By Alison Campbell 30/05/2018


Over the last few years, OracA has written quite a bit about the so-called ‘right to try’ legislation that has been enacted in many US states – and, as this post of his describes, will now most likely become a thing at the federal level.

(I say “most likely”, given President Trump’s history of wanting to significantly reduce FDA regulations and his support of ‘right to try’.)

Orac describes the legislation as a ‘cruel sham’, and if you read the post I’ve linked to, you’ll see why. Basically, under this legislation a drug need have no evidence of safety or efficacy to be a ‘right to try’ medication; only evidence that it’s not dangerously toxic. In addition, patients have no come-back if such a drug should make them sicker, do permanent harm, or be a cause of death. Nor can the Federal Drug Administration use any such negative results in making a decision to allow its use in the healthcare sector without having to justify this to the relevant Secretary.

As Orac says, this last is totally backwards: “In other words, the burden of proof is on the FDA, not the company seeking approval for its drug, as to why right-to-try outcomes should be included.” And it’s likely that this ‘right’ would be available only to those who can afford it or are particularly effective fund-raisers. Certainly sounds pretty cruel to me.

After commenting that

Right-to-try was, is, and has only been very little about actually helping patients. Rather, it’s always been far more about dismantling the FDA and giving drug and device manufacturers more freedom to market drugs and devices with much less testing than it has been about helping patients

Orac concludes by saying that he fears that the outcome of this bill becoming law will

leave the FDA in a state so weakened that a new age of snake oil will be ushered in under the delusion that the free market will guarantee drug safety.

It will almost certainly make it easier for the purveyors of pseudoscientific ‘treatments’ to make money off the suffering and fears of desperate people. (More money than they already do.)

And it makes me wonder, why do we seem so unable to remember the lessons of history? After all, there is a reason for the existence of the FDA. The recent book Quackery: a Brief History of the Worst Ways to Cure Everything (Kang & Pedersen, 2017) amply demonstrates why the US first implemented the Pure Food & Drug Act in 1906, & subsequently transformed the relevant watchdog organisation into the Food & Drug Administration in 1930. The FDA hasn’t eliminated quackery, but certainly plays a significant role in reducing its reach. I found this particular book both informative and shocking. (It also includes a little too much ‘cutesy’ phrasing for my taste, but that is probably just me.)

America (probably in company with many other countries) had a real problem with ‘patent medicines’ back in the 19th and early 20th centuries, when the free market very definitely did little to guarantee drug safety. Labels and advertisements that were false &.or misleading beguiled consumers into buying all sorts of nonsense; food often contained unsafe ingredients; and both foods and medicines were adulterated. Take the radium craze, for example. Products containing radium were sold for all sorts of supposed health issues – including radium suppositories to cure ‘sexual indifference’ in women! Or you could buy a combination of ‘animal glands’ tablets (possibly containing testicular material…) and radium supplements that would help “weak discouraged men bubble over with joyous vitality” (Kang & Petersen, 2017) Kang & Pedersen describe the case of wealthy industrialist Eben Byers, who routinely drank several bottles of the patent radium-containing medicine Radithor every day, convinced it was good for his health.

When he died in 1932, having drunk 1500 bottles of the stuff over a five-year period, the once strong & vigorous Byers weighed just 42kg. His kidneys had failed, his brain was abscessed, the bones of his skull were eroded and pitted with holes, and in an attempt to stop cancer spreading surgeons had removed most of his jaw. His bones were so radioactive that he was buried in a lead-lined coffin.

This high-profile death was followed by swift FDA action to remove Radithor from the market and block further production. As the authors note, this doesn’t mean radium doesn’t have legitimate medical uses, because of course it did and still does, in the treatment of some cancers. But this use is highly regulated and has science to back it.

Quackery includes a host of other examples: strychnine (as a ‘supplement’ for marathon runners and in the Victorian equivalent of energy drinks – and in “JEMS – Nature Engergiser Pep Tablets”, touted to “Married Men & Women” to help them enjoy life, especially night life); tobacco (promoted in a totally innocently non-ironic way back in the 1570s as a cure for cancer); and enemas & colonic irrigation as a means to ‘detox’ – sadly, these last ‘treatments’ remain a mainstay of alt.med cancer treatments such as the Gonzales protocol. It’s an alarmingly long list. Many of the offerings examined by Kang & Pedersen claim to cure cancer, & it’s here that the ‘right to try’ legislation will probably have its first real impact. After all, a cancer diagnosis is a scary thing in itself, & hearing the word ‘terminal’ associated with it can be terrifying. In similar vein to Orac, Kang & Pedersen comment that

There will always be quacks out there ready to take full advantage of human desperation before science and medicine can find solid solutions.

There will indeed; see here, here, & here. Obviously the FDA isn’t perfect: these examples exist despite that organisation, which came into being to help protect consumers, and similar regulatory bodies elsewhere. And as Orac points out, this new US legislation will only make it easier for them, and others, to thrive there.

 

A Orac’s actual identity is pretty much an open secret to those who regularly read his blog.

L.Kang & N.Pedersen (2017) Quackery: a Brief History of the Worst Ways to Cure Everything. Kindle edition, ASIN: B06XDX2X15