Author Archives: dbrunk

PMA Process Taking Longer and Longer

In the medical device arena, pre-market approval (PMA) submissions to the FDA keep taking longer and longer to process, according to Bob Rhatigan, senior vice president of facial aesthetics for Allergan Inc. 

“A decade ago we used to see a PMA approval time of 9-12 months,” Mr. Rhatigan told attendees of the Summit in Aesthetic Medicine 2012. “In the middle of the last decade, that increased to 16 months, and as recently as 2010, that time frame is over 2 years. It’s something that we are anxiously watching. We don’t see any signs of that abating.” 

The implications are gloomy for clinicians engaged in research of medical devices who wish to continue working in the United States. The current regulatory environment, Mr. Rhatigan said, “is working to push clinical research and studies outside of the U.S. market. It is not inconceivable, looking forward, to think about the bulk if not all of clinical research moving offshore as a result of companies like Allergan needing to get products approved more quickly. We are a bit pessimistic right now but [are] attempting to influence [legislators], as we want to make sure innovation in this industry continues to be ripe in the U.S. market.” 

— Doug Brunk (on Twitter@dougbrunk)

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Filed under Dermatology, Drug And Device Safety, health reform, IMNG, Practice Trends

What Drives Change in Medicine?

During the last presentation on the last day of the Summit in Aesthetic Medicine 2012, Dr. R. Rox Anderson shared some of his observations on creating change in the world of medicine. As the person who conceived of or helped develop many of the non-invasive treatments now widely used to remove birthmarks; microvascular and pigmented lesions; tattoos; and hair, he should know a thing or two about that topic.

“It takes people with passion,” Dr. Anderson, professor of dermatology at Harvard Medical School, Boston, said of change-leaders in medicine. “We’re driven to help other people. That is my primary passion. I go to work every-day thinking, ‘Science for the people.’ It’s also important to get very specific about the problem. I’ve noticed that the ability to really define the problem and own it is often where some of the passion comes from. Working on something that someone else told you about often does not sustain the process that you have to go through to make substantial change.”

Dr. Rox Anderson

Dr. Rox Anderson

Medical change-leaders exhibit unbridled curiosity mixed with health skepticism. “It’s interesting how change can happen if you mix people who are very problem-oriented with people who are very technology-oriented,” said Dr. Anderson, who also directs the Wellman Center for Photomedicine. “I kind of walk around with two bags: One of them you might label ‘Problems I care about but don’t know how to solve,’ the other one ‘Stuff I know about technology-wise.’ The challenge is to connect the two. I don’t know how that happens, but when it happens right, you get change.”

Change-leaders tend to be resilient, he said, explaining that real change is usually either threatening or surprising. “There’s a phrase, ‘You can tell the pioneers by the arrows in their backs.’ People are very uncomfortable with change. You will find that if you’re trying to put something new out there, you may threaten someone’s paradigm.”

In the business of medicine, he continued, “the bottom line is helping others. In medicine, if the problem isn’t about helping people, it’s going to fail. If you’re not curious and skeptical about something important, you’ll be off on some tangent that won’t ultimately make a tangible change.”

Strong commitment to the problem you’re trying to solve is essential, he said. He likened the level of commitment to a marriage in which you “Write a grant and start making phone calls to your colleagues, get a collaborative group together and say, ‘We’re going to attack this problem.’ Then you and the problem have ‘children’ – 3 or 4 ideas [of how to] solve the problem. Some of them work, some of them don’t. It’s the ones that don’t work that teach you things. My definition for bad research is that you can predict the outcome.

— Doug Brunk

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Filed under Dermatology, IMNG, Practice Trends

NBA Legend Bill Walton Grateful, ‘Feelin’ Fine’

Five years ago NBA Hall of Famer Bill Walton returned home to San Diego from a road trip when “my spine collapsed,” he told attendees at the annual meeting of the American Academy of Dermatology.

Bill Walton holds court in San Diego. Doug Brunk/IMNG Medical Media

Years of debilitating back problems had finally caught up with him. He had spent more than 4 decades on the road as a basketball player then as a television broadcaster, navigating his 6-foot, 11-inch frame through “horrendous hotels I couldn’t stand up in, sitting in chairs built for children” and being cramped in the cabins during “mind-numbing airplane flights, [logging] 800,000-plus miles a year.”

He spent 2 years mainly lying in a horizontal position on the floor, he said, “in excruciating, unrelenting pain. If I had had a gun, I would have used it. I was standing on a bridge knowing full well that it was better to jump than to go back to what was left.”

But then he was saved, he said, “by doctors like you, by innovating companies like the ones changing the world of dermatology.” More than 3 year ago Mr. Walton underwent an 8-hour experimental surgery on his spine – his 36th orthopedic operation.

“They straightened everything up, bolted it back together,” he said, noting that the foundations of the procedure involved placement of two titanium rods and an Erector-Set-like cage. This was followed by a week in a medically induced coma, 73 postoperative days on morphine, “and the long hard climb back to trying to figure out how to play the game of life and how to get on that mountain one more time.”

During his recovery, Mr. Walton, now 59, said that he was reminded of how lucky he’d been in life, of the support of his parents, friends, and “heroes and role models who stood for principle, who lived their lives with passion and purpose. And they believed in more than material accumulation.”

To borrow a phrase from the Grateful Dead gem “Touch of Grey,” well-known Deadhead Mr. Walton appears to be “feelin’ fine” these days. His views on sports are as colorful as ever. He described basketball as “the perfect game of all, unlike football, which is basically a halfway house between the Army and prison. And baseball, which is a bunch of guys out of shape scratching themselves, standing around, taking steroids, and waiting for the game of life to come to them.”

Welcome back, Bill.

— Doug Brunk

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Filed under Dermatology, Family Medicine, IMNG, Neurology and Neurological Surgery, Primary care, Sports Medicine

Neckties: A Magic Carpet Ride for Bacteria?

My necktie collection needs a makeover, at least some vim and a spray-down with Febreze to mask their musty smell.

Three of my favorite ties, which could be harboring transmittable bacteria. Nice. Photo by Doug Brunk/Elsevier Global Medical News

I keep my collection hanging on a tie rack shoved in the far corner of my closet, barely within reach and safe from potentially damaging ultraviolet rays. Wearing ties underwhelms me, though I consider three as prized possessions. These include a tie that celebrates horseracing at the Del Mar Thoroughbred Club, another tastefully decorated with the Great Seal of the State of New York (my home state), and one littered with different Donald Duck facial expressions, a gift from a former boss who had a tendency to call me “Duck” instead of Doug.

Results from a small controlled experiment published online Feb. 3, 2012, in the Journal of Hospital Infection have me worrying about my tie collection now, though. If its results are correct, these ties collectively might contain enough bacteria to grow mushrooms that I could add to a homemade marinara sauce, perhaps even enough to help spawn life on some planet in a faraway galaxy.

For the experiment, a team of researchers from Scott and White Healthcare, a general medical and surgical hospital based in Temple, Tex., set out to investigate the extent to which shirt sleeve length and/or the wearing of a tie affects the rate of transmission of bacteria from an examiner to a patient. One physician wore four clothing combinations: long sleeve shirt with unsecured tie, long sleeve without tie, short sleeve with tie, and short sleeve without tie. The physician performed mock history and physical examinations on five clothed mannequins dressed in hospital gowns in a simulation center while the researchers obtained cultures from the physician’s tie, shirt sleeves, and from each mannequin’s cheek, right hand, and abdomen before and after the mock examinations.

“The control cultures of the physician’s clothing inoculation sites in each combination group both before the first simulated patient interaction and after the last one demonstrated greater than 300 colony-forming units of micrococcus on each,” the researchers reported. “This confirmed the assumption that the bacteria were alive prior to and at the end of the encounters. The culture of the deliberate contamination site grew 44 colonies, demonstrating the ability of the mannequin to be inoculated by an article of clothing.”

They went on to discover that cultures taken from the abdomen, cheek, and hand sites of the mannequin prior to encounter “grew a total of five colonies of contaminant bacteria. There was no growth of micrococcus on any simulated patient prior to the history and physical examination.”

Simulated patient encounters in which an unsecured tie was worn had significantly more mannequins contaminated with micrococcus compared with those encounters in which an unsecured tie was not worn. However, sleeve length had no significant impact on the colonization rates.

“Neckties most often end at the waist, swing, and are not readily machine washable,” the researchers observed. “In patient interactions, unsecured ties may swing across an infected field either to transmit bacteria to the patient, or to the cleansed hands of the provider which are then transferred to the patient. Our report provides evidence for a policy suggesting that physicians should not wear unsecured ties when seeing patients.”

The experiment did not factor in the game-changing potential of wearing tie tacks to keep neckties from swinging like a pendulum.

I guess it was only a matter of time before neckties would become the subject of healthcare-associated infection risk, with previous studies having established clear bacterial transmission links through unwashed hands, hospital curtains, and white coat sleeves. It begs a sobering question, though: where is the next undiscovered bacterial carrier lurking? Let me mull that over, but I’d like to wash my hands first.

— Doug Brunk (on Twitter@dougbrunk)

Photo by Doug Brunk/Elsevier Global Medical News

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Filed under Allergy and Immunology, Family Medicine, Hospital and Critical Care Medicine, IMNG, Infectious Diseases, Internal Medicine, Uncategorized

Best Friends Cushion Blow From Negative Experiences

One effective remedy for elementary schoolers who present to your office troubled by bullying at school or other negative experiences may be the presence of a best friend to vent to. Not the Facebook kind, but the physical presence of a peer.

Photo courtesy Wikimedia Commons/JC Mar/Creative Commons License

In a study published in the November 2011 edition of the journal Developmental Psychology, 103 fifth- and sixth-graders enrolled in Montreal elementary schools kept a journal on their feelings and experiences over the course of 4 days and underwent regular saliva testing that measured cortisol levels. The 55 boys and 48 girls were asked to write about a negative experience that occurred 20 minutes previously and how they felt about themselves at the moment. They also submitted several saliva samples over the course of each day.

The researchers found that when a best friend was not present during an unpleasant event, children experienced a significant increased in cortisol levels and a significant decrease in feelings of global self-worth. When a best friend was present, there was less of a change in the cortisol levels and feelings of global self-worth from the negativity of the experience.

Study coauthor William M. Bukoswki, Ph.D., professor of psychology at Concordia University, Montreal, said the findings have long-term implications. “Our physiological and psychological reactions to negative experiences as children impact us in later life,” he explained in a press release. “Excessive secretion of cortisol can lead to significant physiological changes, including immune suppression and decreased bone formation. Increased stress can really slow down a children’s development.”

Persistent feelings of low self-worth can also adversely affect development. “If we build up feelings of low self-esteem during childhood, this will translate directly into how we see ourselves as adults,” Dr. Bukowski said.

— Doug Brunk (on Twitter@dougbrunk)

Photo courtesy jcmar.net’s photostream

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Filed under Family Medicine, IMNG, Pediatrics, Psychiatry, Uncategorized

More Docs Are Asking Patients to Exercise

Physicians are getting better at advising adults to exercise.

Photo courtesy National Cancer Institute/Bill Branson

In 2010, 32.4% of adults in the United States who had seen a physician or other health care professional in the past year had received a recommendation to begin or continue to do exercise or physical activity, up from 22.6% in 2000. At each time point, women were more likely than men to have been advised to exercise.

The findings, published this month as a National Center for Health Statistics Data Brief, come from the National Health Interview Surveys conducted in 2000, 2005, and 2010.

Between 2000 and 2010 the percentage of patients aged 85 and older who received a “get fit” recommendation from a physician nearly doubled from 15.3% to 28.9%. The percentage of patients aged 18-24 years receiving such a recommendation also increased during the same time period, but to a lesser extent (from 10.4% to 16.1%).

The report also found that the percentage of adults with hypertension, cardiovascular disease, cancer, and diabetes who received exercise advice from a physician increased between 2000 and 2010.

“Trends over the past 10 years suggest that the medical community is increasing its efforts to recommend participation in exercise and other physical activity that research has shown to be associated with substantial health benefits,” the report states. “Still, the prevalence of receiving this advice remains well below one-half of U.S. adults and varies substantially across population subgroups.” 

 — Doug Brunk (on Twitter@dougbrunk)

Photo courtesy National Cancer Institute Visuals Online

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Filed under Cardiovascular Medicine, Family Medicine, IMNG, Practice Trends, Primary care

Review Not Favorable to Herbs for Osteoarthritis

Patients with osteoarthritis who routinely turn to devil’s claw, Indian frankincense, ginger, and other herbal medicines for symptom relief may want to think twice about this practice.

Image via Flickr user anolobb by Creative Commons License

According to a review of these products that appears in the January 2012 issue of Drug and Therapeutics Bulletin, a publication of the London-based BMJ Group, there is little conclusive evidence to justify their widespread use by patients with the disease (DTB 2012: 50:8-12). A press release about the review points out that few robust studies on the use of herbal medicines for osteoarthritis have been carried out. “And those that have frequently contain design flaws and limitations, such as variations in the chemical make-up of the same herb, all of which comprise the validity of the findings.”

Herbal medicines commonly used to treat osteoarthritis includes vegetable extracts of avocado or soybean oils (ASUs), cat’s claw, devil’s claw, Indian frankincense, ginger, rosehip, turmeric and willow bark. According to the review, the best available clinical evidence suggests that ASUs, Indian frankincense, and rosehip may work, “but more robust data are needed.”

Some herbal medicines may cause adverse reactions in patients taking other medicines and prescription drugs. For example, chronic use of nettle can interfere with drugs used to treat diabetes, lower blood pressure, and depress the central nervous system while willow bark can cause digestive symptoms and renal problems.

The review characterized the use of herbal medicines for osteoarthritis as “generally under-researched, and information on potentially significant herb-drug interactions is limited.”

Although the UK Medicines and Healthcare products Regulatory Agency has approved Traditional Herbal Registrations for several herbal medicinal products containing devil’s claw for rheumatic symptoms, “the trial results for this herb are equivocal,” the review states. “There is little conclusive evidence of benefit from other herbs commonly used for symptoms of osteoarthritis, such as cat’s claw, ginger, nettle, turmeric and willow bark. Healthcare professionals should routinely ask patients with osteoarthritis if they are taking any herbal products.”

The review did not include data on glucosamine and chondroitin sulfate.

— Doug Brunk (on Twitter@dougbrunk)

Photo courtesy anolobb’s photostream

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Filed under Family Medicine, IMNG, Internal Medicine, Primary care, Rheumatology