Archive for October, 2012

Monday, October 29th 2012

Hackable Medical Devices

As we become more and more reliant on active, implanted biotechnology the opportunities for malicious manipulation of such rise. The hacking of medical devices isn’t a new threat. I’ve commented on it, as have publications more prominent than this blog. The issue has taken on enough of intellectual seriousness that it has prompted the creation of a multi-institutional center, the Medical Device Security Center. In 2008 that group published a method of wirelessly accessing information from some models of pacemakers and then injecting active attacks to change the performance of the pacemakers. After publication they presented the same at Defcon.

At the Black Hat Conference last year an independent researcher presented a theoretical method of wirelessly changing the serum glucose readings of an implanted diabetic pump.

An attacker could intercept wireless signals and then broadcast a stronger signal to change the blood-sugar level readout on an insulin pump so that the person wearing the pump would adjust their insulin dosage. If done repeatedly, it could kill a person. Radcliffe suggested scenarios where an attacker could be within a couple hundred feet of a victim, like being on the same airplane or on the same hospital floor, and then launch a wireless attack against the medical device. He added that with a powerful enough antenna, the malicious party could launch an attack from up to a half mile away.

The most recent, highly publicized hack devised by researchers is one concerning implantable cardiac defibrillators. At the Breakpoint conference in Australia this year,

In a video demonstration, [researcher Barnaby] Jack showed how he could remotely cause a pacemaker to suddenly deliver an 830-volt shock, which could be heard with a crisp audible pop.

[...]

In 2006, the U.S. Food and Drug Administration approved full radio-frequency based implantable devices operating in the 400MHz range, Jack said.

With that wide transmitting range, remote attacks against the software become more feasible, Jack said. Upon studying the transmitters, Jack found the devices would give up their serial number and model number after he wirelessly contacted one with a special command.

With the serial and model numbers, Jack could then reprogram the firmware of a transmitter, which would allow reprogramming of a pacemaker or ICD in a person’s body.

Any attacks on medical devices requires more than a common level of expertise but to one dedicated probably something within the ability to be self taught. There are much bigger public health issues, even within the biotechnology sphere, including the function and operating safety of such but this remains a scary prospect and one that deserves more attention. Medical device makers need to put more into the security of these devices and the FDA needs to place a focus on making sure device makers are doing such.

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Saturday, October 27th 2012

The Medicaid Block Grant & Mitt Romney

Sometimes, for a policy proposal to be taken seriously depends on the mouths from which the proposal comes. To their credibility and moral standing on the issue. So to hear Mitt Romney on Medicaid reform is irking as insincere. A Boston Globe opinion piece recently put down the Governor’s run in charge of Massachusetts’ Medicaid program,

Buried in his 2004 [Massachusetts' state] budget, Romney proposed maximizing federal aid by taxing hospitals, shifting the resulting tax payments in and out of an uncompensated care fund, back to hospitals as adjustment payments, and diverting resulting federal Medicaid funds to state general revenue. He also proposed using taxes on nursing homes and pharmacies in his efforts to maximize and divert federal aid.

In such strategies, health care facilities serving the poor are used to claim federal funds to help the poor. But the health care facilities and the poor may get nothing, as the state diverts the federal aid to general coffers — and revenue maximization contractors reap millions in contingency fees.

While Massachusetts wasn’t the only state pulling such a plan, and indeed simliar state accounting practices remain, it did draw the rightful ire of the Government Accountability Office and eventually the Bush administration. As the Boston Globe opinion piece ends,

It’s not hard to imagine how a governor — one that employs complex shell games to find loopholes in federal rules in order to maximize and divert federal aid — would use the federal funds if handed to the state without any federal oversight. The answer to state misuse of federal aid is not to give those states even more discretion to do whatever they wish – but to simplify the claiming process, reduce loopholes allowing the revenue schemes, and improve oversight to ensure Medicaid funds are used as intended.

To be completely sincere I don’t agree one hundred percent with Mr. Hatcher, in the sense that I support state specific Medicaid waivers and perhaps reducing, across the board, requirements for the matching funds and giving states more leeway. However, I’m not sure a man who led a state in playing such a shell game with Medicaid before, should be the man leading such deregulation.

Thursday, October 25th 2012

SSRIs Associated With Intracranial Hemorrhage

Recently I was talking about how skewed my views of some therapies are as a specialist; how, despite intellectually knowing the studies and the benefits certain drugs hold, I have a near visceral reaction to them because I largely only see complications associated with them. If I ever had to go and practice primary care I would be terrible:

Me: “Hmm…you were just discharged following an MI with this new stent that Dr. Peters put in. I see you’re now on Plavix. I don’t know about that…I’m really worried you may fall and bleed in your head.

And so, I always appreciate it when new studies raise my angst a little bit. A literature review and meta analysis published recently in Neurology finds that SSRI use is associated with an increased risk of spontaneous intracranial hemorrhage.

Intracerebral hemorrhage was also associated with SSRI exposure in both unadjusted (RR 1.68, 95% CI 1.46–1.91) and adjusted (RR 1.42, 95% CI 1.23–1.65) analyses

I am trying to be a better doctor and internalize fully what I already know; that out in the real world of medicine most drugs I fear do far more harm than good and the complications I see are a relatively rare event. I don’t think I’m going to add SSRIs to the list of pressing questions I ask every new patient or family with ICH.

Me: “Does he take any medications? Are you sure he isn’t on anything that would thin his blood such as aspirin, Plavix or Coumadin? Are you sure he isn’t taking an antidepressant such as Celexa, Lexapro or Paxil? Are you sure?

Tuesday, October 23rd 2012

Physicians Are Kinda Whiners

I started writing this post on the large Physicians Foundation survey of American physicians which was recently released. As per other surveys of practicing doctors, the situation in medicine and as a physician is painted as grim in this new Physicians Foundation survey.

I was going to opine about how perceptions, such as physicians growing disillusionment with the practice of medicine, are often based on comparative change rather than a flat reality. A man who has three apples and then gets two taken away may be less happy than another who never had any apples. The increasing bureaucracy of medicine, the increasing expectations and litigiousness and the decreasing compensation all likely taint physicians view of their profession.

But as Sarah Kliff of Wonkblog points out,

It’s still one of the top paid fields in the country, with over a quarter of physicians counting themselves among the top 1 percent of earners in the United States. Doctors are among the most trusted professions. Seventy percent of patients think their doctors have high or very high ethical standards. Doctors rank third in terms of most-respected professions, right behind firefighters and scientists.

I couldn’t agree more. The changes in medicine are not wholly to the benefit of physicians to be sure and we should be actively fighting against efforts to reduce physician reimbursement but despite these changes the practice of medicine remains an illustrious profession. Physicians should realize, despite changes for the worse in medicine, how remarkable they still have it.

Saturday, October 20th 2012

Why We Should Be Pooling Medical Data

Maybe you should have to opt out of pooling your anonymized medical data. Something to think about.

Friday, October 19th 2012

Game Theory Got Residents To Where They Are Today

The National Residency Matching Program is a process almost all medical residents go through. Since 1952 the program has strived to match graduating medical students to residency training programs. Medical students are offered interviews at a number of residency programs. The medical students then rank all the residency programs they interviewed at in terms of preference, while the residency programs do the same for all the medical students they interviewed.

The algorithm the NRMP then uses to match medical students with residency programs isn’t terribly complicated to understand, but I’m sure the math behind it and proving its efficiency were.

Now two American economists whose work centered on such matching algorithms and game theory have won the 2012 Noble Prize for Economics. As the NRMP website itself describes the contributions of Lloyd Shapley and Alvin Roth,

Shapley and his colleague, David Gale, developed the “stable marriage” algorithm in which men and women rank each other as potential mates and a series of offer rounds produces a best match. The Gale-Shapley algorithm is the basis of the matching algorithm used by the NRMP, and Roth worked with NRMP to adapt it so that it proposes matches on the basis of the applicant rather than the program rank order lists.

While others built off Dr. Shapley’s work for the debut in 1952, Dr. Roth worked directly with the NRMP in the 1990s to tweak the match, especially as it related to match married couples.

For the fourth year medical students going through interviews for residency right now and the match, just remember however frustrating the process is it was complicated enough to warrant a Noble Prize. So, some respect.

Monday, October 15th 2012

Pay For Perforamnce

Health Affairs periodically published very interesting Health Policy Briefs which are great reads for anyone interested in health policy. Their most recent one is a look at the current state of pay for performance trials. My feelings on such I’ve made known, I think despite the hype their future is limited.

Studies on the effects of pay-for-performance have found mixed results. For example, a study of the Premier Hospital Quality Incentive Demonstration project mentioned earlier, led by Rachel M. Werner at the University of Pennsylvania, found that hospitals in the demonstration initially showed promising improvements in quality compared to a control group. However, the effects were short lived, and after the fifth year of the demonstration, there were no significant differences in performance scores between participating hospitals and a comparison group of hospitals not in the project.

A separate study of the Medicare Premier Hospital Quality Incentive demonstration program, led by Ashish Jha of the Harvard School of Public Health, analyzed 30-day mortality rates for patients with acute myocardial infarction, congestive heart failure, pneumonia, or coronary artery bypass graft surgery between 2004 and 2009. The results showed no difference in mortality rates between hospitals in the Premier demonstration and a control group of nonparticipating hospitals.

Here’s the Premier Hospital Quality Incentive Demonstration Program. Similar CMS, state and private pilot and demonstration programs have failed to live up to the hopes for quality improvement.

Andrew M. Ryan at Cornell University and colleagues studied the first years of the Massachusetts Medicaid hospital pay-for-performance program, which offered financial incentives for improving care for pneumonia and prevention of surgical infections, and found no improvement in quality. Another study led by Steven D. Pearson of Massachusetts General Hospital compared quality performance among Massachusetts’ physician group practices during 2001-03 and found improvement in quality measures across all of the medical groups, regardless of whether or not pay-for-performance incentives were in place. The amount of improvement was consistent with what occurred nationally during the same time period.

Suzanne Felt-Lisk of Mathematica Policy Research conducted a study of seven Medicaid-focused health plans in California from 2002 to 2005, and found that paying financial bonuses to physicians for improving well-child care did not produce significant effects in the majority of participating health plans. The lack of success was attributed to particular characteristics of the Medicaid program, such as enrollees’ lack of transportation and limited staff capacity to do outreach.

Beyond quality, I have doubts about the ability of these programs to substantially shift the health care cost curve. The reality is that true cost control will involve reigning in provider reimbursement, if that is truly a goal, which is inconsistent with the goals of pay for performance.

As for quality improvement, it may be a motivator for such, but the rewards and costs are going to have to be much more substantial. For example, as the Health Affairs Policy Brief notes,

In [a] study assessing the likely effects of Medicare’s Hospital Value-Based Purchasing Program, Werner and coauthors calculated that payments to almost two-thirds of acute care hospitals will be altered by only a fraction of 1 percent.

For any hope of effectiveness I would imagine the numbers involved, and potentially the costs of these programs, are going to have to be much more substantial. I don’t think there’s political will, nor is there likely to be any time soon, to tell providers they’re going to cut their fee schedule 10 or 15% across the board and only give that money back if the physicians meet some quality targets.

Anyway, in sum, you should read the Health Policy Brief from Health Affairs and you should be highly skeptical about the ability of pay for performance initiatives to either improve quality or reduce costs.

Saturday, October 13th 2012

The Criminalization of Medicine

There is a seemingly despicable criminal case pending in the United Arab Emirates against an aged South African pediatric hemeatologist/oncologist. Dr. Cyril Karabus was convicted in abstentia for the care he provided to a UAE child with acute, probably, lymphoblastic leukemia. He had no knowledge of the 10 year old conviction until he was detained at the airport while traveling through the UAE. Despite the fact the family who originally brought the complaint cannot be found and the original police files on the investigation are lost he remained jailed for more than 2 months until his bail yesterday.

The case has drawn criticism from an editorial in the British Medical Journal, amongst other international showings of support.

I’m concerned with the criminilization of medicine. To be fair we don’t know the specifics of the case; perhaps its etiology has nothing to do with what I’m going to opine but it provides a transition to discuss an opinion passionate to me. I think the source of this trend in criminal prosecutions for medical practice is similiar to that behind the rise of the total of civil awards for medical malpractice in the United States. Such is one thing to complain about but criminal prosecutions for similar is something to be truly alarmed about.

There is strong evidence that criminal charges against physicians for medical practices have increased around the world in recent. As republished on Kevin MD the blogger Whitecoat MD had this to say about criminal charges following perceived medical malpractice,

Take their licenses away. File civil actions against them. Jail time shouldn’t be part of the paradigm.

The further we travel down the road of criminalizing medicine, the more difficult it will become to draw a line between what is and is not considered “criminal” behavior … and the fewer physicians that will want to practice medicine.

It is a sentiment I could not agree with more with.

Perceptions of poor physician performance after poor outcomes are related to patient and family expectations of their health care. This view has consequences including an increased risk of malpractice claim, and perhaps by extrapolation criminal charges, for physicians. Other research shows that around the world, including in the middle east where Dr. Karabus’ drama is playing out, expectations of medical care are on the rise. I’m of the opinion that this is part of the rise of litigiousness against physicians and the increasing use of criminal prosecutions against physicians.

Plenty of drivers of expectations fall outside the direct control of physicians. Representations of medical professionals in the media, including dramatic representations, have played a key role. So has direct to consumer marketing of pharmacuticals and medical technologies. Physicians are faced with a considerable task in managing such expectations but have failed to rise to it.

In fact, in part physicians have played into these expectations. These expectations, and the image that physicians can live up to such, are associated with increased occupational prestige and, perhaps more importantly, increased health care utilization. Such utilization plays into the increasing procedure oriented nature of health care, especially in the United States, and the growth in physician income associated with such. I’m sure every one of my colleagues reading this can claim themselves innocent of such and cite their extensive time counseling patients during consents for treatment or their refusing unnecessary requested treatments to patients; examples, I suppose, of managing expectations. It seems much like how it is always someone else doing the equivocal spine surgery.

The criminalization of medical practice is a very bad thing, particularly so in the case of Cyril Karabus with the flaunting of due process in the case. Physicians need to do more in mitigating expectations and bringing such in line with reality, to help reverse the trend.

Thursday, October 11th 2012

Fungal Meningitis After Epidural Steroid Injections

While only level II evidence through the literature I am a firm believer in epidural steroid injections for the short term relief of radicularesque pain. As most etiologies of this type of pain over the long term improve with or without surgery, epidural steroid injections can be a part of controlling symptoms in the short term while the disease process itself, usually a nerve pinched by a disc, improves. I refer plenty of patients, with symptoms that are very young or symptoms that are poorly localized or symptoms I think otherwise may be poorly responsive to decompressive surgery, to pain specialists for consideration of injections.

While hematoma, intravascular embolic events, and infection are all well reported after epidural steroid injections the procedure generally has a low complication rate; seemingly lower than a minimally invasive surgery for decompression of a nerve root. So while I know that reasonably this recent outbreak of fungal meningitis associated with contaminated compounded steroid used in epidural steroid injections does not raise the risk for any patient I refer for such in the future, and should not likely in anyway influence a referal for such, it is still a little scary.

About 13,000 people may have been exposed to the tainted steroid that has been linked to a growing outbreak of fungal meningitis, a spokesman for the Centers for Disease Control and Prevention said.

[...]

The company that made the drug, the New England Compounding Center in Framingham, Mass., has shut down, surrendered its license and recalled all its products, not just the steroid.

The disease centers said that the company began shipping potentially contaminated lots of the drug on May 21, and that people who had the treatment for back pain — called a lumbar epidural steroid injection — after that date should seek medical attention if they develop symptoms like severe or worsening headache, fever, stiff neck, dizziness, weakness, sensitivity to light or loss of balance.

The death toll from the exerohilum and aspergilis meningitis has risen to 14. That’s about a 10% mortality so far considering just under 170 cases have been reported. The CDC has a website listing recommendations for those afraid they may have been exposed, as well as a list of the facilities which used the recalled methylprednisolone. It is scary and a reminder that even the simplest procedures hold inherent risks, but it shouldn’t move us off rationally judging those risks and continuing to use effective treatments when warranted.

Tuesday, October 9th 2012

Intracranial Pressure Monitoring May Need To Be Something Less Routine

The brain is encased in a closed box – the skull. Anything added to the box can raise the pressure inside of it and, the thought is, damage brain potentially secondary to that raised pressure. In situations where things have been added to the box secondary to trauma – blood or edema – it has long been thought that knowing just how high the pressure was inside the skull, and doing things to lower that pressure, would improve the outcomes in patients who have suffered traumatic brain injuries. It has become essentially standard of care. The Guidelines for the Management of Severe Traumatic Brain Injury give level II credence to,

Intracranial pressure (ICP) should be monitored in all salvageable patients with a severe traumatic brain injury (TBI; Glasgow Coma Scale [GCS] score of 3–8 after re- suscitation) and an abnormal computed tomography (CT) scan. An abnormal CT scan of the head is one that re- veals hematomas, contusions, swelling, herniation, or compressed basal cisterns.

And level III credence to,

ICP monitoring is indicated in patients with severe TBI with a normal CT scan if two or more of the following features are noted at admission: age over 40 years, uni- lateral or bilateral motor posturing, or systolic blood pres- sure (BP) 90 mm Hg.

I would say on their training and anecdotal experience plenty of neurosurgeons, those still involved in trauma and critical care, might give intracranial pressure monitoring even more weight.

Despite this, there is considerable equivocality to the role of intracranial pressure monitoring. While a majority of published retrospective studies have claimed that intracranial pressures above a certain level are associated with a worse outcome and have tried to assign causality to such by claims that controlling pressures below such levels leads to better outcomes, the data, even from these retrospective looks, is hardly homogenous.

There were no group differences in age, gender, or GCS. After adjusting for multiple potential confounding factors including, admission GCS, age, blood pressure, head AIS, and injury severity score (ISS), ICP monitoring was associated with a 45% reduction in survival (OR = 0.55; 95% CI, 0.39-0.76; p < 0.001).

There has never been a randomized trial of intracranial pressure monitoring for traumatic brain injury. At least there hadn’t. An ambitious project led by Dr. Randall Chestnut, based on U.S. money but out of centers in latin America with the ALAS and LABIC, just presented at the Congress of Neurological Surgeons. Patients with severe traumatic head injuries (Glasgow Coma Scale =<8) were randomized into those received intracranial pressure monitors and those note. Those not underwent standard therapies for suspected elevated intracranial pressures based on imaging characteristics and neurological exam; the same therapies directed at those patients who had monitors placed and had documented elevated intracranial pressures. There doesn’t appear to be a short term survival difference between the groups.

It isn’t a knock against the role of elevated intracranial pressure in outcomes following traumatic brain injury. It is, at least a slight knock it would appear, against invasive monitoring. Treating for presumed elevated intracranial pressure based solely off imaging findings and clinical exam appears to be just as efficacious, at least on some metrics, as treating a known intracranial pressure.

Monitoring intracranial pressure, while a common and relatively simple procedure, still requires an invasiveness that is not without risk and morbidities. It entails an incision on the scalp and creating a hole in the skull and then opening the cover around the brain to insert a foreign device into the brain itself. If it is true that the information provided by that device does nothing to improve the management and outcomes of brain injured patients then it is hard to justify such insertion on a routine basis as has become the standard of care. I’m interested to read when the results are finally published.