8/13/2019 HTA Waste and Harm in the Treatment of Mild Hypertension-Iona Heat

http://slidepdf.com/reader/full/hta-waste-and-harm-in-the-treatment-of-mild-hypertension-iona-heat 1/2

LESS IS MORE

 VIEWPOINT

Waste and Harm in the Treatmentof Mild Hypertension

THE  2012 COCHRANE

Review on “Pharma-cotherapy for MildHypertension”1 con-cluded that antihy-

pertensive drugs used in the treat-ment of otherwise healthy adultswith mild hypertension (systolicblood pressure [BP], 140-159mm Hg, and/or diastolic BP, 90-99mmHg) have not been shown to re-duce mortality or morbidity in ran-domized clinical trials. Will thislandmark conclusion affect clinicalpractice and slow the inexorable ex-pansion of disease categories? It cer-tainly should because overdiagno-sis and overtreatment are potentcauses of both waste and harm andseem to be operating in the inter-ests of the pharmaceutical industryrather than in those of the patientswhom the industry claims to serve.

 When news of the Cochrane Re-view was published in  BMJ , JulianTudor Hart, the pioneer of screen-

ing for hypertension at the previ-ous threshold of 160/100 mm Hg,submitted a telling response.2 Heasked, “Why has it taken more than30 years to reach this conclusion,when it was already evidentfrom anycareful and critical reading of thetrials claimed originally to justify in-terventions in the diastolic range 90-100 mm Hg?” He went on to de-scribe his recollections of 3 WorldHealth Organization symposia onmild hypertension sponsored by 3multinational pharmaceutical com-

panies. These were held in 1983, andthe invitation letter asked all attend-ees to endorse the proposed conclu-sion, which was that the thresholdfor prescribing medicationshould belowered to a diastolic BP of 90mm Hg.

In 1999, Schwartz and Wo-loshin3 described the effects of changing disease definitions, includ-ing that for hypertension. Redefin-

ing hypertension as systolic BP of atleast 140 mm Hg instead of at least160 mmHg or diastolic BP of at least90 mm Hg instead of at least 100mm Hg creates 13 million new hy-pertensive patients in the UnitedStates alone. Also in 1999, more than800physicians, pharmacists, andsci-entists from 42 countries signed anopen letter to Gro Harlem Brundt-land, the then Director-General, out-lining fears that the World HealthOrganization’s new hypertensionguidelines, which suggested that thegoal of treatment should be restor-ing BP to levels defined as “nor-mal” (130/85 mm Hg) or “opti-mal” (120/80 mm Hg), wouldresult in “increased use of antihy-pertensive drugs, at great expenseand for little benefit.”4(p893)

In 2003, new European guide-lines on cardiovascular disease pre-ventionin clinical practicewerepub-lished.5 These suggested BP above140/90 mm Hg, with no age correc-

tion, andserum total cholesterol lev-els of 193 mg/dL (to convert to mil-limoles per liter, multiply by 0.0259)as the appropriate thresholds for in-tervention. The guidelines consid-ered other risk factors and recom-mended a range of lifestyle advicealongside drug treatment, but thebottom line was that the physicianwas expected to inform the patientthat these measurements mean thathe or she is at increased cardiovas-cular risk regardless of the manage-ment proposed.

The following year, Getz and col-leagues6 described the results of ap-plying these European guidelines tothe entire population of a county inNorway. The Nord-TrondelagHealth Study provides BP and se-rum cholesterol level data for some62 000 adults aged between 20 and79 years in the period 1995 through1997. When the European guide-lines are applied, half the popula-

tion are considered to be at risk bythe early age of 24 years. By the ageof 49 years, this proportion in-creases to 90%, and as much as 76%of the total adult population arefound to be at “increased risk.” Yetthe current life expectancy at birthin Norway is 79 years for men and83 years for women, making it oneof the longest-living populations inhistory. In this context, the thresh-olds cannot be appropriate, and it isperhaps important to note that ev-ery one of the numerous authors of the European guidelines reportedsome degree of support from thepharmaceutical industry.

In 2004, theSeventhReport of the Joint National Committee on Pre-vention, Detection, Evaluation, andTreatment of High Blood Pressure(JNC7)7 sponsored by the US Na-tional Heart, Lung, and Blood Insti-tute pushed the thresholds evenlower, stating that prehypertensiveindividuals (systolic BP, 120-139

mm Hg, or diastolic BP, 80-89mm Hg) require health-promotinglifestyle modificationsto prevent theprogressive rise in BP and cardio-vascular disease. Nine of 10 mem-bers of the Executive Committee re-sponsible for JNC7 record conflictsof interest relating to the receipt of payments from the pharmaceuticalindustry.

In British general practice, en-meshed as it is in a web of guide-lines that are underwritten by thepayment-by-results targets of the

Quality and Outcomes Frame-work,it hasbecome increasingly dif-ficult to resist the trend towardover-treatment. The 2012/2013 version of the Quality and Outcomes Frame-work awards points for those pa-tients with newly diagnosed hyper-tension, BP greater than 140/90mm Hg, without cardiovascular dis-ease, and aged 30 to 74 years, whohave had a face-to-face cardiovas-

 JAMA INTERN MED/ VOL 173 (NO. 11), JUNE 10, 2013 WWW.JA MAINTERNALMED.COM956

©2013 American Medical Association. All rights reserved.

wnloaded From: http://archinte.jamanetwork.com/ by a World Health Organization User on 06/12/2013

8/13/2019 HTA Waste and Harm in the Treatment of Mild Hypertension-Iona Heat

http://slidepdf.com/reader/full/hta-waste-and-harm-in-the-treatment-of-mild-hypertension-iona-heat 2/2

cular risk assessment within 3months of diagnosis, and, most rel-evant to the present discussion, forthe percentage with hypertensionwho have hada BP measurement re-corded in the past 9 months and inwhom measurementis no more than150/90 mm Hg. Guidance from theNational Institute for Health andCare Excellence suggests that drugtreatment should be offered topeople aged younger than 80 yearswithstage 1 hypertension (BP160/ 100 mm Hg) only if they also havetarget organ damage, established car-diovascular disease, renal disease,diabetes, and/or a 10-year cardio-vascular risk equivalent to 20% orgreater. Yet the Quality and Out-comes Framework expects a BP of no more than 150/90 mm Hg, andthis drives the medicating of manypeople with stage 1 hypertensionwho have no comorbidity and who,according to the Cochrane Re-view,1 will derive no benefit.

They will, however, be at risk of harm. Every practicing clinicianknows the fear aroused in manypatients by a diagnosis of hyperten-sion, and this fear has tangible out-comes, which include work absen-teeism andmarital andfamilystress.8

The Cochrane Review also reportsthat antihypertensive drug treat-ment for mild hypertension caused9% of patientsto withdrawowing to

adverse effects.

1

Each of these pa-tients has experienced the harm of an adverse effect for no establishedbenefit.

The waste in terms of the costs of medicationandinvestigationsandthetime of both patients and health careprofessionals is enormous. The 2012 World Health Organization GlobalHealthExpenditure Atlas (http://www.who.int/nha/atlas.pdf) reports that

the Organisation for Economic Co-operationand Development (OECD)countries consume more than 80%of the world’s health care resourcesbut experience less than 10% of theworld’s disability-adjusted life years.This must be unsustainable in termsof both global justice and the earth’scapacity. The problem is that wherethe OECD countries lead, the rest of the world tends to tryandfollow. The World Health Organization GlobalStatus Report on NoncommunicableDiseases 2010  (http://www.who.int /nmh/publications/ncd_report2010 /en/), published as part of the prepa-rations for the 2011 United Nationshigh-level meeting on noncommu-nicable disease prevention and con-trol, includes tables of the percent-ageof each country’spopulation withBPsgreater than 140/90mm Hg,withtheclear implicationto member statesthat this is the appropriate thresh-old for even the poorest countries.

In view of the mounting evi-dence of both waste and harm, it iswell time that we returned to thehigher threshold of 160/100 mm Hgfor the pharmaceutical treatment of hypertension in otherwise healthypeople. The Eighth Report of the Joint National Committee on Pre-vention, Detection, Evaluation, andTreatment of High Blood Pressureprovides a timely opportunity forachieving this, but, with the prob-

able degree of industry entangle-ment, it seems a remote possibility.However, sooner or later the phar-maceutical treatment of mild hyper-tension seems likely to be con-signed to what the novelist AmitavGhosh9(p119) has described as “medi-cine’s vast graveyard of discreditedspeculations.”

Published Online:  May 13, 2013.doi:10.1001/jamainternmed.2013.970Author Affiliations: Royal Collegeof General Practitioners, London,England. Dr Heath is a retired gen-eral practitioner.Correspondence: Dr Heath, RoyalCollege of GeneralPractitioners, UK,30 Euston Square, London NW12FB, England (iona.heath22@yahoo.co.uk).Conflict of Interest Disclosures:None reported.

REFERENCES

1. Diao D, Wright JM, Cundiff DK, Gueyffier F. Phar-

macotherapyfor mildhypertension.Cochrane Da- 

tabase Syst Rev . 2012;8(3):CD006742.

2. Hart JT. Cochrane review finds no proved benefit

i n drug treatment for pat i ents w i th mi l d

hypertension. BMJ . 2012;345:e5511.

3. Schwartz LM, Woloshin S. Changing disease defi-nitions:implications for disease prevalence: analy-

sis of the Third National Health and Nutrition Ex-

aminationSurvey, 1988-1994.EffClin Pract . 1999;

2(2):76-85.

4. Woodman R. Open letterdisputesWHO hyperten-

sion guidelines. BMJ . 1999;318(7188):893B.

5. De Backer G, AmbrosioniE, Borch-Johnsen K,et al;

Third Joint Task Force of European and Other So-

cieties on Cardiovascular Disease Prevention in

Clinical Practice. European guidelines on cardio-

vasculardiseasepreventionin clinical practice. Eur 

Heart J . 2003;24(17):1601-1610.

6. Getz L, Kirkengen AL, Hetlevik I, Romundstad S,

SigurdssonJA. Ethical dilemmasarisingfrom imple-

mentation of the European guidelines on cardio-

vascular disease prevention in clinical practice: a

descriptive epidemiological study.  Scand J Prim Health Care . 2004;22(4):202-208.

7. National Heart, Lung,and BloodInstitute. Thesev-

enthreportof theJoint NationalCommitteeon Pre-

vention, Detection, Evaluation, and Treatment of

HighBlood Pressure: complete report. 2004.http:

 //w ww.n hlbi .ni h.g ov/ guid elin es/ hype rte nsio n

 /jnc7full.htm. Accessed January 8, 2013.

8. Ogedegbe G. Labeling and hypertension: it is time

to intervene on its negative consequences.

Hypertension . 2010;56(3):344-345.

9. Ghosh A.  The Calcutta Chromosome. New Delhi,

India: Ravi Dayal Publisher; 1996.Iona Heath, MA, MB, BCh

 JAMA INTERN MED/ VOL 173 (NO. 11), JUNE 10, 2013 WWW.JA MAINTERNALMED.COM957

©2013 American Medical Association. All rights reserved.

wnloaded From: http://archinte.jamanetwork.com/ by a World Health Organization User on 06/12/2013