Excluding opium, (which the Creator himself seems to prescribe… as if it were foreseen that wherever there is hunger to be fed there must also be a pain to be soothed) … I firmly believe that if the whole materia medica [medical drugs], as now used, could be sunk to the bottom of the sea, it would be all the better for mankind,—and all the worse for the fishes. Harvard Medical School dean, 1860
This is a man who hadn’t experienced the wonder of penicillin, or appreciated commercialization of aspirin for quick and easy pain relief, so the quote from Oliver Wendell Holmes Sr is merely quirky. The opioids have become contentious today, as though dictated by fashion, but dissent on the merit of miraculous pills is a constant. Psychiatrist and pharmacovigilante David Healy wrote with exasperation on the irresponsible prescription of meds for mental health, using images of hanging victims to drive home their accompanied risk of suicidality. After an outcry his next post ‘Spectre of Dissent’ used pictures of self-immolation, such as a Buddhist monk protesting the Vietnam war, in order to emphasise the seriousness of medication harm, legally, by doctor’s orders.
In 1996 Pfizer rushed researchers to trial their experimental antibiotic Trovan at a meningitis outbreak in Nigeria. Ethical approvals were forged, and the drug trial comparator was only administered at 1/3rd the standard dose. Similar numbers of recipients of Trovan died as those in the (undertreated) control group, and the FDA approved the drug for adults although not for children. Within one year, over 100 cases of acute liver failure led to withdrawal of any approval. The Nigerian govt was given $75m to settle the case. The horror/thriller plot of the film, described by its author thus: “by comparison with the reality, my story [is] as tame as a holiday postcard“, stemmed from Pfizer’s damage control by discrediting the Nigerian prosecutor – done in collusion with the US ambassador. Considering that the corpse shown hanging had their genitals cut off and stuffed in its mouth as an inducement to keep quiet, wow.
This was a human rights abuse. “Happens all the time” was the response of Monash’s School of Public Health biostatistics Professor to my concern at another atrocity. Billion dollar fines have been about as worthless as a tax on criminality. A cost of doing business. Trump’s appointee to head up the FDA, Scott Gottlieb, was universally acclaimed as a good choice. But his ‘user-pays’ concept of charging pharma for their time, $905m for reviews in 2017, has been accompanied by a threefold drop in rejections since 2010.
Does fast-tracking approvals carry a greater risk?
Undoubtedly, yes. But that must be weighed against the harm of delay. A dozen years are easily lost between the translational research breakthrough, through safety and then comparative benefit studies, before availability to the public. The question of risk vs benefit becomes a moot point though, when regulators are not sufficiently independent from industry influence. The Drug Utilisation SubCommittee reports to PBS on the subsidies for the market, the consumer patients testing ground. It’s chaired by a Professor who’s taken Pfizer sponsorship for a study, and writes on the benefit of branded over generic, but omits mentioning the commercial conflict of interest. Double standards are rife.
Under AHPRA rules, testimonials are banned: no reviews, or views on a service provider. Head of Victorian AMA, Dr Julian Rait knows it’s OK for a review on a third party website that he does not control – Google reviews clearly aren’t promotional. They can be brutal. Sharing experience is very much in the public interest, and Rait’s recent reply to my memo on open disclosure (‘Duty of Candour’) was appropriately candid. Telstra’s HealthEngine is an alternative service however it is indeed an advertising & booking service, since negative reviews are edited out.
The non-response on this matter from AHPRA chair Dr Joanna Flynn (an aide stating that “All registered medical practitioners are expected to abide by the [Good practice] code)” is merely wishful. And they endorse HealthEngine’s censorship, ostensibly to remove clinical performance ratings, but in effect encouraging a smokescreen for shoddy conduct.
In the UK there’s a statutory Duty of Candour – when a medical error is made, a conciliatory conference is enforceable. It affords a learning opportunity for the contrite doctor, although apologies are non-prejudicial i.e. not an admission of guilt. Our regulatory body in Oz maintains exclusivity on registered practitioners – no public ratings, and all complaints dealt with behind the scenes. An incredible dismissal of an AHPRA complaint and then an expert physician making contentious, unsubstantiated on-air comments led to my testing procedural rigour through such a complaint. Again, dismissed as it was “reasonable for the Prof to proffer an opinion“. Except that this wasn’t a personal, but a professional, opinion that was disparaging to complementary medicine.
Perhaps medicine will one day be called before a Royal Commission, so as to expose the kickbacks paid to advisors, much as financial services has been. I’m overwhelmed by the ‘smoke and mirrors’, and am off to do a ‘snow job’ myself. A real one, as an honorary ski patroller, at the mountain retreat of Mt Stirling. I’ll return after contemplation of humanity’s evils. Geoff