Serena tells of medical reason behind superhero catsuit

A marvel on the tennis court, new mum Serena Williams is now sporting her own superhero outfit as she makes her return to Grand Slam tennis.

“I call it like my Wakanda-inspired catsuit. It’s really fun,” the American laughed, referencing the fictional Sub-Saharan African nation which is home to superhero Black Panther in Marvel Comics.

“I feel like a warrior in it, like a warrior princess kind of, queen from Wakanda maybe,” she said smiling, following her opening round victory over Kristyna Pliskova at the French Open on Tuesday.

“I’m always living in a fantasy world. I always wanted to be a superhero, and it’s kind of my way of being a superhero. I feel like a superhero when I wear it.”

Behind the jokes, there is also a more serious reason for the choice of skin-tight bodysuit outfit for the American who only had her daughter last September.

Serena has spoken about health concerns over blood clots in the days after giving birth, and on Tuesday said: “Yeah, the catsuit, I had a lot of problems with my blood clots, and, God, I don’t know how many I have had in the past 12 months.

“So it is definitely a little functionality to it. I have been wearing pants in general a lot when I play so I can keep, you know, the blood circulation going.

“It’s a fun suit, but it’s also functional so I can be ableto play without any problems.”

Next up for Serena is 17th seed Ashleigh Barty. The Australian would be forgiven for cursing her luck to have landed the most dangerous of floaters — with or without super powers.

https://reut.rs/2JbV5Lb

Labs ‘Safe Havens’ In Health Services, Morgan Stanley Says In Quest Upgrade

Barely a month-and-a-half after upgrading Quest Diagnostics Inc DGX 0.51% to Equal-weight, Morgan Stanley turned incrementally positive on the shares.

The Analyst

Analyst Ricky Goldwasser upgraded shares of Quest Diagnostics from Equal-weight to Overweight and increased the price target from $103 to $120.

The Thesis

The long-term strategic partnership announced by UnitedHealth Group Inc UNH 1.13% with Quest Diagnostics and Laboratory Corp. of America Holdings LH 1.11% — and Aetna Inc AET 0.99%‘s deal with LabCorp — have served to remove contract overhang, signaling a “more disciplined pricing environment” going forward, Goldwasser said in a Tuesday note. (See the analyst’s track record here.)

“… Labs are relative safe havens within the health care services sector,” Goldwasser said.

The removal of contract overhang increases Morgan Stanley’s confidence in Quest’s ability to deliver earnings growth at the high end of its 3-5 percent long-term goal.

The company remains poised to expand its market share from 1.5-3.5 percent to 15 percent as it becomes an in-network provider for UnitedHealth’s members beginning Jan. 1, 2019, Goldwasser said.

“We expect Quest will capitalize the opportunity over a two-to-three-year period, translating to [an] incremental 470bp of volume per year through 2021.”

Citing volume increase from the UnitedHealth contract that was partly offset by lower pricing and lost Aetna volume, Morgan Stanley increased its 2019 revenue and earnings per share estimates for Quest from $7.903 billion and $6.88 to $8.055 billion and $7.02, respectively.

The firm also raised its 2020 estimates, with EPS forecast to come in 6.5 percent higher than Quest’s guidance.

https://bit.ly/2xvVt2a

American Diabetes Assn urges improved insulin access

In a new policy statement, the American Diabetes Association (ADA) provides specific short- and long-term recommendations for improving insulin access and affordability.

The average list price of insulin nearly tripled between 2002 and 2013. The rising costs and lack of access for many with diabetes have become a political flashpoint. On May 8, the US Senate Special Committee on Aging held a hearing devoted to the topic. On the same day, the ADA published a white paper that includes advice for clinicians on how to help minimize out-of-pocket costs for patients.

The new statement, published online by the ADA, is a follow-up to the white paper and provides more specific public policy recommendations. It was written by Krista Maier, JD, Vice President of Public Policy and Strategic Alliances, and Meghan Riley, Vice President of Federal Government Affairs at the ADA.

Maier and Riley address four key areas: streamlining the biosimilar approval process, increasing pricing transparency throughout the insulin supply chain, reducing or removing patient cost-sharing for insulin, and increasing access to healthcare coverage for all people with diabetes.

“As the price of insulin continues to rise, so do patient costs. Individuals with diabetes are often forced to choose between purchasing their medications or paying for other necessities, exposing them to serious short-term and long-term consequences,” they write in the introduction.

The reasons for the increased prices are not entirely clear but “are due in part to the complexity of the drug supply chain,” Maier and Riley write.

“In order to solve this escalating problem of insulin affordability, there must be a better understanding of the transactions throughout the insulin supply chain, the impact each entity has on what people with diabetes pay for insulin, and the relative efficacy of therapeutic options.”

Insulin-Specific Recommendations

The statement calls for more insight into the factors involved in setting the list price, the starting point for negotiations throughout the supply chain, and “how changing list prices impact supply chain entities and patients.”

To that end, the ADA recommends “increased transparency throughout the full insulin supply chain,” and outlines specific information regarding insulin pricing that should be provided by each of the respective players: manufacturers, wholesalers, pharmacy benefit managers (PBMs), health plans, and pharmacies.

The association also makes recommendations regarding competition and biosimilar insulins. To date three such follow-on biologics have been approved by the US Food and Drug Administration (FDA), of which two are currently available. Unlike generic drugs, which are typically priced at 50% to 80% less than the brand-name counterpart, follow-on insulins are listed at approximately 15% less than the original versions.

According to the authors, increasing available options could further lower costs. Thus, the association recommends “the FDA continue its efforts to encourage additional competition within the insulin landscape, including fostering biosimilar competition.”

The association also calls upon both government and private health plans to make changes to prescription drug benefit plans to cover insulin without patient cost-sharing. “At minimum, we recommend insulins not be subject to a deductible nor co-insurance, since this exposes people with diabetes to high list prices…If cost-sharing is imposed for insulins, it should be a flat dollar amount, which can be more manageable and consistent for consumers.”

In addition, when there are deductibles or co-insurance for insulins, “the ADA recommends all discounts negotiated amongst the various supply chain entities (manufacturers, pharmacies, PBMs) be incorporated into the calculation of patient costs, ensuring patients pay the lowest price available.”

Improving Access and Affordability of All Medications

In more general recommendations covering all medications, ADA advises that both Medicare and commercial health plans be required to impose caps on out-of-pocket spending.

They also say health plans should be prohibited from removing medications from prescription drug formularies or moving medications to a higher tier during plan years, barring an FDA-announced safety issue. Moreover, formularies should be evidence-based and offer “a wide range of options within each therapeutic area.”

In line with the original intent of the Affordable Care Act, the ADA statement calls for every US state to expand Medicaid eligibility to people earning less than 138% of the federal poverty level.

In addition, “states should take steps to maintain or improve upon existing consumer protections that ensure people with diabetes have meaningful access to adequate, affordable health insurance coverage,” and ensure that consumers have easy access to all plan information, including in non-English versions.

In their conclusion, Maier and Riley explain that the transparency goals should help achieve the cost-reduction aims.

“When more is known about the transactions throughout the supply chain, it is likely additional promising public policy proposals will emerge,” they state.

“In the meantime, the ADA recommends policymakers take any steps necessary to ensure all people with diabetes have affordable access to insulin, regardless of where they live, whether they have insurance, and how much money they earn.”

The statement authors are employees of the ADA.

ADA Public Policy Statement. Published online May 24, 2018. Full text

https://wb.md/2IWayQb

Oxytocin ‘Not Best’ for Postpartum Hemorrhage Prevention

Postpartum hemorrhage (PPH), defined as maternal blood loss of 500 mL or more within 24 hours after delivery, is the leading cause of maternal mortality worldwide. The World Health Organization (WHO) currently recommends treatment with oxytocin to reduce the risk for excessive postpartum bleeding, but a new meta-analysis suggests that other drug regimens may be more effective.

The meta-analysis included data on more than 88,000 women. Ergometrine plus oxytocin, carbetocin monotherapy, or misoprostol plus oxytocin were all associated with a reduced risk for PPH compared with oxytocin alone, Ioannis D. Gallos, MD, from Tommy’s National Center for Miscarriage Research, Institute of Metabolism and Systems Research, University of Birmingham, UK, and colleagues report. Their findings were published online April 25 in the Cochrane Database of Systemic Reviews.

However, the analysis does not include results from two key studies that were ongoing at the time these findings were published, the authors add. “Both trials are expected to report in 2018 and these results will be incorporated when this review is updated.”

Also, most of the evidence ranged from moderate to very low quality, with only one group of studies associated with high-quality evidence. In addition, the authors warn that more information is needed on practical issues identified as priorities for women and their families.

Avoidable Drain on Resources

PPH accounted for up to one third of the 303,000 postpartum maternal deaths that occurred in 2015, mostly in low- and middle-income countries, Gallos and colleagues write. Even when death is avoided, these patients often require hysterectomy, blood transfusions, and additional care that can tax limited resources in these nations.

Seventy-five percent of PPH cases result from uterine atony, or failure of the uterus to contract following childbirth. To prevent this and lower the risk for PPH, uterotonic agents are recommended as part of the active management of the third stage of labor to promote uterine contraction.

Currently, oxytocin is the most widely used of several uterotonic agents and is the one recommended by WHO, but “it is still debatable which drug is best,” the authors explain. Their aim in this review “was to find out which drug is most effective in preventing excessive blood loss at childbirth and has the least side effects. We collected and analyzed all the relevant studies to answer this question.”

Questions About Data Quality

The network meta-analysis included 140 randomized controlled comparisons or cluster trials of effectiveness or side effects of uterotonic agents. Altogether, there were data on 88,947 women.

Most of the trials were conducted in hospital settings on women undergoing vaginal delivery at more than 37 weeks of gestation. The authors caution that the risk of bias was uncertain as a result of poor study design, particularly in the carbetocin trials.

Gallos and colleagues found that about 10.5% of women treated with oxytocin alone experienced PPH associated with blood loss of 500 mL or more, compared with 7.2%, 7.6%, and 7.7% of women treated with ergometrine plus oxytocin, carbetocin alone, or misoprostol plus oxytocin, respectively.

Compared with oxytocin, the risk ratio (RR) for blood loss of 500 mL or more associated with ergometrine plus oxytocin was 0.69 (95% confidence interval [CI], 0.57 – 0.83). Carbetocin had an RR of 0.72 (95% CI, 0.52 – 1.00), and misoprostol plus oxytocin, of 0.73 (95% CI, 0.60 – 0.90). The evidence underpinning these studies ranged from moderate to very low quality.

In a similar analysis of treatment preventing PPH of 1000 mL or more, ergometrine plus oxytocin was associated with an RR of 0.77 (95% CI, 0.61 – 0.95); carbetocin, of 0.70 (95% CI, 0.38 – 1.28); and misoprostol plus oxytocin, of 0.90 (95% CI, 0.72 – 1.14), compared with oxytocin alone. The evidence for ergometrine plus oxytocin was high quality; for the other studies, it ranged from moderate to low quality.

However, the ergometrine-oxytocin combination also was associated with a higher risk for vomiting compared with oxytocin (RR, 3.10; 95% CI, 2.11 – 4.56; high-quality evidence) and hypertension (RR, 1.77; 95% CI, 0.55 – 5.66; low-quality evidence), and misoprostol-oxytocin carried a higher risk for fever (RR, 3.18; 95% CI, 2.22 – 4.55; moderate-quality evidence). “Carbetocin had similar risk for side effects compared with oxytocin although the quality evidence was very low for vomiting and for fever, and was low for hypertension,” the authors report.

Of the two studies slated for publication in 2018, one is a multicenter study comparing the effectiveness of oxytocin to a new carbetocin preparation in women undergoing vaginal delivery. The trial is being conducted in 10 countries, includes approximately 30,000 women, and is being led by WHO.

The second UK-based trial has enrolled more than 6000 women and consists of a three-group comparison among carbetocin, oxytocin, and the ergometrine-oxytocin combination.

More Attention to Patient Concerns Needed

On the basis of the current analysis, “ergometrine plus oxytocin combination, carbetocin, and misoprostol plus oxytocin combination were more effective for preventing PPH ≥ 500 mL than the current standard oxytocin,” the authors conclude. “Ergometrine plus oxytocin combination was more effective for preventing PPH ≥ 1000 mL than oxytocin.”

However, they caution that the evidence for misoprostol plus oxytocin was less consistent, perhaps as a result of variations in doses and administration routes used in the various studies.

Carbetocin was associated with the most benign side-effect profile, although most of the relevant trials “were small and at high risk of bias.”

Future studies should address issues that are of concern to patients and their families but rarely covered in current research, such as questions about specific drugs, clinical signs of PPH, any impact on ability to breastfeed, and risk for admission to the neonatal unit, the authors add. “Consumers also considered the side effects of uterotonic drugs to be important and these were often not reported.”

In addition to information on the findings of the two large trials now underway, future updates of this review will include a set of standardized PPH outcomes that are currently being developed. “We would hope that future trials would also consider adopting those outcomes,” the authors write.

Ferring Pharmaceuticals and Novartis have provided carbetocin and oxytocin for trials. WHO/Merck for Mothers is providing support for an ongoing study. The authors have reported financial relationships with WHO, MSD for Mothers, and Amma Life. A complete list of disclosures is included in the review.

Cochrane Database Syst Rev. 2018;4:CD011689. Abstract

https://wb.md/2JiXBzm

Healthcare Price Information Availability Worsening

Despite growing support for greater price transparency, US hospitals were worse at providing price estimates for total hip arthroplasty (THA) in 2016 than they were in 2011-2012, a follow-up survey of 120 facilities reports.

“Our results provide sobering evidence that substantial efforts from government and industry to improve pricing transparency have had little tangible effect on availability of prices,” write Safiyyah Mahomed, BSc, a medical student at the University of Toronto, Ontario, Canada, and colleagues in a JAMA Internal Medicine research letter published online May 29.

Posing as the granddaughter of a 62-year-old woman needing a THA, the researchers contacted 120 hospitals in 2016 seeking the lowest cash bundled price, an amount that included all hospital and physician costs. If unable to quote a physician’s THA fee, the hospital was asked for the name of an orthopedic surgery practice that could confirm the fee. Contacting each hospital at least five times, the investigators categorized answers as no price information, partial information (hospital or physician price only), complete information (separately obtained hospital plus doctor cost), or bundled hospital-physician price.

Although clear price information is seen as crucial to patients for informed healthcare decision-making, the 2016 survey showed a decline in transparency across almost all measures since a predecessor survey that was conducted in 2011 and analyzed in 2012. The proportion of hospitals providing a bundled-price estimate dropped from 15.8% (19/120) in 2012 to 6.7% (8/120) in 2016, for an odds ratio (OR) of 0.2 (95% confidence interval [CI], 0.0 – 0.8; P = .001). Those supplying a complete price declined from 47.5% (57/120) to 20.8% (25/120), for an OR of 0.2 (95% CI, 0.1 – 0.5; P < .001). Partial price availability was up slightly to 28.3% (34/120) compared with 22.5% (27/120) in 2012 (OR, 1.4; 95% CI, 0.7 – 2.5; P = .38).

The proportion unable to supply any pricing information rose steeply from 14.2% (17/120) to 44.2% (53/120) for an OR of 4.6 (95% CI, 2.3 – 10.2; P < .001).

“We were quite surprised to see that the availability of price information substantially declined since our last survey,” Mahomed told Medscape Medical News. “We’re not sure why, but the factors are likely complex, and it seems that hospitals have not taken the necessary steps to make it easy for consumers to get this information.”

Because so few hospitals were able to supply details for comparison, the mean bundled or complete price for THA declined slightly from 2012’s $44,306.42 to $37,917.50 in 2016 (P = .11). The mean hospital-only cost was $33,276.78 in 2012 and $35,105.30 in 2016 (P = .72). Mean physician price rose slightly from $6583.62 in 2012 to $6988.05 in 2016.

In an invited commentary, Anna D. Sinaiko, MPP, PhD, an assistant professor of health economics and policy at Harvard T.H. Chan School of Public Health, Boston, Massachusetts, calls out the small minority of hospitals that dispensed full information and the resulting adverse implications for healthcare consumers. “The inaccessibility of price information in the US health care system prevents patients from anticipating and incorporating their health care costs into care-seeking decisions and from choosing the best-value clinician (physician or facility),” she writes.

Greater price transparency, she argues, could streamline the healthcare market by incentivizing doctors to lower costs or stress better quality of care, making it harder to charge significantly higher prices without quality improvement — prices Sinaiko says help drive up US healthcare spending relative to that of other countries belonging to the Organisation for Economic Co-operation and Development.

She notes recent efforts to improve price transparency, including web-based price calculators and legislation in Colorado, Massachusetts, and Ohio mandating the provision of hospital/physician price estimates before treatment. So far, such measures appear to be ineffective. In 2016, Medscape Medical News reported that price transparency and electronic healthcare shopping by consumers did not decrease healthcare spending. Last month it also reported that few consumers were shopping electronically for pretreatment pricing information, suggesting the need for new transparency strategies.

One of these is a new model in which clinicians act as fiduciary healthcare purchasers. An important step toward transparency will be to consider physicians as “‘buyers’ of healthcare services on behalf of their patients when ordering tests and procedures, making referrals, or prescribing drugs,” Sinaiko writes. “[E]fforts should be made to increase physician-patient cost conversations and to improve physician-directed price transparency so that physicians and patients understand tradeoffs and make better decisions about care together.”

To achieve this outcome, Sinaiko says physicians must be rewarded for lower-priced, higher-value care without limiting access, in a carrot-vs-stick approach.

Currently, doctors are not ideal purveyors of pricing information — for reasons including lack of details on patient deductibles and year-to-date out-of-pocket spending. Recasting clinicians as healthcare buyers will be part of the solution to price transparency, she concludes.

This study received no funding. The authors and editorialist have disclosed no relevant financial relationships.

JAMA Intern Med. Published online May 29, 2018. Abstract, Editorial

https://wb.md/2IYaPBZ

European cancer vaccine startup Nouscom poaches Pfizer I-O exec

Swiss oncology biotech Nouscom has nabbed Pfizer’s former global clinical leader of early and late stage immuno-oncology/hematology Adrian Woolfson, M.D., Ph.D., as its new CMO.

At Nouscom, Woolfson “will play a key role in leading the company’s clinical development of its neoantigen off-the-shelf vaccine targeting tumors associated with Microsatellite Instability (MSI), as well as the personalized neoantigen vaccines and oncolytic virus programs,” it says in a statement.

Late last year, the cancer vaccine startup raised €42 million in a round that equipped a team to take off-the-shelf neoantigen cancer vaccine NOUS-209 into the clinic.

Basel, Switzerland-based Nouscom’s near-term prospects rest on programs based on Exovax. The Exovax platform uses single adenovirus vectors that can encode for 100 or more neoantigens to create vaccines that induce development and expansion of T-cell populations, including effector memory T cells.

Like other neoantigen biotechs, Nouscom is planning to combine its vaccines with checkpoint inhibitors. One thing that sets it apart is that its technology is similar to that used by Okairos to create vaccines tested in more than 4,000 people, a fact that gives that gives Nouscom confidence in the safety and immunogenicity—particularly CD8 T-cell response—of its candidates as it heads into the clinic.

Nouscom’s priority is to move NOUS-209 into phase 1/2 testing. If Nouscom hits its target, it thinks NOUS-209 may become the first off-the-shelf neoantigen cancer vaccine to be tested in humans. The company is developing the vaccine as a way to prevent cancer in Lynch syndrome carriers and treat tumors characterized by microsatellite instability.

This latest personnel addition is a nice poach for the small startup, which can lean on Woolfson’s experience at the Big Pharma for building a portfolio of monotherapy and combo studies for Pfizer’s PD-L1 inhibitor Bavencio and 4-1BB agonist utomilumab (although the latter did recently see Pfizer cull a few studies around it, with Bavencio, too, stumbling over some recent trials).

He’s also served stints as global clinical lead at Bristol-Myers Squibb, where he was responsible for the development of a portfolio of small-molecule inhibitors including JAK2, CDC7, SMO and IGF-1R/IR.

“We are pleased to welcome Adrian, a seasoned pharmaceutical industry executive with highly relevant immunotherapy experience, to Nouscom’s management team,” said Alfredo Nicosia, CEO of Nouscom.

“Adrian’s extensive immunotherapy drug development experience will allow us to leverage the clinical potential of our best-in-class platform as we look to enter our lead program, NOUS-209, an off-the-shelf cancer vaccine, into the clinic.”

https://bit.ly/2Jcxtpx

Tax change spurs drugmakers to buy back stock at highest rate in over 10 years

Drugmakers, whose industry pricing faced renewed scorn this month from President Trump, have been taking advantage of the GOP tax overhaul he signed last year to buy back shares of their own underperforming stocks.

Large-cap biopharmaceutical companies took advantage of repatriation of overseas profits and lower corporate tax rates to push share repurchases to the highest level in at least 10 years. Companies led by Amgen Inc. and Pfizer Inc. bought back a combined $16.7 billion in the most recent quarter, according to data compiled by Bloomberg.

And they’re not done. Celgene Corp., whose market value has been cut in half over the course of about seven months, on Thursday boosted its repurchase capacity by $3 billion and planned a $2-billion accelerated buyback.

These biopharma leaders have so far confounded investor expectations for a big pickup in mergers and acquisitions, opting instead to help their earnings per share while taking advantage of their struggling stocks. That might make sense for a group that’s under increasing pressure to deliver strong quarterly results amid rhetoric from the Trump administration about their drug pricing.

“There is pressure from investors to do something with their cash, and if there’s not a great target to add assets to your pipeline, then a buyback will look more attractive,” Credit Suisse analyst Vamil Divan said in a telephone interview. “A lot of these companies have limited growth outlooks in the near-term, so buybacks are a sure way to give yourself a bump if you don’t want to take on risk just yet.”

The larger group has struggled to find its footing in recent months. Biotechnology companies in the S&P 500 have fallen close to 5% to start this year while pharmaceutical stocks sank closer to 6% despite the broader S&P 500 edging up 2%.

Biotech investors came into the year hoping for a wave of deals, spurred by corporate tax reform that left companies with fatter wallets. More capital hasn’t translated into more deals, though, forcing investors to position themselves in potential targets instead.

Leerink analyst Geoffrey Porges blames “lazy balance sheets” for the lack of deals, since companies could create some $460 billion in deal capacity by issuing debt to augment their dry powder.

“In the large-cap space, cash has never been a problem,” Peter Collum, a partner at MTS Health Partners who advises on life sciences deals, said in an interview at his New York office. “They have and continue to have access to cash, so an increase in availability is not a binary switch to prompt buying, especially when valuations for commercial-ready medicines are this high.”

That isn’t to say the well ran dry for international mergers and acquisitions to start the year. Osaka, Japan-based Takeda Pharmaceutical Co. agreed to buy much-larger rival Shire Plc in a $62 billion deal and Novartis AG of Basel, Switzerland, acquired gene therapy company AveXis Inc. for about $8.7 billion. However, the group of top North American biopharma stocks saw deals fall back in-line with recent trends so far this year after hitting a low to end 2017.

Enter buybacks and tender offers, such as the Dutch auction for up to $7.5 billion in stock that AbbVie Inc. began at the beginning of May. The move has lifted shares, putting the company on pace for its best monthly performance since January. Divan noted that the drugmaker made it “very clear that they felt the stock was undervalued after Rova T data.”

Congressional Republicans have argued that cutting taxes would spur an increase in investments by American companies and fuel innovation. Data compiled by Bloomberg on research by the top 20 drugmakers show that while R&D spending grew year-over-year in the first quarter, it remains below quarterly levels seen in the second half of 2017 and comparable to the fourth quarter of 2016.

To be sure, it can be quicker to use buybacks for rewarding shareholders, while waiting for in-house drug development to pay off or scouting promising therapies discovered elsewhere.

“It’s a good thing to do because it can return money to shareholders in a very easy and tax friendly way,” William Blair analyst Matt Phipps said by phone. “But it has to be part of a balanced capital strategy where you can shore up your pipeline.”

https://lat.ms/2H176xH