UPDATE 1: HAVE JUST EMAILED THE FDA AND FBI ASKING THEM TO LOOK INTO THIS CASE OF OFF LABEL PROMOTION OF THE RISKY MERCK VACCINE
UPDATE 2: HAVE EMAILED DIVERSE ORGANIZATIONS IN AFRICA AND THE USA WARNING THEM THE FACT ABOUT THE VACCINE ARE BEING MISREPRESENTED
UPDATE 3: HAVE EMAILED SOME AFRICAN MEDIA OUTLETS, ALSO IN CONGO THOUGH THEIR LANGUAGE IS FRENCH…
I just emailed Dr Seth Berkley, the CEO of GAVI, WHO and the Congo government, warning about false claims concerning the safety of the Ebola vaccine, which violates FDA rules.
The full text is here…
Dear Dr Seth Berkley,
CEO of Gavi,
I am writing to inform you that I am referring your promotion of the Merck Ebola vaccine to the FBI and FDA for violating rules on promoting off label drugs.
You are promoting the Merck vaccine as safe and effective, although there are no good clinical data to support your claim, and although the US drug regulators, the FDA, has not approved the use of the vaccine for this very reason.
I would like to remind you that GlaxoSmithKline was fined $3 billion in 2012 by the federal government, in part for promoting the antidepressant paroxetine on the basis of a flawed 2001 study, despite clear evidence linking the drug to suicidal thoughts in that population and despite the FDA’s never approving the drug for pediatric use.
You are, I allege, exposing GAVI to similar fines by making verifiably false claims such as that the “vaccine has shown high efficacy in clinical trials.”
This quote has been attributed to you in numerous publications.
You know this claim is false. The design of the clinical trials was flawed. There was no control group, for example.
Jon Cohen writes in Sciencemag that the “unusual trial designed” yielded no data proving the vaccine is safe or effective and, therefore, gave no basis for licensing it.
“The unusual trial design yielded data that were not deemed strong enough to lead regulatory bodies to license the vaccine,” he writes.
The Merck vaccine actually gives people Ebola according to interim results published in The Lancet online on July 31st 2015.
The study states 27 people contracted Ebola as a result of a Merck Ebola vaccine and 15 of these died.
Please also see pdf attached.
Please note the study states “the data about the secondary outcomes for efficacy and effectiveness and safety are not included in this Article and will be part of a future report once follow-up is completed for all participants and analyses have been done.”
As far as I know there has been so such proper follow up report other than a rehashed version of the above study published a few days later on August 3rd 2015, which seems to have removed Ebola infections from the data without any satisfactory explanation.
Note, this rehashed study did not convince regulators like the FDA either that the Merck Ebola vaccine was safe.
The July 31st study consigns the serious adverse events, including contracting Ebola from the vaccine, to the Appendix. How can that be considered serious science?
“The information regarding serious adverse events reported so
far is included in the appendix. As of July 20, 2015, a total
of 43 serious adverse events had been documented among
eligible and consenting trial participants, including
27 confirmed cases of Ebola virus disease (see appendix).”
The study also states unambiguously that people contracted Ebola as an adverse event from the vaccination.
“Apart from Ebola virus disease, the three most common
serious adverse events were suspected, unconfirmed Ebola
virus disease (three cases), episodes of febrile illness (three
cases), and road traffic accidents (three cases). 16 deaths
occurred: 15 from Ebola virus disease and one from cardiac
arrest,” says the study.
You are, it seems, promoting a vaccine which could potentially infects healthy people with Ebola and so have catastrophic impact on the Congo or any country that uses it. Yes, you are offering 300,000 doses of this vaccine immediately to the government of the Congo.
As an HIV researcher, I am sure you know that the STEP trial of the Merck AIDS vaccine had to be abandoned because the vaccine was found to give people AIDS as reported in 2012 by the New York Times.
The Merck Ebola vaccine uses the same common cold virus, the adenovirus, as the AIDS vaccine which was found to give people AIDS, adding to its risks.
To conclude, you have no evidence, no good clinical data, no national drug regulatory authority to support your claim that the Merck vaccine has shown “high efficacy in clinical trials.”
The little data that is available suggests the opposite. The FDA has not approved the Merck vaccine. It may do so under Donald Trump’s new chief, but that will not change the underlying data that should not allow it to be approved.
As a result of making these false claims, you are liable for prosecution under the False Claims Act as well as under FDA rules.
“Under FDA rules, any promotional materials distributed by a company should be truthful, balanced, nonmisleading, and supported by substantial evidence. In addition, it has been illegal for drug manufacturers to directly promote or advertise a drug for any indication that the FDA has not approved. However, companies are not categorically prohibited from disseminating information about off-label uses, and the FDA’s approach to regulating and enforcing the distinction between
communication and promotion has evolved over the past several decades in response to both legislative changes and legal challenges,” states health affairs blog.
I also urge you to inform Dr Margaret Chan and other GAVI partners not to repeat the same false claims about the Merck vaccine.