Clinical studies that are designed by pharmaceutical companies to promote use of their drugs are called "seeding" trials. While much has been written about the marketing tactics of the pharmaceutical industry, seeding trials have not been characterized in depth.
A new study finds strong documentary evidence of how a pharmaceutical company framed a marketing effort as a clinical trial. Researchers reviewed internal documents that became public during litigation against the drug manufacturer.
The company's marketing division designed the trial, and handled all collection, analysis, and dissemination of data. The company hid their motive for the trial from participants, investigators, and institutional review board members. Researchers concluded that seeding trials are harmful for three reasons: First, because the company disguises its motives, informed consent is impossible; second, good quality research is at risk when marketers – rather than scientists – design a study; and third, the scientific question posed by a seeding trial often has little merit.
An accompanying editorial warns institutional research review boards to avoid approving seeding trials and physicians to avoid enrolling their patients in them.
Vitamin D Deficiency Puts Older Women at Risk for Hip Fracture
Previous studies of the effect of low blood vitamin D levels on the risk for hip fractures in older women have given inconsistent results.
In this study, researchers took blood to measure vitamin D levels and gathered information about fracture risk from 800 women between the ages of 50 and 79. After following the women for up to nine years, the researchers re-examined them to see who developed hip fractures.
The women with hip fractures had lower vitamin D levels – the very lowest of which seemed to increase the risk for hip fractures independently of other factors known to increase hip fracture risk.
1. Long-term Prognosis After West Nile Virus Infection Good
West Nile virus is a potentially serious central nervous system infection spread by mosquitoes.
Recent studies of persons infected with West Nile virus report that symptoms such as fatigue, cognitive dysfunction, and motor abnormalities can persist for months after onset. However, little is known about long-term recovery among infected persons.
Between 2003 and 2007, researchers followed 156 patients with West Nile virus infection to assess long-term outcomes. They found that physical and mental function as well as mood and fatigue seemed to return to normal within about one year.
Patients with infection affecting their brain took slightly longer to recover, but they recovered to about the same extent as those with infection affecting their spinal cord.
Patients who were healthy at the time of infection recovered more quickly than those who had pre-existing conditions.