New global guidelines on the treatment of heart failure strongly endorse the use of Novartis’ Entresto, boosting the prospects for a drug that has struggled to gain traction since its launch last year.
U.S. and European heart experts gave the highest “class 1” recommendation to Entresto for use in patients with heart failure, a debilitating condition in which the heart is unable to pump enough blood around the body.
The guidance in the key U.S. market says that Entresto should replace two older types of drugs known as ACE inhibitors and ARBs in heart failure patients who have adequate blood pressure and tolerance to standard drugs.
In Europe, doctors are recommended to switch their patients to the medicine if they fit the profile of a 2014 clinical trial that proved Entresto was better than standard treatment.
“The guidelines read favourably. In fact, they are about as favourable as we could have hoped for,” said Bernstein analyst Tim Anderson.
Given Entresto’s sluggish sales, investors were watching carefully to see what the guidelines said and when they would be issued, since this will influence prescribers. There had been concerns the announcements could be staggered and might only recommend limited use.
In the event, the American College of Cardiology, the American Heart Association and the European Society of Cardiology said they issued their guidelines simultaneously to “unify the message, minimize confusion, and improve and standardize the care of patients”.
Novartis said the new guidance, published late on Friday, would redefine the standard of care for treating reduced ejection fraction heart failure.
“We know patients with heart failure suffer reduced quality of life and remain at high risk of hospitalisation or death, and these new guidelines are a strong call to action to ensure patients receive the most effective therapies,” said Vas Narasimhan, chief medical officer for Novartis.
The guidelines do contain some expected caveats, with experts saying that Entresto should not be given together with an ACE inhibitor or used in patients with a history of a swelling condition known as angioedema.
Experts also gave a “class IIa” recommendation to Amgen’s new drug Corlanor for use on top of beta blockers for certain heart failure patients who have a resting heart rate of at least 70 beats per minute. Servier sells the product outside the United States.
There have been few new drugs for heart failure and Novartis has touted Entresto as an eventual $5 billion-a-year seller.
Yet first-quarter sales of the medicine were just $17 million and Novartis now predicts 2016 sales of a modest $200 million, well below initial analyst forecasts.
The lack of specific guidelines from professional bodies until now will have contributed to reticence among some doctors to prescribe Entresto – but cost is also an issue. With a price tag of around $4,500 a year, some physicians worry that patients might quit their medication.
Novartis on Thursday unveiled a battery of new clinical trials for Entresto designed to boost confidence in the drug and assuage doctors’ concerns over switching patients to Entresto when they are stable on older medicines.
Bombshell Investigation Finds Brett Kavanaugh Lied About Sexual Assaults
According to New York Times:
But while we found Dr. Ford’s allegations credible during a 10-month investigation, Ms. Ramirez’s story could be more fully corroborated. During his Senate testimony, Mr. Kavanaugh said that if the incident Ms. Ramirez described had occurred, it would have been “the talk of campus.” Our reporting suggests that it was.
At least seven people, including Ms. Ramirez’s mother, heard about the Yale incident long before Mr. Kavanaugh was a federal judge. Two of those people were classmates who learned of it just days after the party occurred, suggesting that it was discussed among students at the time.
We also uncovered a previously unreported story about Mr. Kavanaugh in his freshman year that echoes Ms. Ramirez’s allegation. A classmate, Max Stier, saw Mr. Kavanaugh with his pants down at a different drunken dorm party, where friends pushed his penis into the hand of a female student. Mr. Stier, who runs a nonprofit organization in Washington, notified senators and the F.B.I. about this account, but the F.B.I. did not investigate and Mr. Stier has declined to discuss it publicly. (We corroborated the story with two officials who have communicated with Mr. Stier.)
The FBI investigation was a sham because Trump and Senate Republicans severely limited what the FBI could investigate.
Kavanaugh lied about everything to the Senate.
As with Trump, Mitch McConnell and Senate Republicans are never going to impeach Brett Kavanaugh and lose their Supreme Court majority, but when Democrats take back the Senate, one can be assured that investigating and potentially impeaching Brett Kavanaugh will be near the top of their list.
For the good of the nation, Brett Kavanaugh can’t be allowed to continue to serve on the Supreme Court.
Kavanaugh lied, and he has got to go.
Trump Again Boosts a Baseless Conspiracy Theory, This One About Jeffrey Epstein
President Donald Trump on Saturday promoted a conspiracy theory linking the Clinton family to the death of multimillionaire and accused sex trafficker Jeffrey Epstein, the latest instance of Trump propagating baseless conspiracy theories and falsehoods.
Trump shared a tweet and video from conservative comedian Terrence Williams that claimed without evidence that former President Bill Clinton and former Secretary of State Hillary Clinton — Trump’s 2016 presidential election rival — were responsible for Epstein’s death. The Federal Bureau of Prisons and Attorney General Bill Barr said Epstein died in an “apparent suicide” while in federal custody.
As a result of Trump’s retweet, the video received more than 3 million views on Twitter by Sunday morning — more than triple Williams’ most recent videos. Both Trump and Bill Clinton were friendly with Epstein in previous decades, but Trump seized on the conspiracy theory Saturday in his latest dig at the Clintons. The tweet also falsely claimed that Epstein died while on suicide watch, even though Epstein had been taken off of suicide watch before his death.
Angel Ureña, a spokesman for the former president, called the conspiracy theory “ridiculous, and of course not true.”
“And Donald Trump knows it,” Ureña tweeted.
Trump promotes conspiracy theories
Lawmakers and government officials have called for inquiries into Epstein’s death, but none have gone so far as to even suggest that political rivals were behind it.
Unlike any other President before him, Trump has repeatedly promoted evidence-free conspiracy theories and falsehoods without regard for the consequences of his rhetoric.
Even before he was a candidate for President, Trump grew his following on the political right by promoting the conspiracy theory that President Barack Obama was born in Kenya — and not the United States — even after Obama released a birth certificate showing he was born in the US.
During his campaign for President, Trump spread a conspiracy theory linking the father of his then-GOP presidential rival Sen. Ted Cruz to the assassination of President John F. Kennedy. The Cruz campaign denied it was Rafael Cruz and Cruz, a Texas Republican, responded at the time by blasting Trump as a pathological liar.
And in the second month of his presidency, Trump accused Obama without evidence of tapping his phones in Trump Tower during the 2016 campaign. More than two years later, there is still no evidence that Trump’s phones were wiretapped during the 2016 campaign.
Trump has also repeatedly claimed without evidence that millions of people voted illegally in the 2016 election; has fed conspiracy theories about a “deep state” of government officials working against him; and has also falsely smeared former special counsel Robert Mueller’s investigation as a “witch hunt” and called the investigation into Russian interference in the 2016 campaign “treason” — among many others.
Trump was not the only official in his administration to promote the Epstein-Clintons conspiracy theory.
Lynne Patton, a senior official at the Department of Housing and Urban Development and a longtime Trump family aide and friend, also gave voice to the conspiracy theory on her Instagram account earlier in the day.
Trump’s tweet promoting the conspiracy theory came about an hour after Florida Republican Sen. Marco Rubio warned of the dangers of spreading partisan conspiracy theories about Epstein’s death.
“Scrutiny of how #Epstein was able to commit suicide is warranted,” Rubio tweeted. “But the immediate rush to spread conspiracy theories about someone on the ‘other side’ of partisan divide having him killed illustrates why our society is so vulnerable to foreign disinformation & influence efforts.”
White House senior counselor Kellyanne Conway appeared on Fox News Sunday defending the President. “I think the President just wants everything to be investigated,” Conway said when asked about Trump’s controversial retweet.
“Just the day before, there was some unsealed information implicating some people very high up,” she said, referring to the hundreds of pages of documents from a defamation lawsuit from one of Epstein’s accusers. Those documents were unsealed Friday by a court.
“I will say that there’s always this rush to (say), ‘We need transparency. We need accountability,’ when it involves fictional accusations like collusion with Russia to swing an election. This seems to be very concrete and that Jeffrey Epstein has done some very bad things over a number of years. So let’s continue to investigate that,” Conway said.
Democrats call out Trump for ‘more recklessness’
Still, two 2020 Democratic presidential candidates on Sunday called out Trump for retweeting the Epstein conspiracy theory and the President’s history of spreading baseless claims.
New Jersey Sen. Cory Booker called Trump’s latest theory-peddling “more recklessness” and “dangerous,” telling CNN’s Jake Tapper on “State of the Union” that Trump has “been using the Clintons as a means for a lot of his false accusations.”
Former Texas Rep. Beto O’Rourke also told Tapper that Trump is attacking his “political enemies with unfounded conspiracy theories” and called it “bizarre behavior.”
O’Rourke said the President is attempting to shift the focus away from last weekend’s mass shootings in El Paso, Texas, and Dayton, Ohio.
“He’s changing the conversation, and if we allow him to do that, then we will never be able to focus on the true problems, of which he is a part, and make sure that we get to the solutions,” O’Rourke, an El Paso native, said.
Jeffrey Epstein Was Not Being Monitored in Jail as Directed Before His Death
Authorities said Epstein died of apparent suicide. He was in jail on sex-trafficking charges.
The law enforcement official told The Times Epstein was supposed to be checked by guards every 30 minutes, but that procedure was not being followed the night he was found dead in the Manhattan jail.
The jail had also transferred Epstein’s cellmate and left him alone ahead of his apparent suicide, The Times reports.
Epstein’s death has left officials and lawmakers asking for answers on how this happened.
Epstein had apparently been taken off suicide watch before he died.
His death comes just weeks after officials investigated a possible suicide attempt.
The FBI is launching an investigation into the circumstances of Epstein’s death, Attorney General William Barr said in a statement.
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