Monday, 18 August 2014

E.R.A STUDIES ZMapp SITUATION

A Genetic Engineer works under a green house condition while transferring Tobacco plants used in the production of the wonder drug:ZMapp in the United States
Ebola-plant-antibodies


E.R.A STUDIES ZMapp SITUATION
BY ABDULMUMINI ADEKU,KATIE SOLA
Whistle blowers, the Environmental Rights Action[E.R.A] have disclosed exclusively to the Paedia Express Multimedia that they were not carried away by the soar away success story revolving around,ZMapp on the fight to contain the raging disease,Ebola Fever worldwide.
In an exclusive chat with this reporter in his office in Lagos ,Nigeria,the Director of Corporate Accountability in the agency  said that they were studying the situation with keen interests but very soon they will make a policy statement on the subject.
In a related issue,the Media and Communications Manager of the Body,Mr Philips Jakpor told this reporter that the management of big Tobacco producers like ,British American Tobacco  Nigeria Limited among other players like that in that genre may help the populace by leaving the production of cigarette for manufacture of Ebola drugs solely.
In a related issue,the body is still at daggers drawn with the tobacco producers as at press time as it accused British American Tobacco of misinterpreting tobacco control laws while alerting the general public,the Lagos state government and the Nigerian Police Force.

In a statement by Philip Jakpor, Head of Media in Lagos, ERA/FoEN said a series of visibility events organised by BATN, including a sensitization exercise last week for police officers in Lagos on enforcement of the anti-smoking law were nothing more than gimmicks to confuse the public and the police.
The event last week, sponsored by the British American Tobacco Marketing Nigeria Ltd, with the theme, “Understanding the Lagos State Regulation of Smoking Law,” took place at the Police Officers’ Wives Association (POWA) Multi-purpose Hall in Ikeja. In attendance were senior police officers, including all the Divisional Police Officers (DPOs) of the command.
Media reports said that Nkem Agboti, Regulation Counsel, British American Tobacco Marketing Nigeria Ltd, and Obafemi Agaba, Partner and Head, Brand Protection and Illicit Trade, among others, facilitated the event.
Mr Akinbode Oluwafemi, ERA/FoEN Director, Corporate Accountability, said: “We are not deceived by BATN’s seeming interest in ensuring the implementation of the bill when in actual fact it is attempting to rewrite the law strictly for its commercial interests through deliberate misinterpretation of the meaning of smoke-free public places.”
Oluwafemi maintained that while the intent of the Lagos State government in fashioning the legislation is targeted at saving lives, the interests of BATN are strictly commercial and that BATN would stop at nothing to confuse the general public and other regulatory agencies of government that are charged with enforcing the law.
“In the months since the bill was signed into law by Governor Babatunde Fashola, we have seen a host of articles syndicated across media organisations poking the law and urging so-called smokers’ groups to challenge sections that protect non-smokers from the hazardous tobacco smoke. Is it not ironic that the same industry that sponsors those groups is now trying to lecture the police and the general public on provisions of the law?
“We urge the Lagos State government to read the lips of BATN officials engaging in the so-called training on implementation of the law. What we hear is double-speak and outright misrepresentation of the intent and spirit of the law. The Lagos State government must wake up to its responsibility of interpreting in clear terms the letters of the law so as not to leave the citizenry in a state of confusion as intended by the tobacco industry.”
Oluwafemi maintained that: “This is simply unacceptable. We must again draw the attention of the Lagos State government and the implementing agencies of government at all levels to Article 5.3 of the Framework Convention on Tobacco Control (FCTC) which de-normalises the kind of interactions that BATN is involved in with the Nigeria Police and other agencies.  Tobacco industry interests run counter to public health interests. The Lagos government must henceforth stamp its feet and put a rein on such exercises.”
The media has been buzzing about ZMapp, widely reported as an experimental top-secret, untested Ebola serum. But what is it? A look into the treatment reveals the marvels of biotechnology — and its limitations.
ZMapp is not a cure or a vaccine. It's a cocktail of genetically engineered antibodies that boosts a patients' ability to fight off Ebola. ZMapp actually combines two different serums made by two different companies.
The first serum is called MB-003, and was developed by San Diego firm Mapp Biopharmaceutical. The second goes by the name ZMAb, and was made by Canadian company Defyrus Inc.. When Mapp Biopharmaceutical's commercial arm LeafBio combined the two, MB-003 plus ZMAb became ZMapp. Antibodies are the body's first line of defense against viruses and bacteria. When we get sick, our immune system produces antibody cells to tear apart the invaders, and restore us to health.
Ebola is deadly because it disrupts the human immune system. Researchers recently discovered exactly how the virus impairs antibody production.
An August 2013 Mapp Biopharmaceutical research paper explains how MB-003 was made, and shows its efficacy in treating Ebola in monkeys. The company has been working with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) on an Ebola treatment, in response to government fears that the virus could be used as a bioweapon. The first step was for scientists to inject Ebola into mice, and extract three types of antibodies that fight different parts of the virus. It's impossible to inject mouse antibodies into humans because the latter's immune system will attack them as foreign invaders; so scientists spliced in human DNA to produce chimera antibodies acceptable to humans. The result was a serum they called MB-003.
The next challenge was producing enough MB-003 for an effective dose. Previous studies found that antibodies could be grown inside genetically engineered Nicotiana Benthamiana, an indigenous Australian tobacco plant, which has also been used to grow West Nile virus antibodies.
Plants make good hosts because they do not carry viruses that can infect humans, and are cheaper than mammals. Researchers also discovered that plant-grown Ebola antibodies are more effective than those grown inside the ovaries of Chinese hamsters, according to Mapp Biopharmaceutical's study.
Next, Mapp Biopharmaceutical tested the MB-003 serum on monkeys. Rhesus macaques were injected with Ebola, samples of which were provided by the USAMRIID. One or two days after infection, the monkeys received an intravenous infusion of MB-003. Forty-three percent of the infected monkeys survived.
Defyrus developed its serum ZMAb in a similar way. ZMAb also contains three antibodies derived from mice, and has been tested in Rhesus Macaques.
In June 2012, Defyrus tested ZMAb in Rhesus Macaques, and found that 100% of infected monkeys survived when treated 24 hours after exposure. Fifty percent survived when treated 48 hours after exposure.
A November 2013 Defyrus study showed that ZMAb offered extended protection against the virus. Scientists reinfected surviving monkeys 10 weeks after their first infection, and 100% survived. What's more, four out of the six monkeys reinfected 13 weeks after initial exposure survived.
Mapp Biopharmaceutical and Defyrus both licensed their serums to Mapp Biopharmaceutical's commercial arm, LeafBio, which combined the two to make ZMapp.
Before ZMapp could begin human trials and get approval from the U.S. Food and Drug Administration, the Ebola outbreak began in Guinea when Patient Zero died in December 2013. Since then, the disease has claimed 1,145 lives, according to the World Health Organization.
Two American doctors were infected with Ebola through their work in a Liberian hospital with the U.S. aid group Samaritan's Purse. Kent Brantly and Nancy Writbol recovered after receiving ZMapp. However, it's unclear whether the drug helped, or if they are getting better on their own. Around 40% of people infected with Ebola are surviving the current outbreak. The WHO said last Tuesday that use of ZMapp is "ethical," despite the fact that it has never been previously tested on humans.
However, the serum's supply has been exhausted, according to a Defyrus' website. A ZMapp information sheet released by LeafBio and Mapp Biopharmaceutical explains that "very little of the drug is currently available" because it has not been evaluated for safety in humans.
To gain FDA approval, a drug must undergo three stages of human trials, which means ZMapp is likely years away from FDA approval.
"Mapp and its partners are cooperating with appropriate government agencies to increase production as quickly as possible," LeafBio said in a statement on its website. Currently, it's unclear how long it will take to manufacture more of the serum.

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