A Legacy of Change

TIMES HEALTH WRITER

While AIDS has largely fallen off the public's radar screen, 20 years of battling the disease have left an indelible mark on medicine in America.

The impact goes far beyond AIDS itself. The massive scientific effort to find treatments and uncover how the HIV virus ravages the immune system has helped to illuminate the causes of other diseases and led to the development of possible treatments.

The epidemic also has been a catalyst for a profound overhaul of how the U.S. government approves new medicines. AIDS activism provided a blueprint for a burgeoning consumer movement in medicine and shifted the balance of power in the doctor-patient relationship.

But there's a downside to this legacy, too. The Food and Drug Administration's expedited drug-approval process--intended to make potential lifesaving therapies available to patients more quickly--has backfired, with reports of deaths and other complications from some of these drugs. And jockeying for medical research dollars has become a high-stakes, celebrity-driven competition based as much on glitz as on real science.

Among First Victims, Activism Blossomed

It was a sheer accident that AIDS first struck a relatively cohesive group: young homosexuals in cities such as New York, Los Angeles and San Francisco, many of whom had honed their organizational and political skills during the gay rights movements of the 1970s. This was extraordinary: Terminal illnesses don't discriminate, hitting rich and poor alike without regard to ethnicity, geography or sexual orientation. That means that people struck by the same disease often don't have much in common, besides their illness, and don't come together so easily to speak with one voice.

But AIDS was different. The urgency of the spreading crisis--people were dying within weeks or months of their diagnosis--helped galvanize activists. This, coupled with the gay community's mistrust of that segment of society that viewed their behavior as aberrant, set the stage for a movement that used 1960s-style street-theater tactics to persuade the medical establishment to change its ways.

"Given the history of how the medical community treated homosexuality--particularly psychiatry, which labeled it a mental illness--there was less intimidation about questioning the medical establishment," says Jeffrey Levi, co-director of the Center for Health Services Research and Policy at George Washington University in Washington, D.C.

Protesters staged sit-ins at the National Institutes of Health, held candlelight vigils on the White House lawn and chained themselves to the floor of the New York Stock Exchange. Their confrontational strategy had the desired effect. Red ribbons became ubiquitous; federal funding for AIDS research zoomed from nothing in 1982 to nearly $300 million less than five years later. Today, AIDS spending in this country is about $2 billion annually.

"The demonstrators were certainly shrill, but what they were saying made a lot of sense," says Dr. Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases in Bethesda, Md. Fauci played a key role in opening doors for AIDS activists to interact directly in the decision-making process with government researchers and policy makers.

Their inclusion marked an important shift in the way medical policy was made in this country. For perhaps the first time, top medical bureaucrats actually listened to patients and recognized that research has to be relevant to the people whose lives scientists were trying to save. "Medical research was an insular world," says John James, editor of AIDS Treatment News, a Philadelphia-based newsletter. "Scientists, government officials and professional fund-raisers usually talked to each other. Patients weren't in the loop, except for the occasional poster persons."

This change in attitude gradually influenced other research areas. Today, consumers and patients routinely have a seat on key governmental panels. They testify before Congress, serve on advisory boards and lead fund-raising drives. They have become expert at political persuasion.

"Patients have learned that talking to politicians and asserting one's rights gets the research dollars flowing and helps the philanthropic public become aware of certain problems that might otherwise have been ignored," says Mathilde Krim, founding co-chair of the American Foundation for AIDS Research in New York.

But there is a flip side. The growth of this grass-roots consumer movement has skewed research funding, with the squeaky wheel gobbling up all the proverbial grease. Advocates for other diseases complain that AIDS receives a disproportionate share of research dollars because of activists' demands. For example, the government spends about $192 million annually on lung cancer research, contrasted with more than $2 billion for AIDS research. But lung cancer kills far more people--165,000 annually--contrasted with the 16,000 to 17,000 annually who die of AIDS.

By the same token, lung cancer strikes far more women than breast cancer. Yet breast cancer, whose activists included many high-profile celebrities, gets far more attention--and federal dollars: $553 million annually. To avoid being shut out, serious illnesses now require high-powered groups, or celebrities such as Michael J. Fox, to raise awareness, and lean on big donors.

'The Start of Grass-Roots

Drug Testing'

The desperate plight of AIDS patients, for whom there was no government-approved treatment until 1987, also highlighted the weaknesses of the FDA's drug-approval process. The chronically understaffed agency often took more than two years to review applications for new drugs that extensive tests had already shown were safe and effective. In October 1988, more then 1,000 demonstrators blockaded the FDA headquarters in suburban Maryland. They feared thousands would die before AIDS drugs were cleared by the agency. A week later, FDA officials announced that experimental drugs that showed potential for saving lives would be made available to dying patients before they received final government approval. This "compassionate use" system has been in effect ever since for terminally ill patients suffering from other diseases, including cancer.

To hasten the drug testing process, the American Foundation for AIDS Research and the Community Consortium in San Francisco, a consortium of community clinics serving AIDS patients, organized doctors and local clinics to collect data on AIDS treatments. In June 1989, the FDA approved aerosolized pentamidine to treat pneumocystis carinii pneumonia. It marked the first time a new drug gained FDA clearance solely on data from community-based trials.

"This was the start of grass-roots drug testing, and it went like gangbusters from there," says Dr. Donald I. Abrams, chairman of the Community Consortium and a professor of medicine at UC San Francisco.

Normally, tests of experimental drugs are conducted in university laboratories or government hospitals on select patient populations. But the FDA now recognizes that these trials are not always the best barometer of how a medication acts in the real world. Since then, the NIH launched the Community Program for Clinical Research on AIDS, a nationwide network of community-based clinics, to test treatments for AIDS. And new medicines for such routine ills as hypertension, enlarged prostates and contraception are now tested in clinics or doctors' offices.

The pharmaceutical industry, however, seized the opportunity created by the FDA's new policies to lobby Congress for quicker reviews of treatments for other serious illnesses. In 1992, President Clinton signed legislation that required the FDA to cut the average approval time for "important" new medicines from two years to a year or less.

Critics contend, however, that the FDA's expedited review process has jeopardized patient safety. Since 1997, 11 drugs suspected of causing more than 1,000 deaths have been pulled off the market for safety reasons, which is unprecedented in the agency's history.

"The proper successes of the AIDS activists were then exploited by the drug companies," says Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, a consumer watchdog organization in Washington, D.C. "It was a clear priority to get breakthrough drugs approved quickly, especially when there were no alternative therapies. But the FDA didn't distinguish between appropriate expedited approval and the inappropriate lowering of standards for other drugs that never would have been approved 10 or 15 years ago."

Discoveries About

Other Diseases

The AIDS epidemic also spurred research into the underlying mechanisms of disease. "Nature did a terrible experiment that we could never do and allowed us to see what happens when you knock out one key cell--the CD4 cell--from the immune system," says NIAID's Fauci. "Because of this, we've taken giant steps forward in our understanding of the complexity of the immune system, which has implications for numerous other diseases."

People with AIDS, for instance, whose immune systems are severely compromised, are more susceptible to cancer. Consequently, we now know that immune response plays a key role in the development of cancers.

Studies also revealed that the culprit behind Kaposi's sarcoma, a once-rare cancer that strikes people with AIDS, is HHV-8, a herpes virus. This discovery rekindled research into the tie between viruses and cancer, which was largely abandoned in the late 1970s when scientists could find no discernible link. More recently, researchers found that cervical cancer is caused by the human papilloma virus.

This knowledge helps pave the way for designing drugs that more precisely target disease. "Cancers caused by viruses can be treated or even prevented by using a vaccine," says Dr. Alexandra Levine, medical director of the USC/Norris Cancer Hospital.

Meanwhile, a revolutionary cancer therapy, known as an angiogenesis inhibitor, has benefited from insights gleaned from fighting AIDS. This experimental new drug blocks the action of the bodily chemical that triggers the formation of the blood vessels that tumors need to survive. On other fronts, researchers have learned much more about combating viral diseases. In fact, the development of protease inhibitors, which interfere with the production of key proteins the AIDS virus needs to reproduce, is considered a scientific tour de force that will lead to precisely targeted therapeutics for other viral illnesses, such as hepatitis.

And this is only the beginning. It will be decades before we have a real sense of all the discoveries sparked by HIV research.

A New Relationship

for Doctor and Patient

Perhaps the most encompassing shift spawned by the AIDS epidemic, however, is the most visible and immediate: what transpires between doctor and patient.

Early in the epidemic, no one knew what caused this horrific illness or how to treat it. Consequently, AIDS patients were frequently better informed than their doctors. Suddenly, physicians no longer called all the shots, while patients, out of sheer necessity, became active participants in devising treatment strategies.

Like Steve Pieters, who was diagnosed with AIDS in 1982 after his immune system collapsed in the face of an onslaught of ills: hepatitis, herpes, shingles and a raging fungal infection. By 1985, he was clinging to life, stricken with two deadly cancers: lymphoma and Kaposi's sarcoma.

With nothing to lose, Pieters worked with his doctor to create his own therapeutic regimen. In addition to conventional treatments, such as drugs to prevent opportunistic infections, he gobbled down supplements, worked out at the gym and watched reruns of "I Love Lucy."

Today, the 48-year-old former minister is in robust health; tests show the virus is barely detectable in his blood. Pieters, who still takes anti-AIDS drugs, says he used to be a passive patient "who would do exactly what my doctor told me. But after I got sick, I learned to do everything I could to create the conditions for my own wellness."

The willingness of AIDS patients to challenge the medical establishmentleft its imprint on patients and their families throughout America. Today, many Americans are much savvier medical consumers. They surf the Internet for the latest medical news, self-medicate with herbs and other remedies, debate the issue of soaring prescription drug prices and pepper doctors with questions.

"Before AIDS, patients didn't walk into my office with big binders containing all the pertinent medical literature they had amassed," says USC's Levine. "Today, it happens all the time. And that's perhaps the biggest thing we've learned from the AIDS epidemic, that treatment is more likely to be effective if the patient is a full member of the health-care team."

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The Face of the Crisis

Several weeks ago, we asked readers to write to us about their experiences living with AIDS. The following is a sampling of the responses we received.

*

For me, it was June 27, 1985. The day I was diagnosed. It was a Thursday. It's something you don't forget. Can't forget. HIV shadows every aspect of my life. Like losing countless friends to the disease. Crying, it sometimes seemed, for years on end. Getting sick, then getting better. But never as well as before, never as well as someone with a healthy immune system. Isolation, fear and rejection often crowd my days.

I've had four blessed years with undetectable levels of the virus in my body, thanks to the new wonder drugs. Four years of chronic nausea and diarrhea, interrupted only by whispered prayers of an end to all this madness. And in my bathroom mirror each morning, the face of AIDS taunts me.

JIM OERTEL

Cathedral City

*

I have been living with HIV/AIDS for the last 15 years, having been diagnosed as having full-blown AIDS in the last 4 1/2 years. All available medications have failed. I am symptomatic and in another clinical trial. (I dislike the use of the word cocktail; it's chemotherapy!)

I am not a "survivor"; there is no cure and it does not go into remission.

Media and marketing of pharmaceuticals are misleading. We are all not healthy and robust. This disease is devastating with or without treatment. AIDS is a killer. It only cares if you are human.

WARREN FUJIMORI

Glendale

*

I lost a lot of friends whom I thought would be there for me. Thank God for my mom and sister, who have been there for me from Day One.

Just by looking at me, you would never know that I have AIDS. We need more education about the virus. People who are afraid need to sit down and read about it. They could never feel what we feel, but they could be a little more understanding of what we have. People will never know if it could happen to someone they love.

DENNIS LEE EDINBYRD

Santa Ana

*

Three days after Christmas 1994, my knees buckled and I collapsed to the floor. Had I heard the health-care specialist correctly? HIV-positive. After a few days of self-pity and isolation in bed, informing family and friends of the test results, I drained all available cash advance credit on my major credit cards, cowardly quit my job and moved to Seattle. All this in just one week.

I sought no medical attention, took no medication and drank hard alcohol daily. To me, this was living. New state, new home, new job, new life. For however long it would last. New chance? Yes. I lived this way for more than three years. At one point I was in utter turmoil for months. Do I stay and die here as planned, away from family and friends or go home? Home was the only answer.

Now that I am back on track and have my supportive family and friends near, there is one more step for this stubborn person to make. Counseling! Hang in there. I am.

LAURIE WURZER

Santa Ana

*

The '90s and I were not on the best of terms. By 1994, roughly 80 of my friends and acquaintances, my best friend and, in the killing blow, Jeff, my partner of 15 years, had all died of AIDS-related ailments.

After his passing, I lit the candle at both ends and was striking matches in the middle. I woke up in the evening with cocaine and went to bed in the morning with Scotch. I was hurt past caring and the only goal I had was to achieve numbness. When the money ran out and the party slowed down, I had lost the friends I hadn't already alienated.

Finally in August 1996, I was sick enough that I went to a physician. I joked that as a lifelong monster movie fan, I was disappointed that I wouldn't be alive to see "The Lost World: Jurassic Park" the following Memorial Day.

"Jurassic Park 3" opens July 18th. I'm going opening day.

That sounds a lot easier than it actually was to get here. But I was luckier than so many; the protease revolution was around the corner by the time I really got sick.

So while I have my good days and my bad days, I remember that I have AIDS--AIDS doesn't have me, and that usually brings a smile.

BOBBY POND

Lakewood

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