Search This Blog

Saturday, July 27, 2019

2% of women have ‘persistent’ opioid use after childbirth

Physicians thinking about prescribing opioid painkillers for women around the time of delivery should think twice, a new study suggests, because some go on to “persistent” opioid use.
A report published Friday in JAMA Network Open examined opioid prescriptions among more than 300,000 women who gave birth between 2008 and 2016. Nearly half were given an opioid prescription shortly before or after giving birth. Among the women who filled the prescriptions, about 2% showed signs of “persistent” opioid use, defined as two subsequent refills within one year after the delivery. These prescriptions are short, on average about one to two weeks of medication.
During the study period, both the percentage of women who filled their prescriptions and the rate of persistent opioid use declined.
But because so many women deliver babies each year, even 2% of persistent opioid use is meaningful from a public health standpoint, said Rishi Desai, an epidemiologist at Brigham and Women’s Hospital, who was not involved in the study.
Dr. Alex Peahl, an OB-GYN from the University of Michigan who led the study, said she was surprised to see so many women prescribed opioids around the time of delivery. The research team expected few women to need subsequent refills because delivery-related pain generally resolves around four to six weeks after delivery.
“It’s of course a topic that is on many people’s minds because pregnancy is one of the most common reasons why a lot of young women without any sort of health conditions come into contact with the health care system,” said Desai.
Persistent opioid use was seen in 1.7% of women with vaginal deliveries and 2.2% of those with cesarean deliveries.
The narrow difference between persistence among women following vaginal birth or C-section “makes us think that there’s something inherent to the prescription rather than what women are going through that’s driving persistent use,” said Peahl.
The researchers chose delivery because pregnancy and delivery are often the first contacts many women have to be exposed to prescription opioids. It raises a concern, said Desai. Once you start a pregnant woman on one opioid prescription, what is the probability that she will go on to use opioids longer term?
In this study, the biggest factor associated with increased odds of developing persistent opioid use is the first fill of a prescription, not the type of delivery.
The authors compared their findings to those of a recent study on similarly young, healthy individuals who had never before taken opioids and who were having their wisdom teeth removed, which can also represent a first exposure to opioids. After oral surgery, 1.3% of those who filled opioid prescriptions showed persistent opioid use, similar to the odds following delivery. Another study comparing major and minor surgical procedures showed similar results about first exposure to opioids.
Peahl and colleagues studied claims from commercial insurance, often through employers, which covers half of women in the U.S. through their pregnancies. Across the U.S., however, Medicaid covers more than 40% of deliveries. Using stricter definitions for persistent use, Desai and his colleagues reported in a presentation to the Society for Epidemiologic Research rates of persistent opioid use as high as 4.6% among women covered by Medicaid.
Painful conditions and complications can occur during vaginal deliveries. The biggest of these linked to new persistent opioid use was tubal ligation. However, the amount of opioids prescribed and the timing — filling an opioid prescription before delivery — had even greater effects. Among women who delivered by C-section, only one complication, a rare and emergency hysterectomy (removal of the uterus), was associated with increased rates of new persistent opioid use.
Other well-known factors, such as tobacco use, prior substance use disorder, and prior pain disorders, were also linked to persistent use.
“This study shows that there continues to be a chance to really intervene on the prevention side,” said Marian Jarlenski, an assistant professor of health policy and management at the University of Pittsburgh Graduate School of Public Health, who was not involved in this study. The decision to write an initial prescription is a low-hanging-fruit point of intervention, she said.
The outcome that Peahl and colleagues used in their study, “new persistent use,” is not the same as persistent use disorder, formerly called substance abuse (a term abandoned by the Diagnostic and Statistical Manual of Mental Disorders in 2013). It’s possible that use of this definition overestimated the number of women who went on to persistent opioid use after delivery, Desai and Jarlenski said. Another limitation, said the study team, is that they were not able to determine if the pills in the prescriptions were actually taken.
“I think it first gives us a validity check that what we’re finding in this population is similar to other populations,” said Peahl. “Pain can be very complicated and affected by a variety of factors. Understanding how to prevent new persistent use, and ultimately abuse, requires really an interdisciplinary nuanced approach to helping patients navigate complex situations.”
To help manage pain following C-section, for example, Peahl and her colleagues at the University of Michigan use opioid-sparing pain protocols, which include steps to help patients prepare for pain control and shared-decision making before and throughout their hospitalization.
The American College of Obstetricians and Gynecologists offer guidelines for managing pain after childbirth that include opioids and alternatives to them. According to a spokesperson, the college reviews its guidelines every 18-24 months, or more frequently based on new information.

Most Americans Unaware of Common Potentially Life-Threatening Skin Cancer

A staggering 74 percent of Americans are not familiar with cutaneous squamous cell carcinoma (CSCC) – a type of skin cancer that is also the second most common type of cancer in the U.S. – according to a new survey conducted by The Harris Poll on behalf of The Skin Cancer Foundation and in coordination with Regeneron and Sanofi./1,2 CSCC is more common than breast, lung and prostate cancer combined and is estimated to cause more deaths than melanoma./3,4 Yet despite these statistics, the survey found a surprising lack of awareness and understanding of CSCC among a majority of Americans.
“During the summer months, skin cancer conversations are largely focused on prevention. Prevention is critical. At the same time, 1 million cases of cutaneous squamous cell carcinoma are expected to be diagnosed in 2019 alone./3 So discussions on skin cancer identification and treatment are equally as important,” said Skin Cancer Foundation President Deborah S. Sarnoff, MD. “Although CSCC is far more common than melanoma, these survey findings reveal that CSCC is virtually unknown to most Americans, and most have signficant misconceptions of how dangerous it can be if it progresses. This large gap in knowledge highlights the urgent need to increase public awareness of CSCC, including understanding of the seriousness of advanced cases.”
“Advanced” is a broad term for CSCC that may have spread extensively or have resisted multiple treatments and recurred. An estimated 40,000 people in the U.S. each year learn they have CSCC that has advanced to the point that it may be very challenging to treat./3,5
The findings of the survey, which was fielded by The Harris Poll in May 2019 and surveyed more than 2,000 adults across the country, are striking:
42 percent of Americans have never heard of CSCC. In contrast, only 11 percent of Americans say they have never heard of melanoma./2
Only 3 percent of people correctly identified CSCC as one of the three most common types of cancer in the U.S.2
More than half of Americans (54 percent) falsely believe melanoma is the most common type of skin cancer in the US.2 In actuality, CSCC is five times more prevalent than melanoma (and basal cell carcinoma [BCC] is the most common type of skin cancer)./3,6
72 percent of Americans don’t understand that non-melanoma skin cancers such as CSCC can spread and become life-threatening./2
A majority of Americans (58 percent) know advanced melanoma can be life-threatening, yet only 28 percent think the same about advanced CSCC./2
Many people at higher risk for developing CSCC are not familiar with it:/2
40 percent of people living in the southern U.S. have never even heard of CSCC, but they are more likely to develop it than those living in northern states./7
Only 26 percent of men are familiar with CSCC, though they are three times as likely as women to develop it./8,9
CSCC is more common in people 65 years and older./10 Yet only 35 percent of people in this age group are familiar with CSCC, although they are more familiar than their younger peers.

Pfizer in talks to merge off-patent drugs business with Mylan

Pfizer Inc (PFE.N) is in talks to merge its off-patent drugs business with Mylan NV (MYL.O) in a stock deal, the Wall Street Journal reported on Saturday, citing people familiar with the matter.
Mylan shareholders would receive a little more than 40% of the newly formed entity, with Pfizer shareholders receiving the remainder, the Journal said, adding Pfizer would also get about $12 billion in proceeds from a new sale of debt.

ResMed posts solid quarter on increased sales of sleep apnea products, software

ResMed posted better than expected financial results for its fiscal fourth quarter, beating Wall Street’s targets for both revenue and adjusted earnings.
The maker of cloud-connected machines to help treat sleep apnea and other respiratory-related conditions said Thursday that fourth quarter revenue came in at $705 million, fueled by an 11 percent increase in U.S. sales and an 111 percent gain in subscription software revenues.
That beat Wall Street analysts’ average forecast of $699 million in sales for the quarter. Last year, ResMed had fourth quarter revenue of $624 million.
The company reported net income of $70 million for the quarter under Generally Accepted Accounting Principles — down 37 percent from the same quarter last year.

The decrease stemmed in part from a $41.2 million charge for a pending legal settlement with the Inspector General of the U.S. Department of Health and Human Services over certain ResMed discount and promotional programs, as well as acquisition and restructuring expenses.
ResMed’s adjusted earnings for the quarter, which exclude one-time items, came in at $138 million, or 95 cents per share. Analysts had expected adjusted earnings of 91 cents per share.
“Our connected health strategy continues to support growth across global markets and the continued traction of our diversified mask and device portfolio, along with an expanding pipeline of new products and enhanced digital health solutions for sleep apnea, COPD (chronic obstructive pulmonary disease) and out-of-hospital medical software markets,” said Chief Executive Mick Farrell in a conference call with analysts.
— In 2018, it acquired Brightree and MatrixCare to boosts its software related product lines.

“We believe ResMed is entering fiscal year 2020 with momentum in its core sleep apnea franchise, a burgeoning COPD business and expanding software-as- a-service systems to deliver high single-digit revenue growth,” said BMO Capital Markets analyst Joanne Wuensch in a research report.
For its full fiscal year ended June 30, ResMed posted sales of $2.6 billion, up 11 percent from 2018.
GAAP earnings came in at $405 million, or $2.80 per share — up 28 percent from the prior year. Adjusted earnings for the year reached $3.64 per share, up 3 percent.

Novartis CEO pledges not to sell Sandoz generics unit

Novartis Chief Executive Vas Narasimhan pledged in an interview published on Saturday not to sell the Swiss drugmaker’s generics unit Sandoz amid a revamp that has prompted speculation he is preparing to offload the business.

“No, we will not sell Sandoz,” Narasimhan told the Sueddeutsche Zeitung newspaper. “We will make Sandoz autonomous within Novartis, so it’s more competitive. Our plan is to focus Sandoz and make it better in the long-term.”
Novartis is revamping Sandoz, a process Narasimhan has previously said will take roughly the next year and a half. He has already sold a generic U.S. pills business and dermatology assets that were under extreme price pressure, and has suggested other divestitures may be forthcoming.
These changes, along with the departure of Sandoz’s former CEO in March, have prompted some analysts to predict Narasimhan may eventually exit generics.
Sandoz, which last year had nearly $10 billion in sales, upgraded its full-year sales target on July 18, holding out the possibility of low-single-digit percentage sales growth, up from a previous prediction of “broadly in line” with 2018.
In the first half of 2018, Sandoz’s business with biosimilar copies of branded blockbusters in Europe helped offset a U.S. business that remains under price pressure.
Narasimhan also said he planned to keep both Sandoz and Hexal brands in Germany. “There will be no changes here,” he told the newspaper.

Align Technology CEO Defends Q2 Results, Highlights Bright Future

Shares of Align Technology, Inc. ALGN 1.02% — maker of Invisalign — plummeted Thursday in reaction to the company’s second-quarter earnings report and guidance but CEO Joe Hogan remains “optimistic about the market.”

What Happened

On top of reporting an earnings miss in the quarter, Align shipped 377,100 of its core Invisalign cases which fell 5,800 units short of expectations. Hogan told CNBC’s Jim Cramer Thursday much of the weakness can be attributed to China.
China is Invisalign’s second largest market and the company hoped to see 70% growth in the second quarter, the CEO told Cramer. But Thursday’s report showed just 20%-30% growth and the weakness is not due to any competitive or operational issues.
“It’s just basically a consumer backlash right now, we feel, from a standpoint of making decisions on going ahead with aligners or not,” Hogan said.
Outside of China, the company saw notable strength across Europe at 39% and a triple-digit growth rate in markets like Brazil.

Why It’s Important

Hogan said he was in Asia for first-hand checks and there is no sign his company is losing market share despite a growing competitive market. In fact, Hogan said he saw higher levels of orders throughout July in China, and encouragingly, also in the U.S. market.
Shares of Align plummeted nearly 30% Thursday and Hogan said the company has around $400 million in remaining share buyback authorization. As such, the company will “certainly take advantage” of its position and when asked by Cramer if he will personally be buyer of the stock the CEO responded “I think you will see that also.”
“There is a broad based growth story here,” he said. “I have to do a better job and the company has to do a better job of getting out. It’s not necessarily a competitive story, it’s an opportunity story for us overall.”

Friday, July 26, 2019

Shield Therapeutics soars on FDA approval of iron deficiency drug

Shares in Shield Therapeutics were soaring this morning after the FDA granted a broader than expected label for its iron deficiency drug.
The London-based company said the FDA had approved its lead product Ferracru/Accrufer (ferric maltol) in a market that could be worth $1 billion annually.
The FDA approved the product for treatment of iron deficiency with or without anaemia, allowing use for as long as necessary to restore iron levels.
This allows for long-term use in patients with chronic disease – there are between 8 million and 9 million patients in the US suffering from iron deficiency anaemia and management estimates two to three times this number require treatment for iron deficiency.
Shield said it is already in discussions with commercial partners to market the drug in the US and will provide an update in due course.
The company noted that salt-based iron therapies can cause a range of mild-to-severe gastrointestinal tract adverse events, including nausea, bloating, and constipation.
These can lead to poor tolerability, reduced patient compliance and treatment failure.
As Ferracru/Accrufer is not an iron salt, iron can be absorbed from the ferric maltol molecule and does not routinely cause the same issues.
Under the brand name Ferracru the drug is already approved and marketed in the EU and Switzerland for iron deficiency in adults.
Mark Brewer, an analyst at finnCap, said: “The FDA granted a broader than expected label, given Feraccru’s tolerability profile and efficacy – the treatment of Iron Deficiency (ID) with or without anaemia – with the label indicating its use for as long as necessary to restore iron levels, implying a chronic therapy.
“This at least doubles the potential addressable market for Accrufer. Together with the non-inferiority data vs. IV iron, announced in March, this offers the potential for Accrufer to remove the need for patients to progress to IV therapy.”
Dr Daniel Wilkinson, analyst at Edison Investment Research, noted this was the “largest possible label” the FDA could have granted.
He said: “This is an upside to our previous assumptions where we had assumed a narrower label and enables a larger commercial opportunity. Shield are in discussion with a number of potential commercial partners in the US who will market Accrufer on its behalf.”
Carl Sterritt, CEO of Shield Therapeutics said: “We have been pleased with the levels of interest and engagement shown by third parties in commercialising Accrufer in the USA and we look forward to finalising these discussions and appointing a commercial partner in the world’s most attractive pharmaceutical market, so that more patients with iron deficiency can benefit from treatment with Accrufer at the earliest opportunity.”