Category Archives: Primary care

Title IX Hits 40

Image courtesy of Sarah Jones via Wikimedia Commons (CC)

What does Title IX mean to you? Athletics is typically high up on the list for many people. Title IX has played an important role in getting girls and young women onto the field. On the 40th anniversary of the landmark gender equity in education legislation, U.S. Secretary of Education Arne Duncan noted in a speech, “when Title IX was enacted in 1972, less than 30,000 female students participated in sports and recreational programs at NCAA member institutions nationwide. Today, that number has increased nearly six-fold. And at the high school level, the number of girls participating in athletics has increased ten-fold since 1972, to three million girls today.”

In an era of nationwide public health concerns over childhood obesity, getting girls and young women involved in sports becomes even more important. However, Title IX’s expansion of school-based athletics programs has more far-reaching benefits as well. As Secretary Duncan pointed out, female athletes “are more likely to graduate from college than female students who don’t play sports.” Female athletes are also less likely to use drugs and become pregnant as teenagers.

Sports are only part of the Title IX picture though. In fact, neither the word “sports” nor “athletics” are used in the text of the legislation. The law has changed the academic landscape for female students.

U.S. Navy photo by Greg Vojtko (Public Domain)

Here’s a few things that you might not know:

  • 57% of students in postsecondary education in 2009-2010 were women; women also accounted for 62.6% of students receiving a master’s degree.
  • Since 1976, girls enrolled in gifted and talented education programs have outnumbered boys enrolled. In 2009, 8.1% of girls participated in gifted and talented education programs, compared to 7.4% of boys.
  • A greater percentage of the girls in 7th or 8th grade (20%) are taking Algebra I, compared with boys (18%).
  • Girls are evenly represented in biology and outnumber boys in chemistry, but are underrepresented in physics.

Welcome to middle age, Title IX. Let’s see what else you can do to get girls on the field and in the classroom.

Kerri Wachter

Data from the “Gender Equity in Education A Data Snapshot” by the U.S. Department of Education’s Civil Rights Data Collection.

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Filed under Family Medicine, Health Policy, IMNG, Obstetrics and Gynecology, Pediatrics, Physical Medicine and Rehabilitation, Primary care, Sports Medicine

New Anti-Inflammatory Drugs Will End Anti-TNF Dominance

Tumor necrosis factor inhibitor drugs began to dominate treatment of inflammatory diseases like rheumatoid arthritis, psoriasis, and the inflammatory bowel diseases ulcerative colitis and Crohn’s disease a little over a decade again. Now, the time when the importance of the anti-TNFs will wane and newer drugs will take their place is clearly visible on the horizon. It hasn’t happened yet, but the era of anti-TNF dominance for treating inflammatory diseases that persisted throughout the 2000s will end in the next 5 years.

The anti-TNF era began in 1998 with the approval of etanercept (Enbrel) for rheumatoid arthritis and infliximab (Remicade) to treat Crohn’s disease. In subsequent years, the list of approved anti-TNFs expanded to include adalimumab (Humira), golimumab (Simponi), and certolizumab (Cimzia), and the approved indications grew to include many inflammatory disease of joints, the GI tract, and skin. The anti-TNFs revolutionized inflammatory disease treatment and made treatment to remission possible for many patients.

tumor necrosis factor (green, purple, black) and TNF receptors (blue)/courtesy Bassil Dahiyat; Science

But reports from just the past month show that new agents are overtaking the anti-TNFs.

In May, I reported from Digestive Disease Week on phase III trial results with vedolizumab, which was compared against placebo for patients with ulcerative colitis. One of the study investigators noted that vedolizumab beat the placebo arm for steroid-free clinical remission by 30 percentage points. “Nothing else is that good,” Dr. William Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego, told me, and the benchmark he had in mind was the performance of the anti-TNFs in similar patients.

More recently, at the European Congress of Rheumatology earlier this month I heard a report on a head-to-head comparison of the anti-IL-6 drug tocilizumab (Actemra) and the anti-TNF adalimumab in patients with rheumatoid arthritis. After 24 weeks of monotherapy, patients on tocilizumab had nearly a fourfold higher remission rate than patients on adalimumab. Though the monotherapy trial design did not mimic the way most rheumatoid arthritis patients get treated, the new drug tocilizumab absolutely blew adalimumab out of the water in a rare head-to-head comparison among different classes of anti-inflammatory drugs.

And at the same meeting several talks highlighted another new anti-inflammatory class of agents coming soon to the U.S. market, the Janus kinase (JAK) inhibitors, such as tofacitinib, which is expected to received FDA approval later this summer. Phase III results show that tofacitinib has safety and efficacy that seems at least comparable to anti-TNF drugs, with the advantage of oral dosing.

Vedolizumab, tocilizumab, and tofacitinib are just the tip of new waves of anti-inflammatory drugs that will soon substantially alter a landscape that the anti-TNFs have mostly had to themselves for the past 14 years. For the moment, the anti-TNFs have the advantage of a longer track record for safety, but changing that is only a matter of time.

—Mitchel Zoler (on Twitter “mitchelzoler)

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Filed under Allergy and Immunology, Dermatology, Drug And Device Safety, Family Medicine, Gastroenterology, Health Policy, IMNG, Internal Medicine, Practice Trends, Primary care, Rheumatology, The Mole

Quickening Pandemic Flu Vaccine Production

If a strain of avian H5N1 influenza that readily spread from person to person were to appear in the real world, the great fear is that it would produce a deadly pandemic to dwarf what happened in 1918.

The best defense against flu pandemics are vaccines, and the most recent experience with a global flu pandemic, in 2009, highlighted the gaps that existed in getting vaccine quickly made in large amounts. Three years ago, despite the U.S. government marshaling all its infectious disease-fighting muscle, the effort wound up delivering most of the vaccine too late to matter. The pandemic peaked in October 2009, while the vaccine supply didn’t hit its stride until sometime in December.

Novartis influenza-vaccine plant in Holly Springs, N.C./courtesy Novartis

In a report published today in Science as part of its H5N1 flu package, Dr. Rino Rappuoli, head of vaccines research for Novartis, spelled out seven steps that could hasten vaccine production for a newly appearing pandemic flu. The two most novel moves involve having vaccine manufacturers prepare in advance synthetic “vaccine seed” viruses and also adopting new ways to quantify viral antigens, a process that alone took about 2 months in 2009, he said. Adopting these two technological innovations could transform the vaccine-producing process “from a mid-20th century system … into a 21st century system of instantaneous electronic information exchange followed by immediate production.”

The modernized system would mean sequencing a newly isolated pandemic virus in the field and then — instead of shipping the virus — just sending gene sequences, followed by replicating the hemagglutinin gene at a remote site, putting the new gene into a waiting scaffold vaccine virus, and launching vaccine production.

If these two changes had been in place in 2009, “the vaccine would have been available in large quantities before the peak of viral infection,” Dr. Rappuoli said in his paper.

More importantly, speaking at a June 20 press conference Dr. Anthony Fauci said that the National Institutes of Health, as well as the Centers for Disease Control and Prevention and the Food and Drug Administration, had already begun to move on this, adopting “the fundamental principles of bringing influenza vaccinology into the 21st century.” Steps already taken along the lines of what Dr. Rappuoli suggested carry the potential for “a significant change right now” in the time needed to get out a pandemic vaccine, Dr. Fauci said.

He particularly cited NIH studies underway using an immunoadjuvant to expand the coverage potential of stockpiled H5N1 vaccine, a step that would “markedly accelerate availability.

“We are right now in a much better position [to distribute pandemic vaccine quickly] than we were in 2009 when we had vaccine available only after the peak of the H1N1 pandemic,” Dr. Fauci said.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Filed under Health Policy, IMNG, Infectious Diseases, Internal Medicine, Primary care

IOM Unveils Hot Reads in Time for Summer

In case you’re looking for something more meaningful to read this summer than Fifty Shades of Grey or Abraham Lincoln: Vampire Hunter, The Institute of Medicine has released some dandy reports suitable for reading or for hiding those trashy beach novels.

First up, in May, IOM released Accelerating Progress in Obesity Prevention: Solving the Weight of the Nation. The report focuses on five critical goals for preventing obesity:

  • integrating physical activity into people’s daily lives,
  • making healthy food and beverage options available everywhere,
  • transforming marketing and messages about nutrition and activity,
  • making schools a gateway to healthy weights, and
  • galvanizing employers and health care professionals to support healthy lifestyles.

The committee outlined specific strategies include: requiring at least 60 minutes per day of physical education and activity in schools, industry-wide guidelines on which foods and beverages can be marketed to children and how, expansion of workplace wellness programs, taking full advantage of physicians’ roles to advocate for obesity prevention with patients and in the community, and increasing the availability of lower-calorie, healthier children’s meals in restaurants.

Also in May, IOM published Ethical and Scientific Issues in Studying the Safety of Approved Drugs. In response to the passage of the Food and Drug Administration Act in 2007, the FDA asked the IOM to evaluate scientific and ethical aspects of safety studies for approved drugs. The IOM concluded that the FDA’s current approach to drug oversight in the postmarket setting is not systematic enough and does not ensure that benefits and risks of drugs are assessed consistently over the drug’s life cycle.  “Adopting a regulatory framework that is standardized across all drugs, yet flexible enough to adapt to regulatory decisions of differing complexity, could help make the agency’s decision-making process more predictable, transparent, and proactive. These changes could allow the FDA to better anticipate postapproval research needs and improve drug safety for all Americans.”

Finally, for the ambitious reader, the IOM had just released the discussion paper A CEO Checklist for High-Value Health Care. Despite risking costs, healthcare remains suboptimal in many areas. “To aid and accelerate the system-wide transformation necessary, we have assembled what we are calling “A CEO Checklist for High-Value Care” (the Checklist). The Checklist’s 10 items reflect the strategies that, in our experiences and those of others, have proven effective and essential to improving quality and reducing costs. They describe the foundational, infrastructure, care delivery, and feedback components of a system oriented around value, and represent basic opportunities—indeed obligations—for hospital and health care delivery system CEOs and Boards to improve the value of health care in their institutions.”

The 10 items include:

  • Governance priority—visible and determined leadership by CEO and Board
  • Culture of continuous improvement—commitment to ongoing, real-time learning
  •  IT best practices—automated, reliable information to and from the point of care
  • Evidence protocols—effective, efficient, and consistent care
  • Resource utilization—optimized use of personnel, physical space, and other resources
  • Integrated care—right care, right setting, right providers, right teamwork
  • Shared decision making—patient–clinician collaboration on care plans
  • Targeted services—tailored community and clinic interventions for resource-intensive patients
  • Embedded safeguards—supports and prompts to reduce injury and infection
  • Internal transparency—visible progress in performance, outcomes, and costs

Kerri Wachter (On Twitter @knwachter)

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Seeking Primary Care Elsewhere

Patients who can’t get in to see their primary care physicians on a timely basis–or when it’s convenient for them–seem to be increasingly voting with their feet, seeking care at retail clinics or after-hours urgent care centers.  And that seems to be one factor that’s expected to drive down the cost of health care next year, says PriceWaterhouseCoopers.

Image Courtesy CVS Caremark

The accounting and consulting behemoth released its annual “Behind the Numbers” report on health cost trends. Health spending has been lower than expected for the last three years and will likely stay low, rising by about 7.5% in 2013, according to the report.

PwC found that one of the slowest areas of growth is physician spending. From 2007-2012, spending on physician services by private health plans grew only 5.4%–compared to 8% growth for inpatient care and 10% for outpatient hospital care.  They slowdown in doctor spending “is expected to continue in 2013 as consumers choose alternatives to the traditional doctor’s office visit,” said the report. Those alternatives include “lower-cost options such as workplace and retail health clinics, telemedicine, and mobile health tools,” which are viewed by employers and consumers “as cost effective and convenient.”

In 2010, about 17% of consumers said they had sought care at a retail clinic; by 2011, that had risen to 24%, according to a PwC survey conducted each year to help flesh out the medical spending picture.

It’s no secret that use of retail clinics and urgent care centers has skyrocketed. Last fall, the RAND Corp. reported that there was a ten-fold increase in use of those retail clinics between 2007 and 2009. Using data from a commercially-insured population of 13.3 million, RAND determined that 3.8 million made at least one clinic visit between 2007 and 2009. Monthly visits jumped from 0.6 per 1,000 in January 2007 to 6.5 per 1,000 in December 2009.

Interestingly, availability of primary care physicians did not seem to be a factor in determining use. Those who went to retail clinics tended to be in good health, between 18 and 44, and have a higher income.

In other words, those are paying customers who are choosing to spend their money elsewhere for their care. PriceWaterhouseCoopers advises physicians to make their pricing “defensible” to help stem the tide of patient outflow to these clinics.

One reason why consumers may be going to a lower-priced environment: because employers are increasingly asking workers to shoulder more of the costs of their care. And that is expected to continue.

“We’re seeing long-term trends that could keep cost increases in check,” said Michael Thompson, principal, human resource services at PwC in a press release.  “As employers shift expenses to their employees, for example, these workers are pursuing lower-cost alternatives. Even as the economy strengthens, changes in behavior by employers and consumers may help limit medical growth.”

Alicia Ault

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Do Medical Tattoos Need Guidelines?

Should medical tattoos be standardized? Should there be guidelines pertaining to their design, and where on the body they’re located? Should physicians prescribe tattoos to patients with hidden medical conditions? And if the answer to any of those questions is yes, should medical personnel be the ones doing the tattooing?

Photo by Miriam E. Tucker / Used with permission

Those were among the questions raised by Dr. Saleh Aldasouqi in a poster presentation and at a press briefing at the annual meeting of the American Association of Clinical Endocrinologists.

Some patients with diabetes and other hidden medical conditions are choosing to be permanently tattooed rather than wear a necklace or bracelet to alert emergency personnel of their conditions. This is particularly common among patients with type 1 diabetes, for whom low blood sugar can result in unconsciousness or odd behavior that can easily be mistaken for drunkenness.

“There are a lot of patients with diabetes who are getting tattoos. Just Google ‘medical tattoos’ or ‘diabetic tattoos’ and you’ll find a large number from around the world.  The problem is they’re not consulting their physicians. They could have high sugar, which can affect wound healing. …There are so many issues now being talked about with regard to medical tattooing,” noted Dr. Aldasouqi, an endocrinologist at Michigan State University, Lansing.

He believes these issues should be addressed by professional medical organizations, possibly including those pertaining to diabetes, dermatology, and emergency medicine.

As for tattoo location on the body,  the wrist would be the most logical place since first responders will always check there, he said.

So who should do the tattooing?  Tattoo parlors that are licensed under state or local laws are typically clean and use sterile equipment, and require customers to read and sign consent forms that address medical conditions and risks.  Of course, tattoo artists would need to be educated about any new standard.

But dermatologists or plastic surgeons could do it as well. “We’re not competing with tattoo artists, but at least we can collaborate with them by standardizing at their level, or make it a minor surgical procedure. In fact, this is being done to mark the skin for radiation therapy in cancer patients, and in reconstructive surgery after breast cancer. Some medical tattooing is already being done  by medical specialists. So, it’s open for discussion.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Filed under Allergy and Immunology, Dermatology, Emergency Medicine, Endocrinology, Diabetes, and Metabolism, Family Medicine, Health Policy, Hospital and Critical Care Medicine, IMNG, Infectious Diseases, Internal Medicine, Plastic Surgery, Primary care, Uncategorized

Teens with Eating Disorders Try Yoga

If the thought of yoga doesn’t bring to mind long-haired, half-naked gurus in India, it probably makes you think of thin young people in pretzel poses. True that, but it’s also become popular among populations that you might not expect. Yoga increasingly is being incorporated into treatment programs for young people who may be too thin or too fat – adolescents with eating disorders.

Yoginis relax and stretch. (Courtesy Wikimedia Commons/zivpu/Creative Commons License)

Dr. Cora C. Breuner helped conduct a study of 50 girls and 4 boys with diagnosed eating disorders. Participants were randomized to treatment with standard care (every-other-week appointments with physicians or dieticians) or standard care plus individualized yoga for 12 weeks. The yoga group showed significantly reduced food preoccupation immediately after each yoga session and significantly decreased Eating Disorder Examination scores at 12 weeks (J. Adolesc. Health;2010;46:346-51).

Speaking at the annual meeting of the North Pacific Pediatric Society, she gave a brief update: the teens in the yoga group showed greater improvements in weight a year after the study ended compared with the control group.

Dr. Cora C. Breuner (Sherry Boschert/IMNG Medical Media)

“Pretty much every eating disorders unit in the country now has yoga,” said Dr. Breuner, professor of pediatrics at the University of Washington, Seattle.

I don’t know about every eating disorders program, but a quick look on the Web found plenty that include yoga and lots of independent yoga classes geared toward people with eating disorders. On this list of eating disorder treatment programs from EDreferral.com, for example, yoga is mentioned by nine facilities in California and one each in Arizona, Hawaii, Mississippi, New Jersey, Pennsylvania, Tennessee, and Virginia. I found others online in Michigan and Washington, too, with just a few clicks.

Dr. Breuner’s 2010 study isn’t the only one endorsing yoga for eating disorders. Here’s another (Psychology of Women Quarterly 2005;29:207-19). Columbia University reported on this trend in 2007. And the Wall Street Journal reported in 2011 on increasing use of yoga not only for kids with disorders but for healthy students, under the clever headline, “Namaste. Now Nap Time.”

Some of the key goals of yoga are to strengthen the mind and body and the connection between the two. It’s not a solo treatment for eating disorders, but it supplements the standard strategies of weight stabilization, nutrition therapy, cognitive behavioral therapy, and family-based therapy.

That last one is another big change in the field that has happened since Stanford University researchers began showing in 2007 that it’s very helpful in treating children and adolescents to use parents as agents for positive change in a non-judgmental manner.

“Now we bring parents in right away to help with refeeding the child,” Dr. Breuner said.

It’s only a matter of time, I suspect, until we see special yoga classes for parents of children with eating disorders.

–Sherry Boschert (on Twitter @sherryboschert)

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