Why do two white Americans get the Ebola serum while hundreds of Africans die?

<div dir="ltr" style="text-align: left;" trbidi="on"> <span style="color: #333333; font-family: FranklinITCProBold, sans-serif; font-size: 16px; line-height: 20px;">By </span><a href="http://pophealth.med.nyu.edu/faculty/caplaa01" style="color: #2e6d9d; font-family: FranklinITCProBold, sans-serif; font-size: 16px; line-height: 20px; outline: 0px; text-decoration: none;">Arthur L. Caplan</a>. <span style="color: #333333; font-family: FranklinITCProLight, HelveticaNeue, 'Helvetica Neue Light', 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 15px; line-height: 20px;">Arthur L. Caplan is the director of the Division of Medical Ethics at NYU Langone Medical Center’s Department of Population Health.</span><br /> <div class="inline-content inline-photo" style="border-bottom-color: rgb(213, 213, 213); border-bottom-style: solid; border-bottom-width: 1px; border-top-width: 0px; color: #333333; font-family: FranklinITCProLight, HelveticaNeue, 'Helvetica Neue Light', 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 14px; line-height: 20px; margin: 0px 0px 20px; padding: 0px 0px 20px;"> <img class="" data-hi-res-src="http://img.washingtonpost.com/rf/image_908w/2010-2019/WashingtonPost/2014/08/05/Foreign/Images/Ebola_Americans-00461.jpg" data-low-res-src="http://www.washingtonpost.com/wp-apps/imrs.php?src=http://img.washingtonpost.com/rf/image_908w/2010-2019/WashingtonPost/2014/08/05/Foreign/Images/Ebola_Americans-00461.jpg&w=480" src="http://img.washingtonpost.com/rf/image_908w/2010-2019/WashingtonPost/2014/08/05/Foreign/Images/Ebola_Americans-00461.jpg" style="border: 0px; width: 599px;" /><br /><span class="pb-caption" style="color: #6e6e6e; font-size: 15px;">Nancy Writebol in Liberia, where she contracted Ebola before being brought to an Atlanta hospital. (AP Photo/Courtesy Jeremy Writebol)</span></div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> What should happen if a massive viral outbreak appears out of nowhere and the only possible treatment is an untested drug? And who should receive it? The two American missionaries who contracted the almost-always-fatal virus in West Africa were given access to an experimental drug cocktail called ZMapp. It consists of immune-boosting monoclonal antibodies that were extracted from mice exposed to bits of Ebola DNA.  Now in isolation at an Atlanta hospital, they appear to be doing well.</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> It’s an opportunity the 900 Africans who’ve died so far never had. Is there a case to suspend ethical norms if lives might be saved by deploying an experimental drug?</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> The reasons for different treatment are partly about logistics, partly about economics and, partly about a lack of any standard policy for giving out untested drugs in emergencies. Before this outbreak, ZMapp had only been tested on monkeys. Mapp, the tiny, San Diego based pharmaceutical company that makes the drug stated two years ago: “When administered one hour after infection [with Ebola], all animals survived…Two-thirds of the animals were protected even when the treatment, known as Zmapp, was administered 48 hours after infection.”</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> But privileged humans were always going to be the first ones to try it. ZMapp requires a lot of refrigeration and careful handling, plus close monitoring by experienced doctors and scientists—better to try it at a big urban hospital than in rural West Africa, where no such infrastructure exists.</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> And because of the drug’s experimental nature, it’s unclear that it <em>should </em>go to anyone else. Even if the drug is cooled correctly, success in a few monkeys (less than 20) tells us little about what will happen in a lot of humans who’d had the infection for more than two days. No one knows how much drug to give, how often, what other pre-existing medical conditions might influence its efficacy or even what route is best, be it IV, pill, syrup, or even surgically right into the liver. With an untested drug, there is always a chance you will kill the first human subject who might otherwise have lived. And the two Americans who got it in Africa had been infected for more than a week, making its efficacy completely unknown. Still, because they are a small group in such a carefully controlled setting, they are better candidates for the drug than others might be.</div> <br /> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> But it’s about more than logistics. Drugs based on monoclonal antibodies usually cost a lot—at least tens of thousands of dollars. This is obviously far more than poor people in poor nations can afford to pay; and a tiny company won’t enthusiastically give away its small supply of drug for free. It is likely that if they were going to donate drugs, it would be to people who would command a lot of press attention and, thus, investors and government money for further research—which is to say, not to poor Liberians, Nigerians or Guineans.</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> The medical missionaries got the experimental drug because the evangelical Christian International Relief organization they work for, Samaritan’s Purse, reached out to the CDC and the NIH to find out if there was any drug to give to them. They were referred to Mapp Pharmaceuticals and evidently struck some kind of deal to get the drug to their employees who were in Africa at the time. (Technically, African health ministries could make a similar request.) The FDA has little oversight over what goes on abroad, and the federal government has no program to consider appeals for use—much less payment—of experimental drugs that have only been tried on animals. Without an organization pushing, no one might have received access to any sort of treatment. The chance of a poor African getting an experimental drug is about the same as Donald Trump contracting Ebola (<a href="https://twitter.com/realDonaldTrump/status/495379061972410369" style="border-bottom-color: rgb(212, 212, 212); border-bottom-style: solid; border-bottom-width: 1px; color: #2e6d9d; text-decoration: none; zoom: 1;">which is apparently his greatest current fear</a>).</div> <div class="has-subscribe-promo borB1S borT1S marB26 padB10 padT10" style="color: #333333; font-family: FranklinITCProLight, HelveticaNeue, 'Helvetica Neue Light', 'Helvetica Neue', Helvetica, Arial, 'Lucida Grande', sans-serif; font-size: 14px; line-height: 20px;"> </div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> Even if logistical and economic obstacles could be surmounted, is there a case for giving Zmapp to Africans still dying from Ebola? Many Africans were infected more recently than the Americans now being treated in Atlanta, so they better fit the conditions in which the drug was tried in the monkey lab.</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> <span style="line-height: 1.8em;">But there is no accepted set of rules for a sick person to request compassionate access to drug that is experimental, expensive, and in short supply. And access to experimental drugs remains a long shot full of risk. While the American Ebola patients gave their consent, and while most people would want to do something rather than nothing, the decision about gaining access is more in the hands of the drug manufacturer than the would-be subject. The dying may feel more cavalier about entering a drug experiment—the rewards (life) could justify the risks (since death approaches anyway)—but  a company may still withhold a drug from a willing volunteer for fear that it will fail and reduce investor interest or increase attention from malpractice attorneys.</span>An ethical case can surely be made for an organization that puts health-care workers in harm’s way to acquire access to experimental drugs and bring staff home to get the best possible care. But that is neither a fair nor just policy for deciding what to do when an emergency arises and rationing is the only option. This Ebola outbreak has taught us two things: that we need to act quickly to shut down emerging epidemics wherever they occur, and it is long past time to have a transparent public policy about what to do when not everyone gets a chance to live.</div> <div style="color: #333333; font-family: Georgia; font-size: 18px; line-height: 1.8em; margin-bottom: 24px;"> <strong>Correction:</strong> <em>This piece originally said the experimental drug was called MB-003. That was an earlier version of the drug now known as ZMapp.</em></div> </div>

Why do two white Americans get the Ebola serum while hundreds of Africans die?

By  Arthur L. Caplan .  Arthur L. Caplan is the director of the Division of Medical Ethics at NYU Langone Medical Center’s Department of Po...

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US doctors say ‘secret serum’ helped save lives of American Ebola patients

<div dir="ltr" style="text-align: left;" trbidi="on"> <h2 class="date-header" style="background-attachment: scroll; background-image: none; background-position: 0% 0%; background-repeat: no-repeat no-repeat; border-bottom-color: transparent; border-bottom-style: solid; border-bottom-width: 1px; border-top-color: rgb(34, 34, 34); border-top-left-radius: 0px; border-top-right-radius: 0px; border-top-style: solid; border-top-width: 0px; bottom: auto; font-weight: normal; margin: 0px -15px 1px; min-height: 0px; padding: 0px; position: static; right: 15px;"> <span style="border-left-color: rgb(34, 34, 34); border-left-style: solid; border-left-width: 0px; border-right-color: rgb(34, 34, 34); border-right-style: solid; border-right-width: 0px; display: block; padding: 0.5em 15px;"><img border="0" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiIcxGvUe1dIoYh8HczQUM2IFjphJCFZBdxZ7GeTe1xDPa-H3TzP7p0BOhyphenhyphenXN7FLaEL6KeVOdoYqyX42UkqPt4NinF4leg7Y8Qz3V_YXbAOy1EL9o8awxtRmZZlL4vPbyOG65c2w6zdPTg/s1600/ebola.png" style="-webkit-box-shadow: rgba(0, 0, 0, 0.2) 0px 0px 0px; border-bottom-left-radius: 0px; border-bottom-right-radius: 0px; border-top-left-radius: 0px; border-top-right-radius: 0px; border: 1px solid rgb(153, 0, 0); box-shadow: rgba(0, 0, 0, 0.2) 0px 0px 0px; padding: 8px;" /></span></h2> <div class="date-posts" style="border-top-color: transparent; border-top-style: solid; border-top-width: 1px; clear: both; margin: 0px -15px; padding: 8px 15px 0px;"> <div class="post-outer" style="border-top-style: none; margin: 0px -15px; padding: 0px 15px 10px;"> <div class="post hentry uncustomized-post-template" itemprop="blogPost" itemscope="itemscope" itemtype="http://schema.org/BlogPosting" style="min-height: 0px; position: relative;"> <div class="post-header" style="margin: 0px 0px 1em;"> <div class="post-header-line-1"> </div> </div> <div class="post-body entry-content" id="post-body-808633980667011432" itemprop="description articleBody" style="position: relative; width: 616px;"> <span style="background-color: rgba(255, 255, 255, 0);">So wait, the US may have found a cure to Ebola? And if they have, will they come help patients of this dreaded disease in Africa? The article below was written by Dr. Sanjay Gupta for <a href="http://edition.cnn.com/2014/08/04/health/experimental-ebola-serum/index.html" style="text-decoration: none;" target="_blank">CNN</a> and they are saying an experimental drug called ZMapp likely saved the lives of 2 US missionary doctors (pictured above) who contracted the disease while working in Liberia...see report below from CNN..</span><blockquote class="tr_bq"> <span style="background-color: rgba(255, 255, 255, 0);">Three vials containing an experimental drug stored at subzero temperatures were flown into Liberia last week in a last-ditch effort to save two American missionary workers who had contracted Ebola, according to a source familiar with details of the treatment.</span></blockquote> <blockquote class="tr_bq"> <div class="cnn_storypgraphtxt cnn_storypgraph2"> <span style="background-color: rgba(255, 255, 255, 0);">The drug appears to have worked, sources say. Dr. Kent Brantly's and Nancy Writebol's conditions significantly improved after receiving the medication, sources say. Brantly was able to walk into Emory University Hospital in Atlanta after being evacuated to the United States last week, and Writebol is expected to arrive in Atlanta on Tuesday.</span></div> <span style="background-color: rgba(255, 255, 255, 0);"><a href="" name="more"></a></span></blockquote> <div class="cnn_storypgraphtxt cnn_storypgraph4"> <span style="background-color: rgba(255, 255, 255, 0);">On July 22, Brantly woke up feeling feverish. Fearing the worst, Brantly immediately isolated himself. Writebol's symptoms started three days later. A rapid field blood test confirmed the infection in both of them after they had become ill with fever, vomiting and diarrhea.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph4"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph5"> <span style="background-color: rgba(255, 255, 255, 0);">It's believed both Brantly and Writebol, who worked with the aid organization Samaritan's Purse, contracted Ebola from another health care worker at their hospital in Liberia, although the official Centers for Disease Control and Prevention case investigation has yet to be released.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph5"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph5"> <span style="background-color: rgba(255, 255, 255, 0);">A representative from the National Institutes of Health contacted Samaritan's Purse in Liberia and offered the experimental treatment, known as ZMapp, for the two patients, according to the source.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph5"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph6"> <span style="background-color: rgba(255, 255, 255, 0);">The drug was developed by the biotech firm Mapp Biopharmaceutical Inc., which is based in San Diego. The patients were told that this treatment had never been tried before in a human being but had shown promise in small experiments with monkeys.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph6"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph7"> <span style="background-color: rgba(255, 255, 255, 0);">According to company documents, four monkeys infected with Ebola survived after being given the therapy within 24 hours after infection. Two of four other monkeys that started therapy within 48 hours after infection also survived. One monkey that was not treated died within five days of exposure to the virus.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph7"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph8"> <span style="background-color: rgba(255, 255, 255, 0);">Brantly and Writebol were aware of the risk of taking a new, little understood treatment and gave informed consent, according to two sources familiar with the care of the missionary workers. In the monkeys, the experimental serum had been given within 48 hours of infection. Brantly didn't receive it until he'd been sick for nine days.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph8"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph10"> <span style="background-color: rgba(255, 255, 255, 0);">The medicine is a three-mouse monoclonal antibody, meaning that mice were exposed to fragments of the Ebola virus and then the antibodies generated within the mice's blood were harvested to create the medicine. It works by preventing the virus from entering and infecting new cells.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph10"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph10"> <span style="background-color: rgba(255, 255, 255, 0);">The Ebola virus causes viral hemorrhagic fever, which refers to a group of viruses that affect multiple organ systems in the body and are often accompanied by bleeding.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph10"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph11"> <span style="background-color: rgba(255, 255, 255, 0);">Early symptoms include sudden onset of fever, weakness, muscle pain, headaches and a sore throat. They later progress to vomiting, diarrhea, impaired kidney and liver function -- and sometimes internal and external bleeding.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph11"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph12"> <span style="background-color: rgba(255, 255, 255, 0);">The ZMapp vials reached the hospital in Liberia where Brantly and Writebol were being treated Thursday morning. Doctors were instructed to allow the serum to thaw naturally without any additional heat. It was expected that it would be eight to 10 hours before the medicine could be given, according to a source familiar with the process.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph12"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph13"> <span style="background-color: rgba(255, 255, 255, 0);">Brantly asked that Writebol be given the first dose because he was younger and he thought he had a better chance of fighting it, and she agreed. However, as the first vial was still thawing, Brantly's condition took a sudden turn for the worse.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph13"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph14"> <span style="background-color: rgba(255, 255, 255, 0);">Brantly began to deteriorate and developed labored breathing. He told his doctors he thought he was dying, according to a source with firsthand knowledge of the situation.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph14"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph15"> <span style="background-color: rgba(255, 255, 255, 0);">Knowing his dose was still frozen, Brantly asked if he could have Writebol's now-thawed medication. It was brought to his room and administered through an IV. Within an hour of receiving the medication, Brantly's condition dramatically improved. He began breathing easier; the rash over his trunk faded away. One of his doctors described the events as "miraculous."</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph15"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph16"> <span style="background-color: rgba(255, 255, 255, 0);">By the next morning, Brantly was able to take a shower on his own before getting on a specially designed Gulfstream air ambulance jet to be evacuated to the United States.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph16"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph17"> <span style="background-color: rgba(255, 255, 255, 0);">Writebol also received a vial of the medication. Her response was not as remarkable, according to sources familiar with the treatment. However, doctors on Sunday administered Writebol a second dose of the medication, which resulted in significant improvement.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph17"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph18"> <span style="background-color: rgba(255, 255, 255, 0);">She was stable enough to be evacuated back to the United States and is expected to arrive before noon Tuesday.</span></div> <div class="cnn_storypgraphtxt cnn_storypgraph18"> <span style="background-color: rgba(255, 255, 255, 0);"><br /></span></div> <div class="cnn_storypgraphtxt cnn_storypgraph19"> <span style="background-color: rgba(255, 255, 255, 0);">The process by which the medication was made available to Brantly and Writebol is highly unusual. ZMapp has not been approved for human use, and has not even gone through the clinical trial process, which is standard to prove the safety and efficacy of a medication. It may have been given under the U.S. Food and Drug Administration's "compassionate use" regulation, which allows access to investigational drugs outside clinical trials.</span></div> </div> </div> </div> </div> </div>

US doctors say ‘secret serum’ helped save lives of American Ebola patients

So wait, the US may have found a cure to Ebola? And if they have, will they come help patients of this dreaded disease in Africa?...

Read more »