Inverse benefit law
Encyclopedia
The Inverse Benefit Law states that the ratio of benefits to harms among patients taking new drug
s tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the Inverse Benefit Law, inspired by Tudor Hart
's Inverse care law
.
A drug effective for a serious disorder
is less and less effective as it is promoted for milder cases and for other conditions for which the drug was not approved. As effectiveness
becomes more diluted, the risks of harmful side effects
proliferate, thus the benefit-harm ratio worsens as a drug is marketed
more widely. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.
Agencies of drugs, committee of ethics and organizations of patients' safety should consider:
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
s tends to vary inversely with how extensively a drug is marketed. Two Americans, Howard Brody and Donald Light, have defined the Inverse Benefit Law, inspired by Tudor Hart
Julian Tudor Hart
Julian Tudor Hart is a British physician.- Biography :He studied medicine at Cambridge University and in London....
's Inverse care law
Inverse care law
The Inverse care law is the principle that the availability of good medical or social care tends to vary inversely with the need of the population served.Proposed by Julian Tudor Hart in 1971, the term has since been widely adopted.The law states that:...
.
A drug effective for a serious disorder
Disorder
Disorder may refer to :* Chaos, unpredictability and in the metaphysical sense, it is the opposite of law and order* Civil disorder, one or more forms of disturbance caused by a group of people...
is less and less effective as it is promoted for milder cases and for other conditions for which the drug was not approved. As effectiveness
Effectiveness
Effectiveness is the capability of producing a desired result. When something is deemed effective, it means it has an intended or expected outcome, or produces a deep, vivid impression.-Etymology:...
becomes more diluted, the risks of harmful side effects
Side Effects
Side Effects is an anthology of 17 comical short stories written by Woody Allen between 1975 and 1980, all but one of which were previously published in, variously, The New Republic, The New York Times, The New Yorker, and The Kenyon Review. It includes Allen's 1978 O...
proliferate, thus the benefit-harm ratio worsens as a drug is marketed
Marketing
Marketing is the process used to determine what products or services may be of interest to customers, and the strategy to use in sales, communications and business development. It generates the strategy that underlies sales techniques, business communication, and business developments...
more widely. The inverse benefit law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing.
State of affairs
The law is manifested through 6 basic marketing strategies:- - reducing thresholds for diagnosing disease,
- - relying on surrogate endpoints,
- - exaggerating safetySafetySafety is the state of being "safe" , the condition of being protected against physical, social, spiritual, financial, political, emotional, occupational, psychological, educational or other types or consequences of failure, damage, error, accidents, harm or any other event which could be...
claims, - - exaggerating efficacyEfficacyEfficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
claims, - - creating new diseasesDisease mongering]Disease mongering is a pejorative term for the practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical companies, physicians, and other...
, - - encouraging unapproved uses.
Impact
Many harms of new drugs are unexpected, and could be as serious as death. 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 very few cases of really important new drugs that solve previous 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.
- - Paying companies more for new drugs in proportion to how much better they are for patients than existing drugs, and marketing according to the value of the new drugs (ratio of benefits to harms and marketing).
- - Considering that market could be a force against the best use of medications.
See also
- Disease mongeringDisease mongering]Disease mongering is a pejorative term for the practice of widening the diagnostic boundaries of illnesses, and promoting public awareness of such, in order to expand the markets for those who sell and deliver treatments, which may include pharmaceutical companies, physicians, and other...
- Health policy
- Inverse care lawInverse care lawThe Inverse care law is the principle that the availability of good medical or social care tends to vary inversely with the need of the population served.Proposed by Julian Tudor Hart in 1971, the term has since been widely adopted.The law states that:...
- MedicalizationMedicalizationMedicalization is the process by which human conditions and problems come to be defined and treated as medical conditions and problems, and thus come under the authority of doctors and other health professionals to study, diagnose, prevent or treat...
- Patient safetyPatient safetyPatient safety is a new healthcare discipline that emphasizes the reporting, analysis, and prevention of medical error that often leads to adverse healthcare events. The frequency and magnitude of avoidable adverse patient events was not well known until the 1990s, when multiple countries reported...
- Pharmaceutical companyPharmaceutical companyThe pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices...
- Pharmaceutical marketingPharmaceutical marketingPharmaceutical marketing , sometimes called medico-marketing, is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs. There is some evidence that marketing practices can negatively affect both patients and the health care profession...
- Public healthPublic healthPublic health is "the science and art of preventing disease, prolonging life and promoting health through the organized efforts and informed choices of society, organizations, public and private, communities and individuals" . It is concerned with threats to health based on population health...
- Quaternary preventionQuaternary preventionThe quaternary prevention, concept coined by the Belgian general practitioner , are the action taken to identify patient at risk of overmedicalisation, to protect him from new medical invasion, and to suggest to him interventions, which are ethically acceptable...
- Medical science liaison