Posted on October 16th, 2018 by admin in Pharma R&D
For many people, taking medication is a regular part of their daily routine, and these medicines are relied upon to treat disease and improve health. The benefits of medicines are the helpful effects you get when you use them, such as the lowering blood pressure, curing infection, or relieving pain. Although medicines can make you feel better and help you get well, it’s important to know that all medicines, both prescription and over-the-counter, have risks as well as benefits.
In fact, almost every drug causes unpleasant side effects in some segment of the population and can range as minor such as an upset stomach to more serious such as liver damage To determine which drug candidates are worthy of ongoing investment, pharmaceutical firms must weigh these adverse drug reactions (ADRs) against a drug’s potential benefits throughout the development pipeline.
Approval from a regulatory body, such as the U.S. Food and Drug Administration (FDA), also comes with caveats — as does a prescription from a physician. In order to be considered safe, a drug must be taken in accordance with the manufacturer’s and physician’s instructions, or it may cause more harm than good.
To reach informed conclusions about the balance between each drug’s risks and benefits, researchers and healthcare professionals need access to organized, up-to-date information on drug effects and interactions.
Investment and approval considerations
Every investment in a drug candidate comes with a risk management strategy. Once a pharma developer discovers that a certain compound may bring therapeutic benefits to patients with certain clinical indications, the ensuing research process must also factor in the risk of adverse reactions that may outweigh those benefits.
Considerations for regulatory approval also require a careful assessment of a drug’s potential to do harm, weighed against its potential to bring relief to patients. As demonstrated in such cases as the 2006 leukemia drug trial that left six young men seriously ill, inadequate regulatory stringency carries a risk of serious harm.
Clinical benefits within limits
When prescribing a drug, physicians must also take potential ADRs into account. Every clinician must consider the possibility that certain side effects may decrease the patient’s quality of life more severely than the disorder for which the drug is being prescribed.
In cases of cancer and other severe diseases, even intensely unpleasant ADRs such as nausea and hair loss may be reasonable prices to pay to save a life. But in cases of more minor disorders, including headaches and colds, a physician is likely to limit the doses of risky pharmaceuticals or recommend milder over-the-counter alternatives.
From development to prescription, the balance of drug risks (and the potential harm) versus the benefits (and the potential good) constitute a delicate balance. The more clearly developers, regulators and clinicians understand the risks of a given compound, the more precisely they can target investments, approvals and prescriptions in order to achieve an ideal balance of risks and benefits to patients worldwide.
Author
Sr. Manager, Pharma and Biotech Segment
As a professional with over 14 years of experience in strategy development and partnership management across a variety of industries, Nicki’s latest role as a Senior Manager, Segment Marketing at Elsevier applies her skills to the area of drug discovery and development in the Pharma and Biotech industry. In this capacity she is focused on understanding biopharmaceutical R&D challenges and turning them into opportunity to further Elsevier’s ability to serve industry executives and the professionals who innovate in the drug discovery and development space. Prior to joining Elsevier, Nicki held senior alliance and strategy roles in the Legal, Tax & Accounting, Life Sciences and Cyber Security industries.
Nicki resides in New York City and holds a BA in English Literature and Mandarin Chinese from Carleton College in Northfield, MN.
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Website: http://www.elsevier.com/rd-solutions/pharma-and-life-sciences
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