Covid and the Market in Research

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April 13, 2020 | 20 Comments

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  1. An update from remdesivir, making Covid-19 drugs cheap, & AstraZeneca’s wins

    STAT: The Readout Unsubscribe
    11:15 AM (7 hours ago)
    to me

    The Readout Damian Garde & Meghana Keshavan
    On that early, early remdesivir data
    Whether or not remdesivir works, one thing is clear: Gilead is moving fast.

    On Friday, the company published preliminary data on the antiviral’s effects on Covid-19 in NEJM. And while the company’s speed is impressive, the small study raised more than a few eyebrows in the scientific community. The data showed that two-thirds of the 53 patients studied improved while taking the drug. But the data weren’t from a randomized, controlled study, and thus many consider the release premature — even irresponsible.

    In yet another open letter, Gilead CEO Daniel O’Day wrote that the company does “recognize the limitations of these compassionate use data from a purely investigational perspective.” He also said more (preliminary) data are set to come at the end of April.

    Read more.

    STAT Expert Advantage conference call: The impact of Covid-19 on rare disease clinical trials
    Subscribe to STAT Expert Advantage to join this month’s conference. The topic: how companies, patients, and the FDA will navigate the impact of Covid-19 on the clinical trials for orphan drugs. Join the call.

    Repurposed Covid-19 drugs could come cheap
    Several existing medicines are being explored as possible treatments for Covid-19. And, if they prove effective, researchers have found that they can be manufactured quite economically — and profitably.

    For instance, Gilead’s remdesivir could be made for just 93 for a day’s supply, STAT’s Ed Silverman writes. A Roche drug called Esbriet, which is used to treat idiopathic pulmonary fibrosis, could be made for just $1.09 for a day’s supply. And, of course, the decades-old drug hydroxychloroquine — again, if it proves to be an effective treatment — could be incredibly inexpensive; it would cost just 8 cents a day.

    “The beauty of the repurposing option is that you can take drugs off the shelf and put them straight to work,” the study’s co-author told STAT. “We already have the means for manufacturing for many people. What we need to do is massively increase supplies from the factories. It’s a big effort, but if it is done, there’s no reason we couldn’t gain access.”

    Read more.

    Approved or not? Positive or not? Testing still murky
    Regulators are sparring with health tech startups over the intricacies of what, precisely, qualifies as a home test for Covid-19. Although two testing startups told STAT this week that their tests were copacetic for at-home use, the FDA remains adamant that this isn’t the case, STAT’s Erin Brodwin writes.

    One company, MicroGen DX, told STAT it didn’t need FDA approval, because it uses an accredited lab to process results. Another, Vault Health, said it’s been “provisionally cleared” and requires a clinician’s sign-off.

    And in other testing news: There appears to be a large number of false negatives when it comes to coronavirus testing in general, Bloomberg writes. Although patients are showing clear symptoms of the disease, many are still turning up negative results — which of course increases the risk of transmission.

  2. The new vaccine will combine a vaccine technology that Sanofi currently uses to make a flu vaccine, FluBlok, with GlaxoSmithKline’s adjuvant, an additive that increases the potency of vaccines, making them more likely to be effective and easier to manufacture in large quantities.

    Sanofi and GlaxoSmithKline collaborate to speed up coronavirus vaccine development

    By Matthew Herper @matthewherper

    April 14, 2020

    https://www.statnews.com/2020/04/14/glaxosmithkline-sanofi-coronavirus-vaccine-collaboration/?utm_source=STAT+Newsletters&utm_campaign=e6b4b384dc-Pharmalot&utm_medium=email&utm_term=0_8cab1d7961-e6b4b384dc-149674737

    Sanofi gets a flu vaccines booster with $650M-plus Protein Sciences buy

    https://www.fiercepharma.com/m-a/sanofi-grows-flu-vaccine-offerings-650m-protein-sciences-buy

    Citing ‘substantial benefit’ for patients, Sanofi hiked Flublok price 12.5% last season

    https://www.fiercepharma.com/vaccines/citing-substantial-benefit-for-patients-sanofi-hiked-flublok-price-12-5-last-season

    The rationale for Flublok’s hike? Sanofi pointed to a study published in the New England Journal of Medicine last June showing that Flublok was 30% more effective than GlaxoSmithKline’s Fluarix Quadrivalent at preventing lab-confirmed flu illnesses in people 50 and older.

    • Business Wire..

      “While CEO of GSK, he gained global recognition for his efforts to develop and expand access to critically needed vaccines.”

      Sir Andrew Witty to Take Leave of Absence From UnitedHealth Group to Co-lead World Health Organization Efforts to Accelerate a COVID-19 Vaccine

      April 15, 2020 05:50 AM Eastern Daylight Time

      https://www.businesswire.com/news/home/20200415005193/en/Sir-Andrew-Witty-Leave-Absence-UnitedHealth-Group

      MINNETONKA, Minn.–(BUSINESS WIRE)–UnitedHealth Group (NYSE: UNH) announced that Sir Andrew Witty, president of UnitedHealth Group and CEO of Optum, has been asked to co-lead a global effort of the World Health Organization (WHO), in partnership with key stakeholders, to accelerate the development of a COVID-19 vaccine. Witty will be on a leave of absence from UnitedHealth Group while leading the initiative and will return to the company at approximately year end.

      “Andrew brings the perfect combination of deep global health expertise, innovation and operating skills and, above all, a passion for, and considerable success in, developing vaccines to drive this critical effort,” said David S. Wichmann, chief executive officer of UnitedHealth Group. “The pride we take in Andrew’s willingness to serve during this global health crisis is exceeded only by our confidence in his ability to support the global vaccine development effort as quickly and effectively as possible.”

      “I am deeply honored to help lead this mission to seek a COVID-19 vaccine and am confident the people of Optum will remain relentless in their work to help their customers, communities and each other each day. I look forward to rejoining them on the other side of this crisis to continue helping make the health system work better for everyone,” said Witty.

      Witty’s appointment to the position with WHO is effective April 20. During Witty’s temporary assignment, Wichmann will oversee Optum.

      Witty was a member of the UnitedHealth Group Board of Directors from August 2017 until March 2018, when he became CEO of Optum. He was named president of UnitedHealth Group in November 2019. Witty served as CEO and a director of GSK from 2008 until 2017, having joined the company in 1985. While CEO of GSK, he gained global recognition for his efforts to develop and expand access to critically needed vaccines.

      About UnitedHealth Group

      UnitedHealth Group (NYSE: UNH) is a diversified health care company dedicated to helping people live healthier lives and helping make the health system work better for everyone. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. For more information, visit UnitedHealth Group at http://www.unitedhealthgroup.com or follow @UnitedHealthGrp on Twitter.

      End Points..

      https://endpts.com/ex-gsk-chief-andrew-witty-summoned-back-to-the-frontlines-of-vaccine-development-at-embattled-who/

      During his 10-year tenure at GlaxoSmithKline, Andrew Witty made vaccines one of his signature areas of focus, leading the pharma giant to an approval for an influenza vaccine during the H1N1 pandemic and bagging Novartis’ vaccine unit in an asset swap before he retired in 2017.

      Whether that timeline is realistic will be up for debate, as critics have cast doubt on Sanofi and GSK’s promise to make a vaccine available in a year. Considering that some side effects take 6 to 12 months to develop, an approval may not come for two years — and even that would be considered incredibly fast, an expert consulted by SVB Leerink said.

  3. Rethinking the Drug Load..

    Repenser la charge médicamenteuse

    Parmi les antidépresseurs, l’amitriptyline (Elavil, Laroxyl, Redomex…), la clomipramine (Anafranil), la doxépine (Quitaxon, Xepin), l’imipramine (Tofranil) et la paroxétine (Deroxat) sont également concernées.

    Kim Witczak
    @woodymatters

    Kim Witczak is a Drug Safety Advocate and Public Speaker. Consumer Representative on FDA Psychopharmacologic Drugs Advisory Committee.

    Seriously, now they are testing antidepressant Luvox as a potential COVID-19 treatment. Will the study participants be told of the dangerous potentials harms of SSRIs? https://medicine.wustl.edu/news/study-to-evaluate-antidepressant-as-potential-covid-19-treatment/… via @wustlmed

    @MISSDFoundation
    – Wonder if the study participants are aware of akathisia?! “Using a psychiatric drug to treat COVID-19 may sound counterintuitive, but it’s no more counterintuitive than using a malaria drug,” said Eric J. Lenze, Prof of Psychiatry and principal investigator.

    https://medicine.wustl.edu/news/study-to-evaluate-antidepressant-as-potential-covid-19-treatment/

  4. Your Country Needs You – You may well die while everyone is clapping and singing – the rxisk is very high while our ‘leaders’ bluster and lie ……..https://content.govdelivery.com/accounts/UKCQC/bulletins/2876c7f

    USA
    The ‘patient groups’ are not named..many are supported by pharma. Even so less than 50% is ‘an improvement’.
    Despite pricing controversies, pharma’s reputation is improving among patient groups
    By ED SILVERMAN @PharmalotAPRIL 21, 2020
    Medicare Pricey Drugs
    Even before the pandemic struck and drug makers were seen as potential saviors, the pharmaceutical industry had slightly improved its battered image among patient groups, according to a new survey.
    The survey found that 46% of patient advocacy groups thought that brand-name drug companies had developed an “excellent” or “good” reputation last year, up from 41% in 2018. That’s the best showing for pharma since the survey was started in 2011 by PatientView, a research firm that canvassed 1,850 patient groups from 95 countries between November 2019 and February 2020. They rated the reputations of 48 drug

  5. RxISK Retweeted
    Juan Gérvas
    @JuanGrvas
    Apr 20
    Replying to
    @RxISK
    Spain.
    Total deaths 21,000.
    Total population 47 M.
    446 total deaths per M
    Total deaths in nursing homes 14.000.
    Total population 0.4 M
    32,500 total deaths per M
    Inappropriate medicantion in this population around 65%.
    The #coronavirus was the last cause of deaths

  6. Indeed, very interesting statistics, Susanne.
    I am still wondering if all the Governors of the world have simply over panicked and have been given misinformation by the experts?
    Which brings me back to David’s expert advice:
    Perhaps the meds people are prescribed are inducing a lot of these respiratory maladies?
    Interesting thought just came to me the other day because someone mentioned to me that the GP changed this dear lady diabetes medication for another generic brand and as soon as she ingested it she experienced some breathing difficulties.
    This is a very real concern if this is happening!

    • Hi Carla – I know when people query a change of their drugs they are told not to worry their little heads – the drugs are just the same and reports of adverse effects get the eyes rolling response. By the way chemists are selling denture fixer with writing in Polish only – some people need to check if there is zinc in it as this has been proved to cause problems. Told the H>A> – nothing done about it –
      Tim has also flagged your concern up as well as DH -tim says:
      April 20, 2020 at 10:27 am
      Prescription Drugs Predisposing to Increased Risk of Pneumonia – to Respiratory Function Impairment.
      These preliminary care home “figures” were anticipated with trepidation when I read and re-read D.H.’s joint paper.
      I am now finding publications reporting ‘Antipsychotic Induced Respiratory Dyskinesia’, going back over some two decades.’

      So just had a look on the net and this entry goes back to 2011 others go up to 2016 and then seem to disappear unless am looking in the wrong places.
      https://www.ncbi.nlm.nih.gov/pubmed/22360044

      • Susanne, I am sorry to have just picked up your comment.

        For Example:

        Acta Psychiatrica Scandinavica. June 1991.

        ‘Misdiagnosis of Respiratory Dyskinesia’.

        HFK Chiu, S Lee CHS Chan.

        ‘Respiratory dyskinesia consists of involuntary movements of the respiratory musculature and manifests as irregular respiratory rate, tachypnoea and grunting. It is probably an under recognised condition and hence is easily misdiagnosed’.

        ‘Two patients with respiratory dyskinesia are reported. One Patient was misdiagnosed as suffering from a generalised anxiety disorder and the second as having chronic obstructive airway disease’.

        I am left discomforted that the possible importance of antipsychotic – (or other Rx) – induced respiratory dyskinesia in Care Home residents may not be recognised as a potential contributory factor to increased respiratory morbidity and mortality.

        Surely: – a detailed prescription drug history, collected from all potential cases, should provide evidence for/or against such an ADR exacerbating vulnerability to Covid-19?

  7. In a ‘democracy’ called the united kingdom – it rapidly became the kingdom of the dead which led to the forming of secretive support groups who used the net to speak out -despite being threatened by their leaders…
    Covid-19: doctors are warned not to go public about PPE shortages
    BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m1592 (Published 21 April 2020)

    As hospitals run out of personal protective equipment (PPE) for frontline healthcare staff fighting the covid-19 pandemic, doctors report that trusts and NHS England are clamping down on their attempts to go public about the situation in mainstream news outlets or on social media.

    More than 50 healthcare workers have died from covid-19 and the lobbying group Doctors’ Association UK (DAUK) has set up an app, http://www.nhsppe.com, for doctors anonymously to report their concerns about shortages of gowns and masks to protect them from infection.

    But many are also reporting attempts to stop them speaking to the media about their fears. One consultant wrote of “a general email from the trust, then personal advice, that social media is being monitored and to be careful.”

    A junior doctor mentioned “an email saying we should not be posting ‘inappropriate’ social media comments or posts regarding the state of PPE.” Another wrote, “We are emailed daily to avoid speaking to anyone in the press or social media as a part of daily covid briefing.”
    Another consultant reported, “I have been forbidden by my trust from posting anything about conditions on social media as my name could link back to my trust. Please keep championing this, you may literally be saving our lives.”
    A GP wrote of being advised by the local clinical commissioning group not to give an interview to a journalist about PPE. “When I told the journalist this, she said lots of doctors have said the same thing. It’s like we’ve all been told not to speak to the media to give the true situation,” they said………….there’s more……

  8. Global Antidepressants Market (2020 to 2030) – COVID-19 Implications and Growth

    AntiDepAware
    @AntiDepAware

    SSRI manufacturers set to make a killing (pun intended) out of Covid-19. Who’d have thought it?

    https://finance.yahoo.com/news/global-antidepressants-market-2020-2030-120356313.html?soc_src=social-sh&soc_trk=tw

    “Globally, rising cases of mental health disorders are the key factor in the growth of the antidepressant drug industry, as many customers rely on these medications to counter depression, anxiety disorder etc. Antidepressant medications are used in conditions such as depression, OCD, childhood enuresis, major depressive disorder, severe anxiety disorder, bipolar disorder, post-traumatic stress disorder (PTSD), social anxiety disorder, etc. Globally, the percentage of people with depression varies from 2% to 6% and the elderly are at greater risk of depression relative to other age groups. According to WHO, in 2020, about 264 million people of all ages worldwide suffer from depression. Therefore, rising cases of mental health disorders is expected to drive the growth of the antidepressant market.”

    Withdrawal from paroxetine can be severe, warns FDA

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1122195/

    Dr Peter Haddad, consultant psychiatrist for Salford’s Mental Health Service NHS Trust, welcomed the FDA’s safety warning. He said: “Withdrawal side effects from antidepressants are far commoner than many people realise, and there’s evidence that paroxetine has one of the highest rates. In most cases the symptoms are mild, but in a minority they are severe and prolonged—and treatable only by restarting the drug.”

    Seroxat: Statement from GlaxoSmithKline

    http://news.bbc.co.uk/1/hi/programmes/panorama/6291947.stm

    In developing Seroxat, GSK has always been strongly conscious of the duty it owes to the millions of patients who suffer from depression and refutes any allegation that it has failed in this duty.

    GSK utterly rejects any suggestion that it has improperly withheld drug trial information.

    • Study 352 – Paxil & Bipolar Documents Released

      Dozens of newly-publicised documents now give the full story of GSK’s ghostwriting campaign for a Paxil (paroxetine) clinical trial report on Study 352.

      https://fiddaman.blogspot.com/2020/04/study-352-paxil-bipolar-documents.html#.XqP9-chKhPY

      GSK Paxil Clinical Trials | Court Documents

      https://www.baumhedlundlaw.com/prescription-drugs/paxil-injuries/gsk-clinical-trials-paxil-fraud/

      The 352 DIDA documents reveal not just ghostwriting and the spinning of negative study results into positive results, but also the abetting of that alleged fraud by an editor of the scientific journal that published the study. Study 352 was initially rejected for publication during the peer review process. It was only after intervention by an American Journal of Psychiatry editor with financial ties to GSK that the study was published.

      The documents also show the whitewashing of wrongdoing by Penn. Penn continues to further stonewall investigation into the malfeasance of its faculty in this matter despite numerous attempts on our part to conduct a thorough investigation.

      Correspondence Re: ORI 2012-33 – Complaint of Scientific Misconduct against Dwight L. Evans, Laszlo Gyulai, Charles B. Nemeroff, Gary S. Sachs, and Charles L. Bowden

      • MIA today, and a repeat of the detailed and informative Study 352 …

        ‘Mad in America has consistently reported on cases of research misconduct, such as a ghostwritten study of paroxetine with misleading results, the details of which have only recently emerged thanks to court cases against pharmaceutical company GlaxoSmithKline.’

        FDA Inspections Revealing Research Misconduct Hidden from Public View

        In a new viewpoint article published in the top-tier medical journal JAMA, researchers urge the US Food and Drug Administration (FDA) to publicly release inspection reports.

        https://www.madinamerica.com/2020/04/fda-inspections-revealing-research-misconduct-hidden-from-public-view/

        Although the general story of ghostwriting in trials of psychiatric drugs is now pretty well known, the details of the corruption in specific trials are still emerging into the public record, often a decade or more after the original sin of fraudulent publication. The latest study to finally see the full light of day is GlaxoSmithKline’s study 352.

        Perhaps the most infamous ghostwritten study is GSK’s study 329, which, in a 2001 report published in the American Journal of Psychiatry, falsely touted paroxetine (Paxil) as an effective treatment for adolescent depression. The company paid over $3 billion in penalties for fraud.

        That same year, study 352 made its first appearance in the research literature. That was when Charles Nemeroff, who in the years ahead would become the public face of research misconduct, “authored” an article on the efficacy of paroxetine for bipolar disorder. It has taken 18 years for the full story of that corruption to become known, the final chapter recently emerging when a large cache of study 352 documents—emails, memos, and other internal correspondence between the key players—was made public.

        The Whistleblower and Penn: A Final Accounting of Study 352

        By

        Peter Simons

        December 29, 2019

        https://www.madinamerica.com/2019/12/the-whistleblower-and-penn-a-final-accounting-of-study-352/

  9. H Pennington (re your link Annie)is a bit of a rebel I seem to remember but his own credibility is questionable here ‘one (idea) that should never have been aired in public’ ?? Exactly where it should have been – maybe they slipped up by making it public so inadvertently had to change the intention to allow thousands of people die to create herd immunity. People were to be treated just like the horrendous way millions of chickens and cows have been slaughtered to treat epidemics. And Funny how journalists cant even find out who is on Sage.

  10. https://www.bbc.co.uk/sounds/play/m000hght
    On World at One – discussion about drugs and vaccines

    The first Human Vaccine Trial starts today in Oxford following adverts for 500 participants One of the first young participants said she had been given plenty of clear information but several times in response to questions said eg ‘ as far as I understand..’ I will receive the vaccine or a meningitis drug…’my understanding is ‘we will go about normal life of being exposed to the virus – ‘yes I guess so’ ‘i think the reaction to vaccine jab will be the same as a flu jab’ My reservations can be seen in context if you download the video. It’s fine to be young and altruistic but the information she had been given didn’t seem good enough . There were other interesting bits by other scientists but I concentrated on this bit. at 23.24 on the bar of R4 Sounds -News at One 23/04/2020

  11. Suzanne, who are going to be exempt from receiving the jab?
    Isn’t big pharma and stakeholders already generating lots of money out of the antidepressant market?
    Imagine how much money they will generate out of this Covird-19 vaccine!
    One can not generate any money out of people that are healthy!
    By placing fear over the masses, we are creating colossal socio-economic loss/ unnecessary financial hardships and massive dire health issues than the pandemic itself. This will impact all of the entire universe in way or another!
    It makes me wonder how many decisions are being made without reliable data?
    How much of the truth is being exposed regarding this Covird-19?
    Many people have told me that they would rather get the Covird-19 any day, than rather have the jab!

    Medical Science is making such remarkable progress that soon none of us will be well ~ Aldous Huxley

  12. Hancock’s volunteer army needling the population

    Go back a stage Carla and what if we refuse to be tested should this army (Army?!)arrive at our doors or in our streets?! ‘People are pushing back on lock down in some places already – they need to take care there is no flagging up of dissidents The army could be usefully asked to pick the fruit and veg. which desperately needs harvesting soon. There’s no discussion of privacy or safety issues …or what if the drug harms people what info given where is all the lovely data stored who accesses it – it’s claimed the info will be destroyed – and pigs might fly.
    UK edition
    Recruit volunteer army (Army ?!)to trace coronavirus contacts now, urge top scientists
    Ministers must take steps to track down possible infections, says new grouping of health experts
    Published onSat 4 Apr 2020 15.25 BST
    383
    Ministers must recruit an army of “contact tracing” volunteers to warn people who mayhave been infected by a Covid-19 sufferer, say public health experts.

    More than 50 leading scientists say health secretary Matt Hancock’s plans to introduce 100,000 tests a day by the end of April will only solve part of the problem of establishing how far the virus has spread.
    The scientists (who are they? we have only just been told Donald Cummings has been attending Sage meetings – he’s not even one of the umpteen pseudo scientists who have popped into home studios lately)
    …have come together to form the UK Covid-19 Group of Experts, and say contact tracing – identifying then alerting people who have been within infection range of a person confirmed to have the virus – will be a vital addition to testing when the lockdown begins to ease. (Let’s identify these ‘experts’ )
    ………… and conduct “surveillance testing” – checking samples of the population to model the extent of the virus’s spread. I.m not daft enough to think no action needs to be taken but some of us remember what was flagged up as solutions to the AIDS?HIV crisis One of the most shameful disgusting campaigns ever was waged against people then .

  13. A thought for these unusual times :-

    At last, we have a cure for all!
    Ailments large and ailments small,
    Good health is not beyond my reach
    If I inject myself with bleach.

    Radiant, I’ll prance along,
    Every trace of limescale gone.
    With disinfectant as my friend,
    Like him, I’m clean around the bend.
    Pam Ayres
    (Found on Twitter)

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