Archive for December, 2008
First Febrile Seizure & LPs
Utility of Lumbar Puncture for First Simple Febrile Seizure Among Children
6 to 18 Months of Age
Amir A. Kimia, Andrew J. Capraro, David Hummel, Patrick Johnston, and
Marvin B. Harper
Pediatrics 2009;123 6-12
ABSTRACT
OBJECTIVES. American Academy of Pediatrics consensus statement recommendations are to consider strongly for infants 6 to 12 months of age with a first simple febrile seizure and to consider for children 12 to 18 months of age with a first simple febrile seizure lumbar puncture for cerebrospinal fluid analysis. Our aims were to determine compliance with these recommendations and to assess the rate of bacterial meningitis detected among these children.
METHODS. A retrospective cohort review was performed for patients 6 to 18 months of age who were evaluated for first simple febrile seizure in a pediatric emergency department between October 1995 and October 2006.
RESULTS. First simple febrile seizure accounted for 1% of all emergency department visits for children of this age, with 704 cases among 71 234 eligible visits during the study period. Twenty-seven percent (n = 188) of first simple febrile seizure visits were for infants 6 to 12 months of age, and 73% (n = 516) were for infants 12 to 18 months of age. Lumbar puncture was performed for 38% of the children (n = 271). Samples were available for 70% of children 6 to 12 months of age (131 of 188 children) and 25% of children 12 to 18 months of age (129 of 516 children). Rates of lumbar puncture decreased significantly over time in both age groups. The cerebrospinal fluid white blood cell count was elevated in 10 cases (3.8%). No pathogen was identified in cerebrospinal fluid cultures. Ten cultures (3.8%) yielded a contaminant. No patient was diagnosed as having bacterial meningitis.
CONCLUSIONS. The risk of bacterial meningitis presenting as first simple febrile seizure at ages 6 to 18 months is very low. Current American Academy of Pediatrics recommendations should be reconsidered.
TaqScreen MPX Test
FDA News Release, 12/30/08
FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood and Tissue
The U.S. Food and Drug Administration today approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue.
“With the MPX test, blood donor testing laboratories will be able to use nucleic acid technology to screen for additional HIV strains, further assuring that donated blood and tissue are free from infection and providing better protection for patients,” said Jesse L. Goodman, M.D., M.P.H., director of the FDA’s Center for Biologics Evaluation and Research.
Nucleic acid is the common name for the large chemical compounds that make up the genetic material in living cells. The new FDA-approved test detects nucleic acid from HIV-2 and from HIV-1 Group O. HIV-2 infections and HIV-1 Group O infections are predominantly found on the African continent. Some cases of infection with these two types of viruses have also been detected in the United States.
In addition to HIV-2 and HIV-1 Group O, the MPX test simultaneously detects nucleic acid from the most common form of HIV, HIV-1 Group M, as well as the Hepatitis C Virus and the Hepatitis B Virus.
The MPX test is designed for use with plasma specimens from human donors of whole blood and blood components, but not for testing donated source plasma. Donated source plasma is considered plasma intended for further manufacturing.
The test is also intended for screening tissue specimens obtained while the donor’s heart is still beating; it is not intended for use on specimens from donors whose heart no longer functions.
The cobas TaqScreen MPX Test runs on the fully-automated cobas s 201 System. It is manufactured by Roche Molecular Systems Inc., Pleasanton, Calif.
Antiviral Table of Choices
CDC, 12/19/08
TABLE
Interim recommendations for the selection of antiviral treatment using laboratory test results and viral surveillance data, United States, 2008-09 season‡
| Rapid antigen or other laboratory test | Predominant virus(es) in community | Preferred medication(s) | Alternative (combination antiviral treatment) |
| Not done or negative, but clinical suspicion for influenza |
H1N1 or unknown |
Zanamivir |
Oseltamivir + Rimantadine* |
| Not done or negative, but clinical suspicion for influenza |
H3N2 or B |
Oseltamivir or Zanamivir |
None |
|
Positive A |
H1N1 or unknown |
Zanamivir |
Oseltamivir + Rimantadine* |
|
Positive A |
H3N2 or B |
Oseltamivir or Zanamivir |
None |
|
Positive B |
Any |
Oseltamivir or Zanamivir |
None |
|
Positive A+B** |
H1N1 or unknown |
Zanamivir |
Oseltamivir + Rimantadine* |
|
Positive A+B** |
H3N2 or B |
Oseltamivir or Zanamivir |
None |
*Amantadine can be substituted for rimantadine but has increased risk of adverse events. Human data are lacking to support the benefits of combination antiviral treatment of influenza; however, these interim recommendations are intended to assist clinicians treating patients who might be infected with oseltamivir-resistant influenza A (H1N1) virus.
**Positive A+B indicates a rapid antigen test that cannot distinguish between influenza and influenza B viruses
‡ Influenza antiviral medications used for treatment are most beneficial when initiated within the first two days of illness. Clinicians should consult the package insert of each antiviral medication for specific dosing information, approved indications and ages, contraindications/warnings/precautions, and adverse effects.
Refresher: Antiviral Usage this year
This is an official
CDC HEALTH ADVISORY
Distributed via Health Alert Network
Friday, December 19, 2008, 11:50 EST (11:50 AM EST)
CDCHAN-00279-2008-12-19-ADV-N
CDC Issues Interim Recommendations for the Use of Influenza Antiviral Medications in the Setting of Oseltamivir Resistance among Circulating Influenza A (H1N1) Viruses,
2008-09 Influenza Season
Although influenza activity is low in the United States to date, preliminary data from a limited number of states indicate that the prevalence of influenza A (H1N1) virus strains resistant to the antiviral medication oseltamivir is high. Therefore, CDC is issuing interim recommendations for antiviral treatment and chemoprophylaxis of influenza during the 2008-09 influenza season. When influenza A (H1N1) virus infection or exposure is suspected, zanamivir or a combination of oseltamivir and rimantadine are more appropriate options than oseltamivir alone. Local influenza surveillance data and laboratory testing can help with physician decision-making regarding the choice of antiviral agents for their patients. The 2008-09 influenza vaccine is expected to be effective in preventing or reducing the severity of illness with currently circulating influenza viruses, including oseltamivir-resistant influenza A (H1N1) virus strains. Since influenza activity remains low and is expected to increase in the weeks and months to come, CDC recommends that influenza vaccination efforts continue.
Background
Influenza A viruses, including two subtypes (H1N1) and (H3N2), and influenza B viruses, currently circulate worldwide, but the prevalence of each can vary among communities and within a single community over the course of an influenza season. In the United States, four prescription antiviral medications (oseltamivir, zanamivir, amantadine and rimantadine) are approved for treatment and chemoprophylaxis of influenza. Since January 2006, the neuraminidase inhibitors (oseltamivir, zanamivir) have been the only recommended influenza antiviral drugs because of widespread resistance to the adamantanes (amantadine, rimantadine) among influenza A (H3N2) virus strains. The neuraminidase inhibitors have activity against influenza A and B viruses while the adamantanes have activity only against influenza A viruses. In 2007-08, a significant increase in the prevalence of oseltamivir resistance was reported among influenza A (H1N1) viruses worldwide. During the 2007-08 influenza season, 10.9% of H1N1 viruses tested in the U.S. were resistant to oseltamivir.
Influenza activity has been low thus far this season in the United States. As of December 19, 2008, a limited number of influenza viruses isolated in the U.S. since October 1 have been available for antiviral resistance testing at CDC. Of the 50 H1N1 viruses tested to date from 12 states, 98% were resistant to oseltamivir, and all were susceptible to zanamivir, amantadine and rimantadine. Preliminary data indicate that oseltamivir-resistant influenza A (H1N1) viruses do not cause different or more severe symptoms compared to oseltamivir sensitive influenza A (H1N1) viruses. Influenza A (H3N2) and B viruses remain susceptible to oseltamivir. The proportion of influenza A (H1N1) viruses among all influenza A and B viruses that will circulate during the 2008-09 season cannot be predicted, and will likely vary over the course of the season and among communities. Oseltamivir-resistant influenza A (H1N1) viruses are antigenically similar to the influenza A (H1N1) virus strain represented in 2008-09 influenza vaccine, and CDC recommends that influenza vaccination efforts continue as the primary method to prevent influenza.
Oseltamivir resistance among circulating influenza A (H1N1) virus strains presents challenges for the selection of antiviral medications for treatment and chemoprophylaxis of influenza, and provides additional reasons for clinicians to test patients for influenza virus infection and to consult surveillance data when evaluating persons with acute respiratory illnesses during influenza season. These interim guidelines provide options for treatment or chemoprophylaxis of influenza in the United States if oseltamivir-resistant H1N1 viruses are circulating widely in a community or if the prevalence of oseltamivir resistant H1N1 viruses is uncertain.
Interim Recommendations
Persons providing medical care for patients with suspected influenza or persons who are candidates for chemoprophylaxis against influenza should consider the following guidance for assessing and treating patients during the 2008-09 influenza season (see Table below). Guidance Table):
1) Review local or state influenza virus surveillance data weekly during influenza season, to determine which types (A or B) and subtypes of influenza A virus (H3N2 or H1N1) are currently circulating in the area. For some communities, surveillance data might not be available or timely enough to provide information useful to clinicians.
2) Consider use of influenza tests that can distinguish influenza A from influenza B.
a. Patients testing positive for influenza B may be given either oseltamivir or zanamivir (no preference) if treatment is indicated.
b. At this time, if a patient tests positive for influenza A, use of zanamivir should be considered if treatment is indicated. Oseltamivir should be used alone only if recent local surveillance data indicate that circulating viruses are likely to be influenza A (H3N2) or influenza B viruses. Combination treatment with oseltamivir and rimantadine is an acceptable alternative, and might be necessary for patients that cannot receive zanamivir, (e.g., patient is <7 years old, has chronic underlying airways disease, or cannot use the zanamivir inhalation device), or zanamivir is unavailable. Amantadine can be substituted for rimantadine if rimantadine is unavailable.
c. If a patient tests negative for influenza, consider treatment options based on local influenza activity and clinical impression of the likelihood of influenza. Because rapid antigen tests may have low sensitivity, treatment should still be considered during periods of high influenza activity for persons with respiratory symptoms consistent with influenza who test negative and have no alternative diagnosis. Use of zanamivir should be considered if treatment is indicated. Combination treatment with oseltamivir and rimantadine (substitute amantadine if rimantadine unavailable) is an acceptable alternative. Oseltamivir should be used alone only if recent local surveillance data indicates that circulating viruses are likely to be influenza A(H3N2) or influenza B viruses.
d. If available, confirmatory testing with a diagnostic test capable of distinguishing influenza caused by influenza A (H1N1) virus from influenza caused by influenza A (H3N2) or influenza B virus can also be used to guide treatment. When treatment is indicated, influenza A (H3N2) and influenza B virus infections should be treated with oseltamivir or zanamivir (no preference). Influenza A (H1N1) virus infections should be treated with zanamivir or combination treatment with oseltamivir and rimantadine is an acceptable alternative.
3) Persons who are candidates for chemoprophylaxis (e.g., residents in an assisted living facility during an influenza outbreak, or persons who are at higher risk for influenza-related complications and have had recent household or other close contact with a person with laboratory confirmed influenza) should be provided with medications most likely to be effective against the influenza virus that is the cause of the outbreak, if known. Respiratory specimens from ill persons during institutional outbreaks should be obtained and sent for testing to determine the type and subtype of influenza A viruses associated with the outbreak and to guide antiviral therapy decisions. Persons whose need for chemoprophylaxis is due to potential exposure to a person with laboratory-confirmed influenza A (H3N2) or influenza B should receive oseltamivir or zanamivir (no preference). Zanamivir should be used when persons require chemoprophylaxis due to exposure to influenza A ( H1N1) virus. Rimantadine can be used if zanamivir use is contraindicated.
Enhanced surveillance for influenza antiviral resistance is ongoing at CDC in collaboration with local and state health departments. Clinicians should remain alert for additional changes in recommendations that might occur as the 2008–09 influenza season progresses. Oseltamivir resistant influenza A (H1N1) viruses are antigenically similar to the influenza A(H1N1) viruses represented in the vaccine, and vaccination should continue to be considered the primary prevention strategy regardless of oseltamivir sensitivity. Information on antiviral resistance will be updated in weekly surveillance reports (available at http://www.cdc.gov/flu/weekly/fluactivity.htm)
For more information on antiviral medications and additional considerations related to antiviral use during the 2008-09 influenza season, visit http://www.cdc.gov/flu/professionals/antivirals/index.htm
OMNI Postings of 12/30/08
Another view on CAM
Wall Street Journal, 12/25/08
Feeling a tad listless? Perhaps your DNA is insufficiently activated. You may want to consult the healers at Oughten House Foundation, specializing in “tools and techniques for self-empowerment . . . through DNA Activations.” Oughten House recommends regular therapy as part of its DNA Activation Healing Project, at $125 per hour-long session.
The foundation isn’t as far from the mainstream as you might think. A survey of 32,000 Americans by the National Center for Health Statistics, released earlier this month, suggests that 38% of adults use some form of “complementary and alternative medicine,” or CAM — now aggressively promoted for everything from Attention Deficit Disorder to the Zoster virus. The survey polled consumers on 10 provider-based therapies — for example, acupuncture — and 26 home remedies, such as herbal supplements.
Hundreds of colleges operating in all 50 states offer coursework in sundry CAM disciplines. Many more advertise online. Typical is the Global College of Natural Medicine, which is somewhat more welcoming than traditional medical schools: Its literature cheerfully advises that even “if you do not hold a high school diploma or equivalent you can still enroll online today.” A 60% grade on an admission exam puts you on the path to becoming a nutritional consultant, master herbalist or holistic chef for animals.
This should be a laughing matter, but it isn’t — not with the Obama administration about to confront the snarling colossus of health-care reform. Today’s ubiquitous celebration of “empowerment,” combined with disenchantment over the cost, bureaucracy and possible side effects of conventional care, has spurred an exodus from medical orthodoxy. As a result, what was once a ragtag assortment of New Age nostrums has metastasized into a multibillion-dollar industry championed by dozens of lobbyists and their congressional sympathizers. Among the most popular therapies are acupuncture, at $50 to $100 per session; reflexology, which involves massaging various parts of the hands and feet, starting at $35 an hour; and aromatherapy, which relies on the supposed healing properties of about 40 “essential oils,” with treatments at $30 to $90 an hour.
The largest well-documented study of CAM’s financial footprint, a decade ago in the Journal of the American Medical Association, estimated that Americans spent $36 billion to $47 billion on CAM in 1997, depending on how one defined the category. Since then, at least 40 states have begun licensing CAM practitioners. Major hospital systems, notably Baltimore’s Johns Hopkins and New York’s Sloan-Kettering Cancer Center, incorporate CAM-based programs like aromatherapy and therapeutic touch, often bracketed as “integrative medicine.”
Indeed, one of the great ironies of modern health care is that many of the august medical centers that once went to great lengths to vilify nontraditional methods as quackery now have brought those regimens in-house. “We’re all channeling East Indian healers along with doing gall-bladder removal,” says Arthur Caplan, director of the University of Pennsylvania’s Center for Bioethics. Mr. Caplan harbors no illusions about what’s behind the trend: “It’s not as noble as, ‘I want to be respectful to Chinese healing arts.’ It’s more, ‘People are spending a fortune on this stuff! We could do this plus our regular stuff and bill ‘em for all of it!’”
Fees for CAM services are increasingly passed on to insurance through a creative — some might say fraudulent — interpretation of the Current Procedural Terminology codes that govern reimbursement for authorized services. (Various tutorials, some online, guide practitioners through the reimbursement maze.) Such creativity may soon be unnecessary if the alternative medicine proponents have their way. For example, ABC Coding Solutions, a medical-software company, has been promulgating a set of 4,000 treatment codes that cover “nearly every healing modality practiced by alternative healthcare providers,” to quote one report. If such codes are fully absorbed by the health-care industry, CAM will have been mainstreamed — while bypassing all the customary peer review, controlled studies and other hallmarks of sound medicine.
Not by coincidence is CAM most avidly touted by a loose alliance of self-help gurus (Andrew Weil, Deepak Chopra, et al.) and veteran hucksters like erstwhile infomercial king Kevin Trudeau. Mr. Trudeau has been sued for deceptive business practices several times by the Federal Trade Commission. In 2004, the agency deemed his sins so egregious that it barred him from “appearing in, producing, or disseminating future infomercials that advertise any type of product, service, or program to the public.” Undaunted, Mr. Trudeau reinvented himself as a health-care expert and, the following year, published the runaway best seller “Natural Cures ‘They’ Don’t Want You to Know About.” The book continued to sell briskly even after the New York State Consumer Protection Board warned that it “does not contain the ‘natural cures’ for cancer and other diseases that Trudeau is promising.”
Meanwhile, CAM has secured its own beachhead within the National Institutes of Health in the form of the National Center for Complementary and Alternative Medicine (NCCAM). “Special commercial interests and irrational, wishful thinking created NCCAM,” writes Wallace Sampson, a medical doctor and director of the National Council Against Health Fraud, on the Web site Quackwatch.com. And Sen. Tom Harkin (D., Iowa), who credited bee pollen with quelling his allergies, was single-handedly responsible for the $2 million earmark that provided seed money for NCCAM, chartered in 1992 as the Office of Alternative Medicine. Despite the $1 billion spent in the interim, the center has failed to affirm a single therapy that can withstand the rigors of science.
Even the center’s own fact sheets unfold as unintentionally comical. After noting that echinacea is “traditionally used to treat or prevent colds, the flu and other infections,” the center concedes that “most studies to date indicate that echinacea does not appear to prevent colds or other infections.” St. John’s Wort as a natural antidepressant? “Two large studies, one sponsored by NCCAM, showed that the herb was no more effective than placebo in treating major depression.” Evening primrose for hot flashes? “Does not appear to affect menopausal symptoms.” And so forth. “It is the only entity in the NIH devoted to an ideological approach to health,” writes Dr. Sampson, who has called for the center to be defunded.
Is there anecdotal evidence that unconventional therapies sometimes yield positive outcomes? Yes. There’s also anecdotal evidence that athletes who refuse to shave during winning streaks sometimes bring home championships. It was George D. Lundberg, a former editor of the Journal of the American Medical Association, who said: “There’s no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data.” We’d do well to keep that in mind as we plot the future of American health care. It’s not like we’ve got billions to waste.
Mr. Salerno is the author of “SHAM: How the Self-Help Movement Made America Helpless.” He blogs at www.shamblog.com.
Excessive Force
Source reference:
Hutson H, et al “Excessive use of force by police: a survey of academic emergency physicians” Emerg Med J 2008; 26: 20-22.
ABSTRACT
Objective: To determine the clinical experience, management and training of emergency physicians in the suspected use of excessive force by law enforcement officers.
Methods: Surveys were mailed to a random sample of academic emergency physicians in the USA.
Results: Of 393 emergency physicians surveyed, 315 (80.2%) responded. Of the respondents, 99.8% (95% CI 98.2% to 100.0%) believed excessive use of force actually occurs and 97.8% (95% CI 95.5% to 99.1%) replied that they had managed patients with suspected excessive use of force. These incidents were not reported by 71.2% (95% CI 65.6% to 76.4%) of respondents, 96.5% (95% CI 93.8% to 98.2%) had no departmental policies and 93.7% (95% CI 90.4% to 96.1%) had not received training in the management of these cases.
Conclusions: Suspected excessive use of force is encountered by academic emergency physicians in the USA. There is only limited training or policies for the management of these cases.
Hospitals being squeezed
AP, 12/27/08
Gainesville’s first community hospital has been on life support since the Shands Healthcare system in northern Florida bought it a dozen years ago.
Now, because of the recession, the plug is being pulled on 80-year-old, money-losing Shands AGH. Next fall, its eight-hospital not-for-profit parent company will shut the 220-bed hospital and shift staff and patients to a newer, bigger teaching hospital nearby as part of an effort to save $65 million over three years across the system.
Like many U.S. hospitals, Shands is being squeezed by tight credit, higher borrowing costs, investment losses and a jump in patients — many recently unemployed or otherwise underinsured — not paying their bills.
All that has begun to trigger more hospital closings — from impoverished Newark, N.J., to wealthy Beverly Hills, Calif. — as well as layoffs, other cost-cutting and scrapping or delaying building projects.
More closings and mergers are on the way, industry consultants predict.
“They’ll get swallowed up by somebody else, if they need to exist, and if they don’t, they’ll just close,” said Tuck Crocker, vice president of the health care practice at management consultant BearingPoint.
Most endangered are rural hospitals and urban ones in areas with excess hospital beds and a lot of poor, uninsured patients.
Hospitals, which employ 5 million people, are reporting that donations and investment returns are down, patient visits are flat and profitable diagnostic procedures and elective surgeries are declining as people with inadequate insurance delay care. But those patients are turning up later at ERs, seriously ill, making it tough for hospitals to lay off nurses and doctors.
All those problems are aggravating long-standing stresses: stingy reimbursements from commercial insurers, even-lower payments that generally don’t cover costs for Medicare and Medicaid patients, and high labor and technology costs.
Hospital executives and consultants say the growing number of people with high-deductible health plans is boosting unpaid patient bills. Many worry health reform efforts by the Obama administration could bring cuts in Medicare reimbursements, and many cash-strapped states already have begun cutting payments for poor people covered by Medicaid.
In the past few months, patients and insurers have been paying hospital bills more slowly. As a result, some think hospitals will start demanding up-front payments for elective procedures.
In November, Moody’s Investors Service changed its 12- to 18-month outlook from “stable” to “negative” for nonprofit and for-profit hospitals, citing “prospects of a protracted recession,” bad debt and the credit crunch.
“Looking forward, the cost of borrowing will likely be higher — and may be nonexistent for lower-rated hospitals,” Moody’s noted, a problem because hospitals borrow for everything from expansions and equipment to payroll and supplies.
Since October, there’s been “a dramatic slowdown” in plans for new wings and building upgrades, with many delayed indefinitely, said Paul Keckley of the Deloitte Center for Health Solutions.
“It probably means we won’t have as many new things in the hospital,” he predicted.
Tim Goldfarb, CEO of Gainesville-based Shands Healthcare, said his system, Florida’s second-largest provider of charity care, this year has seen bad debt jump 20 percent from patients with no insurance.
“We write them off,” Goldfarb said. “It’s a burden that we cannot carry any longer.”
Florida started cutting Medicaid reimbursements two years ago, when its economy started to slow, Goldfarb said. He fears another huge cut next year.
Shands already has paid off variable-rate bonds to avoid higher interest rates, deferred roughly $25 million in equipment purchases, shifted management meetings to church halls and adopted employee suggestions to save millions more.
Goldfarb believes closing Shands AGH will save nearly $100 million over seven years, mainly by avoiding costly renovations, but some administrative jobs will go.
Around the country, while some hospitals still are doing well, closings and bankruptcies seem to be picking up.
In New Jersey, where 47 percent of hospitals posted losses in 2007, five of the 79 acute-care hospitals closed this year, and a sixth may close soon. In Hawaii, nearly every hospital is in trouble, with two filing for bankruptcy and one nearly closing recently.
All over, hospitals are cutting costs by outsourcing services like housekeeping and security and trimming staff through layoffs, hiring freezes and attrition. Most are trying not to touch patient care jobs — nurses, pharmacists, therapists and X-ray technicians — as those already have staff shortages.
“The last thing we can do is skinny down our staffing right where we need it the most,” said Mike Killian, marketing vice president for the three Beaumont Hospitals in suburban Detroit.
There, auto industry job losses and other factors now equal fewer patients with commercial insurance. The system expects a $22 million loss, its first in at least 40 years, Killian said.
So Beaumont this fall announced a $60 million restructuring program that includes 4-10 percent pay cuts for doctors and managers, reducing overtime for some employees and eliminating 500 jobs, 200 already vacant, mostly outside of patient care. Rich Umbdenstock, chief executive of the American Hospital Association, said some of the hardest-hit hospitals began reducing staffing and services as early as last spring and more will follow. He expects some to eliminate services — money-losers such as behavioral health treatment, or those with high operating costs such as burn units — rather than weaken their entire operation.
An association survey of more than 700 hospitals found two-thirds have seen elective procedures and overall admissions fall since July, and half have seen moderate or significant jumps in nonpaying patients.
An industry database on more than 550 hospitals found their third-quarter investment results amounted to a combined loss of $832 million, down from a $396 million gain a year earlier. During the quarter, those hospitals paid 15 percent more in borrowing costs and swung to a 1.6 percent average loss, from an average 6.1 percent profit margin a year ago.
“They’re having serious problems getting the capital they need for needed renovations and upgrading their facilities,” said Mike Rock, a lobbyist at AHA, which is seeking increased federal reimbursements from Medicaid and Medicare.
At Exempla Healthcare, with three hospitals in Denver and its suburbs, Chief Executive Jeff Selberg said there’s usually a 5-7 percent annual profit margin, but this year investment losses wiped that out. He’s scaled back a $200 million plan to upgrade facilities, information technology and clinical equipment and may halt construction of a new maternity unit and operating rooms at one hospital.
Selberg has seen a slight increase in bad debt and expects more problems.
“We feel like the wave is coming, but it hasn’t hit yet, and we don’t know how big this wave is going to be,” he said.
What’s happening flu-wise
EZ-IO: tibial versus humeral intraosseous access
An observational, prospective study comparing tibial and humeral intraosseous access using the EZ-IO
Pages 8-15 in Amer J Emerg Med (1/09) by
Marcus Eng Hock Ong, Yiong Huak Chan, Jen Jen Oh, Adeline Su-Yin Ngo
Original Contribution
Introduction
Intraosseous (IO) access is an alternative to conventional intravenous access. The proximal tibia and proximal humerus have been proposed as suitable sites for IO access.
Methods
A nonrandomized, prospective, observational study comparing flow rates and insertion success with tibial and humeral IO access in adults using the EZ-IO–powered drill device was conducted. The tibia was the first site of insertion, and a second IO was inserted in the humerus if clinically indicated for the same patient.
Results
Twenty-four patients were recruited, with 24 tibial and 11 humeral insertions. All EZ-IO insertions were successful at the first attempt except for 1 tibial insertion that was successful on the second attempt. All insertions were achieved within 20 seconds. Mean ease of IO insertion score (1 = easiest to 10 = most difficult) was 1.1 for both sites. We found tibial flow rates to be significantly faster using a pressure bag (165 mL/min) compared with those achieved without a pressure bag (73 mL/min), with a difference of 92 mL/min (95% confidence interval [CI]: 52, 132). Similarly, humeral flow rates were significantly faster using a pressure bag (153 mL/min) compared with humeral those achieved without pressure bag (84 mL/min), with a difference of 69 mL/min (95% CI: 39, 99). Comparing matched pairs (same patient), there was no significant difference in flow rates between tibial and humeral sites, with or without pressure bag infusion.
Conclusions
Both sites had high-insertion success rates. Flow rates were significantly faster with a pressure bag infusion than without. However, we did not find any significant difference in tibial or humeral flow rates.
Personalized medicine
NY Times, 12/30/08:
For more than two years, Jody Uslan had been taking the drug tamoxifen in hopes of preventing a recurrence of breast cancer. Then a new test suggested that because of her genetic makeup, the drug was not doing her any good.
“I was devastated,” said Ms. Uslan, 52, who stopped taking tamoxifen and is now evaluating alternative treatments. “You find out you’ve been taking this medication for all of this time, and find out you are not getting benefit.”
Ms. Uslan’s situation is all too common — and not just among the hundreds of thousands of women in this country taking tamoxifen.
Experts say that most drugs, whatever the disease, work for only about half the people who take them. Not only is much of the nation’s approximately $300 billion annual drug spending wasted, but countless patients are being exposed unnecessarily to side effects.
No wonder so much hope is riding on the promise of “personalized medicine,” in which genetic screening and other tests give doctors more evidence for tailoring treatments to patients, potentially improving care and saving money.
Many policy experts are calling for more studies to compare the effectiveness of different treatments. One drawback is that such studies tend to be “one size fits all,” with the winning treatment recommended for everybody. Personalized medicine would go beyond that by determining which drug is best for which patient, rather than continuing to treat everyone the same in hopes of benefiting the fortunate few.
The colon cancer drugs Erbitux and Vectibix, for instance, do not work for the 40 percent of patients whose tumors have a particular genetic mutation. The Food and Drug Administration held a meeting this month to discuss whether patients should be tested to narrow use of the drugs, which cost $8,000 to $10,000 a month.
And a genetic test might help doctors determine the optimal dose of warfarin, a blood thinner used by millions of Americans. Tens of thousands of them are hospitalized each year because of internal bleeding from an overdose or a blood clot from an inadequate dose.
“If you save one hospitalization for every 100 new warfarin users, you more than offset the cost of testing all 100,” said Dr. Robert S. Epstein, the chief medical officer of Medco Health Solutions, which manages prescription plans for employers. The test typically costs $100 to $600.
For all the potential, experts see some formidable obstacles on the path to the promised land of personalized medicine.
“It’s going to take 20 to 30 years for all this to fall into place,” said Dr. Gregory Downing, who heads efforts by the Department of Health and Human Services to spur personalized health care.
The hurdles include drug makers, which can be reluctant to develop or encourage tests that may limit the use of their drugs. Insurers may not pay for tests, which can cost up to a few thousand dollars. For makers of the tests, which hope their business becomes one of health care’s next big growth industries, a major obstacle is proving that their products are accurate and useful. While drugs must prove themselves in clinical trials before they can be sold, there is no generally recognized process for evaluating genetic tests, many of which can be marketed by laboratories without F.D.A. approval.
Genentech, a developer of cancer drugs, petitioned the F.D.A. this month to regulate such tests. It warned of “safety risks for patients, as more treatment decisions are based in whole or in part on the claims made by such test makers.”
A cautionary case is Herceptin, a Genentech breast cancer drug that is considered the archetype of personalized medicine because it works only for women whose tumors have a particular genetic characteristic. But now, 10 years after Herceptin reached the market, scientists are finding that the various tests — some approved by the F.D.A., some not — can be inaccurate.
Moreover, doctors do not always conduct the tests or follow the results. The big insurer UnitedHealthcare found in 2005 that 8 percent of the women getting the drug had tested negative for the required genetic characteristic. An additional 4 percent had not been tested at all, or their test results could not be found.
Tamoxifen, the drug Ms. Uslan took, illustrates the promise and current limitations of genetic testing. In 2003, more than 25 years after tamoxifen was introduced, researchers led by Dr. David A. Flockhart at Indiana University School of Medicine figured out that the body coverts tamoxifen into another substance called endoxifen. It is endoxifen that actually exerts the cancer-fighting effect. The conversion is done by an enzyme in the body called CYP2D6, or 2D6 for short.
But variations in people’s 2D6 genes mean the enzymes have different levels of activity. Up to 7 percent of people, depending on their ethnic group, have an inactive enzyme, Dr. Flockhart said, while another 20 to 40 percent have an only modestly active enzyme.
The implications were “scary,” Dr. Flockhart said. Many women were apparently not being protected against cancer’s return because they could not convert tamoxifen to endoxifen.
The economic implications could be just as scary to big pharmaceutical companies.
Tamoxifen, now a generic drug, costs as little as $500 for the typical five-year treatment. But most patients in the United States are currently treated with a newer, much more expensive class of drugs, called aromatase inhibitors, that cost about $18,000 over five years. Those drugs — made by AstraZeneca, Novartis and Pfizer — performed better than tamoxifen in clinical trials before the role of 2D6 was generally understood.
If only women with active 2D6 had been assessed, tamoxifen might have worked as well or better than the newer drugs, according to researchers at the Dana-Farber Cancer Institute in Boston.
But proving these suppositions and having them incorporated into medical practice have not been easy.
The F.D.A., in its meeting this month, said clinical trials were the ideal way to validate a test. But many test developers argue that trials would be too costly and time-consuming, so many tests are validated by reanalyzing patient data from old trials.
In the case of tamoxifen, Dr. Matthew P. Goetz of the Mayo Clinic and colleagues went back to an old trial and used stored tumor samples to test the 2D6 genes of each patient. The researchers reported in 2005 that 32 percent of the women with inactive 2D6 enzyme had relapsed or died within two years, in contrast to only 2 percent of the other women.
But while some subsequent studies have backed those conclusions, two had contradictory results. That leaves many experts hesitant to use the test, which costs about $300.
There are other complications. Dozens of variants of the 2D6 gene exist, and laboratories can differ in their interpretation of test results. And it is not always clear how to act upon the information the test provides.
Ms. Uslan, who lives in the Woodland Hills neighborhood of Los Angeles, is in a predicament since she stopped taking tamoxifen. The newer alternative, aromatase inhibitors, work only for postmenopausal women and she has not yet completed menopause. To take an aromatase inhibitor, she must have her ovaries removed or take a drug to induce menopause. Because both options are unattractive, many experts say there is no point testing premenopausal women for 2D6.
Such complexities are not confined to tamoxifen testing. The labels of about 200 drugs now contain some information relating genes to drug response, said Lawrence J. Lesko, the F.D.A.’s head of clinical pharmacology. But in many cases, he said, doctors are not told specifically enough what to do with the test results, such as how much to change the dose.
Despite all the obstacles, personalized medicine is coming. Even the drug companies, which have been worried that testing would reduce their sales, are starting to realize that their medicines might not be approved or paid for without better evidence that they work.
Last year, for instance, European regulators said Amgen’s colon cancer drug Vectibix did not provide enough benefit to patients to be approved.
So Amgen reanalyzed the data from its clinical trial. After the results showed Vectibix worked better in patients whose tumors did not have a mutation in a gene called KRAS, the drug was approved for those patients only.
As for tamoxifen, an F.D.A. advisory panel recommended two years ago that the 2D6 test be mentioned in the drug’s label. But the agency itself was not persuaded there was enough evidence until just recently, Dr. Lesko said. “There’s no ‘one size fits all’ for evidence that everybody buys into.”
Women & Heart Disease
Chicago Tribune, 12/29/08
Heart disease is the leading cause of death for women in the U.S., yet a wealth of data shows female cardiac patients receive inferior medical care compared with men.
Too many physicians still discount the idea that a woman could be suffering from heart disease, delaying or denying needed medical interventions, experts note. Most community hospitals in the U.S. still are not following guidelines for treating women with heart attacks. And primary care doctors don’t do as much as they could to emphasize prevention.
As a result, women are failing to reap the full benefits of enormous advances in cardiovascular medicine.
The point was underscored this month by a study published in the journal Circulation finding that women who have heart attacks receive fewer recommended treatments in hospitals than men, including aspirin, beta blocker medications, angioplasties, clot-busting drugs and surgeries to re-establish blood flow. Women with the most serious heart attacks, known as STEMIs, were significantly more likely to die at a hospital than men.
“We need to do a better job of defining women’s symptoms and treating them aggressively and rapidly, as we do for men,” said Dr. Hani Jneid, the study’s lead author and assistant professor of medicine at the Baylor College of Medicine in Houston.
In Israel, when guidelines have been applied much more rigorously, the mortality difference between the sexes all but disappeared, according to a July study in the American Journal of Medicine.
Outside hospitals, too few internists, family doctors, obstetricians and gynecologists are implementing recommendations for preventing heart disease in women, experts say. Eighty percent of heart attacks in women could be prevented if women changed their eating habits, got regular exercise, managed their cholesterol and blood pressure, and followed other preventive measures.
Although death rates from cardiovascular disease have fallen, the condition killed 455,000 women in 2006, according to data from the American Heart Association. Heart disease causes about 72 percent of cardiovascular fatalities; the rest are strokes and other related conditions.
The next decade could see major advances as scientists better understand how the biology of heart disease differs in women, said Dr. Joan Briller, director of the Heart Disease in Women program at the University of Illinois Medical Center at Chicago.
Already, for example, researchers have learned that plaque deposits tend to be spread more widely in women than in men, resulting in fewer big blockages in the arteries. That means standard therapies such as angioplasty are often less effective in women. Also, woman metabolize certain heart drugs at a different rate than men.
Women should learn about the symptoms of acute heart disease—which can differ from those in men—respond promptly if they sense something is wrong, and “find physicians who care about them,” said Dr. Annabelle Volgman, medical director of the Heart Center for Women at Rush University Medical Center.
“Ask your doctor: Are you familiar with the guidelines for the prevention of heart disease in women published in 2007? Do you follow them? If they say ‘no,’ find yourself another doctor,” she said.
Trauma & New Year’s Day
NY Times, 12/30/08
With all the open bars, people on the road and rejoicing in the streets, it is easy to imagine that New Year’s is a risky time. Holidays are the most hazardous time for drivers, a result of sharp increases in traveling and drunken driving. And when it comes to New Year’s, research over the years offers sobering statistics.
According to research by the Insurance Institute for Highway Safety, which examined accident data in the United States from 1986 to 2002, the day of the year with the most fatalities from accidents is the Fourth of July, with an average of 161. Not far behind are July 3 (149) and Dec. 23 (145). New Year’s Day is fourth, with 142.
A closer look reveals something peculiar: New Year’s Day is the deadliest for pedestrians. In the study period, 410 of those killed on New Year’s were pedestrians, slightly more than on Halloween (401). For New Year’s, the problem was largely that of increased drinking and celebrations. Half the deaths involved alcohol impairment, and 58 percent of the pedestrians who were killed had a high blood-alcohol concentration, the study found.
Something to keep in mind as the Champagne flows Wednesday night.
THE BOTTOM LINE
New Year’s Day is not the most hazardous day for drivers, but it’s up there.