General News of Saturday, 18 July 2015

Source: kasapafmonline.com

We were not told to halt Ebola Vaccine trial – FDA

Head office of the FDA Head office of the FDA

‘The Chief Executive of the Food and Drugs Authority (FDA), Mr Huudu Mogtari, on Thursday appeared before the Privileges Committee of Parliament and told members that the Authority has not received any official communication from the Ministry of Health (MOH) to halt the Ebola Vaccine trail.

According to him, the Authority became aware of that MOH had suspended the project through the media, noting that the action was contrary to laid down procedures.

His pronouncement stunned members of the committee who had all along was under the impression that the Minister of Health, Alex Segbefia, had prior to the announcement of the suspension of the Ebola Vaccine trial phase 1 project, informed the FDA which is mandated by law to supervise such exercise.

“We read from the newspapers that the Ministry had ordered the suspension of the trial, but there was no official communication from the Ministry of Health regarding the suspension,” he said.

The FDA had appeared before the Privileges Committee to answer to questions relating to the contempt charges that had been brought against a Pharmacologist and lecturer at the School of Medicine and Dentistry of the University of Ghana, Prof. Alex Dodoo.

Prof. Dodoo is alleged to have made unsavory remarks about the legislature in interview on TV3 Network and some other media platforms when responding to calls by some Members of Parliament who had called for the immediate cessation of the Ebola Vaccine trial which was ongoing in the Hohoe Municipality until enough sensitization was made.

The said interview with TV3 Network which was played at the hearing had Prof. Dodoo calling on members of the legislature to shut up if they had no knowledge about the Ebola Vaccine trial.

“I don’t think this is about politics and I think it is wrong for the Volta Region NDC or NPP Caucus to be talking about things that they haven’t even taken the burden to get the facts. I believe that the people should rather ask or shut up,” Prof. Dodoo was quoted as saying in the said news bulletin.

Commenting further, Mr. Mogtari told the Committee that in January 2015, the FDA received two applications from two organizations to conduct clinical trials of Ebola Vaccine in the country.

He said the applications having gone through all the standard operating guidelines of the Authority were granted conditional approval for the trials. With such an approval, he said the companies involved the clinical trial could go ahead to recruit people they intended using for the trial.

He just as the Authority was preparing to announce the final approval, his outfit’s attention was drawn to the negative public reactions of the Ebola Vaccine trail and decided to wait.

He posited that although the Authority was sure the trials could be carried out safely, he regretted that enough sensitization or education wasn’t done as demanded by law.

The FDA, under section eight of the Public Health Act (Act 851) mandates the authority to supervise vaccine trials.