sign in sign up
<<
Home , Bad Pharma

Izindaba

How and regulators fail clinicians Generalists daily make poor while discussing challenges in the ethics as ‘a cancer at the core of evidence-based evidence-based decisions of medical generalism at the 16th National ’. She said Goldacre outlined because regulatory and ethics Family Practitioners conference in the myriad ways in which regulatory committees fail them and Observatory, Cape Town, on 11 May this and research ethics committees let the drug companies habitually year. She said that one of the significant profession down, while numerous studies misrepresent products. The pervasiveness challenges in generalism was the growing involving routine treatments (she singled of this perversion – at least overseas – is best base of easily accessible scientific data, of out antidepressants and ) were deeply illustrated by the equivalent of R131.4 billion which a significant proportion is unreliable. flawed and ‘presented in a skewed direction’. in healthcare fraud settlements made by The ability to critique this data was vital Goldacre estimates that 25% of the massive pharmaceutical corporates in the USA to evidence-based medicine, and doctors/ global turnover of the pharmaceutical over the last 10 years, with the most recent clinicians faced a major dilemma in sifting industry goes to advertising and promotion, individual company fines breaking all out what was falsely presented to them. which translates inter alia to incentives to records. Citing what she termed ‘a favourite book of doctors in the form of gifts, promotional Professor Keymanthri Moodley, head mine’ (Bad Pharma by epidemiologist Ben meetings and conferences, overseas travel of the Centre for and Goldacre),[1] she said that positive findings expenses (including spouses and partners), Law in the Faculty of Health Sciences were twice as likely to be published as sponsored hospital grand rounds and at Stellenbosch University, revealed this negative findings, which Goldacre describes other clinical meetings, and even holidays.

440 July 2013, Vol. 103, No. 7 SAMJ Izindaba

Companies draft study protocols and centre of a network of specialists, medical very hard not to intervene.’ The ethos of trial results for lead investigators to sign funders, and companies medical generalism focused on empathy off, with negative and non-supporting and the . Given this which she described as ‘the intelligent use of results buried and not published. Under web of relationships, conflict was bound to insight into the whole setting of the patient’s such circumstances, doctors are no arise. However, the basic guiding principles plight,’ engagement (or a commitment to better than ordinary consumers, he says. in generalist-specialist disagreements included active involvement in every aspect of the Goldacre provides examples to show patient welfare and best interests, and mutual patient’s care), an appreciation of the GP’s that the industry, profession, research integrity and respect. She urged more limits (understanding and acknowledging ethics committees, medical journals and experienced doctors to become aware that the specialist aspect of care) and knowing regulatory authorities lack vigilance in the they acted as ‘role models’ to students and when to refer a patient. Every GP also design, conduct, analysis and interpretation young doctors who ‘watch us and will replicate had to deal with ‘end of life’ issues; she of clinical studies. inappropriate behaviour’. With generalism emphasised the role of patient autonomy Moodley said that, as a result, and in often regarded as ‘the stepsister’ in healthcare in exercising both the right to life and the pursuit of evidence-based medicine, ‘we may provision, inappropriate remarks were right to a dignified death. Organisations sometimes do more harm than good to our sometimes made by specialists with respect across the globe, especially in Switzerland patients’. She said it was getting worse, citing to generalist referral notes and generalists. She (Dignitas)[4] and Europe, had evolved where some of the most recent billion-dollar fines said it was vital that health resources were used ‘anyone with 10 000 Francs can go and paid by major pharmaceutical companies in ‘appropriately and prudently,’ and referrals deliberately choose to end their life, usually the USA, many of them repeat offenders who were one area where social relationships in the terminal phase of an illness’. ‘End of seemed to write off such punitive measures and specialist touting could contribute to life/suicide tourism is a reality. It’s happening as ‘a mere cost of doing business’. On 2 July suboptimal care. The ultimate responsibility in a more transparent and powerful way than last year, GlaxoSmithKline (GSK) agreed to for co-ordinating patient care lay with the ever before. We’re all comfortable with a plead guilty to three criminal counts for referring doctor. ‘Increasingly problematic’ was patient’s right to life but we need to deal with sales of misbranded Paxil (paroxetine) and specialists becoming the first point of contact their right to end their lives when they so Wellbutrin (bupropion) – drugs promoted for patients and actively encouraging patients desire, especially in the context of terminal for indications for which they had not to book appointments with them instead of and debilitating illnesses,’ she added. been approved by the FDA (aka off-label via their GPs. Dignitas offers assisted suicide to any promotion). Under both criminal and civil member (including foreigners) suffering from charges, they paid today’s equivalent of a terminal or unendurable illness who wishes R28.3 billion to the federal government and to end their life and suffering. They use a participating states. At the time this settlement lethal, fast-acting and painless barbiturate was announced, 25 major companies and dissolved in drinking water. Each permitted 8 of the top 10 global pharmaceutical use of the medication requires a Swiss companies were under ‘corporate integrity doctor’s prescription, an in-depth evaluation agreements’, a routine part of settlements of the member’s written request and medical for healthcare fraud, typically requiring information, and at least two face-to-face enhanced compliance activities within the meetings with Dignitas’ doctors. The member company for 5 years, including reports to the must be of sound judgement and possess a government from an independent monitor. minimum level of physical mobility (sufficient GSK also pleaded guilty to failing to report to self-administer the drug). safety data on Avan­dia () and Professor Moodley said her ‘take home’ violating the Food, Drug and Cosmetic messages were to critically appraise Act. [2] A year earlier, biotechnology company scientific evidence that guides generalist paid R235 million in a settlement clinical care and to encourage teamwork over whistleblower allegations that they in healthcare provision, ‘especially where paid kickbacks to longterm care generalists and specialists work together in a to increase the use of an anaemia drug in Professor Keymanthri Moodley, head of the complementary manner with mutual respect nursing homes. Amgen allegedly pressured Centre for Medical Ethics and Law in the Faculty and open communication for the benefit of pharmacists to recommend Aransep of Health Sciences at Stellenbosch University the patient’. (darbepoetin alfa) for nursing home residents (photo by Chris Bateman). who did not have anaemia associated with Chris Bateman chronic renal failure, and distributed materials Another challenge for generalists was [email protected] and sponsored programmes promoting other professions taking on additional 1. Goldacre B. Bad Pharma: How Drug Companies Mislead Doctors this off-label use of the medication. (The responsibilities, e.g. pharmacies that offered and Harm Patients. London: Fourth Estate, 2012. company denied all allegations as part of the a wide and welcome range of screening tests 2. Outterson K. Punishing health care fraud – is the GSK settlement sufficient? N Engl J Med 2012;367:1082-1085. settlement). In December last year, Amgen but where pharmacists often indulged in 3. FiercePharma. Amgen whistleblower went undercover for the settled another suit for R7.187 billion and diagnosis and therapeutics. ‘I often stand at feds. http://www.fiercepharma.com/story/amgen-whistleblower- went-undercover-feds/2012-12-20 (accessed 20 May 2013). accepted a corporate integrity agreement. A the counter and listen to people 4. http://www.dignitas.ch/index.php?option=com_content&view=a third case against them is pending.[3] presenting symptoms in full earshot of all rticle&id=20&lang=en (accessed 20 May 2013). Moodley said a second major challenge present, and I am amazed at how pharmacists faced by generalists was their relationship come up with diagnoses (and then dispense S Afr Med J 2013;103(7):440-441. with specialists. GPs found themselves at the without examining patients); I have to try DOI:10.7196/SAMJ.7099

441 July 2013, Vol. 103, No. 7 SAMJ