Bibile Formula: Unveil potential or divulge disregard

23 August 2023 12:01 am Views - 563

Before finalizing recommendations, the committee appointed by the President should delve into these insightful works,  ...can make more informed decisions within their six-month timeframe

 

The replacement of Sarath Liyanage, Chairman of SPC, with Dr. Mendis has been likened to changing pillows. However, we emphasize that the real solution lies in adopting the Prof. Bibile Formula with necessary adjustments to address current needs.   
Prescription drugs, administered by doctors, rank as the third leading cause of death, following heart disease and cancer.   


In “Deadly Medicines and Organised Crime: How Big Pharma Has Corrupted Healthcare,” Peter C. Gotzsche exposes the unethical actions of pharmaceutical companies prioritizing profits over lives. He draws parallels with tobacco companies, establishing his work as an independent research benchmark.   
Recent findings reveal that many drug commercials are misleading or false, casting doubts on pharmaceutical companies’ integrity and their role in our healthcare system. Forbes Magazine even questions the trustworthiness of any aspect of the pharmaceutical business.   


Gotzsche’s book meticulously uncovers a flawed drug regulation system marred by crimes and corruption, necessitating substantial reform. Pharmaceutical companies manipulate drug information, inadvertently driving medication overuse. Despite patients’ trust in doctors’ prescriptions, skewed industry data hampers comprehensive medical understanding. His daring inquiry challenges the norm, probing why prescription drugs fuel high mortality rates akin to a deadly epidemic. He urges immediate action against comparable health threats and advocates industry changes prioritizing well-being over profits.   


Professor Peter, the author, holds a Master’s in biology and chemistry and became a physician in 1984. His expertise spans internal medicine, clinical trials, and regulatory affairs (1975–83), followed by hospital work in Copenhagen (1984–95). He now holds the title of Professor of Clinical Research Design and Analysis at the University of Copenhagen.   
In “The Truth About the Drug Companies: How They Deceive Us and What to Do About It,” Dr. Marcia Angell, with over two decades at The New England Journal of Medicine, exposes a troubling shift within the pharmaceutical industry.   


Originally dedicated to beneficial drugs, companies now prioritize profits through aggressive marketing and control over medical research and education. Angell reveals their $200 billion

Prof Senaka Bibile

annual spending on prescription drugs and dismantles the notion that high prices fund research. She highlights manipulative practices in drug development, such as biased clinical trials and the proliferation of copycat drugs. Angell calls for crucial reforms to restore research impartiality and sever ties between drug companies and medical education. Supported by thorough research, her book passionately indicts an industry spinning out of control, offering necessary steps for recovery.   
Before finalizing recommendations, the committee appointed by the President should delve into these insightful works, currently untouched in medical libraries. Utilizing their analyses, the committee can make more informed decisions within their six-month timeframe.


Prof. Senaka Bibile, a significant figure in Sri Lanka, has left an indelible mark on global medicine. Driven by his talents, he devoted his life to reshaping medical education and instituting a national drug policy. His innovative ideas garnered worldwide recognition and found acceptance among various nations and organizations.   
Sri Lanka faced its share of economic challenges, impacting its healthcare sector. The 1960s saw a reduction in foreign exchange allocated for drugs, leading to diminished per capita pharmaceutical supply and compromising healthcare services. In the absence of a national health or drug policy during the 1970s, Sri Lanka relied on drug imports facilitated by government and foreign agents influenced by transnational pharmaceutical giants.   


Prof. Bibile introduced the Ceylon Hospitals Formulary and pioneered the concept of the List of Essential Medicines in 1958. This move ensured a consistent supply of crucial drugs at lower costs, ultimately optimizing the utilization of the healthcare budget, with a special emphasis on essential medications.   
To reduce expenses and wholesalers’ profits, Prof. Bibile championed bulk raw material imports over finished products. By streamlining the drug list and eliminating unnecessary and harmful medications, he created a more efficient inventory of around 600 drugs, all the while maintaining the quality of patient care.   


His report proposed centralizing drug procurement and abolishing patent laws that hindered access to cost-effective alternatives. The recommendations extended to discontinuing drug advertising, educating doctors through impartial channels, promoting generic names over brand names in prescriptions, and establishing a quality control laboratory.   
The Bibile Policy surpassed mere price regulation, presenting a holistic national strategy for the pharmaceutical sector within the healthcare system. He introduced this innovative model at the 1976 United Nations Conference on Trade and Development, garnering support from the WHO and other UN agencies. 

 
By the year 2000, more than 100 countries had embraced national pharmaceutical policies, incorporating the essential drug concept into medical and pharmacy education. Fast-forward to the present, Sri Lanka grapples with an economic crisis, impacting the availability of vital necessities, including healthcare. Despite this, the market remains saturated with unnecessary vitamins, unproven medications, me-too drugs, and counterfeits, consuming a significant portion of health spending.   
Bibile’s visionary ideas continue to shape global pharmaceutical policies. His comprehensive approach, aimed at optimizing healthcare systems and ensuring access to essential medications, stands as a testament to his enduring legacy. Notably, his advocacy for government-controlled pharmaceutical purchasing plans and rational pharmaceutical policies has left a lasting impact, prioritizing affordable and reasonable drug access for impoverished individuals.   


Gambia is preparing for a significant trial in October after the tragic deaths of 300 children in Gambia, Indonesia, and Uzbekistan due to contaminated cough syrups. The focus is on 70 Gambian children’s deaths last year from medicines made by the Indian company Maiden Pharmaceuticals, containing toxic substances found in antifreeze. The World Health Organization (WHO) flagged these syrups for “unacceptable” levels of toxins, urging action against non-compliant medicines. Gambia responded quickly by recalling tainted syrups and products, and the investigation revealed the need for better quality control and registration of imported medicines. The trial aims to bring justice for the victims and emphasizes the importance of strict quality control in the pharmaceutical industry.   


Private sector struggles against deceptive marketing, but strong buyers like health insurance companies have succeeded in negotiating fair prices. However, few such entities exist in Low and Middle-Income Countries (LMICs), leaving National Medicines Regulatory Authorities (NMRAs) to play a crucial role in regulating prices.   
The Senaka Bibile Drug Policy has sadly remained unimplemented, enabling the private sector to sell medicine at inflated prices without constraints. The persistent postponement of this policy’s implementation by successive governments raises significant questions. Reports suggest that political motives and the influence of high-ranking Health Ministry officials have obstructed the passage of the drug policy bill in parliament, undermining efforts to ensure quality healthcare for the public. The delay seems rooted in favouring certain interests. Once the Senaka Bibile drug policy takes effect, arbitrary decisions regarding drug procurement – influenced by personal connections – would no longer be possible.   
The motivation behind this delay appears to be a desire to cater to select individuals, rather than prioritizing the provision of quality medicine to the population. Multinational drug companies are suspected of exerting influence by offering bribes to influential figures.   

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