June 17, 2011
By Leah Voigt and Allison Cohen*
FDA Clears Improved HER2 Test in Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved a new quantitative test for HER2 genes in breast tumor samples that can be performed under a standard microscope, potentially making it easier to identify patients who would benefit from trastuzumab (Herceptin) therapy.
Called Inform Dual ISH, the test allows clinical lab personnel to count the number of HER2 gene copies on chromosome 17 visually under a microscope. It is based on a staining system that colors chromosome 17 red and the HER2 gene black. Such assessments are possible with previous methods but they require fluorescence microscopes, FDA explained in announcing the approval. Also, the Dual ISH system makes the HER2 and chromosome 17 copies visible for longer periods.
The agency said the approval was based on a U.S. study involving tumor samples from 510 patients with breast cancer. It showed that the test was 96% sensitive in identifying HER2-positive tumor samples and 92.3% specific in ruling out HER2 positivity in samples that had the normal number of copies of the HER2 gene. Patients with more than the normal number of copies of the HER2 gene are considered candidates for trastuzumab therapy, whereas those with the normal number are not.
John Gever, FDA Clears Improved HER2 Test in Breast Cancer, MedPage Today (June 15, 2011).
Enthusiasm Rises Among Med Students for Primary Care
As the shortage of primary care doctors worsens in the United States, experts are carefully tracking the interest of today's medical students and residents in primary care to see if a new generation of family doctors might be emerging. By 2020, the Association of American Medical Colleges (AAMC) predicts that the country will be short 45,000 primary care physicians.
So far, the signs are encouraging. For the second year in a row, family medicine residency programs had a record enrollment rate (2011 saw an increase of 11% over 2010). An additional 100 slots were also added to meet the rising demand.
Some say the focus on primary care in the federal health overhaul law, the Affordable Care Act (ACA), deserves much of the credit for rising interest in family medicine. A professor of medicine at the University of California, San Francisco (UCSF) medical school and chief of general medicine at San Francisco General Hospital says he has seen a significant change in his students' attitudes toward primary care. He spoke recently with a Kaiser Health News reporter in San Francisco. The following is an edited version of that conversation.
What have you noticed about residents and medical students and their choice to study primary care?
We're really struck by the number of applicants we had this year, as well as the enthusiasm they have for primary care. In all honesty, in the last few years, we've really struggled sometimes. There has always been a core group of students who've had this interest, but their mood has been a bit somber, and sometimes you see them self-reflecting about whether they're actually making the right choice when some of their colleagues were going into other specialties. But this year, we really saw a pretty significant uptick in the number of applicants.
Can you give me a sense of the numbers?
Our number of applicants [for primary care residencies and fellowships] increased in the range of 20 to 25%. We are also increasing the size of our residency program at SF General from eighteen to twenty-four primary care positions per year. So, we're hopeful this is the beginning of a trend.
Talking to some of the younger UCSF medical students, it's very clear that primary care is on a path to perhaps getting another look by some students who weren't otherwise thinking about it. I think we've given them, maybe through the ACA and some of the discussion that's been associated with it, new enthusiasm and reasons to believe that there will be the rewards associated with that career choice that many of them wanted to make in the first place.
What are you teaching your residents and medical students about the new role of primary care doctors?
We are pointing out some of the provision changes that are going on. I think we're also talking to them about some of the delivery system changes underway, like the accountable care organizations and the role of primary care medical homes. So we're really trying to help them see that primary care may again become the foundation of how the delivery system is organized. And I think many of the students are excited about that.
Can you tell me about any students in particular who have chosen primary care?
I recently met with a woman who's in our internal medicine residency. She first came to talk to me and told me she wanted to do a fellowship in a subspecialty area—endocrinology.
But then when we spoke a bit more, it became clear that she really had a lot of interest in public service, public health, and improving quality. As we started to talk more about the ACA and some of the ways that primary care is going to be supported by it, she wrote me back about two weeks after that visit to say that she had dropped her plans to apply for the subspecialty training in endocrinology and now wanted to pursue a primary care fellowship instead.
I think there may be something starting to happen where some of the students and trainees are thinking about how they want to impact the healthcare system. We'll see. It's a small sample size at this point, but I'm certainly very hopeful it's the beginning of a trend.
Jenny Gold, Enthusiasm Rises Among Med Students For Primary Care—The KHN Interview, Kaiser Health News (June 15, 2010).
Olive Oil Protects Against Stroke
Consuming copious amounts of olive oil may dramatically reduce stroke risk for older adults, according to a population-based study. Heavy use in cooking and dressings was associated with a 41% lower stroke incidence compared with never using olive oil researchers at the Université Bordeaux in France found.
The top one-third on intake by serum measures had a 73% lower stroke risk than those in the bottom third among older adults living in three cities in France. Because these results controlled for other dietary and stroke risk factors, olive oil may be considered "a major protective component" of the Mediterranean diet for stroke, the group suggested online ahead of print Neurology.
Intensive olive oil intake could find a place alongside more fruits and vegetables and less salt in the dietary recommendations to prevent stroke in elderly populations, Samieri and colleagues suggested.
C. Samieri et al., Olive Oil Consumption, Plasma Oleic Acid, and Stroke Incidence: The Three-City Study, Neurology, 2011; DOI: 10.1212/WNL.0b013e318220abeb. Crystal Phend, Olive Oil Protects Against Stroke, MedPage Today (June 15, 2011).
Quantifying Adverse Drug Events: Med Mishaps Send Millions Back for Care
Every year, adverse drug events send more adult patients to American physician offices and emergency departments than do pneumonia or strep throat. The trips add up to an estimated 4.5 million annual outpatient visits related to medication problems, with seniors and patients taking more than six medications the most likely to show up in doctors' offices.
The findings—the first published attempt to estimate the nationwide impact of adverse drug events in the ambulatory setting—come after an April report by the Agency for Healthcare Research and Quality (AHRQ) that said 1.9 million hospitalizations annually are due to medication side effects or errors. Nearly three-quarters of the 4.5 million adverse drug event-related visits were to physician offices, said the study, published online in Health Services Research. About 400,000 of these 4.5 million patients are subsequently hospitalized.
In total, one-half of 1% of all ambulatory visits are related to adverse drug events, the study said. That may not seem like a lot, but the
4.5 million annual adult outpatient visits for medication problems exceed the numbers for conditions such as strep throat (4.4 million) and pneumonia (4.2 million), said the lead author of the study, an assistant professor of medicine in residence at the University of California, San Francisco School of Medicine's Division of General Internal Medicine. "Those are things that we think of as common problems," said the author. "We should think of this as a common problem too."
Patients sixty-five years of age and older were more than twice as likely as middle-age patients and nearly three times likelier than patients between twenty-five and forty-four to experience adverse drug events serious enough to send them to a doctor or an ED, the study said. After adjusting for age, gender, insurance status, and other factors, patients taking six drugs or more had the highest odds of experiencing adverse drug events.
The study's authors analyzed data from the National Center for Health Statistics' National Ambulatory Medical Care Survey and the National Hospital and Ambulatory Medical Care Survey from 2005 to 2007 to generate an annualized estimate. Physicians surveyed were asked if patient visits during a random week of the year were related to the adverse effect of medical or surgical care. Researchers then looked for ICD-9 codes related to adverse drug events associated with those patients to arrive at their estimate. Researchers did not have access to information about which medications were implicated. It is unclear how many of these adverse drug events could be prevented. A 2007 Institute of Medicine report estimated that 1.5 million patients are harmed each year by preventable medication errors, although that figure included injuries in the hospital and among outpatients.
Kevin B. O'Reilly, Quantifying Adverse Drug Events: Med Mishaps Send Millions Back for Care, Am. Med. News (June 13, 2011).
HHS Again Turns Focus to Prevention
Once again, the federal government is rolling out a plan to make the nation healthier—this time it's a National Prevention Strategy. "The most effective and affordable strategy for us to be a healthy nation is to keep people from getting sick in the first place," said U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius at a press conference where the latest plan was unveiled.
The effort cannot just involve HHS, she added, because "if we want to achieve our goals and make a real change in the health of our nation, it can't just be one department doing the work. If we're going to serve healthier school lunches, we need to work with the departments of Agriculture and Education . . . If we want to create healthier homes, we need to work with the Department of Housing and Urban Development."
To foster that intra-departmental work, HHS formed a National Prevention Council under the direction of U.S. Surgeon General Regina Benjamin, MD. The council includes representatives from seventeen different federal agencies and departments, Sebelius noted. "All of us have committed to working together to put this strategy into action."
The prevention effort will also tap leaders in "states, local communities, businesses, and nonprofit groups. It's going to take a commitment from all Americans and their families to take advantage of new healthy choices they have," Sebelius said.
If these goals sound familiar, they are. Healthy People was a program of "science-based, ten-year national objectives for promoting health and preventing disease" launched by the Centers for Disease Control and Prevention (CDC) in 1979. On the CDC's website, the program is described as follows: "Healthy People 2010 is leading the way to achieve increased quality and years of healthy life and the elimination of health disparities."
And, like the Healthy People program, the National Prevention Council will issue yearly reports to the president and Congress. Benjamin, who also spoke at the press conference, outlined the four strategic directions that the National Prevention Strategy will address: (1) healthy and safe community environments; (2) clinical and community preventive services; (3) empowering people; and (4) eliminating health disparities.
Joyce Frieden, HHS Again Turns Focus to Prevention, MedPage Today (June 17, 2011).
A Call for a Radical Shift in Physicians' Prescribing Attitudes and Behaviors
Researchers from Harvard and the University of Illinois at Chicago have published "Principles of Conservative Prescribing" in the Archives of Internal Medicine. They write:
The concept sums up lessons from past experience as well as from recent studies demonstrating that medications are commonly used inappropriately, overused, and associated with significant harm—suggesting the need to more thoughtfully weigh claims for drugs, especially new drugs.
These principles urge clinicians to: (1) think beyond drugs (consider non-drug therapy, treatable underlying causes, and prevention); (2) practice more strategic prescribing (defer non-urgent drug treatment, avoid unwarranted drug switching, be circumspect about unproven drug uses, and start treatment with only one new drug at a time); (3) maintain heightened vigilance regarding adverse effects (suspect drug reactions, be aware of withdrawal syndromes, and educate patients to anticipate reactions); (4) exercise caution and skepticism regarding new drugs (seek out unbiased information, wait until drugs have sufficient time on the market, be skeptical about surrogate rather than true clinical outcomes, avoid stretching indications, avoid seduction by elegant molecular pharmacology, beware of selective drug trial reporting); (5) work with patients for a shared agenda (do not automatically accede to drug requests, consider non-adherence before adding drugs to a regimen, avoid restarting previously unsuccessful drug treatment, discontinue treatment with unneeded medications, and respect patients' reservations about drugs); and (6) consider long-term, broader impacts (weigh long-term outcomes and recognize that improved systems may outweigh marginal benefits of new drugs).
Gary Schwitzer, A Call for a Radical Shift in Physicians' Prescribing Attitudes and Behaviors, MedPage Today (June 15, 2011).
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers weekly and appropriate AHLA practice groups.
*We would like to thank Leah Voigt, Esquire (Spectrum Health, Grand Rapids, MI), and Allison Cohen, Esquire (Washington, DC) for providing this week's update.