The inverse benefit law states that the ratio of benefits to harms among patients taking new
drug
A drug is any chemical substance that causes a change in an organism's physiology or psychology when consumed. Drugs are typically distinguished from food and substances that provide nutritional support. Consumption of drugs can be via insuffla ...
s tends to vary inversely with how extensively a drug is
marketed
Marketing is the process of exploring, creating, and delivering value to meet the needs of a target market in terms of goods and services; potentially including selection of a target audience; selection of certain attributes or themes to emph ...
. Two Americans, Howard Brody and Donald Light, have defined the inverse benefit law, inspired by
Tudor Hart's
inverse care law.
A drug
effective
Effectiveness is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression.
Etymology
The ori ...
for a serious
disorder
Disorder may refer to randomness, non-order, or no intelligible pattern.
Disorder may also refer to:
Healthcare
* Disorder (medicine), a functional abnormality or disturbance
* Mental disorder or psychological disorder, a psychological pattern a ...
is less and less effective as it is promoted for milder cases and for other conditions for which the drug was not approved. Although
effectiveness
Effectiveness is the capability of producing a desired result or the ability to produce desired output. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression.
Etymology
The ori ...
becomes more diluted, the risks of harmful
side effects
In medicine, a side effect is an effect, whether therapeutic or adverse, that is secondary to the one intended; although the term is predominantly employed to describe adverse effects, it can also apply to beneficial, but unintended, consequence ...
persist, and thus the benefit-harm ratio worsens as a drug is
marketed
Marketing is the process of exploring, creating, and delivering value to meet the needs of a target market in terms of goods and services; potentially including selection of a target audience; selection of certain attributes or themes to emph ...
more widely. The inverse benefit law highlights the need for
comparative effectiveness research
Comparative effectiveness research (CER) is the direct comparison of existing health care interventions to determine which work best for which patients and which pose the greatest benefits and harms. The core question of comparative effectiveness r ...
and other reforms to improve
evidence-based
Evidence-based practice (EBP) is the idea that occupational practices ought to be based on scientific evidence. While seemingly obviously desirable, the proposal has been controversial, with some arguing that results may not specialize to indivi ...
prescribing.
[
]
State of affairs
The law is manifested through 6 basic marketing strategies:
* reducing thresholds for diagnosing disease,
* relying on surrogate endpoints,
* exaggerating safety
Safety is the state of being "safe", the condition of being protected from harm or other danger. Safety can also refer to risk management, the control of recognized hazards in order to achieve an acceptable level of risk.
Meanings
There are ...
claims,
* exaggerating efficacy
Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versu ...
claims,
* creating new diseases,
* encouraging unapproved uses.
Impact
This is the reason why organizations like "Worst Pill, Best Pill" recommend not to use/prescribe new medications before being in the market for at least ten years (except in the case of important new drugs that treat previously unsolved problems).
Agencies of drugs, committee of ethics and organizations of patients' safety should consider:
* Requiring that clinical trials run long enough to pick up evidence of side effects and record all adverse reactions, including in subjects who drop out.
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See also
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References
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Bibliography
Light DW (Editor). The Risks of Prescription Drugs. New York: Columbia University Press; 2010.
Evans I, Thornton H, Chalmers I. Testing Treatments: Better Research for Better Healthcare. London: Pinter & Martin Ltd; 2010.
External links
Equipo CESCA
Healthy Skepticism
Worst Pills, Best Pills
Better Healthcare
Pharmaceutics
Health economics
Pharmaceutical industry
Adages