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The health data transparency movement is birthing a new generation of startups
In the early 2000s, Jeff Bezos gave a seminal TED Talk titled “The Electricity Metaphor for the Web’s Future.” In it, he argued that the internet will enable innovation on the same scale that electricity did.
We are at a similar inflection point in healthcare, with the recent movement toward data transparency birthing a new generation of innovation and startups.
Those who follow the space closely may have noticed that there are twin struggles taking place: a push for more transparency on provider and payer data, including anonymous patient data, and another for strict privacy protection for personal patient data. What’s the main difference?
This sector is still somewhat nascent — we are in the first wave of innovation, with much more to come.
Anonymized data is much more freely available, while personal data is being locked even tighter (as it should be) due to regulations like GDPR, CCPA and their equivalents around the world.
The former trend is enabling a host of new vendors and services that will ultimately make healthcare better and more transparent for all of us.
These new companies could not have existed five years ago. The Affordable Care Act was the first step toward making anonymized data more available. It required healthcare institutions (such as hospitals and healthcare systems) to publish data on costs and outcomes. This included the release of detailed data on providers.
Later legislation required biotech and pharma companies to disclose monies paid to research partners. And every physician in the U.S. is now required to be in the National Practitioner Identifier (NPI), a comprehensive public database of providers.
All of this allowed the creation of new types of companies that give both patients and providers more control over their data. Here are some key examples of how.
Allowing patients to access all their own health data in one place
This is a key capability of patients’ newly found access to health data. Think of how often, as a patient, providers aren’t aware of treatment or a test you’ve had elsewhere. Often you end up repeating a test because a provider doesn’t have a record of a test conducted elsewhere.
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Ro makes the weight loss product Plenity commercially available to everyone in the US
In what could be the first step in the development of a significant new line of business for the telemedicine prescription provider Ro, the company is finally announcing the general commercial availability of weight loss product, Plenity.
Developed by Gelesis, a biotech company that makes treatments for gastro-intestinal disorders, Plenity is a weight loss treatment that uses citric acid and cellulose to create a non-toxic paste that makes people feel more full after they ingest it. Taken before meals, the pill becomes a substance that expands to take up about 25% of the stomach, so people eat less.
The product has been approved by the U.S. Food and Drug Administration and is available for a much broader segment of the population than other weight loss products. While most prescription medicines are intended for people who are obese, the Gelesis product is made for people who are overweight, too.
“That’s adults who have a BMI from 25 up to 40. That’s 150 million Americans,” according to Gelesis chief commercial and operating officer, David Pass.
Plenity received FDA approval last April, and Gelesis started working with Ro soon after, according to Pass. The idea was to craft a strategy that could get the treatment, which is classified as a medical device and not a drug, in the hands of as many patients as quickly as possible.
For Ro, the agreement with Gelesis is a sign of potential things to come. The company is the exclusive online provider of the Plenity treatment and Ro founder Zachariah Reitano said that there’s an incredible potential to engage in more of these types of deals.
“We would love to be able to partner with pharmaceutical companies to decrease the cost of distribution,” said Reitano. “We were excited to build an exciting treatment solution for weight management. Our high-level mission is to be the patient’s first call.”
With the Gelesis partnership Ro can add another highly desirable treatment to its roster of therapies — and one that can be a contributing factor to increasing the severity of other conditions that the company already provides treatment for, Reitano said.
“There are a few conditions that we currently treat that are exacerbated by a patient being overweight or obese. People who struggle with weight management will also experience ED. Obesity can lead to heart failure, stroke, coronary heart disease, hypertension, depression,” Reitano said. “The breadth of the label is interesting. Only FDA approved with a BMI from 25 to 40. FDA approved treatment have been between 30 and 40. [It] makes the treatment more accessible to a wider variety of people.”
As the only online provider of the treatment, Ro has developed an onboarding process to ensure that the Plenity therapy isn’t abused by people who suffer from eating disorders.
“During our onboarding we not only ask questions to patients about their weight management. There’s a consecutive set of images that need to be uploaded and taken with the provider. That’s something we’ve taken a lot of time and energy to make sure about,” said Reitano.
Like the other treatments Ro offers, Plenity is a cash-pay prescription, because the weight loss treatments aren’t typically covered by insurance, he said.
The benefit of working with an online pharmacy like Ro to provide distribution for a new therapy was obvious to both startups.
“We turned this market on its head by putting the consumer at the heart of everything we do,” said Pass. The treatment costs $98 per month, compared to other therapies or branded medications that could be as much $300 and $350 per month, according to Pass.
One reason that Gelesis is able to reduce the price of the drug is that it won’t have to hire a massive sales force to pitch it. The company has Ro for that.
“Normally you have a pharmaceutical company that would have to hire a sales force and go door to door and it increases the cost of a new drug. [Ro] can make a new, innovative treatment, like Plenity, available nationwide,” Reitano said.
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Healthcare startups Nurx and Carbon Health ship at-home COVID-19 test sample kits
Efforts to get at-home test kits for the COVID-19 coronavirus are ramping up quickly, and two more health industry startups are bringing their own products to market, with both Carbon Health and Nurx starting to ship their own in-home sample collection kits.
Both of these new offerings are the same in terms of approach to testing: They deliver swab-based sample collection hardware that people can use at home to collect a mucus sample, which they then ship back using included, safety approved, projective packaging to be tested by one of the existing FDA-approved commercial labs across the country.
These tests follow the PCR-based method, which tests for the genetic presence of the COVID-19 virus in a patient. These have a high degree of accuracy, at least when performed in a controlled setting and administered by a medical professional, and are the same tests that are available via drive-through testing stations being set up by state agencies.
At-home use is relatively new to market, and could introduce some potential for error in the collection part of the process, but both Carbon Health and Nurx are offering consultation with medical professionals to help ensure that samples are collected properly, and that results, when available, are correctly interpreted and provided with guidance on next steps for those taking the tests.
None of these tests are free — the Carbon Health test costs $167.50, and the Nurx test costs $181, including shipping and assessment. These are in line with other offerings, including the one from Everlywell we covered earlier this week, which retails for $135. These are described as essentially at-cost prices, and all parties say they are subject to coverage by FSA or HSA money, or potentially by insurers depending on a person’s plan.
One big question around these types of tests is how much supply will be available. Nasopharyngeal swabs used for the in-person type of testing are already reportedly in short supply in some regions, and testing needs are only growing. Carbon is using different swabs to collect a simple saliva sample, which it notes are not in as short supply as the nasopharyngeal version. Other types of tests, including a “serological” one being developed by startup Scanwell, instead work by analyzing a patient’s blood, and could provide some relief for the swab-based tests, especially now that the FDA has expanded its emergency guidance to include their use.
Nurx, which also offers at-home HPV screening, says that it will have 10,000 kits available to patients “over the coming weeks,” and hopes to expand to cover “over 100,000 patients” in the “near future.” Carbon Health CEO and co-founder Eren Bali tells me that it should ramp to around “10,000 per day capacity in about two weeks,” through its medical device partner Curative Inc., and that it can do 50 per day today, with an estimated increase to 150 per day by Monday and 1,000 per day by end of week.
All of these tests are gated by a screening and assessment questionnaire, and the round-trip time is likely to take a few days even with round-trip shipping due to testing times. It may seem like a lot of these are popping up, but these startups at least have proven track records in healthcare services, and there will be a need for very widespread testing in order for any broad attempt to flatten the curve of the virus to prove successful, so expect more of these providers to come on line.
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Scanwell aims to launch at-home 15-minute coronavirus test, but it still needs FDA approval
At-home diagnostics startup Scanwell, which produces smartphone-based testing for UTIs, is working on getting at-home testing for the novel coronavirus into the hands of U.S. residents. The technology, which was developed by Chinese diagnostic technology company INNOVITA and has already been approved by China’s equivalent of the FDA and used by “millions” in China, can be taken at home in 15 minutes with the guidance of a medical professional via telehealth, and produces results in just hours.
Scanwell’s test will require FDA clearance, but the company tells me that it’s in the process of securing approval through the FDA’s accelerated emergency certification program. The FDA guidance says that this approval process should take 6-8 weeks (though that “could be faster,” Scanwell says), and Scanwell is aiming to be ready to go with shipping these as soon as it receives that approval. While the U.S. drug regulatory agency previously had only included PCR tests in its protocols, it updated that guidance to include serological tests earlier this week. Scanwell further says they “don’t anticipate any issues with FDA approval.”
The test that Scanwell is aiming to launch uses what’s called a ‘serological’ technique, which looks for antibodies in a patient’s blood. These are only present if someone has been exposed to the SARS-CoV-2 virus, since as of right now researchers haven’t found any evidence that natural antibodies to this particular virus exist without exposure. By contrast, the types of tests that are currently in use in the U.S. are “PCR” tests, which use a molecular-based approach to determine if the virus is present genetically in a mucus sample.
The PCR type of test is technically more accurate than the serological variety, but the serological version is much easier to administer, and produces results more quickly. It’s also still very accurate on the whole, and is much cheaper to produce than the PCR version. Plus, it could help expand efforts beyond testing only the most severe cases with symptoms present, and do a much better job of illuminating the full extent of the presence of the virus, including among people with mild cases who have already recovered at home, and those who are asymptomatic but carrying the virus with the possibility of infecting others.
Also, while other, PCR-based at-home testing options already exist, like one from Everlywell that will start going out on Monday, require round-tripping test samples, adding time, complexity and cost and relying on testing materials like swabs that are in short supply globally.
Once the test is available, people deemed eligible via Scanwell’s screening process in their Scanwell Health app will be sent the test via next-day delivery. They’ll be guided by telehealth partner Lemonaid‘s licensed doctors and nurse practitioners, and they’ll then receive results and further guidance about those results via the app within a few hours. The whole testing process will cost $70, which Scanwell says just covers its costs (it’s also looking at ways to provide free service to those who need it), and will be deployed first in Washington, California and New York, as well as other areas depending on the severity of their coronavirus situation.
That the tests will take potentially 6-8 weeks to come to market seems like a long time, given the current state of the rapidly evolving COVID-19 situation and testing. But we’ll likely still be very much in need of testing options at that time, especially ones that can serve people who aren’t necessarily meeting the criteria for other available testing resources.
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The FDA proposes further restrictions to sales of flavored e-cig products
The FDA has drafted new guidance for the regulation of e-cigarettes, particularly with regards to flavored nicotine products.
The first big change is that the FDA has bumped up the application due date by one year for FDA approval of flavored products. Manufacturers of all flavored ENDS (electronic nicotine delivery system) products will now have to submit premarket applications by August 8, 2021.
The second change is introducing a new compliance policy with regards to flavored ENDS products.
At the time that the current compliance policy was enforced, in 2017, e-cigarette use among youth was leveling off. But drastic growth in the popularity of e-cigs among minors over the past two years has led to various changes in the policy, including the restriction of sales of flavored ENDS products via certain retail channels from November 2018.
“The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018,” wrote Gottlieb in the announcement. “This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017.”
Identifying flavored pods as a culprit was the first step, but the FDA is now introducing a policy that looks at how accessible any flavored ENDS product is to minors to determine whether or not it can stay on the market.
For online sales, retailers must have an age-verification process that connects to third-party data sources in order to sell flavored nicotine products. For physical retailers, the policy says that flavored nicotine products must be behind some sort of age-gate, whether that’s at the front door of the shop or within a different age-gated section of the store itself. In other words, there must be some barrier to entry before POS between minors and flavored ENDS products.
From the announcement:
Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.
The main point to remember is that the FDA plans to prioritize enforcement of these products based on whether they’re sold in ways that pose a greater risk for minors to access them and become addicted to them.
While this proposal includes further regulation of the budding e-cigarette industry, it could be an important step forward for the space in the long term. The e-cigarette industry won’t reach its potential as an alternative to cigarettes until the issue of underage use is solved for good.
The FDA sees flavored ENDS products as a gateway for young people, and closing off access to those products as soon as possible gives the industry, from manufacturers to retailers to regulators, the opportunity to plan for how these products can be sold and distributed in the future, or if flavored products should exist at all.
The new plan does not propose enforcement of all ENDS products — tobacco, menthol and mint-flavored ENDS products can remain on the market and keep their original 2022 deadline for premarket FDA approval applications.
Juul Labs had this to say in response to the draft guidance:
We are committed to reducing youth usage while preserving our opportunity to eliminate combustible cigarettes, the number one cause of preventable death in the world. As part of our action plan deployed in November 2018 to keep JUUL products out of the hands of youth, we stopped the sale of flavored JUULpods to retail stores, strengthened our retail compliance and secret shopper program, enhanced our online age-verification, exited our Facebook and Instagram accounts and are continuously working to remove inappropriate third-party social media content. We support category-wide action including the responsible, restricted sale of flavored products and will review today’s draft guidance as we continue to work with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in combating underage use.
Commissioner Gottlieb announced his resignation a week ago. National Cancer Institute Director Dr. Ned Sharpless will take over as acting FDA Commissioner in April.
Gottlieb had taken measured steps to keep ENDS products away from minors while still allowing adult smokers to have an alternative on the market. Whether Sharpless will thread the needle quite as well remains to be seen, but Altria stocks fell on word of his appointment.
Today’s proposal is open for public comments for 30 days.
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FDA chief summons Altria and JUUL to Washington to discuss teen vaping
The head of the U.S. Food and Drug Administration is calling Altria and Juul to meet in Washington to discuss their tie-up and how it impacts the companies’ plans to combat teen vaping. Earlier this year, Altria href=”https://techcrunch.com/2018/12/20/juul-labs-gets-12-8-billion-investment-from-marlboro-maker-altria-group/”>invested $12.8 billion investment in Juul.
“After Altria’s acquisition of a 35 percent ownership interest in JUUL Labs, Inc., your newly announced plans with JUUL contradict the commitments you made to the FDA,” Commissioner Scott Gottlieb wrote in a strongly worded letter addressed to Altria chairman and chief executive, Howard A. Willard III.
“When we meet, Altria should be prepared to explain how this acquisition affects the full range of representations you made to the FDA and the public regarding your plans to stop marketing e-cigarettes and to address the crisis of youth use of e-cigarettes,” Gottlieb wrote.
The commissioner sent a similarly worded message to Juul’s chief executive, Kevin Burns.
As part of that deal, Juul is getting access to Altria’s retail shelf space; the company is sending out direct communications pitching Juul to adult smokers through cigarette pack inserts and mailings to the company’s database of customers; and the two will combine the power of their respective sales and distribution backend which reaches roughly 230,000 retailers across America.
The recent deal comes only months after Juul released its plan to combat teen vaping — something the FDA had required of the company.
In the commitments it made last year, the vape manufacturer and retailer said it would expand its secret shopper program to make sure underage buyers weren’t getting access to its products; pull its campaigns from social media; and limit sales of non-traditional cigarette flavors (menthol, mint, Virginia tobacco, and “classic” tobacco) to the company’s website — which requires age verification.
Gottlieb isn’t the only one who has a problem with Juul. We’ve written about how the company has lowered the barrier to entry for nicotine addiction.
For Gottlieb, the addition of Altria’s marketing firepower and network of 230,000 retail locations likely isn’t an indicator of a company that’s willing to winnow down access to its products.
“I am aware of deeply concerning data showing that youth use of JUUL represents a significant proportion of the overall use of e-cigarette products by children. I have no reason to believe these youth patterns of use are abating in the near term, and they certainly do not appear to be reversing,” Gottlieb wrote. “Manufacturers have an independent responsibility to take action to address the epidemic of youth use of their products. My office will contact you to arrange a meeting to discuss these issues. Pursuant to your request, we intend to schedule this as a joint meeting with both Altria and JUUL.”
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Lack of transparency in healthcare startups risks another Theranos implosion
Are more Theranos -style scandals looming for investors in healthcare startups?
A team of researchers associated with the Meta-Research Innovation Center at Stanford thinks so. They’ve published a paper warning investors in life sciences startups that a systemic lack of transparency exists in their portfolio companies — creating the possibility for more multi-billion-dollar implosions and scandals like the one that toppled Theranos and its charismatic founder, Elizabeth Holmes.
Indeed, one of the study’s authors, Dr. John Ioannidis, the co-director of the Meta-Research Innovation Center at Stanford and director of the University’s PhD program in Epidemiology and Clinical Research, was among the first people to identify the risks associated with Theranos and its “stealth research.”
Now Dr. Ioannidis and his co-authors, Ioana A. Cristea and Eli M. Cahan, have published a study surveying the publicly available research from the largest privately held companies in the healthcare space, and found them lacking.
Most of the highest-valued startups in healthcare have not published any significant scientific literature, the study found. Nearly half of the publications from companies worth more than $1 billion came from only two startups — 23andMe and Adaptive Biotechnologies, according to the paper.
“Many years ago I was the first person to say that Theranos had a problem,” says Ioannidis. “The problem that I had then was that Theranos did not have any peer-reviewed evidence to show.”
In an interview and in their paper, Ioannidis and Cahan warn that investors have overlooked systemic problems created by the lack of transparency among healthcare startups.
They write:
It would be tempting to dismiss the Theranos case as just one rotten apple. However, we worry that the focus on fraud puts aside a more fundamental concern. Fraud is making waves in the news, but stealth research may have a more detrimental impact.
According to the study’s findings, more than half of the healthcare startups that are worth more than $1 billion have published no highly cited papers at all. For companies that were acquired or are publicly traded that number is around 40 percent.
In all, healthcare startups that are currently valued at more than $1 billion published 425 Pubmed papers. And of those papers only 34 (8 percent, including two reviews) were highly cited. For companies with valuations of more than $1 billion that had been acquired or are publicly traded on stock exchanges, the researchers counted 413 papers, of which 47 (11 percent, including nine reviews) were highly cited.
Digging deeper into some of the companies that had high valuations but little or no published research revealed scores of operational and technological issues for the researchers.
For instance, StemCentrx, which was bought for $10.2 billion in 2016 by AbbVie, had published 16 papers — and only one highly cited paper. Since the acquisition, the Food and Drug Administration had imposed a delay on the readout of the company’s phase II trial for its Rova T targeted antibody drug for cancer treatment. In December, a Phase III trial for Rova T as a second-line treatment for patients with advanced small cell lung cancer was halted because the treatment wasn’t working, according to a report in Targeted Oncology.
Acerta Pharma, another healthcare-focused startup focused on cancer treatments, was bought by AstraZeneca for $7.3 billion. That company published nine articles and had one highly cited paper for a very early study of a potential treatment for relapsed chronic lymphocytic leukemia. Acerta received accelerated approval for a drug called acalabrutinib, which treats a rare form of lymphoma called mantle cell lymphoma. Two years ago, AstraZeneca had to retract data and admit that Acerta falsified preclinical data for its drug.
Then there’s Intarcia, the developer of a device for diabetes treatment that’s worth $5.5 billion. That company had its device rejected by the FDA and was forced to lay off staff and halt a couple of later-stage trials. It had only published six papers — none of them very highly cited.
Ultimately, the researchers concluded that highly valued healthcare startups don’t contribute to published research and that the valuation of these companies by investors is divorced from any externally validated data.
For the researchers (and for investors) this should present a problem.
“Many unicorns may be overvalued [21] and subject to unrealistic scientific expectations,” the study’s authors write. And they reject the argument that simply applying for — and receiving — patents is enough to prove that a technology in the healthcare space has been thoroughly vetted. “[Patents] do not offer the same level of documentation as peer-reviewed articles. For example, Theranos had over 100 patents [1], but these were unable to supplant the vacuum in their evidence,” the researchers wrote.
Even if companies want to protect their technology, there are still ways for them to be more transparent about the results or benefits of their technology. The authors acknowledge that publishing isn’t the primary mission of startups. They can, however publish a few high-value articles, secure their technology through patents and then work with researchers, universities or hospitals to validate the technology and have those organizations publish results of the tests, the authors argue.
As the authors conclude:
Start-ups are key purveyors of innovation and disruption. Consequently, holding them to a minimal standard of evaluation from the scientific community is crucial. Participation in peer review, with all its limitations, is the best way we have to uphold this standard. We are not arguing that start-ups should divert excessive resources to having peer-reviewed papers. However, when their products are destined to affect patient health, they should neither be solely doing marketing. Confidential data sharing with potential investors or regulators cannot replace more open scrutiny by the scientific community.
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The FDA OK’d an app as a form of birth control
Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S.
Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America.
The app works using an algorithm based on data given by women using the app such as daily body temperature and monthly menstrual cycles. It then calculates the exact window of days each month a woman is most fertile and therefore likely to conceive. Women can then see which days the app recommends they should avoid having sex or use protection to avoid getting pregnant.
Tracking your cycle to determine a fertile window has long been used to either become pregnant or avoid conceiving. But Natural Cycles put a scientific spin on it by evaluating over 15,000 women to determine its algorithm had an effectiveness rate with a margin of error of 1.8 percent for “perfect use” and a 6 percent failure rate for “typical use.”
What that means is almost two in every 100 women could likely conceive on a different date than the calculated fertile window. That’s not exactly fool-proof but it is higher than many other contraceptive methods. A condom, for instance, has an 18 percent margin of error rate, according to the Centers for Disease Control (CDC).
And though the app makers were able to convince the FDA of its effectiveness, at least one hospital in Stockholm has opened an investigation with Sweden’s Medical Products Agency (MPA) after it recorded 37 unwanted pregnancies among women who said they had been using the app as their contraception method.
“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” assistant director for the health of women in the FDA’s Center for Devices and Radiological Health Terri Cornelison said in a statement.
However, she also acknowledged there was a margin of error in the app’s algorithm and other contraceptive methods. “Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she said.
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Enzyme.com wants to make FDA compliance easier for startups
The FDA approval process can be like navigating a minefield for health startups hoping to get through regulations and begin selling to the American public. YC company Enzyme.io hopes to help these small businesses by automating the process for them. Biomedical engineer Jared Seehafer came up with the idea through his own experience consulting with health companies. Read More
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