Anti-HCQ Paper in The Lancet Uses Fabricated Data

The May 22 anti-HCQ paper (Hydroxychloroquine or chloroquine with or without a macrolide for treatment of COVID-19: a multinational registry analysis, Mehra et al., May 22, 2020, The Lancet) is obviously fraudulent. Its data is fake.

The paper claims “We included all patients hospitalised between Dec 20, 2019, and April 14, 2020, at hospitals participating in the registry” with COVID-19 and records of death or discharge. 671 hospitals from six continents allegedly provided their data for this database. The US hospitals were allegedly “selected to match the epidemiological characteristics of the US population”. In this great database, the authors have found 96,032 hospitalized patients with COVID-19, including 14,888 treated with HCQ or CQ with either Azithromycin (AZM) or Clarithromycin. 

Some of the many mysteries in the alleged data:

  • The study data shows only 42% of patients (6,221 out of 14,888) in the treatment groups received HCQ+”macrolide”. However, it is widely known that almost all people treated with HCQ or CQ received HCQ+AZM.
  • In the study data for North America, 35% of patients (3,415) received CQ and 65% of patients (6,462) received HCQ. However, it is widely known that, outside of China, CQ was used significantly less than HCQ.
  • All patients treated with CQ/HCQ received antibiotics, almost always AZM. In the study, 32% of the North American patients received no “microlide” (Appendix, Table S3). Do peer reviewers really believe that almost a third of patients hospitalized with respiratory infection received immunosuppressives without antibiotics?  
  • The population data is very homogeneous, almost the same across the six continents – this is highly unlikely. For example, the patients with qSOFA < 1 are 82.6% in Europe and North America (what a coincidence!), and 82.7% in South America (Table S3).

Tweets from an Australian medical doctor with PhD helped me to understand the mystery. Not only the data is fake, but the database Surgical Outcomes Collaborative is fake as well. This is why:

… the study says that they received data from 600 hospitals up to mid-April, and it was published end-May. This is impossible. If you have ever collected clinical research data you will know how impossible it is.

… you need ethical approval, suitable web servers set up, access set up for each hospital (and ideally each worker). This is what the authors say happened – they say they questioned existing repositories

I’m sorry but these don’t exist. Repositories do exist that maintain some of this data but it is mostly unlinked, relies on it being filled in correctly and exists on different systems that don’t talk to each other. …

… for each hospital system providing access you have to go through a complex ethics approval system (otherwise your hospital has just given your personal data to some strangers). …

An ethics approval of this magnitude would take months but it would take even longer to get the system up and running to allow secure access to hospital data systems externally. IT JUST DOES NOT HAPPEN.

The thread continues. The doctor takes note that the patients data matches nearly perfectly on 23 factors.

This is pretty much statistically impossible, and they are claiming that they got this matching in 7000 patients out of a pool of 96000 patients for which they received high quality information from 671 hospitals. Nope. Sorry, the data is too “clean”.

And

So, this group are telling us that, not only have they got access to 671 hospital clinical record systems but (and this is a problem) … They have access to all the pathology providers linked to those 671 hospitals and THEY CAN DATA LINK THE PATIENT RECORDS. Not a chance. 

This didn’t happen, and if it did it would be a massive privacy scandal. There would be serious financial and potentially criminal repercussions

So, either this data is completely fabricated  -or- The authors have been able to overcome impossible hurdles of data sharing and probably broken a number of laws in the process.

Surgisphere Corporation is a tiny one. Thus, the data is completely fabricated.

The paper also heavily promotes the Surgical Outcomes Collaborative, the fake database from which the data has been obtained. It is owned by the Surgisphere Corporation. Sapan S. Desai, one of the paper’s authors, is a Surgisphere founder (disclosed) and CEO (not disclosed). The “Collaborative”, which was unknown before May 2020, is mentioned by name seven times in the paper. Two paragraphs (~500 words) are Collaborative’s advertisement:  a cloud-based health-care data analytics platform that includes specific modules for data acquisition, data warehousing, data analytics … A manual data entry process is used for quality assurance and validation to ensure that key missing values are kept to a minimum … ensures compliance with the US Food and Drug Administration (FDA) guidance on real-world evidence … data are collected through automated data transfers that capture 100% of the data from each health-care entity at regular, predetermined intervals … the standard operating procedures in place for each of the four ISO 9001:2015 and ISO 27001:2013 certified features of the registry … Collection of a 100% sample from each health-care entity is validated against financial records … capturing all-comer data and consecutive patient enrolment by capturing 100% of the data within electronic systems … compliant with the US Agency for Healthcare Research and Quality guidelines for registries … etc.

The paper does not break down results between AZM and Clarithromycin, nor do they explain why they selected Clarithromycin, so I will. Clarithromycin has harmful interactions with CQ and HCQ (unlike AZM), and Clarithromycin is a strong QT prolonger, (unlike AZM, which is a mild one). This is why physicians did not use Clarithromycin with HCQ as a COVID-19 treatment. I could find only a couple of single patient reports of combining Clarithromycin with CQ.

via Science Defies Politics

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May 23, 2020 at 09:54PM

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