Express Scripts released a statement in response to the Administration’s announcement today on prescription drug costs: “President Trump rightly recognizes drug companies charge way too much, and their prices need to come down. Express Scripts leads the way in reining in costs and improving care. By taking on tough challenges, we helped employers save $32 billion on their prescription drug bill in 2017 alone. We take decisive action to improve affordability and access for the 83 million Americans we serve. For more than 30 years, Express Scripts has been a champion in the fight to lower drug costs. Express Scripts stands up to drug companies and drug stores to make sure that everyone – patients, employers, health plans, unions and public programs – get a fair deal for the money they spend. It is clear, based on today’s comments, that our role has never been more important to improving healthcare. In particular we were pleased that the Administration recognized and endorsed policies that we have advocated for over the years, including increasing access to biosimilars, increasing the number of generic drugs available, and eliminating gag clauses and clawbacks — anti-patient practices that we do not engage in. We look forward to working with the Administration to enact pro-patient, pro-payer policies.”
Friday, May 11, 2018
Many dispensaries in CO proffer marijuana for morning sickness
More than two-thirds of Colorado cannabis dispensaries recommend cannabis products to treat nausea during the first trimester of pregnancy, according to a study published online May 7 in Obstetrics & Gynecology.
Betsy Dickson, M.D., from the University of Colorado in Aurora, and colleagues used a mystery caller to collect advice from marijuana dispensaries regarding cannabis product use during pregnancy.
The researchers contacted 400 dispensaries (37 percent were licensed for medical sale, 28 percent for retail, and 35 percent for both). More than two-thirds of dispensaries (69 percent) recommended cannabis products for the treatment of morning sickness, although the recommendations varied by license type (medical, 83.1 percent; retail, 60.4 percent; both, 61.7 percent; P < 0.001). A similar percent (65 percent) based their recommendation for use in pregnancy on personal opinion, while a lower percent (36 percent) stated cannabis use is safe in pregnancy. Most of the dispensaries (81.5 percent) recommended discussion with a health care provider, but only 31.8 percent made this recommendation without being prompted.
“As cannabis legalization expands, policy and education efforts should involve dispensaries,” the authors write.
More information: Abstract/Full Text (subscription or payment may be required)
Existing drug may be the answer to hair loss
Could a solution to hair loss be on the horizon?
Hair loss can be incredibly distressing for men and women alike.
Consequently, for many years, scientists have made efforts to find a way to combat it.
Over the centuries, in the hunt for a hair loss cure, no path has been left untrodden — no matter how unusual.
For instance, in Ancient Egypt, where premature baldness was thought to be a punishment from the gods, one remedy involved rubbing goat dung into the scalp.
Because goats never lose their hair, this treatment was supposed to trick the gods into believing that the afflicted individual was, in fact, a goat.
Thousands of years later, the options are still limited; there are now two available hair-loss drugs — minoxidil and finasteride — both of which have mixed results and some unpleasant side effects, including allergic reactions, erectile dysfunction, and, paradoxically, hair loss.
The other option is hair transplantation surgery, which is costly, long-winded, and painful.
Searching for a better option
Dr. Nathan Hawkshaw and colleagues, from the University of Manchester’s Centre for Dermatology Research in the United Kingdom, are involved in an ongoing search for a drug to fill this pharmaceutical void.
On this quest, they assess existing drugs that are known to be well tolerated. They hope to find a compound that is already safe for human use that may also be useful in treating androgenetic alopecia, which is also known as male-pattern baldness (although it can affect women, too).
One drug that piqued their interest was an immunosuppressive called cyclosporine A (CsA). It has been used to help prevent the rejection of transplants since the 1980s. And, one of CsA’s side effects is unwanted hair growth.
Dr. Hawkshaw took this as his starting point. If they could understand the mechanism at work, it might provide a novel approach to treating hair loss.
Using isolated human scalp hair follicles, they found that CsA reduced the expression of a protein called SFRP1. This protein is known to inhibit the growth of tissues, including hair follicles.
This explains why CsA promotes hair growth; it effectively takes the brake off of follicle activity. It also offers up a new mechanism to exploit.
Dr. Hawkshaw sought an existing drug that would interact with this pathway and, potentially, encourage hair growth. After a long search, he came across WAY-316606, a drug originally designed to treat osteoporosis. WAY-316606 specifically targets SFRP1.
To investigate whether the drug might work, the team experimented with donated human hair follicles from people undergoing hair transplantation.
“Thanks to our collaboration with a local hair transplant surgeon, Dr. Asim Shahmalak, we were able to conduct our experiments with scalp hair follicles that had generously been donated by over 40 patients and were then tested in organ cultures.”
Using this tissue was important, as Dr. Hawkshaw explains, “This makes our research clinically very relevant, as many hair research studies only use cell culture.”
In fact, previous studies that had looked at the hair growth properties of CsA had drawn completely different conclusions.
Dr. Hawkshaw explains, “When the hair growth-promoting effects of CsA were previously studied in mice, a very different molecular mechanism of action was suggested; had we relied on these mouse research concepts, we would have been barking up the wrong tree.”
Their results were published earlier this week in the journal PLOS Biology.
Did it work?
Application of the osteoporosis drug did indeed encourage new hair growth in the tissue samples. Dr. Hawkshaw believes that WAY-316606 might even outpace CsA, but without the unpalatable side effects.
“The fact this new agent, which had never even been considered in a hair loss context,” he says, “promotes human hair growth is exciting because of its translational potential: it could one day make a real difference to people who suffer from hair loss.”
Many people will greet this discovery with jubilation. However, before large clinical trials have been run, we should be cautious. The study was carried out in relevant human tissue, but, in real-life situations, drugs can respond in subtly different ways.
Only time and research will tell, but the findings are a great start. Even if WAY-316606 does not cut the mustard, investigating related molecules might eventually come up with the goods.
Cholesterol found to play a role in Alzheimer’s
Cholesterol builds up in arteries, but it may play a role in Alzheimer’s, as well.
Cholesterol is a waxy substance that can build up on the walls of arteries, potentially causing health problems.
Approximately 71 million people in the United States live with high levels of low-density lipoprotein (LDL), or “bad cholesterol.”
It is more commonly implicated as a contributing factor in cardiovascular conditions such as heart disease and stroke, but cholesterol is also one of the main constituents of the cell wall.
A new study, published in the journal Nature Chemistry, suggests that this cholesterol could also act as a catalyst for clusters of a protein called amyloid-beta to form in the brain.
Amyloid-beta is well known to be a key contributing factor to Alzheimer’s disease, which currently affects around 5.4 million people in the U.S. When amyloid-beta aggregates, it forms into plaques that are toxic to brain function and kills off brain cells.
However, scientists have struggled to identify how the clusters of amyloid-beta form in the first place.
Cholesterol speeds up aggregation
What scientists do know is that amyloid-beta molecules do not normally stick together in the brain because they are only present in low levels, and they are spread out across the brain.
The Cambridge team joined forces with researchers at Lund University in Sweden to investigate how amyloid-beta manages to form into clusters in Alzheimer’s disease.
They revealed that amyloid-beta can stick to lipids, a type of insoluble molecule that includes fats, steroids, phospholipids, and waxes. In particular, amyloid-beta was found to stick very well to lipid cell membranes containing cholesterol.
Then, once amyloid-beta molecules become stuck to cholesterol-containing lipid cell membranes in the vicinity of other “stuck” amyloid-beta molecules, there is a greater chance that these molecules will encounter each other, causing clusters to begin forming.
The team calculates that the presence of cholesterol caused amyloid-beta clusters to develop 20 times faster than they would have otherwise.
Will eating less cholesterol reduce risk?
Earlier studies have mapped a link between cholesterol and Alzheimer’s; for instance, scientists know that some of the same genes that process cholesterol in the brain are also implicated in Alzheimer’s. However, it is unclear how they are linked.
The authors of the recent study are not sure if dietary cholesterol plays a role in Alzheimer’s, as this kind of cholesterol does not cross into the brain from the bloodstream.
So, although it is generally good for your health to eat a balanced diet without too much LDL cholesterol, how much cholesterol you consume in your diet is not thought to be an issue in regards to your risk of developing Alzheimer’s.
In fact, study co-author Prof. Michele Vendruscolo — of the Centre for Misfolding Diseases at the University of Cambridge — says that it is not the cholesterol in itself that is the problem.
“The question for us now,” he says, “is not how to eliminate cholesterol from the brain, but about how to control cholesterol’s role in Alzheimer’s disease through the regulation of its interaction with amyloid-beta. We’re not saying that cholesterol is the only trigger for the aggregation process, but it’s certainly one of them.”
Prof. Vendruscolo explains that cholesterol is moved around the body by dedicated “protein carriers” such as ApoE, which, in its mutated form, has also been studied as a risk factor for Alzheimer’s.
In older people, protein carriers are less effective, interrupting the movement of cholesterol around the body. So, it may be possible for scientists in the future to design drugs that target this process, helping to control the balance of cholesterol and amyloid-beta in the brain.
“This work has helped us narrow down a specific question in the field of Alzheimer’s research,” concludes Prof. Vendruscolo.
“We now need to understand in more detail how the balance of cholesterol is maintained in the brain in order to find ways to inactivate a trigger of amyloid-beta aggregation.”
FDA Rejects Perrigo’s ProAir Generic
U.S. health regulators have rejected Perrigo Co.’s (PRGO) generic version of Teva Pharmaceutical Industries Ltd.’s ProAir inhalation aerosol, Perrigo said Friday.
Perrigo, which had targeted releasing the generic in the fourth quarter and had built a roughly 9-cent-a-share projected benefit to its 2018 financial forecast, said it had a teleconference call with the Food and Drug Administration late Thursday afternoon and that it expects to receive what is known as a complete response letter, detailing the reasons for the rejection.
Over all, Perrigo had projected annual profit of $2.90 to $3.30 a share and $5.05 to $5.45 a share on an adjusted basis.
Perrigo’s stock fell 4% to $74.10 in after-hours trading while Teva’s was down slightly at $19.30.
London bans junk food ads on public transport to fight child obesity
London plans to ban junk food advertising on its entire public transport network to tackle child obesity, which is among the highest in Europe, Mayor Sadiq Kahn said on Friday.
Almost 40 percent of children aged 10 and 11 in London are overweight or obese, according to research compiled for Britain’s parliament.
“Child obesity in London is a ticking timebomb and I am determined to act. If we don’t take bold steps against it we are not doing right by our young people as well as placing a huge strain on our already pressurized health service,” Kahn said in a statement.
The ban will target food retailers with products deemed high in fat, salt or sugar such as McDonald’s.
McDonald’s here has long been fighting perceptions that it encourages children to eat unhealthily. In 2011, it won a U.S. lawsuit allowing it to continue including toys in Happy Meals.
Coca Cola and Pepsi here – as part of the American Beverage Association – faced scrutiny during the same year following a U.S. campaign to bring awareness to the potential health concerns associated with sugar sweetened drinks.
Slideshow (4 Images)
Food and drink advertising contributed around 20 million pounds ($27 million) to Transport for London’s revenue during the 2016-17 financial year.
A spokesperson from the mayor’s office said :”About two thirds of this comes from high fat, salt and sugar, food and drink.”
The National Centre for Social Research and Cancer Research UK found advertising of unhealthy foods – particularly when aimed at children – creates extra pressure on children and families when it comes to choosing what to eat and drink.
“I want to reduce the influence and pressure that can be put on children and families to make unhealthy choices,” Kahn said. “I’m determined to do all I can to tackle this issue with the powers I have and help Londoners make healthy food choices for themselves and their children.”
The plans are a key part of the mayor’s draft London Food Strategy and echo initiatives that have been introduced in Amsterdam this year.
Khan said: “The government needs to step up and join this fight against child obesity.”
U.S. investigates bloodstream infections for link to heparin syringes
Health agencies are investigating an outbreak of bloodstream infections in children from four U.S. states that may be linked to heparin and saline syringes made by Becton Dickinson and Co, the agencies told Reuters. The U.S. Centers for Disease Control and Prevention has confirmed 14 cases of bloodstream infections in children caused by the same strain of the Serratia marcescens bacterium, the agency’s lead investigator on the outbreak said in a telephone interview.
All of the infections occurred in seriously ill children receiving intravenous medications through a catheter or central line, a device used to deliver medications such as chemotherapy. None of the children have died and the number of cases appears to be winding down, the investigator said.
Health officials said they began testing the Becton Dickinson products when their investigation found the syringes had been used to treat several of the infected children. Central lines are often flushed with saline or heparin, a blood thinner, to keep them clear.
So far, none of the Becton Dickinson products have tested positive for the bacterium. Last month, the company recalled 949 lots of its BD PosiFlush Pre-Filled Heparin Lock Flush Syringes and Pre-Filled Normal Saline saline flush syringes sold between February and December 2017 out of “an abundance of caution.” Becton Dickinson said it was cooperating with the U.S. Food and Drug Administration and CDC.
“The company immediately initiated an internal investigation after being notified of a potential connection between catheter-related blood stream infections and the Serratia marcescens bacterium,” BD said in an emailed statement on Friday.
BD spokesman Troy Kirkpatrick said the company had checked records from its sterility testing, environmental testing and clean room validation.
“To date, no BD flush product has ever tested positive for this bacterium,” Kirkpatrick said in an email.
Dr. Kiran Mayi Perkins of the CDC’s Public Health Program, who is leading the investigation, said if there is contamination, it’s “probably a very low amount,” which makes it very hard to test for.
“Although the product tests have been negative to date, again, in an abundance of caution, we continue to take the steps we have,” she said. “That’s probably why BD has done the recall as well.”
Perkins said the confirmed infections occurred in Tennessee, Colorado, Minnesota and Ohio and most of the children were recovering well.
Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said Serratia marcescens is found in the environment and is a common cause of bloodstream infections in hospitals.
“What’s dangerous is when it’s in something that’s being directly injected into a person,” he said. “That bacteria doesn’t have to go through any kind of barrier. It’s a superhighway into the bloodstream.”
All of the recalled products were made at Becton Dickinson’s facility in Franklin, Wisconsin.
Becton Dickinson also sells the heparin flush and saline syringe products in Canada, Bermuda, and Brazil. The company said it was working with regulators in those countries to issue advisories and recalls. The recalled products make up about 10 percent of the company’s supply of heparin and flush syringes in the countries involved in the recall.
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