Diagnostics & Imaging Week Washington Editor

GAITHERSBURG, Maryland – FDA's hearing, in response to a petition by Russel Thomsen, MD, of Silverdale, Washington, to grant OTC status to ultrasound devices, primarily to listen in on fetal heartbeats, drew a small but intensely engaged audience last week, giving the five-member panel plenty to mull over for some time to come.

Gerald Harris, PhD, research engineer and ultrasonics lab leader at FDA, noted that the agency had not "established a timetable" for the decision, but attendees seemed certain to track the agency's progress closely.

Thomsen could not make the meeting due to illness, leaving Dennis Newman, MD, of Golden, Colorado, to address the panel by reading a letter by Thomsen, stating that ultrasound had ushered in an "epochal" change in prenatal care and that "every expectant mother should have the right" to use Doppler ultrasound listening devices to detect their babies' heartbeats.

Included in the letter was the assertion that OTC availability of such devices might "save hundreds of lives" and might save some fetuses from abortion because of the attachment a woman might feel for a fetus whose heartbeat she has heard. The letter also stated that the expecting mother who has had a miscarriage would be "much relieved by hearing the baby's heart."

Robert Phillips, PhD, at FDA's Division of Reproductive, Abdominal and Radiological Devices, asked why OTC status would present any advantage to users given that they are available by prescription.

Newman replied that "many obstetricians think this is already an OTC" device, that state laws can restrict sales and that most pharmacies do not stock such items.

Speaking on behalf of the American Institute of Ultrasound in Medicine (AIUM; Laurel, Maryland), Joshua Copel, MD, of Yale University (New Haven, Connecticut), said that "little benefit would accrue" from OTC availability of the devices because fetal heartbeats bear little resemblance to those of children or adults and, as a consequence, most women would not recognize an abnormal fetal heartbeat.

Another member of AIUM, Lennard Greenbaum, MD, of Orlando, Florida, pointed out that several studies indicate that fetal exposure to ultrasound may lead to unusually high occurrence of sinistrality, or left-handedness, primarily in males.

Carol Rumack, MD, chair of the Ultrasound Commission at the American College of Radiology (Reston, Virginia), opined that Doppler listening devices "should only be used" when prescribed by a physician, arguing that the dose level observed to have induced therapeutic biological effects were "only slightly higher" than those generated by many of the devices under consideration.

"ACR strongly disagrees" with the petitioner's claim that the lack of data indicating ill effects is equivalent to no danger to the fetus, she said.

Stacie Hansen, daughter of Newman and co-owner of BabyBeat (Arvada, Colorado), a distributor of handheld ultrasound listening devices, made her voice known as a mother, saying that the ability to check a fetus's heartbeat could reduce an expectant mother's stress, especially in high-risk pregnancies. While she insisted that an informal survey showed that expectant mothers "did not use the Dopplers excessively," she admitted that 12% of respondents had used the devices "multiple times a day."

Hansen argued that maternal distress can lead to low birth weight and other sub-optimal outcomes and conveyed the comment of one survey respondent that doctors often fail to recognize "the clear connection between emotional and physical health."

David Jones, vice president of engineering for Summit Doppler (Golden, Colorado), addressed the potential for his company's conflict of interest, acknowledging that OTC availability would boost sales. But he said it might also spur considerable competition. In an OTC marketplace, the fidelity of product labels to the appropriate information "might suffer," he said, and that ultrasound listening devices could be marketed for entertainment.

Jones said that in his research, one offering on the Internet suggested that users "repeat the procedure as often as you like" and failed to include any safety information.

Jones said that in his 20 years in the industry, "I never thought I'd be standing in front of FDA asking for more enforcement."

In a brief interview after the session, he told Diagnostics & Imaging Week that "we would want close oversight" by FDA of advertising practices, should the agency grant the OTC status. He acknowledged that sale of these devices through individual distributors could create a rather imposing obligation for FDA, which "could never get [to] all" of the sponsors of illicit advertising practices. However, he said that a few well-publicized enforcement actions would suppress most unethical advertising.

After the session, Danica Marinac-Dabic, MD, the chief of the Epidemiology Branch at CDER's Office of Surveillance and Biometrics, also referred to studies indicating that exposure to ultrasound may result in more left-handedness in males. She told D&IW that, as far as she knew, maternal distress is "not a very strong" surrogate for pregnancy outcomes.

Documents at FDA's web site show that Thomsen has petitioned FDA on this subject on at least two prior occasions. In a June 14, 2004, letter to Thomsen, Linda Kahan, deputy director of CDRH, said that the agency had decided to deny the petition for Doppler listening devices with maximum outputs of 20 milliwatts per square centimeter (mW/cm²).

One reason for the denial was that "Doppler fetoscopes have been used safely and effectively for years, but underscores that this is true because [emphasis hers] these devices are used under the supervision of a practitioner" and not sold without a prescription.

Thomsen apparently raised a Constitutional privacy claim in the petition in question, but Kahan replied by citing several precedents, including United States v. Burzynski Cancer Research Institute in which the 5th Circuit Court decided that consumers enjoy no "constitutional right to obtain medical treatment that is encompassed by their right to privacy."

Kahan also pointed out that despite Thomsen's reservations about the quality of other products, OTC listening devices based on passive technology are available.

And a bill currently in the California legislature would ban manufacturers or distributors from "selling, leasing or otherwise distributing" ultrasound imaging equipment to anyone other than a physician or medical facility. Violation of Assembly Bill 2360 would be a misdemeanor.