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May 2018 Archives

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 sigificant 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

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A couple of days ago I had a chat with a journalist that resulted in my being quoted - along with Dr Shaun Holt - in this story about purveyors of Kangen water. If you believe the hype, this stuff cures a wide range of ailments & leaves you bright-eyed & bushy-tailed. IF... but sadly, these days personal anecdote seems to count for more than that nasty stuff called evidence, and so many do believe the hype.

The Whanganui Chronicle quotes someone selling Kangen water machines (for $4,000A a pop!) as follows:

"I'd go through two 2.25 litres bottles of Coke every day. That was my normal diet."

Then a cousin in Raetihi told her to try Kangen water and she was hooked straight away.

"I feel a lot more alert - it's given me more of a zing within my body."

Yes, well, as Mark Hanna (who blogs on Honest Universe) commented on Twitter,

The Chronicle comments that the manufacturers of these machines provide fliers that make various claims: that the water they produce has proven therapeutic benefits for "more than 150 diseases including cancer, diabetes and cardiovascular disease". (Seems to me that making therapeutic claims might be stretching the boundaries of the Medicines Act...) And they claim that the water has these effects because

it restore[s] the drinker's body to a more alkaline state. 

Now, the problem with that particular claim (based, ultimately, on misunderstanding &/or misinterpretationB of Otto Warburg's work on tumour metabolism) is that your stomach operates at a low (very acidic) pH. Quaff a glass of alkaline water? It'll likely be neutralised when it hits your stomach. In addition, your body's lungs & kidneys maintain tissue pH within a very narrow range; excess hydrogen (H+) or hydroxyl (OH-) ions are excreted in urine, but the tissue pH remains pretty much constant. So those glasses of expensive H2O will keep you nicely hydrated (& feeling good), but they won't be doing much else, & certainly not making changes to your body's tissue pH, though there may be temporary changes in the urine.

Wikipedia has a good article on how these machines actually work. Basically, they are electrolysing tap water as it passes through them. However:

The effectiveness of the process is debatable because electrolysis requires significant amounts of time and power; hence, the amount of hydroxide that could be generated in a fast moving stream of water such as a running tap would be minimal at best.

They're also highly unlikely to produce 'hexagonal water' (despite claims from head office, that one is chemical quackery), or significantly affect the oxygenation status of your tap water (another claim about the Kangen machines). Plus, as Ben Goldacre once commented (in a different context), you don't have gills in your gut.

Honestly, there are so many resources out there that assess the claims for alkaline water - and find them wanting - anyone considering buying one of these things would find it easy to some due diligence first. (You could start with Skeptoid's explanation, or follow some of the links I've provided.) Then, hopefully, you'll put the $4K back in your bank account, and drink a nice glass of chilled tap water. 

 

A I venture to suggest that once you've bought a machine, there's a significant incentive to keep pushing the product regardless.

B One R.O.Young made a lot of money on the back of pushing that one.

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While I was on holiday (Japan - it was wonderful!) - I read Tom Haig's interesting article about 'curriculum wars' over on Education Central, and it reminded me of the concerns I've held for some time that we don't really talk enough about what to teach in our classrooms, be they university-level or in the secondary sector. 

Several years back (how time flies!) I was involved in developing the 'Living World' component of the New Zealand Curriculum document, as well as entering into the discussions around what the science component of that document should deliver. (Right down to a discussion of what it actaully is to 'do' science.) At the time I was somewhat taken aback to discover that the panel was not required to give any exemplars for teachers, any indication of what they might do to help students master particular concepts - something that's noted by Tom. Yes, I totally get it that schools are free to set their own curricula, but at the same time I couldn't halp thinking that the occasional 'starter for 10' might be useful.

Layered on top of that - & amplified by my experiences in relation to developing and assessing Achievement Standards for NCEA, was the way that while new content or concepts might be loaded on up-front, we didn't seem to remove stuff at the other end. This had the result that the amount of information associated with a standard might just grown & grow (CRISPR, anyone?). Pretty much the same thing tends to happen at university - if you look at one of the standard first-year biology textbooks, Campbell BiologyA, you'll see that it's become steadily thicker over time as new material's added. (In my experience, at least some first-year uni lecturers argue that all the basic stuff should be delivered at school; they shouldn't have to teach that. However, this sits poorly against the fact that no NZ universities have any prerequisites for their first-year biology papers, and also suggests that those making the statement don't really recognise that not all year 13 students are heading for university. Remember, schools have the ability to shape their curricula to suit the needs and requirements of their individual communities.)

In other words, we didn't seem to be having any discussion around what should be taught, and why. And we still don't, although hopefully such issues will be addressed in the review of NCEA. For, as Tom Haig says:

Working out what we should be teaching, and why, is something that we should be discussing together and taking much more seriously as teachers than the second place it's taken to discussions of technique. Hattie, ERO, the Best Evidence Synthesis and so forth are filled with advice about 'how', but shouldn't we be thinking just as hard about 'what'?  

A No relation! I was privileged, though, to meet the late Neil Campbell when he visited New Zealand, and was struck by what a wonderful educator he was. 

 

 

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