• Advertisement
To advertise, place classifieds free ads by category in a forum as a new topic, or in the classified display ads section, or start a classifieds free blog.

Coronavirus Drug: French Researcher Reports Successful Trial Using Malaria Medicine

Healthcare workers & SARS-CoV-2 infection in India: A case-control investigation in the time of COVID-19

Postby smix » Sun Jun 07, 2020 5:32 pm

Healthcare workers & SARS-CoV-2 infection in India: A case-control investigation in the time of COVID-19
Indian Journal of Medical Research

URL: http://www.ijmr.org.in/preprintarticle.asp?id=285520
Category: healthNews
Published: May 28, 2020

Description: Abstract
Background & objectives: Healthcare workers (HCWs) are at an elevated risk of contracting COVID-19. While intense occupational exposure associated with aerosol-generating procedures underlines the necessity of using personal protective equipment (PPE) by HCWs, high-transmission efficiency of the causative agent [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)] could also lead to infections beyond such settings. Hydroxychloroquine (HCQ), a repurposed antimalarial drug, was empirically recommended as prophylaxis by the National COVID-19 Task Force in India to cover such added risk. Against this background, the current investigation was carried out to identify the factors associated with SARS-CoV-2 infection among HCWs in the country.
Methods: A case-control design was adopted and participants were randomly drawn from the countrywide COVID-19 testing data portal maintained by the ICMR. The test results and contact details of HCWs, diagnosed as positive (cases) or negative (controls) for SARS-CoV-2 using real-time reverse transcription-polymerase chain reaction (qRT-PCR), were available from this database. A 20-item brief-questionnaire elicited information on place of work, procedures conducted and use of PPE.
Results : Compared to controls, cases were slightly older (34.7 vs. 33.5 yr) and had more males (58 vs. 50%). In multivariate analyses, HCWs performing endotracheal intubation had higher odds of being SARS-CoV-2 infected [adjusted odds ratio (AOR): 4.33, 95% confidence interval (CI): 1.16-16.07]. Consumption of four or more maintenance doses of HCQ was associated with a significant decline in the odds of getting infected (AOR: 0.44; 95% CI: 0.22-0.88); a dose-response relationship existed between frequency of exposure to HCQ and such reductions (χ2 for trend=48.88; P<0.001). In addition, the use of PPE was independently associated with the reduction in odds of getting infected with SARS-CoV-2.
Interpretations & conclusions: Until results of clinical trials for HCQ prophylaxis become available, this study provides actionable information for policymakers to protect HCWs at the forefront of COVID-19 response. The public health message of sustained intake of HCQ prophylaxis as well as appropriate PPE use need to be considered in conjunction with risk homoeostasis operating at individual levels.
--
PDF: Healthcare workers & SARS-CoV-2 infection in India: A case-control investigation in the time of COVID-19
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

ICMR writes to WHO disagreeing with HCQ assessment, officials say international trial dosage four times higher than India

Postby smix » Mon Jun 08, 2020 6:10 pm

ICMR writes to WHO disagreeing with HCQ assessment, officials say international trial dosage four times higher than India
New Indian Express

URL: https://www.newindianexpress.com/nation ... 49702.html
Category: Politics
Published: May 29, 2020

Description: Buoyed by the preliminary success observed in the treatment of COVID-19 patients through these HCQ tablets, the Indian Council of Medical Research (ICMR) has written to the WHO.

tedros-lower.jpg

NEW DELHI: After the Union Health Ministry expressed reservations about the World Health Organisation's (WHO) advisory to suspend hydroxychloroquine (HCQ) usage in treating COVID-19 patients, now, India's nodal government agency ICMR (Indian Council of Medical Research) overseeing the country's response to the coronavirus pandemic has also written to the WHO citing differences in dosage standards between Indian and international trials that could explain the efficacy issues of HCQ in treating COVID-19 patients. Currently, as per protocols set by the Indian government to treat severe coronavirus patients requiring ICU management, HCQ dosages are administered in the following way- 1st day a heavy dose of 400mg HCQ dose once in the morning and one at night, followed by 200 mg HCQ one in the morning and one at night to be followed for the next four days. The total dosage administered to a patient in 5 days, therefore, amounts to 2400 mg. Speaking to ANI on the condition of anonymity, a Health Ministry official explained the context behind the ICMR and Health Ministry disagreeing with WHO's assessment, the primary point being the wide gap in dosage levels given in India and internationally."Internationally in Solidarity trial COVID-19 patients are being administered with--800 mg x 2 loading doses 6 hours apart followed by 400 mg x 2 doses per day for 10 days. The total dosage given to a patient over 11 days is about 9600 mg which is four times higher than the dose we are giving to our patients," informed the official. "This indicates that in our treatment protocol, the efficacy of HCQ is good and patients are recovering quickly with less amount of dosage being administered," said the official. Buoyed by the preliminary success observed in the treatment of COVID-19 patients through these HCQ tablets, the Indian Council of Medical Research (ICMR) has written to the WHO. In a letter via an email, Dr Sheela Godbole, National Coordinator of the WHO-India Solidarity Trial and Head of the Division of Epidemiology, ICMR-National AIDS Research Institute has written to Dr Soumya Swaminathan, Chief Scientist at World Health Organization. In a letter, Dr Godbole stated: "There was no reason to suspend the trial for safety concern." When contacted Dr Godbole, she said: "Only one arm of the Solidarity trial by WHO has temporary been paused for a time being i.e. HCQ arm, other arms of the clinical trial are still active." On Thursday, Dr VK Paul, Member Niti Aayog and Chairman of empowered group 1 said: "When we see the present evidence of HCQ, there are fewer side-effects...We have studied HCQ drug very closely with our scientists and hence as per the latest government guidelines--HCQ drug can be given to frontline workers and severe coronavirus patients. However, these guidelines would be reviewed from time to time," said Paul. A UK study into HCQ as a COVID-19 treatment is to continue despite the WHO suspending its trial, underway in several countries, due to safety concerns. HCQ is one of the drugs in Oxford's RECOVERY (Randomised Evaluation of Covid-19 therapy trial) study, Professor Peter Horby, Professor of Emerging Infectious Diseases and Global Health in the Nuffield Department of Medicine, University of Oxford, said in a statement. "In response to that paper, we looked very carefully at our data over the weekend, to make sure we are not putting patients at risk. Since RECOVERY patients are randomised, our data are much less vulnerable to the biases that plague studies that use routine health care data," the statement read. An independent committee has looked at our data and did not see any safety concerns. We discussed our findings with Medicines and Healthcare products Regulatory Authority, who have agreed with our interpretation that the data provide reassurance that continued enrolment into the HCQ arm is safe and that we should press ahead with getting a reliable answer on hydroxychloroquine through the RECOVERY trial," the statement further read.



Vadodara administration drive: HCQ helping in containing Covid-19 cases, say docs as analysis begins
The Indian Express

URL: https://indianexpress.com/article/india ... s-6486049/
Category: Politics
Published: July,2, 2020

Description: Authorities say that the analysis is ongoing as is the drive, in accordance with the ICMR recommendation for prophylactic use of HCQ. VMC Health Officer Dr Devesh Patel says, “The debate around HCQ is founded in the side effects of long term use of the drug for treatment of rheumatoid arthritis and other illnesses.
Even as global studies on Covid-19 treatment are yet to arrive on a consensus on the benefits of administration of Hydroxychloro-quine (HCQ) to contain the transmission of coronavirus, the Vadodara administration has begun analysing the effects of the drug in containing the cases in the city. The Vadodara health department has prepared a report analysing its drive of administering HCQ since April, taking a sample of over one lakh residents who took a course of the anti-malarial drug as prophylactic. Until Wednesday, the Vadodara Municipal Corporation (VMC) has administered the drug to 3.42 lakh persons, including health workers and other frontline staff. Each of these persons has or will have completed the entire course of the drug — 400mg twice a day for the first dose and 400 mg per week for a minimum of three weeks. Of this, the administration has analysed a sample of over 1 lakh residents, who were mostly close contacts of positive persons and the effect of HCQ in containing the transmission of the virus. According to the analysis, of the 48,873 close contacts of positive patients who took one dose of HCQ, 102 turned Covid-19 positive and 12 succumbed to the infection whereas 48 of the 17,776 close contacts of positive patients who took two doses of HCQ turned positive and only one died. The study also states that of the 33,563 close contacts of patients who took three HCQ doses, 43 tested positive and one died. Authorities say that the analysis is ongoing as is the drive, in accordance with the ICMR recommendation for prophylactic use of HCQ. VMC Health Officer Dr Devesh Patel says, “The debate around HCQ is founded in the side effects of long term use of the drug for treatment of rheumatoid arthritis and other illnesses… So far, HCQ has not been used as a prophylactic… To us, it has shown positive results. We have the numbers and not one person has complained of complications. The only side effect reported is mild gastritis, which is common with administering heavy medicines and can be effectively handled.” Patel said the drug was administered to close contacts of positive patients in the cluster neighbourhoods of Nagarwada-Saiyedpura area of the old city, which was the city’s first red zone, with a population of around 5,000 persons, in the first week of April. The administration began its analysis in the first week of June. The drug was also prescribed and promoted by the Baroda Muslim Doctor’s Association (BMDA), which has been a core partner of the administration to provide Covid-19 care and screening in minority-dominated areas. Dr Mohammad Hussain, president of BMDA, who also runs Faith Hospital in Panigate area of the city, has been continuously promoting the use of HCQ among the community even now. Dr Hussain told this newspaper, “There are conflicting studies about the use of HCQ. While initially the US studies rejected it and cited side-effects, European countries backed its prophylactic use. In Vadodara, it has shown positive results. We have been able to restrict cases in clusters. Nagarwada no longer has a huge number of cases. We haven’t seen any one developing side effects.” Hussain said that the BMDA took lead in promoting HCQ in the initial red zone areas that were mostly in minority-dominated areas. “There was a lot of resistance to the drive. When the administration approached us, we prescribed HCQ and also created awareness about the need to consent to the course. The result has been fruitful. Even in my hospital, I have ensured that all doctors and employees take HCQ as they are in the frontline. Thankfully, none has contracted the virus yet,” Hussain said. A senior doctor from Gujarat Medical Education Research Society (GMERS)-run Gotri Medical College, the biggest Covid1-9 facility in the city that also caters to neighbouring districts, says, “Our residents and doctors are on rotational duty for seven days at a time. Almost all of them have completed at least two rounds… We haven’t seen our healthcare staff falling to the virus yet, barring a couple of cases where the source of infection could not be traced. Although HCQ, with or without Azithromycin and other supplements like zinc, will not help anyone who has tested positive, it definitely has an impact in preventive measures and reducing the complications.” Officer on Special Duty Vinod Rao said that the administration had apprised the state government about its findings from the analysis so far. “The task force of medical experts, including physicians and super specialists, have recommend and backed the drive to administer HCQ in cluster areas and high exposure cases. We have discussed the analysis and the results with the government. The benefits seem to far outweigh the debate around its risks and it has certainly helped in implementing the preventive strategies planned for the city,” Rao said. On Wednesday, Vadodara’s Covid-19 tally stood at 2,338 with a current doubling rate of 25 days. The VMC, until Wednesday, declared 57 deaths after an audit according to ICMR guidelines.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Morocco: Health Minister Uses Chloroquine Despite WHO Warnings

Postby smix » Tue Jun 09, 2020 12:13 am

Morocco: Health Minister Uses Chloroquine Despite WHO Warnings
Telesur TV

URL: https://www.telesurenglish.net/news/mor ... -0008.html
Category: healthNews
Published: May 28, 2020

Description: Taleb said that over 4,500 recovered patients received hydroxychloroquine as part of their treatment with other complementary medicines.
Morocco Health Minister Khalid Aït Taleb confirmed on May 27 his nation continues using chloroquine in COVID treatments despite WHO warnings on its undesirable side effects. “We found out after the adoption of this treatment on March 23, that patients healed faster than those admitted to hospital before them,” Taleb stated to local news media. In early May, the Moroccan health leader praised chloroquine's alleged virtues on live TV and affirmed the drug inhibits one of COVID stages. “Everyone sees it on the ground. It is not only we who say this, but the same observation is made internationally” Taleb commented. WHO suspended hydroxychloroquine clinical trials after the drug did not show conclusive positive effects on COVID affected patients. The international body suggested its suspension from sanitary protocols and administration cease. Taleb said that over 4,500 recovered patients received hydroxychloroquine as part of their treatment with other complementary medicines. “We found out after the adoption of this treatment on March 23, that patients healed faster than those admitted to hospital before them,” Taleb affirmed. Morocco health authorities stocked chloroquine-based drugs after reporting a COVID case was reported in early March. According to healthleaders, a technical and scientific commission determined the medical protocol for respiratory diseases. Thus far, Morocco registered 7,636 COVID positive cases, 202 deaths, and 5,109 recoveries.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome

Postby smix » Tue Jun 09, 2020 3:21 pm

Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome
Springer Link

URL: https://link.springer.com/article/10.10 ... 20-09689-x
Category: healthNews
Published: May 13, 2020

Description: In March 2020, hydroxychloroquine (HCQ) and azithromycin were tested as potential treatments for COVID-19 pandemic, in an open label non-randomized clinical trial [1]. Data were collected from 36 confirmed COVID-19 patients after receiving no treatment (n = 16) or 200 mg q8h of HCQ with (n = 6) or without (n = 14) azithromycin depending on clinical status. Collected data over six days included one HCQ concentration per patient; respiratory viral loads (PCR assay); azithromycin co-treatment; and clinical status among other variables. Using observed HCQ concentrations and basic pharmacokinetic equations, it was possible to calculate missing concentrations at all days for all patients (Supplementary Fig. S1). Daily viral load, presented as PCR threshold cycle (CT), was converted into a dichotomous variable (positive-PCR or negative-PCR). A logistic regression evaluated whether HCQ concentrations, azithromycin co-treatment (yes/no), clinical status (asymptomatic, upper or lower respiratory tract infection [URTI or LRTI]), time (day 0–6), and other covariates (age, sex) were associated with response (positive-PCR outcome). Model evaluation and selection was performed based on statistical significance (p-value ≤ 0.05) and diagnostic plots (Supplementary Figs. S2, S3). The final model contained HCQ log-concentrations (ng/ml), azithromycin co-treatment, clinical status, and day as statistically significant covariates (Figs. 1 and S4).

Predicted-Probability-of-Positive-PCR.jpg
Predicted Probability of Positive-PCR across treatment days at average hydroxychloroquine concentration.

Results showed that the odds of positive-PCR decrease by 53% for each unit increase in HCQ log-concentration. Similarly, the odds decrease by 61%, and by 12% for each day increase, and for azithromycin co-treatment, respectively. Whereas the odds of positive-PCR increase by 99.4 folds and 212 folds for having URTI and LRTI versus being asymptomatic subject. Using the model, minimum HCQ concentrations to achieve > 50% probability of negative-PCR on day 3 were calculated, with or without azithromycin, for the clinical statuses. A minimum HCQ concentration (ng/ml) of 8103 (without azithromycin) and 282 (with azithromycin) are needed in subjects with LRTI. A minimum HCQ concentration (ng/ml) of 2441 (without azithromycin) and 83.9 (with azithromycin) are needed in subjects with URTI. Asymptomatic patients require minimal HCQ concentrations (< 2 ng/ml) regardless of azithromycin co-treatment. Next, HCQ population PK model [2] was used to simulate dosing regimens needed to achieve targeted HCQ concentrations. Simulations showed that when HCQ is co-administered with azithromycin, a loading dose is critical in rapid achievement of targeted concentrations. The suggested dosing regimen for HCQ (with azithromycin), is 600 mg at 0 and 400 at 8 h followed by 200 mg q8h (Supplementary Fig. S5). When HCQ is administered without azithromycin, no safe and suitable HCQ dose can achieve targeted concentrations in LRTI and URTI patients (Supplementary Fig. S6). The analysis confirms that co-treatment of COVID-19 with HCQ and azithromycin increases the probability of negative-PCR in patients. It also shows that clinical status affects the treatment outcome. This analysis is based on limited published data; therefore, the results should be interpreted with caution. The analysis cannot inform on the eventual patient outcome, it only evaluates time to undetectable viral load. Further clinical evaluation of HCQ and azithromycin are merited. Benefit-risk profile needs to be taken into account due to known adverse events associated with HCQ and azithromycin.
--
PDF: Hydroxychloroquine and azithromycin as potential treatments for COVID-19; clinical status impacts the outcome



Risk Factors for Mortality in Patients with COVID-19 in New York City
Springer Link

URL: https://link.springer.com/article/10.10 ... ticle-info
Category: healthNews
Published: June 30, 2020

Description: Abstract
Background
New York City emerged as an epicenter of the coronavirus disease 2019 (COVID-19) pandemic.
Objective
To describe the clinical characteristics and risk factors associated with mortality in a large patient population in the USA.
Design
Retrospective cohort study.
Participants
6493 patients who had laboratory-confirmed COVID-19 with clinical outcomes between March 13 and April 17, 2020, who were seen in one of the 8 hospitals and/or over 400 ambulatory practices in the New York City metropolitan area
Main Measures
Clinical characteristics and risk factors associated with in-hospital mortality.
Key Results
A total of 858 of 6493 (13.2%) patients in our total cohort died: 52/2785 (1.9%) ambulatory patients and 806/3708 (21.7%) hospitalized patients. Cox proportional hazard regression modeling showed an increased risk of in-hospital mortality associated with age older than 50 years (hazard ratio [HR] 2.34, CI 1.47–3.71), systolic blood pressure less than 90 mmHg (HR 1.38, CI 1.06–1.80), a respiratory rate greater than 24 per min (HR 1.43, CI 1.13–1.83), peripheral oxygen saturation less than 92% (HR 2.12, CI 1.56–2.88), estimated glomerular filtration rate less than 60 mL/min/1.73m2 (HR 1.80, CI 1.60–2.02), IL-6 greater than 100 pg/mL (HR 1.50, CI 1.12–2.03), D-dimer greater than 2 mcg/mL (HR 1.19, CI 1.02–1.39), and troponin greater than 0.03 ng/mL (HR 1.40, CI 1.23–1.62). Decreased risk of in-hospital mortality was associated with female sex (HR 0.84, CI 0.77–0.90), African American race (HR 0.78 CI 0.65–0.95), and hydroxychloroquine use (HR 0.53, CI 0.41–0.67).
Conclusions
Among patients with COVID-19, older age, male sex, hypotension, tachypnea, hypoxia, impaired renal function, elevated D-dimer, and elevated troponin were associated with increased in-hospital mortality and hydroxychloroquine use was associated with decreased in-hospital mortality.
--
PDF: Risk Factors for Mortality in Patients with COVID-19 in New York City
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Hydroxychloroquine: 10% of patients treated at Guadeloupe University Hospital had side effects

Postby smix » Fri Jun 12, 2020 4:09 pm

Hydroxychloroquine: 10% of patients treated at Guadeloupe University Hospital had side effects
France TV info

URL: https://la1ere.francetvinfo.fr/guadelou ... 39818.html
Category: healthNews
Published: June 5, 2020

Description: Translated from French
What should we think of hydroxychloroquine? After multiple reversals concerning the toxic effects of this drug, the WHO is preparing to resume its clinical trials. In the infectious diseases department of the Guadeloupe teaching hospital, during the crisis, around sixty patients benefited from this treatment. More than a week ago, the WHO warned of the toxic effects of this molecule. A warning which led France to prohibit the prescription for the treatment of Covid-19. But a new change in discourse by the authors of this study has caused trouble. The toxicity of the molecule and its ineffectiveness could not be demonstrated. WHO should therefore resume clinical trials. In the service of infectious diseases of the University Hospital of Guadeloupe, in the service of Professor Pierre-Marie Roger, around sixty patients were treated with hydroxychloroquine associated with azythromycin, during the peak of the epidemic.
Little time in intensive care for treated patients
While the last patient left his service two months ago, the Professor tries to objectively analyze the effectiveness of this treatment even if a base of 60 patients is not very representative. First indicator, the rate of presence of the virus in a patient, after a week of treatment.
Treatment discontinuation for 7 patients
Another result noted by Professor Pierre-Marie Roger, fewer side effects than expected. The observed effects had cardiac repercussions. but treatment had to be stopped for only seven patients, or 10% of the patients. Conclusion: in virological terms the effects were less beneficial than expected. On the other hand, for the Professor, the experience of very early treatment deserves to be considered.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Recovery trial: Brexit and overdose

Postby smix » Sun Jun 14, 2020 7:30 pm

Recovery trial: Brexit and overdose
France Soir

URL: http://www.francesoir.fr/politique-mond ... d-overdose
Category: healthNews
Published: June 8, 2020

Description: Yesterday, Recovery the UK covid study announced with immediate effect the end of the clinical trials with hydroxychloroquine immediately. The decision was motivated by the following statement " although it is not showing toxicity or causing more deaths, this drug does not work”. A new tack after the withdrawal of The Lancet’s study that had qualified hydroxychloroquine as dangerous and lethal. The last 10 days will have seen a number of contradictory news, far from reassuring for the population.
Let's take a look at this surprising decision,
First of all let's take a look at the recent chronology (as we have been surfing from development to development for some time)
* On May 22, Mehra published in the journal The Lancet a study over 96,000 patient records, concluding that hydroxychloroquine is not only ineffective but also dangerous.
* On May 28, a release from the Recovery Control Committee indicated that there was no problem with hydroxychloroquine and therefore recommended that recruitment should be continued without interruption until the next meeting, scheduled for June 11.
* On May 29, the Indian Council of Medical Research alerted the World Health Organization about the incredibly high dosing of hydroxychloroquine in Recovery (4 times higher than that used in the Indian trials).
* On Thursday, June 4, the MHRA (counterpart of the French Autorité Nationale de Sécurité du Médicament) asked Recovery to look at the data for hydroxychloroquine, a request probably related to the announcement of the Boulware study and in the continuity of the Mehra study. The French Minister of Health had done the same on May 23, 2020, leading to a hasty suspension of the use of hydroxychloroquine.
* On June 4, The Lancet retracted the publication with an apology, and the New England Journal of Medicine (EJM) withdrew a similar publication by the same author.
* On June 4, FranceSoir denounced the study by Boulware et al. in the New England Journal of Medicine on statistical grounds among others.
* On June 5, Recovery announced the suspension of testing with hydroxychloroquine.
* On June 5, Martin Landray Head of Recovery trial was interviewed by FranceSoir.
He told us some very interesting things:
* The authors had constantly monitored the results of ongoing studies, as evidenced by the inclusion of information on Remdesivir or The Lancet study.
* This drug is prescribed at a high dose of 2400mg on the first day (that is 1860mg of active hydroxychloroquine molecule) followed by 9 days at 800mg/day.
* The doses chosen are in line with the dosages used for other diseases such as amoebic dysentery.
* This drug is not lethal.
* But this drug does not work: there was no difference between the hydroxychloroquine lot and the baseline lot.
In conclusion, there is no point in giving a drug that has no impact in the context of Covid-19. Full stop. Exit hydroxychloroquine.
What did the results say?
“A total of 1,542 patients were randomized to receive hydroxychloroquine compared to 3,132 patients randomized to standard of care. There was no significant difference in the primary endpoint of mortality at 28 days (25.7% hydroxychloroquine vs. 23.5% usual care).
In the report, certain points attracted our attention:
* The mortality rate of the control group (23.6%) is very high compared to the 12.7% observed by Rosenberg et al. in Jama on severe hospitalized patients. This rate is 18.1% in France and 12.9% in Bouches-du-Rhône (department where Professeur Raoult is located).
* Severely ill patients , aged between 50 and 82 years, with 76% of patients requiring oxygen and among the patients, 27% were diabetics, 27% with heart problems and 22% with lung problems.
* The doses of hydroxychloroquine in the Recovery study protocol are 2400mg, in the form of 12 x 200mg tablets (i.e. 1860mg hydroxychloroquine) in the first 24 hours and 9600mg of hydroxychloroquine for the whole treatment.
However, we were surprised at by a number of facts :
* The UK maximum recommended dosage is not respected : in Great Britain, NICE sets a maximum daily dosage recommendation of 6.5mg per kg of active ingredient, i.e. approximately 500mg per person per day, for known pathologies.
* The maximum recommended dosage in the United Kingdom is almost the same as in France, the AMM in France considers the overdose rate at 25mg/kg of hydroxychloroquine, i.e. for a 75kg patient, 1875mg for one day, requiring immediate emergency hospital care.
* Recovery dosage is three times higher than in the Discovery trial: the dosage used in the Recovery trial is well above that used in the Discovery trial (800mg on the first day for an adult testing positive for Cov2 SARS) and recommended by the WMA in France.
* An important alert remained unconsidered: Indian Council of Medical Research had alerted Recovery of the potential bias created by the four-fold increase in hydroxychloroquine in the trial.
* A Chinese study published on may 15 was ignored: no reference to this study on very severe hospitalized patients that recommends 400mg/day for these patients with a very positive effect to reduce mortality and cytokine storm.
* At the IHU in Marseilles, Professor Raoult, an expert of hydroxychloroquine, recommends a dosage in line with what the AMM”s guideline in France.
* English patients with disorders requiring special attention in NICE's hydroxychloroquine guidelines. There is no confirmation that these patients had been tested Covid-19 positive. The inclusion of patients stipulates that they are suspected or confirmed only.

nice.jpg

But why does the MHRA (equivalent to the AMM) leave Recovery with the possibility to prescribe 4 times the dose normally considered as a maximum? Martin Landray tells us:
"There’s no recommended dosage for Covid 19 because it's a new disease."

A reasonable response, but it still does not answer why one would administer such a high dose, that according to Professor Perronne (another French Professor) is 4 times the maximum dose. Nor can we understand why the mortality rate is much higher at 25%, unless the treatment is given to patients that are so ill that they would have died anyway. Therefore, we have to continue searching why Martin Landray told us "that the chosen dosage is in line with the dosages used for other diseases such as amoebic dysentery". Reading our interview, Professor Peronne said: In 1975, when I did my medical internship at the Claude Bernard hospital, which was the temple of infectious diseases, I saw a lot of amoebiasis and chloroquine was no longer used to treat that disease. It is the first time that I learn that we use hydroxychloroquine in amoebic dysentery, in super-toxic doses for humans. The classic treatment for colonic amoebiasis is the hydroxyquinoline combination of tiliquinol and tilbroquinol, the trade name of which is Intetrix. The capsules contain 50 mg of tiliquinol and 50 mg of tilbroquinol. Dosage: 4 capsules per day.
I think he confused hydroxychloroquine with hydroxyquinoline.
"This man, who calls himself a doctor, is incompetent and dangerous." This is scandalous.

Important opinions and information not followed, experts not consulted, lethal dosages and beyond French (AMM) and British (NICE) standards on patients requiring special attention. British friends – you may be leaving Europe (much to our regret), but your government seems to serve you with a lie. Not only we would not have liked you to leave Europe but in the eventuality that you were sick with covid, we would not like you to leave this world too.
Wake up from Recovery’s hypnosis.
The Citizen’s Collective is a group of committed citizens who work collaboratively to decipher, research, analyze, verify and validate information. They come from diverse backgrounds: doctors, engineers, economists, lawyers, entrepreneurs, financial analysts, statisticians, accountants, computer scientists, professors, geeks, journalists – but above all they have a solid experience of life and an unfailing commitment to the search for truth without polemics or bias.



Oxford-Recovery clinical trial & overdose: a hard pill to swallow
France Soir

URL: http://www.francesoir.fr/oxford-recover ... ls-swallow
Category: healthNews
Published: June 19, 2020

Description: Oxford is the circus of a significant scam around the Recovery clinical trial for Covid-19 therapies. Significant errors, excessive doses of hydroxychloroquine on very sick patients with many comorbidities, resulting in what may appear as "death by overdose", could easily have masked a beneficial effect of the molecule.

oxford-circus-tell-the-truth.jpg

Recovery, the British clinical trial of Covid-19 therapies, has taken centre stage in recent days. Recovery removed hydroxychloroquine on the 5th of June because it did not provide any benefits although non-toxic; That treatment arm showed a lethal rate of 25% similar to the placebo arm (group of patients receiving placebo treatment). In an article of June 17, 2020, we announced that "the good news announced by Recovery two days ago was a decoy to hide inconsistencies and faults." HCQ was administered to inpatients, older and in a rather serious health condition, at extremely dangerous or even potentially fatal dose levels, according to the French authorities that have forbidden its usage at much inferior levels because of toxicity. British authorities appear to use the same toxicity levels as was portrayed in a previous paper. Anyone may wonder whether the two co-investigators in the trial (Professors Landray and Horby) had all their heads when they established the treatment in the arm for hydroxychloroquine.
A monumental inconsistency and pages deliberately removed
Returning to our original article is not done for an amendment further to the criticisms that one may have had, but to reinforce its content by exposing the monumental inconsistency of the essential supporting document with regard to the dosage of the HCQ. This document is entitled "Hydroxychloroquine information sheet V3". It is a mandatory document providing the justification regarding the HCQ doses to be administered. Theoretically, it should be distributed to every investigating physicians participating in the trial. As mentioned earlier, version 3 of this document contains 3 pages and refers to a pharmacokinetic model and another link to the World Health Organization. No pharmacokinetic analysis is in the document. However, not easily, we managed to recover version 2. "Hydroxychloroquine information sheet V2 2020-04-01" and version 1 of this document. Between version 2 containing 25 pages and version 3, the lead investigators Pr. Horby and Pr. Landray simply removed 22 pages including 12 pages of references. This document could easily be regarded as the below par effort of a medical student, if it did not involve the lives of human beings and in this case very vulnerable patients; whilst destroying any chance of proving the effectiveness of HCQ. A simple question is raised: to what extent, what appears as a medical error, was knowingly committed? Surprisingly, as stated on June 17, the pharmacokinetic data presented in the HCQ dosing document in Recovery are the result of extrapolations and theoretical simulations that have no place in such a document where only experimental evidence must prevail. Additionally, and perhaps even more serious, some of the simulated curves are for chloroquine and not hydroxychloroquine which is the product tested. Moreover, it is surreal that the pharmacokinetic data of plasma levels and HCQ efficacy that should have been retained by the authors, and set out in this supporting document, were indeed measured by Chinese researchers and published on 9 March. This is also the number 5 reference of the document. The Chinese researchers have established with great rigour the experimental measurements and therefore the parameters (e.g. curve below, evolution of HCQ blood levels administered orally) that allow to deduce the doses of HCQ to be administered, orally or intravenously, to obtain the inhibitory activity of the molecule on the SARS-CoV2 virus.

hcq-blood-conc.png

We do wonder why simulated curves such as the one that follows found their way in the essential document of the Recovery trial, instead of actual experimental curves? In such a document only, the actual experimental curves should prevail.

10-days-of-hcq.png

Confusion between two EC50 and IC50 indicators
Another striking inconsistency in this Recovery test document is the confusion between IC50 and EC50! The Chinese pharmacokinetics study reports the value EC50 - 0.72μM (micro molar) which becomes IC50 - 0.72μM in the Recovery document. This confusion is of no real practical importance in this case but indicative of the total lack of scientific rigour and coherence with which the HCQ arm supporting fact sheet was developed. The Chinese do talk about EC50 which is the measure of the median antiviral efficacy of HCQ, described as the necessary concentration of HCQ to eliminate half of the virus present in cell cultures infected with the SARS-CoV2 virus (after a variable incubation time of infected cells). IC50 is a term that refers to the concentration of HCQ needed to halve the virus by binding directly to it and preventing it from functioning in an experiment where it would be isolated from any living environment in which it can reproduce. But it doesn't matter because the important thing is not the lack of semantic rigour but the fact that the Chinese study established the pharmacokinetic parameters and EC50 that allow to deduct the effective doses of HCQ in the treatment of COVID-19. This fundamental article was also made open access by the publisher of the newspaper where it was published because it is of prime importance to all clinical investigators. The Chinese conclusions take into account variation in the populations, i.e. that Europeans can benefit from the treatment and establish the load dose at 800 mg (in 2 intakes of 400mg) followed by a maintenance dose of 400 mg (in 2 intakes of 200mg ). We are a long way from the doses administered in the Recovery trial, which for memory are: 2400 mg on the first day followed by 800 mg on the following days, and for which we are still waiting for clear justification! The Chinese study also evidenced that hydroxychloroquine is 8 times more effective against SARS-CoV2 than chloroquine (EC50 - 0.72μM vs. EC50 - 5.47μM for chloroquine). By comparison, in the Discovery French clinical trial, the dosage tested is the one calculated by the Chinese is used. It will be well worth knowing the results. Should Professors Horby and Landray of Oxford, the lead investigating of Recovery want to torpedo the use of HCQ in Europe, they could not have done better. Excessive doses of hydroxychloroquine on very sick patients with many comorbidities, resulting in what may appear as "death by overdose", could easily have masked a beneficial effect of the molecule. Should you have any doubt left, in the version 3 of the HCQ information document, the Oxford team of Recovery left in the first page the following mention : "see below and appendix". The below was easy to find as it was below. The appendix was not. Is the devil not in the details?

appendix_0.jpg

As we decrypt the documents that were deleted from the Recovery site, we continue to find inconsistencies. For example, the FAQ document (Frequent Questions), the document in use is version 6 of May 20, 2020. We were able to recover version 4 of April 22. This document answers questions that may be requested by the trial’s investigators. We are particularly interested in hydroxychloroquine. The first inconsistency relates to the fact that a patient already treated with HCQ for another condition, can be recruited in the trial, but not in the hydroxychloroquine arm. No precautions of conflict with other molecules. Simultaneously, patients already treated with azithromycin, cannot be included in the azithromycin or hydroxychloroquine arm. The trial was intentionally designed to avoid testing the dual therapie proposed by Pr Raoult of IHU in France. The second point relates to the important dosage. Version 4 included a specific question on dosage and it was simply removed in version 6. A deletion that says it and speaks for itself : we are aware that there have been concerns about the dosage ... however, after careful consideration, the load dose will remain the same. No dose changes are recommended. The principal investigators were acting in conscience.

corticoide_comparison_faq_english.jpg




Oxford, Recovery et Solidarity : Overdosage in two clinical trials with acts considered criminal?
France Soir

URL: http://www.francesoir.fr/politique-mond ... considered
Category: healthNews
Published: June 25, 2020

Description: In the Recovery and Solidarity clinical trials, it is not excluded that patients died as a result of a therapeutic overdose of hydroxychloroquine. Hydroxychloroquine has not stopped being the subject of many conversations. 27 Brazilian researchers are now facing legal charges for a overdose that resulted in the deaths of 11 patients in Manaus (capital of the state of Amazonas in Brazil). The toxicity alert for the Brazilian clinical trial is dated April 17, 2020. Brazil, often criticized in recent times for its management of the crisis, was the quickest to take legal action against these doctors. In previous articles, we hypothesized that the investigators of the British trial Recovery, Professor Horby and Professor Landray, will surely have to justify in court their usage of an excessive load dose (2.4 g over 24 hours) and the cumulative successive doses (800 mg/day) of oral hydroxychloroquine given the toxicity established for this drug. They carry on trying to justify the excessive dosages even after the events, when they should have known as early as April 7th that the dosages used were dangerous in the light of the publication of the disastrous results of the Brazilian study. On the same day (april 7th) the evaluation criteria of Recovery was changed from "dead in hospital" to "death after 28 days". This is most likely with intended to blur the interpretation of the measure, especially to avoid having to disclose the time elapsed before death. We believe that this diverting act has no other possible explanation. In addition, on April 18, 2020, two days after the final publication of the Brazilian study, Professors Horby and Landray also amended the list of frequently questions (FAQs) to remove the portion on excessive dosage. They also removed the pharmacokinetic analysis from the hydroxychloroquine's descriptive sheet in order to hide the mistakes made. Finally, the information on this arm of the study has still not been published 20 days after the announcement. Some patients will have suffered the dramatic consequences of this inhumane experiment conducted by Prof. Horby and Landray, who not only carried on prescribing high dosages despite the warning of the Brazilians, but clumsily attempted to hide their mistakes. As for the Brazilian team, we believe that a criminal investigation should be opened in the United Kingdom.
How can one explain the abnormal dosages of hydroxychloroquine in Recovery?
The hydroxychloroquine fact sheet refers to a WHO document for the doses administered in the Recovery trial. It indicates that the lethal dose of chloroquine, delivered in a single oral intake, is 50 mg/kg (in the basic form) i.e. around 65 mg/kg in the form phosphate (oral dosage) or a dose between 3 and 5 g depending on the weight of an adult (50 and 80kg). Note that for children the fatal overdose is 1 g or less! It should be noted that hydroxychloroquine, is a derivative similar to chloroquine, has been used replacing chloroquine for decades due to a lower retinal toxicity. Although there is much less data on its toxicity, it is accepted that the lethal dose for hydoxychloroquine is within the same range as that of chloroquine (i.e., around 4 g in one intake for an adult). As such, as described in an investigative paper published on the Recovery trial, The Statements of Professor Landray, who estimated that the fatal overdose of hydroxychloroquine was 10 or 20 times above the doses administered in the Recovery trial is astonishing! More worryingly, a paper, describing a case of fatal intoxication following a suicide attempt with hydroxychloroquine, establishes that: "In short, hydroxychloroquine poisoning is infrequent but potentially fatal, and should be suspected in cases of severe hypopotassemia associated with shock, ventricular arrhythmia or cardiopulmonary arrest." The icing on the cake: the WHO document on the therapeutic use of chloroquine indicates that overdose of chloroquine leads, among other things, to respiratory discomfort due to pulmonary edema!. Therefore, the toxicity of hydroxychloroquine can rightly be considered to be exacerbated by the lung damage and cardiovascular fragility of patients hospitalized at an already serious stage of the disease with an increased risk of precipitating them into acute respiratory failure. Mechanically, exacerbation of toxicity can induce more frequent and lower dose events than those considered potentially fatal. This effect is well known to all clinicians. In addition, this has the effect of seriously complicating the attribution of deaths to treatment in the case of COVID-19, so that a mathematical analysis is required to properly assess the disastrous consequences of HCQ overdose in Recovery. Professor Horby and Landray are obviously counting on this to muddy the waters. With a high degree of certainty, the level of doses given to hospitalized patients in the Recovery trial certainly exacerbated the degraded lung condition of a number of patients, which a thorough and methodical study of medical records would simply and rapidly reveal. The Recovery timeline when placed in parallel to that of the Brazilian study reveals the sinister behaviour of Professors Horby and Landray. If proven that they acted consciously, it would merit a criminal prosecution for proven medical malpractice. April 7 is the day of the 3rd change of the Recovery. It is also the date of registration of the Brazilian study document that reports the toxicity of hydroxychloroquine with a high dosage. That same day Recovery made a significant change in the main study criterion: from "death in hospital" to "death under 28 days of randomization in the trial" On April 22nd , the frequently questions contained the question about the dosage of HCQ: "We are aware that there are questions about the high dosage of hydroxychloroquine. However, after careful consideration, the loading dose will remain the same. No dose modification is recommended." This question and its answer were simply removed from version 5 of April 24, 2020. This is the only modification of the document and corresponds to the alert dates of the Brazilian trial on the toxicity of hydroxychloroquine. Claire Brittain, who is in charge of the hydroxychloroquine document and wrote it under the direction of Prof. Horby and Prof. Landray, was unavailable to answer our questions. The investigators worked to erase the obvious evidence of their shortcomings by removing the pharmacokinetic analysis between version 2 and version 3 on April 18, the day after the Brazilians' announcement, and by modifying the FAQs in the process, thus continuing the clinical trial while minimizing their possible responsibilities. This analysis is the one that determines the dosage and has been the subject of a previous article..Between April 18 and June 4, Professors Horby and Landray consciously continued to overdose hydroxychloroquine on patients in this arm of the trial. We believe, they knew there were very significant risks. This undoubtedly contributed to the deaths of a number of patients who received. hydroxychloroquine. The English health regulatory agency MHRA, under the number of reports of the serious adverse events (SAE), has certainly recorded an excessive number of deaths (1 in 4 patients). Dr. Horby and Landray had to produce an interim analysis at the request of the MHRA. This temporarily sheltered them from having to recognize their errors. One can only say that the announcement of the pseudo-success of dexamethasone, looks more like a decoy exercise to cover their shortcomings.
What next ?
Only an analysis of the reports of serious adverse events (SAE) will provide a detailed understanding of what happened to Recovery patients who received an overdose of hydroxychloroquine. This is essential to verify the conclusions of this analysis, In the Recovery clinical trial, it is dramatic that patients were considered as guinea pigs for reasons that defies medical ethics. In addition, the Patient Protection Act considers, that it is unethical to enter patients into a placebo clinical trial (Huriet-Sérusclat Act 1988 supplemented by the Jardé No. 2012-300 Law of March 5, 2012 relating to research involving the human person).).
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Editors of The Lancet and the New England Journal of Medicine: Pharmaceutical Companies are so Financially Powerful They Press

Postby smix » Sun Jun 14, 2020 9:40 pm

Editors of The Lancet and the New England Journal of Medicine: Pharmaceutical Companies are so Financially Powerful They Pressure us to Accept Papers
Health Impact News

URL: https://healthimpactnews.com/2020/edito ... pt-papers/
Category: Politics
Published: June 14, 2020

Description:
Lancet Editor Spills the Beans
Philippe Douste-Blazy, MD, is a cardiologist and former French Health Minister who served as Under-Secretary General of the United Nations. He was a candidate in 2017 for Director of the World Health Organization. In a videotaped interview on May 24, 2020, Dr. Douste-Blazy provided insight into how a series of negative hydroxychloroquine studies got published in prestigious medical journals. He revealed that at a recent Chatham House top secret, closed door meeting attended by experts only, the editors of both The Lancet and the New England Journal of Medicine expressed their exasperation, citing the pressures put on them by pharmaceutical companies. He states that each of the editors used the word “criminal” to describe the erosion of science. He quotes Dr. Richard Horton who bemoaned the current state of science:
“If this continues, we are not going to be able to publish any more clinical research data because pharmaceutical companies are so financially powerful; they are able to pressure us to accept papers that are apparently methodologically perfect, but their conclusion is what pharmaceutical companies want.”

Dr. Douste-Blazy supports the combination treatment –hydroxychloroquine (HCQ) and azithromycin (AZ) for Covid-19 recommended by Dr. Didier Raoult. In April, 2020. Dr. Douste-Blazy started a petition that has been signed by almost 500,000 French doctors and citizens urging French government officials to permit physicians to prescribe hydroxychloroquine to treat coronavirus patients early, before they require intensive care. The issue has become highly politicized; the left-leaning politicians and public health officials are adamantly against the use of HCQ, whereas those leaning toward the right politically are for the right of doctors to prescribe the drug as they see fit. The journal SCIENCE described the response to French President Emmanuel Macron trip to Marseille to meet Dr. Raoult who prescribes the combination drug regimen and he has documented their effectiveness. However, public health officials, academic physicians and the media – all of who are financially indebted to pharmaceutical companies and their high profit marketing objectives – vehemently oppose the use of HCQ, and use every opportunity to disparage the drug by derisively referring to President Trump as its booster.
--
The Lancet Published a Fraudulent Study: Editor Calls it “Department of Error”
On May 22, 2020, The Lancet published “Hydroxychloroquine or Chloroquine With or Without A Macrolide For Treatment of COVID-19: a Multinational Registry Analysis”. It was described as an observational study purportedly involving more than 96,000 hospitalized Covid-19 patients in 671 hospitals across six continents. What was not disclosed is the fact that the two lead co-authors have significant, relevant financial conflicts of interest that just may have biased the reported findings.
* The database belongs to Surgisphere Corporation whose founder and CEO, is Dr. Sapan Desai, who is a lead co-author of the study. Dr. Desai has refused to disclose the data – for independent confirmatory review. In fact, he refuses to identify the participating hospitals, or even the countries.
* Dr. Mandeep Mehra, the lead co-author is a director at Brigham & Women’s Hospital, which is credited with funding the study. Dr. Mehra and The Lancet failed to disclose that Brigham Hospital has a partnership with Gilead and is currently conducting TWO trials testing Remdesivir, the prime competitor of hydroxychloroquine for the treatment of COVID-19, the focus of the study.
The Lancet report claimed that COVID-19 “patients treated with hydroxychloroquine (with or without a macrolide) were at increased risk of de-novo ventricular arrhythmia and ‘a greater hazard for in-hospital death.’” Such an alarming finding from an inaccessible dataset should have raised concerns for the editor of the Lancet, about the integrity of the study and the accuracy of the claimed findings. In fact, within days of the Lancet publication, concerns about that dataset were raised on social media, on PubPeer, the post-publication discussion website, and in newspapers. Within days of publication, Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) declared on CNN
“The scientific data is really quite evident now about the lack of efficacy.”

A media blitz against hydroxychloroquine (HCQ) created panic: clinical trials aimed at testing hydroxychloroquine for COVID-19 were suspended by International public health institutions including the World Health Organization the UK government regulatory agency and the French government. The chief scientist at the WHO, Soumya Swaminathan, stated that although the Lancet data weren’t from a randomized controlled trial, the data were compelling because they
“came from multiple registries and quite a large number of patients, 96,000 patients.”

Knowledgeable scientists and experienced clinicians around the world were skeptical The alarming findings and serious negative impact of the Lancet report led numerous scientists around the globe to scrutinize the report in detail. That scrutiny by legitimate, independent scientists has led to many serious questions about the integrity of the study, the authenticity of the data, and the validity of the methods the authors used. An Open Letter posted online, is addressed to the authors of the report: Mandeep R Mehra, MD, Sapan S Desai, MD, Frank Ruschitzka, MD, Amit N Patel, MD, and to the editor, Dr. Richard Horton. The letter was signed by more than 200 prominent scientists across the world, including 17 from institutions in Africa. The scientists question the evidence for claimed serious risks posed from the use of hydroxychloroquine in COVID-19 patients. Among the concerns raised by the scientists are the following:
* A range of gross deviations from standard research and clinical practices, such as: patients were prescribed inexplicably high daily doses of hydroxychloroquine –far higher than the FDA-recommended doses.
* There was no ethics review.
* The number of patients reportedly from Australia far exceeded the number of patients in the Australian government database;.
* Gross misrepresentation of the numbers of deaths in Australia.
* “Both the number of cases and deaths [the claimed 40% deaths in Africa], and the details provide seem unlikely.”
* Refusal to identify the hospitals that contributed patient data.
* The ratios of patients who received chloroquine (49 %) to those who received hydroxychloroquine (50% ) are implausible; in Australia chloroquine is not available without special government authorization.
The Guardian reported on May 28th that it could not confirm that UK’s health agencies had even provided data for the study. On May 29th The New York Times reported that 100 scientists and clinicians raised serious questions about the validity of the The Lancet report findings. It reported that on May 29th Dr. Mehra issued the following statement:
“We leveraged the data available through Surgisphere to provide observational guidance to inform the care of hospitalized Covid-19 patients”

[Perhaps someone can translate what “leveraged the data” means ….? The Times understated the number of scientists who signed the open letter; it is closer to 220.]
--
Knowledgeable scientists and experienced clinicians around the world were skeptical
The alarming findings and serious negative impact of the Lancet report led numerous scientists around the globe to scrutinize the report in detail. That scrutiny by legitimate, independent scientists has led to many serious questions about the integrity of the study, the authenticity of the data, and the validity of the methods the authors used. An Open Letter posted online, is addressed to the authors of the report: Mandeep R Mehra, MD, Sapan S Desai, MD, Frank Ruschitzka, MD, Amit N Patel, MD, and to the editor, Dr. Richard Horton. The letter was signed by more than 200 prominent scientists across the world, including 17 from institutions in Africa. The scientists question the evidence for claimed serious risks posed from the use of hydroxychloroquine in COVID-19 patients. Among the concerns raised by the scientists are the following:
* A range of gross deviations from standard research and clinical practices, such as: patients were prescribed inexplicably high daily doses of hydroxychloroquine –far higher than the FDA-recommended doses.
* There was no ethics review.
* The number of patients reportedly from Australia far exceeded the number of patients in the Australian government database;.
* Gross misrepresentation of the numbers of deaths in Australia.
* “Both the number of cases and deaths [the claimed 40% deaths in Africa], and the details provide seem unlikely.”
* Refusal to identify the hospitals that contributed patient data.
* The ratios of patients who received chloroquine (49 %) to those who received hydroxychloroquine (50% ) are implausible; in Australia chloroquine is not available without special government authorization.
The Guardian reported on May 28th that it could not confirm that UK’s health agencies had even provided data for the study. On May 29th The New York Times reported that 100 scientists and clinicians raised serious questions about the validity of the The Lancet report findings. It reported that on May 29th Dr. Mehra issued the following statement:
“We leveraged the data available through Surgisphere to provide observational guidance to inform the care of hospitalized Covid-19 patients”

[Perhaps someone can translate what “leveraged the data” means ….? The Times understated the number of scientists who signed the open letter; it is closer to 220.]
Dr. James Watson, senior scientist at the MORU-Oxford Tropical Medicine Research Unit in Thailand doubts that any research organization could have obtained such detailed massive records for so many people in Africa that quickly. Based on healthcare workers’ descriptions of medical record-keeping, at many hospitals in Africa, he indicated:
“I just find it very hard to believe.”

Dr. Watson contributed concerns regarding the African data to the Open Letter. He had to suspend a just-launched trial of HCQ to comply with UK regulators following the Lancet report. Dr. Anthony Etyang, a consultant physician and clinical epidemiologist with the KEMRI-Wellcome Trust Research Programme in Kenya, who is also a signatory to the Open Letter, wrote to The Scientist expressing his doubts about the numbers of African patients in the Surgisphere dataset, noting that even private hospitals on the continent have poor medical records. Rather than investigating the serious issues raised about the integrity of the report, The Lancet editor posted the authors’ claimed to “correction” of the numbers of patients in Asia and Australia on a page designated “Department of Error” – whatever that means!
* The nature and number of the serious “discrepancies” that have emerged following the Lancet publication of the Surgisphere “study,” lead one to suspect out-and-out FRAUD.
Disputed Hydroxychloroquine Study Brings Scrutiny to Surgisphere, an investigative report by Catherine Offord in The SCIENTIST, May 30, 2020, looked deeper than others and uncovered background information about Dr. Desai and the changes in Surgisphere’s product line and his marketing methods. In 2008, Surgisphere was the publisher of medical textbooks that ran afoul when physicians complained about falsified rave reviews. In 2010, Surgisphere became a high impact, online medical journal, whose website boasts that it
“accrued over 50,000 subscribers spanning almost every country around the world… with almost one million page views per month.”

The Journal of Surgical Radiology had a three-year run; its last issue was published in January 2013. The Scientist reports that Dr. Desai is named in three medical malpractice lawsuits that were filed during the second half of 2019. Additional disturbing facts about Surgisphere have been uncovered by a team of investigative reporters — Melissa Davey, Stephanie Kirchgaessner, and Sarah Boseley – for The Guardian.
Surgisphere, the company that provided the database for studies published by two of the world’s leading medical journals – The Lancet and The New England Journal of Medicine – based on Surgisphere data. The studies were co-authored the hydroxychloroquine studies. “Surgisphere’s employees have little or no data or scientific background. An employee listed as a science editor appears to be a science fiction author and fantasy artist. Another employee listed as a marketing executive is an adult model and events hostess… until Monday, the “get in touch” link on Surgisphere’s homepage redirected to a WordPress template for a cryptocurrency website, raising questions about how hospitals could easily contact the company to join its database.”

The fiasco of the publication of essentially fraudulent reports in the journals with the greatest impact on both clinical treatment and public health policies, reveals how thoroughly corrupted so-called peer review has become because it lacks external, independent review by scientists who have NO STAKE in the study outcome. It was only after the reports by The Scientist andThe Guardian, that the editors of The NEJM and The Lancet were compelled to issue an: “Expression of concern.” This fiasco demonstrates why intelligent people seek alternative sources for reliable information. The website, Science Defies Politics exposes numerous scientifically invalid studies that were essentially “hit jobs” against the use of hydroxychloroquine. WHY are very powerful corporate-government stakeholders so intent on killing a drug with a 70 year track record? Because the drug works against the pandemic; it is readily available, and costs very little. Therefore, it poses a financial threat to both pharma companies and their partners in government and academia, those who are intent on profiting from the COVID-19 pandemic. As uncovered by Science Defies Politics: 16 of the panel members selected by NIH to formulate the official COVID-19 Treatment Guidelines – including two of the three co-chairs – were paid by Gilead. They issued guidelines that raised fear, uncertainty, and doubt about the use of HCQ combined with AZ, while raising no fear, doubt, or uncertainty about using Gilead’s unproven, unapproved, drug remdesivir; a drug that has shown mediocre performance in clinical trials. Seven of the NIH panelists failed to disclose their financial ties to Gilead. They are listed here. The medical scientific literature is infested with financially motivated, shoddy, studies aimed at promoting products and, when a life-saving, non-patentable product, proves effective, scientists are hired to author study reports that are designed to tarnish scientists’ reputations, and to proclaim findings that refute legitimate findings. In this case, studies designed to “debunk” the effectiveness of hydroxychloroquine against COVID-19. Examples of countries and physicians who have witnessed the effectiveness of the HCQ – Az combination as a treatment for covid-19, are viewed by corporate-government collaborating partners as posing a major threat to their marketing agendas. For example, Senegal and India are putting their hopes in hydroxychloroquine, marketed by Sanofi, under the trade name Plaquenil. A Sanofi spokesperson stated:
“We are providing the drug to hospitals and doctors to enable them to carry out clinical trials to determine whether hydroxychloroquine is effective or not, but not to treat Covid-19.”

On May 23rd the Indian Council of Medical Research (ICMR) issued expanded revised guidelines for use of hydroxychloroquine (HCQ) for COVID-19:
“The Joint Monitoring Group and the NTF have recommended prophylactic use of HCQ in asymptomatic frontline workers, such as surveillance workers deployed in containment zones and paramilitary/police personnel involved in Covid-19 related activities, asymptomatic household contacts of laboratory confirmed cases and all asymptomatic healthcare workers involved in containment and treatment of Covid-19 and working in non-Covid hospitals/non-Covid areas of Covid hospitals/blocks.”

Didier Raoult, MD, PhD — “a Science Star” — as the NYT described him in a recent profile, who has identified 500 novel species of human-borne bacteria; a scientist known all over the world as the discoverer of the first giant virus, a discovery that earned him the Grand Prix, one of France’s most prestigious awards. Dr. Raoult is the founder and director of the research hospital, the Institut Hospitalo-Universitaire Méditerranée Infection (IHU). He is a professor on the faculty of Medicine of Ais-Marseille University, and since 2008, he has been the director of the Infectious and Tropical Emergent Diseases Research Unit), which employs more than 200 people and runs a hospital with 3,700 patients. He has more than 2,300 indexed publications and was classified among the ten leading French researchers by the journal Nature. Dr. Raoult has a reputation for bluster but also for creativity that others lack. As the Times noted, “He looks where no one else cares to, with methods no one else is using, and [he] finds things.” Since publishing favorable reports about a treatment combination of two cheap, widely prescribed medicines: hydroxychloroquine and the antibiotic azithromycin, as a treatment of choice against Covid-19, Dr. Raoult has become the subject of intense demonization by the corporate-influenced medical establishment, the media, and the who resort to this tactic whenever they lack evidence or legitimate grounds to support public health policies that cause people harm. Their fallback tactic is to demonize every doctor who challenges them and refuses to adhere to their financially – driven prescribing decrees. Dr. Raoult’s latest scientific report about HCQ, Early Diagnosis and Management of COVID-19 Patients: A Real-Life Cohort study of 3,737 Patients, Marseille, France was posted on May 27, 2020,
It is a retrospective study report of the clinical management of 3,737 patients, including 3,054 (81.7%) treated with hydroxychloroquine and azithromycin (HCQ-AZ) for at least three days and 683 (18.3%) patients treated with other methods. Outcomes were death, transfer to the intensive care unit (ICU), ≥ 10 days of hospitalization and viral shedding. “Treatment with HCQ-AZ was associated with a decreased risk of transfer to the ICU or death (HR 0.19 0.12-0.29), decreased risk of hospitalization ≥10 days (odds ratios 95% CI 0.37 0.26-0.51) and shorter duration of viral shedding (time to negative PCR: HR 1.27 1.16-1.39). QTc prolongation (>60 ms) was observed in 25 patients (0.67%) leading to the cessation of treatment in 3 cases. No cases of torsade de pointe or sudden death were observed.
Conclusion
Early diagnosis, early isolation and early treatment with at least 3 days of HCQ-AZ result in a significantly better clinical outcome and contagiosity in patients with COVID-19 than other treatments.”

In France, doctors who have followed the research of Dr. Raoult, and have themselves witnessed the effectiveness of the HCQ-AZ combination, are suing the government. They demand the right to treat their patients with these drugs before easing of the lockdown. They seek to prevent complications and deaths from a second wave of Covid-19. Dr. Violaine Guérin, an endocrinologist who conducted a trial on 100 doctors infected with COVID-19, and their families, reported her study findings that demonstrated the effectiveness of prescribing HCQ combined with azithromycin at the first sign of symptoms. The drugs substantially reduced the viral load of Covid-19:
“Taking hydroxychloroquine and azithromycin on the outset of flu symptoms can prevent Covid-19 from getting worse. We can treat people now before they end up on a ventilator.”

Her findings replicated those Dr. Didier Raoult. Dr. Guérin recommends prescribing hydroxychloroquine for health workers infected by the coronavirus, which is outside of its approved uses. Health unions in France warned that almost 12,000 health care professionals out of 550,000 – roughly a quarter of the country’s health force – were sick with Covid-19. Dr. Guérin recommends its use on compassionate grounds, stating:
“From the very beginning, doctors have been calling for the right to self-prescribe because they are the ones on the frontline of the coronavirus battle. We cannot waste time when we can treat Covid-19 now, as long as this is done in the early stages of the virus and patients are screened for pre-existing medical conditions.”

Soon after this favorable study was published, the Minister of Health Olivier Veran in bald political arm twisting fashion, asked the highest health authority to review its authorization for the use of HCQ to treat Covid, suggesting further restriction.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Doctors discover effective, life-saving treatment for Covid-19

Postby smix » Mon Jun 15, 2020 3:39 pm

Doctors discover effective, life-saving treatment for Covid-19
Grand Rapids Herald Review

URL: https://www.grandrapidsmn.com/opinion/d ... 0aeb5.html
Category: healthNews
Published: May 30, 2020

Description: As our nation battles a pandemic viral outbreak and suffers from the effects of the resulting national shutdown, the last two weeks have produced some very heartening developments. First, antibody testing in New York state and elsewhere has revealed that roughly ten times more people than first thought show signs of having been infected with the virus. While this at first seems to be an ominous discovery, it is actually the opposite. It means that the vast majority of those who contracted the virus—fully 90%--had such a mild experience with the disease that they weren’t even aware they had it, or they felt no need to seek medical help. Dr. Donald Yealy is Chair of Emergency Medicine at the University of Pittsburgh Medical Center. Citing studies from New York, California, and his own city, Pittsburgh, Yealy explained it this way to reporters, “We’ve learned that way more people, far, far more people have actually been exposed to the infection without any knowledge of it. That makes the overall death rate much lower. Many people just didn’t feel sick at all and recovered without difficulty.” Second, doctors on the front lines in hospitals across America have been reporting remarkable success treating the coronavirus with a new combination of old and tested drugs. Dr. Steven Smith, a board certified Infectious Disease Specialist and founder of the Smith Center for Infectious Disease and Urban Health in Newark, New Jersey, reports that when the virus first broke out, his practice was unaware of how to treat the new disease and within the first two days 20 patients had to be intubated--put on a ventilator. This is a troubling development for patients because nationwide 50%-80% of patients who were put on ventilators never recovered and went on to die. After doing his own research, Dr. Smith began prescribing a combination of Plaquenil (active ingredient HCL), a 70 year old drug with an excellent safety record, and Z-Pack (active ingredient azithromycin), one of the most commonly prescribed antibiotics in America. “Since we began the HCL/Z-Pack regimen,” Dr. Smith reported on national news, “not a single patient has needed intubation. And this is especially significant because roughly one third of our patients were diabetic or pre-diabetic, and another third were considered obese (both under-lying medical conditions that make coronavirus more deadly). But since we began this treatment protocol, we have treated well over 100 patients without a single death. This is absolutely a game changer—the beginning of the end of the pandemic!” One of the clearest facts emerging from this epidemic is that COVID-19 is especially dangerous for older people. Statewide in Minnesota, 80% of all coronavirus deaths have been residents of nursing homes. St. Therese, a 258 bed assisted living facility in suburban Minneapolis has seen 47 of its residents die of the virus in the past few weeks. However, a different story came out of Texas City, Texas, where Dr. Robin Armstrong served the members of a nursing care facility. Dr. Armstrong stated, “I thought the risk of seeing 15% of that nursing home die was just not an acceptable risk.” One third of the residents at the care facility contracted the coronavirus and Dr. Armstrong treated 39 of them with a five-day regimen of Hydroxychloroquine (HCL), Z-pack and zinc. Dr. Armstrong explained his results to his local news affiliate, “Thirty nine patients have now completed their five-day treatment and all have done well—and no one experienced any side effects,” Dr. Vladimir Zelenko serves as a Primary Care Physician in suburban New York City—the epicenter of this outbreak. “I knew that the virus would hit our area hard due to our population density—we have 32,000 people living in one square mile. So I did my own research looking at what had been done in other countries that experienced the virus before us as well as looking at treatments developed for the SARS outbreak in 2003 (another coronavirus). I developed my own protocol of a three drug cocktail: HCL, Azithromycin, and Zinc. In the last few weeks I have seen 1,450 patients with COVID symptoms. I divided my patients into two groups: high risk and low risk. The low risk patients (under age 60 and healthy) statistically get better without treatment, so I sent them home to rest and get over the virus. I gave my drug cocktail to 405 high risk patients (over age 60 or with underlying health problems) whose conditions were most severe. The accepted rate of COVID mortality at that time for high risk patients was 5%, so if I had just relied on ventilators I could have expected to see 20 of my patients die. But using these three drugs I only lost two patients, one of which was very old and had been chronically ill. This was a significant order of magnitude better than expected outcomes.” Dr. Zelenko explains the rationale behind his treatment program. “The zinc is what kills the virus and zinc occurs naturally in the body but has a hard time penetrating the cell where the virus lives. What the hydroxychloroquine does is open a channel into the cell so the zinc can enter and stop the virus from replicating. Adding an extra dose of zinc to the cocktail has been shown to improve outcomes by about 25%. Meanwhile, the azithromycin stands guard to combat any secondary bacterial infection that may crash the party and cause pneumonia.” After seeing the effectiveness of his treatment regimen, Dr. Zelenko stated, “I realized what I had, and I felt like a front line soldier who had stumbled across some very important intelligence—some valuable information that needed to be communicated to the 5-star general because that information could be used to win the war.” Within a few weeks, Dr. Zelenko had published video reports of his findings and was in touch not only with the US Coronavirus Taskforce, but with over a dozen governments around the world from Russia, to South Africa, to Peru. Four weeks ago the government of Brazil began implementing Dr. Zelenko’s protocol, and he explains their results: “One week ago the Brazilians published a study revealing a 95% reduction in deaths after this drug cocktail was introduced for use in their government hospitals.” In France, Dr. Dideraulty Raou, one of Europe’s leading epidemiologist recently presented a study to French President Macron detailing similar results from the use of Hydroxychloroquine. In a study of 1061 patients who had been prescribed HCL/Z-pack, he found that after ten days, 94% had returned to good health and only one half of one percent had died. But just as every death is more than a statistic—it’s someone’s personal story, so these successful treatment numbers represent personal stories of hope and recovery. Evelyn Rand is a 99 year-old resident of a nursing home in Little Rock, Arkansas. When she contracted the coronavirus, her children were understandable concerned. They had become aware of the benefits of HCL and specifically requested Evelyn’s doctor to begin treating her with the drug. Evelyn has been well now for over four weeks. Don Wilkerson, the 80 year-old founder of Teen Challenge—a drug treatment center for inner-city youth in New York City—contracted the virus and was treated with only Tylenol for one week. But after getting very sick, he was prescribed HCL and in less than 24 hours he was feeling better. He called his wife crying tears of joy because he knew he’d turned a corner since his sense of taste had returned. (Loss of taste is a frequent symptom of COVID-19.) Jim Santili had contracted the virus and, though cared for at Henry Ford Hospital for several days and treated with an asthma inhaler and steroids, his condition had gotten steadily worse. “One Saturday I was gasping and felt like I was drowning and might not live till the next day. The doctor came in with the results of a chest x-ray that showed my lungs were collapsing. He said they had basically exhausted all their options and suggested calling in an infectious disease specialist. The specialist recommended trying Hydroxychloroquine and Azithromycin since it had shown very positive outcomes on other patients. Within a few hours after receiving the first dose I had a drastic improvement—almost 180 degrees! My breathing improved, my vitals were better and I actually had hope at that point.” Jim has gone on to make a complete recovery. President Trump called for a national day of prayer on March 15th to ask for divine help in the midst of the coronavirus pandemic. Maybe now we can give thanks for the many life-saving developments we’ve seen in recent weeks.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Before the National Assembly, Didier Raoult castigates the “methodologists”

Postby smix » Wed Jul 01, 2020 12:32 am

Before the National Assembly, Didier Raoult castigates the “methodologists”
Infosurhoy

URL: https://infosurhoy.com/technology/befor ... dologists/
Category: Politics
Published: June 24, 2020

Description: Professor Didier Raoult was heard this Wednesday, June 24 by the commission of inquiry on the coronavirus of the National Assembly. Didier Raoult has said it several times: he opposes what he calls “methodologists”, the partisans of evidence-based medicine, that is to say medical research as it is practiced for over 100 years. It was on this topic that the most interesting exchange took place during its three hours of hearing before the parliamentary commission of inquiry. Asked about his refusal to conduct a clinical trial studying the effects of his dual therapy according to current protocols – randomized trials -, Didier Raoult simply replied that they did not convince him. Everything else comes from this epistemological disagreement. Too bad if the studies he has published since the start of the pandemic are very far from convincing the international scientific community, Didier Raoult does not do science in the same context. Same reasoning on the management of the crisis in France. According to the director of the IHU Méditerranée Infection, in Marseille, methodologists were in charge. Therefore, their decisions do not find favor in his eyes. It is for this reason that he explains that he left a scientific council undermined, according to him, by conflicts of interest. One point should, however, be unanimous: the question of screening. His institute tested massively and very early when the rest of the country was in short supply. But for the rest, Didier Raoult continued to stand alone against the rest of the scientific and medical world.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

Treatment with Hydroxychloroquine Cut Death Rate Significantly in COVID-19 Patients, Henry Ford Health System Study Shows

Postby smix » Thu Jul 09, 2020 4:11 am

Treatment with Hydroxychloroquine Cut Death Rate Significantly in COVID-19 Patients, Henry Ford Health System Study Shows
Henry Ford Health system

URL: https://www.henryford.com/news/2020/07/ ... ment-study
Category: healthNews
Published: July 2, 2020

Description: DETROIT – Treatment with hydroxychloroquine cut the death rate significantly in sick patients hospitalized with COVID-19 – and without heart-related side-effects, according to a new study published by Henry Ford Health System. In a large-scale retrospective analysis of 2,541 patients hospitalized between March 10 and May 2, 2020 across the system’s six hospitals, the study found 13% of those treated with hydroxychloroquine alone died compared to 26.4% not treated with hydroxychloroquine. None of the patients had documented serious heart abnormalities; however, patients were monitored for a heart condition routinely pointed to as a reason to avoid the drug as a treatment for COVID-19. The study was published today in the International Journal of Infectious Diseases, the peer-reviewed, open-access online publication of the International Society of Infectious Diseases (ISID.org). Patients treated with hydroxychloroquine at Henry Ford met specific protocol criteria as outlined by the hospital system’s Division of Infectious Diseases. The vast majority received the drug soon after admission; 82% within 24 hours and 91% within 48 hours of admission. All patients in the study were 18 or over with a median age of 64 years; 51% were men and 56% African American.



“The findings have been highly analyzed and peer-reviewed,” said Dr. Marcus Zervos, division head of Infectious Disease for Henry Ford Health System, who co-authored the study with Henry Ford epidemiologist Samia Arshad. “We attribute our findings that differ from other studies to early treatment, and part of a combination of interventions that were done in supportive care of patients, including careful cardiac monitoring. Our dosing also differed from other studies not showing a benefit of the drug. And other studies are either not peer reviewed, have limited numbers of patients, different patient populations or other differences from our patients.” Zervos said the potential for a surge in the fall or sooner, and infections continuing worldwide, show an urgency to identifying inexpensive and effective therapies and preventions. “We’re glad to add to the scientific knowledge base on the role and how best to use therapies as we work around the world to provide insight,” he said. “Considered in the context of current studies on the use of hydroxychloroquine for COVID-19, our results suggest that the drug may have an important role to play in reducing COVID-19 mortality.” The study also found those treated with azithromycin alone or a combination of hydroxychloroquine and azithromycin also fared slightly better than those not treated with the drugs, according to the Henry Ford data. The analysis found 22.4% of those treated only with azithromycin died, and 20.1% treated with a combination of azithromycin and hydroxychloroquine died, compared to 26.4% of patients dying who were not treated with either medication. “Our analysis shows that using hydroxychloroquine helped saves lives,” said neurosurgeon Dr. Steven Kalkanis, CEO, Henry Ford Medical Group and Senior Vice President and Chief Academic Officer of Henry Ford Health System. “As doctors and scientists, we look to the data for insight. And the data here is clear that there was benefit to using the drug as a treatment for sick, hospitalized patients.” Overall, hospital system patients in the study experienced an 18.1% in-hospital mortality rate. Regardless of treatment, mortality was highest in:
* Patients older than 65,
* Patients who identified as Caucasian,
* Patients admitted with reduced oxygen levels,
* Patients who required ICU admission.
Patients who died commonly had serious underlying diseases, including chronic kidney and lung disease, with 88% dying from respiratory failure. Globally, the overall mortality from SARS-COV-2 is estimated to be approximately 6% to 7%, with mortality in hospitalized patients ranging between 10% and 30%, according to the study. Mortality as high as 58% has been seen among patients requiring ICU care and mechanical ventilation. According to the U.S. Centers for Disease Control & Prevention, hydroxychloroquine (also known as hydroxychloroquine sulfate) is a U.S. Food & Drug Administration (FDA)-approved arthritis medicine that also can be used to prevent or treat malaria. It is available in the United States by prescription only. The drug is sold under the brand name Plaquenil and it is also sold as a generic medicine. It is commonly used by patients with arthritis, lupus or other rheumatic conditions. Dr. Zervos also pointed out, as does the paper, that the study results should be interpreted with some caution, should not be applied to patients treated outside of hospital settings and require further confirmation in prospective, randomized controlled trials that rigorously evaluate the safety and efficacy of hydroxychloroquine therapy for COVID-19. “Currently, the drug should be used only in hospitalized patients with appropriate monitoring, and as part of study protocols, in accordance with all relevant federal regulations,” Dr. Zervos said. Henry Ford Health System, as one of the region’s major academic medical centers with more than $100 million in annual research funding, is involved in numerous COVID-19 trials with national and international partners. Henry Ford Health System is currently also involved in a prophylactic hydroxychloroquine study: “Will Hydroxychloroquine Impede or Prevent COVID-19,” or WHIP COVID-19. The study is a 3,000-person, randomized, double-blinded look at whether hydroxychloroquine prevents healthcare and frontline workers from contracting the COVID-19 virus. The WHIP COVID-19 team is working on expanding study sites while there is a lull in the number of COVID-19 cases in Southeast Michigan. This is in preparation for a potential increase of COVID-19 cases as Fall flu season approaches, with additional sites available for convenient enrollment of healthcare workers and first responders. The WHIP COVID-19 team is also taking this gift of time to reach out to other areas of the world that are seeing a blossoming of cases: Brazil and Argentina. There are currently 619 people enrolled in the study, out of a target of 3,000.
User avatar
smix
 
Posts: 2119984
Images: 1
Joined: Sat Aug 10, 2013 8:05 am
Blog: View Blog (0)

PreviousNext

  • Similar Topics
    Replies
    Views
    Last post

Return to Epidemiology - Contagious Diseases, Vaccines


Mobile Device
  • 1
  • FREE CLASSIFIED ADS
    Free Classified Ads
    There are 3 ways to advertise - your choice: you can place free ads in a forum topic, in the classified display ads section, or you may start your own free blog. Please select the appropriate category and forum for the ad content before you post. Do not spam.
    Caveat emptor - let the buyer beware. Deal at your own risk and peril.
  • Advertisement