16 August 2014

Nigeria: Ebola - U.S. FDA Warns Over Use of Experimental Nano-Silver Drug

The excitement that greeted the arrival in Nigeria of Nano-silver, an experimental drug for the treatment of the deadly Ebola Virus Disease was yesterday blighted with the alarm raised by the United States Food and Drug Administration questioning the claims of the drug.

In a swift reaction, the Co-Chairman of the Treatment Research Group Committee on EVD, Professor Karniyus Gamaniel said the FDA's comment was not helpful and that Nigeria was following laid down procedures for administering experimental drugs

Also yesterday, Governor Babatunde Fashola of Lagos State revealed that 51 of the 198 people placed on the EVD watch list had been certified negative and had been freed. Though, the FDA did not specify any products in its warning, it was obvious that it was referring to Nano silver.

This is because FDA's alarm about "products being sold online that fraudulently claim to prevent or treat Ebola," came on the heels of the statement by Health Minister, Onyebuchi Chukwu on Thursday that eight Ebola patients in Lagos would receive the experimental Nano-silver. The US FDA said it had received consumer complaints about the Ebola claims: "Individuals promoting these unapproved and fraudulent products must take immediate action to correct or remove these claims or face potential FDA action," the agency said.

Erica Jefferson, a spokeswoman for the FDA tactically said she could not provide any information about the product referenced by the Nigerians.

Silver has been used as an anti-bacterial for centuries. Tiny silver particles known as Nano-silver have controversially been incorporated into a variety of consumer products such as socks and bedding to help block odors caused by bacteria and mold.

The U.S. Environmental Protection Agency considers Nano-silver a pesticide. Manufacturers of products that contain it must register them with the agency.

Nano-silver is also sometimes sold online as a dietary supplement even though Danish researchers found in a recent study that Nano-silver can penetrate and damage cells. The FDA regulates dietary supplements and said in its statement that by law, dietary supplements cannot claim to prevent or cure disease.

Nigeria replies US FDA... In a swift reaction to the warning by the US FDA, the Co-Chairman of the Treatment Research Group Committee on EVD, Professor Gamaniel said Nigeria was following laid down procedures for administering experimental drugs.

Gamaniel told THISDAY on telephone: "There are procedures and processes for administering trial drugs and for testing their efficacy and we are ready to follow all these processes. People must participate in the trials of any experimental drugs before the drug is approved for use." Gamaniel who also doubled as the Director General of the National Institute of Pharmaceutical Research and Development (NIPRD) said: "Efforts are on to make sure that things are not done wrongly. It is not an issue of us against them or them against us."

He further stated that though Nigeria welcomes the caution from FDA regarding any kind of drugs, "we are also looking forward to assistance in terms of the US helping us with more scientists and experts, including standard drugs that can assist us in providing treatment for the Ebola patients."

Gamaniel contended that Ebola is a very difficult disease to manage: "A virus like Ebola is complex. Ebola can threaten America too."

Co-Chairman of the research group and Director General of the National Institute of Medical Research (NIMR), Prof. Innocent Ujah also told THISDAY that the group would appraise all claims to the cure, but the final decision will be taken by the Federal Ministry of Health.

The FDA statement is coming amid discontent with US officials over the refusal to offer ZMapp Experimental Drug to Nigeria, which was administered to the two Americans infected by EDV. Nigerian health experts also expressed anger over US decision to give the ZMapp to the Spanish government after a Spanish Catholic priest contracted the virus in Liberia but refused to issue the drugs to Nigeria.

It was after global outcry and condemnation that the US sent ZMapp to Liberia but failed to include countries like Guinea, Sierra Leone and Nigeria.

The Ebola outbreak ravaging West Africa has claimed 1,069 lives so far. Most have been in Guinea, Sierra Leone and Liberia. Nigeria has confirmed 10 cases and four deaths. Health workers treating EVD patients threaten to quit...

While the federal government is battling the warning from the US FDA, the Lagos State Government yesterday disclosed that health workers currently treating EVD patients have threatened to quit, citing unfair media reports.

The state government also denied reports that its medical team was not adequately taking care of the victims of the deadly virus, noting that the patients "are properly being treated."

The state's Governor, Mr. Babatunde Fashola and the Commissioner for Health, Dr. Jide Idris expressed concerns about the reports at separate press briefings in Lagos yesterday.

Giving updates on the dreaded virus, the governor lamented that the report reaching the state government about two hours ago was that some of the health workers at the isolation centre felt unappreciated.

He disclosed that the health workers decided "to stop work because of the media report that they were not working effectively to save the lives of the victims. We do not need that at the moment."

Fashola continued: "While we sympatise with the Ebola victims, the health workers are apparently doing their best to care for the victims. My appeal to the people is that more health workers should sign up.

"From what I was told by experts, even if one is the best physician in the world, the person cannot enter the isolation ward. He or she has to be trained in how to kit up and how to get out of the centre.

"The training takes between five and seven days to achieve. Even if we have the full complement of the doctors signing up today, it is risky to put them inside the isolation centre without adequate training. People must understand the process required.

"When it appears to the people that nothing was being done, it was because we are still building up capacity at the facility. We are better off today than 10 days ago. We know some complaint comes out of empathy, but it is complaint that does not focus on the reality of what is going."

Fashola disclosed that 51 people have been certified negative and have been freed out of the 198 people placed on the EVD watch list. "This is a virus that will run a maximum of 21 days. What we must do when people show some signs is to come in very early," the governor said.

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