Medical journal demands transparency as clinical trial data on new corona vaccine is hidden
Many of the studies on which the governments invested billions of dollars (hundreds of billions of yen) during the swine flu epidemic in 2009 to stockpile anti-influenza drugs were sponsored by pharmaceutical companies. Researchers at a reliable third-party verification agency did not have access to the raw data. This should have led to discussions about data transparency and a new policy, but once again the same thing happened with the new coronavirus vaccine, the British medical journal British Medical. The Journal (BMJ) points out.
Covid-19 vaccines and treatments: we must have raw data, now | The BMJ
According to BMJ, clinical trials of Pfizer's vaccine were funded by Pfizer and were designed, implemented, analyzed, and written by Pfizer employees. All clinical trial data is held by Pfizer and its contract research institutes, and data requests will not be accepted until May 2023.
It is common for other pharmaceutical companies to be reluctant to disclose data, and Moderna says that 'the final result will be released in 2022' and 'after the test is completed, it will be reviewed upon request'. .. The planned completion date for Phase 1 trials is October 27, 2022.
In addition, AstraZeneca is expected to respond to the request to publish the results of Phase 3 trials on December 31, 2021, but on the other hand, the timeline after the request is different, and it will take up to one year to acquire the data. It explains.
According to BMJ, it is difficult to obtain basic data on the therapeutic drug for the new coronavirus infection. We will not provide it to anyone. ' Remdesivir, developed by Gilead Sciences, was funded by the National Institutes of Health and has
Regulators have received much more detailed data as part of their reviews, even with researchers having limited access to the data, but the US Food and Drug Administration (FDA), which should have a lot of data, is also proactive. We do not disclose any information. Initially, the FDA, which was asked to disclose information, proposed 'publication of 500 pages a month', but this would take decades to fully disclose, so it became a court battle, and the FDA's claim was rejected 'month 5'. 'Publishing 15,000 pages' has been ordered. Information is published on the following sites.
Public Health and Medical Professionals for Transparency --Public Health and Medical Professionals for Transparency
https://phmpt.org/
BMJ says that at least three of the pharmaceutical companies that make COVID-19 vaccines have paid billions of dollars in criminal and civil settlements in the past, and other companies. Pointed out that the pandemic has created many 'pharmaceutical leaders' and brought tens of billions of dollars to vaccine makers, despite no prior track record. Regulators argue that what they need to do is keep pace with pharmaceutical companies and protect people's health, not to further enrich the company, and to do so, seek the transparency of the data needed for research. increase.
Related Posts:
in Science, Posted by logc_nt