What Does Diversion Mean?

Diversion has various different meanings in the world of ethics.

Distraction. An idea or activity serves as a distraction from what's important. For example, @juliapowles uses the term "captivating diversion" to refer to ethicists becoming preoccupied with narrow computational puzzles that distract them from far more important issues. See my post on The Game of Wits Between Technologists and Ethics Professors (June 2019)

Substitution. People are redirected from something harmful to something supposedly less harmful. For example, switching from smoking to vaping. See my post on the Ethics of Diversion - Tobacco Example (September 2019). And in the 1840s, a Baptist preacher and temperance activist organized excursions to divert people from drinking. His name: Thomas Cook.

Unauthorized Utilization. Using products for some purpose other than that approved or prescribed for a given purpose in a given market. There are various forms of this, some of which are both illegal and unethical, while others may be ethically justifiable.

• Drug diversion, the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit use.

• Grey imports. Drug companies try to control shipments of drugs between markets, especially when this is done to undercut the official drug prices. However, some people regard the tactics of the drug companies as unethical. Médecins Sans Frontières, the medical charity, has accused one pharma giant of promoting overly-intrusive patient surveillance to stop a generic drug being diverted to patients in developed countries.

• Off-label use. Doctors may prescribe drugs for a purpose or patient group outside the official approval, with various degrees of justification. For more discussion, see my post Off-Label (March 2005)

Exploiting Regulatory Divergence. Carrying out activities (for example, conducting trials) in countries with underdeveloped ethics and weak regulatory oversight. See debate between Wertheimer and Resnick.

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Amy Kazmin, Pharma combats diversion of cheap drugs (FT 12 April 2015)

Julia Powles, The Seductive Diversion of ‘Solving’ Bias in Artificial Intelligence (7 December 2018)

David B. Resnik, Addressing diversion effects (Journal of Law and the Biosciences, 2015) 428–430

Alan Wertheimer, The ethics of promulgating principles of research ethics: the problem of diversion effects (J Law Biosci. 2(1) Feb 2015) 2-32

Wikipedia: Drug Diversion, Thomas Cook

Off-label dog-whistles

originally posted by John

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Richard’s blog on off-label trust rings lots of bells for me. None though, until I read it, rang in the context in which it is presented (my prescribed product of choice being Bushmills). In a pharmaceutical context, Richard writes, Off-Label refers to uses of drugs that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company.

In view of the current state of political play in pre-election Britain, paraphrasing that opening rings quite a revealing bell: In a political context, Dog-whistle refers to uses of issues that are not approved of in terms of civilized politics and cannot therefore be printed in the manifesto or officially promoted by a serious party.

This is powerful medicine in every sense. Within the trust space, the informal, in both cases, takes precedence over the formal, the implied over the expressed and the unknown over the known. It is ‘trust me’ trust of a pretty abusive strain.

In the US electoral context, the political hygiene that got Mr Bush a second term, stemmed directly from successfully manipulating just such off-label trust. Unsurprising then that it should be being copied here.

Unlike politics, hygiene, it needs to be said, may not be the best description of outcomes in the pharmaceutical context.

Off-Label Trust

One of a series of posts about Off-Label

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In a pharmaceutical context, Off-Label refers to uses of drugs that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service. In this blog posting, I shall explore the implications of off-label for trust.

There is a regulatory process that is supposed to allow medical practitioners and their patients to trust pharmaceutical products. Under certain conditions, trust in the regulatory process (authority trust) generates trust in particular products (commodity trust). One of these conditions is strict adherence by all parties to the label.

• Users must confine themselves to using the product as specified on the label.
• Providers must confine themselves to promoting the product solely as specified on the label.
  

Whether the drug company sales force is permitted to hint at off-label uses of a given product or not, this sets up a transference in which the nudge/wink (or enforced silence) of the salesman replaces the bureaucratic authority of the FDA.

Meanwhile, samizdat off-label information may circulate in the medical community, possibly based on direct/indirect trial/error experience by medical practitioners. This is a form of network trust.

Off-Label as Samizdat

One of a series of posts about Off-Label

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In a pharmaceutical context, Off-Label refers to drugs being used in ways that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service. In this blog posting, I shall explore the implications of off-label for knowledge management.

Robert Stern describes some of the difficulties involved in disseminating Off-Label research data. There are clearly some potential conflicts of interest, and doubtless sometimes there is natural suspicion of the motives of the drug companies. However, the result is that data describing the behaviour of certain drugs in certain contexts are not available.

This means that many good uses of drugs may be suppressed by regulators, or self-censored by drug companies in order to get speedy approval. In a separate post, Robert Stern quotes a physician as saying "Often the drug companies will under-dose their labeling to get it through the FDA." So does the physician have some other way of finding out an appropriate dose, or is it all done by trial and error?

If the official channels are blocked, how does the medical community share practical knowledge about Off-Label. Is this all done by unofficial samizdat and word-of-mouth?

There is a newsletter for sceptical patients called What Doctors Don't Tell You. Perhaps there should be, if there isn't already, a newsletter for doctors called What Drug Companies Don't Tell You.

Off-Label as Innovation

One of a series of posts about Off-Label

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In a pharmaceutical context, Off-Label refers to uses of drugs that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service. In this blog posting, I shall explore the implications of off-label for innovation and technological change.

According to Alexander Tabarrok and Daniel Klein, Off-Label Drug Awareness Saves Lives (Independent Institute, Feb 2003). "Off-label prescribing is a vital aspect of modern medicine because it often happens that new and important uses are discovered for old drugs."

For some drugs, it seems there is more off-label usage than on-label usage. The medical state-of-the-art can be found in off-label use of drugs, and professional presentations that restrict themselves to on-label uses may lack medical credibility. Robert Stern describes a communication event that was poorly attended, because it was thought to be on the side of the official label, rather than on the side of emergent practice.

Many good uses of drugs may be suppressed by regulators, or self-censored by drug companies in order to get speedy approval. Robert Stern quotes a physician as saying "Often the drug companies will under-dose their labeling to get it through the FDA."

But drug companies are not permitted to promote off-label uses of drugs. This apparently extends to the dissemination of research data concerning possible off-label uses. See Litigation Threatens Off-Label Pharmaceutical Sales, by Kenneth J. Nolan (HealthLeaders News, January 21, 2004)

Off-label eventually becomes on-label. A well-known example is the use of aspirin for heart conditions. Regulators resisted this use of aspirin for years; it is now widely accepted. This provides us with an important pattern of technology development and dissemination.

[Update] Going beyond pharma, we can see similar innovation processes elsewhere. There's a very familiar example in telecoms. Telephone companies were originally oriented towards providing voice services. Computer users started to use modems, which were designed to extract added value from a voice connection by using it to transmit data. With Voice Over IP, we have now come full-circle: VOIP is designed to extract added value from a data connection by using it to transmit voice. These services are now officially sold by the telephone companies - off-label has become on-label.

Off-Label

In a pharmaceutical context, Off-Label refers to uses of drugs that are not approved by the regulators and cannot therefore be printed on the product label or officially promoted by the drug company. More generally, it refers to any unauthorized or emergent use of a product or service.

From the regulatory point of view, off-label is not merely unapproved but (at least to some extent) disapproved, and subject to secondary regulation.

• US Food and Drug Administration (FDA)
• UK Pesticides Safety Directorate (PSD)

See also Kelli Miller, Off-Label Drug Use: What You Need to Know (WebMD, undated)


But off-label usage is apparently increasing. This raises several questions, which are raised in separate blog postings.

Off-Label as Innovation (March 2005) - the technological leading edge is often/always off the label.

Off-Label Trust (March 2005) - on-label and off-label usage rely on different trust mechanisms.

Off-Label as Samizdat (March 2005) - off-label usage is disseminated by informal knowledge mechanisms

SOA Pharma (March 2005) - there is a critical asymmetry between on-label and off-label, which must be accommodated in the geometry of services

Off-Label Dog Whistles (March 2005) - in a political context, dog-whistle refers to uses of issues that are not approved of in terms of civilized politics and cannot therefore be printed in the manifesto or officially promoted by a serious party. (Guest post by John).

See also On Repurposing AI (November 2018)


Links corrected 3 November 2018