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For Distribution to CPs

Stoke CNEP...... by thArt!cles comm, iss~oned e

Journal qf the Royal Society Of Medicine,collected here to honour the memory of

Edmund Nevi!ie Hey

1.934-2009

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Contents Page

The CNEP triaI: how a good trial was turned rottenKamran Abbasi

Regulating research, regulating professionalsMary Dixon-Woods

Mis-investigating alleged research misconduct can causewidespread, unpredictable damageEdmund Hey and Iain Chalmers

The role of the media in the Stoke CNEP Saga

Jonathan Gornall

The Stoke CNEP Saga - the Government enqui~ in retrospectRoderic Griffiflls

The Stoke CNEP Saga- how it damaged all involvedTereSa Wright

The Stoke CNEP Saga- a view from the General Medical CouncilGraeme Catto

The Stoke CNEP Saga - did it need to take so long?Frank Wells

Edmund Hey - a personal appreciationIain Chalmers

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The CNEP trial: how a good trialwas turned rotten

Kamran AbbasiEditOr. JR£M

Ol~.e nqaWs !-~ioneerJ.F,-~ res£,iu’£h Js Pa’lo?ah~;£ :aw=~’s

reseat~zh miscondacL But back h~ October ]989, atthe tlt’at’t of a r~Qdc, l"E~tigud colyIpariso,[~ ef continu-otis :.K’gative ~.xtrathoracic pre..s~re fCNEP) w~thint~a4-rache;d positire pre..sute ventilatlon [n p]~,-matt~re lleonates, ll*d.’(.iiCR! researql~Pt’s were’ ~lv~-q~estkma.biy shh~fng k;@;hts, in d:e interveningtwo decades, m,’my medical ~e.:<’archcn> have Beenattaek~mt wr their evil iute~tions. Sometimes fairly,when :~searchers have alk~wcd, oo~npetiug ~:~ter-est< usually finandal or career gain. to ;nuddvtheir m~rk and damage thd~ integrky OtJwrr~.~.~<~rcbe~s, howeveg have become victims o~ a~hambo]}c ar, d ffagme~ted reg, ulatm-y system, amta oiminaily amate~riM~ syst~.m for u.we.stigahnga Eteged research misa’onducc

the researchers revolved m the CNEI:’ trial fallint~ the latte~ category a~8~:e Ed Hey and lah~Cbalmers tJR.SM 20"~0;103:132-7). T]~e trial cm~tdbe considered ~o have been ahead of its time. D~epr0toeo] w~s alpha rated by the MRC. It ";,,-ased’.icaHy 3ppmved - tw~;e It was p’~bIkiy r~gisotared at inceptw, n. An ~nformation leaflet wasprovided for pa~ents, aexi po~t-trial questJo~uta~reswere ~>~,d ~ g~the!" parental views A sequentialdesign was used to mottkor accum@atmg resetskrl Lhe days before data m~.mitoring cm’nm~t~eesbecan~.e commonplace, ~:\~d the trial report wasco-authored by doctors, nttrses aDO a qtatlsticidn.

l-lowe~,.eE a combustible mix ot ¢{~vum~mncesturned the CNEP tria! h~to the heat exa;nple o~ howto m/s-vwestigate a!]eged research yrtjbcDrgjDrt.’[>e ace#salines of d tstrauj~ht ~td vulnerable par-ents were understc~ndab~e, the trial participantsweze newborn and at risk of early death, t3ut theseo_,mpfa~nts "were seizcd upor~ };y ~.ampaigt~er_~K, cgv~g to b;terregate the child F ro~ection wm’k <:,ttwo of the pr;’,fes~b~nais assodamd with ti:e trial --M~rti~ .q~muets ann David S;)utha]J. The mediaamp)i#ed ~e nuise, receptive to hart’or ~toncs

about dt~ctors in tile e~a o[ the Bristol hto.uJry intopaediafr~c cardiac smaat’.tv, tile ol’gall reterttiooscandal at AMer ltev a~a tile tnurd~rs of HaroldShipm~ Doctors were vil~:ivd by the med~a, par-traved as a goatees" ga Ilerv of bp.tchers m~d ~;t’¢)p*’r~.

1"he result for the Javes~igatur5 it., the (NF.P tealand the staff at North Staffo;dshJ.r¢ Jq,:~spita t. v~mere@~e trial was ¢onduc:ted was ;~ i.ivji~g hell of a!lega-u(ms media attacks, intl’~.~sive scruti:~v, mtd local midnaiJ,’mal mvest~gat_;ans After !1 vea:’s of acolsatJ;msbwe,iigations, and mqulr:es ~ and £6 mi.Illor~ mcosts . the GMC dt~:ided that there was no case to.~

@e r~:seat’ehers to answer in ~e~pect of the CNEP trial.this mo~th, the j~S,M begins a six-part series

examining tbe outcO: that resul~,d from ailegatl,m’~smade a.b .tat the CNFP trial and its impact on r~=gu-lation of medical research. He’ and Chalmers set(mr the baekgrotn’~tl to the dontm\’ersy &nd call fogthe first t’e~o~se to alT~ega~Jone, o~ research miseon..duct to be that the facts be established by snitab$vquaiided profi,s-hma] investigators. ’D*4_,y aimarena for a ;ttqKl." rob’~lM mspv, lzse ~’rom p~’ofess[on-aS, to unfair at.iegatinn< Why shouldn’t prnSess~on-:~.]S I.f-A20:&t’ ll~llell malJgned hbe[ tav..’e, mt>:’e often [oprotect theh’ reputations? In subst:quet’~t issues.Tonath~;~ Gea’y~a~! will dbs~d the r01e of the mediain or;caring a ;u~tmnc, t s,:anda] on1 of pwneermg~mdJ.cal r<’seard;. Rod Or~fflths will g~x,e a blow-by-[’dOW aecotJfll of the ll~tt,=h-ct’tt~iaed g,>vemmemmg~ try h~_ beaded. He i,ater described his brief a.s’drinking tram a poJ.sop, ed chalice’, l’heresa Wright~II prey.co a personal h:sight init~ the experienceof m4rslng staff at North Sta)iord.q~zre !’h:.p!ta!during tbe he~g~t of the eotl/rl’5\,ersg ~_;I’aellHf Q-ariDwi[i eXp~a:n the CMC’s role i.n iw,,est.igatb~g ~he(:amplaint~ it receh’ed w hiJ.e he was pros!din’it, Ar:dFrank >*’ells will explore some et the .history ,~tnvestigating rese;-wch t’eiscond tic[ il! the UK

’Tile story is o,~r.plex yc4 compelling. But hL~wcan w~ prevet, t ~ repeat t,f this damag:ng episode?

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Journal of the Royal Society of Medicine

We do now have enhanced systems of resealvh gov-ernance, but are they enough? And what evidencesuggests that the media will treat the nsxt medicalresearch scandal more responsibly? Our systems ofregulation and investigation {}f researchers and re-search misconduct have been woefully inadequate,and remain so despite some new initiatives. Oneanswer might be to professionalize research andaccredit professional researchers under the auspicesof a central regulator}, authority, as Dixon-Wi~odsmrgues in an editorial that accompanies the series(JRSM 2010:103:124--5k A proper, professional sys-tem of investigation, )n~ strand of her proposals,should be a mm~mum requirement.

Ihe tragedy of the CNEP trial controversy isthat it could have been prevented, and the damageto people and medical research minimized. Welbintentioned individuals and organizations were

asked to pass judgements on matters that theywere ill-equipped to investigate. The media wastoo willing to extract eveW morsel of sensational-ism out of the misery of families. Government wasunable and tmwiiling to accept that its vilificationof professionals might have been unfair andwrong, its investigations ill-directed.

Ultimatdy, though, the CNEP trial harmedmedical research because the medical professionremains a quarrelling realm of fiefdoms and glory-hunters, readily mavdpulated by power brokersand public outcr): Medical research is a sideshowin an unending power struggle inside and outsidemedicine, Unlike the Bristol Inquiry- and cardio-thoracic surgery performance data, for example, itis hard to see what meaningful steps have beentaken to prevent another damaging research scan-dal of the magnitude of the CNEP trial.

122 d R Son Med 20t0: 12I-!22, DOI t0.1258/jrsm.2010, lOkOIB

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Regulating research, regulatingprofessionals

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DECLARATIONS

Competing interests

None declared

Funding

Mary Dixon-Woods’

work on regulating

doctors is funded by

a fellowship under

the ESRC Public

Services Pregrarllme

iRES-] 53-2?-gO,J).

Her work el!

regulati~lg heNth

research has been

funded by the

Medical Research

Cou ]eli.the

Welicome Trust end

ESRC grant RES-606-

22-1988

I;tbieal approval

Not appl cable

Guaramor

MD-WiiiiillContributorsldp

MD-W is the sole

6ontdbutor

AcknowledgemantsThe views

expressed are the

author’s own

}~ 124 J R Soc MoO 2010: 103: ~24-!2~. DO/10.1258/jrsm.2010.10k013

Mary Dixon-WoodsDepartment of Health Sciences, Adrian Building, University of Leicester, Leicester LE1 7RH, UK

E mail: [email protected]

This issue sees the publication of the first] in aseries of six articles about alleged research mis-conduct. Rarely does one feel so moved and dis-turbed by a collection of articles in an academkjournal. All take as their focus the trial of cominu-ous negative extrathoracie pressure (CNEP) fortreatment of preterm infants with ~espiratory fail-ure at North Staffordshire hospital in the UK,wl~ch ran 1989-1993.a That there is still cnntro-versy over a study that began 20 years ago is per-haps the first hint that this is an epic tale, completewith multiple twists and turns in the plot, and acliff-hanger that is not quite an end ing. In this shortcommea~tary, I offer some reflections on whatmight be learned from what, for maW of thepeople involved, and as the articles demonstrate,was nothing short of a disaster.

Some insight is first needed into why the aIlega-lions about the CNEP trial gained the prominencethey did, and why the}, were handled in the waythey were. Much of the explanation can be tracedto the historical period in which the allegationsemerged, which was rife with scandals involvingdoctors. The murders committed by HaroldShipman were coming to light, while severaldoctors at arom~d the same time were arrested andconvicted of sexual assault on ~heir patients orother forms of gross misconduct. Two 1990scrises - the paediatric cardiac surgery programmeat Bristol, and the organ retention controversies -specifically involved child ran, and were the causeof intense anguish. The official Inquiries that wereto follow these events were highly critical of themedical pro_Eession, and urged greater recognitionof the need to listen to pafients and take theirconcerns seriously.

Given what seemed to be an inexorable patternto stories about abuse, exploitation and disrespectof paeients, it is perhaps unsurprising that parents’

complaints about CNEP (first made in 1997) wereseen at first as plausible evidence of what the BMJtermed ’yet another NHS scandal’.a Despite this, itm~ght have been possible to bring the matter to amuch swifter and more satisfactory conclusionhad regulatory and organizational systems beenup to it. They were not.

Rod Griffiths’ article, later in the series, willdescribe the challenges of trying to run an investi-gation at the same time as making up the rulesabout how the investigation was to be run.Graeme Catto’s article will describe how theGMC’s investigations into the doc~ors involvedin the CNEP case were frustrated by having tooperate trader outdated and inadequate rules thathad already passed into history, but still appIiedbecause of the timing of the complaints. Institu-tional deficiencies further compounded the situ-ation. The regulatory regimes for both doctorsand for research have, since the 1990s, tmdergonesubstantiaI reform. But are they fit to preventproblems Eke those that beset the CNEP trialoccurring in the future?

The emphasis of the current system of regulat-ing resem’ch might be said to be geared towardsprevention. The first problem with this is a familiarone, and concerns the prnportionality and effi-ciency of the system of approvals. The regulatoryenvironment for rEsEarch remains complex, popu-lated by multiple regulatory agencies and officeswho have a say in what researchers can and cannotdo, and there are multiple sources of g’uidance andrequi~emen~s. Recent innovations such as ~he re-search passport and the Comprehensive ResearchNetwork portfolio may simplify the process forsome types of studies, but make it more complexfor others.

The second problem concerns the effectivenessof the system. No matter how many checks are

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Regulating research, regulating professionals

made before projects begin, it is virtually imposs-ible to ensure that nothing will ever go wrong, orthat no researcher will ever engage in misconduct,or that nobody will ever complain. But systems forthe detection and investigation of problems aregenerally ill-specified and poorly coordinated, inpractice relying on complaints from participants orothers, or on the oversight exercised by academicjournals [even though journals are not formallypart of may regulatory system). WEere misconductis suspected, critical weaknesses remain. A pro-cedure for investigating alleged misconduct inresearch4 has been launched by the UK ResearchIntegrity Office (a body ffiat itself lacks a statutorybasis), but it remains voluntary, and it is not c]earhow widely used it is. The situation is ft~rtherconfused and responsibility is diffused, by thenumber of different parties who have a stake,including professional regulators, employers,funders, sponsors, academic iournals and NHStrusts. Different types of b_westigation and sanc-tions may follow depending on who committedthe m~sdemeanour, but many of the partiesinvolved may have Ettle experJence or expertise b.’lconducting investigations into research mis-conduct, and some indeed may have an interest innot exposing misconduct.

This leaves both research participants andmembers of the research community without theassuran~v friar allegations will be investigatedpromptly, effectiveb;, and tair]?, Nor is there a goodway of erksuring that if a researcher [particularlynon-clinical) commits a misdemeanour relevant totheir work, this intcmnatiol~ will be shared withfuture employers or ~rusts hosting his or her re-search. One way of helping to resolve the ~roblemsboth with approving research and dealing withallegatio[xs is to recognize health research a~ aprofessional activity that should have a centralregulatory agency.

Under such a proposal, this regulator wouldrequire that m’=yone who warlts to conduct researchin the NHS be a registered researcher. The regula-tor would make explicit the standards expected ofresearchers, i~eluding a code of conduct. It wouldcarry out checks to ensure that researchers havethe right qualifications and other bona tides before

being registered. The regulator would act as thecentral agency for dealing with complait~ts or alle-gations about research; would have an agreedstandard operating procedure ior respol~ding tocomplaints and conducting investigations: w{,uldbe able to mobilize a specialist, trained team whereneeded to conduct investigations: and would havepowers to deregister or place restrictions on re-searchers’ activities. Where researchers are foundto have committed misconduct, employers andprofessional regulators such as the GMC wouM benotified of such actions, and would be entitled totake appropriate disciplinary acnon, but not mrepeat investigations - flaus avoiding the multiplejeopardy problem Hey and Chalmer~ describe intheir article.

Some may argue that having such a regulatorsimply introduces a further layer of bureaucracyinto an area alreadv ~,tiff with it. But the currentsystem amounts k licensing every prelect andevery researcher, every time, and is wastefuland inefficient. Researchers and tho~ who fundresearch are already paying dearly for this form oflicensing: this proposal would move the costs to amore efficient and effective system. Registrationwould replace the research passport/honorarycontract system, and NHS musts con]d acceptregistered researchers to conduct research withoutfurther checks. Man},’ of the details would requirecareful working out. But professionalising re-search would bring many benefits, in erie placemaking clear and explicit the expectations of Nlresearchers in health, providing a central reposi-tory for advice and guidance, and, by having aproper, professional system of investigation, help-ing to at.err the kind of trauma that followed theCNFP trial.

References! Hey E Chalmers 1, M~-invesLi~cfi,~g a[[eged re,earth

rniscol~dud can ha,,,e dire L¢}llseq~lellcP~. [ R ~q~C M¢~2010:103:132 7

2 Sara~lcls ME R¢,ine l, Alexander J~, etal. Continuousi~aL~:ve extratho;adv p reprove i~. neonatal resp±raro:~SailL:re. P~,d/~ric,; 19c6:9S:1154~0

3 Smith R. Babie~ and consent: vet anothez NH$ ~candal BM]2000:320:1285-6

4 5e~,http://www.ukrio.org/sites/ukrio2/the Fros:arnm~’_of_work procedure.otto

J R Sac Med 2010:103:124-125. DOJ 10.125~/lrsm.2010.10k013 125

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Mis-investigating allegedresearch misconduct can causewidespread, unpredictabledamage

~DECLARATIONS

Competing interests

None declared

Funding

IC’s saIaryi~ fimded

Research Council

and tFe kational

Institute for Health

Research

E~ieal aloFravalNot appl cable

Guarantor

EH

Contributorship

Both a~thors

contributed equally

to the writing of thi~

article and to the

d~velopmelqt of this

se6es. EdnmM HeVdied in D~cen}be[

ZOOS

W .... g[atefulto

all of those who

have helped us by

providing documents

to help ......that

our acceuntis

factually corre.’t

Edmund Hey1 ¯ lain Chalmers2

Retired Paediatrician, Newcastle upon Tyl~ea James Lind Initiative, Summertown Pavilion, Middle Way, Oxford, OX2 7LG, UK

Correspondence to: laln Chalrners E-maih IChalmers@jamesli,~dlibrary.org

Introduction

Twelve years ago, Deborah and Carl Henshall,whose prematurely born daughter Sofie hadreceived respiratory support using continuousnegative extrathoracic pressure (CNEP), allegedr~search mi~’onduct by the clinicians responsiblefor the randomized comparison of CNEP withintra-tracheal positive pressure ventilation beingundertaken in Stoke on Trent.~ These allegationswere very widely publicized, and separate over-lapping investigations were mounted by the localNHS Trust, the NHS Executive, and the GeneralMedical Council (GMC), causing hospital staff andtheir families stress severe enough to end a fewcareers. More generally, the allegations led to theintroduction of a national Research Governance£ramework, and much of the UK’s current hyper-regulation of clioica! research. It took 11 years forthe GMC to conclude that there was no case for thedefendants to m,.swer, and that one of the study’sprincipal critics (and the main expert called in tosupport the Henshalls’ case) was neither an expertnor independent.2’3

Our involvement with this affair began w-henwe were asked by a medical defence society toassess a Government report that had raised seriousquestions about the conduct of the CNEP study.We agreed to do this, and do it unpaid, on theunderstandthg that: (1) our work would be con-fined to the report’s critique of the CNEP trial; (2)we could have access to all the relevant documentsto which the defence society had access; and (3) wewould be free to publish our findings - whatew~rthey were. Four months after the government re-port was released, the BMJ pubiished our assess-ment. We concluded that ’The statements relatingI.o dre CNEP irial ... contain so many en’ors of fact... that the whole report stands discredited’.4

Not only did we find no evidence of the allegedresearch misconduct, we noted that the trial had, inmany ways, been ahead of its time. The protocolhad been alpha-rated by the Medical ResearchCouncil; it had twice been ethically approved; ithad, exceptionally, been registered publicly atinception; an information leaflet had been pro-vided for parents; a sequential desigaa had beenused to monitor accumulating results during anera before data monitoring committees had be-come common; post-trial questionnaires wereused to elicit parental views; the trial report wasco-authored by doctors, nurses and a statistician;and it was published in a prestigious paediatricjnurnal. Our BAd] article concluded that, since thewhole edifice of administrative reform called for inthe government report rested on the implied con-clusion that the CNEP trial was conducted in aflawed and irresponsible way, the NHS Executiveneeded to retract its report and reassess the appropriateness of its recommendations.4

The Government, however, has never publiclyadmitted that its review was flawed. On 10October 2000, Lord Walton of Dctchant asked LordHunt of Kings Heath, the Parliamentary Under-Secretary of State at the Department of Health,’whether they support the findings and conclu-sions of the Griffiths report ... in the light of thecriticisms published h~ the British Medical Journal’.This led to the followi~g exchange:

Lord Turnberg: My Lords, will tire Minister agreethat the Griffiths report appears to havegiven rise to a number of injustices, despitethe Ministers’ comments about the value ofsome elements of it, not least of those beingthe apparent denial of human rights to thedoctors being criticised in that they were notallowed to see the report before itwas produced

132 d R Soc Med 2010: 103: !32-I37. DOi 10.1258/l’rsrn.2010.O91rO45

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Mis-investigating alleged research misconduct can cause widespread, unpredictable damage

in order to be able to answer some of thecriticisms.

Lord Htmt of King Ileath: My Lord, I l~ave noreason to believe file review- was not conductedappropriately ...

Lord Campbell of AI/ow~y: My Lords, I l~aveKstened to a plethora of words but I want to askthe Minister a simp]e question. Is hv preparedto consider giving the apology sought by thenoble Lord, Lord Walton of Detchant, or is henot? Can 1 have a straight answer to a straightquestion?

Lord Hunt t~ Kiags Heath: My Lords. I alwaysthink that ’yes’, ’no" answers are best avoided,

Seldom has the British public been told some-thing that was so blatantly untrue, so col~sistently9mid for so many years, as the story that first brokehi 1997. At that time a quality new;paper came outwith the headline:

’darents say ’guinea-pt;;" trial killed their babies

and claimed that ’ForD, tl~ree premature babies.many only a few hours old, died or suffered per-manent brain damage after being used as "guinea-pigs" in a radical hospital experiment’.5 When norebuttal seemed to appear even after the story hadbeen repeated many times, people naturaUy beganto believe that it must be true. And when. afterthree years, a Government enquiry offered tacitsupport for the story; this strengthened the publiusbelief that the press reports must be true,

l.t has now been established that the stnry wasunfounded, but does the public know this? Domost doctors know this? Do most realize that theallegations were adopted immediately and usedby a small pressure group to attack the work el twopaediatridan co-investigators of the CNEP trialwho had also been working in the fraught field ofchild abuse? ’lhe answer has to be ’no’. How couldit be otherwise when the true _~tory has never beentold in the British lay press, and the medical presshas remained almost as silent?

Since our article appeared 10 years ago we havereiterated, on several occasions, tile vital needfor ’due process’ when investigating allegationsof research misconduct.6-9 This is the first of sixarticles to be published in this ioumal whichwill look at what happened, how it m*ght havebeen different, and what is needed to preveet arecurrence.

What happened?

Box 1 summarizes the main events in this 20-year’saga’. Ln the next article in the series, the invcstigalive journalist Jonathan Gornall will look at theway the press ran with the story. Even respectednational broadsheets implied that the CNEP studyhad ’killed premature babies’:lc and, when thepaper’s editor was later challenged about this by aParliamentary Select Coreanittee. ire said he didnot recall the details of the story.

The third article in the series ha~ been contrib-uted by Professor Rod Griffith~, who chaired thereview that the governanenz initiated in responseto tbLs media pressure. Professor ’Ferry Stacey (apaediatrieian, and regional director el research forthe South Thames Region) and Mr~ Joyce Struthers(the chair of the Association of Community HealthCouncils in England and Wales, were the othermembers of the panel whose report appeared 17months later. Griffiths later characterized the briefhe had been given as ’drinking from a poisonedcha]ice’.11 The article Ire has now v,’ritten 4ives amore detailed account of the way the enquiry wasgenerated, and reflects on whether the ResearchGovernance Framework that was then set up has.on balance, improved the quality and the amountof clinical research nov," beir~g done.~2

The fourth article provides a mov{ng accountof what it was llke for all the staff at the NorthStaffordshire Hospital as they faced a seeminglyunending series of enquiries. Although the CNEP~ial had been about try-ing to fiad a better way ofnursing babies, the voice of fine nursir, g staff hasso far gone almost unheard. Tire article has beenwritten by Teresa Wright, the tria [’s senior researchnurse. To bo repeatedly pilloried in the media, tohave nobody mounting an effective rebuttal, andto be barred from responding personal!> wasdeeply demoralizing.

How might it have been different?

Employers and the medical defenee societies rou-tinely bar those they employ and represent fromsaying an~hing while under investigation, andprofessional respect for patient con fidentiali), hasmade the F ublication ot rebuttals even more diffi-cult. By contrast, there is nothing to stop the pressfrom continuing to make unsnbstantiated allega-tions of misconduct while fuji hearings are pend-ing. Unsurprismgly, the public cannot mlderstand

J R Soc Med 2010:103:132-137 DO110.1258/]rsrn.201009kO45 133 ,%;~

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October 1989A randomized stud~ comparing continuous negative extrathoracic aressure (CNEP) with intra-tracheal positivepressure ventilation in orematL-e neonates StalLS, first in Queen Chadotle’s Hos3it~ , Lonoon, and then in North StaffordshireHospital Stoke on TrentNovember 1993 Recru tment closes when the trial statistician reports that one of the pre-agreed stopping points has been reachedJuly 1994Afterthev [~nd that their 19-month old daughter Sofia wno had been treated with CNEP in the trial) has a disablingdouble hemiplegia Deborah and Carl Henshall start a civil claim for damages a]leging negligent neonatal careOctober 1996 The Hensballs drop their action. Experts believe that their daughter’s problem probably originated duringpregnancyDecember !996 The American journal Padiatrica publishes the reoort of the CNEP trial co-authored by eig ht doctors, two nursesand a statisticianMarch 1997Thc Henshalls are contacted by a freelance journalist. Brian Morgan, who has been leading a media campaign againsttwo of CNEP trial’s authors Professor David Southall ann Dr Martin Samuelsl criticizing the use of video surveillance by Southalland Samuels to identify why some young children only suffer sudden collaese when alone with their parentsMarch 1997 The Henshalls ask Radio Stoke and the editor of the local eager The Sentinel, to he p them make contact with otherfamilies with babies who had been in the CNEP triaAori! 1997 The Henshalls lodge a comalaint with the GMC alleging research misconduct and forgery of trial consent forms, TheGMC’s Preliminary Proceedings Committee finally decides in January 2002 that no public hearing is warranted*May 1997 Morgan writes an article Dublished in the Indeoenaent on Sunday unaer me headline "Parents to sue over clln[cal trialthey knew nothing about’ and 3ersuades the BBC Watchdog programme to carry the same story a few days laterDecember 1998After the aarents of other children cared for using CNEP in the trial also allege research misconduct, Governmentministers ask Professor Rod Griffiths iregional medical officer, West Midlands ReglonJ. "to took into the general framework forboth the aooroval and monitoring clinical researcn pro~ects in North Staffordsbire’March 1999An internal enquiry at the Nc rth Staffordsb]re Hosaital concludes that all the trial consent documents are inorder (but this finding is not reported to Professor GriffithsOctober 1999The Hospital’s chief executive aSKS Professor Sandy McNeish and Dr Geoff Durbln to review a sample of the"esearch being done by Professor Soutbel[, Southa[I ann Samuels are susosnded four weeks laterhlovember 1999The parents of several children treated with CNEP ask the oolice to investigate allegations that consent formswere forged. This investigation closed in October2002January 200gArter Samue[s and Soutball challenge their susoension, Sir David Hull undertakes a further review of the researchfor the hosnital ana reports in December 2000that it was of a high standard. Samuels and Southall are reinstated nine and 15months later, respectivelyMay 2000 The Griffiths reaort is published. It raises questions about the conduct of the CNEP trial and the use of covert videosurveillance, and recommends the creation of a new nationa! framework for anproving and monitoring all clinical research. Fourmonths later the methods and factual accurac,t of the review is criticized in the BMJMarch 2001 Hospital managers init{ate an internal enquiry into whether eight CNEP consent forms had been forged, andconcluaes in OcZober 2001 that there is qo evidence of thisJanuary 2002 The Hensballs corr alain to the chief executive of the GMC that its committee had not looked at all the 1600 pages ofevidence that they had submitled, so the case =s sent back to a new committee in Seotember 2002March 2004 The GMC’s mew committee confirms the earlier committee’s decision in January 2002 - ruling that the Henshal[s’comalaint does not merit a full disciplinary hearingJune 2004 The Henshalls apoeal against this decision to the High Court, which rules in October 2004 that the GMC’a handling ofme coma[aint had not aeen unreasonableJune 2005 The Henshalls appear against this ruling to the Court of Appeal, which rules in December 2005that the GMC’sarocedures had o~.en flawedtJanuar!, 2006The GMC re-oaens the case, and starts a public disciplinary hearing in May2008Julv2OOBThe case is thrown oul even before, th~ case for the defence is heard, oecause the panel decide that there is no case toanswerAugust 2OOBThe Henshal[s ask [he Council for Healthcare Regulatory Excellence to overturn the GMC’s decision. The request iseeclined

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why5 if at least some of the allegations were false.no-one ever initiated a libel action. But libel is anexpensive business and the doctors knew that ifthey took atly such action themselves, they riskedlosing the support of their defame�., societies.

’Ihe hospital Trust’s first investigatkm in re-sponse to the al]egatiorus, in 1999, looked at otherresearch underway at the time, but not the coftdueiof fl~e CNEP trial. Their investigation, which led tothe two consultants being suspended, was con-ducted in a politically charged atmosphere andsomewhat hastily (Box 1). So much seems apparentfrom the result of the Trust’s second, equally secretinvestigation which ultimately famed that therehad been no ca.,e for disciplinary action, let alonefor a two-year snspensiort.

The GMC’s own hwestigation may have beenless swayed by political pressure, but it took ascanda]unsly hmg time. Even here, however, theGMC’s Director of Public Affairs, isabel Nisbet.was alerting colleagues to the dangers confrontingthe Council. in an e-mail (obtained under theFreedom of Information Ac[) sent to colleagues asearly as 24 September 2000, she wrote that theGMC might well end up:

’on the wrong,, side c?f both phases of the &,bate" ...and be criticized ~rst for ~;ot bei~lg vigorousenough in stepping in to protec~ f;atients ... andthen @er we pull our socks ap and start movingmuch more quickly, as we are ~tow -for su¢cumb~ing too readily to political/tabloid pressure toun&rtake "witch-hunt~’. If’we do proceed againstProf Southall it is just possible that his ease cupidmnerge as a test, with a lot of (respectable) uro-fessional sympathy for Prof Southa!l, and us cast aswitch-hunters.’

She goes on, presciently, to make a more generalpoint about the competence with which manyallegations of misconduct are imtially investi~gated, telling h~r colleagues that they may need tobecome:

’sensitit,e to the ei~alzging tone of the debate. Thc~remay be scope for un errwrging role for us to &¢tnestandards of fairness and rigeur itl Trust and otherlocal NHS inquiries if we are to vse them in FTP[fitness to practised procedures.’ The ’point wasmade to me lost week ... that most of them ITrrtsts]would not have any idea how to set up and carryforwalq an enquiry into a dij}qcult and high-profile

case that for many middle-sized and small Trusts itwould only happe,7 unce (at most), and they wouldnave no chance fe lear~z from the exw~qence." ... "Irea/ise thai it could ~e argued that it is thP Dept’slob ~o set sta~Tdards for local inquiries (and that wehave enough to do anywatl;, but w~" do, I think, havea facT,s when lr comes to what we Cat! and canllotxse as ev&Ience and wheat we should stet~ m usingo~r $35A oowers. It is going to be vend ~mw-consuming for us to prosecute zoeak cases based onpoor-quality NHS evidence."

The views expressed in that e-mail have clearl~still not won general acceptance. It was the poorquality of the initial investigations that did muchof the damage described in this and the subsequentarticles in this sm’ies. And. unfortunately, when theTrust did get external assessors to tmdertake amore rigorou£ investigation, their findings werenever made public, thus doing little to silence themedia campaign.

the one merit of the GMC hearing wa~ that itwas held h~ public. Those involved might havewelcomed this had it used the factual informationthat earlier inw,stigations had assembied and hadit been held seven year~ earlier. Yet two monthsbefore this public hearing finally opened, and 29months afber the Court of Appeal had told tt~eGMC m consider the whole case afresh it becameclear that there were still no agreed ’heads ofcharge’; that the GMC had still not obtained theviews & a single expert w~tness to support the casethey were bringhng on the basis of the Henshalls’complaints: and that no use was being made of ~-myat the factual material gathered by the Trust beforeit had concluded, seven years earlier, that therewas no case for the doctors to answer. Unsurprls-ingly~ when the lack of substance supporting theallegations was finally made public, the GMCpanel dismissed them in July 2008 without evenreqmring the defence to set out its case.

What is needed to prevent arecurrence?

In the fifth article in the series Professor SirGraeme Carte. President of the GMC until March2009 admib, that there were many mistakes in theways in which tire case was handled, but he seesno need for any additional hwestigat~ve capacityto deal with allegations of resea~x:h a~sconduct.

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Furthermore, Sir Graeme suggests that there couldnot be any recurrence of this affair because discipli-nary hearings will, in future, be in the hands ofa body separate from the GMC (which remainsresponsible for setting standards).

The CNEP affair shows the extent of the ’col-lateral’ damage that can occur when the initialinvestigation of an allegation is mismanaged.Employers and regulatory bodies often lack theexperience needed to be able to establish the truefacts speedily and well. In addition, when thewhole investigative process is conducted ’inhouse’, it often lacks the independence necessaryto win the trust and respect of those invoDed, orthe confidence of the wider public. In the finalarticle in the series, Frank Wells, an editor of theleading book on research misconduct,~7 describesthe origins and work of a eonsu]tancy establishedto offer forensic expertise to investigate suspicionsor allegatiorus of research misconduct.

What do we conclude andrecommend?

The cost of dealing with tl~e CNEP allegations tothe NHS, to the defence societies, and to the GMCand ~ts nursing counterpart probably exceeded£6 million. And ther~ were other important, if lesstangible, costs borne by those accused and theirfamilies, and by the clinical research community.Separate overlapping investigations were under-taken by the Hospital Trust, Keele University, theNursing ,and Midwifery Council, the GMC and thegovernment, and the GMC’s investigation wasthen reviewed by the Court of Appeal, What is thepoint of delegating the review of most disciplinaryissues to local employers, as the GMC did in thiscase, if, once the employers say they can find nofault, the Council still goes ahead with a furtherprotracted review? Several doctors faced "quad-ruple jeopardy’ of a sort that would not be toler-ated h~ the Crown Court system.

The National Clinical Assessment Service(NCAS) >,’as set up atmuch the same time as mm~yother clinical governance structures some eightyears ago. It was tasked with advising HealthAuthorities on how to go about managing staffwhen ’coftcerns over performance’ arose, and itappears to have dealt effectively with cases o£concern in a constructive, non-confrontational

way. What it has found is that an allegation some-times reveals more about the person lodging thecomplaint than the person being complainedabout.

The problem is that thex~e is no clear dividingline between ’concern over performance’, which issupposed to be a matter for the NCAS, and concernover ’fitness to practise’, which is the statutoryremit of the GMC. There is a "memorandum oftmderstanding’ between the two but this cannotconceal the huge unaddressed overlap of responsi-bility. We }a~ow of at least Va, o cases where theNCAS came to a clear view about the rights andwrongs of an allegation only for the same corn-plaint to be taken up by the GMC and trawled overagain. It is just another example of the oven’egula-tion d~at is now stra~gling the health service artdhealth research.

We do not accept that it can be assumed thatthere can be no recurrence of the expensive injus-tice represented by the CNEP affair, and wesuggest there is a pressing need to develop a morejust, timely and effective way of responding toallegations of research misconduct

Increase forensic capacity toestablish the facts

We believe that the GMC’s director of public policywas right in what she wrote in September 2000about the need for all disciplinary, investigationsto meet mk~imum standards. However, it is notenough to set ’minimum standards’ - the factsneeded to inform any subsequent disciplinarydecisions also need to be established by peoplewith enough experience of this sort of work to do itwell. What seems to have been missing is readyaccess to the expertise needed to mount a timelyand effective investigation of the facts that need toform the basis for any fair and effective ruling as towhether there has been research misconduct. Thisexperience does not reside in the UK’s Panel ofResearch Integrity, nor is that body wholly i~de-pendentJs Currently, MedicoLegal Investigationsappears to be the only UK organization experi-enced th the forensic investigafion of possibleresearch misconduct, whatever the professionaldisciplk~e of the researcher, and which is transpar-ently free of vested interest. It needs to be usedmore widely.

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Mis-investigating alleged research misconduct can cause widespread, unpredictable damage

Increase selective use of the libellaws

The many investigations that the CNEP cliniciansendured might have been avoided had they inhi-ated an action for libel against those who first ranwqth some of the more florid and inaccurate ver-sions of the story. The tactic of saying nothing cansometimes be counterproductive, and suing lotlibel can sometimes deliver justice to those whohave been defamed.

After an NHS report had critidzed one ortho-paedic surgeon’s role in managing a brain-iniuredpa~ent who died after being flown 200 milesto another hospital because no neurosurgiea]intersive-cm’e bed could be found for the patient inthe southeast, the Daily Mirror dubbed hhn ’DoctorDolittle’. The subsequent trial resulted in one ofthe largest libel awards in Britisb_ legal history£625,000J9 Employers and defenee societiesshould consider whether their current reluctanceto sue for libet fulfils their duty of care to re-searchers,

Referencesl qamuels MP, Ra[no J, ~Arr~ght T, pt aL Continuous negative

e×trath;waclc pressure in neoDatal r~sph’atory tailurePed;:l~rlcs I9~6;98;1154-60

2 Gorna][ J. Three doctors and a GMC prosecati,m. BM!2008;337:1907

3 Whitelaw A. Colla~.~" of GMC hearing rote re,earthmisconduct, Lance~ 2008;372"1283M

4 Hey E. Chalmers L Irvestigating allegations of researchmiscol~duct: the vitM need lor due process. BM~2000;321:752-5 1348-9

5 Mor~an B, Blackhurbt C. Paxents ~ay g~lh-lca pig trialkilk, d their babie~, Independent ~l Su,dml 1997 Ma. 11

6 ChalmerM Heyg. LearnmgfromBristo. d~e~eed~oralead from the chief medical oflieer, BM[ 2001 ~23.2~11

7 Hey E Cha[mors t. Abuse uf people t~ying m protecEchildren h’om abu.~e L~;cet 2001 .gsg’182f)Hcy E, Chalmurb I. Are m~y uf d~e critkisms ul the CNEPtrial true7 Lancet 2006;367:1032-3tley E. lho 1996 confintlouy negative extrathoracicpressur+ (’NEP~triahwere parent’~allegalkmsotresearch fraud [raudulent? Pediatrics 20[)6;117.2244-6

10 1.aarance 1 ParonN were mi£led over hospital tria]s thatkilled premature babies. TI~ htdc’z~’nde;# 2lID0 May 8

11 Griffiths R O~ drinking from a poist~ned chalice, B.#’ r23{)8:337:12347

12 Griffiths R. CNFP and research governance La~cet2~]06:367:1037

13 £amanta A.. Samanta J. Research governance: panacea orproblem? Chtl Med 20U~=;5:235-9

14 Aiexmader J. |r.vestigators ¢armot be re|:vd [*n. BMI2DD5:330:472-3

15 Irust Executive Director of Nursin~Q~4aaty NorthStattord~hire ] {ospit~al NHS Trust, Letter to Mrs PennyMelkir 26 January 1999

16 North Staffordshire Hobp±ta] NH~ Irust. Minutes of TrustBoard meeting, 9 March 1999;

17 Wel]~ F, Farthing M, eds, gmmI mid Miscondm t inB~,o~lhcxtI Research. 4th edn London: Royal Society ofMedicine Press 2008

18 An~m. Ttte UK Parcel of Research h~teg~a~y a mis~edoppo~[umly [editorial] La~lr~’tiO4)8372q438

19 Parker G. Con~uJlant wins £69~000 d area ge~ frorrnow~paper. Finaac~a Time~ 1996 February 24

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L iiii ........

The role of the media in theStoke CNEP Saga

DECLARATIONS

Competing inlerests

None declared

Funding

None

Ethical approval

Not apNi~ahl~

GuarantorJ~

Contributorship

JG [sthe sole

contr bud.or

Acknowledgements

None

Jonathan Gornal]Freelance journalist, E-mail; [email protected]

As the boxed summary hi the first article of thisseries shows,~ the way the Stoke neonatal CNEPtriaI was conducted between 1989 and 1993 wasinvestigated 12 times between 1997 and 2008.Much ot the public and political concern that ledto this activity was generated by a decade ofoften sensationalist, irresponsible, frequently rr~s-leading and inadequately rebnfted journalism.

Early media reports

On 24 March 1997, three months after the researchpaper about this trial was published in Pediatrics,2

Carl and Deborah Henshall contacted the Sentinel,their local newspaper in Stoke on Trent. They didso because, as Deborah Hensi~all was to recallbefore the GMC tnore than a decade later, ’Havingtrend out that my children had been in a researchtrial that I had no knowledge of, I wanted toknow whether I was the only parent that did notknow their child had been used in a researchproject@ ’lwo weeks later, the Sentinel reported theHenshalls’ claim that their daughter Sofie had suf-fered brain damage ’caused by slow suffocation’while CNEP was administered in the course of thetrial, a trial which, on their account, had been con-ducted covertly and without their knowledge. Thenewspaper report noted that the couple’s barristerhad ’advised [them] that if they establish liabilityagainst the health authority they would be seekingsubstantial damages’# About a month later, theIIenshalls lodged their first complaint with theGMC .3

’Bvo of the Henshalls" childI~en, born ! 0 monthsa part in 1992, had been entered into the trial, alongwith 242 other babies with life-threatening respir-atory failure. Both were randonlized into theCNEP ,+reatment group. The first, Stacey, was bornby Caesarean section at approximately 27 weeksand died two days later; Sofie was born 10 months

later, also by Caesarean, at just over 32 weeks. Thecottple have six other children, all but the first ofwhom were born prematurely.3

’We were never told the procedure was part of atrial,’ Mrs HenshalI was quoted by the Sentinel assaying. The newspaper’s headline - ’Brain tragedyof baby Sofie. Parents to sue over clinical trial theyknew nothing about’ - uncritically stated as fact

~i~ ii!i!ii!iiiii:i!ii!!~!!~

the parents’ version of events.;When a national newspaper took up the story

some weeks later, it contained new elements.~

According to a report in the Independent on Sundayon 11 May 1997, sensationally headlined ~Parentssay "guinea pig" trial killed their babies’, ’Forty-three premature babies, many only a few hoursold, died oz" suffered brain damage after beingused as "guinea-pigs" in a radical hospital experi-ment’. ’Parents of the babies,’ reported the news-paper, ’claim the}, were not informed of the risks ofallowing their children to take part in the trial’ andthat "they fonnd out about the experimental natureof the study only after the researchers wrote uptheir findings in a medical journal’.

’None of the risks,’ the artiete continued, ’wasspelt out to the parents’, who said they had ’signedconsent forms and were shown an informationsheet but this claimed that CNEP was safe’. Thereport recorded that, ’[a]mong the parents areDeborah and Carl Henshall from Stoke’. TheIlenshalls were quoted specifically, ~ Henshal! asstating, ’We were not made aware that Sofie’s treat-meat was part of a trial,’ while Mrs Henshall wasreported as saving ’I honestly did not know Sofie .....was going into a research trial ... I was told thiswas a new, proven ventilator from America whichwould soon become the no,Thai treatment for pre- ;mature babies in this country. Now I know this~A~asn’t true.’

Ivlrs Henshall, said the article, ’gave her co~sentwhen Sofie was between two and four hours old : : ;

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when "i was still under the effects of morphine inthe recovery morn following a Caesarean".’5 Theday the article was published, the Hensballs wrotea letter to the newspaper insisting fl~aL contrary tothe newspaper’s suggestion, they l~d not signed acon~ent fern1

Two days later, on 13 May 1997, the Tele qv’aphca rric:Kl a ~tory stating that the ’parents ota numberof babies who allegedly died or suffered braindamage during hospital trials of an experimentalventilator are plmming a multi-minion poundlegal action’. The Henshalis’ solicitor was quotedas saying that there were difficult legal hurdies tobe crossed. It would be necessary to prove, he said,that the families who consented to the triall~d notbeen properly informed while ’The major prublemis going to be showing the causative llnk that dem-onstrates that this machine alon~" was responsiblefor what had happened’.~

The Henshalls took their case to their MP, LlinGelding, whose intervention with health rainistersled in 1999 to the settSmg-up of an NHS inquiry intoresearcn practices at 9toke. beaded by ProfessurRod Grittiths_ then the regional director of publichealth.

Further new elements are addedto the storyTo coincide with the publication ot the Griffithsreport, in May 2000 the h~depende~# reported a pre-viously unpublished account of how the Henshallssaid they had learnt that their two chitdren hadbeen m a trial. The article described how ’[alchance remark by a doctor at anoti~er hospitalalerted Carl and Debbie Henshal! to the fact thattwo of their daugi~ters had bee1& involved asgumea pigs in a research trial’.

The couple, reported the newspaper, had "con-sulted a solicitor and started legal action againstthe hospit,’d in 1994. In 1996 the solicitor sent themto a medical expert at St James’s Hospita] Leeds.He said to us "What do you expect from an experi-mental ta’eatment?" We said "What do you mem~experimental?" Until then we had believed thatour daughter had been given the best treatmentavailable.’7 Despite occupying a central position inthe story, the newspaper apparently did not see fitto approacn the doctor in question re see if hisrecollection of his encounter with the Henshallsaccorded with theirs. Certainly he was not quoted

in the article. As it happens, he denies that anyconversation h~ fire terms reported by the In&pen-dent ever took place (personal eommunJcation,26 May 2009).

The hzdepcnde, nt also failed to address or explainthe fact that its article did not chime with theearlier version of the reiev ant events recorded in itsown sister newspaper, the ~ndqJendeni on Su~d~y.Three years before the report of the doctor’s’chance remark’ that had allegedly alerted theHenshaIla to the fact that their child had been in aresearch trial, the h~depe~zde.,zt on Sunday reportedthat the experknental nature of the trial i~ad beendiscovered by the Henshalls among other parentsfrom a paper published in an American medicaljournal.5

The disciplinary authorities bowto media pressureThere is evidence that from the ouLset the GMCwas more interested in the Her~shalls’ complaintsbecause of the media coverage they bad attractedrather than their intrinsic merits. In an intern!!email sent to GMC medical and lay screeners hrFebruary 1998, a caseworker wrote that while theallegations "are serious - they inc]ude that consentwas not properly obtained, ll~at the potentialbenefits of CNFP were not adequately establishedbefore the trial began, and that the test results havebeen massaged’, the case was ’long on speculation,particularly on the part of the Henshalls, but shorton evidence, especially of an order whidr n’dghtresult in charges against hrdi~q~’dual doctors’.

Nevertlneless, added the GMC caseworker, thecouple were ’aggressively mobilising the media,including Channel 4 News, and MPs, includingMrs Llin Gelding, on their behalf’. The writer was’not optimistic about the prospects of provinganything concrete against individua! doctors.However ... in view of the serious nature of theallegations, we sl~ould respond to the campaignbehrg orchestrated by the HenshaLls by askh~gFFW [GMC solicitors, Field Fisher Waterhouse] toundertake an investigatioin ...,3

~lhe following year, North StaffordshireHospital Trust responded in a similar mannerto the wider campaign being waged againstDr Southa!! in relation to his cbild-protectionwork, notJx~g that all complaints they receivedwere being copied to the media as well as to a host

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of people in Whiteha!l, including the Secretary ofState for Health, the Home ~retary, the £ocialServices Ir<spectorate, the Lord Chancel!or andAnn Widdecombe MR As a Trust Board minuteon 9 March 1999 noted, the normal responsewould have been to ’write back and ask for evi-dence before Initiating an investigation. Howeverbecause the allegations have received wide-spread distribution ... they warrant furtherinvestigation.’9

How the central media mythemerged

The centTal myth a t the h cart of the media coverageof CNEP, that it had "killed babies’, originated inone of the first articles published about the trial.written by Brian Morgan, a freelance iournalistwho had already developed a particu tar interest inDr ~,uthall and various aspects of his workF

In 1995, before CN-EP became headline news. itwas Mr Morgan who had first written about thecovert video surveillance being conducted byDr Southall and colleagues to investigare suspi-cions of Ja~duced illiress among children who hadbeen referred for apparent life-threatening events.Covert video surveillance conducted in twocentres between Iune 1986 and December 1994 hadrevealed abuse in 33 of 39 suspected cases. Thiswas work later r~ported in PedD.trics as a ’descrlp-live, retrospective, partially controlled casestudy’,~° but characterized by Mr Morgan, writingfor tlie Times Hi@or Edzlcatien Suppfemen~ in 1995.as ’unapproved research’]~

Two years later, Mr Morgan turned hi~ attentionto CNFE which he described in his May 1997article for the Independel~t on Sunday, headlined’Parents say "guinea-pig" trial killed their babies’,as ’a radical hospital experiment’.~ The articlebegan: ’Forty-three premature babies, many only afew hours old, died or suffered permanent braindamage after being used as "guinea-pigs" in aradical hospital experiment’. Nowhere i~ the arti-cle was it made clear that 32 babies who had beenentered into the control side of the trim sufferedsimilarly.~

The inference - that CNEP had caused theseoutcomes - was clear, but there has never been anyevidence of this;x2 indeed, a long-term studv rec-ommended in the report of the Griffitt~ inquiWlater found the CNEP-treated survivors to be mak-

mg progress similar to, and possibly better thanthat of the conventionally managed children,la Butthe m} th had been born. and it stuck. Ln 1999.following the news that an inquiry had beenordered into the CNEP affair, the Independent re-ported unequivocally that CNEP had "resnlted inthe death or ir~iury of 43" premature babies.-*

The independent was far trom a!one in the natureof its coverage of the C_\EP story and there aremany examples of even worse treatment - one ofthe worst being the "exclusive’ story that appearedin the S’,*nday Mh’ror in July 2000, begtm~mg withthe words: Twenty-eight babies died after suffer-mg appalling injuries in controversial experimentscarried out by one of Brffain’s toF COl~Sultants, ti~eSunday Mirror can reveal today’ ’~

MPs highlight the inaccuracy ofpress reports

In March 2003, Simon Kehner, editor of the Imh ~Je~7-dent, was giving evidence during the fifth sessionof the House of Commons Culture, Media andSport Comrmttee. which was examining the workof the Press Complaints Commission. At one point.he was asked by Ad rian Hook, the MP for Taunton.whether he thought the headlines m his news-paper ’should reflect the words underneath’. Yes,he said. ’1 would be distraught if it did not alwayshappen’.

Keiner had walked into a small trap. Earlier thatday, the MPs had heard from another wlmess, IvorRowlands. a retired engineer, who had brought totheir attention the front-page CNTEp article thathad been published in the h~devendent in 1999,under the headline: ’Investigation ordered after 28babies die in hospital experiment’.~4 That headline,suggested Fiook, ’was not completely accurate’.Neither, he added, was the one that fl~llowed in thehzdoendent a year later: ’Parents were misled overhospital trials which killed premature babies’]6

In the first story, said Fiook, the Indeven&nt hadburied "right at the end’ the fact tliat, despite itsheadline, the ’rates of death and disability amongthe 122 babies w’ho received the experimentaltreatment were no different from those who re-ceived conventional treatment’. In fact, he said, "itwas not "28 babies die in hospital experiment", itwas 50 in total. Yet they were all premature andthere is a mortality of 20-25%, so you would expectsomething along those lines.’

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The headlines, said Flook. were "very emo-tive.., bear no resemblance to the story [and] havedone a lot of damage to the hospital and doctorconcerned’.

Kelner told the committee he did not remembertile details of the story.17

But the inaccuracies keep oncoming

Even the finding that CNEP was no mo]~e harmfulthan the standard treatment, which was reportedin March 2006.t~*a failed to halt the tide. thefollowing year the Sunday Exmess repeated yetagain allegations that ’[cJhild spedali~t Dr DavidSouthai1 ran research on babies which was likely tolead to brain damage or death’, while also labellingits reports ’exclusive’ 1s,,2cl The article that appearedin March 200?. under the headline ’Baby doctorexperhnent left our girl paralysed’, added anothertwist to the tale. imputing an extraordinary allega-tion to the Henshalls that ’Women have had unnec-essary caesareans to F rovide premature babies furcontroversial research’.2°

The role of an expert

hr the 10-vear period 1997-2007 during which theCNEP-related claims repeatedly resurfaced in themedia several newspapers and tel.vision pro-glammes made use of a ’medical expert’ whoalways seemed ready ~o make himself available tospeak out against Dr Southall on a wide range oftopics, namely, Dr Richard N-ieho]son. the editor otthe Bulleti~i of Medicai Ethics. It was therefore, amatter ol some surprise to interested observersthat Dr Nicholson was called to give expert evi-dence at the G_MC fitness to practise hearing con-vened m 2008 to evaluate the charges agatr~st threedoctors, including Dr 5outhall. arising out of theirconduct of the C\TP trial. £his decision to callDr Nicholson led to some of the more startlingfindings to be made by the GMC panel in decidingto dismiss all the charges: that Dr Nicholsolr notordy lacked independence and ob)ect~wty but overthe years had, in the w~rds of the panel also ’con-ducted himself as a supporter’ of the Henshallsand had shown ~ deep animosi~ towardsDr Southall’ in interviews he had given to themedia 2122

Why the witch-hunt?

The explanation for the CNEP media w~tch-buntmust lle in part in the potent nature of the moregeneral campaign against Dr Southall, which hadbeen attacking his child-protection work for sev-eral years. For ~,ome in the media, CNEP wasmerely a convenient way of extending that cam-paign to discredit him, but as a result all involvedin the CNEP study, and paedlatric research in gen-eral, snffered severe collateral damage (Modl emdMacintosh, submitted for publication). If anyonedoubts the potency of such a sustained media cam-paign, they need look no further than the decisiontaken by Keele University in 200S not to offer DrSouthall the customary title of’professor emeritus"wren he retired, largely because the universityfeared a backlash of ’adverse publicity’.2:~

Irresponsible journalism: lessons

The kmnecessary and tmjustified nature of thewhole media-driven CNEP Saga was emphasizedin revelatory postscripts written by two of theke) players. The report published by ProfessorGriffiths in 2000 was severely criticized24 and in2006 he wrote that he had come to look on the taskhe had been given as ’a poisoned cha]ice’. In anarticle for the BMJ he also revealed the extent towhich media pressure had led to the inquiry.]’here had, he recalled, been ’repeated headlines’about CNEP, alleging ’that excessive deaths hadoccurred’. As regional director of public health, hehad ’already con-oriented to the media that prema-ture babies of that age had a significant mortalityand tha ~ the children in the trial had fa red no worsethaL expected’. Nevertheless, "the story did not goaway and local MPs took it up’ - and the inquirywent attend.~

In 2007, the Henshalls’ former MP, nowBarooess Guiding, publicly expressed her regret atthe chain of evel~ts she had helped to set in motion.In an open letter to the Set:fine!, she wrote that shewished to apologise to Dr Southan "and say howsorry l am if my initial concern has given fuel Lowhat can only be described as a witch-hunt, aidedand abetted by some professional poopte whosurely should know better’.27

One of the key lessons to emerge from theCNEP Saga is tl~at, left unchallenged, adversemedia coverage can have a catastrophic outcome

4 d R Soc Mad 20!0: 103: I 5. DQf 10 1258,/]rsm.2010.10k071

=

MOD100061919


15


for medical professinnals, institutions, research0a~d, ultimately, patient care} Tile NIP who trig-gered the initial inquiry and the man who then ledit have both acknowledged that it was unchal-lengvd media pressure that set the ball rolling.[ntc~rnal minutes, memoranda and emails showthat it also drove the actions oi the hospital inStoke, Keele University and the GMC.

if those in aufl~ority take only one lesson fromthe costly CNEP Saga, perhaps it should be this:that what interests the public should not beconfused with what is in the public interest.

References1 Hey E, Chalmers T M .s~inve.~tigating alleged rc,earch

miscond ucf can cause widest3read unorodlctable damage] R Foc Me~ 2011 .’103:132-7

2 gamucls MP Raine J, Wright 1 e* ,~I. Continuous neganveextrath~acic pr~st~re in ~conatal respiratory f.dlurcpo.dhltncs 1996;98:1154-60

3 General Medical Louncil. Fitness to Practis~ Panel: Cas~ ofSpencer, Suuthail. Bamuds. day 9, 22 May 2110~Exami~at{on ar~d cros~examina~on of Deborah Henshall

4 Biackhurst D. Brain tragedy of b~by ?,ofie. The $~’~lt&~i997 April 9

5 Morgan B, Blackhurst C. Parents say ’guinea-pig tr~lkilled their babiv~. Now they are going to sue./udeuena~nton StWdmd 1997 May 11

6 Smzth M. Parents to sue over mlury and death otventilator babies. Telegr~tph 1997 Ma’~ 13

7 lal rance T Chance remark alerted parents. The"hutcp~ndent 2000 May 9

8 Genera~ Medical Council. Professor gouthall [internalmemo]. 10 February 1998

9 North Stafford~ire Ht~pita.~Trust. Board mitres. 9March 1999

_O Southall D Plunkett M. Banks M. ct aL Covert videoreccrom~ of llfe thrc’atering :hild abuse: lessons for childprorectmn. P~diatrics 2997.100:735~0

I1 Morgan g. Bahivs u:-.~d in research trials without co sum7 m~es H&q~er L&~cation Supplement 1995 March 17

12 Hey m Chalmers L Are anv of the criticisms of the CN’~Ptrial true? g~Lel 200~:367:1032 3

13 T~lford K, W,l’.era L, Vvas H ct (d. O’a teome attel’ neorta/alcontlnu,~u~ negatlvt’-|~resml-e w,~nlila~iurl f,~lh~w L~passessment. Lancx~t 2tX16:367:1080-5

14 Laurance J havcstiga’don ordm~d alter 28 babies die :nhospital experiment. The h~de~em&,nt 1999 February 18

15 Rimmer A. X flies of the guinea pig babies. Surlday Mirror20110 July 9

16 Laura~ce t Parents >.,ere *rti~lo¢ over h~,pffal trials t}’alkilled olemature babies. The Independent 2000 September

17 House of Commons Culture. Media Sport Committt, c.P~ivacy and medda h~irt~ion. Fifth Report of Session200)~’~. HC4~9-I1 Ev4O2

18 March B. Study vindicates &~ctor bebind babyex~erimenL D~ly Teleqravh 2006 March 20

19 Murray J haqucst demand over baby deatlzs, aunffayFACIngS 2007 N{ar~_h 4

20 M, rray } Baby docx)r experiment l~a ottr girl patalys~d.Slul&u E,xI~’ess 2007 March 18

21 General Medical Gotmcal l-_tness to Practise Panel:rran~criu: Case of Spencer SouthalL Samuel,, :ay22 May/00,q

22 Genial] ] */hn~o dtlclors and a GMC prose~ubo*q BMJ200~ 337:a907

23 Gornali J. Bad publicity denied SouthaiJ a KeeJeprofessorship. "fT~e Guardtal’~ 2007 November 8

24 Hey E. Chahners 1. Investigating aEegations o~ researchmlscondllOt: flip vital need :or due process BM]20011 321:752-5

25 Gnfhdas X. CNEIa al3d research Kovernance. Lancet200fi.367.10378

26 Gritfkh,s R. On drinking f-nm a F ~i.-oned chalice. BMJ2006.332:801

27 Goldmg, Baroness, Dr SoLithall was a ram voice ftwabused child~,~n. The Sentin~’l 20B8 January 10

J R SOC Med2OfO: 103; t-5. DOt 10,12SS/]rsm2010,10k01! 5 : ~’~

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17

The Stoke CNEP Saga - theGovernment enquiry inretrospect*

Rod GriffithsFormerly of NHS Executive West Midlands Regional Office, Birmingham. UKE-mail: rod,griff@ googlemail,com

DECLARATIONS

Competingioterests

Ne~e declared

Funding

None

Ethical approval

Not apglica hie

Guarantor

RG

Contrih~rmrship

RG isle so}e

~,ontributor

Acknowtedgements

~ene

Disclaimer

The events to which

this article relales

occurred a long time

age The

organization for

which I worked at

the time has since

been reorganized

several dines, and I

left it five yea rs ago

I have no accessto

a comprehensive set

af papers, This

article is based on

my memor,¢ ef

events and is writtel~

with the intention of

assisting learning

Why was there a review ofresearch governance in NorthStaffordshire?

Sustained media coverage of allegations about theCNEP ti’ial created pressure on the Department ofHealth. The responsible mirdster quite rigl’41ystuck to the line that appropriate mechanisms al-ready existed to investigate matters of individualcare (the NHS complaints process) or individualprofessional misconduct (the GMC and other pro-fessional reg~flators) but this was not enough tomake the problem go away. Eventually the minis-t~r came tu the conclusion that o~e aspect that wasnot being investigated was the framework throughwhich research was supervised in the NorthStaffordahire NHS Trust. The review" thus coveredresearch governance, though many have mistak-enly assumed that it was about misconduct. Had itbeen about research misconduct I might well haverefused to lead it.

Why was it called a review?

The minister believed that the issue did not justifythe cost and complexity of a legally-based enquir}5under any of the available protocols. This lack of alegal framework had the side-effect that witnessescould not be subpoenaed, and there was no sane-tion if they make false statements.

The terms of reference

Following the minister’s announcement therewas a widely communicated general invitation tosubmit written evidence. A research consultancywas commissioned to interview all those whoappeared to have something relevant to say, anda group of witnesses were selected for oral

hearings, This wide process led to the submissionof mass~ve amounts of material related ro childabuse and tl-ds led to that topic being includedin the review. In many" ways coupling these twoissues together makes little sense, but it was apragmatic selution to the problem and less com-plex than having two rewews, The review thusexamined a number of x~esearcb studies in NorthStaffordshire, as well as issues related to childabu;e. This paper discusses only a~pec~s relatedto the CNEP trial, but all the recommendationsmade by the government review are included inBox I.

Criticisms of the review

Some moaths after publication, Hev and Cha liners~

made a number of criticisms some of which aredealt with below. They wrote, ’Almost everythingthat the revtew said about the CNEF trial waswrong’. This was hardly surpnsmg because everywitness ~:ave a different version of events, The jobof the panel was not to make judgements as to whatwas r~ght and wrong, it was to examine the govern-ante issues. Furthermore th~ lack of legal or foren-sic resources meant that the panel could nordetermine lit a secure way whether some of thewitnes~s were mistaken, or did not understandevems, or may have been malevolent. From a gov-ernance point of view it does not matter who tscorrect, each can be viewed as a t~st of the govern-ance system and process.

We concluded that careful thought given tothe governance process might strengthen bothsupervision of researcn and learning~ to mebenefit of everyone. That is ~,hv we recon’anendedthat a better svstem of research governance bedeveloped.

d R ~qoa Med 20,0:10a: ~i-5 ~0t fo 12687]rsrn.20&~ 09k076 1

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18


I have avo~dBd dslrg

names of ndlvidLlals

in order t0 try to

0e0erso~alize the

co n~enm~ ana ~0

focus ’nstead on

ndarstanding the

ssues

Why was the review not in public?

Several potential wimesses indicated that theywere only prepared to speak or write in confi-dence. "lhese included the Nt IS Trust and severalparents of children who had been involved witheither CNEP or child protection issues. A smallnumber of people refused to appear in person,some because they were abroad and others because they llad considerable fears. All the latterwere parents who had in some way interacted withthe cl~ild protection system, I’hcv teared that giv-ing evidence h’t person would lead to their childrenbeing taken away truce them. Whether these fearshad any basis in fact we were not able to deter-mtne, because they remained anonymous, but itd oe~ give some idea of the emolional intensity thatsurrounded parts ,f the review. Ifi nd it distressh’tgthat some of tho.~ interviewed found the processintbni.dating. The panel did everything it could toavoid that - we allowed any witness who wishedit, tu be accompanied by friends or trade unionrepresentatives, and ever~ witness was inter-~,’iewed before the oral hearing by the researchconsultants and was allowed to edit the record oftheir first interview. No-one could have been inany doubt as to the process. An obvious lesson tolearn is that any prOCL~S is probably intimidatingto someoiTe who has not encountered it before. A

(1) That formal guidance on research governance withinthe NHS be devetepeo and issued to the NHS and tooartners whose research it hosts

{2) That the Deoartment of Health, professio qal andregulatory bodies coooerate to consult on and 3roduceagreed guidance clarifying issues of consent foroarticieation in cl qical trials.

{3) That Department of Health considers the establishmentof a surveillance system for unexoected outcomes fromnon-drug treatments.

{4) That a substantial audit of the use of CNEP in NorthStaffordshire Hosoital NHS Trust be carried out to see ifclaims of significant benefits or damage can besubstantiated" and that North Staffordshire HospitalNHS Trust considers carefully the use of CNER anddefines the scooe of its use by a strict orotocol until theevidence base is stronger,

public, legal hearing wotlld pK~bably be the mostintimidating of all.

It was quite dear that if we did not agree toconfidentiality then we would have a b~ased andh~complete review, If we had been able to sub-poena witnesses and take evidence under oaththen we would not have been in this position.

A further issue was that ministers wanted ’toavoid a circus’. If we had taken evidence in publicthen there is no doubt that it would have been amud~ more conrplex and expensive process. Manyof those who did submit material to us also sent itto the media at the same thne. Several gave pressconferences. If we had worked in public then therewould have been significant costs in security andin providing facilities for the media, and the pro-cess would have taken much longer.

I have written elsewhere:~ that the ideal mightbe a public process. I support the notion that thingsneed ’to be seen to be done’, and i thhLk that Lherewould have been less controversy afterwards ifeveryone had heard what the review panel hadheard. There are disadvantages, of course: wit-nesses can feel intimidated and there is a risk thatinnocent researchers might be smeared.

Why was the report not shown to those itaffected?We were criticized because those who had givenevidence were not shown the final report before itwas published. I asked for penrdssion to do this,but it was denied. To some extent that was unfair,but in the months before the report was published,and indeed before it was even drafted, some of thewitnesses claimed to have seen the report andmade press staten-tents announcing what they saidit contained. None of these had any basis ]n fact,but it is easy to see why officials a t every level werereluctartt to feed this ’run-tour mill’.

Attempts to raise the stakes

The process was inherently more transparent thanthe processes used by the GMC and the Trust, bothof,a, bich, for most of their course, we~ out of sightof the public and media, As soon as ~e miPdster’soffice annum’teed tee review, however, there wasmedia interest. Unfortunatet,~; interest frolrt anumber of quarters made the review appear lrtoreimportant than was Lntended. Various lobby

2 J R SOC Med 20 JO: 103: "!-5. DOt 10,1258/jrsm.2009.09k075

MOD100061922


19

The Stoke CNEP Saga -the Government enquiry in retrospect

groups saw tt~e review as a means of elain~ing thaiwhat they had to say was important. The nroreimportant that the review appeared to be, thegreater their status and credibility appeared to be.A mirror image of that was seen in the attitude ofthe press department within the region, whichseemed to regard the review as a means of enhanc-ing their reputation. I doubt if this phenomenon isunique to our review. I imagine that all processeswith a public profile may suffer in this waF:

One question leads to another

The original research question addressed in theC~P trial was perfectly sensible and, seen in thecontext of supporting newbon~s in intensive care, itis easy to see why outcome measurements ceasedwhen the children were eight months o]d. Thatlimited follow-up carried a risk, however: from theviewpoint of the parents, life usually goes on aftereight months. If survival is associated with handi-caps, particularly neurological handicaps, thesemay net become obvious matil later. Neurologicalhandicaps are not uncommon among children bornprematurely, and such children will often attendspecialized fact]tries. It was inevitable, therefore,that there would be a cohort of children who hadbeen in the CNEP trial who would mc*et regularly,along ~*ith their parents as the}, progressed throughnursery and infant school. There is no escape fromchronic handicap; parents are reminded of it everyday. It is not difficult to imagine the conversationsthat may have gone on alongside the daily routineof taldng children to nursery: If one parent won-dered if the research trial had affected their child,then it would not be long before they all did.

These questic~s could only be resolved by ex-ten ding the fo!low-up of survivors of children whohad participated h~ the CNEP trial. One of theadvantages of trial methodology is that it is theo-retically possible to re-contact trial participants.Accordingly, one of our reconm’Lendations wasthat a fullow-up of trial participants should beundertaken. Obviously there would be a risk thatparticipants could not be found or that those whocould be found might be a biased sample of theoriginal cohorts, but that could be tested in afollow-up study. Interestingly the cost of tl~efollow-up stud y w as three times tlmt of our review.~i he Department of Heal th in Wtfitehall refused toprovide funds for this, but I eventually persuaded

West Midland Regional Office to support thefollow-up. The report by Kate Telford and her col-leagues* did not detect ,~my statistically significantadvantage or disadvantage of CNEP comparedwith intra~tracheal positive pressure ventilation.

One lesson now easlty seen is that if fundinghad been available front me outset to support toschool age the whole sad tale might have beenavoided. The cost of ~uch follow-up would havebeen substantial but far less than all the costsincurred by the various enquiries. It is a difficultdilemma for any researcher when heed with tin~-1ted funds. Is a lhnited study better than no stud~at all? In this particular case. the initial]y limitedfollow-up resulted in costs in th+" long r~m

The need to protect researchers, patientsand the public interest

Research is about tile unknown, ~ld going into theunknown nvolve~ risks. Neither the c]iniriansprescribing the treatments compared, the r~’-searchers studying them. the patients receivingthem, nor the public who pays for them, knows forsure what will happen when a new treatment iscompared with an existing treatment, Each of themhas something different at stake, and each must beprotected, as far as is possible, from misunder-stm~dings or even mistakes that might occur. A gov-ernance system should provide that proteetlon andit should have a means to mount an mveshgationwhen something appears to have gone wrong

We examined the various statements about re-search governance that were current at the thne, Jtwas clear that some professional bodies had pro-duced recommendations that were in advance ofDepartment of Health policy. We tried to identifyTrusts similar to North .qtaffordshire which wouldbe prepared to allow us to compare the system wehad been asked to rewew with their own. To or~rsurprise, all the Frusts we asked refused Thatseemed to be a further indication that change wasneeded. We briefed the Research and DevelopmontDirectorate of the Department of Health in deptl~

as we developed our thinking~ and everything thatwe said about research governance in the reportwas approved by them.

A political failure in research governance

I was disappointed with the way thai researchgovernance developed subsequently. I thought it

J R $oc Mec12010:103: ~ 5 DOI ~0. ~25~/jrsm.2009.09k075 3 iiii~iiii~i~~iil iiiiiiiii~

MOD100061923


20


was too bureaucratic and seemed to have ’lost theplot’.51 think this was partly because, allltough theResearch and Development Directorate developedthe policies, people with little experience of re-search often implemented them. At a local level itsometimes appears that the simplest way to avoidtrouble is to make it as difticult as possible to carryout research. In such circumstances it is hardlysurprisLa g thai horror stones began to appear.Lengthy documentation was required even forvery simple studies, and tl~s in turn incurred de-lays and costs that made research more difficult.

If so many people now say that the current~ystem is i;ladequate why was ~t l~ot pnss~ble tn doit better? Ultimately the failure was political. At thetmle the NHS was undergoing repeated reorgani-zations at every level, and research governance,and the training and education that should haveunderpim~ed it. were sHnply not a high enoughpriority. As a result there was inadequate leader-sl’dp and resources, at every level, for ensuring thatthe governance process was fit for purpose.

What can we leam?

Research governance should have included threethings: a framework for the conduct of research, asystem for learning and training, and a mechanismfor investigating suspected or alleged misconduct.Some of this is now in place, but I believe that thelearnLng and investigation elements are still weak.

The estabEshment of the UK Research IntegrityOffice (UKRIO)6 followed publication of ritesecond edition of the Department of Health’sResearch Governance Framework. UKRIO shouldat least provide a repository of expertise. Itrecommends that a named local individual shouldinvestigate allegations of research misconduct.Unfortunatel}; this means that investigati.ons willusually be carried out by someone who has neverconducted such an investigation before, and whotherefore lacks legal and forensic expertise. A bet-ter solution might be for UKRIO to make availablea panel of independent experts who know what~’~ey are doing.

What were the outcomes of the review?q~he inaht recorIl_rnendatlons from the review are

set out in rite Box 1. They contain no criticisms ofindividuals, nor do they criticize the CNEP trial.

Research governance was introduced. Guidanceon consent was issued.7 The idea of a system toreport an adverse event from non-drug treatmentswas later endorsed by the government documententitled An Orgmffs2thm with a Memory.~ ’Ibis waspublished Jn the year follmving our report, andresponsibility for implementing it now resideswithin the National Patient Safety Agency. At asystem level I believe that ottr recommendationswere sensible and the UK health system is betterfor the actions taken. I am particularly pleased thatwe found the resources that made possible theextended follow-up of the children who had par-ticipated in the CNEP trial.4

Unfortunately there is more to say. Despite ourinsistence, reiterated at several press conferencesand in interviews, that we were looking at systemissues, much of the report was interpreted as criti-cism of individuals. Sometimes people see whatthey want to see and read what they expect to see.Because our report was the first to appear (longbefore those condn cted by the Trust or the GMC), itbecame the vehicle for a number of groups to con-thtue to air their particular views. An Orgmdsetionwith ~ Memo~! would later say how important it isto try to avoid blame and learn lessons, but whenwe reported we were probably the first to try thatline. It need~ repeating rnany times.

What did I learn about report writing?

Writh’lg a report as a civil servant responding to arequest from a minister is not the same as writing areport as an indepertdent investigator. Ck~r reportwas a team effort, and was in two parts. The firstcontained a set of recommendations, which wereaccompanied by an explanatory text, following, inspirit, the legal model of judgement and obiter d~cta(’said by the way’, words introduced by way ofillustration, or analogy or argument). The secondpart was the evidence submitted to the mirdster,which was not pubEshed.

The draft report was circulated for comment tothe relevant divisions in the Department of Health.The recommendations remained unchanged, butpublication of the report was delayed because therewas disagreement between the public relations peo-ple, who thought it read better in a eertah’l order, andthe legal team, who had a different view. FEe pubfished report eventually followed rite advice of thelegal team, which coincided with fl~e original draft.

4 J R Soc Med 2010: I03:1-5. DO110,1258/jrsm,2009 09k075

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21

The Stoke CNEP Saga - the Government enquiry in r~trospect

It is h~teresth~g that many subseq uent criticLsmsof the report related to the explanatory material.which was derived :from the conflicting views thathad been presented to us, I sometimes v~ish wecould have shllply published our recommenda-tions, with a short statemc~lt noting that everyonehad told us something differealt. But that is not theway these things are done,

References

"[ I[ey E, ~ha|mers L lnve~gating allegatimT~ of researchrnisclmdu~t" the, ~ i~a± need for due ~n~cess IL~q)2000;321:752.-5,1348-9

2 NHS Executiw West MidJands Office, R~oort ot a ~eviezl or~he r~sv~rclI @anlewOTi, fn North StJtordshit~, Hosz)ihd NHSFrust. Leeds: NHS Executi~c: 2000. See tlt[v ’ www.doh go~/wmro nor thbtaffb.htm

3 Griffitb, s R fh~ drinking from a polqoned chalice. ~3~ "200~);33 Y)a 2347

4 TelfordK "¢vStersk.\~,asH. eta;.Uutcomea,’terneonatalcontinuous i~egativ~pressure ventilaaon: ±ollow-ttp¯ s~p~sment. Lanca4 2006;367:1080~5

5 GriffitIls R. CNEP ~md research gax echo, nee r t.’~n2006:367:1 f]37-8

" See 11ttp:i/www.ukrio.org.uk7 D~partment o~ Health. HSC 2ffJI/023: Goo;~ ~yacucv in

coas’~’~zt u~rzir’ottt,~; &¢ NHS P~ra~l romtmtll~t,~tl ~0 patty’hi2~’rllt~d canseni on,trice London: Department of Health2OO1Department ot Health. Ai~ OrR*masa|;,o~ with a M~’morv.London: Departmen~ of Hea]tt. 2000

J R So¢ Med 2010: I03: 1-5. DO110. !25B/jrsm.2009.09k075 5

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23

The Stoke CNEP Saga - how itdamaged all involved

Teresa WrightFormerly Senior Research Nurse, Neonatal Unit, North Staffordshire Hospital Stoke on Trent¯ UK

E-mail: tamthor r @ btinternet,eom

DECLARATIONS

Competing interests

Nofla declared

Funding

N0na

Ethical approval

Net appl cable

Guarantor

TW

Ceatributorship

TW is th(, s ula

contrib~tor

Acknowled.qemenls

I am ver,/indebted to

Kaith Prowse for

sharing his

perspactiva of what

the ’CNEP Saga’

meant to

management irJ the

Hospital Trust in

St~ke, to lay ex-

calleLcue Kate

Luck ng far reading.

with such care, what

I have wriLt~’l here,

a£d to all the ex-

colleagues who told

me, in confider)ca,

about the impact

that the affair had on

them and their

fami!ies,

After one family made allegations about the waytire study of an iPmovative strategy for providingnursing care was conducted, staff in the neonatalunit at North Staftordshire Hospital endured 11years of disciplinary~ enquiry~ And, because staffare barred from talking whi]e under investigation,it has only recently become possible to describe h~detail much of what then went on.

CNEP was a study of nursing careW-atchg~g a ~n}; preterm baby supported by inva-sive tecl~tology cling tentatively to life, or struggleto breathe for itself, is something most people havenever seen. Providing these fragile infants withcontinuous negative extrathoracic pressure. (CNEP)presented quite a nursing challenge, and the trialin which we participated was a Lest of what wasbasically a nursing procedure,t There was, as aresult, substantial nursing input rlgbt from thestart, milch of which went unreported at the time.Had some of those who criticized the triala beenaware of this, their views about parental involve-ment, and the way consent was sought, might havebeen more balanced,a

Nurses realize just how bewildering the firstfew hours can be for the parents of any recentlyborn sick or premature bab~; and are trained tohandle this sensitively and supportively Theirdecision to try and advance neonatal care, andavoid some of the long-term cnnsequences ofconventional ventilation with a tube through thelaD,nx, was ta ken with some care. tt was a decisionalso balanced by a clear reeogo~ition that the needto get parental consent as soon as eligibility wasconfirmed (just four hours after birth) also pre-sented a major challenge. This was highlighted bya small nurse-instigated survey, performed mid-way through the study3 which showed that two-thirds of the mothers had not been able to visit the

unit and see the various pieces of equipment, beforeagreeh~g to support the trial. To meet this need. theassistant research nurse~ produced a 14 page bookletwith photographs of the unit and the equipment tosupplement the trial’s information leaflet.

[’his small survey also showed that. although90% of the parents m~derstood that their baby wasin a clinical tria_, one-third did not fu£y under-stand what the trial was about. Tt’ds higNightedthe need for staff to} make sure tidal families werekept fully informed, and given ample opporttmityto ask questions over the subsequent days andweeks. A serious i~.ursh’tg concern from [b.e outsetwas that families would have less access to theirbabies due to the complexity of the equipment, orconcern that the CNEP equipment causec discomfort. A questionnaire about these and otherissues was dtstrtbuted to all parents m Stoke, m~d79% ,~=137~ of these anonymized questionnaireswere returned. Tlte replies were very reassuring,suggesting that parents did not tl’~nk tl’tat CNEPimpeded access or cause more discomfort. Nor did~t seem to reduce the chance of the baby beingbreastfed. ALmost ail the paregts in both trialgroups felt that neonatal staff had don~- a lot tuhelp them relate to. and interact with. their baby.

As the lead research nurse- togetbe~ with myassistant researcher Kate Lucking, 1 was responsiblefor collecting aI1 the clinical data and. because I wasalso responsible for training the medical and nurs-ing staff in the new- equtpmen~, I was on-call 24hours a day. seven days a week. for much of thetrial, t. an,wet questions about eligibility, randomi-zation and getting CN~EP started. Luckily [ foundmyself working with a team of highly-motivatednurses, and had the unstinted ~upport of all themedical team. I also bad excellent technical supportfrom a senior member of the biomedical engmeeringteam. Dave Evans. who played a vital role in thedevelopment and maintenance of eqmpment.

J R Soc Med 2010: I0~: 1 6 taOt 10 12ra~/irsn-,2010. ~OkO12 1~il~!!liil!!ili ~¸ ,ii~ i~i~

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Mv soec,al manKs re

=dmund He~ for his

gui[larl¢ e, suppor[,

encouragement an~

cornmi~Tent to Us as

n divid~lals Wi:hou~

his determination for

me trurn. ; would

never nave oeen

able to te our story

The first complaint surfaces

Mr and Mrs Henshall lodged a first complaintabout their child’s care with the Trust in August1994. Initially this was dealt with by discussionusing the hospital’s complaints procedure, butallegations started to proliferate in May 1997 aftera campaign was launched in the local pres~. Muchot me publicity claimed that parents had not real-ized. or been told, that their baby was in a clinica!trial. Eveutuallv the claim was made that consentforms, including the Henshalls’, had been forged.~lhis aspect of the whole affair particularly puzzledand saddened the nursing staff, because the)" hadnlways ~ried to work with families openly, honestlyand closely, with axt emphasis on continuity of care.

It is well-known that. when questioned after aninterlude, recall of events can be fragile,5 but thisonly makes contemporaneous records an evenmore valuable way of showing that staff were dilPgent in the way that they took consent, and keptfamilies briefed on progress after trial entry.¢"

Thirty-five iunior doctors were inw~lved in takingconsent, and e31 had to try, and establish their ca-reers while knowing that allegations of dishonestycould come back to haunt them at an), time. TheTrust had ]0 allegations oi consent form fraudunder review at one stage.7 Most of these allega-tkms were later dropped, but for one family doctorthis issue still remains unresolved because theGMC, for legal reasons, declined to rule on thisissue when it finally got round to hearing theHenshalls’ complaint in May 2008.

When the press onslaught went unrebutted,staff morale soon started to suffer. Indeed, as thesecond article m this ser~es has documented,s

the press were soon linking our CNEP work withthe child-abuse week being done elsewhere in the’trust. Uam~er headlines proclaiming that "Parentssay guinea-pig taial killed their babies’,v weresoon followed by ’Spy cameras capture torture ofinnncents’,a~ Reports claimed that 43 babies diedor "suffered permanent brain damage’ but failedto say that, because all had to be seriously ill to beeligible for the study, this was also true of 32"conmol’ babies. In fact the true figures were 35m’td 27, because double-com’tting failed to ~lowfor the fact that many ,~t the babies with a severecerebral ultrasound abnormality died,

I had recently bad a new baby and, withinweeks, the nightmare began. Like other members

of the nursing team, l found myself giving ’state-ments’ to the Trust soliciton The early months offamily life were blighted by bewilderment anxietyartd the fact that itwas all so public.

The Henshalls report theTrust’sMedical Director to the GMC

By mid-1997, the press were repeatedly publiciz-ing the most shocking of all the Henshalls" allega-tions - that their signature on Sofie’s consent formhad beert forged - and totally ignoring all theTrust’s vigorous denials. Finally, on hearing thatthe allegation was to be repeated yet again onChannel 4 News, Dr Keith Prowse, the Trust’sMedical Director, decided to show the completedform to the press because of ’fears for the morale,status and future of the paediatric department’.However, even this action was turned on its head,because the Henshalls promptly complained to theGMC that Dr Prowse had failed to obtain theircorusent before showing anyone this form. tte re-members the ’awful sinking feeling" when he readthat he was under investigation for serious pro-fessional misconduct m-~d might, if lound guilt?;be struck off.

Worse still was the fact that the preliminaryhearing took nearly three years, while the futl pub-lic hearing only took place almost four years afterthe initial complaint had been lodged. ~j While DrProwse had to c~’tdure this lengthy investigation,he did, however, have ’immense support’ fromwithin the Frust. More than 50 of his patients alsotook the trouble to write to him personally offeringtheiz support. When it was pointed out that certainfan-allies were ’serial’ complainers, the GMCmerely said that ’it was their duty to investigate allcomplaints’ - a response that led most people inthe Trust to conclude, like Dr Prowse, that theGMC seemed more concerned with its own sur-vival and with public criticism, than with the factsof the case. It also seemed very clear that the cou-tinued press frenzy over anything remotely relatedto David Southan was having a widespread effect.

Facing the first Government-sponsored enquiry

Ear!)" in 1999 1 was asked to attend the first of twointerviews in com~ection with the Griffiths enquir):2

2 d R So(: Med 20~0:103:1-6. DO/10.125Bijrsrrl.2010. !0k012

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The Stoke CNEP Saga - how it damaged atl involved

I was not told what the ir,Zerview would be about.but [ was told that it wotfld be informal and f wouldnot need to prepare for it. What actually happenedleft me deeply" shocked. The questioning Mt hosti]eand, because * was not allowed access to any re-search material. I formal it very difficult to respondadequately.

My experience was not unique, howeve5 Severalof the medical team also reported a lack of infor-malion prior to inter-Jew and ’aggressive’ question-ing.~ Most staff appeared with no representationand no suppomng documer4afion. No-or-re saw adraft of the report so they could make commentsprior to publicatlor’, even lhough the Trust bad acopy. My nurse colleague and I felt so misrepre-sented in the final report that we felt we had Eorespond in the BMl and ~ay ’We strongly refute thesuggestion that there was an inadequate protocol ormeans of documenting atl of the material relating ~oeach of the parents in the trial ,..’J3 It seemed as ifthe complainants’ testimony was simply acceptect atface value and never checked against medical notes.Nor were the doctors who witnessed the signing ofconsent forms ever asked to testify.

Facing yet further investigation

Soon alter this intervir,w was over I was told thatthe Henshalls had lodged a torn-tal complaint withthe United Kingdom Certtral Council rUKCC/- theregulatory body with the power to strike nurse s offtim register. The worst allegation was that I had’supplied inaccurate inLormation and corrupt data,giving the trial a false conclusion’. I was told that Iwould have to wait for the HenshalIs to provideevidence to support their allegations, but 16months later l was informed that no supportingevidence had materialized. In parallel with this theTrust then launched their own internal enquiry,and I faced two more long, hostile interviews andwas told not to speak to my medical colleagues.Indeed all the nurses who had helped to care forthe [{enshall babies were questioned, which wasdistressing because they could not understandwhat was supposed to h ave gone wrong.

Nine months later, I eventoa]iy took extendedsick leave and never returned to work - a source ofmuch regret. The press onslaught seemed relent-less but it was my only source of iirformati~m.because 1 heard nothing from the Trust. Just asrite UKCC fatally closed their investigation of the

Henshalls’ allegation of serious professional mis-conducL. I was told that yet another complaintabout mv involvement in the trial had been filedwith the UKCC by another person. 1 l~ad neverhad any contact with the complainant but wastold that she was representing ’other parents"who had children involved in the CNEP trial. Yetagain the UKCC urdy dropped this further inves-tigation after seven months when I was inforumdonce again that rio supporting evidence had bee~supplied,

TNs became a recobmizable pattern as me presscampaign gained momentum. At least 18 doctorswere so targeted by one pressure group, allowingthem to tell the press that those doctors ’wereunder h-westigation by the GMC’]4 And when nofurther supporting evidence was submitted formore than a year those named, if they" pressed theGMC, were merely told that the hwestigatian wasno longer ’current’. Modified rules allowing vexa-tious complaints’ to be dealt with more quicklywere cvel~tually agreed bv the GMC seven yearslater, but their effectiveness has yet to be assessed.

One senior nursh~g colleague within the researchteam with an exb’emety promising career before herwas in ll-.e m~tortunate position of applying for postsin o;ber Dusts when targeted in this way. A steadyflow of complaints about her were reaching theregulatory body. ’this greatly complicated the wholeappointments process as each complaint generatedfresh correspondence with the Nursing and Mid-wife13, Council. My" close colleague throughout thetrial, Kate Lucking, also eventually decided to leavethe profession and says that her experience of theway the ’CNEP Saga’ was manageu certainly con-tributed to tl’k~t decision.

Further problems for the wholeTrust

One major problem was the amount of time theTrust had to spend responding to the press and torequests for information from the District andRegional Health Authorities, and the GMC. Themedia posed a particular problem because, eachtime a fresh allegation appeared, the Trust wasasked for an immediate response and, for a while,fresh allegations were appearing ahnost :tally.Management felt under ’siege" and were given nosupport bv ll~e District and Regional HealthAuthorities External advisers were brought in to

J R SOc Mud2010:103: t~. DOI 10.1258/]rsm.201n !0k012 3

..... 4i’

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~:~ ~o~rna! b~ihe Roya! Society of Med Cine

deal with the press. ~nd this cost the ’2Crust evenmore molley. 1"he reported cost at the time wasaround £1 ndliion, but it is now- thought that it wascloser to £3 million. Dr Prowse, as Medical Directo~;tried very bard to rebut press lies, and fclt greatfrustration that all the Trust’s statements fell on deafears

The Trust did, howex.er, resist the pressure forsuspension of Professor Southall u~lti] earlyNovember 1999 when there was an abruptchange of approach shortly after a meeting withthe Director of the West Midlands NHS Execu-five. ~s Two independent experts were then askedto examine the Paediatric Department’s otherresearch work. After holding just a single formalmeeting, they quickly issued a verbal recom-mendation that Professor Southall shotdd besuspended, and be referred to the GMC.~ TheTrust also suspended Dr Samuels at the sametwne because of still unresolved child protectionissues

Two of my medical colleagues aresuspended

As a result of this very :luick investigation both theconsultants were promptly interviewed by meActing Medical Director and the Director ofHuman Resource~¢. told that they were being sus-pended, and that they had ~o leave the hospitalwithin an bour. ~ey were expressly [orbidden totalk to any hospital employee or reh~m to the hos-pital site without permission. I was never formallytold about this, and when I did hear through ’thegrapevine’ it onlv [urther increased m,, fear andconfusion.

A t no szage prior to suspension was Dr SamueIstold that his conduct was under review, and theTrust were n~t. at first, able to give any reason loteither of the suspensions. Once the inadequacy ofthe initial investigation became apparent sevenweeks later after the two doctors did finally get tosee copies of the preli~rdnary reports, two morecomprehensive invesVlgations were started, but itwas a ftdl 12 months before the case-notes of oneof the consults nts were sent for expert reviou~ Thefurther externally-staffed ~x~quiries eveJ~tuallvexonerated both doctors, recommending re-instatement because there was no valid caseagainst them, but Dr Samuels only returned towork after 20 months, and Professor Southall only

returned after 27 months. When the NationalAudit Office undertook a cotu~h’y-wide review ofthe way NHS staff suspensions were managed,they highlighted the way these two doctors hadbeen treated as particularly gross examples ofinappropriate Trust practice,~7 but Trust manage-ment say that it was lawyers at the RegionalHealth Authority who made them handle thesuspensions this way.

Dr Samuels has, not surprisingly, said that hefelt ’crin’~inalized’ when told not to make contactwith colleagues or enter any hospital building.Both the doctors received many letters of suppo~-tfrom colleagu~ after their suspension and severalalso wrote to the Trust. Letters also came in fromthe parents of patients, and letters of support alsoappeared in the local paper,~s’~9 but support fromthe Trust was conspieuous by its absence eventhough the press statement that they had putout stressed that the ’suspensions are not adisciplinary action’.

The oft unrecognized familyrepercussions

One thing that is often forgotten is the impact thatthis has on the families of those inw~lved. There isno ’normal" family life when one member is notworking and is distracted by the need to defendthemselves. Constant media reports only makethings worse. ’The press "informs" the com3nunit~;within which they work, tlve, attend school andplay.’" ’Being the wife or child of a doctor who kills,harms and experiments on babies, and who forgesconsent forms ... does not make for a comfortableexistence.’ It can be very difficult to interact withothers in the local community-when you ka’~ow tb atthis, though untrue, is what others are reading inthe local paper week after week. [he doctors them-selves q~ave their own community and network ofsupport’ but their family have none. The fac~ thatthe investiga tio~,s took so long further exacerbatedthe feelings of frustration, anger and (in my owncase) depression.

I know that this distress was ultimately respon~sible for the breakdown of at least one and possiblytwo marriages. The etfect on the children also wentlargely unrecognized. Some were bullied and

’~ All the quotation,s in this paragraph co~e ff~m a letterw~’itte~ 15, the spouse of o,~e ~f the c]~nidan~ invo’ved

4 d R Soc Med 2010:103:1-6. DQ110. !2.S8/jrsm.2010. I0k0~2

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The Stoke CNEP Saga - how it damaged all involved

abused at school as children of ’babv Milers’ andfor one child, this had a sermus and long-lastingpsychological effect. What compmmded this dis-tress was the failure of the author~tJe~ re counterthe exaggerated press daims, whUe simul-taneously barring ali staff from talking to themedia. Fhe families feel that the Trust failed ’in itsmoral duty’ to the staff in its empIo?; and saddledthem with a ’Iife-Iong sentence’?

Knock-on consequences forothers in theTrust

inaccurate and sensationalist media reports alsocontributed to a lack ot trus~ and suspicion in thelocal community. Chic mother whose baby wasadmitted with cyanotic episodes, became con-cemed that she had been "secretly filmed’ when thelocal press reported the child protection work thaihad been going on. In the absence of any balancedand informed reportmg, she must have be, an one ofmany who imagitaed that every parent had beenfilmed~ if their cbild had been under the care of thetwo consultm’tts concerned.

And, long after an externally conducted reviewhad shown that that the CNEP trial had been well-conducted, Whitehall was stilI refusing re acceptthis,~5 In 2002. for example, the Paediatric lnter-t-sive Care Unit was initially" denied a Charter MarkAward for Excellence simply because it was in thesame hospital as the Neonatal Unit and wastreated, in the eyes of the civil servants in theDepartment of Health, as being part of a unit thatthey still classified as being "tff concern’. Althoughthe Trust eventually managed, on appeal, to getthis ruling withdrawn, the initial intervention hadby then, made many staff in the Paediatric Unitboth cynical and angry.

The wider damage to research

Professors Neena Modi and Neil Mclntosh.present and former Royal College of Paediatrics &Child Health Vice Presidents for Science & Re-search, comment that "th~ CNEP Lrial was welldesigned, and could have been used as a templatefor sensible and effective resoarch govenance,Instead it was attacked by a l~bby group al-Ld

All the quotations in this paragraph come from a letteiwritten by me ~p~u~e of one ~f the ~lmlcmn~ ilwoIved

received a flawed evaluation, thus cornprolmsingthe protection that babies and all patients deserveto receive from research to assess the effects oftreatments’. It also remains a Ios~ to the neonataland paadiatric community tlnat the expertisegained in non-invasive ventilation was thensquandered. Calls for further research and devel-opment continue to be made ~7 but clinicians inStoke are still barred from using CNEP even molder children despite the interest in this type oftreatment that persists elsewhere. As recently as2008 an Italian team published a small trial using ahood-andmeck seal instead of ’nasal prongs" todeliver continuous positive alrwav pressure.~this showed that pharyngeal pressure was morestable when a hood-and-neck seal device wasused. lhe o~y difference between the approachthat we had started to use ill 1989 and the approachnow being studied in italy is that we used negativepressure rourtd the chest and they are now usingpositive pressure round the head.

Paediatric research came to an ahnost completehalt, :rod the careers of several medical ana nurs-ing staff were abruptly ended or curtailed. Profes-sor Southall was eventuall? for’end to resign. DrSam uels w as made to ’re-train’ before coming backre work, not because he had been found to havedone anything wrong, but simply because he hadbeen suspended from all work for 20 mo~lths. DrSpencer, who had been deeply involved in a rangeof hrnovafive research, has vowed re do no more.All three were omy finally acquitted of any wrong-doing by the GMC in July 2008. The unit has beenurged to join several important, nationally funded.multicentre trials in tlre last 10 years hut ktrned allrequests down. The sears still run deep.

Conclusion

Behind this very public story; the private cost to theindividuals concerned has been pahld-ul and far-reaching. ’lhe "fall out’ did not only affect the doc-tors whose names appeared in the press, and theirfamilies, it also involved the nursing staff, and Unitand Ikust managers as weli as "shop floor" clini-cians. ’lhe way complaints were handled seemedgrossly unfair and unjust and this feelfaag wasonly reinforced whma it eventually became clearthat almost all had been misguided, it not overtlymalickms. When clinical staff mismanage the careof patients they can, rightly, expect to bo held to

~;7~ii!iilii!i

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account ou~ when allegations are mishandled althe way that these allegations were, those respon-sible for that mismm~agemen~ never seem to beheld to account.

References

] Samuul~ IX’[ P. Rdirtt, ], Wrigld T. vt a~. I~on[lrtuuub rtl,[~id [iveexLrdth~lra~ic pt~’ssm~ ill nt,unatsl rE~spir~tL~ry tafltn~.Pediatrf~ 199b,98:115’4~]0

2 Natkm~d Health Service EK£K alive ~%’~sl Midiat~ds OfficeRe~orr f o R~:r~i¢il~ r;~ the Re~eard~ Franu, wc, rk i I ,\-orthSt,%~ordshire ilo~ih+t NTiS Trttst l.eed~: NSH Executive:

2000. See http;/i www.cm.gov.uk/assetRoot/04/0145,’42/04014542 pat

"~ Gritfiths R. CNEP and r+,search governance, t.!l*irer2006;367:1037-8

-i Lucking K The CN£P Tri:li: d~m’e+lt hl"+rmM,’~m Booklet.North Staffs Ivlaternitv He,Fire[ N conat,ql Unit: 1992Stenson BJ, Becher JC. McIntosh N. Neonatal researcJn: thep+~rental perspective. Arch Dis Child 2D(14.89 F321 4Allmark P. Ma_aon 5. Improving the quality ot consent tor,mdml~ised con~roUed trials by using continuous consentand clinici,nn training in the consent proceus, i Med EthDs2(}00,32:439~3

7 Itc~ E The 1996 cuntmuous negaLlvc extrathordcicpressure (CNEP] tvlal’ were parents’ aIIcgatlons ofre~earch fraud traudu]ew? Pediatrics 20C6;117.2244~

8 Gorr~al]J The ro~e of the media in the Stoke CNEP Saga[ Rou’ Soc Me~ (in press

9 Morgan B, Blackhurst C. Parents Say ’Guinea-pig TrialKillect Their Babies. Now they are going to Sue’Jl’~dov.’nde~It o:l gutld++lt 1997 May 1i

10 Blackhurst D Spy cameras capture torture of innocentsThe Semffnel 1997 ©~ober 27

11 Dver C. Hoapital chief was right to relea~ patJe~nt conaenth~rms t~> the media, BM] 21101 ;332:1266

12 Spencer A. Punishment by process. BM] 2004;328:77413 ~?rlg.h t T, Lu ckin g K N ur.~es und ertaking the C?N];.P Tri al

give their suppurt and[ dcs~riSe fl~ir experienoe~ BMJ21K)0:321:] %~6

14 Marcovi~ch H. GMC must reco~ise and deal withvexatious complair ts fast./334[ 2002;0~4:167

15 Hey E Chalmcrs I. Mis-invcstigating alleged research~d~ccnduci c,m ci~use ~idesp:ead tmpred~ctabi~ damage.] R0k 5oc MM 2010;103:132-7

16 Hey F, F’emirtg P, Sihert J. Learning b’om the sad, sorrybaga at Stoke. Arch DI~ Child 20t]2;86:1-3

17 ,National Audit Office. Roper t by file Controllc~r andAuditor General The Monagement ~ff gu.~p~nsions ufU~inical SIaff n NItS/tospi/al and A_mbul~nce rruMslnEnglanc HC1 ! 43 Sesslim 2002-2003; 6 N~wmver 20f~3

18 BLackhurst D. CNEP chamber helped to save oztr son’s life.The Sentnwl 2iX)4 March 6

19 Blackhurst D. Treatment gave us pzecious time TtleSePltind 2001 November

2~ IIe~.derson J. Respiratory support of infants withbronchioiitis related apnoea: is there a m]e for negativepressure? Arch L)i; Lhild 21105;90:2245

21 Colnagh~ M. N~taKha PG: Fumagalh M. Mess[ha D, MoscaF. l~harFatgeal press~trc value usi~g two c~ntillut~usp¢,~itlve Mrw’ay pres~+++e devices Atoll Di~ Clliid200~:93:F302-~

° ,R oo+ +o ,+,,+ °0, + +++++ +o1 iiii+ l+++

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The Stoke CNEP Saga- a viewfrom the General Medical Council

Graeme CattoGeneral Medical Council, London, UKE-mail: gcatto @ btinterr]et.corn

DECLARATIONS

Competing interests

None declared

Funding

None

Ethical approval

Not applicable

Guarantor

GC

Contributorship

GC is the sole

corlribJtel He

wrote this Raper in

his persl)l~al

ca0acity

AcknowledgementsNone

The General Medical Coun,Al’s (GMC) purpose isto protect, promote and maintain the health andsafety of file public by ensuring proper standardsin the practice of medicine. ~Ib support that pur-pose, the GMC has four main regulatory functions:registration (which, in future, will ~nclude revalidation); education and trairdng; standards andethics; and the fitness-to-practise procedures(sometimes misleadingly labelled disciplinaryprocedures).

The fitness-to-practise procedures seem g’nar-anteed to polarize opinions; over the years, fherehave been criticisms from both sides of the yawn-ing divide that separates those who believe theGMC is too lenient and those who believe it is tooharsh. Neither caricature is accurate, as evidencedby the outcomes of appeals and other referrals tothe High Court. As with all activities based onhuman judgements, errors are made but the num-bers are very small and they do not reflect systemicbias. The GMC is committed to having processesand procedures that are fair, objective, transparentmid free from discrimination.

Nevertheless, some criticisms of the fitness-to-practise procedures have been justified. The proce-dures that operated in the 1990s and in the earlypart of the 2000s were no longer fit for purpose.That is why the GMC launched a programme offundamental review in 2000 and introducedreformed procedures in November 2004. [t is alsowhy, at the Shipman Inquiry in November 2003,the GMC frankly recognized past deficienciesin three areas - operational effectiveness; con-sistency and quality of decision-making; and thearchitecture of the procedures.

Other criticisms are not justified. Some reflect ahistorical rather than a current perspective; someare based on misculderstanding; and some arepartisan. They include that the GMC bears down

unfairly on particular groups of doctors, forexample paediatr[cians: o[ that ti-tc GMC is ill-equipped to investigate allegation~, of researchmisconduct. Both are contradicted bv the facts andneither is substantiated bv the CNEP case.

This is not to say that the GMC did not makeserious errors in relation to the CNEP allegations.The GMC has acknowledged that there weremistakes and has ~pologised for them. But thosen’dstakes do not justify the claims sometm’tesmade.

The GMC first received allegations about theCNEP trial in 1997. The alle~ations included thatconsent had not been properly obtained, that someof the babies had not been suitable for inclusion inthe trial; .~nd that the trial had not been conductedproperly and safely. Although the CNEP case ranbeyond the introduction of the re|armed proce-dures, m November 2004 it continued, for legalreasons and all practical purposes, to be subject ~othe legislation in force when the allegauons werereceived in 1997. To understand why this is signifi-cant, it is necessary to look at the architecture.

The fitness-to-practise procedures are governedby the Medical Act 1983 tas amended from time totin’re) and bv statutory Rifles. Before November2004, me procedures had three stages - screening;preliminary proceedings; and an inquiry con-ducted by the Professional Conduct Committee(PCC). The Rules determined the nature of the testto be applied at each stage. The GMC’s interpreta-tion and application of the taw are subject k) theoversight of the courts, whether by way of judicialreview r}r appeal.

The Rules also provided that the complainantwa~ a party to the proceedings and was, therefore,entitled to pursue the complaint against the doctor.This included a right, which was exercised by thecomplainants in the CNEP case. to instruct the

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legal team and to control the conduct of the case,including their choice of expert witnesses. Thereare no corresponding provisions for complainantcases in the reformed pmeedures.

Within the first stage, the allegations were considered by a medical screener who, at the tin’m, bylaw had to be a medical member of the Council ofthe GMC £he screener decided whether the caseshould proceed to the Preliminary ProceedingsCommittee (PPC). A decision not to refer theallegations to the PPC had to be agreed by a layscreener, who was also a Council member.

The presumphon i~ the Rules was that theallegations should be referred by the screener tothe P[~,d unless ’it appears to the screener that thematter need not proceed further It was a test thatscreened out. not a test that screened in. M r Justicegightman (R v GMC ex parte ’Iotb [2000] 1 WLR2209~ had said:

’Tha rol4~ of the scret, ller is a I~arl, o~ otte It is tofilter out 6"ore the f!;rmally correcl complaints ...thos~ which he is satisfied (for some sn~c~ent andsubstm~tial reasom hem t~ol proceed f!~rther, forthis purpose he must be satisfied of a negative,namely that the normal course of the complaintproceedin,g to the PPC need ~tot be ;oltoraed.’

Within the ~econd s~age, the allegations wereconsidered ov the PPC. The role of the PPC ",,,-as tod~cide if the allegations should be suoject to aninquiry conducted Dy the PCC. The test in theRules was whether the matter "ought to be referredh~r inquiry by the PCC ...-.

1-he PPC’s discretion was also limited. Again inthe words of Mr Justice Lightman, ’The PPC mayexamine whether the complaint has any real pros-pect of being establlshed; _. and may refuse torefer if satisfied thai the real prospect is notpresent, but it most do so with the utmost caution.. It is not its role to resM ve conflicts of evidence ...

In the case of the PPC { as in the case of the screener)any doubt should be wsolved in favour of themvestigauon proceeding.’ The lh~ited role of thePFC in resolving issues of evidence proved to be~ignificant in the CNEP case.

Within the third stage, the allegations were con-sidered by the PCC, which conducted an inquir~lhe PCC decided whether the a I legations had beenproved: whether those found proved corlstitotedserious professional misconduct; and when seri-ous professional misconduct was found, the nature

of any sanction to be imposed on the doctor’sregistration.

ttaving received tbe CNEP related allegationsin 1997, the GMC was slow- to take effective action.In January 1999, the NHS Executive commissioneda report from Professor Rod Griffiths. The GMCconcluded that it should await publication of thatreport before making any decisions on the allega-tions. The report was published in May 2000; andit conrail’ted criticisms of the CNEP trial. Separ-ately, the Trust had commissioned a report fromProfessor Sir David Hull, whose report wasdelivered to the frust in December 2000.

The medical screener decided that the CNEPallegations should be referred to the PPC. This wasinevitable given the screening test to be applied.On 16 January 2002, the PPC decided that thefllreshold required for reference to the PCC hadnot been reached. ’lhe complainants protested an d,on review in September 2002, it emerged that thescreener had not been presented with all the rel-evant material when making the screening deci-sion. Consequently, the PPC had not beenpresented with a complete picture. The decisionswere set aside; and the medical screener, havingconsidered all the material, again referred theallegations to the PPC.

By this stage, the GMC had made three ntis-takes. First. it had taken too long before making thefirst screet~ng decision. Second, the first screec-ngdecision and the PPC decision were defective be-cause relevant material had not been taken intoaccount. Third, it took too long to make the secondscreening decision, based on all the avaklablematerial. Over six years had passed from receipt ofthe original complaint. The GMC has apologizedfor the mistakes made and for the delays.

In February 2004, fl’~e PPC again decided not torefer the allegations to the PCC, and the complain-ants were notified of this decision on 12 Marct~2004. The complainants sought judicial review ofthe PPC’s decision. Following Mr Justice Pitch-ford’s refusal of that claim, in December 2004, thecomplah~ants were granted permission to appeal.The appeal was heard in June 2005.

In December 2005, the Court of Appeal, by atwo to one majority, quashed the PPC’s decision!and remitted the case for consideration by a differ-ently constituted PPC. One of the grom~ds was thatthe PPC had exceeded its proper function in plac-ing substantial reliance on the BM] article by tIey

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The Stoke CNEP Saga - a view from the General Medical Council

and Chatmer,~ which had criticized the GriffithsRepcn~t. l ,c~rd Justice Jonathan Parker ,aid:

"it is one tfm~q to evaluate the available evidential,~aleriaI in orde; to determine whether in its opin-ion’] 9~tCh ~Ha[L~rial avoears 1o raise g ~tesliotz

whelh~r the practitioner has coramitted seriouspn~t~h~iona! Yalsco!’zal~JF bat as it seems to ~le]qui~e a~othar to purport to resolw’ disputed factualissues, I consider that ... the PPC went hzrNer &an~oas necessa~ .fiJr the purpose cf deciding whetherthe inateriai beJ~re it raised the Rule "l I(21 questzontn so deing, it tresptcssed or7 an area whiH, l zonspeeperIy the ~rovmce of the PCC, should the case berefi~rred to it "

As a result of the iudiciaI review and the appeal,almost two further years had passed since thescreener’s decision in January 2004 re ref~,r theatlegahons to the PPC.

It took further time to comply with the Court ofAppeal’s directions. A differently constituted PPCdecided in November 2006 to refer the allegationsfor inquiry oy the PCC. Given the reasons forthe Court of Appeat’s quashing of the earlier PPCdecision, tt’ds is not. perhaps, surprising.

The PCC u7 .]utry was held between May andJuly 2008. llaving heard the evidence of the cornplainants and their witnesses, the panel acceptedthe argument advanced by Counsel for the doctorsthat ~’tsufficient evidence had been adduced ~osupport a finding of serious professional miscon-duct. The doctors were consequently found notguilty- ot serious protessional misconduct

It has been argued that the eventual outcome, mJuly 2008, demonstrates that the PPC was wrong,in November 2006. to reter the allegations for in-quiry by the PCC. That is based on a misunder-standing. Unfortunate though it was tor thedt~ctors concerr~ed the limited ftmction of the PPC.under the pre 2004 Rules which continued toapply; did not entitle it to trespa~a on the rote of thePCC. The implication of the Court of Appeal’sdecision is not that the GMC should have closedthe case earlier but rather the reverae.

It has also been argued thai tP~e CNEP casedemonstrates the GMC’s inability, when there isalleged research misconduct to fulfil the requiredinvestigative function in a transparently lair aixlindependent wa~ Again, that is based on a misun-derstanding. The GMC certainly made mistakes.However, [hose mistakes were tardiness and a fail-

ure to heed the ]imited discretion available toscreeners and the PPC under the statutory Rules.They were not the restflt of ineffecth,’e investiration. There may be an argument for a UK organi-zation equipped to investigate any allegation ofresearch misconduct but it is not made by theGMC’s handling of the CNEP case,

Nevertheless. doctors and others are entitled toask whether the GMC would or could make thesarne mistakes again, lhe confident m’kswer is no.

The reformed fitness4o-practise procedures.introduced in 2\ovember 2004 after extensive con-sultation, have two stages the Investigation Stageand the Adjudicatioa Stage.

W~thin the Investigation Stage, allegations areconsidered by medical and ]aZ. case examiners whohave been recruited by {}pen competition andtrained for the role. [n deciding whether re referallegations to the Adjudication Stage, they appty a’realistic proapect’ test. The question is whether, ifestablished, the facts would demonstrate that thedoctor’s fitness to practise is impaired to a degreejustifying action on registration, It reflects not aprobability but rather a genuine .not remote orfanciful) possibility, It is m no-one’s interest forcases to be referred for mqmry when they arebound to fail. On the other hand, cases that raisea genuine lSSU~ of fitness to practise are for anadjudication pane1 to decide.

There is detailed guidance for case examiners.including the criteria flcey must appl)~ and thisbmidance is published on the GMC’s website.2Case examiners have access re all the materialavailable ar the poi~-~t of decision and the fui1decision ~s disclosed to ~1] parties, including thereasons for the decision.

Within the Adjudication Stage, inqmries areconducted by fitness-to-practise panels whosemembers are reci"uited by open competition andtrained for the role. Panels decide whether theallegations have been proved, whether the doc-tor’s illness to practise is impaired, and whenfitness to practise is impaired, the sanction tobe imposed o1~ Lhe doctor’s registration. Panelstake into account the GMC’s Indicative SanctionsGuidance, which is published on the GMC’swebsite.~

Much has changed si~’lce the CNEP allegationswere lodged with theGMC in 1997, and the causesof the GMC’s mistakes have been addressed in allthree areas identLfied for the Shipman Inquiry -

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operational effectiveness, consistency and qualityof decision-making, and arct~dtecture. A decadeago, fl~e PCC t3npically considered 40-00 new caseseach year. Fitness-~o-practlse panels now consider200-300 new cases each year. Despite this hugeexpansion, or perhaps in response to it. tile GMC’soperational performance and the col’tsistency andquality of decision-making stand comparison withany regulator.

The GMC’s mistakes in relation to the CNEPallegations were not related to the quality of theinvestigation. Nevertheless, an obvious question iswhether it would help, when there is allegedresearch misconduct, if tirere was a body, separatefrom the GMC. with the expertise needed to mounta tirn~’ly and eifective investigatitm of the facts?

On the lace of it. ti~e existence of such a bodymay do no harm and it may cto some good, How-over. Ii~e claimed advantages, or some of them,ct,uld prove illusory.

A fitness-to-practise panel has three tasks: de-t~ermine the facts; determine whether fitness topractise is mlpaired: and. if fitness to practise isimpaired determine the sanction on registration.Determining the facts is what takes the time - andrightly so, given what i~ at stake. Panels often haveto chemise between two or ml)re conflictingaccourtts, sometbrtes based on hazy recollectionand imperfect records.

In very specific circumstances, the GMC is i’~otrequired to put allegations to strict proof - broadlyspeaking, criminal convictinns and deternrinatiunsbv other regulators, which, if prc)perly certified,are accep~d as fact.

In tl~eory, it would be possible to add a thirdcategory that could be accepted without strictproof- facts fuund by a (new) competent authoritycharged with iovestigathtg allegations of researchmisconduct. However, even if that was acceptablein principle, it could simply shift the problem. The{l’~ewl competent authority’s processes and proce-dures would need to provide a]l the safeguards,and rights of representation, that are present incriminal and regulatory proceedings. A profession-al’s right to pursue their profvssJon is a civil rightea~td any process that threatens this civil fi get has tocomply with the European Convention on HumanRighrs

No doubt i~ could be argued that, even if the(new) compe~en~ authority’s fh’tdings of fact couldbe challenged in front of a fitness-~o-practise panel,they would, nevertheless, assist the case examln-el’s, within the Investigation Stage, to decidewhether there was a realistic pn~spect of findingfitness to practise impaired. Thus, fewer doctorswould be required to appear unnecessarily beforea £it~ess-to-practise panel.

This is an argument for effective i:westigationbefore the case examiners’ decision: it is not aJ~argument for a new bed}< The shift to effectiveinvestigation was reflected in the reformed proce-dures introduced in November 2004. Most casesconsidered by the case examiners are not referredfor adjudication. The majori~ are concluded with-out further action, or with a formal warning ~lrat isplaced on the doctor’s registratinn record, orthrough consensual disposal when the doctor iswilling to give and comply with undertakings aspart of a programme of retraining or remediatinn.

Rebmlation is dynamic emd must continue todevelop in order to command the confidence andsupport of key interests. An effective regulatormust learn from experience and be willing to try toforesee, and to meet, the legitimate expectatiolrs ofthose whose interests it is there to protect. Theprocedures in place today ate substantially moreeffective, and fairez; than thuse they replaced.There is, however, no room for complacency andthe GMC coutinoes to encourage and to welcon’~econstructive debate about what more might bedone. That is why the GMC is consulfing this yearon further changes to the fitness-to-practise proce-dures, to ensure that they remain fit for purp,se.4"~

ReferencesDeborah Hensha]t v Thc~ General Medical Council, C1/2004/2706, Court of Appeal (Civi! Diviuk~::) [20Q51 E~qCA Civ2520

2 GeneralMedicaICounciLMaki~lgdeci~ionsatiJwe~zdof&ei~vesHg, atfcn stng~’: Guidance ~i" C~se Ex~n~iners a~d thehive~ll~l~tJott C~mmittee London: GMC; 2004

3 Gerlera] Medical Cou]~ci] The hldhcatlw, S,~tcti~ Gzllt*a~tl{?~&r the Pi#ness to Prael@e Panel I.ond~n: GM(I; 21K)9

4 General Medical Co,moil. Proposals !o eate*,.d Ihe use ofcur, sens{~ai dispo~!L Londo~*: GMC; 2009

5 G~’neral Medical Council Monagemen~ qffitne>s to practise],nr~el helz~hlg~ l ondon: CTMC; ~0119

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The Stoke CNEP Saga- did itneed to take so long?

Frank WellsEuropean Forum for Good Clinica{ Proctic-eE-maik Frankwel[s36f~aoLcom

DECL~RAT[QNS

Competing interests

Noae declared

Funding

None

Ethical approval

Not app[icsl~le

Guarantor

FW

Contributo=shlp

FW is the sc, le

c0atr butor

Acknowledgements

Nolle

E1 1999, the Royal College of Physicians ofEdinburgh, the Royal College of Physiciansand Surgeons of Glasgo~s5 the Royal Collegeof Physidans of London, and the Faculty ofPharmaceutical MedicLne convened a consensusconference on MiKonduct in Biomedical Re-search. The conference concluded that a nationalpanel should be established - with public rep-resentation - to provide advice and assistance(on issues of research misconduct) on requestJIt was suggested that the panel might developand promote models of good practice for localimplementation; provide assistance with the in-vestigation of alleged research lnisconduct; andcollect, collate artd publish information on inci-dents of research misconduct. It was hoped thatthe report of the Conference would be given thefullest possible dissemh~atk)n by the sponsoringbodies, and that they would convene at the earli-est opportunity a meeting with the GeneralMedical Council and appropriate partners toestablish and consider the remit of the nationalpanel.2

A national proposal, 2001

For m, era year, nothing seemed to happen. As aresult, a striking editorial in the BMJ stated that’the largely submerged problem of research rots-conduct is surfacing like a decomposing corpse’.:*Behind the scenes, however, there was someappropriate activity: h~ 2001, a proposed blueprintfor the prevention and investigation of misconductin biornedlcal research was published, under thetitle A Nation~l Panel for Resea~vh Tntegrily.~ Theauthors of this blueprint represented tire RoyalCollege of Physicians of Edinburgh, the RoyalCollege of Physicians and Surgeons of Glasgow,m~d the Faculty of Pharmaceutical Medicine,

with subdued support from the Reval College ofPhysicians of London. We concluded (for [ wasone of the authors’~ that the outcome of the 1999Edinburgh conference had been a landmark ivhighlighth~g an agreed need - though with hLnd-sight the word ’agreed’ was far too optimisticnamely, that all stakeholders un biomeL~calresearch should co]laborate i~q establishing snational booty to promote education standard-setting and audit of biomedical research wi thin theUK. We had discussed with many other parties thepractical developments needed, and, by publish-mg our ’blueprint’, we thought we had do~eenough 1o help establish a National Panel onResearch Integrity during 2002. In retrospect, wewere mweal~stkally optLmistic.

One of the pivotal recommendations within the’blueprint’ was the need to establish an agreedm~d recognized ’rapid response process’ throughwhich institutlons could call on independentteams with members drawn from national lists oftrained external assessors, to Lnvestigate confiden-tially allegations of research misconduct. Onesuch team already existed - MedicoLegeJ Investi-gations Ltd (MLIL I had helped to set it up in 1996with a colleague, Peter Ja~; who had previouslybeen m the Metropolitan Police and had latterlybeen a forensic investigator of alleged cases ofresearch misconduct referred to the solicitorsemployed by the General Medical Com~dl GMCLHe and I had worked in sequer~ce for several yearsbetore we established MLL In my capacity asmedical director of the Associab2on of the BritishPharmaceutical Industry ~ABPI), 1 had receivedsuspect cases from pharmaceutical companymedical directors who were concerned that datahad been ~abricated or falsified and above all, thatpatients had been exploited. I had worked up thecases as far as 1 cou]d from within the ABPI

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enough to warrant referral to the GMC; Peter thencompleted the forensic investigation. On my rehrement from the ABPI, it made sec~se for us towork together. We were always aware that thegate was wide open for other investigatory teamsto enter this field, and we would have welcomedthat.

It was emphasized in the ’blueprint’ that theexternal investigations should be conducted ac-cording to due process,"~ nsing standard operatin~procedures {SOPs), as agreed by the NationalPanel. Additionally, it was emphasized that theprinciples of such confidential external investiga-tions should include a rapid response to requests;investigation by a team of trained, impartial ex-perts; protection of patients and volunteers inresearch studies: protection of whistleblowers;6

and protection of cli~cal and scientific researcherstrorn unjustified allegations of research miscon-dull.s Cases seldom took more than abou! sixmontt~s to complete. MLi remains the only inde-pendent operator in tl’ds field, has appropriateSOPs. and subscribes to all the requirements justmentioned.

So what has happened since 2001? Did all thestakeholders get together in order to establish aNational Panel in 2002? No. Things have movedon, though nor to establish what the authors ofthe ’blueprint" recommended, l’he UK Researchh~tegrity Office (UKI~dO) was launched in 2006,hosted by Universities UK. It purports to offer~upport, bofl~ ro research organizatiol"~s and toindividual researchers, and to promote integrity inresearch and good practice in addi’essing rmscon-duct in research.7 Although its advice and guid-ance is available to all, by the end of 2008 it had aprofile so low that seemingly very tow workers inthe field knew of its existence.~ [’he Lancet wasdismissive. It called the UKRIO an ’ineffectiveenterpnse’ which ’is at b~st boulld arLd gagged byits ties - at worst a smokescreen set up byuniversities themselves’.’~ It was critical of the factthat its procedure for the investigation of miscon-duct in research, published in 2008,"~ failed to en-courage organizations faced with cases of allegedresearch misconduct t, be they ur~iversities, researchcouncils, pharmaceutical companies or otherbodies) to involve an independent, trained, rapidresponse team ro advise at an early stage ol1 bo~.a¢-fire investigation should be handled. This omission~s a fundamental flaw.

My own more recent experience

The way in which the CNEP case was handled (seeprevious articles in this sm’ies) demonstrates veryclearty what went wrong, and what will continueto go wrong if current UKRIO advice ix followed.The overwhehning evidence is that the GM(2, theRoyal Colleges, the universities and NHS Trustsale unable tx~ fulfil fl~is investigative function andto do this in a transparently fair and independentway. My experier~ce, before and after file inceptionof MLI, confirms that this function requires anexperienced, but above all, independent, ap-proach. It also requires great sensitivity, particu-larly when a case, on investigation, proves not tohave been dishonest, which happens not infre-quentl)~ Then, indeed as always, arty whistle-blower also has to be handled and advisedappropriately, so that no criticism follows whenthe whistleblower has acted in good faith.

The first case m which I was involved was thatof a consultant psychiatrist in Durham. He wassuspected by the sponsoring pharmaceuticalcompany to have fabricated biochemistry andhaematology results for patients recruited intoa pivotal study for a new tricyclie antidepres-sant.~x.x2 The company did not wish to be involvedin investigating the case itself and sou~lt theadvice of the ABPL Although not fully indepen-dent, as medical director of ABPI I was sufficientlyremote from the company itself to set up lines ofinvestigation that were not readily open to thecompau-ty, mrd thus to establish the facts of whathad happened. Tlre psychiatrist claimed that hehad delegated the management of the t~’ial to hisregistrar (whose name he had forgotten) and thatit was her responsibility to ensure that the datawere correct. His claim was incorrect: it had beenaccepted since 1986 that it was the principal inves-tigator’s responsibility to ensure the veracity ofdata submitted to a sponsoring company. After theregional caedical officer of the Northern RegionalHealLh Authority had provided the maligned reg-istrar’s name and new place of work, I invited herto comment on the accusations of her former con-sultant. She responded, indignantly, that she hadhad nothing whatsoever to do with his researchprojeets. The compm~y was pleased that the ABPIhad been involved, as they did not feel confidentenough to refer the case to the GMC by themselves,so the ABPI prese~lted the case to the GMC on

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The Stoke CNEP Saga -did it need to take so long?

behalf of the coinpany, by means of a statutorydeclaration. The case wa~- eventually consideredby the GMC’s Professional Conduct Committee;the doctor was found guilty of serious professinnaln’dsconduct; m’~d his name was erased from themedical register.

Several cases followed, Some were referred tothe ABPI only afler a series of compaa~y proce-dures, others were referred just as soon as suspi-cion of an irregularly, had been aroused, By thetime I retired from the ABPI in t996, I had handled12 confirmed cases of research ndsconduct, allof which were referred to the GMC by meal~ ofstatutory declarations. Subsequently, many morecases wore referred direct to MLI, because we hadinspired confidc,nc, within the pharmaceutical imdustry and between us had a track record of cost-effective, rapid and expert forensic thvestigation,and at least another 17 ended up being referred tothe GMC. Many other referrals turned out to beexamples of sloppiness or misunderstanding, notof fraud or misconduct. The companies concernedsoon learnt not to use these doctors again. Referralto the GMC only occurred where data seemed tohave been generated with an intent to deceive< Allof the cases were handled in the strictest confi-dence: those doctors m’tder suspicion, but whowere not guilty of any misconduct, never knewthey were being investigated and were found inno-cent; all the more serious cases, where the suspl-don was justified, only eventually found out thatthey had been found out when a 1citer arrived fromthe GMC setth~g out the case against them. All ofthe cases dealt with in that way were referred to theProfessional Conduct Committee or its successor.the Fitness to Practise Committee. All but one werefound gui]ty of serious professional misconduc~and dealt with appropriately. The procedure weused worked well, and, indeed, still does, thoughfew cases have been referred recently.

Two cases involving two different universitiesare worth describing in detail in the context of thisseries of articles. The first is that of a consultmltphysician at the Western General Hospital inEdinburgh, a disdnguistned doctor who had pre=viously served as an office holder in one of the

1314medical royal colleges. "’ A clinical trial monitorworking for one of the major pharmaceuticalcompanies had noticed that several patiunt signa-tures on the study consent forms differed fromtheir signatures in the hospital notes. The company

drew tl~e attention of the ABPI and the hospitalauthorities to its cox~cerns, Neither the hospitalnor the medical heulty of the uldversity took artyaction, possiblybecause the hospital was in a stateof conbiderable geographical flux at the time, Bycontrast, the ABPI called on MLI to h’tvestigate an da number of witnesses were interviewed It tran-spired that several of the recruited patients werenot aware that they had been put into a clinkaltrial; their consent had not been sought let aluueobtained. Several other irregularities were re-vealed and the case was referred to the GMC,which foui&d the doctor guilty of serious pro-fessional misconduct. It is i’~ot clear what the con-clusion of rids case might have 9een if thethdependeni forensic team fMLt) had not beenavailable. At best. it w’ould have taken consider-ably longer to reach the same outcome.

The second case coircerned a professor of psy-ch~logy at a university in the United Kingdom. Hehad devised a frequei’ttly cited model for nrakingrats either depressed or stressed.~’~ The model wasbased on the drinking of a glucose solution by therats: if they were stressed, they drank les~. Heasked a PhD ~tud~lt Lo be an investigator in anearly trim of a new anxMlytic produced by aFrench pharmaceutical company, using the modelfu see if the stressed rats became less stressed afteringesting tile anxiolytic. She duly began the trial.dividing the rats into subjects ant] controls, usingthe model devised by the professor, but could notmake the model work as the so-called stressed ratsdrank exactly the same amount of glucose solutionas the control rats. The professor asked the studeutto repeat the study, telling her that the rats camefrom different breeding sources, and to switch thestressed and cmrtrM groups rouncl. There werestill no differences. Undaunted. the professor hr-structed tho student to proceed with any of the ratsthat had been subjected to stress, and to give themthe rtew ai~xiolytic. They drank as much gmcose asthe control animals but, as the student had pointedout, they were never demonstrably stressed in thefirst place. Despite this, the professor submitted areport to the sponsoring company on the ~uccessof the new anxiolyt~c in eliminating stress m therats.

The student expressed her concerns to her tutorwho shared them, and they duly challenged theprofessor, wno took no notice. ’lhey then went tothe relevant senio~c oliicer within the tuliversity~

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Journal of the Royal Soc}ety of Medicine

who effocfively told them to go away as the profes-sor had an international repu~anon and who werethey to challenge him! The student and her tutorthen turned to MLL At the same time the studentdecided to take her PhD studies to a different uni-versity, over 200 miles away.l* I was closely in-volved m this case and suggested that the validityof the rat model be tested bv the student f~r thebenefit of her new professor, who confirmed thatit did not work. I also visited the sponsoring phar-maceutical company m France, whero there wasincredulity that an eminent psychologist, whosemodel for stressing rats was widely cited, might bemisleading them. Yhe evidence from the seconduniversity nevertheless conN’med the likelihoodthat the results from the first university" wereflawed because the rats had never been effectivelystressed before being given the anxiolyt~c. Thecompany disregarded the results of the researchfrom the first university and took their subsequentstudies elsewhere.

The inconsistencies and anomalies revealed inthis case could not be accounted for by chance, nordid there appear to be other innocent explanations.l’here appeared to be prhna facie evidence of falsi-fication of data with the intent to deceivc, and thusserious professional misconduct. At that th’ne therewas no regulatory body (comparable to tire GMCfor doctorM for psychologists, so MLI submittedthe case ~o the vice-chancellor of the universit):The outcome of this case was far from satksfactor~;but the professor eventually, retired, tlad therebeen a proper mechanism in place within the uni-versity ±or the consideration of such cases, much ofthe t~me and effort spent internally on trykng tocome to terms with an irregularity would havebeen saved and mud~ useless research would havebeen avoided. The forensic team had neverthelessproduced robust evidence, quite fast. that a reportto a sponsoring pharmaceutical company had beenfalse.

So, where do we go from here?

So I come to the CNEP case, m which MLI wasthroned transitoriI); at an early stage. We wereapproached early in 1997 by one of the famiIiesalleging forgery of consent forms. We spent a daywith the person who had contacted us and empha-sized that these allegations were very serious andneeded to be coi~tirmed or refuted. We said that

MLI could undertake the investigations needed,but that we were not able to do so philmrthropi-cally. As the family who had contacted us was notLv~ a position to fund this exercise, and the regulat-ory authority investigating the allegation neverasked for help, MZFs involvement ceased at thatpoint.

Looking dispa~ionately at these three cases,what could have been done differently and how"might outcomes have been altered if these differ-ences had been made? The early successes of MLIwere because we were recognized as a small dedi-cated team of experts in the handling of suspectedor aEeged research misconduct, in whom pharma-ceutical companies could have confidence. Wewere always funded by the sponsor who hadcalled us in; we were scrupulously confidential inot~r dealings with clients, witnesses and patients;and we were fast. 1he cases we submitted to theGMC were, beyond all peradventure, [ikeiy to leadto a finding of serious professional misconduct. Asa result, we were told we had inspfred confidencein the veracity and Lr~tegrity of our submissionsamortg membe~ of the Pndessional ConductCommittees, who heard the cases we brought for-ward. Subsequerttly, however, the climate changedand the GMC increasingly h’~sisted on its ownsoEciters being more involved in tlie work up ofcases, which added considerably to the delaythat already occurred between submission andhearing.

The conlidence that pharmaceutical compaalieshad in ore" ability to do a complete and effectivehwestigation on their behalf, including many caseswbere we concluded that there was no case toal"Lswel; was never reflected by other outsidebodies, including the universities, although oneNHS Family Practitioner Comlrdttee did use ourservices to investigate a series of false claims madeby one of its GPs. Tile National Health Service,unlike the University Grants Committee, does atleast have a Counter Fraud Service, but Lhis feelyadmits that it does not deal with research fraud,only financial fraud. Many will, of course, find thedistinction hard to grasp. Indeed in America it wasprecisely because federal money was underpin-nLng at least some aspect of almost all researchactivity that central Government felt able to tell theOffice of Research Intebqvity that they ought to in-vestigate what was going on if no adequate inves-tigation had been organized locall?~ The attitude in

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The Stoke CNEP Saga - did it need to take so long?

the UK has always been teat universities, N-HSTrusts and the medical research charities all havetheir own internal procedures, which cart be in-voked in time of need. Paradoxica]ly~ because thatneed is, fortunately, rare, the procedures becomerus~r and there is no recently used expertise avail-able to activate such procedures with any degree ofconfidence.

So is tl~s where UKRIO should come in? Cer-tainly it appears that recently it is raising its profileand is able to offer good advice on what to do if it issuspected that sometl’dng in the research contextIlas gone wrong7"m But UKRIO has no intentloo ofinvestigating any cases itself., having encouragedthe various stakehoIders involved in research tohave standard operating procedures in place onhow to conduct such an investigation. Othercountries in Europe have also adopted the sameapproach at present. However, in the UK at least,the evidence suggests that this is not working as itshould. I reiterate tltat one of the pivotal recom-mendations of the original ’blueprint’ was theneed h)r a recognized rapid response to any allega-tion, with confidential external investigation usingteams from xtational lists of trained expert asses-sors who could be called in by institutions asrequired.4 As already stated, only MLI currentlyfulfils this criterion of trained expert assessors, butit was never intended to be exclusive. However,it does exist, as a unR to be invoked wheneverrequired. If UKRIO were to invoke such experts or,more usefully, to recommend that institutionsshould call in the experts themselves at the earliestopportuult}; then the future for the management

of research misconduct may become less bleakthan it currently appears.

References

1 Nimmo ¥\ ]o~tt Conserksus Co_rtlerellce on M;sconduct i~tBzomodical Research, t’roc R Colt Phu>’cz¢ms Editd~ 2000:30(Suppl. 7).2

2 Christie B PaaeI n;’eded to combat re~eawh fraud. BM[~ eaa,319:1222Farthing M Horton R~ Smith iL Research misconductBritain’s ~ailure to ~ct. BMI2003 321:I485 6

4 btonierP LoweG, Mch’mc~G, Murie| PetrieJ, WdlsF. ANa~{ona" Panel f~,r re~eard~ ineegnry. Pl’cle R CoilPhy~iclmzy Edf~b N)O" ".31:7~53-5

5 ltey E Cha_mers L lnt estigation alle~adons of researchmisconduct: th~ vital need for due prucess 8Mr2000:321:752 6Yamoy G. Probectlng whisLoblowers. BM 2000:320:70-1

7 See http i/www,ukrio,c rgj si’:es/ukrio2/uk r~.searct~_integrity office ukno index.elmW~.lls F. Hislorical a spec~a of re~earch mis~’t:duct: LuropeIn" W{,’ls F Farthing M. eds, fraudandMisconauc~ illBtoltledica! Researcl;, 4e!~ edn London: Royal Society otMedicine Pres~: 2C1)8, pp. 72~$6

n Editorial "[he UK Pand ot re~e~a’ch tntegr ly: a mi~edu~purtunity. !~Irlr,,t 20D8;372 1438

11" Seeht~jrL, wwwHkrinorg/gites/ukrio2/tho_programme_o;_work/proeedure.ctm

iI ;*mort. GMC t~rotessmnai co.n.dttc~ comrru|tce. BMI.988;296:30~

12 ’V%~IIs F. The Britiqh pt:arn~a:eu~icalindusvry’~ res~ rose.In: Ia3ck 5 WeAs I" eds. t mt~u ahd .MlscJi~dact in M.aikalResearch. 2~d edn. London BM- Books; 1996

13 Mi|d~dl P. EdL~btt~gh doctnr .trllck off because ot clinic&h’ial fraud. Lancer !997:3N]:272

! 4 Walls F. Counteracting research miscoll0.uct, in: Lock S.Wells F. Far/hing M eds. Fr~,u:l arm Mis,-atlduc~ mBi:,~aMkd R.s~:,rdz 3rd ~dn London: BMI Books 2C){I"pp. 64-86

- 5 Willner P Mitchell P. Animal models at deoresston" Ad~ath~,sis-sDess approach. In: D’Haezmn H. Den Btmr H.W~llncr P :ds. gi~!ogical Pst~c~hl!,y Voh~.4a, 2 Chichester:Wiley; 2002 pp 703-2~

J R So~" Med 2010: 1-5. DOI 1& 1258/jr~m.2010.10k010 5

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Edmund Hey- a personal appreciationlain ChalmersEditor, James Lind Library

39

Edmund Hey was my friend and colleague for over thirtyyears, and a fellow campaigner for human rights duringthe decade before he died. With others, we worked togetherto expose untruths propagated about paediatricians andpaediatric nurses in Stoke on Trent, and to draw attention tothe resulting injustices they suffered. The articles collectedhere provide a record of a cynically manufactured ’non-scandal’, and the damage it has caused. The series beginsand ends by emphasising that allegations of researchmisconduct should be judged only after the facts have beenascertained by suitably qualified forensic investigators.

This compilation of articles is dedicated to the memory ofEdmund Hey, not just because his attention to detail madsheer hard work was the main driving force in bringingthe series to completion, but also because, as one of his lastprojects, it reflects the moral and scientific principles thathave characterised his whole career.

I came to know Ed in the autumn of 1978, soon after I hadbecome director of the National Perinatal EpidemiologyUnit (NPEU). Ed’s first visit to the Unit resulted infriendship and longstanding collaborations with himand his colleagues in the Northern Region in a variety ofepidemiological studies of perinatal mortality and morbidly.Under Ed’s leadership the quality of this epidemiologicalresearch became second to none in the world, as did theRegion’s contributions to collaborative clinical trials.

During the 1980s, Ed was a member of the NPEU’s advisorycommittee. He tended not to make many verbal contributionsduring meetings. Instead, promptly after meetings, he sentup to four pages of thoughtful, single spaced assessmentsof the matters - scientific and ’political’ - to which he feltwe needed to pay attention. When I left the NPEU in 1992,I wrote to him to say that his loyalty to the Unit had beensecond to none, and that I did not know how to thankhim adequately for everything he had done to help us.

After leaving the perinatal field in tt¢e early 1990s, mycontacts with Ed were sporadic; but other things wereanyway happening in his life. After contacting himin May 1995 to find out what he was up to he wrote:

’When I eventually decided to take early retirement frommy university post late last year I made a binding promiseto Sue and the family that I would not take on ~ newwork for at least a yea~, and thai I would a]so clear my deskOf all the backlog of old work before taking on anything new.A complete break with my workacoholie past was part o fanimportant family pact, and one that I am not going to raton at this stage after discovering, for the first time since tqualified, what it fs to havea bit of what is [rather unctuouslylcalled ’quality time’, both for myself and for the family.’

Over the subsequent couple of years Ed occasionally copiedme messages sent to others. In response to one of these sentin August 1999, I replied "it’s so good to know that you’realive and kicking. I miss you."

A few days later he wrote:

"I took early retirement three years ago in order to makeup for my workaholic past and have some time with mywij’e but, sadly, she developed multiple sclerosis not longafter that and it has run rampant in the recent past. Shecould walk three miles a year ago, but cannot move a singlemuscle now and nee& round the clock home nursingcare. It only makes me more relieved &at I did decide toget out qf paid employment when I did, so I could havesome quality time with her and the children. You maythink that your own hints to &at end went unheededbut they did not. There will be enough time to bu~iVmy head in medical matters afresh once this is all oven"

Sue died two months later, at home, in Ed’s arms.

Unsurprisingly after this bereavement, in addition tocontinuing to spend time with his children mad grandchildren,Ed began to crank up his work schedule again - compiling hisNeonatal Formulary, chairing a Wellcome Witness Seminar ontire story o fprenatal corticosteroids, and contribu ring to vario usresearch advisory committees, becoming particularly deeplyinvolved in plans for BOOST-2 UK, one of several ongoingtrials to address longstanding unanswered questions aboutwhat level of oxygen to aim for in prematurely born infants.In addition, Ed continued to respond to people who lookedto him for wise counsel, and particularly to provide advicemad moral support to paediatricians and other professionalswhom he believed had been unjustly accused of wrongdoing.

It was unjust accusations of health professionals which ledus, a decade ago, to resume the collaboration we had enjoyeddaring the 1980s. Our article in the series co!lected hereprovides some idea of the featttres of our collaboration overthe past decade. The work has not been straightforward,and, like the clinicians in Stoke-on-Trent and many otherswho are deemed to have encouraged belief that parentssometimes abuse their children, Ed and I have both beenreported to the General Medical Council. Indeed, becausehe was ’under investigation’ by the GMC, payment couldnot be made to him for one of his research advisory roles.However, 1 think he would have regarded this injusticeto have been compensated by eventual publication ofthe series of articles on which he had worked so hard.

Two days before Ed died, I called him to discuss aspects of thedraft articles about which the journal’s lawyer was still notsatisfied. He seemed fine. I suppose it must have been laterthat day or the next day that he may have fried to ignore adeveloping headache while workingto finalise the forthcomingedition of his Neonatal Formulary, only to be struck down bymeningitis - a potentially treatable condition. Itwas a tragedy.

As I wrote to Ed in a book I gave to him not long ago, "You havebeen and are an inspiration- one of the most hard-working andgenerous-spirited people onthe plmaet.Thanks for everything."

Oxford, April 2010

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