Today Carl Icahn released the following statement regarding Cigna Corporation: In light of the ISS and Glass Lewis recommendations in favor of the Cigna (CI) / Express Scripts (ESRX) transaction and the significant stockholder overlap between the two companies, we have informed the SEC that we no longer intend to solicit proxies to vote against the transaction.
Monday, August 13, 2018
Rethinking the stroke rule ‘time is brain’
In 1993, neurologist Camilo R. Gomez, MD, coined a phrase that for a quarter century has been a fundamental rule of stroke care: “Time is brain!”
“Unquestionably the longer therapy is delayed, the lesser the chance that it will be successful,” Dr. Gomez wrote in an editorial 25 years ago. “Simply stated: time is brain!”
But the “time is brain” rule is not as simple as it once seemed, Dr. Gomez now argues in his most recent paper, published in the August, 2018 Journal of Stroke & Cerebrovascular Diseases(published online April 25). Dr. Gomez is a Loyola Medicine stroke specialist and nationally known expert in minimally invasive neuroendovascular surgery.
It is still true that stroke outcomes generally are worse the longer treatment is delayed so it remains critically important to call 911 immediately after the first signs of stroke. But, Dr. Gomez reports, the effect of time can vary greatly among patients. Depending on the blood circulation pattern in the brain, emergency treatment could greatly help one patient, but be too late for another patient treated at the same time.
“It’s clearly evident that the effect of time on the ischemic process is relative,” Dr. Gomez wrote.
About 85 percent of strokes are ischemic, meaning the stroke is caused by a blood clot that blocks blood flow to an area of the brain. Starved of blood and oxygen, brain cells begin dying.
Traditionally, there was little physicians could do to halt this ischemic process, so there was no rush to treat stroke patients. But in his groundbreaking editorial, Dr. Gomez wrote that rapid improvements in imaging technologies and treatments might enable physicians to minimize stroke damage during the critical first hours.
“It is imperative that clinicians begin to look upon stroke as a medical emergency of a magnitude similar to that of myocardial infarction (heart attack) or head trauma,” he wrote.
As new treatments such as the clot-busting drug tPA became available, doctors did indeed begin treating strokes as emergencies. In select patients, intravenous tPA was shown to stop strokes in their tracks by dissolving clots and restoring blood flow. Initially, tPA was recommended in select patients within three hours of the onset of symptoms. This therapeutic window later was lengthened to 4.5 hours.
But Dr. Gomez said there should be no hard-and-fast rule governing when therapy can be given because strokes progress differently in different patients. Time is not the only important factor. Also critical is the blood circulation pattern in the brain.
After an ischemic stroke strikes, a core of brain tissue begins to die. Around this core is a penumbra of cells that continue to receive blood from surrounding arteries in a process called collateral circulation. Collateral circulation can keep cells in the penumbra alive for a time before they too begin to die. Good circulation slows down the rate at which the cells die.
In his latest project, Dr. Gomez used computational modeling to identify four distinct types of ischemic stroke based on the collateral circulation. “It is no longer reasonable to believe that the effect of time on the ischemic process represents an absolute paradigm,” Dr. Gomez wrote. “It is increasingly evident that the volume of injured tissue within a given interval after the time of onset shows considerable variability, in large part due to the beneficial effect of a robust collateral circulation.”
Dr. Gomez added that this computational modeling “represents a first step in our journey to enhance clinical decisions and predictions under conditions of considerable uncertainty.”
Story Source:
Materials provided by Loyola University Health System. Note: Content may be edited for style and length.
Journal Reference:
- Camilo R. Gomez. Time Is Brain: The Stroke Theory of Relativity. Journal of Stroke and Cerebrovascular Diseases, 2018; 27 (8): 2214 DOI: 10.1016/j.jstrokecerebrovasdis.2018.04.001
Cannabis link to relieving intestinal inflammation explained
Reports from cannabis users that the drug reduces the symptoms of inflammatory bowel disease (IBD) may finally be explained by new research from the University of Massachusetts Medical School and the University of Bath showing that endocannabinoids help control and prevent intestinal inflammation in mice.
This is the first-time scientists have reported a biological mechanism to explain why some marijuana users have reported beneficial effects from cannabis on intestine inflammation conditions such as ulcerative colitis and Crohn’s disease. Researchers hope that their findings will lead to the development of drugs and treatments for gut disorders, which affect millions of people around the world and are caused when the body’s immune defenses mistakenly attack the lining of the intestine.
The findings appear in the Journal of Clinical Investigation.
“There’s been a lot of anecdotal evidence about the benefits of medical marijuana, but there hasn’t been a lot of science to back it up,” said Beth A. McCormick, PhD, vice chair and professor of microbiology & physiological systems at UMass Medical School. “For the first time, we have an understanding of the molecules involved in the process and how endocannabinoids and cannabinoids control inflammation. This gives clinical researchers a new drug target to explore to treat patients that suffer from inflammatory bowel diseases, and perhaps other diseases, as well.”
The researchers discovered that gut inflammation is regulated by two important processes, which are constantly in flux and responding to changing conditions in the intestinal environment. The first process, identified in previous scientific research, promotes an aggressive immune response in the gut that destroys dangerous pathogens, but which can also damage the lining of the intestine when immune cells attack indiscriminately.
The second pathway, first described in this paper, turns off the inflammation response via special molecules transported across the epithelial cells lining the gut by the same process already known to remove toxins from these cells into the intestine cavity. Crucially, this response requires a naturally-produced molecule called an endocannabinoid, which is very similar to cannabinoid molecules found in cannabis.
If the endocannabinoid isn’t present, inflammation isn’t kept in balance and it can run unchecked, as the body’s immune cells attack the intestinal lining.
McCormick and colleagues believe that because cannabis use introduces cannabinoids into the body, these molecules could help relieve gut inflammation, as the naturally produced endocannabinoids normally would.
“We need to be clear that while this is a plausible explanation for why marijuana users have reported cannabis relieves symptoms of IBD, we have thus far only evaluated this in mice and have not proven this experimentally in humans. We hope, however, that these findings will help us develop new ways to treat bowel diseases in humans” said professor Randy Mrsny from the University of Bath Department of Pharmacy and Pharmacology.
Story Source:
Materials provided by University of Massachusetts Medical School. Original written by James R Fessenden. Note: Content may be edited for style and length.
Journal Reference:
- Rose L. Szabady, Christopher Louissaint, Anneke Lubben, Bailu Xie, Shaun Reeksting, Christine Tuohy, Zachary Demma, Sage E. Foley, Christina S. Faherty, Alejandro Llanos-Chea, Andrew J. Olive, Randall J. Mrsny, Beth A. McCormick. Intestinal P-glycoprotein exports endocannabinoids to prevent inflammation and maintain homeostasis. Journal of Clinical Investigation, 2018; DOI: 10.1172/JCI96817
Still Shunning Medicaid Patients
Hello. I’m Dr Charles Vega, and I am a clinical professor of family medicine at the University of California at Irvine. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
Physician participation in the Medicaid program was largely unaffected by Affordable Care Act (ACA)-mandated payment increases to primary care providers or the expanded access programs established in some states. This conclusion comes from data collected between 2012 and 2015.
Compared with family physicians, pediatricians were more likely to report accepting new Medicaid patients, and internists were less likely. While the ACA resulted in a 20% increase in adult Medicaid patients, these patients remained concentrated among a small number of primary care physicians, with 60% of them treated by 20% of the physicians who participated in Medicaid.
The fact that most primary care physicians made little or no change to their Medicaid participation despite the influx of millions of newly Medicaid-covered patients may be a reflection of low reimbursement rates, administrative burdens, the temporary nature of the reimbursement increases, or other factors that make participation difficult or unappealing.
But whatever the reason, physicians and policymakers need to tackle this together if we’re going to address the health concerns of this vast population of adults.
Biogen pricey muscle drug Spinraza too costly for Britain
Biogen muscle disease treatment Spinraza has been deemed too expensive for use on Britain's state-run health service, even after a price discount offered by the U.S. drugmaker.
Spinraza, which has a U.S. list price of $750,000 in the first year of treatment, is a big money-spinner in Biogen's home market. But Britain's healthcare cost agency NICE said on Tuesday it could not recommend it as a cost effective treatment.
That is despite Spinraza, which is also known as nusinersen, having a lower British price tag of 450,000 pounds ($573,000) for the first year and Biogen offering an undisclosed discount to the National Health Service (NHS).
"Even with the proposed confidential discount the cost of nusinersen is too high for it to be considered a cost-effective use of NHS resources," the National Institute for Health and Care Excellence (NICE) said.
NICE's committee of experts also raised concerns that there were still significant uncertainties around the long-term benefits of the medicine.
"We are actively engaging with Biogen to discuss how they might address the uncertainties identified by the committee, while demonstrating the potential for nusinersen to be considered cost effective and managing the risk to the NHS of allowing access to this treatment," said Meindert Boysen, NICE's health technology evaluation director.
Spinraza is the first approved treatment for the rare and often fatal disease spinal muscular atrophy or SMA.
https://bit.ly/2P3zVyO
That is despite Spinraza, which is also known as nusinersen, having a lower British price tag of 450,000 pounds ($573,000) for the first year and Biogen offering an undisclosed discount to the National Health Service (NHS).
"Even with the proposed confidential discount the cost of nusinersen is too high for it to be considered a cost-effective use of NHS resources," the National Institute for Health and Care Excellence (NICE) said.
NICE's committee of experts also raised concerns that there were still significant uncertainties around the long-term benefits of the medicine.
"We are actively engaging with Biogen to discuss how they might address the uncertainties identified by the committee, while demonstrating the potential for nusinersen to be considered cost effective and managing the risk to the NHS of allowing access to this treatment," said Meindert Boysen, NICE's health technology evaluation director.
Spinraza is the first approved treatment for the rare and often fatal disease spinal muscular atrophy or SMA.
https://bit.ly/2P3zVyO
Drugmakers say R&D spending hit record in 2017
- Pharmaceutical companies report spending a record $71.4 billion on research and development in 2017, according to an annual survey of members of PhRMA, the powerful industry lobbying group.
- The group’s annual report found R&D spending was up in not only absolute terms as total spending, but also in relative terms as percentage of total sales. Proportionally, companies spent 21.4% of total sales on R&D.
- The report comes as pharmas are under pressure for escalating drug costs, with President Donald Trump proposing an array of measures to tamp down. Some critics have for years called into question the industry figures, which are a common rationale for steep drug prices.
Figures on pharmaceutical R&D spending do not come without controversy, with some questioning the verifiability of the numbers, and the industry’s interest in reporting increased spending.
Still, R&D is one of the most important metrics for biopharma companies. While serious investment can demonstrate dedication to finding new drugs and treatments for diseases, other companies with low R&D spending occasionally come under criticism.
For example, Valeant Pharmaceuticals leaned on M&A to fill its drug pipeline instead of R&D, leading to massive divesting in a late-2017 turnaround push. To further shake its reputation, Valeant announced earlier this year it will change its named to Bausch Health Companies.
PhRMA changed membership criteria in May 2017 requiring member companies to invest a minimum of 10% of global sales in R&D, resulting in seven companies leaving at the time. That move could have also artificially boosted the figures in this report by removing the lowest-spending companies from the membership pool.
The 8-page report found increases in R&D spending in a variety of measurements for 2017 compared to 2016. Total R&D increased nearly 9% from $65.5 billion to $71.4 billion. As a percentage of total sales, R&D spending modestly increase from 20.4% to 21.4%.
The report also showed a slight trend of R&D dollars shifting from the U.S. and toward western Europe from 2016 to 2017, with the geographic concentration of dollars decreasing by 1.9% in the U.S. and increasing 1.1% in western Europe.
The report did show a slight decrease in the concentration of R&D dollars in the U.S. While domestic spending went up in absolute terms by roughly $5 billion, it decreased as a global percentage from 80% to 78.1% from 2016 to 2017, when compared to last year’s report.
Western Europe grew over that same time period in R&D dollars from $9.1 billion to $10.8 billion, an 18.5% increase. As a geographic share, western Europe grew from 14% to 15.1%.
The most expensive area was Phase 3 testing, which accounted for nearly 30% of total R&D spending.
Overall, the industry group’s findings fit BioPharma Dive’s own analysis from last year, which showed an average R&D expenditure increase of about 10% year over year for the first quarter of 2017.
Salix, US WorldMeds eye 2019 push into mainstream for opioid withdrawal drug
Salix and US WorldMeds are zeroing in on doctors, payers and pharmacy shelves as they roll out their opioid withdrawal drug Lucemyra. But it won’t be long before marketing expands to a mainstream audience.
The partners officially launched Lucemyra last week with the usual physician outreach, coupled with some digital and print marketing targeted at consumers, including a support app for patients. Their mainstream push will go bigger next year, said executives from both companies.
“We’re really focused on phase one, but as we get into 2019, we’ll broaden our digital efforts and add other ways to address consumers where they get their information. Right now the big challenge is that as patients are on these opiates, they don’t even know that withdrawal can happen,” said Mark McKenna, president at Salix Pharmaceuticals, a specialty pharma brand of Bausch Health Companies, formerly Valeant.
That makes for a much broader audience for Lucemyra beyond patients already addicted to opioids and seeking help to quit. Studies have shown people can suffer withdrawal symptoms even after taking the drugs for as few as five days, making them susceptible to withdrawal symptoms—often described as the worst flu of your life—including debilitating nausea, aches, pains, chills and tremors.
The partners hope they can get Lucemyra, a nonopioid withdrawal treatment, incorporated into opioid use protocols and comprehensive management plans for opioid use disorder.
But the key marketing message at launch doesn’t distinguish between patients who don’t know they could suffer opioid withdrawal and those who need treatment to quit abusing the meds. Instead, it’s all about the approved indication, and the message is control—control of the physical symptoms needed to get through withdrawal, said H. Lee Warren, chief operating officer at US WorldMeds.
“Let’s get patients back in control, let’s get healthcare providers back in control and give them an evidence-based medicine to do that,” Warren said, adding, “That’s the initial message we’re getting out. We’re talking to the indication and to all the many stakeholders involved.” He ticked off some of those including pharmacies, employers and PBMs that all have opioid management programs—meant to educate and highlight the benefits, risk and costs of opioid prescribing—where Lucemyra might fit.
To get the word out, the partners are mobilizing their combined sales forces—Salix’ reps for opioid-induced constipation drug Relistor, who already have experience dealing with the effects of opioids and have established relationships with doctors, plus US WorldMeds’ specifically hired sales force for Lucemyra—to the tune of hundreds of feet on the street.
Along with education and support, they’ll also be talking up the patient app called Luminate, which tracks Lucemyra doses, sends reminders, offers daily support messages and guided meditations, and also includes education, advice and tips on symptoms and relief.
“It’s not a cure, but we have clinical data showing that this product can really help patients. We’re going to put a lot of marketing muscle behind it and we’re going to put a lot of physician education around it, however, this is not going to be some kind of revolution, it will be an evolution over time. We’re going to stay the course and stay focused on eliminating these deaths that happen unnecessarily,” McKenna said.
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