Fawlty Stars

December, 13, 2020 | 3 Comments


  1. I can’t say I’ve studied ALL these responses — that’ll take some time! But a couple of points in Dr. Barbui’s response (the first one) struck me as classic Defensive Medicine — defending the medical-industrial complex, that is. And being unable to imagine a different path:

    First, if he believes that “nobody in the world” thinks decision-making for real-world patients should be steered by the results of the latest trials? I’d like him to meet some doctors over here. They have been willing to turn on a dime and transfer millions of people from “normal” to “high-risk” on the strength of some rather dodgy clinical trials. Especially when it comes to blood pressure and blood sugar standards. I’m just one person, but already know three people who’ve been rushed to the hospital with sudden hypo-glycemia as a result of shiny new meds for Type II diabetes, ushered in with strict new blood-sugar limits.

    Some of their doctors may be fools — but others may have no choice. Their marching orders are given to them by their hospitals, their private practices or the insurance company.

    I’m also struck that he can see no alternative to the current dependence on flawed clinical trials. Except a return to the Bad Old Days when every doctor relied on their own habits and customs, and their resulting skewed view of what “experience” had taught them. It’s not as though you want to ban RCT’s. But even if you did, he acts as though that means banning Research Itself! Of course it doesn’t.

    There are lots of other forms of research–including research that looks to find the basis for the responses that we see in the natural world. Drug companies benefit from that research but they don’t do a lot of it. They concentrate on research that results in Product Development. Maybe one reason RCT’s have become so over-valued is that they’re so well suited to Product Development.

    The current Covid-19 crisis shows how well that is serving us (NOT). There’s so much we don’t know yet about vulnerabilities to the virus, how it spreads, who is most infectious, why it’s so benign in some people and deadly in others … Yet billions have been wasted on RTC’s of every biologic drug in the book that some drug company wants to squeeze another billion out of. Some of them with fairly extreme side effects. Not to mention the billions we’ll now spend on Remdesivir (in the US at least) which required huge trials to demonstrate an itsy-bitsy advantage.

    Imagine how far along we might be if we’d put the billions elsewhere. Including the scientific study of adverse effects, which may answer all kinds of good questions we just hadn’t thought to ask yet.

  2. Fawlty Towers or Faulty Towers ——which need rebuilding?

    The comments are such an interesting and tough read ,am still reading in chunks. I imagine most are more detailed than always the case which proves there is a serious interest . Something we /everybody couldn’t access any other way. When it clicked I realise this is a totally new way of dealing with peer review. It is more democratic, more open, it is free. there is a huge array of feedback as opposed to having to satisfy a few reviewers chosen by journals or other editors. The reviewers /commentaters were invited from a huge pool giving a more useful feedback . In most? publications which invite comments even these are ‘edited’ Could this kind of publishing be extended to become a Journal? I imagine calling it a Samizdat Journal would frighten the horses , some contributors and commentators would be put off – or start contributing anonymously. All the reviewers/commentators here were happy to put their names and organisations. There could still be contributions made to the what could become the old fuddy duddy journals or they my even be encouraged to copy a new more relevant style more accessible to everyone as well as experts and practitioners. In baby steps maybe. Normally interested outsiders have to rely on finding a publication – then going through masses of references – wonder how many of them get read even by those working on the subject.?
    Hope we get more like The Fault Lies in Our Stars from DH Rxisk and others who might be influenced to have ago.

  3. And then something unexpected happened. The Randomized Controlled Trials became the gold standard for everything – called Evidence Based Medicine. Randomized Clinical Trials are hardly the only form of valid evidence in medicine. That was a reform idea that kept people from shooting from the hip, but was also capable of throwing the baby out with the bathwater.

     It’s an abnormal situation on purpose, suitable for the yes-no questions in approval, but not the for-whom information of clinical experience.

    The commercial strangle-hold…


    Structured RCTs may well be the best method for our regulatory agencies use to evaluate new drugs. They cost a mint to do and about the only people who can fund them are the companies who can capitalize on success – the drug companies. But medicine  doesn’t need to  shouldn’t buy into the notion that they’re the only way to evaluate the effectiveness of medicinal products. As modern medicine has become increasingly organized and documented, there are huge caches of data available. And it’s not just patient data or clinic data.

    What about the pharmacy data that’s already being used by PHARMA to track physician’s prescribing patterns? And where are the departments of pharmacology and the schools of pharmacy in following medication efficacy and safety? or the HMOs? or the Health Plans? the VAH? What about the waiting room questionnaires? I’d much rather they ask about the medications the patient is on than being used to screen for depression. It’s really the ongoing data after a drug is in use that clinicians need anyway – more important than the RTC that gets things started.

    So while it’s important to continue the push for data transparency and clinical trial reporting reform, it’s also time to explore other ways of gathering and evaluating the mass of information that might free us from the commercial strangle-hold we live with now – and potentially give us an even better picture of what our medications are doing over time.

    There’s a way out of this conundrum. The task is to find it…

Leave a Reply