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For those of us in unaffected countries, are you concerned about the ebola virus spreading? Would you care for ebola patients? I live in an area with a very high density of African immigrants and come into contact with these individuals regularly. We have a lot of African immigrants who bring back tuberculosis from their home countries and at my unit we end up caring for them. We take care of a lot of rare infectious diseases. I was reading an article and it dawned on me how plausible it would be for me to encounter this virus. And I admit, it's terrifying and I might refuse that assignment. Many healthcare workers in Africa are dying because of caring for the ill.
I understand the concern but thalimide by the germans became popular for tx of aniexty,morning sickness, not really life threatening conditions. It also actualky became an OTC drug ans way widely used. Yes terrible side effects. But with tjhis ebola we need to release it and fast. This virus is a rapid RNA type. Which replicates very quick and has a strong consequence of mutation. If we can try to eradatate this pathogen quick as we can before it crosses into worse adaptability and mutation. Afterall there are cases of ebola in primates that have crossed in airborne transfer, and even this stria. Ebola azaire,has already made some drastic mutations. Ebola has been deemed a public enemy. No lawyer should be permitted to chase these cases. I dont know who can authorize this drug to be used without lefgal implications. But its time to allows waivers. Like i sacid in an earlier post. What this pathogen and its behavior is now may be much different tomorrow!!!
What do you think of this? Texas CNA family is quarantined, but he is allowed to come and go, to work, as a CNA. While he lives with family, and they appear sick.
I understand the concern but thalimide by the germans became popular for tx of aniexty,morning sickness, not really life threatening conditions. It also actualky became an OTC drug ans way widely used. Yes terrible side effects. But with tjhis ebola we need to release it and fast. This virus is a rapid RNA type. Which replicates very quick and has a strong consequence of mutation. If we can try to eradatate this pathogen quick as we can before it crosses into worse adaptability and mutation. Afterall there are cases of ebola in primates that have crossed in airborne transfer, and even this stria. Ebola azaire,has already made some drastic mutations. Ebola has been deemed a public enemy. No lawyer should be permitted to chase these cases. I dont know who can authorize this drug to be used without lefgal implications. But its time to allows waivers. Like i sacid in an earlier post. What this pathogen and its behavior is now may be much different tomorrow!!!
Actually, you will find that Thalidomide, while released early in Europe but was never cleared by FDA for use in the USA. The head of the FDA at that time was under pressure to release it, but declined to so, even though some Americans brought it in from trips to Europe, and used it until the connection to severe birth defects.
Second, as ZMapp is an experimental drug that has not even indicated whether phase one testing has begun. Which means we have very little data of whether it works, appropriate/safe dosing. It is a pipeline drug. And while, due to the rarity of the disease, the FDA in conjunction with a company,may release limited Amts for use (which it has) in controlled circumstances. Then there is assessment of results. While I do not know the total number of recipients, it is widely know that several have died, regardless of receiving it. I presume that the FDA and the company are trying to see if there were improvements in condition of pts that had similar situation vs those that did not get the drug, while they produce more. The drug is not very useful if it doesn't improve things vs not receiving the drug in pts with similar levels of disease. Given the number of deaths among those that receive the drug, it may not be effective.
It is also interesting that mention mutation. Mutation is going to occur regardless. Viruses are never cpmpletely disappear and many do mutate. Giving a drug that is not that effective for that disease may just creat a carrier state. But also allow a disease to become resistant. Though I have not seen that occur much with monoclonal antibodies.
Which brings to the next issue. Monoclonal antibodies are not something that can be produced rapidly or easily. When research has proven successful with one, then you setup production lines. There would not likely a production line for an experimental monoclonal antibody for a what has been a limited illness. It is also quite expensive as well as time consuming to produce monoclonal antibodies. So even one wanted to, there is no way to suddenly ramp up production, no matter how we need it.
And while I am not familiar with ZMapp specifically, I am very familiar with administering monoclonals. They can cause severe reactions. While we in the first world (who have access to better hygiene, safer hospitals ) can probably handle and afford this drug, many pts in the third world with ebola do not. This is one of the reasons for the lower mortality in some areas vs others - better basic supportive care.
The time to have worked heavily for vaccines/treatments for Ebola was over the last 40 years. There have been numerous outbreaks on regular basis. But until threatens the USA or Europe , no one really cared. CDC has worked toward, but budgets at the CDC and NIH have been repeatedly cut. Several presidential candidates have threaten to close the CDC, saying that private companies would take care of these issues (really!).
I would love to see this drug and others to get clearance for use, and be rapidly produced. But I do not foresee it. There have been very IV antibiotics, electrolytes and several chemos that have been on the shortage list for 3 months to several years, because of limited production. IV saline for infusion was on shortage because of production. If we as a nation cannot adequately these needs taken care of, how can one expect immediate production of experimental monoclonal antibody?
how do you know it was noted in the triage? People (and media) can say all they want, but until we see the documents, it is all speculation. None of us have seen the triage, as per privacy laws, obviously. All over the news, the hospital is stating "it wasn't communicated to the provider" - EVEN if it wasn't noted in triage, the DOCTOR is responsible for their history and physical, AS WELL as the discharge plan.
Because that is what the hospital said themselves.....
Add in that ZMapp is a monoclonal antibody. These are difficult to produce and can provoke severe hypersensitive reactions.
I'm familiar with Rituxan. I work Onc and it's given frequently with our chemo regimens. Serious reactions are still fairly rare and rigors can often be remedied by slowing the infusion and giving Demerol.
Texas Ebola patient's friend has been told he can return to work as nursing assistant | Daily Mail OnlineWhat do you think of this? Texas CNA family is quarantined, but he is allowed to come and go, to work, as a CNA. While he lives with family, and they appear sick.
I am skeptical of this story....
Because that is what the hospital said themselves.....
That is called CYA. Politicians, large corporations, and government bodies will say anything to cover what is really going on, to prevent panic or widespread fear.
Working in an ER and knowing how it operates, as well as management, it is a very telling story and one that needs to be told. The miscommunication and lapses in judgement are what occurs daily. Physicians need to be paying attention to their front line nurses. Regardless of what happened here, this is a wake up call.
caroladybelle, BSN, RN
5,486 Posts
The drug in question, per my understanding is a pure research drug. I could be wrong but my understanding is that it is not approved by the FDA or other such regulatory groups, and is not yet far enough in the testing process, that it should or could be used in any widespread manner, much less be produced in any large amounts. Add in the extreme legal risks and ethical breaches that company would take on, by attempting any major distribution of an inadequately tested drug.
Add in, if something does go wrong, the drug has seriously problematic issues, there will be outrage for "experimenting" on a population at need.
Even drugs that are administered "per compassionate use" have gone through significant testing prior to that being permitted. And there are very strict ethical standards to be followed when doing. Pts are often desperate, reaching for anything that may save them. They often will beg for a drug or surgery regardless of known and unknown risks. At times, it may be very inappropriate or less than ethical that to do a treatment on someone that is reaching out of desperation, and the HCW has to say no because of some or all of these issues.
Add in that a great deal of money goes into these drugs, and often the drugs need to be tweaked or altered several times in testing phases due to unexpected side effects. The drug may pulled back and altered.
Forcing the drug out on the market, without adequate, appropriate testing, and having something go wrong, and the company may have shelve the drug just because of legal issues and extremely bad PR. If you have doubts, just google Thalidomide, a drug that is very helpful now, but was for the most part pulled from the market for several issues, that arose from putting it to market too early in Europe.
I know that people often believe that what does it hurt to use drugs for almost any for compassionate use, but that that can be a big minefield to navigate, and there generally won't be amounts of the drug available in any large amounts as there would not be equipment or personnel to produce adequate amounts until the drug is in final stages of approval when the company knows that drug will go to market. You cannot increase production for something, when likely there is no "production line".
And yes, the drug also will most likely be extremely expensive.
Amarket