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Wednesday, January 1, 2020

Travel Alert Issued for The Americas’ Dengue Outbreaks

The latest Travel Alert issued by the US Centers for Disease Control and Prevention (CDC) regarding Dengue outbreaks in the Americas may influence winter vaccination plans during 2020.
The CDC said in an updated Level 1 Travel Alert ‘dengue is an ongoing risk in many parts of Central and South America, Mexico, and the Caribbean.’
On December 23, 2019, this updated ‘Practice Usual Precaution’ Travel Alert said ‘the countries listed below are reporting higher-than-usual numbers of dengue cases, and travelers visiting these countries may be at increased risk:
Dengue is common in more than 100 countries around the world, and about 3 billion people, live in areas with a risk of contracting 1 of dengue’s 4 virus types.
The CDC said ‘because dengue is spread by mosquito bites, all travelers to risk areas should prevent mosquito bites by using an EPA-registered insect repellent, wearing long-sleeved shirts and long pants when outdoors, and sleeping in an air-conditioned room or room with window screens or under an insecticide-treated bed net.’
There is no specific treatment for dengue, but early detection and access to proper medical care lowers fatality rates to below 1 percent, says the CDC.

In the USA, an infected mosquito (Ae. aegypti or Ae. albopictus) can spread the dengue virus to people through bites.
And, the CDC says a pregnant woman already infected with dengue can pass the virus to her fetus during pregnancy or around the time of birth.
Dengue disease can take up to 2 weeks to develop with illness generally lasting less than a week. The health effects from dengue include fever, headache, nausea, vomiting, rash, muscle and joint pain, and minor bleeding.
Dengue can become severe within a few hours. Severe Dengue is a medical emergency, usually requiring hospitalization. In severe cases, health effects can include hemorrhage, shock, organ failure, and death says the CDC.
Regarding diagnosing a potential dengue patient, the CDC suggests healthcare providers should review the patient’s past medical history, recent travel history, travel notices regarding disease outbreaks, and vaccination record, especially for yellow fever and Japanese encephalitis vaccinations, to determine the likelihood that the patient’s recent illness is due to an infection with dengue virus.
On December 26, 2019, a new study reported the ‘screen and vaccinate’ strategy is more effective in reducing the number of hospitalized and Severe Dengue cases.
In the USA, the state of Florida has reported both travel-related and locally acquired Dengue cases in 2019.
On December 24th, 2019, the Florida Department of Health in Miami-Dade County (DOH-Miami-Dade) announced 2 new dengue cases of local transmission confirmed in Miami-Dade residents.
In total, Florida has confirmed 16 locally-transmitted dengue cases this year.
Previously, Florida’s Arbovirus Surveillance Week #51 report confirmed 391 travel-associated dengue cases in Florida, as of December 21, 2019. Miami-Dade County and Broward counties have reported the most travel-related dengue cases during 2019.
In total, the CDC confirmed 1,026 dengue cases in the USA, and an additional 46 in the US Territories, as of December 6, 2019.
Regarding preventive vaccines, Dengvaxia is the only approved dengue vaccine in the USA and in about 20 other countries. Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
The CDC suggests people considering a dengue vaccination should speak with a qualified healthcare provider.
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Short on Funding, NPXe Files for Bankruptcy and Seeks to Sell Assets

One year ago, startup NPXe Limited and Mallinckrodt were enrolling patients in a Phase III trial to assess the efficacy of its xenon gas for neuro- and cardio-protection and improvement in survival for post-cardiac arrest syndrome (PCAS). Now, the company has filed for bankruptcy and its development partner is eying bankruptcy.
On Monday, Buffalo, N.Y.-based NPXe, formerly known as NeuroproteXeon, filed a voluntary petition to reorganize under Chapter 11 of the Bankruptcy Code and is also seeking permission to auction off its assets. NPXe has been developing Xenex, a xenon gas for inhalation in development to treat PCAS. Even though the company is looking to sell off assets, Chief Executive Officer Bill Burns believes that Xenex can be brought to market and serve as a potential treatment for PCAS patients.
“Inhaled Xenon gas has a history of safe use in humans, and based on Phase II data, we believe bringing Xenex to market represents an essential element for critical care treatment for PCAS patients, a population in which no approved pharmacotherapy exists,” Burns said in a statement Monday.
The decision to file Chapter 11 followed a close examination of the company’s strategic options and current financing. The company’s board of directors unanimously agreed that a “structured sale process” represents the best path forward for the company. The company retained Lincoln International as its banking advisor. Lincoln International will manage the sale and auction process, which is expected to be concluded by the Feb. 26. Bids for the assets are expected by Feb. 19 and the auction will begin no later than Feb. 21, the company announced.
In preparation for the sale of its assets, NPXe provided a brief list of highlights to entice potential buyers. It pointed to positive Phase II data for Xenex, which showed the inhaled gas “demonstrated neuro- and cardio-protection with a significant reduction in white matter brain damage and a suggested improvement in survival outcomes.” The company said there is a solid market for the therapeutic, given the fact there are more than 286,000 addressable cardiac arrests in North America and the European Union each year. The company added that there are potential opportunities for Xenex in other indications, such as stroke and traumatic brain injury. Additionally, Xenex has received Fast Track designation and Special Protocol Assessment for the Phase III trial.
PCAS is a range of complications that affect the brain and heart following ischemia after a heart attack. There is no approved pharmacotherapy for neuroprotection for PCAS. There are approximately 140,000 potential cardiac arrest patients in the U.S. and 145,000 in Europe each year who may be eligible for xenon gas treatment, if approved.
Mallinckrodt, which licensed the Xenon gas asset in 2017, is also facing its own financial cliff. The company is eying potential bankruptcy due in part to legal liabilities related to opioid lawsuits in the United States, as well as a debt load of $5 billion. In September, the U.K.-based company hired advisers to assist it in its potential restructuring.
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More drugmakers hike U.S. prices as new year begins

Drugmakers including Bristol-Myers Squibb Co, Gilead Sciences Inc, and Biogen Inc hiked U.S. list prices on more than 50 drugs on Wednesday, bringing total New Year’s Day drug price increases to more than 250, according to data analyzed by healthcare research firm 3 Axis Advisors.

Reuters reported on Tuesday that drugmakers including Pfizer Inc, GlaxoSmithKline PLC and Sanofi were planning to increase prices on more than 200 drugs in the United States on Jan. 1.
Nearly all of the price increases are below 10% and the median price increase is around 5%, according to 3 Axis.
More early year price increases could still be announced.
Soaring U.S. prescription drug prices are expected to again be a central issue in the presidential election. President Donald Trump, who made bringing them down a core pledge of his 2016 campaign, is running for re-election in 2020.
Many branded drugmakers have pledged to keep their U.S. list price increases below 10% a year, under pressure from politicians and patients.
The United States, which leaves drug pricing to market competition, has higher prices than in other countries where governments directly or indirectly control the costs, making it the world’s most lucrative market for manufacturers.
Drugmakers often negotiate rebates on their list prices in exchange for favorable treatment from healthcare payers. As a result, health insurers and patients rarely pay the full list price of a drug.
Bristol-Myers said in a statement it will not raise list prices on its drugs by more than 6% this year.
The drugmaker raised the price on 10 drugs on Wednesday, including 1.5% price hikes on cancer immunotherapies Opdivo and Yervoy and a 6% increase on its blood thinner Eliquis, all of which bring in billions of dollars in revenue annually.
It also raised the price on Celgene’s flagship multiple myeloma drug, Revlimid, 6%. Bristol acquired rival Celgene in a $74 billion deal last year.
Gilead raised prices on more than 15 drugs including HIV treatments Biktarvy and Truvada less than 5%, according to 3 Axis.
Biogen price increases included a 6% price hike on multiple sclerosis treatment Tecfidera, according to 3 Axis.
Gilead and Biogen could not be immediately reached for comment.
3 Axis advises pharmacy industry groups on identifying inefficiencies in the U.S. drug supply chain and has provided consulting work to hedge fund billionaire John Arnold, a prominent critic of high drug prices.
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Google AI Beats Doctors at Breast Cancer Detection — Sometimes

Google’s health research unit said it has developed an artificial-intelligence system that can match or outperform radiologists at detecting breast cancer, according to new research. But doctors still beat the machines in some cases.
The model, developed by an international team of researchers, caught cancers that were originally missed and reduced false-positive cancer flags for patients who didn’t actually have cancer, according to a paper published on Wednesday in the journal Nature. Data from thousands of mammograms from women in the U.K. and the U.S. was used to train the AI system.
But the algorithm isn’t yet ready for clinical use, the researchers said.
The model is the latest step in Google’s push into health care. The Alphabet Inc. company has developed similar systems to detect lung cancer, eye disease and kidney injury.
Google and Alphabet have come under scrutiny for privacy concerns related to the use of patient data. A deal with Ascension, the second-largest health system in the U.S., allows Google to use AI to mine personal, identifiable health information from millions of patients to improve processes and care.
The health data used in the breast-cancer project doesn’t include identifiable information, Google Health officials said, and the data was stripped of personal indicators before given to Google.
Radiologists and AI specialists said the model is promising, and officials at Google Health said the system could eventually support radiologists in improving breast-cancer detection and outcomes, as well as efficiency in mammogram reading.
“There’s enormous opportunity, not just in breast cancer but more widely, to use this type of technology to make screening more equitable and more accurate,” said Dominic King, the U.K. lead at Google Health. “It feels like this is another step towards this technology actually making a difference in the real world.”
Breast cancer is the second-leading cause of cancer death in women after lung cancer, and roughly one in eight women in the U.S. are likely to develop breast cancer throughout their lifetime, according to the American Cancer Society. Early breast-cancer detection and treatment can save lives, experts said, and most health systems have screening protocols.
But many cases of breast cancer are missed. And sometimes mammograms are flagged for women who don’t have breast cancer or whose cancer is generally harmless, leading to extra testing or unnecessary treatment.
“It’s this balance of finding the important cancers and not causing undue distress over false positives that aren’t going to hurt a woman,” said Emily Conant, a radiologist and division chief of breast imaging at Penn Medicine.
When developing the AI system from the U.K. dataset, researchers fed the algorithm mammograms from the U.K. National Health Service’s breast-screening program. The U.S. dataset comprised mammograms taken from Northwestern Memorial Hospital in Chicago. Whether a woman had breast cancer was previously determined, and researchers told the algorithm which cases had confirmed breast cancer.
The AI system was then tested on different mammograms of more than 25,000 women in the U.K. and 3,000 women in the U.S. from those datasets. The AI system reduced missed cases by 9.4% in the U.S. and 2.7% in the U.K. compared with the original radiologist diagnoses. It also reduced incorrect positive readings by 5.7% and 1.2%, respectively.
In the U.K., where two radiologists typically read a mammogram, the study found that the model didn’t perform worse than the second reader and could potentially reduce their workload by 88%.
The researchers then had six U.S. radiologists who didn’t make the original diagnoses look at 500 U.S. mammograms and compared their responses with the AI system’s. The radiologists also received the patients’ history and past mammograms when available, while the AI system didn’t. The AI system outperformed the average radiologist in determining whether the women would develop breast cancer.
While the AI system caught cancers that the radiologists missed, the radiologists in both the U.K. and the U.S. caught cancers that the AI system missed. Sometimes, all six U.S. readers caught a cancer that slipped past the AI, and vice versa, said Mozziyar Etemadi, a research assistant professor in anesthesiology and biomedical engineering at Northwestern University and a co-author of the paper.
The cancers that the AI system caught were generally more invasive than those caught by the radiologists; the researchers didn’t have an explanation for the discrepancies.
“I found it sobering,” said Ziad Obermeyer, acting associate professor of health policy and management at the University of California, Berkeley who studies machine learning and health and wasn’t involved in the research. “I think this is a testament to how difficult the task is and how weirdly good humans are at it, even with some of the best data in the world.”
Researchers now want to see how the model would behave in the clinic.
“The real world is more complicated and potentially more diverse than the type of controlled research environment reported in this study,” Etta Pisano, chief research officer at the American College of Radiology, wrote in an editorial in the journal Nature about the paper.
Google Health said it is talking with health systems and research groups about how best to incorporate the AI system into clinical workflow.
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Check-Cap Swallowable X-Ray Pill Allows For Prep-Free Colon Cancer Screening

It’s no secret that preparation for a colonoscopy is an uncomfortable experience. At times, the preparation can be so off-putting, that some chose to forgo the procedure altogether. For this reason, Check-Cap has created an indigestible capsule for prep-free colon cancer screening to ensure that no patient gets left behind in cancer precaution. The device is already approved in Israel and Europe, and tests for U.S. approval are currently underway.
Check-Cap’s swallow-able capsule uses low-dose x-rays to screen the digestive system while it moves along the GI tract. These scans are used to primarily detect precancerous polyps in the colon, making the capsule a preventative test, not a cancer treatment.
“Most colon screening technologies use video technology while entering into the colon and this requires preparation because there can be obstructions that interfere with visualization”, explained Alex Ovadia, CEO of Check-Cap. “The creator tried to think of something that could overcome that and could change the pre-screening requirements. The technology that came to his mind was x-ray.”
The test is non-invasive and patients are allowed to carry on with their normal activities as the screening is being conducted. Once the scan is completed, the capsule is eliminated through the natural excretion process and flushed away, as the data has already been transmitted to a device attached to the patient’s back. This data is then used by doctors to outline a patient’s personal cancer risk and note which patients should be advised to undergo a colonoscopy procedure.
While other devices such as the PillCam also work off swallow-able colon screening technology, the concept of using x-ray technology instead of video is unique.
X-ray technology may bring to mind dangerous and serious equipment, but according to Ovadia, the x-rays used in the Check-Cap’s capsule are low-dose and do not cause patients any harm or damage.
Colon cancer is one of the most widespread and deadly forms of cancer in the U.S. killing about 50,000 Americans annually. The gold standard for colon cancer screening is the colonoscopy, but many patients chose to forgo this in order to avoid the uncomfortable laxative cleanse required beforehand. Check-Cap cites this demographic as their target client.
“We are not trying to replace the colonoscopy,” said Ovadia. “Instead, we are aiming towards the population that is most at risk because they chose to not undergo any type of screening.”
Most colon cancer begins as growths called polyps, and it’s these pre-cancerous polyps that the capsule detects. As a result, the device aims to help patients stop cancer from forming in the first place.
“We believe that our solution is intended to prevent colon cancer ahead of time,” said Ovadia, explaining that one of the company’s slogans is “Why Wait For Cancer?”
The technology was developed in 2005 and first received the go-ahead for use in Israel, where it was originally developed. Now, Check-Cap is in the midst of undergoing the strenuous FDA qualification to allow the device to be used in the United States. Eventual U.S. commercialization is expected to begin in 2022.
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Doctors Use Youtube And Google All The Time. Should You Be Worried?

I’m going to tell you a little secret about modern medical practice that most doctors know, but most patients don’t: Doctors rely on Google and Youtube all the time to look stuff up.
I recently sat at a physicians-only area of a hospital, when I overheard one doctor asking a colleague, “How do you perform a such-and-such procedure?” The other immediately replied in all seriousness, “Just Youtube it!” This happens every day in hospitals across the country. Similarly, I (and colleagues) use Google all the time to look up subtle details of diseases, side effects of medications, and lists of possible conditions that might cause certain abnormal findings on MRI and CT scans. I’ve also used Youtube on multiple occasions to refresh my memory on the details of procedures I might not have performed in a while.
So how worried should patients be that their physicians get medical information from Youtube and Google? As the old joke goes, “There’s a lot of great information on the Internet — and some of it is even true!”
A recent article by CNBC technology reporter Christina Farr ominously warns, “Doctors are turning to YouTube to learn how to do surgical procedures, but there’s no quality control.” There are thousands of online videos that demonstrate how to perform various invasive and surgical procedures in graphic detail. Farr observes:
The videos are a particular boon for doctors in training. When the University of Iowa surveyed its surgeons, including its fourth-year medical students and residents, it found that YouTube was the most-used video source for surgical preparation by far.
And it’s not just young trainee physicians using these videos. Experienced surgeons often consult them for guidance. Yet these videos don’t always contain reliable information. Farr notes: “A group of researchers found that for a surgical technique called a laparoscopic cholecystectomy, about half the videos showed unsafe maneuvers.”
From my own experience, I’ve found that videos demonstrating procedures I’m already familiar with to be of mixed quality, varying from superb to adequate to abysmally bad. I assume this is holds true for videos covering branches of medicine I am less familiar with.
So how do good doctors make the best use of all this online information? Based on my own experience as well as talking with colleagues, we tend to adopt the following guidelines before using information from a Youtube video:
1) We check the source.
Is the video from a established physician whose credentials we can verify? Is the video author affiliated with a reputable medical school or medical center? Have they published articles in the regular medical literature that establishes their expertise in the subject? Or are they just “some guy”?
2) We see if the content fits with our pre-existing medical knowledge.
Do the details illustrated by the video adhere to standard “best practices” for good surgical technique? Do they make good sense from an anatomic and physiologic perspective? Do they include good tips on things to do (or not do) during the procedure?
For example, I’ve viewed many videos on ultrasound-guided invasive pain management procedures, which is an area I’m already familiar with. The good videos typically include detailed discussions of how to identify critical arteries and nerves and “best practices” to avoid injuring those vital structures during the procedure.
3) We double-check the video content with other sources.
Even after I watch a seemingly trustworthy Youtube video, I’ll typically run the details past a colleague. Or I’ll cross-reference them with other available literature on the same topic.
In other words, good physicians take what they learn from Youtube and Google and integrate that information with the full context of their prior medical knowledge built upon years of formal training and years of real-world practice.
In my opinion, this is how physicians can best “vet” the information they find on Youtube and Google. This is also why physicians can generally sift through medical websites and videos more efficiently than non-physicians who Google their own symptoms. Physicians usually have enough additional background context to find the nuggets of useful information amidst the background noise more efficiently than lay persons — not always, but usually.
Furthermore, I don’t think that having a government agency act as a regulatory “watchdog” to approve or reject medical videos would do much good. I can envision medical societies (such as the American College of Surgeons) maintaining a list of approved videos resources they endorse. In matters such as this, I trust independent physicians acting on their own best judgment much more than I trust bureaucrats.
If patients are concerned how their doctors are utilizing online information, they should ask their physicians directly. And in particular, patients can ask their doctors what sources they use, what cross-checking methods they adopt, and how they compare with the guidelines above.
Overall, I’m glad there’s a proliferation of medical information online, in forms that are easy to locate and evaluate. Youtube and Google have allowed me to find helpful information directly applicable in daily practice much faster than back in the 1990s, when I used to have to drive to a medical library and look up paper articles in heavy bound volumes on the shelves.
Just as modern technologies help drivers find their way to unknown destinations more efficiently, or help consumers find the best shopping deals more easily, they can help physicians take care of their patients more effectively. Physicians have to use reason and good judgment when evaluating these new sources of information — just as they have had to for centuries. When used properly, resources like Youtube and Google help make me a better doctor, and I’m thankful they exist.
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Why Amazon Makes A Big Pharmacy Move In 2020

Amazon is quietly talking to health insurance companies about new ways to integrate its online pharmacy services into their medical plans and employer health benefits.
The online retail giant, working under the PillPack by Amazon pharmacy brand rolled out in the last year, is winning over health insurers through their health plan enrollees.
Take Blue Cross Blue Shield of Massachusetts, which is working with Pillpack to integrate pharmacy services in the insurer’s app and website, in the kind of deal that could be a boon of new customers for the online pharmacy. The Massachusetts Blues plan said it was the first health plan to offer such “direct integration” and they did so because PillPack by Amazon’s services were so popular with Blue Cross health plan enrollees.
The health insurer wouldn’t say whether more customers were using PillPack services over Walgreens Boots Alliance or CVS Health pharmacies. However, PillPack’s so-called “net promoter score,” which measures how likely consumers are to recommend a product, was higher than other pharmacies, the Massachusetts Blue Cross plan said.
“Members have reported higher satisfaction with PillPack than with other pharmacy options,” a spokeswoman for Blue Cross Blue Shield of Massachusetts said referring to a “net promoter score” of 74 for PillPack compared to 26 for “other Rx.” That is why Massachusetts Blue Cross wanted to work with PillPack, the spokeswoman said.
Analysts have doubted Pillpack’s deeper entrance into the pharmacy space without a health insurer or pharmacy benefit manager under Amazon ownership. “We continue to believe that Amazon’s ability to gain market share will be slow given Pillpack’s lack of relationships with major payers,” Mizuho Securities analyst Ann Hynes said in a report last month.
“We believe Amazon’s strategy is to gain more of the Prime member’s wallet. Prime members tend to be less price sensitive,” Hynes said. “Ultimately, we believe Amazon will need to buy a PBM/payer to move major market share in pharmacy.”
Whether such net promoter scores will translate into more business for PillPack is unclear, but it’s yet another way the online pharmacy can lure new business with employers and insurers looking for quality and low cost pharmacy services. “We’re proud to be part of this integration and look forward to serving more Blue Cross members,” a PillPack spokeswoman said.
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