News (Media Awareness Project) - UK: The Needle and the Damage Done |
Title: | UK: The Needle and the Damage Done |
Published On: | 2004-05-12 |
Source: | Daily Telegraph (UK) |
Fetched On: | 2008-01-18 09:55:27 |
THE NEEDLE AND THE DAMAGE DONE
The biggest case in the General Medical Council's 145-year history sees
seven doctors from the Stapleford Centre, a leading addiction clinic,
accused of irresponsible practice.
It has been billed as a showdown not only between two opposing schools of
opinion about how heroin addicts should be handled, but also between the
NHS and private practice.
Mick Brown reports on the culmination of four decades of disagreement
In June 1998 Tim Willocks, a doctor at the Stapleford Centre in London -
Britain's largest private drug-addiction treatment clinic - received an
inquiry from the General Medical Council about a prescription he had written.
The prescription was for drugs for a long-term heroin addict who had been a
patient at the Stapleford for three years.
Grim reality: opinions differ on treatment for heroin addicts
Having tried, and failed, to withdraw from drugs on innumerable occasions,
the patient was on what is known as a maintenance prescription, designed to
stabilise the addict's life and keep them out of harm's way.
At the time of the GMC query, the patient was in regular work, supporting a
family, paying for his own prescriptions and, to all intents and purposes,
leading a normal and stable life.
Thinking little of it - such queries are not unusual in the drug-addiction
field - Willocks consulted his records and replied to the GMC with a
detailed explanation of the patient's history and treatment, then promptly
put the matter out of his mind. He was shocked, therefore, in April 2001 -
three years later - to receive a letter from the GMC informing him that he
was facing a charge of serious professional misconduct.
What began as a simple query about prescribing practice has now become the
biggest case in the GMC's 145-year history. Never before have so many
doctors been jointly charged with serious professional misconduct.
In February of this year, Willocks and five other doctors from the
Stapleford Centre appeared before the professional conduct committee of the
GMC in London to answer a wide range of charges against them. Also charged,
but not present at the hearing, was the founder and medical director of the
Stapleford, Dr Colin Brewer. Internationally acknowledged as an expert in
the addiction-treatment field, Brewer, who is 62, is said to have been so
devastated by the charges that he was too ill to attend.
The case has now been adjourned until October.
The charges against the Stapleford doctors, which took more than an hour to
read out, enumerated on 33 sheets of A4 paper, allege a wide range of
malpractices. They include prescribing irresponsibly in regard to the
nature, amounts and combinations of drugs; failure to provide adequate
initial assessment of patients' condition and needs; failure to provide
adequate dose assessment; failure to monitor patients properly, or to
establish that they were able to pay for treatment 'through legitimate
means'; and prescribing at intervals that would create 'the potential for
diversion' - that is, selling drugs on the black market. Colin Brewer
personally faces 14 separate charges, including what is perhaps the most
serious, relating to the death of a Stapleford patient after a 'DIY home
detox' arranged by the clinic.
More than just a routine inquiry into alleged medical malpractice, the case
has galvanised the world of addiction medicine.
It has been described - not altogether correctly - as a showdown between
the two conflicting approaches to the treatment of addiction: on the one
hand, the philosophy of reduction and abstinence - the prevailing orthodoxy
for the past 25 years, whereby addicts are prescribed oral methadone in
diminishing doses in an attempt to wean them off the drug completely; and,
on the other hand, maintenance, where addicts are prescribed drugs, often
over a period of years, in an attempt to stabilise their lives until they
are ready to quit. Like everything to do with drug addiction, however, it
is much more complicated than that.
More sensationally, the GMC action has been characterised by some as part
of an establishment campaign against private addiction practice in general,
and against Colin Brewer and the Stapleford in particular.
Drug addiction is the epidemic that nobody wants, and nobody seems sure how
to contain.
The Home Office British Crime Survey estimates that there are presently up
to 67,000 people in Britain using heroin.
Unofficial estimates put the number at anywhere up to half a million.
For 40 years, the history of addiction treatment in Britain has been
fraught with dispute, argument and disagreement over the best approach.
Addiction treatment is complicated and problematic; it embraces medicine
and psychiatry; it has profound implications in politics, crime and
punishment. It raises imponderable philosophical questions about the rights
of the individual versus the imperatives of society.
It is almost totally devoid of absolutes.
"If you put all the experts in one room at the same time, they wouldn't be
able to agree on anything," one addiction specialist says.
"Any research on the subject is inevitably flawed and incomplete. There's a
lot of dogma - people saying this is how we've done it and this is how
we're always going to do it - and there's the political question: no
government wants to be seen to be lenient on drug addicts, and so the
government always sits on the fence."
Until the late 1960s, Britain took a uniquely tolerant attitude towards
drug addiction.
Heroin addicts, of whom there were very few, were able to obtain the drug
on prescription from their GP, with no pressure to withdraw or abstain -
indeed, there was no 'industry' at that time to help people conquer addiction.
But that practice - the so-called British model - was abolished in 1968 (at
a time when there were fewer than 2,000 addicts 'known to the Home Office')
in favour of setting up specialist Drug Dependency Units, or DDUs, under
the NHS, usually under the control of consultant psychiatrists.
Private GPs were obliged to apply for a special licence to prescribe heroin.
Few were given.
As heroin use began to spiral towards epidemic proportions through the
1970s and 1980s, the prescribing of heroin was phased out, and instead
Britain began to adopt the American model of prescribing oral methadone - a
heroin substitute - rather than injectable drugs, with a view towards rapid
reduction and abstinence.
Underpinning this policy was a belief that patients would be kept away from
the black market and could conquer their addiction through a mixture of
medicine and will-power. But this blanket approach, which was to become the
orthodoxy for 20 years, was seen by many as deeply flawed.
'"We've sold this idea that anyone can stop being opiate dependent," says
Bill Nelles, director of the Alliance, a governmentfunded voluntary agency
formed to give addicts advice and information about drug treatment.
"They just have to want it hard enough and be motivated. But while some
people do recover from opiate dependency like that, the numbers are much
smaller than we want the public to believe."
The problem is that heroin is a particularly tenacious drug, which when
taken for prolonged periods fundamentally alters the chemistry of the
brain. According to the National Treatment Outcome Research Study, in even
the best detox and rehabilitation programmes only 40 per cent of people who
manage to complete the programme are still drug-free five years later.
While they share the same basic problem, addicts - like anyone else -
differ in their responses.
Oral methadone suits some people, but it does not suit others.
For many, the oral doses prescribed in NHS clinics prove inadequate to
stave off withdrawal, and they find themselves turning to the black market
with all its attendant dangers.
The drawback of methadone is that it is even more addictive than heroin,
and the physical effects of withdrawal are even worse.
Some patients find detoxing harder than others; indeed, all the evidence
suggests that coercing a patient towards detoxification by reducing his
supply is largely fruitless, and that addicts have to come to a decision of
abstinence in their own time; they have to really want to give up.
Perhaps most critically, addicts complain that the regime in NHS centres
tends to be unwelcoming, even punitive, steeped in a philosophy that
addicts are not so much patients as criminals and social outcasts.
"Traditionally, some DDUs are perceived to be very humiliating places to go
to," Nelles says. "Sometimes patients have been treated in a way they would
never have been treated in any other branch of medicine.
The great problem opiates users face is that, as a group, they are
perceived to be untrustworthy and not capable of properly looking after the
drugs that they want prescribed. Until they can change that perception,
their situation will remain difficult."
In recent years, however, there has been some acknowledgement of the
failure of the 'reduction and abstinence' approach and a shift towards the
philosophy of 'maintenance'. The most recent Department of Health
guidelines on addiction, published in 1999, advise that for some patients
maintenance prescribing should be the preferred course, and acknowledge
that for some addicts injectables are more suitable than oral methadone.
(These guidelines, written for doctors by doctors, shape recommended
practice but are not mandatory.) There has been some re-evaluation of
dosages, and a recognition that the 'mean standards' are generally too low.
Professor John Strang, the chairman of the group that wrote the DoH
guidelines, says that he is in favour of higher-dose maintenance
prescribing for some patients but notes that it has "intrinsic greater
dangers because each higher dose you're prescribing is a potential lethal
dose, and it increases the potential for diversion to the black market.
Our priority in any treatment must be patient care."
Accused: Dr Hugh Kindness
But while the effectiveness of maintenance has been an accepted philosophy
for 10 years, it is only in the past three or four that it has become
widely practised within the NHS. And some NHS centres are still seen as
operating tough, restrictive rules.
It is against this background that the GMC action against the Stapleford
Centre should be understood.
As the orthodoxy of reduction and abstinence began to take hold through the
1970s and 1980s, private practices prescribing to addicts began to
flourish, largely taking up patients who had either failed or couldn't get
on in the NHS. The Stapleford, founded in 1987 by Colin Brewer, the former
director of the Westminster Hospital's alcoholism unit, in a building near
Victoria Station, was to become the largest.
Ironically, given the current case against him, Brewer's first patients
were addicts who had formerly been treated by a private Harley Street
doctor (Ann Dalley, who had been forced to give up her practice after a
series of GMC prosecutions for irresponsible prescribing) and patients who
had been referred to Brewer by the Home Office.
The Stapleford offered an 'outpatient' service, different to the private
residential rehabs such as the Priory and Promise, which tend to detox
patients fairly quickly and concentrate on therapy and counselling based on
the 12-step principle.
Brewer took what was generally construed as a more liberal approach.
Long-term, hardened users who were either not ready for, or unable to,
detox were offered a maintenance programme - not in itself curative, but a
steady, regular dosage which would prevent withdrawal symptoms, without
intoxication, and which would theoretically enable them to get on with
their lives and manage their drug consumption.
Contrary, perhaps, to popular belief, many addicts are able to function
quite normally on a maintenance programme; some do it for years.
The dosages which the Stapleford provided were often higher than those
suggested by national guidelines, and as well as methadone, Brewer offered
patients a variety of drugs according to their perceived needs.
Among them the Stapleford offered Naltrexone, an opiate blocking drug, used
in both rapid detoxification and in relapse prevention, which the clinic
introduced to this country. Brewer also offered injectable prescribing for
those who found it particularly difficult to deal with oral methadone.
(More than 50 per cent of Stapleford patients are on injectables. In the
NHS the figure is less than 10 per cent.)
"An addiction treatment unit," Brewer argued, "should be rather like a
family planning unit. You do not go to a family planning clinic to be told
you can have the pill and nothing else. Everybody who goes to a family
planning clinic knows broadly why they are there and you discuss sensibly
with the staff a range of options, and if you do not like one, they will
offer you another. Addiction treatment has to be like that."
Perhaps Brewer's biggest departure from established principle was on the
question of duration of prescribing, and allowing addicts to hold custody
of their drugs.
The DoH guidelines recommend that addicts should collect their prescription
from chemists or DDUs on a daily basis; it is usually swallowed on the
premises. This, it is argued, minimises the risk of misuse and diversion to
the black market.
But Brewer maintained that collecting daily made it impossible for patients
to hold down a job and 'condemned' them to a life of dependency. The
Stapleford adopted a more flexible approach, often entrusting patients with
prescriptions giving them a week's, or sometimes two weeks', supply of
drugs. (A recent survey showed that 72 per cent of the Stapleford patients
are either working or in college education.)
This aspect of the clinic's practice, and the potential it creates for risk
of diversion, figures highly in the GMC's charges.
Underpinning the clinic's approach was the belief that treatment centres
should form a partnership with addicts to help them safely manage their
problems and carry on living relatively normal lives, while keeping them
away from the black market and criminal connections.
"Dr Brewer's philosophy has always been that if you take trust out of the
therapeutic alliance, you're never going to get very far," Tim Willocks
says. "If your base line is that the patient is a liar and a criminal,
that's going to put severe limits on the therapeutic relationship. If you
treat patients as responsible individuals who want to do something about
their lives and health, they respond to that."
Brewer's liberal approach meant that many patients who had tried and failed
in NHS clinics turned to him. As word of his methods spread, so his
practice expanded. He opened a second clinic in Essex; other doctors
flocked to join him, and he gained a public reputation when figures such as
the pop singer Shaun Ryder and the music entrepreneur Alan McGee talked in
the press of how he had helped them overcome their drug problems.
Over the years the Stapleford has treated more than 4,000 patients.
It presently has some 300 maintenance patients on its books and many more
recovered patients who continue to attend the clinic to prevent relapse.
But Brewer's methods set him at odds with many in the medical
establishment, among them one of the most influential voices on drug
addiction treatment in Britain - the director of the National Addiction
Centre, Prof John Strang.
A psychiatrist, Strang was formerly director of the NHS drug clinic at
Prestwich Hospital in Greater Manchester. Since 1995 he has been director
of the National Addiction Centre at the Institute of Psychiatry in the
University of London, based at the Maudsley Hospital - actively involved in
policy formulation. He is often to be found on advisory committees and he
was chairman of the groups which prepared the DoH Misuse of Drugs
Guidelines in 1991 and 1999.
Over the years Brewer and Strang have clashed in medical journals about the
best approaches to the treatment of drug addiction.
In 1996 Strang published a paper in the British Medical Journal which
criticised private practices for disregarding DoH advice on daily
dispensing, and suggested that the 'stark' differences between NHS and
private prescriptions should be 'examined critically'.
Brewer responded, expressing concern and 'some irritation at [the paper's]
occasional unrealities', not least at the idea that patients should collect
prescriptions daily.
Arguing for a greater 'flexibility' in methadone programmes, Brewer went on
to say, 'We hope that the concerns raised by Strang and colleagues will not
prevent us making a clinical judgement that is as necessary to the practice
of medicine as the research that should inform it.'
But it was over the question of rapid opiate detoxification under
anaesthesia, or Roda, that the two men would have their most public
disagreement. Roda utilises Naltrexone, an 'opium antagonist' that blocks
the effects of heroin and methadone by occupying the receptor sites in the
brain normally favoured by opiates. Once in place it rejects any narcotic
molecules it finds, and builds a total chemical blockade against the
effects of opiates.
In conventional detox programmes, between 70 and 80 per cent of relapses
occur within the first month.
But the blockading effects of Naltrexone make relapse virtually impossible.
Brewer has described Naltrexone as 'psychiatry's most effective drug', and
its use in relapse prevention as 'the only treatment that comes with a
guarantee'. (Not quite - obviously Naltrexone does not address the
psychological problems that underpin addiction, which traditionally are
addressed by therapy and counselling.)
Administered orally, Naltrexone is effective for up to three days, but it
can also be administered by implant - a small surgical procedure taking a
matter of minutes - where it is effective for a minimum of five weeks and
up to six months.
While short-acting oral Naltrexone is available in NHS treatment centres,
the Naltrexone implant is not licensed in Britain (though the procedure can
be done under the umbrella of research into the method of application).
Roda using Naltrexone can be done over the course of 24 hours, as opposed
to the five or six days it usually takes addicts to become opiate-free
using more conventional detox methods. However, it is a very expensive
treatment (between #3,000 and #4,000, which includes accommodation and the
use of an anaesthetist), and is actually seldom used.
Instead, the Stapleford has promoted the socalled 'DIY home detox' - a more
affordable option - where the patient detoxes at home under heavy sedation,
before returning to the clinic for a Naltrexone implant to be inserted. The
process requires a complicated cocktail of drugs, and careful supervision.
The centre claims to have overseen 'hundreds' of such procedures over the
past five years, and claims a 70 per cent success rate in avoiding relapse.
In August 2001, however, a Stapleford patient died after choking on his own
vomit during a DIY detox.
It is this case that figures in the charges against Colin Brewer.
Prof Strang has taken a more sanguine approach to Naltrexone. The drug, he
says, has 'not been the major influence in the addiction field everybody
thought it would be' - and he has been particularly cautious about Roda.
(According to the DoH, its effectiveness and safety as a treatment method
'has not yet been established'.)
In November 1997 Strang wrote an editorial in the BMJ, maintaining that
until there was adequate evidence of the effectiveness and safety of the
technique, it should be used only in clinical trials.
Brewer replied, pointing out that in 1995 he had invited Strang to
collaborate in precisely the kind of trials that he, Strang, was
advocating, but that Strang had not responded.
Strang responded in a letter published on January 23, 1999, stating that
the selection of an appropriate study design and of collaborators "of
appropriate objectivity and equipoise" was of great importance since
(quoting two other authorities in the field, Kleber and Riordan) "the
history of narcotics withdrawal is filled with 'cures' enthusiastically
received and then quietly dropped when they turn out to be either
ineffective or dangerous, or both".
Dr Tom Willocks arrives at the GMC to answer charges of misconduct
"We chose not to collaborate with Brewer for various reasons," Strang went
on. "The professional reasons included our concern about the potential
hazards of the procedure... and our dislike of Brewer's proposal that NHS
funds should be diverted from the NHS into his private treatment business."
Brewer was incensed.
He had recently been appointed as chairman of the ethics sub-committee of
the newly inaugurated International Society of Addiction Medicine, and was
due to deliver a paper on ethical issues on addiction treatment in a few
weeks' time. He believed Strang's allegations were a serious charge against
his integrity.
Along with an anaesthetist colleague, Dr Jonathan Williams of the Royal
Sussex County Hospital, Brewer wrote a stinging letter of reply to the BMJ.
The references to 'objectivity' and 'equipoise', he wrote, clearly implied
that he, Brewer, was lacking these qualities, while Strang's claim that
Brewer was intent on diverting NHS funds into 'his private addiction
business' was completely without foundation. On July 31, 1999, Strang
published an apology in the pages of the BMJ, accepting that Brewer's
offers of collaboration 'were made on an ordinary friendly basis. We regret
that we misunderstood this,' Strang went on, 'and we apologise if our
letter seemed to cast doubt on his probity and objectivity.' In the same
issue, Brewer accepted Strang's apology, while expressing his displeasure
that it had been so long in coming.
It was around the same time that the GMC case began to unfold. In fact, the
first Stapleford doctors to be charged were two colleagues of Brewer's, Tim
Willocks and Tony Haines.
Tim Willocks is something of a curiosity in the world of addiction treatment.
Forty-six years old, and a black belt in shotokan karate, he is better
known as the author of a bestselling thriller, Green River Rising. After
qualifying as a doctor of medicine in 1983, and with a particular interest
in addiction treatment, Willocks worked in NHS Drug Dependency Units in
Manchester and London but found the work 'extremely dispiriting and
depressing'. Enthused by Colin Brewer's pioneering approach and techniques,
he joined the Stapleford in 1992.
Green River Rising was published in 1996. The film rights were snapped up
by Hollywood, and Willocks became a literary celebrity and made the gossip
columns when he enjoyed a brief relationship with Madonna. Many people
might have been tempted to abandon the field of addiction medicine for the
more lucrative pastures of Hollywood. But Willocks continued to work three
days a week at the Stapleford, being paid the clinic's standard #160 a session.
"It never occurred to me to stop practising," he says. "It was exciting
work, the results were amazing compared with anything I'd seen anywhere
else, and I considered it an honour to work alongside Colin. I thought he
was a great man in the best tradition of medicine, and still think so."
Willocks says that he thought little of it when, in June 1998, he and Tony
Haines, the deputy medical director of the Stapleford, received the first
letter from the GMC, inquiring about two prescriptions which had been
written for a Stapleford patient.
Unfamiliar with the patient, the pharmacist where the prescriptions had
been filled had queried them with the Royal Pharmaceutical Society, which
in turn had passed the query on to the GMC.
The patient in question was a 39-year-old man who had begun injecting
heroin intravenously at the age of 18. He first presented himself to the
Stapleford in 1995, when he was seen by Colin Brewer. Brewer evaluated him
as a "stable and well-motivated" patient who should be encouraged to detox,
but felt that maintenance was the best course for the time being.
He was prescribed 150mg of methadone daily, picking up three times a week.
As he was stable, by mid-May he was allowed to pick up on a weekly basis.
In October 1996, he was asking about detoxification and, after various
discussions, in August 1997 he was placed on a programme of gradual
reduction using a drug called dextromoramide, or Palfium - a short-acting
opiate usually used in pain-relief. After six months, it became apparent
that the detox was not working for him, and he was put back on a
maintenance prescription of methadone, which he was continuing to take,
while in work and supporting his family.
In April 2001 the charges against Willocks and Haines arrived. The case
against Willocks was that in November 1997 and April 1998 he had issued
prescriptions of Temazepam, Palfium and methadone.
The charge read: 'You knew or should have known that Palfium is generally
considered to be inappropriate as a substitute medication in the treatment
of opiate addiction.You knew or should have known that the amount of drugs
prescribed was excessive.
By your actions as described above you a) failed to safeguard the best
medical interest of your patient, b) failed to take precautions to prevent
the abuse of the drugs by your patient or a third party.'
Along with the charges came two expert opinions, one from Strang and the
second from Dr Susan Ruben, consultant psychiatrist at the NHS Substance
Misuse Directorate on Merseyside. Strang, quite properly, prefaced his
report by declaring his history of disagreements with Brewer and including
the BMJ correspondence over Roda, acknowledging that it could have a
potential bearing on 'any possible allegation that might be made about
whether or not I am capable of providing an independent report...'
He then moved on to express his concerns not only about the use of
dextromoramide (Palfium) as a medication, but over the dosage in the
prescriptions, which he described as 'extraordinarily high'. The daily dose
of up to 900mg of dextromoramide cited in the prescriptions, Strang wrote,
was not only many times higher than the recommended daily dose but also
many times higher 'than the dose which would normally prove fatal'.
Quoting the DoH guidelines, he suggested that the conversion between
dextromoramide and methadone is that each 10mg tablet of dextromoramide
should be considered as 10-20mg of methadone.
On this basis, the dose prescribed was equivalent to 900-1,800mg of
methadone daily - '20-40 times the mean daily dose of methadone prescribed
nationally, and 10-20 times the generally accepted interpretation of
high-dose methadone prescribing'.
Willocks read Strang's evidence with mounting disbelief. To Willocks, it
appeared that Strang had made a significant error in his calculations about
Palfium and methadone ratios and the duration of effect of each drug.
Willocks consulted Colin Brewer, who had initiated the treatment, and who,
in turn, solicited an independent opinion from a leading toxicologist, John
Henry, professor of accident and emergency medicine at St Mary's Hospital,
London.
Henry's report appeared to confirm that Strang had omitted to factor into
his calculations the respective 'half-life' of each drug. According to
Henry, the elimination half-life of methadone is in the region of 12-48
hours; its effect persists for more than 24 hours, which means that the
drug need be administered only once a day to avoid withdrawal symptoms.
By comparison, dextromoramide has an elimination half-life of 1.5-4.7
hours, which means that its ability to prevent the onset of withdrawal
symptoms will essentially be gone by an hour or two after the peak effect,
and another dose will be required within three hours of the previous one.
Therefore, an addict would need to take as many as eight doses in a 24-hour
period - in the order of 800mg - to replicate the effects of 100-200mg of
methadone.
Susan Ruben, in her evidence, appeared to make exactly the same error as
Strang, concluding that the doses prescribed were 'unusually high and many
times higher than the dose equivalent to high-dose oral methadone maintenance'.
Along with the charges and the expert opinions from Strang and Ruben came a
'screening memorandum', prepared by a GMC caseworker. (It is the job of the
screener - a member of the GMC - to evaluate the charges and consider
whether the case should go forward to the next stage of the GMC's
fitness-to-practise procedures.) The screener's report stated that the
allegations 'appear to raise a question as to whether the conduct of Dr
Willocks fell seriously below that which can be expected of a registered
medical practitioner', and concluded, 'The case has to go forward. Dr
Willocks [has] prescribed controlled drugs recklessly, breaching good
medical practice.
If we are to protect the public these doctors have to be called to account.'
Determined to contest Strang and Ruben's evidence, Brewer wrote to the
Professional Conduct Committee of the GMC, enclosing Henry's report: 'I do
think it raises some very serious questions about the process...' He also
wrote to Strang and Ruben, pointing out the apparent error in their reports
and inviting them to withdraw their evidence.
The GMC's Professional Standards Committee was due to meet on December 4,
2001, to decide whether or not to proceed with the case against Willocks
and Haines. In his letter to Strang, Brewer suggested that if the committee
were to decide not to go forward with the case, it would not only spare
Willocks and Haines 'considerable distress' but it would also spare Strang
and Ruben 'the embarrassment' of their evidence being apparently shown to
be incorrect on such crucially important area of knowledge in the case.
'It is also an area about which both of you would be presumed to have
particularly expert knowledge if you accept an invitation to criticise
other doctors' prescribing.' Brewer concluded his letter by saying that as
medical director of the Stapleford Centre, and the physician who first saw
the patient in question, it would have been 'at least equally appropriate'
for the GMC's inquiries to have been directed at him, Brewer, rather than
at Willocks and Haines. What Brewer was not aware of at that point was that
charges against him would soon be forthcoming.
In September 2002 Willocks and Haines travelled to Manchester for the first
hearing against them. Brewer was also in attendance to give evidence on his
colleagues' behalf.
Before he could do so, however, he was told that charges were also being
levelled against him and other doctors from the Stapleford. The case
against Willocks and Haines was adjourned.
It would be a further 18 months before they next appeared in front of the
GMC committee.
Among the 14 charges of professional misconduct which Brewer now faces is
one of seeking 'to interfere with potential witnesses', arising out of his
attempt to persuade Strang and Ruben to withdraw their evidence against
Willocks and Haines. A week before the hearing in February, Willocks learnt
that the Strang and Ruben evidence was no longer to be presented as part of
the GMC case. However, the evidence will now be presented as part of the
defence case.
Contacted by The Telegraph , John Strang declined to comment on the GMC
action against the Stapleford, on the grounds that he is due to be what he
says is 'a fairly minor witness' to do with one of the charges. How then,
did a simple inquiry from a chemist about a prescription turn into the
biggest case in the GMC's history? The GMC has declined to make any comment
to The Telegraph about the Stapleford case, explaining that it is unable to
discuss the detail of cases that have not yet started in a public hearing.
Under normal circumstances, such disciplinary cases arise from complaints
to the GMC, usually from patients. But it is understood there have been no
complaints from any patients at the Stapleford about the clinic.
On the contrary, many have offered to give testimony on the clinic's behalf.
But there does appear to have been a complaint registered with the GMC by
the parents of the patient who died during the DIY home detox. It is
understood that this complaint arrived in the autumn of 2001 - a few months
after the GMC had filed its initial charges against Haines and Willocks.
As the case against Willocks and Haines began to unfold, it seems, so the
GMC broadened its inquiry to include Brewer and the four other Stapleford
doctors. "The GMC realised they couldn't accuse one or two doctors of doing
something if other doctors had been doing exactly the same thing," one
source says. "They were forced to widen things out."
Charged: Dr Ronald Tovey
It appears that the GMC inquiry into the Stapleford doctors was done in
concert with the Home Office Drugs Inspectorate, which has overall
responsibility for supervising and regulating the use of controlled drugs
in the UK. The Home Office employs area inspectors, whose job is to liaise
regularly with all doctors using controlled drugs.
Sources at the Stapleford say they have always had good relations with
their inspector, and there was no hint that they were under investigation.
However, the clinic's relations with the head of the Home Office Drugs
Inspectorate, Alan Macfarlane, have been less cordial.
According to the Home Office, Macfarlane, a civil servant, has visited the
centre once, in 1997, 'on a liaison basis'. But one Stapleford doctor says,
"It seems that if one tries to open a dialogue, it's not reciprocated."
The Home Office Drugs Inspectorate is widely regarded as being antagonistic
towards the private practise of addiction treatment.
In the 1980s there were about 50 private practices in Britain. There are
now fewer than 20. And in the past three years some half-a-dozen private
doctors have been struck off following GMC action.
Perhaps the most controversial case was that of Adrian Garfoot, who was
struck off in September 2001 after 25 years of treating hundreds of
long-term users both in the NHS and as a private practitioner. Garfoot had
already faced a five-year Home Office inquiry under the mechanism of the
Misuse of Drugs Tribunal, in which he was eventually acquitted.
When the Home Office prosecutions failed, the case against him was taken up
by the GMC, which, while accepting that Garfoot had acted on what he
believed were the best interests of his patients, concluded that his
prescribing was irresponsible. The tribunal was abolished shortly
afterwards, with the government accepting the recommendation that
henceforth reliance would be placed on the GMC 'to provide an effective
remedy'.
Critics claim that the Home Office had 'moved the goalposts', and was
turning to the GMC to act as its 'enforcer'. The Home Office denies that it
has lodged any complaint about the Stapleford with the GMC. But it is
believed that evidence has been submitted to the GMC by Police Chemist
Inspecting Officers. These 'pharmacy inspectors', as they are sometimes
known, routinely monitor all controlled drug dispensing as recorded in
pharmacy registers, reporting unusual supplies to the Drugs Inspectorate.
"They are likely to pay closer attention to private prescribing than NHS
[prescribing] on account of the historic difficulties of the private sector
dating back to the 1960s," a Home Office spokesman says. And one source
claims to know of a case where a pharmacy inspector in Norfolk specifically
stated that he was looking for evidence to "stop Dr Brewer prescribing".
Critics of the Stapleford argue that it was almost inevitable that its
liberal prescribing practices would eventually bring it into conflict with
the establishment. "They have a reputation of being eccentric in their
prescription practices, and in prescribing drugs in certain unusual
combinations," says one NHS psychiatrist.
There are criticisms, too, that the Stapleford did not have the resources
effectively to monitor patients on long-duration prescriptions, and ensure
that they were not selling on their supply. "It's impossible to say that
with the number of patients we've had over the years that no one has ever
sold or shared their methadone with a friend," Tim Willocks admits. "Like
any human community, addicts tend to look after each other. Many of them
have partners who are addicted.
But that goes on with NHS patients, too."
The most serious charge facing the clinic concerns Grant Smith, the patient
who died the age of 29 during DIY home detox in August 2001. Home detox,
the GMC maintains, 'should only be performed in a setting in which there is
provided trained nursing and medical care'.
According to the charge, Brewer prescribed 16 different drugs, including a
range of sedatives, among them Rohypnol, for the treatment.
Smith's mother was provided with written instructions for the
administration of the drugs.
But three days into the programme she telephoned Brewer to advise him that
the supply of Rohypnol was running low and that her son was having
difficulty sleeping.
Brewer spoke to Smith and agreed to prescribe two more sedatives, Temazepam
and hemineverin, but, it is alleged, he failed to advise his parents that
hemineverin was an alternative to, not additional to, the Rohypnol. Smith
took the new medication and a few hours later died in his sleep, as a
result of choking on his own vomit.
At the inquest in Northampton the following June, the coroner recorded a
verdict of death by misadventure but noted that "no specific instructions
were given to either of Grant's parents about the administration of
Temazepam... any alteration to medication should be discussed personally
with the carer".
"It's a prime aim at the Stapleford to make detox comfortable for
patients," says Bill Nelles of the Alliance, "and in contrast to NHS
centres they have been prepared to be relatively generous with the sedation
that is often necessary to get people through it. What appears to have
happened here is a tragic misunderstanding. But when you look at how many
of Stapleford's patients have died over the years, it's been a very small
number.
And if you look at how many patients in the care of the clinic, hard drug
users on injectable prescriptions, are still alive 10 years on, the answer
is nearly all of them. And in some NHS clinics there does seem to be much
higher levels of patient mortality."
Drug addiction experts agree that the irony in the Stapleford case is that
the clinic should have found itself before the GMC at a time when NHS
practice, in theory at least, is beginning to accommodate some of the
principles which the Stapleford has practised for years.
"There has been a definite shift in NHS thinking," Nelles says. "The
problem is, in my opinion, they don't say it robustly enough.
We now have the science to say that heroin addiction is a chronic relapsing
condition - all the doctors know that. But if you say that to the general
public, how much incentive is that going to give a 23-year-old who is
strung out on heroin to try to stop?"
Even Colin Brewer's harshest professional critics express a regret that his
career could end in a disciplinary hearing.
Brewer can be arrogant, you hear it said; he is not the most diplomatic man
in the field, but nobody doubts that he is a brilliant and a conscientious
doctor who has always had the best interests of his patients at heart.
"Whatever the rights and wrongs of the case, it's a great shame," says one
NHS psychiatrist, "because Colin's been an innovator in a very positive
way. He's been an inspiring person to me."
Among the Stapleford patients there is a very real concern that should the
clinic be forced to close as a result of the GMC action, there is no
existing provision to deal with their cases, and they will be forced to
look to the black market instead.
One patient, who has been on a maintenance programme of morphine and
dexamphetamine for the past 12 years, collecting his prescription once a
fortnight, while holding down a stable job in the IT field, says that he
would struggle to find another practice that would provide the same
treatment. "And if I couldn't, I'd just get an illegal supply."
Nelles shares the patients' concerns. "What the NHS are saying is that
these people have never tried to fit into our programmes, but we've changed
now. They may be right. But certainly those Stapleford patients who are on
things other than methadone will have a hard time getting those drugs from
the NHS. Of the 300 or so Stapleford patients, I would say 100 of them have
clinical needs that the NHS does not presently seem prepared to meet."
For Tim Willocks, the GMC case has done what literary success could not. He
says that whatever the outcome of the case, he is so disillusioned that he
is now contemplating quitting medical practice altogether.
It seems clear that Colin Brewer, too, will never practise medicine again.
One colleague describes him as "a broken man".
"Dr Brewer," he says, "is a doctor who has spent a good proportion of his
life and career promoting humane treatments for drug addiction problems,
and seeing himself as part of the medical profession and expecting to be
respected by his peers and other organisations for what he's doing.
To have that thrown in his face and be almost humiliated by the government
body is a terrible blow."
The biggest case in the General Medical Council's 145-year history sees
seven doctors from the Stapleford Centre, a leading addiction clinic,
accused of irresponsible practice.
It has been billed as a showdown not only between two opposing schools of
opinion about how heroin addicts should be handled, but also between the
NHS and private practice.
Mick Brown reports on the culmination of four decades of disagreement
In June 1998 Tim Willocks, a doctor at the Stapleford Centre in London -
Britain's largest private drug-addiction treatment clinic - received an
inquiry from the General Medical Council about a prescription he had written.
The prescription was for drugs for a long-term heroin addict who had been a
patient at the Stapleford for three years.
Grim reality: opinions differ on treatment for heroin addicts
Having tried, and failed, to withdraw from drugs on innumerable occasions,
the patient was on what is known as a maintenance prescription, designed to
stabilise the addict's life and keep them out of harm's way.
At the time of the GMC query, the patient was in regular work, supporting a
family, paying for his own prescriptions and, to all intents and purposes,
leading a normal and stable life.
Thinking little of it - such queries are not unusual in the drug-addiction
field - Willocks consulted his records and replied to the GMC with a
detailed explanation of the patient's history and treatment, then promptly
put the matter out of his mind. He was shocked, therefore, in April 2001 -
three years later - to receive a letter from the GMC informing him that he
was facing a charge of serious professional misconduct.
What began as a simple query about prescribing practice has now become the
biggest case in the GMC's 145-year history. Never before have so many
doctors been jointly charged with serious professional misconduct.
In February of this year, Willocks and five other doctors from the
Stapleford Centre appeared before the professional conduct committee of the
GMC in London to answer a wide range of charges against them. Also charged,
but not present at the hearing, was the founder and medical director of the
Stapleford, Dr Colin Brewer. Internationally acknowledged as an expert in
the addiction-treatment field, Brewer, who is 62, is said to have been so
devastated by the charges that he was too ill to attend.
The case has now been adjourned until October.
The charges against the Stapleford doctors, which took more than an hour to
read out, enumerated on 33 sheets of A4 paper, allege a wide range of
malpractices. They include prescribing irresponsibly in regard to the
nature, amounts and combinations of drugs; failure to provide adequate
initial assessment of patients' condition and needs; failure to provide
adequate dose assessment; failure to monitor patients properly, or to
establish that they were able to pay for treatment 'through legitimate
means'; and prescribing at intervals that would create 'the potential for
diversion' - that is, selling drugs on the black market. Colin Brewer
personally faces 14 separate charges, including what is perhaps the most
serious, relating to the death of a Stapleford patient after a 'DIY home
detox' arranged by the clinic.
More than just a routine inquiry into alleged medical malpractice, the case
has galvanised the world of addiction medicine.
It has been described - not altogether correctly - as a showdown between
the two conflicting approaches to the treatment of addiction: on the one
hand, the philosophy of reduction and abstinence - the prevailing orthodoxy
for the past 25 years, whereby addicts are prescribed oral methadone in
diminishing doses in an attempt to wean them off the drug completely; and,
on the other hand, maintenance, where addicts are prescribed drugs, often
over a period of years, in an attempt to stabilise their lives until they
are ready to quit. Like everything to do with drug addiction, however, it
is much more complicated than that.
More sensationally, the GMC action has been characterised by some as part
of an establishment campaign against private addiction practice in general,
and against Colin Brewer and the Stapleford in particular.
Drug addiction is the epidemic that nobody wants, and nobody seems sure how
to contain.
The Home Office British Crime Survey estimates that there are presently up
to 67,000 people in Britain using heroin.
Unofficial estimates put the number at anywhere up to half a million.
For 40 years, the history of addiction treatment in Britain has been
fraught with dispute, argument and disagreement over the best approach.
Addiction treatment is complicated and problematic; it embraces medicine
and psychiatry; it has profound implications in politics, crime and
punishment. It raises imponderable philosophical questions about the rights
of the individual versus the imperatives of society.
It is almost totally devoid of absolutes.
"If you put all the experts in one room at the same time, they wouldn't be
able to agree on anything," one addiction specialist says.
"Any research on the subject is inevitably flawed and incomplete. There's a
lot of dogma - people saying this is how we've done it and this is how
we're always going to do it - and there's the political question: no
government wants to be seen to be lenient on drug addicts, and so the
government always sits on the fence."
Until the late 1960s, Britain took a uniquely tolerant attitude towards
drug addiction.
Heroin addicts, of whom there were very few, were able to obtain the drug
on prescription from their GP, with no pressure to withdraw or abstain -
indeed, there was no 'industry' at that time to help people conquer addiction.
But that practice - the so-called British model - was abolished in 1968 (at
a time when there were fewer than 2,000 addicts 'known to the Home Office')
in favour of setting up specialist Drug Dependency Units, or DDUs, under
the NHS, usually under the control of consultant psychiatrists.
Private GPs were obliged to apply for a special licence to prescribe heroin.
Few were given.
As heroin use began to spiral towards epidemic proportions through the
1970s and 1980s, the prescribing of heroin was phased out, and instead
Britain began to adopt the American model of prescribing oral methadone - a
heroin substitute - rather than injectable drugs, with a view towards rapid
reduction and abstinence.
Underpinning this policy was a belief that patients would be kept away from
the black market and could conquer their addiction through a mixture of
medicine and will-power. But this blanket approach, which was to become the
orthodoxy for 20 years, was seen by many as deeply flawed.
'"We've sold this idea that anyone can stop being opiate dependent," says
Bill Nelles, director of the Alliance, a governmentfunded voluntary agency
formed to give addicts advice and information about drug treatment.
"They just have to want it hard enough and be motivated. But while some
people do recover from opiate dependency like that, the numbers are much
smaller than we want the public to believe."
The problem is that heroin is a particularly tenacious drug, which when
taken for prolonged periods fundamentally alters the chemistry of the
brain. According to the National Treatment Outcome Research Study, in even
the best detox and rehabilitation programmes only 40 per cent of people who
manage to complete the programme are still drug-free five years later.
While they share the same basic problem, addicts - like anyone else -
differ in their responses.
Oral methadone suits some people, but it does not suit others.
For many, the oral doses prescribed in NHS clinics prove inadequate to
stave off withdrawal, and they find themselves turning to the black market
with all its attendant dangers.
The drawback of methadone is that it is even more addictive than heroin,
and the physical effects of withdrawal are even worse.
Some patients find detoxing harder than others; indeed, all the evidence
suggests that coercing a patient towards detoxification by reducing his
supply is largely fruitless, and that addicts have to come to a decision of
abstinence in their own time; they have to really want to give up.
Perhaps most critically, addicts complain that the regime in NHS centres
tends to be unwelcoming, even punitive, steeped in a philosophy that
addicts are not so much patients as criminals and social outcasts.
"Traditionally, some DDUs are perceived to be very humiliating places to go
to," Nelles says. "Sometimes patients have been treated in a way they would
never have been treated in any other branch of medicine.
The great problem opiates users face is that, as a group, they are
perceived to be untrustworthy and not capable of properly looking after the
drugs that they want prescribed. Until they can change that perception,
their situation will remain difficult."
In recent years, however, there has been some acknowledgement of the
failure of the 'reduction and abstinence' approach and a shift towards the
philosophy of 'maintenance'. The most recent Department of Health
guidelines on addiction, published in 1999, advise that for some patients
maintenance prescribing should be the preferred course, and acknowledge
that for some addicts injectables are more suitable than oral methadone.
(These guidelines, written for doctors by doctors, shape recommended
practice but are not mandatory.) There has been some re-evaluation of
dosages, and a recognition that the 'mean standards' are generally too low.
Professor John Strang, the chairman of the group that wrote the DoH
guidelines, says that he is in favour of higher-dose maintenance
prescribing for some patients but notes that it has "intrinsic greater
dangers because each higher dose you're prescribing is a potential lethal
dose, and it increases the potential for diversion to the black market.
Our priority in any treatment must be patient care."
Accused: Dr Hugh Kindness
But while the effectiveness of maintenance has been an accepted philosophy
for 10 years, it is only in the past three or four that it has become
widely practised within the NHS. And some NHS centres are still seen as
operating tough, restrictive rules.
It is against this background that the GMC action against the Stapleford
Centre should be understood.
As the orthodoxy of reduction and abstinence began to take hold through the
1970s and 1980s, private practices prescribing to addicts began to
flourish, largely taking up patients who had either failed or couldn't get
on in the NHS. The Stapleford, founded in 1987 by Colin Brewer, the former
director of the Westminster Hospital's alcoholism unit, in a building near
Victoria Station, was to become the largest.
Ironically, given the current case against him, Brewer's first patients
were addicts who had formerly been treated by a private Harley Street
doctor (Ann Dalley, who had been forced to give up her practice after a
series of GMC prosecutions for irresponsible prescribing) and patients who
had been referred to Brewer by the Home Office.
The Stapleford offered an 'outpatient' service, different to the private
residential rehabs such as the Priory and Promise, which tend to detox
patients fairly quickly and concentrate on therapy and counselling based on
the 12-step principle.
Brewer took what was generally construed as a more liberal approach.
Long-term, hardened users who were either not ready for, or unable to,
detox were offered a maintenance programme - not in itself curative, but a
steady, regular dosage which would prevent withdrawal symptoms, without
intoxication, and which would theoretically enable them to get on with
their lives and manage their drug consumption.
Contrary, perhaps, to popular belief, many addicts are able to function
quite normally on a maintenance programme; some do it for years.
The dosages which the Stapleford provided were often higher than those
suggested by national guidelines, and as well as methadone, Brewer offered
patients a variety of drugs according to their perceived needs.
Among them the Stapleford offered Naltrexone, an opiate blocking drug, used
in both rapid detoxification and in relapse prevention, which the clinic
introduced to this country. Brewer also offered injectable prescribing for
those who found it particularly difficult to deal with oral methadone.
(More than 50 per cent of Stapleford patients are on injectables. In the
NHS the figure is less than 10 per cent.)
"An addiction treatment unit," Brewer argued, "should be rather like a
family planning unit. You do not go to a family planning clinic to be told
you can have the pill and nothing else. Everybody who goes to a family
planning clinic knows broadly why they are there and you discuss sensibly
with the staff a range of options, and if you do not like one, they will
offer you another. Addiction treatment has to be like that."
Perhaps Brewer's biggest departure from established principle was on the
question of duration of prescribing, and allowing addicts to hold custody
of their drugs.
The DoH guidelines recommend that addicts should collect their prescription
from chemists or DDUs on a daily basis; it is usually swallowed on the
premises. This, it is argued, minimises the risk of misuse and diversion to
the black market.
But Brewer maintained that collecting daily made it impossible for patients
to hold down a job and 'condemned' them to a life of dependency. The
Stapleford adopted a more flexible approach, often entrusting patients with
prescriptions giving them a week's, or sometimes two weeks', supply of
drugs. (A recent survey showed that 72 per cent of the Stapleford patients
are either working or in college education.)
This aspect of the clinic's practice, and the potential it creates for risk
of diversion, figures highly in the GMC's charges.
Underpinning the clinic's approach was the belief that treatment centres
should form a partnership with addicts to help them safely manage their
problems and carry on living relatively normal lives, while keeping them
away from the black market and criminal connections.
"Dr Brewer's philosophy has always been that if you take trust out of the
therapeutic alliance, you're never going to get very far," Tim Willocks
says. "If your base line is that the patient is a liar and a criminal,
that's going to put severe limits on the therapeutic relationship. If you
treat patients as responsible individuals who want to do something about
their lives and health, they respond to that."
Brewer's liberal approach meant that many patients who had tried and failed
in NHS clinics turned to him. As word of his methods spread, so his
practice expanded. He opened a second clinic in Essex; other doctors
flocked to join him, and he gained a public reputation when figures such as
the pop singer Shaun Ryder and the music entrepreneur Alan McGee talked in
the press of how he had helped them overcome their drug problems.
Over the years the Stapleford has treated more than 4,000 patients.
It presently has some 300 maintenance patients on its books and many more
recovered patients who continue to attend the clinic to prevent relapse.
But Brewer's methods set him at odds with many in the medical
establishment, among them one of the most influential voices on drug
addiction treatment in Britain - the director of the National Addiction
Centre, Prof John Strang.
A psychiatrist, Strang was formerly director of the NHS drug clinic at
Prestwich Hospital in Greater Manchester. Since 1995 he has been director
of the National Addiction Centre at the Institute of Psychiatry in the
University of London, based at the Maudsley Hospital - actively involved in
policy formulation. He is often to be found on advisory committees and he
was chairman of the groups which prepared the DoH Misuse of Drugs
Guidelines in 1991 and 1999.
Over the years Brewer and Strang have clashed in medical journals about the
best approaches to the treatment of drug addiction.
In 1996 Strang published a paper in the British Medical Journal which
criticised private practices for disregarding DoH advice on daily
dispensing, and suggested that the 'stark' differences between NHS and
private prescriptions should be 'examined critically'.
Brewer responded, expressing concern and 'some irritation at [the paper's]
occasional unrealities', not least at the idea that patients should collect
prescriptions daily.
Arguing for a greater 'flexibility' in methadone programmes, Brewer went on
to say, 'We hope that the concerns raised by Strang and colleagues will not
prevent us making a clinical judgement that is as necessary to the practice
of medicine as the research that should inform it.'
But it was over the question of rapid opiate detoxification under
anaesthesia, or Roda, that the two men would have their most public
disagreement. Roda utilises Naltrexone, an 'opium antagonist' that blocks
the effects of heroin and methadone by occupying the receptor sites in the
brain normally favoured by opiates. Once in place it rejects any narcotic
molecules it finds, and builds a total chemical blockade against the
effects of opiates.
In conventional detox programmes, between 70 and 80 per cent of relapses
occur within the first month.
But the blockading effects of Naltrexone make relapse virtually impossible.
Brewer has described Naltrexone as 'psychiatry's most effective drug', and
its use in relapse prevention as 'the only treatment that comes with a
guarantee'. (Not quite - obviously Naltrexone does not address the
psychological problems that underpin addiction, which traditionally are
addressed by therapy and counselling.)
Administered orally, Naltrexone is effective for up to three days, but it
can also be administered by implant - a small surgical procedure taking a
matter of minutes - where it is effective for a minimum of five weeks and
up to six months.
While short-acting oral Naltrexone is available in NHS treatment centres,
the Naltrexone implant is not licensed in Britain (though the procedure can
be done under the umbrella of research into the method of application).
Roda using Naltrexone can be done over the course of 24 hours, as opposed
to the five or six days it usually takes addicts to become opiate-free
using more conventional detox methods. However, it is a very expensive
treatment (between #3,000 and #4,000, which includes accommodation and the
use of an anaesthetist), and is actually seldom used.
Instead, the Stapleford has promoted the socalled 'DIY home detox' - a more
affordable option - where the patient detoxes at home under heavy sedation,
before returning to the clinic for a Naltrexone implant to be inserted. The
process requires a complicated cocktail of drugs, and careful supervision.
The centre claims to have overseen 'hundreds' of such procedures over the
past five years, and claims a 70 per cent success rate in avoiding relapse.
In August 2001, however, a Stapleford patient died after choking on his own
vomit during a DIY detox.
It is this case that figures in the charges against Colin Brewer.
Prof Strang has taken a more sanguine approach to Naltrexone. The drug, he
says, has 'not been the major influence in the addiction field everybody
thought it would be' - and he has been particularly cautious about Roda.
(According to the DoH, its effectiveness and safety as a treatment method
'has not yet been established'.)
In November 1997 Strang wrote an editorial in the BMJ, maintaining that
until there was adequate evidence of the effectiveness and safety of the
technique, it should be used only in clinical trials.
Brewer replied, pointing out that in 1995 he had invited Strang to
collaborate in precisely the kind of trials that he, Strang, was
advocating, but that Strang had not responded.
Strang responded in a letter published on January 23, 1999, stating that
the selection of an appropriate study design and of collaborators "of
appropriate objectivity and equipoise" was of great importance since
(quoting two other authorities in the field, Kleber and Riordan) "the
history of narcotics withdrawal is filled with 'cures' enthusiastically
received and then quietly dropped when they turn out to be either
ineffective or dangerous, or both".
Dr Tom Willocks arrives at the GMC to answer charges of misconduct
"We chose not to collaborate with Brewer for various reasons," Strang went
on. "The professional reasons included our concern about the potential
hazards of the procedure... and our dislike of Brewer's proposal that NHS
funds should be diverted from the NHS into his private treatment business."
Brewer was incensed.
He had recently been appointed as chairman of the ethics sub-committee of
the newly inaugurated International Society of Addiction Medicine, and was
due to deliver a paper on ethical issues on addiction treatment in a few
weeks' time. He believed Strang's allegations were a serious charge against
his integrity.
Along with an anaesthetist colleague, Dr Jonathan Williams of the Royal
Sussex County Hospital, Brewer wrote a stinging letter of reply to the BMJ.
The references to 'objectivity' and 'equipoise', he wrote, clearly implied
that he, Brewer, was lacking these qualities, while Strang's claim that
Brewer was intent on diverting NHS funds into 'his private addiction
business' was completely without foundation. On July 31, 1999, Strang
published an apology in the pages of the BMJ, accepting that Brewer's
offers of collaboration 'were made on an ordinary friendly basis. We regret
that we misunderstood this,' Strang went on, 'and we apologise if our
letter seemed to cast doubt on his probity and objectivity.' In the same
issue, Brewer accepted Strang's apology, while expressing his displeasure
that it had been so long in coming.
It was around the same time that the GMC case began to unfold. In fact, the
first Stapleford doctors to be charged were two colleagues of Brewer's, Tim
Willocks and Tony Haines.
Tim Willocks is something of a curiosity in the world of addiction treatment.
Forty-six years old, and a black belt in shotokan karate, he is better
known as the author of a bestselling thriller, Green River Rising. After
qualifying as a doctor of medicine in 1983, and with a particular interest
in addiction treatment, Willocks worked in NHS Drug Dependency Units in
Manchester and London but found the work 'extremely dispiriting and
depressing'. Enthused by Colin Brewer's pioneering approach and techniques,
he joined the Stapleford in 1992.
Green River Rising was published in 1996. The film rights were snapped up
by Hollywood, and Willocks became a literary celebrity and made the gossip
columns when he enjoyed a brief relationship with Madonna. Many people
might have been tempted to abandon the field of addiction medicine for the
more lucrative pastures of Hollywood. But Willocks continued to work three
days a week at the Stapleford, being paid the clinic's standard #160 a session.
"It never occurred to me to stop practising," he says. "It was exciting
work, the results were amazing compared with anything I'd seen anywhere
else, and I considered it an honour to work alongside Colin. I thought he
was a great man in the best tradition of medicine, and still think so."
Willocks says that he thought little of it when, in June 1998, he and Tony
Haines, the deputy medical director of the Stapleford, received the first
letter from the GMC, inquiring about two prescriptions which had been
written for a Stapleford patient.
Unfamiliar with the patient, the pharmacist where the prescriptions had
been filled had queried them with the Royal Pharmaceutical Society, which
in turn had passed the query on to the GMC.
The patient in question was a 39-year-old man who had begun injecting
heroin intravenously at the age of 18. He first presented himself to the
Stapleford in 1995, when he was seen by Colin Brewer. Brewer evaluated him
as a "stable and well-motivated" patient who should be encouraged to detox,
but felt that maintenance was the best course for the time being.
He was prescribed 150mg of methadone daily, picking up three times a week.
As he was stable, by mid-May he was allowed to pick up on a weekly basis.
In October 1996, he was asking about detoxification and, after various
discussions, in August 1997 he was placed on a programme of gradual
reduction using a drug called dextromoramide, or Palfium - a short-acting
opiate usually used in pain-relief. After six months, it became apparent
that the detox was not working for him, and he was put back on a
maintenance prescription of methadone, which he was continuing to take,
while in work and supporting his family.
In April 2001 the charges against Willocks and Haines arrived. The case
against Willocks was that in November 1997 and April 1998 he had issued
prescriptions of Temazepam, Palfium and methadone.
The charge read: 'You knew or should have known that Palfium is generally
considered to be inappropriate as a substitute medication in the treatment
of opiate addiction.You knew or should have known that the amount of drugs
prescribed was excessive.
By your actions as described above you a) failed to safeguard the best
medical interest of your patient, b) failed to take precautions to prevent
the abuse of the drugs by your patient or a third party.'
Along with the charges came two expert opinions, one from Strang and the
second from Dr Susan Ruben, consultant psychiatrist at the NHS Substance
Misuse Directorate on Merseyside. Strang, quite properly, prefaced his
report by declaring his history of disagreements with Brewer and including
the BMJ correspondence over Roda, acknowledging that it could have a
potential bearing on 'any possible allegation that might be made about
whether or not I am capable of providing an independent report...'
He then moved on to express his concerns not only about the use of
dextromoramide (Palfium) as a medication, but over the dosage in the
prescriptions, which he described as 'extraordinarily high'. The daily dose
of up to 900mg of dextromoramide cited in the prescriptions, Strang wrote,
was not only many times higher than the recommended daily dose but also
many times higher 'than the dose which would normally prove fatal'.
Quoting the DoH guidelines, he suggested that the conversion between
dextromoramide and methadone is that each 10mg tablet of dextromoramide
should be considered as 10-20mg of methadone.
On this basis, the dose prescribed was equivalent to 900-1,800mg of
methadone daily - '20-40 times the mean daily dose of methadone prescribed
nationally, and 10-20 times the generally accepted interpretation of
high-dose methadone prescribing'.
Willocks read Strang's evidence with mounting disbelief. To Willocks, it
appeared that Strang had made a significant error in his calculations about
Palfium and methadone ratios and the duration of effect of each drug.
Willocks consulted Colin Brewer, who had initiated the treatment, and who,
in turn, solicited an independent opinion from a leading toxicologist, John
Henry, professor of accident and emergency medicine at St Mary's Hospital,
London.
Henry's report appeared to confirm that Strang had omitted to factor into
his calculations the respective 'half-life' of each drug. According to
Henry, the elimination half-life of methadone is in the region of 12-48
hours; its effect persists for more than 24 hours, which means that the
drug need be administered only once a day to avoid withdrawal symptoms.
By comparison, dextromoramide has an elimination half-life of 1.5-4.7
hours, which means that its ability to prevent the onset of withdrawal
symptoms will essentially be gone by an hour or two after the peak effect,
and another dose will be required within three hours of the previous one.
Therefore, an addict would need to take as many as eight doses in a 24-hour
period - in the order of 800mg - to replicate the effects of 100-200mg of
methadone.
Susan Ruben, in her evidence, appeared to make exactly the same error as
Strang, concluding that the doses prescribed were 'unusually high and many
times higher than the dose equivalent to high-dose oral methadone maintenance'.
Along with the charges and the expert opinions from Strang and Ruben came a
'screening memorandum', prepared by a GMC caseworker. (It is the job of the
screener - a member of the GMC - to evaluate the charges and consider
whether the case should go forward to the next stage of the GMC's
fitness-to-practise procedures.) The screener's report stated that the
allegations 'appear to raise a question as to whether the conduct of Dr
Willocks fell seriously below that which can be expected of a registered
medical practitioner', and concluded, 'The case has to go forward. Dr
Willocks [has] prescribed controlled drugs recklessly, breaching good
medical practice.
If we are to protect the public these doctors have to be called to account.'
Determined to contest Strang and Ruben's evidence, Brewer wrote to the
Professional Conduct Committee of the GMC, enclosing Henry's report: 'I do
think it raises some very serious questions about the process...' He also
wrote to Strang and Ruben, pointing out the apparent error in their reports
and inviting them to withdraw their evidence.
The GMC's Professional Standards Committee was due to meet on December 4,
2001, to decide whether or not to proceed with the case against Willocks
and Haines. In his letter to Strang, Brewer suggested that if the committee
were to decide not to go forward with the case, it would not only spare
Willocks and Haines 'considerable distress' but it would also spare Strang
and Ruben 'the embarrassment' of their evidence being apparently shown to
be incorrect on such crucially important area of knowledge in the case.
'It is also an area about which both of you would be presumed to have
particularly expert knowledge if you accept an invitation to criticise
other doctors' prescribing.' Brewer concluded his letter by saying that as
medical director of the Stapleford Centre, and the physician who first saw
the patient in question, it would have been 'at least equally appropriate'
for the GMC's inquiries to have been directed at him, Brewer, rather than
at Willocks and Haines. What Brewer was not aware of at that point was that
charges against him would soon be forthcoming.
In September 2002 Willocks and Haines travelled to Manchester for the first
hearing against them. Brewer was also in attendance to give evidence on his
colleagues' behalf.
Before he could do so, however, he was told that charges were also being
levelled against him and other doctors from the Stapleford. The case
against Willocks and Haines was adjourned.
It would be a further 18 months before they next appeared in front of the
GMC committee.
Among the 14 charges of professional misconduct which Brewer now faces is
one of seeking 'to interfere with potential witnesses', arising out of his
attempt to persuade Strang and Ruben to withdraw their evidence against
Willocks and Haines. A week before the hearing in February, Willocks learnt
that the Strang and Ruben evidence was no longer to be presented as part of
the GMC case. However, the evidence will now be presented as part of the
defence case.
Contacted by The Telegraph , John Strang declined to comment on the GMC
action against the Stapleford, on the grounds that he is due to be what he
says is 'a fairly minor witness' to do with one of the charges. How then,
did a simple inquiry from a chemist about a prescription turn into the
biggest case in the GMC's history? The GMC has declined to make any comment
to The Telegraph about the Stapleford case, explaining that it is unable to
discuss the detail of cases that have not yet started in a public hearing.
Under normal circumstances, such disciplinary cases arise from complaints
to the GMC, usually from patients. But it is understood there have been no
complaints from any patients at the Stapleford about the clinic.
On the contrary, many have offered to give testimony on the clinic's behalf.
But there does appear to have been a complaint registered with the GMC by
the parents of the patient who died during the DIY home detox. It is
understood that this complaint arrived in the autumn of 2001 - a few months
after the GMC had filed its initial charges against Haines and Willocks.
As the case against Willocks and Haines began to unfold, it seems, so the
GMC broadened its inquiry to include Brewer and the four other Stapleford
doctors. "The GMC realised they couldn't accuse one or two doctors of doing
something if other doctors had been doing exactly the same thing," one
source says. "They were forced to widen things out."
Charged: Dr Ronald Tovey
It appears that the GMC inquiry into the Stapleford doctors was done in
concert with the Home Office Drugs Inspectorate, which has overall
responsibility for supervising and regulating the use of controlled drugs
in the UK. The Home Office employs area inspectors, whose job is to liaise
regularly with all doctors using controlled drugs.
Sources at the Stapleford say they have always had good relations with
their inspector, and there was no hint that they were under investigation.
However, the clinic's relations with the head of the Home Office Drugs
Inspectorate, Alan Macfarlane, have been less cordial.
According to the Home Office, Macfarlane, a civil servant, has visited the
centre once, in 1997, 'on a liaison basis'. But one Stapleford doctor says,
"It seems that if one tries to open a dialogue, it's not reciprocated."
The Home Office Drugs Inspectorate is widely regarded as being antagonistic
towards the private practise of addiction treatment.
In the 1980s there were about 50 private practices in Britain. There are
now fewer than 20. And in the past three years some half-a-dozen private
doctors have been struck off following GMC action.
Perhaps the most controversial case was that of Adrian Garfoot, who was
struck off in September 2001 after 25 years of treating hundreds of
long-term users both in the NHS and as a private practitioner. Garfoot had
already faced a five-year Home Office inquiry under the mechanism of the
Misuse of Drugs Tribunal, in which he was eventually acquitted.
When the Home Office prosecutions failed, the case against him was taken up
by the GMC, which, while accepting that Garfoot had acted on what he
believed were the best interests of his patients, concluded that his
prescribing was irresponsible. The tribunal was abolished shortly
afterwards, with the government accepting the recommendation that
henceforth reliance would be placed on the GMC 'to provide an effective
remedy'.
Critics claim that the Home Office had 'moved the goalposts', and was
turning to the GMC to act as its 'enforcer'. The Home Office denies that it
has lodged any complaint about the Stapleford with the GMC. But it is
believed that evidence has been submitted to the GMC by Police Chemist
Inspecting Officers. These 'pharmacy inspectors', as they are sometimes
known, routinely monitor all controlled drug dispensing as recorded in
pharmacy registers, reporting unusual supplies to the Drugs Inspectorate.
"They are likely to pay closer attention to private prescribing than NHS
[prescribing] on account of the historic difficulties of the private sector
dating back to the 1960s," a Home Office spokesman says. And one source
claims to know of a case where a pharmacy inspector in Norfolk specifically
stated that he was looking for evidence to "stop Dr Brewer prescribing".
Critics of the Stapleford argue that it was almost inevitable that its
liberal prescribing practices would eventually bring it into conflict with
the establishment. "They have a reputation of being eccentric in their
prescription practices, and in prescribing drugs in certain unusual
combinations," says one NHS psychiatrist.
There are criticisms, too, that the Stapleford did not have the resources
effectively to monitor patients on long-duration prescriptions, and ensure
that they were not selling on their supply. "It's impossible to say that
with the number of patients we've had over the years that no one has ever
sold or shared their methadone with a friend," Tim Willocks admits. "Like
any human community, addicts tend to look after each other. Many of them
have partners who are addicted.
But that goes on with NHS patients, too."
The most serious charge facing the clinic concerns Grant Smith, the patient
who died the age of 29 during DIY home detox in August 2001. Home detox,
the GMC maintains, 'should only be performed in a setting in which there is
provided trained nursing and medical care'.
According to the charge, Brewer prescribed 16 different drugs, including a
range of sedatives, among them Rohypnol, for the treatment.
Smith's mother was provided with written instructions for the
administration of the drugs.
But three days into the programme she telephoned Brewer to advise him that
the supply of Rohypnol was running low and that her son was having
difficulty sleeping.
Brewer spoke to Smith and agreed to prescribe two more sedatives, Temazepam
and hemineverin, but, it is alleged, he failed to advise his parents that
hemineverin was an alternative to, not additional to, the Rohypnol. Smith
took the new medication and a few hours later died in his sleep, as a
result of choking on his own vomit.
At the inquest in Northampton the following June, the coroner recorded a
verdict of death by misadventure but noted that "no specific instructions
were given to either of Grant's parents about the administration of
Temazepam... any alteration to medication should be discussed personally
with the carer".
"It's a prime aim at the Stapleford to make detox comfortable for
patients," says Bill Nelles of the Alliance, "and in contrast to NHS
centres they have been prepared to be relatively generous with the sedation
that is often necessary to get people through it. What appears to have
happened here is a tragic misunderstanding. But when you look at how many
of Stapleford's patients have died over the years, it's been a very small
number.
And if you look at how many patients in the care of the clinic, hard drug
users on injectable prescriptions, are still alive 10 years on, the answer
is nearly all of them. And in some NHS clinics there does seem to be much
higher levels of patient mortality."
Drug addiction experts agree that the irony in the Stapleford case is that
the clinic should have found itself before the GMC at a time when NHS
practice, in theory at least, is beginning to accommodate some of the
principles which the Stapleford has practised for years.
"There has been a definite shift in NHS thinking," Nelles says. "The
problem is, in my opinion, they don't say it robustly enough.
We now have the science to say that heroin addiction is a chronic relapsing
condition - all the doctors know that. But if you say that to the general
public, how much incentive is that going to give a 23-year-old who is
strung out on heroin to try to stop?"
Even Colin Brewer's harshest professional critics express a regret that his
career could end in a disciplinary hearing.
Brewer can be arrogant, you hear it said; he is not the most diplomatic man
in the field, but nobody doubts that he is a brilliant and a conscientious
doctor who has always had the best interests of his patients at heart.
"Whatever the rights and wrongs of the case, it's a great shame," says one
NHS psychiatrist, "because Colin's been an innovator in a very positive
way. He's been an inspiring person to me."
Among the Stapleford patients there is a very real concern that should the
clinic be forced to close as a result of the GMC action, there is no
existing provision to deal with their cases, and they will be forced to
look to the black market instead.
One patient, who has been on a maintenance programme of morphine and
dexamphetamine for the past 12 years, collecting his prescription once a
fortnight, while holding down a stable job in the IT field, says that he
would struggle to find another practice that would provide the same
treatment. "And if I couldn't, I'd just get an illegal supply."
Nelles shares the patients' concerns. "What the NHS are saying is that
these people have never tried to fit into our programmes, but we've changed
now. They may be right. But certainly those Stapleford patients who are on
things other than methadone will have a hard time getting those drugs from
the NHS. Of the 300 or so Stapleford patients, I would say 100 of them have
clinical needs that the NHS does not presently seem prepared to meet."
For Tim Willocks, the GMC case has done what literary success could not. He
says that whatever the outcome of the case, he is so disillusioned that he
is now contemplating quitting medical practice altogether.
It seems clear that Colin Brewer, too, will never practise medicine again.
One colleague describes him as "a broken man".
"Dr Brewer," he says, "is a doctor who has spent a good proportion of his
life and career promoting humane treatments for drug addiction problems,
and seeing himself as part of the medical profession and expecting to be
respected by his peers and other organisations for what he's doing.
To have that thrown in his face and be almost humiliated by the government
body is a terrible blow."
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