U.S. charges hundreds in major healthcare fraud, opioid crackdown

U.S. Attorney General Jeff Sessions addresses a news conference to announce a nation-wide health care fraud and opioid enforcement action, at the Justice Department in Washington, U.S. June 28, 2018. REUTERS/Jonathan Ernst

By Nate Raymond

(Reuters) – The U.S. Justice Department on Thursday announced charges against 601 people including doctors for taking part in healthcare frauds that resulted in over $2 billion in losses and contributed to the nation’s opioid epidemic in some cases.

The arrests came as part of what the department said was the largest healthcare fraud takedown in U.S. history and included 162 doctors and other suspects charged for their roles in prescribing and distributing addictive opioid painkillers.

“Some of our most trusted medical professionals look at their patients – vulnerable people suffering from addiction – and they see dollar signs,” U.S. Attorney General Jeff Sessions said.

The arrests came as part of an annual fraud takedown overseen by the Justice Department. The crackdown resulted in authorities bringing dozens of unrelated cases involving alleged frauds that cost government healthcare programs and insurers more than $2 billion.

Officials sought in the latest crackdown to emphasize their efforts to combat the nation’s opioid epidemic. According to the U.S. Centers for Disease Control and Prevention, the epidemic caused more than 42,000 deaths from opioid overdoses in the United States in 2016.

In a report released on Thursday, the U.S. Department of Health and Human Services’ Office of Inspector General said about 460,000 patients covered by Medicare received high amounts of opioids in 2017 and 71,000 were at risk of misuse or overdose.

Those figures were slightly down from 2016, but the report said the high level of opioid use remained a concern. The report said almost 300 prescribers had “questionable prescribing” that warranted further scrutiny.

Many of the criminal cases announced on Thursday involved charges against medical professionals who authorities said had contributed to the country’s opioid epidemic by participating in the unlawful distribution of prescription painkillers.

The cases included charges in Texas against a pharmacy chain owner and two other people accused of using fraudulent prescriptions to fill bulk orders for over 1 million hydrocodone and oxycodone pills that were sold to drug couriers.

“The perpetrators really are despicable and greedy people,” U.S. Health and Human Services Secretary Alex Azar said at a press conference.

The Justice Department also announced other cases unrelated to opioids, including schemes to bill the government healthcare programs Medicare, Medicaid and Tricare as well as private insurers for medically unnecessary prescription drugs and compounded medications.

(Reporting by Nate Raymond in Boston; Editing by Chizu Nomiyama and Tom Brown)

Trump declares opioids a U.S. public health emergency

Trump declares opioids a U.S. public health emergency

By Yasmeen Abutaleb and Jeff Mason

WASHINGTON (Reuters) – U.S. President Donald Trump declared the opioid crisis a public health emergency on Thursday, stopping short of a national emergency declaration he promised months ago that would have freed up more federal money.

Responding to a growing problem wreaking havoc in rural areas, Trump’s declaration will redirect federal resources and loosen regulations to combat opioid abuse, senior administration officials said on a conference call with reporters.

But it does not mean there will be more money to combat the crisis. Some critics, including Democratic lawmakers, said the declaration was meaningless without additional funding.

“This epidemic is a national health emergency,” Trump said at the White House. “Nobody has seen anything like what’s going on now. As Americans, we cannot allow this to continue.”

The announcement disappointed some advocates and experts in the addiction fight, who said it was inadequate to fight a scourge that played a role in more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention. The death rate has kept rising, estimates show.

Opioids, primarily prescription painkillers, heroin and fentanyl, are fueling the drug overdoses. More than 100 Americans die daily from related overdoses, according to the CDC.

A White House commission on the drug crisis had urged Trump to declare a national emergency. On Wednesday, the president told Fox Business Network he would do so.

Officials told reporters on the conference call that Federal Emergency Management Agency funds that would have been released under a national emergency are already exhausted from recent storms that struck Puerto Rico, Texas and Florida.

The administration would have to work with Congress to help provide additional funding to address drug abuse, they added.

Under Thursday’s declaration, treatment would be made more accessible for abusers of prescription painkillers, heroin and fentanyl, while ensuring fewer delays in staffing the Department of Health and Human Services to help states grapple with the crisis.

‘BAD ACTORS’

Trump said he would discuss stopping the flow of fentanyl, a drug 50 to 100 times more powerful than morphine, with Chinese President Xi Jinping during his visit to Asia next month.

In his remarks, Trump said the U.S. Postal Service and Department of Homeland Security were “strengthening the inspection of packages coming into our country to hold back the flood of cheap and deadly fentanyl, a synthetic opioid manufactured in China.”

He added he would consider bringing lawsuits against “bad actors” in the epidemic. Several states have sued opioid manufacturers for deceptive marketing. Congress is investigating the business practices of manufacturers.

The president also said the government should focus on teaching young people not to take drugs. “There is nothing desirable about drugs. They’re bad,” he said.

Thursday’s declaration also allows the Department of Labor to issue grants to help dislocated workers affected by the crisis. HIV/AIDS health funding would also be prioritized for those who need substance abuse treatment, officials said.

As a candidate, Trump promised to address the crisis, including by building a wall on the U.S.-Mexico border to stop the flow of illicit drugs, which he touched on in his speech.

Additional actions under the move would be announced in coming weeks by various agencies, officials said.

(Additional reporting by James Oliphant, Susan Heavey and Jason Lange; Editing by Kevin Drawbaugh and Peter Cooney)

Rhode Island doctor pleads guilty to opioid kickback scheme related to Insys

FILE PHOTO: A box of the Fentanyl-based drug Subsys, made by Insys Therapeutics Inc, is seen in an undated photograph provided by the U.S. Attorney's Office for the Southern District of Alabama. U.S. Attorney's Office for the Southern District of Alabama/Handout via REUTERS

By Nate Raymond

BOSTON (Reuters) – A Rhode Island doctor pleaded guilty on Wednesday to charges he participated in a scheme to obtain kickbacks in exchange for writing prescriptions for an addictive fentanyl-based cancer pain drug produced by Insys Therapeutics Inc.

The plea by Jerrold Rosenberg came amid ongoing investigations of Insys related to Subsys, an under-the-tongue spray that contains fentanyl, a synthetic opioid.

Rosenberg, 63, pleaded guilty in federal court in Providence, Rhode Island, to charges that he committed healthcare fraud and conspired to receive kickbacks to prescribe Subsys.

Prosecutors said that from 2012 to 2015, Rosenberg schemed to receive $188,000 in kickbacks in the form of speaker fees from Insys, which were a major factor in his decision to prescribe Subsys to patients.

He also fraudulently indicated that his patients suffered from cancer pain when they did not in order to secure insurance approvals for Subsys, prosecutors said.

Under a plea agreement, Rosenberg agreed to pay $754,736 in restitution to healthcare benefit programs. He faces a maximum prison sentence of 15 years and is scheduled to be sentenced on Jan. 16.

Rosenberg’s lawyer did not respond to a request for comment. Chandler, Arizona-based Insys in a statement said it has “taken necessary and appropriate steps to prevent past mistakes from happening in the future.”

The investigations into Insys have come during a national epidemic of opioid abuse. According to the U.S. Centers for Disease Control and Prevention, opioids were involved in more than 33,000 deaths in 2015. The death rate has continued to rise, according to estimates.

In December, federal prosecutors in Boston charged six former Insys executives and managers, including ex-Chief Executive Michael Babich, with engaging in a scheme to bribe doctors to prescribe Subsys and defraud insurers.

All six have pleaded not guilty. Federal charges have also been filed in several other states against other ex-Insys employees and medical practitioners who prescribed Subsys.

Insys has been in settlement talks with the U.S. Justice Department. It said on Wednesday it is working “with relevant authorities to resolve issues related to the misdeeds of former employees.”

Insys also faces lawsuits by attorneys general in Arizona and New Jersey. It previously paid $9.45 million to resolve investigations by attorneys general in Oregon, New Hampshire, Illinois and Massachusetts.

The case is U.S. v. Rosenberg, U.S. District Court, District of Rhode Island, No. 17-cr-00009.

(Reporting by Nate Raymond in Boston; Editing by Matthew Lewis)

Trump to issue emergency declaration next week on opioids

Trump to issue emergency declaration next week on opioids

WASHINGTON (Reuters) – U.S. President Donald Trump said on Wednesday he would declare next week a national emergency on opioid abuse, a move that could give states access to federal funds to fight the drug crisis.

The United States is battling a surge in opioid-related deaths, including 33,000 lives lost in 2015, more than any year on record, according to federal data.

“The opioid is a tremendous emergency,” Trump told Fox Business Network. “Next week, I’m going to (be) declaring an emergency, (a) national emergency on drugs.”

Trump is expected to provide a preview of his plans for tackling drug demand and the opioid crisis in remarks on Thursday.

Trump said in August that he would declare opioid abuse a national emergency.

Opioids, primarily prescription painkillers, heroin and fentanyl – a drug 50 to 100 times more powerful than morphine – are fueling the drug overdoses.

The declaration by Trump could help unlock more support and resources to address the drug overdose epidemic, such as additional funding and expanded access to various forms of treatment, and it gives the government more flexibility in waiving rules and restrictions to expedite action.

(Reporting by Jason Lange; Editing by Peter Cooney)

Washington state sues OxyContin maker Purdue Pharma

Kentucky accuses Endo of contributing to opioid epidemic

By Nate Raymond

(Reuters) – Washington state on Thursday sued OxyContin maker Purdue Pharma LP, becoming the latest state or local government to file a lawsuit seeking to hold pharmaceutical companies accountable for a national opioid addiction epidemic.

The city of Seattle also filed a separate lawsuit against Purdue as well as units of Teva Pharmaceutical Industries Ltd, Johnson & Johnson, Endo International Plc and Allergan plc.

The lawsuit by Washington Attorney General Bob Ferguson accused Purdue of deceptive marketing of OxyContin and convincing doctors and the public that its drugs had a low-risk of addiction and were effective for treating chronic pain.

He said he would be seeking to force Purdue to pay a “significant” sum for engaging in marketing practices that downplayed the addictiveness of its drugs, allowing it to earn billions of dollars while fuelling the opioid crisis.

“I don’t know how executives at Purdue sleep at night,” Ferguson told reporters.

Stamford, Connecticut-based Purdue said in a statement it was “deeply troubled” by the opioid crisis and that its U.S. Food and Drug Administration-approved products account for just 2 percent of all opioid prescriptions.

“We vigorously deny these allegations and look forward to the opportunity to present our defense,” Purdue said.

According to the U.S. Centers for Disease Control and Prevention, opioids were involved in over 33,000 deaths in 2015, the latest year for which data is available. The death rate has continued rising, according to estimates.

The lawsuits followed a wave of cases against opioid manufacturers and distributors by Louisiana, West Virginia, New Mexico, Oklahoma, Mississippi, Ohio, Missouri, New Hampshire and South Carolina, as well as several cities and counties.

Purdue and three executives pleaded guilty in 2007 to federal charges related to the misbranding of OxyContin, which is used to relieve pain, and agreed to pay a total of $634.5 million to resolve a U.S. Justice Department probe.

That year, the privately held company also reached a $19.5 million settlement with 26 states and the District of Columbia. It had agreed in 2015 to pay $24 million to resolve a lawsuit by Kentucky.

In filing his lawsuit in King County Superior Court in Seattle on Thursday, Ferguson said he was breaking off from an ongoing multi-state probe by various attorneys general into companies that manufacture and distribute opioids.

While Ferguson said looked forward to seeing its results, “we felt we had a case ready to go.”

(Reporting by Nate Raymond in Boston; Editing by Susan Thomas and Tom Brown)

Unbudgeted: How the opioid crisis is blowing a hole in small-town America’s finances

Unbudgeted: How the opioid crisis is blowing a hole in small-town America's finances

By Paula Seligson and Tim Reid

INDIANA, Pa./CHILLICOTHE, Ohio (Reuters) – As deaths mount in America’s opioid crisis, communities on the front lines face a hidden toll: the financial cost.

Ross County, a largely rural region of 77,000 people an hour south of Columbus, Ohio, is wrestling with an explosion in opioid-related deaths – 44 last year compared to 19 in 2009. The drug addiction epidemic is shattering not just lives but also stressing the county budget.

About 75 percent of the 200 children placed into state care in the county have parents with opioid addictions, up from about 40 percent five years ago, local officials say. Their care is more expensive because they need specialist counseling, longer stays and therapy.

That has caused a near doubling in the county’s child services budget to almost $2.4 million from $1.3 million, said Doug Corcoran, a county commissioner.

For a county with a general fund of just $23 million, that is a big financial burden, Corcoran said. He and his colleagues are now exploring what they might cut to pay for the growing costs of the epidemic, such as youth programs and economic development schemes.

“There’s very little discretionary spending in our budget to cut. It’s really tough,” Corcoran said.

Cities, towns and counties across the United States are struggling to deal with the financial costs of a drug addiction epidemic that killed 33,000 people in 2015 alone, data and interviews with more than two dozen local officials and county budget professionals shows. (For graphics on the opioid crisis click here: http://tmsnrt.rs/2hO4YC7)

The interviews and data provide one of the first glimpses into the financial impact on local governments but it is far from complete because there is no central database collating information from counties and states. So, the true scale is still mostly hidden from view.

Opioids, primarily prescription painkillers, heroin and fentanyl – a drug 50 to 100 times more powerful than morphine – are fueling the drug overdoses.

President Donald Trump last month called the epidemic a “national emergency” but has not yet made an official national emergency declaration. Such a move would give states access to federal funds to fight it.

BUILDING A PICTURE

Counties grappling with rising overdoses face higher costs in emergency call volumes, medical examiner and coroner bills, and overcrowded jails and courtrooms, said Matt Chase, executive director of the National Association of Counties, which represents 3,069 county and local governments.

At his group’s July annual meeting, a presentation where county officials shared tips on tackling the opioid crisis, and the budget problems the crisis is triggering, played to a packed room, Chase said.

The organization is in the early stage of collecting information to build a more complete picture of the financial impact of the crisis on county budgets, Chase said.

Indiana County, Pennsylvania, a mountainous, predominantly rural region, provides a snapshot of how the crisis is stressing local services and budgets.

Its county seat, the borough of Indiana, is home to a modern college campus and a main street lined by restaurants and American flags. Yet beneath its outward tranquility, the opioid epidemic is everywhere, said David Rostis, an undercover detective and head of the county’s drug task force.

On a recent ride-along in Rostis’ car, he points to a building where a doctor used to sell opioid prescriptions for sex; a large, affluent home where a teenager died of an overdose; a trail where a drug-related killing recently occurred; and the local gas station where a woman recently overdosed and died in her car while people passed by.

In 2016, the county’s drug overdose death rate was 50.6 deaths per 100,000, compared to the state average of 36.5.

Autopsy and toxicology costs there have nearly doubled in six years, from about $89,000 in 2010 to $165,000 in 2016, county data shows.

Court costs are soaring, mainly because of the expense of prosecuting opioid-related crimes and providing accused with a public defender, local officials say.

The county is using contingency funds to pay for the added coroner costs, said Mike Baker, the county’s top government official. Last year, the county drew $63,000 from those funds, up from $19,000 in 2014, he said. In 2014, the county saw 10 drug-related deaths. In 2016, the number had grown to 53.

In Mercer County, West Virginia, 300 miles (483 km) to the south of Indiana County, opioid-related jail costs are carving into the small annual budget of $12 million for the community of 62,000 people.

The county’s jail expenses are on course to increase by $100,000 this year, compared to 2015. The county pays $48.50 per inmate per day to the jail, and this year the jail is on course to have over 2,000 more “inmate days” compared to 2015, according to county data.

“At least 90 percent of those extra jail costs are opioid-related,” said Greg Puckett, a county commissioner who sits on a national county opioid task force. “We spend more in one month on our jail bill than we spend per month on economic development, our health department and our emergency services combined.”

West Virginia has been on the front line of the opioid crisis. In 2015, the state led the nation in drug overdose death rates for the third consecutive year. Preliminary numbers for 2016 recorded 883 drug overdose deaths, with 755 involving at least one opioid, up from 629 total deaths in 2014.

AUTOPSIES INC.

Few know the opioid crisis like the father-son duo Sidney and Curtis Goldblatt. The pair run two companies, ForensicDx for autopsies and MolecularDx for drug testing, out of Windber, Pennsylvania. Together they conduct autopsies for 10 Pennsylvania counties, including Indiana, charging between $2,000 and $3,000 per body.

In 2014, overdoses represented about 40 percent of the deaths they handled, the Goldblatts said. Last year, that shot up to 62 percent. Goldblatt senior has been performing autopsies for 50 years and says he has never seen anything on the scale of the current epidemic. When he started, a drug overdose was rare.

The pair opened ForensicDx in 2014 with a staff of three, serving only three counties. That’s grown to seven staff and 10 counties, mainly to meet demand from drug-related deaths, the Goldblatts said.

Indiana County’s ambulance service is also under financial stress because of the opioid crisis. The county’s primary ambulance provider, Citizens’ Ambulance Service, has lost more than $100,000 since 2016 alone on opioid calls, said Randy Thomas, director of operations.

The non-profit is reimbursed only if an opioid overdose patient is transported to the hospital. It doesn’t get paid for successfully treating people who have overdosed but then refuse to go to the hospital, Thomas said.

People brought back from the brink of death after a dose of the life-saving drug naloxone, also known as Narcan, often awake angry and combative and refuse hospitalization, Thomas said.

As costs related to the opioid epidemic increase, Indiana County commissioner Baker isn’t sure what will happen next. Unless the state or federal government intervene, the county will have to either cut services or increase taxes, Baker said.

“This has introduced an entirely different metric, an entirely different level of unpredictability in budgeting,” he said.

For all the budget problems Baker faces because of the crisis, the human toll is what distresses him most. Last fall, Baker’s nephew died of a fentanyl overdose. He was 23. Talking about his nephew’s death, Baker pauses to collect his thoughts.

“It is a most painful and difficult experience and I wouldn’t wish it on anyone in the world,” he said.

(Editing by Jason Szep and Ross Colvin)

Trump vows to ‘win’ against opioid epidemic

Paramedics display a dose of the opioid overdose reversal drug Narcan, or Naloxone Hydrochloride, in an ambulance in Peabody, Massachusetts, U.S., August 8, 2017. REUTERS/Brian Snyder

By James Oliphant

BRIDGEWATER, N.J. (Reuters) – President Donald Trump promised to win the fight against a U.S. epidemic of opioid drug use, but offered no new steps to do so and did not act on a recommendation made by a presidential commission that he declare a national emergency.

Trump spoke at an event he had billed as a “major briefing” on the opioid crisis during a two-week “working vacation” at his private golf club in New Jersey. He also used the appearance to unexpectedly issue a stern warning to North Korea over its threats to the United States.

The Republican president said the United States has no alternative but to stem spreading opioid use, but more than six months into his presidency announced no new policies to combat a public health crisis that kills more than 100 Americans daily.

“I’m confidant that by working with our healthcare and law enforcement experts we will fight this deadly epidemic and the United States will win,” Trump told reporters. “We’re also very, very tough on the southern border where much of this comes in, and we’re talking to China, where certain forms of man-made drug comes in, and it is bad.”

U.S. Health and Human Services Secretary Tom Price said the administration was still working to devise “a comprehensive strategy” to be presented to Trump “in the near future.”

A commission created by Trump to study opioid abuse urged him last week to declare a national emergency to address what it called an opioids crisis, framing its death toll in the context of the Sept. 11, 2001, attacks on the United States. An emergency declaration could free up federal resources for the effort.

“The resources that we need or the focus that we need to bring to bear to the opioid crisis at this point can be addressed without the declaration of an emergency, although all things are on the table for the president,” Price told a later news briefing.

According to the U.S. Centers for Disease Control and Prevention, opioids were involved in more than 33,000 U.S. deaths in 2015, the latest year for which data is available, and estimates show the death rate has continued rising.

The commission, headed by Republican New Jersey Governor Chris Christie, recommended steps such as waiving a federal rule that restricts the number of people who can get residential addiction treatment under the Medicaid healthcare program for the poor and disabled.

The commission cited government data showing that since 1999 U.S. opioid overdoses have quadrupled, adding that nearly two thirds of U.S. drug overdoses were linked to opioids such as heroin and the powerful painkillers Percocet, OxyContin and fentanyl.

‘THE LOSING SIDE’

Speaking alongside Price, White House senior counselor Kellyanne Conway said, “We are a nation that consumes legal and illegal drugs at a very high and alarming rate. The problem is very complicated, and currently we are on the losing side of this war.”

Conway said the crisis cannot be solved overnight, and that “most of the great work is being done at the state and local levels.” Conway called it a “nonpartisan issue in search of bipartisan support and bipartisan solutions.”

Even before Trump’s event, the Democratic National Committee slammed him, with spokesman Daniel Wessel saying in a statement: “Trump promised he’d come to the aid of communities ravaged by the opioid epidemic, but so far he’s done nothing for them.”

Trump’s initial federal budget called for a 2 percent increase in drug treatment programs and would provide funds to increase border security to stop the flow of drugs into the country.

Substance abuse treatment activists have criticized his proposed cuts to federal prevention and research programs as well as his calls to shrink Medicaid, which covers drug treatment for hundreds of thousands of Americans.

Officials from New Hampshire criticized Trump last week after a leaked transcript of a January conversation with Mexican President Enrique Pena Nieto showed Trump had called the New England state, hard-hit by the opioid epidemic, a “drug-infested den.”

New Hampshire sued OxyContin maker Purdue Pharma LP on Tuesday, joining several state and local governments in accusing the drugmaker of engaging in deceptive marketing practices that helped fuel opioid addiction.

The lawsuit followed similar ones against Purdue and other drugmakers by Oklahoma, Mississippi, Ohio and Missouri and several cities and counties in California, Illinois, Ohio, Oregon, Tennessee and New York.

Price said Trump’s administration was taking no position on such suits.

(Reporting by Doina Chiacu and James Oliphant; Additional reporting by Eric Beech, Yasmeen Abutaleb and Susan Cornwell; Writing by Alistair Bell and Kevin Drawbaugh; Editing by Will Dunham)

Trump plans ‘major briefing’ on opioid crisis

Paramedics display a dose of the opioid overdose reversal drug Narcan, or Naloxone Hydrochloride, in an ambulance in Peabody, Massachusetts, U.S., August 8, 2017. REUTERS/Brian Snyder

By James Oliphant

BRIDGEWATER, N.J. (Reuters) – President Donald Trump has scheduled what he called a “major briefing” for Tuesday on the epidemic of opioid drug use in the United States, a health crisis that kills more than 100 Americans daily.

In the midst of a two-week getaway at his golf club in New Jersey, Trump will meet with Health and Human Services Secretary Tom Price to discuss the matter. Trump frequently mentioned the opioid crisis as a presidential candidate, but has given it less public attention since taking office in January.

A commission created by Trump to study the matter urged him last week to declare a national emergency to address what it called a crisis involving the epidemic use of opioids, framing its death toll in the context of the Sept. 11, 2001, attacks on the United States.

The commission, headed by Republican New Jersey Governor Chris Christie, recommended a series of steps Trump could take on his own without Congress. It called for waiving a federal rule that restricts the number of people who can receive residential addiction treatment under the Medicaid healthcare program for the poor and disabled.

According to the U.S. Centers for Disease Control and Prevention, opioids were involved in more than 33,000 U.S. deaths in 2015, the latest year for which data is available, and estimates show the death rate has continued rising. Price has called the epidemic one of his agency’s top priorities.

The commission cited government data showing that since 1999 U.S. opioid overdoses have quadrupled, adding that nearly two thirds of U.S. drug overdoses were linked to opioids such as heroin and the powerful painkillers Percocet, OxyContin and fentanyl.

“With approximately 142 Americans dying every day, America is enduring a death toll equal to Sept. 11 every three weeks,” commission members wrote in a report. “Your declaration would empower your cabinet to take bold steps and would force Congress to focus on funding and empowering the executive branch even further to deal with this loss of life.”

So far, the White House has given no indication Trump will adopt the panel’s recommendations.

The Republican president’s initial federal budget called for a 2 percent increase in drug treatment programs and would provide funds to increase border security to stop the flow of drugs into the country.

Substance abuse treatment activists have criticized his proposed cuts to federal prevention and research programs as well as his calls to shrink Medicaid, which covers drug treatment for hundreds of thousands of Americans.

Preserving funds to confront the opioid epidemic emerged as a sticking point in congressional efforts to repeal the Affordable Care Act this year.

Republican legislation in the Senate to dismantle the Obamacare healthcare law included $45 billion for fighting the opioid epidemic, on top of the $2 billion in an earlier version of the bill, but the measure was defeated last month.

Trump is away from Washington until later this month while the White House is undergoing renovations. He and his aides have said he is maintaining a daily working schedule. Tuesday’s meeting with Price marks his first public event in days.

“I will be holding a major briefing on the Opioid crisis, a major problem for our country, today at 3:00 P.M. in Bedminster, N.J.,” Trump wrote on Twitter.

Even before the event, the Democratic National Committee slammed Trump, with spokesman Daniel Wessel saying in a statement: “Trump promised he’d come to the aid of communities ravaged by the opioid epidemic, but so far he’s done nothing for them.”

Officials from New Hampshire criticized Trump last week after a leaked transcript of a January conversation with Mexican President Enrique Pena Nieto showed that Trump had called the New England state, hard-hit by the opioid epidemic, a “drug-infested den.”

A study published on Monday in the American Journal of Preventive Medicine and led by University of Virginia researchers found that official figures issued by states on deaths caused by opioid and heroin overdoses were substantially under-reported.

The researchers examined death certificates dating from 2008 to 2014 and found that national mortality rates for opioids were 24 percent above previously reported data, and the heroin mortality rate was 22 percent higher.

(Reporting by Doina Chiacu and James Oliphant; Additional reporting by Yasmeen Abutaleb and Susan Cornwell; Editing by Will Dunham)

U.S. Senate joins House to pass sweeping new health bill

A participant prepares to receive an antibody infusion of a drug that is part of a clinical trial for a functional HIV cure at the National Institutes of Health in Bethesda, Maryland, U.S. November 22, 2016 in this still image from video.

By Toni Clarke

(Reuters) – The U.S. Senate voted overwhelmingly on Wednesday to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.

It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine.

Two years in the making, the 21st Century Cures Act was passed last week by the House of Representatives and will now go to President Barack Obama to sign into law. Supporters say it will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.

“For the second consecutive year, the Senate is sending the President another Christmas miracle for his signature,” Senator Lamar Alexander, a Republican from Tennessee said in a statement. “Last year, it was the Every Student Succeeds Act, and this time, it’s the 21st Century Cures Act — a bill that will help virtually every American family.”

Critics of the legislation say it gives massive handouts to the pharmaceutical industry and will lower standards for drug and medical device approvals.

“This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” consumer watchdog Public Citizen said in a statement.

Democratic Senator Elizabeth Warren was among the handful of senators who voted against the bill, as was independent senator and former Democratic presidential candidate Bernie Sanders. Each decried what they described as big handouts to the pharma industry. Even so the bill passed 94-5. The House passed it by a vote of 392-26.

The $6.3 billion act, sponsored by Republican Representative Fred Upton, authorizes $4.8 billion for the National Institutes of Health and $500 million to the Food and Drug Administration.

It also calls for $1 billion over two years to battle the opioid epidemic. On Tuesday the Drug Enforcement Administration issued a report showing that in 2014 about 129 people died every day as a result of drug poisoning. Of those, 61 percent are opioid or heroin related.

“Opioids such as heroin and fentanyl – and diverted prescription pain pills – are killing people in this country at a horrifying rate,” Acting Administrator Chuck Rosenberg said. “We face a public health crisis of historic proportions.”

The bill also calls for $1.8 billion in funding for Vice President Joseph Biden’s Cancer Moonshot initiative designed to bolster cancer research by reducing bureaucracy and promoting research collaboration.

Critics note that the money described in the bill must be appropriated by separate funding bills and that the money may ultimately never materialize. Yet the changes to the clinical trial process, something long sought by the drug industry, will be set in stone regardless of whether money for the research projects is forthcoming.

Among those changes: Greater prominence will be given to “real world” evidence gathered outside the framework of a randomized, controlled clinical trial, the gold standard for determining whether a drug is safe and effective. Such evidence could be much easier for drug companies to collect.

“The passing of 21st Century Cures Act is a show of extraordinary bipartisan unity after a divisive election that should be celebrated,” said Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research.

Under the Act patient input will be formally incorporated into the FDA’s drug review process.

Funding for the Act will be offset by reductions in some Medicaid payments and through the sale of oil from the Strategic Petroleum Reserve. The White House supports the bill but said earlier it was concerned that draining the Petroleum Reserve “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”

(Reporting by Toni Clarke in Washington; editing by Leslie Adler and Tom Brown)