On Dr. Joseph Mercola's popular website, women are warned against getting mammograms to screen for breast cancer.
Instead, the Chicago-area physician touts thermograms — digital images of skin surface temperatures — as an early detection tool for a wide range of conditions from cancer to back pain, from lupus to arthritis.
Now Mercola is in a fight with federal regulators about his claims for the Med2000, a thermographic camera that he calls "revolutionary," though science has yet to back his claims.
Last month, the U.S. Food and Drug Administration sent the osteopathic physician a warning letter accusing him of violating federal law by marketing the Med2000 for uses not approved by the federal agency.
The letter is the third since 2005 for Mercola, whose online empire draws traffic that places it in the top 400 websites nationally. He offers thermography through his Natural Health Center in Hoffman Estates.
Mercola said he stands by his right to make the claims about thermograms on his site. "We will fight the FDA on this issue if they decide to take this further," he wrote in an email to the Tribune.
The letter is part of a recent FDA crackdown on health care providers who make broad claims about thermographic cameras, which are approved to produce images of skin temperatures but, according to the agency, are not to be used as stand-alone tools for diagnosing disease or for screening.
On April 4, the agency sent Meditherm, the Florida-based maker of the Med2000, a warning letter for allegedly making illegal "false or misleading claims" about its device. Since 2007, the FDA has sent three other providers and companies similar warning letters about claims involving thermographic cameras.
The FDA's letter to Mercola notes that his website promotes the Med2000 as a "revolutionary and safe diagnostic tool" that "detects hidden inflammation" and as "the newest safe cancer screening tool."
"Yes, it's true," the site states. "Thermograms provide you with early diagnosis and treatment assistance in such problems as cancer, inflammatory processes, neurological and vascular dysfunction and musculoskeletal injury."
In the letter, the FDA asked Mercola to respond in writing within 15 working days and to "immediately cease making claims, identical or similar to those described above."
As of Monday, Mercola had not taken down or altered the statements singled out in the warning letter.
In an email, Mercola wrote: "We believe that the FDA's warning letter is without merit and is an attempt to regulate the practice of medicine, which the agency does not have the regulatory authority to do. Our use of the thermography device is consistent with its 510(k) clearance for use by health care professionals in their diagnosis and treatment of patients."
Mercola pointed to a sentence in the FDA's 2001 approval of the Med2000: "Use of this device is determined by the health care professional upon his or her assessment of the patient's medical condition and requirements."
Providers have marketed thermography as a diagnostic tool for many conditions but especially as an alternative to mammography or as an early warning system for breast cancer. "If you're female, please don't go the mammogram route," Mercola's website states. "Consider thermography part of your annual health prevention regimen."
Mercola's website also links to other thermography centers. "Don't wait to feel a lump," advises one. "Heal before you can Feel!"
Breast thermograms cost around $200, with full-body scans costing about $350. Many insurance providers rarely if ever cover thermography, considering it to be experimental and unproven.
The American Cancer Society states that "no study has ever shown that it is an effective screening tool for finding breast cancer early. It should not be used as a substitute for mammograms."
The American Medical Association's position statement on thermography concludes that "the use of thermography for diagnostic purposes cannot be recommended at this time" because of lack of evidence proving its effectiveness.
The FDA, in its warning letter to Meditherm, ordered the company to stop making broad claims about its cameras, pointing to a Web page that lists "76 specific conditions for which you say your device can be used … for example, lower motor neuron disease, neoplasias (melanoma, squamous cell, basal) and nutritional disease (alcoholism, diabetes)."
"Cease making claims, identical or similar to those described above, for your product," the letter states.
Dr. Peter Leando, named in the FDA letter as president of Meditherm, did not respond to repeated requests for an interview.
Thermography can generate big money. On its website, Meditherm points viewers to a spreadsheet showing potential profits from a hypothetical Meditherm thermography clinic charging $150 for a targeted thermography exam and $350 for a full-body scan. The spreadsheet projects profits of more than $300,000 for the first year in business, if the clinic sells about 1,100 scans annually.
Meditherm sells its latest camera as part of a package that also includes training and promotional materials for $29,950. "The earning potential is excellent," the website states.
Mercola, who has twice been featured on "The Dr. Oz Show," has built a massive online edifice offering readers thousands of pages of health information that include speculative and unproven ideas. The website has promoted the unsupported idea that cancer is caused by a fungus, for example.
"Dr. Mercola" brand supplements, beauty products and even ceramic cookware are for sale on mercola.com, which Alexa, a company that measures Web traffic, ranks as the 390th most popular site in the U.S.
A recent issue of Mercola's newsletter touted "a recent breakthrough" for joint problems and directed readers to a page on his website selling Dr. Mercola's Joint Formula. A three-month supply was being sold for $52.97. "These four breakthrough ingredients could change your life," the website states.
The ingredients listed in the supplement are not FDA-approved for joint problems.
In 2005, the FDA ordered Mercola to stop making drug claims — statements allowed only for FDA-approved medications — about three supplements being marketed on his website. In 2006, the FDA sent another warning letter, ordering him to stop making drug claims about four products that did not have drug clearance.
A spokesman for Mercola said he removed claims not supported by clinical research.
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