Microsoft, Amazon and IBM access millions of US hospital records

• The tech giants are each working with medical centers in Washington, Massachusetts and Minnesota, The Wall Street Journal reports
• Each deal means information from millions of records could be handed over 
• Hospitals are allowed to share patient data as long as they follow privacy laws
• It has already been revealed how Google has teamed up with Ascension, a leading healthcare services company, to access health data 
• Certain laws allow for people’s medical data to be shared without them knowing

Hospitals across the United States are said to have granted Microsoft, Amazon and IBM access to sensitive identifiable medical records.

The tech giants are each working with medical centers in Washington, Massachusetts and Minnesota, The Wall Street Journal reports.

But the breadth of access was not made immediately clear as the contracts were signed, according to the paper, although there is no suggestion of legal wrongdoing.

And it means information from millions of identifiable records could be handed over available as part of the deals to crunch the data.

Microsoft is said to be building cancer algorithms with the help of data from Providence Health & Services, which is based Renton, Washington

In Boston a deal between IBM and Brigham and Women’s Hospital allows the medical center to share data for particular requests, although they are yet to do so

Federal privacy laws do allow hospitals to share patient data. Consultant Lisa Bari said: ‘Hospitals are massive containers of patient data. The data belongs to whoever has it.’

Microsoft is said to be building cancer algorithms with the help of data from Providence Health & Services, which is based Renton, Washington.

The doctor’s notes they are using are said to still contain information which can identify patients.

In Boston a deal between IBM and Brigham and Women’s Hospital allows the medical center to share data for particular requests, although they are yet to do so.

And in Seattle Amazon Web Services have access to individual patient information at the Fred Hutchinson Cancer Research Center.

DailyMail.com has contacted each of the health services and tech giants connected.

Microsoft executive Peter Lee said in December the data is still in Providence’s control. A spokesman for Providence said their actions were ‘not intended to mislead’.

IBM said: ‘Responsible data stewardship is core to our mission.’ Brigham and Women’s Hospital have not commented publicly on the tech giant’s ability to look at identifiable information.

Amazon Web Services say that any data protected under federal privacy laws is not used.

The US has seen a rise in the percentage of hospitals using electronic health records

It comes in the wake of Google’s Project Nightingale, alongside leading healthcare company Ascension, to gather millions of Americans’ health data without them knowing it.

The two companies announced the collaboration in a press release where they revealed that Ascension’s data will move onto Google’s Cloud platform.

Google will now have access to patients’ test results, diagnoses and hospitalizations to give them a full digital health history. Neither doctors nor the patients in the 21 states where it will be used had been told about it.

The practice is legal under the Health Insurance Portability and Accountability Act of 1996 which allows hospitals to share patients’ medical data with business partners on the condition that it is used to ‘help the entity carry out its healthcare functions.’

But a whistleblower said that the lack of transparency made many members of the team working on the project uneasy and could put the healthcare data of millions at risk

‘Two simple questions kept hounding me: did patients know about the transfer of their data to the tech giant? Should they be informed and given a chance to opt in or out?’ the whistleblower wrote.

‘The answer to the first question quickly became apparent: no. The answer to the second I became increasingly convinced about: yes. Put the two together, and how could I say nothing?’ the person continued.

The person said that about 150 Google employees and 100 Ascension staff collaborated on Project Nightingale, transferring the personal data of more than 50 million Americans to Google.

‘I’d like to hope that the result of my raising the lid on this issue will be open debate leading to concrete change,’ the person wrote. ‘Transfers of healthcare data to big tech companies need to be shared with the public and made fully transparent, with monitoring by an independent watchdog.’

The whistleblower also insisted: ‘Patients must have the right to opt in or out.’

A spokesman for Providence said their actions were ‘not intended to mislead’

Google is also said to have a deal with the Mayo clinic in Rochester, Minnesota

Google is also said to have a deal with the Mayo clinic in Rochester, Minnesota. Mayo spokesman said: ‘It was not our intention to mislead the public.’ Data-team member Lois Krahn said: ‘We are a tremendously cautious and conservative organization.’

Head of Google Health Dr. David Feinberg said: ‘We didn’t hide it.’

The Health Insurance Portability and Accountability Act does not leave patients with ‘much control’, one ethics professor has said. Hospitals do not have to warn users of deals if it can be argued the records are needed for treatment, payment or surgery.

https://www.dailymail.co.uk/news/article-7908761/Hospitals-granted-Microsoft-Amazon-IBM-access-medical-records.html

Researchers trace coronavirus outbreak in China to snakes

Emerging viral infections—from bird flu to Ebola to Zika infections—pose major threats to global public health, and understanding their origins can help investigators design defensive strategies against future outbreaks. A new study provides important insights on the potential origins of the most recent outbreak of viral pneumonia in China, which started in the middle of December and now is spreading to Hong Kong, Singapore, Thailand, and Japan. The findings are published early online in the Journal of Medical Virology.

The study notes that patients who became infected with the virus—which is a type of virus called a coronavirus and was named 2019-nCoV by the World Health Organization—were exposed to wildlife animals at a wholesale market, where seafood, poultry, snake, bats, and farm animals were sold.

By conducting a detailed genetic analysis of the virus and comparing it with available genetic information on different viruses from various geographic locations and host species, the investigators concluded that the 2019-nCoV appears to be a virus that formed from a combination of a coronavirus found in bats and another coronavirus of unknown origin. The resulting virus developed a mix or “recombination” of a viral protein that recognizes and binds to receptors on host cells. Such recognition is key to allowing viruses to enter host cells, which can lead to infection and disease.

Finally, the team uncovered evidence that the 2019-nCoV likely resided in snakes before being transmitted to humans. Recombination within the viral receptor-binding protein may have allowed for cross-species transmission from snake to humans.

“Results derived from our evolutionary analysis suggest for the first time that snake is the most probable wildlife animal reservoir for the 2019-nCoV,” the authors wrote. “New information obtained from our evolutionary analysis is highly significant for effective control of the outbreak caused by the 2019-nCoV-induced pneumonia.”

An accompanying editorial notes that although the ultimate control of emerging viral infections requires the discovery and development of effective vaccines and/or antiviral drugs, currently licensed antiviral drugs should be tested against the 2019-nCoV.

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More information: Wei Ji et al, Homologous recombination within the spike glycoprotein of the newly identified coronavirus may boost cross‐species transmission from snake to human, Journal of Medical Virology (2020). DOI: 10.1002/jmv.25682Guangxiang (George) Luo et al. Global Health Concern Stirred by Emerging Viral Infections, Journal of Medical Virology (2020). DOI: 10.1002/jmv.25683

https://medicalxpress.com/news/2020-01-coronavirus-outbreak-china-snakes.html

Ex-FDA Chief Brushes Off Some Coronavirus Concerns

Former FDA Commissioner Scott Gottlieb said Tuesday afternoon on CNBC the coronavirus “so far seems to be a mild illness.”

The total reported cases rose to 440 in China with nine confirmed fatalities, at time of publication Wednesday afternoon.

Gottlieb: Not That Serious

The current coronavirus has about a 70% overlap with SARS and the illness associated with the coronavirus isn’t as significant, Gottlieb said on Tuesday. As such, there are likely a lot of mild or moderate cases of infection which implies the 300 cases of infection which has been reported so far is not an accurate number.

However, the coronavirus appears to be spreading more rapidly and may have already achieved sustained human-to-human transmission. The U.S. government and relevant parties likely have the necessary tools to conduct an effective screening process.

All indications suggest the coronavirus outbreak “isn’t necessarily that serious” for people who aren’t young or old, he said. In fact, people get sick from some strain of a coronavirus “all the time.”

Sector Rotation Towards Med Stocks

If the coronavirus continues to spread investors may look to move away from hospitality and travel stocks and into companies who manufacture medical devices, Taurus Wealth Advisors’ Rainer Michael Preiss said Wednesday on CNBC’s “Street Signs Asia.” This trend started playing out over the past few days and could play out “longer than people think.”

The timing of the outbreak comes at a time of “peak optimism” in the markets and could not rebound until “peak pessimism” passes, he said.

“Anybody who thinks this will be a quick fix most probably needs to realize these things take time and also they are very complicated and deep issues,” he said.

Cramer: Buy Unrelated Stocks

So far the coronavirus looks to be less lethal than the SARS virus but will likely have a visible impact on companies with a strong presence in China, particularly travel, tourism and gaming companies, Jim Cramer said Tuesday on “Mad Money.” But if unrelated stocks start to sell off, investors should take advantage and buy high-quality stocks on any weakness.

“It’s collateral damage where there shouldn’t be damage,” Cramer said.

https://www.benzinga.com/news/20/01/15163921/ex-fda-chief-brushes-off-some-coronavirus-concerns-as-investors-brace-for-impact

FDA: Study of Biohaven’s verdiperstat in ALS can proceed

Biohaven Pharmaceuticals (NYSE:BHVN) announces that the FDA has notified its collaborators at Boston’s Massachusetts General Hospital that they may proceed with a clinical trial of verdiperstat in patients with amyotrophic lateral sclerosis (ALS).

The study, HEALEY ALS, is a basket study that will evaluate multiple drugs in parallel.

Verdiperstat is also being evaluated for the treatment of multiple system atrophy.

https://seekingalpha.com/news/3533688-fda-signs-off-on-study-of-biohavens-verdiperstat-in-als

Mobile Monitoring System vs Usual Care in Depression, Psychological Health

Early detection and monitoring of mental health symptoms are crucial, yet many patients and clinicians are unable to receive timely and reliable indicators of clinical progress. Mobile monitoring systems allow for passive tracking of vocal and behavioral indicators of symptoms and can provide infrastructure to securely store, analyze, and provide feedback to patients and clinicians.¹ However, the evidence for the effectiveness of mobile monitoring systems in clinical settings is limited.² We conducted a randomized clinical trial to assess whether patients using a mobile monitoring system with clinician access experienced improvements in depression symptoms and well-being.

Methods

Recruitment

Between February 2016 and June 2017, patients from 2 Brigham and Women’s Hospital Patient-Centered Medical Homes with colocated primary care and behavioral services were recruited through clinician referrals, online advertising, and within-clinic advertising. Exclusion criteria included the presence of a psychotic disorder, suicidal or homicidal risk, history of a cognitive disorder, or not owning an Android smartphone (Figure 1). Researchers obtained Partners Healthcare institutional review board approval and written informed consent from all participants. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline. The trial protocol appears in Supplement 1.

Mobile Monitoring System

Patients were randomized to receive usual care (control) or usual care plus the mobile monitoring system (intervention). Patients in the intervention group downloaded the mobile monitoring application to their smartphones. For the 6-month study duration, the application passively collected metadata on smartphone use, including short message service logs, call logs, and geolocation data. Metadata were analyzed against 3 previously modeled Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) diagnostic criteria for depression and posttraumatic stress disorder, including fatigue, social isolation, and diminished interest.¹ Patients could also leave short audio recordings through the application, which enabled voice feature analyses and provided an additional measure of depressed mood. Visual feedback on these 4 metrics were provided to patients via the mobile application (eFigure 1 in Supplement 2) and to clinicians via a desktop dashboard (eFigure 2 in Supplement 2). Clinicians were trained to review the dashboard as part of daily workflows, weekly team huddles, and routine clinical visits with patients in the intervention group.

Outcome Measures

At baseline and 6-month follow-up, patients completed the 2 following primary outcome measures: the Patient Health Questionnaire³ sum score for depression severity, ranging from no depressive symptoms (0-4) to severe major depression (>20), and the Schwartz Outcome Scale⁴ sum score, ranging from 0 to 60, with higher scores indicating better overall psychological health. A subset of patients in the intervention group completed questions at follow-up on their level of comfort with sharing data with clinicians and whether the application changed their patient-clinician communication. Patients were asked whether they believed this mobile monitoring system respected their privacy (range, 0-10, with 10 indicating very much so).

We used 2 mixed-design 1-within, 1-between analyses of variance with repeated measures on the assessment time factor for our 2 primary outcomes, ie, the Patient Health Questionnaire and the Schwartz Outcome Scale. Statistical significance was set at P < .05, and all tests were 2-tailed. Data were analyzed beginning in July 2018. Final data analysis was conducted in November 2019. All analyses were conducted using SPSS statistical software version 25 (IBM Corp). Additional detail appears in the eMethods in Supplement 2.

Results

Sixty-eight patients were randomized (33 to usual care and 35 to usual care plus the mobile monitoring system). Among them, 55 patients (40 [73%] women; 18 [33%] non-Hispanic white; 14 [25%] non-Hispanic black/African American; 11 [20%] Hispanic/Latinx; mean [SD] age, 36.8 [12.9 ] years) received usual care (27 [49%]) or usual care plus the mobile monitoring system (28 [51%]) as allocated. Overall, 53 patients (96%) completed follow-up surveys, and from the intervention group, 15 patients (54%) completed the user experience survey.

Analysis of variance revealed a significant treatment-by-time interaction effect, supporting decreased depressive symptoms (F_1,51 = 4.36; P = .042; partial η² = 0.08) and improved psychological health (F_1,51 = 4.24; P = .045; partial η² = 0.08) among patients receiving the mobile monitoring system compared with usual care (Figure 2). A total of 12 patients (80%) from the intervention group who completed the user experience survey reported that they would likely or definitely share mobile monitoring data with clinicians. Eight (53%) reported that the mobile monitoring application had at least somewhat improved their communication with clinicians, and 4 (27%) reported directly discussing scores with their clinicians. Patients felt the application respected their privacy (mean [SD] score, 8.80 [1.82]).

Discussion

In this randomized clinical trial, patients using a mobile monitoring system with clinician access showed significant improvement on depressive symptoms and psychological health compared with patients receiving usual care. This study has limitations, including its small sample size in 1 metropolitan area in the northeastern United States. These results provide initial empirical support for the effectiveness of mobile monitoring systems in outpatient clinical settings.⁵ Future research will test the intervention in additional clinical populations and examine potential mechanisms by which information on symptoms is associated with clinical decisions and behavioral health outcomes.

Article Information

Accepted for Publication: November 21, 2019.

Published: January 17, 2020. doi:10.1001/jamanetworkopen.2019.19403

Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2020 Place S et al. JAMA Network Open.

Corresponding Author: Danielle Blanch-Hartigan, PhD, MPH, Department of Natural and Applied Sciences, Bentley University, 175 Forest St, Waltham, MA 02452 (danielleblanch@gmail.com).

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2758857

Which OTC Cold Medications Are Safe for the Heart?

Little has changed in the $8 billion world of useless and confusing over-the-counter (OTC) cold, flu, and sinus medications since the Skeptical Cardiologist first tackled “What Cold Medications Are Safe For My Heart” in 2015.

I still advise avoiding combination OTC cold meds and utilizing specific medications for specific symptoms.

The original post covers most of the usual suspects in this mostly useless arena. I updated it in 2016 with comments on a few additional OTC components. That post on Alka-Seltzer, phenylephrine, and doxylamine is included below.

Alka-Seltzer Plops Into the OTC Cold Market

I had always viewed Alka-Seltzer as an effervescent tablet for acid reflux, but the brand (now owned by Bayer) has moved aggressively into the bewildering morass of OTC cold meds. Indeed, when Alka-Seltzer began in 1931, it was a combination of aspirin and sodium bicarbonate (baking soda) marketed for upset stomachs. Popular commercials from the 1960s featured the catchy jingle (still stuck in my head) “Plop, plop, fizz, fizz. Oh what a relief it is” often sung by Speedy, an odd anthropomorphic creature with an Alka-Seltzer thorax and cap. (The jingle was written by Tom Dawes of The Cyrkle [“Red Rubber Ball”], not by the father of Julianna Margulies.)

Recently, I received a request from an out-of-town guest who was suffering from a cough and upper respiratory infection to purchase Alka-Seltzer Plus in the form of a tablet that dissolves in hot water.

At his request, Alka-Seltzer Plus Day Multi-Symptom Cold and Flu was purchased at the local Walgreens.

The ingredients are typical for many of the Alka-Seltzer products:

• Dextromethorphan (promoted for cough but ineffective and with considerable side effects, see my initial post)
• Acetaminophen (Tylenol, for pain and fever)
• Phenylephrine (decongestant)

Phenylephrine: Ineffective Substitute for Pseudoephedrine

I didn’t cover phenylephrine previously. It has taken the place of pseudoephedrine in on-the-shelf OTC cold medications.

Like pseudoephedrine, phenylephrine is a sympathomimetic drug, meaning it stimulates receptors of the sympathetic nervous system. Unlike pseudoephedrine, phenylephrine is useless as a decongestant when taken in the dosages available over the counter.

A study published in 2015 confirmed what previous studies had suggested: Phenylephrine in dosages of 10 to 40 mg daily was no more effective than placebo in reducing symptoms of nasal congestion.

An accompanying editorial called on manufacturers to remove this useless drug from their products.

Alas, all of the Alka-Seltzer preparations that claim to treat congestion utilize phenylephrine as the decongestant.

The transition to useless phenylephrine took place when pseudoephedrine was taken off the shelves and put behind the counter to reduce its usage in making methamphetamine.

Therefore, Alka-Seltzer Plus Cold and Flu contains two useless ingredients plus acetaminophen (Tylenol).

You can buy a large bottle of cheap generic acetaminophen and take exactly the right dose you need for relieving fever or body aches without paying for two useless accompanying drugs that have the potential for giving you unwanted side effects.

Sleep Aids in OTC Cold Meds

I covered the most common drug found in OTC cold meds promoted for nighttime use, diphenhydramine (Benadryl), in my previous post.

Nighttime Alka-Seltzer products contain a similar sedating antihistamine called doxylamine succinate.

Doxylamine is the active ingredient in the brand-name sleep aid Unisom and the “ZzzQuil” products from the NyQuil brand that are promoted for inducing sleep. It is available in cheap, generic form.

According to DrugBank, “It is also the most powerful over-the-counter sedative available in the U.S., and more sedating than many prescription hypnotics. In a study, it was found to be superior to even the barbiturate, phenobarbital for use as a sedative.”

Note that the effective dosage recommended in separate sleep aids is 25 mg, not the 12.5 mg found in Alka-Seltzer OTC cold meds. Thus, if you want an effective dosage of doxylamine to help you sleep, you must double the recommended dosage of Alka-seltzer’s nighttime product, which then gives you too much acetaminophen and dextromethorphan.

Doubling these drugs raises the potential for side effects. Common dextromethorphan side effects include nausea/vomiting, dizziness, diarrhea, and nervousness. Too much acetaminophen can damage the liver.

In addition, both dextromethorphan and acetaminophen interact with multiple other medications. Dextromethorphan is known to interact with many medications.

Acetaminophen can interfere with warfarin and increase the risk of dangerous bleeding.

My advice for 2020 is unchanged from 2015. As I summarized previously:

“I think you are much better off avoiding these brand name mixtures of different active ingredients.

Instead, you should take what you need for a specific symptom in the appropriate dosage and time interval.

Thus, if you have pain, take the minimal dose of Tylenol that relieves it and repeat when it comes back.

If you have a cough, recognize that the OTC ingredients are no better than placebo and are being abused as recreational drugs. Most coughs go away shortly; but if one is particularly troublesome and persistent, get a cough suppressing drug from your physician.

If you have a really runny nose with a lot of sneezing, it is probably OK to take pseudoephedrine even if you are a heart patient or have high blood pressure. Take it as I described above. Start with 30 mg of the little red pseudoephedrine pills. Wait an hour to see how you feel. Take a second if it has not been effective. Repeat at 4 to 6 hour intervals as needed. Take your blood pressure at least once after starting it.

Don’t buy the multi-symptom multiple ingredient combinations, which are simply a marketing tool to get you to spend more money on something from which you won’t benefit.”

Consumer Reports seems to agree with me in a 2017 post on this topic (which doesn’t credit me).

Anthony Pearson, MD, is a private practice noninvasive cardiologist and medical director of echocardiography at St. Luke’s Hospital in St. Louis. He blogs on nutrition, cardiac testing, quackery, and other things worthy of skepticism at The Skeptical Cardiologist, where a version of this post first appeared.

https://www.medpagetoday.com/blogs/skeptical-cardiologist/84478

Congress calls Juul, four other e-cig companies to testify about youth vaping

Five leading e-cigarette companies will be dragged before Congress early next month, according to a Wednesday afternoon announcement from Rep. Diana DeGette (D-Colo.).

It’ll be the first chance for lawmakers on both sides of the aisle to question or scold many of these companies for their alleged role in fueling the growing youth vaping epidemic. Five companies, Juul, Logic, NJOY, Fontem, which makes the product “blu,” and Reynolds American, which makes “VUSE,” will testify on Feb. 5.

It’s the latest in a spate of bad news for the beleaguered industry, which has been staring down the possibility of the government banning flavored e-cigarettes altogether. Many of these companies are also the subject of multiple congressional investigations into marketing and business practices that targeted young people, according to lawmakers.

“While consumers remain in the dark of the possible health consequences, these companies are making billions of dollars as they lure a new generation of young people into a lifetime of nicotine addiction,” DeGette, the chair of the oversight panel conducting the hearing, wrote in a press release.

It’s a time-honored tradition for unpopular industries to be called before Congress for high-profile tongue lashings. In years prior, drug makers, drug wholesalers, bankers, and airlines have felt Congress’ wrath. Most famously, seven tobacco executives irreparably damaged their industry’s reputation when they testified before the Energy and Commerce Committee in 1994.

Juul will share the stage with its competitors, but it is likely to take more heat on the dais than the other four participants.

Despite spending more than $4 million lobbying Congress in 2019, Juul has been criticized by everyone from former FDA Commissioner Scott Gottlieb to presidential hopeful Sen. Elizabeth Warren (D-Mass.) for its role in fueling the youth vaping epidemic.

The company has already been hauled before Congress this year. Juul’s co-founder and chief product officer, James Monsees, and chief administrative officer, Ashley Gould, faced a grilling before the House Oversight Committee back in July.

The hearing is also the latest sign of Congress’ desire to seriously shake up the booming vaping market. Congress held roughly half a dozen hearings on the topic last year and recently raised the minimum age for vaping to 21.

Congress calls Juul, four other vape companies to testify about youth vaping