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May 1, 2004
Pharmaceutical Technology Europe
For more than 30 years, Charles Medawar has been calling to account the corporate world - and in particular the international pharmaceutical industry. His UK-based campaigning organization, Social Audit, has been one of the most prominent and prolific critics of profit-based medicine worldwide. With his latest denunciation - specifically of the marketing of Lilly's Prozac and GSK's Seroxat, but more generally of the inadequacies of contemporary medicines' regulatory systems - he has come close to scoring a direct hit. This summer should see the results of official British, European and US investigations into this class of antidepressants, in the face of mounting evidence regarding their side-s. Because Medawar locates his criticisms of these particular medicines within his general argument about regulatory passivity, laxity and hesitancy, widespread repercussions can be expected if negative conclusions are reached by the ongoing investigations by major drug control agencies.
Selective seroton reuptake inhibitors ( SSRIs ) in the dock The first Social Audit alerts regarding these medicines date back more than 7 years, in the light of adverse effect reports: weight gain, loss of libido, sensory disturbances and mood swings, even suicidal feelings. Since then, Medawar and his colleagues in sister organizations such as Health Action International have been painstakingly trawling for evidence, quizzing regulatory authorities and compiling the results.
The main thrust of the criticism is presented in a new book, "Medicines out of Control?" ( http://www.haiweb.org), which charts the promotion, regulation, prescribing and use of mood-regulating drugs. "The problems antidepressant users now face are largely the making of the present systems of medicines control. The nature and magnitude of these problems signal the urgent need to inject pharma-ceutical medicine with a dose of democracy and to subdue commercial pressures in the interests of health," says Medawar.
What Medawar is calling for is "an overhaul of the secretive and profoundly inadequate system of medicines control," and hopes the unfolding crisis of dependency on antidepressants will prove to be a watershed. In questioning the adequacy of the official action taken so far, he raises basic questions about the competency of drug regulators and the lack of transparency in tackling user dependency and complaints in many countries.
"Drug benefit-risk assessments are increasingly made on the strength of evidence that is hugely incomplete and highly partial, using evaluation procedures that are often chaotic and misconceived," he alleges. "Drug safety and effectiveness is, in part, a myth sustained by entrenched secrecy, the dominance of vested interests, misplaced optimism and an overwhelming lack of public accountability." He documents what he claims is "scrutiny that is often badly flawed;" official neglect of "the risks of dependency on antidepressants when user evidence suggests the contrary; the refusal of drug regulators to take account of valuable evidence from users;"and "failure to take stock of the extent of iatrogenic illness."
There is a familiar ring to Medawar's charge that the results of much scientific research on medicines is tainted because most is financed by a pharmaceutical industry seeking products that will generate sales. But the gravity of concerns regarding selective serotonin reuptake inhibitors lends a new resonance to his rhetoric. Recent research suggests the number of users affected by drug withdrawal reactions from GSK's paroxetine (Seroxat/Paxil) is dramatically greater than earlier estimated.
Reliable medicines control in the dock too "The turning point can be quite precisely dated - it came with a heavy flurry of revelations between October 2002 and the summer of 2003. If there was a pivotal moment, it was probably 25 June - when GSK quietly published a small print amendment to the prescribing instructions for Seroxat. The company had upwardly revised its 2002 estimate of the risk of withdrawal reactions - from 0.2% to 25%. The official risk of Seroxat/Paxil withdrawal problems had increased overnight from 1 in 500 to 1 in 4," underlines Medawar. And he goes on to demand: "What does it reveal about the quality and direction of medical science and the reliability of the medicines control system that - in spite of all the fuss and the precedents - it took more than a decade to identify a prominent and potentially hazardous adverse drug reaction that affects one user in every four?"
And against this background, some of the other equally familiar Social Audit allegations take on a new significance: secrecy about drugs' benefits and risks, inadequate and insufficiently independent postmarketing surveillance, and undue focus on commercial considerations at the expense of health considerations. The arguments are carefully marshalled to support some alarming suggestions.