I Think You'll Find It's a Bit More Complicated Than That (30 page)

Hartnoll et al. (1980) studied ninety-six addicts randomised to oral methadone (OM) or heroin maintenance (HM). After twelve months, 74 per cent of the HM group were still attending, but only 29 per cent of the OM group had maintained contact with the clinic. For both groups, illicit heroin use decreased, in the HM group from 74 to 21 mg/day, but in the OM group from 74 mg to 37 mg/day. There was no difference between the two groups in employment status, but over the course of the year 32 per cent of the OM group had spent some time in prison, whereas 19 per cent of the HM group did so.

Perneger et al. (1998) studied fifty-one patients randomised similarly to heroin or methadone for six months in Geneva in 1995. At follow-up, there was a significant difference in use of street heroin, with 48 per cent of the OM group using street heroin on a daily basis, as opposed to 4 per cent of the HM group (p = 0.002). There was also a significant difference in the amount of money spent on drugs between the two groups, with the OM group spending approximately ten times the amount of the HM group (p = 0.039). Associated with this, the HM group were less likely to be charged with theft (p = 0.015) and less likely to be charged with drug dealing or possession (p = 0.067 and p = 0.008 respectively); overall, 57 per cent of the OM group were charged with any offence over the course of the six-month trial, whereas 19 per cent of the HM group were charged (p = 0.0004).

There was also a significant difference in mental-health status, with six suicide attempts in the OM group, against one in the HM group (p = 0.022). Finally, health-related quality of life was measured with the SF-36 scale, which found a greater improvement for the HM group in mental health (p = 0.025) and social functioning (p = 0.041). There was no differential improvement in employment status, housing situation, or somatic health between the two groups over six months.

McCusker and Davies (1996) found similar results at a clinic in Northern Ireland over six months. The HM group manifested lower levels of psychopathology and showed greater retention in treatment, criminal activity was significantly more reduced, as was illicit heroin use, and although there were again no differences in physical health, the OM group was the only one to report the sharing of used injecting equipment.

Thus our three trials demonstrated many advantages to the prescription of heroin, and none to methadone.

Conclusions

Clearly there are stout grounds for scepticism concerning the validity of prescribing methadone in the treatment of heroin addiction. It is also clear that there is a paucity of research in this field, a failure which must surely be redressed.

There are certain things of which we can be certain. Heroin is the most attractive drug for heroin addicts, and however we might wish them to behave, they continue to use illicit sources of the drug even if a substitute is prescribed. Methadone is undoubtedly a dangerous drug, and one that retards entry of addicts into the treatment programmes offered; it is also a drug whose effects have not been comprehensively researched. Heroin maintenance may well prove to be the best option we have.

Drug addiction is not a phenomenon that lends itself generously to empirical investigation. Even the outcome indicators are a subject for debate, and a viable study of what many would see as the ultimate index of success, abstention, would require a trial lasting more than a decade.

However, quantifiable indices of health status, social functioning, criminal behaviour, total opiate consumption, needle-sharing and so on are all viable and uncontroversial outcome measures, and should be comprehensively investigated for methadone and heroin. Furthermore, no indications have been found that prescribing heroin would inflict harm of a kind that might make such trials unacceptable.

Perneger et al. (1998) have noted that although the Swiss trial was small, it was similar to the initial evaluations of methadone, such as the seminal paper by Dole and Nyswander (1965), which led to its widespread use in the treatment of drug addiction. It seems likely that a contributory factor was the medical profession’s emotional and moral attitudes towards drug users.

However noble our intentions when we approach a clinical or social problem, we may often be confounded by extraneous factors and preconceptions, and fail in our objectivity. We share an obligation to submit all medical interventions to rigorous, continuous and objective reassessment. Drug addiction affects 100,000 people in Britain directly, and many more indirectly; it is responsible for an enormous drain on health-care resources, a large proportion of acquisitive crime, and the fastest-growing group of HIV infection. That we should apparently neglect our obligations in such an important field is astonishing.

LIBEL

NMT Is Suing
Dr Peter Wilmshurst. So How Trustworthy Is This Company? Let’s Look at Its Website . . .

Guardian
, 11 December 2010

You will hopefully remember – from the era before WikiLeaks – that US medical-device company NMT is suing NHS cardiologist Peter Wilmshurst over his comments about the conduct and results of the MIST trial, which sadly for NMT found no evidence that their device prevents migraine. The
MIST trial was funded
by NMT, and Wilmshurst was lead investigator until problems arose.

Wilmshurst has already paid £100,000 of his own money to defend himself, risking his house, and has spent every weekend and all his annual leave, unpaid, dealing with this, at great cost to his family. So what kind of a company is NMT Medical, which the British libel courts have allowed to hound one man for almost two years? And how trustworthy are its utterances?

Let’s
go to its website
and find out. On the front page you will see positive quotes from three patients prominently displayed, on a rotating banner (reload the page to see the full collection), accompanied by smiling studio photographs.

At this point we should remember that the
outcome of the MIST trial
– the study in question here –
really was negative
. It set out to see if the device permanently prevents migraine. One hundred and forty-seven patients with migraine took part. Seventy-four had the NMT STARFlex device implanted, seventy-three had a fake operation with no device implanted, and three people in each group stopped having migraines. The NMT STARFlex device made no difference at all. This is not a statement of opinion, and there are no complex statistics involved.

This might also be a good point to mention that the journal
Circulation
had to publish
a lengthy correction
for the MIST trial because the original paper failed to mention, for example, that Wilmshurst had declined to be listed as an author over concerns about how the study was conducted; that two of the devices were lost in patients’ bodies during the procedure (one embolised to the right atrium, one to the left pulmonary artery, both worrying, both were luckily able to be retrieved); and so on.

Back to NMT’s three positive case studies with their smiling studio photographs. They were all (it explains in the
2005 NMT annual report
) treated with the STARFlex device in the MIST trial. Jean Richards says: ‘I feel so much better now. I don’t live in fear of a migraine coming on all the time.’ Zoe Willows says: ‘People at my new job have never known me to have a migraine. I’m a totally different person.’

There are several problems here. Firstly, two of these patients, it seems, are advertising devices they were not treated with. Jean is smiling and advertising CardioSEAL, a successor to the failed STARFlex device, although she was not treated with CardioSEAL; and Liz is advertising BioSTAR, but she was not treated with BioSTAR. I asked NMT why these patients were advertising products with which they were not treated. NMT declined to answer.

Secondly, the patients’ anecdotal experiences are entirely misleading: the MIST trial was negative (though I can find no mention of its final results anywhere on the NMT site, which is odd, because it’s the only published trial I’m aware of that tests whether NMT’s device prevents migraine).

But lastly, the protocol for the MIST trial, as is standard, states that the sponsoring company is not supposed to have access to individual patients. How did NMT get hold of these patients?

I tried to contact Dr Michael Mullen, previously of the Royal Brompton Hospital, now of University College London Hospitals, cardiologist on the MIST trial, to see if he knew how these patients hit the public domain, since the RBH website has a page – hurriedly removed since I contacted them – stating that the MIST trial results were positive (these appear to be initial results, from before the final paper was published), and also featuring the patient Zoe Willows saying ‘I’ve now been completely cured.’ Dr Mullen himself appears in a smiling studio shot on the NMT website, and in 2008 declared owning shares in NMT. I invited him to criticise NMT’s use of misleading patient anecdotes. He declined. I asked if he knew how the company got hold of the patients, or how these positive results appeared on the RBH website. He said he could not remember.

So I asked NMT. It told me that all three patients got in touch with the medical-device company themselves, spontaneously. I asked NMT if the three patients whose migraines stopped after the fake operation had also got in touch to express their gratitude, because they might be able to provide useful and less misleading anecdotes. NMT declined to answer.

I could then have asked Dr Andrew Dowson, the new lead investigator on MIST, whose licence to practise was
restricted by the GMC
at the time of the MIST trial, as he had been found guilty of research misconduct in an earlier clinical trial. But by then I was exhausted, and not sure it was worth it.

Meanwhile, NMT’s share price has
fallen from $20
to 20 cents over four years, perhaps unsurprisingly after the negative results of the MIST trial. A judge has now insisted that the company puts £200,000 into a UK account in case it loses its libel case against Dr Wilmshurst, or the case will be struck out next month, but NMT’s solicitor argues that the company’s financial situation is ‘dire’. This suggests that even if Dr Wilmshurst successfully defends himself, he may never get his £100,000 back. I’m not convinced that a libel law which allows a company like NMT to do this to one man is in society’s best interests.

‘We Are More Possible Than You Can Powerfully Imagine’

Guardian
, 29 July 2009

Today the Australian magazine
Cosmos
, along with a vast number of other blogs and publications, reprinted an article by Simon Singh, in slightly tweaked form, as an act of solidarity. The British Chiropractic Association has been suing Singh personally for the past fifteen months, over a piece in the
Guardian
in which he criticised the BCA for claiming that its members could treat children for colic, ear infections, asthma, prolonged crying, and sleeping and feeding conditions, by manipulating their spines.

The BCA maintains that the efficacy of these treatments is well documented. Singh said the claims were made without sufficient evidence, described the treatments as ‘bogus’, and criticised the BCA for ‘happily promoting’ them. At a preliminary hearing in May to decide the meaning of this article, Mr Justice Eady ruled that Singh’s wording implied that the BCA was being deliberately dishonest. Singh has repeatedly been clear that he never intended this meaning, but has been forced to defend this single utterance, out of his own pocket, at a cost that has run to six figures.

Soon we will get to the story of the backlash, but first, while you may view this as a free-speech issue, there are also some specific worries raised when people sue in medicine and science.

It is possible in healthcare to do great harm, while
intending to do good
, and so medicine thrives on criticism: this is how ideas improve, and therefore how lives are saved. The three most highly rated articles in the latest chart from the
British Medical Journal
are all highly critical of medical practice. Academic conferences are often bloodbaths. To stand in the way of ideas and practices being improved through critical appraisal is not just dangerous, it is disrespectful to patients, and even if someone has been technically defamatory in their wording, it is plainly undesirable for all critical discourse in healthcare to be conducted in a stifling climate of fear. Neither the General Medical Council nor the British Medical Association has ever sued anyone for saying that their members are up to no good. I asked them. The idea is laughable.

But beyond whether it is right, there is the more entertaining issue of whether it was wise, and here it is hard to contain a sense of
Schadenfreude
as the chiropractors’ world unravels. First, there is the media exposure. This case, and the chilling effects of libel threats in science, have now been covered by
The Times
, the
Daily Mail
, the
Daily Telegraph
, the
Independent
,
Nature
, the
Economist
,
Times Higher Education
, the
Sunday Times
,
Channel 4
, the
Financial Times
, the
Wall Street Journal
,
Private Eye
, the
Observer
, the BBC, and an editorial in the
British Medical Journal
, to name just a few. This story has travelled around the world.

Most of these articles and programmes drew attention to the evidence for chiropractic’s efficacy, which is often not compelling. Some discussed chiropractic’s dubious origins: it was invented by a magnet therapist, convicted of practising medicine without a licence, who suddenly decided in 1895 that 95 per cent of all diseases are caused by displaced vertebrae, and compared himself to Christ, Mohammed and Martin Luther. Who knew?