Medical Errors

Meningitis deaths could have been avoided

December 18, 2012
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This op-ed is co-authored by Jeff Borkan, Chair of the Department of Family Medicine at Brown University School of Medicine.

The media attention and Congressional investigation into the tragic epidemic of spinal meningitis in people who had injections for back pain has focused on unsanitary conditions at the compounding pharmacy that produced the medications. At last count 620 cases and 39 deaths have been confirmed in 19 states because the steroids used in the injections were contaminated with a common fungus. Yet remarkably little has been said about the underlying cause of this tragic outbreak -- the widespread overuse of an unproven procedure (epidural steroid injections) that put the contaminated steroids into the spinal cords of patients in the first place.

The procedure involves inserting a needle into the spinal canal, one of the most vulnerable parts of the human body, and then injecting steroids, which are supposed to reduce inflammation and allow the back to heal. Each year, more than 9 million Americans are treated with spinal steroid injections, and one study found that the number of Medicare recipients undergoing this procedure increased by 159 percent between 2000 and 2010.

How did steroid injections come to be performed so often? Patients assume that most medical treatments are supported by years of careful studies. They think any invasive procedure that might put them at risk of harm is performed only by trained and certified physicians with rigorous clinical oversight.

In the case of spinal steroid injections, nothing could be further from the truth. There is no widely accepted guideline for the use of epidural steroids, and the U.S. Food and Drug Administration has never specifically approved steroids for that use. There is scant medical evidence to show that the use of epidural steroids is any more effective at relieving back pain than routine, conservative care or even sham (fake) injections. There are many possible side effects of this procedure, and while the most serious complications are rare, they can be disabling or life threatening. Yet this unproven, risky treatment is routinely offered on an outpatient basis by physicians who have widely varying levels of training and expertise. While most of those physicians undoubtedly believe they are acting in their patient’s best interest, there is no escaping the fact that they are paid nicely for a procedure that takes only a few minutes to perform.

There's no doubt that regulators should go after the makers of unsafe medications. Slipshod manufacturing practices can't be tolerated when people's lives are at stake. At the same time, we need to rethink our willingness to pay for procedures and tests that have known risks and unknown benefits. Epidural steroid injections are just one of myriad examples of such treatments, and taken together, the overuse and misuse of medical procedures is costing us dearly, both in terms of wasted dollars and wasted lives. It’s time to build a health care system that serves patients rather than profits, and the first step is recognizing tragedies like the spinal meningitis outbreak for what they are, cases of overuse.

Advanced Screening of "Escape Fire" in NYC

July 26, 2012
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On Friday August 6th, the New America Foundation will be hosting an advanced screening of "Escape Fire: The Fight to Rescue American Healthcare." The event will take place in New York City from 6:30pm-8:30pm. Watch the trailer here.

Directed by Matthew Heineman, “Escape Fire” is a stirring documentary about the perilous situation of our current healthcare system, and what can be done to fix it. The film, which has been honored at both the Sundance Film Festival and the Full Frame Festival, is being screened nearly two months before it comes out in theaters. More details, as well as a link to RSVP, are available here, at the event's page:  "Escape Fire - Screening Event"

NEJM Headed in the Right Direction on Overuse

July 26, 2012

The New England Journal of Medicine just published a great article about physician stewardship as it relates to medical spending. The piece, called "Cents and Sensitivity—Teaching Physicians to Think about Costs," discusses whether or not we should be training physicians to consider the bills patients will face when making decisions about what treatment to choose. (Aaron Carroll’s treatment of this piece is here.) The authors propose that teaching physicians to be more cost-conscious will increase their capacity to care for the whole patient, not just their symptoms:

"Whether it’s lack of time, fear of “missing something,” or simple ignorance, the incentives to do more often overwhelm our impulse to use resources wisely. Now some educational reformers are offering us an added ethical incentive. Put simply, helping a patient become well enough to climb the stairs to his apartment is meaningless if our care leaves him unable to afford that apartment. Protecting our patients from financial ruin is fundamental to doing no harm."

We agree that overtreatment is a problem, and we applaud the NEJM for addressing it. It says a lot about how far we have come from even five years ago when everyone was thumping their chests and talking about how we have “the best healthcare in the world.” But we believe that there’s an even greater reason to address the topic of overtreatment: because it is dangerous. Starting with the Institute of Medicine’s 1999 report, “To Err is Human,” the research has continued to demonstrate that more does not always mean better

So yes, physicians should consider what patients can afford, but even before that, physicians need to realize that doing nothing is often safer than putting patients at risk with treatments that don’t work. Fiscal responsibility—making sure we aren’t sending Grandpa Frank from the ICU to the poor house—will be the natural consequence.

Drug Regulation, Symbolic Votes, and Hospital Safety

July 16, 2012

Here's our wrap-up of last week's articles by our own Shannnon Brownlee and Joe Colucci:

Letting Big Pharma Review Its Own Drugs — What Could Go Wrong? (The Atlantic Health Channel):

Earlier this month GlaxoSmithKline agreed to pay a record breaking $3 billion fine for a slew of criminal and civil violations. But is a fine really enough? In a piece in The Atlantic, Shannon Brownlee and Joe Colucci argue that we need to stop letting drug companies track the post-market safety of their drugs and establish an external automatic review system. 

 

12 Ways Health Care Could Be Improved If the House Wanted to Hold More Than Symbolic Votes (The Atlantic Politics Channel):

In the wake of the House's 33rd vote to repeal/defund Obamacare, Joe and Shannon propose a list of 12 things the House could have done to make a better use of tax payers' dollars and actually improve health care. In the article in The Atlantic the proposals range from enacting a less intrusive mandate to funding after school programs to teach kids how to cook. Any of them would have worked better than another "symbolic vote."

 

Why The ‘Best’ Hospitals Might Also Be The Most Dangerous (TIME Ideas):

We've all seen them—the U.S. News Rankings of everything from colleges to cars. How do their hospital rankings look? In her latest article for TIME, Shannon argues that, based on new rankings by Consumer Reports, many top-name hospitals fail to measure up in terms of safety. Hospital rankings would be a lot more useful if they considered how medical care affects most patients, not whether a hospital performs some cutting-edge procedure on three patients per year.

We need universal Phase IV clinical trials!

July 5, 2012
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PharmedOut, a project of the Georgetown University Medical Center, had its third annual conference a couple weeks ago in DC. The meeting was called “Missing The Target: When Practitioners Harm More Than Heal,” and it addressed some of the most important issues in health policy—issues that have been disturbingly absent from the public discussion. While the news media and members of Congress have spent the last several years discussing insurance coverage (or, more often, what the most recent vacuous coverage-related talking point means for the political horse race), issues of patient safety have been left on the sidelines. The PharmedOut meeting was a welcome opportunity to return to focusing on patients.

One of the most compelling moments came during Dr. Amy Friedman’s talk. Dr. Friedman is a transplant surgeon, and frequently speaks to groups of surgeons. She asks them a number of questions during these presentations—her favorite of which is “True or false: All medical devices used in the US have been proven safe and effective.” A large majority of the surgeons she talks to know that the answer is “true.”

The trouble is, of course, it’s not.

I can understand members of the public getting that wrong--after all, the Food and Drug Administration is responsible for making sure that all foods, cosmetics, pharmaceuticals, and medical devices are safe, and that the latter two are effective. But it's inexcusable for doctors to be so ignorant of the weaknesses in our regulatory system.The fact is, there are gaping holes in device approval processes, to the extent that many medical devices in use today have never been tested for effectiveness.

When the FDA started regulating medical devices in 1976, the agency established rules that assumed any device already in use was  safe and effective (unless it was already known not to be), and those devices continued to be sold. That grandfather clause included a number of basic and obviously safe devices, like tongue depressors and scissors, but it also covered higher-tech devices like the implantable pacemaker (invented 1958).

The FDA also waives testing requirements for "low or moderate risk” devices that are "substantially equivalent” to devices already on the market, in what’s known as the 510(k) process. For those devices, the device maker doesn't have to get approval from the FDA to sell it--they just have to give the FDA notification before they sell it. That means minor modifications to existing devices don’t require new clinical trials. When used intelligently, the rule is entirely appropriate--there's no need to redo clinical trials for small tweaks to products that can't affect the safety or effectiveness of the device. As the FDA has applied it, though, the 510(k) rule has become a giant loophole, and the vast majority (over 90%) of newly approved devices are approved through that pathway.

The problem is simple if you think of medical devices as undergoing evolution: each new device is slightly different from its parent (known as the "predicate" device). Once it's on the market, the modified device can be used as a predicate for another modification. Over time, compounding small changes can get you a tool or implant that bears no resemblance to the original device that actually went through clinical trials. Worse, some of the original predicates are those devices the FDA grandfathered in, and may never have gone through clinical trials.

The holes in the approval process have caused real harm. Take the example of metal-on-metal artificial hips: DePuy ASR hips were approved based on substantial equivalence to another hip with a metal head and a ceramic or polyethylene socket joint, so they were never tested prior to market. It was only after thousands of people received the hip that it became clear that the metal-on-metal joint was scraping off bits of cobalt-chromium alloy into patients’ bodies—and worse, the hips were failing early and often. If clinical trials had been conducted, thousands of patients might have been saved the pain and hassle of a failed hip and an extra operation to fix it.

There’s a better way to do device approvals—a middle ground between requiring randomized trials for every minute change in a device’s design and letting device manufacturers run completely free. We should be tracking what happens to patients after they receive new or experimental devices. We should develop a national, automated database that registers each patient who receives a recently-approved device, and monitor those patients for device-related complications for several years. During that time, all patients receiving the new device should be informed that their device is still semi-experimental, and that they are part of a Phase IV clinical trial to find out more about what the device actually does. If that information makes patients want to use older, better-understood devices, that's not a reason to claim regulations are holding back progress in medicine--it's giving patients complete information, and letting them choose the care they want. Forcing patients to use new, unproven devices (by failing to tell them about the experimental status) is no more ethical than denying patients new treatments in favor of old.

Tracking outcomes in a large-scale database works: a similar registry was a key part of the Australian research that discovered problems with DePuy hips. Reporting doesn't don’t have to be intrusive or an administrative burden, either. Wal-Mart and Amazon collect data on every transaction, every day, to better understand their customers and manage their inventory; customers hardly even notice. Even the data analysis can be largely automatic.

Tracking new, untested devices is a no-brainer. There are legitimate privacy concerns with such a database, but large datasets with  medical, personal, and financial information are routinely scrubbed so researchers can’t find private information about any individual. There’s no excuse for continuing to let Wal-Mart do better at understanding what affects its sales than researchers and doctors do at understanding how to make patients healthy.

The Number of the Day

June 12, 2012

The number of the day:  11%

That's right, kiddos.  The number of the day is 11%--the probability of randomly picking Grumpy if Snow White, the Seven Dwarves, and Prince Charming all sit down for tea... or, in this case, the 11% of people in the US, according to the CDC, who are taking five or more prescribed medicines. 

You read that right.  One in nine Americans is taking five or more prescription drugs.  In the medical world we call that "polypharmacy," and it makes the doctor's job a lot harder. Each new medicine that is introduced into your body increases the chance of drug-drug interactions with undesirable side effects. While practitioners receive extensive training on how these drugs interact and which ones not to combine, there still remains a risk associated with polypharmacy. The more possible interactions, the more likely it is that a doctor might miss one. That becomes even more likely when the evidence on drug interactions can be flawed, incomplete, or falsified. Having so many people on so many drugs is practically begging for errors to happen.

Such a suggestion is made by Jeanne Lenzer in a recent article published in the BMJ.  Lenzer cited a report from the Institute for Safe Medication Practices (ISMP) which "calculated that in 2011 prescription drugs were associated with two to four million people in the US experiencing serious, disabling, or fatal injuries, and 128,000 deaths."

Leading this pack of oft-misused drugs are anticoagulants like warfarin, which the authors report "prevents ischemic strokes in approximately 1% of high risk patients a year, but causes major bleeding in an estimated 3%."  Other harm-causing drugs include an antibiotic (levofloxacin); a cancer drug (carboplatin) and a hypertension drug (lisinopril).

Numbers like 11% suggest that we need to re-evaluate the safety and effectiveness of many "standard" practices.  Numbers like 11% contribute to the staggering 128,000 deaths associated with prescription drugs--that's 10 times the number of people killed in drunk driving accidents each year.  It's not surprising, then, that ISMP calls prescribed medicines "one of the most significant perils to human health resulting from human activity."  We have Mothers Against Drunk Driving, but maybe it's time for Mothers Against Profligate Prescription.

A Humorous – But Revealing – Aside

April 12, 2012
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Over at The New Yorker, David Sedaris has an amusing piece on his experiences with “socialized medicine.” It’s worth a read – if not for the humor, then for its helpful illustrations of concepts directly relevant to health policy.

Take, for example, this section:

The time before that, I was lying in bed and found a lump on my right side, just below my rib cage. It was like a devilled egg tucked beneath my skin. Cancer, I thought. A phone call and twenty minutes later, I was stretched out on the examining table with my shirt raised.

“Oh, that’s nothing,” the doctor said. “A little fatty tumor. Dogs get them all the time.”

I thought of other things dogs have that I don’t want: Dewclaws, for example. Hookworms.

“Can I have it removed?”

“I guess you could, but why would you want to?”

He made me feel vain and frivolous for even thinking about it. “You’re right,” I told him. “I’ll just pull my bathing suit up a little higher.”

While certainly a humorous tale, there are also several relevant kernels of truth for health policy. Most people wouldn’t blame Mr. Sedaris for wanting the tumor out – it seems, after all, a perfectly logical reaction for a patient. Notice his doctor’s response, however: “why would you want to?”

The doctor in this story could easily have said, “You’re right: let’s get it removed right away!” Mr. Sedaris, not knowing any better, would probably have gone right along with the program, and the harmless tumor would have been removed. Taken in aggregate, however, these decisions can generate significant costs without corresponding positive health returns. Sure, Mr. Sedaris would be able to wear his bathing suit as he likes, but the French government – or whoever insures his care – would have borne the cost for this convenience.

Similar situations occur every day in the US, with distinctly different results. Patients seem to expect care from their physicians, and doing nothing can seem like the exact opposite of care – despite the fact that it might often be the more prudent medical decision. Removing the harmless tumor or performing an unnecessary MRI  may not be worth the cost, and poses the risk that Mr. Sedaris might contract an infection or have some other complication. In aggregate, such care accounts for a not-insignificant chunk of America’s health care costs.

American medicine, therefore, might do well to take note of Mr. Sedaris’ cautionary – if humorous – tale, and start getting the country used to the idea that we might all be better of if doctors provided less care instead of more. If that means we all might have to pull our bathing suits up a little higher in support for Mr. Sedaris and his fatty tumor, so be it. 

One in Seven

January 10, 2012
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If you ran a summer camp that never reported the vast majority of times that you hurt one of your campers, you'd probably be shut down, arrested, or worse. The situation would be similar if a restaurant repeatedly made customers sick, or if a skydiving business habitually gave people the wrong parachutes.

Why, then, do hospitals only report about one in seven of the hundreds of thousands of medical errors, infections, and other adverse events that harm patients every year? And why can they get away with it?

That's a crucial question posed by Shannon Brownlee's most recent piece on TIME Ideas: An American Hospital: The Most Dangerous Place? Brownlee addresses the recent report from the US Department of Health and Human Services, which catalogued problems with the reporting system for medical errors and other patient harm. She argues that the reporting problems are only a piece of a larger quality and safety problem, and that hospitals need to move quickly to adopt checklists and other types of safety mechanisms:

"Some hospitals have made great strides in reducing errors and infections using — you guessed it — checklists. About 10 years ago, Dr. Peter Pronovost, an intensive-care specialist at Johns Hopkins Hospital in Baltimore, and a team of colleagues put together a series of checklists for some of the most common procedures performed in the intensive-care unit. For example, they created a list of steps for how to put in a central line — a tube for delivering medication directly into a vein in the patient’s chest — in a way that reduced the risk of infection. They made a checklist to prevent patients on a ventilator, or breathing machine, from contracting pneumonia. When Pronovost was given a grant to get every ICU in the state of Michigan to use just three of his checklists, the result was 1,500 lives saved and the state of Michigan saved $100 million."

You can read the full story here: http://ideas.time.com/2012/01/09/american-hospitals-the-most-dangerous-place/

Graphic Interlude!

September 16, 2011

We don't often post raw links or pictures without commentary, but the last few weeks have involved a few great ones that we couldn't pass up.

First: via the new Washington Post Wonkblog (congrats on the new site, guys!), Dr Seuss explains the medical arms race in the video to the right! (Watch it fullscreen--it's worth it!)

Innovative Health Care Companies

September 12, 2011
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In March, Fast Company magazine recently released their “10 Most Innovative Companies in Health Care” list for 2011. Somehow the article about it popped up on our Google Reader last week, so we decided to take a look. The list didn't seem to get much attention the first time around, and it's worth taking another look now. 

 

The list ranges from industrial titan GE, recognized for their vastly miniaturized handheld ultrasound machine, to the Cleveland Clinic, for “rethinking the entire hospital experience.” Nice to see companies on the list who are focusing on making medicine better, rather than simply making it more technologically advanced.

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