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=C2=AB=20 INJECTING ROOM FAILS | Mai= n |=20 The=20 Alphamusic of John Levine =C2=BB

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October 07, 2009

DODGY DOSSIERS OF ADDICTION NON-TREATMENT

=20 In the week of the Labour Party=20 Conference, Jack Straw publicly called for heroin on the NHS =E2=80=93 = based on=20 publicity for a project called Riott which had not been independently = evaluated=20 nor peer reviewed (click for critique).

The Goliath of Labour=E2=80=99s = National=20 Treatment Agency for Substance Misuse, to guard its large well-fed body, = also=20 funded a=20 =E2=80=93 Effectiveness of community = treatments for=20 heroin and crack cocaine addiction in England: a prospective, = in-treatment=20 cohort study =E2=80=93 proclaiming its own = effectiveness,=20 deflecting attention from the fact that it has failed to set up a = treatment=20 system in this country offering drug-free lives.=20 Professor John Strang was named = as lead=20 researcher on the first document, his long-time prot=C3=A9g=C3=A9 John = Marsden on the=20 second. Both have rich links with the=20 NTA.

Labour=E2=80=99s =E2=80=98dodgy = dossier=E2=80=99 led this country=20 into war and an unacceptable loss of lives =E2=80=93 but the loss of = lives which could=20 be incurred due to questionable addiction-treatment =E2=80=98research = papers=E2=80=99 could be=20 many multiples of the lives lost in the Iraq and Afghanistan wars=20 combined.

INFLUENCING THE = MEDIA

=20 Neither flaws in the = contents of=20 Effectiveness of community=20 treatments... nor the intertwined interests were spotted by the = medical=20 journal Lancet, which = published the=20 NTA document in what appears to be a leap of faith. Due to the Lancet =E2=80=98s prior = reputation, national=20 and international media picked up the story in good faith. Yet = seven of=20 the report authors are employed by the NTA, the other two receive = benefit=20 financially from it.

=E2=80=9CScientists: drug = treatment does work.=20 Therapy or counselling help heroin and crack addicts to quit their = habit,=E2=80=9D wrote=20 Jeremy Laurance in the Independent. Even the BBC took the bait: = =E2=80=9CDrug=20 therapy record encouraging,=E2=80=9D it states its website. So, = too, did Sky: =E2=80=9CA=20 recent study has shown that there is indeed a way out for users of crack = cocaine=20 and heroin=E2=80=9D. Medical = News Today and=20 academic health-publication websites around the world carry a similar=20 message.

Well... we have seen a = =E2=80=9Cway out=E2=80=9D of drugs=20 for those getting rehab and day services based on similar psychosocial = and=20 mutual-aid principles. Sadly, under the NTA=E2=80=99s regime only about = 2% of patients=20 manage to get into rehab and the ilk, with a similar percentage becoming = drug=20 free. So why, instead of improving the numbers of patients onto this = drug-free=20 path, would the NTA publicise a more expensive, unproven route of=20 non-treatment?

=E2=80=9CTwo-thirds of heroin = and crack cocaine=20 addicts on drug treatment programmes either abstain or substantially = reduce=20 their use of street drugs during the first six months, according to the = biggest=20 study of outcomes ever attempted,=E2=80=9D lauded Sarah Boseley in the = Guardian.

It builds on our hopes = =E2=80=93 if only that was=20 true! We would embrace = the news=20 with joy. But, as with Labour=E2=80=99s other media-grabbing dossier, = all is not what it=20 seems: we must look at both the content and the interests behind the=20 report.

FIRST NOTE OF = CAUTION

In a paper accompanying Effectiveness of community=20 treatments... Dr Thomas McLellan, deputy of the White House Office = of=20 National Drug Control Policy, warned that short-term interventions might = not=20 produce long-lasting, positive effects. "It=20 may be more reasonable to expect enduring improvements through sustained = outpatient clinical management with drugs and behavioural therapies = =E2=80=93 like=20 expectations we have for the management of diabetes and=20 hypertension."

CONFLICTS OF = INTEREST

Seven of the nine authors in = the NTA=20 document =E2=80=93 Effectiveness of community = treatments for=20 heroin and crack cocaine addiction in England: a prospective, = in-treatment=20 cohort study =E2=80=93 are employed by it and the other two = received funding from=20 the NTA, whose employees also designed the study, gathered data and = interpreted=20 it. Study =E2=80=98treatment=E2=80=99 settings depend on the NTA = for funding. The TOP form=20 (Download TOP=20 form) measuring the results, which feeds into the = faulty=20 National Drug Treatment Monitoring System from which results were=20 extracted, was created by the report=E2=80=99s lead author as a = commission for the NTA=20 some years ago; we have not had time to confirm the suggestion that the = NTA paid=20 more for it than the yearly salaries of all Addiction Today=E2=80=99s = staff combined. So=20 the report seems envisaged to make the NTA look good, and divert = attention away=20 from hard questions about non-treatment.

=E2=80=9CThis is scandalous! = The Lancet, which accepted = the piece=20 and thus provided a base for the NTA to hand it to newspapers, should be = asked=20 if this is its standard practice. This is like a tobacco company funding = a piece=20 of research where the authors are in their company,=E2=80=9D = complained one=20 professor to Addiction=20 Today.

The most accessible financial=20 relationships can be viewed in the NTA Accounts (Download NTA annual accounts=20 2008-9): it gave =C2=A3577,000 to Strang=E2=80=99s = Riott, and discloses a=20 =E2=80=9Cmaterial transaction=E2=80=9D of =C2=A3419,696 as = =E2=80=98consultancy=E2=80=99 between the NTA and South=20 London and Maudsley (SLAM) NHS Foundation Trust. =E2=80=9CDisclosures in = accounts are=20 due to the fact such transactions are between bodies that are legally = related,=E2=80=9D=20 explained an accountant. Strang is clinical director of SLAM. Marsden = works at=20 the National Addiction Centre in the Maudsley Hospital, where other = authors also=20 gain work.

=20 Is there also a financial = relationship between the NTA and the Lancet=E2=80=99s unnamed = report reviewers? If the process was transparent, and = their names=20 given, we could answer that question.

=E2=80=9CResearch is at its = best when it is=20 dispassionate from any specific set of industry or sectoral = interests,=E2=80=9D=20 commented Professor Neil McKeganey, professor of Drug Misuse Research at = the=20 University of Glasgow. =E2=80=9CIt is striking in this context = that employees of=20 the study-sponsor [NTA] =E2=80=98contributed to the study design, data = analysis, data=20 collection, data interpretation and writing of the report=E2=80=99. The = NTA is the=20 agency responsible for funding most drug-abuse treatment in England and = for=20 overseeing the effectiveness of drug treatment provision. It is = remarkable that=20 it should have been so deeply involved in all aspects of this = effectiveness=20 assessment.

"If one were to substitute the = NTA=20 initials for the name of a drug company in the statement above, it is=20 questionable if such a paper would have been accepted by such a = prestigious=20 journal as the Lancet. = The fact=20 that seven of the nine authors on this paper are either employed by or = have=20 received funding from the NTA should have sounded a note of = caution.

=E2=80=9CAnd both the initial = assessments of=20 drug-use behaviour and the follow-ups to assess the effectiveness of = drug=20 treatment agencies were collected by drug treatment agency staff = themselves =E2=80=93=20 who will have had a particular interest in the judgment as to the = effectiveness=20 of the services they were working within.=E2=80=9D

Perhaps the peer review should = have been=20 more rigorous? =E2=80=9CPeer review has long been criticised for failing = to identify=20 flaws in research,=E2=80=9D stated Professor Peter Bacchetti in=20 the British = Medical=20 Journal (BMJ 2002;324:1271-1273 ( 25 May ). = =E2=80=9CThe=20 judgment of colleagues plays a critical part in how grants are = distributed,=20 journal articles are selected, and careers are formed. Yet this system = may raise=20 ethical dilemmas,=E2=80=9D states a Columbia University in 21stC on Ethics in Research.

=E2=80=9CControversies = regarding potential=20 conflicts of interest have led some journals to re-examine their rules = for=20 revealing the financial relationships of published researchers,=E2=80=9D = wrote the New Atlantic Journal of Technology = &=20 Society. =E2=80=9CSome notable journals concerned about fraudulent = research have=20 reportedly improved the screening of manuscripts under consideration, in = an=20 attempt to catch those who would misrepresent or = =E2=80=98beautify=E2=80=99 their=20 data.=E2=80=9D

=E2=80=9CCREDIBILITY OF NTA = CALLED INTO QUESTION=20 AFTER DRUG STUDY=E2=80=9D

=20 This was the title of a news-agency release Addiction Today received on 5 = October.=20 =E2=80=9CLast year the success rate of the addiction services was just = 3.6% [getting=20 into rehab, off drugs]. However, this year the NTA published a study in = the Lancet medical journal = [2.10.09]=20 claiming two thirds (66%) of people stopped using these drugs within six = months=20 of treatment initiation. Either the addiction services have dramatically = increased their powers of persuasion or the study is an utter = sham,=E2=80=9D wrote Tony=20 Wilks of London- and Manchester-based New Ways Clinic. =

=E2=80=9CThe=20 information in the Lancet = is flawed=20 on many levels. The truth is, a few addicts might have temporarily = stopped or=20 reduced their use of =E2=80=98street drugs' only, because they = transferred to the=20 more-addictive but legal methadone =E2=80=93 but they were still opiate = dependant.=20 Despite the additional drugs provided by the state at taxpayers=E2=80=99 = expense, the=20 vast majority were still street-drug dependent as well, at the end of = the=20 study,=E2=80=9D the news-agency release continued. =

=E2=80=9CThe=20 only thing this study proves is that NTA treatment programmes do not = work. They=20 treated 14,656 addicts over six months and not a single person is = reported as=20 leaving the programme drug free. It is a waste of tax-payers=E2=80=99=20 money.=E2=80=9D

Critics=20 of the NTA-funded report believe it is desperate to keep its = =C2=A320million funding=20 (the vast bulk for bureaucracy) and its power to = approve budgets of an=20 estimated =C2=A3800million a year. And senior NTA staff were given a 10% = salary bonus=20 if they were shown to meet targets on paper. A radical overhaul=E2=80=9D = or =E2=80=9Ctotal=20 dismantling=E2=80=9D of the NTA has been discussed among professionals = and politicians=20 alike.

QUESTIONS ON=20 FINDINGS...

I can see no mention in the NTA = Accounts=20 (Download NTA annual accounts=20 2008-9), which must be formally submitted to = parliament,=20 of the NTA Goliath of a system getting people off drugs, unlike the = impression=20 given by Effectiveness of = community=20 treatments ... document disseminated by the Lancet. Indeed, although the = NTA=20 claimed to have treated 202,000 people in the previous year, the latest = accounts=20 reduce the number as 163,000 problem drug users =E2=80=9Cin effective = treatment=E2=80=9D. It=20 also states that =E2=80=9C30,000 individuals completed treatment = satisfactorily=E2=80=9D =E2=80=93=20 whatever that means. It is a small percentage of the total, and no = indication is=20 given that they are drug free.

Nowhere in the Lancet document, either, can = I find a=20 reference to anyone becoming drug free =E2=80=93 merely that = participants in the project=20 no longer use their main drug of dependency. It does not state whether = they have=20 become addicted/dependent on other drugs or alcohol =E2=80=93 for = example, 40% of the=20 people on the NTORS methadone maintenance became alcohol dependent. Methadone manufacturers = themselves=20 advise that alcohol should never be taken in conjunction with the drug,=20 particularly in pregnancy, and UK Advocates is on the path to a judicial = review=20 of medical negligence where heavy drinkers are prescribed = methadone.

=E2=80=9CWe should regard the = results set out in=20 Effectiveness of community = treatments...=20 paper with considerable caution,=E2=80=9D confirmed Professor = McKeganey. =E2=80=9CThe paper=20 reports that six-months after starting addiction treatment, 37% of = heroin users=20 and 52% of crack cocaine users were abstinent from those specific drugs = in the=20 28-days before their first review. Recovery from dependent drug use is = about=20 sustained not temporary abstinence. And it is striking that the authors = refer to=20 individuals being abstinent from these drugs =E2=80=9Cin=E2=80=9D the 28 = days before review but=20 we are not told how many days these individuals were free of all drugs = over the=20 28-day period.=E2=80=9D Or, indeed, afterwards.

Lancet document states that=20 =E2=80=9CPsychosocial treatment is given to individuals with addiction = to heroin or=20 crack cocaine, or both, who might also use other substances=E2=80=9D. = There is a basic=20 lack of understanding of dependency here: the US Diagnostic &Statistical = Manual=20 and the World Health Organisation International Classification of=20 Diseases do not differentiate between types of drugs when = diagnosing=20 dependency/addiction.

The paper describes = psychosocial=20 treatment as if this was a standard part of treatment. But it is well = known in=20 the field that most agencies provide little if any psychosocial = treatment; only=20 about 2% of people seeing help manage to get referred to rehab; day = programmes=20 on similar lines are even rarer. Research from Dr David Best in = Addiction=20 Theory & Science shows that psychosocial support in community=20 programmes averages only four hours a year.

There does not seem to be a = control group=20 to compare the study results against. The measurement tool depends on=20 self-report: there is no independent check, such as daily urine or = mouth-swab=20 tests. A one-off swab, when the client knows s/he is to be interviewed = and given=20 that heroin leaves the system quickly, means little =E2=80=93 recovered = addicts report=20 that they have lied about street use in order to maintain their script = or even=20 use it as a bargaining point for more methadone which they then = sell on the=20 black market.

The dossier contrasts markedly = with that=20 from McLellan and colleagues (2008) reporting long-term abstinence rates = among a=20 treated sample of substance-misusing clinicians, in which urine testing = data=20 were presented. =

THE STORY OF DRUG=20 TREATMENT

To find that elusive success = story, the=20 NTA regional office sent a message to user representatives. = =E2=80=9CI am contacting you to ask for = help in=20 identifying individuals who would be willing to talk to the media about = their=20 personal experience of drug treatment services. This would be as = part of=20 the launch of the NTA annual report, on 8 October,=E2=80=9D it = wrote. =E2=80=9CWe=20 are looking for the following... 25-29 year old man... preferably = someone who=20 doesn=E2=80=99t want or knows he is not ready for rehab... [and] a woman = problem drug=20 user who... didn=E2=80=99t want resi rehab.=E2=80=9D Well, no attempt to = skew the story here,=20 then.

The NTA then requests the user=20 representatives to =E2=80=9Clet me have some information on their = [patients'] situation=20 along with their name and contact telephone number=E2=80=9D. This seems = to seriously=20 breach the Data Protection Act.

NTA=E2=80=99s=20 own Service User=20 Survey=20 in 2006 showed that most service users aspire to abstinence, perceiving = it as=20 the goal of treatment, and found that there is no link between = satisfaction and=20 doses of substitute medication. The users appear to have been=20 ignored.

CONCLUSION

This = government=20 organisation is trying to justify its expenditure and how it has = influenced=20 Local Authority and Primary Care Trust budgets, among others. Shouldn't = research=20 be conducted and funded independently? The problem is that, despite all = the=20 =C2=A3=C2=A3=C2=A3millions flushing around, no funding can be found for = others to monitor if=20 the system is working.

We must = all be=20 very careful about data taken from agencies which are potentially under = threat=20 if they are not seen to be getting good outcomes. At the end of the day, these = findings=20 will be used to continue with the same ineffective system of = non-treatment and=20 denying patients, their families and society the promise of improved = lives.

ADDENDUM: NTA=E2=80=99S HISTORY = ON=20 FACTS

In = October 2008=20 Addiction Today posed questions to the NTA = querying=20 its statistics. After more than a year, they remain = unanswered=20 =E2=80=93 but inspiration for much of the NTA correspondence to Addiction Today.

The = lancet dossier=20 can be found here.

Posted at 07:27 = AM in Policies,=20 legislation, Research<= /A>=20 | Permalink=20

Comments

Self evaluation is a risky business - a bad outcome is bad but a good = outcome=20 is viewed with suspicion. So it is with this study, albeit that the = authors all=20 declare their conflict of interest: this is the National Treatment = Agency (NTA)=20 evaluating itself.

Starting the title with the word 'effectiveness' is somewhat = disingenuous.=20 The study shows what happens to a cohort of drug users entering two = treatment=20 modalities according to self report data. It might be proper to avoid a = =E2=80=98no=20 treatment=E2=80=99 control condition but then there needs to be a 'gold = standard'=20 reference treatment and herein lies the problem: process rating the = delivery of=20 =E2=80=98treatment as usual=E2=80=99 has shown that, despite models of = care, there is not the=20 standardisation of treatment modalities that the authors describe in the = introduction. In this study we do not know what treatment was received = although=20 practitioners in the field will have a picture of the variation in what = happens=20 in substitute prescribing and psychosocial interventions.

There is also a problem with the data collection. The NTA has imposed = a=20 burdensome system which was created for political not clinical purposes. = Fair=20 minded people would support some form of national outcome measurement = but this=20 needs to be of universal application, simple, and preferably using = international=20 conventions such as EQ5D and ICD10. To impose something that is not seen = to be=20 useful, indeed is seen to be for another purpose, will not be embraced = by=20 clinicians. Furthermore, these same data are used to performance manage = service=20 providers =E2=80=93 contracts depend on achieving good outcomes. In = short, data quality=20 will be uncertain.

The finding of 60-70% of heroin and crack users being abstinent or = reliably=20 improved at (a mean of) 19weeks is unexpectedly good. However, the = difficulty=20 with these data is that everybody, the service user, the agencies, the = NTA, the=20 government has a vested interest in these results being true, and yet = there is=20 no assurance that any of these sources of bias have been eliminated = =E2=80=93 for=20 example what treatment was actually received and what checks were there = on the=20 self report drug use data?

In summary this looks like good analysis of bad data. A crucial = finding, not=20 discussed, appears to be that both heroin and crack users do as well or = better=20 in the psychosocial intervention as compared to the more costly = pharmacotherapy=20 (presumably substitute prescribing). If these findings are valid is it = not=20 logical that the NTA should be rapidly dismantling methadone=20 programmes?

Posted by: Duncan Raistrick | October=20 08, 2009 at 06:12 PM

In 30+ years as a scientist, I have rarely been so concerned about a=20 scientific publication as this paper published by The Lancet.

It is a piece of research that could have enormous implications for = the drug=20 treatment field in the UK and therefore for the lives of many people who = are=20 affected by substance use problems, either directly or indirectly. As = the many=20 points raised by Deirdre Boyd, Neil McKeganey and Duncan Raistrick = reveal, the=20 research itself and the conclusions derived are deeply flawed. There is = clearly=20 a vested interest, in that seven of the nine authors of this manuscript = are=20 employees of the NTA. The NTA is responsible for funding most drug = treatment in=20 England and trying to ensure good practice; it in effect tells = commissioners and=20 services what they can and cannot do; it develops systems to try to = determine=20 treatment effectiveness; it has helped create a situation whereby many = services=20 are worried that they will lose money if they do not obtain good = outcomes. And=20 now they are the sponsor of a piece of research to look at treatment=20 effectiveness within their system where they =E2=80=98contributed to the = study design,=20 data analysis, data collection, data interpretation and writing of the = report=E2=80=99.=20 [I would like to know how much they also paid the first author of the = manuscript=20 as a consultant, either directly or indirectly].

The piece of research comes out just before the NTA annual report. It = is=20 accompanied by a mass of =E2=80=98positive=E2=80=99 media articles. In = my humble opinion, it has=20 quite simply been set up as a PR exercise by the NTA... Isn=E2=80=99t = this the sort of=20 approach that drug companies and the tobacco industry have been = seriously=20 criticised for?

How could the Editor of The Lancet judge this paper as acceptable for = publication given that it is so flawed? Wasn=E2=80=99t he concerned = about the clear=20 vested interests? Didn=E2=80=99t the reviewers of this paper spot these = problems?

[As an aside, I had to laugh at the section on psychosocial = interventions, as=20 it implies they are =E2=80=98part-and=E2=80=93parcel=E2=80=99 of = treatment. People in the treatment=20 industry know that this is rarely the case, as revealed by David = Best=E2=80=99s=20 research]

If we are going to examine the effectiveness of our treatment system, = the=20 research should be conducted by independent researchers. The research = should be=20 of a high quality and be focused on =E2=80=98real=E2=80=99 outcomes and = also examine whether the=20 well-being of clients is improved.

I am deeply concerned and angered by the fact that a piece of = research has=20 been conducted that is deeply flawed, has a clear vested interest, and = is=20 publicised widely in the media as showing the NTA is doing a good job. = This=20 whole agenda was about protecting the so-called integrity of the NTA = (and the=20 government-supported treatment system), rather than caring whether we = are=20 actually helping people whose lives have been so badly affected.

This is a disgraceful matter and should be looked into further. The=20 implications for the future of drug treatment are potentially very = serious.

Professor David Clark
Director, Wired In

Posted by: Prof David Clark | October=20 11, 2009 at 12:49 PM