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HomeHealth & LifestyleBeyond the Lawsuits: Addressing Systemic Issues in Prescription Drug Safety

Beyond the Lawsuits: Addressing Systemic Issues in Prescription Drug Safety

Prescription drugs promise life-changing benefits for patients. However, the dangerous side effects from medications like Tepezza can upend lives. Tepezza was approved for the treatment of thyroid eye disease(TED) by the Food and Drug Administration in January 2020.

It was the only drug to get the FDA’s approval to treat TED. But, its manufacturer Horizon Therapeutics underplayed its darker side. Many patients who were administered this drug complained of hearing-related issues.

Several lawsuits were filed by the affected against Horizon. These lawsuits spotlight flaws in the system. How do we balance innovation with safety? This blog examines prescription drug safety issues. It also explores solutions to better protect patients. The aim here is to spark dialogue on reforms.

The Landscape of Drug Safety

The FDA oversees the approval and monitoring of prescription drugs. Manufacturers test drugs on limited patient samples pre-approval and on many occasions, testing often misses less common side effects.

Long-term effects may take years to emerge. Manufacturers also face conflicts balancing patient well-being and profits. This is especially true during patent periods when there is an incentive to rush drugs to market. Post basic approval, monitoring systems also rely on voluntary reporting of issues by doctors, patients, and manufacturers. Yet few report.

Understaffed FDA offices struggle to review reports received. Pharmaceutical companies finance and oversee clinical trials that assess the safety and efficacy of their products.

The motivation of these entities to secure marketing authorization for pharmaceuticals and to endorse their usage once they are available for purchase may introduce bias into the design, oversight, and reporting of clinical trial outcomes.

Lack of transparency also concerns advocates. Vital testing data remains undisclosed. Patients lack access to complete risk information for informed decisions. A movement toward greater transparency is still nascent.

Tepezza—A Painful Example

Recent headlines captured the agony of Tepezza patients coping with serious side effects from the thyroid disease drug rushed to market. Tepezza sped through an expedited FDA approval process in early 2020 intended to spur innovation, manufacturer Horizon Therapeutics announced proudly at the time.

What followed revealed the consequences of limited clinical testing. According to TorHoerman Law, weeks after taking Tepezza, patients reported alarming symptoms – sudden painful pressure behind the eyes, muscle spasms, hair loss, diarrhea, and blurry vision, to name a few.

Recent research has indicated that hearing loss or hearing problems affect as many as 65 percent of patients, according to one study published by the Endocrine Society.

While Horizon maintains confidence in Tepezza’s benefits for thyroid patients, they lack explanations for what caused painful eye damage in many recipients. With no cure, patients demand answers on why risks went unforeseen and how to prevent repeating similar oversights.

You might qualify to submit a Tepezza lawsuit if you or a family member who was prescribed Tepezza for the treatment of Thyroid Eye Disease experienced adverse effects related to hearing.

As with other high-profile drug controversies, the Tepezza situation feeds growing calls for reforms realigning stakeholder incentives with patient well-being.

Critics contend regulators must close loopholes allowing limited clinical trials, while manufacturers require encouragement to pursue safety with equal zeal as profits or breakthrough designations. With patient health at stake, preventing toxicity crises demands addressing root causes within current systems.

Systemic Issues and Their Impact

Powerful pharmaceutical interests retain a strong influence over policy decisions in Washington. Corporate lobbying groups representing drug manufacturers spent over $356 million in 2022 alone aimed at shaping laws and regulations to benefit the industry’s bottom lines.

Patient advocates argue this lobbying clout serves to maintain the status quo on issues like rushed drug approvals and limited pre-market safety testing protocols that inadequately protect consumer well-being.

Oversight mechanisms also demonstrate considerable weaknesses that leave patients exposed.

For example, the FDA grants authorization to medical device makers to modify high-risk products from their original approved design without repeating exhaustive clinical trials.  One analysis found that over 99% of approved device modifications made it to market based only on paperwork filings rather than actual patient testing to detect potential new safety issues.

Ultimately, patients and consumers shoulder the burden and elevated risks created by these systemic deficiencies. Numerous prescription drugs or medical devices have demonstrated severe side effects or chronic conditions only years after market introduction. By then, thousands of patients have already suffered harm that earlier oversight reforms may have prevented.

Moving Towards a Safer Future 

The need of the hour is for meaningful reforms to realign incentives balancing innovation with safety. Potential solutions center on strengthening oversight and post-market vigilance while also fostering transparency.

For example, greater regulatory scrutiny could demand more extensive, long-term pre-market trials before approval. Resources for larger FDA trial reviews and guidance could reduce the risks of missing side effects.

Post-approval, transferring monitoring duties to independent third parties could strengthen oversight integrity. Sophisticated AI systems analyzing patient electronic health records nationwide may also enhance detection capacities for emerging issues.

Increased transparency from manufacturers represents the most critical piece. Full public disclosure of trial and testing data could enable fully informed patient decisions while letting independent researchers reanalyze results. Patient education programs similarly work to share safety resources and warning signs for those relying on high-risk drugs.

To conclude, grassroots advocacy campaigns can also pressure agencies and the people in power for bolder reforms in the public interest over industry objections. While meaningful change takes time, even incremental steps that strengthen accountability and safety-focused incentives can better uphold patient well-being.

IEMLabs is an ISO 27001:2013 and ISO 9001:2015 certified company, we are also a proud member of EC Council, NASSCOM, Data Security Council of India (DSCI), Indian Chamber of Commerce (ICC), U.S. Chamber of Commerce, and Confederation of Indian Industry (CII). The company was established in 2016 with a vision in mind to provide Cyber Security to the digital world and make them Hack Proof. The question is why are we suddenly talking about Cyber Security and all this stuff? With the development of technology, more and more companies are shifting their business to Digital World which is resulting in the increase in Cyber Crimes.


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