Posted 14 November 2012
Many health apps are based on flimsy science at best, and they often do not work
By Rochelle Sharpe | New England Center for Investigative Reporting
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 pursue 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 high-tech products, and government officials have not pursued any other app developers for making medically dubious claims. Now, both the iTunes store and the Google Play store are riddled with health apps that experts say do not work and in some cases could even endanger people.
These apps offer quick fixes for everything from flabby abs to alcoholism, and they promise relief from pain, stress, stuttering and even ringing in the ears. Many of these apps do not follow established medical guidelines, and 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 has found.
While some are free, thousands must be purchased, at prices ranging from 69 cents to $999. Nearly 247 million mobile phone users around the world are expected to download a health app 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. Of the 331 therapeutic apps, nearly 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 expert in online health technology, pointing out that the vast majority of apps have not been scientifically tested. “Developers are just preying on people’s vulnerabilities.”
Satish Misra, a physician and the managing editor of the app review Web site 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.”
To be sure, 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 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 must 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 its apps or its app development process. The company’s lengthy guidelines for app developers say it will reject apps that crash, have bugs, do not perform as advertised or are sexually explicit. A Google spokeswoman also declined to discuss its apps or rules for developers. The company’s content guidelines say it bans sexually explicit material, gratuitous violence or anything that may damage users’ devices.
The FDA is drafting regulations that outline which types of health apps would need government approval before they can be marketed. 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 Federal Communications Commission, reflecting some of the concern.
A few private groups, meanwhile, are working to assess the quality of various apps. Misra’s 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.
Smartphone stress test
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 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 performs 30 squats in less than a minute and then enters his heart rate into the app’s calculator, which reports whether the user 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 his 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,” he said in an e-mail, “go to see a doctor.”
Later, in an interview by phone from France, Bertrand said his app was available for sale on Google Play within minutes of his submitting it to the company. “It’s just a test. It’s not an application that claims to cure.”
Cellphone light as therapy
Apps that rely on cellphone light 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-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. Neither is available anymore.
Sesha Kalapatapu, an attorney for the Houston dermatologist who helped create AcneApp, said his client “was not making any claims of efficacy. ”
Cellphone lights are being marketed to treat other conditions, too, including seasonal affective disorder (SAD), a type of depression that occurs during winter because of lack of sunlight. The iSAD lamp app, which sells for $2.99, tells users to turn their cellphone light to its highest brightness and use the app for 15 to 45 minutes a day to “put a smile on your face and help wash away the Winter Blues.”
But SAD experts say even the most powerful cellphone lights are far too weak to treat depression. The iPhone 3G can reach an intensity of only around 200 lux, according to Wirelessinfo.com, a cellphone news and review Web site. Yet it takes 10 times that, or 2,000 lux, to treat SAD in a two-hour session, says Alfred Lewy, a professor of psychiatry and ophthalmology at Oregon Health and Science University, who has studied the effect of light therapy on winter depression.
A representative of iSAD Lamp said in an e-mail that the app is for “entertainment purposes only.” Consumers who look at the app on the iTunes site will find a disclaimer that says, “IMPORTANT. The iSAD Lamp is meant for entertainment purposes” and adds: “We are not responsible for any misuse or failure.”
There’s also little proof that apps relying on cellphone sounds can be effective.
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, physiologic way in which something like this would help,” said Misra.
Tiziana Formica, a spokesman for AG Method, said in an e-mail, “AG Method is the result of 25 years of research and includes several technologies and methodologies developed and widely tested.” Formica pointed to the company’s Web site, which says the app is the product of an Italian research association that developed a neural reprogramming system. “Fear and sickness are just an incorrect allocation of memories,” the Web site says. The neural reprogramming treatment “is like a natural defragmentation and reallocation of memory files.”
Some apps distort nuggets of scientific truth, while others veer into the realm of medical myths.
Breast Augmentation, sold on Google Play for 99 cents, attempts to capitalize on the notion that breast-feeding women have larger breasts. While lactating women’s breasts may get bigger when they fill with milk, Breast Augmentation claims that all kinds of women can get larger breasts just by listening to the sounds of a crying baby at least 20 times a day, a claim that experts say has no basis. “The tone works by stimulating the brain subliminally,” the app’s advertisement says.
A spokesman for the developer, CowKnow, said in an e-mail that despite lack of scientific proof, there have been many positive comments from users. “I suppose that effects depend on the subject, possible brain suggestion and placebo effect,” the spokesman wrote.
More than 10 apps in the iTunes store claim they can help buyers choose the sex of their future babies. Some estimate accuracy rates as high as 97 percent. The most expensive, uBaby, an app developed in Ukraine, sells for $29.99 and features a calculator where users enter the birthdates of the future parents and grandparents, as well as time and date of conception and the phase of the moon. The app carries a disclaimer saying many biological factors can influence a future baby’s sex and “any method of prediction, including this application, does not give 100% of guarantee.” It also says the app is “not an alternative to traditional medical tests” for determining gender.
UBaby’s marketing manager, Oxana Shaposhnikova, said in an e-mail that the app contains “unique algorithms and is based on some calculation techniques checked and confirmed in practice.”
But Corey Whelan, program director of the American Fertility Association, said, “Gender selection techniques are all old wives’ tales.”
Meanwhile, an app to help people who have ringing in their ears, or tinnitus, 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.
Ed Williams, the app’s developer, withdrew it 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-pitch 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,” Williams said. He said the app hadn’t sold well; after hearing about the proposed FDA regulations, he said he wanted to submit the app for government approval. “I want to make sure that I’m proactive about following regulations and doing things correctly.”
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 times and earns him thousands of dollars every month.
The New England Center for Investigative Reporting is a nonprofit organization based at Boston University. Marion Halftermeyer, Sarah Kuranda, John Wayne Ferguson, Maddie Powell, Divya Shankar and Elizabeth Peters contributed to this report.