Analysis of the EAP, page-482

As a follow up to my post above, someone has opened another thread on HC pointing out that one of the authors of both The Lancet paper and the NEJM paper has previously received consulting fees from Mesoblast. In fact, it's the lead author of both studies, Dr Mandeep Mehra, a cardiologist at the prestigious Brigham and Women's Hospital of Boston, an affiliate hospital of Harvard University and a participating hospital enrolling patients in the 300-patient Mesoblast C-19 ARDS phase 3 study.

The other poster calls the paper in The Lancet "completely fake"... whoa, let's take a look.

So, there were 4 authors of the paper: Dr. Mehra, Dr. Sapan Desai, Dr. F Ruschitzka and Dr. A Patel... The paper involved an analysis of approximately 9000 patients drawn from the records of 169 hospitals around the world, and again it was a retrospective study. Associations may be gleaned but it's not the gold standard for drawing therapeutic conclusions. Prospective studies are preferred. The problem here arose when other experts in the cardiology community questioned the source of the data. That source was a company headed by Dr. Desai that collected and compiled the data. When criticism arose, the other three authors of the paper, led by Dr. Mehra, called for an independent audit of the data. Dr. Desai refused the audit citing confidentiality reasons. So, the other 3 authors LED BY Dr. Mehra essentially turned against Dr. Desai. Only three of the four authors requested a retraction of the paper and they made this statement.

"We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic. We deeply apologise to you, the editors, and the journal readership for any embarrassment or inconvenience that this may have caused."

So, I would say the good guy in the story is Dr. Mehra. He took corrective action for withdrawing a paper that could not be adequately peer reviewed. I applaud his action which comes approximately two weeks after the initial publication. Some damage was done perhaps, but quick corrective action was taken.... nothing like the 12 years and demonstrable bad faith of the MMR study by Dr. Wakefield mentioned above.

I think it's an unfortunate incident. I'm sure Dr. Mehra is embarrassed, but he did the right thing. Meanwhile, we cannot say the data are "completely fake". All we can say is that the data are "unverified", perhaps unverifiable. So, we must avoid drawing treatment conclusions. It underlines the need for accurate studies which in the case of hydroxychloroquine are still underway.

There's no evidence The Lancet paper was politically motivated, but given the controversy surrounding the subject of HCQ, the incident also underlines the need for careful scientific analysis and thorough peer review. Molecules do not cure or kill along party lines. These are issues that impact all of humanity.

It does not appear Dr Mehra is involved in the phase 3 Mesoblast C-19 ARDS study; Dr Peter Hou is listed as the contact. The Brigham and Women's Hospital remains a trusted participant in the study. Data continue to be collected. Over 900 C-19 deaths occurred in the US just yesterday, many of these were ICU patients on ventilators, the target population for rem-L. A solid, verifiable, peer-reviewed study of rem-L in C-19 ARDS is essential to make good treatment decisions on thousands of patients or more in the future.

Data continue to be collected, no harm done.