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Author Topic: Lawsuit Claims Gilead Delayed a Less Toxic Version of Tenofovir (TAF) :o  (Read 4070 times)

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Offline hiv_rizzy

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  • Posts: 139
  • Male. 28. Positive
I hope this is the right forum for this... What do you guys think about the accusations?? If this is true then I'm so disappointed. Side effects of higher bone and kidney toxicities could have been avoided for years

Link source:  POZ Newsfeed
https://www.poz.com/article/lawsuit-claims-gilead-delayed-release-less-toxic-version-hiv-med-tenofovir


Since its approval in 2001, the med tenofovir has become the most prescribed HIV drug in the world, earning about $11 billion each year for its manufacturer, Gilead Sciences. As the Los Angeles Times reports, a lawsuit against Gilead by AIDS Healthcare Foundation (AHF) claims that the pharmaceutical giant delayed the development of a newer and safer version of the med in an attempt to extend its patent.

 

The original version of the drug, tenofovir disoproxil fumarate (TDF), sold as the brand-name Viread, can be toxic to kidneys and bones. More than 10 years ago, Gilead developed a newer, less harmful version called tenofovir alafenamide (TAF), but after promising results from clinical trials, Gilead stopped research into the med. In 2010, research resumed, and in November 2015, the new med received approval from the Food and Drug Administration (FDA).

TAF is included in several new combo tablets, including Genvoya, which is an updated version of Stribild. However, TAF is not approved for use as pre-exposure prophylaxis (PrEP), the daily prevention pill taken by people who are HIV negative.

 

The lawsuit by AHF claims that Gilead could have developed the safer version sooner but failed to do so in order to increase its profits and patents. “That’s a decade of potentially avoidable kidney and bone toxicity,” AIDS advocate Tim Horn of Treatment Action Group, told the Times.

 

The article also points out that in the early 2000s, the FDA had sent warning letters to Gilead because the company’s sales reps were downplaying TDF’s risks to bone and kidney health.

 

POZ founder and long-term survivor Sean Strub is quoted in the Times story as a person whose bones deteriorated after taking the original tenofovir. He began taking the med while in his 40s and within a few years had the bones of an 85-year-old woman.

 

According to the newspaper, Gilead says it originally stopped research on TAF because it was focused on developing a new type of HIV med called an integrase inhibitor.

 

AHF, which operates HIV clinics across the globe, filed the lawsuit against Gilead on April 11, 2016. You can read the entire document at an LA Times link here, but below is an excerpt from the lawsuit:

 

“In a relentless effort to maximize its profits, Gilead manipulated the patent system and engaged in anticompetitive practices to prevent economical access to TAF—an antiviral agent used in the treatment of HIV. TAF is not a new compound. TAF is a prodrug of the compound Tenofovir, which was first synthesized over thirty years ago in the Czech Republic. Nor was TAF the first prodrug of Tenofovir. Several years before Gilead obtained a patent on TAF, Gilead had patented a similar prodrug called Tenofovir Disoproxil (“TDF”). Despite similarities between TAF and TDF and the weakness of the patents covering TAF, Gilead illegally seeks to extend the period of patent exclusivity for drugs incorporating Tenofovir by decades.

 

“Gilead’s attempt to extend the period of patent exclusivity for drugs incorporating Tenofovir arises from Gilead manipulating the patent system, entering into a licensing agreement with Japan Tobacco, and expanding its licensing agreement with Johnson & Johnson subsidiary Janssen Sciences to block entry by potential competitors and prevent competition.…

 

“The delay in conducting clinical trials deprived those suffering from HIV of TAF for more than a decade. Those people suffering with HIV were forced to take TDF, which because of TDF’s lower absorption rates had higher bone and kidney toxicities. It is possible that HIV patients suffered from 10 years of additional accumulated kidney and bone toxicity using TDF while TAF stayed on the shelf.”
Discovery! April 26, 2016
- Positive test confirmed by blood test
2016
-Viral load and CD4 unknown
-May 31st update - big delay at gov hosp lab
#July 9th late Results: CD4 16/ VL 13, 027
*Prescribed Atripla combo with Bactrim
#September CD4 97 / VL UD
2017
February CD4 137 / VL UD

Offline LukasAtlPZ

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  • Posts: 83
While corporate shenanigans in pursuit of higher profits are no surprise, I doubt this particular case will go anywhere but the circular file. I don't see how AHF is "injured" by these corporate actions. Higher drug costs perhaps?

However, if some of the evidence is as they suggest, one or more "injured" parties could sue the company. "injured" meaning a person who was prescribed and took the drug and experienced this side effect.

Offline leatherman

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Quote
The lawsuit by AHF claims that Gilead could have developed the safer version sooner but failed to do so in order to increase its profits and patents.
of course, they could have just shelved the research at some point because no corporation is legally mandated to continue to improve a product. Of course, we hope they continue to perfect their products (ie fewer doses, fewer side effect, more effective), but there's probably not even a moral mandate for any company to keep perfecting it's product.

just because they pulled this research back up years later, to maximize profits on an expiring patent, doesn't mean they had malicious intent to harm. It will definitely take a court battle to get the information about whether this situation happened because Pharma is "evil" and wanted people to suffer and die, or just because they are soulless capitalists who would sell their own mother for a buck, but don't want her to die.  ::)
leatherman (aka Michael)

We were standing all alone
You were leaning in to speak to me
Acting like a mover shaker
Dancing to Madonna then you kissed me
And I think about it all the time
- Darren Hayes, "Chained to You"

Offline bocker3

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  • Posts: 4,285
  • You gotta enjoy life......
This is a perfect example of why frivolous litigation is one of the reasons our health care costs continue to rise (just one reason, not the only).  People have a tough time distinguishing what may be a moral justification from a legal one.  I can't imagine there is a law anywhere in the U.S. that says a company has to improve a product.  Or that failing to do so makes them liable for any "harm". 
What's next -- sue grocery stores because they withhold food from the needy buy selling it to increase profits??

Granted -- Gilead may have done a shitty thing - but it's certainly not an illegal thing.

Offline leatherman

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This is a perfect example of why frivolous litigation
well, it is an AHF lawsuit  ::)
leatherman (aka Michael)

We were standing all alone
You were leaning in to speak to me
Acting like a mover shaker
Dancing to Madonna then you kissed me
And I think about it all the time
- Darren Hayes, "Chained to You"

Offline CaveyUK

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  • Member
  • Posts: 1,642
I think there is little doubt that Gilead cranked TAF back up when TDF was reaching the end of it's patent. And yes, that meant that people couldn't take advantage of TAF during that time.

But I can't see how they have legally done anything wrong.

If any drug company decides to shelve or stagger development for business reasons, then the risk they run is that rivals will develop better drugs in the meantime. In this case, whilst there had been drug development by others, Truvada remained the go-to drug for many, as well as establishing itself as the number one option for PrEP which is why the focus remains on it. Perhaps Gilead were lucky.

So cynical corporate behaviour? Perhaps. Illegal? Nope
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