Here Come the Lawyers

Over the past month, 5 lawsuits have been filed in California Superior Court, Los Angeles County, over the deaths and debilitating infections caused by the superbug CRE (carbapenem-resistant Enterobacteria) to patients at the Ronald Reagan UCLA Medical Center. The harm resulted from the use of CRE-contaminated scopes that are threaded down the throat into the intestines of patients to diagnose and treat various GI tract illnesses.

The plaintiff’s argue – and virtually everybody agrees – that these scopes have a design flaw: they are such intricate devices that they can’t be properly cleaned between procedures, thus CRE bacteria are transferred from one patient to the next. Accordingly, the makers of this device have been sued on the grounds that they knew their scope had this problem yet they failed to correct it. These lawsuits are a big deal because the scopes are used in about 570,000 procedures each year across the country. And because once CRE enters your bloodstream there’s a 1 in 2 chance you will die.

As the escalating number of CRE infections become known to the general public, more lawsuits are likely to be filed nationwide. What’s more, we are learning that researchers have issued unheeded warnings to the medical community about these scopes since at least 1984. In other words, we’re entitled to ask how much of this pain and suffering could have been avoided. For instance, to 18-year-old high school student Aaron Young, 1 of our 5 plaintiffs.

Lori (a nurse), and Glenn Smith, are the adoptive parents of Aaron Young.

Lori Smith, who is a nurse, and husband Glenn, are the adoptive parents of Aaron Young.

Aaron is still in the hospital fighting his infection. Though he’s expected to eventually return home he will do so with this knowledge: the CRE bug will remain in his body for the rest of his life forever putting him at an elevated risk for infection. And just because he’s beat it so far is no guarantee he will again, especially if he becomes immunocompromised by age or disease.

Aaron is not alone. We’re learning of more cases like his in Seattle, Chicago, Pittsburg, Philadelphia, Tampa, and Charlotte. And there’ll be more to come: “Most hospitals that do these procedures are not even looking for this problem, or they may not be aware, and that’s got to change,” says Jeffrey Duchin, an infectious disease expert in Seattle. Thus, these infections “may go unnoticed.”

The reported cases of CRE are “probably the tip of an iceberg,” says Marcia Patrick, of the Association for Professionals in Infection Control and Epidemiology. “But we don’t know how big that iceberg is.”

But we know when the iceberg began forming – some 30 years ago:

“We have known about this even as early as 1983 or 1984,” said John Allen, a professor at the Yale School of Medicine who is president of the American Gastroenterological Association. In 1987, Allen wrote in an academic journal about 10 of his patients in Minnesota mysteriously becoming infected with a bacteria known as Pseudomonas. He and his colleagues traced the infections to a single [scope], whose small crevices harbored bacteria despite repeated cleanings.

An investigation this month by the LA Times offers further evidence of years of red flags:

“Since 2007, ECRI Institute, a nonprofit group that evaluates medical devices for hospitals and other organizations, has listed the risk of contaminated endoscopes and other surgical instruments among its top 10 health hazards.

In 2008, the U.S. Centers for Disease Control and Prevention urged that endoscopes be redesigned so they don’t represent a ‘potential source of infectious agents.’

Last year, the Joint Commission, which accredits and inspects hospitals, raised alarms about tainted endoscopes and other equipment posing an immediate threat to patients’ lives.

The FDA said it has received 75 reports of contaminated scopes causing possible infections in 135 patients who underwent [the scope procedure], from January 2013 to December 2014.”

But there’s more. Where the LA Times really earns its stripes is in showing us that there are deep, often hidden institutional structures that drive disease – it’s not as simple as bug bites boy:

“Three years ago, [the maker of the scope] Japanese electronics giant Olympus Corp. was in crisis amid a massive accounting scandal and plunging sales of its signature cameras.

Executives vowed to save the 93-year-old firm by turning aggressively to healthcare and selling more medical scopes to doctors and hospitals in the U.S. and worldwide.

The bet paid off: Medical sales soared 25% last year, and Olympus boasts a commanding 70% share of the global market for gastrointestinal endoscopes … a record breaking performance.”

The Times also questions doctors and their conflict of interest:

“One key part of that success has been the company’s close ties to doctors, industry analysts say.

Olympus is a major donor to the American Society for Gastrointestinal Endoscopy. The company also contributed more than $1 million to the society’s new Institute for Training and Technology.”

And now the feds are on the case:

“The company’s relationship with medical providers has already come under scrutiny. Last month, Olympus said federal investigators are looking into whether it violated laws that ban improper kickbacks to doctors and other customers.”

aaron 9The Times report ends with a cruel observation. As hospitals replace the contaminated scopes with new ones it’s generating more business for Olympus. In Seattle, Virginia Mason Medical Center bought 20 additional scopes, at a price close to $1 million. Dr. Andrew Ross, the hospital’s section chief of gastroenterology, said placing such a big order with Olympus “certainly seemed ironic from our perspective.”

None of this is pretty. But neither is this photo. It’s Aaron, hardly visible, in the bed where he lives these days.

 

 

 

 

 

 

The Personal Side of the Current CRE Outbreak

ricci“I just thought it’s just an infection, you know? I really didn’t realize what they meant by infection.” Those are the words of Cheryl Perron, mother of then 19 year old David Ricci (“reach-y”) who was struck down by the superbug CRE. (p.53)

David’s story began one morning on his way to work. Walking along side railway tracks he got sucked underneath a speeding train by its backdraft. His right leg crushed, he was rushed to hospital. Still conscious, he watched a doctor take out a machete-style knife and begin “hacking” his leg off. His friends, standing outside the room, could hear him screaming before he passed out. David never made it to the Mother Theresa Orphanage in Calcutta where he worked as an HIV/AIDS volunteer.

Then things got worse. Some of his amputated leg became infected with CRE. “They said I don’t have that much longer,” says a weakened David on what looks like a cell phone video taken by one of his friends. His family got him home to Seattle as soon as they could but the ordeal continued. David was placed under quarantine. His infection continued to spread. Multiple antibiotics were tried but failed. Then a doctor remembered one from the 1940s that was shelved because it was too poisonous. But it was the only one left so they tried it. As David put it, “It started to eat away at my organs on the inside, you know? I could just feel it, just— just this poison rushing through my blood.” One option remained – cut off the rest of his right leg to within 6 inches of his hip and maybe, just maybe, they’d get all the CRE. But they wouldn’t know for months, so in the meantime all they could do was wait …

That was 2011. David’s story was told 2 years later in the outstanding PBS Frontline episode “Hunting the Nightmare Bacteria.” We’re presenting it here because CRE is now on the move across the United States. As we reported 2 weeks ago, it was an outbreak at the University of California hospital system in Los Angeles this year that brought the problem to the public’s attention. But with a little digging we found out that CRE had also surfaced in Illinois, Pennsylvania, and Washington, dating back to 2012. And since our last report we’ve learned of more outbreaks occurring this year in North Carolina, Wisconsin, and a second hospital in California, Cedars-Sinai.

The unique feature of the US outbreak is they’re all caused by the same thing, a medical device called an endoscope. It’s threaded down the throat deep into the intestines to diagnose and treat people suffering serious illnesses of the GI tract. It’s the only tool we have to do the job and so it’s used all the time, in about 500,000 procedures every year across the country. The problem is, the endoscope has a design flaw. It’s such an intricate complex device that it can’t be properly cleaned between procedures and so the CRE from one patient will sometimes transfer to the next. Nevertheless, because it’s an indispensable tool in the treatment of life-threatening disease we continue to use it.

The total number of people affected so far is probably less than 1,000. But the story doesn’t lie in the numbers. It lies in the lives of the people afflicted and everyone close to them. And what it does to the ones that survive changes them forever.

David’s story begins at the 12 minute mark and resumes again at 46 minutes. Our hope, though, is that once you meet David you’ll want to see the episode in its entirety.

Our Current CRE Outbreak is Probably Just the Tip of an Iceberg

We have a problem and it will probably get worse before it gets better.

CRE (carbapenem-resistant enterobacteriaceae) is a superbug picked up in hospitals – for now – that kills about half the people it infects, roughly equivalent to the vicious Ebola virus.

For the past few days media outlets across the U.S. have been reporting on a CRE outbreak at the University of California hospital system in Los Angeles. So far 2 people have died, 5 more have become infected, and a further 179 are suspected of having been exposed to it and are being monitored.

endoscope 4But the real story isn’t in the numbers – at least not yet – it’s in how these people became infected, i.e. through the use of a medical device called an endoscope. The scope has a long fiber-optic cable with a light and camera at the end so doctors can see inside the body. It’s inserted down the throat into the stomach and then into the intestines. It’s used to treat digestive-system problems from cancer to gallstones, and it does a very good job.

But there’s a problem. The GI tract is lined with a host of different germs. As the endoscope is withdrawn from the body those tiny invisible germs adhere to the scope and can then transferred to the next patient the scope is used on.

But isn’t the scope cleaned between patients? Yes, and according to FDA-approved manufacturer’s guidelines which the hospitals have apparently followed. However, the issue is more insidious: parts of the scope are so small and intricately designed that you simply can’t access all the areas you need to to properly clean it. So the bugs remain on the scope ready to be transferred to some unsuspecting patient down the line.

But that’s just the beginning of the story. Two more facts bring us to the heart of it.

One, the endoscope is used across the country on about 500,000 patients every year, so why would the problem arise only in L.A.?

Two, if the GI tract is lined with oodles of different germs why would the scope only pick up one of them, CRE?

A little digging reveals that the endoscope-induced CRE problem isn’t confined to L.A. For example, at Virginia Mason Medical Center in Seattle, between 2012 and 2014, at least 35 patients fell ill and 11 died after contracting a CRE infection via the contaminated endoscopes.

Similar cases involving a half dozen outbreaks and about 150 patients have also occurred in health facilities in Chicago and Pittsburgh.

And we’re learning that “almost certainly,” the endoscope is transmitting other kinds of infections as well. Infection control specialist Marcia Patrick says these cases tend to go unnoticed because doctors simply prescribe antibiotics and don’t give much thought to where or how the illness was contracted.

That’s why Patrick says the reported cases of CRE are “probably the tip of an iceberg,” and adds, ominously: “But we don’t know how big that iceberg is.”

The More Doctors You Have in Your Community the Better off You are, Right?

doctorsIf you’re a poor or underserved community then the answer is yes, get more doctors in there. However, for “wealthy” communities, you have to be careful because the business side of medicine can hurt you.

It goes like this. More doctors in your area means more competition for patients; one way to please patients is to give them what they want, and what they too often want is … antibiotics. That’s the conclusion of researchers at Princeton University and the Johns Hopkins University School of Medicine, published online yesterday.

What drew their attention to the issue is the explosion of the so-called “Doc-in-the-Box” establishments across the US – which are attracting a growing Wall St-type investor interest. These are the retail, walk-in, and urgent care clinics that are open nights and weekends when many doctor’s offices are closed and don’t require appointments.

What concerns the researchers is the rising plague of antibiotic-resistant bacteria. They know that the reason these bacteria have become a problem is because we take too many antibiotics. In the US for example, in 2010, 258 million antibiotic prescriptions were written nationally, which is almost 1 prescription per person.

They also know that the more physicians there are per person in an area, the more prescriptions per person there will be. So with this background in mind, they wanted to know if the rise in Doc-in-the-Box establishments, i.e., if an increased competition among providers, leads to more prescriptions for antibiotics.

In finding that that is indeed the case the authors explain it this way: “The second reason is that physicians are competing for business either by increasing the number of patients they see by adding walk-in hours and same-day scheduling or by prescribing antibiotics more readily – even if they wouldn’t do any good – to maintain good patient relationships or to help retain patients.”

The idea of having to please patients in order to keep them was also investigated by the online journal Medscape, last summer. They specifically looked at why physicians cave-in to patient demands for antibiotics.

Physician responses show them feeling pestered endlessly for unnecessary antibiotics. One provider put it this way: “I often have patients, sometimes multiple times each day, get quite upset when an antibiotic prescription is denied to them. Even after explaining my rationale, some [patients] argue with me or head straight over to an urgent care center and obtain their antibiotics there instead.” (My emphasis.)

Dr. Bartlett would subscribe to the "you-have-to-sometimes-be-cruel-to-be-kind" school of medicine

Dr. Bartlett subscribes to the “sometimes-you-have-to-be-cruel-to-be-kind” school of medicine

This Medscape survey of almost 800 clinicians found that 28% of them prescribe antibiotics simply because the patient asked for them. Their thinking is that if you don’t keep the patient happy not only will you lose their business, you risk falling out of favor with administrators, and this in turn affects both your job satisfaction and, indeed, whether you will keep your job. And how do administrators know what patients think? The increasingly ubiquitous patient-satisfaction surveys.

Just how far down the customer-is-always-right road have we gone? Here’s what one equity firm manager who has invested in a chain of Doc-in-the-Box facilities has to say: “We borrow a lot from the restaurant industry,” therefore, “We have to be good, fast, and kind to be successful.”

But there’s a crucial difference between the guy who wants to know what you want for dinner and the guy who wants to know what’s wrong with you. John G. Bartlett, MD, Professor Emeritus at the Johns Hopkins University School of Medicine, offers us this sobering observation: “The use of patient satisfaction scores to evaluate physicians is just plain wrong, not to mention the fact that there is a direct correlation between patient satisfaction scores and mortality.”

And just what is this link between happy patients and dead patients? “The happier the patients, the more likely they are to die,” says Bartlett.

Oops.

President Obama Doubles Down on the Fight against Superbugs

Calling antibiotic resistance “one of the most pressing public health issues facing the world today,” the President’s FY 2016 Budget, announced Tuesday, proposes an historic investment – almost doubling the current budget to an unprecedented $1.2 billion – to combat antibiotic-resistant bacteria.

A meeting of PCAST members with President Obama, 2014

The Budget is Obama’s effort to pay for the game plan on antibiotic resistance, announced in September, drawn up by his eminently qualified President’s Council of Advisors on Science and Technology (PCAST).

Eric Lander, PhD, founding director of the Broad Institute of MIT and Harvard, and co-chair of PCAST, assessed the state of play at the time: “There is no permanent victory against microbes. If you use antibiotics, whether in human health care or in agriculture, you will over time see resistance. If we fail, if we fall behind in our stewardship, in our creation [of new antibiotics or equivalent therapies], or if we fail to surveil to understand what’s going on, it’s a very real risk to see a resurgence of what life looked like a century ago when we had bugs we could not treat. It’s a terrifying prospect. Now … it doesn’t help to do scare tactics around these things but it’s just plain scary.”

Since then, there have been two notable events.

One, the announcement in December by UK Prime Minister David Cameron’s working group on antimicrobial resistance that deaths caused by untreatable infection will overtake deaths caused by cancer by the year 2050.

Two, the report in the New York Times that India’s infants are born with bacterial infections that are resistant to most known antibiotics, and more than 58,000 died last year as a result. That if these “resistant infections keep growing … it would be a disaster for not only India but the entire world.”

Quoting health officials, the Times reports that the infections are in fact growing rapidly: “Five years ago, we almost never saw these kinds of infections. Now, close to 100 percent of the babies referred to us have multidrug resistant infections. It’s scary … And these resistant infections have already begun to migrate elsewhere … reaching just about every country in the world … including … the United States.”

Migrate here? The recent Ebola scare in the US is a useful reminder of a bedrock principle of infectious disease: “A disease outbreak anywhere is a disease risk everywhere,” says Tom Frieden, MD, Director of the Centers for Disease Control and Prevention.

Of course, there is a crucial difference between Ebola and antibiotic- resistant infections: Ebola is transferred only from the very sick through their body fluids. Most ABR infections, on the other hand, travel through the air and are therefore as easy to catch as the common cold. So imagine then, if Thomas Eric Duncan, the only person to die in the US from Ebola, was left wandering Dallas for 5 days with an undiagnosed case of MRSA, say, as he was with Ebola. What then?

That is just one scenario that would constitute Dr. Landers’ “terrifying prospect.” And that is why President Obama rightly calls antibiotic resistance one of the most pressing public health issues facing the world today.

The Day the Earth Stood Still

Last week we wrote about the new British report that said drug resistant infections will cause more deaths than cancer by 2050.

We focused on how untreatable infections will fundamentally change how we practice medicine, citing 3 examples: an increased inability to treat cancer; an increase in deaths during child birth – to mother and child; and how surgery will become too dangerous to perform in most cases.

There is, crucially, a whole other aspect to the global rise of drug resistant infection that is stressed in the report. It is summed up in one sentence by the lead author, former Goldman Sachs economist Jim Nill, in the video below, where he says:

“Something like this which is going to affect everybody; you know it could have a devastating impact on international trade and travel and globalization.

A devastating economic and social impact – what does he mean?

Remember the great American Ebola freakout of 2014? The one where, in the US, 1 person died and a half a dozen or so were sick but recovered. Well, what if the number of deaths in the US and Canada was not 1, but, as the report predicts concerning drug resistant infection, over 300,000? What if the number of infected people were several multiples of that? And what if these infections, unlike Ebola, are airborne – meaning you catch them easily, the way you catch the cold or the flu?

Deaths attributable to drug resistant infections every year, by 2050

A partial answer to these questions has been before our eyes for the past 6 months or so with Ebola virus disease in West Africa. As of yesterday, the US Centers for Disease Control and Prevention reported more than 8,000 deaths and over 21,000 cases.

As a consequence, life over there has stood comparatively still. Take just 2 brief examples.

The World Bank reported this month that in Liberia “The Ebola virus has tempered our economy. It has hurt our economic investments. Our businesses have been closed down and our country has been abandoned.”

And from the Financial Times in October: Airlines, hotels, tour operators and cruise businesses are resigned to a period of crisis management as investors retreat from their stocks on fears that the Ebola threat will blunt people’s willingness to travel.”

Now imagine that scenario playing out over here and in Europe and you have the kind of “devastating impact,” from the rise of drug resistant infections “which is going to affect everybody,” that the conservative, experienced, elite economist Jim Nill is warning us about.

In other words, closed businesses, truncated trade and travel, investment crises, and other globalization effects will be such that the world could virtually end up at a stand still — and don’t forget the fear that will accompany it all.

Here’s the brief video where Mr. Nill and a few others voice these stark concerns:

Drug-resistant infections are going to cause more deaths than cancer

Deaths caused by untreatable infection will overtake deaths caused by cancer by the year 2050. So says the first report produced by UK Prime Minister David Cameron’s working group on antimicrobial resistance, formed last July. As you look over the graphic keep this warning from the Cameron group in mind: “Despite the staggering size of the figures set out … they do not capture the full picture of what a world without antimicrobials would look like.”

The “full picture” of a world without these drugs means we will be forced to stop practicing medicine the way we do now. Stuff we have long taken for granted will be taken from us. The report gives us 3 concrete examples: surgery, cancer treatment, and child birth.

On surgery: “When most surgery is undertaken, patients are given prophylactic antibiotics to reduce the risk of bacterial infections. In a world where antibiotics do not work, this measure would become largely useless and surgery would become far more dangerous.”

On cancer treatment: “Modern cancer treatments often suppress patients’ immune systems, making them more susceptible to infections. Therefore without effective antibiotics to prevent or treat infection, chemotherapy would become a much riskier proposition.”

On childbirth: “Rising drug resistance would also have alarming secondary effects in terms of the safety of childbirth, including caesarean sections, with consequential increases in maternal and infant mortality. The 20th century saw childbirth in high income countries move from being something that carried significant risk to something that we take for granted as being safe: the world witnessed a 50-fold decrease in maternal deaths over the course of that century. Much of this progress could risk being undermined if AMR is allowed to continue rising significantly.”

Here’s the most important point: You and I have a role to play. We are are not meant to be mere bystanders. Since the problem is driven by the overuse of antibiotics our job is to lessen the demand. How so? Stop asking for antibiotics. That’s the message that people such as the Harvard School of Public Health are trying to get across. It’s well worth watching their presentation – meant for the public – by clicking on the preceding link.

How Concerned Should We Be With the Continuing Deadly Outbreak of Antibiotic Resistant ‘Superbugs’ That Killed 58,000 Infants in India Last Year?

How we assess threats depends on where we live in the world. For example, a Pew Research Center report from last month tells us that if you live in Sub-Saharan Africa you see Aids and disease as our greatest threat. In the Middle East it’s religious and ethnic hatred, and in the US and Europe it’s inequality.

But our recent experience with Ebola may have changed that. This Wednesday the New York Times ran the story ‘Superbugs’ Kill India’s Babies and Pose an Overseas Threat. It was on the front page and two days later at 8:00 this morning it was still on the most viewed and most emailed lists, reaching as high as number 3 yesterday. That’s a first. Apart from Ebola, stories on infectious disease in the US and Canada are generally ignored.

But not the Times report, which says that India’s infants are born with bacterial infections that are resistant to most known antibiotics, and more than 58,000 died last year as a result. That if these “resistant infections keep growing … it would be a disaster for not only India but the entire world.”

Quoting health officials, the Times reports that the infections are in fact growing rapidly: “Five years ago, we almost never saw these kinds of infections. Now, close to 100 percent of the babies referred to us have multidrug resistant infections. It’s scary.” And these resistant infections have already begun to migrate elsewhere “… reaching just about every country in the world … including … the United States.”

So are Times readers right to keep this story front and center?

Let’s ask one of our foremost experts on infectious disease, Tom Frieden, MD, Director of the US Centers for Disease Control and Prevention. You may recall Dr. Frieden as the guy who, in the midst of the great American Ebola freakout, was telling the President, the Congress, the media, and the public, that “I have no doubt that we’ll stop this in its tracks in the U.S.” And as we know he was proven absolutely right.

But this past July in a talk to the National Press Club in Washington, DC – a talk that got zero publicity – Tom Frieden told us what we will not stop in its tracks in the US:

But the next pandemic is not likely to be MERS … But maybe the next thing that we are most at risk for is not the thing that we don’t know, but something that’s hiding in plain sight, something that could kill any of us, something that could undermine our ability to practice modern medicine, something that could devastate our economy and something that could sicken or kill millions … Antibiotic resistance…

I’m an infectious disease physician. I’ve treated patients for many infections and I’ve also treated patients for whom there are no antibiotics left. I felt like a time traveler going back to an era before antibiotics. We talk about the pre-antibiotic era and the antibiotic era. If we’re not careful we’ll soon be in a post-antibiotic era. And, in fact, for some patients and some pathogens, we’re already there.

And what does this post-antibiotic era look like? It looks like India, right now; that’s the compelling story in the Times that its readers, rightfully, aren’t letting go of. They seem to intuitively grasp, perhaps because of our recent Ebola experience, what Frieden says explicitly: “A disease outbreak anywhere is a disease risk everywhere.”

Riddle Me This: What’s an Infectious Disease?

Infectious disease?

I came across this brain-teaser in David Quammen’s masterful book Spillover: Animal Infections and the Next Human Pandemic.

In general terms, we’re pretty comfortable with what a disease is. And we certainly know the difference between an attack by bacteria versus that of a lion, say. But not so fast. Here’s Mr. Quammen’s take:

Infectious disease is all around us…. It’s one of the basic processes that ecologists study…. Predators are relatively large beasts that eat their prey from the outside. Pathogens (disease-causing agents, such as viruses) are relatively small beasts that eat their prey from within. Although infectious disease can seem gristly and dreadful, under ordinary conditions it’s as natural as what lions do to wildebeests and zebras, or what owls do to mice.

So are a pack of wolves – or human cannibals – the functional equivalent of a bunch of pneumonia bugs?

Perhaps after dinner and over a glass of wine we could discuss it. Oh wait … how would we characterize what we just did to that side of beef?

What’s safer: a stint in your local hospital or a stint in the Iraq war?

A nursing group in Texas sent us a compelling (disturbing?) chart on hospital safety which we’ve posted below (original source: http://www.accelerated-nursing.net/hospital-safety/ ). Notice how it refers to preventable deaths and that a full 25% of these are due solely to infections you pick up simply because you’re in a hospital.

And no, this isn’t just a U.S. phenomenon. In fact, Canadian numbers may be worse. For example, a CBC Fifth Estate investigation found that about 1 in 10 patients admitted to hospital in Canada contract hospital-acquired infections (versus 1 in 25 in the U.S.), and that between 8,000 and 12,000 of these patients die from them each year.

So it turns out that we’re not as safe in hospitals as we think. But that we’re even less safe in our hospitals than in the entire Iraq theater of war … what’s going on?


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