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31

EEE / Cell Phones Affect Brain Activity

« on: April 22, 2017, 03:13:12 PM »

Holding a cell phone to your ear for a long period of time increases activity in parts of the brain close to the antenna, researchers have found.

Glucose metabolism — that’s a measurement of how the brain uses energy — in these areas increased significantly when the phone was turned on and muted, compared with when it was off, Dr. Nora Volkow, director of the National Institute on Drug Abuse, and colleagues reported in the Journal of the American Medical Association.

“Although we cannot determine the clinical significance, our results give evidence that the human brain is sensitive to the effects of radiofrequency-electromagnetic fields from acute cell phone exposures,” co-author Dr. Gene-Jack Wang of Brookhaven National Laboratory in Long Island, where the study was conducted, told MedPage Today.

32

EEE / Questions to Ask Your Doctor About Fatigue

« on: April 22, 2017, 03:12:20 PM »

Some patient groups have expressed strong disagreement with these recommendations, arguing that cognitive behavioral and graded exercise therapies actually have caused harm to some patients.

These groups advocate exercise pacing and specialist medical care, according to the investigators.

To address this controversy, White and colleagues conducted the largest trial thus far of treatment for chronic fatigue, enrolling 641 patients from six U.K. specialty clinics.

Patients were randomized to receive specialist medical care alone, or specialist medical care plus cognitive behavioral therapy, graded exercise therapy, or adaptive pacing therapy for 24 weeks.

More than three-quarters were women, average age 38, and most had been diagnosed with chronic fatigue syndrome almost three years before entering the study.

At week 52, these percentages of patients improved by at least two points on the fatigue scale and by eight points or more on a physical function scale:

Cognitive behavioral therapy, 59 percent
Graded exercise therapy, 61 percent
Adaptive pacing therapy, 42 percent
Specialist medical care, 45 percent
The investigators also looked at percentages of patients who were in the normal range for fatigue and functioning at 52 weeks:

Cognitive behavioral therapy, 30 percent
Graded exercise therapy, 28 percent
Adaptive pacing therapy, 16 percent
Specialist medical care, 15 percent
Better outcomes also were seen for cognitive behavioral therapy and graded exercise therapy in a number of secondary outcomes such as social adjustment and sleep disturbances.

Serious adverse events were seen in 2 percent of patients in the cognitive behavioral therapy group, and in 1percent of each of the other three groups.

White's group acknowledged that the trial had certain limitations, including the exclusion of patients unable to attend the therapy sessions, self-rating by participants, and the unblinded structure of the study.

They plan further study of factors such as cost-effectiveness of the treatments, possible differences in response among subgroups of patients, and long-term outcomes.

33

EEE / 4 Ways to Save Energy With Chronic Fatigue Syndrome

« on: April 22, 2017, 03:11:52 PM »

However, the investigators conceded that the beneficial effects of these treatments were only moderate, with less than one-third of participants being within normal ranges for fatigue and functioning, and only about 40 percent reporting that their overall health was much better or very much better.

"Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed," they wrote.

In addition, they stated that their finding of efficacy for cognitive behavioral therapy "does not imply that the condition is psychological in nature."

The importance of cognitive behavioral therapy was further emphasized by Dr. Benjamin H. Natelson, of Albert Einstein College of Medicine in New York.

"This approach of encouragement of activity and discouragement of negative thinking should be a tool in every physician's armamentarium," he said.

"We know that cognitive behavioral therapy and gentle physical conditioning help people cope with any chronic disease — even congestive heart failure and multiple sclerosis," Natelson said in an interview with MedPage Today.

Chronic fatigue syndrome is characterized by persisting or relapsing fatigue for at least six months that cannot be explained by any other physical or psychiatric disorder.

The fatigue is debilitating, and often is accompanied by joint and muscle pain, headaches, and tenderness of the lymph nodes.

In an editorial published with the study, Dr. Gijs Bleijenberg, and Dr. Hans Knoop, of Radboud University in Nijmegen, the Netherlands, explained the differences in these types of treatment for chronic fatigue.

"Both graded exercise therapy and cognitive behavior therapy assume that recovery from chronic fatigue syndrome is possible and convey this hope more or less explicitly to patients. Adaptive pacing therapy emphasizes that chronic fatigue syndrome is a chronic condition, to which the patient has to adapt," Bleijenberg and Knoop wrote.

Graded exercise therapy and cognitive behavioral therapy have both been recommended by the U.K. National Institute for Health and Clinical Excellence, although evidence supporting these approaches remains sparse.

34

EEE / Exercise and Talk Help Ease Chronic Fatigue Syndrome

« on: April 22, 2017, 03:11:13 PM »

Patients with chronic fatigue syndrome who participated in programs aimed at helping them overcome their symptoms — a combination of exercise and counseling — improved more than those whose treatment was intended to help them adapt to the limitations of the disease, a large randomized trial found.

Mean fatigue scores among patients treated with graded exercise therapy — a tailored program that gradually increases exercise capacity — were 3.2 points lower than scores in patients who received specialist medical care alone, according to Dr. Peter D. White, of Queen Mary University of London, and colleagues.

Furthermore, fatigue scores were lower by 3.4 points among patients receiving cognitive behavioral therapy, in which a therapist works with the patient to understand the disease, alleviate fears about activity, and help overcome obstacles to functioning.

In contrast, among patients who were treated with a program known as adaptive pacing therapy, which emphasizes energy limitations and avoidance of excess activity, scores differed by only 0.7 points the researchers reported online in The Lancet.

In a press briefing describing the study findings, co-investigator Dr. Trudie Chalder, of King's College London, said, "We monitored safety very carefully, because we wanted to be sure we weren't causing harm to any patients."

"The number of serious adverse events was miniscule," she added.

Another co-investigator, Dr. Michael Sharpe, of the University of Edinburgh, commented that a difficulty in the management of chronic fatigue syndrome has been ambiguity — about the causes and whether these treatments recommended by NICE actually are effective.

"The evidence up to now has suggested benefit, but this study gives pretty clear-cut evidence of safety and efficacy. So I hope that addresses the ambiguity," Sharpe said during the press briefing.

35

EEE / Practical Ways to Save

« on: April 22, 2017, 03:10:18 PM »

There are many different ways to approach starting — and adding to — your health emergency savings. "You can take advantage of a health savings account if this is offered at your job, but start a general emergency fund also," suggests Porco.

Here are more health savings tips:

Put any money you get from a tax refund or earned income credit into your health savings fund.
Ask your bank or credit union to automatically transfer funds into your emergency account.
Explain the importance of an emergency fund to your family and get everyone involved in cutting back on unnecessary expenditures.

36

EEE / How to Save for a Health Emergency

« on: April 22, 2017, 03:09:42 PM »

Once you know what your insurance actually covers and how much you need to put away for an emergency, the next question is where to put it. "Money that you put aside for a health emergency needs to be liquid and secure," says Porco. "That means you need to be able to get it when you need it.”

And your money needs to remain liquid. “Those who fail to set up an emergency fund may find themselves running up credit card debts to cover their expenses. The last thing you need is to be paying interest on your emergency," warns Porco.

Examples of places to put your emergency fund include an interest-bearing checking or savings account, money market fund, or bond fund. Don't tie your money up in anything that would penalize you for early withdrawals or any investment or account that has the potential for loss.

37

EEE / What Insurance May Not Cover

« on: April 22, 2017, 03:09:21 PM »

How much insurance companies actually pay for accidents, cancer treatment, or surgery depends on what kind of insurance you have, but there are usually limits. Here are some facts to consider:

Cost of illness. Most insurance companies have a cap on how much they will pay for a long-term illness. A recent survey found that 10 percent of people with cancer have hit their lifetime cap and are no longer covered by insurance. Looking forward, however, the new health care reform law will eliminate caps on lifetime insurance by 2014.
Emergency room cost. If you have an accident that requires emergency treatment and you end up in an emergency room outside your insurance network, you may not be covered. One study found that HMOs in California denied one out of every six claims for emergency room costs.
Surgical coverage. You may be surprised at what your insurance company considers non-covered surgery. There can be a big gray area between covered “reconstructive” surgery and uncovered “cosmetic” surgery. Even when surgery is covered, your deductible may be $500 or more, and you may still be responsible for up to 25 percent or more of surgical costs, depending on the specifics of your plan.

38

EEE / How Much of an Emergency Fund Do You Need?

« on: April 22, 2017, 03:08:53 PM »

For an older adult, a health emergency might result in the need for long-term care, possibly for the rest of the senior’s life. For a young adult supporting a family, a medical emergency might be much more than just the cost of illness. Your health emergency could cause a disability that results in loss of income over an extended period. That means you should save enough to cover all your expenses.

"Most advisers would say you should have enough emergency funds saved to cover your family expenses for three to six months. I would recommend trying to put enough aside to cover all your expenses, not just health expenses, for 6 to 12 months," says Porco.

How much you need for a health emergency and how much you can actually put into an emergency fund will depend on your family size, your income, your health status, and your age. But your first step is to understand your health insurance situation.

"The best way to start is to sit down with a financial adviser and figure out what your insurance actually covers and what it doesn't cover. What are your insurance limits? What kind of medical bills might arise that you would be responsible for? Get some expert advice on how best to cover your actual needs," advises Porco.

39

EEE / Why You Need a Health Emergency Fund

« on: April 22, 2017, 03:08:20 PM »

Even with good health insurance, a health emergency or a prolonged illness can be a financial disaster. Health insurance deductibles, co-payments, emergency room costs, and other costs of illness can add up in a hurry.

A health savings account (HSA) is one way you can put aside tax-free money for a health emergency. HSAs were established in 2003. If you are covered by a type of insurance known as a high-deductible insurance plan, you can make tax-deductible contributions to an HSA. Your employer may also make tax-deductible contributions.

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"An HSA account is very different from having a general emergency fund account," says Joseph J. Porco, managing member of the Financial Security Group, LLC, in Newtown, Conn. “An emergency fund is about more than just out-of-pocket medical expenses. If possible, it’s a good idea to have both.”

40

EEE / Could You Have a Fractured Bone?

« on: April 22, 2017, 03:07:10 PM »

Any crack or break in a bone is considered to be a fractured bone. Although auto accidents are a common cause of fractured bones, most fractures actually occur inside the home.

The most common fractured bone in children is an arm bone, because kids hold out their arms when they fall. For people over age 65 who fall, the most common fractures are hip, spine, arm, and leg fractures.

Fractured bone symptoms depend on what bone is fractured and the type of break you experience, from a stress fracture in the shin or a compression fracture in the spine. The shin bone is the most commonly broken long bone in the body, but fractured leg symptoms from the shin bone can range from mild swelling to a bone actually sticking out through the skin.

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Symptoms that may occur with most fractured bones include:
A misshapen or deformed bone or joint
Bruising and swelling around the fracture
Severe pain that is worse with movement
Broken skin with visible bone showing
Loss of sensation or a tingling
Limited or complete loss of movement
Types of Bone Fractures

A bone fracture can range from a tiny crack in one spot to multiple complete breaks. Doctors use different terms to describe these types of fractured bones:

Greenstick. A greenstick fracture is a crack on one side of a bone that does not go all the way through.
Complete. A complete fracture is one that goes all the way through the bone.
Stress. A stress fracture is a hairline crack that occurs from overuse. Minor leg fracture symptoms often occur from stress fractures.
Compression. A compression fracture is when a bone collapses. This type of fracture usually occurs in the bones of the spine.
Open. An open fracture is a fracture that has broken the skin. These are also called compound fractures.
Comminuted. A comminuted fracture means that the bone is broken in more than one place.
Who Is at Risk for Fractures?

You are at greatest risk for a fractured bone when you are under age 20 or over age 65. After middle age, women are at greater risk for fractured bones than men because of osteoporosis. Loss of estrogen after menopause can cause low levels of calcium, which can make a woman's bones weaker and easier to fracture.

Other risk factors include:

Participating in sports, especially contact sports
Weak muscles and bones from not getting enough exercise
Having a bone tumor
Having a disease that weakens bones
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What to Do for a Fractured Bone

If you or a loved one might have a fractured bone, the first thing to do is stay calm and get help. Movement of a fractured bone can make things worse. Lower leg fracture symptoms or suspected fracture of a hand or arm may require a call to the doctor. More severe fractures may require first aid and emergency treatment. Here are some basic first-aid rules for fractures:

Never move a broken bone if it is unstable or if it involves the head, neck, spine, or hip. If a person needs to be moved to safety, he should be grabbed by his clothing (the top of the shirt, belt, or pant legs) and dragged gently.
Apply ice packs to reduce swelling.
Avoid shock by keeping the person flat and warm with a blanket. The feet can be elevated 12 inches above the head. Do not move a person to get him flat or raise his legs if a head, neck, or back injury is suspected.
For an open fracture, rinse the wound to remove dirt and cover it with a clean dressing. Control bleeding with gentle pressure.
Not all fractured bones are medical emergencies, but all fractured bone symptoms need to be checked by a doctor. Call 911 for fractured bone emergencies such as open fractures; severe bleeding; cold, clammy, or blue skin; and possible fractures of the head, neck, back, hip, or upper leg.

41

EEE / What Is Appendicitis?

« on: April 22, 2017, 03:05:33 PM »

Appendicitis is a painful medical condition in which the appendix becomes inflamed and filled with pus, a fluid made up of dead cells that often results from an infection.

Appendicitis is the leading cause of emergency abdominal operations in the United States, according to the National Institutes of Health (NIH).

The appendix is a small, finger-shaped pouch attached to your large intestine on the lower right side of your abdomen.

It's not entirely clear what role the appendix plays in the body, but some research suggests that it isn’t the useless organ it was once thought to be.

Though people can live perfectly normal lives without their appendix, inflammation of this abdominal organ can be a serious, life-threatening condition.

If not treated promptly, appendicitis may cause the appendix to burst, spreading an infection throughout the abdomen.

When people discuss appendicitis, they're typically referring to acute appendicitis, which is marked by a sharp abdominal pain that quickly spreads and worsens over a matter of hours.

In some cases, however, people may develop chronic appendicitis, which causes mild, recurrent abdominal pain that often subsides on its own — these patients usually don't realize they have appendicitis until an acute episode strikes.

Prevalence and Risk Factors for Appendicitis

Acute appendicitis now affects about 9 in 10,000 people each year in the United States (roughly 300,000 people annually) — this prevalence is higher than it was just 20 years ago, according to a 2012 report from the Journal of Surgical Research.

People of any age can get the condition, though appendicitis is most common among children and teenagers between 10 and 19 years old, according to the 2012 report.

It affects males more often than females, but scientists have yet to identify why this is the case.

Appendicitis is more common in Western societies, and may be more common in urban industrialized areas, compared with rural communities.

The typical "Western diet" that's low in fiber and high in carbohydrates is thought to be behind this pattern.

It also appears that having a family history of appendicitis increases the risk of getting the condition for both children and adults.

The NIH estimates that almost 400 people die in the United States each year from appendicitis.

Causes of Appendicitis

It's not always clear what causes appendicitis, but the condition often arises from one of two issues: A gastrointestinal infection that has spread to the appendix, or an obstruction that blocks the opening of the appendix.

In the second case, there are several different sources of blockage. These include:


Lymph tissue in the wall of the appendix that has become enlarged
Hardened stool, parasites, or growths
Irritation and ulcers in the gastrointestinal tract
Abdominal injury or trauma
Foreign objects, such as pins or bullets
When a person's appendix becomes infected or obstructed, bacteria inside the organ multiply rapidly. This bacterial takeover causes the appendix to become infected and swollen with pus.

Symptoms of Appendicitis

At the onset of appendicitis, people often feel an aching pain that begins around the belly button, and slowly creeps over to the lower right abdomen.

The pain sharpens over several hours, and can spike during movement, deep breaths, coughing, and sneezing. Other symptoms of appendicitis may follow, including:

Nausea
Vomiting
Constipation or diarrhea
Inability to pass gas
Loss of appetite
Abdominal swelling
Fever
Diagnosing Appendicitis

Because the symptoms of appendicitis are very similar to other conditions, including Crohn's disease, urinary tract infections (UTI), gynecologic disorders, and gastritis, diagnosing appendicitis is no simple matter.

After learning about a patient's medical history and recent pattern of symptoms, doctors will use a number of tests to help them diagnose appendicitis.

They may:

Conduct an abdominal exam to assess pain and detect inflammation
Take a blood test to determine white blood cell counts, which could indicate an infection
Order a urine test to rule out urinary tract infection and kidney stones
Perform a bimanual (two-handed) gynecologic exam in women
Use imaging tests, including computerized tomography (CT) scans, abdominal X-rays, ultrasounds, or magnetic resonance imaging (MRI) scans to confirm the appendicitis diagnosis or find other causes of abdominal pain
Treating Appendicitis

In rare cases, doctors will treat appendicitis with antibiotics, but the infection needs to be very mild.

Most often, appendicitis is considered a medical emergency, and doctors treat the condition with an appendectomy, the surgical removal of the appendix.

Surgeons will remove the appendix using one of two methods: open or laparoscopic surgery.

An open appendectomy requires a single incision in the appendix region (the lower right area of the abdomen).

During laparoscopic surgery, on the other hand, surgeons feed special surgical tools into several smaller incisions — this option is believed to have fewer complications and a shorter recovery time.


If a person's appendix isn't treated in time, it may burst and spread the infection throughout the abdomen, leading to a life-threatening condition called peritonitis, an infection of the peritoneum (the lining of the gut).

In other cases, abscesses may form on the burst appendix.

In both these cases, surgeons will usually drain the abdomen or abscess of pus and treat the infection with antibiotics before removing the appendix.

42

EEE / Healthy Living One Quarter of Older U.S. Adults Take Statins

« on: April 22, 2017, 03:04:21 PM »

More medicine cabinets across the country are stocked with bottles of Lipitor, Zocor, and Crestor — three of the top selling cholesterol-lowering drugs known as statins — than they were two decades ago, and that might be a good thing.

A quarter of Americans age 45 and older are currently taking these medications, up from just 2 percent about 20 years ago, according to the latest report on the country’s health from the National Center for Healthcare Statistics.

Several cardiologists contacted by MedPage Today and ABC News said they were unaware that such a high proportion of patients take statins, but noted the findings go hand-in-hand with recent statistics on heart disease.

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"These results ... may explain some of the recent remarkable declines in hospitalizations for heart attacks and heart failure," Dr. Harlan Krumholz, a cardiologist from Yale University, said in an e-mail.

Dr. Christopher Cannon of Harvard and Brigham and Women’s Hospital in Boston said there is "no disconnect. The increased statin use is a direct cause of a lower rate of cardiovascular morbidity and mortality that has been observed over the past decade."

Indeed, the report shows that the percentage of adults with high cholesterol has fallen over the last two decades, from 20 percent to about 15 percent. As well, deaths from heart disease have declined across all age groups, while the prevalence of heart disease itself has remained stable over the last 10 years.

Thus, the total burden of heart disease may be high, said Dr. Robert Califf of Duke University, but "the age of onset and death are significantly later."

Still, researchers are hesitant to attribute all good outcomes in heart disease to statins alone.

"The decline in death rates comes from improved risk factor control, especially blood pressure reductions, smoking cessation and bans, improved lipids, and better care of heart attacks," Dr. James Stein, director of preventive cardiology at the University of Wisconsin, said in an e-mail.

Dr. Krumholz added that the value of leading a healthy lifestyle shouldn’t be lost in the increased use of medication.

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Overall, heart disease is responsible for 25 percent of deaths in the U.S. — but cancer comes in at a close second, accounting for 23 percent of mortality, according to the report, which paints an overarching portrait of health in the United States.

Stroke follows at 6 percent, and chronic lower respiratory diseases and unintentional injuries are each responsible for 5 percent of deaths.

In general, however, life expectancy is getting longer, climbing over the past two decades. It’s greatest among white women, who in 2007 were expected to live 80 years, up from 77 in 1980.

And while the gap in life expectancy between whites and blacks still exists, it narrowed after 1990, the researchers said.

Obesity rates still remain high, with a third of adults and a fifth of children over age 5 classified as such — and two-thirds of adults are either overweight or obese.

Yet after rising through the 1980s and 1990s, the prevalence of the condition seems to have plateaued across groups, slowing in 1999 in women, in 2000 for children, and in 2005 for men.

The report also finds that children are suffering from more allergies. The prevalence of food allergies recently jumped to 5 percent from 3 percent about 10 years ago, while skin allergies rose to 11 percent from 7 percent during that time.

43

EEE / Chemical Found in Blood Holds Clues to Survival

« on: April 22, 2017, 03:03:34 PM »

Even within the normal range, higher bilirubin levels appear to be associated with reduced risks of lung cancer, chronic obstructive pulmonary disease (COPD), and death, a longitudinal, prospective analysis of a large database showed.

For every 0.1-mg/dL increase in bilirubin level, the rate of lung cancer dropped by 8 percent in men and 11 percent in women, according to Laura Horsfall, MSc, of University College London, and colleagues.

In addition, the same incremental increase in bilirubin was associated with a 6 percent decline in the rate of COPD and a 3 percent decline in mortality for both sexes, the researchers reported in the Feb. 16 issue of the Journal of the American Medical Association.

"Based on our findings, bilirubin levels within the normal range appear to capture information about patients that may reflect a combination of environmental and genetically determined susceptibility to respiratory diseases," they wrote.

Most people are familiar with bilirubin because of its role in jaundice — the yellowing of the skin that is sometimes seen in newborns but is also associated with liver disease.

Bilirubin is actually a byproduct of the turn over of red blood cells — the cells that carry oxygen throughout the body. Healthy individuals constantly replace old red blood cells with new ones. As the old cells are broken down they produce bilirubin, a chemical characterized by a distinctive yellow color.

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The spleen and the liver taking in bilirubin and use it to break down or metabolize other substances into bile, which is used to aid digestion.

Although the study cannot establish causality for any of the relationships, there is some experimental evidence that bilirubin has benefits for respiratory health because of its cytoprotective properties, including antioxidant, anti-inflammatory, and antiproliferative effects, according to the researchers.

They noted that a better understanding of the possible mechanisms linking bilirubin levels to lung cancer, COPD, and death may lead to potential therapies that target the activity of UGT1A1, a liver enzyme responsible for converting insoluble bilirubin to an excretable form.

Horsfall and her colleagues examined data from the Health Improvement Network, a U.K. primary care research database.

Their analysis included 504,206 patients ages 20 and older from 371 practices. All of the patients had recorded serum bilirubin levels but no evidence of hepatobiliary or hemolytic disease.

Median bilirubin levels were 0.64 mg/dL in men and 0.53 mg/dL in women.

Through a median follow-up of eight years, there were 1,341 incident cases of lung cancer, 5,863 incident cases of COPD, and 23,103 all-cause deaths. The corresponding rates per 10,000 person-years were 2.5, 11.9, and 42.5.

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For men, the rate of lung cancer per 10,000 person-years dropped from 5.0 in the lowest decile of bilirubin levels to 3.0 in the fifth decile. Similar declines were seen for COPD (19.5 to 14.4) and death (51.3 to 38.1).

The findings were similar for all outcomes in women, and the declines in both sexes remained significant after adjustment for age, body mass index, systolic blood pressure, smoking, alcohol intake, and a measure of social deprivation.

The authors acknowledged some limitations of the study, including possible residual confounding by unmeasured environmental exposures or race/ethnicity and the inability to establish causality for the observed relationships.

44

EEE / Medical Device Recalls Raise Questions About FDA Process

« on: April 22, 2017, 03:02:40 PM »

 A large proportion of the medical devices recalled in recent years because they posed a significant safety hazard made their way to market via the a FDA process that is too lenient, researchers say.

In a review of 113 urgent recalls from 2005 to 2009, more than 70 percent of the recalled devices were found to have been cleared via the 510(k) program — compared with 19 percent approved through the FDA's more rigorous premarket approval (PMA) system, Dr. Steven Nissen, of the Cleveland Clinic, and colleagues reported.

The findings demonstrate "systematic problems" in current medical device regulation "that have exposed patients to serious harm," Nissen and co-authors wrote in the Feb. 14 issue of the Archives of Internal Medicine.

"There should be NO recalls for 'serious injuries or death' amongst 510(k) approved devices," Nissen said in an e-mail to MedPage Today. "The FDA is supposed to require a PMA for Class III devices, those used to sustain life or preserve health.

"If a PMA is required for devices used to support or sustain life," Nissen continued, "why were so many of the devices recalled for 'serious injury or death' originally approved using 510(k)?"

Several researchers contacted by MedPage Today and ABC News via e-mail said the study highlights a major flaw in the FDA approval process for medical devices.

"The system is set up so that safety and innovation are opposed to each other. It doesn't have to be that way," said Dr. Cam Patterson, of the University of North Carolina at Chapel Hill. "The requirements for premarket testing have gotten so over the top that it is almost considered the kiss of death for a company if the FDA requires their product to reach approval through this pathway."

"This creates a perverse incentive for companies to seek 510(k) approval rather than premarket testing," Patterson added. "This situation may reflect in part the observations in this study."

Dr. Mark Adelman, of the NYU Langone Medical Center in New York City, called the 510(k) program a "double-edged sword."

"While some lives have been lost by expedited approval, many lives have been saved by getting better devices to market quickly," Adelman said. "How many lives have been saved by the 510(k) fast track?

Several other physicians contacted by MedPage Today and ABC News via e-mail noted the need for a balance between expensive premarket testing and getting devices to market fast enough to save lives.

They also pointed out that Nissen and colleagues didn't compare the proportions of devices recalled in each category.

Nissen acknowledged in his e-mail to MedPage Today that a "higher percentage of PMAs result in serious injuries or deaths, but we think that is not very relevant." Rather, he said, the question is whether fewer recalls would occur if the life-sustaining devices were more frequently subject to the PMA approval process.

The FDA began officially regulating devices with the dual-pathway strategy in 1976. At that time, few devices were permanently implanted or intended to sustain life. Thus, the system was challenged as new devices changed more dramatically and became more complex, the researchers said.

In 2002, the Medical Device User Fee and Modernization Act further loosened regulations, allowing products made from different materials and using a different mechanism of action to go the route of 510(k) if they had a similar safety profile. It also expanded to include similarities to devices cleared through the 510(k) or PMA process.

But in September 2009, the agency asked the Institute of Medicine to review the approval process (which is expected to be completed in mid-2011), and released its own pair of reports in August 2010.

Yet last month, the FDA held off on implementing many of its proposed revisions after criticism from industry, and last week it announced a new "Innovation" pathway for outstanding medical devices.

For their study, Nissen and colleagues analyzed the FDA's high-risk list of device recalls from 2005 to 2009.

There were a total of 113 Class I recalls — the most urgent -- during that time for devices the FDA determined had the potential to cause serious health problems or death.

About 7 percent of recalls involved devices that were exempt from any regulation — while about 4 percent were counterfeit or categorized as "other" and didn't go through any of the three processes for approval, clearance, or registration, Nissen and colleagues noted.

Cardiovascular devices comprised the largest recall category, accounting for 31 percent of high-risk recalls. About two-thirds of these recalled devices were cleared via the 510(k) program; most of them were automated external defibrillators (AEDs).

Nissen said more than 20% of the almost one million AEDs in circulation were recalled by the FDA, and hundreds of people died due to AED malfunctions.

The next largest risk category, accounting for 24% of recalls, involved general hospital devices — insulin pumps, intravenous infusion devices, and patient lifts. Of these, 74% had been approved via the 510(k) pathway, the researchers said.

They concluded that the findings suggest "reform of the regulatory process is needed to ensure the safety of medical devices."

Nissen and co-authors made several recommendations at the end of their report, including:

Life-saving and life-sustaining Class III devices should be subject to the PMA process.
FDA should expand its authority and inspect the manufacturing of 510(k) devices.
FDA must use controls for these devices, such as postmarket surveillance and performance standards.
In an accompanying editorial, Rita Redberg, MD, and Sanket Dhruva, MD, of the University of California San Francisco, agreed that there should be tougher standards for approval of more complicated devices.

"Although the FDA committed some time ago to require that high-risk devices be either evaluated through PMA or reclassified to a lower-risk class, neither has yet occurred," they wrote.

Redberg and Dhruva also called it "unfortunate" that the FDA had "backed down from several essential safeguards when it released its implementation plan in January 2011."

They concluded that the study "deepen our concern about approved devices by showing that millions of Americans may be at risk for device-related injuries and recalls from high-risk devices that were cleared by FDA without any supporting clinical trial data."

The study was supported by the National Research Center for Women & Families, which "does not accept contributions from medical device companies."

Nissen reported consulting for many pharmaceutical companies but "requires them to donate all honoraria or consulting fees directly to charity so that he neither receives income nor a tax deduction for his services."

45

Life Style / Giffords Walking and Talking as Recovery Continues

« on: April 22, 2017, 03:00:42 PM »

U.S. Rep. Gabrielle Giffords is walking with assistance, mouthing the words to songs, and speaking simple sentences as she recovers after being shot through the head at a public event on Jan. 8, according to reports from friends, family, and the congresswoman's staff.

Although doctors have not provided an update on Giffords' condition since she began full-time rehabilitation on Jan. 26 at The Institute for Rehabilitation and Research (TIRR) Memorial Hermann in Houston, a report in the New York Times noted that she has lip-synched words to several songs and is walking the halls with assistance.

A spokesman from the congresswoman's office confirmed the information from the Times report for MedPage Today.

Experts contacted by ABC News and MedPage Today said reports of her progress are about what would be expected for someone with a good recovery pattern.

"Her overall recovery seems good but perhaps not overly surprising for someone who regained consciousness so quickly after her injury," according to Dr. Shari Wade, of the division of physical medicine and rehabilitation at Cincinnati Children's Hospital Medical Center.

Giffords was reportedly able to respond to requests immediately after the shooting and shortly before undergoing surgery at University Medical Center in Tucson, Ariz., where she was treated before moving to Houston for rehabilitation.

"Duration of unconsciousness is the single best predictor of recovery," Wade explained in an e-mail, "and someone who is unconscious for a few hours or a few days will recover much more rapidly and more completely than someone who is unconscious for a month or more."

According to Dr. Gregory O'Shanick, chair of the board of directors of the Brain Injury Association of America, "her recovery curve is somewhat rapid but is what we expect to see when someone has the benefit of a comprehensive inpatient rehab program immediately after their brain injury and receives therapies from an experienced team in an aggressive program."

Singing during rehabilitation is often used as a way to stimulate language functions, which are largely located in the left hemisphere. The ability to sing is largely located in the right hemisphere. Giffords was shot through the left side of the brain, leaving the right side untouched.

"The intonation or inflection in speech, called prosody, is a function of the right hemisphere of the brain and has regions analogous to propositional language ... in the left hemisphere," O'Shanick wrote in an e-mail. "When working with patients like [Congresswoman] Giffords, the use of melodic intonation to sing or speak is used to stimulate both regions."

Dr. Joel Stein, chair of the department of rehabilitation and regenerative medicine at Columbia University, said the "essential idea is to sing the intended statement, rather than merely say it. It has some value, but provides only limited benefit to most individuals with this condition."

The fact that Giffords is singing is a hopeful sign, added Dr. Paul Schulz, a neurologist at the University of Texas Health Science Center, "but would be less significant than the degree to which she is talking."

The report in the New York Times stated that Giffords has lip-synched to "Twinkle, Twinkle, Little Star" and "I Can't Give You Anything but Love, Baby" as friends and family members sang. She has also been videotaped mouthing "Happy Birthday to You" for her husband, astronaut Mark Kelly.

According to Giffords' chief of staff Pia Carusone, the congresswoman recently spoke with Kelly's twin brother Scott, an astronaut aboard the International Space Station, saying "Hi, I'm good." "It's not like she's speaking the way she spoke, but she is vocalizing and making progress every day," Carusone was quoted as saying by the Times.

Giffords is also walking through the halls of the rehabilitation center with the assistance of a shopping cart, according to an e-mail written by her mother to friends.

Several experts agreed that reports of Giffords' progress can give other patients with traumatic brain injuries hope for their own recoveries, but Schulz noted that patients should be counseled on how injuries and brain plasticity differ between patients.

"Each person's improvement will differ and expectations should be tempered by their individual circumstances," Schulz wrote in an e-mail.

O'Shanick pointed out, too, that the intensity of services and length of inpatient rehabilitation Giffords is receiving is not what the average patient would receive.

Dr. Brian Greenwald, from Mount Sinai School of Medicine's department of rehabilitation medicine, cautioned that, even with such a high level of care, Giffords will have a protracted recovery from her wound.

The singing, the walking, and the speaking "are all good things on the road to recovery," he wrote in an e-mail.

But, he added, "The road back after this type of injury is long to get to independence. The road to being a congresswoman again is much longer.