Does My Bias Look Big in This?

March, 18, 2020 | 15 Comments

Comments

  1. Excellent, as usual! Not many could put across these serious issues in such a homely way. I marvel at the way that you can change your language to suit your audience BUT THE SAME MESSAGE IS THERE LOUD AND CLEAR.
    Now to your audience. I take it there was a Q&A session once the recording was done? How did the audience react? Two walked out, as we saw (maybe with good reason) – I fail to see how anyone could walk out, unless in a crisis!, as, from beginning to end one is left wondering what new facts you are about to present.
    Knowing that these same facts have now been presented over the course of a few years – plus or minus a few facts as time/audience changes – how is it that so few ACKNOWLEDGE what you have to say or are willing to admit that they know who you are, even if they don’t like what you say?
    Do you feel that, at the time of giving a lecture/ talk, that you are winning over an audience and that they, on returning to their life outside the lecture hall, forget all about it? Or is it pressure in the workplace that causes them to put all that they heard to one side? I know that I keep referring to the times when you came to Prestatyn, but there the majority were amazed, shocked and believed – and are still talking about points that you made. There were two who come to mind who didn’t see eye to eye with what you had to say – both professionals, either in the medical world or involved with drug trials. That leads me to feel that the ‘blockage’ is to do with ‘brainwashing in the workplace’! It is also why I feel so strongly that the only way to move forward may well be to keep ‘ordinary folk’ topped up with these messages whenever possible.

    • The talk was in a hospital setting so some people will have been bleeped out. The Q & A was constructive. Clearly one of the themes will always be, well what do we do now and I don’t have or am not going to provide an answer for that.

      Will it make any difference – no. It takes too many people beyond a critical comfort zone. The trouble is there is no ready point of compromise. Do we encourage people to trust their own judgement or don’t we – there isn’t a half-way on this one

      D

      • I’m not sure that I can see an option – we’ve trusted the ‘professionals’ for so long only to find out that, in many instances, we were given false hope therefore it’s time to think for ourselves. That, to my mind, doesn’t mean that we don’t rely on expert knowledge to some degree, rather it means that we enter into a dialogue with the ‘professionals’, question matters that we don’t understand, share concerns that we may have regarding medications etc. The days of ‘them’ and ‘us’ should be gone – we must work together, us with them and them with us, all with one aim of improving standards of care. Maybe doctors NEED to see that we are fast waking up to what is going on ( and has gone on for far too long) and are no longer willing to meekly carry on with their suggestions of what is best for us.
        One question I would love an answer to is – how on earth do YOU carry on? Each lecture or talk that you give feels like the first time you’ve given it, as if you’re sharing some ‘new found truth’. You’ve been sharing the basics for many years now – adding new bits as they become relevant and yet the presentation continues to have the same energy time after time. It must be hard work – but much appreciated. Without your show of energy, I guess ours would have long disappeared too!

  2. It would be fine and dandy if the RCTs shown were put in to the boiling cauldron of a court of law. In the UK we have never taken a pharmaceutical company to court over a defective product. Not for want of trying.

    It will seem unbelievable that the law operates in mysterious ways and despite overwhelming evidence, that points of law come before the actual frauds committed. Since thousands have been catastrophically injured with Paroxetine, 67,000 emails to Panorama, all those years ago.

    http://news.bbc.co.uk/1/hi/programmes/panorama/3154053.stm

    This puts Paroxetine in a peculiar position.

    As I see it, the view is that lectures like this are for informative learning about RCTs and ghostwriters and the mountains of information that they should know. To make them think and realise that the undercurrents of SSRIs don’t make them the hale and hearty helper they are perceived as being.

    The Petitions by Marion Brown and Stevie Lewis. PHE and RCP reluctantly giving a little noise. NICE rewriting guidelines. Necessary steps.

    But they don’t address the fraud by GlaxoSmithKline having got approval for Paroxetine with shady write-ups, distorted RCTs and 329.

    All these years and no-one speaks about “Betrayal and Social Kapital” quote, Grand Round, and, K, a special K…

    Of course, it might have occurred to David’s audience, if that is the case with Paroxetine, why hasn’t there been a hue and cry.

    So all those who could talk about this ‘No-Show’, don’t.
    Those in high places; GSK will not form to their lips.

    Interestingly, the Government Chief Scientist is quoted as saying, yesterday –

    “But that’s still horrible, it’s still an enormous number of deaths and an enormous pressure on the health service, and having spent twenty years as an NHS consultant as well as an academic, I know what that looks and feels like.”

    https://www.fiercebiotech.com/special-report/patrick-vallance-glaxosmithkline

    As more than one research expert noted, Glaxo ($GSK) has been feeling the heat of blistering criticism for its past secretive ways. Bold action was required to help counter an increasingly dour public image, and Vallance has played a leading part in the drive to change the public’s perception of GSK.

    So, lots to talk about … in the ‘Grand Round’ of things …

    • Cherry-picked … ”did not apply any bias either”

      ‘It’s clear that GSK does not do that and the medical journals did not apply any bias either.’

      Setting the record straight…

      Sharing our trial results, regardless of whether they reflect positively or negatively on our medicines is the right thing to do.

      https://us.gsk.com/en-us/behind-the-science/how-we-do-business/setting-the-record-straight-why-we-publish-data-both-positive-and-negative/

      Patrick Vallance, President, R&D commented: “The results of this analysis allow us to challenge perceptions that pharmaceutical companies cherry-pick what is submitted for publication according to favourability towards their medicines. It’s clear that GSK does not do that and the medical journals did not apply any bias either. These results reinforce our strong belief that the scientific community can derive as much, if not more, insights from negative data as positive data, and we must continue to ensure access to all of our clinical study data involving patients, with the aim of ultimately benefitting patients”.

      With Transparency Pledge, Glaxo Makes Promises No Other Drug Company Has

      Matthew Herper Former Staff

      https://www.forbes.com/sites/matthewherper/2012/10/11/with-transparency-pledge-glaxo-makes-promises-no-other-drug-company-has/#e59d7b64b90b

      Putting GlaxoSmithKline to the test over paroxetine

      BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f6754 (Published 12 November 2013) Cite this as: BMJ 2013;347:f6754

      Blockbuster antidepressant paroxetine is no stranger to headlines. The drug is now back centre stage as requests for clinical data from one of its trials are testing manufacturer GlaxoSmithKline’s commitment to full transparency,

      Peter Doshi reports

      https://www.bmj.com/content/347/bmj.f6754

      Below is the exchange of letters between Jon Jureidini and GlaxoSmithKline between April 26 and November 8, 2013, in which Jureidini requests data from paroxetine study 329.

      https://www.bmj.com/content/347/bmj.f6754/rapid-responses

      Jorge Hernán Ramirez

      Professor of Pharmacology
      Universidad del Valle

      ‘Concerns expressed by other authors, regarding the efficacy and safety of antidepressant drugs in humans, are legitimate and well-founded.(3,4) The evidence in peer-review medical journals supporting the efficacy and safety of antidepressants in humans have been cherry-picked.’

  3. But bear in mind also that the cost of vaccinating a single child according to the schedule has gone up by more than a hundred times since the beginning of the millennium.

    https://www.bmj.com/content/366/bmj.l5576/rr-4

    The biggest spoke that Andrew Wakefield threw into the emergent project in 1998 was to suggest that parents might want to continue to pick and choose with single vaccines when the project required multivacs – which in themselves were a tool against choice. Of course, even by the standards of the pharmaceutical industry testing of vaccines was rock bottom, while compliance was all – the effort to remove choice is the pursuit of the millennium. Child health on the other hand is not so good. “Forwards, not backwards!” as Tony Blair used to say.

    • Talking of vaccines, and the present apparent rush to find one to stop the spread of Covid -19, what will we do? Will we stand strong and refuse it? Will we spread the word about the dangers of the substances within it ( if we know them)? Or will we oblige and turn up for our jab?
      Maybe more to the point – WILL WE HAVE A CHOICE? If we DON’T have a choice, how can we ensure that EVERY SINGLE PERSON has that right of choice taken away from them? We cannot allow ‘them’ to follow one rule whilst ‘they’, who are deemed superior, decide what is ‘good enough for the majority’ as, unfortunately, ‘good enough’ hardly ever is that.

      • Mary

        It is a very interesting and troubling point. In 2009 the Department of Health in the UK only managed to persuade about 10% of the population (~6m people) to accept Pandemrix although they had ordered 132m rounds.

        https://www.bmj.com/content/364/bmj.l1259/rr

        Of course, by that stage everyone thought the swine flu pandemic was pretty much a farce, but it does not actually follow when people are offered new vaccines in Africa for scary diseases like Ebola or Malaria that the immediate reaction is one of trust either. If, of course, the government try and force the new vaccine on people the trust will be even less, though I see for instance the Danish parliament have already legislated for it and thrown mandates for the established schedule opportunistically into the emergency legislation as well, in a great fit of communal virtue-signalling.

        Alas, even with a decade’s development the prospects for a non-lethal, effective SARS-CoV-2 vaccine would be virtually infinitesimal. It is wrong to tell people there will be one in 12/18 months, and even scarier if “they” actually mean it.

        https://www.linkedin.com/pulse/moderna-us-niaid-poised-endanger-world-population-james-lyons-weiler?trk=portfolio_article-card_title

        • Thanks John – this rush for a vaccine is the part that I find most worrying. I have a niece who is a medical statistician at a UK Uni., now working from home, whose workload is greater than ever because of all the work that’s being done by different groups at the Uni “on the science of Covid-19”. ‘The way to go far is by going slowly’ needs to be their motto I guess!

        • Pandemrix vaccine: why was the public not told of early warning signs?

          BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3948 (Published 20 September 2018) Cite this as: BMJ 2018;362:k3948

          https://www.bmj.com/content/362/bmj.k3948.full

          Eight years after the pandemic influenza outbreak, a lawsuit alleging that GlaxoSmithKline’s Pandemrix vaccine caused narcolepsy has unearthed internal reports suggesting problems with the vaccine’s safety. Peter Doshi asks what this means for the future of transparency during public health emergencies

          In October 2009, the US National Institutes of Health infectious diseases chief, Anthony Fauci, appeared on YouTube to reassure Americans about the safety of the “swine flu” vaccine. “The track record for serious adverse events is very good. It’s very, very, very rare that you ever see anything that’s associated with the vaccine that’s a serious event,”1 he said.

          Four months earlier, the World Health Organization had declared H1N1 influenza a pandemic, and by October 2009 the new vaccines were being rolled out across the world. A similar story was playing out in the UK, with prominent organisations, including the Department of Health, British Medical Association, and Royal Colleges of General Practitioners, working hard to convince a reluctant NHS workforce to get vaccinated.2 “We fully support the swine flu vaccination programme … The vaccine has been thoroughly tested,” they declared in a joint statement.3

          Except, it hadn’t. Anticipating a severe influenza pandemic, governments around the world had made various logistical and legal arrangements to shorten the time between recognition of a pandemic virus and the production of a vaccine and administration of that vaccine in the population. In Europe, one element of those plans was an agreement to grant licences to pandemic vaccines based on data from pre-pandemic “mock-up” vaccines produced using a different virus (H5N1 influenza).

          Another element, adopted by countries such as Canada, the US, UK, France, and Germany, was to provide vaccine manufacturers indemnity from liability for wrongdoing, thereby reducing the risk of a lawsuit stemming from vaccine related injury.45

          In …

          https://www.bmj.com/content/362/bmj.k3948/rapid-responses

          Thomas Breuer
          Chief Medical Officer, GSK Vaccines

          ‘We are concerned that publications such as the one in the BMJ could generate undue concern and negatively influence trust in vaccines and vaccination. GSK remains firmly committed to transparency of safety information but calls upon the scientific community, including the publications that serve that community, to ensure that the disclosure of such information is driven by scientific responsibility and integrity.’

      • I also think we need to urgently look at therapeutic solutions for this disease – I have just seen the highly successful results of an obviously small trial combining hydroxychloroquine and azithromycin. Things do seem to be spinning out of control. On Italy’s worst day on Saturday 561 people died of Covid-19 related illness in Lombardy which has a normal death rate of only 250-300 people a day.

        https://i.imgur.com/7TtEbEW.jpg
        https://en.wikipedia.org/wiki/2020_coronavirus_pandemic_in_Italy

  4. The Coronavirus Outbreak

    Gilead Withdraws Request for Special Orphan Status on Experimental Virus Treatment
    Critics said the company was profiteering from the coronavirus pandemic by seeking tax and monopoly benefits under a program intended to encourage drug development for rare diseases.
    Credit…David Paul Morris/Bloomberg
    By Katie Thomas
    March 25, 2020

    Bowing to criticism that it was exploiting the coronavirus pandemic, the drugmaker Gilead said on Wednesday that it would no longer seek orphan-drug status for remdesivir, an experimental drug that is being tested as a possible treatment.
    The Food and Drug Administration had only granted the special designation on Monday — which gives drug companies a seven-year monopoly on sales, tax credits and expedited approval. Gilead said it asked the agency to rescind the status.
    The company’s decision to seek orphan status for the drug had drawn immediate criticism. Senator Bernie Sanders of Vermont, who is seeking the Democratic presidential nomination, called it “truly outrageous,” noting that Gilead had received “tens of millions” of dollars from the federal government to develop the drug.
    The consumer group Public Citizen and other health groups sent a letter on Wednesday to Gilead’s chief executive, Daniel O’Day, asking him to reverse course. “This is an unconscionable abuse of a program designed to incentivize research and development of treatments for rare diseases,” the letter said. “Calling Covid-19 a rare disease mocks people’s suffering and exploits a loophole in the law to profiteer off a deadly pandemic.
    No treatment has been proved to be effective against Covid-19, the disease caused by the coronavirus, and Gilead is just one of several companies with drugs in trials around the world. More than 438,100 people have been sickened in at least 168 countries, according to official counts. As of Wednesday afternoon, at least 19,641 people had died.

    The Orphan Drug Act, passed in 1983, was intended to encourage development of drugs that treat diseases affecting fewer than 200,000 people in the United States. But in recent years, drug companies have been accused of exploiting the law to reap millions, if not billions, in sales. Companies have gotten orphan designation for products that were already blockbusters, including Humira, which has long been the world’s top-selling drug.

    Without orphan-drug status, a company like Gilead would receive five years of monopoly protection for a new drug approval.. A drug like Gilead’s remdesivir or another treatment could ultimately be administered to millions of people around the world over the course of the pandemic.
    In a statement, Gilead said it had sought the orphan status to expedite approval of the drug, in particular a required pediatric study plan that, without such a designation, the company said could have taken up to 210 days to complete. But Gilead said that after speaking to regulators, it was confident the application would move quickly.
    “Gilead recognizes the urgent public health needs posed by the Covid-19 pandemic,” the drugmaker said. “The company is working to advance the development of remdesivir as quickly as possible and will provide updates as they become available.”

    Peter Maybarduk, the director of a Public Citizen program that advocates for global access to medicines, rejected the company’s argument that the requirement that it complete a pediatric study plan — which would be waived with an orphan designation — would have slowed the process. “We have to know whether a drug may affect children differently than adults,” he said. “Gilead should not have been looking to skip this step in the first place.”

    Remdesivir is being studied in several large-scale clinical trials around the world, including in a huge trial announced last week by the World Health Organization. But the results have not been reported yet, and it is still unclear whether the drug works against the coronavirus. It was studied to treat Ebola, but it did not work well enough against that virus.

    Last week, President Trump promoted the drug as one of a handful that might work against the coronavirus. Gilead has been inundated with requests for “compassionate use” access to the drug from doctors with dying patients who are desperate to try anything that might help.
    This past weekend, Gilead said that the overwhelming demand had created a backlog and that it was switching from approving access on a case-by-case basis to a system in which patients would be approved in large groups. But that new program has not yet gotten underway, leaving some doctors and patients scrambling. A Gilead spokeswoman said on Wednesday that the company’s goal was to have the broader program up and running at some sites in the United States this week, with others to come after that.

  5. Around two weeks ago the power to be given to police was being described as powers of ‘sectioning’ members of the public It was not coupled to mental health. The word ‘sectioning’ has now disappeared relating to the public in general and replaced with powers to ‘arrest’. The suggestion that powers to section those who opposed authorities using a mental illness tag had obviously been flagged up It is is a stark reminder of what happens in totalitarian states . But People who do have mental health issues are going to be in a perilous position with these new powers already in force from today. The increase in forcible medicating is more than likely along with increase in sections.

    PUBLISHED: 16:54, 25 March 2020 | UPDATED: 21:35, 25 March 20
    Emergency coronavirus powers are set to come into law after being approved by Parliament today.

    The Coronavirus Bill passed its final legislative hurdle this afternoon after it was approved by the House of Lords.

    The changes include reducing the number of doctors required to sign off on sectioning those with mental health issues from two to one, while police would be given authority to force those infected with Covid-19 to self-isolate, with the threat of four-figure fines for refusing to be tested.

    After just two days of debate in the upper chamber, the fast-tracked Coronavirus Bill was given an unopposed third reading by peers today. It then received Royal Assent from the Queen late this afternoon.

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