In the News for the Week of 6-21-05
- Agency approves new antibiotic for inpatient infections
- FDA panel endorses use of heart failure drug in African Americans
Clinical news in the headlines
- Highlights of Annals of Internal Medicine
- New bill targets health information technology
- Drug benefit likely to be better than expected
- Free patient education video focuses on keys to a healthy heart
The FDA last week approved the first in a new class of antibiotics designed as first-line treatment for hospital infections that are resistant to other antibiotics.
The FDA approved tigecycline (Tygacil), an intravenous medication that is the first in the class of glycylcyclines to be approved. The broad-spectrum antibiotic was approved for use in skin and stomach infections, according to the June 17 Washington Post, and can be used before physicians know the bacterial cause of an infection.
While the drug class is similar to tetracycline, tigecycline can be used to treat infections that are tetracycline-resistant. The Washington Post reported that it can also be used to treat methicillin-resistant S. aureus and that Wyeth Pharmaceuticals, which manufactures the drug, is testing its use against pneumonia.
More than 2 million patients a year acquire hospital-borne infections, which kill 90,000 patients each year, according to CDC figures quoted in the Washington Post. Almost three-quarters of all hospital infections show resistance to at least one antibiotic class.
The approval comes at a time when antibiotic use is on the rise but the development and approval of new antibiotics has been curtailed.
The Washington Post is online.
An FDA advisory panel last week recommended approval of a heart failure drug that targets African Americans. If approved for use only in African Americans, the medication would become the first "ethnic" drug.
The drug is a combination of isosorbide dinitrate and hydralazine (BiDil), manufactured by NitroMed Inc. In 1997, the FDA did not approve the drug for use in heart failure patients, due to insufficient evidence of its effectiveness.
The manufacturer resubmitted the drug for approval following the results of the African American Heart Failure Trial (A-HeFT), which involved more than 1,000 African-American heart failure patients. That trial was halted early because the drug was found to have a 43% reduction in mortality and a 39% reduction in the number of hospitalizations vs. placebo, according to the June 17 Washington Post.
Critics of approving the drug only for use in African Americans decry what they see as "racialized medicine," according to experts quoted in the Washington Post. They claim that BiDil should not be marketed only to a particular race because there is no biological basis for racial differences in drug responses. The A-HeFT trial included only African Americans, they point out, which didn't allow comparisons among patients of different races.
Supporters say approving BiDil only for African Americans would move medicine toward more personalized medical care for a population that has long been neglected in clinical research, the Washington Post said.
There are currently more than 700,000 African Americans with heart failure. The agency, which typically follows the panel's counsel, could approve the drug later this month.
The Washington Post is online.
For more on BiDil, see "From bench to bedside: Does race count?" in the November 2004 ACP Observer.
Clinical news in the headlines
The following articles appear in the June 21 issue of Annals of Internal Medicine. Full text is available to College members and subscribers online.
Physicians performing independent medical exams can be liable for damage. Physicians performing independent medical examinations for a third party, such as an employer in disability disputes, still have some legal duties to the patient, even in the absence of a traditional physician-patient relationship. The author reviews judicial rulings, outlines four potential duties the physician performing the independent medical exam may owe the patient and discusses actions that physicians can take to limit their liability.
The article is online.
"Provider power" is a key factor in rising health care costs. In this third in a four-article series on this country's rising health care costs, the author discusses how the strong U.S. health care provider market of physicians and hospitals keeps health care costs high, along with the number of visits and procedures. This "provider power" and the rapid dissemination of new technologies, he writes, explains why health expenditures are higher in the United States than in other developed countries and why they are growing so quickly.
The article is online.
Federal legislation was introduced last week that would, if passed, create a significant government investment in health information technology, making it easier for physicians to adopt new information technology in their offices.
Introduced by Sens. Hillary Clinton (D-N.Y.) and Bill Frist (R.-Tenn.), the bill would provide $125 million a year to local health information networks, giving thousands of providers the ability to communicate patient safety information.
The Health Technology to Enhance Quality Act of 2005 (S. 1262) would also increase physician reimbursement for doctors who participate in information technology networks.
The bill would also provide for the adoption of national and uniform information standards, and give hospitals and other groups a safe harbor to include physicians and medical groups in their information technology systems.
In a June 15 letter to both senators, College President C. Anderson Hedberg, FACP, said that the College agrees with the bill's provisions on reporting data on quality improvements and measures. However, Dr. Hedberg said that ACP believes that without positive updates through legislative changes to the sustainable growth rate formula, physicians will not have the financial resources to incorporate information technology into their practice.
The new bill comes on the heels of another health information technology bill introduced earlier this year. The Health Information Technology Act of 2005 calls for adopting uniform health information technology standards within two years and would authorize adjusting the Medicare payment system to recognize physicians who use information technology to manage patients with chronic illnesses.
The College's letter is online.
With the Medicare drug benefit taking effect next year, it now seems likely that patients will have access to a broad range of frequently prescribed drugs, according to industry officials interviewed last week.
In negotiations with private insurers contracted to deliver the new drug benefit, government officials have pushed for coverage of most or all drugs in the six classes most commonly prescribed for the elderly and disabled, according to the June 15 New York Times. Those classes are antidepressants, antipsychotics, anticonvulsants, HIV drugs, chemotherapy drugs and immunosuppressants.
As a result, the new Medicare plan may cover more drugs than are currently available through many private employer-sponsored plans, the New York Times reported. Insurers were required to file their proposed formularies in mid-April and most have been approved with changes. Marketing of approved plans can begin this fall, with voluntary enrollment starting Nov. 15.
Medicare officials said the inclusion of a variety of drugs to treat each disease will ensure that beneficiaries have affordable access to needed drugs, the New York Times said. In addition, officials noted that expanding the formulary could attract more enrollees, thus making the program more cost-effective for insurers.
However, others interviewed in the article expressed concern that the government's more-inclusive policy will result in higher costs and escalating premiums. Insurers and pharmacy benefit managers have lobbied to limit the scope of formularies, claiming they can hold down costs by getting large-volume discounts from individual manufacturers.
According to the New York Times, government officials have had the upper hand in negotiations because so many companies have applied to participate in the potentially lucrative market.
Premiums are expected to average $37 a month in the first year of the program, plus a $250 annual deductible and a 25% copay on drug costs up to $2,250. Beneficiaries will also be responsible for 100% of drug costs between $2,250 and $5,100, beyond which point Medicare will pay 95% of the cost.
The New York Times is online.
The College has advocated for comprehensive formularies under the new Medicare drug benefit, directing comments in a Jan. 7, 2005, letter to the CMS administrator and in a Sept. 17, 2004, letter to the United States Pharmacopeia.
ACP's newest addition to its free patient education video series helps African-American patients understand how to keep their hearts healthy.
The program, "5 Keys to a Healthy Heart: A Guide for African-Americans," is a 30-minute video and accompanying guidebook that can be used in the office or given to patients to take home.
The program gives patients tips on managing their cholesterol and blood pressure levels and on how to prevent diabetes. It also covers making healthy food choices and the importance of regular exercise. The video features actress Marla Gibbs and New York Jets Coach Herman Edwards, as well as leading African-American physicians providing medical advice.
"5 Keys to a Healthy Heart" is the fifth video in the series targeting common minority health issues. Other titles include "Cancer and the African-American"; "Diabetes Prevention and Control: A Guide for Hispanic-Americans"; "A Guide to Depression for African Americans"; and "Living with Diabetes: A Guide for African Americans."
The videos and accompanying guidebooks are free to ACP members. Shipping costs range from $5 for one-five items to $20 for 16-20 items. Quantities are limited.
More details and ordering information are available online.
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Copyright 2005 by the American College of Physicians.
A 66-year-old man is evaluated for vague abdominal pain of several months' duration and a 10-kg (22-lb) weight loss. He drinks alcohol socially but does not smoke. The patient is otherwise well, has good performance status, and takes no medications. Following a physical exam, lab studies, and a CT scan, what is the most appropriate initial management of this patient?
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