In new headache, WeWork finds cancer-causing chemical in its phone booths

Cash-strapped WeWork, the office-sharing company that is trying to negotiate a financial lifeline, has a new problem that may prove costly. It has closed about 2,300 phone booths at some of its 223 sites in the United States and Canada after it says it discovered elevated levels of formaldehyde.

The company, which abandoned plans for an initial public offering last month after investors questioned its mounting losses and the way it was being run, said in an email to its tenants on Monday that the chemical could pose a cancer-risk if there is long-term exposure.
After a tenant complained of odor and eye irritation, WeWork began testing and based on the results took 1,600 phone booths out of service, the company said in the email to tenants, which it calls members.
An additional 700 booths are closed while more testing is conducted, it said. All the phone booths closed were installed over the past several months, WeWork said.
“The safety and well-being of our members is our top priority and we are working to remedy this situation as quickly as possible,” WeWork said in a statement.
More costs are the last thing needed at the company, which some analysts say is fast running out of cash. WeWork declined to comment on the cost of testing and replacing the booths.
It is currently in talks for a multi-billion dollar rescue deal that could lead to its largest shareholder, Japan’s SoftBank Group Corp, taking control, two people familiar with the matter said. WeWork is also talking to JPMorgan Chase over a possible debt package, they said.
WeWork declined to identify the manufacturer of the phone booths.
“Long-term exposure to formaldehyde, such as that experienced by workers in jobs who experience high concentrations over many years, has been associated with certain types of cancers,” WeWork told tenants in the email.
In 1987, the U.S. Environmental Protection Agency classified formaldehyde as a probable human carcinogen under conditions of unusually high or prolonged exposure. Some studies since then suggested that formaldehyde exposure is associated with certain types of cancer, according to the National Cancer Institute.
A tenant, who did not wish to be identified, said she was worried about the risk of cancer as she had spent hundreds of hours inside phone booths at a San Francisco WeWork that has the problem.
Phone booths are popular in WeWork’s open-plan offices as they provide privacy and noise reduction, the tenant said.

https://www.marketscreener.com/news/In-new-headache-WeWork-says-it-found-cancer-causing-chemical-in-its-phone-booths–29374615/?countview=0

Adverum and Regenxbio go opposite ways on macular degeneration data

Gene therapy developers REGENXBIO (RGNX -11%) and Adverum Biotechnologies (ADVM +17.4%) have diverged after data presentations on their respective gene therapy candidates for wet age-related macular degeneration (wet AMD) at the American Academy of Ophthalmology Annual Meeting in San Francisco.

Additional results from the first cohort (median follow-up of 34 weeks) in the Phase 1 OPTIC study showed that treatment-experienced patients (n=6) previously requiring frequent anti-VEGF injections to maintain vision did not require any rescue injections after receiving a single administration of ADVM-022 while maintaining stable visual acuity.

Preliminary results from cohort 5 in a Phase 1/2a study of RGX-314 showed that 75% (n=9/12) of patients were anti-VEGF injection-free at months 5 or 6 while the remaining subjects still required injections. Across all 12 patients, the mean annualized anti-VEGF injection rate was 0.8, implying that three patients required an annualized average of more than three injections [(0.8 x 12)/3=3.2]. In cohort 4, 42% (n=5/12) were anti-VEGF injection-free at month 6 with an average of 2.2 injections over that time period, implying that seven patients received an average of almost four injections over six months [(2.2 x 12)/7=3.8].

Regeneron Pharmaceuticals (REGN +2.5%), maker of top wet AMD seller Eylea (aflibercept), an anti-VEGF therapy, is up on average volume.

https://seekingalpha.com/news/3505590-adverum-regenxbio-go-opposite-ways-wet-amd-data

Johnson & Johnson Q3 2019 Earnings Preview

Johnson & Johnson (NYSE:JNJ) is scheduled to announce Q3 earnings results on Tuesday, October 15th, before market open.

The consensus EPS Estimate is $2.01 (-2.0% Y/Y) and the consensus Revenue Estimate is $20.16B (-0.9% Y/Y).

Over the last 2 years, JNJ has beaten EPS estimates 100% of the time and has beaten revenue estimates 100% of the time.

Over the last 3 months, EPS estimates have seen 1 upward revision and 15 downward. Revenue estimates have seen 8 upward revisions and 3 downward.

https://seekingalpha.com/news/3505582-johnson-and-johnson-q3-2019-earnings-preview

Sleep apnea linked to blinding eye disease in people with diabetes

New research from Taiwan shows that severe sleep apnea is a risk factor for developing diabetic macular edema, a complication of diabetes that can cause vision loss or blindness. Diabetic macular edema was also more difficult to treat in patients with severe sleep apnea. While earlier research showed a weak connection between the two conditions, evidence is mounting that sleep apnea exacerbates underlying eye disease. The researchers present their study today at AAO 2019, the 123rd Annual Meeting of the American Academy of Ophthalmology.
When people with diabetes have poor control over their blood sugar levels, the tiny blood vessels at the back of the eye can become damaged. This condition is called diabetic retinopathy and it’s a leading cause of blindness in the United States.
Sometimes, tiny bulges protrude from the blood vessels, leaking fluid and blood into the retina. This fluid can cause swelling or edema in an area of the retina that allows us to see clearly.
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts, disrupting sleep and causing blood oxygen levels to drop. This drop in oxygen appears to unleash a host of changes in the body that may play a role in injuring blood vessels. People with sleep apnea are at risk of developing hypertension, heart attacks, stroke and type 2 diabetes.
But what about the eyes? Researchers believe that sleep apnea may contribute to the development and worsening of diabetic retinopathy by increasing insulin resistance, elevating inflammation and raising blood pressure, all of which can damage the blood vessels at the back of the eye.
To learn more, lead researcher Juifan Chiang, MD, and colleagues looked at data from all patients diagnosed with diabetic retinopathy over an 8-year period at Chang Gung Memorial Hospital in Taiwan. They found that the rate of severe sleep apnea was significantly higher in patients with diabetic macular edema compared with those without diabetic macular edema (80.6 percent vs. 45.5 percent). They also found that the worse their sleep apnea was, the worse their macular edema. Severe sleep apnea was also more prevalent in patients who needed more treatment to control their macular edema. These patients required three or more treatments of medical or laser therapy.
“Based on these results, we hope that more medical professionals will approach sleep apnea as a risk factor for diabetic macular edema,” Dr. Chiang said. “This could allow for earlier medical intervention so patients can keep more of their vision and preserve their overall health as much as possible.”
https://www.eurekalert.org/pub_releases/2019-10/aaoo-sal100919.php

Premier joins forces with Amphastar on 7 drugs in short supply

• Premier, the country’s largest group purchasing organization, has announced a partnership with Amphastar Pharmaceuticals to offer seven drugs in short supply to providers.
• The agreement is part of Premier’s ProvideGx program and will focus mostly on pre-filled syringes for emergency use, according to a Tuesday statement. Premier didn’t release financial details, but said the deal won’t materially affect its fiscal year 2020 results.
• Amphastar said it’s bringing on new manufacturing capacity by the end of the year that will help it meet the demand for drugs experiencing supply shortages. The agreement with ProvideGx, which works with a network of about 4,000 hospitals and health systems, covers phytonadione injection and pre-filled syringes of calcium chloride, epinephrine, sodium bicarbonate, atropine sulfate, dextrose and lidocaine.

The Premier-Amphastar agreement is another example of how healthcare companies are searching for new ways to address drug shortages. About 113 medicines are either not readily available at U.S. hospitals or at risk of becoming in short supply, Premier said.
Also this week, Premier said ProvideGx, working with Exela Pharma Sciences, has put an end to a multiyear national shortage of cysteine hydrochloride injection, which is used for patients who need parenteral nutrition.
“We hope to replicate this success for many other drugs currently in shortage,” Premier President Michael Alkire said in the company’s statement. More than 4,000 U.S. hospitals and health systems aggregate under Premier to leverage their volume to negotiate lower prices with manufacturers and other vendors.
Exela is also working with Civica Rx, a group of health systems that joined together to make generic drugs in a bid to address shortages and rising costs. Under that agreement, Exela will supply member hospitals with sodium bicarbonate.
The ProvideGx program has provided reliable supplies of scarce drugs, including metoprolol, sodium bicarbonate, and hydromorphone, according to Premier. The program plans to introduce further drugs from a list of more than 60 targets in coming months, Premier said.
Several of the medicines for pre-filled syringes have been in short supply for years and not available at all in some parts of the country, Alkire said.
https://www.healthcaredive.com/news/premier-joins-forces-with-amphastar-on-7-drugs-in-short-supply/564811/

Few alternatives to cancer-causing chemical used for sterilization

A recent push from the Food and Drug Administration to find alternatives to ethylene oxide, a gas used to sterilize about 50% of the nation’s medical devices, is challenged by the lack of substitutes and the industry’s huge reliance on the gas.
The FDA has asked the industry to bring forward new processes that can effectively sterilize medical devices amid renewed concerns that ethylene oxide is harmful to workers and surrounding communities, after an Illinois sterilization facility run by Sterigenics closed.

The Illinois Environmental Protection Agency forced the plant to stop operations in February when it was prohibited from using ethylene oxide after high emissions of the gas were found. While effective at cleaning medical devices, it’s considered a human carcinogen and has been tied to some instances of cancer.

Sterigenics declined to comment.

The FDA said the proposed methods must be able to do all that ethylene oxide can do. Therefore the agency asked for submissions of sterilizing agents compatible with lots of different packing materials and fabrics as well as able to sterilize large volumes of devices.
Ethylene oxide is a low-temperature gas so it’s able to sterilize wound dressings and gowns as well as plastics and complex devices like pacemakers without causing damage to the products. It can also sterilize in bulk.
The deadline to submit alternatives to the FDA closes Oct. 15 and a review period runs until Nov. 16.
In light of FDA’s scrutiny, devicemakers are exploring alternatives to ethylene oxide, said Greg Crist, spokesman for AdvaMed, which represents the medical technology industry. Manufacturers recognize that the gas is harmful to people, but it’s difficult to find another method that is as effective. For instance, hydrogen peroxide is commonly mentioned as an alternative because it’s a very good germ killer. The problem is it hasn’t been used before to sterilize large fleets of devices, said Chris Lavanchy, engineering director of the health services group at the ECRI Institute, a not-for-profit focused on the safety of medical technologies and practices. Crist also said hydrogen peroxide can’t penetrate some materials.
The hospital industry supports finding alternatives to ethylene oxide but emphasizes how much it relies on the gas right now. The closure of the Sterigenics plant in Illinois briefly led to shortages in breathing tubes.
“We can’t just stop using it,” said Nancy Foster, vice president of quality and patient safety at the American Hospital Association. Until sufficient alternatives are available, Foster said devicemakers must do all they can to ensure they’re using the gas safely.
Devicemakers are examining how to reduce the amount of ethylene oxide currently in use, Crist said. There may be opportunities to lower emissions by using materials that are less difficult to penetrate. Right now, ethylene oxide sterilizes devices in cardboard, which requires a lot of the gas, he said.
The FDA is also interested in ways to slash emissions. Along with its inquiry for alternatives to the gas, it’s also seeking methods “to reduce emissions to as close to zero as possible from the ethylene oxide sterilization process.”
https://www.modernhealthcare.com/medical-devices/few-alternatives-cancer-causing-chemical-used-sterilization

Dialysis companies to feel squeeze from Calif. reimbursement bill

California’s governor dealt a blow to dialysis companies over the weekend when he signed into law a bill that limits the reimbursement they receive for kidney disease patients who get insurance premium assistance from third-party organizations.

Gov. Gavin Newsom signed the bill, known as Assembly Bill 290, in the face of intense opposition from dialysis companies DaVita and Fresenius Medical Care, which together control most of California’s dialysis clinics. A similar measure was vetoed by then-Gov. Jerry Brown last year. The companies have argued the legislation would increase patients’ out-of-pocket medical costs and hinder their access to care.

“This bill will directly affect nearly 4,000 low-income, primarily minority, California dialysis patients who rely on charitable support to pay for their healthcare costs,” DaVita Kidney Care commented on Monday. “Based on statements made by the American Kidney Fund regarding their inability to continue operations in the state were AB 290 to become state law, we anticipate thousands of California dialysis patients face financial harm.”

Fresenius suggested the legislation would also increase hospital utilization.

“This charitable support helps ensure vulnerable patients don’t have to choose paying for their healthcare over housing and food. We are also concerned that this law will result in patients only being able to access their life-saving care at hospitals due to lack of insurance coverage, and we will support these patients’ transitions to whatever extent possible,” the company said in a statement on Monday.

While in their public statements the companies focused on how the new law would affect patients, the companies are also likely worried about their bottom lines. Early this year DaVita’s then-CEO, Kent Thiry, said that the law could reduce operating income by $24 million to $40 million. DaVita’s 2018 revenue totaled $11.4 billion, while its operating income was $1.5 billion.

Meanwhile, Fresenius Medical Care, whose parent company is based in Germany, reported 2018 revenue of 16.5 billion euros and operating income of 3 billion euros.

Rice Powell, CEO of Fresenius Medical Care, told Modern Healthcare in August that the company would “work our way through it” should the bill succeed. He argued it doesn’t make sense that the state should be able to determine how much the company makes.

“That doesn’t necessarily work with the way that capitalism in the United States works,” he said.

AB 290, which was introduced by Calif. Assemblyman Jim Wood, a Democrat, is meant to stop dialysis companies from collecting what Wood called excessive profits. It caps payments to dialysis companies at Medicare rates or a rate determined by a dispute resolution process when patients’ insurance premiums are paid by not-for-profit organizations, such as the American Kidney Fund. The American Kidney Fund, which receives most of its donations from DaVita and Fresenius, helps pay for health coverage for low-income dialysis patients.

Wood and other supporters of AB 290 have argued this system of premium assistance allows the dialysis companies to collect higher reimbursement by directing patients to private insurance, which pays more than Medicare or Medicaid.

“We can’t allow corporations to boost their profits at the expense of patients and increasing healthcare costs and I will continue to uncover these abusive practices in order to contain healthcare costs and bring healthcare to all Californians,” Wood said in a statement Sunday.

The American Kidney Fund on Sunday said it will be forced to stop providing financial assistance to about 3,700 low-income patients in California when the law goes into effect. Certain provisions of the law will take effect in 2020 while the reimbursement changes go into effect in 2022.

https://www.modernhealthcare.com/politics-policy/dialysis-companies-feel-squeeze-calif-reimbursement-bill