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Early Indicators of Kidney Failure

  • Abnormal protein levels in urine
  • High creatinine levels
  • Abnormal GFR
  • Acute Kidney Injury
  • Low Kidney Function

Diagnoses: Kidney Disease, Chronic Kidney Disease, Fanconi Syndrome, Kidney Failure

Early Indicators of Bone Loss

  • Bone Density Loss
  • Bone Demineralization
  • Bone Weakening
  • Bone Fracture
  • Tooth Loss

Diagnoses: Osteopenia, Osteoporosis, Osteomalacia

What They Knew

Gilead knew that TAF was superior to TDF in both safety and superiority.  Their patent application showed that TAF produced a 10 fold increase in antiviral activity compared to TDF. Gilead knew it had a better option all along and deliberately selected against that option. Profit motivated their decision not to bring TAF to the market since their TDF patent meant big dollars.

When They Knew It

In 2000, knowing they had a superior, safer alternative to TDF in TAF, they patented TDF.  In 2001, Viread, the first TDF medication went on the market. From 2004-2012, Gilead strung out their patent and released four more TDF drugs, all while knowing TAF was safer and more effective. In July 16, 2012, the FDA approved Truvada® (F/TDF) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually-acquired HIV-1 infection in at-risk adults. 

What You Can Do

If you or a loved one have been diagnosed with HIV and have taken Viread, Truvada, Atripla, Complera, Stribild or Truvada for PrEP and have subsequently been diagnosed with kidney disease, chronic kidney disease, Fanconi Syndrome, Kidney Failure, Osteopenia, Osteoporosis, or Osteomalacia, contact us today to see if you qualify to make a claim.

Truvada Warnings In The News

BREAKING (11/7/19): Trump Administration Sues Drug Company Over HIV Prevention Drug Truvada

A woman living in Marin County died from complications related to vaping, the county’s health officer said Wednesday — the first such death in the Bay Area and the fourth in California since July.

The Trump administration on Wednesday sued the drug manufacturer Gilead Sciences, which sells a landmark HIV drug touted as one of the most important mechanisms to stop the spread of the virus across the nation.

The U.S. government, on behalf of the Department of Health and Human Services, filed a lawsuit alleging Gilead, which makes the pre-exposure prophylaxis (PrEP) drug Truvada, had infringed on patents owned by the federal government.

Read Full Article

5/16/19: A Leading HIV Drug Is Way Overpriced in the U.S.

Gilead Sciences Inc. CEO Daniel O’Day has only been on the job since March, and he’s already found himself having to defend his company in front of the House Oversight and Reform committee.

O’Day faced questioning at a Thursday hearing over the high price of Truvada, a medicine approved to treat HIV and prevent infection. Activists claim that the price prevents at-risk people from accessing the drug and has helped keep infection rates high.

Read Full Article

5/9/19: Gilead Will Donate Truvada to U.S. for H.I.V. Prevention

The manufacturer will provide enough of the drug to supply 200,000 patients annually for more than a decade. Critics said it would not be enough to end the AIDS epidemic and questioned the company’s motives.

Read Full Article

2/15/19: Truvada TDF Litigation Document

 

When HIV/AIDS first hit, panic ensued as it was first considered a death sentence. The pharmaceutical industry was racing to find a treatment or a cure. TDF (later Viread, Truvada, and other names) entered the market and gave hopes of a potential miracle drug, rendering HIV a chronic disease. However, it caused kidney failure and bone deterioration. It seemed that patients were left with a choice – either death by AIDS or kidney failure and bone loss.  Little did they know that Gilead, the manufacturer of Truvada and other such drugs, had a safer, more effective alternative design in their back pocket – TAF. They sat on this alternative in silence for over a decade and moved forward with TDF drugs in order to maximize the profit from its first patent with TDF.

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GET YOUR FREE TRUVADA CASE REVIEW TODAY

Truvada cases are now being reviewed, but there is a limited window to pursue help. If you think you, a friend, or a family member may qualify, get your free case review today… before it’s too late!

  • * Submit now to learn if you may be eligible for a cash settlement or call (800) 511-3838 now.

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The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

Free Guide Download

The Step-By-Step Guide To Taking Action

How to File for Financial Settlement After Injury from an Unsafe Drug or Device

LATEST ARTICLES

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

Dr. Chris DeArmitt, who is a consultant to the top technology firms in America, told Sky News: “I see an absolute disregard for proper testing. Testing is way less than you would see on a vacuum cleaner or a washing machine. It’s shocking. I’ve never seen anything like it in my career.”

No Testing, Fast Approval, Injured Patients: Is the FDA Finally Listening to Mesh Survivors?

You might be wondering “Testing for what?” You would probably be shocked to find out that “more than 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to FDA clearance for distribution or sale,” shares Consumers Union project director Lisa McGiffert in an article from the Fowler Tribune.

This loophole in the FDA is called the 510(k) process and it has allowed millions of patients to be irreparably harmed – and even killed – by the very device that was intended to help them. Now after several decades of patient injuries, billions of dollars being fought over in court, and countless devices being pulled from market (too little, too late, we might add), the FDA is only now looking into changing this horrific flaw in their system.

What is the FDA’s 510(k) Process?

The FDA’s 510(k) process allows medical devices companies to quickly fast-track a product to market based on a pre-approved product. This idea came about decades ago with the purpose to promote innovation but has instead become a way for big companies to slip their products to market for high profits while avoiding expensive testing. This has caused several inexcusable problems to arise. Here’s one tragic example: 

Transvaginal Mesh

A medical device can be approved for market based on a previous model, even one that was recalled. This is what happened in the huge debacle involving vaginal mesh. Protegen was the first vaginal mesh product on the market, but was recalled due to patient harm. However, even after it was pulled, dozens of additional mesh devices were sold and implanted in patients based on this poor design. Currently, hundreds of thousands of women are suffering from mesh and many will have to live with chronic pain, the impossibility of holding down a job, and the inability to have sex with their partners for the rest of their lives. 

But this story includes many more products beyond vaginal mesh-like IVC filters to prevent blood clots, Essure female sterilization devices, hip replacement products, and countless others.  The New York Times reports that these fast-tracked devices have caused 80,000 deaths and more than two million injuries.

Change is in the Air 

Fortunately, with documentaries like The Bleeding Edge, social media groups criticizing the FDA’s process, and advocacy groups, the FDA is reevaluating how it approves devices for market. According to the JAMA (Journal of the American Medical Association) Network,

“For premarket review of 510(k) devices, on February 1, 2019, the FDA released a Final Guidance Document for the ‘Safety and Performance Based Pathway.’ This optional pathway consists of using criteria that involve conformance to FDA-recognized consensus standards, FDA guidance, and/or special controls. It enables 510(k) clearance for certain medical devices if the device meets these specific criteria, which should include safety and effectiveness (as opposed to the often ill-defined ‘substantial equivalence’ to predicate devices). The decision to use this new pathway is determined by manufacturers, although the FDA can disagree with this determination.”

While this is a step in the right direction by requiring device companies to prove safety and effectiveness, many think that these changes don’t go far enough towards protecting patient health. For instance, JAMA suggests that “legislation should mandate that 510(k) devices show improved safety and effectiveness compared with marketed devices for the same clinical purpose, using meaningful clinical criteria to gain clearance. Although these criteria will differ based on the intended use of the device, all criteria should be based on patient-oriented clinical outcomes.”

Additionally, once a product is approved for market, many times the post-market surveillance falls to the wayside. Medical devices should have a registry so that patients can know what devices are implanted in them, doctors can properly treat problems that may arise, and companies can monitor their products more effectively. Car parts are meticulously tracked, shouldn’t medical devices be all the more!?!

Too Little, Too Late

It’s great that the FDA is reviewing it’s 510(k) process that has been grossly overused and under monitored for decades, but what about those who have already been harmed by an agency that favored billion-dollar medical device companies over the health and wellness of patients?

One way that this FDA change was brought about was through the voices and bravery of those who were injured by these faulty medical devices. If you or a loved one had vaginal mesh and had corrective surgery, your voice needs to be heard. Please call Periscope Group today at (800) 511-3838. It’s time to hold medical device companies accountable for the unbearable pain they caused you. We want to hear your story and we want to help you if we can.

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Sources
“Vaginal mesh: Tests on plastic material ‘way less’ thorough than on washing machine”. Sky News. Accessed August 5, 2019. https://news.sky.com/story/vaginal-mesh-tests-on-plastic-material-way-less-thorough-than-on-washing-machine-11772530?fbclid=IwAR0ieT27Sh1V8q53Vt7y3BH2PK1M9akqoLCAFvnf1JskMeAOu10yvzgEi20
“Moving From Substantial Equivalence to Substantial Improvement for 510(k) Devices”. JAMA Network. Accessed August 5, 2019. https://jamanetwork.com/journals/jama/fullarticle/2744408?fbclid=IwAR04Fkrn-A1NbJDUkuOOOU-EhA55G5kkXUYJWGIb8y-MftOdFTQ0hrk_Bl0
“Medical Device Testing: Too Much, or Not Enough?” ADMET. Accessed August 5, 2019. https://www.admet.com/medical-device-testing-too-much-or-not-enough/

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

Periscope Group is not owned by or operated on behalf of any attorney or law firm. We are not affiliated with any drug or medical device companies. We do not host advertisements nor do we accept advertising requests. We are here to help YOU, the consumer, become better educated and supported. You pay absolutely nothing for our help. It’s as simple as that.

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