DayTwo Scores $37M to Expand Microbiome-Based Personalized Nutrition Treatment for Diabetes

By JESSICA DaMASSA, WTF HEALTH

People with Diabetes can get ready to celebrate: “The ‘Era of Lancets’ is over.” Precision nutrition startup, DayTwo, is scaling up its microbiome-based program, which takes the guesswork (and finger pricks) out of Diabetes management by offering its members food predictions that identify how their bodies will respond to any food BEFORE they eat it. The startup just closed a fresh $37M in Series B funding (led by aMoon and Cathay Ventures) and is expanding the rollout of their fee-for-outcomes Diabetes program to health plans and large self-insured employers.

The science behind this has yielded DayTwo the largest gut microbiome dataset in the world, and years of empirical studies on exactly what happens in our bodies as our digestive systems process different foods. Josh Stevens, DayTwo’s President & Chief Commercial Officer, walks us through the research behind the offering, which uses a gut microbiome analysis to rank foods and food combinations based on how eating them will impact a person’s blood sugar – essentially revealing what foods will (or won’t) cause a member’s blood sugar to spike before they even take a bite.

Its 70,000+ members report lower A1C levels (1 point on average), sustained weight loss, and, probably most exciting, an ability to stick with the program because the app (and wrap-around telehealth support from registered dieticians) creates a completely bespoke diet that lets people learn how to eat their favorite foods and keep their blood glucose levels within range. Will this predictive approach really bring about the end of lancet-based blood glucose testing for Diabetes management? Josh says Diabetes remission is a goal made easier by this predictive approach, but how does it stack up to other food-as-medicine approaches out there? I have a gut-feeling that you’ll want to tune in and find out!

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Health Care, Meet Gall’s Law

By KIM BELLARD

I can’t believe I’ve gone this long without knowing about Gall’s Law (thanks to @niquola for tweeting it!).  For those of you similarly unaware, John Gall was a pediatrician who, seemingly in his spare time, wrote Systemantics: How Systems Work and Especially How They Fail in 1975.  His “law,” contained therein, is:

Have you ever heard of anything that applied so perfectly to our healthcare system? 

As anyone who has been reading my prior articles may know, I’m a big believer in simple.  I’ve advocated that healthcare’s billing and paperwork should be much simpler, that “less is more” when it comes to design,  that healthcare should first do simple better but, above all,  that healthcare should stop doing stupid things.  I’ve equated the ever-increasing intricacies of our healthcare system to the epicycles that kept getting added to the Ptolemaic theory in a desperate attempt to justify it. 

Few would disagree that the U.S. healthcare system is complex.  Healthcare systems in general have evolved towards more complex, but the U.S. system takes complexity to extremes, with its thousands of payors, its powerful pharma/medical device industry, and its highly concentrated hospital markets (including ownership of physician practices), among other things. 

Simple isn’t always better, of course.  Life is complicated and so is our health, but, come on: how many people can explain why PBMs exist, what their heath insurance plan actually covers, how their health care bill was arrived at, or why we spend so much time in the healthcare system just waiting?  Literally no one understands our healthcare system.

It shouldn’t be that way.  It doesn’t have to be that way.  But it is.

Some pundits argue we don’t even have “a system” but, rather, thousand or even millions of smaller health-related markets that co-exist but don’t really work together.  For anyone who doubts that, try to explain the presence of workers compensation healthcare or why dental is at best a separate form of coverage (last I looked, the mouth was part of the body).  Try to explain why child care is most definitely not part of healthcare but home care is – depending, of course, on whether it is “custodial” or not.   Silos abound.

It could be argued that healthcare started with a simple system that “worked.”  Some are nostalgic for the days when people saw their family doctor, paid their doctor, and that was it.  It doesn’t get much simpler than that.  Of course, those doctors couldn’t really do all that much for their patients and didn’t really get paid all that much, so to say that it “worked” for either party is debatable. 

Many reform advocates propose what they see as a simple solution – Medicare For All!  Having everyone with the same coverage could lessen some administrative burdens, but no one who has been covered by Medicare, nor treated patients with Medicare, would describe Medicare as either a simple system nor one that “works.”  Medicare For All would have to be radically different from the Medicare program we know now, and that would seem to risk Gall’s “inverse proposition.”

We need, to use Dr. Gall’s words, a “working simple system.”

The trouble is, I’m not sure I can imagine what that is.  Group practice HMOs were supposed to be one, but that experiment has not gone the way it was forecast to.  More recently, new entrants like Oscar Health or Iora Health were going to reinvent health insurance, but, as it turns out, not so much. 

Health system integration/consolidation was supposed to make care more effective and efficient, but it turns out that is a false promise.  Companies like TelaDoc and AmWell have been preaching telehealth for a couple decades now, and the world has awoken to its potential, but it keeps tripping over the complexities of the non-digital parts of our healthcare system.  

One of the barriers to developing a working simple system in healthcare is lack of agreement on which of healthcare’s many problems to focus on.  Is it lack of universal coverage, or excessive costs?  Is it our poor health behaviors?  Is it how health prices are so radically different between payors?  Is it how we continue to tolerate our intolerable health inequities?  Is it our lack of data interoperability?  

For me, though, the core problem that needs to be addressed is this: we don’t really know what “quality” is – not only whether care has been delivered “correctly” but whether the treatment was even likely to be effective (e.g., look at NNT or any number of studies on unnecessary procedures). 

“Quality” in healthcare is like what Supreme Court Justice Potter Stewart said about pornography: he can’t define it “but I know it when I see it.”  Unfortunately, in healthcare, we don’t even know it when we see it.  Without actual evidence, we all think our doctors are the “best” and our faith in even fringe remedies is enduring (how many supplements do you take?).   

Oh, we have lots of quality measures.  We spend lots of money collecting them, and even make some of them available to the general public.  But we’re kidding ourselves if we think that any of these various measures actually measure quality, or that consumers understand, much less really use, them. 

As consumers/patients, we’re not demanding better measures, and, as healthcare professionals/institutions, we’re more worried about increasing our malpractice exposure than in figuring what we’re doing “right” and who is doing it better.  Shame on all of us.

Job #1 of our healthcare system should be to find a simple working system for measuring quality for something important – a condition, a treatment, a procedure.  Something accurate, easy to measure, and easy to understand.  Get agreement on it, and use that to drive decisions about what to pay how much for that part of healthcare.  Then iterate.

I’m not saying this is going to be easy—it’s not – but I am saying that if we don’t do this, then all the brainpower we’re using on other problems in healthcare is, essentially, wasted.   

Our healthcare system is broken.  It’s way too complex yet way too ineffective at every level.  As Dr. Gall urged us, we have to start over, and starting with a simple working system for measuring quality seems like as good a place as any.

Kim is a former emarketing exec at a major Blues plan, editor of the late & lamented Tincture.io, and now regular THCB contributor.

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Policies|Techies|VCs: What’s Next For Health Care–Virtual Conference is Sept 7-10

Policies|Techies|VCs: What’s Next For Health Care? is the conference bringing together the CEOs of the next generation of virtual & real-life care delivery, and all the permutations thereof. You can register here or learn how to sponsor.

This is a big week. We are one week out and we’ve started pre-recording a few sessions and they’ve been fascinating. Keynotes include government officials from the 3 most important agencies for digital health –Pauline Lapin (CMS), Micky Tripathi (ONC) & Bakul Patel (FDA). But wait there’s more! Keynotes from techies Glen Tullman (Transcarent), Sean Lane (Olive), Jonathan Bush (Zus Health), Jeff Dachis (One Drop) & Andrew Dudum (Hims & Hers). And we’re not forgetting the VCs sprinkled through the program, with a keynote from Andreesen Horowitz’s Julie Yoo.

Please look at the agenda for 20 power-packed panels and over 100 speakers – and then sign up!

Shout out to our sponsors – This week we welcome new Gold sponsor data privacy company Skyflow and new Silver sponsor Amwell. Thanks to both of them for supporting the conference. They join Avaneer Health (our Platinum sponsor) & exclusive Agency sponsor 120/80. Sliver sponsors are Transcarent & Lark . More sponsors are Aetion. Merck GHIF, Crossover Health, Zus Health, Newtopia, Aetion & Big Health! Many of them will have sessions you can catch on the web site.

It’s going to be a great conference–no need to leave your seat as it’s happening virtually September 7-10. Register here!! — Matthew Holt

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Sleepless Nights For Evolutionary Biologists: A Greek Tragedy in The Making

By MIKE MAGEE

In my Jesuit high school, we were offered only one science course – chemistry. I took it in my Senior year and did pretty well. In contrast, I took four years of Latin, and three years of Greek, as part of the school’s Greek Honors tract.

Little did I know that Covid would create a pathologic convergence of sorts six decades later. Let’s review the Covid mutants:

Alpha – A variant first detected in Kent, UK with 50% more transmissibility than the original and has spread widely.

Beta – Originating in South Africa and the first to show a mutation that partially provided evasion of the human immune system, but may have also made it less infectious.

Gamma – First detected in Brazil with rapid spread throughout South America.

Delta – First seen in India with 50% more transmissibility than the Alpha variant, and now the dominant variant in America and around the world.

Our ability to track and identify mutating viruses in real time is now extraordinary. Over 2 million Covid genomes have been cataloged and published. But describing the “anatomy” of the virus is miles away from understanding the functional significance of their codes, or the various biochemical instructions they may instruct.

These deeper questions are in the realm of evolutionary biologists who are currently experiencing sleepless nights. Their recurrent nightmare? “What comes after Delta?”

What they know already is that Delta’s genetic mutation, P681R, affected a spot on the virus spike that cuts through protein chains and sped up human cell entry 1000 times. The speed lit a fuse under colony growth, which in turn allowed the virus’s spread to other unsuspecting human contacts before any immune response generated symptoms appeared. Of course the state of being asymptomatic didn’t last for long. Speedy virus multiplication rates accelerated the microbes’ movement from upper airways to lower airways leading to hospitalization rates that are twice as common as they were in the original Covid.

What’s next in the Greek alphabet? First a few basics.

1. A virus’s survival, and threat to us, relies on three factors:

a)Infectiousness, b) Virulence, c) Immune Evasion.

But these factors can as easily play against each other as for each other. Natural or vaccine induced immunity slows down infectiousness and potential virulence. But (by narrowing a virus’s options for survival) it also creates a Darwinian reward for any mutant that figures out the Rubik’s Cube solution to becoming “invisible” to the human immune system.

According to Rockefeller University virologists, such a change requires the coalescence of 20 independent random changes in the genome. Bottom line: Random escape is a tall order. But under the current system, with Delta transmissibility likely to eventually burn through most of its potential future victims, such a change would be richly rewarded.

2. Viruses depend on us. But we no longer look or act as we did in 2019. Two billion citizens worldwide have had at least one dose of the vaccine, and hundreds of millions of others have survived the infection. The virus each day is increasingly pressured to find its next human victim. One way out is to figure a way past our immune defenses provided by prior infection or vaccination.

So this is a cyclical game, likely to go on for some time. If we global citizens play our vaccination cards right, the virus has fewer turns in the game, and is less likely to draw the cards it needs to evade our human defenses.

So here are five take-away facts:

• The longer we allow Covid to stick around, the worse this could get.
• The majority of the messy replication mistakes are inconsequential, but there are occasional windfalls that rise to Greek alphabet mythical status.
• Delta’s critical weakness – it leaves behind high antibody titers that limit its future.
• Give the virus more time, or access to compromised hosts, and anything can happen. Viruses are constantly rolling the evolutionary dice.
• Mutations hurt us by increasing transmissibility/virulence or immune evasion. The good news is there is some evidence that an immune escaping Covid might not be efficiently transmissible any more.

A guy like Ron DeSantis is not only ignorant of evolutionary biology, he’s playing with fire – and with our human lives. This cannot go unchallenged. Whatever it takes, we need to force this virus into a corner. Otherwise, we run the risk of becoming a Greek tragedy ourselves.

Mike Magee, MD is a Medical Historian and Health Economist and author of “Code Blue: Inside the Medical Industrial Complex.“

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Matthew’s health care tidbits

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

For my health care tidbits this week, I am getting very close to home. I live in Marin County, California which is an incredibly wealthy, well-educated, liberal place. My little town voted 90% for Biden and, as you’d expect, county-wide 87% of those eligible (over 12) are fully immunized with most of the rest on the way. But Marin also has a small hard core of anti-vaxxers, and by that I mean those who reject childhood vaccinations. At one Waldorf school nearby only 22% of kids are vaccinated (MMR et al).This week the CDC released a study about how this past May an unvaccinated elementary school teacher who was sneezing but didn’t wear a mask infected 55% of their class.

I know that public schools in Marin have insisted on their teachers and students wearing masks and have highly, highly encouraged vaccinations among teachers and staff. Furthermore that school had only 205 pupils which is well below the average for elementary schools (at least in my school district). So I am prepared to bet that the maskless teacher was at a charter school or other private school. (Post newsletter update: I found out that it was a parochial school in Navato)

Clearly we need vaccines for kids ASAP. But I also am starting to wonder that, as COVID-19 becomes endemic and probably never goes away and as studies like this show how rapidly it spreads, will the majority who believe in masking, vaccines et al start to impose more medical and social mandates and bans on those who do not?

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Health Insurance is a Stumbling Block in Many Patients’ Thinking

By HANS DUVEFELT

I have a patient with no health insurance but a brand new Mercedes. He says he can’t afford health insurance. He cringes at the cost of his medications and our office visit charges. His car cost a lot of money and I know that authorized Mercedes dealers charge around $140/hour for their technicians’ (not mere mechanics) time. A routine service costs several hundred dollars, which he seems more okay with than the cost of his own healthcare visits.

His new Mercedes is under warranty, but his body is not. He is risking financial disaster if he gets seriously ill with no insurance coverage.

I have another patient who needed a muscle relaxer for a short period of time. His insurance wouldn’t cover it without a prior authorization. The cash cost was about $14. We suggested he pay for the medication and told him his condition would have resolved by the time a prior auth might have been granted. He elected to go without.

The brutal truth is that a primary care doctor’s opportunity cost, how much revenue we can potentially generate by seeing patients, is around $400/hour or $7/minute. There is no way I could request a prior authorization in under two minutes. So it would have been more cost effective to pay for his medication than to do the unreimbursed paperwork (or computer work, or phone work) on his behalf. But, of course, we can’t do that.

That patient and many others think that health insurance is such a complete package deal that everything should be covered. They feel moral indignation if they have to pay out of pocket.

Even Sweden’s socialized medicine system has copays. Why do some Americans balk at a one-time cash cost of $14 for a non-covered drug when monthly, lifelong copays for modern COPD inhalers that many fixed-income seniors depend on can be over $100?

Hans Duvefelt is a Swedish-born rural Family Physician in Maine. This post originally appeared on his blog, A Country Doctor Writes, here.

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THCB Gang Episode 64 – Thurs August 26, 1pm PT- 4pm ET

THCB Gang is back from its summer break. Joining me Matthew Holt (@boltyboy) for an hour of topical and sometime combative conversation on what’s happening in health care and beyond will be patient safety expert and all around wit Michael Millenson (@MLMillenson); fierce patient activist Casey Quinlan (@MightyCasey), medical historian Mike Magee (@drmikemagee), WTF Health host & Health IT girl Jessica DaMassa (@jessdamassa); and making a rare but welcome appearance cardiologist & provocateur Anish Koka (@anish_koka). Watch it live below.

If you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels

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Inside 1-Year-Old Calibrate’s $100M Raise for ‘Rx + Behavior Change’ Weight Loss

By JESSICA DaMASSA, WTF HEALTH

Just ONE-year in market, and Calibrate has already closed a $100M Series B co-led by Founders Fund and Tiger Global, with participation from Optum Ventures, Forerunner Ventures, Threshold Ventures, and Redesign Health. Why is this virtual care startup getting so much attention (and funding) from so many notable health tech investors? Founder & CEO Isabelle Kenyon is here to introduce us to the telehealth-plus-prescription-drugs business she’s building to help people lose weight.

This is NOT a Noom. Calibrate’s business model is built around a class of $700-$1,300-per month, prescription weight loss drugs called GLP-1s, which it helps its members sort through for both fit AND health insurance coverage (Isabelle says 90% of Calibrate members get the drugs covered by their health plan.) Once the drug is prescribed, the Calibrate member is wrapped in a telehealth-driven, lifestyle intervention program that addresses sleep, eating, exercise, and emotional health to help support the reset of their metabolism. As a result, Calibrate members are losing an average of 14% of their body weight, a significantly better, more sustainable outcome than achieved in clinical research when the drugs were prescribed without support.

There are lots of compelling aspects to the Calibrate story here, and we get through all of them: the 175M-person total addressable market of Americans diagnosed with obesity… the recent FDA-approval of Novo Nordisk’s new GLP-1 drug called Wegovy… and how Calibrate will use its fresh funding to build-out an Enterprise program aimed at meeting the shifting thinking employers, Medicare Advantage plans, and other health insurers have about obesity treatment as “preventative care” against more costly chronic diseases.

What else could this “behavior change + drug” framework – and its unique de-coupled payment model – be applied to? Diabetes, cholesterol, and hypertension sound like they’re all on the table, but how defensible is this? What stops a pharma company from doing this themselves? Isn’t this digital therapeutics?? A VERY interesting discussion about the often-taboo subject of weight loss, pharma, and the disruption of the healthcare delivery system behind both.

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The FDA’s Culture: Should Safety Dominate All Practices?

By STEVEN ZECOLA

An organization’s culture is an internal set of shared values, attitudes and practices. The cohesiveness of the organizational culture will affect whether the entity will meet its vision, purpose, and goals.

One type of organizational culture is hierarchical in nature.   Unlike a risk-taking culture, this structure features policy, process and precision. It is best suited for mature and stable organizations.

The disadvantage of a hierarchal culture is that its stability and control can turn into rigidity. In many cases, the organization develops a negative attitude towards ideas supplied by third parties. It paints itself as having the perfect answer for every issue, no matter how large or small.

My interactions with the FDA suggest that its cultural practices are focused on safety, seemingly to the exclusion of all other issues.  This practice may be appropriate in the regulation of food, but not for drug research where flexibility and creativity are required to cure complex diseases.

Over the past decade, I have witnessed an excessive adherence to its existing practices in the context of BRCA1-related breast cancer, metastatic cancer, precision medicines, “Big Data” and Parkinson’s disease. While the rulings were directed at me, the FDA’s position on these issues has impacted millions of people for the worse.

My first interaction with the FDA came when my fiancée was diagnosed with breast cancer and received the news that she had a BCRA1 mutation.  As is the case for most BCRA1 carriers, she was also diagnosed as Triple-Negative, implying a more aggressive form of cancer with fewer approved pathways for treatment.

She reluctantly accepted the recommendation to undergo a double mastectomy and a chemotherapy regime consisting of Adriamycin, Cytoxan and Taxol (ACT).

ACT is a powerful concoction that has a deleterious effect on many parts of the body, including one’s hair. Patients wonder out loud if it is worth the bother.

Hearing that feedback, I began looking into the research to see if there were any alternatives in the pipeline. At the time, there was some encouraging news coming out of the early trials with PARP inhibitors and platinum-based drugs for BRCA1 victims.

Additionally, I realized that only one trial had been designed to show the effect of ACT on BRCA1 cancer victims as opposed to the broader class of Triple-Negative victims.  Looking at raw data, BRCA1 victims were worse off than non-BRCA1 victims when receiving ACT.

I then Petitioned the FDA to change its approach.  My fiancée was up to her third bout of metastatic cancer and it seemed that ACT was the culprit, and even if not, it was causing much pain without much benefit.

Luckily, she managed to get into a trial featuring Olaparib. Within months, the tumors completely disappeared.   However, the potency of Olaparib wears off after a couple of years and the bouts of metastatic cancer returned. She died at the age of 57 from her eighth bout of cancer that had metastasized to the brain.  It was the same age that her mother had died of the same cause.

Meanwhile, the FDA was busy defending its approach. It produced a 12-page letter rejecting my petition. It contained several non sequiturs and outright falsehoods to support its position, including:

“But the prognostic significance of having a BRCA mutation is not clear” and “it is not completely understood how similar BRC1-related breast cancers are to non-BRCA1 breast cancers”. FDA Letter, page 6.

“There are side effects with all chemotherapeutic agents (not just ACT).  In addition, you have not presented any evidence suggesting that side effects are more deleterious in BRCA1 patients being treated with ACT drugs than in other patients”.  FDA Letter, page 7.

“Given that adjuvant treatment was not assigned, it is not statistically valid to compare the survival rates of the 24 BRCA-1 patients who received chemotherapy and the 17 patients who did not receive chemotherapy”. FDA Letter, page 7.

“There is no evidence, however, that the deleterious effect of ACT on DNA in BRCA1 mutations is greater than the deleterious effect caused by other agents (e.g., platinum-based chemotherapy agents).”  FDA Letter, page 8.

“We do not agree with your claim that the results of any clinical trial of TNBC cannot be applied with statistical validity to the BRCA1 subcategory of TNBC unless that subcategory is specifically separated out and monitored.” FDA Letter, page 9.

I believe that all of these statements have been proven to be false.  Certainly, the author’s understanding of multivariable statistics is lacking. More importantly, the drug Lynparza® (Olaparib) has since been approved by the FDA for patients with metastatic breast cancer who have inherited mutations in the BRCA1 gene.

In reality, there was enough information for the FDA to be flexible and responsive to BRCA1 cancer victims before Lynparza was approved.   Over 500,000 women would have lived longer and with less pain if the FDA did not rigidly apply its cultural norms to the situation.

My second encounter with the FDA unsurprisingly involved metastatic cancer.  I noticed that only 8% of government spending on cancer research was directed to metastatic cancer but that 90% of the deaths from cancer were from metastatic cancer.  I suggested that the FDA champion an increase to 15% of the funding and to establish a separate center to raise the visibility and focus on this very efficient killer. I also suggested a modification of the standard FDA approval process for metastatic cancer.

The FDA responded with a seven-page letter denying my request.

The FDA wrote that their regulations “do not prescribe any particular type of trial design” and “nothing…requires that drugs undergo testing in distinct phases”.  

The FDA said: “in addition to flexibility in designing clinical trials, FDA has various other programs to expedite development and review of new drugs including…metastatic cancer”.

It added: “The Agency reorganized its oncology review office in 2011….and does not believe that its current structure lacks ‘sufficient organizational structure’ on metastatic disease, is inefficient, or otherwise impedes the conduct of clinical trials for…. metastatic cancer”.

These statements reflect an Agency that is in denial of reality. The reality is that eight years after this letter was written, the goal posts for metastatic cancer have not moved appreciably. Virtually all drug candidates go through multiple phases before approval. It is a long and costly process.

The budgets for metastatic cancer remain underfunded in general and in relation to other cancer targets. Metastatic cancer continues to be bad news no matter how you slice it.  Whatever the FDA is doing for metastatic cancer, it is far from perfect and hardly enough.

My third encounter with the FDA relates to precision medicines. In his 2015 State of the Union address, President Obama announced the launch of the Precision Medicine initiative “to revolutionize how we improve health and treat disease”. The White House subsequently specified that the Initiative “will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model”. White House Fact Sheet: January 30, 2015.

On September 17, 2015, under the leadership of the NIH Director, the Precision Medicine Initiative Working Group recommended the creation of a national research participant group (a cohort) that would lead to trials of precision therapies, among other things.

In February 2016, I filed a Petition for the FDA to initiate a rulemaking seeking, legal, economic, scientific input on how best to analyze and approve new Precision Medicine Initiatives.

In March 2020, I received a letter denying my Petition.  The FDA said that “between 2013 and 2018, 76 out of 240 novel new drugs approved (31.7%) would likely be considered precision medicines…Additionally, we note that FDA currently employs many vehicles and authorities to encourage drug development”.

The FDA relies upon a serious case of tunnel vision to miss the point. There are likely to be several breakthrough findings emanating from the data in the cohort, but the sponsors of the research findings will need to deal with the FDA’s existing regulatory process.   I don’t think that is what President Obama had in mind when he said the PMI would: “revolutionize how we improve health and treat disease”.  The ensuing applications will take years if not decades to gain FDA approval at a cost of over $1 billion per approved drug. 

My fourth entanglement with the FDA revolved around “Big Data”.  More specifically, researchers collaborating between China and Iowa had found a correlation between Terazosin and Parkinson’s disease.  This was not a trial.  It was what actually happened in the real world. Terazosin had been approved 30 years ago for prostate issues.  The researchers then tracked what effect Terazosin had on the incidence of Parkinson’s and the progression of the disease.  The results were noticeably beneficial on both scores.  This is exactly the type of breakthrough that “Big Data” had promised (presuming the results are not fraudulent).

Despite this fantastic news, I saw little activity around Terazosin so I filed a Freedom of Information Act request with the FDA to determine if the FDA was putting unwarranted burdens on Terazosin before it could be used in the filing of an IND.

I received a phone call denying my request.  The caller said my request would be rejected orally so that no processing fee would be applied.

As a point of reference, FDA’s website says that “if a request for records is denied, a letter of explanation will be sent to the requester, who has the right to appeal the denial”.  This language reflects the wording of federal law.  No such letter was sent.

My fifth and less formal interaction with the FDA transpired with a senior executive to whom I had suggested that not much progress had been made in finding a cure for Parkinson’s disease since I had been diagnosed with the disease over twenty years ago.

I was told that: “Parkinson’s disease research is a very vibrant scientific field. There are a number of different streams of research that are ongoing that we hope will lead to highly impactful therapies…We have frequent communications with all of the U.S. Parkinson’s disease organizations, the Parkinson’s Study Group, academic investigators, and we coordinate on a variety of projects. The NIH system of funding the most meritorious projects has substantially increased our knowledge of Parkinson’s. Our failures in bringing treatments to the goal line are due to remaining large gaps in knowledge of the underlying biology that causes and drives the disease. As we fill in these gaps, the chances of success will increase. Some of the gaps we know about, others we only find out about when the science opens another door”.

While these remarks are sincere, the reality is that there is no plan with tangible steps to find a cure for Parkinson’s disease by a reasonably attainable target date.  The agency appears to be tone deaf to the negative impact that it perpetuates upon the cost and delays of research.

Do these instances provide a basis for concluding the nature of the FDA’s culture?  I think not, but I believe that The House Committee on Oversight and Reform should investigate the FDA’s culture and its practices to determine if the behavior described herein is the exception or the rule.  If the Committee members get answers to their questions that suggest what the FDA is doing is perfect or near perfect, they will have the answer.  The end-result will be that the FDA will not listen to outside ideas or change its practices.  This is particularly harmful in the area of drug research.

My view is that the FDA ignores the “big picture” of the massive hurdles to research it has created by its practices. The rigidity surrounding the practice of safety has overwhelmed the flexibility and creativity needed to cure complex diseases. The cultural trait of believing it has the perfect approach produces results that are nowhere near perfect and its practices – if left unchecked — will continue to bog down progress in the healthcare industry.

Steven Zecola is the managing director of Competitive Strategies and has held executive positions in large companies and the federal government.

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#Healthin2Point00, Episode 229 | Headspace & Ginger merge, Connect America buys 100Plus

It’s M&A day here on Health in 2 Point 00! On Episode 229, Jess and I chat about the big news that Headspace and Ginger are merging to create Headspace Health (for more deets tune into Jess’s interview on WTF Health here). Next up, Connect America buys remote patient monitoring platform 100Plus. Finally, AllStripes raises $50 million in a Series B, bringing their total up to $67 million – this is a rare disease play for clinical trial recruiting. —Matthew Holt

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