Watchdog: NIH failed to ensure clinical trial results were always made public

08/23/2022 / By Belle Carter

A watchdog has found that the National Institutes of Health (NIH) failed to ensure that results from clinical trials that it funded are published. Furthermore, the agency just let groups that failed to follow the rule get away with it.

Results from just 35 clinical trials out of the 72 funded by the NIH from 2019 and 2020 were submitted on time, according to a 14-page report from the Department of Health and Human Services (HHS) Office of Inspector General. The results of 12 were submitted late, while results from the other 25 were never submitted.

As per federal law, the responsible sponsor or the principal investigator should present the trial results within a year or whichever comes earlier between the estimated and actual completion date. That rule applies to tests on drugs, vaccines and other products. Once NIH receives the studies, it must post them within 30 days on ClinicalTrials.gov, the largest clinical trials database.

However, the NIH Office of Intramural Research, which is responsible for the implementation of NIH-wide projects and policies, only sent notices of noncompliance and took no other action.

The watchdog recommended that NIH improve its procedures to make sure trial results are submitted in a timely manner; enforce the rules against parties that submit results late or not at all; and help parties who find submitting to the government website challenging.

“The NIH didn’t respond to a request for comment. In a written response to the watchdog, the agency concurred with the recommendations and said it has taken actions or plans to take actions to address the issues. That includes adding consequences to parties funded by the Intramural Research Office that submit results late or not at all,” reported the Epoch Times.

Primate researcher admits to manipulating study, NIH grant applications

The NIH has also allowed a researcher to rig grant applications.

Deepak Kaushal, director of the Southwest National Primate Research Center at Texas Biomedical Research Institute (Texas Biomed), fabricated information in two grant applications submitted to the National Institute of Allergy and Infectious Diseases, which is part of the NIH. One of the applications was lodged in 2019 while the other was submitted in 2020. (Related: Research director (who helped approve Pfizer’s COVID-19 vaccine) was recently outed for fabricating data to obtain NIH grants.)

He also admitted to falsifying data in a research paper. The HHS Office of Research Integrity stated that Kaushal manipulated the numbers of treated and untreated primates in a study published in 2020. Additionally, the researcher fabricated the number of weekly doses of treatment administered to treat Mycobacterium tuberculosis, which causes tuberculosis.

A separate article in the Epoch Times stated that the American Journal of Respiratory and Critical Care Medicine published a retraction of the said study in 2021. In the recall, the authors said that this specific paper “did not conform to the stated experimental protocol.”

Kaushal kept his job despite the misconduct.

“Dr. Kaushal has received internal consequences, including significant oversight of his lab. Texas Biomed is confident that this will not happen again and that Dr. Kaushal can continue to lead the Southwest National Primate Research Center capably and with integrity,” Dr. Larry Schlesinger, president of the Texas center, said.

The decision drew criticisms from other scientists and researchers.

“Any scientist who knowingly and intentionally falsifies data for the purpose of scientific publication and/or receipt of government funding should not be allowed to lead a research institution,” Ronald Desrosiers, former director of Harvard’s Primate Research Center, told Science magazine.

Visit ScienceDeception.com for more articles related to rigged research papers and grant applications.

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