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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Dec '10
Re: The NIH Superbug
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.
Edited on September 21, 2012 at 2:52pmMay '11
Re: The NIH Superbug
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.
Edited on September 21, 2012 at 5:05pmJul '12
Re: The NIH Superbug
What you call "dumb luck", us Presbyterians call "Good Providence". :)
Apr '12
Re: The NIH Superbug
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.
Jul '11
Re: The NIH Superbug
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
Dec '10
Re: The NIH Superbug
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.
May '10
Re: The NIH Superbug
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.
May '10
Re: The NIH Superbug
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.
Apr '11
Re: The NIH Superbug
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.
Oct '10
Re: The NIH Superbug
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.
Mar '11
Re: The NIH Superbug
Casey Way
I do not know if it's true or not, but I didn't think you could buy a breakthrough.
One can't. The IR&D I was involved in wasn't medical, just plain ol' engineering. The questions are more straightforward, and the field was one in which the government has some competence, and they still alternated between cutting off funding for promising projects and throwing good money after bad.
I can't imagine they'd be more effective in antibiotics development.
Mar '11
Re: The NIH Superbug
Casey Way
I do not know if it's true or not, but I didn't think you could buy a breakthrough.
Actually, it could be feasible - more so than a government-funded breakthrough in, say, curing cancer. While the search for new antibiotics has a very low probability of success, the methods for identifying new antibiotics are well-established. Thus, throwing tons of government money in could have a high chance of success, even though it would also still have a low return on investment (because any new antibiotic would have to be used very sparingly).
Mar '11
Re: The NIH Superbug
Casey Way
@Mendel - Where can I read more about the association between livestock domestication and ID outbreaks? I had not heard of this before.
Even though he has lost some cachet on the right, Jared Diamond has a decent layman's explanation both in Guns, Germs and Steel as well as this article.
The gist is that infectious diseases can mutate very quickly into deadlier variants, but only if they have a dense population to use as an incubator. Animal domestication brought animals close enough to provide such an incubator for veterinary bugs, and it also brought the humans close to the animals (so those diseases could cross the species barrier), and also brought humans closer to each other (allowing the animal diseases to adapt to humans).
One under-recognized risk factor is the lack of genetic diversity: we think of inbreeding as dangerous because it brings out recessive traits, but a greater danger is that inbred (genetically homogeneous) populations are much more susceptible to being completely wiped out by a virus or bacteria. Animal domestication led to an increase of inbreeding both in the animals and in their human herders.