Bayer’s darolutamide extends survival in late-state prostate cancer study

A Phase 3 clinical trial, ARAMIS, evaluating Bayer’s (OTCPK:BAYRY) darolutamide plus androgen deprivation therapy (ADT) in men with non-metastatic castration-resistant prostate cancer demonstrated a statistically significant improvement in overall survival (OS) compared to placebo plus ADT, a key secondary endpoint.

Previously published data showed that darolutamide + ADT met the primary endpoint of metastasis-free survival compared to placebo + ADT.

Detailed results will be presented at a future medical conference.

Darolutamide, branded as Nubeqa, is currently approved in the U.S., Japan and Brazil. Filings in the EU and other regions are in process or planned.

https://seekingalpha.com/news/3536246-bayers-darolutamide-extends-survival-in-late-state-prostate-cancer-study

Biogen EPS beats by $0.28, beats on revenue

Biogen (NASDAQ:BIIB): Q4 Non-GAAP EPS of $8.34 beats by $0.28; GAAP EPS of $8.08 beats by $0.78.

Revenue of $3.67B (+4.0% Y/Y) beats by $140M.

Press Release

https://seekingalpha.com/news/3536212-biogen-eps-beats-0_28-beats-on-revenue

EHR Vendor Practice Fusion Settles Opioid Kickback Case for $145M

Practice Fusion, a San Francisco-based electronic health records (EHR) vendor and a subsidiary of Allscripts, has agreed to a $145 million settlement with the federal government to resolve allegations that it took kickbacks from an opioid drug maker and other pharmaceutical companies in return for creating clinical decision support (CDS) tools that promoted those companies’ drugs at the point of care.
The settlement includes a criminal fine of $25.4 million and the forfeiture of nearly $1 million in illegal proceeds, according to a US Department of Justice (DOJ) press release. This is the first-ever criminal action against an EHR vendor, the release said.
The agreement also settles a civil suit against Practice Fusion for $118.6 million, including $113.4 million to the federal government and up to $5.2 million to states that opt to participate in separate agreements. Besides the illegal kickbacks from drug companies, the civil agreement also covers multiple instances in which Practice Fusion misrepresented the features of its EHR so that its users could attest to using a certified EHR required for “meaningful use” incentive payments, according to the release.
Under the overall settlement, Practice Fusion admits that the criminal charges against it are true and agrees to post documents related to its misconduct on a website. The DOJ said “the civil claims resolved by the settlement are allegations only, and there has been no determination of liability as to such civil claims.”

As part of the resolution of the criminal case, Practice Fusion acknowledges that it solicited and received kickbacks from a major opioid company in exchange for using its EHR to influence physician prescribing of opioid pain medications. “Practice Fusion solicited a payment of nearly $1 million from the opioid company to create a CDS alert that would cause doctors to prescribe more extended release opioids,” the Justice Department news release said.
Besides the fine and forfeiture, the company must retain an independent oversight organization that is required to review and approve any “sponsored CDS” before Practice Fusion can implement the CDS software. It also has to create a “comprehensive compliance program” to prevent future similar abuses.
The civil settlement covers not only Practice Fusion’s kickback deal with the opioid company, but “also resolves allegations of kickbacks relating to thirteen other CDS arrangements where Practice Fusion agreed with pharmaceutical companies to implement CDS alerts intended to increase sales of their products.”
“In exchange for ‘sponsorship’ payments from pharmaceutical companies,” the Justice Department noted, “Practice Fusion allowed the companies to influence the development and implementation of the CDS alerts in ways aimed at increasing sales of the companies’ products.”
“Practice Fusion’s conduct is abhorrent. During the height of the opioid crisis, the company took a million-dollar kickback to allow an opioid company to inject itself in the sacred doctor-patient relationship so that it could peddle even more of its highly addictive and dangerous opioids. The companies illegally conspired to allow the drug company to have its thumb on the scale at precisely the moment a doctor was making incredibly intimate, personal, and important decisions about a patient’s medical care,” Christina E. Nolan, US attorney for the District of Vermont, where the case was brought, commented in the release.

More Shoes to Drop?

The Justice Department said that Practice Fusion had agreed “to cooperate in any ongoing investigations of the kickback arrangement [with the opioid maker] and report any evidence of kickback violations by any other EHR vendors.”
While there is no indication that other EHR companies have participated in similar schemes with drug companies, Dan O’Neill, a former vice president of Practice Fusion, said on Twitter that some pharma firms have flogged their products through EHR ads and emails to users. O’Neill, who was with Practice Fusion from 2013 to 2015, stresses that he was not there when the company’s misconduct occurred.

Dan O’Neill @dp_oneill

I’m inclined to share a few thoughts on this (rather nauseating) news, having worked at Practice Fusion for a couple of yrs, though not when this episode occurred.

As @chrissyfarr notes, PF has become a bit of a cautionary tale. Perhaps there are useful lessons in that tale. 1/n https://twitter.com/chrissyfarr/status/1221949163434233857 …

Christina Farr @chrissyfarr

New from DOJ: “Practice Fusion admits that it solicited and received kickbacks from a major opioid company in exchange for utilizing its EHR software to influence physician prescribing of opioid pain medications.” https://www.justice.gov/opa/pr/electronic-health-records-vendor-pay-145-million-resolve-criminal-and-civil-investigations-0 …

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12:10 AM – Jan 28, 2020

The Justice Department announcement also laid out the details of Practice Fusion’s allegedly fraudulent claims about its EHR’s features. To be certified under the 2014 criteria of the Office of the National Coordinator of Health IT (ONC), EHR software had to allow users to electronically create a set of standardized clinical summaries for export. Practice Fusion falsely represented to the certifying body that its EHR could do this, although it could not. In addition, the company’s software failed to incorporate standardized vocabularies, as required, the DOJ said.
These actions, the news release said, “caused [Practice Fusion’s] users to submit false claims for federal incentive payments by misrepresenting the capabilities of its EHR.”
Practice Fusion was purchased by Allscripts, a much larger EHR vendor, in 2018. It is not named in the Justice Department news release.
In a statement emailed to Medscape Medical News, Brian Farley, executive vice president of Allscripts, said, “We are pleased to complete the settlement of these legacy matters, which as disclosed last August involve conduct predating Allscripts’ acquisition of Practice Fusion. As a company, we are committed to maintaining the highest levels of professionalism and integrity, and since learning of this matter we have further strengthened Practice Fusion’s compliance program.
“Allscripts recognizes the devastating impact that opioids have had on communities nationwide, and we are using our technology to fight this epidemic. We remain committed to Practice Fusion and believe this matter should not overshadow the important and valuable work it is currently performing.”
https://www.medscape.com/viewarticle/924533#vp_1

Medicare Opts to Cover Acupuncture for Pain Amid Opioid Crisis

Medicare this month said it would cover acupuncture for people with chronic low back pain, seeking to give patients alternatives to potentially addictive narcotic painkillers.
The Centers for Medicare and Medicaid Services (CMS) on January 21 announced a national coverage determination for this treatment. For purposes of coverage, people need to have had chronic low back pain that has persisted for at least 12 weeks or longer, the agency said. This pain must have no identifiable cause, such as infections, disease, surgery, and pregnancy.
Under these circumstances, CMS will cover as many as 12 visits in 90 days. The agency said it will cover an additional eight sessions for those patients demonstrating an improvement. There is a limit of 20 covered acupuncture treatments a year. Treatment should be discontinued if patients don’t show improvement, CMS said.
“We are building on important lessons learned from the private sector in this critical aspect of patient care,” CMS Principal Deputy Administrator of Operations and Policy Kimberly Brandt said in the announcement. “Over-reliance on opioids for people with chronic pain is one of the factors that led to the crisis, so it is vital that we offer a range of treatment options for our beneficiaries.”

In the decision memo, CMS said that insurers including Aetna, various Blue Cross Blue Shield plans, Cigna, Kaiser Permanente, and United Healthcare provide some coverage of acupuncture. The agency said that the relative safety of acupuncture and the grave consequences of the opioid crisis in the United States provided “sufficient rationale to provide this nonpharmacologic treatment” to people enrolled in Medicare who have chronic low back pain.
“While a small number of adults 65 years of age or older have been enrolled in published acupuncture studies, patients with chronic low back pain in these studies showed improvements in function and pain,” CMS said.

Back-and-Forth Issue

In the decision memo, CMS said it had mulled and then in 1980 rejected the idea of covering acupuncture. In 2004, CMS considered acupuncture for fibromyalgia but found no convincing evidence for this benefit. In that same year, CMS also drew the same conclusion about the use of acupuncture for pain relief in patients with osteoarthritis.
CMS also noted in the memo that many groups and individuals had written to the agency in support of Medicare coverage of acupuncture, with patients often including personal reports of pain relief.
But a few commenters told CMS that acupuncture was a “pseudoscience,” with positive results described in some report likely due to the placebo effect.
Among the critics of the proposal was Steven L. Salzberg, PhD, director of the Center for Computational Biology at Johns Hopkins University School of Medicine. He told CMS he was concerned about the use of taxpayers’ money to cover acupuncture.
“No well-designed study has ever shown that it has any benefit beyond a placebo effect, and scientifically there is no serious debate about its efficacy,” Salzberg said in his comment submitted to CMS in January 2019. “Simply put, it does not work, and patients who believe in acupuncture are being misled. Testimonials such as those in the comments here do not comprise evidence.”
https://www.medscape.com/viewarticle/924534

Half of Family Physicians Report Being Sued for Malpractice

Nearly half (49%) of family physicians who responded to Medscape’s latest survey on malpractice said they have been named in at least one lawsuit.
In the Medscape Malpractice Family Physicians Report 2019, 41% said other defendants also were named in the suit, and 11% said they were the only person named.
More than one third (39%) of those sued said their case was settled before trial. Asked whether insurers instructed them to settle, 38% said their insurer encouraged them to settle and 25% said they required it.
When cases did go to trial, a judge ruled for the defendants 10% of the time and for the person who brought the lawsuit (the plaintiff) 2% of the time.

In most family physician cases (42%), claims centered on a failure to diagnose or a delay in diagnosing. In comparison, that reason was cited by 33% of physicians overall. Next most prominent for family physicians was poor outcome or disease progression (22%), followed by failure to treat or delayed treatment (19%) and wrongful death (18%).
For 62%, the lawsuit was “a complete shock.” Most said they thought the cases were unwarranted, but 14% were unsure and 7% said they were warranted.
“There’s a whole host of what you could call psychological factors that can contribute to the filing of a claim,” David S. Szabo, a malpractice defense attorney with Locke Lord LLC in Boston told Medscape Medical News. “These can occur when a patient perceives a breakdown in the doctor-patient relationship, or is pretty certain that there’s been a mistake, and they feel like they’ve been shut out of productive conversation with their healthcare provider or providers.”
Defending a lawsuit always takes time in gathering records, meeting with attorneys, and preparing for depositions, and 42% of family physicians who were sued said work on their defense cost them more than 40 hours.
About the same percentage (41%) said the case spanned 1 to 2 years; 27% said less than 1 year; 24% said 3 to 5 years; and 8% said more than 5 years.
When judges ruled for the plaintiff, the award generally maxed out at $500,000. Among cases in which the plaintiff received money, 44% received $100,000 or less and 34% got between $100,000 and $500,000. Six percent of plaintiffs received more than $2 million.
The survey asked physicians what changed after the lawsuit, and nearly half (47%) said nothing changed. Among those who did report change, 23% said they no longer trust their patients or they treat patients differently.
Sixty percent of those who lost their case said they would have done something differently; the top two regrets were wishing they had ordered more tests that would have “covered” them or had better documentation.

Only 1% of physicians said saying “I’m sorry” would have made any difference in the outcome of the lawsuit.
Asked whether medical organizations or state societies were doing enough to discourage lawsuits, 56% of all physicians and 53% of family physicians said no.
Medscape. Published online January 22, 2020. Slideshow
https://www.medscape.com/viewarticle/924498

Airlines suspend, scale back direct flights to China amid virus fears

Global airlines on Wednesday suspended or scaled back more direct flights to China’s major cities amid an increase in travel warnings and decline in demand from passengers due to a growing outbreak of coronavirus. Fears over the spread of the flu-like virus, which originated in the central Chinese city of Wuhan, are increasing as the death toll topped 160.

The virus appears to represent the biggest epidemic threat to the airline industry since the SARS outbreak, which at its peak in April 2003 led to a 45% plunge in passenger demand in Asia, analysts said.
The White House is considering further restrictions on U.S. airlines flying to and from China in addition to voluntary restrictions the companies have put into place, President Donald Trump’s economic adviser Larry Kudlow said on Wednesday.
“The matter is under discussion every day,” he said.
British Airways (ICAG.L) said it suspended all direct flights to and from mainland China.
BA.com, the airline’s website, shows no direct flights to mainland China available to book in January or February. But the airline said in an email the cancellations were in effect until Jan. 31 while it assesses the situation.
Air Canada (AC.TO), which planned earlier this week to cancel just a select number of its 33 weekly flights to China, said on Wednesday it would suspend all direct flights to Beijing and Shanghai.
The suspension, from Jan. 30 to Feb. 29, came after the government of Canada updated its travel advisory urging its citizens to avoid non-essential travel to China.
American Airlines Group Inc (AAL.O) said on Wednesday it would suspend flights from Los Angeles to Beijing and Shanghai but continue flying from Dallas, and Delta Air Lines (DAL.N) said it was halving its U.S.-China schedule to about 21 weekly flights.
U.S. officials said the White House had decided against suspending all flights to China for now, but it could revisit the decision if events warrant.
Among European carriers, Germany’s Lufthansa (LHAG.DE) suspended its own, Swiss and Austrian Airlines flights to and from China until Feb. 9, while Air France (AIRF.PA) said it would reduce its flight schedule to Beijing and Shanghai this week.
Iberia, part of the IAG group along with BA, said it was temporarily suspending all flights to Shanghai.
Asia-Pacific accounts for about 19% of both Air France-KLM and Lufthansa’s available seat kilometers and 8% of IAG’s in 2019, Goodbody analysts said.
“The airline industry has proven resilient to shocks in the past,” S&P Global Ratings said. “However, the impact on Asia-Pacific airlines and other operators will depend on how quickly the virus is contained and the extent to which it spreads beyond China.”
Indonesia’s Lion Air said on Wednesday it would suspend all direct flights to China. India’s IndiGo is also suspending flights to Chengdu and Hong Kong.
Carriers including Hong Kong’s Cathay Pacific Airways said on Wednesday amenities such as hot towels, blankets and magazines would not be offered on flights to and from mainland China from Thursday until further notice.
Cathay Pacific and other airlines are allowing their flight attendants to wear face masks and gloves on flights to protect against fears of contagion.
Wesley Lesosky, president of the Canadian Union of Public Employees unit that represents Air Canada flight attendants, said by email that members have the option of wearing masks and gloves on flights to China.
But flight attendants remained “concerned with the effects the virus could have if contracted, how to recognize an infected passenger and how to deal with the nervous passengers onboard,” Lesosky said.
https://www.reuters.com/article/us-china-health-airlines/airlines-suspend-scale-back-direct-flights-to-china-amid-virus-fears-idUSKBN1ZS341

China virus evacuations begin as death toll rises at outbreak epicenter

Foreign governments began flying their citizens out of China’s Hubei province, the epicenter of the coronavirus outbreak, as authorities said the death toll there had topped 160.
The health commission for Hubei said on Thursday that deaths in the province from the new coronavirus had risen by 37 to 162, while a further 1,032 cases had been detected.
Although the majority of cases have been in Hubei, cases have been detected elsewhere in China and in at least 15 other countries.

The World Health Organization’s (WHO) Emergency Committee is set to reconvene behind closed doors in Geneva later on Thursday to decide whether the rapid spread of the virus now constitutes a global emergency.
“In the last few days the progress of the virus, especially in some countries, especially human-to-human transmission, worries us,” WHO Director-General Tedros Adhanom Ghebreyesus told a news conference on Wednesday, naming Germany, Vietnam and Japan.
“Although the numbers outside China are still relatively small, they hold the potential for a much larger outbreak.”

The United States flew about 200 Americans out of Wuhan, capital of Hubei where most of the cases are concentrated. They were being screened on arrival in California. France, Britain and Canada also have organized evacuations.
The effects of the virus are already weighing heavily on China’s economy, the world’s second-biggest, with companies cutting corporate travel and tourists cancelling trips.
Various airlines are cutting flights, from British Airways and Lufthansa to Air Canada and American Airlines.
https://www.reuters.com/article/us-china-health/china-virus-evacuations-begin-as-death-toll-rises-at-outbreak-epicenter-idUSKBN1ZS35G