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Monday, 25 March 2013

Another view of Side Effects - a cautionary tale from Soderbergh

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.
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.

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