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Archive for May, 2012

Thursday, May 31st 2012

Therapeutic Effects of Intra-Arterial Delivery of Bone Marrow Stromal Cells in Traumatic Brain Injury of Rats

Background
No where in medicine are the dreams for stem cells bigger than in treatment of diseases of the central nervous system. From neurodegenerative diseases to strokes to traumatic brain and spine injuries considerable work has been done. Specific attention being paid to autologous adult bone marrow stem cells which do not carry the risk of cancer, rejection and are readily available. Previous work has documented their ability to cross the blood brain barrier and to differentiate from BMSCs into microglia and neural cells. In a recent edition of Neurosurgery a group from the Hokkaido University Graduate School of Medicine presented BMSC use in a rat model of TBI.

Osanai, Toshiya, Satoshi Kuroda, Taku Sugiyama, Masahito Kawabori, Masaki Ito, Hideo Shichinohe, Yuji Kuge, Kiyohiro Houkin, Nagara Tamaki, and Yoshinobu Iwasaki. “Therapeutic Effects of Intra-Arterial Delivery of Bone Marrow Stromal Cells in Traumatic Brain Injury of Rats – In Vivo Cell Tracking Study by Near-Infrared Fluorescence Imaging.” Neurosurgery 70:435-444, 2012.

A link to the article is here.

Design
The group induced “traumatic” lesions in 12 Sprague-Dawley rats by exposing a unilateral sensorimotor area with craniotomy and applying a freezing 7mm cylinder (cooled in liquid nitrogen) to the dura over the area causing an underlying lesion and significant post injury motor dysfunction.

Of the 12 rats 6 were then injected with an extimated 2 x 10^6 bone marrow stem cells in 200 microliters of saline through the ipsilateral internal carotid and 6 were injected similiarly with 200 microliters of saline. The injections occured 7 days post injury. The group derived the BMSC non-autologous bone marrow from the femurs of other Sprague-Dawley rats after death. These were labeled with PKH26 prior to implantation and with fluroscent cell markers for optical imaging.

The outcomes were functional recovery, in vivo optical imaging and histological examination after euthanasia.

Results
Optical imaging showed that in the ipsilateral side to the injury the injected BMSC left the vasculature and began engrafting into the damaged cortex as quickly as 1-3 hours after injection.

After death of the animals histological examination of the brain showed that the PKH26 labeled cells were primarily to be found in the damaged hemisphere and 22% showed NeuN and 18% showed GFAP implying that the BMSC were differentiating into neural elements.

The implanted animals showed statistically better motor improvement at 2 and 3 weeks post implantation.

Discussion
More importantly than showing functional recovery this paper’s biggest showing is a clinically, real world applicable method of stem cell administration, within a time frame that would be reasonable for clinicians and patient’s suffering traumatic brain injury.

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Thursday, May 31st 2012

International Medical Device Sales Should Have More Regulation

I can’t believe that title considering my typical political ideology. But consider the case of DuPuy’s ASR hip.

The health care products giant Johnson & Johnson continued to market an artificial hip in Europe and elsewhere overseas after the Food and Drug Administration rejected its sale in the United States based on a review of company safety studies.

[...]

There is no suggestion that Johnson & Johnson broke the law. Regulatory standards in other countries, like those in Europe, for approving the sale of medical devices are typically lower than here. A spokeswoman for a British regulatory agency, the Medicines and Healthcare Products Regulatory Agency, said that companies like Johnson & Johnson were not required to notify it when the F.D.A. refused to approve a product that was used in patients there.

The ASR is now under recall.

I guess I’m not truly in favor of MORE regulation. But if you’re going to have regulation in place, it seems reasonable for different regulatory agencies to communicate across international lines. It seems a small step for every medical device regulatory agency to require companies to report decisions on their devices from other regulatory agencies. So, say, if DuPuy got a non-approval letter from the FDA they would be required to let the MHPRA in the United Kingdom know that. The bureaucrats in England can do whatever they want with that information – no one is holding them to the same decision as the FDA – but it would provide them with a better picture as they regulate the DuPuy’s device.

Tuesday, May 29th 2012

Debt Collection Is A Brutal Business

Accretive Health provides ‘financial’ services to health systems. Chief amongst them, collecting overdue bills from patients. As the debt collection practices grow more and more aggressive, collectors like Accretive are coming under the microscope. No longer is this solely a matter of outpatient letters or calls, but instead increasingly bold steps at the inpatient level.

Hospitals have long hired outside collection agencies to pursue patients after they have left hospital facilities. But financial pressures are altering the collection landscape so that they are now letting collection firms in the front door, according to Don May, the policy adviser for the American Hospital Association, a trade group.

To achieve promised savings, hospitals turn over the management of their front-line staffing — like patient registration and scheduling — and their back-office collection activities.

Accretive Health in particular is drawing a lot of attention for actions in Minnesota. Attention going all the way up to the State Attorney General’s office.

Employees were told to stall patients entering the emergency room until they had agreed to pay a previous balance, according to the documents. Employees in the emergency room, for example, were told to ask incoming patients first for a credit card payment. If that failed, employees were told to say, “If you have your checkbook in your car I will be happy to wait for you,” internal documents show.

Employees at Accretive’s client hospitals ask patients to make “point of service” payments before they receive treatment. Until she went to Fairview for her son Maxx’s ear tube surgery in November, Marcia Newton, a stay-at-home mother in Corcoran, Minn., said she had never been asked to pay for care before receiving it. “They were really aggressive about getting that money upfront,” she said in an interview.

In particular there is concern that employees may have violated provisions of EMTALA by discouraging patient’s from seeking care and that they and the hospitals may have violated provisions of HIPPA by having access to protected information.

Not that Accretive doesn’t have its proponents, including Rahm Emanuel who has spoken up for their body of work if not for their strategies in Minnesota.

On reading about this my libertarian tendencies surface. In general I think aggressive collections prior to care are tactless, morally repugnant and in many cases bad business. It isn’t how I would run a hospital. However, if that’s the way companies like Accretive and hospitals like Fairview want to play it then I think that should be within their rights. I’m against legislating them off of such.

Monday, May 28th 2012

Resident Physicians As Colleagues

I was half asleep typing a consult note as my last call creeped closer to finishing, about one in the eerie morning, when a string of pages awoke me. Amongst them was a consult for a patient who the neurosurgical service had recently discharged with a non-operative traumatic subdural and who had returned with an episode of vomiting. As the other resident talked and mentioned that the repeat head CT looked exactly the same I made an off handed remark, “Yeah, doesn’t sound like there is anything really to do.” But I take down the patient’s location and the call ends.

Less than 5 minutes later I get a page to the same number. On returning it it’s the resident’s in house attending who picks up to chastise me a little and make his expectations for this bounce back patient clear. Take the quotes with a grain of salt but the jist is there,

“You need to come lay eyes on this patient and examine him. And you need to drop a note. And if you think this patient can go home then you need to do that sooner rather than later, not three hours from now, so we can get him out. Is that understood?”

No yelling, nothing unprofessional but certainly putting me in my place.

Apparently my line above about not doing anything had drawn some concern from the resident that perhaps I wasn’t coming to see that patient, despite the fact I went on in the conversation to ask where the patient was located. That aside, what if I had truly thought the patient could go home without being seen?

It would’ve been a completely clinically appropriate decision that this patient did not need to be seen by a neurosurgeon again. One that plenty of neurosurgeons would have made. I can envision rare scenarios where the above lines of commands would’ve been given to a private neurosurgeon at 1 A.M. if he had decided he didn’t need to see this patient.

“You need to come into the hospital, examine this patient and drop a note. Yeah, he’s GCS 15, completely intact and his scans look exactly the same from the last time you saw him, but you need to get your ass in here,” just does not happen. And certainly not at 1 A.M. If it does, that’s maybe the end of neuro specialty coverage for that physician who called.

But there is something different about academics, and not for the better.

Resident coverage gets taken for granted. I’ve discussed this before as it relates to nurses. It appears okay to call at 2 A.M. about an incentive spirometer for a patient at an academic hospital because you’re only paging a resident and they’re already in house but it’s not okay to make that same call to a private physician at home. Something similar was going on here.

But I think we deserve a little bit more respect.

Let’s imagine the attending who called me is both young and has spent his entire practice in academics. Let’s imagine that because it highlights the problem.

What if I was a fifth or sixth or seventh year resident? I would be getting these lines from an attending who essentially I had been an M.D. as long as he or she had. And these interactions certainly happen between residents in specialties with lengthy training and young attendings on other services.

The point is, while there was nothing unprofessional per se about what happened, it would’ve been far more appropriate for this attending to have a less teacher-pupil/parent-child conversation and more of a colleague-colleague one with me.

“Hey, I’m just giving you a call back to see if you’re gonna come see this guy, I guess it was unclear if you thought we could just send him out or not. I’d really appreciate it if you’d see him, I think it’s really important for him to talk to the neurosurgery team again because he has some questions and concerns.”

Tuesday, May 22nd 2012

Metastatic Brain Tumors

In a patient with a known history of cancer, what percentage of new intracranial lesions will be metastatic?

Read More »

Monday, May 21st 2012

A Surgeon Is A Surgeon

A Laredo dentist is on the hot seat for Medicaid fraud and practicing medicine without a license. Insurance fraud is an everyday thing unfortunately and worth a further post. What I find incredible though was the dentist’s defense of his cosmetic surgery procedures – including tummy tucks and breast augmentations,

The dentist argued that he was “qualified to perform the challenged procedures because he is a surgeon and, under the Texas Medical Practice Act, ‘the terms “physician” and “surgeon” are synonyms,’” according to court documents. But in August 2009, he “pleaded guilty to seven counts of the third degree felony offense,” reported the Fort Worth Star-Telegram in a blog post accompanied by curious artwork. He received a five years in prison for those crimes, but had his sentence suspended and was placed on probation.

I suppose he has some know how and it certainly does not rise to the level of this incredible story I read last year from Florida.

A transgender woman in South Florida faces charges of practicing cosmetic surgery without a license, after police say she injected an unwitting patient’s buttocks with a handful of unsafe substances, including tire mender Fix-A-Flat

[...]

The injection took place in a residential setting, where Morris shot a mix of cement, glue, mineral oil and tire sealant into the woman’s buttocks

The “practitioner” in this case was paid $700 for a butt injection; an attempt at a fuller behind for cosmetic reasons. Needless to say the patient required hospitalization. A part of my libertarian side says we should open up the practice of medicine. As a patient you should be able to cipher through the claims of all practitioners, go over their creditionals and if you want to pay someone to do something to you, then go for it. Then you read stories like the one from Florida and rethink it.

Sunday, May 20th 2012

Counterfeit Medications

Counterfeit pharmaceuticals are on the rise. Consider the several discoveries of fake Avastin in the United States, the latest announcement of such coming just last month.

The FDA said on Tuesday it had identified a new batch of bogus vials of the injectable cancer treatment containing none of Avastin’s active ingredient, bevacizumab.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said it was looking into how the latest counterfeit batch entered Britain before being sold in the U.S. market.

With costs of a complete treatment running $40,000 to $100,000 specialized drugs like Avastin are probably the most promising target for counterfeiters. The problem is hard to get ahold of. Many pharmacutical companies in India for example blatantly ignore international patents and produce technically counterfeit drugs, but, admitting the potential questionable production quality, at least intended as efficacious. If you include these violations of intellectual property rights India produces more than 75% of all counterfeit drugs.

What is obviously more alarming however is the problem in the western world, the example like that of Avastin. Less than 1% of all drugs in the United States are counterfeit it is true. But the problem appears to be on the rise.

[T]here is no question that counterfeit medicines are a huge and growing problem, the human costs of which are immense. Patients the world over have suffered injury, nontreatment, and death. High-profile cases include individual tragedies — such as the death of the 18-year-old American Ryan Haight, who in 2001 overdosed on prescription drugs he had purchased online — to public health disasters. During a 1995 meningitis outbreak in Niger, for example, 50,000 people were accidentally inoculated with fake vaccinations. 2,500 of them died. And over the last decade, hundreds of children have died from tainted counterfeit cough syrup.

International organizations like Interpol and WHO certainly take the problems seriously but obviously the tracking of international drugs, as they start to cross borders, is difficult. Without domestic enforcement in countries where production happens the problem is difficult to address. And in many of these country’s their is little available police resources for such a problem low on the triage, and indeed, sometimes there is even a lack of will for such.

Wednesday, May 16th 2012

Plavix Coming Off Patent

If I was a cardiologist or a primary care physician or a neurologist I might love Plavix. As a neurosurgery resident I have a decidedly different view.

We know that anticoagulation therapy is associated with larger intracranial bleeds in trauma as well as worse outcomes. And we should have no doubt that antiplatelet therapy carries a similar risk. Indeed, Plavix is probably associated with worse outcomes in traumatic brain injury, although the data is scarcer for a drug like Plavix as compared to say warfarin.

Don’t get me wrong, cerebrally I know that the data supports its use whole heartedly. These are, typically, patients whom Plavix has helped save from further heart or brain attacks. The risk they face from such far outweighs the risk of an intracranial bleed. That said, it is hard to put aside what I see everyday; that is trauma patients with large bleeds associated with antiplatelet or anticoagulant use.

Well, Plavix, one of my largest scourges, is coming off patent.

The drug is set to lose its patent protection on Thursday. Faced with an expected influx of cheaper generic alternatives, Bristol-Myers Squibb, which sells Plavix in the United States under a partnership with Sanofi-Aventis, has said it no longer plans to actively promote the drug.

“This is one of the behemoth drugs that really defined the drug industry in the ’90s,” said Catherine J. Arnold, an analyst for Credit Suisse.

I’ll take comfort in the fact that the cheaper costs of generics typically does not actually lead to increased use of a drug. For me that would be a horror scenario. And I’ll keep telling myself that, despite my very limited view point, these are drugs that actually do far more good than harm.

Tuesday, May 15th 2012

Lovesickness Is An ICD-10 Diagnosis

This is an incredible story out of the United Kingdom. A family is claiming malpractice over a little girl’s death from tuberculous. The most sensational stuff is some of the etiologies some of the physicians tried to ascribe to the girl’s symptoms.

An inquest heard that her GP, Dr Sharad Shripadrao Pandit, accused her parents of “mollycoddling” her.

Shockingly, he even claimed her symptoms were brought on because she was ‘lovesick’.

Inappropriate to judge stories of malpractice out of a newspaper. But if even a modicum of truth is in the transcripts out of the Coroner’s Court are true then this is a horror. My thoughts are with her family.

 

Saturday, May 12th 2012

Talking About Sudden Health Issues

I love patient blogs. I love the personal narrative as a patient, hearing patients tell their stories. Especially concerning sudden, acute life altering health issues. It’s not watching a train wreck; it is uplifting and motivational. I once heard Jill Taylor speak and while I was underwhelmed with the performance as a public speaker (no offense) I did enjoy her book talking about her experience recognizing she was having a stroke to being a patient to recovering.

Senator Mark Kirk, the man who followed Roland Burris who followed Barack Obama in the United States Senate, details his similar experience as a stroke patient in the Chicago Tribune.

The medical team at Northwestern, in consultation with my family, decided to operate. Sunday evening, Dr. Fessler and his surgical team removed a 4-by-8-inch section of my skull to relieve the swelling. I am told that I woke up on Monday morning and asked for my BlackBerry, although I have no recollection of that now.

Over the next two days, the swelling in my brain did not go down, and Dr. Fessler and Dr. H. Hunt Batjer operated again, removing the dead portion of my brain as well as more bone to allow for more swelling. Since that second surgery, I have been on a steady course of recovery. Two weeks later, the removed section of my skull was replaced and my head was back in one piece. A week after that, I transferred out of Northwestern’s intensive care unit and moved into the Rehabilitation Institute of Chicago, just a few blocks away. For the past two months, I have been working for hours each day to regain my ability to walk and other motor functions.

I was very fortunate that the stroke affected the right side of my brain. While I could not at first move the left side of my body, my cognitive and speech functions were not impaired. With a lot of work and a lot of help, I have been slowly regaining movement on the left side of my body.

Throughout this time, I have been blessed with great care from some of the finest health care workers in the world. Jesserine, “Jazz,” one of my nurses at RIC, has become a great friend. I do not know what I would have done without her skills and professionalism. Jazz and her colleagues saved my life and have facilitated my recovery in more ways than I could list.

Not the most personal of memoirs but a good read.

I’m a little surprised the Senator got such an aggressive and early decompression. There is good evidence for aggressive, early hemicraniectomy in large non-dominant middle cerebral artery strokes to circumvent the effects of swelling, see here and here. The thing that surprises me, just inferred from his own piece in the Tribune, it seems like he was awake and talky leading up to the surgery. If that’s the case certainly not a patient, at that point, suffering from a malignant MCA stroke. Then again the fact they went back to the operating room for further decompression days later…

I guess all to take away is I should play physician from afar and based on a 1000 word article in the newspaper. We all remember this.

But you should read Senator Kirk’s piece and remember, as he employs, remember American Stroke Month.