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  • Ren Morrill

About Those Truvada Lawsuits...

By now you have probably seen some posts or ads on social media about lawsuits concerning Truvada's safety. These ads, bought and paid for by personal injury firms, use misleading language to suggest Truvada for PrEP causes harmful effects on bone density or the kidneys. The scientific evidence continues to show that PrEP, whether it's Truvada, Descovy or the generic version of Truvada, is safe. Nevertheless, we wanted to take a closer look at these ads, their claims, why you are seeing them, and most importantly, why they can be safely ignored.


Have there been any actual lawsuits?

Yes, but it's not quite what you think. There are currently several, on-going lawsuits concerning Truvada neither of which have anything to do with the actual safety of Truvada for PrEP. Peter Staley, et al. v. Gilead Sciences, Inc., et. al., is an antitrust lawsuit that claims Gilead was motivated by profit to engage in the evergreening of Tenofovir (TDF) patent.


To understand why this is a potential problem we need to do a little history on Truvada. Tenofovir was created in 1984 in Europe, but was purchased by Gilead in the 1990s after its potential as a treatment for HIV was discovered. Gilead and University of California, San Francisco modified the drug so it could be taken by mouth (at the time which it only effective if taken intravenously). This is the drug we know today as tenofovir disoproxil fumarate or TDF. TDF was approved by the FDA in 2001 for treatment of HIV (and later hepatitis B), and sold under the brand name Viread or under other brand names in combination with other HIV medications, such as Truvada.


Right around the time of the FDA approval for TDF in 2001, Gilead published evidence about a different formulation of the drug, tenofovir alafenamide fumarate (or TAF for short). TAF showed promising evidence that it offered the same or potentially even better treatment for HIV with a significantly lower dosage. Mysteriously in 2004, Gilead appeared to shelve TAF for treatment in favor of TDF. Then, in 2010, as the patent expiration date for TDF was nearing expiration, TAF once again began appearing in Gilead's development schedule, but now as an entirely new drug. By 2016, TAF had received FDA approval, and began appearing in combination with other HIV medications. Gilead began to encourage providers to switch their patients to these new drugs, one they held the patent for.


With that in mind, Peter Staley, et al. v. Gilead Sciences, Inc., et. al. claims that Gilead shelved TAF in order to save it for when the patent on TDF ran out. This lawsuit is about breaking Gilead's patent not about the safety of Truvada for PrEP. The goal here is to make HIV medications more affordable over all not to raise safety concerns.


Gilead Sciences Inc. v. USA was brought by the Federal Government in 2019, and it contends that while Gilead owns the patent for Truvada, the Center for Disease Control and Prevention owns the patent for PrEP. While this lawsuit does concern PrEP, the safety of PrEP is not being disputed. This lawsuit is intended to break Gilead's patent on PrEP which could mean drastic reductions in consumers costs for Truvada for PrEP.


Why Are We Seeing These Ads and What Do They Mean?

The short answer is because they can. Facebook in particular has been criticized for allowing misleading political information on to its platform, but this also includes incorrect health information as well. Social media companies do a poor job gate keeping what kinds of ads appear on their platform. Anyone can buy an ad on social media, and there is very little oversight concerning the accuracy of claims made. These ads were bought and paid for by personal injury firms seeking to profit using misleading claims, scare tactics, and stigmatizing language. The hope is that these personal injury firms can take advantage of the public's misunderstanding of complicated legal matters for their own gain.


The outcry has caused Facebook to recently make show of removing the ad. Even members of congress have called for their removal, but they continue to appear on Facebook's platforms as more firms purchase ad space. Links to websites with misleading language promoting personal injury lawsuits appear in the top searches on search engines as well. Despite theses ads being misleading and harmful to public health it's not clear what can be done about them. This is why it is so important that we are getting our health information from public health experts and clinical providers not ads on Facebook.


So Is PrEP Safe?

Yes. The information these ads are trumping up isn't new. The side-effects of Truvada are known, and these law firms are using the known side-effects of Truvada to mislead the public into thinking that the drug is dangerous. The potential impacts on kidneys and bone density are well documented, and while some people do have side-effects from Truvada, the vast majority of people taking Truvada for PrEP have negligible side-effects.


The key take away here is that these ads are designed to get your attention by stoking fear through misleading information. The antidote to that is reputable, evidence based education. Here is a great piece over at the San Francisco AIDS Foundation's blog by nurse practitioner Jonathan Van Nuys that dispels much of the misleading information about PrEP safety being pushed by these ads. If you still have questions PrEP207 can answer them or get you in contact with a provider who can.


Is Descovy for PrEP Better Than Truvada?

We talked about this in a little more depth in our last blog post, but the answer is no. Truvada and Descovy are quite similar, and work equally as well.


Conclusion

The ads on social media aren't based on medical science or evidence. They are opportunistic lawsuits designed to profit from fear and misleading information. The reason you might have seen them more often than the abundance of media coverage disputing the ads's claims is because the firms bought and paid for the space on social media. Don't be fooled by their misleading claims. Healthcare providers and public health authorities all agree that PrEP remains safe and well tolerated by most people who want to use it as a HIV prevention option.


Got questions? We've got answers. Don't hesitate to contact us at 207-553-PREP. We'll do our best to answer them, and anything we can't handle our great clinical partners can!



References & Further Reading

Daskalakis, D, et al. “Misleading Ads About PrEP Are Threatening Progress to End the HIV Epidemic. They Must Be Removed.” For the HIV/AIDS Workforce, TheBodyPro, 7 Nov. 2019, www.thebodypro.com/article/misleading-prep-ads-must-be-removed


“Facebook Removes False HIV-Prevention Ads after LGBTQ+ Outcry.” The Guardian, Guardian News and Media, 30 Dec. 2019, www.theguardian.com/technology/2019/dec/30/facebook-prep-hiv-ads-removal


Fitzsimons, Tim. “U.S. Sues Gilead, Claiming It Owns HIV PrEP Patent.” NBCNews.com, NBCUniversal News Group, 7 Nov. 2019, www.nbcnews.com/feature/nbc-out/u-s-sues-gilead-claiming-it-owns-hiv-prep-patent-n1078346


Gilbert, Ben. “Facebook Ads Are Misleading People about the Effects of a Major HIV Prevention Drug, Putting 'Real People's Lives in Imminent Danger,' Health Advocates Say.” Business Insider, Business Insider, 10 Dec. 2019, www.businessinsider.com/facebook-hiv-prevention-drug-ad-misinformation-2019-12


Highleyman, Liz. “CDC Has Patents on PrEP, Advocates Find.” POZ, 17 Oct. 2019, www.poz.com/article/cdc-patent-prep-advocates-find


Knox, Liam. “Facebook's 'Inaccurate' HIV PrEP Ads an 'Imminent Danger,' LGBTQ Groups Say.” NBCNews.com, NBCUniversal News Group, 11 Dec. 2019, www.nbcnews.com/feature/nbc-out/facebook-s-inaccurate-hiv-prep-ads-imminent-danger-lgbtq-groups-n1099716


Nuys, Jonathan Van. “Truvada Lawsuit Ads Are Misleading.” San Francisco AIDS Foundation, 16 July 2020, www.sfaf.org/collections/beta/truvada-lawsuit-ads-are-misleading/


Romm, Tony. “Facebook Disables Some Misleading Ads on HIV Prevention Drugs, Responding to Growing Outcry.” The Washington Post, WP Company, 30 Dec. 2019, www.washingtonpost.com/technology/2019/12/30/facebook-disables-some-misleading-ads-hiv-prevention-drugs-responding-growing-outcry/


Rowland, Christopher. “An HIV Treatment Cost Taxpayers Millions. The Government Patented It. But a Pharma Giant Is Making Billions.” The Washington Post, WP Company, 27 Mar. 2019, www.washingtonpost.com/business/economy/pharma-giant-profits-from-hiv-treatment-funded-by-taxpayers-and-patented-by-the-government/2019/03/26/cee5afb4-40fc-11e9-9361-301ffb5bd5e6_story.html


Rowland, Christopher. “Gilead Is Accused of Cutting Anti-Competitive Deals to Extend Profit on HIV Drug Combinations.” The Washington Post, WP Company, 14 May 2019, www.washingtonpost.com/business/economy/gilead-is-accused-of-cutting-anti-competitive-deals-to-extend-profit-on-hiv-drug-cocktails/2019/05/14/94e79c56-75ad-11e9-bd25-c989555e7766_story.html


Straube, Trenton. “AIDS Activists File Antitrust Lawsuit Against HIV Drug Manufacturers.” POZ, 14 May 2019, www.poz.com/article/aids-activists-file-antitrust-lawsuit-hiv-drug-manufacturers#search-query=Peter%20Staley,%20et%20al.%20v.%20Gilead%20Sciences,%20Inc.,%20et.%20al


Victor, Daniel. “Trump Administration Sues Gilead, Maker of H.I.V.-Prevention Drugs.” The New York Times, The New York Times, 7 Nov. 2019, www.nytimes.com/2019/11/07/business/gilead-truvada-hiv-lawsuit.html


Wilder, Terry. “Oral Arguments in Antitrust Case Against HIV Drug Companies Began Last Week. Plaintiff Peter Staley Explains the Case.” For the HIV/AIDS Workforce, TheBodyPro, 28 Jan. 2020, www.thebodypro.com/article/peter-staley-oral-arguments-in-antitrust-case-against-hiv-drug-companies

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