FDA: Be wary of sites touting fraudulent radiation treatments
SILVER SPRING, Md. — Due to the public concern related to the nuclear incident in Japan, there has been an increased demand for such drugs as potassium iodide (KI), used to prevent and treat the harmful effects of radiation, according to a Food and Drug Administration Web page updated Thursday.
According to the Nuclear Regulatory Commission, all the available information continues to indicate that the United States, including U.S. Territories, are not expected to experience any harmful levels of radiation from the event in Japan. However, the agency is concerned that less-than-scrupulous people will try to take advantage of the latest health-related scare.
The FDA is alerting consumers to be wary of Internet sites and other retail outlets promoting products making false claims to prevent or treat effects of radiation, or products that are not FDA-approved. These fraudulent products come in all varieties and could include dietary supplements, food items, or products purporting to be drugs, devices or vaccines.
Consumers should be wary of the following:
Claims that a product not approved by the FDA can prevent or treat the harmful effects of radiation exposure;
Suggestions that a potassium iodide product will treat conditions other than those for which it is approved. KI floods the thyroid with nonradioactive iodine and prevents the uptake of the radioactive molecules, which subsequently are excreted in the urine;
Promotions using such words as “scientific breakthrough,” “new products,” “miraculous cure,” ”secret ingredient” and ”ancient remedy”;
Testimonials by consumers or doctors claiming amazing results;
Limited availability and advance-payment requirements;
Promises of no-risk, money-back guarantees;
Promises of an “easy” fix; and
Claims that the product is “natural” or has fewer side effects than approved drugs.
“Don’t be fooled by professional-looking websites,” the FDA stated. “Avoid websites that fail to list the company’s name, physical address, phone number or other contact information.”
Bausch + Lomb names chief medical officer
ROCHESTER, N.Y. — Bausch + Lomb on Friday appointed a clinical professor of ophthalmology to serve as the company’s first-ever chief medical officer.
As CMO, Calvin Roberts will coordinate B + L’s research and development efforts across its vision care, pharmaceuticals and surgical business units.
In addition to his role at Bausch + Lomb, Roberts is a clinical professor of ophthalmology at Weill Medical College of Cornell University. He also is a member of the board of directors at Alimera Sciences, a biopharmaceutical company he co-founded in 2003.
“I look forward to bringing the perspective of clinical optometrists and ophthalmologists to the development of new, innovative products to benefit our patients,” Roberts said. “Bausch + Lomb has a history of great science and great scientists, and working together we can best serve the needs of our customers and patients.”
NAD reviews Exergen’s ad claims for temporal thermometers
NEW YORK — The National Advertising Division of the Council of Better Business Bureaus on Thursday recommended that Exergen modify superior performance claims for its temporal thermometers as compared with tympanic (in-the-ear) readings.
The NAD, the advertising industry’s self-regulatory forum, reviewed print and Internet advertising claims made by Exergen following a challenge by Kaz USA, the maker of Braun ear thermometers. Exergen explained to the NAD that temporal thermometry is the newest form of noninvasive temperature measurement, measuring temperature on the skin’s surface of the temporal artery when it is swept across the forehead. The advertiser asserted that the technology has been widely recognized as accurate.
The NAD noted in its decision that many of the studies, which relied upon by the advertiser to support its claims, failed to test the most recent generation of ear thermometry and compared temporal artery thermometers to oral, rectal or other thermometers. While such studies might support other performance claims for the advertiser’s temporal thermometer, they are insufficient to provide direct support for the advertiser’s superior accuracy claims regarding ear thermometers, the NAD said.
The NAD recommended that Exergen modify its claims to clearly and conspicuously disclose that the comparison being made is with cold-tip ear thermometry, since Kaz markets a tympanic thermometer featuring a patented pre-warmed tip.
Exergen, in its advertiser’s statement, said that it disagrees “with [the] NAD that there is any need to modify our superiority claims. However, in the spirit of cooperation with the self-regulatory process, we will take [the] NAD’s recommendations into account in future advertising.”