Tag Archives: neurology

CCSVI and MS: Desperate Patients Find It Hard to Wait

In less than 3 years, a new explanation of what might trigger multiple sclerosis in many patients swept out of a small Italian city to capture the attention of MS patients worldwide. 

Venography of an open azygous vein in a control individual(A), and a stenosed vein in three MS patients (B, C, D). (Image courtesy Paolo Zamboni, J Neurol Neurosurg Psychiatry 2009;80:392-9)

The notion that MS might stem from a narrowing or blockage of one or more veins that direct  blood out of the brain — a condition known as chronic cerebrospinal venous insufficiency (CCSVI) — led to immense interest by MS patients in endovascular treatments aimed at opening these veins to improve blood outflow and hopefully relieve their symptoms. The condition was identified and named by Dr. Paolo Zamboni, a vascular surgeon at the University of Ferrara, Italy.

 The CCSVI Alliance,  among other groups, provides patients with a central source for information.

Endovascular treatments aimed at relieving CCSVI and possibly resolving MS symptoms have also attracted some physician enthusiasts. Speaking during a session devoted to this topic at the International Symposium on Endovascular Therapy (ISET)  in Miami Beach last week, Dr. Salvatore J.A. Sclafani briefly described his own recent story. Last spring, he resigned as chairman of radiology at Downstate Medical Center in Brooklyn because he was thwarted by his hospital’s investigational review board from conducting the CCSVI treatment study he designed. He left for a nearby ambulatory-care center where, he said, he can now treat and study 1,000 patients with CCSVI a year and gather the information he feels is needed before a randomized, controlled trial should start.

But others who spoke during the ISET   session said it was a mistake for interventionalists to continue to open veins in MS patients outside of formal, controlled trials.

“It’s a slippery slope to treat patients based on their anatomy alone,” said Dr. Michael Dake, a professor of cardiothoracic surgery at Stanford and the first U.S. physician to treat CCSVI in Spring 2009. “I want to know if a patient with MS has CCSVI and if the narrowing is successfully treated is it possible to objectively demonstrate physiologic improvement in relevant parameters and an associated relief of symptoms. New metrics are needed to address the effects of treatments on new targets. We see lots of patients with venous problems who don’t have MS. It’s time to look [for evidence} in a randomized trial.”

The unfortunate truth is that in this setting, as often happens in medicine, many affected patients don’t share the prudence and patience of researchers like Dr. Dake.

“Many patients do not want to wait for a lengthy trial. They’ll seek treatment on their own,” said Sharon Richardson, president of the CCSVI Alliance and a MS patient who says she received some symptom relief after receiving a pair of vein-opening stents in a procedure done by Dr. Dake.

—Mitchel Zoler (on Twitter @mitchelzoler)

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When Silence Turns Deadly

Epilepsy killed Christopher Donalty, and as sure as his mother Jeanne Donalty is that the 21-year-old student athlete from Utica, N.Y., died too young, she is even more certain that the failure of his physicians to be frank with the family about the potential risk—albeit rare—of fatality linked to the disease contributed to his death.

“Patients need to know that they can die from epilepsy,” Mrs. Donalty stressed in a press conference about Sudden Unexplained Death in Epilepsy (SUDEP) at the annual meeting of the American Epilepsy Society held this week in San Antonio. “If we had known, if Chris had known, he might be alive today to tell his own story.” Instead, his mother travels the country on behalf of Citizens United for Research in Epilepsy (CURE) delivering the message that her son cannot.

Christopher Donalty died on February 21, 2002 of Sudden Unexplained Death in Epilepsy (SUDEP). Photo courtesey of http://www.cureepilepsy.org.

Christopher died in his bed, surrounded by his textbooks, in 2002, just months before he was set to graduate with honors from Florida’s Stetson University. Diagnosed with epilepsy before his senior year in high school – eight years after suffering his first seizure of unknown etiology in fourth grade and four years after a similar second seizure in eighth grade – Christopher was able to manage his seizures successfully with phenytoin (Dilantin) until his sophomore year in college. A breakthrough seizure early in his sophomore year led to the short-lived addition of valproic acid (Depakote) to his therapy regimen, which was discontinued after a few months because of intolerable side effects.

Even without the Depakote, Christopher was seizure free—or so his family and physician believed—until his death. In fact, Christopher had experienced seizures during that period, “but he didn’t tell us about them and he didn’t tell his doctor,” Mrs. Donalty explained. She hypothesized that her son’s desire to live a “normal” life not defined by epilepsy and its restrictions led to his silence. “We will never know for sure why Chris didn’t tell us about the seizures, but I do know for sure that he loved life, and if he knew that uncontrolled seizures could kill him, he would have made different choices,” she said. “The possibility of death was never once mentioned to us after his diagnosis or in the years of treatment [that followed.] We believed epilepsy was a benign, manageable disease.”

In the years since her son’s death, Mrs. Donalty has learned that many physicians never tell their patients about the possibility of SUDEP, despite the fact that it is estimated to account for 8%-17% of deaths in people with the disorder and occurs at a rate of approximately 1 in 1,000 person-years, when combining all epilepsy types and severities, and increases to 1 in 150 person-years for those with refractory epilepsy (Lancet Neurol. 2008 [7]:1021–1031; Epilepsia 2009 [50]:917–922).  “I don’t know why this is. Maybe it’s because there is no cure, or because it’s a difficult conversation,” Mrs. Donalty said. The failure to communicate the risk, however, is “unethical,” she stressed. “Doctors have no right to deny patients and their families the full story. There’s nothing worse than losing a child. But I think it’s particularly cruel when you don’t have the information that you should have had to make informed decisions.”

Neurologists Dr. Dag Aurlien of Stavanger University Hospital, Stavanger, Norway, who reported a study at the meeting about the incidence of SUDEP associated with lamotrigine therapy, and Dr. Jakob Christensen of Aarhus University Hospital in Aarhus, Denmark, who presented new data on mortality in epilepsy agreed with Mrs. Donalty’s position. “It might not be a discussion to have at the time of the initial diagnosis, but it is a discussion that has to happen,” Dr. Aurlien said in an interview. The fear of overdramatizing the risk may be behind physicians’ hesitancy to bring it up, he hypothesized.

Dr. Christensen agreed that no information, including the possibility of death, should be withheld from patients and their families. “In our [clinic] it is part of the checklist of information that should be communicated,” he said in an interview, noting that patients’ individual situations and risk factors should help guide when and how the information is offered. —Diana Mahoney

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Filed under Emergency Medicine, Family Medicine, Health Policy, health reform, Hospital and Critical Care Medicine, IMNG, Internal Medicine, Neurology and Neurological Surgery, Pediatrics, Primary care

Registry Homes In on Hydrocephalus

Treatment for pediatric hydrocephalus has not advanced substantially since the invention of cerebrospinal fluid shunts more than 50 years ago, in part because its relatively low prevalence has hampered research efforts.

 A 2005 white paper by the National Institutes of Health highlighted research priorities and called for multicenter collaboratives for data collection and longitudinal studies to assess natural history.

The Hydrocephalus Clinical Research Network  was subsequently launched and began enrolling children in April 2008 at a central data coordinating center and four research centers at high-volume pediatric hospitals in the U.S. and Canada. Six additional pediatric neurosurgery centers have recently applied to join.

 HCRN has six key research initiatives including reducing infections associated with shunt surgery, understanding the epidemiology and outcomes of endoscopic third ventriculostomy (ETV), and creating a detailed registry of all hydrocephalus patients at participating institutions.

At the recent Pediatric Hospital Medicine 2010 meeting, Dr. Tamara Simon shared some early HCRN data based on 1,384 children who had undergone 2,316 neurosurgical procedures.

Age (mean 7.1 years) and gender (55% male) were similar between HCRN centers, but there were differences in practice variation in initial procedures and management of intraventricular hemorrhage, said Dr. Simon, a hospitalist with Seattle Children’s Research Institute, a participating HCRN center.

 CSF shunts were used for primary procedures in an average of 86% of cases, with a range of 76% to 90%, while ETV, which is widely used in Europe, was utilized in 10% to 24% of cases depending on the center.

 CSF shunts and ETV work in opposite ways: Shunts drain the fluid from the ventricles in the brain to a site elsewhere in the body, while ETV uses a small hole made in the floor of the third ventricle to allow the CSF fluid to  bypass the obstruction and be reabsorbed in the brain’s sub arachnoid space.

 The Pediatric Health Information System (PHIS) has been collecting data on hydrocephalus for years, but it is hoped that the HCRN will focus specific attention on this life-threatening condition for which there is no cure. This may be a difficult task given the small numbers of patients, but money talks.

Each year in the U.S., pediatric hydrocephalus patients account for $1.4 to $2 billion in total hospital charges, but only 0.6% of admissions, Dr. Simon noted.

– Patrice Wendling (on Twitter @pwendl)

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Where Have All The Free Pens Gone?

 

courtesy of flickr user titanium studio (creative commons)

From the annual meeting of the American Academy of Neurology, Toronto, Canada:

Neurologists: They are smart, organized, and NOT high maintenance, based on what I’ve seen here at the AAN annual meeting.

I have certainly noticed the lack of freebies in the exhibit halls over the last couple of years, mostly owing to Pharmaceutical Research and Manufacturers of America (PhRMA) 2009 rule prohibiting noneducational gifts for physicians, from simpler or nonexistent free bags to the absence of goodies like beach towels, hats, T-shirts, and those little squishy toys. But pens?

Doctors have noticed, too. While stuck on a crowded escalator, I overheard one of the doctors attending the meeting comment to her colleague: “You can’t get so much as a ChapStick at meetings now. All I want is a ChapStick and a free pen.” This struck me as funny (I’m not sure why), but who doesn’t want a free pen? That doesn’t seem to be asking too much.

I made a brief, unscientific study of the exhibit hall, and even free pens were remarkably hard to come by. It took me a few minutes of walking around before I could locate one. I was unable to determine an association between the presence of pens and the few exhibitors who had coffee and biscotti. In addition, the type of exhibitor (drug company, organization, products/services for physicians) did not appear to have an impact on the presence of pens.

My study findings suggest that there are pens to be found in exhibit halls these days, but it takes some work. As for the ChapStick, try a dermatology meeting.

–Heidi Splete (on twitter @hsplete)

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MS Research Suggests More Supplementation With Vitamin D

  

courtesy of flickr user Village Green Apothecary (creative commons)

 

From the annual meeting of the American Academy of Neurology, Toronto, Canada: 

Multiple sclerosis is always an important topic at the AAN meeting, but in covering the poster sessions, I was surprised by the generous sprinkling of posters related to vitamin D. I guess I shouldn’t have been. Previous research has show that vitamin D deficiency is a risk factor in the development of multiple sclerosis (MS), and it might affect the disease course of MS. How are vitamin D levels related to MS? No one knows for sure, but it looks like many researchers are trying to find out.   

One poster by Dr. Asfa Y. Shad, a neurologist in Detroit, and her colleagues simply noted that, compared with 304 controls, 238 MS patients were significantly more likely to have insufficient vitamin D levels, regardless of gender, MS type, or MS duration. 

In another poster, Dr. Fredric K. Cantor, a Bethesda, Md.-based neurologist, and his colleagues suggested that vitamin D levels might play a role in the occurrence of relapsing-remitting MS (RRMS), after comparing MRI contrast-enhancing lesions (markers of acute inflammation) and vitamin D levels in patients with RRMS. Data from this study showed that lesions were present in 48% of vitamin D-deficient patients, 35% of vitamin D-insufficient patients, and 21% of patients with adequate vitamin D levels. 

In a third poster, Dr. Jodie Benton conducted a meta-analysis to identify possible nongenetic risk factors in MS patients that might impair vitamin D activity. She found that anticonvulsant use, vitamin A, pregnancy, and type 2 diabetes appeared to be risk factors for low vitamin D in MS patients, as did obesity and a high body mass index. Dr. Burton noted that megadoses of as much as 50,000 IU per week are becoming common in MS treatment centers, and her study results support increased vitamin D supplementation. 

 Taken together, the take-home message I got from these posters is that if clinicians who treat MS patients are able to modify any of the risk factors for vitamin D deficiency and promote high doses of vitamin D supplementation, they might have a relatively simple way to improve their patients’ health. 

 Most people (with or without MS) could benefit from more vitamin D, Dr. Benton told me. The current U.S. guidelines for adequate intake (200-400 IU for adults) are outdated, she said. 

 So I guess this is another reason to get outside for (moderate) vitamin D exposure, and maybe keep some of those chewy chocolate vitamin D supplements on hand (Mmm, chocolate!). 

 Food for thought: Doctors, are you checking vitamin D levels in patients more often and prescribing more supplements than you used to? 

–Heidi Splete (on twitter @hsplete)

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Filed under Alternative and Complementary Medicine, IMNG, Neurology and Neurological Surgery

Be an iPioneer

By K. Wachter

In the interest of full disclosure, I’m open source and proud of it.  Still, it’s hard to ignore the frenzy these days over iThings.  The launch of the iPad may be what first springs to mind but if you’re getting ready to attend the annual meeting of the American Association of Neurological Surgeons in late April, you should be thinking iTouch (officially the Apple iPod Touch).

If you’re an AANS member, you’ll be getting one at the meeting.  According to the association, “instead of a 165-page final program book and briefcase-size bag weighing just under 2 pounds, they will be receiving the Apple iPod touch and a convenient lightweight nylon pouch with neck strap to house it.”

That’s right.  The 2-inch thick abstract book is gone.  Please try to contain your glee.  This is hardly new.  Many medical organizations have been offering program and abstract books on CDs or flash drives for a while now. It was the adoption and gift of a single technology at a medical meeting that raised a lot of interesting questions in the newsroom—not the least of which was “do reporters get one too?”  [In a word, NO.  Press will get CDs or access to iPods in the press room.  Good. No need to worry about that whole conflict of interest thing.]

Curious about how all this was going to work, I called the media relations department at AANS and spoke with Betsy van Die, director of communications.  The big question: Who is paying for this?  According to Ms. van Die, part of the money comes from registration fees and corporate sponsorship, though she decined to give any specifics.

So what’s special about the AANS  iPod?  Of course, it will be loaded with the program book and abstracts.  There are special tutorials available online.  Members will have the ability download and listen to meeting podcasts, message other members, and vote in polls during some presentations and sessions.  It’s all very hip.

Of course, advertisers and exhibitors can get in on the fun too.  The association has lined up special advertising and marketing opportunities—splash ads, banner ads, stand-alone icons on the patrons page, exhibitor website listings, videocasts, podcasts, eBlasts, and sponsorships of iPod accessories (cases, chargers, iTunes cards to distribute at booths).

The initiative to embrace new technology comes from AANS leadership. Dr. Michael Oh—who heads the AANS iPod task force—pitched the idea.  (Read the Philadelphia Inquirer’s story on the birth of this intiative)  A member survey followed with positive results and the rest, as they say, is history.

As for those who might prefer not to use iAnything…well, they’re on their own. When I asked about this, Ms. van Die told me “well, they’ll just have to learn to use the iPod.”

Don’t be shy.  We want to know what you think about the iMeeting.

—Kerri Wachter (@knwachter on Twitter)

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Scientist or Seer?

Last week, I spent one fascinating day at the Eighth World Congress on Brain Injury  in Washington, D.C.  where I heard a compelling talk on the potential benefits of hyperbaric oxygen therapy for brain-injured patients.

Dr. Paul G. Harch described his pilot study: 30 young soldiers, all of whom had sustained blast concussion injuries while fighting in Iran and Iraq. After 40 treatments of hyperbaric oxygen therapy (HBOT), they had significantly improved cognition, memory, and mood, and fewer headaches and symptoms of PTSD. Dr. Harch also showed some brain imaging data that indicated increased blood flow to the brain after these treatments.

SPECT images show increased cerebral blood flow after HBOT. Photo courtesy of Dr. Paul Harch

The injuries occurred an average of 6 months before treatment, suggesting that hyperbaric oxygen (HBOT) may stimulate a natural repair process in the brain as has been seen in other injured tissue, Dr. Harch said. Angiogenesis could bring new blood to damaged neurons that have been idling in neutral, awakening them to full function. Neurogenesis also could be at work, he said, although he had no data to support either of these ideas.

For nearly an hour at the meeting, physicians thronged Dr. Harch asking him about the potential of HBOT for various brain injuries, multiple sclerosis, and other neurologic problems. More often than not, Dr. Harch’s reply to their question was: “That [person] is treatable and will benefit from HBOT.” 

Clearly passionate, Dr. Harch zealously preached the Book of HBOT. But his missal is incomplete, because he did not disclose the details of his practice and commercial interests. Dr. Harch didn’t mention the new book  he just published, which touts HBOT for just about everything from brain injury to Alzheimer’s to wrinkles. Also, he runs a business in New Orleans  that provides hyperbaric therapy for approved uses, like decompression sickness and wound healing, as well as for off-label uses like autism, cerebral palsy, multiple sclerosis, and traumatic brain injury. 

And, while the results of his 30-person observational trial were intriguing, they do not a miracle make. He now hopes to launch a 1,000-person trial. But, again, he plans another single-arm observational study with no comparator group. Bayesian statistics would negate the use of a comparator, he told me.  

That comment, combined with the undisclosed financial information, gave me that weird stomach lump feeling – an irrefutable warning sign familiar to any journalist. For perspective, I turned to Dr. Steven Novella, a fellow blogger and Yale University neurologist who writes NeuroLogica.  Let’s just say he wasn’t impressed by the results of Dr. Harch’s study.

“The claim that with Bayesian analysis you do not need a control group is completely wrong and displays a frightening misunderstanding of scientific methodology,” he told me. “The point of a control group is to control for variables. Bayesian analysis does not replace that. In fact, Bayesian analysis can only be meaningfully done if you have some p-value or other measure of probability based on the study, which you do not have if you don’t have a control group.  It seems to me that he wants to do the kind of study that is guaranteed to show that his treatment works. This is what you do if you want to promote a treatment, not study it.”

The next proper step, according to Dr. Novella, would be a larger, double-blind study. And, in fact, three randomized, sham-controlled trials of HBOT are being planned by the Department of Defense.

Dr. Harch told me the research money should have supported his endeavors. Ironically, two of the principal investigators on the new trials each told me that Dr. Harch refused to assist with their trial’s design. Yet his work – with all its methodological flaws – is the genesis for the very studies that could ultimately substantiate the gospel truth of his preaching that hyperbaric oxygen can heal the wounded brain.

But until data replace simple faith, Dr. Harch remains the prophet crying in the wilderness.

– Michele Sullivan (on twitter @MGsullivan)

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