Gary B. Rollman,
Emeritus Professor of Psychology,
University of Western Ontario,
London, ON N6A 5C2
(in addition to links below, see weekly archives in the right column)
Tuesday, November 27, 2012
Medical apps could hurt, not help - Sioux City Journal
When the iTunes Store began offering apps that used cellphone light to cure acne, federal investigators knew that hucksters had found a new spot in cyberspace.
"We realized this could be a medium for mischief," said James Prunty, a Federal Trade Commission attorney who helped prosecute the government's only cases against health app developers last year, shutting down two acne apps.
Since then, the Food and Drug Administration has been mired in a debate over how to oversee these new high-tech products and government officials have not pursued any other app developers for making medically dubious claims. Now, both the iTunes Store and Google Play Store for Android users are riddled with health apps that experts say do not work and in some case could even endanger people.
These apps offer quick fixes for everything from flabby abs to alcoholism, promising relief from pain, stress, stuttering and even ringing in the ears. Many of these apps do not follow established medical guidelines. Few have been tested through the sort of clinical research that is standard for less new-fangled treatments sold by other means, a probe by The New England Center for Investigative Reporting (NECIR) has found.
While some apps are free, thousands must be purchased, ranging from 69 cents to $999. Nearly 247 million mobile phone users worldwide are expected to download health apps in 2012, according to Research2Guidance, a global market research firm.
In an examination of 1,500 health apps that cost money and have been available since June 2011, the center found that more than one out of five claims to treat or cure medical problems -- exactly the sorts of apps that FDA-proposed guidelines suggest need regulation. Of the 331 therapeutic apps, 142 -- or 43 percent -- relied on cellphone sound for treatments. Another dozen used the light of the cellphone, and two others used phone vibrations. Scientists say none of these methods could possibly work for the conditions in question.
"Virtually any app that claims it will cure someone of a disease, condition or mental health condition is bogus," says John Grohol, an online health technology expert, pointing out that the vast majority of available apps have not been scientifically tested. "Developers are just preying on people's vulnerabilities."
Satish Misra, a physician and managing editor of the app review website iMedicalApps, adds: "They take some therapeutic method that is real -- and in some cases experimental -- and create a grossly simplified version of that therapy using the iPhone. Who knows? Maybe it works." But until testing shows otherwise, "my feeling would be that it doesn't."
There are many outstanding health apps, particularly those intended for doctors and hospitals, that are helping to revolutionize medical care, according to physicians and others. Among the most well-regarded apps for consumers: Lose It for weight loss, Azumio to measure heart rates and iTriage to check symptoms and locate the closest hospitals with the shortest emergency-room wait times.
But consumers have almost no way of distinguishing great high-tech tools from what Prunty called the "snake oil." Without government oversight or independent testing of apps, people mainly rely on developers' advertisements and anonymous online reviews, many of which are positive but some, such as this one, are not: "Shame on Apple for even allowing this piece of crap on here. ... It preys on people with health issues."
When contacted, Apple declined to discuss anything about its apps. The company has issued lengthy guidelines for app developers, which say it will reject apps that crash, have bugs or do not perform as advertised.
A Google spokeswoman also declined to discuss its apps or its rules for developers. Google's content guidelines also ban sexually explicit material, gratuitous violence or anything that may damage users' devices.
The FDA is drafting regulations that outline what types of health apps will need government approval before they can be marketed in the United States. But the regulations have been bogged down by debates, hearings and legislative back and forth over whether government oversight would stifle innovation.
"Applying a complex regulatory framework could inhibit future growth and innovation in this promising market," six Republican members of Congress wrote last spring to the heads of the FDA and the Federal Communications Commission, reflecting some of the concern.
A few private groups are working to assess the quality of various apps. iMedicalApps gets health care professionals to review software applications that mainly interest physicians. Happtique, a subsidiary of the Greater New York Hospital Association, is about to launch the nation's first app certification service, which will evaluate apps for safety and effectiveness. It will award some apps the high-tech equivalent of the Good Housekeeping Seal of Approval. "We truly believe people need a trusted source," said Ben Chodor, Happtique's CEO.
Misra, an internal medicine resident at Johns Hopkins Hospital, says he's most concerned about apps that claim to test or treat consumers for serious diseases. These apps can sometimes give inaccurate information or can lull people into ignoring symptoms that might need medical attention.
Cardiac Stress Test, for instance, says on Google Play (where it sells for $3.07) that it can determine "if you are ready for sports or if your heart is not in a healthy condition." A person takes his heart rate after performing 30 squats in less than 60 seconds and enters the number into the app's calculator, which then reports whether the user's heart is in shape for exercise.
"It's hard not to imagine how this app could give folks a false sense of security," Misra says, noting that assessing someone's cardiac status is not just a matter of looking at heart rate.
Simon Bertrand, who developed the app for his own use, said it is designed to help healthy people monitor their heart, similar to apps that monitor weight or body mass. "If you are in poor health condition ... go to see a doctor," he said in an email.
Later, in an interview by phone from France, Bertrand said his app was being offered for sale on Google Play within minutes of submitting it to the company. "It's just a test. It's not an application that claims to cure."
Apps that rely on cellphone light, meanwhile, cannot possibly have any therapeutic value, experts say. While light treatments can be used to relieve some medical problems, cellphone light is in the wrong spectrum and far too weak to make any impact at all, said the FTC's Prunty.
"Using the light of the cellphone is automatically suspect," Prunty said, which is why the agency decided last year to file complaints against two developers who claimed cellphone light could cure acne.
The FTC argued in its complaints that the developers' claims were "false or misleading." AcneApp, which sold for $1.99 on iTunes, claimed that blue light fought bacteria and red light helped heal skin. "Rest the iPhone against your skin's acne-prone areas for two minutes daily to improve skin health without prescription drugs," it said. The app was downloaded 11,600 times, according to the FTC complaint.
A similar app for Android phones, Acne Pwner, was downloaded 3,300 times, the FTC said.
AcneApp cited a study in the British Journal of Dermatology, which suggested that light therapy was almost twice as effective as over-the-the counter blemish treatments. But the FTC said in its complaint that the study "does not prove that blue and red light therapy" effectively treats acne.
The two companies settled the complaints, without admitting any violation of the law, by paying fines of $14,294 in AcneApp's case, and $1,700 in Acne Pwner's case.
Gregory Pearson, the Houston dermatologist who helped create AcneApp, "was not making any claims of efficacy," said his attorney, Sesha Kalapatapu.
Cellphone lights are being marketing to treat other conditions too including seasonal affective disorder (SAD), a type of depression that occurs during the winter because of lack of sunlight. But SAD experts say even the most powerful cellphone lights are far too weak to treat depression.
There's also little proof that apps relying on cellphone sounds can be effective, yet there are many such apps.
AG Method, which sells for $9.99 on the iTunes Store, says that users can get relief for everything from insomnia to toothaches by listening to something that sounds like running water for 20 minutes. "Put the sound-source on the maximum pain," it says. All the while, "HEALING IN PROGRESS" flashes in big red letters on the iPhone screen.
"There is no plausible, physiological way in which something like this would help," Misra said.
But that may not stop people from buying it. "People in pain are very gullible. They would pay their last dollar for relief," said Penney Cowan, executive director of the American Chronic Pain Association.
Tiziana Formica, a spokesman for AG Method, said in and email: "AG Method is the result of 25 years of research and includes several technologies and methodologies developed and widely tested."
Even health apps that seem more conventional often have fundamental flaws. Many don't conform to clinical practice guidelines.
An app to help people with tinnitus, or ringing in the ears, was sold in both the iTunes and Google Play stores until early August and contained multiple medical misconceptions.
"Ringing Relief Pro," which sold for $2.99, advertised itself as "an easy and inexpensive way to cure your tinnitus. ... Simply play the low frequency hum that sounds best to you for 90 seconds and your ears should ring no more!" It claimed that tinnitus occurs "when tiny hairs in your inner ear get stuck in the bent position and send false signals to the brain."
In fact, tinnitus is not caused by stuck ear hairs and can be a sign of many underlying medical conditions, including hearing loss, high blood pressure, allergies and anxiety, says Rhonda Ruby, an audiologist who has treated patients for 35 years at the West Newton Hearing Center in Massachusetts.
"There is no cure for tinnitus," she says. "When you download these sorts of apps without consulting a medical professional, it's like putting a Band-Aid on something and not figuring out what is causing the problem."
Ed Williams, the app's developer, withdrew the app from the market after being contacted by the New England Center for Investigative Reporting. A 28-year-old computer scientist, he said he developed the app after reading a newspaper article about researchers who discovered that a low-pitched sound could provide tinnitus relief.
"I am not a medical expert, and I wouldn't want anyone using my app in lieu of medical treatment, but it does seem to work for some people," he said. Once he was told about the proposed FDA regulations, though, Williams said he wanted to submit the app for government approval.
His tinnitus app may not have done very well, but Williams also developed Fake-A-Call, which allows people to set up fake phone calls when they are in meetings or awkward social situations. He said it has been downloaded millions of time and earns him thousands of dollars every month.