Page 46 Daily Mail, Tuesday, August 27, 2019
IT’S HIGH TIME MEDICS
By JOHN NAISH
SPECIAL
INVESTIGATION
REVEALED:
drugs don’t
are funded
... and, as this
report reveals,
a treatment for
depression using
Class B drug
ketamine is just
the latest example
and expenses from Janssen in- Such transparency matters,
for while drug company funding is
vital to the creation of new drugs,
UK health professionals, regulators
and the public need to be able to
fathom whether an expert opinion
is potentially biased.
This need not be deliberate or
done in a corrupt way, but the fact
is that evidence shows drug
company links can influence expert
opinion in ways that may be so sub-
tle as to be subliminal.
For example, a review in 2017 by
the highly respected Cochrane
group concluded that clinical
trials tend to find more favourable
A
brighT hope has
suddenly appeared
in depression
therapy: the ‘party’
drug, ketamine.
Known best as a horse
tranquilliser, it is also
used as an anaesthetic
in hospitals.
but ketamine can cause
soaring highs and is used illegally,
with potentially nightmarish
results; the drug is addictive and
can trigger psychosis.
recently, leading depression
experts lined up at a London
briefing to explain how an
engineered version of the drug,
called esketamine, promises a
breakthrough in providing fast-
acting help to sufferers of
treatment-resistant depression.
This severe form of depression
carries a very high risk of suicide.
Around a third of those affected
will attempt to kill themselves at
some point, according to Dutch
research published last year.
At the briefing, the experts
declared that while conventional
SSri antidepressants can take
weeks or months to take effect,
esketamine, a ketamine-type
nasal spray, may bring enduring
benefits within hours.
This made headlines in UK
national newspapers and The
bMJ. Myriad internet news sites
then swept the excitement
around the world.
Newspapers reported Professor
Allan Young, director of the
Centre for Affective Disorders at
the institute of Psychiatry, Psy-
chology and Neuroscience, King’s
College London, telling the brief-
ing: ‘We haven’t had anything
really new for 50 or 60 years.
What’s particularly exciting is the
arrival of a new type of treatment;
and that’s ketamine.
‘it’s got a different pharmacol-
ogy. it’s not just the same old
steam engine. it seems to workin a different way and it seems to
work more quickly.’
Dr Carlos Zarate, head of
experimental therapeutics at the
U.S. National institute of Mental
health, who conducted the first
clinical trial of ketamine for
depression in 2006, added his
authoritative voice, saying:
‘Ketamine is now the prototype
of the future generation of
antidepressants that will
h a v e rapid robust effects within
a few hours.’
The third expert, Dr rupert
McShane, a consultant psychia-
trist and associate professor at
the University of Oxford, who
runs the UK’s only experimental
ketamine clinic for depression,
was quoted saying that although
there were safety concerns about
the drug, ‘Ketamine, in my
experience, and esketamine,
according to the data, are potent
and potentially transformative
antidepressants’.DOES FUNDING
BIAS RESEARCH?
WhAT was not made clear in
reports of the briefing is
that Professor Young, Dr
McShane and Dr Zarate have
conflicts of interest that could
potentially compromise their
independence as advocates of
ketamine and esketamine.
A document issued at the
briefing acknowledged that
Dr McShane and Professor
Young have links with Janssen-
Cilag, the maker of esketamine,have been paid by Janssen and
have conducted trials for it
that bolstered claims for
esketamine’s usefulness.
Such links are far from
uncommon nowadays. however,
they are an increasing concern
because studies show that when
research is funded by drug
makers, it is significantly more
likely to reach positive conclu-
sions about effectiveness and
safety of the funders’ drugs.
The need for transparency is
paramount when the drug
involved may cause serious side-
effects and potential addiction.
And even more so when the drug
is expensive: esketamine costs
an estimated £29,000 to treat a
patient for a year.
Janssen, a subsidiary of the
U.S. multinational Johnson &
Johnson (for which Professor
Young says he is a consultant), is
lobbying UK and European
authorities to have esketamine
approved for depression.
Dr Zarate may consequently
profit from this. he holds patents
entitling him to receive royalties
on future sales of ketamine-type
drugs for severe depression.
Professor Young, who is ‘ranked
as one of the world’s leading
scientific minds in the field of
psychiatry’ according to the
King’s College London website,
has made few previous public
disclosures of his links with
Janssen-Cilag.
he features frequently in
briefings hosted by the Science
Media Centre in London, a
charity that fosters communica-
tion between scientists and jour-
nalists, and while the recent
briefing set out his potential
conflict of interest, he has not
listed Janssen in his income
disclosures on Disclosure UK.
This online register was set up
in 2016 by the drug companies’
official body, The Association of
british Pharmaceutical industry
(AbPi) to create transparency,
by enabling healthcare
professionals to show payments
and hospitality received from
drug companies.
in his AbPi income disclosures
for 2016, 2017 and 2018, Professor
Young declares receipt of £14,700
from three other companies but
he does not mention Janssen,
despite having a research con-
tract with them from April 2016
to September 2017 for £163,635.DOCTORS ALLOWED
TO KEEP SILENT
UNDEr AbPi rules, he doesn’t
actually have to: individual
healthcare professionals can
require that information on
their payments be withheld —
without having to provide a
reason why.
The british Association for
Psychopharmacology, of which
Professor Young is president,
received £22,000 in sponsorship
last year from Janssen and had
Dr Zarate as the guest speaker
at its recent annual conference.
by contrast, Dr McShane’s
links with Janssen are compara-
tively easy to discern.
in several journal papers, he
lists himself as a principal
investigator for Janssen’s trials
of esketamine, and as a
consultant to the company.
his AbPi voluntary disclosure
shows he received £8,937 in feesMORE than four in ten British
health professionals who take
money from drug companies don’t
disclose those payments or say
where the money came from,
according to the latest figures.
The shocking statistic was
revealed in June by the Associa-
tion of British Pharmaceutical
Industry (ABPI), which runs a data-
base where drug companies dis-
close their payments to health-
care professionals — and where
those professionals can declarewhat they received in fees,
sponsorship and expenses.
There is no requirement that
they do so. Disclosure is voluntary
and doctors and researchers can
redact information that drug
companies give the ABPI about
any payment or relationship,
without having to give reasons.
Last year, 43 per cent of health-
care professionals did this — up
from just 35 per cent at the
database’s 2016 launch.
This is disturbing because studiesoutcomes about a drug
company’s products if the company
sponsors the trial. Moreover, an
editorial in The bMJ last year
warned that it is becoming increas-
ingly difficult to untangle the links
between drug companies and trial
research: ‘Without more
transparency, we risk undermining
the integrity of some of medicine’s
most influential research.’
but as Dr ben goldacre, the best-
selling author of bad Science and
campaigner for research transpar-
ency, told good health, we are often
on a cleft stick because we rely on
drug company funds to research
new therapies. ‘how are you goingV1