The dilemmas science faces

With Ebola outbreak reaching unimaginable proportions and the hope for drugs and a cure very far away, WHO says it is ethical to use untested drugs to fight Ebola virus.

The ethical issues in using an experimental Ebola drug is one of the biggest dilemmas science faces. Reflecting unanimous agreement from a panel of experts, the World Health Organization said in a statement recently that it is ethical to offer unproven drugs to treat or prevent the spread of the Ebola virus.

The panel, including ethicists, researchers, regulators and patient advocacy experts, met to consider the dilemma brought to the forefront after two American health care workers and one Spanish clergyman, who later died, were treated with experimental drugs in scarce supply. The virus, spreading out of control through West Africa, has already infected more than 1,800 people, killing more than 1,200.

The WHO said it was ethical in light of the scale of the outbreak and high number of deaths .
The statement was made after its medical experts met in Switzerland recently to discuss the issue.

But officials warned there were very limited supplies of potential treatments.
The WHO said where experimental treatments are used there must be informed consent and the results of the treatment collected and shared.

In a statement, it said: "In the particular circumstances of this outbreak, and provided certain conditions are met, the panel reached consensus that it is ethical to offer unproven interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention."

But the organization conceded there were still many questions to be answered including how data could be gathered effectively while the focus remained on providing good medical care.
It was also unclear where the funding for the treatment would come from.

Last week the WHO declared the Ebola outbreak was a global health emergency.

Up to 30,000 people could have used experimental treatments or vaccines so far in the world's worst outbreak of Ebola currently plaguing West Africa, British scientists said on 20th Aug., 2014.

The calculation highlights the dilemma facing officials considering how to distribute the tiny quantities of unproven drugs that are likely to be available in the near term to fight the deadly disease.

The World Health Organisation (WHO) is hoping for improved supplies of experimental treatments and progress with a vaccine by the end of the year, after last week backing the use of untested drugs and vaccines.

As the Ebola virus outbreak continues to run amok in West Africa, scientists are looking ahead to the possibly pivotal use of experimental drugs and vaccines against the disease. It will take months to test, produce and deploy the therapies. But researchers hold out hope that these products — even incompletely vetted — might help to turn the tide against an illness that has defied public health efforts to bring it under control.

One rare experimental drug, ZMapp, has already been used on two American aid workers and is now being given to three African healthcare workers who showed symptoms of the disease, all of whom have shown very promising signs of recovery.

But California-based Mapp Biopharmaceutical, which makes the drug, has said its scarce supplies are now exhausted and producing more will take time. It is currently working with Kentucky BioProcessing and the U.S. government to accelerate scaled-up production.

             There are other drugs in the pipeline but all are unproven and have yet to clear even the earliest stage of clinical trials. Brady said available stocks were limited to treatment courses for tens or at most hundreds of people.

Only one treatment, made by Tekmira Pharmaceuticals , has yet begun human safety trials, while the others have been tested only in non-human primates.

In total, 17 Ebola drugs and 12 vaccines are in the pipeline at various companies and institutions, according to BioWorld, a Thomson Reuters publication. Some have been languishing in animal studies and other preclinical research for more than a decade. 

Experimental drugs has downsides: Even if the treatments help some patients, it will be hard to determine their true effectiveness.  Without control groups we cannot decide whether people have recovered because of the drugs or on their own. And failed treatments could exacerbate the despair and distrust already hampering public health efforts. But public health officials and bioethics experts say the situation in West Africa is severe enough to warrant putting candidate therapies into use after minimal human safety testing. People are so desperate. And desperate situations demand extreme measures.

These are really tough situations for science. There are hundreds of people dying of a deadly disease on one hand. The tests on drugs are still in an experimental stage. Nobody knows what the side effects will be when these drugs are taken by human beings. Then what would one do? Wait for the drugs to arrive for years and meanwhile watch helplessly people dying? Or take a small risk and go ahead and try the drugs?

A few years back our family faced a similar situation. One of our Paternal Aunties had a medical emergency when the fetus in her uterus died in her eight month of pregnancy, rupturing her uterus very badly and she had a very severe bleeding which was very dangerous. She had a rare blood group. To get the blood of her group was very difficult. Then doctors used untested available blood (testing was not usual as HIV was not a dreaded disease then) to save her. Her life was saved at that time. But she developed liver cancer because of Hepatitis infection some 18 years later! And she died because of the cancer. The doctors said there was a possibility that the blood used for transfusion could have been infected with Hepatitis virus and this could have lead to the cancer , which was found to be true in recent studies too that showed that particularly in Asia, infection with either hepatitis B or C is often associated with such cancers (1,2).

Well at least she lived for 18 long years after her medical emergency because of the blood transfusion she got.

A small danger that we might face later is always better than the big danger we are facing now!

If somebody asks me would you take a drug that is untested to save your life, I would say, 'yes definitely'. Instead of dying now, I would get some more years to live and do some more work. Then why not?' The US doctor who worked in Ebola outbreak areas of Africa and got the infection too said he didn't mind testing the drug on himself and went ahead with the treatment.

But I think it is up to each individual to decide what is best for him or her in such cases.

At the same time I think what WHO says is right under the circumstances and as the decision is taken with the right intentions, i.e., save as many lives as possible. WHO needs all the support from the world in this regard.

References:

1. http://www.nature.com/ncomms/2015/150130/ncomms7120/full/ncomms7120...

2. http://www.sciguru.org/newsitem/18330/hot-trail-hepatitis-liver-can...