that she, like most doctors, already regularly contends with suspect information patients bring in from any number of existing, questionable sources.

TDP must also contend with the issue of fraud. How do you prevent a pharmaceutical company, say, from pushing its product by enrolling bogus patients? After much consideration, it was agreed that in order to prevent such fraud, patients would have to surrender a degree of anonymity, supplying certain personal information at the time of application. Such information will then be encrypted and kept separate from patient data which will henceforth be identified only with ID numbers.

People with AIDS and activists at a TDP meeting earlier this year at Lotus headquarters in Boston were convinced patients would be willing to make that sacrifice. Aggregate data will not include patient identifiers and will only be provided where small sub-groups will not compromise individual identify. Kramer is comfortable with Lotus's Domino Security System and its ability to assure participants' privacy. "We believe this is a perfectly secure Internet site," says Kramer. "We've had an army of lawyers and AIDS activists looking over our shoulder and helping design it. Everyone's enormously impressed with what Lotus has come up with in this regard."

And what if TDP is successful? Will HMOs use the information the study generates to limit the treatment regimens they cover? Empire Blue Cross's Stocker does not see this happening, since, as he points out, even the costliest drug regimens are less expensive than hospital stays.


The Future

Sheldon Greenfield, MD, chief of the division of Health Service Research at the New England Medical Center, has overseen a number of important medical research initiatives including traditional randomized clinical trials and observational studies using large patient databases. Greenfield thinks "computer-based patient reporting will play an increasingly significant role in future research, and this project will teach us a great deal in that regard." Like others, Greenfield believes TDP could serve as a model for similar studies with other diseases such as "diabetes, asthma, osteoporosis, many cancers, and even certain kinds of congestive heart failure."

While most everyone at TDP remains guarded with expectations, Kramer wants the project "to revolutionize how medical data are collected." No one at TDP sees anyone telling people what to take anytime soon, but it is widely agreed there is much to learn from such a study. TDP may prove to be a great new tool to augment traditional research at the very least. As usual, Kramer has little patience for those bound by convention or institutionalized pessimism, insisting "it's time to hit the keyboards like we hit the streets."

Speaking recently at a march in Washington demanding more money for cancer research led by such notable cancer survivors as Norman Schwartzkopf and Bob Dole, Allen Lichter, MD, president of the American Society of Clinical Oncology admitted, "we've all learned from AIDS activists that sometimes you need to toot your own horn and shake the tree a little bit." It could be time for another lesson.


Brad Miskell is an artist and writer living in Los Angeles.


References

1. Kramer L. 5985 and Counting. POZ 1997;March:69.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!



  
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This article was provided by International Association of Physicians in AIDS Care. It is a part of the publication Journal of the International Association of Physicians in AIDS Care.
 
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