The tale of ‘have money, buy miracle drug’
For several weeks now, newspapers have been featuring articles about the use of so-called 'magic injections' that promise weight loss. These injections contain Semaglutide, a drug initially used to treat Type 2 diabetes mellitus but also known for inducing weight loss. However, a concerning trend has emerged where these drugs are being administered in India despite not being approved for sale, particularly to affluent patients.
Lack of Approval and Risk Disclosure
Many of these promotional articles fail to mention that Semaglutide, as a weight loss drug, has not received approval for sale in India. This lack of transparency raises questions about the ethical considerations of administering such drugs without proper regulatory clearance. Furthermore, the media often overlook the significant side effects associated with these drugs, neglecting to inform the public about potential risks.
Global Pharma Warnings
Global pharmaceutical companies have issued press releases cautioning patients against using these unapproved products in India. However, these warnings receive minimal attention in the media, contributing to the misinformation and potential misuse of such drugs.
Parallels with Past Incidents
The situation is reminiscent of historical instances like Rimonabant and Fen-Phen, where weight loss drugs were marketed as miraculous solutions but later revealed significant health risks. In the United States, such incidents led to massive damages paid by pharmaceutical companies in mass tort litigations, highlighting the dangers of unapproved medications.
Broader Issue of Unauthorized Drugs
While weight loss drugs are a focal point, they represent only a fraction of the larger concern surrounding unauthorized drugs in the market. This broader issue underscores the need for stringent regulations, responsible reporting by the media, and public awareness regarding the risks associated with unapproved medications.
2. Promoting Cervical Health through HPV Vaccination
- Cervical cancer is a major health concern affecting women globally, claiming the lives of over 300,000 women annually, with one life lost every two minutes. It ranks as the fourth most common cancer among women worldwide, and its impact is particularly severe in lower- and middle-income countries, where nine out of 10 deaths due to cervical cancer occur.
- In India, cervical cancer is the second most prevalent cancer among women, following breast cancer. With a population of approximately 500 million women aged 15 and above at risk, the need for preventive measures is critical. Without decisive action, projections indicate a significant rise in cervical cancer cases and deaths in the coming years.
- The introduction of HPV (Human Papillomavirus) vaccination has shown promise in preventing cervical cancers associated with HPV infections. By promoting HPV vaccination, we can significantly reduce the burden of cervical cancer and safeguard women's health. It is crucial to raise awareness about the importance of vaccination, especially among at-risk populations, to combat the projected increase in cervical cancer cases.
- Efforts in education, advocacy, and access to vaccination programs are vital in the fight against cervical cancer. Through coordinated initiatives and public health campaigns, we can work towards a future where cervical cancer becomes a preventable disease, saving countless lives and improving women's health outcomes.
3. Strategies for Cervical Cancer Prevention
- In 1983, German scientist Harald zur Hausen's groundbreaking work established that certain papillomaviruses (HPV) are linked to cervical cancer in humans. This discovery paved the way for two key strategies in preventing and detecting cervical cancer: HPV vaccination and screening for precancerous lesions. Despite the potential for cervical cancer elimination, many communities, especially those with limited resources, lack effective programs to combat this public health challenge.
- The World Health Organization (WHO) has outlined a comprehensive strategy known as the 90-70-90 triple pillar intervention, aiming for significant progress by 2030. This strategy emphasizes HPV vaccination, screening, and treatment to reduce cervical cancer incidence and mortality.
- In India, the HPV vaccination was introduced in 2008 and recommended for inclusion in the Universal Immunization Programme in 2023 after successful state-level roll-outs. However, challenges persist in ensuring widespread access, particularly for underserved populations. The vaccine remains primarily available in the private market at a considerable cost, limiting its accessibility to all eligible girls.
- Physicians play a crucial role in promoting HPV vaccination and addressing misconceptions about its safety and effectiveness. Some healthcare providers may underestimate the risks associated with HPV infections and cervical cancer, leading to hesitancy in recommending the vaccine. Additionally, concerns about discussing sensitive topics with parents, addressing vaccine myths, and time constraints contribute to lower vaccination rates.
- Efforts are needed to enhance awareness among healthcare providers, parents, and communities about the importance of HPV vaccination in preventing cervical cancer. Accessible and affordable vaccination programs, along with comprehensive education campaigns, can help bridge the gap and save lives by reducing the burden of cervical cancer in India and globally.
4. Facts and Best Practices for HPV Vaccination and Cervical Cancer Prevention
The Federation of Obstetric and Gynaecological Societies of India (FOGSI) and the Indian Academy of Pediatrics (IAP), representing over 80,000 physicians, have collaboratively emphasized the importance of HPV vaccination in preventing cervical cancer. These medical societies are working to disseminate accurate information and best practices among their members, including obstetricians-gynaecologists and paediatricians, regarding HPV vaccination.
Key Facts and Recommendations
- HPV Vaccine Benefits: The HPV vaccine is safe and effective in preventing six types of HPV-related cancers, including cervical cancer. It also protects against vulvar, anal, vaginal, throat, and cervical cancers.
- Vaccination Age: It is recommended to start HPV vaccination for all adolescents, beginning at the age of 9 years, as part of the standard immunization schedule endorsed by IAP.
- Screening Guidelines: Regular screening is crucial for early detection of cervical cancer. The FOGSI Good Clinical Practice Recommendations emphasize regular screening for women above the age of 30 years.
- Intervention Targets: The target is to achieve a 90% vaccination rate for girls by the age of 15, 70% screening rate for women by the age of 35 and 45, and 90% treatment rate for women with pre-cancerous or cancerous lesions.
- Physician Leadership: FOGSI and IAP aim to create 20,000 HPV physician champions by mid-2024. These champions will educate their peers and communities about the importance of HPV vaccination and cervical cancer prevention.
Global Health Commitment: India's G20 presidency has shown a commitment to promoting equitable access to vaccines, particularly for lower- and middle-income countries. This includes initiatives to enhance HPV vaccination and cervical cancer screening, aligning with global efforts to eliminate cervical cancer as a public health concern.
Physicians as Leaders: Physicians are regarded as trusted leaders in society and are essential in promoting preventive healthcare measures like HPV vaccination. Their active involvement is crucial in achieving the goal of eliminating cervical cancer through widespread vaccination and screening programs.
- Clinical Trials Requirement: In India, drugs are typically approved for sale after the Indian subsidiary or licensee of the global brand owner conducts clinical trials. These trials are essential to assess the safety and efficacy of the drug within the Indian population.
- Monitoring and Reporting: Once a drug is approved, the regulatory authority mandates monitoring and reporting of all adverse events related to the drug for two years. This post-marketing surveillance helps in identifying any unforeseen side effects or issues with the drug.
Exceptions and Importing Process
- Pharma Companies' Market Decisions: There are instances where global pharmaceutical companies choose not to launch certain drugs in the Indian market, opting to stay out due to various reasons such as market dynamics or regulatory concerns.
- Patient and Hospital Import Licenses: In exceptional cases, patients can obtain a license from the drug regulator based on a doctor’s prescription to import unapproved drugs for personal use. Hospitals also have the option to apply for import licenses for specific drugs not available in the local market.
Risks Associated with Unapproved Drugs
- Lack of Clinical Trials in India: With unapproved "miracle drugs" like Semaglutide injections, there have been no clinical trials conducted in India. This absence of trials raises concerns about how the Indian population might react differently to the drug compared to other populations.
- Unknown Interactions and Risks: The lack of clinical data means that doctors in India cannot accurately predict how patients, especially those with underlying conditions like diabetes and hypertension, will respond to these injections. The potential risks and interactions with other medications remain largely unknown and unmitigated.
- Significant Risk Factors: This situation poses a significant risk that cannot be easily dismissed. Without local clinical trials and data, accurately estimating and managing these risks becomes challenging, potentially jeopardizing patient safety and well-being.
The recent trend of doctors prescribing Semaglutide, an unapproved weight-loss drug, raises several ethical concerns
- Prescribing Unapproved Drugs: Should doctors prescribe medications like Semaglutide when they haven't undergone clinical trials and received regulatory approval in India?
- Patient Demand vs. Doctor Recommendation: Are doctors actively recommending these drugs, or are patients pressuring them due to media reports?
- Doctor's Duty: In such situations, what is a doctor's ethical and professional duty? Should they prioritize patient desires or prioritize potential health risks associated with unapproved drugs?
- Doctor's Knowledge and Training: How many doctors prescribing these injections have fully researched the potential side effects of Semaglutide? Are they adequately trained to identify and manage potential adverse events?
- Unaware of Illegal Imports: Given the unapproved status of Semaglutide, how many doctors are aware that patients might be using illegally imported versions of the drug?
- Spurious Drugs and Delayed Response: The recent Adcetris scandal highlights the dangers of counterfeit drugs. This raises the question of how confident doctors can be about the authenticity and safety of these unapproved medications. Should they not verify the source of the drugs before administration?
- Doctor Complicity: Considering the warnings issued by Semaglutide's manufacturers against its use in India, are doctors inadvertently complicit in a potential scam?
- Transparency and Patient Safety: Shouldn't doctors ensure transparency with patients about the unapproved status and potential risks associated with Semaglutide injections?
Import Control Measures
- What measures are being taken by the government and drug regulators to control the import of unapproved drugs?
- Is there sufficient enforcement to deter doctors from prescribing illegal drugs?
Deterrents and Legal Action
- How effective would arrests and legal action against doctors be as a deterrent to the illegal importation and prescription of unapproved drugs?
Social Responsibility
- Do societal attitudes reflect a lack of concern regarding the illegal importation and prescription of expensive drugs?
- Is there a perception that such issues only affect the affluent and therefore are not a priority for intervention?
Ethical Considerations
- Is there a societal indifference towards the suffering of affluent individuals who may fall victim to misadventures with unapproved drugs?
- Do societal attitudes towards luxury items like designer watches and scotch whisky influence perceptions about the illegal importation and use of expensive drugs?
Resource Allocation
- Does the government prioritize other issues over the regulation of illegal drug imports due to limited resources?
- How does the government balance its responsibilities regarding public health and regulatory oversight amidst competing priorities?
Accountability
- To what extent does the government prioritize addressing issues like the illegal importation of drugs compared to other public health concerns?
- How does societal indifference impact government accountability and responsiveness to healthcare-related issues, including the importation of unapproved drugs?
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Mains Pratice Questions 1. Discuss the ethical considerations surrounding the use of unapproved drugs in India. What measures should regulatory bodies take to control the import and sale of such drugs? (250 Words)
2. Evaluate the effectiveness of HPV vaccination in preventing cervical cancer and its implementation challenges in India. What strategies can be adopted to improve vaccination rates and reduce cervical cancer burden? (250 Words)
3. Discuss societal attitudes towards the illegal importation and prescription of expensive drugs. How can public awareness campaigns and responsible reporting influence public behaviour and priorities in healthcare? (250 Words)
4. How can the government and civil society organizations encourage responsible media practices that promote public health? (250 Words)
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