Nine questions about new Ebola drug

<div dir="ltr" style="text-align: left;" trbidi="on"> <h1 class="entry-title posttitle" itemprop="name headline" style="border: 0px; margin: 10px 0px 30px; outline: 0px; padding: 0px; vertical-align: baseline; width: 2462px;"> <span style="background-color: rgba(255, 255, 255, 0);">Two American missionary workers infected with the deadly Ebola virus were given an experimental drug that seems to have saved their lives.</span></h1> <div id="entryContainer" style="border: 0px; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"> <div class="entry entry-content" itemprop="articleBody" style="border: 0px; margin: 0px; outline: 0px; padding: 0px 6px 0px 0px; text-align: justify; vertical-align: baseline;"> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">Dr. Kent Brantly was given the medication, ZMapp, shortly after telling his doctors he thought he would die, according to a source familiar with his case. Within an hour, doctors say his symptoms — labored breathing and a widespread rash — dramatically improved. Nancy Writebol, another missionary working with Samaritan’s Purse, received two doses of the medication and has also shown significant improvement, sources say.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">As there is no proven treatment and no vaccine for Ebola, this experimental drug is raising lots of questions.</span></div> <br /> <div class="wp-caption alignleft" id="attachment_458445" style="border: 0px; float: left; font-style: inherit; margin: 0px 20px 20px 0px; outline: 0px; padding: 0px; vertical-align: baseline; width: 422px;"> <div style="text-align: left;"> <a href="http://dvsl3w2q45hb8.cloudfront.net/wp-content/uploads/2014/08/Ebola-doc.gif" style="-webkit-transition: background-color, border-top-color; background-color: rgba(255, 255, 255, 0); border: 0px; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; text-decoration: none; transition: background-color, border-top-color; vertical-align: baseline;"><span style="color: black;"><img alt="Health workers evacuating the remains of an Ebola Virus Disease victim." class="wp-image-458445 size-full" height="274" src="http://dvsl3w2q45hb8.cloudfront.net/wp-content/uploads/2014/08/Ebola-doc.gif" style="-webkit-transition: margin 0.2s linear, box-shadow; border: none; box-shadow: rgba(0, 0, 0, 0.247059) 1px 1px 1px; margin: 0px; padding: 0px; transition: margin 0.2s linear, box-shadow;" width="412" /></span></a></div> <div class="wp-caption-text" style="border: 0px; outline: 0px; padding: 0px 8px 0px 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">Health workers evacuating the remains of an Ebola Virus Disease victim.</span></div> </div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">1. Who makes the drug?</span></div> <div style="text-align: left;"> <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 company was founded in 2003 “to develop novel pharmaceuticals for the prevention and treatment of infectious diseases, focusing on unmet needs in global health and biodefense,” according to its website.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">Mapp Biopharmaceutical has been working with the National Institutes of Health and the Defense Threat Reduction Agency, an arm of the military responsible for countering weapons of mass destruction, to develop an Ebola treatment for several years.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">2. Are there other experimental Ebola drugs out there?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">Yes. In March, the NIH awarded a five-year, $28 million grant to establish a collaboration between researchers from 15 institutions who were working to fight Ebola.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">“A whole menu of antibodies have been identified as potentially therapeutic, and researchers are eager to figure out which combinations are most effective and why,” a news release about the grant said.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">Tekmira, a Vancouver-based company that has a $140 million contract with the U.S. Department of Defense to develop an Ebola drug, began Phase 1 trials with its drug in January. But the FDA recently halted the trial, asking for more information.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">At least one potential Ebola vaccine has been tested in healthy human volunteers, according to Thomas Geisbert, a leading researcher at the University of Texas Medical Branch. And last week, the NIH announced a safety trial of another Ebola vaccine will start as early as September.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">3. How does ZMapp work?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">Antibodies are proteins used by the immune system to mark and destroy foreign, or harmful, cells. A monoclonal antibody is similar, except it’s engineered in a lab so it will attach to specific parts of a dangerous cell, according to the Mayo Clinic, mimicking your immune system’s natural response. Monoclonal antibodies are used to treat many different types of conditions.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">The medicine given to Brantly and Writebol abroad was 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.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">However, the drug can also be produced with proteins made from tobacco plants. ZMapp manufacturer Kentucky BioProcessing in Owensboro has been working with Samaritan’s Purse and Emory University Hospital to provide limited quantities of the drug to Emory, according to company spokesman David Howard.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">4. Why did American missionary workers get the drug?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">Many have asked why these two workers received the experimental drug when so many — around 1,600 — others in West Africa also have the virus.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">The World Health Organization says it was not involved in the decision to treat Brantly and Writebol. Both patients had to give consent to receive the drug, knowing it had never been tested in humans before.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">The process by which the medication was made available to the American patients may have fallen under the U.S. Food and Drug Administration’s “compassionate use” regulation, which allows access to investigational drugs outside clinical trials.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">5. Did doctors know it would work?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">No. The drug had shown promise in primates, but even in those experiments, just eight monkeys received the treatment. In any case, the human immune system can react differently than primates’, which is why drugs are required to undergo human clinical trials before being approved by government agencies for widespread use.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">The two Americans’ cases will be studied further to determine how the drug worked with their immune systems.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">6. Will the drug be made available to other Ebola patients?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">It’s unclear. Rolling out an untested drug during a massive outbreak would be very difficult, Doctors Without Borders said in a statement. Experimental drugs typically not mass-produced, and tracking the success of such a drug if used would require extra medical staff where resources are already scarce.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, says scientists have to be careful about assuming this drug will work in other patients as it appears to have worked in Brantly.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">“Having worked with administering antibodies for people for a really long time, that would be distinctly unusual,” he told CNN. “As we all know in medicine … you have to withhold judgment.”</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">7. Does the company have more vials of the drug?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">The company has very few doses ready for patient use, Fauci told CNN.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">“(Kentucky BioProcessing) is working closely with Mapp, various government agencies, and other parties to increase production of ZMapp, but this process will take several months,” Howard said.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">8. Who paid for the drug and how much did it cost?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">We don’t know. Samaritan’s Purse covered the cost of Brantly and Writebol’s evacuations but did not pay for the drug, according to a spokesman.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">When a patient gets an experimental drug, the drug company can donate the product under compassionate use. Mapp Biopharmaceutical Inc. might have done that in this case.</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">Health insurance companies typically do not pick up the tab for treatments that have not been approved by the FDA. But they usually would cover the cost of any doctor fees associated with giving the drug and any costs associated with monitoring how the drug is working.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; vertical-align: baseline;"> </div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">9. Would this drug stop the Ebola epidemic?</span></div> <div style="text-align: left;"> <span style="background-color: rgba(255, 255, 255, 0);">If it were widely available, it certainly couldn’t hurt. An effective Ebola drug could help doctors treat the deadly virus, which is killing about 60% of the people infected in West Africa. But a vaccine would be a much more effective tool in stopping this, and future, epidemics.</span></div> <br /> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">Vaccines are given to healthy people to prevent them from ever becoming infected. One challenge with Ebola, experts say, is that companies don’t believe they could make much money from developing a vaccine, so few companies show interest.</span></div> <div style="border: 0px; margin-bottom: 15px; outline: 0px; padding: 0px; text-align: left; vertical-align: baseline;"> <span style="background-color: rgba(255, 255, 255, 0);">*Source: CNN</span></div> <div class="OUTBRAIN" data-browser="safari" data-dynload="" data-ob-mark="true" data-os="ipad" data-src="http://www.vanguardngr.com/2014/08/nine-questions-new-ebola-drug/" id="outbrain_widget_0" obdone="true" style="border: 0px; clear: both; font-style: inherit; margin: 0px; outline: 0px; padding: 5px 0px; vertical-align: baseline;"> <div class="ob_brnBox_cont NA" style="border: 0px; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"> <span class="ob_empty" style="background-color: rgba(255, 255, 255, 0); border: 0px; font-style: inherit; margin: 0px; outline: 0px; padding: 0px; vertical-align: baseline;"><wbr style="margin: 0px; padding: 0px;"></wbr></span><span class="ob_org_header" style="border: 0px; float: left; font-style: inherit; font-weight: 600; margin: 0px; outline: 0px; padding: 0px 0px 3px; text-align: left; vertical-align: baseline;"></span></div> </div> </div> </div> <span style="background-color: rgba(255, 255, 255, 0);">- See more at: http://www.vanguardngr.com/2014/08/nine-questions-new-ebola-drug/#sthash.2eWIM9Po.dpuf</span></div>

Nine questions about new Ebola drug

Two American missionary workers infected with the deadly Ebola virus were given an experimental drug that seems to have saved their lives....

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