Reconceptualizing Risk-Benefit Assessment of Novel Cancer Therapies to Expand Global Access and Reduce Worldwide Mortality

JAMA Oncology ◽  
2021 ◽  
Author(s):  
Rebecca J. DeBoer ◽  
Hope S. Rugo ◽  
Lawrence N. Shulman
Medicines ◽  
2021 ◽  
Vol 8 (7) ◽  
pp. 36
Author(s):  
George J. Kontoghiorghes

Regulatory policies on drugs have a major impact on patient safety and survival. Some pharmaceutical companies employ all possible methods to achieve maximum sales in relation to the monopoly of their patented drugs, leading sometimes to irregularities and illegal activities. Misinformation on the orphan drug deferasirox has reached the stage of criminal investigations and fines exceeding USD 100 million. Additional lawsuits of USD 3.5 billion for damages and civil fines were also filed by the FBI of the USA involving deferasirox and mycophenolic acid, which were later settled with an additional fine of USD 390 million. Furthermore, a USD 345 million fine was also settled for bribes and other illegal overseas operations including an EU country. However, no similar fines for illegal practises or regulatory control violations have been issued in the EU. Misconceptions and a lack of clear guidelines for the use of deferasirox in comparison to deferiprone and deferoxamine appear to reduce the effective treatment prospects and to increase the toxicity risks for thalassaemia and other iron loaded patients. Similar issues have been raised for the activities of other pharmaceutical companies promoting the use of new patented versus generic drugs. Treatments for different categories of patients using new patented drugs are mostly market driven with no clear safeguards or guidelines for risk/benefit assessment indications or for individualised effective and safe optimum therapies. There is a need for the establishment of an international organisation, which can monitor and assess the risk/benefit assessment and marketing of drugs in the EU and globally for the benefit of patients. The pivotal role of the regulatory drug authorities and the prescribing physicians for identifying individualised optimum therapies is essential for improving the survival and safety of millions of patients worldwide.


Risk Analysis ◽  
2017 ◽  
Vol 37 (12) ◽  
pp. 2360-2388 ◽  
Author(s):  
Géraldine Boué ◽  
Enda Cummins ◽  
Sandrine Guillou ◽  
Jean-Philippe Antignac ◽  
Bruno Le Bizec ◽  
...  

Drug Safety ◽  
1991 ◽  
Vol 6 (5) ◽  
pp. 323-331 ◽  
Author(s):  
Lawrence Friedman ◽  
Eleanor Schron ◽  
Salim Yusuf

Drug Safety ◽  
1997 ◽  
Vol 17 (4) ◽  
pp. 251-264 ◽  
Author(s):  
Siegfried Kasper ◽  
Nicole Praschak-Rieder ◽  
Johannes Tauscher ◽  
Rainer Wolf

2014 ◽  
pp. 47
Author(s):  
Pawel Ptaszynski ◽  
Irmina Urbanek ◽  
Krzysztof Kaczmarek ◽  
Iwona Cygankiewicz

2021 ◽  
pp. 1-12
Author(s):  
Manoj Menon ◽  
Amelia Smith ◽  
Joseph Fennell

Abstract Rice is consumed by nearly half of the global population and a significant source of energy and nutrients. However, rice consumption can also be a significant pathway of inorganic arsenic (iAs) exposure, thus requiring a risk–benefit assessment. This study assessed nutrient element (NE) densities in fifty-five rice types (white, brown and wild rice) marketed in the UK. Densities of essential NE were used to rank rice types in meeting daily NE targets under different consumption scenarios through a newly developed optimisation approach. Using iAs data from these rice types, we assessed the margin of exposure (MOE) for low (the UK) and high (Bangladesh) rice intake scenarios. Our results showed that brown and wild rice are significantly higher in many NE and significantly contribute to dietary reference value (DRV). Our modelling showed that switching to brown or wild rice could increase the intake of several essential nutrients by up to eight times that of white rice. Using rice consumption data for mid-to-high-consumption countries, we estimate that brown rice could provide 100 % adult DRV for Fe, Mg, Cr, P and Mo, and substantial contributions for Zn, Se and K. Our results show that the amount of rice primarily determines risk from iAs consumed rather than the type of rice. Therefore, switching from white to brown or wild rice could be beneficial, provided iAs concentration in rice is within the recommended limits.


Drug Safety ◽  
1995 ◽  
Vol 12 (5) ◽  
pp. 348-357 ◽  
Author(s):  
Michael Winkler ◽  
Uwe Christians

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