Counterfeit HIV Meds Are Endangering Some of America’s Most Vulnerable People
Brandon Macsata urgently needed his medication. Most people who are diagnosed as HIV positive have the virus for several years before it becomes full-blown AIDS, but Macsata, like a small portion of people, went from HIV positive to AIDS in a matter of weeks.
“I was very, very ill,” says Macsata, who was diagnosed in 2001. “I was desperate. I needed the drugs.”
Macsata was working at a disability advocacy organization at the time and was shocked to discover that his insurance plan had a $1,000 cap on individual prescriptions. His prescription cost $1,300 a month. In 2022, the $1,000 cap would be worth approximately $1,600 and still wouldn’t cover the monthly cost of some antiretrovirals (ARVs).
He paid $1,300 out of pocket for his first month of medication. Then he researched online and found that he could order the same medication from Canada for $450 a month. So he did that for five months, until his physician found out and told him, in no uncertain terms, how dangerous online medication orders can be. When he ordered online, Macsata had no idea if the medications were actually coming from Canada, or through a legitimate pharmacy, or if they were counterfeit.
Macsata was fortunate: He didn’t have any adverse effects from the online medications, and he stopped ordering his meds online. His doctor helped him apply for the AIDS Assistance Drug Assistance Program (ADAP). He received help paying for his medications for six months until he was able to obtain another health insurance policy.
Macsata is now the CEO of ADAP Advocacy Association, an organization that works to provide prescription assistance to people with HIV/AIDS. As a result of his own prescription experience, he now uses his blog to warn others of the risk of counterfeit medications. He advises people with HIV/AIDS to advocate for themselves by checking their medication refills to make sure they’re identical to their previous prescription.
“I am the last line of defense against counterfeits,” he says in a PSA for ADAP. “If you spot differences, then take questions to your pharmacist or call the manufacturer’s quality hotline.”
The medication Macsata and the people he represents take are antiretrovirals, which stop the HIV virus from reproducing itself and allow the immune system to heal. They are available as a combination of pills taken daily or injections given every two months, and they can cost up to $6,000 a month. People with HIV/AIDS who skip medication doses or who try to stretch out their medication run the risk of weakening their immune systems and allowing the virus to multiply quickly.
Counterfeit ARVs are a longstanding problem, and counterfeiters are aided, in part, by street sales of the drugs, when people living with HIV selling their medications. AIDS advocates say that’s a symptom of larger, interconnected, and unaddressed problems: a stigmatized chronic illness, drug pricing, and poverty. When ARVs are sold and end up in the hands of counterfeiting networks, the drugs are either resold, sometimes in combination with other illegal drugs to enhance their effect, or the appearance and markings of the ARV are used as models for fake medication.
In a 2016 study, Antonio Saravia, associate professor of economics and director of the Center for the Study of Economics and Liberty at Mercer University, found that Black men with HIV/AIDS in Atlanta sold their medications because the rent was due, they needed food, or they had some other personal expense. To a lesser extent, Saravia says, some of the men sold their medication to obtain illegal drugs.
“I have to sell in order to eat, get food, personal hygiene,” one study participant told him. “And If I come up on extra money, I buy it back.”
Atlanta has one of the highest rates of HIV/AIDS in the country. A report published by Emory University in 2018 revealed that some ZIP codes in Atlanta have rates of HIV infection that are six to eight times higher than the national average, and rival those of African cities like Harare in Zimbabwe or Durban in South Africa, two countries whose rates of HIV diagnoses are among the highest in the world.
Dazon Dixon Diallo founded the Atlanta organization SisterLove in 1989 to ensure the concerns and voices of women stayed at the forefront of AIDS-related research, public policy, and services. SisterLove is the first women’s HIV, reproductive, and sexual health justice organization in the Southeastern United States; it offers free HIV testing and education, and does policy advocacy. Diallo thinks the high HIV rates in Atlanta result from several factors: It’s an urban area in a part of the country marked by political and social conservatism, and HIV/AIDS are still stigmatized conditions.
“Because we are in the South, we are decades behind,” she says. “We are behind in service delivery. We are behind in education, and we are segregated, as far as health services are concerned.”
Diallo says her organization serves “everyday people,” each of them with a unique relationship to HIV. She says most SisterLove clients are in monogamous relationships and come to the organization for information or to get tested because their partner has engaged in sex with other people.
“These are folks who need more information,” she says. “They want to know how to get the best from their sexual health.”
Getting the proper medication at the proper dosage is vital for anyone diagnosed with HIV, but it is particularly important for Black people. ARVs reduce levels of the virus in the bloodstream, and can reduce it to the level of being undetectable, at which point the individual can no longer transmit the virus. However, as many as one in five Black people do not get diagnosed until they have full-blown AIDS, meaning they’ve had the HIV virus untreated for several years. Even with the correct ARVs, it is sometimes difficult to reduce the viral load or to maintain the reduction in Black people living with HIV/AIDS. The stressors of living in poverty, which may include inconsistent medical care, add to the challenge of decreasing the viral load.
Diallo believes the fact that some Atlantans with HIV/AIDS sell their medications points to the impossible choices that come with poverty.
“We’re still hoping for people to get consistent healthcare that is affordable and accessible regardless of whether you work or not,” she says.
Although the state-run AIDS Drug Assistance Program (ADAP) helps people with low incomes pay for their medication, Diallo says not everyone qualifies for the program. Some people earn too much to qualify but don’t have health insurance and don’t earn enough to buy insurance that would cover their medications. The exact income requirements for ADAP, a federally funded program, vary from state to state, but applicants are required to have a low income as defined by that state’s ADAP, little or no insurance, and an HIV diagnosis. In most states, HIV diagnosis and other documentation must be reconfirmed every six months. In recent years, some states have adopted cost-saving measures by limiting how many people receive ADAP. As a result, several states now have ADAP waiting lists.
Drugmakers Gilead Sciences and Johnson & Johnson have civil lawsuits underway to halt the distribution of counterfeit versions of their ARVs.The Gilead Sciences lawsuit names 22 defendants allegedly responsible for distributing $250 million worth of two ARVs. As a result of the company’s investigation, 85,000 counterfeit bottles of medication and fake medication sales documents were confiscated before being sold to the public. Johnson & Johnson, in a lawsuit filed in New York federal court, is asking for $25 million in damages from defendants who allegedly sold counterfeit medication through a pharmacy in New York. The lawsuit states that the counterfeiting ring allegedly made millions of dollars from selling counterfeit ARVs and the pharmacy shut down abruptly in January 2022 when the counterfeit operation was uncovered.
Counterfeited drugs are usually sold via shady websites, but in recent cases, counterfeit ARVs were sold wholesale to legitimate pharmacies and passed along to consumers. As Macsata was warned, counterfeit medications can be dangerous for a few reasons: they don’t contain the genuine medication’s active ingredient; they contain the active ingredient but not an appropriate amount of it; or the medication has been switched with another medication entirely.
Gilead Sciences was alerted to an apparent counterfeit scheme when it started receiving complaints about unusual drug reactions and reports that its ARVs suddenly stopped being effective. The Johnson & Johnson lawsuit followed similar customer complaints. According to the Gilead Sciences lawsuit, one pharmacy patient purchased a counterfeit ARV that had been switched with a powerful anti-psychotic medication. After taking it, the individual could not speak or walk.
“These are highly sophisticated criminal operations,” says Jen Laws, CEO of Community Access National Network (CANN), a New Orleans-based organization that works to promote and improve healthcare and support for people living with HIV/AIDS.
Laws is not a newcomer to the issue of counterfeit ARVs. CANN, in conjunction with Partnership for Safe Medicines, released a highly publicized alert in 2014 warning that there were irregularities in insurance billings with people who had no HIV diagnosis being billed for HIV medications. This was a red flag that certain ARVs had been targeted for counterfeiting.
Laws’ organization continues to monitor for counterfeit activities and works to keep pharmacists and consumers informed.
HIV medications aren’t the only medications that are being counterfeited. Counterfeiters have produced fake medications for Hepatitis C, fake insulin, and even fake medications used to treat certain cancers.
Laws, Diallo, and Macsata are hesitant about increasing police involvement with people selling their medications. They don’t believe it solves a problem that is often the result of poverty.
“One of the biggest problems, especially in the HIV space, is blaming patients for not having access to healthcare,” Laws says.
But he also says that tracking counterfeit medications is largely left to drug manufacturers, who are ill-equipped to do that work. He advocates for a coordinated international effort in tracking down counterfeiters, who are making millions by selling counterfeit medications in the U.S. and other countries. And both Laws and Diallo believe that public policy addressing the unmet needs of people living with AIDS will help solve the issue.
“In particular, private-industry payers have gotten very, very creative at figuring out how to deny coverage of care,” Laws says of insurance companies that sometimes make it difficult for patients to get the healthcare and medications they need.
Despite the current lawsuits, counterfeit ARVs are unlikely to disappear entirely. Laws advises people taking ARVs to protect themselves by purchasing their medications from a trusted pharmacy and never ordering medications online. He also offers a calming assurance to those who might accidentally acquire counterfeit medication in the future.
“There’s nothing that cannot be fixed. [You’re] entitled to good healthcare,” he says. “[You’re] entitled to safe medication.”
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Elaine Shelly, Khareem Sudlow
