Lippman, Abby

English

Dépôt Institutionnel Numérique

Blog  RCTs and Exclusion of the Elderly  March 22, 2017   Bryn   clinical drug trials, elderly, participants, RCT, validity  EditBlogChercheuse en résidence / Scholar in ResidenceAbby Lippman, Professor Emerita in the Department of Epidemiology, Biostatistics and OccupationalHealth at McGill UniversityPublié/Published: 22 Mar 2017 2017 A Lippman, Creative Commons Attribution 4.0 International LicenseCon it d’intérêts Con icts of InterestAucun déclaré None to declareExonération DisclaimerLes opinions exprimées ici sont celles de l’auteur et nere ètent pas nécessairement celles de la revue.The views expressed here are the author’s and donot necessarily re ect those of the journal.We’ve known for a long time, for too long a time, that what is formally called “external validity” is oftenlacking when there are randomized clinical trials of medical and pharmacologic interventions. Oldertrials, and some still today, have no female or otherwise gendered women enrolled. Some still think“marital status” has any meaning when probably knowing about sex partners (male, female,ACCUEIL  AUTEURS  PUBLICATIONS  COMMUNAUTÉ both, neither) is more relevant – as it would be for STIs (sexually transmitted infections). And othersprovide  nancial inducements or patent extensions if children are participants.But the one that right now irks me – perhaps because I have an interest in interventions which mightbe recommended for me or my peers – is the continuing exclusion of “older” people…with “older”starting variably at some age between about 60/65 and 80+ years of age. The latest evidence of this isthe article just published in the Journal of the American Geriatric Society that examined the exclusionof “elderly adults” from trials of drugs for a fairly common condition among them, ischemic heartdisease (Bourgeois et al., 2017).So, once again an entire group is “pro led” and must therefore take medications or have othermedical practices “o  label” – and this with not only their e ectiveness but also all the possibleattendant “side” e ects unknown. And this unknown is willful: researchers have not wanted to knowit. A further example, perhaps, of what is becoming a popular focus of social sciences literature,epistemological ignorance. And from another viewpoint, probably a “knowable unknown.”It is not easy to determine if this exclusion by age (too young; too old) stems from these populationsbeing seen as too small to warrant investments into knowing what works for them: the  nancialreturns aren’t “big enough.” Or if it is simple age discrimination. And with those otherwise possiblyeligible (their ages are, as in the story of the “3 Bears,” “just right!”) too often themselves excludedbecause they have one or more chronic disorders which may, itself, be age-associated, the young andthe “old” often, if not always, remain undocumented research participants. They must take their“steps into the unknown” (Silverman, 1986) without the “guidance” provided to those healthy enoughto remain eligible.Why don’t ALL committees reviewing protocols for funding reject those that cannot be applied to realpeople in the real world? Of course, “internal validity” is necessary, and while these may reduce type 1and type 2 errors (false positives and false negatives), research is also open to what might be calledtype 3 errors. In these situations, we get the “right” answer but it’s to the wrong question – unlikework that leads to type 4 problems: the wrong answer to the wrong question.To be clear: I am not now pushing for any expanded use of medications, not for those over 65, under16, or of any age. Too many drugs already do too little good and too much harm for their allegede ectiveness. Nor will insisting on absolute rate reductions rather than relative rates su ce.Moreover, the overuse of medicines often stems from the overuse of screening and diagnostic teststhat are, themselves, of marginal if any value. A vicious cycle.Ethicists and environmental activists have been urging practice of the “precautionary principle” – aninverse formulation of the outdated “what you don’t know can’t hurt you” maxim. In fact, theunknown has sharp teeth and can bite hard. And because the unknown, as the known, is a socialconstruction, things can be built di erently. And this reconstruction is perhaps urgent. And no moreso than now. With private-public collaborations favoured by funding agencies, including the CIHR, andwith pharmaceutical companies responsible for many, if not most, trials, there is de nitely need to← Flesh, Foil, and Authenticity: Re ections on Johann AR Roduit’s “Flesh and Foil”Remerciements 2016 / Acknowledgements 2016 →rethink the entire system of drug testing especially. (And how, in Canada, no one seems to be fullycharged with evaluating devices and screening tests…)The more pro ts can be made for shareholders, the less vigilance there may be about getting drugsto the market.  And Health Canada is, itself, complicit in this when it grants approval for marketing:most of these newer products are hugely expensive and add, at best, a few months, even only weeks,to pain-free high quality life. Why is the latter, HOW one lives, not given priority over the length ofsurvival? What does a patient want? A few millimetres reduced in the size of a tumour? Or time forlaughter and love with family and friends? And if one asks, it does seem that for older folks, too,quality does seem to get priority – with, perhaps, the increasing demand for physician-assisted deathan expression of this?Further complicating matters: researchers, even those university-based, have multiple con icts ofinterest – and putting disclaimers into articles is only necessary, but not su cient. As well, evenpatient groups demanding the newest and the latest treatments have major funding support fromcommercially-interested donours and so are  nancially implicated, even if indirectly. This all matters,since we will all pay for this when healthcare costs rise to cover the new pharma pills that will bemarketed.We all, of all ages and genders – and abilities, etc. – do not need all the screening, testing,medications, interventions we are recommended, if not coerced, to take. Rather, we do want thosethat are used to be truly e ective for US who live real lives in a real world and not only for the idealperson often thought of as being a male, with a single health problem, who is of a certain size, colour,and age. Maybe there is one such prototype in each of our friendship circles, but likely most of thosewe know come with some “baggage.”Randomized clinical trials must not become like airline inspectors measuring this baggage to ensure it ts their needs. We need researchers to stop thinking one-size- ts-all and to ensure they  t our needsby studying what matters to us, to all of us. To do otherwise is unethical.Partager:   ISSN 1923-2799Copyright © 2018 BioéthiqueOnline. All rights reserved. Theme: ColorMag by ThemeGrill. Powered by WordPress.

RCTs and Exclusion of the Elderly

https://papyrus.bib.umontreal.ca/xmlui/bitstream/1866/19724/1/Lippman-Mar22-2017.pdf

RCTs and Exclusion of the Elderly

Abstract

Similar works

Full text

Available Versions

Dépôt Institutionnel Numérique