(Circulation. 2001;103:e9034.)
© 2001 American Heart Association, Inc.
Cardiovascular News
Bush Administration Releases Medical Privacy Rules but Promises Later Modifications
In an unexpected move, the Bush administration announced that it would allow medical privacy rules issued by the Clinton administration to take effect as planned on April 14, 2001, but the rules will be modified by US Health and Human Services Secretary Tommy Thompson over the next few months.
The fate of the regulations had been in limbo since January when President George W. Bush took office. Former President Clinton had issued a host of new rules in the days before leaving office, but many of those rules were stayed by the new administration. The privacy rules would require doctors to obtain the consent of patients before disclosing their medical records to third parties. It would also strictly limit the use of patient information by health plans, hospitals, and other healthcare entities.
Hospitals, managed care organizations, and pharmaceutical firms had opposed the rules, calling them costly and complicated. It is expected that some of the changes Secretary Thompson will put into effect over the next year will alleviate some industry concerns, but most doubt that they will go as far as the industry wants.
In announcing the plan on April 12, 2001, Secretary Thompson said, "The rules make sure that private health information doesn’t fall victim to the progress of the information and technology age, where an array of data is already available in computer systems and too often just a keystroke away from being accessed. We are giving patients peace of mind in knowing that their medical records are indeed confidential and their privacy is not vulnerable to intrusion."
Secretary Thompson said he has had the advice of lawmakers, interest groups, healthcare leaders and individual citizens on the proposed rules. He said many of the 24 000 written comments received in his department were part of organized mass mailing efforts.
"We will keep these comments in mind as we continue to make sure patients receive the highest quality care and begin the process of issuing guidelines on how this rule should be implemented. The guidelines will allow us to clarify some of the confusion regarding the impact this rule might have on healthcare delivery and access. And we will consider any necessary modifications that will ensure the quality of care does not suffer inadvertently from this rule," he said in announcing the decision.
In response to the decision, Chip Kahn, president of the Health Insurance Association of America (HIAA), said, "We are disappointed by Secretary Thompson’s decision not to postpone the Clinton administration’s medical privacy regulations but encouraged that he intends to fix serious problems contained in the regulations that would affect patient care. Currently, the regulations are seriously flawed and likely to adversely affect the quality and affordability of care. ... HIAA supports strong, uniform national standards that would assure the confidentiality of patients’ personal medical records."
In the same vein, Dick Davidson, president of the American Heart Association, said his organization is "profoundly disappointed" by the Bush administration’s decision not to delay the privacy regulations. Mary Grealy of the Washington-based Healthcare Leadership Council followed suit, saying the Bush administration had to "act swiftly" to amend the regulations.
Federal Aviation Administration Requires Automated External Defibrillators on All Airplanes
The US Federal Aviation Administration (FAA) issued final rules on April 12, 2001, requiring all airlines to equip their airplanes with automated external defibrillators (AEDs) and to update their emergency medical kits. The airlines are given 3 years to comply.
The rule was required by the Aviation Medical Assistance Act of 1998. "Nine airlines either currently carry AEDs and enhanced kits or have made a commitment to do so," said FAA Administrator Jane F. Garvey. "Our rule will ensure that all airline passengers have access to this potentially life-saving device."
The new rules also add to the equipment to be carried as part of the airlines’ emergency medical kits. Among the pieces of equipment added are oral antihistamines, non-narcotic analgesics, aspirin, atropine, bronchodilator inhalers, lidocaine, saline, an intravenous administration kit with connectors, an AMBU (ambulatory manual breathing unit) bag (to assist with respiration after defibrillation), and cardiopulmonary resuscitation (CPR) masks. All crew members will receive initial training on the emergency medical kit and on the location, function, and intended operation of an AED. Flight attendants will receive initial and recurrent training in CPR and on the use of AEDs. The total estimated cost to the airline industry over 10 years for equipment, medications, and initial and recurrent crew training is $16 million.
Stenting Less Expensive Than and as Protective as Coronary Artery Bypass
A comparison of stenting and coronary artery bypass surgery published in the April 12, 2001 issue of the New England Journal of Medicine (2001;344:1117–1124) demonstrated no difference between the 2 treatment groups in the combined rate of death, stroke, and myocardial infarction. However, there was a difference of 17.2 percentage points in rates of repeat vascularization in favor of surgery. Coronary stenting, however, was cheaper by $2973 at 12 months.
The study, which was conducted under the auspices of the European Academy of Sciences and Arts, was a multicenter European trial involving the Arterial Revascularization Therapies Study (ARTS) group. A total of 1205 patients were randomly assigned to either stent or bypass surgery when a surgeon and an interventional cardiologist agreed that the same degree of revascularization could be achieved by either method.
At 1 year, there was no statistically significant difference in the patients who survived without a stroke or myocardial infarction. However 16.8% of those in the stent group underwent a second revascularization, an amount significantly different from the 3.5% in the surgery group who underwent revascularization.
When the costs at 1 year were adjusted for the
revascularizations, the difference in favor of
stenting was $2973, according to the study participants. "Our results
present physicians with a dilemma," said the authors led by
Patrick W. Serruys, MD, of the Academisch Ziekenhuis Rotterdam
Dijkzigt, Rotterdam, the Netherlands. "Angioplasty with stenting is
less invasive than surgery and is associated with a faster recovery and
a better quality of life 1 month after the intervention. Bypass surgery
is associated with a lower incidence of angina, less need for
antianginal medications, and fewer repeated interventions in the first
year after the procedure. A decision to perform bypass surgery will
probably cost 
$3000 more than the decision to perform angioplasty
with stenting, but it may result in 14 additional patients with
event-free survival per 100 treated patients, as suggested by the
difference of 14 percentage points in event-free survival in our
study."
The Brain After Bypass
Cognitive studies by Johns Hopkins University Medical Center researchers demonstrated significant declines between baseline and 5 years in patients who had undergone coronary artery bypass grafting (Arch Neurol. 2001;58:598–604). The authors of the study followed 102 patients who had completed preoperative and follow-up cognitive testing for 5 years after undergoing the bypass surgery. The patients underwent tests of 8 cognitive domains, including attention, language, verbal and visual memory, visuoconstruction, executive function, and psychomotor and motor speed.
These tests were administered before the surgery and at 1 month, 1 year, and 5 years afterward. In the period between the 1-year testing and the 5-year testing, there were significant declines in all cognitive tests except for attention and executive function. The authors said, "The change in cognitive test performance between baseline and 5 years is likely related to several factors, including low baseline performance and practice effects. The significant decline between 1 and 5 years, however, raises the possibility that a late cognitive decline may be occurring in this population. Additional studies, with the use of a nonsurgical control group, are needed to determine if the observed cognitive decline is related to the bypass surgery itself, normal aging in a population with cardiovascular risk factors, or some combination of these and other factors."
Streptococcus pyogenes Genome Sequenced
Researchers at the University of Oklahoma Health Sciences Center have sequenced the genome for the virulent Streptococcus pyogenes organism (Proc Natl Acad Sci U S A. 2001;98:4658–4663). The single, circular chromosome that contains the bacterium’s genetic material has >1.8 million DNA base pairs said Joseph J. Feretti, PhD, the head of the Oklahoma genome sequencing team.
"This exceptionally virulent organism is difficult to study because it infects only humans, and very few animal models of group A strep diseases exist," said Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), in a released statement. "We need to know more about how group A strep interact with humans to cause so many different illnesses. The genetic sequence should shed light on these questions and pave the way for better treatment and prevention." This bacterium is also known as group A streptococci (GAS), and it can lead to strep throat, scarlet fever, impetigo, pneumonia, acute kidney inflammation, toxic shock syndrome, blood poisoning, acute rheumatic fever, rheumatic heart disease, and the flesh-eating disease known as necrotizing fasciitis.
Published in the April 10, 2001 issue of the Proceedings of the National Academy of Sciences, the sequence uncovered 40 possible virulence genes, genes that allow the organism to mimic certain molecules in the people it infects and 4 sections inserted by bacteriophages. These sections are believed to provoke the immune system into starting the series of events that lead to the potentially deadly toxic shock syndrome.
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