False dawns: implications for patients of the Theranos debacle
BMJ 2022; 376 doi: https://doi.org/10.1136/bmj.o178 (Published 21 January 2022) Cite this as: BMJ 2022;376:o178
All rapid responses
Rapid responses are electronic comments to the editor. They enable our users to debate issues raised in articles published on bmj.com. A rapid response is first posted online. If you need the URL (web address) of an individual response, simply click on the response headline and copy the URL from the browser window. A proportion of responses will, after editing, be published online and in the print journal as letters, which are indexed in PubMed. Rapid responses are not indexed in PubMed and they are not journal articles. The BMJ reserves the right to remove responses which are being wilfully misrepresented as published articles or when it is brought to our attention that a response spreads misinformation.
From March 2022, the word limit for rapid responses will be 600 words not including references and author details. We will no longer post responses that exceed this limit.
The word limit for letters selected from posted responses remains 300 words.
Dear Editor, The entire sequence of happenings, so revealingly narrated, reflects gullibility of humans- both folks and professionals too. With the prevalent culture of overindulgence in foods and drinks, and known 'perils of plenty ' such as obesity, Metabolic Syndrome and T2 DM, stress on minds in an atmosphere of advertised fitness or 'being superfit' , the craving for getting self-tested is visibly obvious. As much as the right method of estimation, the 'interpretation ' is crucial ; ' a slightly elevated LDL, borderline raised fasting sugar, early changes suggestive of fatty liver ' can easily set the tone for endless testing and follow up, coupled with self perpetuating anxiety that can contribute to ' vitiating laboratory profile'. Another area is the ' longevity bug ' if not the 'fountain of youth' where aging, the single most important unidirectional risk factor is promised /attempted to be ' stopped, reversed and banished', but not without multiple tests often on an repetitive basis. Screening, rightly advised, after evaluation has been a boon, but there exist situations of 'overdoing'. Public force can be overwhelming and when combined with conniving commercial intent, can be disturbing and damaging to health concerns. The case illustrated leaves many a lesson to be learnt, particularly for regulatory authority for the vigilance to be exercised and corrections to be made. Dr Murar E Yeolekar, Mumbai.
Competing interests: No competing interests
Thank you for pointing to what we all should have seen!
Dear Editor
I was embarrassed then outraged when Dr. Richards' message sank in - embarrassed that I hadn't thought of it myself, because it's so outrageous. Now I've been looking for the jurors' rationale, and haven't found one. Surely something in the regulatory framework needs patching, as surely as literal snake-oil needed to be banned. At least investors know that they're taking a chance - patients are supposed to be protected. If we can't isolate the point of regulatory failure here, we can't fix it.
In the past year I've tumbled down a different rabbit hole - ophthalmology - and have found similar outrageous inconsistency. I experienced botched cataract surgery (posterior capsular rupture (PCR) with retained fragments, known in the profession as "a dreaded complication" [1], which led to vitrectomy, and which required insertion of my replacement lens in the sulcus, i.e. not at the correct focal length.
I know that accidents can happen but I was astounded to discover in my research that PCRs happen in about 1 case in 90! There is no requirement that this common complication (which four academic articles call "dreaded") be clearly publicised before the operation. It's not patient perspectives that are top priority in this lack of policy.
It gets worse. As a possible consequence of the PCR and vitrectomy, or perhaps unrelated, months later I developed macular edema in that eye, requiring eye drops, one of which apparently rapidly killed 30% of the optical nerve in my left eye, destroying its peripheral vision and leading to chronically elevated pressure in the eye, requiring multiple daily eye drops for the rest of my life. And here's the kicker: I've since learned that delivery of medication into the eyes via eye drops is haphazard and poorly regulated. [2]
I could go on about this (my own self-education is barely started), but suffice it to say that all the informative insights and literature links I've found have come not from public health or private health or regulators but from an online community of empowered, engaged patients. [3] From them I've learned that drops dispensed from common bottles are often too large, leading to waste and side effects as described in that article.
On a completely different aspect, the entire industry is lax and inconsistent about the importance of "punctal occlusion" after eye drops - pressing the edge of the eye to ensure drops don't drain out. Many patients say they've never been told; meanwhile it's not a factor at all in clinical trials of efficacy and side effects, yet numerous YouTubes by esteemed ophthalmologists augustly say we must do it for 2 minutes, or five, or ten .... all based on no scientific studies at all! What the heck!
It's a reversion to the 1900s practice of "eminence-based medicine" instead of evidence-based.
It really is outrageous, and I strongly suspect that the "mechanism of failure" in policy is that everything is fine for the people in the industry until patients start trying to understand their bodies and be responsible .... and ask questions
And this is precisely why the Holmes verdict - no criminal consequence for defrauding and harming patients - is a disaster. Can we find out the legal rationale and work to repair it?
And yes, as you say, this certainly does make me doubt the credibility of any test that hasn't been around and validated. Which could be death to startups.
1. https://www.hindawi.com/journals/joph/2019/1594152/#introduction
2. https://www.npr.org/sections/health-shots/2017/10/18/558358137/drug-comp...
3. http://www.fiteyes.com
Competing interests: No competing interests