A Spanish nurse became the first person to contract Ebola outside of Africa. She helped treat the second of two priests who had been evacuated from Liberia with the dread disease. One might be forgiven for thinking Ebola was contagious. But this as the Daily Mail says the CDC told the stepdaughter of Texas Ebola victim Thomas Duncan that it was alright for her to return to work as a nurse’s assistant in a local hospital. Fortunately, Ms Jallah has decided not to return to work — yet.
Ms Jallah whose contact with Mr Duncan – who remains in a critical condition – was far more intimate and prolonged than that of her husband, told MailOnline on Monday: ‘The CDC came yesterday. They said I can go back to work but I do not know what I will do. I will not go back yet.’
Doctors say that no-one is at risk of catching the virus unless they come into contact with a sufferer who is exhibiting symptoms.
All-clears are all important. Just now authorities gave the all-clear to allow the Dallas hospital to use an experimental medicine called brincidofovir to treat Mr. Duncan, probably inasmuch as his condition is “critical” and there is not much hope without trying a new tack.
“We are hopeful that brincidofovir may offer a potential treatment for Ebola Virus Disease during this outbreak,” Dr. M. Michelle Berrey, the president and chief executive officer of Chimerix, said in a statement released Monday by the company.
Chimerix is working closely with the Food and Drug Administration to finalize a clinical trial protocol early this week to assess the safety, tolerability, and efficacy of brincidofovir in patients who are confirmed to have an Ebola infection, said the statement.
The story of brincidofovir is itself the tale of regulation, permissions and guidelines. Modern medicine is as much about law and protocol as it is about treatments. Brincidofovir was recently in the news as part of a campaign to make it available for a dying boy.
David Kroll at Forbes explained it is generically known as CMX001 and developed as part of an anti-bioterrorism initiative. Although it showed great promise, the active ingredient cidofovir was extremely toxic to patients and could not be stored for any length of time. A company called Chimerix, however, spliced cidofovir with lipids thereby synthesizing a drug which could be stored on a shelf and administered orally. It was also, for some reason they could not completely understand, far less toxic that cidofovir.
the lipid attachment had two immediate benefits. First, it increased the antiviral effect by 40 to 400 times that of cidofovir. Second, oral CMX001 was taken up into the bloodstream of animals – and later, humans – more than 50 times better than cidofovir.
Hostetler noted that another advantage of adding this lipid was that it neutralized a chemical charge on the cidofovir molecule that caused the drug to concentrate in the kidney via a pump that we normally use to rid ourselves of certain acidic substances. Since CMX001 wasn’t used by this pump, it didn’t seem to concentrate in the kidney like cidofovir does.
But drugs are not merely chemical substances. They are political objects. Chimerix found that developing a last-chance drug attracted the attention of the desperately ill and put them in the vortex of a legal, media and compassionate crisis crisis. Chimerix, despite the poorly understood safety, became the subject of “relentless pressure to provide its potent antiviral drug to Josh Hardy, the Virginia first-grader who received a bone marrow transplant and is now fighting off the potentially lethal adenovirus.”
At first Chimerix refused for “ethical reasons” but also probably because any failure with a high profile case might doom the development of the drug and potentially expose it to blame. Eventually, a solution was found that satisfied all the constraints.
Chimerix had refused the family’s pleas because it would have been unethical to release an unapproved medication selectively. To get the drug to Josh, the company had to devise a program in which the treatment was available to other needy patients, Moch said.
Brincidofovir was designed to prevent infection, not to treat it, and Josh’s prospects for recovery remain unclear. A test on 48 infected patients last year was not statistically meaningful, and the company planned to continue testing the medication.
Moch emphasized Wednesday that Chimerex had been in talks with federal regulators for six months to come up with a drug trial to test brincidofovir’s effectiveness on treating adenovirus, which causes organ failure in patients with compromised immune systems.
The decision to offer the drug to Josh as part of a small trial merely “compressed the outcome into a week,” he said.
“It wasn’t just about Josh,” Moch said. “It was about many Joshes.”
The episode ended with interesting results. The good news is that Josh Hardy made what until now has been a spectacular recovery. The bad but not entirely unexpected news is the CEO of Chimerix lost his job after enduring death threats in the interval.
Moch had been in the middle of a traditional and social media firestorm when the company denied compassionate use access of their investigational antiviral drug, brincidofovir (CMX001), to 8-year-old Joshua Hardy. The Virginia boy has been suffering from a potentially-fatal adenovirus infection following a bone marrow transplant for his nearly life-long struggle with rhabdoid carcinoma of the kidney.
John Murawski of the Raleigh News & Observer reported on March 12 that Moch had subsequently received death threats and was placed under armed escort. …
This case came to national attention when reporters picked up on #SaveJosh, an aggressive social media campaign by Hardy’s family to gain compassionate “extended use access” to Chimerix’s CMX001. This FDA designation allows companies to provide pre-approval access to FDA uses to work with companies to provide experimental drugs to patients.
Although Chimerix had a compassionate use program early in the drug’s development, their current focus has been to get CMX001 approved quickly so that it can be made available to as many patients as possible. A small company like Chimerix without any products generating revenue is in a particularly difficult situation, lacking the resources to handle individual compassionate use cases while also trying to get difficult and expensive controlled clinical trials completed on the road to potential FDA approval.
Politics is part and parcel of the medical game. The Dallas Judge in charge of overseeing the Ebola response “made a point of visiting the home of the infected man without protective clothing, took the responsibility for driving his quarantined family to their new home, and has been doing what he can to coordinate the state and federal response, while keeping his voters calm.”
A Democrat first elected to office in 2010, Jenkins cut his teeth in emergency response with an outbreak of West Nile virus in in 2012. Earlier this year he stirred up controversy by offering Dallas County facilities to house undocumented immigrant children flooding across the U.S.-Mexico border. He’s up for re-election in just a few weeks. …
by entering the apartment Jenkins was also, at least as importantly, sending the message to the wider world that hazmat suits milling around or not these people, lacking any symptoms, were incapable, even if infected, of passing along Ebola.
The medical wisdom of his beau geste may be doubtful, but the political advantages are not. There are probably two kinds of truth in the world. The first is the factual truth, which in all scientific or empirical cases is a working hypothesis, often ambiguous or fraught with uncertainty or qualification. Questions like how dangerous is CMX001? How contagious is Ebola? Was Jenkin’s visit medically advisable? are all factual truth questions.
The second kind of truth is the legal or media narrative. Here things are far more categorical because messaging must be simplistic to be widely understood. Simplistic as in the way that Jenkins perceived it, not complex in the manner that Moch had to navigate. Examples of this second kind of truth are: will a treatment be perceived as “insensitive” or “racist” and, “how many votes will this stunt get me?”
In the modern narrative universe of persistent communications, whenever the first kind of truth conflicts with the second kind of truth, the latter prevails over the former. This was not always the case. In the old days the narrative was written after the fact. It was rarely pre-ordained and forced into a procrustean bed beforehand. The old emphasis on results made it possible to for them to enjoy “freedom of action”.
In the age of sail communications were only as fast as the ships themselves. Therefore the men on the spot were free to act as they saw fit, subject to the proviso that they brought home the bacon. During the Battle of Copenhagen, Horatio Nelson was caught between the demands of standing regulations and tactical necessity. Fearing Nelson would die battering his forces against a wall, Admiral Parker gave him a pretext to withdraw in the face of enemy fire. But he also knew that Nelson would disobey as he saw fit.
Admiral Parker could see little of the battle owing to gun smoke, but could see the signals on the three grounded British ships, with Bellona and Russell flying signals of distress and Agamemnon a signal of inability to proceed. Thinking that Nelson might have fought to a stand-still but might be unable to retreat without orders (the Articles of War demanded that all ranks ‘do their utmost’ against the enemy in battle), at 1:30pm Parker told his flag captain, “I will make the signal of recall for Nelson’s sake. If he is in condition to continue the action, he will disregard it; if he is not, it will be an excuse for his retreat and no blame can be imputed to him.”
Nelson ordered that the signal be acknowledged, but not repeated. He turned to his flag captain, Thomas Foley, and said “You know, Foley, I only have one eye — I have the right to be blind sometimes,” and then, holding his telescope to his blind eye, said “I really do not see the signal!”
Now if Ms Jallah has received the all-clear from the CDC but sees fit to enjoy her vacation from work, she would be exercising the a similar right to be deaf when the situation demanded. Like Chimerix finding a formula by which it could offer an experimental treatment without breaking the rules, she may have found the formula for obeying without complying.
Nelson threw away the book at Trafalgar. But by the time his subordinates had to report the infraction, Nelson had won for Britain mastery of the seas. The message was then composed in the light of the result. “It fell to Admiral Cuthbert Collingwood to write the dispatch for the Admiralty. He selected the schooner, Pickle, one of the fast advice boats, to take the news back to Britain.”
The schooner set off on the 26 October and took 9 days to reach Britain, enduring a gale off Cape Finisterre. The vessel was blown off course and Lapenotiere ordered that 4 carronades to be cast overboard to lighten the load.
At 9.45am on November 4, the Pickle anchored in Falmouth Bay. By midday, Lapenotiere was on his way to London in a hired post-chaise coach, displaying a Union Flag and a tattered Tricolour on a broomstick as a flagpole. The normal journey took a week, but within 37 hours, after 19 horse changes, Lapenotiere arrived at the Admiralty at 1am on 6 November.
He was shown through to the First Secretary of the Admiralty, Mr Marsden. Lord Barham, First Lord of the Admiralty was raised from his sleep to receive the news. The Prime Minister, William Pitt received the news at 3am and King George III and Queen Charlotte heard at 7am. As the news was being broadcast across the city with saluting guns from the Tower of London, the news was also received by an hysterical Emma Hamilton. Lapenotiere was later given an audience with the King and Queen and was presented with a silver cruet, the first thing the King could find to hand.
The facts in those days were established a posteriori and not a priori. Today, however with everyone tethered by an immense communications chain to an immense mass of regulation enforced by an army of lawyers and pundits, success often depends upon finding ways to evade the stupidity of the system such that it can subsequently be credited for being ignored. Because everyone knows the trick is to give your superiors what they want and not what they asked for. Or as Bill Maher so eloquently put it with when he debated the need to sometimes think ill of radical Islam in his debate with Ben Affleck:
We’re liberals! We’re liberals. We’re not crazy tea-baggers, y’know, and so it’s kind of hard to be making this case — based on facts, based on polling, I think based on what everybody really knows… I mean, do the people arguing with us, would they really open a lesbian art gallery in Ramallah? [Laughs] Or Karachi? Or Cairo? I don’t know if they would back up what they’re saying with actions.
We are not bigoted people. On the contrary, we’re trying to stand up for the principles of liberalism! And so, y’know, I think we’re just saying we need to identify illiberalism wherever we find it in the world, and not forgive it because it comes from [a group] people perceive as a minority.
Which means, insofar as I can determine: don’t me take me seriously. The powers that be have declared that Ebola will be stopped in its tracks. Now is a the time for all good men to accomplish this. Just don’t tell them how you did it.
The “official truth” is a fascinating thing. Just now the New York Times notes that vice-President Biden will soon be busy apologizing to a third country, Saudi Arabia, for his ill-considered idea that they might have something to do with radical Islam.
WASHINGTON — Vice President Joseph R. Biden Jr. has one more stop on what has become a Middle East apology tour in the wake of his impolitic answer to a Harvard student’s question: Saudi Arabia.
After apologizing to officials from Turkey and the United Arab Emirates over the weekend, Mr. Biden is trying to connect with Saudi leaders, a senior official said, to clarify that he did not mean to suggest that Saudi Arabia backed Al Qaeda or other extremist groups in Syria.
The vice president’s troubles began Thursday when he declared, in a question-and-answer session at the John F. Kennedy School of Government, that the biggest problem the United States faced in dealing with Syria and the rise of the Islamic State was America’s allies in the region.
Perhaps Mr. Biden, who is getting along in years, suffered a momentary lapse and uttered the ‘really true’ when he should have stuck to the officially true. Perhaps if Biden had lived in the Age of Sail, his mistake would not have caught up with him before his thought and perhaps his actions, ran to their ultimate conclusion. But in todays world the ‘officially true’ catches up with you long before you can respond to the actually true. If Judge Jenkins ever gets actually sick he can take comfort in the thought that, for the record, it could never officially be of Ebola.
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