“It’s become clear that the disease we thought was one disease related to tobacco and alcohol is now being parsed into two major categories,” Dr. Maura L. Gillison said last week in Phoenix at the 2012 Multidisciplinary Head and Neck Cancer Symposium. At the meeting, she presented her group’s data showing that the overall prevalence of oral HPV infection in people aged 14-69 years is 6.9%, and that the prevalence is much higher among men than women. The Merck-supported trial paper was published online in JAMA on January 26, coinciding with her presentation.

Tissue section from a head and neck cancer patient / Courtesy of Tom Carey, Ph.D.

In a separate talk, Dr. Gillison summarized previous work from her group showing that the incidence of HPV-related cancer is rising while HPV-negative cancer is declining, consistent with the decline in tobacco use and changes in sexual behavior that increase HPV transmission. Overall survival of head and neck cancer has improved over the last decade, a trend that is likely due both to the improved prognosis among HPV-positive patients and to the decline in tobacco use rather than to advances in treatment, she said.

This recently heightened role of HPV in head and neck cancer  – and the awareness of it - has impacted the field of oncology in several ways. For one, it has dramatically changed the way research is done, conference chair Dr. Ezra Cohen told me. “It has made a tremendous difference in the way clinical trials are conducted, because it makes absolutely no sense to lump these patients together. Now all clinical trials will either stratify for HPV status or design completely separate studies, because they truly are two biologically different diseases.”

Clinically, patients with head and neck cancers are now routinely tested for HPV. This wasn’t the case prior to 2010. And those who test positive are counseled differently, since their prognosis is better. Indeed, Dr. Cohen said, HPV-positive head/neck cancer patients appear to respond better to just about every type of treatment, including surgery.

What’s more, Dr. Gillison told me, HPV has essentially upended some of the tools oncologists use to predict outcomes in head and neck cancer patients. One example is the current tumor staging system, which doesn’t take into account HPV status. A Stage 3 or 4 cancer which carries a poor prognosis among HPV-negative patients might carry the prognosis now associated with Stage 1 cancer among those who are HPV-positive. And another factor that has been shown to predict poor outcome in HPV-negative patients, the presence of extracapsular extension, appears to have little impact in those who are HPV-positive.

“So all these things that we take as firmly established and drivers of treatment decisions in this new setting are all in question,” she said.

Tissue section from the same head/neck cancer, with brown stain of an HPV marker protein called p16 / Courtesy of Tom Carey, Ph.D.

Thus far there have been no major changes in treatment, but Dr. Cohen believes that is likely to change as more data become available. He is currently leading a clinical trial  in collaboration with Novartis Pharmaceuticals looking at treatment with reduced radiation doses – and thereby reduced toxicity - for patients who have a good response to induction chemotherapy. Such patients are usually HPV positive.

Another study, funded by the National Cancer Institute, randomizes HPV positive patients to radiation combined with either chemotherapy or a monoclonal antibody, with the hypothesis that the latter will be better tolerated.

Dr. Cohen cautioned that treatment changes won’t come immediately. “Many of us in the field believe that there will be different therapies developed for [HPV-positive] patients, but it takes time to do that. It’s hard to make those changes, especially when we are curing the majority of these patients.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

Under the Affordable Care Act, his new center is charged with rapidly testing alternative payment and health care delivery models. If those pilot projects are proven to both improve the quality of care and bring down health care costs, the Secretary of Health and Human Services can roll out the program nationally. There’s a little more paperwork involved, but that’s the general idea.

Dr. Richard Gilfillan (R), with HHS Secretary Kathleen Sebelius and former head of the Centers for Medicare and Medicaid Services, Dr. Don Berwick, in November. HHS Photo by Chris Smith.

What that means is that in a relatively short amount of time, Medicare could fundamentally change the way it pays doctors. That is, if the pilot projects sponsored by the Innovation Center are successful.

Dr. Gilfillan offered an example: Let’s say the Innovation Center launches a project where it pays primary care physicians an extra $10 per patient per month to coordinate care. If officials at the Innovation Center can prove that the project improves outcomes and reduces costs, HHS can publish regulations to roll it out to primary care physicians around the country. “As you can see, this is a powerful tool for changing the way we deliver care,” Dr. Gilfillan said at the summit.

The Innovation Center has been around for about a year and officials there have been busy putting together a set of pilot projects that look at new ways to deliver primary care and home-based care. They are also testing other concepts like bundled payments and accountable care organizations. Check out the Innovation Center’s report on its first year for descriptions of all the projects.

One thing they are trying to do in each of the projects, Dr. Gilfillan said, is to work closely with private payers. The goal, he said, is to make life a little simpler for doctors by ensuring that when they find new payment mechanisms that work, all the payers, both public and private, will adopt it in the same way.

— Mary Ellen Schneider (on Twitter @MaryEllenNY)

The CDC identified a Mexican-made cream as the likely source of mercury exposure in 22 people in 5 households in California and Virginia. While previous cases have shows similar levels of mercury exposure from skin-lightening creams, this is the first instance where exposure has been measured in non-users, CDC said. The non-labeled creams contained  2%-5.7% mercury.

Skin lightening agents that are readily available for sale in Ghana/ ©2011 Elsevier Inc. All rights reserved.

Among the sample, 15 people ages 8 months to 67 years had elevated urinary mercury concentrations (9 users and 6 non-users). Non-users were exposed to the mercury through contact with cream users or with contaminated household items, the CDC said.  Younger children, compared to older children, had much higher concentrations.

While 15 people had elevated mercury levels, only 6 (all users) exhibited symptoms of mercury exposure. Users of the skin-lightening creams said they had used it as an acne treatment, for skin-lightening, and to fade freckles.

Although mercury-containing creams are banned by the Food and Drug Administration, high levels of mercury have been found in foreign-made skin-lightening creams across the country, including Chicago, New York, Minnesota, and Baltimore.

In 2010, an FDA spokesperson told the Chicago Tribune that with fewer than 500 inspectors dedicated to reviewing imports, banned items often get through anyway. The FDA could not comment before press time.

The CDC advises clinicians who recognize mercury toxicity to consider mercury-containing creams as a possible cause, even for children. Consult a medical toxicologist before beginning treatment, CDC advises.

—Frances Correa (@FMCReporting on Twitter)

Courtesy Wikimedia Commons/johnfekner/GNU Free Documentation License

With its eery, conspiratorial music and accusatory title fadeouts, I half expected to see Gary Oldman in a bespoke suit proclaim that the Joe Biden is a mole. (That reference may be lost on those of you who have not seen Tinker Tailor Soldier Spy.)

Indeed, in that January 2011 speech, according to a fact sheet issued by the White House,

…the President pledged to work with Republicans to support state reforms of medical malpractice systems to bring down costs and improve care – building on Administration efforts already underway to assess what works in medical malpractice reform.

The House Republicans charge that they’ve reached out to the White House but have had no response.

About 134 House members — Republicans and Democrats — have put their names on a bill to overhaul the medical liability system that was  introduced in Jan. 2011 by Rep. Phil Gingrey (R-Ga.).

Physician organizations have en masse backed that bill, H.R. 5. But it has languished since May last year when it was reported out of the Energy & Commerce Committee.

Meanwhile, the Obama Administration did offer up an olive branch on tort reform in the Affordable Care Act. But nothing has come of that, either.

The ACA authorized $50 million in grants to states looking to demonstrate new models. The Agency for Healthcare Research and Quality was charged with managing the program, and it put out requests for proposal in Nov. 2010. The funds were supposed to be available beginning in Oct. 2011 but, according to an AHRQ spokesperson, Congress has not yet appropriated the funds for the initiative.

That means no grants have been issued under that program, although the AHRQ has funded other liability reform projects through an initiative announced by President Obama in the fall of 2009.

The leading GOP presidential candidates have promised that they will address medical liability reform. But even if a Republican does take the White House in November, the fulfillment of that promise is likely a long way off.

—Alicia Ault

Courtesy Wikimedia Commons/Jsonp/Public domain

Research presented at the Eastern Association for the Surgery of Trauma shows that central venous line insertion significantly decreases clotting time and initial clot formation time and accelerates fibrin cross-linking in both healthy swine and critically ill patients.

The findings indicate that CV catheters induce a systemic hypercoagulable state, probably because of the endothelial injury, which may explain the increased risk for venous thromboembolism associated with central venous lines, said lead author Dr. Mark Ryan, with the University of Miami School of Medicine.

The group previously reported that placing a pulmonary artery catheter in critically ill patients and healthy swine significantly decreases the time to initial fibrin formation, thereby inducing a hypercoagulable state.

WENDLING/Elsevier Global Medical News

As in the current study, however, no changes were observed in conventional coagulation parameters, raising questions as to why standard coagulation tests fail to correlate with TEG and whether the prothrombotic state identified by TEG truly indicates an increased risk for deep vein thrombosis, Dr. Ryan said.

Finally, as has been suggested by other investigators, pigs may simply have a very different hypercoagulable state than humans do. I selfishly hope so.

–Patrice Wendling

Renal denervation is a new procedure for lowering blood pressure that involves placing a radiofrequency catheter inside both of a patient’s renal arteries and zapping the tissue four to eight times on each side, gently enough not to cause trauma but firmly enough to damage the renal nerves and block sympathetic activity and the kidneys’ renin release. It remains investigational in the United States, where a 500-patient pivotal trial recently started, but it’s been available on a routine basis in Europe since 2010, and according to Horst Sievert, a German interventional cardiologist who’s done many denervations since then, it’s been taking off both in terms of the number of endovascular physicians offering it and the number of patients with drug-resistant hypertension being treated.

image courtesy Wikimedia Commons

Though still off the U.S. market, the prospect of FDA approval within the next couple of years was enough to win renal denervation a special session at ISET 2012 last week in Miami Beach. My news article on those talks is here.

An apparently safe, relatively easy, 60-minute procedure that can durably cut systolic blood pressure by about 30 mm Hg in patients who remain hypertensive despite treatment with multiple drugs is certainly very attractive. It may be even more appealing if early evidence pans out and the treatment also helps normalize glycemic control and reduce hyperinsulinemia in at least some patients.

But when vascular medicine specialist Michael Jaff said at the meeting that renal denervation “could arguably be the most exciting advance in interventional vascular medicine,” and that “in the near term I’m incredibly bullish,” it was hard not to imagine that it was more than optimized patient care that made his pulse quicken.

Endovascular medicine became a medical growth industry more than 30 years ago, when it started to become a routine part of cardiology, a way to less-invasively treat stenotic coronary arteries. Since then, it’s become a major part of all vascular medicine, but in recent years the coronary part showed a definite leveling off. Just last year in a talk at ISET, Martin Leon, one of the world’s foremost interventional cardiologists, declared that endovascular coronary interventions appeared to have reached a volume plateau that would not change anytime soon. He said his early recognition of this trend was a motivation for him to turn his attention to transcatheter aortic valve replacement, which has now emerged as a new way for interventional cardiologists to ply their trade.

Renal denervation may be the next step along the same path. If the pivotal trial results and further clinical experience confirm the early findings of safety and efficacy, and especially if the very early findings of a beneficial glycemic effect also pan out, it may well fulfill Dr. Sievert’s prediction that “renal denervation will become as important as percutaneous coronary intervention.”

Important not just for patients, but for practitioners too. Busy hands are happy hands.

—Mitchel Zoler (on Twitter @mitchelzoler)

Dr. Atul Gawande / Frances Correa/ Elsevier Global Medical News

“Washington will not be able to save the costs. They’ll provide the framework, but in your communities, that’s where you’ll do it,” said Dr. Gawande, a health policy researcher and endocrine surgeon at Brigham and Women’s Hospital in Boston. Dr. Gawande said that the Affordable Care Act will provide the data for doctors to identify where to trim costs. Both Dr. Gawande and Dr. Emanuel said doctors can take a leading role in cost control by focusing on the sickest 5% of patients. According to a 2009 report from the Agency for Healthcare Research and Quality, the sickest 5% of patients account for 50% of national health care expenditures.

Dr. Gawande cited the work of Dr. Jeffrey Brenner. By analyzing medical billing data from practices in Camden, N.J., Dr. Brenner, a primary care physician, was able to map out the most impoverished areas with the highest health care costs. With a focused approach that included home visits and the help of social workers, Dr. Brenner decreased one patient’s inpatient hospital time from 7 months in one year to 3 weeks. While under his care, the patient lost 200 pounds, and quit smoking, drinking, and using cocaine. At the same time, the patient’s hospital costs decreased by 60%. Dr. Gawande wrote about Dr. Brenner’s strategy in a January 2011 article in the New Yorker.

Dr. Emanuel, a recognized expert on health and chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, said rising health care costs threaten many aspects of American society, particularly education, workers’ wages, and the nation’s position in the world, as well as by putting an economic squeeze on middle class. Dr. Emanuel also served as special adviser for health policy to the director of the White House Office of Management and Budget from January 2009 to January 2011, where he helped craft the Affordable Care Act.

Dr. Ezekiel Emanuel / Frances Correa/Elsevier Global Medical News

“If you care about how our kids are going to educated in the future, you have to care about heath care costs,” Dr. Emanuel said, adding that increased health care costs directly affect tuition rates. For example, from 2001 to 2011, employer contributions to health insurance increased by 113%, according to the Kaiser Family Foundation. Meanwhile, tuition for public universities increased 72% over the past decade, according to the College Board. Dr. Emanuel projected that, as health care costs continue to rise, states will be forced to take the money from other programs, leaving education and health care at the greatest risk.

“We can reduce costs without sacrificing access … [doctors] have to be committed to doing that,” Dr. Emanuel said.

The moratorium statement, coauthored by the lead pair of airborne H5N1 flu researchers and 37 other influenza researchers from around the world, also highlighted the degree to which these scientists stand behind the importance and safety of airborne H5N1 research.

image courtesy Wikimedia Commons

The statement, published online on Jan. 20 in Science and in Nature, received bylined support from an international group of flu researchers from the United States, the Netherlands, United Kingdom, Japan, China, Canada, Germany, and Italy, including staffers from the Centers for Disease Control and Prevention and the National Institutes of Health.

They said that the airborne H5N1 avian flu research, which first became public knowledge a month ago, “is critical information that advances our understanding of influenza transmission. However, more research is needed to determine how influenza viruses in nature become human pandemic threats, so that they can be contained before they acquire the ability to transmit from human to human, or so that appropriate countermeasures can be deployed if adaptation to humans occurs.”

The authors acknowledged the “perceived fear” about possible escape of the ferret transmissible H5N1 that labs in Rotterdam and Madison, Wisc., created, and they reaffirmed that “these experiments have been conducted with appropriate regulatory oversight in secure containment facilities by highly trained and responsible personnel to minimize any risk of accidental release.”

Finally, the moratorium group explained what they hoped to achieve with their 60-day pause: “We recognize that we and the rest of the scientific community need to clearly explain the benefits of this important research and the measures taken to minimize its possible risks. We propose to do that in an international forum in which the scientific community comes together to discuss and debate these issues.”

An interview that also ran in Science on Friday with Ron Fouchier, the Rotterdam virologist who leads one of these H5N1 studies, quoted him as saying that an international forum will be organized in the next couple of weeks, and that he hopes it will include representatives from the World Health Organization and the U.S. government. In the interview with Martin Enserink, Fouchier said that the idea for the moratorium began with himself, Yoshihiro Kawaoka, who independently also produced an air-transmissible H5N1 strain in ferrets, and Adolfo Garcia-Sastre, a flu researcher at Mount Sinai Medical Center in New York.

Fouchier also drew the inevitable comparison between this moratorium and the one called by recombinant DNA researchers prior to their historic 1975 meeting at the Asilomar Conference Center in California.

What seems most notable about the moratorium statement is the number and diversity of the signatories, and their willingness to stand fully behind this work despite the criticisms leveled against it over the past month. The upcoming public forum is something to look forward to.

—Mitchel Zoler (on Twitter @mitchelzoler)

Researchers at the University of Louisville report that trauma patients were 1.6 times more likely to develop a cerebrovascular accident (CVA) after admission than medical and surgical controls matched for known CVA risk factors such as age, hypertension, diabetes, atrial fibrillation, and tobacco use.

On logistic regression, trauma was the only significant risk factor for CVA between the two groups, Dr. Jason W. Smith reported at the recent meeting of the Eastern Association for the Surgery of Trauma.

By Patrice Wendling/Elsevier Global Medical News

Dr. Smith called for more studies concerning the etiology and management of post-traumatic hypercoagulability and suggested that “CVA prophylaxis may be warranted in select trauma patients.”

The analysis identified 64 strokes after admission among 7,633 trauma admissions from 2008-2010, for an overall CVA rate of 0.8%. Out of this group, 23 strokes were found to be related to TBI and blunt cervical vascular injury, leaving 41 patients with non-injury related CVA in the analysis. The medical/surgical controls included 14,121 patients obtained from the university’s hospital database over the same time period.

When compared with a second control group of 120 trauma patients matched for Injury Severity Score and mechanism of action, the 41 trauma-related CVA patients presented with significantly more stroke risk factors, including older age, pre-existing hypertension, diabetes, and tobacco use.

Their chance of placement in an extended care facility also skyrocketed from 28% to 81%, while mortality rates more than tripled from 7% in controls to 22% in the trauma-related CVA patients, Dr. Smith and his co-authors reported.

The one bright spot was that on follow-up in the medical/surgical analysis, trauma patients had higher six-month post-CVA functional assessment compared with the controls.

–Patrice Wendling

Dr. Baum’s talk, ostensibly on practice and financial pearls, was peppered with funny sports quotes and pearls about saving money by combining family vacations with CME meetings.

Read more in The Mole blog on SkinandAllergyNews.com. …

Image courtesy of The Tango! Desktop Project via wikimedia commons

—Heidi Splete (on Twitter @hsplete)