In the News for the Week of 7-27-04
- Government issues framework for information technology network
- IDSA: Drug industry needs incentives to develop antibiotics
Clinical news in the headlines
- Drug shows promise in treating heart failure in black patients
- Timing after starting antidepressant therapy more important than drug choice for suicide risk
- Highlights of ACP Journal Club
- College issues e-prescribing recommendations
- ACP calls for major changes in SGR
- College elects new Treasurer
- ACP Regent appointed to key Medicare advisory committee
- College urges Congress to regulate tobacco products
The federal government last week issued a broad framework for modernizing the nation's health care system by encouraging the development and adoption of electronic medical records (EMRs) for all Americans within 10 years.
The government report, released by HHS, called for national interoperable technology standards and collaboration between private- and public-sector leaders to build health networks and assess the costs and benefits of technology adoption.
According to a July 21 HHS fact sheet, the government's outline includes four basic strategies, including:
Introducing incentives for physicians to adopt EMRs by reducing the risk of investment and promoting EMR use in rural areas. Incentives for physicians could include expansion of regional grants, access to low-rate loans, reimbursement for EMR use and performance bonuses.
Developing a national health information network that would connect physicians in different parts of the country and allow medical information to be portable.
Encouraging consumers to have personal health records and to use telemedicine services, and providing quality measurements to help them select providers.
Improving public health by, for example, streamlining health status monitoring and speeding up the transfer of evidence-based medicine to practice.
The government's plan also calls for certifying EMR products to set minimum interoperability and security standards. The July 21 Modern Physician reported that three organizations--the American Health Information Management Association, the Health Care Information and Management Systems Society, and the National Alliance for Health Information Technology--have formed an independent consortium to certify EMR systems.
The College has strongly advocated for financial assistance for physicians to encourage information technology adoption. It recently proposed legislation that would include tax credits, grant and loan programs, and reimbursement incentives to help small practices invest in technology.
The full government report is online.
The HHS fact sheet is online.
Modern Physician is online.
In related news, the Department of Veterans Affairs (VA) last week said it will distribute low-cost copies of its EMR system to office-based physicians beginning next year.
The interoperable system now links more than 1,300 VA facilities nationwide with records on 5 million patients. According to the July 22 Modern Physician, the system includes reminders for preventive services as well as e-prescribing, lab, referral, X-ray and pathology functions.
A VA spokesperson said the software could be used in hospitals as well as in medical groups.
Modern Physician is online.
The drug industry's dramatic slowdown in developing antibiotics has created a looming public health crisis, an infectious disease society warned.
To avert disaster, the government must create incentives for drug companies to invest in antibiotic research and development, according to a report presented to Congress last week by the Infectious Diseases Society of America (IDSA). Currently, there are not enough drugs under development to keep up with the emergence of "superbugs" caused by bacterial resistance.
Drug makers have largely abandoned developing antibiotic drugs-which are typically prescribed for short periods and have low profit potential-in favor of drugs for chronic conditions like high cholesterol and diabetes, a July 21 IDSA news release reported. Only five of the 506 drugs currently under development are antibiotics, the release said.
The report recommended establishing an independent commission to target infectious pathogens and prioritize research; allowing companies to extend patent protection on successful drugs in exchange for investing some of those profits back into antibiotic research; providing tax incentives related to antibiotic research and development; and granting companies some liability protections for antibiotic products, similar to those given to companies that develop vaccines.
The report cited Project Bioshield, which was signed into law last week, as an example of the type of Congressional action needed, the IDSA said. The Project Bioshield legislation, which calls for stockpiling vaccines and antidotes in case of chemical or germ warfare, includes research and development incentives for the drug industry, according to the July 21 Modern Physician. It also streamlines the approval process for vaccines and allows the government to take emergency action to distribute certain medications prior to FDA approval.
The full report can be downloaded from the IDSA's Web site.
The IDSA news release is online.
Modern Physician is online.
Clinical news in the headlines
A drug used to treat heart failure may receive earlier than expected FDA approval after it proved highly effective in treating black patients in a clinical trial.
If approved, isosorbide dinitrate hydralazine (BiDil, manufactured by NitroMed), would be the first drug approved for a specific ethnic group, according to the July 20 New York Times. A clinical trial begun in 2001 with more than 1,000 enrollees was stopped early because patients receiving the drug were living longer than those on placebo.
The controversial trial tested the drug only on black heart failure patients after an earlier trial found the drug to be effective in treating blacks, although it didn't produce statistically significant results in whites, according to the July 20 New York Times. Blacks have been shown to have a higher rate of heart failure than the overall population. In addition, heart disease in blacks appears to be linked more to hypertension than to clogging of the arteries, a major factor in whites.
The trial led to debate over whether race should influence medical treatment decisions. While some experts say people of the same race share certain genetic traits, others contend that genetic factors cross racial lines and that the differences in disease rates among races could be attributed to socio-economic factors or access to care issues.
The New York Times article is online.
The timing of antidepressant therapy appears to be a greater factor than the choice of antidepressant medication in predicting the risk of suicide, a new study concluded.
The study found that patients prescribed one of three common antidepressants were three to four times more likely to attempt or to think about suicide during the first month of treatment than were patients who had been on a medication for more than 90 days. Researchers found no significant difference in the risk of suicidal behavior among patients taking fluoxetine (Prozac) paroxetine (Paxil), or amitriptyline. (Some patients also took dothiepin, which is not sold in the United States.) The findings, which were published in the July 21 Journal of the American Medical Association, were similar for adults and children.
According to the July 21 New York Times, the study should reassure physicians and patients concerned about the suicide risks of one medication versus another. It should also alert physicians to carefully monitor patients during the first few weeks of antidepressant treatment.
In the observational study, researchers from Boston University analyzed records of almost 160,000 patients treated between 1993 and 1999 in Britain, which maintains a comprehensive database on more than 3 million patients ranging in age from 10 to 69.
The study did not address the question of whether taking an antidepressant causes some people to consider suicide. Researchers speculated, however, that patients might be at higher risk early in treatment because the medications become more effective over time. Another theory is that patients often start treatment at a low point in their depression.
The JAMA abstract is online.
The New York Times is online.
See also "SSRIs: Too much—or too little—of a good thing," in the March ACP Observer.
Prophylactic antibiotic therapy is effective in treating patients who develop pancreatic necrosis following severe acute pancreatitis.
A meta-analysis of four randomized controlled trials, abstracted in the July/August ACP Journal Club, involved more than 200 patients ages 41 to 52 with pancreatitis and pancreatic necrosis. All four trials compared antibiotic therapy for preventing infection within seven days of the onset of the attack with placebo or best supportive care.
All-cause mortality was 6% for patients receiving antibiotics versus 17% among patients who received supportive medical therapy. In addition, patients treated with antibiotics were less likely to develop sepsis. No differences were found in the incidence of fungal infections.
Super infection of pancreatic necrosis is the most common cause of death in patients with necrotizing pancreatitis. This analysis suggests that early treatment with antibiotics prevents potentially lethal complications that typically set in within two to three weeks after the onset of severe pancreatitis.
The ACP Journal Club is online.
The College this month sent a series of recommendations to federal lawmakers on ways to encourage the expanded use of electronic prescribing.
In written comments sent to the House of Representatives Ways and Means Committee's Subcommittee on Health, the College noted that e-prescribing would lower health care costs and reduce medication errors. However, the College pointed out that widespread adoption of e-prescribing faces several practical and technical barriers.
To help remove those barriers, the College included more than a dozen recommendations. They included:
Developing a single universal vocabulary and classification system for prescription drug information, as well as uniform standards for e-prescribing.
Making e-prescribing a voluntary and cooperative process between the federal government and the health care industry.
Designing e-prescribing systems to be easily integrated with electronic health records and decision support tools.
Pilot testing e-prescribing systems in a wide range of provider settings to identify and correct any underlying problems.
Ensuring that e-prescribing is not used by health plans or pharmacy benefits managers to pressure physicians to prescribe specific medications.
The College's comments are online.
The College has joined with more than 90 other medical organizations and institutions in asking the CMS to make changes to the sustainable growth rate (SGR) formula, including removing the cost of prescription drugs from the formula. The SGR governs updates for physicians' Medicare payments.
In a letter sent this month to CMS administrator Mark McClellan, FACP, the College noted that it would require Congressional action to replace the SGR. However, the letter pointed out that Dr. McClellan has the authority to fix fundamental flaws in the formula that would improve updates for physicians.
Specifically, the letter called on Dr. McClellan to remove the cost of prescription drugs from the SGR. With spending on drugs rising much more rapidly than spending on physician services, combining prescription drug costs with service costs leads to fundamental inaccuracies in the formula, the letter said.
The letter also called on Dr. McClellan to include in the SGR the impact of changes to laws and regulations that increase physician services. The letter noted, for example, that while Medicare has new screening benefits, the SGR does not account for services needed when that screening reveals health problems.
Without changes in the SGR, the letter said, payment levels for some physicians in 2014 are projected to be about 30% less than in 2005.
The letter is online.
Former ACP Regent Robert B. Gibbons, FACP, was elected College Treasurer earlier this month by the ACP Boards of Regents and Governors. Dr. Gibbons' term began July 9.
A rheumatologist, Dr. Gibbons is presently chair of the department of medicine and director of the internal medicine residency program at Denver's Exempla St. Joseph Hospital. He is also clinical professor of medicine at the University of Colorado School of Medicine.
Dr. Gibbons has either chaired or been a member of several ACP committees, including the Finance Committee, Membership Committee, Compensation Subcommittee, and the Insurance and Financial Services Subcommittee. He has been a College member since 1967 and became a Fellow of the College in 1971.
Dr. Gibbons served on the Board of Regents from 1998 until April 2004.
A press release about his election is online.
Regent David C. Dale, FACP, has been appointed to the Medicare Coverage Advisory Committee (MCAC). The committee advises the CMS on specific medical items and services that are reasonable and necessary under Medicare law.
Dr. Dale is Editor-in-Chief of ACP Medicine, a medical textbook published by the College and WebMD. He is also professor of medicine and a former dean of the University of Washington School of Medicine. A member of the Board of Regents, he is also the former Chair of the College's Board of Governors.
Dr. Dale's MCAC appointment will begin next winter.
A link to the MCACs Web site is online.
ACP is urging members of Congress to support a bill that would give the FDA authority to regulate the manufacturing, marketing and sale of tobacco products.
In a letter sent earlier this month, the College joined close to 50 medical societies and consumer advocacy groups in asking members of Congress to support the Davis-Waxman Bill (HR 4433). If passed, the bill would mandate the disclosure of the contents of tobacco products and of tobacco industry research, as well as the use of larger health warnings on tobacco product packages.
The bill would also give the FDA authority to restrict tobacco advertising that appeals to children and stop illegal sales of those products to children.
Greater FDA oversight, the letter stated, would help reduce the health consequences of tobacco products, which kill more than 400,000 Americans every year and cost the nation $75 billion.
The letter is online.
An ACP letter sent earlier this month to the chair of the Federal Trade Commission calling for more prominent health warnings on cigarette packs is also online.
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Copyright 2004 by the American College of Physicians.
A 25-year-old woman e-mails her internist from Mexico with a report of diarrhea for 2 days. She is traveling and reports three to four loose bowel movements per day. She has been dining in the hotel restaurants but has also consumed foods and bottled soft drinks served with ice from local food vendors. She was given levofloxacin and loperamide to take with her on her trip. In addition to encouraging oral hydration, what is the most appropriate treatment recommendation for this patient?
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