Below are extended comments arising from a Guardian interview by Laura Barnett in the Another View series.
I went to see the Soderbergh film Side
Effects expecting a story about drugs and serious side-effects: a version
of the Constant
Gardner translated from Africa to New York.
Instead I was completely absorbed in a much more complex thriller set
within the overlapping worlds of big Pharma, psychiatry, US private medicine,
and financial fraud.
The title is very clever, hinting
not only at side effects of drugs, but also side effects of lax medical and
financial regulation, of a private medical system, of love of money, and of
one-to-one interactions of doctor with patient.
A key message of the film: public and
professionals should keep an open mind on cause, consequence or incidental link
between drugs and side effects.
Jude Law portrays his character Dr
Jonathan Banks as flawed but well-meaning and a very astute medical detective
when challenged and able to see beyond the US psychiatric culture he is shown
as having accepted after training in the UK. When pressed on why has moved to
work in the US, he talks about the US as taking a more positive view of health
care than the UK, commenting on a greater optimism among US physicians that
patients will return to health, rather than his view of the UK where he says
clinicians are resigned to illness as the model.
This appears simplistic as Banks
also appears drawn by the prospect of greater financial gain within the US
private system. He is likely to have moved from a UK NHS, with in the main more
severely ill patients referred to him by family doctors, within the UK
treatment for all model, in contrast to the US where many of his private
outpatients would be likely to be direct self referrals with many nearer the
healthy end of the mental health spectrum (ie without GP screening of whom to
refer). And in the US having chronic severe disease may lead to patients being
no longer able to afford to be seen privately.
This thriller uses a smokescreen of casual interactions among psychiatrists and drug researchers in Pharma, serious risk of powerful drugs, especially in vulnerable patient groups (specifically young people with depression), the judgement of patients and prescribers such as Jude Law’s Dr Jonathan Banks being clouded by financial conflicts in the dominantly private US health system, compounded by direct-to-patient advertising, and the impact of peers on preference for medicines. Both peers as friends of a patient, and advice with little supporting evidence from professional peers such as Catherine Zeta-Jones’s ‘opinion leader’ Dr Victoria Siebert during her contact with Law’s Dr Banks at an educational meeting.
This thriller uses a smokescreen of casual interactions among psychiatrists and drug researchers in Pharma, serious risk of powerful drugs, especially in vulnerable patient groups (specifically young people with depression), the judgement of patients and prescribers such as Jude Law’s Dr Jonathan Banks being clouded by financial conflicts in the dominantly private US health system, compounded by direct-to-patient advertising, and the impact of peers on preference for medicines. Both peers as friends of a patient, and advice with little supporting evidence from professional peers such as Catherine Zeta-Jones’s ‘opinion leader’ Dr Victoria Siebert during her contact with Law’s Dr Banks at an educational meeting.
Worth noting that Law’s Dr Banks
starts by using an older established treatment for depression with an SSRI
(thought to help depression by raising the level of the brain transmitter
serotonin at nerve endings). It is only when this appears to be causing
unacceptable side effects that he takes advice from Siebert and uses a very new
drug - ablixa.
There are several potential risks of private
medicine portrayed in the film:
- Rooney
Mara’s Emily threatens to move to another doctor if Jude Law’s Dr Banks does not
agree with her treatment preference, a move that would result in loss of income
for Banks.
- A
patient’s ‘informed’ consent to take part in a study being run by Law’s Dr
Banks (for a personal fee) is biased by being told by Dr Banks that she won’t
have to pay for drugs (much more expensive in US) – or tell her health
insurance company (with the risk that she would have her premium increased),
although Banks does mention his conflict of interest in telling the patient
that he is receiving money for carrying out the trial;
- doctor
colleagues ostracize Banks because of concerns about losing business ie
patients.
The film raises concerns about US pharma industry
strategy to promote selling of drugs, flawed ethics from industry and
clinicians in engaging in research ‘studies’ and questions about safeguards in
place, especially for new medicines and for people at high risk of side
effects, but also at high risks of complications if their disease is not
treated.
Side effects can be good or bad – e.g. unexpected
and surprising benefit of sildenafil (Viagra) when trialed for angina – or in
this film the apparent increase in sex drive associated with a drug prescribed
by Jude Law’s character. We see good practice with a dispensing pharmacist
listing side effects for Rooney Mara’s Emily – including some unpleasant,
others beneficial [although a list spoken too rapidly for a depressed patient
to follow].
A better term for harmful effects of drugs is adverse
drug reactions (ADRs). These are common and may be serious – estimated in the
UK to be a major cause of ~10% of hospital emergency medical admissions or
delayed discharges from hospital. The thalidomide scandal led since 1964 in the
UK to a yellow card reporting system, with everyone, including patients now
empowered to report suspected concerns.
The UK has the advantage of
stronger efforts to regulate cost-effectiveness and safety of medicines than
shown in the film – joint efforts of:
-
National Institute for Health and Clinical
Excellence (NICE) (since 1997; and other agencies
in Scotland and Wales);
-
MHRA monitoring system, its
suspected adverse drug effect reporting Yellow Card scheme in place since 1964;
-
direct marketing to the public of
prescription only medicines being illegal in UK.
-
and in prospect aims from 2015-2016
for a public database of payments from Pharma to health professionals – which would
help to reveal conflicts of interest in prescribing, research
and medical education
In UK, a new drug such as the ‘ablixa’ in the
film would at least during the 2 years after launch have had a ‘black
triangle’ warning to prescribers to report any concerns about major or
apparently minor adverse drug reactions to the government’s Medicines Agency.
Useful weblinks
Medicines and Healthcare Regulatory Agency Patients
concerned about possible drug-related unwanted side effects from psychiatric or
other drugs should talk to their doctor or pharmacist. Members of the public
can also use the online Yellow Card system to report directly to the
government Medicines Agency any serious or worrying problem suspected to be due
to a medicine, whether or not mentioned on a patient information leaflet about
a drug.
UK All
Trials initiative – recommends that all trials
should be registered, and full methods and all results reported.