There are 3 bits to this post – an interview with Joan-Ramon Laporte. An article by Ariane Denoyel and a Q and A with Laporte and Healy.
Laporte Interview
As part of a series for ROAR Magazine, Frank Barat has run some striking interviews about aspects of the Covid pandemic not usually mentioned.
Here is Joan-Ramon Laporte talking about the market in research for drugs or vaccines that we have in lieu of the solidarity needed to do the job in a trustworthy way.
The full interview is Here. Some of the key points Joan-Ramon made are:
- At the end of Jan the WHO recommended trials of already known drugs with known effects such as adverse effects, dosage, contra- indications.
- Hydroxychloroquine has been researched in 50 separate trials and 400 studies although there is no evidence it works as a successful treatment for people humans. ( recorded on a link to Covid on the Register for Clinical Trials.gov.)
- The ‘Marseille’ clinical trial claiming hydroxychloroquine works is at odds with trials carried out in China.
- The Marseille trial is seriously flawed. It does not conform to a genuine clinical trial. A series of patients 50 people in good health with good prognosis were given Hydroxychloroquine and it was stated there were zer0 deaths and all discharged. In fact 1 or 2 did die but were excluded from analysis. There was no comparative group included in the trial. And the group behind the claim are not willing to publish the results.
- By comparison a separate trial completed in China found there were no favourable results from taking Hydroxychloroquine.
- Joan-Ramon describes the way pharma companies approach different research establishments with incentives in the way of offers of payment to carry out certain trials – the priority is decided by pharma with the payments on offer being according to type of research they want eg 500 Euros for one condition 2000 for another.
- They set up a competitive market. It is not known how much is being paid for Covid trials. This is causing harm to the public health and older people in particular who are prescribed massive amounts of unnecessary medication. Patients like this may be excluded from trials claiming the vaccine works.
- All these drugs prescribed for other conditions need to be investigated to see how much they influence the chance of catching Covid and responding to a vaccine.
- The ‘sacred cows’ of clinical research should be replaced with a collaborative system for clinical research overseen by international authorities.
- Meanwhile the public can best protect themselves by keeping things simple , Cutting out or reducing all the dangerous cocktails of prescribed drugs which will then reduce the chance of contracting Covid
The full interview is HERE
Denoyel Article
Ariane Denoyel wrote an article linked to last week’s post on medicines compromising our responses to Covid in L’Arriere Cour. The google translation is not too bad.
CoVid-19 : ces médicaments qu’il vaudrait mieux éviter pendant l’épidémie
Somnifères, anti-douleurs opioïdes, anti-allergiques, antiparkinsoniens et antipsychotiques… Deux professeurs de pharmacologie de réputation internationale alertent, dans L’Arrière-Cour, sur les nombreux médicaments qui augmentent le risque de pneumonie et sont donc fortement soupçonnés de fragiliser les patients face au CoVid-19. Les Prs Laporte et Healy estiment urgent de réévaluer l’intérêt de poursuivre ces traitements particulièrement prescrits dans les EHPAD où, selon des données encore incomplètes, 2 400 décès ont été comptabilisés depuis le début de l’épidémie en France.
La surprescription médicamenteuse chronique et généralisée des pays occidentaux est-elle en train d’aggraver la pandémie en cours ? Deux éminents professeurs de pharmacologie le pensent. Dans un appel publié en anglais sur le site de pharmacovigilance collaborative Rxisk.org et en espagnol sur le site de NoGracias, le Catalan Joan-Ramon Laporte (Université autonome de Barcelone) et l’Irlandais David Healy (Université McMaster, Canada) estiment nécessaire de réévaluer l’utilisation de certains médicaments connus pour fragiliser les poumons, le temps que leur impact sur les chances de survie des patients soit connu. Pour eux, il faut de toute urgence que soient recueillies toutes les données sur les traitements que suivaient les patients qui ont succombé au virus, ce qui n’est toujours pas le cas aujourd’hui.
Le CoVid-19 provoque un « syndrome respiratoire sévère aigu » – d’où l’acronyme en anglais SARS, Severe acute respiratory syndrome, sous lequel il est également connu (« SARS-CoV-2 »). C’est la pneumonie qu’il cause qui peut s’avérer mortelle. Contacté par L’Arrière-Cour, David Healy précise : « La mortalité par CoVid-19 la plus élevée est observée au sein de groupes de patients dont la charge médicamenteuse est, statistiquement, beaucoup plus importante que dans le reste de la population. Nombre de ces patients suivent des traitements qu’on soupçonne d’affecter leur réponse immunitaire ou de les prédisposer à des caillots sanguins qui semblent courants dans ce type de pneumonies. Par ailleurs, nous savons que plus une personne prend de traitements, plus son risque d’hospitalisation et de décès augmente. Vérifier les corrélations entre traitements suivis et risque de décès semble donc absolument nécessaire et urgent. »
Protéger les poumons
Joint aussi par L’Arrière-Cour, le Pr Joan-Ramon Laporte poursuit : « Dans le contexte actuel de pandémie de SARS-CoV-2, il faut absolument se protéger autant qu’il est possible des pneumonies et autres pathologies du poumon. Or plusieurs traitements courants augmentent le risque de pneumonie et de complications pulmonaires. Les antipsychotiques, certains anti-douleurs opioïdes, les “inhibiteurs de la pompe à protons” (NDLR, médicaments donnés notamment contre l’acidité gastrique et le reflux gastro-oesophagien), les immunosuppresseurs (NDLR, que l’on donne aux greffés pour éviter le rejet du greffon et dans certaines maladies auto-immunes) ainsi que les anti-histaminiques (NDLR : pour diminuer les réactions allergiques) agissent notamment en faisant baisser l’immunité. D’autres possèdent une action sédative qui augmente le risque de ce qu’on appelle la “pneumonie par aspiration”, lorsque des agents infectieux issus de la sphère ORL ou de l’estomac parviennent dans le poumon. » Pour ce dernier cas, on parle aussi de « pneumonie de fausse route » ; les sécrétions ainsi aspirées par inadvertance dans le poumon peuvent causer des réactions inflammatoires et infectieuses.
La corrélation entre les décès du CoVid-19 et la prise de ces médicaments n’est pour l’heure pas formellement établie, puisque – et c’est bien le problème – les bases de données internationales ne répertorient pas systématiquement les traitements suivis par les victimes de cette maladie. En revanche, les deux pharmacologues l’assurent : les risques de pneumonie liés à ces médicaments sont, eux, solidement documentés. Ils citent ainsi en annexe de leur appel pas moins de 78 études et articles scientifiques.
Risque de mortalité multiplié par trois
« Les psychotropes sont également concernés ; ils limitent la ventilation pulmonaire et favorisent l’affaissement de tout ou partie des alvéoles – une pathologie nommée atélectasie, détaille David Healy. Les antipsychotiques peuvent multiplier par trois le risque d’hospitalisation et de mortalité par pneumonie. » En pratique, les effets sédatifs marqués de ces molécules empêchent une respiration efficace – ils créent une “hypoventilation”. Le fait qu’ils affectent le bon fonctionnement du système respiratoire (les médecins parlent de “dyskinésie respiratoire”) est souvent confondu avec l’asthme et en conséquence, ces troubles sont mal pris en charge. Ce qui ajoute encore à une charge médicamenteuse déjà problématique.
Les antipsychotiques sont encore très prescrits à des doses trop élevées
Dans les EHPAD notamment, les antipsychotiques sont couramment donnés aux personnes âgées considérées comme agressives. En 2008, l’Agence européenne du médicament a recommandé de limiter ce type de prescriptions aux patients qui ne répondent pas aux autres traitements. Elle a souligné la nécessité d’un suivi étroit de ces patients et d’une réévaluation de la nécessité du traitement lors de chaque consultation. « Malgré ces recommandations de bon sens, les antipsychotiques sont encore très prescrits aux personnes âgées, à des doses trop élevées et pour des périodes trop longues, dénonce l’auteur de Pharmageddon. Il s’agit souvent, de surcroît, de prescriptions “hors AMM”, c’est-à-dire en dehors du champ autorisé par les régulateurs. »
Nous avons pu contacter une pharmacienne exerçant en EHPAD (1), qui confirme : « Quand un nouveau patient arrive, je commence par passer au crible ses traitements. Presque immanquablement, je repère “du lourd’, notamment en matière de psychotropes : des médicaments dangereux, inutiles ou les deux, des combinaisons de remèdes connus pour être incompatibles, des substances prescrites des années, voire des décennies auparavant, que personne n’a songé à arrêter. En tout, sept, dix, douze médicaments. Comme un jardinier, je procède à une taille sévère. Et les patients vont immédiatement mieux, ils ne sont plus assommés, drogués : ils revivent. »
« Rien qu’en Catalogne, où 90.000 personnes de plus de 70 ans sont maintenues sous antipsychotiques de façon continue et en tenant compte des facteurs de risque spécifiques de ceux hébergés en institutions, ces médicaments pourraient être à l’origine de 1.400 cas supplémentaires de pneumonie dans les EHPAD catalans », assure Joan-Ramon Laporte, qui rappelle également que du point de vue chimique, plusieurs molécules données comme anti-nauséeux et pour les troubles gastriques ressemblent énormément aux antipsychotiques et peuvent entraîner le même type de problèmes pulmonaires.
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. Tout comme les anti-épileptiques, les antispasmodiques et les médicaments contre les vertiges.
Laure, 53 ans, témoigne : « Lors d’une hospitalisation pour une chirurgie de routine, on m’a donné du midazolam (NDLR : un sédatif et anxiolytique de la famille des benzodiazépines). Pendant la nuit, j’ai souffert d’apnées du sommeil terribles, je me suis réveillée plusieurs fois brusquement, cherchant à récupérer ma respiration. Je n’ai pas osé me rendormir et ai attendu toute la nuit que l’effet du médicament se dissipe. Je ne veux plus jamais prendre de cette molécule, même si je sais qu’il est possible que ses effets aient été multipliés par l’antidépresseur qu’on m’avait prescrit à l’époque, à savoir de la mirtazapine. »
Dans leur tribune, les Prs Laporte et Healy concluent qu’il est « urgent d’évaluer – et quand c’est possible, d’arrêter – les traitements par psychotropes, tout particulièrement par antipsychotiques, ainsi que les anti-cholinergiques et les analgésiques opioïdes ». Ils appellent à examiner d’un œil critique la charge médicamenteuse des personnes hébergées en institution. À leurs yeux, le contexte de pandémie impose de réfléchir à l’utilité de toutes les médications en cours et de supprimer tout le superflu. Et ce non seulement pour limiter le risque de pneumonie et de complications liées à cette maladie mais aussi pour éviter les autres effets indésirables pouvant mener à des hospitalisations (par exemple en cas de fracture – de nombreux psychotropes créent des problèmes d’équilibre, de vision et des vertiges à l’origine de chutes). « Nous avons un urgent besoin de comptes rendus détaillés des essais cliniques et des études d’observation portant sur l’association entre exposition aux médicaments et risques de pneumonie et ses complications, écrivent-ils. Une initiative collaborative doit prendre forme pour soutenir les efforts des professionnels de santé visant à limiter la charge médicamenteuse dans ce contexte de pandémie. Il faut aussi une coopération internationale pour mener des études d’observation sur l’ensemble des facteurs de risque pour la pneumonie et les décès qu’elle provoque. »
L’excès de traitements est une réalité majeure dans notre pays
Une analyse à laquelle le Pr Denis Vital-Durand, ancien doyen de la Faculté de médecine de Lyon et professeur de thérapeutique à Lyon-I, « souscrit dans l’ensemble » : « L’excès de traitements en général et chez les personnes âgées est une réalité majeure dans notre pays. Et personne ne cherche vraiment à le réduire, que ce soit en général ou en particulier dans les EHPAD », déplore-t-il, ajoutant qu’il a d’ailleurs pu le constater récemment pour une proche dont il n’est pas le médecin. L’idée d’études complémentaires sur les victimes du CoVid-19 lui semble donc « intéressante, mais le déficit de main-d’œuvre dans cette période ne le facilite pas ».
Pharmacologue et psychiatre, le Pr Healy n’est pas un « anti-médicaments », puisqu’il prescrit lui-même des psychotropes à certains de ses patients. Il joue en revanche, depuis les années 1990, un rôle de lanceur d’alerte au sujet des effets indésirables des traitements et des surprescriptions. Et depuis trois ans, il revient régulièrement sur la baisse de l’espérance de vie qu’on observe outre-Atlantique et outre-Manche et qu’il attribue – statistiques à l’appui (2) – au cumul de traitements souvent dangereux et fréquemment inutiles. « Une relation possible », juge le Pr Vital-Durand, qui lui semble cependant « difficile à établir – même si l’hypothèse d’hypoventilation est correcte – en particulier parce qu’il s’agit des sujets les plus détériorés, et que des co-facteurs ne peuvent pas être exclus ».
La recherche se focalise sur l’efficacité des molécules, pas sur leurs effets nocifs
Le Dr Bruno Toussaint, directeur éditorial de Prescrire, seule revue médicale francophone indépendante de l’industrie, qualifie la mise en garde des Prs Laporte et Healy de « tout à fait fondée ». « Il est établi que ces médicaments exposent à une hausse de la fréquence des pneumonies et ce par plusieurs mécanismes. On peut présumer que cela accroît la vulnérabilité des patients, donc qu’il est prudent de revoir les traitements en cours. » Le médecin rappelle que dans nombre de situations, le médicament n’est pas très utile et que certaines molécules sont maintenues par crainte d’un effet de sevrage. Interrogé par L’Arrière-Cour sur la probabilité que des études de grande ampleur soient menées pour déterminer l’impact sur la mortalité par CoVid-19 des traitements pris par les patients, le médecin se montre modérément optimiste. Pas seulement à cause du contexte de raz-de-marée qui submerge actuellement les hôpitaux mais parce que « la pharmacovigilance est le parent pauvre des études sur les médicaments. On ne bâtit pas une belle carrière à l’hôpital en misant sur cette discipline ; les essais cliniques, la recherche et les publications se focalisent sur l’efficacité des molécules, pas sur leurs effets nocifs… Pourtant, on estime que 20.000 personnes meurent chaque année en France à cause de ces effets – et 190.000 dans l’Union européenne. Bien plus que le nombre de morts du CoVid-19… »
Ariane Denoyel (avec RRF)
- Ce témoin n’a pas souhaité que son nom apparaisse.
- Parmi les sources (en anglais) sur ce sujet, citons plusieurs éditoriaux récents du BMJ ainsi que les articles suivants : Hiam L, Dorling D. Rise in mortality in England and Wales in the first seven weeks of 2018. BMJ 2018;360:k1090 doi: 10.1136/bmj.k1090, Hiam L, Harrison D, McKee M, et al Why is life expectancy in England and Wales ‘stalling’? J Epidemiol Community Healthdoi: 10.1136/jech-2017-210401, Ho JY, Hendi AS. Recent trends in life expectancy across high income countries. BMJ 2018, 362, k2562., Woolf SH, Aron L. Failing Health in the United States. BMJ 2018;360:k496 doi: 10.1136/bmj.k496
Laporte – Healy Thumbnail Interview
Would you take any of the following prophylactically to ward off the risk of Covid infection, manage stress or other risks
Chloroquine
JRL No (unless new evidence turns up)
DH No
Hydroxychloroquine
JRL Same as chloroquine
DH No
Azithromycin
JRL No (unless new evidence turns up)
DH No
Ivermectin
JRL Perhaps (well tolerated)
DH No – because of neurological side effects
Other Prophylactic Antibiotics
JRL No
DH No
To manage other conditions
Statins
JRL No
DH No – because of cognitive and muscular problems
Asthma
JRL Depends on whether severe
DH Would minimise steroids but important to keep good control. Would avoid montelukast and other leukotriene antagonists
Antipsychotics
JRL No
DH No
Opioids
JRL No
DH No – except for acute injury – a fracture perhaps. Would use clonidine to withdraw from these if I had been on them chronically
Antidepressants
JRL Never.
DH Never. Would try to minimise the dose if I had already been on them. This may be very difficult to do
Immunosuppressants
JRL
DH In the case of drugs like biologicals for arthritis or inflammatory bowel disease, patients often have to pause when they get infections – so they know if they are likely to have a flare of their condition if they pause. If not likely to have a flare, I would consider pausing – otherwise no.
Gabapentin – Pregabalin
JRL Never
DH Never
Hypnotics
JRL
DH Tricky. Perhaps if sleepless because of an acute shock, as sleep is likely important. Would not take routinely. Withdrawal makes stopping difficult
Proton Pump Inhibitors
JRL
DH No. If already on them, stopping can cause reflux and anxiety and needs to be done slowly using a sodium alginate-bicarbonate mix (Gaviscon).
Antihypertensives
JRL
DH Would not start one now. Would reduce the number of antihypertensives if already on one, and particularly would stop a beta-blocker. A modest elevation of blood pressure is not a problem.
Multi-medicines
JRL
DH This is a time to be on less than 5 medicines. A time when less will offer greater efficacy than more
If you contract Covid, would you take any of the following if initially ill
Chloroquine
JRL No
DH No. Covid is heat sensitive – it might be a better bet to get a dose of malaria than take this anti-malarial drug (chloroquine).
Hydroxychloroquine
JRL No
DH No. See chloroquine response.
Azithromycin
JRL Would depend on ECG – more acceptable than chloroquine and hydroxychloroquine
DH Possibly
Ivermectin
JRL I suppose yes
DH Will monitor the evidence – possible if only for a few days
Ibuprofen/NSAIDS
JRL No – would take paracetamol
DH Yes – low dose – I am more NSAID than paracetamol responsive
Steroids – Immunosuppressants
JRL Depends on the condition
DH Would pause if possible
susanne says
Just heard R4 You and Yours is asking for people to call in about concerns about what is happening in Care Homes . Tomorrow midday 14April – With Winifrid Robinson Phone 0161 836 1346 email youandyours@bbc.co.uk
Suzanne says
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.
annie says
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.
annie says
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.
annie says
It comes after Sir Patrick Vallance, the UK’s chief scientific adviser, caused alarm earlier this month talking about “herd immunity”, suggesting between 60-80% of the population becoming infected could stop the virus returning in the winter.
Professor Hugh Pennington: ‘Herd immunity is a crazy idea, not really supported by any sound science’
A leading microbiologist has criticised a controversial “herd immunity” policy as a “crazy idea” to tackle coronavirus and one that should have never been aired in public.
https://www.pressandjournal.co.uk/fp/news/politics/uk-politics/2093482/professor-hugh-pennington-herd-immunity-is-a-crazy-idea-not-really-supported-by-any-sound-science/
He said: “I’m reluctant to criticise without knowing what’s gone on in secret meetings but the government does appear to be in the hands of the mathematical modellers.”
Vital Sage evidence used to guide ministers through the coronavirus crisis will remain a SECRET until the pandemic is over, says government’s chief scientific adviser Sir Patrick Vallance
https://www.dailymail.co.uk/news/article-8240423/Sage-evidence-used-guide-ministers-coronavirus-crisis-remain-SECRET-over.html
‘This contributes towards safeguarding individual members personal security and protects them from lobbying and other forms of unwanted influence which may hinder their ability to give impartial advice.’
Is Glaxo Grandee, Patrick Vallance, worth his ‘R’ value …
annie says
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/
susanne says
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
susanne says
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
Carla says
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!
susanne says
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
tim says
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?
susanne says
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……
annie says
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.
annie says
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
annie says
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/
susanne says
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.
susanne says
[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
Carla says
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
susanne says
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 .
mary H says
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)