January 16, 1997

Get a Life - If you can Afford to

Laura Conaway

Sidebar Stories:
Looking at Stan's skeleton-thin body, it's easy to believe he could have died last year. A Portland resident in his late 40s, Stan- (not his real name) was diagnosed with AIDS in 1990.- Even though tests showed the disease was battering his immune system, he'd been mostly symptom-free until last fall. Then Stan started "wasting," AIDS lingo for rapidly losing weight from nausea, diarrhea and decreased appetite. Pounds disappeared daily from his already slender frame. For AIDS patients, seeing their weight drop is like watching grains of sand fall through an hourglass: The skinner patients get, the closer they are to the end. But then he started taking the newest generation of AIDS drugs, and Stan's hourglass turned upside down.

"I looked very bad," Stan said, as he moved around his Parkside kitchen making coffee. "It got to the point where I looked like 'the AIDS victim." I looked like a Somali, the malnutrition. You could see every bone in my body when I undressed to shower."

Stan doesn't look much better now. His clothes still hang loosely, and his body seems scarcely strong enough to hold up its own shadow. But since starting a potent new drug regimen a few months ago, he's steadily grown healthier and put on weight - more than 20 pounds since Thanksgiving. Blood tests indicate his body has more T cells, a key measure of the immune system's strength. HIV, the virus that causes AIDS, seems to be retreating from his body.

The medication required to get those results is literally a lot to swallow. Three times a day, Stan is supposed to take a handful of pills. Two are relatively old-line drugs. There's the AZT - a white capsule with blue stripes and a unicorn logo - and there's the football-shaped 3TC. Then there's the Crixivan, a huge, green-lettered, white capsule representing the brightest hope AIDS patients have ever had. Crixivan is part of a new family of drugs called protease inhibitors. First marketed in March 1996, Crixivan, like the other drugs in its class, works to prevent HIV from reproducing.

Together, the medicines cost upward of $20,000 a year - in some cases, $30,000 - but Stan is lucky. He's on Medicaid, which pays all but a few dollars of his pharmaceutical tab.

Other AIDS patients in Maine who don't qualify for help or who lack adequate insurance are watching their immune systems crumble while the drugs that might save them remain out of reach, doctors say. Even if patients are able to get older drugs, they have no real hope of getting better without the new medicines. "If you're going to start treatment, either you start with the three-drug cocktail or you don't treat at all," said Dr. Owen Pickus a Portland AIDS specialist. Pickus aid most of his patients - over l50 people - are taking the protease inhibitors but some are having trouble paying for the medicine. "I'm playing all kinds of games with," he said. "I'm giving them drugs that another patient brought back because they couldn't take them."

Besides costing a fortune, the new drugs sometimes cause side effects so severe that patients have to stop treatment. Stan said he spent his first weeks on Crixivan vomiting. Now he takes one-third of the amount his doctor prescribes. Scientists don't know much yet about long-term use of protease inhibitors, but what they have learned suggests that taking less than the full dose gives the virus a chance to mutate into a more deadly, drug- resistant form. A person like Stan "would be better off doing nothing," said Brian Marcotte, an independent biologist and AIDS expert from Massachusetts. "He's inviting resistance. Once his virus becomes resistant, he could transmit the virus to others if he practices unsafe sex or engages in other unsafe behavior. He's becoming a danger to himself and the community he lives in."

Stan worries his physician would refuse to treat him if he were honest about how little he's taking, so he lies. Meanwhile, the drugs keep arriving by mail.

"This is what I'm embarrassed about," he said, opening a kitchen cabinet stuffed with jars of Crixivan. "There are some people who can't get it, and here I have all these bottles."

$20,000 Question

Because Maine's population is small, the state's AIDS numbers barely register on worldwide charts. Globally, researchers estimate 29.4 million people are HIV positive, and nearly 6.5 million have died from AIDS. Here in Maine, 746 people had been diagnosed with full-blown AIDS as of Sept. 30,1996. Of those, 417 are already dead. An estimated 1,200-1,800 additional people are HIV-positive, but haven't fallen ill yet. That means some 2,000 people in the state right now need a cure. Many are hoping they'll get the protease inhibitors and with their help, stay alive.

Don't bet on it.

"There isn't funding in the state for everyone who's HIV- positive to get protease inhibitors," said Steve Moskey, executive director of The AIDS Project in Portland. Moskey's agency now has about $350,000 to spend helping clients in southern Maine find treatment. He said he'd need twice that amount to serve everyone in this area who has HIV.

Cost aside, the question for scientists and service workers has been when to put patients on the three-drug regimen. Should patients receive the treatment as soon as they contract the virus, after other drugs have failed to help them, or when their immune systems start to crash?

The answer, said biologist Marcotte, is to put everyone on the drugs immediately before the virus has time to multiply in the body and build up what scientists call the viral load "Basically, anybody who has any detectable viral load should be on the protease. I tend to be aggressive I think you'll find physicians in mainland Europe and in the United States will agree with me."

Bureaucrats and service directors who have to fund that treatment have a different answer. "Not everybody with AIDS is a candidate for these protease inhibitors" said Robert Carroll, a state Medicaid official. "Just because you have AIDS doesn't mean you need the protease inhibitors, but when your viral load changes, then you get them."

"Not everyone needs protease inhibitors," said Moskey. "You start out with other treatments. It's when those don't work that you move on to protease inhibitors."

In Portland, many doctors aren't waiting for other drugs not to work. They've seen patients get better on protease inhibitors, and they're not wasting time before prescribing them. "A number of people who had both feet in the grave have been brought back and are now working," Pickus said. He expresses frustration with officials who would choose to delay treatment. "All they're doing is deferring the future. The longer [patients] stay with an active viral load, the more their immune system is going to be damaged."

But multiply the 2,000 people in Maine estimated to need the drugs by the $20,000 annual cost of treatment and it's easy to see one reason officials would be "deferring the future." Caring for all those people could cost $40 million a year. While most of that expense is borne by the federal government, more than a third of it must be raised at home. "Other states have the same problem," said Medicaid's Carroll. "Everybody is wrestling with it." The money has to come from somewhere, and how big of an impact it's going to have we're studying now."

Some states are already moving to place limits on the new treatments.

Because Medicaid is partially funded by the individual states, local governments have some control over what they'll pay for. In Maine, Medicaid pays for protease inhibitors like any other prescription, but some states are capping the lifetime amount patients can spend, or restricting access to the drugs until patients meet certain clinical criteria. If the medicines turn out to be as promising as they appear, advocates say, AIDS patients in states where treatment isn't fully covered may start moving to places where they can get help. "The same could be said of welfare in this country," said Marcotte. "The Southern states were notorious for not providing welfare, so everybody fled to the North. The difference is these people are going to be carrying viruses with them wherever they go."

Chosen Few

With limited resources for buying medicines, getting treatment is a game of chance for some AIDS patients in Maine.

"I'm having trouble getting all kinds of drugs," said Bruce Fournier, an Augusta man who's been HIV-positive for 12 years. Due to other health problems, Fournier said he receives $ 1,100 a month in disability benefits from Social Security. While that may be a modest income, it's enough to put him over the limit for Medicaid. Instead, he signed up for Medicare, a federally funded program that helps with doctor and hospital visits but gives him nothing for medications. To cover costs left over after Medicare, Fournier bought additional insurance through Blue Cross/Blue Shield, though he couldn't afford a plan that covered prescriptions.

Even if he'd had the money for drug coverage, he couldn't have handled the 20 percent of each prescription he'd have to fork over himself. Now he pays $90 a month for insurance and $ 155 a month for part of his pharmaceutical needs. For the expensive protease inhibitors - the medicine that could well save his life -Fournier has turned to drug company giveaways known as "compassionate use."

Each month, Roche Laboratories in New Jersey, maker of the protease inhibitor, Invirase, mails out his allotment of the drug for free. Trouble is, Fournier said, the company only sends him enough for the minimum dose recommenced by the FDA, instead of the higher amount his doctor said he needs.

"They only supply me the minimum amount because of the cost," Fournier said. "Corporate greed - they've got you by the short hairs."

The Invirase he takes has become less effective, and, results from his blood tests have become less encouraging. His doctor wants him to switch to Crixivan. "I'll probably qualify for them if I qualified for Invirase," Fournier said. But there's no way to know for sure, because the company's compassionate use workers won't say what the income guidelines are.

Other patients, especially those signed up with AIDS service agencies, report having no trouble getting medications. "If we have recommended a protease inhibitor," said Sandy Putnam, nurse coordinator at the AIDS Consultation Service, "we've never had a problem where someone couldn't get it. Never."

Likewise, Diana Carrigan, a caseworker for The AIDS Project, said her clients have all been able to get protease inhibitors, and haven't experienced Fournier's trouble with small allotments. Still, Carrigan said, compassionate use is not without its problems. She said the companies that manufacture protease inhibitors want to get as many people as possible on their drugs, so they're willing to give them away - for now.

"They want the word getting out that this stuff works. [Compassionate use] is going to start drying up, because they're going to want people to start paying for it," Carrigan said. "Clients are raving to other clients. People have had their T cells go up 200 points. They feel like they're ready to go back to work. Other people say, 'Hey, I want to be on those, too.' What, are they going to have the bulk of America on compassionate use? I don't think so."

Fatal flaw

While the overall number of HIV-infected people in Maine is still small, it continues to grow. State officials estimate 100 persons test positive for the virus each year. Under the increasing weight of patients who need expensive treatments, the cracks in Maine's health care system are beginning to show.

Portland resident Ann Sachs, 43, has had AIDS for almost three years. Sachs' doctor, Pickus, helped her get on protease inhibitors through Medicaid several months ago. The drugs have worked well, and Sachs hasn't had side effects. At one point, her viral load had dropped to 500 copies per cubic milliliter of blood, a level that's almost undetectable. Then, she said, a test came back indicating the load had grown to 7,000. "Pickus said it's not too bad, but when Pickus said it's not too bad, I immediately think it's not too good," she said.

Normally the doctor would have run another test to determine whether the virus was continuing to multiply. After getting viral load measures regularly for a year, Sachs said, she expected getting another one would be no problem, but she was wrong. "He said he couldn't get the test for people anymore, because Medicaid won't pay for it," she said.

The fact is, Medicaid does cover the viral load tests, but what it pays would barely buy a meal at McDonald's, let alone a cutting-edge medical procedure. Connie Nadeau, office manager for Pickus' practice, said each test costs labs up to $200. Depending on how the test is billed, Medicaid reimburses labs anywhere from $5.67 to $14. Private insurance companies aren't paying much more. "It's a joke," she said. "These labs are having to write the rest off. Obviously they can only do that so many times before it's not good business." Faced with continued losses, she explains, labs have given her office the choice of paying for the test themselves, or not running them. "Obviously I can't eat the $200 either," Nadeau said.

"Anyone whose viral load is 5,000-10,000 should be on the inhibitors," Pickus said "but I can't get the viral loads, so how do I know? It's outrageous that we can't get the viral load testing."

"Tell him to refer them to the AIDS Consultation Service," said nurse coordinator Putnam. Being lucky enough to hook up with the right agency increases a patient's chance of getting necessary tests, as well as appropriate drugs. Putnam's program, funded by Maine Medical Center, gets viral load testing free from the hospital's research lab. The service accepts all patients referred there by doctors, and getting an appointment takes as little as two weeks.

So while some patients go without, others get all the treatment they need. Levels of care vary not only in Maine, but across the country. Each state, for example, has an AIDS Drug Assistance Program, jointly funded by state and federal money. The programs are designed to help patients with full-blown AIDS who can't get drugs any other way - not through Medicaid, not through private insurance, not through compassionate use. A recent survey showed some states are paying for all three protease inhibitors on the market, while others aren't paying for them at all.

In January, Maine's program made protease inhibitors available for the first time to 12 of the 45 people currently enrolled. The other 33, if they wanted those drugs, would have to wait.

"We don't want to get people on a program and then say, "Oops, we can't pay for this,"' said program director Sally-Lou Patterson. "Because once you get on protease inhibitors, you can't get off them. We don't want to be irresponsible."

Dr. Owen Pickus, who treats many of Portland's AIDS patients, argued it will ultimately be cheaper for society to fund the expensive protease inhibitors drugs now. He calculates that each person who dies from AIDS costs the health care system between $250,000 amd $500, 000, but that current studies suggest patients who respond well to the regimen can eventually stop taking the drugs. "We can cure everybody in perhaps three years," he said "So for 60 to 80 grand, we can cure thes people, or put them in long-term remissions.
file photo / Colin Malakie
Many states say covering the new drugs for everyone who needs would be financially impossible. Florida, which doesn't pay for the inhibitors, estimates it would be $ 18-20 million in the hole by March if it offered that assistance. Texas is instituting a combined lottery/waiting list for patients who need the drugs.

Massachusetts now pays for the drugs, but said it will have a $6-9 million shortfall by June. New Hampshire, like Maine, has enough money to cover just 12 patients.

"I understand why it is the way it is, but when you thinkabout it -- 12 people in the state?" caseworker Carrigan at The AIDS Project said. "I don't want to be the person telling somebody that, 'No, there's no options for you. You've got to come up with that $30,000."'

Swim for the lifeboat

Most doctors and AIDS workers stop short of saying the protease inhibitors are the long-sought cure. Some patients simply haven't responded to the drugs, or get too sick from side effects to continue taking the medication. Some have experienced dramatic improvements, only to crash again as they develop resistance to the drugs. Others were already too near death when the medicines arrived to receive much benefit. But the luckiest patients, like Sachs and Stan, say they're now well enough to find jobs and resume their normal lives. What stops them is fear that by earning an income, they'd lose the benefits that helped them buy the medicine that keeps them alive. No one knows yet whether recovering patients can ever stop taking the drugs.

"I would love to go back to work and be a real person," Sachs said. "As a patient, you're going to feel better if you're doing something other than just sitting around waiting for the next drug, or to die. And for the government and service organizations, it's going to be cheaper."

"Here I am, educated, perfectly able to work," said Stan. "I could get a decent job and pay taxes. But if I did, I would lose all my benefits. I now represent a drain on the treasury and social services, when I could very easily be helping to support them. Where is the middle ground program that makes sense?"

Nationally, activists are studying ways to ease AIDS patients back into the working world without forfeiting access to the medications that are keeping them healthy. "Some people are going back to work almost in an irresponsible way, in a way that's going to get them screwed," said Ed Straub, a volunteer researcher with the National AIDS Fund. Straub sees people with AIDS leaving government benefits and taking jobs without first making sure their employer's insurance will cover prescriptions. He also sees healthy patients who are scared the government will cut off their assistance. "There's a rumor flying round California right now that Social Security is getting ready to yank all these people off disability," he said, adding the rumor has so far proved unfounded.

Keeping people who are working on government benefits will exact a price. Pickus argued it will ultimately be cheaper for society to fund the drugs now. Using estimates from insurance companies, he calculates that each person who dies from AIDS has cost the health care system between $250,000 and 500,000 in treatment that failed to keep them alive. He said current studies suggest patients who respond well to the three-drug combination can eventually stop taking the drugs. "We can cure everybody in perhaps three years," he said. "They're thinking two to three years, and then we can stop the drugs. So for 60 to 80 grand, we can cure these people, or put them in long-term remissions."

Victor Rash, who works for The AIDS Project in Portland, remembers the first time he learned the full potential of the new drugs. Rash was listening to biologist Marcotte give a lecture. "He was the first person I ever heard say that in clinical trials with protease inhibitors, the virus was undetectable," Rash says. "It was like you thought you were dreaming, or it was a mirage. I got a sense of what Moses must have felt like on the Mount."

While Marcotte agreed the prospects for treatment are bright, he warned against thinking society no longer has to shell out millions for AIDS. So far, he said, we've been working with molecules that occur naturally. The next generation of pharmaceuticals will be "totally designed," he said, and those are going to be very pricey.

Marcotte said doctors will need that next generation of drugs to fight the-highly contagious, more virulent strains of HIV that are working their way toward North America, including the Type E now prevalent in Africa and Asia. "Folks, you know nothing about what HIV is going to do this country until Type E gets here. It is here," he said. "It came over with soldiers. You're going to see E do what it's done to Central Africa where 70 percent of the people are infected and whole villages are ghost towns unless this country starts dealing with the problem responsibly. People need to realize they're not saving an IV drug user, they're not saving a faggot, they're not saving a hemophiliac. They're saving their own damned skins."


Augury and signs

Portland resident Ann Sachs has been on Crixivan for 10 months -- long enough, she said, for the protease inhibitor to start losing effectiveness (patients sometimes develop resistance to the drugs). Sachs' most recent blood tests indicate HIV, the virus that causes AIDS, is again multiplying in her body. Now she's counting the days till a new drug, Viracept, gets
Ann Sachs has had AIDS for three years. She has been doing well on protease inhibitors, but is having trouble paying for vital medical tests to monitor her condition
Photo/Tonee Harbert
government permission to hit the market. While she waits, she looks for signs of hope, including the cost of buying stock in Viracept's manufacturer, Agouron Pharmaceuticals.

"They had a big drop just recently," said Sachs. "It could be anything. It wouldn't be a takeover, 'cause that would make it go up. Maybe a problem with getting approval, or their initial studies were not that promising. That worries me, because that was the one I was thinking of taking next."

Despite Sachs' worries, by Jan. 6 Agouron's stock had shot up over 20 points as the company applied for approval to market Viracept. In addition to treating adults, Agouron is seeking permission to treat children with the medicine. If approved, Viracept would be the fourth drug in its class, but the first protease inhibitor cleared for use in kids. With new drugs arriving faster than physicians can learn about them, patients have to watch out for themselves, Sachs said. But since much of the AIDS treatment grapevine is operated by gay men, getting information can be hard for straight women. "I make it my business to know what's coming out. I go and ferret information in the library. I study medical journals. I've been surfing the `net' Sachs said. "You have to be proactive with this disease. You have to make sure you're getting the best that's available. Being a woman, you're on the outside of the Beltway. You're just a priori excluded from a lot of the discussion."

Sachs said she's been HIV-positive for 13 years, though she found out less than three years ago when she was diagnosed with full-blown AIDS. By the time doctors figured out what was killing her, Sachs had already suffered many classic symptoms of the disease -- pneumonia, hepatitis, shingles, wasting -- and she was close to dying. "I'm convinced that part of the reason I was so late in getting diagnosed was because I was a woman," she said. "The doctor said six months. So I kind of gave it six months, and after six months I knew we had longer than that." Now she said she expects to live another two years, maybe more: "I'd like to make it to the millennium"

Get Out of the House

Peabody House opened in 1995 as a hospice for AIDS patients expected to die in six months. And die they did, one after another, 17 people in the first two years. But on Nov. 23, 1996, a Peabody resident broke the grim tradition. His immune system newly bolstered by combination drug therapy, including protease inhibitors, the man packed his bags and walked out the door, heading for the rest of his life.

Others have since followed. Michael Fournier, 33, moved into one of Peabody's six-rooms on Sept. 12. "They didn't think I was going to live," Fournier says. "They told my parents I wasn't going to make it." Two weeks after moving in, Fournier started taking protease inhibitors. The staff, rather than helping him die, cared for him through the initial weeks of side effects. They gave him medicine to alleviate nausea and vomiting, and made sure he took the other drugs at the right times and in the proper combinations. His health improved. "When I started feeling better, the doctor said I was OK to take care of myself. I didn't need 24-hour nursing anymore, 'he said.

On Dec. 12, Fournier's boyfriend packed his bags into a car. "He just came and picked me up and I left," he said. "I've been back to visit. I don't miss it. I don't miss being woken-up in the middle of the night to see if I'm alive."