3
Commentary CMAJ AUG. 20, 2002; 167 (4) 363 © 2002 Canadian Medica l Association or its licensor s ß See related articles pages 357, 361, 377 and 387 P reventive medicine displays all 3 elements of arro- gance. First, it is aggressively assertive, pursuing symptomless individuals and telling them what they must do to remain healthy. Occasionally invoking the force of law (immunizations, seat belts), it prescribes and pro- scribes for both individual patients and the general citi- zenry of every age and stage. Second, preventive medicine is presumpt uous , confident that the interventions it espouses  will, o n average, d o more goo d than har m to those w ho ac- cept and adhere to them. Finally, preventive medicine is overbearing , attacking those who question the value of its recommendations.  Alth ough one could level these same accus atio ns against the “curative” medicine delivered to symptomatic patients  who see k hea lth car e, t he 2 d isc ipl ine s ar e ab sol ute ly a nd f un- damentally different in their obligations and implied promises to the individuals whose lives they modify. When patients sought me out for help with their established, symptomatic diseases, I promised them only to do my best and never guar- anteed that my interventions would make them better. Al- though many of my interventions had been validated in ran- domized trials, 1 the need to intervene in rapidly advancing, life-threatening disorders forced me to use treatments justi- fied only on the basis of past experience, expert advice, and the first principles of physiology and pharmacology. But surely the fundamental promise we make when we actively solicit individuals and exhort them to accept pre-  ventive in tervent ions must be that , on average, they wil l be the better for it. 2  Accord ingly , the  presumpt ion that justifies the aggressive assertiveness  with whi ch we go after t he unsus- pecting healthy must be based on the highest level of ran- domized evidence that our preventive manoeuvre will, in fact, do more good than harm. Without evidence from pos- itive randomized trials (and, better still, systematic reviews of randomized trials) we cannot justify soliciting the well to accept any personal health intervention. There are simply too many examples of the disastrous inadequacy of lesser evidence as a basis for individual interventions among the  well: suppleme ntal oxygen for healthy premies (causin g retrolental fibroplasia), healthy babies sleeping face down (causing SIDS), thymic irradiation in healthy children, and the list goes on.  To thi s sad l ist we must no w add e strogen plus p rogesti n  when given to healthy postmenopausa l women under the presumption that they will be protected against cardiovas- cular disease. The Women’s Health Initiative randomized controlled trial, as reported in the July 17 issue of  JAMA, 3  was stopped when it became clear that the participating  women’s risk of cardiovascu lar disease went up, not down, on active therapy. This damage began to develop soon after randomization, and after a mean follow-up of 5.2 years the trial was stopped for harm. In human terms, the 8506  women treated with estrogen plus progestin had about 40 more coronary events, 40 more strokes, 80 more episodes of venous thromboembolism and 40 more invasive breast cancers than the 8102 women assigned to placebo. Given the frequency with which this treatment is prescribed to postmenopausal women worldwide, hundreds of thousands of healthy women have been harmed.  As with other disaste rs, there are heroes and villa ins in this piece. First place among the heroes is shared by each of the 16 608 women who agreed to coll abora te in the estro- gen-plus-progestin portion of the Women’s Health Initia- tive randomized trial. Second come the investigators, clini- cal collaborators, and members of the data safety and monitoring board, followed closely by the reviewers and members of the US National Heart, Lung, and Blood In- stitute who saw to it that a rigorous, adequately funded trial  was desi gned, ex ecuted and sto pped w hen the answer t o the study question became clear (Canadian Institutes of Health Research, please note).  What about the vill ains? Who is to blame for the wide- spread application of this and the other harmful “preven- tive” interventions that cause disability and untimely death? I suggest that we not waste time blaming the manufacturers of “preventive” drugs and devices, for they are pursuing profit, not health, and anyone who looks to their print ad-  vertisements and television spots for health guidance ar- guably deserves whatever harm comes to them (according to the New York T imes 4 the company that supplied the study drug has already sent 500 000 “Dear Doctor” letters stress- ing the symptomatic benefits of their combination). Nor, I suggest, should we blame “demanding” patients who insist on receiving some bogus preventive intervention of un- known efficacy, for they are simply doing their best to im- prove their lives in an “evidence-vacuum.” I place the blame directly on the medical “experts” who, to gain private profit (from their industry affiliations), to  The arrogance of preventive medicine David L. Sackett Hormone relacement therapy

Arrogância da Medicina Preventiva

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Commentary

CMAJ AUG. 20, 2002; 167 (4) 363

© 2002 Canadian Medical Association or its licensors 

ß See related articles pages 357, 361, 377 and 387

Preventive medicine displays all 3 elements of arro-gance. First, it is aggressively assertive, pursuingsymptomless individuals and telling them what they 

must do to remain healthy. Occasionally invoking the forceof law (immunizations, seat belts), it prescribes and pro-scribes for both individual patients and the general citi-zenry of every age and stage. Second, preventive medicine

is presumptuous , confident that the interventions it espouses will, on average, do more good than harm to those who ac-cept and adhere to them. Finally, preventive medicine isoverbearing , attacking those who question the value of itsrecommendations.

 Although one could level these same accusations against the “curative” medicine delivered to symptomatic patients who seek health care, the 2 disciplines are absolutely and fun-damentally different in their obligations and implied promisesto the individuals whose lives they modify. When patientssought me out for help with their established, symptomaticdiseases, I promised them only to do my best and never guar-anteed that my interventions would make them better. Al-

though many of my interventions had been validated in ran-domized trials,1 the need to intervene in rapidly advancing,life-threatening disorders forced me to use treatments justi-fied only on the basis of past experience, expert advice, andthe first principles of physiology and pharmacology.

But surely the fundamental promise we make when weactively solicit individuals and exhort them to accept pre- ventive interventions must be that, on average, they will bethe better for it.2 Accordingly, the  presumption that justifiesthe aggressive assertiveness  with which we go after the unsus-pecting healthy must be based on the highest level of ran-domized evidence that our preventive manoeuvre will, infact, do more good than harm. Without evidence from pos-

itive randomized trials (and, better still, systematic reviewsof randomized trials) we cannot justify soliciting the well toaccept any personal health intervention. There are simply too many examples of the disastrous inadequacy of lesserevidence as a basis for individual interventions among the well: supplemental oxygen for healthy premies (causingretrolental fibroplasia), healthy babies sleeping face down(causing SIDS), thymic irradiation in healthy children, andthe list goes on.

 To this sad list we must now add estrogen plus progestin when given to healthy postmenopausal women under the

presumption that they will be protected against cardiovas-cular disease. The Women’s Health Initiative randomizedcontrolled trial, as reported in the July 17 issue of  JAMA,3

 was stopped when it became clear that the participating women’s risk of cardiovascular disease went up, not down,on active therapy. This damage began to develop soon afterrandomization, and after a mean follow-up of 5.2 years the

trial was stopped for harm. In human terms, the 8506 women treated with estrogen plus progestin had about 40more coronary events, 40 more strokes, 80 more episodesof venous thromboembolism and 40 more invasive breast cancers than the 8102 women assigned to placebo. Giventhe frequency with which this treatment is prescribed topostmenopausal women worldwide, hundreds of thousandsof healthy women have been harmed.

 As with other disasters, there are heroes and villains inthis piece. First place among the heroes is shared by each of the 16 608 women who agreed to collaborate in the estro-gen-plus-progestin portion of the Women’s Health Initia-tive randomized trial. Second come the investigators, clini-

cal collaborators, and members of the data safety andmonitoring board, followed closely by the reviewers andmembers of the US National Heart, Lung, and Blood In-stitute who saw to it that a rigorous, adequately funded trial was designed, executed and stopped when the answer to thestudy question became clear (Canadian Institutes of HealthResearch, please note).

 What about the villains? Who is to blame for the wide-spread application of this and the other harmful “preven-tive” interventions that cause disability and untimely death?I suggest that we not waste time blaming the manufacturersof “preventive” drugs and devices, for they are pursuingprofit, not health, and anyone who looks to their print ad-

 vertisements and television spots for health guidance ar-guably deserves whatever harm comes to them (accordingto the New York Times 4 the company that supplied the study drug has already sent 500 000 “Dear Doctor” letters stress-ing the symptomatic benefits of their combination). Nor, Isuggest, should we blame “demanding” patients who insist on receiving some bogus preventive intervention of un-known efficacy, for they are simply doing their best to im-prove their lives in an “evidence-vacuum.”

I place the blame directly on the medical “experts” who,to gain private profit (from their industry affiliations), to

 The arrogance of preventive medicine

David L. Sackett

Hormone relacement therapy

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Commentaire

364  JAMC • 20 AOÛT 2002; 167 (4)

Thèmes de la conférence

Vous  Santé et mieux-être : habitudes personnelles du médecin

Le service  Programmes et stratégies de promotion de la santé, du mieux-être et du rétablissement

Le leadership  Activités des programmes et des administrateurs en santé des médecins dans les établissements de santé

Conférenciers vedettes

Olaf G. Aasland, MD, MHA - Directeur de l’Institut de recherche de l’Association médicale norvégienne

Robert Buckman, MD - Médecin oncologue, auteur et chercheur clinique réputé en théorie des communications

 William Eaton, MD - Professeur à l’Université Memorial et humoriste

 Wayne M. Sotile, PhD and Mary O. Sotile, MA - Auteurs de The Medical Marriage: Sustaining Healthy Relationships  for Physicians and their Families and Resilient Physicians and Medical Organizations 

 John Ulwelling, PhD - Vice-président exécutif de la Foundation for Medical Excellence

Qui devrait y assister?Médecins, résidents, étudiants en médecine, membres de leur famille, autres professionnels de la santé, membres dupersonnel de sociétés médicales et de leurs comités sur l’incapacité des médecins, administrateurs d’hôpitaux, membresdes ordres des médecins, et médecins qui soignent d'autres médecins

Crédits d’EMC: L'étude de la demande de crédits pour les médecins canadiens est en cours 

Conférence internationale 2002 sur la santédes médecins Du 16 au 19 octobre 2002 • Westin Bayshore Resort and Marina • Vancouver, (C.-B.)

Information et inscription: Détails disponibles sur le site www.amc.ca, ou composer le 312-464-5476; courriel : [email protected]

satisfy a narcissistic need for public acclaim or in a mis-guided attempt to do good, advocate “preventive” manoeu- vres that have never been validated in rigorous randomizedtrials. Not only do they abuse their positions by advocatingunproven “preventives,” they also stifle dissent. Others, who should know better than to promote “preventive” ma-

noeuvres without clinical trials evidence, are simply wrong-headed. When a 1997 systematic review of 23 trials of post-menopausal hormone therapy concluded that thistreatment substantially increased the risk of cardiovasculardisease,5 the attack on its results included a public an-nouncement from a prominent editorialist: “For one, Ishall continue to tell my patients that hormone replace-ment therapy is likely to help prevent coronary disease.”6

Experts refuse to learn from history until they make it them-selves, and the price for their arrogance is paid by the innocent.Preventive medicine is too important to be led by them.7

References

1. Ellis J, Mulligan I, Rowe J, Sackett DL. Inpatient general medicine is evi-

dence based. Lancet 1995;346:407-10.2. Sackett DL, Holland WW. Controversy in the detection of disease. Lancet 1975;2:357-9.

3. Writing Group for the Women’s Health Initiative Investigators. Risks andbenefits of estrogen plus progestin in healthy postmenopausal women. Princi-pal results from the Women’s Health Initiative randomized controlled trial.

 JAMA 2002;288(3):321-33.4. Petersen M. Company sends letter to retain hormone sales. New York Times 

2002 Jul 11. Sect A:21.5. Hemminki E, McPherson K. Impact of postmenopausal hormone therapy on

cardiovascular events and cancer: pooled data from clinical trials. BMJ 1997;315:149-53.

6. Naylor CD. Meta-analysis and the meta-epidemiology of clinical research.BMJ 1997;315:617-9.

7. McPherson K. For and against: public health does not need to be led by doc-tors. For. BMJ 2001;322:1593-4.

Dr. Sackett is with the Trout Research & Education Centre at Irish Lake, Mark-dale, Ont.

Competing interests : None declared.

Acknowledgements : I thank Iain Chalmers, Brian Haynes, Klim McPherson, An-drew Oxman and William Silverman for their comments on the initial draft of thiscommentary.

Correspondence to: Dr. David L. Sackett, Trout Research & 

Education Centre at Irish Lake, RR1, Markdale ON N0C 1H0; fax 519 986-9951; [email protected]