More and more molecular data will arrive over the next few years; some of it will be very valuable for more deeply understanding when and how diseases arise. Consider, for example, the fact that genes matter a great deal because they contain the instructions for producing proteins, but we need to know more about actual outputs of proteins coded for by the genes. The proteins, after all, are the actual doers of the work to promote health or fight off disease. Accordingly, it is useful to know which inherited or somatic mutations completely cut off production of a protein (null mutations), while other mutations may have a range of effects, from very little to material.

Today, researchers can answer many questions about the effect of mutations in some genes, and some combinations of genes. However, researchers seek to know more about the protein production results that arise from different combinations of inherited mutations.  With that in mind, consider the disease-related knowledge, questions and hypotheses that will arise from the following collaboration, which is described in a December 14, 2018 press release from SomaLogic and deCode.

___________________________________________

Largest-ever Protein Measurement Study Enhances deCODE’s Efforts in Basic Research, Drug Discovery and Novel Protein-based Diagnostics

deCODE genetics, an Amgen subsidiary, and SomaLogic, Inc. today announced a collaboration that brings together SomaLogic’s expertise in human proteins with deCODE’s expertise in human genetics. The collaboration combines deCODE’s rich data sets with SomaLogic’s leading protein measurement capabilities to enhance the understanding of how human disease and health are mediated through proteins to influence health outcomes.

“I am excited to see what deep proteomic analysis will add to what we already know about human health based on our study of genetics,” said Kári Stefánsson, M.D., Dr. Med., founder and chief executive officer of deCODE genetics. “SomaLogic’s ability to measure thousands of proteins brings a whole new dimension to our efforts, and we look forward to seeing the results.”

Under the collaboration agreement, SomaLogic will analyze up to 40,000 deCODE samples with the proprietary SOMAscan® assay, which can rapidly measure the levels of 5,000 proteins in each sample across a wide range of concentrations. deCODE will use the assay data for therapeutic drug discovery and development. SomaLogic will use the assay results and related clinical information to further develop clinical applications of the SOMAscan assay in an effort to improve health management.

“This collaboration with deCODE gives us an exciting opportunity to work with one of the most highly characterized and understood datasets in the world, as well as with world-class genomic and pharmaceutical scientists,” said Stephen Williams, M.D., chief medical officer at SomaLogic. “We are undertaking together the largest protein study ever performed — over 200 million individual protein measurements — to gain substantial new knowledge about normal and disease biology across many common and rare conditions.”

Specific details of the collaboration were not disclosed.

###

deCODE Contact
Jon Gustafsson
T: +354 664 1905
jon@decode.is

SomaLogic Contact 
Laura S. Mizoue, Ph.D.
Communications Specialist
T: 720 417 7509
lmizoue@somalogic.com

About deCODE genetics
Based in Reykjavik, Iceland, deCODE is a global leader in analyzing and understanding the human genome. Using its unique expertise and population resources, deCODE has discovered genetic risk factors for dozens of common diseases. The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease. deCODE is a wholly-owned subsidiary of Amgen.

About SomaLogic
SomaLogic seeks to empower a healthier world by delivering actionable health-management insights for every seeker and enabler of human health. These essential insights, which are provided through a global network of partners and users, are derived from SomaLogic’s unique ability to measure changes in thousands of individual human proteins over time with high precision, sensitivity and throughput. For more information, visit www.somalogic.com and follow @somalogic on Twitter.

Forward Looking Statement
This news release contains forward-looking statements that are based on the current expectations and beliefs of deCODE and its affiliates. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements regarding improvements in scientific understanding and drug discovery and development.  No forward-looking statement can be guaranteed and actual results may differ materially from those deCODE and its affiliates project. Results may be affected by clinical and regulatory developments and their research, testing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any research and testing will lead to the identification of any particular product candidate or new potential indication for an existing product or aid in their development, or that the development of a particular product candidate or development of a new indication for an existing product will be successful and become a commercial product.

Weekend reading led to an interesting, long form story on the private, automated and apparently  arbitrary and capricious world of  “law” in the Amazon marketplace; see this December 19, 2018 article in the Verge. If one assumes the article is accurate, it seems Amazon is yet another company that disregards existing law (e.g. Uber, Lyft) and just plunges ahead until someone stops it. That conclusion is reinforced by thinking back to Amazon’s many years of refusing to collect sales tax.

Two paragraphs are pasted below to whet the appetite for more:

“Amazon is far from the only tech company that, having annexed a vast sphere of human activity, finds itself in the position of having to govern it. But Amazon is the only platform that has a $175 billion prize pool tempting people to game it, and the company must constantly implement new rules and penalties, which in turn, become tools for new abuses, which require yet more rules to police. The evolution of its moderation system has been hyper-charged. While Mark Zuckerberg mused recently that Facebook might need an analog to the Supreme Court to adjudicate disputes and hear appeals, Amazon already has something like a judicial system — one that is secretive, volatile, and often terrifying.

***

And what’s a seller to do when they end up in Amazon court? They can turn to someone like Cynthia Stine, who is part of a growing industry of consultants who help sellers navigate the ruthless world of Marketplace and the byzantine rules by which Amazon governs it. They are like lawyers, only their legal code is the Amazon Terms of Service, their court is a secretive and semiautomated corporate bureaucracy, and their jurisdiction is an algorithmically policed global bazaar rife with devious plots to hijack listings for novelty socks and plastic watches. People like Stine are fixers, guides to the cutthroat land of Amazon, who are willing to give their assistance to the desperate — for a price, of course.”

Interesting times ahead. Presumably some group with litigation funding will take on Amazon using due process and antitrust law. Or, maybe not.

The U.S. Chamber of Commerce (via its American Tort Reform Foundation) has issued the 2018-19 version of its annual “Judicial Hellholes” report. Of special note this year, the report concludes some hellholes are threatening to appear in “red states,” including Georgia. The entire report is online at this page; pasted below are excerpts about a newly named entrant (the Twin Cities of Minnesota), and the watch list, which includes the Georgia Supreme Court and the Montana Supreme Court.

__________________________

“#9 TWIN CITIES, MINNESOTA A newcomer to the Judicial Hellholes report, the Twin Cities’ position was solidified after the attorney general mishandled a lawsuit against a large Twin Cities employer and a Hennepin County trial judge stripped a company’s defenses. The lower courts appear to be following the lead of the state’s high court after it subjected property owners to expanded liability in 2018 and rejected a measure intended to remove “junk science” from the state’s courts.

WATCH LIST

Beyond the Judicial Hellholes, this report calls attention to seven additional jurisdictions that bear watching due to their histories of abusive litigation or troubling developments. Watch List jurisdictions fall on the cusp—they may drop into the Hellholes abyss or rise to the promise of Equal Justice Under Law.

COLORADO SUPREME COURT Liability-expanding decisions and rulemaking by the court coupled with prospects of a pro-plaintiff legislative agenda in 2019 has created an unfair and unbalanced environment for defendants in the Centennial State.

GEORGIA SUPREME COURT Georgia’s Supreme Court in recent years has issued decisions that significantly expanded civil liability, and that troubling trend continued in 2018.

MONTANA SUPREME COURT The Montana Supreme Court’s penchant for expanding liability, judicial activism, and defiance of U.S. Supreme Court precedent once again landed it on the Judicial Hellholes Watch List.

NEWPORT NEWS, VIRGINIA Perhaps most notable in 2018 is the lack of cases to go to trial in Newport News. Plaintiffs and defendants alike have sought to litigate asbestos cases in federal court, as a result, it is hard to know whether problems and inequities that have manifested themselves in the past will persist. Newport News has been known for its evidentiary double standards, unsound legal rulings and lack of transparency in asbestos litigation.

OHIO EIGHTH DISTRICT COURT OF APPEALS–CUYAHOGA COUNTY A newcomer to the Watch List, the district has developed a reputation for handing down large damage awards and being a “haven” for class action lawsuits. It has developed a troublesome pattern of issuing unbalanced plaintiff-friendly decisions, which had to be overturned multiple times by the Ohio Supreme Court.

PENNSYLVANIA SUPREME COURT The high court issued a series of liability expanding decisions and has been selective, at best, in following U.S. Supreme Court precedent, inexplicably opening its doors to out-of-state plaintiffs.

WEST VIRGINIA SUPREME COURT OF APPEALS In an unprecedented move, West Virginia lawmakers voted to recommend the impeachment of all sitting members of the state’s highest court in 2018. Prior to the impeachment chaos, the court also issued a disappointing class certification decision that rejects U.S. Supreme Court precedent and encourages plaintiffs’ lawyers from all over the country to flock to West Virginia courts to file class action lawsuits. The 2018 elections did bring about some encouraging news with the election of U.S Representative Evan Jenkins and former House of Delegates Speaker Tim Armstead to fill the vacancies on the court.

 

 

“Nationwide, 14% of law-school enrollees are pursuing non-J.D. programs, newly released numbers from the American Bar Association show, compared with 8% five years ago.” The chart and the quote are from a December 20, 2018 WSJ article noting the trend.

It is good to see a focus on the evolution of law schools to offer various forms of degrees and specialized learning, rather like like some specialized MBA programs.  The article would be more cogent if it focused more attention on law school programs focused multidisciplinary programs. A prime example is the Center for Law Science & Innovation at Arizona State University’s Sandra Day O’Connor School of Law.  That program is now 30 years old, and has inspired other similar programs. The LS&I Center is a great success in providing both lawyers to be and science specialists with the legal and non-legal knowledge needed to work in rapidly evolving areas, such as the intersections between genomics and law. See https://law.asu.edu/degree-programs/law-technology.

With trial court approval of a settlement, the parties are close to reaching the end of the long and winding road of the Avery case.   It’s about 20 years old and a fascinating case’ class claim approval occurred in 2016; see here.  As explained by Law360 in a September 16, 2016 article, “the RICO plaintiffs allege that State Farm deliberately sought to “recruit, finance, direct and elect a candidate to the Illinois Supreme Court who, once elected, would vote to overturn the $1.05 billion judgment,” in a plan hatched in 2003. ….The plaintiffs claim State Farm, acting in conjunction with Murnane, Shephard and the Illinois Civil Justice League, tapped into a network of contributors to pour as much as $4 million into Karmeier’s campaign — a sum representing about 80 percent of the campaign’s contributions.  The crux of the RICO allegations are two communications conducted through the U.S. Postal Service: written misrepresentations allegedly sent to the Illinois Supreme Court and to the plaintiffs’ counsel in 2005 and 2011 regarding the magnitude of the insurer’s financial support to Karmeier’s campaign.”

Approval of the settlement is described with some color commentary in a December 14, 2018 post at the Madison- St. Clair Record.

A brilliant new study on parachute use was recently published in the British Journal of Medicine. The researchers/authors presumably will go on to enjoy long careers as expert witnesses in lawsuits involving injuries related to sky-diving. The study is open access and online; it is titled: Parachute use to prevent death and major trauma when jumping from aircraft: randomized controlled trial
BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k5094 (Published 13 December 2018)
Cite this as: BMJ 2018;363:k5094

The authors included the following notable disclosure:

“RWY had the original idea but was reluctant to say it out loud for years. In a moment of weakness, he shared it with MWY and BKN, both of whom immediately recognized this as the best idea RWY will ever have. RWY and LRV wrote the first draft. CS, DBK, JBS, EAS, and JLH provided critical review. RMD provided subject matter expertise. DSK took this work to another satirical level. All authors suffered substantial abdominal discomfort from laughter. RWY worried that BKN would not keep his mouth shut until the Christmas issue was published.”

Set out below is an image of a twitter post from one of the authors.

 

 

 

 

The robocalling epidemic is an example of the complete failure of federal and state regulation and enforcement, the failure of litigation to block the calls, and the ills of shrink-wrapped “terms of service” and blanket consents.   Despite the “do not call” law and lists, the scale of robocalls is massive and growing:  “There were 5.1 billion robocalls made in November — a record 1,963 per second — meaning that the average person did in fact hear more annoying health insurance, easy-money and interest rate scam pitches than ever before, according to a monthly YouMail survey.” That quote is from a December 6, 2018 article in the Chicago Tribune. The article also reports that states are taking some further steps to try to stop robocalls, but it appears they are mainly just trying to facilitate private service solutions needed because of the failure to enforce the existing federal laws.

Over the last couple of years, defense oriented commentators have used the meme “event driven securities litigation” as part of complaining about the increasing volume of class action litigation. From my perspective, there could be merit to some complaints, but the meme is far too broad and all “event driven” cases are not equal. Why? Because the events at issue may range from allegedly causing massive fires to allegedly concealing product liability risks to allegedly failing to disclose accurate facts regarding regulatory interactions with agencies such as FDA to losing verdicts in cases alleging perpetration of massive fraudulent conveyances. Simply put, one size memes do not fit all fact patterns.

That said, the “event driven” meme also came to mind while reading a December 5, 2018 article in LAW360 regarding oral arguments in the Delaware Supreme Court regarding the Fresenius case. There, a would be buyer terminated a corporate m&a deal based on the plummeting value of a target due to regulatory failures, which caused the buyer  to invoke a “material adverse event” clause. The issues went to trial, and a Delaware chancery judge (Lasker) upheld the termination based on adverse outcomes in events prior to the intended closing date for the transaction. In a nutshell, “What mattered was the root of this shortfall. Fresenius claimed that Akorn made misrepresentations when it claimed to be in compliance with Food and Drug Administration regulations and making progress in fixing manufacturing shortfalls. In particular, according to a NYT article of October 2, 2018, Fresenius said that Akorn had been sloppy with — or, worse, fabricated — the data that underlies F.D.A. drug approvals.”

Now, in just three days, the Delaware Supreme Court has affirmed the Fresenius ruling by Judge Lasker, in a brief three page order by Chief Justice Strine. It therefore seems logical to infer that the Delaware Supreme court found it easy to conclude that “event driven” problems could indeed alter the value of an entity so much that the material adverse event clause was properly invoked to terminate the deal. Therefore, one might see merit to at least some “event driven” securities suits.

Another step forward is happening in the effort to find lung cancers early.  It’s an early detection study – in the UK – using both liquid biopsy and LDCT scans.  The program will start in 2019. The program is a joint effort between Grail, UK government agencies and UK medical centers.

The pace of change remains significant. Just under three years ago, Grail and its liquid biopsy goals were publicly announced.  The business is now well underway;  the SUMMIT  project is the third for Grail. The December 3, 2018 press release is pasted below; it provides further specifics.

GRAIL Announces Plans to Initiate SUMMIT Study to Support Development of Blood Test for  Early Cancer Detection

SUMMIT Study Partners Include UCL and University College London Hospitals NHS Foundation Trust in the United Kingdom, and Lung Cancer Alliance

December 03, 2018 07:01 PM Eastern Standard Time

MENLO PARK, Calif.–(BUSINESS WIRE)–GRAIL, Inc., a healthcare company focused on the early detection of cancer, today announced plans to initiate the SUMMIT study in early 2019. SUMMIT is a prospective, observational, longitudinal, cohort study designed to enroll approximately 50,000 men and women age 50 to 77 years who do not have a cancer diagnosis at the time of enrollment. The study will evaluate the ability of an investigational blood test using next-generation sequencing (NGS) technology to detect multiple cancer types, including lung cancer. Approximately half the participants will be people at high risk for lung and other cancers due to a significant smoking history, and the other half will be people who are not at high risk for cancer based on smoking history.

SUMMIT will be conducted in the United Kingdom in partnership with UCL (University College London) and University College London Hospitals National Health Service (NHS) Foundation Trust (UCLH). Lung Cancer Alliance (LCA), a non-profit organization based in Washington, DC, is also a SUMMIT study partner and provided guidance on the study design.

“The SUMMIT study will support the development of our blood test for the early detection of multiple cancer types in a diverse population,” said Anne-Renee Hartman, MD, Vice President of Clinical Development at GRAIL. “We are excited to partner with UCL, University College London Hospitals NHS Foundation Trust, and Lung Cancer Alliance on the SUMMIT study, as we continue to evaluate new ways to improve the early detection of cancer.”

SUMMIT also supports UCL’s and UCLH’s goal of assessing the feasibility of implementing lung cancer screening in the United Kingdom. By participating in the study, people determined to be at high risk for lung cancer will have an opportunity to undergo lung cancer screening with low dose computed tomography (LDCT) and will have access to resources for smoking cessation through the NHS in the United Kingdom. In the United States, LDCT is recommended by the U.S. Preventive Services Task Force (USPSTF) for people at high risk for lung cancer due to current or former smoking. However, currently in the United Kingdom, LDCT is not widely used as a screening tool.

“We have a common goal with GRAIL in conducting the SUMMIT study – the early detection of cancer,” said Sam Janes, Professor of Respiratory Medicine at UCL and Principal Investigator of the SUMMIT study. “By working together, we hope to bring lung cancer screening to people in the United Kingdom, while we also deepen our understanding of potential new technologies for early cancer detection.”

About GRAIL’s Clinical Research Program

GRAIL is conducting what the company believes to be one of the largest clinical research programs ever pursued in genomic medicine in collaboration with leading community and academic medical centers globally. In addition to SUMMIT, GRAIL is conducting two other large-scale studies, which are designed to characterize the landscape of genomic cancer signals in the blood, and to develop and evaluate GRAIL’s blood test for the early detection of multiple cancer types. The Circulating Cell-free Genome Atlas (CCGA) study is a prospective, observational, longitudinal study enrolling at least 15,000 people with and without cancer across 142 sites in the United States and Canada. The STRIVE study is a prospective, observational, longitudinal, cohort study that has enrolled approximately 100,000 women at the time of their screening mammogram across 37 sites in the United States.

About GRAIL

GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is using the power of high-intensity sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop and commercialize pioneering products for the early detection of cancer. The company is located in Menlo Park, California and Hong Kong. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

About UCLH

UCLH (University College London Hospitals NHS Foundation Trust) provides first-class acute and specialist services in six hospitals in Central London. UCLH is committed to education and research and forms part of UCLPartners which in March 2009 was officially designated as one of the United Kingdom’s first academic health science centres by the Department of Health. UCLH works closely with UCL, translating research into treatments for patients. For more information visit www.uclh.nhs.uk or follow on Facebook (UCLHNHS), Twitter (@uclh), Youtube (UCLHvideo), or instagram (@uclh).

UCLH Cancer Collaborative is the Cancer Alliance for north and east London and brings together hospital trusts, GPs, health service commissioners, local authorities and patients to improve early cancer diagnosis, outcomes and care for patients in our area. Working with its stakeholders, its mission is to achieve world-leading patient outcomes and experience for our local population.

About UCL (University College London)

UCL was founded in 1826. UCL was the first English university established after Oxford and Cambridge, the first to open up university education to those previously excluded from it, and the first to provide systematic teaching of law, architecture and medicine. UCL is among the world’s top universities, as reflected by performance in a range of international rankings and tables. UCL currently has over 39,000 students from 150 countries and over 12,500 staff. UCL’s annual income is more than £1 billion. For more information visit www.ucl.ac.uk, or follow on Twitter (@uclnews), or YouTube (YouTube.com/UCLTV).

About Lung Cancer Alliance

Lung Cancer Alliance (LCA) serves and listens to those living with and at risk for lung cancer to reduce stigma, improve quality of life and increase survival. LCA empowers its community by helping people navigate the paths of early detection, diagnosis and treatment. Insights allow LCA to improve care, amplify awareness, drive advocacy and lead research with the vision of tripling the number of survivors in the next decade. For more information, please visit www.lungcanceralliance.org.

Contacts
GRAIL, Inc.
Charlotte Arnold, 650-255-1909
pr@grail.com

 

 

It’s an interesting week for thinking about risk. As it happens, I’m presenting on lethal diseases and “real world evidence” at the annual meeting of the Society for Risk Analysis. Meanwhile, the General Counsel of Praedicat recently published an interesting article on:  “What’s the risk in learning about risks?” It’s well worth reading. The article starts out as follows:

“In talking with product stewardship and risk management professionals, we occasionally see a fear of too much knowledge.  You may believe that knowing about a specific risk means being held legally responsible if the risk manifests.  Unfortunately, that’s true.

Proving liability when a harm results requires showing that the risk was reasonably foreseeable.  And known risks are by definition reasonably foreseeable.  In product liability cases in particular, a manufacturer has a duty to warn consumers of any risks that it knows about or reasonably should know about.”