What Does It Better? Immune System Or Experimental Drugs

On 25/Aug/2014 / In Medical News

It is the morning after for American missionary health workers, Dr. Kent Brantly and Mrs. Nancy Writebol. The duo who contracted the Ebola Virus Disease while working with patients in Liberia have since been declared cured of the virus. However, science is still unclear what the cure agent is and what role the experimental drug, ZMapp, played in nursing the duo back to health.
Indeed, the director, Emory Hospital’s Infectious Disease Unit, Atlanta, United States, Dr. Bruce Ribner, admitted that being an experimental drug, it is erroneous to give credit to ZMapp.
“Frankly, we do not know if it helped them, made any difference or even delayed their recovery,’’ said Ribner during a press conference.
The doctor’s comments have called to question how a cure is being achieved in the survivors. Across Liberia, Sierra Leone and Guinea, tens of patients have survived the infection. It is no different in Nigeria, where four survivors have been released from the Infectious Diseases Hospital, Yaba, Lagos, to resume normal activities.
According to the Minister for Health, Professor Onyebuchi Chulwu, none of the survivors got any experimental drug during treatment. He emphasised that all the survivors got was supportive treatment such as intravenous fluid and keeping their vital signs stable.
Even with its benefits still in doubt, experts are calling on the government to make ZMapp and other experimental drugs available in large quantities to patients who need it. A research fellow at the Nigerian Institute of Medical Research, Lagos, Dr. Dan Onwujekwe, noted that while the immune system might help most patients survive the onslaught of the virus, it could be difficult for elderly and young Ebola patients to stage a recovery without the drug.
“Anyone with a competent immune system will produce antibodies to fight most infections. But because the progression is very rapid, elderly and young Ebola patients may not be able to mount immune defense rapidly enough. Ebola is still something new. It is a hemorrhagic fever which causes bleeding. That is why supportive treatment is given to patients. If the person is having diarrhea, you replace the lost fluid as quickly as the body is losing it through intravenous fluid. You are not likely to succeed by giving oral rehydration therapy. If the person is bleeding, you should be prepared before the bleeding starts and you replace the platelets as fast as possible. If you are able to do that and quickly enough, you will be able to keep the patient alive until he or she produces enough antibodies to kill the virus,’’ he said.
But the dilemma of whether to administer the experimental drugs remains in the three African countries most hit by Ebola. As the flesh-eating Ebola virus ravages West Africa, two American health workers who contracted the disease in Liberia were airlifted back to the United States to be treated with an experimental drug. They have since recovered.
But colleagues of a doctor in Sierra Leone, stricken as he led his country’s fight against the virus, decided against giving him the same medicine. He has since died.
The worst Ebola outbreak in history, combined with the existence, in small amounts, of untested drugs that might prove effective in combating it, is raising questions about the ethics of fighting an epidemic.
Chief among them: Can a drug be used to treat the sick when it has yet to be tested for efficacy, or even safety? When supplies of such drugs are scarce, who should get them first? And who should decide?
“Everybody has the same goals here,” said Dr. Nancy Kass, a professor of bioethics at the Bloomberg School of Public Health at the Johns Hopkins University. “To treat people if it works, and to not treat people if it doesn’t work — and certainly not treat people if it’s harmful.
“The problem is, we’re looking at this black box, and not knowing what the answers are.”
The lethality of Ebola has helped make the answer to the first question easier. The World Health Organization estimates the case mortality rate of the virus at up to 90 percent. With at least 1,350 dead, this outbreak is on pace to surpass the death toll from all previous outbreaks combined.
In the face of such statistics, the Food and Drug Administration in White Oak eased a restriction this month on the use of the experimental drug TKM-Ebola, developed by a Canadian firm on a U.S. Defense Department contract. A panel of ethicists convened by the World Health Organization has voted unanimously to support the use of experimental treatments such as ZMapp, the medicine given to Dr. Kent Brantly and Nancy Writebol, the Americans who were airlifted from Liberia to Emory University in Atlanta. And the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health in Bethesda, said last week that it would move up clinical trials for a promising Ebola
Under the circumstances, Dr. Henry Silverman said, the decision to try drugs that might work seems “noncontroversial.”
“In a time of epidemic, when we have limited time to go through the normal regulatory procedures, you have to weigh risk and benefit,” said Silverman, a physician and bioethicist who chairs the ethics committee at the University of Maryland Medical Center. “In this case, this is an illness with a high fatality rate, and we don’t have any other good medicines.”
Still, there remain questions about who should get such drugs, given the limited quantities in which they tend to be produced.
The supply of ZMapp, used to treat the two Americans, three Liberian doctors and a Spanish priest, is now “exhausted,” according to San Diego-based Mapp Biopharmaceutical Inc. Tekmira Pharmaceuticals, the British Columbia firm behind TKM-Ebola, has yet to allow the drug to be used to treat the sick.
“For the first time, we have a range of potential treatments and vaccines that could be important assets supporting our efforts to control Ebola virus disease,” Marie-Paule Kieny, assistant director general of the World Health Organization, told reporters in Geneva.
She added: “I don’t think that there could be any fair distribution of something which is available in such a small quantity.”
Silverman calls the question of who gets the experimental drugs the “justice issue.” It makes sense to prioritize health workers, he says, for at least a couple of reasons.
“You want to keep a functioning health care structure in place,” Silverman said. And doctors, nurses and other professionals are likely to be the most able to give informed consent.
Kass adds a third reason to prioritize health workers. She points to the case of Brantley and Writebol.
“These were not any two Americans, but they were two Americans who had volunteered to go into the heart of this really terrible epidemic,” she said. “I think when someone is willing do that, we have to have certain kinds of commitments to them, both to give them as much protective equipment and training as possible on the front end, and to also make a promise that if you get sick, we’re going to airlift you home, we’re going to do everything we can.”
After health workers, Silverman said, authorities may weigh a variety of criteria for determining whom to prioritize: Those who are most vulnerable, those who are most sick, those who stand to benefit most.
“This is traditional triage,” he said.
History offers some examples. During the H1N1 pandemic in 2009, the Centers for Disease Control recommended giving the limited vaccinations to pregnant women, caregivers for children under six months and health and emergency services workers.
But each emergency will demand its own reasoning, Silverman said. He said transparency is vital.

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