For many Facebook users, it's increasingly common to see ads asking them to join a class action lawsuit against Gilead, the makers of HIV drugs like Truvada and Genvoya. Most of the ads seem innocuous, featuring language used by similar kinds of personal-injury legal advertisements promising to "get you the money you deserve," as injury-firm TV spots so often say. But they may be having an unintended, and potentially harmful, effect on people's willingness to take these drugs for HIV prevention or treatment.
The ads don't have anything new to say about the safety of tenofovir-containing drugs like Truvada. Any person who has begun a regimen with Truvada has long been informed that it may affect kidney function or bone density. But these ads also claim that Gilead, the maker of these drugs, might be liable if you've experienced any of these detrimental side effects.
The ads often strike an odd balance. On the one hand, they assure you that you can have a hand in making sure a pharmaceutical company gets its rightful comeuppance. But, for those who may see the ad and are not on the drug, these ads potentially induce worry that they, too, may one day experience harmful side effects.
Origin of a Lawsuit: TDF vs. TAF
The flurry of ads first appeared after two Southern California gay men filed a lawsuit against Gilead in May 2018, after they discovered that the drug manufacturer appeared to delay development of a safer tenofovir forumlation to maximize its profits. At the heart of the lawsuit is Gilead's alleged decision to delay the development and release of the drug tenofovir alafenamide (TAF), which has a safer toxicity profile than tenofovir disoproxil fumarate (TDF), the formulation of tenofovir that has been among the most popular drugs in HIV treatment regimens this decade -- and part of the only regimen currently approved for PrEP.
Because of the way U.S. patent law works, some people allege that Gilead delayed the development of TAF in order to keep the patent on TDF-containing drugs like Truvada. This would allow for separate patents for TDF and TAF, and make them each last as long as possible. Gilead could present TAF as a new drug instead of as a new formulation of TDF, which would have only extended the original patent's life.
According to the Los Angeles Times, the lawsuit claims Gilead deliberately put patients' kidneys and bones at risk by not developing TAF sooner.
"A company I trusted with my life took advantage of that trust by misrepresenting the side effects," Los Angeles resident Michael Lujano, one of the plaintiffs, told the Times. "Gilead shelved a far safer drug … simply to increase its long-term profits."
The ads began to pop up earlier this year, after California superior court judge Carolyn B. Kuhl turned down Gilead's request to dismiss the lawsuit.
Are Truvada Lawsuit Ads Going Too Far?
Some advocates are happy to see Gilead's feet held to the fire for its alleged wrongdoings. But some are worried that the law firms behind the Facebook ads are misrepresenting the nature of the case and don't have the breadth and depth of information they need.
"Some of these ambulance-chasing firms, when they Googled 'Truvada,' all they saw was PrEP -- and that's become part of their advertising. And it's a disaster, it's a mess," said longtime HIV activist Peter Staley, who is also a member of the prevention-based activist group PrEP4All.
While some people who take pre-exposure prophylaxis (PrEP) do experience side effects, most of them are negligible and reversible, according to clinical trial data. Those who bear the brunt of TDF's toxicity are people living with HIV who have taken TDF along with drugs like Norvir (ritonavir) or Tybost (cobicistat). Staley warned that any law firm whose advertisements focus on PrEP or use pictures of the sky-blue Truvada pill probably do not understand the nature of the original lawsuit.
These ads are not only on Facebook. Googling "Truvada side effects" will, for example, lead a user to lawfirm-sponsored ads that lead with the words "Osteoporosis or kidney damage -- caused by HIV drugs?" Those who click through are led to a site from attorneys Ketterer Browne & Anderson that warns that "serious side effects" of Truvada were "kept secret." Some of these firms have also begun placing ads on daytime television.
Of course, for many who are seeking money from Gilead, the problem is not that the drug company allegedly downplayed side effects. After all, those side effects have to be clearly labled on medications as part of the Food and Drug Administration's approval process. Physicians also warn patients of minimal side effects as part of the onboarding of Truvada, or any drug. Rather, the issue is that Gilead potentially withheld a safer formulation of the drug that could have helped patients avoid kidney or bone problems in the first place.
TheBody contacted a number of firms featured in these ads to seek their comments for this article, including Ketterer Browne & Anderson, the Texas-based law offices of Craig Eiland, and National Injury Advocates. Ketterer Browne & Anderson did not respond as of the time of publication. Eiland's team, after a few weeks back and forth, said they were not available for comment because the firm was in the middle of a jury trial. And National Injury Advocates ultimately canceled a scheduled phone call with an attorney and several other people at the firm. In early August, one lawyer said the firm's attorneys would be willing to go on the record about the case if they saw some questions in advance to prepare. When TheBody supplied them with questions, National Injury Advocates said the appropriate attorneys would respond in a timely manner. After three follow-up emails, our questions have gone unanswered.
Despite Appeal for Some, Truvada Lawsuit Ads May Damage PrEP Cred
TheBody spoke to one HIV-negative person, who chose to remain anonymous, who contacted a law firm through one of the Facebook ads. He says that after he began taking PrEP he began to feel "excruciating" joint and bone pain, to the point that he stopped going to the gym. Though his doctor did not link the pain to his Truvada use, he stopped taking the pill, as the pain caused him to lose sleep.
After contacting a Midwest-based firm through Facebook, he had a phone consultation, after which the firm sent him a questionnaire to fill out and forms to sign. They didn't ask for any money upfront but did say that, as is standard, they'd take about 40% of anything he earned from the class action lawsuit.
He said he contacted the firm because he wanted to make Gilead "accountable for having a pill with less side effects."
Some of the ads from law firms play on long-held fears regarding the toxicity of HIV meds. Though no medicine is without side effects, many of these fears are holdovers from the time of AZT, when incorrect dosing was toxic. Yes, there are side effects to many HIV meds, but modern regimens are rarely dangerous.
Leandro Mena, M.D., M.P.H., founding chair of the department of population health science at the University of Mississippi Medical Center and director of the Center for HIV/AIDS Research, Education and Policy at the Myrlie Evers-Williams Institute for Elimination of Health Disparities, told TheBody in an interview that several patients have raised questions about these ads with staff at the clinic where he works. According to Mena, a patient texted him an attorney ad, asking him if he should be worried.
"These ads are really undermining our efforts to mitigate the concerns and fears that people have about the potential side effects of taking Truvada for PrEP," Mena said. "They are undoing work done in the HIV community to educate people at risk and improve access to PrEP."
Mena says it's hard to gauge whether the ads have influenced people to discontinue their PrEP regimen. He said many people who stop taking PrEP don't return to his clinic, making follow-up difficult. However, he added, side effects are one of the main concerns potential PrEP users raise prior to taking the drug. These ads play into those worries.
Prior to starting patients on PrEP, Mena says that each patient is made aware of potential side effects as part of the informed consent process. In his time prescribing Truvada to hundreds of patients, both HIV negative and HIV positive, Mena says he's only stopped the drug due to adverse kidney effects for one person. That person, Mena adds, also had other health issues that affected their kidneys.
"We share with [potential clients] the trial data that shows that these harms are really rare and the side effects are very infrequent," he said. "In the young population we care for, these complications are even rarer."
Mena added that Truvada is one of the most common antiretrovirals used in the world. In fact, the World Health Organization's guidelines for HIV treatment prescription begin with TDF alongside two or three more drugs. "Like any drugs," he said, "there are risks. But the benefits outweigh any risk that it may have."
On Facebook, where many of these ads appear, activists have also used the platform to express their dismay. In the ACT UP New York Facebook group, one member wrote, "I know we all hate Gilead and are working to lower the price of PrEP. But now I'm seeing people avoid PrEP, due to ads like this that completely exaggerate the risks of Truvada. How do we hold Gilead accountable for its bad behavior without scaring people? How do we counter all these ads, which are destroying years of hard work to get people on PrEP?"
In PrEP Facts, a private group dedicated to PrEP that boasts over 21,000 members worldwide, a member posted a screenshot of an ad from a page called, "Truvada Injury Claims," that was taken down after he reported it. He called the taking down of the post "a small victory" in his caption. Several other members reported hearing people say that the ads were scaring away potential PrEP users. Others said that they have begun to use Facebook's "report" feature on the ads daily.
Involvement of AIDS Healthcare Foundation Gives Some Pause
Complicating the matter is that some of the earliest lawsuits against Gilead are funded by AIDS Healthcare Foundation (AHF), a massive U.S. HIV service provider and a longtime bogeyman of the PrEP activist community. Under the "Global News" and "News" tabs on its website, tucked away among stories about AHF's domestic and foreign initiatives, are stories about the pending lawsuits. They include a quote from attorney Liza Brereton, who is identified as a member of HIV Litigation Attorneys, a firm that helped 41 patients who took Truvada either for HIV treatment or prevention to file lawsuits against Gilead. Brereton is also, according to one of the articles, legal counsel for AHF.
"More and more plaintiffs are coming forward to tell their stories of how they have been harmed by Gilead's practice of putting profits over patient health. We look forward to working with this new group of plaintiffs from around the country to hold Gilead accountable and seek justice for the people it has harmed. We will continue filing lawsuits against Gilead regarding its TDF medications," Brereton told AHF.
AIDS Healthcare Foundation had not responded to TheBody's request for comment by the time of publication.
Cori Blum, M.D., AAHIVS, medical director of new initiatives at Chicago's Howard Brown Health, wrote a recent op-ed in Positively Aware decrying the lawsuits.
In the op-ed, Blum called the ads "hyperbolic" and "misleading" and said they cause "unnecessary fear, confusion and anxiety." Blum also indicated, like Mena, that patients were asking health care providers and clinic staff about the ads.
According to Blum, some people taking Truvada discontinued their PrEP use because of the ads without consulting their physicians, "leaving a gap in prevention that could lead to more new HIV infections."
Blum points out, as Mena did as well, that these lawsuits may use alarming language, but are peddling information that every patient should already know before they take their first pill: that Truvada comes with the risk of certain side effects, which are often negligible or reversible.
Activist Peter Staley contends that it's the responsibility of these firms to use less alarmist language, and to do their homework. "The ambulance chasing law firms are way out of bounds," he said. "This is not a PrEP case."
Staley says that the damage from the ads is twofold: The ads prioritize the minimal damage that Truvada may have done to some HIV-negative people over the real damage TDF has done to people living with HIV, while also scaring off people who could benefit from making PrEP a part of their HIV prevention regimen.
"The advertising is causing huge damage to community efforts to convince people to look at PrEP," Staley said. "It's going to be a lot of meetings with these Better Call Saul outfits and educating them on this history of HIV and AIDS prevention and saying, 'Do you realize that you're killing people?'"
He added, "Hopefully activists will get our asses in gear and try to chase down every ambulance chaser and fix this problem, because it's a mess."