Pharma company ‘breaks the Internet’ with Kim K, gets FDA testy

August 14, 2015 | by

But it may break them…well, give them a fracture. Or a good hard marketing lesson. Specialty pharma Duchesnay thought it had hit the jackpot with negotiating a promotional spokeswoman endorsement from pregnant celebrity Kim Kardashian of its morning sickness drug Diclegis. The Kardashian Marketing Machine cranked up. Kim (and mom Kris Jenner) took to Instagram, Facebook and Twitter in late July with (scripted) singing of Diclegis’ praises to their tens of millions of followers. The Instagram posts linked to an ‘important safety page’ a/k/a The Disclaimers. That wasn’t near enough for the Federal Drug Administration (FDA) which governs the acceptable marketing of all drugs in the US. On August 7th a tartly worded letter arrived at Duchesnay’s Pennsylvania HQ cited multiple violations of marketing regulations, notably risk information, and told Duchesnay to cease these communications immediately or withdraw the drug, which would be highly unlikely as it is successful. They also were require to provide “corrective messages” to the “violative materials”.

Our takeaway:

* Duchesnay reaped a bounty of free media (see below), on top of the (undoubtedly expensive) Kardashian endorsement. Yes, they did pay the cost of a FDA nastygram and a legal response, and the warning will live on in their file. However, a lot of target-age women now know Diclegis and others know about the relatively obscure Duchesnay.

* This was a calculated marketing risk that tested the boundaries of social media and celebrity endorsement. (more…)

Rock Health’s mid-year report: 2015 investment leveling off

July 10, 2015 | by

Rock Health‘s 2015 report is revealing in one aspect–that the authors try to put a game face on what is a flat situation in digital health investment for first half. Not even the most optimistic of the digerati expected a lift of 16 percent as we saw in 2014 versus 2013 [TTA 2 July 14], but the 8.7 percent fall off from 2014’s blistering $2.3 billion to $2.1 billion in 2015 year-to-date was unexpected. StartUp Health’s report indicated a slower start to 2015, though slightly less, so the reports correspond. Digital health still is growing faster than software, biotech and medical device.

Other highlights:

* The top six categories accounted for 50 percent of investment funding: wearables, analytics, consumer engagement, telemedicine, enterprise wellness, EHR/clinical workflow

*  In M&A action, this year’s first half has almost matched 2014’s full year total, but with only 13 percent of the investment. Most are digital health companies acquiring others for small amounts. (more…)

Kickstarting the 1st week of summer: news from all over

June 23, 2015 | by

No deal yet between insurer giants. Cigna turned down a $53.8 billion bid from Anthem. According to Healthcare Finance, concerns ranged from corporate governance problems, their membership in the Blue Cross Blue Shield Association, the probable chairman’s (from the Anthem side) qualifications and data security (ahem!). Given that Anthem’s 60 million record breach was an inadvertent inside job [TTA 11 Feb], the last is perfectly understandable. But the door appears to be open for the emollient of additional money (to mix a metaphor). Extra: a tart take on this from the WSJ…..Jaguar is looking to increase driving safety by reading your brain waves to detect if you are distracted or daydreaming, via sensors embedded into the steering wheel. It’s based on technology used by NASA and the US bobsled team. They are also working on mood enhancing lighting and a predictive system to speed your interactions with the dashboard to minimize eyes off the road. But will these detect if you feel good to be bad, as their adverts say? Gizmag….The FT gets into digital health via business, profiling startups such as Lyra Health, Genomics England and Heartflow, as well as 23andme and Google X (including the glucose-detecting contact lens we profiled 18 months ago. Hat tips to Eric Topol and David Doherty (mHealth Insight) via Twitter….The NY Times looks at the dark side of ‘senior independence’ with a group of NYC homebound seniors, but other than tut-tutting the desire of older mainly limited income New Yorkers to remain in familiar surroundings, our ‘national celebration of independence’ (!) and not to be institutionalized (their words), the article doesn’t offer much in the way of solutions. And solutions are badly needed for the nearly 2 million over 65 who rarely or never leave their homes, because not all of them will be in assisted living. Hat tip to Joseph Coughlin of MIT AgeLab via Twitter…. But in Australia, they’re exploring ‘future proofing’ and ‘dignity enabling’ homes for an aging population to make them more livable and accessible, via landscaped ramps, larger bathrooms, and sensor rich floors that connect to gait tracking and analysis. Smart Homes 2.0. Sydney Morning Herald…..Neil Versel over at his new MedCityNews stand reports on Doctor On Demand‘s test of tablet-based medical kiosks adjacent to the pharmacy department at four Wegman’s grocery stores here in the Northeast. Is Weis Market far behind?….And Fitbit has a bit part in ‘Law and Order’…well, not the TV show in perpetual reruns, but in a real-life case in Lancaster County, Pennsylvania which is not all Amish farms, black carriages and the so-called Amish Mafia. The police used Fitbit activity data to determine that a local resident (and Fitbit wearer), who claimed she was raped by a stranger, staged the crime scene with overturned furniture, a knife, and a bottle of vodka in her home. ABC27 News via David Lee Scher.

Set that disease data free! A call to break down those data silos.

March 31, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/BlueSiloCollapsing-41.jpg” thumb_width=”175″ /]Awash in a rising sea of data generated by devices and analytics–around treatments, population health, costs–there’s a struggle to make sense of it. We’ve noted the high value and merchandisability of 23andme‘s genomic data (gained by individual user consent) [TTA 5 Mar], but our healthcare institutions which should be codifying and sharing disease and treatment data, largely do not. Those with rare or ‘orphan’ diseases struggle to find information, diagnosis, fellow patients, treatments. They sometimes win breakthroughs by, believe it or not, blogging, and having their articles widely disseminated. Reasons why? According to David Shaywitz in Forbes, they are:

  • Hospitals, even research based centers, struggle to codify their genotype and phenotype data of their patients in a meaningful way that would be usable for clinical decision making. We’ve also noted (oddly not Mr Shaywitz) the long implementation process of IBM Watson cognitive processing/decision making tools in healthcare, the concentration on single diseases and their spread into other industries plus third-party integration outside of healthcare [TTA 9 Oct 14].  (more…)

23andMe’s FDA coup hazardous to personal DNA data security?

March 5, 2015 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/03/DNA-do-not-access.jpg” thumb_width=”150″ /]Genetic test developer 23andMe’s wins with the FDA [TTA 20 Feb] served to clear the path for their current Bloom Syndrome and future kits as Class II devices. It’s long been believed that the company’s real diamond mine is in selling the DNA data gained through the kits, and with consent, to major pharma and medical companies. Proof: recent collaboration announcements with Genentech and Pfizer on genetic research. But how will this data be safeguarded? It may not be a significant concern now, but “Personal DNA information will become far more critical and more important to safeguard than the details of our life circumstances”. Hackermania’s Running Wild with AnthemHealth-sized data breaches (more…)

23andMe finally gets a nod from FDA

February 20, 2015 | by

Breaking news: Foot in door? Crack in the wall? This week’s Big News among the genomics enthusiasts among the healthdigerati is that 23andMe finally got one test through FDA, for Bloom Syndrome where the gene is carried by both parents, and now can freely sell the kits. Much is being made of wording in the press release from a major FDA executive as opening the door:

“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information. Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children.”

But far more of a startling admission by FDA is that 1) these genetic screening kits are now classified as Class II and 2) they intend to exempt them from the arduous pre-market review that is in Class III:

Along with this authorization, the FDA is also classifying carrier screening tests as class II. In addition, the FDA intends to exempt these devices from FDA premarket review. The agency plans to issue a notice that announces the intent to exempt these tests and that provides a 30-day period for public comment. This action creates the least burdensome regulatory path for autosomal recessive carrier screening tests with similar uses to enter the market.

There will be much more; this article by Chris Seper in MedCityNews is an excellent recap. Our articles previously in TTA.

Would one of our UK readers expand our knowledge on these kits’ regulatory status in the UK and EU? According to the MedCityNews article, the UK permits 23andMe’s genetic testing, but is vague on the details (CE approval?)

Looking back over Telehealth & Telecare Aware’s predictions for 2014, part II

January 9, 2015 | by

[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2015/01/magic-8-ball.jpg” thumb_width=”150″ /]Editor Charles has treated you to a look back on his 2014 predictions, daring Editor Donna to look back on hers. Were they ‘Decidedly so’, ‘Yes’, ‘Reply hazy, try again’ or ‘My sources say no’? Read on…

On New Year’s Day 2014, it looked like “the year of reckoning for the ‘better mousetraps’”? But the reckoning wasn’t quite as dramatic as this Editor thought.

We are whipping past the 2012-13 Peak of Inflated Expectations in health tech, diving into the Trough of Disillusionment in 2014.

There surely were companies which turned up ‘Insolvent with a great idea’ in Joe Hage’s (LinkedIn’s huge Medical Devices Group) terms, but it was more a year of Big Ideas Going Sideways than Crash and Burns.

Some formerly Great Ideas may have a future, just not the one originally envisioned. (more…)

Funding, granting and executive moves

August 8, 2014 | by

Summer hasn’t been beach holiday time for some of the companies we’ve been following….Genetic testing for the masses 23andMe, only last fall in much hot water with FDA (but recently making nice–TTA 2 July), received a two-year, $1.4 million grant from the National Institutes for Health (NIH). iHealthBeat….’Smart pill’ developer Proteus Digital Health received a Series G round of $52 million, adding to a June round of $120 million. Investors not disclosed, but Proteus currently has a blue-chip list including Novartis, Medtronic and Kaiser. BusinessWire….Pre/post-procedure education and recovery monitoring service VOX Telehealth received another $1.1 million round of angel financing primarily from original investors, preliminary to an institutional round of financing in 1st Quarter 2015. Release….HealthSpot Station is reinforcing its retail reach (more…)

23andme and FDA: making nice?

July 2, 2014 | by

In a reversal from the ‘¡No pasarán!’ (‘They shall not pass!’) position 23andme and its QS fans famously took back in the winter and spring [TTA 2 Apr, with prior links] vis-a-vis FDA on interpretation of genetic tests, this report from VentureBeat indicates that 23andme is holding out an olive branch. It’s not your usual cutting. It’s an application for Bloom’s Syndrome, a rare inherited genetic disorder, which FDA just accepted. Adding to it is that CEO Anne Wojcicki is a carrier of this disorder. VentureBeat’s speculation is that if successful, the Bloom’s Syndrome application would be the template for future test applications. The tone on both sides has grown conciliatory. For example: sitting on the same Congressional panel on healthcare last Tuesday was an FDA physician directly involved in the approval situation and Ms Wojcicki. There was a well-timed, quite emollient interview with Ms Wojcicki in the Wall Street Journal this past weekend. Certainly a factor is that 23andme is still growing, but less quickly–up 150,000 from its pre-FDA contretemps level of 550,000. And its funders, even though closely related to Ms Wojcicki, hate to wait on numbers which are certainly below projections.

Picture murky: 23andMe and the FDA

April 2, 2014 | by | 2 Comments

Genetic testing company 23andMe seems to be in no rush to resolve its differences with the FDA, and the digitalhealtherati a/k/a D3H (Digital Health Hypester Horde) are wondering why. In late November, 23andMe executives undoubtedly had a depressing Thanksgiving when the FDA ordered them to stop providing health reports (interpretation of genetic results) and marketing kits. Four months later, 23andMe continues to sell its kits for $99, providing only raw genetic data and ancestry reports–and according to its 31 March blog posting, will do so for the foreseeable future as they complete the regulatory review process. The blog quoted CEO and co-founder Anne Wojcicki, “My main priority is resolution with the FDA,” but actions speak louder than words–and the FDA isn’t talking. The FDA standard is still validation–the company has to analytically and clinically validate 23andMe for its intended uses, which is why the FDA took action against them in the first place.

  • Is the lack of urgency more about continuing to gather raw genetic and health data unimpeded? Ms Wojcicki had widely stated her real aim was to build a 25-million-strong database (Fast Company).
  • Is the real revenue stream of the company not the kits but in monetizing a massive database, selling it to researchers and others (Matthew Herper in Forbes)–the Google model which Ms Wojcicki is quite familiar with? Consider that there’s $126 million into the company, that is a lot of $99 kits.

Most companies in this situation would be imploding. This one is not. Interestingly. FierceMedicalDevices, The Verge

Previously in TTA: all you ever wanted to know about the 23andMe kerfuffle in FDA tells 23andMe genomic test to stop marketing (including this Editor’s analysis of their pre-FDA website with copy breathlessly expressing potentially life-saving or critical lifestyle changing claims, countered by legal ‘educational use’ boilerplate) and The inevitable: class action lawsuit against 23andMe (a check of the Ankcorn blog has no updates)

How insecure can health data get? Very.

April 2, 2014 | by

Gigaom is one of our go-to sites for enthusiastic whiz-bang health gadget coverage (and more), but here’s the downside of all those devices: all that data. And it’s not only not secure, but also getting more insecure. Grégoire Ribordy of Swiss encryption company ID Quantique makes some key (and scary) points on the data breaches looming–and he doesn’t mention that block of Swiss cheese Healthcare.gov once:

  1. One-stop storage for your total health records and data, an idée fixe among government and single-payer theoreticians, just makes it one-stop-shopping for hackers.
  2. Richer health data means more to steal and exploit.  There’s also the illegal use of genetic information for employment discrimination–hard to enforce regulations, easy to misuse personal data.
  3. Biological crime isn’t just a future plot of ‘Law & Order.’ Criminals can target patients with specific conditions–or healthcare workers can make money on the side by supplying accident victim data to personal injury attorneys, as recently happened in NY. For prominent people, their sensitive health information can be leaked to the press for profit. (more…)

2014: the year of reckoning for the ‘better mousetraps’

January 1, 2014 | by

Or, the Incredible Immutability of the Gartner Hype Cycle

From Editor Donna, her take on the ‘mega-trend’ of 2014

This Editor expected that her ‘trends for next year’ article would be filled with Sensors, Wearables, Glasses, Smartwatches, 3D Printing, Tablets and Other Whiz-Bang Gizmos, with splashes of color from Continuing Crises like Healthcare.gov in the US, the NHS’ 3million lives plus ‘whither UK telecare’, various Corporate ‘Oops-ses’, IP/Patent Trolls and Assaults on Privacy. While these will continue to spread like storm debris on the beach, providing continuing fodder for your Editors (and The Gimlet Eye) to pick through, speculate and opine on, what in my view rises above–or is under it all–for 2014?

We are whipping past the 2012-13 Peak of Inflated Expectations in health tech…

…diving into the Trough of Disillusionment in 2014. Crystallizing this certainty (more…)

23andMe as Rorschach test

December 14, 2013 | by
[grow_thumb image=”https://telecareaware.com/wp-content/uploads/2013/12/rorschach1.jpg” thumb_width=”125″ /]Just like the good doctor’s ink blot, there’s a lot of ‘reading into’ the travails of genomic ‘spit test’ 23andMe. Blogger PF Anderson, the Emerging Technologies Librarian for the University of Michigan Health Sciences Libraries, has collected them in pithy quotes and citations. For your weekend or holiday exploration: Collecting Thoughts on the FDA vs. 23andMe

The inevitable: class action lawsuit against 23andMe

December 3, 2013 | by

Breaking News (which is No Big Surprise)

Updated 6 December: 23andMe continues to sell kits, but will provide only minimal genomic information and has suspended advertising. The Washington Post reports that “In a statement Thursday night, the firm went a step further, announcing that it would only provide ancestry information and raw health data. A spokesperson for the company said that “interpreted results” would not be included.” 23andMe had earlier this week suspended advertising (Cnet/Reuters). Customers who had purchased kits prior to the FDA letter on 22 November will receive full reports. 23andMe statement on website. Matthew Herper in Forbes today on how both parties were in a ‘kind of detente’ until the bolder claims (and undoubtedly the adverts with those claims) started. And for weekend consideration, the CoreGenomics (UK) blog looks at the genomic truth-or-consequences.

The Class Action Lawsuit:  Gigaom reports that a California plaintiff, Lisa Casey, filed on 27 November against 23andMe in the US District Court, Southern California citing false and misleading advertising of the Personal Genome Service (PGS) without “‘analytical or clinical validation” and that 23andMe “advertises and markets PGS as a reliable health aid”. Included in the class action complaint is (of course) every online and advertising claim regarding diseases and conditions that 23andMe’s genetic testing can assist a consumer, that (of course) FDA has not approved the marketing of the kits and that 23andMe markets the information to others even though “the test results are meaningless”. The lawsuit seeks damages extending well beyond the cost of the kit (of course), a jury trial and importantly to certify the class action and the attorney’s representation of same. Most interesting is the seemingly modest representation of Ms. Casey, Mark Ankcorn of his eponymous law firm (see his blog entry here). However, in tracing back his email domain, this Editor discovered that Mr. Ankcorn, a trial lawyer with a major-league track record of wins, recently joined the high-powered CaseyGerry firm of San Diego, which specializes in high-profile personal injury/death class action lawsuits including litigation against the NFL on TBI and CTE plus the 2011 Reno Air Races crash.

Our readers should not be surprised as our article last week was blunt on the red carpet 23andMe was figuratively rolling out for the lawyers: Get what your product does (your implied warrant of service) rock solid (23andMe is not at this point) and backed up by studies. Structure your claims as if a trial lawyer will come after you, because they come with the territory.

Well, they are here, and the mystery remains why 23andMe has chosen a path that for most early-stage companies would be corporate annihilation. 23andMe hit with class action over “misleading” genetic ads  Filing (PDF) Hat tip to David E. Albert, MD of AliveCor via Twitter (@DrDave01)

Related articles of interest: Dan Munro in Forbes, writing at the same time as this Editor on the kerfuffle, analyzes far more than here on the ‘test results are meaningless’ point. My comment is below his article (expand comments). See also Mr. Munro’s comment on Illumina (which 23andMe uses for its testing–and just gained premarket clearance for their MiSeqDx test) also confirming that 23andMe lost its Chief Legal Officer in July without a replacement, which would tend to cramp dealings with FDA.  See also Bernard Munos’ ‘fumbling gene’ takedown, from a scientific POV, of same. KPBS (San Diego) coverage.

Previously in TTA: FDA tells 23andMe genomic test to stop marketing

FDA tells 23andMe genomic test to stop marketing (US)

November 27, 2013 | by | 2 Comments

Quantified Selfers and the D3H (Digital Health Hypester Horde) are in a swivet. This past Friday, FDA slammed the door shut on the 23andMe Personal Genome Service (PGS) saliva test. This past summer, the company broadly marketed to US consumers, including a TV campaign [Charles Lowe, TTA 7 Aug]. The FDA cease-and-desist letter cites that 23andMe never provided requested data on their July and September 510(k) filings, which are now ‘considered withdrawn’, and cites that “after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions.” The danger is that people will make medical decisions based on the testing information and that the results produced may be faulty. It appears from FierceHealthcare that the kit has actually been marketed for five years. According to MedCityNews, it is backed by Google Ventures (the CEO/co-founder is the estranged wife of Google head Sergey Brin), New Enterprise Associates, MPM Capital and the Moscow billionaire Yuri Milner. A private citizen is petitioning the White House to overrule the FDA (as if that extra-legal move would be possible, but who knows with the influence of the Googlesphere?) and states that the agency ‘grossly overstates the risks’ (also MedCityNews). As of 2 Dec there are 3,306 signatures of the 100,000 needed; one suspects this administration has bigger slices of uncooked turkey on its plate such as Obamacare and a kind-of-achieved 30 Nov deadline on Healthcare.gov, which is now clearly seen as just one problem.

The 23andMe website is still fully up and still selling kits.

Editor Donna sorts through the noise for possible reasons why:  (more…)

23andMe advertising nationally in the US (sign of the times)

August 7, 2013 | by | 1 Comment

23andMe, the US personal genetics company, launched Portraits of  Health, the company’s first (US) television advertising campaign on 5th August.

Anyone unaware of the company and its ambitions could do worse than watch the excellent video of Anne Wojcicki’s presentation at a recent RSM innovations summit.

Whilst the NHS talks about building a 100,000 person genomic database, and the RCGP sees the most advanced medical development in the life of the average GP by 2022 will be remote delivery of test results, it seems that 23and Me is powering toward’s Anne’s goal of one million genomes sequenced.

It’s not a totally fair comparison of course as the NHS ambition is full sequencing, whereas, as she explains in the video, 23andMe focuses on what they consider the key areas; nevertheless it’s impressive stuff and an indication of just how quickly technology is changing healthcare.