Cure For Multiple Sclerosis? Treatment Wildly Popular Despite Scant Evidence It Works | Singularity Hub

There are 2.1 million people worldwide suffering from multiple sclerosis. It is thought to be an autoimmune disorder in which the immune system attacks the body's own nervous system. To date there is no known cure. At best, some therapies can slow the progression of the disease. The array of symptoms, such as loss of muscle control, some vision and widespread pain plague patients. Desperate, some of these patients are turning to a treatment that is widely condemned by experts in the MS field. The treatment, pioneered by an Italian surgeon, also has powerful support from a small handful of practitioners and patients continually in search of options.

The layer of cells surrounding neurons, myelin, have been shown to be damaged in the brains and spinal cords of MS patients. Myelin serves as an insulator for neurons and is vital to the ability of neurons to pass electrical signals to one another. When they're damaged, as in MS, signaling between neurons is impaired, resulting in lack of bodily control, pain, and other symptoms.

Most researchers and clinicians attribute the myelin damage to autoimmunity, the cause of which still remains uncertain. But Paolo Zamboni, a vascular surgeon at the University of Ferrara in Italy, disagrees. He doesn't think MS is primarily an autoimmune disorder. Instead, he hypothesizes that the disease is caused by chronic cerebrospinal venous insufficiency, or CCSVI, a vascular disorder that results in the insufficient drainage of blood from the brain and spinal cord. Zamboni thinks that the accumulation of blood in the brain causes a buildup of iron and that the iron damages the layer of tissue surrounding neurons, myelin.

Zamboni published a study in 2009 in which he found CCSVI to be present in 100 percent of M.S. patients at a particular stage in the disease. Following the finding he tested a treatment for M.S. that included inflating a balloon to open the veins that carry blood away from the brain and thus restoring normal blood flow.

But there were problems with the study. First, with only 65 subjects, it wasn't large enough to reach a robust conclusion about whether or not the treatment was effective. And even though the study compared the treatment between people with MS and healthy controls, Zamboni wasn't blinded to the groups – he knew which participants had MS and which did not, making bias a serious concern.

But for many patients these concerns paled in comparison to the possibility, no matter how remote, of being cured. In the face of this new demand the procedure spread quickly. The first neck angioplasty for MS in the US was thought to have been performed in 2009. The unproven procedure was restricted in many countries, but patients could still travel to the US, Costa Rica, Poland, Bulgaria and Egypt to have it performed.

Paolo Zamboni's procedure to treat MS has generated great enthusiasm among patients. Not so much among fellow researchers and clinicians.

Patients also generated pressure to investigate the link between CCSVI and MS, eventually prompting the US National Multiple Sclerosis Society toannounce in 2010 that $2.4 million, or about 7 percent of its research funding, would support research on CCSVI.

Robert Fox, medical director at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, was not impressed. As he told the New York Times, "People without a scientific background often view all scientific papers with equal weight. Well, scientists don't. I don't know of a more prominent example where there's been such profound pressure, driven by a nonmedical and nonscientific – though rightfully very self-motivated – constituency on what specific treatments should be explored with weak scientific basis."

Zamboni isn't the only one to look into CCSVI. The largest study to date was performed by Robert Zivandinov at State University at Buffalo. He did find an association between CCSVI and MS but at just 56 percent association compared to 23 percent in healthy controls, it falls well short of Zamboni's all-or-nothing finding. Furthermore, the increased CCSVI wasn't seen only in MS patients but in patients with other neurological disorders, suggesting that it may not have a specific link to MS.

Florian Doepp, a researcher at the Department of Neurology at Charité Hospital in Berlin, published a study in 2010 looking at blood flow in 56 MS patients. Except for a single patient, blood flow for the group was perfectly normal. As Doepp decisively told the New York Times, "I conclude there is no evidence for CCSVI in multiple sclerosis and no evidence to support" the surgical procedure to treat it.

The notion that MS is caused by faulty blood flow and too much iron – and not primarily an immune disorder – is not only weak on evidence, it's also weakened by evidence. Previous research has pointed to over 50 genes associated with M.S., and all of them are involved in the immune system. Also, Parkinson's disease patients have abnormally high levels of iron in their brains, yet do not consequently develop MS.

The proper study would be to perform the angioplasty on some MS patients and a sham operation on others – in a double-blind study where neither the patients nor the researchers know who received the procedure and who received the sham. But these studies are hard to perform because they're costly and unattractive for a condition like MS which is incurable, and for which present medications can significantly prolong life. However, two such studies are now being conducted, largely due to patient demands.

This past May the FDA issued a warning about CCSVI, saying "there is no reliable evidence from controlled clinical trials that this procedure is effective," adding that "the criteria used to diagnose CCSVI has not been adequately established." One person has died following the procedure, and the FDA has learned of "stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure."

What the science lacks in hard data, patients are making up for in an abundance of testimonials. The CCSVI procedure overwhelmingly makes them feel better, sleep better, move around better with more energy. Many patients even come back for repeat procedures when the effects of a previous one had seemed to wear off.

Is there something to Zamboni's procedure or is this some kind of mass placebo effect? Michael Arata, a vascular surgeon who has performed the procedure on about 1,200 patients, thinks it works, but for CCSVI patients. Not those with MS. He acknowledges that changing a person's blood flow will make them feel different regardless of whether or not it's beneficial. As he told the New York Times, "If I would operate on people's veins, I'm quite sure I'd have effects. Yet I know those effects will disappear and will not be really clear."

Sounds like placebo to me, and probably also to attendees at a recent conference of European MS researchers and clinicians. Data from a study was presented at the conference that included 462 patients. The study showed that, while the CCSVI surgery lacked any benefits revealed by "objective measurements," about half of the patients reported feeling better. One professional group at the meeting attributed the effects to "high expectations."

More studies, like the ones being performed by the Multiple Sclerosis Society, are still needed to definitively assess any link between CCSVI and MS. Hopefully, at the end of it all, the patients will be proven right, that the surgery does work. It would be a shame to reach the alternate conclusion with so much time, work, and funding wasted on a procedure with lots of devotion but not much data.

http://singularityhub.com/2012/11/03/cure-for-multiple-sclerosis-treatment-wildly-popular-despite-scant-evidence-it-works/

Creating A Living Lab For Health And Wellness | Co.Exist: World changing ideas and innovation

If you're venturing to Orlando, Florida, there's a decent chance that you're one of the 51 million-plus tourists that goes there every year, mainly to one of the city's theme parks. But over the next decade, a planned community in Orlando called Lake Nona will become something of an attraction as well--not for tourists, but for researchers and medical professionals.

Today, Lake Nona is a health-focused community that has about 7,000 people living and working in its borders. It's home to the Orlando VA Medical Center, the University of Central Florida's Health Sciences Campus, and the Sanford-Burnham Medical Research Institute. In the coming years, that number will balloon to 40,000 to 50,000 people as the community grows its "innovation cluster" of "health and life science innovation," according to Thad Seymour, president of the Lake Nona Institute.

That means looking at biomarker and genetic assessments to predict the likelihood of disease, but also studying online personal health assessments from the residents. Wellness & Prevention isn't just sitting on the sidelines, observing people throughout their lives--it also plans on intervening with real-time coaching and advice. Says Wiegand: "We want to understand the cohort first. If we see there is a propensity for obesity, we can provide access to weight-loss counseling."But here's where things get interesting: Johnson & Johnson's Wellness & Prevention Inc. is teaming up with the Lake Nona Institute to create a longitudinal health and wellness study of people living and working the community. "Traditionally [longitudinal studies] have always looked at disease progression, but we want to understand how people are healthy and how to keep them healthy," explains Ben Wiegand, vice president of science and innovation at Wellness & Prevention Inc.

Wellness & Prevention can also intervene in Lake Nona's many health care settings, potentially controlling how care is provided for the better. Among the initiative's goals: improving modifiable risk factors for disease, cutting down on chronic disease rates, and reducing participants' RealAge by 10%. In other words, the initiative is attempting to turn a slice of Orlando into a model of health for the rest of the country (and the world) to follow.

In addition to the longitudinal study, Lake Nona is also teaming up with Cisco, which just named it a "Smart+Connected" city for its built-in connectivity (i.e. gigabit Internet connections for all new homes). As Lake Nona grows, Cisco will help add IP video surveillance systems, energy-management systems, better cellular connections, and more.

http://www.fastcoexist.com/1680801/creating-a-living-lab-for-health-and-wellness?#1

Nurses, Addicted to Helping People - NYTimes.com

When a book is heavy with glossy photographs, you seldom expect too much from its words. In "The American Nurse," though, it's the narrative that hits you in the solar plexus.

Take the comments of Jason Short, a hospice nurse in rural Kentucky. Mr. Short started out as an auto mechanic, then became a commercial trucker. "When the economy went under," he says, "I thought it would be a good idea to get into health care." But a purely pragmatic decision became a mission: Mr. Short found his calling among the desperately ill of Appalachia and will not be changing careers again.

"Once you get a taste for helping people, it's kind of addictive," he says, dodging the inspirational verbiage that often smothers the healing professions in favor of a single incontrovertible point.

Some of the 75 nurses who tell their stories in this coffee-table book headed into the work with adolescent passion; others backed in reluctantly just to pay the bills. But all of them speak of their difficult, exhilarating job with the same surprised gratitude: "It's a privilege and honor to do what I do," says one. "I walk on sacred ground every day."

They hail from a few dozen health care settings around the country, ranging from large academic institutions like Johns Hopkins in Baltimore to tiny facilities like the Villa Loretto Nursing Home in Mount Calvary, Wis., home to 50 patients and a collection of goats, sheep and other animals on a therapeutic farm. Some nurses are administrators, some staff wards or emergency rooms, some visit patients at home. Many are deeply religious, a few are members of the military, and a handful of immigrants were doctors in their home countries.

All describe unique professional paths in short first-person essays culled from video interviews conducted by the photographer Carolyn Jones. Their faces beam out from the book in Ms. Jones's black-and-white headshots, a few posing with a favorite patient or with their work tools - a medevac helicopter, a stack of prosthetic limbs or a couple of goats.

But even the best photographs are too static to capture people who never stop moving once they get to work. For a real idea of what goes on in their lives, you have to listen to them talk.

Here is Mary Helen Barletti, an intensive care nurse in the Bronx: "My whole life I've marched to a the beat of a different drummer. I used to have purple hair, which I'd blow-dry straight up. I wore tight jeans, high heels and - God forgive me - fur (now I am an animal rights activist). My patients loved it. They said I was like sunshine coming into their room."

Says Judy Ramsay, a pediatric nurse in Chicago: "For twelve years I took care of children who would never get better. People ask how I could do it, but it was the most fulfilling job of my life. We couldn't cure these kids, but we could give them a better hour or even a better minute of life. All we wanted to do was make their day a little brighter."

Says Brad Henderson, a nursing student in Wyoming: "I decided to be a nurse because taking care of patients interested me. Once I started, nursing just grabbed me and made me grow up."

Says Amanda Owen, a wound care nurse at Johns Hopkins: "My nickname here is 'Pus Princess.' I don't talk about my work at cocktail parties."

John Barbe, a hospice nurse in Florida, sums it up: "When I am out in the community and get asked what I do for a living, I say that I work at Tidewell Hospice, and there's complete silence. You can hear the crickets chirping. It doesn't matter because I love what I do; I can't stay away from this place."

The volume is not entirely about selfless service: It was underwritten by Fresenius-Kabi, a German health care corporation and leading supplier of intravenous drugs in the United States. Presumably, crass public relations motives lurk somewhere in the background. But that's no real reason to be meanspirited about the result, a compelling advertisement for an honorable profession.

Young people with kind hearts and uncertain futures might just sit themselves down with the book, or wander through the Web site featuring its video interviews, www.americannurseproject.com, and see what happens.

http://well.blogs.nytimes.com/2012/10/29/nurses-addicted-to-helping-people/?src=rechp

Four Myths About Doctor-Assisted Suicide - NYTimes.com

Four Myths About Doctor-Assisted Suicide

By EZEKIEL J. EMANUEL

Philadelphia

IN a little more than a week, voters in Massachusetts will decide whether to allow doctors to "prescribe medication, at the request of a terminally ill patient meeting certain conditions, to end that person's life." A similar bill is being debated in New Jersey. Unfortunately, like so many health care questions, the debate about physician-assisted suicide is confused, characterized by four major falsehoods.

PAIN The fundamental claim behind arguments for physician-assisted suicide is that most patients who desire it are experiencing excruciating physical pain. The 1996 decision of the United States Court of Appeals for the Ninth Circuit supporting a constitutional right to physician-assisted suicide in Washington State summarized the conventional wisdom: "Americans are living longer, and when they finally succumb to illness, lingering longer, either in great pain or in astuporous, semi-comatose condition that results from the infusion of vast amounts of painkilling medications."

But this view is false. A multitude of studies based on interviews of patients with cancer, AIDS, Lou Gehrig's disease and other conditions have demonstrated that patients who desire euthanasia (in which a doctor administers a lethal drug) or physician-assisted suicide (in which the patient himself takes the lethal drug prescribed by the physician) tend not to be motivated by pain. Only 22 percent of patients who died between 1998 and 2009 by assisted suicide in Oregon- one of three states, along with Washington and Montana, where it is legal - were in pain or afraid of being in pain, according to their doctors. Among the seven patients who received euthanasia in Australia in the brief time it was legal in the '90s, three reported no pain, and the pain of the other four was adequately controlled by medications.

Patients themselves say that the primary motive is not to escape physical pain but psychological distress; the main drivers are depression, hopelessness and fear of loss of autonomy and control. Dutch researchers, for a report published in 2005, followed 138 terminally ill cancer patients and found that depressed patients were four times more likely to request euthanasia or physician-assisted suicide. Nearly half of those who requested euthanasia were depressed.

In this light, physician-assisted suicide looks less like a good death in the face of unremitting pain and more like plain old suicide. Typically, our response to suicidal feelings associated with depression and hopelessness is not to give people the means to end their lives but to offer them counseling and caring.

ADVANCED TECHNOLOGY A second misconception about assisted suicide is that it is the inevitable result of a high-tech medical culture that can sustain life even when people have become debilitated, incontinent, incoherent and bound to a machine. It is the "inevitable consequence of changes in the causes of death, advances in medical science, and the development of new technologies," as the appeals court put it.

But the ancient Greeks and Romans advocated euthanasia. In modern times, debate about legalizing euthanasia and assisted suicide was revived with intensity in England in the late 19th century, after a famous debate at the Birmingham Speculative Club. The first such bill introduced in the United States was in 1905, before the discovery of antibiotics and dialysis, much less respirators and feeding tubes. If interest in legalizing euthanasia is tied to any trend in history, it is the rise of individualistic strains of thought that glorify personal choice, not the advances of high-tech medicine.

MASS APPEAL A third misconception about assisted suicide is that it will improve the end of life for everyone. After all, death afflicts everyone, and legalized assisted suicide would allow any individual to avoid an excruciatingly painful death. But the fact is that, even in places where physician-assisted suicide is legal, very few people take advantage of it. In Oregon, between 1998 and 2011, 596 patients used physician-assisted suicide - about 0.2 percent of dying patients in the state. In the Netherlands, where euthanasia and physician-assisted suicide have been permitted for more than three decades, fewer than 3 percent of people die by these means. And even if we add all the dying patients who even vaguely express an interest in assisted suicide, it amounts to much less than 10 percent. For the vast majority of dying patients, it will have no impact on improving the ends of their lives.

Whom does legalizing assisted suicide really benefit? Well-off, well-educated people, typically suffering from cancer, who are used to controlling everything in their lives - the top 0.2 percent. And who are the people most likely to be abused if assisted suicide is legalized? The poor, poorly educated, dying patients who pose a burden to their relatives.

A GOOD DEATHThe last misconception about assisted suicide is that it is a quick, painless and guaranteed way to die. But nothing in medicine - not even simple blood draws - is without complications. It turns out that many things can go wrong during an assisted suicide. Patients vomit up the pills they take. They don't take enough pills. They wake up instead of dying. Patients in the Dutch study vomited up their medications in 7 percent of cases; in 15 percent of cases, patients either did not die or took a very long time to die - hours, even days; in 18 percent, doctors had to intervene to administer a lethal medication themselves, converting a physician-assisted suicide into euthanasia. (In the states where assisted suicide is legal, and under the proposed Massachusetts law, this intervention would be illegal.)

Instead of attempting to legalize physician-assisted suicide, we should focus our energies on what really matters: improving care for the dying - ensuring that all patients can openly talk with their physicians and families about their wishes and have access to high-quality palliative or hospice care before they suffer needless medical procedures. The appeal of physician-assisted suicide is based on a fantasy. The real goal should be a good death for all dying patients.

http://opinionator.blogs.nytimes.com/2012/10/27/four-myths-about-doctor-assisted-suicide/?hp&pagewanted=print

Women Who Quit Smoking Do Live Longer - MedPage Today

Life expectancy was dramatically improved among participants in Great Britain's Million Women Study who quit smoking compared with continuous smokers, confirming the previously uncertain benefits of smoking cessation in women, researchers said.

Although women who stopped smoking around age 50 remained at significantly higher risk of all-cause mortality compared with never-smokers (relative risk 1.56, 95% CI 1.49 to 1.64), it was much lower than the tripled risk of death seen in current smokers, according to Kirstin Pirie, MSc, of the University of Oxford in England, and colleagues.

"Even cessation at about 50 years of age avoids at least two-thirds of the continuing smoker's excess mortality in later middle age," the researchers wrote online in The Lancet.

Deaths from lung cancer were reduced markedly in quitters as well, irrespective of participants' age when they stopped smoking, Pirie and colleagues reported.

The Lancet published the report the day before the 100th anniversary of the birth of Richard Doll, MD, who led many of the early studies proving the dangers of smoking. Pirie and most of her co-authors work in the Richard Doll Building at the University of Oxford.

Changing Times, New Research

Although Doll's research clearly documented the early mortality suffered by smokers, it was conducted at a time when most longtime smokers were men. Smoking among young women did not peak until the 1960s. Thus, the mortality risks faced by women smokers have appeared to be lower in the available data.

That is now set to change with the Million Women Study results, according to Sandra Adams, MD, of the University of Texas Health Science Center in San Antonio.

"We knew this about men," she told MedPage Today. "We knew that, as people age and they continue to smoke, they have a lot of smoking-related diseases, and the earlier that they stop the better. But what this demonstrates is that the smoking-related deaths have been markedly underestimated in women."

In an accompanying editorial in The Lancet, Rachel R. Huxley, PhD, of the University of Minnesota in Minneapolis, and Mark Woodward, MD, of the University of Sydney in Australia, also applauded the study.

"Aside from its impressive sample size, the Million Women Study is distinct from previous large cohorts -- and superior for assessment among women of the full eventual hazards of prolonged smoking and the full benefits of long-term cessation -- because the participants were among the first generation of women in the U.K. in which smoking was widespread in early adult life, and although many continued smoking, many stopped before age 30 or 40 years," they wrote.

They also noted estimates that some eight million tobacco-caused deaths will occur annually by 2030.

"Such estimates rely on hazard ratios from previous large cohort studies. Although most of the projected deaths are male, these new results suggest that the projected burden of smoking-related disease in women might need to be revised upwards," Huxley and Woodward suggested.

More Than a Million Women

The Million Women Study was actually larger than that, with a total of more than 1.3 million originally enrolled from 1996 to 2001. The present analysis excluded about 100,000 with previous disease. Included were about 620,000 never-smokers at recruitment, 329,000 who had quit at some point in the past, and 232,000 who reported current smoking.

Participants completed questionnaires on current and past smoking at recruitment and again 3 years and 8 years later. Some 23% of current smokers at enrollment said they had since quit in the second survey. At the 8-year follow-up, a total of 44% of the original group of current smokers indicated they had quit.

Data on subsequent mortality, including causes recorded on death certificates, were taken from Great Britain's comprehensive registry.

The median birth year in the cohort was 1943 (interquartile range 1938 to 1946), putting the participants squarely in the female demographic that had the highest smoking rates. Mean age at enrollment was 55.

During follow-up, some 66,000 participants died (6% of the total).

Pirie and colleagues found that 12-year mortality rates among those reporting current smoking at the 3-year follow-up were roughly triple those of never-smokers, "largely irrespective of age," they reported (rate ratio 2.97, 95% CI 2.88 to 3.07).

Light smokers (fewer than 10 cigarettes per day) were at substantially increased risk of death relative to never-smokers (12-year mortality RR 1.98, 95% CI 1.91 to 2.04).

The results also confirmed that, of the 30 most common causes of death in the U.K., 23 were significantly greater in current smokers. The rate ratio for chronic lung diseases was a whopping 35.3 (95% CI 29.2 to 42.5), and for lung cancer it was 21.4 (95% CI 19.7 to 23.2).

Other causes of death more common in smokers than nonsmokers were as varied as pancreatic cancer, motor neuron disease, and accidental or intentional injuries.

Dramatic Mortality Numbers

But perhaps the most dramatic findings were on mortality risks in former smokers. Pirie and colleagues stratified the results according to the age at which ex-smokers reported having quit (younger than 25, 25 to 34, 35 to 44, and 45 to 54).

For participants who stopped smoking by their mid-30s, the risk of all-cause mortality was hardly different from that of never-smokers (RR 1.05, 95% CI 1.00 to 1.11). Those quitting at 35 to 44 were at 20% greater risk of death than never-smokers, and those quitting at 45 to 54 were at 56% increased risk.

Lung cancer risk was significantly increased in ex-smokers regardless of the age at quitting -- with relative risks of 1.56 in those stopping before age 25 to 5.91 in participants quitting at 45 to 54, all with minuscule P values -- but still vastly lower than the relative risk of greater than 20 in those still smoking.

"Stopping well before age 40 years would avoid well over 90% of the excess hazard in continuing smokers," Pirie and colleagues wrote.

But, they stressed, "this does not ... mean that it is safe to smoke until age 40 years and then stop."

The 20% excess mortality risk in early quitters is still substantial, they argued, "causing one in six of the deaths among these ex-smokers."

They also noted that their results reflected adjustments for age, socioeconomic status, drinking habits, physical activity levels, oral contraceptive use, menopausal status, and use of menopausal hormone therapy, all as reported by participants. Except as reflected in these variables, however, exposures to disease-causing agents other than tobacco smoke were not tracked.

In their commentary, Huxley and Woodward said the results point up "the need for effective sex-specific and culturally specific tobacco control policies that encourage adults who already smoke to quit and discourage children and young adults from starting to smoke."

Adams agreed, telling MedPage Today that, with the dangers of cigarette smoking now thoroughly proven in women as well as men, the major research need now is to identify such policies and interventions.

But she added that cigarette smoking is not the only tobacco-related hazard, and that it would be helpful to have better data on health effects of other tobacco products.

These include hookah (also known as shisha), smokeless tobacco, and so-called electronic cigarettes that deliver nicotine vapor along with a variety of flavorings and other chemicals, some of which are known to be hazardous in other settings.

http://www.medpagetoday.com/PrimaryCare/Smoking/35605