Criminal Counterfeits Threaten Patient Safety

In February 2021, a patient in New York City opened a sealed bottle of the HIV drug Biktarvy, took his pill, and found that he couldn’t walk or speak. The medicine in the bottle was actually Seroquel, an antipsychotic that can cause dangerous sedation and poses additional risks for patients with high blood pressure, diabetes, or low white blood counts. This patient’s experience reflects a worrying uptick in financial fraud, counterfeiting and drug diversion in the HIV medicine world since 2019. Read on to learn about recent court cases that shed light on the problem, and it threatens HIV patients.

Forged documents helped sell tens of thousands of bottles of questionable HIV meds 

Between February and April 2021, at least eight different patients found Seroquel, the wrong HIV treatment or, in one case, over-the-counter painkillers, in what appeared to be factory-sealed bottles of Biktarvy or Descovy. The Janssen Pharmaceutical Companies had warned about a similar issue in December 2020, when bottles labeled Symtuza turned out to contain Seroquel or Prezcobix, a different Janssen HIV treatment which contains half of Symtuza’s active ingredients, and won’t, by itself, control a patient’s viral load.

After investigating, Gilead Sciences and Janssen filed lawsuits against more than 70 defendants, including licensed distributors and pharmacies, who allegedly sold unsafe versions of HIV drugs acquired in nefarious ways. They used a variety of methods to get perfect looking bottles, including buying them at the street level from HIV patients who needed money. According to court papers and investigative journalists, the medicine the alleged criminals sold was unsafe: some bottles contained the wrong pills altogether, some were no longer factory-sterile because they had been opened and resealed, and all of them came with forged documentation.  According to Gilead, the ring made hundreds of millions of dollars by putting more than 85,000 fake bottles of its products on pharmacy shelves over a two-year period.

Florida HIV prevention medicine assistance program bilked of $68MM

In May, Gilead Sciences settled a lawsuit it filed in November 2020 to stop a scam run by 58 Florida-based clinics, pharmacies, labs and affiliated individuals. According to Gilead’s complaint, the defendants hired van drivers who visited sites like soup kitchens, public libraries, bus terminals, and churches to offer homeless and low-income people money to sign up to receive PrEP, which helps prevent HIV infection, through the program, regardless of whether PrEP was an appropriate treatment for them. Sometimes, after patients received the medicine they had never wanted, the drivers bought it back so that it could be resold into the black market. More than $68M of assistance was diverted from patients who actually needed help paying for their medicine and the scheme provided an avenue for more mishandled, secondhand and potentially expired medicines to reach patients.

Another $230MM in black market HIV drugs slipped into U.S. pharmacies

In June, the Justice Department (DOJ) indicted a Miami man for his alleged role in distributing $230 million in HIV drugs he had acquired illegally. According to the DOJ, he and his co-conspirators established licensed wholesale drug distributors in four states and used them, with false documentation, to sell the medicines at a discount to other co-conspirators running distribution companies in Mississippi, Maryland, and New York. Ultimately, those treatments reached pharmacies, and patients across the country.     

We’re likely to hear more about rings like this; according to the Wall Street Journal, the Department of Justice launched a criminal investigation that involves products from at least 12 drugmakers.

Resold and diverted drugs threaten patients

Patients in the early years of the HIV/AIDS epidemic pooled resources to share medicines with those who could not access new treatments. No one could ensure that those drugs were safe and effective, but community action was critical, and it saved many lives. These days, regulated, safely manufactured HIV medicines are available through public and private insurance and through assistance programs. By steadily controlling viral loads, these drugs help people live long, healthy lives.

These medications only work, however, if patients take the right pills with the right ingredients all the time—and there’s no way to ensure that that’s happening if black market drug rings are breaking into the drug supply. In these cases, vast networks of drug diverters and counterfeiters are enriching themselves while endangering the lives of people living with HIV/AIDS, and they must be stopped.

The scale of these crimes—committed in the last three years— is staggering. The last major drug counterfeiting charge was pegged at around US$80mm, and just this year we’ve had three cases, each one of them around that size or larger. While law enforcement and brand protection attorneys are actively using every last civil and criminal option to protect patients, patients can also take steps to protect themselves using the tips in HIV survivor Brandon Macsata’s recent PSA about counterfeits. PSM urges all HIV patients to take two minutes to learn how to stay safer.