US$200 Million Ebola Drug Trial Still Coming

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The Ministry of Health, will from tomorrow, June 18 begin a sensitisation exercise in the Greater Accra Region on the US$200 million Ebola vaccine clinical trial being driven by the multibillion pharmaceutical company, Johnson and Johnson of America.

Parliament, has also summoned Prof Alex Dodoo of the School of Medicine and Dentistry of the University of Ghana (UG) before its Privileges Committee for allegedly attacking Members of Parliament (MPs), over the botched Ebola vaccines trial in Hohoe.

Prof. Dodoo in a media interview last week, asked the lawmakers to apologise to Ghanaians for their “incorrect, misleading and unfounded” comments on the Ebola vaccines trial.

Ghana’s image and ability to develop, would be damaged because no pharmaceutical company, would come to the country as it appears that our laws are arbitrarily applied,” he said. ““When Ghana was hit with the H1N1, we begged other countries for vaccines.”

The public education, will subsequently be carried out in the Volta, Brong Ahafo and the Upper East Regions.

The exercise is aimed at disabusing the minds of Ghanaians against the perception that, the vaccine trial would end up spreading the Ebola virus in Ghana.

The Health Minister, Alex Segbefia, made this known yesterday when he appeared before Parliament to explain the rationale behind the intended clinical trial.

Last week, Parliament ordered that the trial be suspended following growing concerns raised by some Civil Society Organizations (CSOs), the Volta Regional branch of the National Democratic Congress (NDC) and some MPs.

Mr. Segbefia, who was then out of the country, called for an immediate suspension of the exercise with the explanation that, Ghanaians were not psychologically ready to undergo the clinical trial.

The Minister in his address to Parliament, explained the choice of Hohoe as the center for the clinical trial saying, Hohoe and Kintampo, have over the years been sites for clinical trial of vaccines.

He said, standard protocol had been followed prior to the approval for the vaccination to take place, but he conceded that despite the rigorous nature of the approval process, the stakeholder consultation that needed to have been done was not thorough enough.

The Minister, said public education would be based on “what is likely to happen and what is likely not to happen, and why we must cooperate with the world in finding a vaccine that is potent enough to deal with the Ebola virus.”

He stressed that not a single test has so far been conducted and the vaccines in question, have not been imported yet for the exercise to be carried out.

Mr Segbefia, further made it clear that the government would not in any way, at any point, put the lives of Ghanaians at risk.
Prof. Dodoo’s comments, have not gone down well with the House, prompting the Speaker to haul him before the Chamber.

The Speaker said, though in such matters he had been reluctant in referring members of the public to the committee, in this particular matter, the House was on the same wavelength as the Ghana Academy of Arts and Sciences.

The Speaker, has also directed the Health Committee to engage the Academy over the Ebola vaccine trial and inform the House accordingly.

A painstaking investigation by The Herald, had revealed that the companies behind the intended Ebola Vaccine trial in the Hohoe Municipality of the Volta Region, set a whopping sum of US$200 million for the experiment, and reports are that Ghanaian officials at the Food and Drugs Authority (FDA), and other health technocrats, have collected huge cash to test-run the drugs on their compatriots for cheap mobile phones and a paltry GHC200.

The Ebola Vaccines, were manufactured by Janssen Pharmaceutical Companies, together with Crucell Holland B.V. under their parent company, Johnson & Johnson, and they have been carrying out the first-in-human clinical trials since January, this year.

Company sources at New Brunswick in the US city of New Jersey, are saying millions of dollars have exchanged hands between them and health officials of some African countries, including Ghana, to have the experiment done. Clinical trials, according to Ghanaian insiders, are goldmines pouring millions of United States dollars
into the pockets of many Ghanaian health officials.

Indeed, in October 2014, Johnson & Johnson, had announced a US$200 million financial commitment “..to accelerate and significantly expand production of an Ebola vaccine program in development at its Janssen Pharmaceutical Companies.”

Johnson & Johnson said, it was “…seeking to share the financial risk of these vaccine and development clinical trial costs by pursuing governmental and non-governmental funding sources”.

In Ghana, names making the rounds as pushing the Ebola drug trials for the multibillion pharmaceutical companies are, those of Delese Mimi Darko, Head of Pharmacovigilance & Clinical Trials at FDA, Prof. Fred Newton Binka, Vice-Chancellor, University of Health and Allied Sciences (UHAS). The Ho-based University, has
an out campus in Hohoe, where Ebola Research Centre, has been set up.

One Dr. Margaret Kweku, a native of Hohoe, is also mentioned as one of the lead researchers, involved in the Ebola drug trials at Hohoe. The FDA, is currently testing the vaccine before giving the green light for the trial to take off. But other health officials, have already approached students of the Hohoe Midwifery
Training School to volunteer for the trial.

Other names, fiercely championing the experiment are, Pharmacist, Alex Dodoo, who claims to work with the World Health Organisation (WHO) as its Chairman of Global Vaccine Safety Initiative and ex-Health Minister, Joseph Yileh Chireh, now Chairman of the Health Committee in Parliament.

In January this year, Johnson & Johnson, announced the start of “Phase 1 Clinical Trial of Ebola Vaccine Regimen saying “company has produced more than 400,000 vaccine regimens for use in large-scale clinical trials by April 2015”.

It explained in a press statement issued by the company at New Brunswick in the US city of New Jersey on January 6, 2015 that the Phase 1, first-in-human clinical trial, is a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies.

According to Johnson & Johnson, “the trial is being led by the Oxford Vaccine Group, part of the University Of Oxford Department Of Paediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January”.

In that statement, Johnson & Johnson also announced that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period.

This increased projection is an update to Janssen’s previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015.

“As a leader in the field of global health, we have a responsibility to act swiftly as Ebola continues to cause suffering among patients, families and health care workers in West Africa,” said Alex Gorsky, Chairman and CEO of Johnson & Johnson.

Modelling by the London School of Hygiene and Tropical Medicine to advise the World Health Organization (WHO) indicates that to bring the epidemic under control, current projected demand for a preventive vaccine ranges from a minimum of 100,000 doses to protect frontline workers to a high-end of 12 million doses for large-scale adult vaccination in the three affected countries.

“Because every day counts, we are substantially accelerating the production of our vaccine regimen,” said Paul Stoffels, M.D., Chief Scientific Officer and Worldwide Chairman, Pharmaceuticals, Johnson & Johnson.

“Through the unprecedented collaboration among the global health community, our goal is to bring this vaccine to families and frontline health care professionals as fast as possible.”

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