Category Archives: Primary care

Don’t Forget Travelers’ Health at the London Olympic Games

Photo courtesy of m.gifford (Flickr CC)

London may not be considered by everyone as exotic a locale as Beijing, but travel safety shouldn’t be overlooked across the pond. The CDC has several travel factsheets and resources for physicians and patients heading to the London Olympic Games, which start July 27  and run through Aug. 12.

Start by checking out Healthy Travel to the 2012 Olympic Games — the CDC’s rundown on basic health information for the UK, including a handy translation guide for UK health-related terms. If you’ve ever been curious about national healthcare, a mishap in London could answer a lot of questions.  Of course, so could an informational website developed by the UK’s National Health Service. The CDC also offers a link to travel tips from the U.S. State Department.

Wondering about the top travel advice for Americans headed to the games? Update your routine vaccines, including measles. “In 2011, some U.S. residents who traveled abroad got measles. When they returned to the U.S. they caused 17 measles outbreaks in various communities.” Probably the most important tip for a Yank in London: look both ways.  “Look right, look left, and look right again to avoid stepping into the path of traffic. In England, people drive on the left side of the road, not the right. Your safety is important. Road traffic is one of the leading causes of injury death to U.S. travelers in foreign countries.”

Kerri Wachter

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Preventing Youth Violence: Where’s the Research?

Photo courtesy of Thierry Geoffroy (Wikimedia CC)

Instead of focusing exclusively on risk factors for youth violence, it’s time to start looking at protective factors.  At least that’s what a CDC expert panel recommended in a special supplement of the American Journal of Preventive Medicine.

Homicide continues to be the second leading cause of death for youth aged15-24, and the leading cause of death for African American youth, according the CDC. More than 700,000 young people aged 10 to 24 were treated in emergency departments in 2010 for injuries sustained due to violence.

While identifying risk factors for teen violence is a necessary component of combating the problem, the experts recognize that it’s also important to identify factors that protect youth against youth embracing violence — such as resilience, positive youth development and community assets. “Most youth, even those living in high risk situations, are not violent and more must be learned about the factors that are helping youth, protecting them from engaging in violent behavior so that others can benefit,” the experts wrote in the supplement.

The CDC convened the Expert Panel on Protective Factors for Youth Violence Perpetration to clarify unresolved definitional and analytic issues on protective factors; review the state of evidence regarding the factors that appropriately can be labeled as direct protective, buffering protective, or both; carry out new analyses of major longitudinal surveys of youth to discover new knowledge about protective factors; an assessing the implications of research identifying protective factors for prevention programs, policies, and future research. This supplement presents the group’s work on direct protective factors — in particular identifying factors that exhibit mostly direct protective effects.

For more information about youth violence in the United States, check out a number of resources available on the CDC’s violence prevention Web page.

Kerri Wachter

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ACA: Helping or Hurting Solo Practice?

It won’t surprise many to learn that the age of the solo practitioner has, for the most part, come to an end. Over the past several years, small and solo practices have closed, been sold to hospitals, or merged with larger groups. The reasons are fairly obvious. Declining payments, rising malpractice costs, increasing regulatory burdens, costly new health information technology requirements, and crushing medical school debt have made it difficult for physicians to operate the small practices that once were commonplace around the country.

Now add the Affordable Care Act (ACA) to the mix. At a July 19 hearing of the House Small Business Subcommittee on Investigations, Oversight and Regulations, lawmakers questioned whether the health reform law would help or hurt physicians looking to keep their practices small and independent. The answers from the expert panel were mixed.

Gone are the days of Marcus Welby. Courtesy Wikimedia Commons/Public Domain License

The emergence of accountable care organizations (ACOs) will drive more hospitals to buy up small physician practices, Mark Smith, president of the physician recruiting firm Merritt Hawkins, predicted. The health reform law heavily promotes the formation of ACOs, which call for physicians and hospitals to work more closely and to share in bundled payments for episodes of care. Mr. Smith said small practices aren’t well-positioned to enter the ACO world if they aren’t integrated with a hospital because the ACO model calls on practices to assume financial risk.

But Joseph M. Yasso, Jr., DO, a family physician in Independence, Mo., who sold his practice to a hospital group 20 years ago, said the ACA’s promotion of patient-centered medical homes could be a lifeline for small practices. Physicians are adapting to the new environment by becoming medical homes and participating in government pilots where they can share in the savings they generate by providing more efficient care, he said.

One thing everyone on the panel did agree on was the need to fix the Sustainable Growth Rate (SGR) formula used in setting physician payments under Medicare. No surprises there either.

— Mary Ellen Schneider

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Louisiana’s Medicaid Nightmare

Physicians in Louisiana may find themselves holding the short end of the stick very soon, as the state struggles to figure out how to make up a sudden $859 million shortfall in Medicaid funding.

And it comes at a time when the state’s Republican governor, Bobby Jindal, has said that he will not take any additional federal money to expand the Medicaid program in 2014, as offered under the Affordable Care Act. He also said he would not accept federal funds to set up health insurance exchanges under the law.

Bobby Jindal. Courtesy Wikimedia Commons/dsb nola/Creative Commons Attribution 2.0 Generic License

If any hospital or physician wanted to know what it would feel like to go without that federal money, they now have their chance. The $859 million hole is the result of a reduction in the federal matching rate that Congress approved as part of the transportation bill that was signed by President Obama on July 6.

The provision affects only Louisiana. After Hurricanes Katrina and Rita, the state received hundreds of millions in aid. But there was no adjustment at that time in the federal Medicaid matching rate. So Louisiana’s Medicaid program was the recipient of millions of dollars more than what it was due. (For more on this byzantine situation, see the New Orleans Times-Picayune’s story here.)

Congress fixed that error in the transportation and student loan bill by dropping the state’s current match rate. But Gov. Jindal, in creating and finalizing his fiscal 2013 budget, was, ironically, depending on that federal money.

On July 13, his administration announced cuts to make up the shortfall. The decrease in the federal matching rate meant that the state had to come up with $287 million in cuts on its own; the rest of the $859 million will come from reductions in pay from the federal government.

According to the state Dept. of Health and Human Services, $518 million will come out of the pockets of physicians and hospitals.  The state already had announced an across-the-board almost 4% cut in Medicaid provider rates for fiscal 2013.

Under the latest cuts, the Louisiana State University system is taking the biggest hit: $329 million, or a quarter of its budget, according to news reports. LSU is one of the biggest charity care providers in the state. Interestingly, DHHS commented in its press release that it “does not anticipate this reduction of [disproportionate share hospitals] and Medicaid payments to affect Medicaid recipients’ access to hospital care.”

Among the other programs absorbing blows: the Greater New Orleans Community Health Connection (GNOCHC), a pilot that expanded health coverage to uninsured adults in the wake of Hurricane Katrina. Another program that provided family planning services to low-income women will have its qualifying income limit reduced from 200% to 133% of the Federal Poverty Level.

The state is also tightening its review of eligibility for all Medicaid recipients.

After the cuts were announced, the Louisiana Hospital Association said in a statement that, the total elimination of DSH payments to rural hospitals “will be critical and will lead to reductions in services and possible hospital closures.” That in turn will leave ” gaps in healthcare delivery for patients in rural areas, as well as economic losses to those communities,” said LHA.

With hospitals across the state possibly delivering less care, it seems likely that physicians could expect to see more pressure on their practices.

Alicia Ault

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Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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“Turning the Tide” on HIV/AIDS

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

Everyone is urged to sign the Declaration.

It calls for:

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington.  It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs  in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

Plenaries and other conference sessions will be webcast at http://globalhealth.kff.org/aids2012.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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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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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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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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