Search This Blog

Friday, February 7, 2020

Coronavirus concerns spur global run on health worker supplies, cause shortages

Concern about the new coronavirus spreading in China has triggered a run on global supplies of equipment used to protect health workers from infection, the World Health Organization said Friday, with stockpiles depleted and producers reporting four- to six-month waits for new supplies.
WHO Director General Tedros Adhanom Ghebreyesus said demand for personal protective equipment, or PPE as it is called, is 100 times higher than normal and prices have skyrocketed to 20 times usual rates.
Tedros said “widespread, inappropriate use of PPE outside of patient care” is the cause, and he urged the public as well as all parties in the supply chain to adjust their practices to ensure fair and rational use of supplies.
“There is limited stock of PPE, and we need to make sure we get it to the people who need it most, in the places that need it most,” the WHO leader said.
Tedros spoke Friday about the issue with what is known as the “pandemic supply chain network” — manufacturers, distributors and logistics providers. Some companies, he said, have taken the decision to only supply masks to medical professionals.
The concern is less about paper surgical masks, the thin, pleated type seen in TV hospital dramas. It relates instead to hard, domed masks known as N-95 respirators, which are the types needed to protect against the spread of a respiratory pathogen in a hospital setting.
“At every stage of the supply chain there is a possibility for disruption or profiteering or diversion,” said Dr. Mike Ryan, head of WHO’s health emergencies program. “So this is not an easy problem to solve. There are many players, both in the public and private sector.”
But he said it’s critical to ensure supplies are available for the health workers who are or will care for people suffering from infection with the new virus — provisionally called 2019-nCoV.
“We need to start looking at what is the minimum amount of supply that needs to be protected and directed to those institutions and systems that require it for the next number of months,” Ryan said. “If we start to see the normal civilian market being flooded with N-95 and other respirator-type masks and we see doctors and nurses in hospitals not having those, then there is a problem.”
The shortage doesn’t just threaten the safety of health workers responding to the coronavirus epidemic, Ryan said. There could be knock-on effects, with supply shortages impacting the response to Ebola, Lassa fever, and other dangerous pathogens that threaten the health of doctors and nurses who care for the sick.
Fortunately, Ryan said, the WHO had pre-purchased equipment for the ongoing Ebola outbreak in the Democratic Republic of the Congo, with enough PPE in stock to take the response through to April or May.
Coronavirus concerns trigger global run on supplies for health workers, causing shortages

FDA OKs AI software to help doctors take ultrasound pictures of heart

The Food and Drug Administration has approved a software product from an artificial intelligence startup that is aimed at making it easier for doctors and other medical professionals to take ultrasound pictures of the heart, also known as echocardiograms.
The technology, developed by San Francisco-based Caption Health, could help more hospitals use the diagnostic test, which currently requires expertise that is in short supply.
“Today’s marketing authorization enables medical professionals who may not be experts in ultrasonography, such as a registered nurse in a family care clinic or others, to use this tool,” said Robert Ochs, deputy director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This is especially important because it demonstrates the potential for artificial intelligence and machine learning technologies to increase access to safe and effective cardiac diagnostics that can be life-saving for patients.”
The FDA approved the software through its “de novo” pathway, a process used for brand new medical devices. It will be called Caption Guidance.
Although the software helps medical professionals obtain the echocardiogram image, a trained cardiologist still views the images in order to make any diagnosis.
The data reviewed by the FDA came from two different studies. In one, 50 trained sonographers scanned patients with and without the software, and were able to obtain similar images in both settings. In a second study, eight registered nurses who were not trained on using ultrasound used Caption Guidance to obtain images. Five cardiologists reviewed the images, and found that the images and videos were “of diagnostic quality,” the FDA said.

“No patient should have to forgo a potentially lifesaving cardiac ultrasound,” Andy Page, Caption’s CEO, said in a statement. “Through the power of artificial intelligence, Caption Guidance will provide patients with unprecedented access to ultrasound when and where they need it most.”
Caption has raised $18 million to date, the company has previously said. Page was previously a top executive at 23andMe.
A STAT reporter took a look at the new technology in October — using it to take an ultrasound in a matter of minutes. In January, cardiologist Dr. Eric Topol of Scripps Research tweeted that he’d tried the technology for the first time. He seemed enthusiastic.
FDA approves AI-based software that helps doctors take ultrasound pictures of the heart

Avoiding Endocrine-Disrupting Chemicals: 5 Tips

As a medical student in the late 1990s, I learned about the effects of childhood lead exposure on the developing brain, and of air pollution in children with asthma. Environmental health questions have not yet found their way into the medical board exams, yet a large body of literature tells us that the endocrine system is exquisitely vulnerable to the effects of synthetic chemicals commonly used in furniture, agriculture, cookware, food packaging materials, cosmetics, and personal care products.
Scientific statements from the Endocrine Society, American Academy of Pediatrics, International Federation of Gynecology and Obstetrics, and World Health Organization and United Nations Environment Programme describe the role that these preventable exposures have in a variety of chronic conditions, such as cognitive deficits and developmental disabilities, obesity, diabetes, endometriosis, fibroids, infertility, birth defects, prematurity, and even cardiovascular disease.
I remember being taught the adage that “only the dose makes the poison,” which is akin to the notion that we should consume everything in moderation. This Paracelsian paradigm stood for 500 years even though hundreds of studies suggest that timing, other coexisting exposures, genetics, and many other factors can produce serious health consequences at the lowest levels of exposure.
As clinicians, we might react with a sense of powerlessness because we have no medication or treatment to counteract past exposures as we do with lead poisoning (ie, chelation). There is much opportunity for prevention, however, especially because many of these exposures have been proven to dissipate within 1-3 days if certain measures are taken.
There are safe and simple steps to help avoid exposure to endocrine-disrupting chemicals. In the context of the busy and ever shortening clinical visit, the following tips shouldn’t take more than a couple of minutes to discuss.

1. Mind your cookware.

Nonstick pans contain perfluoroalkyl substances (best known as PFAS). Patients may have heard of the movie Dark Waters, which documents the consequences of industrial water contamination with PFAS. These chemicals have been shown to slow metabolic rate and promote the return of weight after a successful dietary intervention. Cast iron and stainless steel cookware are good alternatives.

2. Open your windows and use a wet mop.

Flame retardants and other persistent organic pollutants used in electronics and other products accumulate in household dust and can impair thyroid function. Using a wet mop will help to better rid the house of these pollutants. Patients should also be on the lookout when buying new furniture. A California law now requires disclosure when flame retardants are added to upholstery.

3. Eat organic.

Organophosphate pesticides are well-known thyroid disruptors, and multiple studies have shown their effects on cognitive potential. Some studies have suggested associations with an increased risk for cancer.
Eating organic has become much less expensive because of growing market share, such that the big-box stores are displaying organic and conventional products side by side with competitive pricing. I focus on prioritizing organic leafy greens and vegetables, where pesticides are more likely to be ingested, and place foods like avocados, which have a protective outer rind, further down the list.

4. Avoid canned foods.

Bisphenols are estrogenic, antagonize adiponectin, and make fat cells larger. Studies suggest that stopping canned-food consumption can decrease bisphenol levels in urine as much as 90% or more. BPA-free cans are misleading in many cases because there are 40 or so replacement bisphenols. What little we know about one BPS suggests similar estrogenicity and toxicity to embryos, as well as persistence in the environment. A doubling of type 2 diabetes risk was also observed among adults with higher levels of BPS in their urine.

5. Don’t microwave or machine-wash plastics.

Phthalates commonly found in food packaging can negatively influence lipid and carbohydrate metabolism, with exposure linked to increased weight gain over multiple years. The “microwave safe” label was intended for gross misshaping or warping. The reality is that the polymers break down at the microscopic level and get into food, and the noncovalently bound additives are mostly not tested.
I’ve learned the hard way that giving too many suggestions can overwhelm patients, even those with the best intentions. My advice is to prioritize the first two tips; write them down (prescription pad optional) and follow up at each visit to see how families are doing. And perhaps you and your loved ones will see the benefits at home too!
Leonardo Trasande, MD, MPP, is the Jim G. Hendrick, MD, Professor of pediatrics and directs the NYU Center for the Investigation of Environmental Hazards. His recent book, Sicker, Fatter, Poorer: The Urgent Threat of Hormone-Disrupting Chemicals on Our Health and Future…and What We Can Do About It , describes the effects of synthetic chemicals that disrupt hormones on our health.
https://www.medscape.com/viewarticle/924846#vp_1

Primary Care Visits Fell Nearly One Quarter in Less Than 10 Years

Primary care visits among commercially insured adults decreased 24.2% over 9 years, while specialist visits remained largely unchanged, according to a new report published this week in the Annals of Internal Medicine.
The large study, based on insurance claims from January 2008 through December 2016, also showed that the number of adults with no primary care visits in an entire year grew from 38.1% to 46.4% over the study period.
“The reason alarm bells ring is that we  know that primary care is associated, at a population level, with lower mortality and has been associated with better health outcomes, less need for emergency care, lower costs of care and better patient satisfaction,” lead author Ishani Ganguli, MD, MPH, an assistant professor at  Harvard Medical School in Boston, Massachusetts, told Medscape Medical News.
Healthcare reform efforts in the United States rely on primary care as a foundation, added Ganguli, who is also an internist at Brigham and Women’s Hospital.
For the current study, the researchers looked at 142 million primary care visits over 94 million person-years with a single insurer. They defined PCPs as physicians, nurse practitioners (NPs), and physician assistants (PAs) whose National Provider Identifier included general practice, medicine, family practice, pediatrics, or geriatric, internal, or adolescent medicine.

Possible Reasons for the Decline

The researchers suggest three main reasons for the decline in visits.
One is that more are seeking care online. Decreases in use were found across all age groups, but were largest among the young and healthy who may be more comfortable with online consults and Internet searches for minor needs.
“[V]isit rates decreased sharply for low-acuity conditions, such as conjunctivitis, that might be addressed more easily by calling a nurse or searching the Internet,” the authors note.
Another reason may be the rising deductibles and out-of-pocket costs for care. The study found, as others have, that the decline in PCP visits was largest in low-income communities, though the drop in visits was evident across all income levels.
“[W]e estimate that the 32% increase in out-of-pocket costs for problem-based visits we observed may explain approximately 3 to 6 percentage points of the 24-percentage point decline (that is, 12.5% to 25% of the decline),” they write.
The study pointed out that the average out-of-pocket cost for a primary care visit related to a health problem rose from about $30 to $40 during the study period. Additionally, the percentage of visits that involved a deductible jumped from less than 10% in 2008 to more than 25% in 2016.
Meanwhile, preventive care visits, which are largely free under provisions of the Affordable Care Act, went up 40.6% in that time.

Some Seeking Care Elsewhere

The authors also note that visits to urgent care centers, retail clinics, and emergency departments, as well as telemedicine visits, were up by 9 visits per 100 member-years, “offsetting about one quarter of the PCP visit decline (35 visits per 100 member-years).”
However, Ganguli emphasized these visits are a small percentage of total visits.
While such alternative visits can be very useful for some transactional needs, such as testing for strep throat, she said, “They don’t replace a relationship with a primary care clinician who knows you well. That’s the big distinction.”

Some Positives in the Data

The positive news from the research, Ganguli says, is that PCPs are finding other, more convenient ways to interact with patients besides office visits.
She gave an example in her own practice: Ganguli said she might see a patient for high blood pressure in the office and then, instead of scheduling a follow-up visit in a month, she’ll give information on buying a home blood pressure cuff with instructions to email her with results.
PCP visits may also be getting more efficient, and physicians may be getting more done at each appointment — so fewer are necessary. Ganguli said their previous research supports this idea, with evidence of longer visits and more objectives accomplished during the visits.
The downward trend may also reflect the move away from needing to have a PCP referral for specialist services, said John Hargraves, MPP, senior researcher with the Health Care Cost Institute, based in Washington, DC.
“For many specialists, patients have enough knowledge to choose the appropriate provider and don’t need the referral,” said Hargraves, who analyzes trends in primary care visits.
Hargraves told Medscape Medical News the Ganguli study helps confirm previous reports of declines in the numbers of PCP visits.
He said the concern is not necessarily with people who are healthy and perhaps can skip some annual primary care checkups. “But if you’ve been diagnosed with asthma or are diabetic and are not going to the doctor, that could lead to serious complications down the line — and is much more costly to the system and the patient.”
What the study was not able to show — and what remains a gray area in medicine — is where the line is between necessary and unnecessary care.
“We don’t know that we’re looking at a decline in necessary care,” he said.

Coverage Does Not Equal Access

In an accompanying editorial, Kimberly Rask, MD, PhD, with Emory University and Alliant Health Group in Atlanta, Georgia, notes that the strengths of the study are that it used a large database and it showed that even people with commercial insurance are using PCP care less.
But coverage does not equate to access, Rask notes. And this study shows that applies to those who are commercially insured just as previous studies have shown that to be the case among publicly-insured patients.
She draws her own conclusions of the problem, writing: “The steady decline in PCP visit rates across age, health status, and income may be the unintended consequence of using cost sharing to reduce unnecessary care in an uncoordinated health care system.”
While cost-sharing and high-deductibles have been designed to decrease use of unneeded care and require patient investment, research suggests that needed care is being decreased along with unnecessary care, she pointed out.
Ganguli, who reports receiving compensation as a consultant from Haven (a nonprofit healthcare venture), said that studies over the long term that evaluate whether the decline in PCP visits is related to poorer outcomes will  help to clarify that question and aid in effecting change.
The study had no primary funding source. Apart from Ganguli’s consultancy with Haven, the other study authors and the editorialist have disclosed no relevant financial relationships.
Ann Intern Med. Published online February 3, 2020. AbstractEditorial
https://www.medscape.com/viewarticle/924951#vp_1

AbbVie Reports 4Q Profit, Bump in Net Revenue

AbbVie Inc. (ABBV) reported a profit, compared with a loss a year earlier, as its research and development costs fell by billions.
The company’s profit was $2.8 billion, compared with a loss of $1.83 billion a year earlier. Earnings were $1.88 a share, compared with a loss of $1.23 a share.
Adjusted earnings were $2.21 a share, up from $1.90 a share. According to FactSet, analysts were expecting $2.19 a share.
Net revenue was $8.7 billion, up 4.8%. Analysts were expecting $8.69 billion.
The company’s research and development costs sank to $1.54 billion. In the fourth quarter of 2018, they were $6.5 billion. AbbVie also reported $890 million in other operating income.
At the same time, the company reported $416 million in net other expense, compared with net other income of $393 million a year earlier. AbbVie also had $273 million in income tax expense compared with an income tax benefit of $547 million a year earlier.

https://www.marketscreener.com/ABBVIE-INC-12136589/news/AbbVie-Reports-4Q-Profit-Bump-in-Net-Revenue-29958596/?countview=0

VTv Therapeutics up 21% after hours ahead of key data readout

Thinly traded micro cap vTv Therapeutics (NASDAQ:VTVT) is up 21% after hours in response to its announcement that it will release topline data from Part 2 of a Phase 2 clinical trial, Simplici-T1, evaluating TTP399 as oral adjunctive therapy to insulin in adults with type 1 diabetes (T1D) at 7:00 am ET on Monday, February 10.
A conference call will follow at 8:30 am.
In June 2019, it announced positive results from Part 1 of the study that showed treatment with TTP399 lowered HbA1c levels by an average of 8.2% at week 12 compared to a 1.4% increase in the placebo group.
The company says TTP399 activates an enzyme called glucokinase (GK) which is a key regulator of glucose levels, adding that it only activates GK in the liver thereby avoiding disruption in the interaction between GK and glucokinase regulatory protein which can lead to hypoglycemia, limited durability of response and other side effects, problems that have troubled other GK activators.
https://seekingalpha.com/news/3539835-vtv-therapeutics-up-21-after-hours-ahead-of-key-data-readout

Gilead an acquisition target? Deep pockets required

Jefferies’ Michael Yee says investors believe that Gilead Sciences (GILD +0.6%) is an acquisition target considering its near-term share performance (at the same level as three years ago with some volatility thrown in) and tepid growth prospects (little or no topline increase expected this year).
He equates its current situation with Allergan (AGN +2%), acquired by AbbVie (ABBV +5.2%) for $63B and Celgene (CELG), acquired by Bristol-Myers Squibb (BMY -1.6%) for $74B, albeit it is not an “obvious” takeover target.
Any potential suitor will need deep pockets. For comparison purposes, AbbVie paid a 2.8x multiple of Allergan’s trailing 12-month revenues while BMY paid 4.4x for Celgene. GILD’s current market cap is ~$90B or 4.0x times its most recent 12-month revenues. Since management is unlikely to embrace a no-premium bid, an offer would probably need to be $100B – 125B, an amount very few companies could digest.
https://seekingalpha.com/news/3539763-gilead-acquisition-target-deep-pockets-required