Covid Observational Studies

Author of Two Retracted COVID-19 Studies Once Bemoaned Misconduct

The Lancet retracted a controversial “observational study” on the use of hydroxychloroquine or chloroquine with or without antibiotics or zinc in the treatment of COVID-19. The retraction came after scientists, doctors, etc.  raised questions about the data used to draw the the study’s conclusions.   The authors were not able to access and vouch for the underlying data, which came from the company Surgisphere. The New England Journal of Medicine also retracted a similar paper that drew on the same Surgisphere’s proprietary database of global hospital medical records. This action came after it had asked the authors to provide evidence that the data was reliable.

Surgisphere’s CEO, coauthored both papers.

What appears to have happened is Surgisphere data-mined the data from a multiple hospital data bases which lead to its findings. Data mining is a common process used to extract usable  data  from a larger set of any raw data.

To get to the source and use of the data in the observational study, The Lancet‘s editor-in-chief posted on May 28 an open letter  to the authors citing 10 concerns with it. Identifying themselves (letter’s authors) as “clinicians, medical researchers, statisticians, and ethicists from across the world; the signatories” claim the researchers failed to sufficiently identify factors which may have influenced their results such as disease severity, dosage used, lack of ethics review, and errors in the underlying database. This is nothing that has not been pointed out before and ignored by others touting other potential drugs.

Interesting enough, Surgisphere’s CEO and a coauthor of the study had written an earlier publication warning against research misconduct .

One doctor had noted the speed of which both the Lancet and the NEJM publications had been submitted.

Dr. Jimmy Chang: “Mandeep Mehra, Sapan Desai, Amit Patel, same authors.  Surgisphere database (same database? authentic?), 1 study in NEJM (1 May 2020) and 1 study in Lancet (22 May 2020), within very short time.  Lightning speed publications.

Very creative ways of doing dirty things.”

I have found Dr. Chang comments in other articles discussing the efficacy of HCQ + Zinc. This particular statement can be found in the comments section (link above – Dr. Jimmy Chang) as listed as number “5.”

The Lancet and NEJM articles on the two studies have been retracted by both publications due to the unwillingness of Surgishere to allow their data to be reviewed. Due to both the Lancet and NEJM articles taken seriously, studies on HCL have halted and its use banned. Even so, reports showed the proper use of HCQ within two weeks of Covid detection (and not hospitalization), at a lesser dosage than what was used in studies, and in conjunction with Zinc have shown an ability to block Covid from replicating. As read; after a certain period of time after contracting Covid, HCL dosage and Zinc loses much of its effectiveness on Covid if it has already replicated.

Some Detail

HCQ + Zinc is not a cure and neither is Gilead’s drug Remdesivir which also has issues the same as HCQ with regard to usage and effects from its use. Gilead Science also has the Pro-drug (the body converts it into triphosphate)  GS-441524 which is similar to Remdesivir, is easier to manufacture (synthesize), and is made in three steps as compared to the 7-step process for Remdesivir. HCQ  is a decades old drug and is readily available as opposed to Gilead having to ramp up manufacturing to meet a global growing.

There is a history to  Remdesivir also. It was developed to be used in the treatment of Hepatitis C and did not have the impact necessary to be classified as effective. It was repurposed in the treatment of Ebola and was found to less effective than monoclonal antibody treatments; however, Remdesivir does exhibit antiviral activity hence the use in treating Covid.

Remdesivir was recently approved as an orphan drug and later changed back to a normal drug status even though the approval came before Covid had reached 200,000 cases the limit for orphan drug status.  It is thought their profits will be even higher with the Covid pandemic. Pricing for Remdesivir is still an issue when compared to the lower HCQ’s pricing. Gilead Sciences had more than $22 billion of revenue in 2019 and stands to make money from Remdesivir for many years  to come when FDA approved.

Former Gilead Vice President Joseph Grogan sits on a Vice President Pence led 16 person task force of which 4 members have scientific skills. His position on the task force as well as the former Lilly’s employee “We can’t control the price” – Alex Azar’s presents a conflict in favor of Gilead Sciences and other drug companies. Joseph Grogan was a lobbyist for Gilead Sciences before he joined the Trump administration as director of the Domestic Policy Council leading the Drug Pricing and Innovation Work Group.

The timing of the usage of either of these drugs is extremely important with regard to the impact on replication of Covid in the body. If not used early on and before hospitalization, the impact of either is limited with Covid (reduce viral load). The immune system whose function is to fight infections over reacts and eventually leads to the “death of the patient from over-activation of white blood cells, which release too – great amounts of cytokines – inflammation – stimulating molecules – into the blood” which impacts the organs of the body. HQC alone or with other elements has been used too late in the process of treating Covid and preventing replication which causes the body to fight back with white cells.

I had hoped by now others would have written on the issues with the Lancet and NEJM studies which were touted extensively. Then there are the issues surrounding further studies of HCQ.  And yes, there are issues if the dose is too great initially or over a period of time, if it is used by itself without the addition of Zinc, etc., and if it is used too late in the process of treating Covid as it has already replicated. The commentary on the two flawed studies was not forth coming, hence my comments.

Meanwhile, India has approved the use of hydroxychloroquine as a preventive medication for asymptomatic healthcare workers working in non-COVID-19 hospitals, frontline staff on surveillance duty in containment zones and paramilitary/police personnel involved in coronavirus infection related activities. Like South Korea, India is a country far away, not white, and not as cultured as we are.

A last comment, one has to wonder if Trump tested positive as detected by a doctor and was prescribed HCQ to prevent replication? We are only getting part of the story if true.