AIDS care in America is like a set of nested Russian dolls, each figure smaller than the one it’s inside. ¶ About 1.2 million Americans are infected with HIV, the virus that causes AIDS, according to the U.S. Centers for Disease Control and Prevention. Of that total, 80 percent know they are infected; 62 percent have sought medical care after diagnosis; 41 percent have stayed in care; 36 percent are receiving life-extending antiretroviral drugs; and 28 percent have no HIV detectable in their bloodstream as a result of treatment. ¶ “The issue of how to treat patients is a done deal. We know what to do,” said John G. Bartlett, 76, who watched the AIDS epidemic unfold as head of the division of infectious diseases at Johns Hopkins Hospital from 1980 to 2006. ¶ Today, the big issues are how to find the patients, test them, get them into medical care and keep them there, provide them medicines, educate them and follow their progress.
This cascade of challenges reflects both the peculiarities of this disease and medical care in the United States.
HIV infection is an ailment associated with poverty, denial, prejudice and risky behavior. Unlike nearly every other infectious disease, it requires meticulous, lifelong therapy, which also happens to be expensive, averaging $25,000 a year. Half of the money goes for pills, which must be taken every day.
At the moment, virtually all HIV-positive Americans who need medical care — including combination antiretroviral therapy — can get it if they want. That’s true even for people with no money. But it requires a huge investment of time and energy by patients, doctors and case managers — and will require more if the Russian-doll statistics are ever going to change.
“If we’re going to actually see ‘the Beginning of the End of AIDS’ that everyone is talking about, we’re going to have to help people move through each and every step of care,” said David R. Holtgrave, head of the Department of Health, Behavior and Society at Johns Hopkins’s school of public health.
Untreated HIV infection is usually fatal. Since the start of the epidemic, 620,000 Americans have died from AIDS, with about 18,000 more dying each year. The illness progresses slowly, however, and for many HIV-positive people, finding treatment isn’t the most pressing problem in their lives.
That was clear last year when the organization AIDS United, which is overseeing 10 outreach projects for HIV-positive people across the country, asked a sample of its clients to name their “most urgent need.”
Housing was the top answer in San Francisco (38 percent) and Louisiana (37 percent). Nine percent of people in San Francisco cited food as their most pressing need while 10 percent in Louisiana said it was dental care.
Queried about “barriers to care,” 53 percent of people in San Francisco named transportation, 29 percent of people in North Carolina said money and 26 percent in Louisiana said stigma.
“We know that folks are out of care for a reason. This gives us an idea what the reasons are,” said Cathy Maulsby, a Johns Hopkins researcher.
A new generation of AIDS researchers has emerged that’s trying to discover “risk factors” for inadequate HIV care the way a previous generation had sought the risk factors for infection.
A study published last year followed for four years 842 New Yorkers whose HIV infections were diagnosed during one three-month period. Three-quarters of them entered medical care, but less than half had regular clinic visits, according to the study from the New York City Department of Health and Mental Hygiene. Drug users, African Americans, people younger than 25 at time of diagnosis, and those in the early stage of infection were most likely to disappear.
There’s unlikely to be a single fix for the high dropout rate. One thing is certain, however. For the moment, the suppression of “viral load” in the bloodstream — the goal of therapy — can’t be achieved without antiretroviral drugs.
Securing those drugs for patients has preoccupied the AIDS community from the time the first one, AZT, came on the market in 1987. Federally funded AIDS drug assistance programs (ADAPs) have existed in every state and territory since 1990. They became an essential element in American medicine after 1996, when research showed that taking three antiretroviral drugs — what became known as an “AIDS cocktail” — could stop HIV from growing and often restored a person to good health.
About 325,000 of the 1.2 million Americans with HIV have no health insurance and don’t qualify for Medicaid or Medicare. Many of them rely on ADAPs for their survival. As of December, 134,000 got their HIV drugs for free through them, according to the National Alliance of State and Territorial AIDS Directors.
New clients arrive as they’re diagnosed, decide they want to start treatment, or lose insurance coverage that was previously paying for their medicines. They leave when they get insurance again, find other ways to buy their drugs, or drop out of treatment.
As a consequence, the ADAP rolls are constantly in flux.
The federal government’s contribution to ADAPs this year is $933 million. Some states chip in millions more.
Making that money go as far as possible has become an obsession in the HIV community. It is a homegrown version of the better-known fight to make AIDS treatment available and affordable to poor people in Africa and other parts of the developing world.
The struggle by ADAPs to secure lower prices for antiretroviral drugs for their clients has been successful (although not as dramatically as for African patients). Today, ADAPs pay less than other American buyers. As of a few years ago, their prices were even lower than what most European governments, which buy in huge quantities for national health systems, were paying, said Lanny Cross, former director of the New York ADAP.
Pressure has been more important than magnanimity in making this happen.
In the 1990s, Congress required drug companies to give rebates worth 15 percent of a drug’s price to Medicaid and other government purchasers, including ADAPs. In 2010, that went up to 23 percent in the Affordable Care Act (also known as “Obamacare”). Drug companies also must limit price increases to the rate of inflation.
The best ADAP prices are now roughly 50 percent below retail, with a year’s worth of medicine costing $10,428 on average. In contrast, first-line antiretroviral combinations for use in Africa can cost as little as $183 per year — less than 1 percent of their retail price in the United States. (The cheap drugs are generic versions made in India through special arrangement with pharmaceutical companies, which make little or no money from the drugs’ sales in low-income countries. The generics can’t be sold in the United States and other places where the pharmaceutical compounds are still protected by patents.)
As the recession has progressed, ADAP directors have jawboned drug companies to lower prices further. Many have agreed. Last year, the average monthly cost of an ADAP client’s drugs was $80 less than in 2010.
“If they didn’t do this, the AIDS community was going to give them a lot of bad publicity,” said Cross, who is now a consultant. “Also, if they didn’t do it, they would end up seeing the patients through their own patient-assistance programs.”
Access to AIDS medicines, however, is not an entitlement, and waiting lists at ADAPs have been common over the past 15 years.
As of this month, about 2,000 people in nine states were on ADAP waiting lists that ranged in size from from a single person in Montana to 570 people in Virginia. That may change soon. On July 13, Virginia’s health commissioner, Karen Remley, announced a plan she says will eliminate her state’s waiting list by mid-September. On July 19, Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, said that $69 million will be transferred to 25 states, clearing all lists.
In September, waiting lists contained nearly 10,000 people. By World AIDS Day on Dec. 1, it was a national embarrassment.
At an event that day at George Washington University, President Obama announced that $35 million more would be provided to ADAPs in an effort to whittle down the lists. Speaking by videolink, former president Bill Clinton made a suggestion that made almost as much news: He proposed that Congress allow generic versions of patented AIDS drugs to be sold in the United States under certain circumstances until 2014, when the economy would presumably be healthier and the Obama health-care law in full effect.
The idea went nowhere.
“The reality is that just could not have happened,” said a health specialist in the office of Rep. Barbara Lee (D-Calif.) who was involved in follow-up discussions with pharmaceutical companies after Clinton’s speech. ADAPs and other needy buyers would get used to the low prices and protest when they shot back up in two years.
“Once you go generic, you can never go back,” the staff member said. “Very quickly, the discussion shifted from that to something else.”
The “something else” is an effort to make it easier for people to get free AIDS drugs from pharmaceutical companies. Those companies’ patient-assistance programs (PAPs) are the final safety net for HIV-positive Americans. Each year, about 25,000 people get their medicines that way. The companies do this for both humanitarian reasons and because it establishes brand use, if not brand loyalty.
The Clinton Health Access Initiative — a branch of the former president’s charitable foundation — is in the process of creating a single portal to these more than half-dozen drug company programs. Patients — or, more often, their case managers — would have to fill out a single application, which is far simpler than what they do today. The program, managed by a new foundation called HarborPath, is opening pilot projects in five Southern states this month.
Texas is one of them. For Paula McNeely, the program can’t come a moment too soon.
She is a 38-year-old case manager at the Tarrant County Public Health Preventive Medicine Clinic in Fort Worth. She has worked there for 11 years. The clinic cares for 800 HIV patients. Fewer than half have health insurance. Each day, she spends about three hours helping them fill out applications to the Texas ADAP or the many pharmaceutical company programs.
“It’s pretty time-consuming,” she said. “I know that other patients who don’t have access to case managers go without the medicines. But we don’t ever let patients fall through the cracks.”
Falling through the cracks — that’s America’s AIDS problem.
Thomas Decker, 59, knows it and is determined not to become one of the statistics.
He was infected more than 20 years ago. He started antiretroviral therapy in 1997, went off it for two years in the early 2000s and then back on.
In 2009, the printing company in Northern Virginia where he worked closed down. For the first time in 30 years, he was without health insurance. With the help of the Arlington County health department, he began to get his medicines through Virginia’s AIDS Drug Assistance Program.
A year later, however, he was dropped when the state changed the ADAP eligibility rules in order to save money. (His CD4-cell count was normal, indicating his immune system wasn’t yet damaged.) With the help of the Inova Health System, a hospital chain in Northern Virginia, he turned to several pharmaceutical company programs and started getting his medicines for free.
“For me, it’s been seamless. But I’m not saying that’s been true for everyone,” he said recently. “It’s really important to live in an area where people are willing to help you work around obstacles.”
More obstacles remain.
Decker is still without health insurance. He recently learned of a federal program that will sell him insurance despite his “pre-existing condition” — his HIV infection — and will also provide his medicines. But to qualify, he must be rejected by a commercial insurance company. He’s just applied to Aetna and is looking forward to a letter of denial.
Decker acknowledged the irony that in America today, some people with HIV infections have to prove they’re too sick to be insured in order to get the drugs that will keep them healthy.