Patterico's Pontifications

10/14/2014

Breach of Protocol? Try “No Protocol”

Filed under: General — Patterico @ 10:07 pm



This is a really good story — in the Los Angeles Times, of all places:

A Liberian man who arrived by ambulance at a Dallas hospital with symptoms of Ebola sat for “several hours” in a room with other patients before being put in isolation, and the nurses who treated him wore flimsy gowns and had little protective gear, nurses alleged Tuesday as they fought back against suggestions that one of their own had erred in handling him.

The statements came as Nina Pham, a 26-year-old nurse at Texas Health Presbyterian Hospital in Dallas, fought off the Ebola virus after contracting it from the Liberian, Thomas Eric Duncan. The statements by the Dallas hospital nurses were read by representatives of the Oakland-based group National Nurses United.

RoseAnn DeMoro, executive director of National Nurses United, said the nonunionized Texas nurses could not identify themselves, speak to the media independently or even read their statements over the phone because they feared losing their jobs. In a conference call, questions from the media were relayed to the unknown number of nurses by National Nurses United representatives, and the responses were read back to reporters.

DeMoro said all of the nurses had direct knowledge of what had transpired in the days after Duncan arrived at the hospital on Sept. 28.

I wish I could excerpt more; just go read it all. The whole story is devastating. In addition to the issues discussed in the first paragraph, we are told that Duncan’s lab specimens were sent through a common tube system and could have contaminated numerous other samples. One notable quote:

There was no advanced preparedness on what to do with the patient. There was no protocol; there was no system.

I will remind you once again what the Full-Time Golfer/Liar said on September 16:

In the unlikely event that someone with Ebola does reach our shores, we’ve taken new measures so that we’re prepared here at home. We’re working to help flight crews identify people who are sick, and more labs across our country now have the capacity to quickly test for the virus. We’re working with hospitals to make sure that they are prepared, and to ensure that our doctors, our nurses and our medical staff are trained, are ready, and are able to deal with a possible case safely.

I told you: these people lie like most people breathe.

UPDATE BY PATTERICO: Another double post.

50 Responses to “Breach of Protocol? Try “No Protocol””

  1. Do I really get to say “ding” first???

    “Ding!”

    reff (4dcda2)

  2. unexpectedly…

    redc1c4 (269d8e)

  3. and the nurses who treated him wore flimsy gowns and had little protective gear, nurses alleged Tuesday as they fought back against suggestions that one of their own had erred in handling him.

    If they weren’t wearing proper gear, then isn’t it a contradiction for them to also claim they didn’t err in the way they approached and dealt with Thomas Duncan? Things aren’t adding up correctly in this particular instance.

    What a mess.

    Welcome to Obama’s America 2014.

    Mark (c160ec)

  4. they likely wore what they were told to wear…and what was available from Central Supply.
    you can’t use what isn’t available.

    also, when was the definitive diagnosis of Obola made?

    redc1c4 (cf3b04)

  5. Why accept the word of a union rep who doesn’t even represent the nurses in question?

    Even before Ebola, most major city hospitals have those suits on hand for the potential virulent cases, at least since SARS. And the CDC Director apologized for saying the nurse/staff breached protocol, admitting he had no knowledge that they did or how she was infected. Odd, if the union rep is telling the truth.

    Lies from Obama and the CDC have been unremitting, but it would be premature to assume this is one of them.

    Estragon (ada867)

  6. It would appear Duncan’s extended family are out of the woods.

    Thank Heaven.

    gary gulrud (46ca75)

  7. i’ve w*rked in a few hospitals here in Lost Angels over the years, and if any of them had these suits, it’s news to me.

    i was even involved in disaster response for some of them, and they would have been a subject of conversation.

    the only thing that even came close was the head gear worn by the joint replacement teams, and a few others, but they are a far cry from RACAL suits

    redc1c4 (b340a6)

  8. this would be funnier if it wasn’t so true:

    $500 million Obola research facility found in #Failifornia

    redc1c4 (b340a6)

  9. I am willing to bet that even though the hospital administrators didn’t want to isolate him, or even admit him, none of them ventured down to get a close look at the patient.

    Kevin M (b357ee)

  10. If only IRS IT workers would be so bold.

    Kevin M (b357ee)

  11. I agree with you that the national Democratic Party post-1990 has been sociopathic by default (and this administration just amazes with the brazenness), but labor meatheads are no more trustworthy than paid flacks, so I would not give this woman’s words any weight.

    Art Deco (ee8de5)

  12. Uh-huh.
    I surmised yesterday that these protocols were like ISO9000 processes: developed in a vacuum with no coordination with the actual workers, and kept in a shiny display case outside the boardroom, away from the grubby eyes of those who are supposed to be following them.
    I wouldn’t be the least bit surprised if actually following the official protocols, even if the workers knew what they were, turned out to be flat-out impossible.
    But in principle they’re perfect.

    Eric Wilner (3936fd)

  13. A second health care worker per thi found at the link above:
    http://twitchy.com/2014/10/15/uh-oh-second-texas-health-care-worker-tests-positive-for-ebola/

    MD in Philly (f9371b)

  14. Did you read the link, Estragon? It says the nurses came to the union rep because they were upset that officials blamed nurse Nina Pham for her Eola infection. The nurses aren’t even union members but they went to the union because they want anonymity.

    DRJ (a83b8b)

  15. I will remind you once again what the Full-Time Golfer/Liar said on September 16:

    In the unlikely event that someone with Ebola does reach our shores, we’ve taken new measures so that we’re prepared here at home. We’re working to help flight crews identify people who are sick, and more labs across our country now have the capacity to quickly test for the virus. We’re working with hospitals to make sure that they are prepared, and to ensure that our doctors, our nurses and our medical staff are trained, are ready, and are able to deal with a possible case safely.

    I told you: these people lie like most people breathe.

    Gee. Where have I read Obama lying about having done everything humanly possible to prepare for a predictable disaster before. Oh, that’s right, almost two years to the day prior to the above.

    http://www.whitehouse.gov/the-press-office/2012/09/10/readout-president-s-meeting-senior-administration-officials-our-prepared

    The White House

    Office of the Press Secretary

    For Immediate Release September 10, 2012

    Readout of the President’s Meeting with Senior Administration Officials on Our Preparedness and Security Posture on the Eleventh Anniversary of September 11th

    Earlier today the President heard from key national security principals on our preparedness and security posture on the eve of the eleventh anniversary of September 11th. Over the past month, Assistant to the President for Homeland Security and Counterterrorism John Brennan has convened numerous meetings to review security measures in place. During the briefing today, the President and the Principals discussed specific measures we are taking in the Homeland to prevent 9/11 related attacks as well as the steps taken to protect U.S. persons and facilities abroad, as well as force protection. The President reiterated that Departments and agencies must do everything possible to protect the American people, both at home and abroad.

    If you adopt as a working assumption that Barack Obama hates and despises Americans and has complete contempt for us and our lives, as I have, then you can generally predict his course of action in every situation.

    It’s why the Norwegians gave him a preemptive Nobel peace prize.

    Steve57 (4d34f4)

  16. The Dallas Morning News has published the text of the nurses’ statement.

    DRJ (a83b8b)

  17. “preparedness” is merely a buzzword used by politicians and beaurocrats. It means very little in reality.

    Rorschach (61bf43)

  18. True, DRJ.
    I think estragon’s point was that in this day and age, anonymous reports need to be looked at in the context of who is doing the reporting and what agendas they may have.
    It is entirely possible that feeling there is no place else to turn, some nurses from Dallas contacted some group based in CA. It is also possible that a pro-union group might stoop to “disease hustling”, just as some do “race hustling”, adding more smoke than light for secondary gain.
    My guess is that some of both are true.

    MD in Philly (f9371b)

  19. Thread on the second health care worker testing positive here.

    Patterico (9c670f)

  20. I think the blame game here is pathetic and stems from living in a society where even an ongoing crisis is highly politicized by everybody. Union vs Dem admin is amusing but still pathetic.

    It’s too bad there isn’t a private sector solution to epidemic diseases. We’ll need government for that. Inevitably they are going to screw it up a lot, because that’s how it goes. A few people will surely die before they get their act together, at best. There is no government solution that is smooth, except with discipline (like in the military) that we don’t seek in most government agencies.

    Sure, the CDC would be more effective if 90% of their make-work was eliminated. That’s a given for the entirely of the federal government. But either way, nurses will make mistakes and protocols will be imperfect. I doubt we totally understand how this strain is spread anyway, and it’s not like it’s the only disease out there.

    Prayer helps. These days that sounds like hopelessness, but it really isn’t.

    Dustin (801032)

  21. At what point do we bring in the unthinkable measures? I said in the thread when Emory brought in the doctor and his assistant to Atlanta – if Ebola -(which can be transmitted airborne and can gestate for much more than 21 days) ever made it to an urban area – its going to spread like wildfire – these two nurses had protection and awareness – think of the thousands, millions that don’t – there isn’t enough medical supplies to treat even 5 million people at once in the united states so at some point when the first case OUTSIDE the hospital and immediate family is discovered – the unthinkable has to be considered – with the long gestation period and no real means to screen the disease.

    Dallas airports roads schools and business’s need to be shut down for 30 days food supplys brought in – got to inconvenience 2 million to save 200 million

    EPWJ (c12453)

  22. At what point do we bring in the unthinkable measures? I said in the thread when Emory brought in the doctor and his assistant to Atlanta – if Ebola -(which can be transmitted airborne and can gestate for much more than 21 days) ever made it to an urban area – its going to spread like wildfire – these two nurses had protection and awareness – think of the thousands, millions that don’t – there isn’t enough medical supplies to treat even 5 million people at once in the united states so at some point when the first case OUTSIDE the hospital and immediate family is discovered – the unthinkable has to be considered – with the long gestation period and no real means to screen the disease.

    Dallas airports roads schools and business’s need to be shut down for 30 days food supplies brought in – got to inconvenience 2 million to save 200 million

    EPWJ (c12453)

  23. But right now the reserve army needs to be put on alert –

    EPWJ (db4127)

  24. Open borders is positively wunnerful for business.

    Bring out yer dead!

    gary gulrud (46ca75)

  25. 20. …It’s too bad there isn’t a private sector solution to epidemic diseases. We’ll need government for that.

    Dustin (801032) — 10/15/2014 @ 6:39 am

    ?!?!

    http://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

    …Pre-Clinical Stage

    Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke an immune response. Animal subjects may include mice and monkeys. These studies give researchers an idea of the cellular responses they might expect in humans. They may also suggest a safe starting dose for the next phase of research as well as a safe method of administering the vaccine.

    Researchers may adapt the candidate vaccine during the pre-clinical state to try to make it more effective. They may also do challenge studies with the animals, meaning that they vaccinate the animals and then try to infect them with the target pathogen. Challenge studies are never conducted in humans.

    Many candidate vaccines never progress beyond this stage because they fail to produce the desired immune response. The pre-clinical stages often lasts 1-2 years and usually involves researchers in private industry.

    IND Application

    A sponsor, usually a private company, submits an application for an Investigational New Drug (IND) to the U.S. Food and Drug Administration. The sponsor describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study. An institutional review board, representing an institution where the clinical trial will be conducted, must approve the clinical protocol. The FDA has 30 days to approve the application.

    Once the IND application has been approved, the vaccine is subject to three phases of testing….

    “Needing government” for this sort of thing is the exception. Not the rule. And true to form the private sector is leading the way to finding a solution to this epidemic disease:

    http://www.cbc.ca/news/health/ebola-outbreak-canadian-company-says-its-vaccine-looks-promising-1.2746313

    Four monkeys survived the Ebola virus after being injected with a vaccine that included Immunovaccine Inc’s technology, the tiny Canadian company said on Monday, and the announcement sent its stock soaring.

    The Halifax, Nova Scotia-based company said four monkeys received the vaccine and later survived a dose of Ebola virus that normally would have been lethal. Two other animals that did not receive the vaccine died within a week…

    Where did you get this impression that is 180 degrees out from reality, Dustin? The same PR flacks from the government agencies who said “don’t worry, be happy” because they were on top of everything?

    And I’m not just talking about the CDC, the NIH, nor am I just talking about disease outbreaks.

    Steve57 (4d34f4)

  26. 1. We’re talking here and now. There is nobody in a position, outside government, to stop this.
    2. Ebola has been known at least since Dustin Hoffman made a movie about it and I know of no law that made it illegal for private industry to find a vaccine.

    Dustin is fully on course on reality.

    nk (dbc370)

  27. nk

    There is no vaccine and many have tried

    EPWJ (db4127)

  28. nk @26, no, he’s not.

    1. The government has a role in stopping the spread of infectious diseases like Ebola. But the government is refusing to perform its role. Which in the past was controlling the spread of disease through measures like quarantine. No one outside government has the power to do that. And the government won’t do it. It is however complaining its budget isn’t big enough to usurp the private sector’s role in stopping the spread of infections diseases like Ebola. As long as government agencies refuse to do what only the government can do, and lobby for a larger budget so it can do what those outside of government can do far more efficiently then those government agencies are destroying their justification to exist.

    2. No one has made it explicitly illegal for a private company to find a vaccine for anything. But governments, particularly this government, have gone a long way down the road to effectively do exactly that. See Mike K’s comment here:

    http://patterico.com/2014/10/13/nih-we-could-have-developed-an-ebola-vaccine-but-for-budget-cuts/#comment-1695548

    15. The vaccine story should be that the Clintons decimated the vaccine industry in the 90s. They took over the production and distribution with a single source and price cuts that caused many companies to go out of the business. The following from 2003…

    You might as well point out that no one has made opening a coal-fired power plant illegal. But someone (guess who) has gone a long way to deliver on his promise to bankrupt you if you do. When you start experiencing rolling brown outs and blackouts are you going to blame the private sector for failing to meet the energy demand because no one made building power plants explicitly illegal? After all the government stopped short of that and just made it economically suicidal.

    3. You can’t be on course with reality if you don’t account for it.

    Steve57 (4d34f4)

  29. #26, nk: And the tools that the government can use effectively are pretty much all related to quarantine and the collection of information. As the Kelly interview so clearly demonstrated, the CDC Director is absolutely fixated on the idea that he knows everything he needs to know, and thus he is certain his efforts will be effective. So the collection of information will be limited to those anecdotes supporting his preconception of the problem, difficulties will be blamed on subordinates who didn’t “follow protocol”, and to top it off, he has ruled out quarantine.

    If you are correct in your thesis that only government can save us, we are screwed.

    bobathome (5ccbd8)

  30. That’s because, at this point, we have a bad government. Erections* have consequences.

    *Not a typo. If only Stanley Ann Dunham had insisted on a condom.

    nk (dbc370)

  31. nk, my point is that in situations like this bad government is worse than no government. There is no solution to something like an epidemic that is 100% public sector or 100% private sector. At least, there isn’t as long as government were willing and able to play a constructive role, instead of being hell bent on screwing up the response of both the public and private sector (the latter through its misuse of its power to tax and regulate).

    Steve57 (4d34f4)

  32. Steve, you are correct that medicine and vaccines are best developed in the private sector, but you are mistaken to think that’s where we should turn today with this type of problem. That’s an organic thing that society should best not interfere with. AKA Government shouldn’t get in the way. And even then, when a disease like this is cured or a great vaccine is developed that is practically if not actually a miracle. I don’t bank on that happening.

    As nk said, I’m talking about the here and now. We do need a center for disease control. We need government. It’s going to be inefficient by nature.

    Dustin (801032)

  33. bad government is worse than no government.

    It’s funny how this is almost exactly the opposite of what I am saying.

    All government is necessarily kinda bad, yet better than nothing. We need a government, but would be foolish to plan for an efficient one. That doesn’t mean one isn’t less corrupt than another, but by nature it’s going to be a bit of a cluster____. Elections have consequences, yet I suspect partisanship blinds us to their limitations.

    Dustin (801032)

  34. 15. 26.

    That’s talking about existing vaccines.

    New vaccines are even worse.

    http://www.businessweek.com/articles/2014-09-24/ebola-drug-zmapps-development-delayed-by-pentagon-agency

    “For things like Ebola, there is no clear buyer other than the government,” says Thomas Inglesby, the director of the Center for Health Security at the University of Pittsburgh Medical Center who’s advised three White Houses on biosecurity issues. Normally, he notes, market potential “pulls” a drug forward. With relatively rare tropical diseases, “you basically have to start and finish that process” within the government, “because there is no other buyer in the world.”

    And the government doesn’t pay enough to make pushing something through the FDA drug approval process worthwhile.

    So – Congress created:

    BARDA the Biomedical Advanced Research and Development Authority, whose job it was to get things through the FDA drug approval process.

    But it didn’t get enough money or contracting freedom to overcome FDA regulations.

    Pharma companies generally spend about a billion dollars to get a single drug from idea to FDA license. “Look at $100 million for Barda,” says [Robert] Kadlec, referring to the agency’s annual budget. “We’ve been operating literally on dimes when they need dollars.” In the last months of the Bush administration, he says, he persuaded the president to propose an appropriation of $900 million. Unlike almost every other pet project in Washington, it didn’t make it into the 2009 stimulus bill.
    Sammy Finkelman (6f9c3d)

  35. Dustin, the here and now is that we don’t have an inefficient government. It’s pretty efficient at being malevolent.

    The private sector will develop a vaccine before this government stops deliberately working against us. At one time that would have been the private sector in the US but that was before the government put it out of business.

    Steve57 (4d34f4)

  36. Steve, you really think that an AbbVie CEO is more socially responsible and less scared of the quarterly P&L than a CDC official when it comes to spending a billion on a drug that will bring in a few million if they’re lucky, and luck means an outbreak like this? Ok, then.

    nk (dbc370)

  37. nk, do you really think that the CDC official has any more reason to be “socially responsible” than a corporate CEO? Ok, then.

    Steve57 (4d34f4)

  38. #36, nk: You presume that a CDC official is capable of creating an effective drug. I’ll grant that it might be possible for the CDC to set up a contractual situation where a competent private sector entity, or entities, could develop something, but simply giving the CDC $1B would be just another PR gesture. In WWII FDR had the good sense to recruit top Detroit executives to figure out how to mass produce our armaments. These men weren’t necessarily engineers, but they knew how the process worked, and they knew where to apply the right sort of incentives and what was feasible. The drones in the government have opted out of that portion of our economy, and about all you can expect of them is to use a list of Democrat donors to divvy up the cash.

    bobathome (5ccbd8)

  39. http://pjmedia.com/victordavishanson/from-comedy-to-farce/2/

    Why such farce? We have forgotten two truths about the Obama administration. No president in recent memory has so hectored the American people on the dangers of elites, and no president in the last half-century has so enjoyed the perks and culture of the elite. Unfortunately, this is not just mindless hypocrisy, but rather calibrated medieval exemption: the more Barack Obama berates the high life of others, the more he feels he deserves it for himself.

    Clearly, people who go into government so they can vote to give themselves raises and expensive perks at taxpayer expense (and those who work for them in bureaucracies so they too can have taxpayer-provided six figure salaries, luxury jets at their disposal [You didn’t think Eric Holder should have to pay for an airplane ticket to transport his daughters and their boyfriends to sporting and entertainment events around the country like you lesser beings, did you, peasant?] and Capitol Hill mansions) have higher and purer motives than those who are so base as to have a profit motive. Ick.

    Steve57 (4d34f4)

  40. bobathome (5ccbd8) — 10/15/2014 @ 8:20 am

    simply giving the CDC $1B would be just another PR gesture.

    $1 billion is only enough to get one drug (or vaccine?) thriouygh the FDA drug approval process.

    But if you gave them $15 billion, simply by chance, something they would do would be right, or good enough.

    Sammy Finkelman (6f9c3d)

  41. #40, Sammy: I think you’re on to something here. Aunt Yellen is concerned about ending QE, and this could be its replacement. But why settle for $15B, follow Krugman and make it $2T. And then you could require the recipients to be unemployed. Pelosi assures us that we will get a 2-fold return meaning that the economy would log a $4T jump in GDP. And with all that money sloshing around, surely someone would discover a cure. It’s like 200 monkeys with typewriters right?

    bobathome (5ccbd8)

  42. redc1c4 (cf3b04) — 10/15/2014 @ 12:48 am

    also, when was the definitive diagnosis of Obola made?

    The hospital lied about that, too. It was September 30, not September 29, and only because a member of Duncan’s family had insisted that the CDC be called in Atlanta (or maybe called themselves)

    The CDC person on the other end of the telephone line went through a screening questionnaire, and found that Duncan qualified for an ebola test, and he was tested, and when the results came back positive, he was diagnosed with ebola.

    Sammy Finkelman (6f9c3d)

  43. bobathome (5ccbd8) — 10/15/2014 @ 8:52 am

    It’s like 200 monkeys with typewriters right?

    Well, no, that wouldn’t get you anything.

    It’s that, with so much money being handed out, somebody who wanted to do some good and who also knew what he was doing, would get some of the money, while if they had to prioritize things, the money would go to all of the wrong people.

    Sammy Finkelman (6f9c3d)

  44. #43, Sammy: That sounds like a plan! Just find someone who wants to do some good. Only difficulty I can see is that all the wrong people would take a very serious interest in the handing out process. But by all means, proceed! Maybe Zuckerman and Gates could fund your plan?

    bobathome (5ccbd8)

  45. From Breitbart:

    A statement from National Nurses United on the treatment of Dallas Ebola patient said that “nurses were asked to call the Infectious Disease Department” to learn the policies on how to treat Duncan.

    The statement, which was played in its entirety on CNN on Wednesday morning, also reports that Ebola training at the hospital was “optional,” “nurses have been left to train each other,” and that nurses who interacted with Duncan simply continued treating other patients.

    According to the statement, “there was no advanced preparedness on what to do with the patient. There was no protocol, there was no system. The nurses were asked to call the Infectious Disease Department. The Infectious Disease Department did not have clear policies to provide either.”

    So there was not breach of protocol, there was none.

    Hoagie (4dfb34)

  46. Hoagie (4dfb34) — 10/15/2014 @ 9:10 am

    So there was not breach of protocol, there was none

    There may have been a breach of protocols the CDC recommended. The breach,, however, may have bene committed not by the nurses, but by the hospital.

    Sammy Finkelman (6f9c3d)

  47. bobathome (5ccbd8) — 10/15/2014 @ 9:04 am

    Maybe Zuckerman and Gates could fund your plan?

    They should. But they don’t try getting things licensed. They are only interested in- or Gates is anyway, low tech things that don’t require anyone to take a leap of faith and try it.

    What’s needed is not so much original research, as translating that into action. You really philanthropists for this thing. It doesn’t make senswe for companies, and governments just stand in the way, that’s all.

    But it’s not even that.

    What about giving ebola patients statins, and seeing of that works, and if so, when?

    Sammy Finkelman (6f9c3d)

  48. #47: Sammy: The problem as you define it is the excessive cost of licensing the drug, say $1B. How about eliminating 95% of this process? Does it really protect us? Probably not. A lot of the analysis is focused on comparing the new drug to existing drugs, and then denying approval if the improvement isn’t significant. Even if the drug is effective. This is nonsense. And the “gold standard” of the double blind test using large populations is crazy. There used to be a field of study that was called decision making under uncertainty. It used Bayesian methods to wrap up all the elements of the problem in one consistent methodology. The FDA never appeared to understand the usefulness of such techniques, particularly for small sample problems.

    bobathome (5ccbd8)

  49. A CDC epidemiologist talks about how Texas Presbyterian hospital tried to control infection:

    The hospital that treated Ebola victim Thomas Eric Duncan had to learn on the fly how to control the deadly virus, adding new layers of protective gear for workers in what became a losing battle to keep the contagion from spreading, a top official with the Centers for Disease Control and Prevention said Tuesday.

    “They kept adding more protective equipment as the patient [Duncan] deteriorated. They had masks first, then face shields, then the positive-pressure respirator. They added a second pair of gloves,” said Pierre Rollin, a CDC epidemiologist.

    I guess the CDC is also learning from its mistakes:

    CDC Director Thomas Frieden expressed regret Tuesday that his agency had not done more to help the hospital control the infection. He said that, from now on, “Ebola response teams” will travel within hours to any hospital in the United States with a confirmed Ebola case. Already, one of those teams is in Texas and has put in place a site-manager system, requiring that someone monitor the use of personal protective equipment.

    “I wish we had put a team like this on the ground the day the first patient was diagnosed,” he said. “That might have prevented this infection.”

    DRJ (a83b8b)

  50. bobathome (5ccbd8) — 10/15/2014 @ 9:32 am

    The problem as you define it is the excessive cost of licensing the drug, say $1B. How about eliminating 95% of this process? Does it really protect us? Probably not.

    But get them to admit it.

    A lot of the analysis is focused on comparing the new drug to existing drugs, and then denying approval if the improvement isn’t significant. Even if the drug is effective. This is nonsense.

    Such drugs may be pointless and maybe even more likely to have worse side effects, and they’ll charge more. A lot of new drugs may be like that, and that’s a problem, but that’s not where the loss is.

    The loss is where there is nothing else quite like it.

    The New York Post had an op-ed article on Friday by Robert Goldberg who publishes a website about drugs or treatments that could be given but aren’t.

    http://nypost.com/2014/10/16/how-the-feds-block-ebola-cures/

    Here it is on Lucianne Goldberg’s website:

    http://www.lucianne.com/thread/?artnum=805857

    He notes that, back in 2008, a company, Synthetic Genomics, sequenced the genes of every variety of meningitus, and engineered a vaccine against it. (and I think he is saying this can be done now with any virus – quickly. The main real worry I think might be stimulating an auto-immune reaction, but you can figure out a way to test out for that kind of problem.)

    In Europe and Canada and Australia this reverse-engineered 2008 meningitis vaccine was approved for use in children in 2010.

    Maybe four years later it still hadn’t been approved in the United States. When a meningitus outbreak hit Princeton University and UC-Santa Cruz, the FDA gave special permission for it to be used this year.

    With Ebola the FDA ordered the company making ZMapp to stop testing it in July, just as the epidemic was beginning (and they did that with the Canadian treatment too – both of which I think are probably much less good than what you could do, and have really gotten so far not because they are the best ideas but because they could be patented. I mean ZMapp is nothing but a Rube Goldberg process for producing ebola antibodies, but because it is such a Rube Goldberg process, it can be patented, and the FDA will prevent anything simpler from being done till somebody pays for approval.)

    Here is Robert Goldberg’s website:

    I think he’s a little bit, even a lot, too enthusiastic about a few cures or approaches, and he doesn’t understand the half of what’s being lost. You have to compare the situation now with the kind of medical progress that was made before 1950 to really understand what’s going wrong.

    valueofinnovation.org/

    We are using 20th-century approaches to evaluate 21st-century medicine. We must change how we develop and approve life-saving innovations

    That’s not the half of it anyway, although it is true that the FDA rejects shortcuts. But that’s only one little thing, although that itself may be something of a big thing, in that years could be cut from conception to approval.

    We don’t need faster FDA approval. We need to have an ability to bypass it. And that’s true, even though some mistakes may be made.

    And I will say again, we may not able to tolerate this nonsense without sustaining a great deal of unnecessary suffering if any kind of new disease hits, or if antibiotic resistant organisms proliferate.

    But I don’t know of any politicians that might have any inclination to take this up, or the slightest glimmer that this is real problem, with the possible exception of Governor Moonbeam.

    Sammy Finkelman (c2bb62)


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