Where Have All the AIDS Drugs Gone?

Along with inadequate funding on the federal level, ADAPs have been hard hit by state budgets reeling from economic recession and lowered tax revenues due to continued high unemployment and residual carryover from corporate investment scheme scandals. In FY 2002, states contributed 18 percent of the national ADAP budget. As employer-sponsored health insurance declines and the numbers of the uninsured increases, the outlook for finding ways to fill in the gaps at the state level has grown increasingly grim. 

States have reacted by tightening eligibility requirements, capping enrollments, reducing drug formularies, and creating waiting lists. Patient Access Programs (PAPs) offered through pharmaceutical companies are an option, but the paperwork is time consuming for patients, doctors, and case managers. (With patients using three or more drugs in combination as standard treatment today, it is unlikely that all drugs needed by the individual will have been manufactured by the same pharmaceutical company, exacerbating the application process.) In a macabre Russian Roulette, PWAs are forced into a continuous holding pattern waiting for someone else to die, except that in today’s world—at least in the U.S.—fewer people are dying. AIDS related deaths have declined by over 64 percent and utilization of ADAP has increased by 154 percent since 1996, when protease inhibitors were introduced as a new class of HIV medicine and highly active antiretroviral therapy (HAART) that utilized multi-drug combinations became the standard for HIV/AIDS treatment. 

On average 25 percent of the 40,000 persons who test HIV positive each year in the United States will be found to have progressed far enough along in their disease that they require immediate medication. Of those, 600 individuals per month are eligible to apply for medication access from ADAPs. Treatment regimens available today can control the virus’ replication and forestall progression to the advanced diagnosis of AIDS, in some persons indefinitely. 

AIDS is clinically defined as a patient who has experienced an opportunistic infection or whose CD4 count falls below 200. The United States Department of Health and Human Services (HHS) Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents recommends that antiretroviral treatment be offered to all patients with 350 or fewer CD4 cells or over 55,000 viral load. Persons on ADAP waiting lists have been clinically diagnosed as meeting these guidelines with prescriptions in hand to prove it; nevertheless federal and state governments have ignored HHS guidelines by denying them treatment. 

Grassroots Action 

A t the 2001 Conference on Retroviruses and Opportunistic Infections (CROI) in Chicago, a handful of attendees brainstormed the idea of creating a new, broadly inclusive group of PWAs to address issues around new drug development, clinical trials and research, and treatment concerns such as side effects and adherence. Although some initially thought such a group might be redundant, others saw the need for “not an organization of organizations, but an organization of people,” said Fred Schaich, a founding member of ATAC (AIDS Treatment Activist Coalition). After two meetings facilitated and hosted by the Center for AIDS in Houston, ATAC was born, modeled after a successful European organization. 

ATAC soon saw the dwindling commitment to fund treatment access programs—both federally and in states. Restrictions on eligibility for ADAP assistance and waiting lists had appeared. A conference call in 2002 that attracted 20 participants to discuss waiting lists for ADAP resulted in what became an ATAC working group called Save ADAP. At first it operated as an unstructured “virtual” organization with communication exclusively via email. As of July 2002, no activists had been dedicated to ADAP funding, but before year’s end, 30 activists were roused to lobby for $160 million in Washington, DC for FY 2003. While they won only half of the requested amount, $80 million was considered a significant victory. 

By mid-year 2003, the severity of the crisis took hold. Everyone who is HIV positive can remember the shock of that first test result and the second reality check—sometimes years later—of being told the disease had progressed to a point where commitment to a treatment regimen would now define the rest of your life. No one could imagine the terror of being told you would have to wait a month, a year, or more, to receive medications. 

 A July 31, 2003 letter addressed to President George W. Bush from ATAC quoted the National Alliance of State and Territorial AIDS Directors (NASTAD) who reported over 500 U.S. citizens on state ADAP waiting lists. One hundred eighty-seven professional and grassroots organizations, coalitions, foundations, and networks co-signed the letter, even attracting the attention of an organization in Nairobi, Kenya.

An amendment to the House Labor/Health and Human Services Appropriations bill offered by Senator Charles Schumer (D-NY) that would have added $241.8 million to the FY 2004 ADAP budget was defeated on a starkly partisan vote of 53 to 44. A compromise between House and Senate resulted in a final increase of $35 million being passed, still $180 million short of need. 

 In October 2003 it was reported that five people who had been on Kentucky’s wait list had died. Two deaths had also occurred in West Virginia. Congress was flooded with over 2,200 personalized letters from HIV providers across the country responding to an extensive mailing campaign spearheaded by the American Academy of HIV Medicine (AAHIVM). NASTAD reported that, as of November 2003, the wait list had grown to nearly 700 people. 

In December, ATAC convened their first strategy summit at the Gay Men’s Health Crisis offices in New York City. The coalition’s Drug Development Committee was already established, working with the pharmaceutical industry and boasting representative liaisons to each company with approved drugs or drugs in clinical research. Save ADAP, in comparison, was relatively new and confronting an immediate crisis. Most of its members had never even met in person. The summit produced long-term strategy goals and established an effective communication structure. 

In January, Save ADAP launched its “Message in an Empty Pill Bottle Campaign.” Members of Congress and President George Bush received empty pill bottles with personalized labels and a message inside calling for support of a $180 million emergency supplement for ADAP. An ATAC-sponsored Washington, DC lobbying effort in February attracted clients of ADAPs, people on waiting lists and front-line workers representing 32 states. The 100 attendees helped create “the best grassroots event I’ve seen in 12 years,” said Ryan Clary of Project Inform. Fully 40 percent of the nation’s states were now affected in some way by budget restrictions. Members of Congress and President Bush received a letter signed by 450 organizations asking for $180 million emergency supplemental assistance for FY 2004. 

AIDS activists again converged on Capitol Hill in May for the annual AIDSWatch lobbying event organized by the National Association of People with AIDS (NAPWA). The three-day event was followed by a march, demonstration (that attracted nearly 1,000 participants), and civil disobedience on the steps of the Capitol during which 100 were arrested for unlawful assembly. 

Mid-March found the Bush administration’s grand plan for Medicare prescription drug coverage coming under the threat of investigation looking for threats and bribery, hiding information from Congress, and misuse of taxpayer dollars to pay for TV advertising for the questionable drug card plan. At the same time, the nation’s other medical insurance program, Medicaid, was being threatened with extreme spending cuts—this from a program that had already been eviscerated in varying degrees depending on the state. The Senate confronted an overall spending cut of 11 percent by 2009 in the Senate Budget Resolution. After receiving enormous grass-roots pressure, one week later the Senate voted to strip $11 billion in proposed Medicaid cuts from their FY 2004-05 budget resolution. 

The House blueprint of this resolution called for imposing binding restrictive caps for domestic discretionary programs, including Ryan White and ADAP, and cuts in entitlement programs, especially Medicaid, the HIV Medicaid Workgroup said. In June, the Labor/HHS appropriations subcommittee was reported to be “under enormous pressure to reduce spending to offset the nation’s mounting debt, recent tax cuts, and the escalating cost of war,” according to NAPWA. A stridently partisan Congress left Washington for August recess leaving these and other serious issues unresolved, assumedly until after the November elections. 

Behind such draconian squabbles, health of PWAs continues to be compromised. HIV positive people are ineligible for Medicaid until they become seriously ill and are determined to be clinically disabled with advanced stages of the disease. A Stanford University study found patients facing a “cruel choice: spend most of their savings on AIDS drugs until they are poor enough to qualify for Medicaid (HAART costs an average of $13,000 per year) or forego the drugs and wait until they are sick enough to qualify for [Medicaid] under medical eligibility rules.” The study found significantly lower death rates (66 percent less) in states with publicly insured AIDS patients given less-restrictive eligibility rules and more generous drug coverage. 

Abbott Arrogance 

I n December 2003, the HIV/AIDS community became furious over Abbott Laboratories’ announcement of a five-fold increase of ritonavir (Norvir®) from an average wholesale price of $130 a month to $650 a month for a 200mg daily dose. The drug had been best used to boost blood levels of other drugs in anti-HIV treatment combinations, after failing as a drug in larger doses. It was especially effective for those with few existing treatment options whose viruses had become resistant. 

 It was believed that Abbott’s rationale was that the drug’s use as a booster in combination with other drugs entitled it to raise the price to more closely match the prices of other protease inhibitors. Abbott had modified its patient assistance program to help individuals who needed Norvir and the price ADAPs pay for the drug had been frozen via previous negotiations through June 2005, but what would happen after was unclear. Plus, there was no deal for third-party insurers who would likely pass the cost on to patients’ out-of-pocket expenses. ATAC Drug Development Committee co-chair Matt Sharp called it “one of the most blatant and heinous acts of pharmaceutical greed I have seen in my 15 years of AIDS activism.” 

AIDS Treatment News editor and Save ADAP member John S. James wrote in an email, the “case may be the biggest unexpected, overnight prescription-drug price increase for a life-threatening condition in all of human history” and cautioned that people “outside of AIDS” should not “dismiss the Norvir increase because it’s for HIV and therefore doesn’t apply to them.” He said the “increase sets a precedent that can hurt almost anybody. And it moves us toward a world where the big advances of 21st century medicine will routinely be reserved for a rich or well-insured minority.” 

 Generic medicine supplier Essential Inventions, Inc. filed a petition to request Secretary of Health and Human Services Tommy Thompson to allow for the licensing of the drug as a generic because the medicine had been discovered in the performance of federal research grants awarded by the National Institutes of Health. The Bayh-Dole Act, passed in 1980, gives the Secretary authority to “march-in” on each patent and license other producers to supply U.S. consumers when necessary to alleviate health needs or because the patent holder has failed to make the invention available on reasonable terms. 

Illinois Attorney General Lisa Madigan, whose office is investigating Abbott, said, “Norvir is not like a hay fever medicine that people take to lessen symptoms to be more comfortable. It is a drug they take to survive.” An investigation by the Attorney General of New York, a California class action suit and a complaint filed with the Federal Trade Commission are all currently pending. 

Abbott Laboratories corporate offices were Fax-zapped. ACT UP/NY and ACT UP/Philadelphia members demonstrated at Abbott Laboratories’ Whip- pany, New Jersey manufacturing facility on February 19, chanting, “Abbott Lies, We Die: Drop the Price of Norvir.” Activists showered the facility with “blood money” and left a funeral wreath “in protest of deaths that will occur due to increasing pharmaceutical price-gouging.” 

On March 15, Abbott Laboratories publicly announced that chief executive Miles White’s total pay had increased 20 percent from 2002, totaling $3.4 million. “The inflated compensation package comes just weeks after Abbott Lab’s astounding announcement that they have increased the price of a key AIDS drug, Norvir, by 400 percent—inducing anxiety and alarm in many cash-strapped HIV/AIDS patients,” PRNewswire said. 

Physicians supported boycotts of Abbott research, consultation fees, and some products, with the American Academy of HIV Medicine and the HIV Medicine Association registering complaints. The National Institutes of Health held hearings on allowing a generic version of Norvir under the Bayh-Dole Act and the Food and Drug Administration issued a warning to Abbott about its marketing literature, which touted Norvir’s lowest price but for which the low dose offers no anti-HIV activity. 

 In July it was announced that an antitrust and restraint of trade lawsuit that had been filed against Abbott by the AIDS Healthcare Foundation (AHF)— the largest AIDS organization in the United States with clinics in the U.S., Central America, and Africa—had reached a settlement. But ADAP member and Project Inform founder Martin Delany was critical of the settlement and said that AHF had a “history of bargaining for its own interests to the exclusion of those in the community as a whole…. The net effect is that people are being forced, through the Norvir price increase, to fund AHF’s programs—without their consent.”

“The HIV/AIDS community will not cease its efforts to bring Abbott’s injustice and disease profiteering to the center spotlight of what is fast becoming an inflammatory debate on the future of healthcare in the U.S.,” said Thomas Gegeny, executive director of the Center for AIDS in Houston and ATAC member. “With any luck, the Norvir price hike will become a textbook example of what pharmaceutical companies should not do and may even push the envelope further toward reasonable price controls for lifesaving medications in the U.S.” 

ADAPs across the country, cash-strapped or not, have been reeling from the adjustment in accommodating the $20,000 a year wholesale price (three times as much as most other AIDS medicines) for the newest most expensive HIV drug on the market, Fuzeon (T-20). All previous antiretrovirals attack the virus after it enters T Cells. Fuzeon is first in a new class of drug called Fusion Inhibitors that target HIV on the outside before it enters T Cells and starts to replicate. The drug offers hope to patients whose virus has become resistant to all other approved drugs. Because Fuzeon is protein-based, the body’s digestive system breaks it down just as it does with food; therefore, it must be administered by subcutaneous injection. Fuzeon is first delivered to the doctor’s office where the patient is instructed on how to self-inject. Thereafter, it is delivered directly to the patient’s home in individual vials in powder form that has to be reconstituted under sterile procedures and allowed to sit for one hour prior to administering.  

Medicaid does not pay for the time it takes doctors to teach patients how to inject a drug, requiring HIV doctors to absorb yet another cost. A majority of insurance companies define drugs that must be injected as a medical treatment instead of a prescription product, covering the drugs at the same rate as an office procedure. That may mean a high deductible and then a payment of 20 to 30 percent coinsurance, which for Fuzeon could cost $4,000 per year, POZ magazine says. 

In a pattern that is being duplicated in other states, the Wall Street Journal (January 13, 2004) reported that North Carolina’s ADAP ran out of money for new patients two months after enrolling its first Fuzeon patient. Buying Fuzeon for one patient created a wait list for three others whose virus was not resistant to less expensive HIV medicines. 

Testing, Treatment, and Ethics 

V isiting with researchers and clinicians at the University of Alabama at Birmingham in January, HHS Secretary Thompson touted research that supports the need to treat HIV infections early because the cost of treatment is much lower and the outcomes better. Paramount to achieving that goal was the U.S. Food and Drug Administration approval in March 2004 of its OraQuick® Rapid HIV Antibody Test, the first test approved for use using oral fluid that produces results in 20 minutes. A jubilant Sen. Arlen Specter (R-PA) said it was a “giant step forward in combating the global AIDS crisis” by giving “new hope to those at risk of this dreaded disease.” Sen. Specter’s pronouncement was duplicitous since six months prior to this statement he had voted against the Schumer Amendment which, if passed, would have fully funded ADAP and truly guaranteed “new hope” for the global AIDS crisis.  

 The Center for Disease Control and Prevention has expressed alarm that an estimated 200,000 U.S. citizens are unaware they could be infected with HIV and supports an aggressive testing initiative to identify those individuals. With OraQuick at the ready, those people could be lining up at the doors of ADAPS nationwide any time now. Yet few elected officials have seriously pondered the ethics of testing for HIV in the “medically indigent” when they may not be able to access life-saving drugs through cash-strapped ADAPS, said Gordon Nary, executive director of Medical Advocates for Social Justice (June 24, 2003). 

“One might therefore question the morality of the national HIV testing outreach hype without the appropriate caveat” to explain there is no money to treat someone who tests positive. Nary suggests that in states where ADAP is closed or threatened with closure, “there is an implicit contract in HIV testing—if one agrees to be tested, then he or she will receive timely and appropriate treatment if the test is positive.” Failure to do so invites a reoccurrence of the “pre-HAART resistance to HIV testing when many at risk for HIV did not want to be tested or know their status since the therapies available…offered minimal hope.” 

 Writing in the Journal of Timely and Appropriate Care of People with HIV Disease (January 2004), J. Kevin Carmichael, MD advocates for establishing a minimum formulary that includes antiretroviral therapy, prophylaxis for opportunistic infections, and required immunizations. In the same journal, John Bartlett, MD, says some method of judging “severity of need” might be established. 

In the wake of President Bush’s Philadelphia speech, two successes have been reported, sans Bush. After New Mexico faced having to put patients on waiting lists in the near future, Senator Jeff Bingaman  issued a press statement in July calling for support of a $217 million funding increase in 2005 for ADAP and sent letters to the two top health care appropriators in the Senate. Soon after, Governor Bill Richardson directed the state secretary of health to explore options to reinstate $2.6 million into the HIV/AIDS budget and to reaffirm commitment to the Billy Griego AIDS Act, named for Sen. Phil Griego’s brother who died of AIDS. New Mexico had been looking at implementing restrictions during FY 04. 

Colorado’s 315 people on its ADAP waiting list have been given a reprieve on life due to a nearly $3 million influx from the state’s tobacco settlement, although it is described as a “one-time lift” to the program. Colorado has a “dismal record on providing life-saving drugs to uninsured people,” the Denver Post reported (July 16, 2004), coming in second only to Alabama in the number of people “languishing” on its wait list. 

 Initial information provided by the Kaiser Family Foundation soon after the Bush bailout only provided information on three states—Alabama, Arkansas, and Iowa. No other information has been provided to the public on other states as of the date of this writing. Kaiser reported that Alabama, with 353 on their list, would receive about $3.52 million ensuring that everyone would be removed from the list. The state had carried a waiting list since 1999, making it the longest-running list in the country. Arkansas was mentioned as not receiving funds because no one was on the wait list on the “official” date when counts were made on June 21. However, state health officials and doctors testified that the state’s appropriations were inadequate to meet state needs, and since then new people have been added to the list.  

Iowa was slated to have their 16 people served by the emergency funding. Arkansas, Colorado, Indiana, Oklahoma, South Dakota, Utah, and Washington were anticipating “other cost-containment strategies,” and Massachusetts, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, Oregon, South Carolina, and Texas anticipated new or additional restrictions during FY 04. With Colorado and New Mexico off the danger list at least for the near future, that leaves Alaska (with 7 people on lists), Idaho (13), Iowa (6), Kentucky (113), Montana (8), North Carolina (716), South Dakota (23), and West Virginia (35), quoting figures from June. 

Since the initial response from Kaiser on June 30, an eerie silence has prevailed. Bush’s bailout has yet to see delivery of any medications and the process has been steeped in such secrecy that Beltway insiders, professionals, and respected advocates have all been locked out of the process. Many AIDS Directors remain unsure whether their states will receive funding or how the assistance will be managed. 

 Lei Chou of the AIDS Treatment Data Network, an organization that monitors ADAP data, says their model had predicted the emergency 18 months ago. “Whether or not they get the care they need will be more of a matter of the state they live in than anything else. It has become a kind of geographic lottery.” If this scenario continues unchecked, the United States could begin to look like a third world continent, with states acting like individual countries and people engaging in migrations to states with the best AIDS programs. In fact, it has already been happening. 

Michelle Rachel England, MSW, social worker for the South Dakota Ryan White CARE Program, expressed such a sentiment in her press statement for a press conference that was held in conjunction with the Save ADAP legislative visits earlier this year. Working with two individuals from different African countries living in South Dakota for a time, she said, was an “eye opener.” When they returned to their countries of Ethiopia and Cameroon, both were able to access medicines more readily in Africa than in South Dakota. South Dakota is the only state that still does not pay for protease inhibitors, the one breakthrough class of HIV medicine that transformed the disease’s treatment options in 1996 and has become a standard of care protocol ever since.

To see how irresponsible fiscal management and disregard for a state’s most poor, needy, and sick plays out, just look at Oregon. Once one of the best places for people with HIV/AIDS to live, it became one of the worst in less than a year. After making drastic cuts in its Medicaid program, hundreds of people rushed to ADAP, which then responded by restricting eligibility, cutting the formulary and instituting co-pays, forcing clients to choose between rent, food, utilities, or medications. 

 Sane Solutions 

O ne option that would provide access to antiretroviral medicines before PWAs become seriously ill is the Early Treatment for HIV Act (ETHA). Modeled after the successful Breast and Cervical Cancer Prevention and Treatment Act of 2000, it would give states the option of readily amending their Medicaid eligibility requirements to include uninsured and underinsured, pre-disabled poor, and low-income people living with HIV. Treating HIV early, when it is more easily controlled, costs an average of $14,000 per year, compared to $34,000 per year if treatment waits until the patient has progressed to AIDS disability. 

A report by the Institute of Medicine (IOM) goes further than ETHA in strongly advising creation of a new national program with uniform eligibility, standard of care and benefits; and in ending the vast disparity between state ADAP programs that in many cases do not even provide for all FDA approved antiretroviral medicines or medicines that treat and/or prevent various serious infections inherent to the disease. It was found that Medicaid is unsuitable to meet IOM’s needs because of “statewide variability in eligibility levels and benefits and inadequate provider payments that encourage substandard care.”  

The report calls for the program to pay the same discounted prices for antiretrovirals as it does for the Veterans Administration and other federal agencies. Patients treated by HIV specialists for their first regimen show higher rates of success, significantly lowering the cost of their lifetime treatment. The recommendations suggest cost savings over 5 years of $7.35 billion dollars to the federal budget and $10.35 billion to states (in 2002 dollars). By changing funding from a discretionary program to an entitlement, the yearly appropriations process would be eliminated, allowing for more stability. 

 Yet another rational solution exists, one that embraces the elderly, as well as people with HIV/AIDS, heart disease, diabetes, cancer, hepatitis A, B or C, congenital deformities, and any other malady of human existence. Michigan Congressperson John Conyers has proposed the United States National Health Insurance Act (HR676) that would establish a new national health care insurance program by creating a single payer health care system using the already existing Medicare program and expanding and improving it to all residents. The bill’s summary says it would “guarantee…the highest quality and cost effective healthcare services regardless of one’s employment, income, or health care status.” It also identifies the current system as an “inefficient and costly fragmented health care system” and says it would “reduce overall annual health care spending by over $50 billion in the first year” by using “rational bulk purchasing of medications.” 

It could be argued that withholding medical treatment for people with AIDS is a form of control over a population whose only fault has been to be infected with a disease that incurred the most political interference and moralistic stigma of any in modern times. While difficult to admit, the exacerbation of multiple attacks on many fronts—from stifling comprehensive reality-based prevention messages that do not stop infection rates in marginalized populations such as gays and people of color where the epidemic still runs rampant to doling out medicines piecemeal while transferring billions of taxpayer money to support a war machine—looks a lot like willful and intentional genocide. Residents of New Jersey who participated in the Save ADAP Capitol Hill visits experienced firsthand the indifference typical of some Republican staffers. There’s a war going on, they were told, and sacrifices have to be made.