Two articles in this issue of THE JOURNAL challenge the belief that
a large percentage of patients with coronary heart disease (CHD) lack any
of the major conventional CHD risk factors—diabetes, cigarette smoking,
hyperlipidemia, and hypertension. In an analysis of data from
3 prospective US cohort studies, Greenland and colleaguesArticle found that 87% to 100% of patients who experienced a fatal CHD event had an
antecedent exposure to at least 1 conventional risk factor. Khot and colleaguesArticle analyzed data from patients with CHD enrolled in 14 international
randomized clinical trials and, similarly, found that more than 80% of patients
with CHD had at least 1 of the 4 conventional CHD risk factors. In an editorial,
Canto and IskandrianArticle urge physicians to increase efforts
to control conventional CHD risk factors in their patients.
The 1997 Food and Drug Administration Modernization Act provides an
additional 6 months of marketing exclusivity for conducting pediatric studies
requested by the FDA on approved drugs that are being used off label in children.
To examine the health benefits derived from these pediatric studies, Roberts
and colleaguesArticle analyzed the new labeling changes that
resulted from these studies. Between July 1988 and April 2002, 53 drugs were
granted pediatric exclusivity, and 33 drug products have new labels with important
pediatric information on dosing, safety, and efficacy. In an editorial, BudettiArticle calls for additional action to encourage appropriate testing
of drugs for use in children.
The ketogenic diet, a high-fat, low-carbohydrate, adequate-protein diet,
is used for the management of difficult-to-control seizures in children. Kwiterovich
and colleagues conducted a prospective study of children with intractable
seizures initiating treatment with a high-fat ketogenic diet to determine
the effect of the diet on plasma lipoproteins. After 6 months, mean plasma
levels of atherogenic apolipoprotein B–containing lipoproteins, total
cholesterol, and triglycerides increased significantly, and antiatherogenic
high-density lipoprotein cholesterol decreased significantly.
Als-Nielsen and colleagues analyzed data from randomized drug trials
included in meta-analyses published in the Cochrane Library to assess whether
an association between trial funding source and study conclusions reflects
the magnitude of the treatment effect or occurrence of adverse events. Conclusions
of drug trials funded by for-profit organizations were significantly more
likely to recommend the experimental drug as the treatment of choice than
conclusions of trials funded by nonprofit organizations or by both nonprofit
and for-profit organizations, or than those of trials in which funding was
not reported. In adjusted analyses, the association between trial conclusions
and funding source did not appear to reflect treatment effect or adverse events.
A new plan will allow companies to seek Food and Drug Administration
approval for health-related claims on food labels based on a wide range of
evidence. Critics say the approach will confuse consumers.
In an analysis of sex ratio in the offspring of families with at least
3 breast and/or ovarian cancer cases in 2 generations, mutations in BRCA1 but not BRCA2 were associated
with an excess of female births.
A review of the evidence on the predictive ability of 4 emerging risk
factors for atherosclerotic vascular disease—C-reactive protein, lipoprotein(a),
fibrinogen, and homocysteine.
Mechanic examines sources of physician dissatisfaction and strategies
to address the time pressures and changing demands of medical practice.
Analyses of paired surveys of general internists and their patients
compare their beliefs and practices about discussions of out-of-pocket health
For your patients: Information about risk factors for heart disease.
This Week in JAMA. JAMA. 2003;290(7):853. doi:10.1001/jama.290.7.853