Tekmira Pharmaceutical Corp said on Thursday that the US Food and Drug Administration had modified its clinical hold status on Tekmira’s experimental Ebola treatment to enable its potential use in humans infected with the virus.
A victim of Ebola virus
The FDA told Burnaby, British Columbia-based Tekmira that it had modified the full clinical hold on the drug to a partial clinical hold, the company said in a statement.
“We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients,” said Dr. Mark Murray, Tekmira’s chief executive officer. “We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola.”
The recent Ebola outbreak has killed nearly 1,000 people in West Africa.
The World Health Organization on Wednesday said it would convene a meeting of medical ethics experts next week to consider the implications of making experimental Ebola drugs more widely available.
Tekmira’s Ebola treatment is one of three worldwide that have shown especially promising results in monkeys, but it is unproven in humans.
Tiny California biotech Mapp Biopharmaceutical gained international prominence this week when its drug was given to two US aid workers who contracted Ebola in West Africa and have since shown signs of improvement.
Shares of Burnaby, British Columbia-based Tekmira surged 40 percent last week as the worst-ever outbreak of the Ebola virus intensified. The buying spree came even as human tests of Tekmira’s treatment, TKM-Ebola, were put on hold last month.
Tekmira’s drug has only been tested in a few dozen healthy people.
The FDA stopped its study in July because of safety concerns among people taking the highest doses of the drug who experienced problematic immune responses.
The hold meant that that particular study cannot proceed, but it does not prevent the company from submitting a new study proposal, say in people already infected with Ebola, for whom any safety risks from the treatment would be mitigated by the risk of dying.
In that case, “the benefit-risk ratio changes completely,” a source within the FDA told Reuters last week. “Anything that would shift the risk-benefit to a more favorable outcome could potentially allow the authorization of that study.”
In that case, the source said, a company would have a partial clinical hold in which the original study in healthy patients remained on hold and the new study in sick patients could proceed.
Tekmira stock finished trading on Thursday in Toronto up 6.6 percent at C$15.61, after a late rally prior to a trading halt pending the news.
African countries have been advised to develop and implement prudent macro-economic management policies, deepen structural reforms and build economic buffers in order to sustain their current economic growth rates.
The advice was given on Thursday in Abuja by Dr. Ousmane Dore, Nigeria’s Country Director of the African Development Bank.
Dore stated this at the launch of the bank’s “African Economic Outlook 2014″, tagged: “Global Value Chain and Africa’s Industrialisation.”
He noted that Nigeria was the major force behind the robust economic performance in the African continent.
According to him, Nigeria’s recent rebased Gross Domestic Product revealed that the country was the largest economy in the continent with evidence of a more diversified economy.
Dore said new sectors were emerging with stronger capacity to spur inclusive growth through increased job creation and poverty reduction.
He said: “The entertainment and creative industry is now a major income and job creation sources along its diverse activities’ value chain.
“These positive developments have been made possible through deeper structural reforms and focused infrastructure development strategy.
“The Staple Crop Processing Zones, Nigeria Industrial Revolution Plan, National Integrated Infrastructure Master Plan, power sector reform and job creation initiatives are government-driven changes we witness today.”
Dore said that the continent’s growth was gradually returning to the pre-crisis level, driven largely by increased domestic demand, infrastructure development and intra-African trade in more sophisticated and semi-processed goods.
He said that more effective participation in regional and global value chains could serve as springboard for Africa in economic diversification, domestic resource mobilisation and investment in critical infrastructure.
Dore said that Africa and Nigeria in particular should view participation in global value chain as a viable opportunity and strategy to achieve strong, sustained inclusive growth and structural transformation.
This, he said, provides the needed avenue to acquire needed new technologies, international expertise and skills with a view to moving into the global value chain system.
The ECOWAS Commission has suspended all meetings involving member states of the commission due to the outbreak of the Ebola virus in some West African countries.
The Vice President of ECOWAS Commission, Toga McIntosh, announced this at a briefing organised by the Nigerian Government for the diplomatic corps on Ebola outbreak in Abuja on Thursday.
McIntosh said the management of the commission took the decision as a precautionary measure to check the spread of the virus.
He said only meetings that were “very essential” would be convened by the commission but he did not provide any specifics.
He said: “We know that all of our meetings bring together stakeholders from the member states.“So, on August 4, when we had our management meeting, we took a decision to suspend all meetings that will bring us together from our various countries.
“Let’s watch this spread and let’s see how this will go down and then thereafter we can see how we can proceed.
“Except if the meeting is so essential and we are well guided, we will approve.”
Patrick Sawyer, the 40-year-old Liberian and American, who died of the virus in Lagos, flew in from Monrovia, Liberia to attend an ECOWAS meeting in Calabar, Cross River State.
Sawyer was said to be aware of having the disease but still flew to Nigeria. The nurse who treated him in a Lagos hospital has since died. One of the doctors of the hospital is also said to be down with the disease.
McIntosh expressed thanks to the Lagos State Government, the hospital that treated Sawyer in Lagos and the Nigerian media for their support to contain and combat the deadly disease. “ECOWAS is sad that the disease is spreading like wildfire in our community,” he said.
He condoled with families and West African countries that have lost their citizens to the Ebola virus.
The ECOWAS official said all staff of the commission, including the driver and protocol officers who made direct contact with Sawyer before his death, have been placed under surveillance.
He said a request had been made to the Lagos State Government for the fumigation of the ECOWAS office in the state and the vehicle used by Sawyer.
He said this was because the staff that made contact with Sawyer returned to the office and they used the toilets and also interacted with others.
According to him, the Lagos office of ECOWAS has been temporarily closed until after the fumigation exercise.
He added that the commission had also established a task force to monitor all information on Ebola and also establish a hotline for enquiries and emergencies.
McIntosh appealed to member states and the international community to contribute to a special fund established by the regional bloc to fight the disease.
Most of the efforts are geared toward public enlightenment and procurement of safety materials for health workers.
The ECOWAS vice president thanked Nigeria for being one of the first countries to donate to the fund after its launch in Accra during the last ECOWAS Heads of State and government meeting.
President Goodluck Jonathan donated $3 million in support of three Ebola-stricken three West African countries.
A breakdown of Nigeria’s contribution shows that $1 million will go Guinea; $500,000 to Sierra Leone; $500,000 to Liberia; and $1 million to the ECOWAS Pool Fund for Ebola.
McIntosh said: “ECOWAS community has a challenge. “That challenge goes beyond the health sector.
“It requires a collective approach to put our commitment together and deal with this destructive element to development.”
According to the World Health Organisation, the death toll from the outbreak has risen to 932, with more than 1,711 total cases.
As part of effort to guide against the outbreak of Ebola in Kwara State, the state government has ordered owners of corpses entering the state to obtain truly certified death certificates to ascertain the cause of death.
Gov Abdulfatai Ahmed of Kwara State
Alhaji Abdul-Kayode Issa, the Commissioner for Health, gave this order in llorinon Thursday while addressing newsmen on the measures the state government has put in place to guide against the outbreak of the disease.
Issa said the request for certified death certificates for corpses entering the state is to further guide against the outbreak of Ebola since it is contagious.
He directed anybody or group of people bringing corpses to the state to register with the nearest health centre before going to their destinations.
Issa said the state government has set up a rapid response committee on the disease to urgently attend to any victim discovered in the state.
The Commissioner added that the state government has provided free ambulances in all the three senatorial districts of the state to cater for any unforeseen circumstances.
He said the state government has commenced cross border collaboration at international borders in the state to check against the outbreak of the disease.
The Commissioner assured the people of the state that there is no case of the Ebola virus in all part of the state.
Issa advised the residents in the state to complement government’s efforts by maintaining a decent environment, wash hands regularly and avoid taking bush meats among others.
After a critical look at the fast killer virus, Ebola, the Delta State Government on Thursday placed the infection in category ‘A’ of biological warfare.
Governor Emmanuel Uduaghan of Delta State
The state went ahead to bar its residents from travelling to Ebola infested states, especially Lagos, where a medical personnel who came in contact with it died within a few days.
The state further warned its residents to avoid hand shake, coming in contact with the blood, vomit, urine, sweat, faeces of and eating with an infected persons.
The committee set up by Governor Emmanuel Uduaghan, comprising the state Commissioner for Health, Dr. Joseph Otumara, and his counterpart in Information, Chike Ogeah, to sensitizd the people of the state, which swung into action in Asaba on Thursday, said although measures have been put in place to checkmate its possible outbreak in the state, warned against burying any corpse in either private or public cemetery without a death certificate.
“Since infected dead bodies carry the virus, mourners who have direct contact with the bodies of the deceased as part of burial ceremonies and hunters in the rain forest who come in contact with dead animals found lying in the forest should stay away,” Otumara warned.
The committee, named the Inter-Ministerial Ebola Virus Ourbreak Preparedness and Response Committee, said since Deltans are widely traveled, special isolation wards have been set up for suspected cases.
While the state recommended strict adherence to hand washing with soap, it further warned health workers in the state, especially at the seven designated hospitals in Warri, Ughelli, Agbor, Oleh, Eku, Sapele and Delta State University Teaching Hospital in Oghara, from jettisoning the practical universal precautions and standard barrier nursing techniques.
Patrick Sawyer, the Liberian who died in Nigeria knew he had the Ebola virus before flying to Nigeria from his country.
In fact, Sawyer was in quarantine before he escaped to come to Nigeria.
Sawyer
These facts were disclosed on Thursday at a news briefing by the Minister of State 2 for Foreign Affairs, Alhaji Nurudeen Mohammed.
Mohammed said the President of Liberia, Ellen Sirleaf-Johnson, has apologised to Nigeria over the development.
Sirleaf-Johnson was reported to have said that Sawyer escaped from where he was quarantined.
The Liberian Ambassador to Nigeria, Prof. Al-Hassan Conteh, who was also at the briefing, apologised to Nigeria over Sawyer’s behaviour.
Conteh pleaded that Liberians should no longer be stigmatised over the behaviour of Sawyer, who is also an American.
He begged the Minister of Health, Prof. Onyebuchi Chukwu, to help save the situation.
He said: “The fact that the person who brought the disease was from Liberia does not mean all Liberians were positive of Ebola Virus Disease.
“The Liberian President had put measures in place by declaring 90 days emergency in the country beginning from August 6 to strategize on how to stop the spread of the disease to other countries.”
The Vice President of the Commission of the Economic Community of West African States, Dr. Toga Mcintosh, confirmed that Sawyer escaped from quarantine in Liberia.
Mcintosh said: “Because he had contact with somebody who died from Ebola, he was quarantined in his own country but he evaded the quarantine and came to Nigeria.”
Sawyer’s sister was said to have died from the Ebola Virus disease a few days before he headed to Nigeria.
He was reported to have been with the corpse after his sister died.
The #Bringbackourgirls group on Thursday slammed President Goodluck Jonathan for what it described as his insincerity in the efforts to rescue the abducted Chibok girls after 115 days.
Goodluck Jonathan, President of Nigeria
The group, in statement issued on Thursday, said that there is double talk in what President Jonathan is saying on the issue of the abduction of the over 200 girls in Borno State.
The #Bringbackourgirls group recalled President Jonathan’s statement recently that the government will not negotiate with Boko-Haram but in a statement credited to him in Washington DC, United States of America during the week made a u-turn, saying that efforts to negotiate with the insurgents were ongoing.
The group described the President as one who engages in double talk, which gives the movement great cause for concern about the sincerity of the effort to rescue the abducted girls.
It said: “The world seems to have moved on, as we note with concern the lack of evidence to back the statements by the Government that all is being done to rescue our girls.
“We also note statements credited to the US Government over sighting of the girls in July 2014. Knowing the location of the girls is a positive development but this is not the first time Nigerians have been told that the location of the girls is already known. We also note the ambiguity in the statement credited to the President in Washington DC that efforts to negotiate with the insurgents are ongoing even though the earlier position of the government had been that it would not negotiate with Boko Haram.
“It is this ambiguity and double talk which gives our movement great cause for concern about the sincerity of the effort to rescue the abducted girls.
“At its meeting on July 30, 2014, the Council of State promised that the insurgency in the North East will end by December 2014. We call on the Government to provide adequate information on how this is to be achieved considering that the insurgency in the North East has only escalated in the past several months and previous assurances by the Government and its functionaries have not produced any results.
“We urge the Government to scale up its efforts in the rescue operation, to ensure that this debacle comes to an end because of the separation of the innocent girls from their grieving parents. Their education has come to a stand still, as they remain in captivity with the insurgents.
“Worse still, their continued stay in captivity has given room for unfounded speculations about the role the girls are purported to have played in recent suicide attacks. We should all bury our heads in shame that 115 days since their abduction, we have not produced any visible results. Instead, the girls are being victimized further by associating them with heinous crime.”
In the spirit of the third year anniversary of the release of the report on Ogoniland by the United Nations Environment Programme (UNEP), Nnimmo Bassey, who heads the Health of Mother Earth Foundation (HOMEF), reflects at a recent forum on the travails of the community, scarred by decades of land and sea degradation as a result of oil and gas pollution. He believes women have a vital role to play in the clean-up of Ogoniland
Bassey
My oldest memories of Ogoni are those of pain, despoliation and neglect. They are memories of the military absolutely unable to understand why citizens could dare to demand for any modicum of justcie and dignity. It is the memory of the many Ogoni exiles flung across the globe from nearby Benin Republic to the furthest places you could imagine. The memories are stuff that many wish to never experience. Yet in these memories we derive deep inspiration to never be silent in the face of tyranny.
Ogoniland has undeniably suffered peculiar ecological damage, yet the people remain resilient, organised and hopeful. They remain forward looking despite the many dark moments that history will never ignore.
My recent memories of Ogoniland are not as dramatic as of the events and personae of the early 1990s. These memories may not fond memories but they have hetched indelible marks on my conscience. One memory is of a little boy one early morning at the banks of the creek at Goi. He had just waded from to where we stood from a crude oil ravaged stumps of what were once mangroves. He had in his hand a crude oil coated broken plastic bucket. In the bucket were crude oil coated crayfish. When we asked what he would do with the crayfish, the boy told us that he would wash them and then sell them. He needed some cash for school fees, you see. And how much would the crayfish fetch? N500!
Bassey standing by the Goi Creek
The next mark on my memory was during a visit with the Environment Committee of the Senate. After visiting the emblematic Ebubu Ejama at Eleme and the Bomu flow station, we went up to the spot where the little lad had emerged with his catch. This time our attention was captured by an old lady who was processing cassava in the same oil coated creek. Why was she doing that? She was fermenting cassava in the creek the way she had been doing from when she was a youth. The memory, the knowledge and the food processing method had been developed over the ages and had served her well. But the creek was no longer what it used to be.
More recently, I was again at this same location. About a dozen teenagers were frolicking in the creek. I was aghast. A debate with the lads on why they should not swim in the polluted water dragged on for minutes before they eventually stepped out of the water. A conversation ensued. My guide on this visit was one of their teachers in a nearby secondary school. We asked them what dreams they had for the future. What did they hope to become in life? Except for one boy who said he would like to be a civil servant, the rest wanted to be politicians. I will not be tired of relating this story. Why would a bunch of kids think of being nothing but politicians?
These stories could be replicated in various forms across the oil field communities of the Niger Delta.
Three years have gone by since the report of the Environmental Assessment of Ogoniland was submitted by the United Nations Environment Programme (UNEP) to the Federal Government of Nigeria. The report clearly stated some emergency steps and other longterm steps that needed to be taken based on the findings of the assessment.
Some of the recommended emergency measures could be seen as low hanging fruits that the government and Shell could have quickly embarked as an indication that the lives of the people matter, that the Ogoni environment matters. The measures include:
Providing adequate sources of drinking water to those households whose drinking water supply is impacted.
People in Nsisioken Ogale should be recorded in a medical registry and have their health status assessed and followed up as they have been drinking water laced with benzene, a known carcinogen, at 900 times above WHO standards.
Initiate a survey of all drinking water wells in areas where hydrocarbon pollution had been observed.
Related measures included posting signs at polluted locations warning the people not to swim, bathe or fish in the contaminated waters. They were also to be warned not to drink such waters and not to walk in contaminated sites.
The signposts have been put up at some locations, but how would people not walk in their communities when the signposts warn them to keep off?
The report shows that many of the flow stations and manifolds are located within communities and have residential buildings and schools just a few metres away. The report also warned that at places where the surface of the ground appears to be unimpacted a little digging beneath the surface revealed hydrocarbon pollutions. At some locations the pollutants went as deep as five metres.
At the third anniversary of the UNEP report, the people are justifiably scandalised that they have been left to fate as though nothing was wrong with their environment. No one believed that this much time could elapse with no real action taken.
Today we not merely examine how women have coped with living in such a deadly environment, we will also examine what measures can be taken to literally reverse the tide and what are the obstacles that have made it possible for government and Shell to carry on as though nothing was amiss.
We will also look at the other pollutants in the land that are less spoken of and also see whether there are loopholes in the UNEP report that has been or can be exploited to the detriment of the people.
Commentators have pointed out that a location like Goi was studiously avoided by the study. We have also noted that undue emphasis has been placed on the ecological damage caused by artisanal refining – almost as though to suggest that the new phenomenon was responsible for decades old pollution piled up by Shell. While the report is the most definitive official and public document that we have on the environmental damage of any part of the Niger Delta, we also note that there appears to be a subtle reliance on scientific neutrality or caution to pass on the idea that dangerous situations may not really be so dangerous after all. The report did not draw any conclusions that the pollutions caused any serious health problems. They data collected from 5000 records were said to be insufficient and that the information was not adequately segregated to allow for a judgement to be made.
Even the fact that untreated produced water with normally occurring radioactive elements are discharged “into neighbouring trenches, wetlands or burrow pits” is nothing to worry about. See Page 45 of the report. The reduction in fish stocks in Ogoni water is attributed to over fishing and not to the extreme hydrocarbon pollution (Page 178).
What can women do to ensure a clean-up of Ogoniland? Can we build hope on the scaffoldings of memory? Can we indeed assert our right to a clean environment and the way we relate to Mother Earth on the platform of Re-Source Democracy?
Can we overcome the mistrust between communities that provides the wedges for divisions and go ahead to build peace, solidarity and cooperation across the Niger Delta?
Here we are. Let the conversations begin. In one of his last poems, Ken Saro-Wiwa wrote that Silence Would be Treason. There is a sense in the resilience of the Ogoni people that shows that neither silence nor inaction will be an acceptable option.
Following the outbreak of Ebola Virus in Lagos, Nigeria, the Federal Government has assured that it was taking adequate measures to contain the spread of the disease in the country.
The Minister of Health, Prof. Onyebuchi Chukwu, told newsmen in Abuja that the government was scaling up public awareness on the dangers of the scourge to prevent citizens from contracted the disease.
Chukwu also said that government was procuring kits for medical and health workers to protect them from the disease.
He called for synergy of all stakeholders to nip the development in the bud.
To this end, South-West governors had an emergency meeting on Wednesday in Lagos on how to curtail the disease.
They also called for collaboration between the federal government and states to curtail a further spread of the virus in the country.
Gov. Babatunde Fashola of Lagos State, who spoke on behalf of the governors, described the virus as a threat, not only to the region, but also to the entire country.
Fashola said that there must be collaboration and coordination of efforts by states and the federal government to manage the situation.
He said that the governors had met with all the commissioners for health in the region, and had been equipped with technical details of the virus and how to curtail it.
Fashola said it was time for the federal government to ensure proper manning of the country’s borders, adding that unchecked cross-border movements could undermine efforts to curtail the spread of the virus.
The governor urged other states not to panic about the virus, assuring that efforts were being made to combat the virus.
Also speaking, Gov. Ibikunle Amosun of Ogun said the 70 illegal borders in Ogun and the more than 100 in the other states could jeopardise the fight against the virus.
Amosun urged the federal government to deploy its security personnel to man the borders in a bid to check the threat of the disease.
“Two weeks ago, NMA was having its Week and I mentioned that Ogun and some other states have illegal borders.
“We are more prone and more at risk really in this Ebola virus than others.
“We have put all our security agencies and the respective medical personnel at the illegal borders.
“But, when you have in excess of 100, you and I know that the state doesn’t have the capacity really in manning these borders.
“Indeed, it is not our responsibility in manning the borders, we should collaborate with the government which is what we are doing’’ he said.
Gov. Olusegun Mimiko of Ondo also said it was high time the government checked illegal movement of people into the country to curtail the Ebola virus threat.
The News Agency of Nigeria (NAN) reports that a lot of Nigerians are becoming aware of the Ebola virus as they are taking precautions to ensure they do not contract it.
The Chairman of Chibok Community in Abuja, Mr Tsambido Abana, appealed to the federal government to deploy health workers and researchers to investigate the community.
This, according to Abana, is to make sure that the disease has not spread to the area, adding that the call became necessary as they live close to the forest.
“We are fearful about our area because we are close to the forest and we have direct contact with animals, the government should send researchers to confirm that the Ebola virus disease is not in Chibok.
“We need the help of the government because one cannot be too sure, probably enlightenment campaigns on the diseases,’’ he said.
In Benin, the level of awareness of residents about the dreaded Ebola virus seems to be high as bush meat sellers’ record low patronage.
Many of the residents told NAN that they became aware of the disease through the mass media.
They urged the government and other stakeholders to intensify or device means to pass the message across to those in the rural areas.
A NAN correspondent, who visited some major markets in Benin, observed that the prices of different types of bush meat had dropped by more than 50 per cent since the virus claimed its first victim in Lagos.
Madam Esosa Obosa, a bush meat seller at the popular Uwa meat market, said “my son, this new disease is affecting our meat business.
“Since last week, we have experienced a drop in the sales of all kinds of bush meat such as monkey, grass cutter, pumpkin pine and snake.
“Because of the drop in sales, we have not been able to purchase fresh bush meat.
“Some of our big customers, especially hotels and operators of guest houses, have reduced the quantity they used to buy from us,’’ she said.
Another meat seller, Mr Eti Idahosa, who had been in the business for more than 20 years, said “we have never seen this sharp drop in sales within so short a time of the news of any disease.
“Although we are not happy about the low sales, but we are happy that people are now conscious about happenings around them and therefore are taking precautions.
“We are praying that the concerned authority should quickly find cure or solution to this disease, otherwise, we may need to find new businesses for ourselves,’’ he said.
A resident, Miss Gloria Adams, who was seen buying some snails, said she usually buys bush meat, but she has decided to settle for snails for now.
“I want everybody concerned to increase the level of sensitisation so that the causes, mode of transmission and effects of the disease can be fully understood, especially for uneducated persons and those in the rural areas, she said.
She also called on the government to strengthen health care services and research institutes, so that the country would not be thrown into confusion.
Mr Moses Emeka, a student, said the current happenings around the world were signs of end time, and urged the human race to turn back to God.
Mrs Olafunke Atiku, a fashion designer, claimed to know about the disease in her church.
A food vendor, Mrs Rebecca Ojo, said she was aware of the Ebola virus and its mode of transmission.
According to her, she no longer sells bush meat but goat meat.
Ojo, however, said government should include the distribution of handbills, motorised rallies and jingles in the different local languages to create awareness at the grassroots. (NAN)
Police and soldiers in Sierra Leone on Thursday, blockaded rural areas hit by the deadly Ebola virus.
A senior health official said, this has become imperative following the declaration of state of emergency by its neighbouring Liberia to tackle the worst-ever outbreak of the disease, which has killed 932 people.
Liberian President Ellen Johnson, declared 90 days state of emergency in the late Wednesday to combat an outbreak of Ebola.
She said with Liberian troops being deployed to quarantine badly hit communities, stressed that the state of emergency was necessary for “the very survival of our state and for the protection of the lives of our people”.
Johnson said the military deployment “Operation White Shield – was expected to be fully in place by Friday.
She said the epidemic, which has killed at least 282 people in Liberia alone, was spread through contact with bodily fluids of those infected.
“Ignorance and poverty, as well as entrenched religious and cultural practices, continue to exacerbate the spread of the disease,”she said.
Johnson said 32 health workers had already died of the disease and many sick people were going untreated after doctors deserted their posts.
She said schools across the country were shut last week and non-essential government workers temporarily laid off.
In the ramshackle, ocean-front capital, residents greeted the announcement with alarm.
Nancy Poure, a trader in the suburb of Johnsonville said, “This is the beginning of hardship, 90 days of fear and suffering.”
She called on American government to urgently come to their aid before it gets out of hands.
“We need help from America. We need help, this is urgent,”she said. (Reuters)
