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Monday, June 16, 2014

Medical CrowdFunding Often A Scam



If it works, the GoBe will be life-changing. But it’s a big if.

The GoBe is a bracelet that looks like a small microplane has been affixed to a black watchband—the top of the microplane is a display, and its underside is a sensor. Through its “patented flow technology,” the GoBe promises to measure the wearer’s heart rate, calories burned, sleep, and stress levels. That’s all conceivable, given what the FitBit and other body trackers already measure. But the GoBe also promises something a little more sensational: Automatically tracking the calories of everything the wearer eats, through his or her skin.
“We live in an age where people struggle with their diets and need simple ways to take control of their health,” Artem Shipitsyn, the CEO of GoBe’s parent company, HealBe, says in a video on the device’s Indiegogo campaign page. He says the technology would help “people like me live a healthy life with less effort.”

The automatic calorie-tracking, which GoBe claims to do by reading glucose levels in cells, would revolutionize dieting—even the best calorie-counting apps today rely on manual food logging.


“Tell it nothing. Know everything,” the soothing video narrator’s voice says over b-roll of people skiing and clicking on their smartphones.
The premise was so lofty, in fact, that it didn’t take long for tech reporters, led by PandoDaily’s James Robinson, to attack.

Let’s say GoBe does measure glucose levels without piercing the skin, as it claims to do. That would be a godsend to diabetics, who, as it stands, must regularly prick their fingers to test blood sugar. The less-invasive technology is probably coming soon, Michelle MacDonald, a clinical dietician at the National Jewish Health hospital in Denvertold PandoDaily, “but when it does it will be the size of a shoebox ... It will come from a big lab, will be huge news and make a lot of money.”

But on top of that, blood glucose is only a rough measure of total energy intake. Eat a tablespoon of olive oil, and you’ve consumed 119 calories, but your blood sugar would barely rise. A very thin slice of white bread, meanwhile, would send blood sugar soaring and only yields 40 calories.

From its launch in March, the GoBe campaign steadily raked in Indiegogo donations—it’s now at 1,081 percent of its original $100,000 goal. Robinson stayed on the warpath, citing more and more experts who denounced the GoBe technology and publishing several more articles about what he considers to be a complete scam.

HealBe began commenting negatively on Robinson’s articles, then deleting the comments. GoBe backers started demanding refunds. Delivery of the finished device was pushed back to August.

“I’ve been seeing some disturbing articles regarding this project,” one commenter wrote on the HealBe Indiegogo campaign page. “Various articles stating that the things that the GoBe promises cannot be done ... Can anyone offer a rebuttal? Worried about all of the delays and negative statements. Thanks!”
***

Kickstarter doesn’t have a special section for medical projects, but a quick perusal of Indiegogo’s “Health” tab reveals several medically questionable endeavors, like an exercise regimen that promises to improve your sex life and an herbal oral spray that claims to “eliminate stress and anxiety.” One of the most eyebrow-raising is Prime, a substance that says it prevents hangovers because it contains “amino acids and biochemicals your liver needs to naturally break down acetaldehyde and prevent it from harming your body.”


Indiegogo
The only problem? There’s no scientific proof that acetaldehyde, a byproduct of alcohol metabolism, causes hangovers. According to Damaris J. Rohsenow from Brown University’s Center for Alcohol and Addiction Studies, acetaldehyde likely does not affect hangovers because most hangovers don’t begin until long after acetaldehyde’s byproduct, acetate, leaves the blood.
“Actually, it is largely unknown what causes hangovers, but altered immune functioning as a result of excessive alcohol consumption is more likely,” Joris Verster, a professor of pharmacology at the University of Utrecht, told me. “There is no published scientific evidence that this hangover treatment is effective.”

By Friday morning, Prime had raised $2,402 on Indiegogo.

Of course, many of these campaigns aren’t real products yet. Until they finish fundraising and testing prototypes, many only exist as a twinkle in their creators’ eyes and as slick videos on the Indiegogo campaign pages. It could be that after they’re released, they’ll work flawlessly.

But the dual booms in crowdfunding and medical technology have given rise to a generation of health-ish devices that are, at best, based on shaky scientific evidence, and at worst, dramatically over-promise what they're capable of. Many of these gadgets get fully funded by their crowdfunding patrons, sometimes to several times their original goal.

Health start-ups can be particularly difficult for donors to scrutinize because medical science itself is obscure and confusing. Studies come and go; things that once seemed “good” are now “bad” (e.g. agave nectar). And yet, we all want to be healthy—especially if it requires little more effort than strapping on a wristband.
Jason Haensly and Michael Ciuffo, two engineers and former product consultants, started the site Drop Kicker in 2013 in order to confront dubious crowdfunding claims. They say the health space is a particularly egregious offender.

“Everyone loves a good underdog story and there are a bunch of stories about companies that were funded in a garage by some guy,” Ciuffo said. “But if someone’s advertising a project that seems too good to be true, it probably is.”
The heartwarming story of the lonely tinkerer who brings his product to market with little more than ingenuity and pluck is much rarer than that of the marketing guru whose primary skill is the ability to make a sleek campaign video.

Drop Kicker recently reviewed Angel, a bracelet that aims to measure heart rate, among other things. The site points out that past similar devices struggled to make their bracelets snug-fitting enough to accurately measure heart rate through layers of skin and muscle. Meanwhile, Angel’s campaign video is papered with “sciencey” stock images from around the web and flashy animated graphics. Though funded three times over, Angel, too, has pushed back its delivery to mid-August.

The economics of life-changing medical technology aren’t well-suited for crowdfunding, Haensly and Ciuffo say. Pharmaceutical companies pay big bucks for actual breakthroughs, and the government approval process for medical devices is far more strict and complicated than for other gadgets.
“If it was really that good of a project, they wouldn’t be selling it on Indiegogo, they’d be selling it to Eli Lilly,” Ciuffo said.

The variability of human biology also means any one treatment or device is unlikely to be perfected without the aid of a large, expensive longitudinal study —one a company that is rummaging for change on Indiegogo probably doesn’t have the cash to conduct before it launches.

Still, that’s not to say that even the projects that get delayed or turn out to be duds amount to blatant hucksterism. Kickstarter and Indiegogo both have fraud protections in place, but an Indiegogo representative told me the company doesn’t independently vet the medical claims of projects on the site.

It’s hard to know, Haensly said, “How much of [the faulty projects] are outright fraud, how much is exuberant optimism, and how much is ignorance about how much it takes to take a project through manufacturing. I would like to believe that the majority are put up in good faith, but there’s a high likelihood of hitting a speed bump along the way. Medical devices are even harder.”

***

Start-ups are notoriously secretive about their inner-workings, and founders who believe they’re sitting on revolutionary technology are even more protective. One complaint by PandoDaily’s Robinson and others is that tech journalists often can’t get their hands on crowd-funded devices until their campaigns have already been fulfilled. That means knowing whether the devices are genuine requires waiting for them to ship to consumers—which also usually means thousands of people have already opened their wallets.

Last month, Christian Brazil Bautista, a writer for Digital Trends, said he saw alive, working demonstration of the GoBe, though he was not allowed to wear the device himself:
Healbe Managing Director George Mikaberydze ingested a can of Mountain Dew, and then observed as the bracelet detected that he had ingested a lot of sugar. When he took it off on our request, we saw his glucose levels fall to zero on a companion iPhone app. He put the bracelet back on. They soared again.
In an email, HealBe told me that they are still conducting research to substantiate the legitimacy of the Flow technology, and they they plan to demonstrate the GoBe before an audience later this month.

“New ideas are often met with skepticism,” the company told me. “We anticipated critics when introducing such a groundbreaking device into the market. We understand that ‘seeing is believing’ and expect opinions to change once the device and research results are available.”

I independently contacted a number of experts who specialize in metabolism, and none could vouch for the science behind the GoBe.

“While the idea is laudatory, it seems primitive and lacks appreciation of the body complexities (not even commenting on the fact that we are all different),” said George Grunberger, an endocrinologist who runs a diabetes center in Michigan.

Yoni Freedhoff, a weight-management specialist and an assistant professor of family medicine at the University of Ottawa, said in an email:
Even were GoBe to beat the odds and truly deliver what would amount to be a world-changing technology, the leap from the measurement of blood or cellular glucose to its translation into calories consumed is about as probable as a human powered leap across the grand canyon. Simply put, not only would the algorithm required to deliver those results differ between individuals due to variations in insulin sensitivity, they would even differwithin individuals depending on the composition of the foods they consumed, their activity levels and their body compositions.
Indiegogo contributions are nonrefundable, and the company advises donors to take their refund requests up with the individual start-ups. The Indiegogo rep suggested that donations should not be seen as an exchange of money for a product, per se:
There are many facets to a campaign and crowdfunding is more than just a simple purchase of a perk. What's important is that the campaigner has clear communication during and after their campaign and be in constant contact with their audience. This can help alleviate problems and questions surrounding delivery.
Then again, not all products use crowdfunding sites just to get from idea to iTunes store. Some take their Indiegogo buzz to investors or medical manufacturers in an attempt to drum up larger sums of capital, Haensly said.
Other times, the product changes radically from the time it’s funded to the time it ships.

TellSpec, a Toronto-based Indiegogo campaign, was panned by PandoDaily for claiming it would use a “Raman spectrometer” to use pulses of light to measure the particle density of food on a plate, and thus to calculate its nutritional information. In essence, it would be the GoBe for before you chow down. Drop Kicker and other sites pointed out that Raman spectrometers are enormous and cost tens of thousands of dollars each.


Screenshot of a TellSpec demo video. (YouTube)
In response to the criticisms, TellSpec told me it has since changed the type of spectrometer in the device. In fact, there is no deviceunlike what the Indiegogo page would suggest. TellSpec says, “the technology and our proprietary algorithms are complete, the compressing of the technology into its final shell is what still needs to be finalized.” And unlike the Indiegogo pictures, which show a colorful, computer-mouse-sized oval pointing at a tray of chocolate truffles, the ability to read the calories of an entire plate is still “in the future,” the company tells me—the current version would only know how many calories are in your food per gram or per ounce.

***

Reddit has an ongoing thread of Kickstarter projects that have been cancelled or never fulfilled. Last month Washington state’s attorney general filed suit against a Kickstarted card game that donors say surpassed its goal and was never received. There are also sites where you can buy real products that have their origins in crowdfunding.

Whether the flimsiness of some crowdfunding claims is a problem depends on how you think about crowdfunding. If you see it like some sort of proto-Amazon.com, where people pay to snatch up the hottest new devices, it certainly can feel like a rip-off if a product changes substantially, doesn’t work as promised, or delays its shipping. It’s less painful, though, if you see it as a gift meant to help a scrappy entrepreneur along.

In 2012, Congress passed the JOBS Act, which intended to open up angel investing to small-dollar investors. Previously, only millionaires could buy equity in companies. Experts expect that within a year, though, a new provision of the JOBS Act will allow companies to raise capital $20 or $30 at a time by doling out small slices of equity to people with little net worth. In other words, Grandma can be like Marc Andreessen, investing in companies she likes in exchange for a tiny stake in them—potentially through crowdfunding sites like Indiegogo and Kickstarter.


But the vast majority of startups fail, according to Jeff Stibel, an internet entrepreneur and CEO of the Dun & Bradstreet Credibility Corp. in Malibu, California. “The best investors have a 10 percent success rate with startups. Those are the best of the best,” he said. “The average is one to two percent. Now imagine when naive investors start investing. Most of those are going to fail, and they’re going to fail miserably.”

Stibel predicts that the new age of crowdfunding will be more like Vegas, with the very best startup pickers winning big, and everyone else sinking cash into companies that go nowhere. That’s not to say people shouldn’t invest, he says, just “take more of a lighthearted approach to it. These opportunities are going to be closer to gambling.”

PandoDaily’s Robinson writes that crowdfunded companies could shore up confidence in their products if they would demo them for journalists before they close their campaigns, as one TellSpec-like spectroscopy device did for him recently. He points out that there are now companies that aim to analyze the validity of crowdfunded projects’ claims and to offer insurance in case they turn out to be bunk.

When it comes to health apps, Haensly suggests looking for data, in the form of published studies, as well as a demo depicting a working device. If the company does provide research, make sure it’s a double-blind study to reduce the likelihood that you’re funding a placebo effect. Still, it will be tough for laymen to independently evaluate medical claims, especially when they come in the form of promo videos.

“There’s a reason why medical school takes four years and then a residency,” Haensly said.


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OLGA KHAZAN is an associate editor at The Atlantic, where she covers health.

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