(Circulation. 2001;104:e9009.)
© 2001 American Heart Association, Inc.
Circulation Newswriter
Circulation Impact Factor Is Highest Ever
The impact factor of Circulation has reached 10.893, the highest ever in the publication’s history. According to figures from the Institute for Scientific Information, the factor puts Circulation above such prestigious publications as The Lancet (10.232) and Proceedings of the National Academies of Science (10.789) for the first time in its history.
For the editors, the Editor-in-Chief, James T. Willerson, MD, said, "Circulation wants to serve a worldwide group of scientists and physicians at war with cardiovascular disease, as well as the patients that they serve. Markers like that of the impact factor are encouraging and helpful to all who contribute to Circulation."
A journal’s impact factor is based on 2 elements: the numerator, which is the number of citations in the current year to any items published in a journal in the previous 2 years, and the denominator, which is the number of substantive articles (source items) published in the same 2 years (CMAJ. 1999;161:979–980).
Dr Willerson said the Journal and the cardiovascular community had benefited from the Journal’s opportunity to be published weekly. The support of the American Heart Association and Lippincott Williams & Wilkins (the publisher) has also been crucial, he said.
Beginning in January, Circulation will publish all articles accepted by the journal online within 7 to 10 days of the time of acceptance. Printed publication will take place within 4 to 5 weeks. Those were among Dr Willerson’s top goals when he took on the editorship of the Journal.
The publication has also begun a patient and physician information page that alternates monthly. It is designed to give members of the public the information they need to be informed patients. The Physicians’ Page describes state-of-the-art treatment for a variety of heart diseases, and Dr Willerson hopes that by October, the pages will alternate every other week.
Some Federal Research Still Suspended at Johns Hopkins Hospital
A week after Johns Hopkins Hospital was named the top US hospital by US News and World Report for the 11th year in a row, federal officials officially suspended most experimental treatment at the facility in the wake of the death of a healthy volunteer. That occurred Thursday, July 19, 2001. By Sunday July 22, 2001, Hopkins officials had worked out a short-term solution with officials of the federal Office for Human Research Protections (OHRP) that allowed low-risk research to continue but required that most ongoing studies be re-reviewed by one of the hospital’s institutional review boards (IRB). Under the agreement, Hopkins officials added a fourth IRB to make the workload less onerous.
In a letter to Hopkins officials, Michael Carome, MD, director of OHRP’s division of compliance oversight, said the Baltimore institution’s plan to address deficiencies in its human subject protections was adequate. He also said that any federally funded studies eligible for expedited review (meaning they are of low risk and had been reviewed and approved by one of the IRBs) could resume, as could any protocol that had been reviewed appropriately by one of the institution’s IRBs in the past year. "To be considered reviewed by the convened IRB, the minutes of the relevant IRB meeting(s) must document a substantive individual review, approval action, and vote to approve for a given research protocol."
All other federally funded studies involving humans remain suspended until one of the IRBs reviews and approves the research with appropriate discussion, procedures, and votes, all of which must be recorded in minutes and submitted in writing to the appropriate agency. This means that no new subjects can be enrolled in the studies until approval is given. Patient continuation in the study can continue only when it is in the patient’s best interests according to his physician and the enrolling physician.
OHRP officials took action on July 19, 2001, after an investigation into the death of a healthy 24-year-old woman volunteer, who died as a result of inhaling a chemical used in an asthma study. Although the death generated the investigation, federal officials said they took the wide-ranging action because of serious lapses in safety procedures in the school’s human protection activities. The agency’s officials said that Hopkins researchers had conducted the asthma experiment without warning patients about reports of sometimes fatal drug reactions, reactions of which researchers claimed to be unaware but that could have been found easily by researching the Internet or medical textbooks.
In its report, OHRP called the pattern of safety lapses pervasive. The suspension covered 2400 federally funded human experiments involving 15 000 patients and volunteers. Some studies involving patients with life-threatening diseases were allowed to proceed.
"We are outraged by the actions of the OHRP," Edward D. Miller, Hopkins’ medical dean, told the Baltimore Sun in its July 20, 2001 edition. "We find it hard to understand how a new agency would take a draconian measure against an institution that has been conducting trials for thousands of patients over many years . . . and providing medical care for more than a century." Hopkins’ official response called the suspension "unwarranted, unnecessary, paralyzing and precipitous."
Yet the institution’s own internal review panel that looked into the death of Ellen Roche of Reisterstown criticized both the researchers involved in the asthma experiment and the IRB that approved the experiment. Roche, a 24-year-old lab technician at Hopkins’ Bayview campus, died during an experiment designed to understand how the lungs of healthy people are protected against asthma attacks. The Hopkins board decided that she died from inhaling hexamethonium. In the consent form, according to OHRP, hexamethonium was described as a "medication," although the US Food and Drug Administration suspended its approval of the drug because of adverse effects to patients in the 1950s. The investigating panel attributed Roche’s death to hexamethonium.
The suspension caused a tidal wave of concern in the research community because it seems to increase the responsibilities of already overloaded IRBs at large institutions. Not only were the researchers involved criticized for the use of the unapproved drug and for not mentioning its risks in their documentation, but the IRB, by inference, was censured for not determining if the chemical could cause harm.
Bill Hall, a spokesman for OHRP, told the Baltimore Sun in its June 20, 2001, edition that the suspension was necessary to protect human subjects. "We don’t do this lightly . . . In this case, they [the OHRP investigators] found broad systematic problems throughout the Hopkins institutions. Because of the potential risk to human lives, we had to suspend the trials."
In its July 22, 2001, letter that accepted Hopkins’ plan for remediation, OHRP officials also said that by August 10, 2001, the Baltimore healthcare institution must give the agency a list of all federally supported research protocols that were suspended, including all identifying information and the name of the principal investigator. It must also identify the projects in which treatment of previously enrolled subjects continued and describe how it was determined that this was in the patients’ best interests.
OHRP is also requiring detailed monthly progress reports regarding implementation of Hopkins corrective action plan and educational programs for all members of the IRBs.
Black Men at Increased Risk for Cardiovascular Health
Differences in the way medicine is practiced in various locales and long-standing social inequities combine to put black men over the age of 35 at increased risk of death and disability from cardiovascular disease, according to a new study released by the federal Centers for Disease Control and Prevention and West Virginia University in Morgantown.
The information is included in a publication called Men and Heart Disease: An Atlas of Racial and Ethnic Disparities in Mortality that was published by the Centers for Disease Control and Prevention and West Virginia University in 2001. Online versions of the document can be accessed at http://oseahr.hsc.wvu.edu and http://www.cdc.gov/nccdphp/cvd/mensatlas/index.htm.
Black men and men living in the rural south bear the greatest burden of heart disease, according to the new report. The researchers found that black men are 26% more likely to die of heart disease than white men. Their risk of dying of heart disease is twice that of Hispanic men. Not only is the risk to black men greater than that of white men, it also is more likely to occur at an earlier age. The researchers who compiled the atlas noted that 40% of deaths from heart disease in black men occur before they reach age 65, whereas only 21% of white men died of heart disease at an early age.
The report estimated that the overall heart death rates among US men were 675 per 100 000 from 1991 to 1995. Heart disease death rates for states ranged from 482 to 878 per 100 000. Higher rates of heart disease deaths occurred among men who live in parts of the rural South, including the Mississippi River Valley and Appalachian regions, than men living in most parts of the western United States and upper Midwest. "The highest rates in death from heart disease for men are found in the regions of this country with the poorest economies and few health care resources, particularly in underdeveloped rural areas," said Elizabeth Barnett, PhD, director of the Office for Social Environment and Health Research at West Virginia University, and lead author of the atlas. "High risks of heart disease are also concentrated in groups of men who have historically been socially disadvantaged, often as a result of racism and other forms of discrimination."
According to the atlas report, the national death rate from heart disease in black men was 841 deaths per 100 000 population; the rates for other groups follows: white men, 666 deaths per 100 000; American Indian and Alaska Native men, 465 per 100 000; and Asian and Pacific Islander men, 372 per 100 000. The death rate for Hispanic men of all races was 432 per 100 000.
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