11 Feb 2015

The US National Institute of Health has admitted that participants in the GSK Ebola vaccine trials in Liberia could be infected with Ebola.

In a document called “QUESTIONS AND ANSWERS PREVAIL Phase 2/3 Clinical Trial of Investigational Ebola Vaccine”, the possibility of people being infected with Ebola is clearly stated

“If a study participant becomes infected with Ebola during the course of the clinical trial, he or she will be directed to medical care for treatment.”

As this blog has pointed out, the GSK vaccine is a combination of a cold virus and an Ebola virus. A Merck vaccine with a combination of a similar cold virus and an AIDS virus was found to give people AIDS.

At the very least, NIH is admitting that the experimental vaccine will not protect people against Ebola.

Also, the trial is classified as a phase 2 and 3 trial, suggesting that no clearly separate phase 2 clinical trial is taking place as Dr Stephen Kennedy, the leader of the trial, has suggested.

The US clinical trials data base states that enrolment will continue after initial tests on 600 people in the absence of major safety issues, but there is no definition of what constitutes a major safety issue.

Also, the NIH document states the vaccine was developed by US bioweapons scientists:

“Nancy J. Sullivan, Ph.D., chief of the Biodefense Research Section in NIAID’s Vaccine Research Center (VRC), working in collaboration with a team of VRC researchers and scientists at the Army Medical Research Institute of Infectious Diseases and Okairos, a Swiss-Italian biotechnology company acquired by GSK in 2013, developed the vaccine.”

It has to be asked whether this and other information addressing the risks of the experimental vaccine have really been communicated to participants in the GSK Ebola vaccine trial as part of the informed consent process, or if there has been a real informed consent process at all. Media reports from Liberia indicate people do not feel they have been given information.

One of the key people backing the Ebola trial, Dr Fatoma Baloy, is the director of the Liberian Institute for Biomedical Research (LIBR), where US army bioweapons researchers were working on Ebola before the current outbreak.

In addition, the NIH document on the PREVAIL Ebola trials underway in Liberia refuses to state that the results from the phase 1 trials showed that vaccine was safe. Instead, reference is made only to the results which were published.

Presumably these results, which have been called misleading by Hans Tolzin.

No answer is given to how the safety of the study participants will be ensured.

“10. How will the safety of the PREVAIL study participants be ensuredWhen will the PREVAIL trial be completed?

The trial is currently anticipated to be completed in June 2016″

Documents recently released by an Italian court found that GSK manipulated clinical data to hide the fact that 67 infants had died within ten days of receiving a GSK vaccine. 90% died within five days.

“This is all quite revealing — the stuff of lawsuits, no doubt, with which GSK is more than familiar. As you may recall, GSK is the same drug company that was fined $3 billion for promoting antidepressant drugs for off-label uses. The case has since been dubbed the largest health fraud settlement in U.S. history, which says a whole lot about the integrity of this company.

Should GSK ever be found guilty of deliberately withholding critical safety data that, while it probably would have cut into the company’s bottom line to make it public, may have saved children from early death, it could potentially make history again as earning the title of the most shamefully greedy and profiteering corporation in the world (next to Monsanto, of course).”

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