Medical Device Makers Scrutinized for Misleading Claims on Web Sites

For people with high-blood pressure, the Bioelectrical Discharger must have seemed like a wonder treatment.

On its Web site, El Monte-based Z’Strong International said the battery-operated device helps regulate and stabilize hypertension without dangerous side effects. Online testimonials bolstered those claims. Only one problem: The U.S. Food and Drug Administration approved the Bioelectrical Discharger for sale as a muscle relaxer--not for hypertension.

On Aug. 25, the FDA slapped Z’Strong with a warning letter, ordering it to bring its promotional materials into compliance with the law or risk seizure, an injunction or a fine.

Z’Strong executives refused to comment, although they have since removed the promotions in question. But the case illustrates what experts believe is a burgeoning problem on the Web: distorted claims by medical products companies.

This year, the FDA has issued 15 reprimands to medical device makers for online promotion violations, up from just four two years ago. The agency also issued dozens of informal warnings.

“It’s just a drop in the bucket compared to the abuses taking place out there on the Internet,” said Dr. Peter Lurie, who has monitored the problem as deputy director of health research for Public Citizen, the advocacy group. Lurie knows that the FDA has stepped up its enforcement, but he said “it’s clear that they’re not able to keep up with the quantity of misinformation out there.”

Misinformation, of course, is a pervasive problem on the Internet, involving many industries and consumer businesses. But one of the most significant uses of the Internet is for health information, and though millions have found valuable leads online about the latest treatments, drugs and medical research, consumers may be especially vulnerable when it comes to false or exaggerated claims about what health products can do.

“On the Internet, you may be getting something ineffective or even potentially harmful,” said Paul Torrens, professor of health services at UCLA School of Public Health.

FDA officials won’t say how many complaints they have received involving ads by medical device makers. Nor would they talk about their caseload of inspections. But officials said the agency is devoting more resources to tracking and fighting unscrupulous online marketing practices. “There are a lot of eyes out there,” said Byron Tart, who oversees ad and promotion investigations for the FDA’s center for devices and radiological health.

The FDA routinely follows up on complaints about false or misleading ads, but recently has focused more on ads disseminated online. While the vast majority of promotions by medical companies online appear to be credible, agency officials are finding a growing number of questionable practices, from posting inappropriate testimonials to establishing so-called hyperlinks to other Web sites that could be misleading to consumers.

Stephen J. Northrup, executive director of the Medical Device Manufactures Assn. in Washington, commended the FDA for cracking down on Internet advertising abuses. However, he faulted the agency for failing to articulate a formal Web promotions policy that would “shed light on the gray areas.”

The FDA said it evaluates Internet violations on a case-by-case basis.

In a warning letter dated March 1, the FDA criticized Sands Hyperbaric Systems in Beverly Hills for linking its Web site to “affiliated businesses” that implied hyperbaric or pressurized chambers could treat sickle cell anemia, multiple sclerosis, brown recluse spider bites and other conditions for which the chamber has not been cleared by the FDA.

The FDA has approved hyperbaric chambers for 13 uses, including thermal burns, carbon monoxide poisoning and decompression sickness. In these chambers, patients inhale pure oxygen in a pressurized environment, which raises the oxygen level in the bloodstream and increases the capacity of blood cells to fight disease.

Robert L. Sands, chief executive of Sands Hyperbaric, said the FDA had singled out his company and acted arbitrarily, noting that there are “bootleg” manufacturers operating entirely outside the agency’s control. Nonetheless, Sands said, he cut his company’s links to the questionable Web sites the day he received the letter from the FDA.

The agency posts its warning letters on its Web site. Companies sometimes disclose the reprimands. On Tuesday, ChromaVision Medical Systems Inc. in San Juan Capistrano said it had been warned for certain online and other promotional materials. The FDA alleged that the promotions improperly claimed that the company’s cell imaging system can be used to track the spread of cancer. The agency said the device has been cleared only to detect, count and classify cells.

ChromaVision said it has modified its advertising material.

FDA officials won’t comment about specific cases. But the agency says it is not quick to issue a warning letter, one of the more serious actions the FDA can take.

One common violation appears to be in the use of testimonials--statements by customers and users, which are often posted on Web sites by companies to promote products.

For some time, Phazx Systems Inc.’s Web site had testimonials indicating that its BodyScan 2010 could diagnose medical conditions ranging from headaches to cancer. “A friend recommended a new type of biofeedback test called the BodyScan,” one testimonial said. “The quick, nonintrusive scan tested for hundreds of substances within minutes.”

In fact, the FDA has approved the Colorado Springs company’s biofeedback machine only as a device to help people relax and to evaluate skin resistance, which some believe measures stress levels in the body.

Michelle Vandepas, Phazx co-owner, said she discarded the controversial material within a week of being contacted by the FDA. She admitted some testimonials might have “pushed the envelope,” but she also said several of Phazx’s rivals continue to make claims about their biofeedback machines similar to those for which the FDA cited her.

FDA officials declined to discuss the case but said they take all violations seriously. “If consumers, competitors or government officials find something objectionable or untrue, they can call our agency,” the FDA’s Tart said. “We’ll follow up.”

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Telling It Like It Is

Federal regulators are issuing more letters ordering medical device makers to cleanup distorted claims on the Internet.

Sources: U.S. Food and Drug Administration, Phazx Systems Inc.