Fewer Concussions After Football Rule Change

Markedly fewer concussions occurred following a minor-seeming rule change in Ivy League college football, an analysis of team physician reports found.

Concussion rates dropped 81% — from 10.93 to 2.04 per 1,000 plays — after kickoffs were moved up 5 yards to the 40-yard line in 2016, which had the effect of cutting the frequency of returns, reported Douglas Wiebe, PhD, of the University of Pennsylvania in Philadelphia, and co-authors in JAMA.

The rule change in 2016 was designed to limit kickoff returns, which previously had accounted for 21% of concussions but only 6% of overall plays in the Ivy League, a top-level conference in American college football. Overall, fewer injuries occur during kickoffs that result in touchbacks than on kickoffs that are returned.

“The kickoff is the most violent play in football,” explained Robert Cantu, MD, of Boston University’s Chronic Traumatic Encephalopathy (CTE) Center and the Concussion Legacy Foundation, who was not involved with the study.

“You have people from opposite ends of the field running toward each other at a very high rate of speed. It’s not a surprise that particular play would lead to a disproportionate amount of injuries,” Cantu told MedPage Today.

Starting in 2016, Ivy players kicked off from the 40- instead of the 35-yard line and touchbacks were placed at the 20-yard line. Ivy coaches supported this experimental rule change, hoping it would lead to more touchbacks and fewer violent collisions.

With kickoffs from the 40-yard line, 48% in Ivy games were touchbacks — no returns because the ball was downed in the end zone or kicked through it — up from 17.9% when kickoffs were at the 35.

Wiebe and colleagues analyzed data from the Ivy League’s concussion surveillance system — a web-based repository of team physician reports with 95% participation — and National Collegiate Athletic Association (NCAA) archives during 2013-2015 prior to the rule change and during 2016-2017 after it went into effect:

• During 68,479 plays from 2013 through 2017, a total of 159 concussions occurred, for an overall concussion rate of 2.3 per 1,000 plays
• 126 concussions occurred in 2013-2015 versus 33 in 2016-2017
• For other types of plays, the concussion rate was 2.56 per 1,000 plays before the rule change and 1.18 after
• A difference-in-differences analysis identified that 7.51 fewer concussions occurred for every 1,000 kickoff plays after the rule change versus before

These results show “how targeted policy changes can reduce sport-related concussion” and “may inform the NCAA as it considers adjusting the kickoff rules in football in all collegiate conferences,” Wiebe and colleagues wrote.

Concussion is not the only potential harm in kickoffs, Cantu noted: “That play also is at significant risk for neck injuries, and there have been a number of quadriplegic injuries that have happened.”

And it’s not just the Ivy League that’s paying attention to kickoffs. In 2011, the National Football League (NFL) moved the kickoff up 5 yards from the 30-yard line to the 35. More recently, there have been other changes in NFL kickoff play and discussions about whether the kickoff would be changed further or eliminated.

To make the play safer, the NCAA also changed its kickoff rules this year to allow the receiving team to “fair catch” the kick (i.e., signal that it won’t be returned) between the goal and the 25-yard line and have it be treated as a touchback.

Limitations to the Ivy League study include possible confounding by another rule implemented in 2016, which banned full-contact hitting during practices, and by other changes to player or game characteristics that may have occurred over time.

This research was part of the Ivy League–Big Ten Epidemiology of Concussion Study, an initiative of the Big Ten–Ivy League Traumatic Brain Injury Research Collaboration. The concussion surveillance system and repository is funded by the Presidents of the Ivy League Universities and the Big Ten athletic conference. The researchers were funded through a contract from the Ivy League and supported by the Penn Injury Science Center, which is funded by the CDC. Two co-authors were employed by the Ivy League. No other relationships were reported.

LAST UPDATED 10.01.2018

• Primary Source

  JAMA

  Source Reference: Wiebe D, et al: “Association between the experimental kickoff rule and concussion rates in Ivy League football” JAMA 2018; DOI:10.1001/jama.2018.14165.

https://www.medpagetoday.com/neurology/headtrauma/75423

Telemed Docs Often Prescribe Antibiotics for Respiratory Tract Infections

Two out of three patients who sought treatment for respiratory tract infections (RTIs) through direct-to-consumer telemedicine services were prescribed antibiotics, according to Cleveland Clinic researchers.

In addition, patients who received largely unneeded antibiotic drugs also tended to be happier with their remote physician encounters. Also, telemedicine encounters were, on average, shorter than those of RTI patients prescribed non-antibiotic drugs or no drugs at all, reported Kathryn Martinez, PhD, MPH, of the Center for Value-Based Care at the clinic, and colleagues in two separate articles in JAMA Internal Medicine and the Annals of Internal Medicine.

The researchers examined RTI prescribing practices of a large commercial telemedicine platform.

Despite the fact that antibiotics are rarely warranted in the treatment of RTIs, which are mostly viral, they continue to be prescribed frequently because patients expect them, Martinez told MedPage Today.

With regard to reducing unnecessary antibiotic use, she said the findings highlight the unique challenges posed by the increasingly common practice of treating RTIs through direct-to-consumer telemedicine.

“Telemedicine is a rapidly growing field, and respiratory tract infections are the most common reason that people use telemedicine,” she said.

Because telemedicine systems automatically record encounter length, the setting was ideal to examine the impact of RTI prescribing practices on patient-physician encounter times, Martinez added.

The study sample included telemedicine encounters for patients diagnosed with RTIs from Jan. 1, 2013 to Aug. 31, 2016 through the commercial online care group American Well.

Specific diagnoses included sinusitis, pharyngitis, bronchitis, or other RTIs, according to physician-recorded codes from the International Classification of Diseases (9th and 10th Revisions). Prescriptions were recorded as none, antibiotic, or non-antibiotic. Encounter length was defined as the time patients were connected to and interacted with the physician, recorded automatically by the system in minutes.

In their analysis of 8,437 encounters for RTIs with 85 physicians, 5,580 encounters (66.1%) resulted in the prescribing of an antibiotic, while 1,309 (15.5%) resulted in the prescribing of a non-antibiotic, and 1,548 (18.3%) resulted in no prescription.

Most encounters (87%) received the highest (5-star) satisfaction rating from patients, with patients prescribed antibiotics most likely to give a 5-star rating (90.9% vs 86.0% among patients receiving non-antibiotics and 72.5% among patients prescribed no drug treatments).

Compared with receiving no prescription, receipt of a prescription for an antibiotic was strongly associated with a rating of 5 stars (adjusted OR 3.2, 95% CI 1.80-2.71). For individual physicians, frequent prescription of antibiotics was associated with better satisfaction ratings.

In a sample of 13,438 encounters (49% sinusitis, 14% pharyngitis, 12% bronchitis, and 25% other RTIs) antibiotics were prescribed 67% of the time.

Adjusted modelling revealed that physician encounters resulting in no prescriptions lasted 0.33 minutes longer than those resulting in antibiotic prescriptions (95% CI 0.13-0.53 minutes). Encounters resulting in the prescribing of non-antibiotics lasted, on average, 1.12 minutes longer (95% CI 0.90-1.35 minutes).

“Although prescribing non-antibiotics has been suggested as a way to improve patient satisfaction while avoiding unnecessary antibiotic prescriptions, doing so seems to take more time than prescribing nothing,” the researchers wrote.

Given that patient encounter volume is often used to determine clinician remuneration in telemedicine, antibiotic stewardship efforts may be a particular challenge in this setting, they pointed out.

Martinez said telemedicine providers are starting to adopt some strategies being used by traditional providers to address antibiotic overuse, such as keeping track of individual provider prescribing practices.

“It is not clear at this point what incentives will be needed in telemedicine specifically, because these physicians work from all over the country and they aren’t necessarily part of a single practice group,” she said. “Some incentives in telemedicine, like shorter visit length and high patient satisfaction, might be different, so it could be harder to overcome some of the incentives to reduce antibiotic overprescribing.”

Martinez and co-authors disclosed no relevant relationships with industry.

• Primary Source

  JAMA Internal Medicine

  Source Reference: Martinez KA, et al “Association between antibiotic prescribing for respiratory tract infections and patient satisfaction in direct-to-consumer telemedicine” JAMA Intern Med 2018; DOI:10.1001/jamainternmed.2018.4318.

• Secondary Source

  Annals of Internal Medicine

  Source Reference: Martinez KA, et al “Antibiotic prescribing for respiratory tract infections and encounter length: an observational study of telemedicine” Ann Intern Med 2018; DOI:10.7326/M18-2042.

https://www.medpagetoday.com/infectiousdisease/uritheflu/75428

Nobel Prize in Medicine Awarded to Checkpoint Inhibitor Pioneers

Harnessing the body’s own immune system to fight cancer has been one of the key focuses of drugmakers over the past several years. This year, the Nobel committee recognized two research pioneers for their trailblazing efforts in this field.

The Nobel committee awarded American doctor James Allison and Japan doctor Tasuku Honjo with the 2018 Nobel Prize in Medicine. In its announcement, the Nobel committee pointed to the wide-spread effects of cancer and lauded the two doctors for their “discovery of cancer therapy by inhibition of negative immune regulation.” Allison, the committee said, studied a protein at MD Anderson Cancer Center that functions as a brake on the immune system and developed the concept into an approach for fighting cancer. Honjo, a professor at Kyoto University, also discovered an immune cell protein that acts in a similar braking manner, although with a different action.

“By stimulating the inherent ability of our immune system to attack tumor cells this year’s Nobel Laureates have established an entirely new principle for cancer therapy,” the committee said in a statement.

Honjo has been credited with discovering the PD-1 protein that is expressed on T-cells. In his research, Honjo explored how the protein served as a break in the immune system. After years of research, the committee said a 2012 clinical study “demonstrated clear efficacy in the treatment of patients with different types of cancer.”

PD-1 inhibitors are now key lynchpins in the pipelines of several companies, particularly Merck and its leading drug Keytruda and Bristol-Myers Squibb’s Opdivo.

In the 1990s, Allison studied the T-cell protein CTLA-4. While others looked at harnessing the discovery for autoimmune diseases, the Nobel committee said Allison developed an antibody that could bind to CTLA-4 and block its function. Allison continued his research with mice and discovered what the committee called a cure in the mice. Allison continued his research and the committee said a 2010 clinical study “showed striking effects in patients with advanced melanoma.” Several of the patients saw signs of their cancer disappear, the committee said.

In the pharmaceutical industry, PD-1 inhibitors have demonstrated a greater efficacy, and more of those types of checkpoint inhibitors are on the market. There are some CTLA-4 inhibitors, including BMS’ Yervoy. AstraZeneca is also on the hunt for an approved CTLA-4 inhibitor with its experimental treatment tremelimumab.

The committee noted that there is research showing promise for combination therapies, treatments that target CTLA-4 and PD-1, can be even more effective in treating some cancers. Because of the groundbreaking work of Allison and Honjo, the Nobel committee said a large number of checkpoint therapy trials are currently underway against most types of cancer, and new checkpoint proteins are being tested as targets.

“For more than 100 years scientists attempted to engage the immune system in the fight against cancer. Until the seminal discoveries by the two laureates, progress into clinical development was modest. Checkpoint therapy has now revolutionized cancer treatment and has fundamentally changed the way we view how cancer can be managed,” the Nobel committee said.

https://www.biospace.com/article/nobel-prize-in-medicine-awarded-to-checkpoint-inhibitor-pioneers/

Mayo Clinic, Helix launch at-home DNA testing program

The Mayo Clinic, in collaboration with Helix, has released a new personal genomics product in collaboration with Helix aimed at providing healthy individuals with DNA testing and a focus on education.

The GeneGuide consists of an app and a saliva collection kit provided through the mail. The process begins with a Mayo-affiliated physician reviewing the person’s medical history and ordering the test, which is then evaluated by Helix’s clinical lab.

There the DNA will be sequenced and the data stored for future use, with results available through the web application—including reports on health and disease risks, mutations associated with hereditary genetic conditions and enzyme levels related to how the body processes certain anesthesia and over-the-counter medications.

Users also can share their results with their healthcare provider and give consent regarding how the genetic data is used and shared with a third party. The program will not be available in Maryland, New York or Pennsylvania, which have passed laws restricting who can order or market genetic tests.

“Mayo Clinic GeneGuide is an important step forward in helping people make informed health decisions involving DNA, and is a critical health product on the Helix platform,” said Justin Kao, senior VP and co-founder at Helix. “People are highly motivated to learn about how their DNA impacts their health.”

Other features of the GeneGuide include educational modules by the Mayo Clinic that teach users about genetics and the specific conditions tested, as well as access to Mayo-affiliated healthcare providers and genetic counselors.

In addition, other tests and content can be added over time through Helix’s Exome+ platform and can be accessed without the requiring users to provide a new sample.

https://www.fiercebiotech.com/medtech/mayo-clinic-helix-launch-at-home-dna-testing-program

Novo picks up Calif. plant from Asterias as it moves stem cell work forward

Novo Nordisk has been gathering a phalanx of assets around a stem cell development program that could cure Type 1 diabetes. Now it has a U.S. manufacturing facility where it can produce them.

The diabetes specialist announced today that it will build out a facility in Fremont, California, that it has leased from stem cell biotech Asterias Biotherapeutics. Along with manufacturing intellectual rights it is picking up in the deal, the facility gives Novo a plant that can produce stem cell-based therapies while kick-starting Asterias’ stem-cell program.

Novo paid $2 million for the plant and production know-how. It expects the reworked facility, previously operated by Asterias, to be up and running by the end of next year to support its clinical work in stem cells. Novo couldn’t put a number on how many employees would work at the facility but said in an email today that “there will be a significant workforce operating the facility.”

“Our ambition is to develop stem cell-based therapies for a range of serious chronic diseases where we see significant unmet medical need,” Jacob Sten Petersen, Novo’s head of stem cell R&D, said in a statement. “The reliable, large-scale supply of therapies is a vital component in our efforts, so I am delighted that we have established this facility that further demonstrates our strong commitment to this field.”

The Denmark drugmaker said that in addition to the long-term lease of the facility, it has signed a two-year nonexclusive license on Asterias’ intellectual property for manufacturing stem cells. It will also permit Asterias to move forward with its own clinical program by subleasing laboratory, manufacturing and office space in the facility back to Asterias until the end of 2021.

Before Lars Rebien Sorensen gave up the CEO role at Novo Nordisk in 2016, he predicted that the Denmark diabetes specialist would have a stem cell therapy approach that could cure Type 1 diabetes in the clinic in five years.

It has been working toward that goal, and the drugmaker has centralized its stem cell R&D in at its recently established Stem Cell Transformational Research Unit in Måløv, Denmark, where it is working on treatments not only for diabetes but also for Parkinson’s disease, chronic heart failure and dry age-related macular degeneration (AMD).

Much of its work, however, is taking place in the U.S. In May, Novo struck an agreement with the University of California, San Francisco (UCSF), to license a technology to enable the generation of GMP-compliant human embryonic stem cell lines, along with the rights to develop them into future regenerative therapies. It claims that its work in the GMP lab at UCSF is “deriving cell lines that are defining a new quality standard in the production of stem cell-based therapies.”

With cell line work advancing at UCSF and a collaboration with Cornell raising hopes that a major barrier to curing diabetes can be overcome, Novo has set its sights on getting a diabetes candidate into human testing in the next few years. That makes Novo one of the bigger players in a race that includes Eli Lilly partner Sigilon Therapeutics and well-financed Semma Therapeutics, which in May named Bastiano Sanna, formerly of Novartis’ cell and gene therapy unit and Magenta Therapeutics, as its CEO.

An effective stem cell treatment for Type 1 diabetes and other chronic disease would be a huge boost for Novo, which has been laying off employees, including in R&D, as pricing pressures for insulin in the U.S. have slammed its revenue lines. It sees drugs to treat other serious chronic diseases as critical to its future. With that in mind, Novo is restructuring its R&D unit, investing in artificial intelligence and planning to rely more on third parties for innovation.

https://www.fiercepharma.com/manufacturing/novo-picks-up-california-plant-from-asterias-as-it-moves-stem-cell-work-forward

Omeros hit after kidney disease trial results

Omeros Corp. OMER, -42.81% shares dropped nearly 45% in Monday afternoon trade after the company released results from a phase 2 trial testing its OMS721 therapy in a progressive kidney disease called immunoglobulin A (IgA) nephropathy. The trial measured reductions in protein levels in patients’ urine, called proteinuria, the “most reliable prognostic factor for loss of kidney function” in this disease. The most recent results were based on a group of nine patients who had not received corticosteroid treatment and had a high risk of disease progression, or “a difficult-to-treat population,” according to Jonathan Barratt, professor of renal medicine at the University of Leicester. Of those individuals, median reductions in proteinuria after 12 weeks of therapy were very similar: 18.4% for OMS721 and 18% for placebo groups. Omeros continued to treat patients after 12 weeks, and of those eight patients, median proteinuria reductions were nearly 56%, the company said. Four individuals on Omeros’ therapy in the dosing-extension period had reductions of between 53.9% and 67.8%, it said. The company continues to treat patients in this dosing-extension period and plans to present additional data at a future medical meeting. IgA nephropathy’s most common symptoms are blood in the urine and foamy urine, according to the American Kidney Foundation, and doctors try to slow down the disease’s characteristic kidney damage. It affects an estimated 1 in 1,400 individuals in the U.S. and currently has no approved treatments, according to Omeros. Omeros shares have dropped nearly 26% over the last three months, compared with a 7.7% rise in the S&P 500 SPX, +0.36% and a nearly 10% rise in the Dow Jones Industrial Average DJIA, +0.73%

https://www.marketwatch.com/story/omeros-stock-drops-45-after-kidney-disease-trial-results-2018-10-01

DaVita unit to pay $270 million to resolve Medicare payments probe

A medical care unit of DaVita Inc (DVA.N) has agreed to pay $270 million to resolve claims it provided inaccurate information about patients that caused Medicare Advantage plans operated by private insurers to obtain inflated payments from the government.

The civil settlement with HealthCare Partners Holdings, which Denver-based DaVita acquired in 2012 and is in the process of selling to UnitedHealth Group Inc (UNH.N), was announced on Monday by the U.S. Justice Department.

HealthCare Partners did not admit wrongdoing. DaVita in a statement said the $270 million will be paid for out of escrow funds that it required HealthCare Partners’ former owners to set aside when DaVita acquired it in 2012.

According to court papers, HealthCare Partners, a California-based independent physician association, contracted with insurers to provide medical services to Medicare Advantage patients.

More than one-third of Medicare recipients receive benefits through Medicare Advantage plans run by private insurers, who the government pays a predetermined monthly sum for each person they cover based on individual diagnostic traits.

Under this part of Medicare, the healthcare program for the elderly, the government makes so-called “risk adjustment” payments based on data it receives regarding the health status of a patient covered by a Medicare Advantage plan.

The case stemmed from a broader investigation into data that insurers who operate Medicare Advantage plans submit to receive “risk adjustment” payments. The probe has already led to the U.S. Justice Department suing UnitedHealth in a similar case.

DaVita Inc74.04

DVA.NNEW YORK STOCK EXCHANGE

+2.41(+3.36%)

• DVA.N
• UNH.N

The Justice Departments said HealthCare Partners instituted practices that led insurers operating Medicare Advantage plans to submit incorrect information about patients’ diagnoses and obtain inflated payments, which the company shared in.

HealthCare Partners also scoured patients’ records for diagnoses its medical providers failed to record which it then submitted to the insurers for use in obtaining increased Medicare payments, the Justice Department said.

Those allegations stemmed from a whistleblower lawsuit filed in 2009 against various insurers and, later, HealthCare Partners by James Swoben, a former employee of an insurer that did business with DaVita, the Justice Department said.

His lawsuit, pending in federal court in Los Angeles, was filed under the False Claims Act, which allows whistleblowers to sue companies on the government’s behalf to recover funds paid out based on fraudulent claims.

The government may intervene in such cases. For his role in bringing the case, Swoben will receive nearly $10.2 million, the Justice Department said.

The case is U.S. ex rel. Swoben v. Secure Horizons, et al, U.S. District Court, Central District of California, No. 09-5013.

https://www.reuters.com/article/us-davita-settlement/davita-to-pay-270-mln-to-end-u-s-probe-into-medicare-payments-idUSKCN1MB3J1