Lab Soft News

Unsung Physician Hero in the Theranos News; "It's Too Good to Be True"

In terms of the hospital partners of Theranos, the Cleveland Clinic has gotten much of the attention. However, there is another announced hospital relationship of note with Intermountain Healthcare (see: Doctor Questions Theranos as His Employer Plans Lab-Test Pilot; This CEO is out for blood). Below is an excerpt from the first link published on October 16, 2015:

A senior doctor at one of Theranos Inc.’s partners for a pilot program of its blood-testing technology questioned the accuracy of the startup’s tests, adding to mounting criticism of the Silicon Valley company.....The Wall Street Journal reported...that the health-care startup, which the newspaper valued at $9 billion, has used the same technology as its competitors for most of its blood tests, undermining the company’s promotion of its technology as an advance in the healthcare industry. "Theranos has refused to disclose their methods, they have never made their data public, they have not gone through the peer review process," Joel Ehrenkranz, director of endocrinology at Utah-based hospital system Intermountain Healthcare, said during an interview with Emily Chang on Bloomberg Television...."They don’t play by the rules of science or medicine. They are not transparent."A spokesman for Intermountain said Ehrenkranz wasn’t speaking for the hospital system. In an interview ....Theranos Chief Executive Officer Elizabeth Holmes responded to Ehrenkranz’s comments, saying the medical industry is typically resistant to change."It is completely normal for someone to say, ‘I don’t know if this is real,’" she said.....Theranos and Intermountain are still planning their limited pilot program for blood testing, and a start date hasn’t been determined....Intermountain will run the study at one clinic where Theranos technology will be used alongside traditional blood testing.... Ehrenkranz isn’t involved in the pilot program...."Within the industry, the consensus is that this is too good to be true," he said.

It's unusual for a lone-wolf critic of a major enterprise like Intermountain Healthcare to get attention. We thus need to give credit to Emily Chang on Bloomberg Television for bringing Dr. Ehrenkranz's opinion to the forefront. However and more importantly, I want to emphasize his integrity and courage for speaking out in the face of an announced relationship of his large health system employer. Note the sentence above: A spokesman for Intermountain said Ehrenkranz wasn’t speaking for the hospital system. I suspect that this spokesperson might want to rephrase this announcement in the light of recent events.

The specific nature of the relationship between Intermountain and Theranos has never been detailed other than it's pilot program. However, Intermountain also has an excellent reference lab that could be used by Theranos for referral of some its esoteric testing. To finish, let me just reiterate the prescient quote from Dr. Ehrenkranz that a lot of other lab professionals were thinking but not saying to the press: Within the industry, the consensus is that...[the Theranos story] is too good to be true.

Holmes May Have Exaggerated Data about Theranos Business Relationships

Much of the early press coverage of Theranos has been very adulatory (see: Another Puff-Piece about Theranos; Extracting the Most Salient Points; Five Visionary Tech Entrepreneurs Who Are Changing the World). It's possible that journalists were so enthralled with the Elizabeth Holmes' "story" and they did insufficient fact-checking about some of the claimed business relationships of the company. Hints of this emerged in a story about Theranos in the Financial Times (see: Theranos blood labs under fresh scrutiny on staffing and quality) Below is an excerpt from it:

On its website and in the press, Theranos has trumpeted its partnerships with larger companies and organizations  including big pharma groups, the Cleveland Clinic, and Walgreens, the pharmacy. Several articles about the company, including a profile of Ms Holmes in the New Yorker in December, have said that the company “earned income from large pharmaceutical companies, including Pfizer and GlaxoSmithKline, which use its tests when they are conducting clinical trials on new drugs”. A spokesperson for Pfizer said: “We’ve done only very limited historical exploratory work with Theranos through a few pilot projects, and we do not have any current or active projects with them.”“I cannot find any evidence that we’ve done business with them in recent years,” said a spokesperson for GSK. The Cleveland Clinic said that it had not yet used the group’s technology, and emphasized the early stage of their partnership.

Here's another perspective about these phantom drug company contracts from the Verge (see: Theranos didn’t work with the huge drug company it supposedly made money from, huge drug company says):

It's unclear why so many news outlets reported a partnership between Theranos and GSK when the pharmaceutical company has no record that one ever existed. It's also unclear what "limited historical exploratory work" means for Pfizer....But if these two large pharmaceutical companies are correct, then it means that Theranos has allowed incorrect information to spread for more than a year — most notably in a prominent New Yorker profile of Elizabeth Holmes, the company's founder. 

One of the claims of Theranos is that the company has been running tests and generating revenue from military contracts (see: Scientists are skeptical about the secret blood test that has made Elizabeth Holmes a billionaire). Here is a quote from this article:

We know enough to say that there is something promising about Theranos....Holmes has teamed up with Walgreens to put Theranos labs inside its pharmacies....; Theranos has been conducting tests for GlaxoSmithKline and Pfizer and several hospital systems; it recently set up a partnership with Cleveland Clinic; and it earns revenue from the work it does for the US military, though Holmes has previously declined to elaborate on that, beyond saying that it's an important area with the potential to save lives. Each lab is certified, and it can operate officially in a clinical capacity.

It should be easy enough to nail down the Theranos relationship with the military, given the number of generals who sit on the company Board. 

Sunquest Announces Roper Technologies' Acquisition of CliniSys and Atlas Medical

In a major announcement, Sunquest has reported that its parent, Roper Technologies, has acquired both CliniSys and Atlas Medical (see: Sunquest Announces Roper Technologies' Acquisition of CliniSys and Atlas Medical). Here is an excerpt from the press release:

These acquisitions, combined with Sunquest and Data Innovations, expand Roper's portfolio of companies focused on diagnostic solutions excellence even further....CliniSys is one of the largest European suppliers of laboratory information systems, providing comprehensive clinical laboratory and order communication systems to more than 2,000 laboratories in 34 countries....Atlas's LabWorks platform connects diagnostic testing facilities to their customers and enables smart ordering, dramatically improved test utilization, and results reporting. Atlas also connects physicians and patients with lab test results via Atlas Physician Portal. Atlas is the industry leader in connecting laboratories to electronic health records (EHRs), Accountable Care Organizations (ACOs) and Health Information Exchanges (HIEs).

Walgreens Scrutinizes Its Theranos Relationship More Closely

A key feature of the Theranos business model is the location of the company's blood collection/testing centers in Walgreens drug stores in California and Arizona. Because of the recent media attention regarding problems with the quality control of the Theranos lab tests (see:Theranos Business Model Begins to Unravel; Much Negative Press Follows), Walgreens has decided not to open any new Theranos blood-testing centers in its stores until Theranos successfully resolves questions about its technology (see: Walgreens Scrutinizes Theranos Testing). This is a logical and appropriate action by Walgreens. The company can't tolerate any damage to its reputation on the basis of its relationship with Theranos. All of this calls into question, however, the due diligence that was exercised by Walgreens when the company launched its alliance with Theranos. Some interesting morsels about this topic were buried in its WSJ article referenced above. I quote them below:

Walgreens Boots Alliance Inc. won’t open any new Theranos Inc. blood-testing centers until the startup company resolves questions about its technology, according to a Walgreens official....Walgreens officials... were concerned after finding out in a follow-up article in the Journal that Theranos had stopped collecting tiny vials of blood drawn from finger pricks for all but one of its more than 240 tests. Walgreens officials also were unaware of the Food and Drug Administration’s surprise inspection of Theranos facilities in August and September, the people added....[T]he drugstore chain has “no concrete plans at this stage” to expand the partnership beyond the 41 stores in Arizona and California that now include Theranos “wellness centers,”....“We’re trying to figure out where we are and what we do going forward. We need to understand the truth,” the official added....The drugstore chain has an equity stake in Theranos as part of the partnership, according to a person familiar with the matter....

Some of the [Walgreens] directors discussed how to reach out to Theranos, how they would try to understand any regulatory review and scrutinize why Theranos sharply narrowed its use of tiny vials of blood from finger pricks without telling Walgreens officials....For Walgreens, the [Theranos] deal was part of a larger push to make “back-of-store” pharmacies more valuable, while luring more customer traffic to the “front end,” where beauty products, snacks and other higher-margin products are sold, according to current and former Walgreens executives....The drugstore chain’s clinical-services group typically vets the science and practices of prospective outside medical partners early in the process, but was brought in later with Theranos, according to current and former Walgreens officials. The Theranos deal “went down a different route,” one former Walgreens executive said. 

There seems to be a familiar pattern unfolding here with regard to Theranos. Investors and business partners like Walgreens may have made assumptions about the quality of its yet unproved Edison analyzer technology based on vague Theranos assurances. As noted above and in the case of Walgreens, the "vetting" of a potential partner is usually done by its clinic services group but this business unit was "brought in later" according the Walgreens executives. Perhaps the project was also propelled by the fact that the drug store chain had a financial stake in a company that seemed like a hot prospect. I can understand that VC's might be a little vague about IVD technology but the pharmaceutical industry, like the clinical lab industry, is based on scientific principles and is highly regulated. Bypassing the clinical services group seems to have caused problems for Walgreens.  

From my point of view, one of the next "shoes to drop" in the Theranos story could be the relationship between the Cleveland Clinic and Theranos (see: (see: Cleveland Clinic Develops Business Partnership with Theranos; Further Discussion about the Cleveland Clinic Relationship with Theranos)). Although not as well publicized as the one with Walgreens, it may elicit more discussion in the future. The Clinic could be in a position to silence the Theranos critics if it acts quickly to validate the Theranos testing methodologies. At this point, I don't think that the critics will be satisfied with the Theranos explanation that this depends on the FDA. They will demand comparisons of the Edison technology with standard, FDA-approved, IVD instruments and reagents. Is this a project that the Cleveland Clinic pathology department is willing to undertake and Theranos will support?

Questions Continue about Theranos; Company Intends to Publish Rebuttal

The debate continues about the Edison analyzer technology used at Theranos, at least on a restricted basis currently. Huge media attention was invoked by a recent investigative piece in the Wall Street Journal that was also the centerpiece in my recent blog note (see: Theranos Business Model Begins to Unravel; Much Negative Press Follows). The New York Times subsequently published an interesting follow-up piece (see: Theranos, a Blood Testing Start-Up, Defends Its Accuracy); Below is an excerpt from it:

Ms. Holmes now says she is planning to release a 16-page point-by-point rebuttal of the articles, a document that concludes by accusing the articles’ author of having an agenda that considered Theranos “a target to be taken down.” The rebuttal even dissects the motivations of various people quoted in the articles.“We’ll put this out there and let people judge for themselves what the facts are,” Ms. Holmes said on Tuesday in an interview with The New York Times.....But the company, which is highly secretive about its technology, has not announced any new policies in response to the criticism. Theranos, Ms. Holmes said, had no immediate plans to do what skeptics say would most persuade them: publish data in peer-reviewed medical journals showing that its test results were as accurate as those of more established laboratories. She said that other institutions testing Theranos’s products might eventually publish papers, but that the company, for now, was concentrating on getting its tests approved by the Food and Drug Administration. That, she said, would provide even better external validation....

Ms. Holmes, who started the company at age 19 and has said that she devotes nearly every waking hour to it, has graced the covers of magazines including Fortune, Inc. and The New York Times’s T magazine, and she is a frequent presence on the conference circuit. She recently appeared at Vanity Fair’s New Establishment Summit alongside Facebook’s chief executive, Mark Zuckerberg, and Walt Disney’s chief, Robert A. Iger.....A spokesman for The Wall Street Journal thanked Ms. Holmes for attending the conference but added, “Nothing said at the conference by Ms. Holmes refutes the accuracy” of the articles. The Wall Street Journal is not the only one raising questions. Jean-Louis Gassée, a former senior executive at Apple, wrote in a [recent] blog post ...that the results of two tests from Theranos raised alarms about his health when results for the same tests on the same day from Stanford Hospital did not (see: Theranos Trouble: A First Person Account). Moreover, the Theranos results varied more widely from one day to the next than those from Stanford, he said. 

I have the following brief comments:

• Never before has the founder/CEO of a clinical reference lab achieved the status of a media rock star. This attention should (hopefully) die down soon but I it seems possible that a number of VC's in Silicon Valley may be heatedly discussing the relative merits of lab proficiency testing over their morning latte's. 
• Ms. Holmes continues to avoid publication of comparison validation data in peer-reviewed medical journals, the gold standard in the field of clinical pathology. I have blogged previously about the announced relationship between Cleveland Clinic and Theranos, which could potentially provide such scientific validation (see: Cleveland Clinic Develops Business Partnership with Theranos; Further Discussion about the Cleveland Clinic Relationship with Theranos). However, I doubt whether the Clinic would risk wading into this media frenzy in any way with a publication about Edison, either pro or con. The latter type of report, of course, would never be permitted by Theranos.
• I am encouraged by the fact that a single customer complaint about the accuracy of the Theranos lab results could seem to shake the foundations of what is reportedly a company with a market value of $9B. Perhaps we need to take into account that the specific customer was, in fact, Jean-Louis Gassée, a former senior executive at Apple.
• As to whether Theranos is a considered “a target to be taken down,” I think that a lot of lab professionals are highly concerned that her current modus operandi ignores institutions and processes that have delivered many decades of high quality lab testing in the U.S.

Update on 10/23/2015 @ 1:48 PM EDST: Ok, Theranos: Here's the Data the World Need to See

eClinicalWorks Launches New Cloud Service; EHR Label Becoming Obsolete?

It seems logical to me that cloud computing is the answer for most healthcare IT services. This approach is much more common for EHRs than LISs although Xifin has a cloud-based AP-LIS (see: Xifin's ProNet Expands Business Opportunities in Telepathology). eClnicalWorks has just rechristened its flagship EHR service but wants to move away from the EHR label (see: eClinicalWorks rechristens flagship cloud service: 'Don't call it an EHR). Below is an excerpt from the article:

In what has become something of a grand tradition among technology vendors, eClinicalWorks announced a fresh version of its software and cloud services and bestowed a new 'e' upon its name....[Founder Girish] Navani...[was quoted in the following way:] "We're coming out with what will be the expectation of next-generation EHRs."  To that end, Navani described eClinicalWorks 10e as a hardware-agnostic quiver of cloud-based tools including big data, home monitoring, mobile features, patient engagement, population health, social media, telehealth tools, some revenue cycle capabilities, and the ability to incorporate data from wearables....[The product]...also includes core EHR functionality like e-prescribing and physician notes.....EHR makers such as Allscripts, athenahealth, Cerner, Epic, Greenway, McKesson, and NextGen are also sprouting up from the electronic health records pot. Greenway, for its part, released new population health tools this spring and followed that with a "refreshed brand" that it claims focuses "on the next chapter of healthcare" involving chronic disease management and patient-provider interaction...Navani claimed that 10e makes eClinicalWorks among only a few national vendors to offer hardware-agnostic services.The software or service runs on Windows machines, Mac operating systems, Android, and supports HTML 5.

For me, one of the most interesting aspects of this new eClinicalWorks product is that it integrates "telehealth visits from within the EHR" (see: New Cloud Services Platform Changes Definition of Electronic Health Records to Include Population Health and Patient Engagement). I am not sure how the documentation of a telehealth visit differs from the usual type of visit with the patient and the healthcare provider in the same room. Perhaps the documentation of all telehealth visits will, or should, store a video record of the visit. I also think that it's possible that the EHR label is a little shopworn. Garish Navani's list of new features of his system that move beyond our current definition of an EHR are interesting and help to make his point: big data, home monitoring, mobile features, patient engagement, population health, social media, telehealth tools, and the ability to incorporate data from wearables.

Changes in the Cause of U.S. Deaths; Insights into Preventable Diseases

I came across a very interesting infographic published by the Cleveland Clinic about changes in the cause of U.S. deaths in 1900 compared to 2015 (see: Causes of U.S. Deaths Have Changed Greatly (Infographic)), In 1900, the top four causes of death were pneumonia and flu, tuberculosis, digestive diseases, and health disease. In 2015, the top four were heart disease, cancer, lung disease stroke. The infographic then goes on to state that none of the top four causes of death in 1900 were preventable at that time but all of the top four causes of death in 2015 are partly preventable. In 1900, there were no antibiotics and vaccines for pneumonia, flu, or infections. The cause of tuberculosis was not well understood and there was no BCG, a vaccine to prevent TB. There were no medical treatments for digestive diseases. There was also no understanding of the relationship between heart diseases and diet or lifestyle.

I have blogged frequently about the contribution of lifestyle to chronic diseases, which is now clearly understood (see: Seeking the Correct Definition for a "Lifestyle Disease"; Add Colonic Cancer to the List of "Lifestyle" Neoplasms; Disease Management Programs Provide More Cost Savings than Lifestyle Programs). The infographic makes the following points about the extent to which the four major causes of diseases today can be prevented: (1) about 1/3 of all heart disease is preventable through lifestyle changes; (2) about 1/5 of all cancers may be preventable/treatable through lifestyle changes and screening; (3) most lung diseases can be prevented by not smoking; and (4) about 1/3 of all stokes can be prevented through healthy lifestyles.These percentages are very illustrative of how we could change the health status of much of our population by spending a relatively minor amount of money on health education as opposed to drugs and surgery. I do not envision such changes as coming easily. However, we spend billions tempting people to eat unhealthy foods and beverages or use drugs to treat our ailments. Could we not ramp up our efforts to persuade people to lead healthier lives? One of the answer to this question involves enhanced patient engagement however that can be achieved (see: What does 'patient engagement' really mean?).

I want to focus very briefly on the changes which occur when one stops smoking (see: Improve Your Odds for a Long and Healthy Life). Below is a list of statements about the changes that occur when cigarette smoking ceases. What is fascinating about these statements is how quickly benefits accrue.

• A smoker's heart rate drops within 20 minutes after the last cigarette.
• Carbon monoxide levels in the blood drop to normal 12 hours after quitting.
• Within 2 weeks to 3 months after quitting, a smoker's heart attack risk begins to drop, and lung function begins to improve.
• One year of not smoking cuts the risk of heart disease in half,

Theranos Business Model Begins to Unravel; Much Negative Press Follows

The recent negative press about Theranos was initiated last Friday when the Wall Street Journal published a hard-hitting investigative piece by John Carreyrou about the company (see: Hot Startup Theranos Has Struggled With Its Blood-Test Technology). He was able to interview former Theranos employees who indicated that the company was having difficulty deploying its secretive analytic technology which supposedly requires only small aliquots of blood. The device was named for the first time in the article as Edison. The article claimed that the company was using "standard" analyzers from Siemens for most of its testing. The article also indicated that the company was struggling with its lab proficiency testing. Here's a quote from it:

Whether labs buy their testing instruments or develop them internally, all are required to prove to the federal Centers for Medicare and Medicaid Services that they can produce accurate results. The process is known as proficiency testing and is administered by accredited organizations that send samples to labs several times a year. Labs must test those samples and report back the results, which aren’t disclosed to the public. If a lab’s results are close to the average of those in a peer group, the lab receives a passing grade.In early 2014, Theranos split some of the proficiency-testing samples it got into two pieces, according to internal emails reviewed by the Journal. One was tested with Edison machines and the other with instruments from other companies. The two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer. The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings.

A follow-up article in the Wall Street Journal indicated that Theranos was now performing only one test from its very large test menu with the Edison device (see: Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest): 

Under pressure from regulators, laboratory firm Theranos Inc. has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests, according to a person familiar with the matter.... As a result of the halt, Theranos is operating more like a traditional lab that draws blood with needles from patients’ arms....During the inspection, FDA officials indicated to Theranos that the agency considers the “nanotainers” made and used by the company to collect finger-pricked blood an unapproved medical device, the person familiar with the matter said.

To the uninitiated, it may seem strange that the FDA would pick the sample collection device as a regulatory target. Why not focus on the innovative and high-tech Edison device? I think that reason for this choice is that the tests performed by Edison fall under the rules of a laboratory developed test (LDT) and are thus given greater latitude under the current FDA regulations. By referring to the nanotainers as an unapproved medical device, the FDA has an opportunity to ask questions about the broader Theranos operations. Elizabeth Holmes, the company founder and CEO, commented on the company's relationship with the FDA in a recent interview (see: A comprehensive guide to Theranos’s troubles and what it means for you). Below is an excerpt:

“We believe the model for the lab of the future is to take all tests through FDA review,” the company said in a statement. “The FDA is putting our tube that transports the blood for our devices through its rigorous review process. That’s what we are advocating for. During this process, we also made the decision to move our existing quality systems operations over to FDA quality systems completely, while we work with FDA for clearance on our tubes.”

In the opinion of many people, Theranos has been viewed with an uncritical eye by the press thus far, partly because of its Silicon Valley credentials and the charisma of its young founder (see: The Theranos Affair: When Silicon Valley hype outpaces reality). Moreover, the Theranos board of directors has always been perceived as atypical for a reference laboratory. It's made up of former high-level federal officials like Henry Kissinger and retired generals who seemingly would have little knowledge about the clinical lab industry (see: Theranos' board: Plenty of political connections, little relevant expertise). However, even this Board with all of its political connections should have understood that that the FDA would not take kindly to being embarrassed in the light of recent questions about Theranos test quality (see: The Dispute between the FDA and 23andMe; What's Really Going On?). It's also of interest that Theranos has now turned to Washington insider attorney David Boies for help. His billing rate is very high so he tends to be called in only when a company has a very big problem.

Why have questions about test quality at Theranos been so explosive? Did the business model not contain other innovative ideas like direct access testing (DAT) and locations inside Walgreens drug stores (see: Theranos Trouble: A First Person Account)? Much of the Theranos hype has been based on interviews with founder Elizabeth Holmes' who is needle-phobic and has stressed the fact that a finger stick and a small blood sample would be less traumatic for the patient (see: Theranos Isn’t the Only One Chasing Needle-Free Blood Tests). Multiplexed lab testing should also be cheaper to perform than standard testing because little reagent is used and many more test results are generated per sample. As a result, Theranos has trumpeted its low lab test prices -- no more than half of Medicare reimbursement fees. The secretive, Edison technology has also been perceived as being innovative and thus worthy of Silicon Valley attention and financial backing. Ergo, if Edison turns out to be a bust, so may Theranos.

Legislation Introduced in Senate to Address Gag Orders in EHR Contracts

I have posted a number of previous blog notes about the so-called gag clauses that are commonly inserted into hospital EHR contracts. They tend to classify all of the EHR software as proprietary, thus placing any public discussion of the product out-of-bounds (see, for example: Gag Clauses in EHR Contracts Documented; Concerns Raised about Patient Safety; Parallels between Volkswagen and EHR Vendors Regarding "Proprietary" Software; Recall of the United HealthCare Picis PulseCheck Emergency Department Software; Sutter Health System EHR Crash Reported by Nursing Union). Such an embargo restricts the reporting of software errors and poses a threat to patient safety. We are now seeing the possibility of legislative corrective action of such contracts by the U.S. Senate. A bi­par­tis­an pair of sen­at­ors has in­tro­duced le­gis­la­tion aimed at im­prov­ing elec­tron­ic health re­cords’ trans­par­ency and ac­count­ab­il­ity (see: SENATORS AIM TO REVAMP FEDERAL RULES FOR ELECTRONIC MEDICAL CHARTS). Below is an excerpt from the article with some more details:

As Sen. Shel­don White­house re­calls, he heard Sen. Bill Cas­sidy ask­ing tough ques­tions on gag or­ders bar­ring doc­tors and hos­pit­als from dis­cuss­ing spe­cif­ic glitches in their pur­chased sys­tems....[T]he two [senators]...teamed up and in­tro­duced the Trust IT Act of 2015...recently. The meas­ure would es­tab­lish a health IT rat­ing sys­tem that lets con­sumers com­pare dif­fer­ent products; ban health IT vendors from hav­ing nondis­clos­ure clauses in con­tracts; re­quire products meet­ing cer­tain se­cur­ity and in­ter­op­er­ab­il­ity re­quire­ments for cer­ti­fic­a­tion; and more. The bill comes at a time when the HELP Com­mit­tee has made im­prov­ing health in­form­a­tion tech­no­logy a pri­or­ity, and as Obama­care aims to bol­ster the ex­change of health in­form­a­tion through elec­tron­ic health re­cords. Also, the le­gis­la­tion’s in­tro­duc­tion came on the same af­ter­noon that the Health and Hu­man Ser­vices De­part­ment re­leased two fi­nal rules aimed at in­creas­ing in­ter­op­er­ab­il­ity and im­prov­ing pa­tient out­comes....The le­gis­la­tion would [require[ health vendors to at­test that they don’t par­ti­cip­ate in cer­tain in­form­a­tion-block­ing tac­tics and al­low­ing the HHS in­spect­or gen­er­al to in­vest­ig­ate such al­leg­a­tions and as­sess pen­al­ties for those en­ga­ging in such prac­tices. An­oth­er key com­pon­ent of the bill is let­ting health care pro­viders com­pare products based on se­cur­ity, us­ab­il­ity, and in­ter­op­er­ab­il­ity. It would es­tab­lish a health IT rat­ing sys­tem that would be avail­able on­line at the Of­fice of the Na­tion­al Co­ordin­at­or for Health In­form­a­tion Tech­no­logy web­site.

In general, this proposed legislation to counter EHR vendor information blocking seems to be a step in the right direction. I have always been surprised that the legal staffs of some of the most prestigious hospitals in the country would tolerate contracts containing such broad "gag" clauses. This is no empty threat on the part of the EHR vendors. I have blogged about the so-called  "Epic police" that enforce information blocking, not only among their own hospitals clients but also among people who view the product at healthcare IT conferences (see: Parallels between Volkswagen and EHR Vendors Regarding "Proprietary" Software).

My experience with hospital attorneys is that they would spend hours pouring over contracts and minutiae. How could they then tolerate such gag clauses and then be forced to look to the federal government for relief. My only explanation for this lapse is that such clauses seem to have been standard operating procedure among EHR vendors so they may have been accepted without a whimper. At the very least and failing rescue by the Senate, the news spotlight now seems to be shining brightly on EHR contracts as well as the lack of interoperability of these systems. 

Google Gets More Deeply Involved in Longevity Research with Calico

Google is extending its reach into age-related diseases and longevity research with a recently announced relationship between the pharmaceutical company, AbbVie, and its life sciences company Calico (see: AbbVIe and Calico Announce a Novel Collaboration to Accelerate the Discovery, Development, and Commercialization of New Therapies). Here are more details from the article:

AbbVie and Calico announced a novel R&D collaboration intended to help the two companies discover, develop and bring to market new therapies for patients with age-related diseases, including for neurodegeneration and cancer. Calico is the Google-backed life sciences company....The agreement paves the way for Calico to establish a world-class research and development facility in the San Francisco Bay Area. Under the agreement, the companies will combine their complementary strengths to accelerate the availability of new therapies for age-related diseases: Calico will use its scientific expertise to establish a world-class research and development facility, with a focus on drug discovery and early drug development; and Abbie will provide scientific and clinical development support and its commercial expertise to bring new discoveries to market....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. Calico will be responsible for research and early development during the first five years and continue to advance collaboration projects through Phase 2a for a ten-year period 

Calico's (and Google's) mission in this collaborative effort was described in another article as "curing death" (see: Google's project to 'cure death,' Calico, announces $1.5 billion research center). Here's another interesting quote from this article:

Remember, Google introduced Calico to the world with the bold ambition of "curing death." CEO Larry Page, Google Ventures head honcho Bill Maris, and futurist Ray Kurzweil, who Google hired as its director of engineering, have all expressed a deep interest in radical life extension and the Singularity. Up until today we haven't had a lot of detail about how Calico would pursue that goal. 

I blogged more than nine years ago about anti-aging physicians and their longevity treatments (see: Anti-Aging, Longevity Medicine, and Lab Testing) but have not thought much about the topic since then. The relevance of the anti-aging approach for the lab world is that these physicians often launch their workups with an extensive battery of lab tests to assess biologic age as opposed to chronologic age. From my perspective, probably the best and most scientifically valid way to prolong one's life is through weight reduction and even extreme calorie restriction (see: Calorie Restriction Extends Lifespan of Normal Cells and Inhibits Atypical Cells). The former helps avoid obesity-related diseases like diabetes and cardiovascular diseases.

I did a quick Google search on the topic of anti-aging and much of the material retrieved still seems to be fall into what I would call the "alternative medicine" realm. It's thus interesting that Calico with its partnership with AbbVie seem intent on bringing more respectability to this area of medical research. Here's a quote from the Wikipedia article on life extension to provide a rough perspective on the size of this market (see: Life extension):

The sale of putative anti-aging products such as nutrition, physical fitness, skin care, hormone replacements, vitamins, supplements and herbs is a lucrative global industry, with the US market generating about $50 billion of revenue each year. Some medical experts state that the use of such products has not been proven to affect the aging process and many claims regarding the efficacy of these marketed products have been roundly criticized by medical experts, including the American Medical Association.