November 18, 2012

Lacking regulation, many medical apps questionable at best

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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 based at Boston University has found. While some are free, thousands must be purchased, at prices ranging from 69 cents to $999.

Nearly 247 million mobile phone users 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, 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.

'Bogus' claims

"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 majority of available 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.

Donna Cryer, a health-care consultant in Washington, DC who suffers from an inflammatory bowel disease, uses apps to track her weight, heart rate, blood pressure and bowel habits. The tracking helps her and her doctor better determine whether worsening symptoms mean she needs more potent medications.

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 anything about its apps or app development process. 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 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 final regulations that outline what types of health apps would 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 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. "We truly believe people need a trusted source," said Ben Chodor, Happtique's chief executive.

Cardiac stress test by smartphone

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 a minute and enters it 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," he said in an email, " go to see a doctor."

Later, in an interview by phone from France, Bertrand said his app was being offered 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 any more.

Gregory Pearson, the Houston dermatologist who helped create AcneApp, "was not making any claims of efficacy," said his attorney, Sesha Kalapatapu. Shortly after the app was released, Pearson told the New York Times that he was "fascinated by the concept that users would potentially be able to treat their acne while talking
on the phone" but said the app would have to undergo "a lot more clinical study before I could quantify its efficacy."

Cellphone lights are being marketed to treat other conditions, too. The iTunes store sells a $2.99 app to treat seasonal affective disorder (SAD), a type of depression that occurs during winter because of lack of sunlight. The iSAD lamp app says it "will put a smile on your face and help wash away the Winter Blues." It tells consumers to turn the phone light to its highest brightness
and use the app for 15 to 45 minutes every day.

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, a cellphone news and review website.Yet it takes 10 times that, or 2,000 lux, to treat SAD in a two-hour session, says Alfred
Lewy, a professor psychiatry and ophthamology at Oregon Health and Science University, who has studied the effect of light therapy on winter depression.

"The app might be cool and hip, but there is no evidence that it works," says Norman Rosenthal, a psychiatry professor at Georgetown University School of Medicine, who pioneered light therapy research for SAD. He said the apps should not be used.

Asked about the effectiveness of the app, a representative of iSAD Lamp said in an e-mail that it 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." The disclaimer The disclaimer also says: "We are not responsible for any misuse or failure."

Healing by cellphone sound

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, physiologic way in which something like this would help," said Misra of iMedicalApps.

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 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 describes the app as 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."

Other sound-based apps say their tones can place people in trancelike states that then permit hypnotic suggestions to work, allowing users to deal with everything from weight loss to addiction to pain.

Joseph Zastrow, a North Carolina family practitioner who is president of the American Society for Clinical Hypnosis, says hypnosis can't really be done effectively at a distance; it needs a personal connection, because people have different susceptibilities to hypnosis.

Grohol says he was not aware of any research that would suggest addiction could be cured by using "isochronic tones," single tones rapidly turning on and off. But the Addiction Help Brainwave app, sold for $9.99 in both the iTunes and Google Play stores, says these tones can alter frequencies in the subconscious mind, which can break the cycle of addictive behavior when people listen to them. "People spend time, effort and money trying to combat addiction," Grohol said. "It's an incredible claim to make."

The developers of Addiction Help Brainwave did not respond to four email requests for comment.

Medical distortions, medical myths

Some apps distort nuggets of scientific truth, while others veer into the realm of medical myths.

Breast Augmentation, for instance, 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 by listening to the sounds of a crying baby at least 20 times a day. "The tone works by stimulating the brain subliminally," the app's advertisement says, adding that there is evidence that women's breasts can grow by three centimeters - a claim that experts say has no basis.

A spokesman for the developer, CowKnow, said in an email 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 email 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," adding that she worries that the app could be harmful if someone uses it to avoid a having a child who mith carry a sex-specific genetic disease.

Not conforming with medical research

Even health apps that seem more conventional often have fundamental flaws. Many don't conform to clinical practice guidelines.

A 2011 George Washington University study analyzed 47 apps for quitting smoking found that none followed the majority of the U.S. Public Health Service's best-practices guidelines for curbing tobacco addiction.

None, for instance, strongly endorsed combining counseling and medication to help people quit smoking, the study found. And only a few suggested that smokers consider calling quit lines or getting support from peers.

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 andcontained 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 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 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," he said. He said he'd thought long ago about taking the app off the market because of liability reasons and poor sales but said he decided to keep it on iTunes after getting a lengthy voice mail from a customer saying it had changed his life.

Once he was told about the proposed FDA regulations, though, 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 investigative reporting newsroom at Boston University. Marion Halftermeyer, Sarah Kuranda, John Wayne Ferguson, Maddie Powell, Divya Shankar and Elizabeth Peters contributed to this report.

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