Status Update on FOIA request of NIAID Remdesivir trials.

I have received a status update from Gorka Garcia-Malene, Freedom of Information Act Officer of the NIH, on my FOIA request regarding Anthony Fauci’s NIAID ACTT-1 Remdesivir trials. Malene has a Master’s in Biotechnology (2009) from The Johns Hopkins University and a degree in Law (2003) from Rutgers.

.

The request was denied because the information that I have requested contains personally identifiable information (PII) and that they are under no obligation to remove the PII.

I have a strong respect for HIPAA laws. I would not be comfortable receiving the data with personally identifiable information. So on that, we agree. The point of contention is the cost to be incurred in removing the PII.

Let’s take a look at some of the text of the denial letter. The complete letter is included below.

We queried the NIAID and while the NIAID has the full datasets, these data sets have personally identifiable information (PII) and cannot be shared in their entirety.

So the data could be shared if it did not contain PII. That’s important. I’m fine with it being redacted. Some PII could be useful in the type of statistical analysis of the data that I intend to use, but sometimes you have to make use of what you have. The results would not be as sharp as I would like, but I think the data will still be very informative without PII.

Furthermore, the NIAID is not able to segregate the requested data from the PII and is not required under the FOIA to incur expense to do so through the data management contractor.

I am willing to pay to have the data segregated. I believe Malene should simply present a reasonable bill. I do not believe that the NIAID is unable to segregate data. I don’t see how the NIAID could possibly do their job if they did not have the ability to segregate data. An NIAID webpage on “Data and Tools” states:

NIAID offers many resources to support data science research, including data sharing, databases, and datasets. Search and filter the list available at Resources for Researchers to find what you are looking for!

There was a redirect to another link on “primary and secondary outcomes.”

A set of data supporting the primary and secondary outcomes that were reported and is constructed in a way that maintains the privacy of the participants has already been created and can be found at the link: https://accessclinicaldata.niaid.nih.gov.

The link provided does not function even while I am logged in to the NIH FOIA portal. It is unclear if the link would satisfy the requirements of my FOIA request. I doubt it would. What I want is to have 1062 rows of data, one for each study participant. For each patient, I need to know how much remdesivir they received, how much opioids they received, if they were ventilated, and what hospital they were in. Something super simple like this. I’ll compile the data in this format if necessary.

Malene also redirected to the New England Journal of Medicine, which does not have the raw data that I requested.

The data was constructed to allow researchers to re- create analyses in the ACTT-1 final report manuscript (https://www.nejm.org/doi/full/10.1056/nejmoa2007764).

I also requested protocols. This was his response:

Further, the Study Protocol contains any requirements by NIAID to the investigators and clinical teams taking care of the participants, and this protocol is posted at https://clinicaltrials.gov/ct2/show/NCT04280705.

I’ve looked at the “study details” section of the trials in the link he provided. It contains basic information on dosing, visit scheduling for family members, blood testing, and a few other things. I do not believe that this is the only information communicated to hospitals participating in the NIAID Remdesivir clinical trials.

For instance, there is a mention of providing oxygen to patients.

Hospitalized, requiring supplemental oxygen" or "Hospitalized, not requiring supplemental oxygen

What was the standard used to provide or not provide oxygen? These details are not provided in the Adaptive COVID-19 Treatment Trial (ACTT) study details section.

To be clear, my FOIA request covers any and all communications between NIAID employees, subcontractors of the NIAID, and any individuals in the hospitals who participated in the study. There had to be some type of handbook or written instructions. There had to be some communication between hospitals and the NIAID when questions arose. If it is Malene’s contention that the only information communicated to the hospitals can be found in the link he provided, he should say so.

Please be advised that the records you seek are protected from release as they are private. I have determined to withhold all of the records in full pursuant to Exemption 6 of the FOIA, 5 5 U.S.C. 552 (b)(6) and section 5.67 of the HHS FOIA Regulations, 45 C.F.R. Part 5. Exemption 6 exempts from disclosure records the release of which would cause a clearly unwarranted invasion of personal privacy.

If you are not satisfied with the processing and handling of this request, you may contact the NIH FOIA Public Liaison and/or the Office of Government Information Services (OGIS):

In addition, you have the right to appeal this determination to deny you records responsive to your request. Should you wish to do so, your appeal must be sent within ninety (90) days of the date of this letter, following the procedures outlined in Subpart C of the HHS FOIA Regulations http://www.nih.gov/icd/od/foia/cfr45.htm) to the Assistant Secretary for Public Affairs, at: https://requests.publiclink.hhs.gov/App/Index.aspx.

So it is now my task to file an appeal.

SUMMARY

Let’s get real here. The law is on my side, but the employees of government agencies are not. The information that I am requested could potentially be used to prove that Anthony Fauci and other government employees knew that the protocols used in this study were killing hospitalized patients. This information could be used against them in a court of law resulting in imprisonment or the death penalty for government employees.

I’ll go though with filing the appeal. I expect it to be denied for whatever reason. After that, I think if people want to pursue it, I will need some help. If the appeal is denied, it will take a lawsuit to force them to provide the data. At that point I would need to hire a Law Firm due to the amount of legal red tape involved. I think it’s worth doing and I hope you agree.

The complete denial letter is below. And Happy Fourth of July. It’s sad that we have to fight our government today, but so be it. What’s done is done, cannot be undone, and cannot be forgiven. What will we do about it?

END