Effect Measure

I first read Barbara Ehrenreich in 1971 when she wrote The American Health Empire: Power, Profits, and Politics with her (then) husband John Ehrenreich (Health PAC, 1971). She was by then a PhD in cell biology (Rockefeller University) and anti-war activist. We traveled in the same circles and I knew her slightly at the time. Her next book, Witches, Midwives, and Nurses: A History of Women Healers (with Deirdre English) was a new reading of women in medical history. It was an influential text in the emerging women’s health movement. Since then she has published many books, several making the best seller lists and throughout an astute and still influential observer. Now she has penned a brief comment on the the alleged swine flu vaccine supply problem and who’s to blame. And I find myself in complete agreement with her:

In July, the federal government promised to have 160 million doses of H1N1 vaccine ready for distribution by the end of October. Instead, only 28 million doses are now ready to go, and optimism is the obvious culprit. “Road to Flu Vaccine Shortfall, Paved With Undue Optimism,” was the headline of a front page article in the October 26th New York Times. In the conventional spin, the vaccine shortage is now “threatening to undermine public confidence in government.” If the federal government couldn’t get this right, the pundits are already asking, how can we trust it with health reform? (Barbara Ehrenreich via Tom Dispatch)

We just heard this from alleged libertarian but anti-choice whack job, Ron Paul (who was right on the Iraq war, proving that even nut cases can get some things right). Her response?

But let’s stop a minute and also ask: Who really screwed up here — the government or private pharmaceutical companies, including GlaxoSmithKline, Novartis, and three others that had agreed to manufacture and deliver the vaccine by late fall? Last spring and summer, those companies gleefully gobbled up $2 billion worth of government contracts for vaccine production, promising to have every American, or at least every American child and pregnant woman, supplied with vaccine before trick-or-treating season began.

According to Health and Human Services Secretary Kathleen Sebelius, the government was misled by these companies, which failed to report manufacturing delays as they arose. Her department, she says, was “relying on the manufacturers to give us their numbers, and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy.”

This is not Ehrenreich’s attempt to hold the Obama administration blameless. Far from it. She points out that trusting in the word of Big Pharma, who wouldn’t have bothered with a flu vaccine if they didn’t think governments would give them a guaranteed market and with such a guarantee didn’t even have to bother to invest in any new technology, using eggs as they have done for half a century. Slow, tricky, inefficient, but who cares when you can invest capital plant in erectile dysfunction drugs?

Let the private insurance companies manage health financing; let profit-making hospital chains deliver health care; let Big Pharma provide safe and affordable medications. As it happens, though, all these entities have a priority that regularly overrides the public’s health, and that is, of course, profit — which has led insurance companies to function as “death panels,” excluding those who might ever need care, and for-profit hospitals to turn away the indigent, the pregnant, and the uninsured.

We have complained that flu planning under both the Bush and Obama administrations turned planning dogma on its head, from plan for the worst, hope for the best to plan for the best (that an effective vaccine will be produced in time and be efficiently deployed) and hope the worst won’t happen. We’ve called for regional international vaccine institutes to share the latest technologies under public licenses to supply the global need for vaccines. It could be done through intergovernmental agencies like WHO or UNICEF.

But we haven’t done that. We haven’t even thought about doing it. So the Bush and Obama administrations and both Republican and Democratic Congresses have put their faith and trust in the least humane and most untrustworthy vaccine source: the private sector.

If your flu symptoms become serious for more than four hours, call your doctor.

Comments

  1. #1 Speechless
    November 7, 2009

    As with most people, our society’s greatest strength is also one of our most severe weaknesses– American optimism has allowed us come up with creative solutions when we were in quandries which good sense would name hopeless. But of course such optimism is also a the root of much of the right wing reasoning that the playing field of the American economy is level, and all people have equal opportunity to succeed. It’s a great dream, a great vision — but (if you don’t read in more sinister reasons) it doesn’t square with the on the ground experience of many who struggle. — But I digress. Anyway, it’s hooray!! and boo, hiss!! for American optimism. It’s who we are as a people, most of us anyway. We know we should proceed with caution, but caution belongs to the scolds, and history to the victors. Those who survive the pandemic — and let’s hope that’s all of us!– will try to draw lessons from these mistakes and we’ll feel hopeful that next time, things will be different.

    Let’s hope so!

  2. #2 Catharine
    November 7, 2009

    Call me a conspiracy theorist but I have to say that I do believe that the only reason that my major medical institution is not making a serious effort to have all of our health care workers vaccinated is because if people actually wanted the vaccine, we wouldn’t have enough of a supply to make good on the promise (the promise that was made months ago – to offer the vaccine to every employee). It’s a good thing so many people are entirely motivated to act (or not) by superstition. Feh.

  3. #3 Kellie
    November 7, 2009

    If not something like this, what are all those Czar’s for?

  4. #4 Don S
    November 7, 2009

    Too easy.

    Big Bad Pharma indeed has much disincentive to invest in vaccines and is motivated by making money. And most years betting on demand for a flu vaccine is a huge gamble that many of them would rather not bet on. There are easier and less risky ways to earn their bread. But blaming them for our reliance on the old and our reluctance to accept new production technologies is political responsibility dodge ball.

    See http://online.wsj.com/article/SB10001424052748704335904574497324151841690.html?mod=googlenews_wsj for some of another perspective. Yeah, even the WSJ can nail it once in a while. As I’ve sourced earlier, Sebelius is misdirecting blame when she says they were not told early on – they were and the Feds poo-poo’ed Pharma’s warnings of production shortfalls. Pharma HAS invested mightily in new technologies American firms have developed cell culture techniques for pandemic flu and are ready to use them http://www.in-pharmatechnologist.com/Materials-Formulation/Cell-culture-H1N1-vacc-could-be-ready-in-3-months – but they could not get approval to use them HERE. And THAT is not Pharma’s fault but “ours”.

    Heck, even with the nasal vaccine the situation is made worse by “our” cloddishness. The vaccine virus grew great for them. Why do we not have more delivered? Because the manufacturer of the officially approved nasal squirt syringe couldn’t keep up and there was no emergency approval for using any other device that Medimmune could get their hands on.

    The EU also depends on Big Pharma to make vaccines yet they don’t have our degree of problems. Why? The answer – http://www.msnbc.msn.com/id/33731376/ns/health-cold_and_flu/

    “In Britain, there are no long lines of people seeking swine flu vaccine. Doctor’s offices aren’t swamped with desperate calls. And there are no cries of injustice that the vaccine is going to wealthy corporations or healthy people who don’t really need it.

    Here, and across most of Europe, vaccine to protect against the pandemic flu is mostly given by invitation only to those at highest risk for flu complications.

    “That is one of the great advantages of the British health system,” said Dr. Steve Field, president of the Royal College of General Physicians. … Field said Britain’s socialized health care system allows the country to target people who need to be vaccinated quickly: “It’s not like the U.S., where it’s the survival of the fittest and the richest.” … ”

    Indeed as a progressive my beef is not with Pharma – whose hands have been tied by an excessively timid approval process and regulators fearful of the Beck’s and Paul’s of the world spinning a “rushed through and untested experimental vaccine” – which they do ANYWAY – but with the timidity of a Federal system that is afraid to, or unable to, even STRONGLY SUGGEST, that the most needful must go first, instead of remaining completely deferential to the states to decide how to prioritize. Problem is that giving the Fed level any more power won’t help if they do not have the spine to use it wisely. (Still better than the mishmosh that is our current irrationing of resources …).

  5. #5 Dr Denise
    November 7, 2009

    Revere
    Thank you much. I just wanted to ask you to look at the link for the four hour flu comment, when I hit it it went to an ED remedy.
    Regards
    Denise

  6. #6 jay
    November 7, 2009

    conspiracy nonsense on both sides.

    I get really annoyed by these attempts by both the statists and the marketeers to mold something into an ideological argument.

    Vaccine, especially a new one, is not easy to mass produce. Lots of stuff goes wrong, production lots need to be scrapped, difficulties getting the virus to grow right, testing problems….

    Every one of those companies, I guarantee you, would have met their quota if they could… they had a guaranteed market and it would have really helped the bottom line. But reality is as it is… sometimes desire, or even throwing money is simply not enough.

    Get reality folks. The government asked for something that was impossible to achieve under current circumstances and the companies responded by promising more than they could actually do.

    Not everything is possible no matter how much money and will is behind it.

  7. #7 revere
    November 7, 2009

    jay: First of all, I agree with your main point. Just because you want or need something, doesn’t mean you can have it. The world is as it is.

    But somethings shouldn’t be left to the market and vaccines are one of them. I am happy to have impotence drugs and botox and the like left to the market. If it works, fine. If not, fine, too. But vaccines and orphan drugs in general are not fine to be left to the market and worse, we subsidize private enterprise to bribe them to do it (via publicly sponsored research and other means) and let them take a big cut and then find out it’s too little too late.

  8. #8 jay
    November 7, 2009

    Revere

    Agreed, time and logistics are a problem especially with vaccines. Flu vaccines are not really left to the market, however, the government agrees to buy so much to keep the production viable, which is fine. But if there is suddenly a demand that goes way beyond that, is that the fault of the manufacturers? or, for that matter, of the government? If it is determined that we need vaccine production capacity always available far beyond a typical year’s use, then the cost of that idle capacity has to be born somewhere.

    It’s not a matter of ‘bribing’ manufacturers. The government is saying we think this is necessary and worth spending what is necessary to make it viable.

  9. #9 revere
    November 7, 2009

    Don: I have been traveling and my non-flu/non-blog life especially demanding of late, so I confess not to have given your remonstrances the total attention they deserve considering the amount of intellectual and emotional energy you have put into them. Rather than apologize, I will only explain that’s the nature of the beast, but let me try to remedy some of it with this long reply. I do this only sometimes because of lack of time, but I think I owe you this. I’ll put some of your points in block quotes, interspersed with my reaction.

    Too easy.

    Let’s agree that the format doesn’t encourage nuance and complete treatments of some subjects that are highly ramified, complex and confusing. I am guilty of this (although considering the venue I don’t consider it a crime, just a circumstance), but I will also claim you are too, and try to make the case.

    Big Bad Pharma indeed has much disincentive to invest in vaccines and is motivated by making money. And most years betting on demand for a flu vaccine is a huge gamble that many of them would rather not bet on. There are easier and less risky ways to earn their bread. But blaming them for our reliance on the old and our reluctance to accept new production technologies is political responsibility dodge ball.

    So we agree that Big Pharma is not the ideal vehicle to make vaccines. It isn’t a question of blaming them for not being innovative, however. It is a matter of explaining their lack of innovation. As your next point shows, innovation has barriers of all kinds to overcome (after all, it’s “new” and must gain acceptance of all kinds, both regulatory and market). So on to your next point, which involves the regulatory apparatus, at least to some extent.

    See http://online.wsj.com/article/SB10001424052748704335904574497324151841690.html?mod=googlenews_wsj for some of another perspective. Yeah, even the WSJ can nail it once in a while. As I’ve sourced earlier, Sebelius is misdirecting blame when she says they were not told early on – they were and the Feds poo-poo’ed Pharma’s warnings of production shortfalls. Pharma HAS invested mightily in new technologies American firms have developed cell culture techniques for pandemic flu and are ready to use them http://www.in-pharmatechnologist.com/Materials-Formulation/Cell-culture-H1N1-vacc-could-be-ready-in-3-months – but they could not get approval to use them HERE. And THAT is not Pharma’s fault but “ours”.

    I think a re-reading of my post will indicate we are in agreement here, except for a (factual but unresolved disagreement) about how much and what the companies really told CDC and HHS. The WSJ piece is interesting in two ways. First, it makes points we have made here repeatedly. We favored adjuvants (and took a lot of heat for it), but there are some important issues that have to be faced. There is a powerful antivax movement who would have loved to see an adjuvant in the flu vaccine (and even now lie that the vaccine contains adjuvant to serve their purposes). We would be arguing about adjuvants while people died because they were afraid to be vaccinated. And it is the case that regulations on the books do require appropriate testing for safety and efficacy. There is not time to do this in a pandemic. It is clear that the Europeans are meeting considerable resistance with their vaccine programs on account of adjuvants (as are the Canadians). As for the UK being able to do things we can’t because they have a NHS, I couldn’t agree more. We don’t have that system (I am a strong single-payer advocate but what I think doesn’t seem to matter to Congress, and it isn’t because doctors and the public disagree but because they are being unduly swayed by drug and insurance companies). The second reason the WSJ piece is interesting is that it presents Big Pharma’s view (Gottlieb is essentially a Pharma lobbyist, although he doesn’t list it as such). They don’t want to be regulated and this Op Ed is their attempt to use swine flu to bolster their arguments. If they convince Congress or the FDA to loosen regulations, they won’t use their freedom to make vaccines but to make to high volume drugs like Vioxx or Viagra.

    Cell culture techniques are in clinical trials. These trials are complicated to do and can’t be done over night. They have been underway for some time. They just aren’t ready yet, and the acceptance of cell culture techniques would by problematic in this anti-vax environment in any event. They were started and encouraged by government stimulus (Bush administration) and I have no doubt will be used in the near future. The declaration of Emergency could probably allow them to be used now, but it would so confuse matters that unless things go south very fast and very badly I doubt they will take a chance on the public reaction. For every Don S. there are a thousand Rush Limbaughs.

    Heck, even with the nasal vaccine the situation is made worse by “our” cloddishness. The vaccine virus grew great for them. Why do we not have more delivered? Because the manufacturer of the officially approved nasal squirt syringe couldn’t keep up and there was no emergency approval for using any other device that Medimmune could get their hands on.

    I doubt this was a genuine problem. An EUA could have been issued. I don’t know the details of MedImmune’s problem so I can’t comment.

    The EU also depends on Big Pharma to make vaccines yet they don’t have our degree of problems. Why? The answer – http://www.msnbc.msn.com/id/33731376/ns/health-cold_and_flu/

    “In Britain, there are no long lines of people seeking swine flu vaccine. Doctor’s offices aren’t swamped with desperate calls. And there are no cries of injustice that the vaccine is going to wealthy corporations or healthy people who don’t really need it.

    Here, and across most of Europe, vaccine to protect against the pandemic flu is mostly given by invitation only to those at highest risk for flu complications.

    “That is one of the great advantages of the British health system,” said Dr. Steve Field, president of the Royal College of General Physicians. … Field said Britain’s socialized health care system allows the country to target people who need to be vaccinated quickly: “It’s not like the U.S., where it’s the survival of the fittest and the richest.” … “

    While we are in complete agreement here, don’t you think Big Pharma is one of the reasons we don’t have UHC in this country, along with the insurance and hospital industries? I remember the days when the AMA fought Medicare tooth and nail. Yes, UHC would make a big difference, but it is CongressThings bought and paid for by drug and insurance companies that have prevented it.

    Indeed as a progressive my beef is not with Pharma – whose hands have been tied by an excessively timid approval process and regulators fearful of the Beck’s and Paul’s of the world spinning a “rushed through and untested experimental vaccine” – which they do ANYWAY – but with the timidity of a Federal system that is afraid to, or unable to, even STRONGLY SUGGEST, that the most needful must go first, instead of remaining completely deferential to the states to decide how to prioritize. Problem is that giving the Fed level any more power won’t help if they do not have the spine to use it wisely. (Still better than the mishmosh that is our current irrationing of resources …).

    As a progressive you should have a beef with Pharma and the insurance and hospital industries and organized medicine and Congress. They are the ones who brought us the system that is killing us. The FDA regulatory system is flawed but not because it is too stringent. The cumbersome regulatory process evolved because anything less and Pharma tried to wiggle through. The result is a Rube Goldberg system of patches to take care of their constant attempt to make a buck without taking responsibility (getting immunity for vaccines was just another of their tactics).

    As for how strongly CDC has pushed the priorities, we see this very differently. CDC cannot enforce this but even at the last presser on Friday, Anne Schuchat was clear and definite on the priorities. The states know them. The providers know them. That some of our colleagues don’t honor them is not CDC’s fault. They cannot force anyone. But this, I guess, is something you and I are going to have to agree to disagree on.

  10. #10 Mary
    November 7, 2009

    You know, sometimes I mentally play around with the idea of some sort of not-for-profit drug development system. I try to imagine how this could work.

    I was just reading an article about how clinical trials are funded by drug companies. Well, yeah, they are ones who can afford it. What if it was some kind of government agency? Ok–maybe they could get funding. Maybe not. It would have to spend much of the time wrangling money. And some people would complain like hell about tax spending for this.

    And so let’s say they did get something approved. How much of this could they do? Further, it would be loaded with government conspiracy baggage.

    There are additional benefits to a public mechanism–because few people really trained in the whole thing in the academic realm. And what happens is then people are critical of the folks who came from pharma to monitor this, yet they are the only ones who know the whole process.

    I wish I understood what a viable alternative looked like. Are there existing examples?

  11. #11 revere
    November 7, 2009

    jay: You give some of the reasons why we have advocated taking the vaccine business out of the private sector. Vaccines used to be made by some states (Massachusetts and Michigan), although no longer. It’s time to have internationally supported vaccine institutes serving every region of the world on an equal basis with license free vaccine technology.

  12. #12 Harfang des Neiges
    November 7, 2009

    This is certainly the first time that Big Pharma makes false representations or statements.

    Harfang des Neiges

  13. #13 Harfang des Neiges
    November 7, 2009

    @DonScan

    You can rant on the US system but officially they have not authorized adjuvanted vaccine in US, while one of your Highest Minister of Health recommendator was not long ago the ex lobbyist at the highest level of GSK and is now your highest authoritative position of one of the caryathide of the City (GlaxoSmithKline) and who decided which vaccine to use for UK and Canada Dominion and backed up by a certain Robert Murdoch, who btw is an administrator of GSK and a major stock holder of GSK and owner of one of the major media network in the World.

    Humbleness is `de mise’.

    Harfang des Neiges

  14. #14 Don S
    November 7, 2009

    revere,

    Thank you for the response. No you do not “owe” me anything, but your engagement is appreciated.

    We can certainly agree on many things but I must disagree that this format does not allow for the handling of complex subjects with some nuance. Some of your posts in the past disprove that claim – in particular your explanation of T-Cells, dendritic cell, cytokine storm, and the response to immunizations – a wonderfully nuanced yet clear explanation of a very complex subject! So it can be done.

    I think we can agree that, like it or nor, Pharma is the vehicle that innovates and produces. While I went purely clinical I did “hang” in med school with the MD-PhD crowd. Most went academic for a while, but sooner or later Pharma got them – whether it was out of frustration with academic politics, with the never-ending process of grant writing, or the lure of facilities to pursue their dreams, Pharma has captured the many of the best minds and has the money to fund them. It IS a problem in that Big Pharma’s motivation is the blockbuster lifelong drug, not the better antibiotic, or the better vaccine. How we incentivize the development of that which we need more another med for erectile dysfunction, or for anxiety, or for anxiety about erectile dysfunction … I don’t know. But they are what we got to work with. And the fact is that given the obstacles they had to deal with – from the poor growth of the virus, to the regulatory reality – they did the best they could and the best that could be expected. We will have to disagree about the who knew what when aspect and whether or not those on the governmental side were guilty of refusing to hear anything that didn’t jibe with their PR plan.

    For your interest, the ample supply of H1N1 FluMist is detailed here: http://id_center.apic.org/cidrap/content/influenza/swineflu/news/jul3009medimmune.html from the end of July “The company has produced more than 20 million bulk doses of the vaccine … and has the capacity to make 205 million bulk doses … But he said the company has the capability to put only 41 million doses in sprayers, so it is looking into the possibility of using droppers instead—an option that would require additional regulatory review but may permit making more vaccine available sooner.” And since then? No word of any approval given to use the droppers. No fast track approval given. If it had been given 205 million doses could have covered most healthy school aged children and prevented much of the spread.

    Big Pharma would LOVE UHC. More customers. But to be sure, we will have no reform that deals any major player too bad of a hand. That said I am actually quite optimistic that this current attempt will produce something of value, albeit not ideal.

    As to the CDC priorities – yes, we see it differently: Anne Schuchat clearly spelling out THE WRONG GUIDELINE (the “Initial Target Group” Guideline instead of the “Limited Vaccine Availability” one) is not the leadership I am looking for.

    Again thank you for discussing this.

  15. #15 revere
    November 7, 2009

    Don S.; Since we’ve reached a kind of rapprochement I am reluctant to continue this with a demur, but as an academic I guess I can’t help myself. Pharma does precious little innovating. They sponge off of small start ups and biotech companies (Tamiflu and Relenza are both examples) and they all use publicly financed research, without which they couldn’t do anything. Even many of the swine flu vaccine trials are being done by NIH (although that is a special case, I’ll grant you). My medical school roommate went to work for Pharma 40 years ago and he did well and I hope he did some good, but the heavy lifting in drug development depends on NIH sponsored work. Pharma is coming in at the tail end. I have always opposed being able to patent work done with my tax money and as a researcher myself for 40 years have always refused to license or patent and even refuse to sign copyright agreements. Taxpayers paid once, they shouldn’t pay twice. I now edit an Open Access journal and authors own the copyright and anyone can reprint and use without permission. In other words, it is a subject close to my heart and my principles.

  16. #16 Don S
    November 7, 2009

    Well as an argumentive middle aged coot I can’t help myself either!

    My knowledge is limited to secondhand but my friends who went to Pharma didn’t do so for the bucks but were instead tempted by the funding to explore their basic science ideas with MORE freedom than they had in academe. The one that I respect most will note that he must “sell” his research as having some potential future commercial pay-off but his research is still quite basic science oriented.

    It is NOT the best way to come up with new ideas (open exchange of ideas is and I admire your principles) but their pockets are deep and they are more willing to invest in riskier research than that which usually gets NIH grants.

    Our grant system grinds promising minds down. See http://www.nytimes.com/2009/06/28/health/research/28cancer.html?_r=1 for example. Mind you they are trying to change things, and I, uh, grant, them that.

    Oh yes, small firms that come up with good ideas get bought.

  17. #17 Charlie Madison
    November 7, 2009

    Government-owned, contractor-operated (GOCO) vaccine production has been discussed FOR YEARS. Is this a model you would like to see resurrected? I would like to at least re-open the discussion.

    Charlie Madison
    http://twitter.com/Charlie_Madison

  18. #18 revere
    November 7, 2009

    Charlie Madison: We’ve suggested this here so often I can’t even count the times, but here are two examples:

    http://scienceblogs.com/effectmeasure/2007/03/the_indonesian_vaccine_solutio.php
    http://scienceblogs.com/effectmeasure/2007/03/having_sympathy_for_indonesias.php

  19. #19 Ben Hyde
    November 7, 2009

    minor typo: “… hope for the best to plant for the best …”

    [no need to keep this comment :)]

  20. #20 Charlie Madison
    November 7, 2009

    Thanks, Revere. Good posts that predate my reading of your blog.

    Interesting that the MSM has not pursued this angle of late …it seems more salient than ever.

    http://twitter.com/Charlie_Madison

  21. #21 bostonERDoc
    November 7, 2009

    This (vaccine shortage) is what you get when the govt totally gets out of the vaccine producing business and leaves it to individuals who answer to the stock market. We (the USA) have no flu vaccine manufacturing capacity currently in the US borders. This is too important to let pharma control and the govt needs to get back in the vaccine making business.

    The vaccine shortage is not the only major problem that is brewing–we dont have enough face mask supply and the sh..t has yet to hit the fan. My medical center ran out of N95 masks last week and they say they are having trouble restocking–although you can order them on Amazon.com as of today–so much for that “just in time” inventory process practiced at every single US hospital in order to save money. This (Obama) administration is just as incompetent–if not more with respect to public health–as the Bush administration. They were warned well in advance on this–even before the summer–but failed to act or check up on the facts themselves. The SNS inventory had no requirement for stockpiling PPE so there was only ~ 79 million N95 masks in the SNS inventory as of Sept. 2009. Here is where it gets scary: Supply models suggest a 120 day influenza pandemic in the USA would require about 6.2 billion N-95 masks and 26 billion surgical masks. Now the harsh reality: The manufacturing capacity for face masks is 125 million N95 masks per month (only 1 plant in the USA) and 300 million surgical masks per month (only 3 plants in the USA). During the summer months these plants were working around the clock but all supplies were being shipped overseas. So here we sit at the beginning of the second wave–no vaccine to adequately improve herd immunity and not enough face masks either. Time for competence not change eh?

  22. #22 Paula
    November 7, 2009

    Revere–like Dr Denise, I too had trouble with the “for more than four hours” link at the end of your post. Sounds like something of value; can you fix it for us? —Glad you, too, agree with Ehrenreich’s points. Only, I’m inclined not to “blame” Pharma for having to, as part of a system requiring it make profits, focus on making profits; though perhaps it could so focus somewhat less.

  23. #23 revere
    November 7, 2009

    Puala: The link worked for me (the contents are below the 404 error message, which is weird), and it is nothing of value. It is in fact a lame joke, linking to the Cialis site that says if you have an erection lasting longer than 4 hours call your doctor. I should have know better.

  24. #24 Path Forward
    November 7, 2009

    Dr. Denise and Paula, I howled with laughter when I read Revere’s line, “If your flu symptoms become serious for more than four hours, call your doctor.”

    I am guessing that Revere is contrasting the (justified) urgency about a dangerous side effect of Cialis (grotesquely prolonged erections, called priapism, that are a major danger to the organ in question), versus the lack of similarly urgent messages to get flu treatment quickly, unless you are in a high risk group.

    Given that at one third or more of pan flu H1N1 deaths are in people without underlying high risk conditions, it is problematic that such people are discouraged from calling their caregivers early on when they start to have flu-like symptoms.

    Despite revisionist history, starting Tamiflu or Relenza EARLY in the course of the flu is still better than starting it several days later.

    If you scroll down the “more than four hours” link, you will see this:

    >Uncommon side effects include:

    >An erection that won’t go away: As with any ED tablet, in the rare event of an erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.<

    If only we took early flu symptoms as seriously.

  25. #25 Paula
    November 7, 2009

    Actually, this “link” discussion brings up another issue–how much discouraging of people from contacting their physician regarding flu symptoms is coming from those physicians (or their offices)? In this rural/small-town area in Oregon, few physicians have the expertise or confidence to question any CDC recommendation (in whatever understanding they or the local hospital may first have given it), and I suspect this is common outside the major teaching/research regions. Any thoughts on this? Also, my interest in (what I thought would be the content of) the “four hours” link was in finding, in a serious way, just what “serious symptoms” in (adult) flu are; “short of breath” in particular is not exactly uncommon with respiratory disease, nor is feeling horribly sick, nor having fever 102 or a bit higher, when one has a flu. I think this confusion may be dissuading persons from contacting physicians–and physicians’ phone-answerers from urging they come in. Again, any thoughts on this?

  26. #26 Karen
    November 7, 2009

    A friend of mine whose one son ended up with pneumonia and and ear infection following the flu, while the other had a major sinus infection got a cursory exam when they first went in, then had to argue with her pediatricians office to get a follow up appointment when they were getting worse. The first response for the follow up was to keep taking the Rx cough meds that had been prescribed. Luckily, she persevered and got the boys in. Had she simply followed the phone advice, she might have ended up with one in the hospital. It’s not only confusion keeping people from seeing the doctors. In some cases it is the front line people at the offices.

    I wonder if some of them aren’t getting the message to dissuade people from above. On her first visit, the clinic was so full with sick people that they were using office space for overflow exam rooms. On her second, the clinic was nearly empty. This at a time where area schools were reporting 25-40% absentee rates.

  27. #27 Paula
    November 7, 2009

    Karen, agreed. This happens in adult primary care offices, too, even before this flu, certainly now. Some of it seems to be misuse by some physicians of lower-rank staff–nurses, phone receptionists–to do their work for them. I remember Kaiser’s abuse in this regard, in the SF East Bay, a few years ago (and probably still), with (not very well trained) “telephone answerers” in a central office in the southern Bay Area replying to calls from patients throughout the area–so it is not just lack of enough primary care physicians that is the issue.

  28. #28 Karen
    November 8, 2009

    This was a private pediatric office with 4 docs on staff. I suppose they could have been very short handed but with very sick kids and worsening symptoms, I can’t see any way to justify dissuading the family from medical care. Mom is not one to call lightly either. Once they got in, they actually got a thorough exam that picked up on the secondary infections. But man, if mom hadn’t been persistent, I suspect I’d be writing about a kid in the hospital.

  29. #29 Spiny Norman
    November 8, 2009

    Kellie: you’re an imbecile. (There. Now I’ve made a post that is precisely as substantive as yours, but more relevant to this thread.)

  30. #30 Paula
    November 8, 2009

    Karen and everyone, one thing I like enormously with this blog is the way everyone, editors and commenters alike, treat one another with respect. One thing I dislike enormously in physicians’ offices and clinics is the way staff, doctors through receptionists alike, treat patients and family members with too little respect, whether for their fears or fot their knowledge or concerns or questions. Karen, your experience points up one danger of this.

  31. #31 Don S
    November 8, 2009

    Speaking as the general pediatrician …

    The inexact science (or perhaps dark art) of phone triage is always difficult in pediatrics and it should surprise no one that it is a likely place for things to break down at “surge capacity” and above.

    I suspect that most other pediatric offices have it set up similarly to mine – most of the patient care hours office day clinical questions are handled by nurses who pass on some issues and questions to us (to either comment on or to call back later in the day when time permits) but who also answer many questions directly and often help parents make the decision about whether they need to come in (or back in) or whether it is reasonable to continue with home symptomatic care. (Paula, using nurses to do this is the right level of provider, not misuse of lower-rank staff to do our work for us. Receptionists, not.) Making those assessments is a difficult task. The easy answer is to see everyone who calls – easy and profitable too – but it is a wrong answer as well. For example, if a child’s course is doing what it should – still within the 3-4 days of fever we expect with influenza for example, alert, drinking well, not breathing hard, not a high-risker. etc., then a pediatrician’s office staff SHOULD be advising a family to stay the TLC course, discuss the warning signs of more serious complications, and save the family the time and the co-pay of coming in. Nurses and doctors make many hundreds of those phone assessments every day and many more during times like this. And adding in the rule that you always see someone who really wants to be seen, ie that you listen to and respect the anxiety as a telling sign of something more potentially going on than is being articulated, and you miss very very few who are really needing evaluation without “milling” the worried well. Impossible to be perfect, but you can do pretty well.

    Now add in a phone volume MUCH larger than normal (and right now pediatric offices are dealing with several times normal phone volumes and with calls that each require a certain extra amount of time to offset the misinformation that is being handed out in the media and by well intended friends, and to explain why we, no, still do not have vaccine and what our plan is to handle it when we get some) etc, and a large number of people who normally be comfortable going the TLC route and trusting their own gut assessment of their child’s health for a few days scared by the media to want to come in on day one and day three (and more) of illness so openings perhaps in short supply (as in we’ve already double booked a bunch of spots for emergency add-ons)… oh and maybe a nurse out sick too … ie classic pandemic surge … and you can see how phone triage slipping up once or twice is a canary in the mine.

    This is not an issue of disrespecting patients or of the wrong level provider making assessments or being short handed even. It is instead an illustration of how systems can only scale up so far in a surge without starting to have problems. This particular example however is not much of a failure for it also shows how the back-stop of seeing the family that insists they need to be seen works. The child’s story perhaps hit none of the traditional guidelines flags for bringing the kid back in, but Mom was noticing something nevertheless. The nurse making the assessment responding to the perseverance and bringing the child in even though the child otherwise seemed to fit the “continue TLC” rubric is a system working as it should.

    Bottom line is that it seems they have a good set of pediatricians who run an office as well as can be expected under the circumstances with a triage system that did its job. But that surge will inevitably come with triage systems making mistakes despite the best efforts using the best systems.

  32. #32 MoM
    November 8, 2009

    I love it that Paula’s (#30) post about respect immediately follows Norman’s (#29) that added so much to the discussion.

  33. #33 MoM
    November 8, 2009

    As I was reading this, I was already composing my comment that we spent 3 years planning for the worst and hoping for the best (when we thought H5N1 would be the strain), and then after May, we did a 180 and started planning for the best, but Revere beat me to it.

    This bug is different (Thank God), and so Don’s approach is right for most victims. The caveat, and he notes this, is that parents or adult patients need to get enough education to know when the TLC treatment isn’t enough. Public Health can help with that, but only by letting people know when it is time to call their private provider. At the same time, the private provider, who knows their patient’s history (or should) is the one in a position to say “Given your particular situation, go get treated immediately” when that is the need. Again, Don is correct that it has to be someone with enough background to make a valid decision. That is not to say that some receptionists or telephone answerers don’t have the background and knowledge, but that would be the exception, not the rule. It would be possible to take any reasonably intelligent individual and give them a set of criteria to use to make such a recommendation, but such training would go much easier and faster if the trainee had some background.

  34. #34 Karen
    November 8, 2009

    Don,

    I agree with most of what you’ve said, but not in the case I brought up. Hopefully it’s a blip, but given that the office was just about empty on visit two and the mom was actively dissuaded from coming in for a recheck on very sick kids who were worsening rather than getting better? I’m not so much inclined to give the benefit of the doubt to this particular office. Someone at some level messed up. Suggesting that people deal with the flu symptoms at home is one thing. Telling a family that has already been in because of very bad symptoms, that is now calling you to say that several days later things are even worse to wait it out? That rings as a very bad triage call. Given that the doc on duty took her seriously, it may be that some front line person didn’t quite understand who should be told to do watchful care at home. The doc taking you seriously doesn’t do you a bit of good if you can’t get to see her.

    MoM – the mom in the case I mentioned did the right things, and has a long standing relationship with this office. She’s not one to take the kids in for every sniffle. She was very sick herself and she ended up having to argue her case to get the boys seen again for what should have been, IMO, a no brainer, given the patterns of this particular influenza.

    I’m very grateful that my family weathered the storm with only mild symptoms and I didn’t have to go through this.

    While I realize that this is anecdote, I think the problem it brings up is one that should at least be looked at and given consideration in dealing with future problems.

    To the docs out there – are you sure something like this wouldn’t happen in your office? Clear and explicit instruction may be necessary. Maybe not what you want to do in a high volume situation, but possibly quite necessary. The health care office workers I know don’t seem to have much more information than the general public, nor do they seem to have much desire to go and find out more on their own.

  35. #35 Don S
    November 8, 2009

    As one doc out here I am SURE it can happen in my office. That’s why I am responding as I am. Whether it is a nurse triaging or an MD all we can do is our best but phone triage is not looking at the kid. Information can be misunderstood, especially in high call volume, high public anxiety circumstances. And that is with clear and explicit instructions.

    As for this particular case – well all I can go by is your description of what another person told you was their recalled perception of events. Third hand information from a single source is not the best sort of information upon which to state a solid conclusion about a particular case. However, I wouldn’t use a snapshot of an empty office to conclude how busy they were that day. An office day is uneven – a period where several people are late right when we got ahead of the schedule followed by the proverbial bus coming in. You know this person; I do not. If she indeed clearly communicated that her child was significantly worse and was told to ride it out then a ball was dropped. My only point is that that particular fumble WILL occur in every office – a triage nurse will not hear what a parent believes they are clearly saying. The failsafe for that fumble, built into the system just like having a pharmacist check that a med’s dosage isn’t accidentally written with the decimal point placed in the wrong spot, is seeing the patient whose parent or caregiver feels they need to be seen even if they did not hit any of your triage flags.

    Believe me, I appreciate the hazard and that it occurs. I’ve had a nurse who thought she was doing me a favor by being the “wall” keeping those who seem, in her phone assessment, to not be “sick enough” out of the schedule even when the parent is concerned, especially during extremely busy times. It is important for those of us responsible for the practice to make sure that our triage nurses appreciate the limits of phone assessment and respect that failsafe, that they know to listen for the anxiety or other clues that TLC alone is necessarily the right choice this time.

  36. #36 Karen
    November 8, 2009

    Thanks Don,

    I like that you recognize the importance of looking at this from the patient side as well. I understand – too many degrees of separation for you to make any real call on the particular situation. :) It was more for illustrative purposes that the people not getting health care early weren’t always at fault in that lack.

    I did strongly suggest to her that she write down what happened and get that note into the hands of the owners of the practice. Whatever the cause, the docs need to know about it.

  37. #37 Paula
    November 8, 2009

    Don, I agree re nurses for phone triage except where the nurse may be too busy “protecting” the physician/s from unnecessary visits to let failsafe happen by hearing a parent’s (or adult patient’s) anxiety as real. I may have miscategorized in terming this a (lack of) “respect”.