Thyroid eye disease (TED) is a rare autoimmune condition that can wreak havoc on your vision. In severe cases, bulging eyes and optic nerve compression can lead to permanent vision loss. Until 2020, the diagnosis felt like a desperate situation, with no proper, approved medications to halt the autoimmune attack.
But in 2020, Tepezza, the first FDA-approved treatment for TED, appeared as a glimmer of hope. Marketers marketed the drug as a game-changer. However, Tepezza was gradually gaining public disapproval due to its severe side-effects.
This blog post aims to highlight the importance of balancing the three pillars—accessibility, affordability, and safety—of pharmaceutical companies. In addition to the three, even accountability is of utmost importance, as we will see in the following sections.
Early Promise and Patient Outcomes
Clinical trials conducted by Horizon Therapeutics, the drug’s manufacturer, reported positive results in a majority of participants. Patients described a significant improvement in their quality of life, with reduced bulging eyes, diplopia, lessened pain, and stabilized vision.
Based on these promising findings, Horizon petitioned for an accelerated FDA approval in early 2020. This pathway allows patients with serious conditions lacking treatment options to access potentially life-changing therapies quickly. For many battling rapidly deteriorating vision, Tepezza represented a glimmer of hope.
According to Forbes, during the clinical trials, around 10% of patients reported hearing problems. Surprisingly, a study conducted in 2021 shed light on the fact that the true risk was significantly greater. It suggested that a staggering 65% of individuals who use drugs could potentially encounter these kinds of complications.
Emerging Side Effects
The initial excitement surrounding Tepezza was soon overshadowed by growing concerns about its safety profile. Accelerated approval, based on limited data, meant the full spectrum of side effects remained unclear.
Disturbing reports of adverse reactions began to surface. According to TorHoerman Law, weeks into treatment, patients described experiencing sudden issues with hearing and heightened sensitivity to sound. The drug can also pose risks of alopecia, worsening of inflammatory bowel illness, altered gustatory perception, and diarrhea, among others.
Research published by the National Library of Medicine, encompassing 131 patients, revealed a troubling trend: over 80% reported adverse events.
Horizon Therapeutics maintained confidence in Tepezza’s overall benefit-risk profile. However, the lack of a definitive cause for these painful side effects left patients questioning if the expedited approval process had compromised their safety.
Legal Action and the Pursuit of Accountability
Have you experienced tinnitus or other severe hearing problems after taking Tepezza? If yes, then you can explore the possibility of filing a Tepezza lawsuit against Horizon Therapeutics.
The crux of the prevailing lawsuits is that Horizon was aware of the drug’s mechanism of action. It should have foreseen potential immuno-inflammatory risks. By failing to warn both patients and physicians through labeling and clear guidance, the manufacturer is accused of negligence and design flaws.
What can work in favor of patients is that in cases where medicines go awry, product liability law comes into play. According to Forbes, unlike other legal avenues, product liability law doesn’t require proof of negligence by the defendant.
In a product liability action, the plaintiff must establish the following:
- The product exhibited some form of flaw.
- You utilized the product according to its intended purpose.
- The product flaw resulted in you experiencing some form of harm, for which you are eligible to get compensation.
Here, you just need to demonstrate that the product’s issue directly caused you unforeseen harm.
Access vs. Safety
The debate surrounding Tepezza revolves around a central question: should access to a potentially sight-saving medication outweigh concerns about safety?
Access advocates argue that despite the side effects, patients should rely on their doctor’s guidance. They should use only FDA-approved treatments available for their condition. They emphasize the positive experiences of a majority of patients, cautioning against panic due to risks affecting a smaller group.
However, critics raise a compelling counterpoint. Could restricting access to Tepezza until further testing is completed be a more ethical and responsible approach? Public interest groups advocate for stricter guidelines, limiting Tepezza’s use to specialized physicians until additional safety monitoring measures are established. Lawsuits may also uncover crucial safety data that can inform future policy decisions.
The Road to a Balanced Approach
Experts recommend a few possible routes to strike a compromise between access and safety, as opposed to a simple binary decision.
Affordability
According to Drugwatch, Tepezza comes at a high cost. A single vial might range from $15,000 to $16,300 in the US. This places a significant burden on patients and insurers.
Exploring more affordable treatment options or broader insurance coverage is important. It could alleviate some of the financial strain associated with Tepezza, particularly if safer alternatives emerge in the future.
Collaborative Research
Collaboration between federal agencies and pharmaceutical companies could pave the way for research into more cost-effective therapies or alternative treatment protocols. This could ease the financial burden on patients and healthcare systems.
Open Communication
Ultimately, fostering open and constructive dialogue between all stakeholders—patients, physicians, manufacturers, and regulatory bodies —is crucial. Patients should maintain cautious optimism while working closely with their doctors to mitigate potential risks if they choose to resume Tepezza treatment.
FAQs
1. What is Tepezza?
According to Healthline, Tepezza is the first FDA-approved medication to treat thyroid eye disease (TED), a rare autoimmune condition that can affect vision.
2. What are the benefits of Tepezza?
Tepezza can help to improve vision, reduce bulging eyes, and lessen pain and light sensitivity in people with TED.
3. What are the side effects of Tepezza?
Tepezza can cause serious side effects, including hearing loss, hair loss, and worsening of inflammatory bowel disease.
4. Who should not take Tepezza?
Tepezza is not right for everyone. You should not take Tepezza if you are pregnant or breastfeeding, or if you have a history of certain medical conditions.
To conclude, the development of Tepezza has been a significant step forward in the treatment of thyroid eye disease. However, as with any medication, there are risks and benefits to consider. Talking to your doctor is the best way to decide if Tepezza is right for you.
Tepezza is a complex medication with a fascinating story. It highlights the challenges of balancing access to treatment with patient safety. Finding the right balance will require ongoing research, open communication, and collaboration between all stakeholders. The goal is to ensure that patients with TED have access to safe and effective treatments that can improve their quality of life.
