The NIH Superbug

 

Regarding capital punishment, Samuel Johnson once observed that the prospect of being hanged concentrates the mind wonderfully. I have always suspected that he was right, but I can only offer myself as evidence – for, in the course of the last few months, the prospect of mortality has repeatedly reminded me just how lucky I am to be alive.

About twenty-one months ago, I took a PSA test. The previous year, my score had been 1.27 (a low level). On this occasion, it was 2.07 (also quite low). Percentage-wise, however, the jump was considerable, and I was on track to have doubled my PSA in the course of eighteen months. This, because my brother had been diagnosed with aggressive prostate cancer when he was in his early sixties, I took as a warning, and I called an old friend, a physician who worked at the National Institutes of Health (NIH), for advice. Had I not been so wary, had I waited another year, as my local physician advised, I would have found it consoling when my PSA score dropped back from 2.07 to 1.77.

As it happened, however, my friend drew my attention to an experimental program in diagnosing prostate cancer then underway at NIH, and I signed up to be a guinea pig. As I spelled out in detail in an earlier post, in March 2011, at the Clinical Research Center, I underwent a trans-rectal MRI, and, with the help of the images thereby produced, I had a targeted (as well as the standard scattershot) biopsy. Because the biopsy was targeted, the surgeon in charge, Dr. Peter Pinto in the Department of Urology at NIH, was able to sample the lesions revealed by the MRI. On this occasion, Pinto and his team found cancer, but only 2% of the tissue gathered was cancerous, and it was graded in the laboratory report as Gleason 6 (not especially aggressive).

A year later, both procedures were repeated. The MRI suggested that nothing much had changed, but, on this occasion, the samples taken were 50% cancerous. Although they were once again graded Gleason 6, Dr. Pinto told me that intervention was advisable; and, being not so terribly old and otherwise healthy, I opted for surgery, and Dr. Pinto did the job on 25 June.. I have, in previous posts, described the surgery and the immediate aftermath. It should suffice to say that it was no picnic but that the effort was successful, that my prostate was removed, that the surgical reconstruction of my urethra was successful, that I am neither incontinent nor impotent, that the cancer was in fact Gleason 7, rather than Gleason 6, and much more aggressive than previously thought, and that it had not spread to the lymph nodes nearby. My PSA is now zero, and there is every reason to suppose that I am cancer-free.

There was, to be sure, a complication. To sample the lymph nodes in the immediate vicinity of the prostate, Dr. Pinto cut into them, and in the aftermath of the operation the lymph nodes that remained bled fluid in considerable amounts. This collected in the cavity near my left kidney and formed a lymphocele (not a lymphedema, as I erroneously reported in an earlier post). This collection of fluid pressed hard on the muscles controlling axial motion in my left leg, and in late July I experienced considerable pain. In consequence of this, I returned to NIH on 24 July; a catheter was inserted into my lower back to drain the fluids, and, in the period stretching from that date to 21 August, various attempts (mainly via sclerotherapy) to reduce the flow.

While in the Clinical Research Center, about a week after my return, I came down with pneumonia. This raised on the part of the staff a level of concern that, initially, I did not understand. Their worry was that I had what they called “hospital pneumonia” and not the more ordinary “community pneumonia.” The former was said to be resistant to antibiotics, and, on the off-chance that I had it, I was put on a cocktail of antibiotics, delivered intravenously, that I had never heard of. They were harsh and corrosive, and, after a day or so, the vein into which they had been introduced would collapse. In time, the staff in the Department of Infectious Diseases, managed to grow a culture on my sputum, and from this they learned that I had “community pneumonia.” When the word came through, I was put on Amoxycylin, and I recovered with reasonable alacrity.

What I did not know the time was that the previous summer a woman with an antibiotic-resistant strain of Klebsiella pneumoniae, who was in desperate straits, had been brought from another hospital to the Clinical Research Center at NIH; that the antibiotics given her had failed to do the job; that, in the six or seven months that followed, the disease had spread to seventeen other patients at NIH; and that five of these had, as a consequence, died. The “hospital pneumonia” that the staff feared that I had contracted was the so-called superbug; and, as they almost certainly knew when they treated me, another patient – a boy who had had arrived in April – had been diagnosed with the disease on 25 July, the day after my return to the facility. He died this past week.

That I am now cancer-free and that I did not contract the superbug is a matter of dumb luck, and it gives one an appreciation for what modern science can do and for what it cannot do. It should also give one pause.

The particular superbug that ended the life of my fellow patient at NIH is found today in only 6% of American hospitals, but there are other antibiotic-resistant diseases lurking in other hospitals, such as Staphylococcus aureus, MRSA, E. coli, and Clostridium difficile, to mention just a few. In the years to come, their number will grow, and in the pipeline, I am told, there are almost no new antibiotics. If nothing is done, our children may live in a world akin to that of our forebears – in which there are no antibiotics capable of being deployed against the most common diseases.

Just how this situation is to be headed off is unclear. The physicians I spoke with blamed the pharmaceutical industry, which is not investing the requisite sums in research. This may well have to do, however, with the fact that the scientists have reached a dead-end and that no breakthrough is on the horizon. It may also have to do with the way we fund medical care both in this country and abroad. Socialized medicine of one sort or another is the norm – even in the United States where Medicare and Medicaid rule the roost. The cost of developing new antibiotics and of shepherding them past the Food and Drug Administration is immense. The risk of failure is great, and the likelihood of generous recompense is small. Wherever there are monopsonies – single buyers – the cost of an item or service may easily be forced down – but at the price of suppressing innovation.

It is not enough that we repeal Obamacare. If we do not reform Medicare and Medicaid, if we do not return to the free market, we will in all likelihood be sacrificing the prospects of our progeny.

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There are 33 comments.

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  1. Profile Photo Inactive
    @dash
    Melissa:  …we can’t leave our medical malpractice system as it is […]

    I don’t think the social democracies of Europe are like this.  

    I touched upon this in my post about my own (wildly successful, BTW, let’s give credit where credit is due) experience with socialized medicine in France.

    It is beyond folly to create a State controlled medical system in the US without scrapping the current tort laws. This is so obvious, I can only assume that either the drafters of Obamacare had an ulterior motive, or they are remarkable stupid, although these are not mutually exclusive.

    Mel Foil: We sometimes wonder why our forebears were so interested in eternity. It’s because it was always so near. 

    And still is. Just a breath, just a heartbeat away. Just a falling piano, a swerving car, an angry jihadist away…

    • #1
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    @PaulARahe
    katievs: Not dumb luck, dear Professor.  Divine Providence.  · 8 hours ago

    Fair enough.

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    @Percival

    @Mendel, a friend of mine responded that the government would be able to fund the R&D necessary to come up with new antibiotics.

    I’ve participated in government IR&D projects.  I’ve watched them make decisions.

    We’re all doomed.

    • #3
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    @NickStuart

    Any story with the phrase “trans-rectal” is likely to keep you awake thinking about it.

    If Obamacare isn’t repealed, 10 years from now we will be blessed (HT to Katievs) if we can get AAA care:  basic Antibiotics (penicillin, nothing much fancier), Analgesics, and basic first aid for Accidents. Everything else will be reserved for the nomenclatura, like in Cuba. The Obamas will be OK, so will John Boenher and Eric Cantor for that matter (which helps explain the lack of urgency on their part).

    If we’re not blessed, there will have been an event like an Iranian or North Korean nuke over Kansas, and those of us who are left will join PBO in eating Fido.

    • #4
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    @JanMichaelRives

    MRSA (Methicillin-resistant Staph aureus) is the worry these days, because it’s already resistant to just about everything (in its hospital-acquired form) except Vancomycin.  And there’s a nasty little strain of Enterococcus that carries a Vancomycin resistance gene that could easily be taken up into MRSA under the right conditions. Doctors here really are  pretty freaked out about the thing, because, as you said, Vancomycin is the last bullet. What they really don’t seem to understand, though, is how much of a role the FDA and the government is playing in keeping new antibiotics from being developed. “We’re doomed! Doomed!” they cry, while every new drug Pharma invents spends 9 years of its 20 year patent in FDA-mandated clinical trials. And even when they get through, the FDA will ban them at the drop of a hat (think Vioxx.) And even if they don’t, the government lets foreigncompanies infringe on the patent and manufacture generics, undercutting foreign sales.

    • #5
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    @FredCole

    What a hell of a thing.

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    @KarlUB
    Not JMR: MRSA (Methicillin-resistant Staph aureus) is the worry these days, because it’s already resistant to just about everything (in its hospital-acquired form) except Vancomycin.

    Not quite. One of my company’s clients sells [redacted] which is indicated for complicated intra-abdominal infection caused by– amongst other pathogens– methicilln-resistant S. aureus.

    Not disputing your larger point, though, and you did say “just about” everything! It is a real challenge for docs. So many bugs. So many antibiotics with varying degrees of effectiveness and adverse events. So little time to take cultures and whatnot.

    And in regards to the FDA, this is one of the few places where I think part of the problem with a government agency is that they are understaffed and underfunded. They simply don’t have the expertise or resources to do their jobs effectively in our litigious society. So their behavior is erratic, inconsistent, and often purely responsive and informed by little more than fear or terrible PR ginned up by trial lawyers.

    I rarely sympathize with government agencies, but in this case I do. And, believe me, on a day-to-day basis the FDA makes my life very difficult!

    • #7
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    @KarlUB

    It occurs to me, that in case anyone with whom I work see’s this post:

    Please see the safety information included in the link above, especially if you are a health care professional. Also, be aware [redacted] may cause fetal harm when administered to a pregnant woman.

    Finally, the opinions above are my own, and not those of my employer or [redacted].

    (See what paranoia of the FDA can do to you?)

    EDIT: Redacted information about the specific drug since this is on the main page, and is not a private communication.

    • #8
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    @PaulARahe

    For the record, the surgery that I underwent on 29 August appears to have been a success. Three weeks have passed, the lymphocele has not reappeared, and I am not in pain. I am waiting for the incisions (one of which is slightly infected at the surface) to heal. Then I will declare victory.

    • #9
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    @ctlaw
    Not JMR: while every new drug Pharma invents spends 9 years of its 20 year patent in FDA-mandated clinical trials. … foreigncompanies infringe on the patent and manufacture generics, undercutting foreign sales. 

    There are patent extensions to at least partially make up for lost time.

    The generics come in after patent expiration.

    The bigger problems are: 1) that the rest of the world does not respect patents, thereby depriving the developer of most of its potential revenue; 2) fear of creating new resistant strains will cause the government to limit use of a new antibiotic whereas they would not limit the use of a new blood pressure medication; and 3) the big money is in therapeutic drugs  taken long term rather than one-shot deals (how many men would pay $100/month for a baldness cure?).

    Imagine you spend $2b on developing a new antibiotic and the government says (to prevent resistant strains from developing) you can only use it in confirmed superbug cases  (and not, for example, as a preventative given to every patient in a hospital where there is one confirmed case). Meanwhile foreigners knock it off and abuse it so that the resistant strains develop anyhow.

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    @DocJay

    Way to crush the competition Paul.

    Indeed we have some nasty flora here and on the horizon.  The issue is very complicated.

    • #11
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    @BenjaminGlaser

    What you call “dumb luck”, us Presbyterians call “Good Providence”. :)

    • #12
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    @Devereaux

    It is good to know you are well, Mr. Rahe. That is always a questionable result, no matter how well you are prepared.

    I have long been of the opinion that the costs that we see in medicine today are directly related to governmental interventions in the field. Today there is little to no “competition” in medicine as fees are generally set by the government. When you then add the costs of the useless HIPPA law, the overall condition of malpractice law, the increasing requirements for paper input, it is of little surprise that medicine is as expensive as it is today – and so moribund in innovation.

    • #13
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    @katievs

    Not dumb luck, dear Professor.  Divine Providence. 

    • #14
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    @Melissa

    Something in this country has to give and I’m not referring only to medical stuff, but that’s a big enough problem by itself.  If we’re going to socialize medicine (I don’t want it either, but let’s say if), we can’t leave our medical malpractice system as it is, and we can’t leave our loose borders unattended because then there will be more people coming in and taking advantage of the socialized medicine and the easy lawsuits. 

    I don’t think the social democracies of Europe are like this.  Doesn’t the UK have a “loser pays” rule regarding lawsuits?  And I think Sweden has some limit on the ability to sue the govt. provided health system.  And from  what I understand, the borders of most European countries aren’t quite as open as our Southern one.  Are we so stupid that we think we can pay for all the goodies the left thinks everyone should have?  Our European friends should be proof that there have to be limits somewhere on some things.  Everyone can’t have everything.  Am I wrong or just cruel?

    • #15
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    @ColinBLane

    The “I’m better” part of your message cheered me greatly.  The rest . . . thanks for helping me not sleep!

    • #16
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    @DocJay

    Melissa, but Obama said tort reform really wouldn’t help costs and we know he never lies.  

    • #17
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    @

    How much of modern medicine and process originates in the USA? How many drugs originate in countries with govt. Rn and paid health care?

    I do know that in Canada, the funding for medical devices and for new drugs is from the USA. I just met with a drug company with ten years into four worthwhile drugs and the best doctors. They have been funded by doctors and dentists and lawyers, not a single venture capital fund. There are some companies with drugs going through trials who get onto our venture stock exchange but then languish, not attracting capital. Innovation in medical and bio can be a big winner but it takes 10 years and the money is not there. 

    Our hospitals are mandated to buy from big suppliers so as to simplify the purchasing which means the  medical device and drug companies do not even get to meet the buyers. One Canadian company I know sells to GE as she is a female registered company in the US. These get minority listing status, an advantage. Then GE sells to the Govt. in Canada.

    We do not help raise capital for medical companies in Canada. It’s a losing proposition.

    • #18
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    @Palestrina

    To your last point, the road to Central Planning is littered with the victims of the Unintended Consequence. Pride goeth, as they say.

    • #19
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    @DocJay

    I feel you KarlUB.  Paranoia isn’t so bad when it protects your rear.

    KarlUB: It occurs to me, that in case anyone with whom I work see’s this post:

    Please see the safety information included in the link above, especially if you are a health care professional. Also, be aware [redacted] may cause fetal harm when administered to a pregnant woman.

    Finally, the opinions above are my own, and not those of my employer or [redacted].

    (See what paranoia of the FDA can do to you?)

    EDIT: Redacted information about the specific drug since this is on the main page, and is not a private communication. · 2 hours ago

    Edited 2 hours ago

    • #20
  21. Profile Photo Inactive
    @karamazov59

    I hope this doesn’t sound weird, but boy do you write well. I was reading your post because I was interested in your health, but then I noticed how much I enjoyed your prose.  Godspeed and thanks for your informed and eloquent missives.

    • #21
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    @Mendel

    I felt a sense of dread when I read the title of this post, but I am relieved to hear that you did not catch the “superbug” Dr. Rahe.

    It is one of the paradoxes of human development that almost each major step in improving our health also brings with it a new danger.  Infectious disease outbreaks were probably unknown until we domesticated livestock.  Many allergies may well be caused by overcleanliness.  Now we have disease-resistant bugs which thrive, of all places, in hospitals.

    I fear that your doctor was correct about the economics of antibiotics.  Even without the FDA, the ROI on antibiotics is much too low for the high risk involved – especially since most bugs are still susceptible to them.  Unfortunately, the demand will need to increase before that changes – and in medicine, increased demand is a nice way of saying more dead people. 

    Glad to hear you are healthy.

    • #22
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    @JosephStanko
    Paul A. Rahe: For the record, the surgery that I underwent on 29 August appears to have been a success. Three weeks have passed, the lymphocele has not reappeared, and I am not in pain. 

    Wonderful news!

    I agree wholeheartedly that socialized medicine will drastically reduce investment and innovation in health care, and that’s a serious problem.  However, isn’t the over-prescription of antibiotics also a contributing factor here?

    In a purely free-market system, if a patient wants antibiotics to treat his common cold, and is willing to pay for them, and the doctor and pharmacy can make a profit selling them, it seems inevitable they will be over-prescribed and abused.  

    This strikes me as a “tragedy of the commons” scenario, where the antibiotics don’t harm the person using them irresponsibly, but if everyone does it we all pay the price.  How do we fix that incentive structure?

    • #23
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    @KingsKnight1

    Misadventures in modern medicine! One day I’ll tell you about hoe mu “routine” hip replacement turned into a life and death bacterial struggle. Wasn’t ptetty. :(

    • #24
  25. Profile Photo Inactive
    @MelFoil

    We sometimes wonder why our forebears were so interested in eternity. It’s because it was always so near. If your nutrition and your shelter are substandard, and there’s no medicine, lots of bugs are superbugs.

    • #25
  26. Profile Photo Inactive
    @KarlUB
    DocJay: I feel you KarlUB.  Paranoia isn’t so bad when it protects your rear.

    The tragedy is that if the FDA had the expertise and time to offer clear guidance about digital communications– which it has been promising for over a decade– forums such has this could be excellent sources for health information.

    Instead, people who might have helpful things to share have to keep it to themselves, which is bad for keeping people healthy.

    • #26
  27. Profile Photo Member
    @

    Paul Rahe: “That I am now cancer-free and that I did not contract the superbug is a matter of dumb luck, …”

    There is no such thing. 

    • #27
  28. Profile Photo Member
    @
    Melissa: Something in this country has to give and I’m not referring only to medical stuff, but that’s a big enough problem by itself.  If we’re going to socialize medicine (I don’t want it either, but let’s say if), we can’t leave our medical malpractice system as it is, and we can’t leave our loose borders unattended because then there will be more people coming in and taking advantage of the socialized medicine and the easy lawsuits. 

    I don’t think the social democracies of Europe are like this.  Doesn’t the UK have a “loser pays” rule regarding lawsuits?  And I think Sweden has some limit on the ability to sue the govt. provided health system.  …. Our European friends should be proof that there have to be limits somewhere on some things.  Everyone can’t have everything.  Am I wrong or just cruel?

    I believe that America is one of only two industrialized countries that does not have a “loser pays” tort system. 

    • #28
  29. Profile Photo Member
    @NormD

    This issue has nothing to do with Obamacare.  Its been discussed for 25 or so years.

    Most “new” antibiotics are slight modifications of existing drugs and are not truly new, ie, working via a new mechanism.

    Truly new types of antibiotics are extremely difficult to develop.  Failures rates are high.

    All drugs are extremely costly to develop and get through the FDA

    To limit resistance, doctors would try to limit use of a truly new antibiotic to cases where all other antibiotics have failed.

    The above means that each use of a truly new antibiotic will have to cost a very large amount for the drug company to recover its costs.

    People whose lives are on the line will not have life denied to themselves or their loved ones because of high costs.

    Are you people really going to let your child die because you don’t want to violate a patent?   Even if you could mortgage your house, what about people in other countries who simply cannot raise the money?

    Does a drug company want the grief of choosing between losing money or causing deaths?

    I don’t see a good free market solution.

    • #29
  30. Profile Photo Inactive
    @CaseyWay
    Percival: @Mendel, a friend of mine responded that the government would be able to fund the R&D necessary to come up with new antibiotics.

    I do not know if it’s true or not, but I didn’t think you could buy a breakthrough.

    @KarlUB – Could you message me the name, just wanted to look it up.

    @Mendel – Where can I read more about the association between livestock domestication and ID outbreaks? I had not heard of this before.

    All the mentioned bugs are terrible, but there is also CRNG: Ceph-Resistant N. gonorrhoeae. At least with that bug there is a “health risk behavior” you can point to that’s not just getting the superbug from the hospital.

    • #30
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