Aging Population and % of Healthcare GDP

Here to compare the % of population ages 65 and older and healthcare expenditure as a % of GDP.

United States

1960: 9.1%

2017: 15.4%

The number of Americans ages 65 and older is projected to more than double from 46 million today to over 98 million by 2060, and the 65-and-older age group’s share of the total population will rise to nearly 24 percent from 15 percent.

prb.org

Healthcare expenditure rose from 5% of GDP in 1960 to 17.9% in 2017.

China

1960: 3.7%

2013: 9%

2017: 10.6%

By 2050, 330 million Chinese will be over age 65.

The population ages 60+ will reach its highest in 2050:  nearly 35%, at 487 million

预计到2025年,我国60岁及以上老年人口数将达到3亿,占总人口的五分之一;到2033年将突破4亿,占总人口的四分之一左右;而到2050年前后将达到4.87亿,约占总人口的三分之一,老年人口数量和占总人口比例双双达到峰值。

Healthcare expenditure mainly ranges from 4% to 5% from 2000 to 2016, rising constantly in recent years. Considering the rapid growth in its GDP, the healthcare expenditure in China is growing fast.

The percentage of GDP is expected to rise to more than 26% for elders’ caring related costs. [2015-2050年,我国用于老年人养老、医疗、照料等方面的费用占GDP的比例将从7.33%升至26.24%]


Just by comparing China to US, China’s healthcare expenditure percentage is a little lagging behind (~10% 65+ population for 7% healthcare GDP). But the opportunity is large as Chinese demographic is changing rapidly. With the historical “one child policy”, China’s working population will experience a “squeeze”.

「Podcast of the Week」Dog and Human Oncology Connection

Veterinary oncology can be very informative and unveil some otherwise unseen connections and undiscovered research path.

For one thing, pets are exposed to the similar environment as their human owners.

Also their immune systems are better a research/drug development target than lab mice.

And eventually, we will need cancer drugs for pets. They could be developed along with drugs for humans.

And cancer is more than a genetic mutation. It is a systematic disease and needs a comprehensive context study.

EHR and HIPAA, A Dilemma

EHR and HIPAA – Overview

Both are essential parts of running a successful business in health care.

An electronic health record (EHR) is a digital version of a patient’s paper chart. EHRs are real-time, patient-centered records that make information available instantly and securely to authorized users. (healthit.gov)

The Health Insurance Portability and Accountability Act (HIPAA) sets the standard for sensitive patient data protection. Companies that deal with protected health information (PHI) must have physical, network, and process security measures in place and follow them to ensure HIPAA Compliance. (digitalguardian.com)

PHI is any demographic information that can be used to identify a patient. Examples include: names, dates of birth, Social Security numbers, insurance information, phone numbers, full facial photos, and health care records, to name a few examples. (compliancy-group.com)

A Short History

EHR Emerging in the 1970s

US federal government began implementing VistA (formerly known as the Decentralized Hospital Computer Program) at the Department of Veteran Affairs. A study by the Institute of Medicine (now National Academy of Medicine) began in the 1980s, and its findings recommended the use of EHRs when they were published in 1991. (readwrite.com)

The Health Insurance Portability and Accountability Act introduced in 1996

The Health Insurance Portability and Accountability Act (HIPAA) was passed on August 21, 1996, with the dual goals of making health care delivery more efficient and increasing the number of Americans with health insurance coverage. Since its implementation, healthcare organizations have been issued huge fines for non-compliance, e.g. Anthem $16 million HIPPA fine paid in 2018.

The Dilemma

Tough regulations were implemented before the applications (EHRs, etc.) grow into their best format/position  in the healthcare system. The regulations made the softwares slow to upgrade/adjust themselves and prevented certain competitions.

EHRs are only an example of healthcare data regulated by HIPAA but a good one. It could have been a program like Apple Health Kit (on patients’ end) in the current era of well-designed apps like uber/gmail/amazon/instagram; but it was limited at the beginning stage and was left no time to refine itself. No wonder most parts are a vivid demonstration of tech/IT system some twenty years ago.

VistA/CPRS | Source: youtube

Novel FDA Approvals

Since the new FDA Commissioner Dr. Scott Gottlieb was sworn in on May 11, 2017, the traditionally cumbersome regulatory body has shown an unprecedented embracement for novelty in treatments and beyond.

Overarching guidelines:

Here is a roundup of those approvals

Novartis, Kymriah, first gene (transfer) therapy (first CAR-T) available in the United States

  • August 30, 2017
  • Biologics License Application (BLA) submitted on February 2, 2017
  • Approval basis: the safety and efficacy of Kymriah were demonstrated in one multicenter clinical trial of 63 pediatric and young adult patients with relapsed or refractory B-cell precursor ALL. The overall remission rate within three months of treatment was 83 percent. (FDA statement)

Pear Therapeutics, the Reset app, first mobile application to treat substance use disorders (SUD)

  • September 14, 2017
  • de novo premarket review pathway
  • Technology: the device delivers cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUD and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs. The system is intended to be used in conjunction with outpatient therapy and in addition to a contingency management system, a widely-used program for treating SUD that uses a series of incentives to reward patients for adherence to their treatment program.
  • Approval basis: a multi-site, unblinded 12-week clinical trial of 399 patients who received either standard treatment or standard treatment with the addition of a desktop-based version of Reset which could be accessed at the clinic or at home. The data showed a statistically significant increase in adherence to abstinence for the patients with alcohol, cocaine, marijuana and stimulant SUD in those who used Reset, 40.3 percent, compared to the patients who did not, 17.6 percent. The clinical trial did not demonstrate the effectiveness of using the Reset device in patients reporting opioids as their substance of abuse. (FDA statement)
reSET app | Source: New York Times

Memorial Sloan Kettering Cancer Center,  IMPACT test, first tumor-profiling laboratory-developed test to receive authorization through the FDA

  • November 15, 2017
  • de novo premarket review pathway
  • Technology: the IMPACT test uses next-generation sequencing (NGS) to rapidly identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a person’s tumor.
  • Approval basis: results indicated that the assay is highly accurate (greater than 99 percent) and capable of detecting a mutation at a frequency of approximately 5 percent (range of 2-5 percent). Additionally, detection of certain molecular changes (microsatellite instability) using the IMPACT test was concordant more than 92 percent of the time across multiple cancer types in 175 cases, when compared to traditional methods of detection.
  • Along with this authorization, the FDA is also establishing a Class II regulatory pathway for the review of other NGS-based tumor profiling tests for use in patients diagnosed with cancer. Class II designation allows these types of tests to be eligible to use the FDA’s 510(k) clearance process, either by submitting the application. (FDA statements)
Source: mskcc.org

Proteus Digital Health x Otsuka Pharma, Abilify MyCite, first drug in the U.S. with a digital ingestion tracking system

  • November 13, 2017
  • New Drug Application (NDA) dated and received June 26, 2015
  • Technology: the system works by sending a message from the pill’s sensor to a wearable patch. The patch transmits the information to a mobile application so that patients can track the ingestion of the medication on their smart phone. Patients can also permit their caregivers and physician to access the information through a web-based portal.
  • Approval basis: Abilify was first approved by the FDA in 2002 to treat schizophrenia. The ingestible sensor used in Abilify MyCite was first permitted for marketing by the FDA in 2012. (FDA statement)
Source: npr.org

Spark Therapeutics, Luxturna, first (directly administered) gene therapy approved in the U.S. to target a disease caused by mutations in a specific gene

  • December 19, 2017
  • Biologics License Application (BLA) dated April 26, 2017, and received May 16, 2017
  • Approval basis: The efficacy of LUXTURNA in the Phase 3 study was established based on the multi-luminance mobility test (MLMT) score change from baseline to one year. LUXTURNA Phase 3 clinical study results showed a statistically significant difference between the intervention group (n=21) and control participants (n=10) at one year in median bilateral MLMT score change (intervention minus control group difference of 2; p=0.001) and median first-treated eye MLMT score change (intervention minus control group difference of 2; p=0.003). (Spark press release)
  • FDA statement
Luxturna | Source: Spark Therapeutics

Loxo Oncology, Vitrakvi, first time that an entirely new treatment has received a tumor-agnostic indication at its initial approval

Source: genengnews.com

Apple, the ECG app (with Apple Watch), first FDA clearance for retail ECG watch technology

  • September 11, 2018
  • De Novo clearance from the Center for Devices and Radiological Health, classified as Class II under the generic name electrocardiograph software for over-the-counter use
  • Technology: the ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform
  • FDA statement
  • FDA letter to Apple
  • covered in a previous blog: New Era of Medical Grade Consumer Device
Apple Watch Series 4, the ECG app | Source: Apple
  • January 17, 2019 update: Alphabet’s life sciences unit Verily received 510(k) clearance from FDA as a Class II medical device for its on-demand ECG feature
Study Watch | Source: Verily

 

Current Anti-Aging Startups Roundup

Anti-aging is a centuries-long problem and we don’t have an answer.

Here is a summary of current notable efforts that might provide some sort of solution.

Biopharma/Therapeutics Approach

Unity Biotechnology – eliminate senescent cells
Source: Unity Cellular Senescence Investor & Analyst Presentation on Dec. 11, 2018
  • Lead candidate UBX0101, a first-in-class senolytic molecule
  • UBX1967
    • January 2019, completed license agreement with Ascentage Pharma, granting Unity the exclusive worldwide development and commercialization rights and non-exclusive manufacturing rights outside of Greater China (China, Hong Kong, Macau and Taiwan) for UBX1967 in all non-oncology indications. Inside Greater China, UNITY is obligated to commercialize UBX1967 through a joint venture with Ascentage Pharma. The UBX1967 License Agreement also grants UNITY the right to continue its preclinical development efforts with respect to another Ascentage Pharma-controlled Bcl-2 inhibitor compound that will serve as a back-up to UBX1967.
    • Per the 2016 pact, should Unity choose to license at least one more products, the Chinese biotech will gain a total of 1,333,338 shares
    • plans to file an IND application for UBX1967 in the second half of 2019
Calico – A previous google company
  • Founded in 2013, Calico started within Google (later Alphabet) and soon jump-started with huge fundings – a $1.5 billion initiative/collaboration in September 2014 with Abbvie. “AbbVie and Calico will each initially provide up to $250 million to fund the collaboration with the potential for both sides to contribute an additional $500 million.”
  • In June 2018, the collaboration was extended with another $1 billion. “AbbVie and Calico will each commit to contribute an additional $500 million to the collaboration.”
  • It was also cited that “since 2014, the collaboration between the two companies has produced more than two dozen early-stage programs addressing disease states across oncology and neuroscience and yielded new insights into the biology of aging.”
samumed
Napa Therapeutics

Data Approach

Juvenescence AI
  • A subsidiary of Juvenescence, a joint effort of Juvenescence + Insilico Medicine
  • Formed in July 2017
Human Longevity
  • Was valued at $1.6 billion in 2017 with fundings from Celgene, Illumina, GE Ventures, etc.
  • Declined to a valuation of $310 million according to a WSJ report

Portfolio Approach

Juvenescence
Life Biosciences
  • Jan. 2019 Series B of $50 million
  • co-founded in 2017 by David Sinclair and Tristan Edwards
  • 8 Subsidiaries
    • Prana Biotechnology (an initial $7.5 million investment in Jan.2019)
    • Lua, HIPAA-compliant medical technology platform (acquired in Oct. 2018)
    • Senolytic Therapeutics acquired at a very early stage
    • Jumpstart Fertility acquired at a very early stage
    • the other four were formed in-house (Selphagy Tx, Spotlight Biosciences, Continuum Biosciences, Animal Biosciences)

Somehow, reminded me of Theranos… also an area that might not be reguated by FDA… (Ageing is not a disease by FDA’s definition) and some are backed by non-traditional biotech VC firms… But most seemed to be more experienced and sophisticated in biology and medicine (than Theranos’ average).

2019 US Cancer Update by American Cancer Society

The annual report from American Cancer Society is up today, available 1) in the article format “Cancer Statistics, 2019” (published in the American Cancer Society’s journal CA: A Cancer Journal for Clinicians), 2) in a companion report, Cancer Facts and Figures 2019, and 3) on the interactive website, the Cancer Statistics Center.

Steady Decline In Cancer Death in US

Compiled within includes the death rate of cancer through 2016. It marked a continuous 25-year of decline in cancer death in US since 1991.

The overall age-adjusted cancer death rate rose during most of the 20th century, peaking in 1991 at 215 cancer deaths per 100,000 people, mainly because of the tobacco epidemic. As of 2016, the rate had dropped to 156 per 100,000 (a decline of 27%) because of reductions in smoking, as well as improvements in early detection and treatment.

– American Cancer Soceity

Female death rate from major cancers
Male death rate from major cancers
Lung cancer & smoking

While lung cancer is still the largest category, it is declining with the smoking trend as mentioned above.

2019 Cancer Estimation

The 2019 cancer estimation has also come in.

2019 Estimated new cases and deaths of cancer | Source: cancerstatisticscenter.cancer.org

Incidence rates are estimated to be 494.8 and 419.3 per 100,000 population for male and female; death rates are estimated to be 193.1 and 137.7 per 100,000 population for male and female.

In total, there will be an estimated 1,762,450 new cancer cases and 606,880 cancer deaths.

Two Eggs a Day? Nutrition Facts 和 玄学

前两天了解营养成分表,除了看 Vc 也顺带看了其它项目,比如胆固醇 (cholesterol)。

常识告诉我鸡蛋里胆固醇很多,尤其蛋黄,于是搜了一下 – 一个鸡蛋 (50g) 含胆固醇 187mg,占 Daily Value % 的 62%

意味着一天两个鸡蛋是超标的饮食?

于是找了下具体的解释 – 胆固醇被看作是心血管疾病的风险因素。但更细地说应该是其中一种:Low-density lipoprotein (LDL) 低密度脂蛋白胆固醇。

high levels of LDL (bad) cholesterol in the blood increased the risk of cardiovascular disease

LDL cholesterol 主要由有人自身肝脏产生,而不来自于饮食。肝脏主要由 saturated fat 饱和脂肪和 trans fat 反式脂肪刺激产生低密度脂蛋白胆固醇。

但即使这样,似乎正式说法也只有 – 对于大多数人,每天一个鸡蛋不会增加心血管疾病风险。

食品领域没有太多准入制度,不像药品。也不存在跟踪长达50年的临床试验来说明这些问题。何况有太多因素影响营养摄入,我很难想象能做出有意义的长期大型对照实验。何况,即使做出来,证明一天两鸡蛋增加风险亦或不增加风险,也不会对社会有极大影响,也没有集中的利益体现。对于普通人的生活来说,这一点风险的回报也很难体现,或许人类平均寿命会因此提高个0.5年?没有significant的benefit…

这大概是为什么连鸡蛋这种基础的食物,在摄入问题上,还依旧处于类玄学的状态。

我相信会有一个明晰的路径可以分子级别地解释每天摄入食物的影响,并通过实时的指标反映出来。

只是我们对生物营养的理解,大多还停留在高速计算模拟时代前。

等待全面提速的那一天。

A Long-Term Investment – (Orange) Juice

投资的概念可以很广泛,比如,一个每日补充Vitamin C的50年计划

很多生物可以自行合成维生素C,但高等灵长类除外,例如人类。直接原因是我们祖先的某项基因突变;如果用主流的进化论来解释 – 我们的祖先可以轻易获得V-c含量丰富的食物后,自然选择导致。

小时候关于坏血病的故事大概是最早对V-c有印象的来源。关于V-c的作用,描述相当多。我从Mayo Clinic上提取一些关键词:1. healing process 修复愈合 2. protect your cells against the effects of free radicals (自由基) 3. 铁等矿物质的吸收 etc.

FDA规定食品上标注的营养指标,包括了V-c,基准每日摄入 (DV, Daily Value) 是60mg(推荐摄入含量为19岁及以上男 90 mg,女 75 mg)。以常见的tropicana橙汁为例,在FDA官网可以查到它的营养成分表 – 每240ml含有72mg V-c,也就是包装上常见到的Vitamin C %DV – 120%。

240ml 是什么概念 – 星巴克的Tall size咖啡是12 oz (350 ml),short size是8oz (240ml)。

现在来做一下小学算术 – 假设就拿橙汁作为补充V-c的方法(mixed水果蔬菜更好),一天8oz,wholefoods 的 tropicana 59oz装标价 $4,算它一周的quota (7 x 8oz = 56oz);一年 50 x $4 = $200 (实际52周);50年的话,不算 inflation discount rate 之类,50 x $200 = $10,000

作为一项 life time 的投资,且不说潜在的医疗花费减少,仅仅是50年后更好的精神/身体状况,就绝对算超值投资了。You can’t put a price on that.

一大波 disclaimer – 1. 合理健康的饮食永远好过其它方式补充V-c 2. 橙汁只是一种补充V-c的例子,不能一直喝橙汁,需要考虑其它添加剂等潜在不健康因素,哪怕就是超量的糖摄入,也是不好 3. V-c不是药,也不是什么神奇补品,只是人所必须的基础维生素之一 4. 补充V-c的未来价值建立与长期 V-c 摄入不足的对比上(比如肉米饭面食鸡蛋牛奶,基本没有V-c)5. V-c 只是健康饮食的一个元素,这是一个例子,需要注意各方面的摄入 6. 过量摄入各类营养元素有副作用

所以,其实想说的是两点:

  1. 投资不只是买股票等金融资产,投资自身健康是一个获得超值回报的思路,虽然最终的return很难量化
  2. 与FDA相比,中国的食品监管 still a long way to go,已经看到很多好的开始,还需各方努力多年,不出大事或者控制事态只是minimum,不应该是目标,一个全民更健康的未来才是