Thermography claims ‘misleading’: FDA
Some Florida health-care providers who promote thermography as a screening test for breast cancer say they plan to continue, despite an official warning that there’s no evidence it works.
The Food and Drug Administration issued a warning last week that said thermography, which uses an infrared camera to measure skin-surface temperatures, is not a replacement for mammograms.
FDA said it was issuing the warning to counter “misleading claims” that could lead women to skip their mammogram in favor of the heat scans.
“The FDA is not aware of any valid scientific data to show that thermographic devices …are an effective screening tool for any medical condition…,” the statement says.
Some promoters have claimed that thermograms are superior at finding early cancers and have even suggested that mammograms are dangerous.
Such false claims have become so widespread that FDA felt it had to put out a warning, said agency spokesman Jeffrey Ventura. “There’s a serious concern that people will get these and then skip their mammograms.”
The FDA warning does not ban vendors from offering thermograms, as long as they aren’t promoted as an alternative to mammograms.
Lakeland acupuncture specialist Carol Chandler said she’s careful to follow FDA guidelines, but that doesn’t mean she agrees with them.
“Doctors do the mammogram because it is the standard of care, and that’s what the doctors go by because that's what they’re supposed to do. It’s just the American way," said Chandler, who specializes in Oriental medicine.
While few, if any, websites for Florida facilities say outright that thermograms are better at detecting cancer than mammograms, several facilities come close.
Donna Tomey, for example, who operates a small business called Thermography First, LLC from several offices in Southeast Florida, says on her website that “an abnormal thermogram is the single most important marker of high risk for developing future breast cancer.”
The website also states that thermograms are “97% effective at detecting benign vs malignant breast abnormalities” without emitting the radiation found in mammogram tests. The site’s “my journey” section shows several colored thermographic images of Tomey before and after she had a mastectomy on her right breast.
“Since I’m a breast cancer survivor, I tell people both sides to the story,” she said in a phone interview. “I tell them you’d have to drag me to a mammogram.”
Registered nurse Claudia Barrington, owner of South Florida Thermography, also advertises that thermograms are a "safe, painless, reliable and risk-free breast screening option."
Chandler, Tomey and Barrington have not received any indication from the FDA that they are non-compliant.
That could be because they meet the FDA promotion guidelines or it could be that the FDA doesn't know about them, said Ventura, the FDA spokesman.
But officials did issue warnings to some vendors—including one in Florida-- who promoted the thermogram as a standalone cancer-detection device.
An April 4 FDA warning letter to Meditherm, Inc., an Oregon-based manufacturer with an office in Fort Myers, insists that the company remove website claims that thermography devices are a "reliable and accurate" way to detect breast abnormalities.
Dr. Peter Leondo, the company's owner, said he did not knowingly mislead people but took the claims down from the website. “We didn’t dispute it, we just changed it," he said.
Among the groups that say thermography is not an effective screening tool, according to FDA, are the American Cancer Society and the Centers for Disease Control and Prevention and the National Cancer Institute.
Just because the FDA does not ban a product doesn't mean that it has value, said Dr. Kenneth Johnson, chair of the Obstetrics and Gynecological Department at Nova Southeastern University in Fort Lauderdale.
For many of the vendors, making money is probably the biggest incentive, Johnson said. Several websites list prices for breast thermograms at about $150 and a full-body image at about $500.
“There are plenty of entrepreneurs who own these thermography machines that are willing to make all of these exciting claims, but there’s just no evidence to support them,” Johnson said.
--Reporter Brittany Davis can be reached at 954-239-8968 or Brittany.Davis@HealthNewsFlorida.org.