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- The Times 10th October 2015
Posted by Michael Fitzpatrick on 04 March 2014
This is a guest blog from our trustee Dr Michael Fitzpatrick
The success of Dallas Buyers Club – which won three Oscars this week – reflects the enduring power of a number of myths surrounding Aids and its treatment, and the roles of Aids activists ranged against the malign forces of Big Pharma, the medical establishment and the regulatory bureaucracy.
Combining elements from the genres of fairy tale, pantomime and the Western, Dallas Buyers Club celebrates the life of Ron Woodruff, Texas redneck electrician and rodeo rider (he’s the one wearing the white Stetson cowboy hat) who was diagnosed with Aids in 1985 and ‘given 30 days to live’. Woodruff (Matthew McConaughey) has a fondness for beer, whiskey and cocaine, and a penchant for strippers and hookers. Though at the outset he shares the homophobic and misogynist prejudices of his peers, he achieves redemption through the inspirational influences of Rayon (Jared Leto), a transgender drug addict, and Eve (Jennifer Garner), an idealistic junior doctor (who still wears her hospital white coat when she visits her patients in their seedy motel rooms).
Woodruff is outraged at the lack of availability of treatment and the callous obstructiveness of the twin villains of the piece, the hospital specialist supervising an early drug trial (boo!) and the suit from the Food and Drug Administration (hiss!). In response, Woodruff conducts his own research in the local library and then dresses up in black as a vicar (of course!) to smuggle alternative treatments into the USA, first from Mexico and later from around the world, to be distributed to a booming market of customers through the scam ‘Dallas Buyers Club’. In defiance of both the odds and the authorities, Woodruff outlives his grim prognosis by seven years: our last glimpse is of him at the rodeo riding – bareback (geddit?) – a bucking bull.
The central myth promoted by this film is the notion that AZT (azidothymidine, or zidovudine) is an ineffective and toxic - ‘poisonous’ – treatment for Aids. It is implicitly blamed for Woodruff’s deterioration, his heart attack and Rayon’s death. In fact, AZT, a reverse transcriptase inhibitor, is one of the great success stories of modern medicine: the product of earlier research into cancer treatments, it underwent preliminary (‘phase one’) trials in humans in 1985 (only a year after HIV was identified as the cause of Aids) and was then the subject of a randomized control trial (as depicted in the film). This study reported favourable results in 1987, when AZT was licensed by the FDA (a process normally taking years reduced to an unprecedented 25 months). More than 25 years later, AZT remains the mainstay of Aids treatment – now usually in combination with other drugs – and it is also widely used to prevent mother-to-child transmission of HIV and in post-exposure prophylaxis. Like any drug, it has adverse effects, though these are mostly relatively minor and generally reversible. There can be little doubt that AZT has saved thousands of lives and has played a key part in the transformation of Aids from being a rapidly fatal disease to a chronic condition with a good long-term prognosis.
Dallas Buyers Club presents a disparaging portrayal of the randomized control trial (RCT) process through which AZT was introduced. It implies – inaccurately - that it was unethical to ‘fast-track’ AZT into human trials because earlier animal studies were inadequate – a criticism that runs counter to the familiar condemnation of the FDA for bureaucratically delaying the introduction of new treatments. The film also implies that there is something unethical about half the patients in an RCT being given a placebo, when, of course, this is intrinsic to the RCT method. It is not that half the patients are being denied an effective treatment, but that the only way to discover whether the treatment is effective is to compare the outcome in two groups, one receiving the active agent, the others not, in conditions in which neither they, nor their doctors (hence ‘double blind’) know who is getting what. At the conclusion of Dallas Buyers Club a feeble caption appears indicating that AZT is now used at lower doses than were used in the early trials – but this too was something learned from trials conducted when nobody knew what doses were appropriate, not the result of activist pressures.
There are many legitimate criticisms that can be made of the FDA and of the development of AZT – notably of the ways in which Burroughs Wellcome (later subsumed in Glaxo Smith Klein) made extraordinary profits out of research largely carried out in government, university and non-profit agencies (see Marcia Angell, The Truth About the Drug Companies: How They Deceive Us and What To Do About It, p24-27). None of these criticisms is made in Dallas Buyers Club.
The second set of myths presented in Dallas Buyers Club concerns the alternative Aids treatments presented as superior to AZT: these include ddC (dideooxycytidine, or zalcitabine), peptide T (dala1-peptideT-amide, or Dapta), and alpha interferon. All these drugs are variously gobbled up or injected by Woodruff in the course of the film. In fact, ddC turned out to be less effective than other reverse transcriptase inhibitors and to have more serious adverse effects – it is now rarely used. Though Peptide T was claimed to have beneficial effects on patients with cognitive impairments, studies showed it was no better than placebo (except in relation to a small group with more severe dementia). Though extravagant claims have been made for interferon in a wide range of conditions, its efficacy in Aids has not been established.
In an early episode in Dallas Buyers Club, Woodruff visits a clinic in Mexico run by a disgraced former US doctor, who, in addition to prescribing some of the above drugs, claims great benefits to his Aids patients from a combination of vitamins, minerals and herbal preparations. It is ironic that this regime is similar to that promoted under the aegis of former South African president Thabo Mbeki – for which he has been stridently condemned by Western Aids activists.
McConaughey and Leto richly deserve their Oscars for their bravura performances in Dallas Buyers Club. But just as, like many Hollywood productions, this film reveals brilliant actors in search of a decent script, its popularity reveals a society in search of a mature understanding of the relationship between science and medicine, on the one hand, and capitalism and the state, on the other. Fairy tales are reassuring to children, but Woodruff’s self-indulgent posturing, like that of the wider Aids activism that this film endorses, reflects an evasion of the realities involved in the treatment of Aids. These realities are that academic and clinical researchers (however self-serving), pharmaceutical corporations (however venal) and government regulators (however corrupt) have delivered remarkably effective treatments for Aids, over a remarkably short time period.