The founder of screening services provider AmeriScan was hit with a lawsuit yesterday in a San Francisco court charging his company with false advertising of its breast MRI screening services. The lawsuit claims that AmeriScan’s advertising makes statements on the effectiveness of MRI breast screening that are not supported by the medical literature.
The Medical Board of California and the San Francisco District Attorney’s Office jointly filed the lawsuit in San Francisco Superior Court against Dr. Craig Bittner, founder and medical director of HealthScan America, which does business in California as AmeriScan. The lawsuit seeks to "halt alleged false and deceptive advertising used in the promotion of AmeriScan's MRI BreastScreen, a test marketed as an alternative to mammography for the detection of breast cancer."
The suit charges that a series of AmeriScan television, radio, and newspaper ads touted MRI BreastScreen as "the absolute most accurate technology available for the early detection of breast cancer" and "proven to find nearly 100% of all breast cancers" -- claims not supported by the medical literature, according to the complaint.
The lawsuit also found fault with AmeriScan claims that "mammograms miss two out of three breast cancers" and that AmeriScan’s breast MRI screening was "proven to be three times better at detecting early breast cancer than regular x-ray mammography." California law prohibits physicians in the state from disseminating false, misleading, or deceptive advertising.
The District Attorney's Office began pursuing the case earlier this year, after receiving complaints from medical professionals and consumers about the ads, which were appearing in San Francisco and other Northern California cities, according to David Pfeifer, chief of the special operations division in the office. AmeriScan at one time had several centers in the San Francisco Bay Area, but now maintains just one facility, in San Jose.
To assess whether the claims were supported by the medical literature, the Medical Board and the District Attorney’s Office consulted with members of the radiology community, including the American College of Radiology (ACR) of Reston, VA, and Dr. Edward Sickles, professor of radiology at the University of California, San Francisco.
Sickles said that while some breast MRI applications are supported by the literature, screening is not one of them. MRI has been proven effective for uses such as evaluating women with breast implants that may have ruptured. It’s also used for women known to have breast cancer to evaluate the extent of tumors prior to surgery, or after surgery to monitor response to treatment, he said.
"It has not been tested nor is there reliable evidence that it is useful to screen average-risk women," Sickles said.
The complaint seeks an injunction prohibiting AmeriScan from making claims about the efficacy of its MRI BreastScreen without having a reliable scientific basis for such claims. It also calls for civil penalties of up to $2,500 for each "deceptive advertisement" and for each "unlawful business practice." AmeriScan representatives were not immediately available for comment.
Both Sickles and Pfeifer said the AmeriScan ads were particularly troubling in that they could lead women to question the effectiveness of x-ray mammography. "We are concerned that there is false and misleading advertising going on regarding the efficacy of mammography and MRI," Pfeifer said. "We believe it ends up being a public health issue. We don’t want women feeling they should not go and get a mammography, because it is the best screening tool for the general population."
But Sickles worries that the case could have negative implications for research into breast MRI screening, by discouraging women from participating in clinical trials. "MRI may ultimately have a useful role, but we don’t know that yet," he said. "Women participating in that research should not view this lawsuit as a reason not to participate."
By Brian CaseyAuntMinnie.com staff writer
October 24, 2003
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