Republicans fail again to kill off Obamacare in Senate

WASHINGTON (Reuters) – U.S. Republicans on Tuesday fell short yet again in their seven-year drive to repeal Obamacare, in a bitter defeat that raises more questions about their ability to enact President Donald Trump’s agenda.

The party was unable to win enough support from its own senators for a bill to repeal the 2010 Affordable Care Act and decided not to put it to a vote, several Republicans said. The bill’s sponsors vowed to try again, but face steeper odds after Sunday, when special rules expire that allow them to pass healthcare legislation without Democratic support.

“We basically ran out of time,” said Senator Ron Johnson, a co-sponsor of the measure with Senators Bill Cassidy, Lindsey Graham and Dean Heller.

Republicans have now repeatedly failed to deliver on their longtime promise to roll back former Democratic President Barack Obama’s signature domestic accomplishment.

They have yet to achieve any major domestic policy successes in Congress this year, which could hurt their efforts to retain control of the Senate and House of Representatives in the November 2018 congressional elections.

Republicans widely view Obamacare, which provides coverage to 20 million Americans, as a costly government overreach. Trump vowed frequently during the 2016 election campaign to scrap it. Democrats have fiercely defended it, saying it has extended health insurance to millions.

After falling short in July, Senate Republicans tried again this month with a bill that would have given states greater control over the hundreds of billions of dollars that the federal government spends annually on health care.

As before, they ran into objections from members on the right and the center who opposed repeal for essentially opposite reasons.

Senator Susan Collins, a moderate, complained it undermined the Medicaid program for the poor and weakened consumer protections. Senator Rand Paul, a conservative, said it left too many of Obamacare’s regulations and spending programs in place.

Democrats said it was time for Republicans to work with them to fix Obamacare’s shortcomings, and Republican Senator Lamar Alexander said he would resume talks with Democratic Senator Patty Murray to shore up the law’s insurance subsidies.

Shares of healthcare providers ended broadly higher. Hospital company HCA Healthcare Inc rose 1.8 percent, while insurer Centene Corp, which focuses on Medicaid, rose 2.2 percent.

Senate Majority Leader Mitch McConnell, accompanied by (L-R) Sen. Lindsey Graham (R-SC), Sen. John Barrasso (R-WY), Sen. John Thune (R-SD), Sen. Bill Cassidy (R-LA) and Sen. John Cornyn (R-TX), speaks with reporters following the party luncheons on Capitol Hill in Washington, U.S., September 26, 2017. REUTERS/Aaron P. Bernstein

The insurance industry, hospitals, medical advocacy groups such as the American Medical Association, American Heart Association and American Cancer Society, the AARP advocacy group for the elderly and consumer activists opposed the latest bill.

TRUMP DISAPPOINTED

Trump said on Tuesday his administration was disappointed in “certain so-called Republicans” who did not support the bill. The Republican president said later he still had not given up hope that the law would eventually be repealed. “It’ll happen,” he told reporters while traveling to New York for a fundraiser.

Republicans hold a slim 52-48 majority in the Senate and

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at least three senators – Collins, Paul and John McCain of Arizona – had publicly rejected the bill.

Republicans crafted special rules earlier this year that allowed them to pass a bill with a simple majority in the 100-seat chamber. After those rules expire at the start of the new fiscal year on Sunday, they will need at least 60 votes to advance most legislation.

John Thune, a member of the Republican leadership in the Senate, said the party would likely not try to undo Obamacare again until it was clear there were enough votes for it. He said the party would now focus on overhauling the U.S. tax code – another complex undertaking that could meet with stiff resistance from a wide range of interest groups.

A CBS poll on Monday showed 52 percent of Americans disapproved of the Graham-Cassidy healthcare bill, while 20 percent approved.

“I will readily admit that the Republican Party has done a bad job of explaining what we’re for in terms of replace on Obamacare,” Republican Senator Ben Sasse said on the Senate floor.

Six protesters staged a “die-in” on the floor of a Senate office building, lying on the ground and covering their heads and bodies with a white shroud to represent what they said would be lives lost if the bill passed.

The non-partisan Congressional Budget Office said the number of people with health insurance covering high-cost medical events would be slashed by millions if the latest Republican bill had it become law.

The CBO also found that federal spending on Medicaid would be cut by about $1 trillion from 2017 to 2026 and that millions of people would lose their coverage in the program, mainly from a repeal of federal funding for Obamacare’s Medicaid expansion.

Additional reporting by Richard Cowan, Amanda Becker Yasmeen Abutaleb and Susan Heavey in Washington and Jeff Mason and Lewis Krauskopf in New York; Writing by Andy Sullivan and Alistair Bell; Editing by Bill Trott and Peter Cooney

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Trump ‘not happy’ with U.S. health chief Price over private travel

WASHINGTON (Reuters) – U.S. President Donald Trump said on Wednesday he was “not happy” with Health and Human Services Secretary Tom Price amid reports he used expensive private charter jets to travel for government business rather than cheaper commercial flights.

Asked if he would fire Price, Trump told reporters, “We’ll see.”

The House of Representatives Oversight and Government Reform Committee opened an investigation this week into travel by top U.S. officials.

Asked if he had confidence in Price after the reports on his travel, Trump said, “I am looking at that very closely. I am not happy with it. I will tell you I am not happy with it.”

Price has taken at least two dozen charter flights since May at a cost to U.S. taxpayers of about $300,000, according to Politico, which first reported the travel.

On Friday, the HHS inspector general “is conducting a review of Secretary Price’s government travel using chartered aircraft. The review focuses on whether the travel complied with Federal Travel Regulations, but may encompass other issues related to the travel,” said Tesia Williams, a spokeswoman for the inspector general’s office.

As a U.S. lawmaker in 2009, Price chastised “the fiscal irresponsibility” of private plane use by government officials in an appearance on CNBC television that he also posted on Twitter.

Another top official, Treasury Secretary Steve Mnuchin, is facing scrutiny over his use of a government plane to fly to Kentucky for a visit to Louisville and Fort Knox in Kentucky.

Mnuchin and his wife viewed the solar eclipse during the trip.

Reporting by Jeff Mason; Writing by Susan Heavey and Eric Walsh; Editing by James Dalgleish and Jeffrey Benkoe

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Existing drugs may be able to improve therapy for chronic myeloid leukemia, mice study shows

September 26, 2017

Two drugs, already approved for safe use in people, may be able to improve therapy for chronic myeloid leukemia (CML), a blood cancer that affects myeloid cells, according to results from a University of Iowa study in mice.

CML is a relatively common cancer. The American Cancer Society estimates that in 2017 there will be about 8,950 new cases and about 1,080 people will die of the disease.

In its initial, chronic stage, CML is relatively easy to treat. Drugs called tyrosine kinase inhibitors (TKIs) are generally successful at controlling the cancer. However, patients need to continue the expensive treatment for their lifetime. In some cases, even with that treatment, the cancer can progress to a more advanced stage that is no longer controlled.

One reason for this, explains Hai-Hui (Howard) Xue, MD, PhD, UI professor of microbiology and immunology, is that there are two kinds of tumor cells-;bulk leukemia cells that can be killed by TKI drugs, and a subset of cells called leukemia stem cells, which are resistant to TKIs and to chemotherapy.

“A successful treatment is expected to kill the bulk leukemia cells and at the same time get rid of the leukemic stem cells. Potentially, that could lead to a cure,” says Xue, who is senior author of the study published in the September issue of the journal Cell Stem Cell as the cover story.

With that goal in mind, Xue and his team joined forces with Chen Zhao, MD, PhD, UI assistant professor of pathology, and used their understanding of CML genetics to look for small molecules or drug compounds that might be able to eradicate the leukemia stem cells.

Focusing on two proteins known as transcription factors, the researchers showed that genetically removing the two transcription factors, Tcf1 and Lef1, in mice is sufficient to prevent leukemia stem cells from persisting. Importantly, this genetic alteration did not affect normal hematopoietic (blood) stem cells.

Next the researchers used an informatics method called connectivity maps to identify drugs or small molecules that can replicate the gene expression pattern that occurs when the two transcription factors are removed. This screening test identified a drug called prostaglandin E1 (PGE1).

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The team tested a combination of PGE1 and the TKI drug called imatinib in a mouse model of CML. The mice lived longer than control mice; 30 percent lived longer than 80 days compared to mice treated with only imatinib, all of which died within 60 days.

The team also looked at a different mouse model of CML, where human CML cells were transplanted into an immunocompromised mouse. When the mice received no treatment or were treated with imatinib alone, the human leukemia stem cells propagated and grew to relatively large numbers. In contrast, when the animals were treated with a combination of imatinib and PGE1, those numbers were greatly reduced, and mice did not develop leukemia.

“The results are a pleasant surprise,” says Xue who also is a member of Holden Comprehensive Cancer Center at the UI. “We do these kinds of genetic studies all the time- looking at transcription factors and what they do. This is a good opportunity to connect what we do at the bench to something that could be useful clinically.”

Investigating how the PGE1 works to suppress the leukemia stem cells, the team found that the effect relies on a critical interaction between PGE1 and its receptor EP4. They then tested the effect of a second drug molecule called misoprostol, which also interacts with EP4, and showed that misoprostol also has the ability to combine with TKI and significantly reduce the number of leukemia stem cells.

Both PGE1 and misoprostol are currently approved by the FDA for use in people. PGE1 is an injectable drug that is used to treat erectile dysfunction. Misoprostol is a pill that is used to treat ulcers.

“We would like to be able to test these compounds in a clinical trial,” Xue says. “If we could show that the combination of TKI with PGE1, or misoprostol, can eliminate both the bulk tumor cells and the stem cells that keep the tumor going, that could potentially eliminate the cancer to the point where a patient would no longer need to depend on TKI.”

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Nowhere To Go: Young People With Severe Autism Languish In Hospitals

Teenagers and young adults with severe autism are spending weeks or even months in emergency rooms and acute-care hospitals, sometimes sedated, restrained or confined to mesh-tented beds, a Kaiser Health News investigation shows.

These young people — who may shout for hours, bang their heads on walls or lash out violently at home — are taken to the hospital after community social services and programs fall short and families call 911 for help, according to more than two dozen interviews with parents, advocates and physicians in states from Maine to California.

There, they wait for beds in specialized programs that focus on treating people with autism and other developmental disabilities, or they return home once families recover from the crisis or find additional support.

Sixteen-year-old Ben Cohen spent 304 days in the ER of Erie County Medical Center in Buffalo. His room was retrofitted so the staff could view him through a windowpane and pass a tray of food through a slot in a locked door. His mother, who felt it wasn’t safe to take him home, worried that staff “were all afraid of him … [and] not trained on his type of aggressive behaviors.”

The hospital “is the incredibly wrong place for these individuals to go in the beginning,” said Michael Cummings, the Buffalo facility’s associate medical director and a psychiatrist who worked on Ben’s case. “It’s a balancing act of trying to do the … least harm in a setting that is not meant for this situation.”

Ben Cohen (Courtesy of Mary Cohen)

Nationally, the number of people with an autism diagnosis who were seen in hospital ERs nearly doubled from 81,628 in 2009 to 159,517 five years later, according to the latest available data from the federal Agency for Healthcare Research and Quality. The number admitted also soared, from 13,903 in 2009 to 26,811 in 2014.

That same year, California’s state health planning and development department recorded acute-care hospital stays of at least a month for 60 cases of patients with an autism diagnosis. The longest were 211 and 333 days.

The problem parallels the issue known as psychiatric boarding, which has been an increasing concern in recent years for a range of mental illnesses. Both trace to the shortcomings of deinstitutionalization, the national movement that aimed to close large public facilities and provide care through community settings. But the resources to support that dwindled long ago, and then came the Great Recession of 2008, when local, state and federal budget woes forced sharp cuts in developmental and mental health services.

“As more children with autism are identified, and as the population is growing larger and older, we see a lot more mental health needs in children and adolescents with autism,” explained Aaron Nayfack, a developmental pediatrician at Sutter Health’s Palo Alto Medical Foundation in California who has researched the rise in lengthy hospitalizations. “And we have nowhere near the resources in most communities to take care of these children in home settings.”

James Cordone, 11, left the group home where he lives on July 9 to visit his family’s home nearby in Cheektowaga, N.Y. Cordone was hospitalized for seven weeks in 2015 after his family grew unable to quell his rages. (Nancy J. Parisi for KHN)

So, families struggle — with waiting lists for programs, low pay for government-supported in-home help and backlogged or ineffective crisis support. Often they’ve faced some of these challenges for years. Autism is a neurodevelopmental disorder typically diagnosed at a young age and characterized by impaired communication, difficulty with social interaction and repetitive behaviors that fall along a spectrum of mild to severe.

Adolescents and young adults with severe autism may still have the mental age of a child, and short-term care to stabilize those in crisis who are nonverbal or combative is practically nonexistent. Longer-term care can be almost as hard to find. It must be highly specialized, usually involving intensive behavioral therapy; someone with severe autism gets little benefit from traditional psychiatric services.

General hospitals “are not really equipped to handle someone who is autistic,” said Mark De Antonio, director of adolescent inpatient services at Resnick Neuropsychiatric Hospital in Los Angeles. Several times a month, he said, he hears about patients with no immediate care options being medicated and sedated as they’re held. “It’s a huge problem.”

Alex Sanok (Courtesy of Ann Sanok and Geskus Photography)

In New Hampshire this summer, 22-year-old Alex Sanok spent a month in Exeter Hospital after he became violent at home, breaking windows and hurling objects at walls. His mother called 911, and paramedics spent half an hour trying to calm him before restraining him.

At the hospital, his wrists and ankles were strapped to an ER bed for the first week, and he spent several more weeks in a private room before he could be transferred, according to his mother, Ann Sanok. State agencies that handle developmental disabilities and mental health offered little help, she said.

As the days passed, she said, she and her husband wondered: “What if [Alex] escalates again, what are we doing to do? We were getting no answers. Everyone seemed to kick the can down the road.”

Exeter Hospital said in a statement that its policy is not to use restraints unless there is an “imminent threat to patient or staff safety” and that any use is reviewed hourly. Sanok was moved in June to a special-needs residential school in Massachusetts, where his mother said he is doing well.

The federal government does no routine tracking of how autism is treated in ERs, but many experts say the problem of lengthy and inappropriate stays is nationwide and growing. Kaiser Health News identified some of the more extreme cases through interviews with autism and disability advocates, physicians and families in California, New Hampshire, New York and six other states: Arizona, Connecticut, Maine, Maryland, Michigan and Rhode Island.

Nancy Pineles, a managing attorney with the nonprofit group Disability Rights Maryland, said a group home took one young adult to a Baltimore ER earlier this year after he hit a staff member. And that’s where he remained for several weeks before the hospital moved him to a room in its hospice wing, she said — not because he was dying, but because there was nowhere else for him to go.

Such cases have been “on the increase,” Pineles said. “People with autism and more intense behavioral needs are just being frozen out.”

In Connecticut, the head of the state’s Office of the Child Advocate told lawmakers during a hearing on disability issues in May that the problem had reached a “crisis” level.

Private-insurance data underscore the concerns. In a study published in February in the Journal of Autism and Developmental Disorders, researchers from Pennsylvania State University found that young people ages 12 to 21 with autism are four times more likely to go to the emergency room than peers without autism. Once there, they are 3½ times more likely to be admitted to a hospital floor — at which point they stay in the hospital nearly 30 percent longer.

The analysis, based on a sample of 87,000 insurance claims, also showed that older adolescents with autism are in the ER more than their younger counterparts. The percentage of their visits associated with a mental health crisis almost doubled from 2005 to 2013.

“You’re looking at an increase in unmet need,” said Nayfack, who with Stanford University colleagues documented a similar trend from 1999 to 2009 in hospital admissions for young Californians with autism. By contrast, they found, hospitalization rates held steady during that decade for children and teens with Down syndrome, cerebral palsy and other diagnoses.

Tyler Stolz, a 26-year-old woman with autism and a seizure disorder, was stabilized after a few weeks in a Sacramento hospital, yet she remained there 10 months, according to Disability Rights California, an advocacy group that described her case in its 2015 annual report.

Ultimately, Mercy San Juan Medical Center went to court to demand that Stolz’s public guardian move her. The court filing noted that Stolz “previously harmed hospital staff” and that “a security officer is posted to the patient’s room 24/7.”

Although her conditions no longer required her hospitalization, they still “represent dangers to defendant and possibly to others if she were discharged to the community,” the facility contended. “There is no safe place for the client to go.”

The advocacy nonprofit helped place Stolz at a Northern California center that offered intensive behavioral therapy, recounted Katie Hornberger, its director of clients’ rights. The medical center did not respond to a request for comment, but two years after an investigator found Stolz in a bed covered by a mesh tent, the case remains vivid in Hornberger’s mind.

“I don’t believe we put people in cages,” she said.

New York Stands Out

Some of the longest hospital stays in the nation, averaging 16.5 days, occur in New York state.

James Cordone, 11, spent seven weeks in a Buffalo, N.Y., children’s hospital in a tent-like bed, with a hospital receptionist or instrument sterilization tech in his room at all times, his mother said. The difficulty families like hers face is “the dirty little secret no one wants to talk about.”

Debbie Cordone embraces her son, James, who she said benefited tremendously from intensive behavioral therapy at the Kennedy Krieger Institute in Baltimore. (Nancy J. Parisi for KHN)

Debbie Cordone of Cheektowaga, N.Y., was a retired police dispatcher who had raised her own children when she and her husband adopted James as a toddler. Diagnosed with autism at 3, James was a boy with a bright smile who loved to cuddle, she said. At 8½, James began to grow combative. To ward off injury, the Cordones locked up their knives and forks and put away glass picture frames.

But then their son started head-banging — a problem with some children who have a severe case of autism. The Cordones’ house bears the scars of his pain, including holes in the drywall and a shattered window.

On his 9th birthday, in December 2014, James went into a rage, Cordone said. It took four adults to restrain him.

“He was trying to put his head through the window, sweating profusely,” she said. “He was not there. It was a blank stare.”

The family called 911. James was taken to the Women & Children’s Hospital of Buffalo, where he was sedated on and off for 13 days. He went home, but a fit of rage a few months later landed the young boy in the same hospital for seven weeks in March 2015. “We couldn’t ride out the storm any longer,” Cordone said.

Debbie Cordone installed locks on her refrigerator after her son James began to dump the contents of food and drink containers. (Nancy J. Parisi for KHN)

James damaged walls by banging his head on them, a problem that contributed to Cordone’s decision to call 911 for the first time in late 2014. (Nancy J. Parisi for KHN)

Cordone said her son lived out those weeks in a “Posey Bed,” which resembles a child’s playpen propped on top of a hospital bed. During that time, she joined her adult children in a social media campaign to pressure her insurer to pay for intensive behavioral therapy.

The family prevailed, and James went to a center in Baltimore where staff — three counselors for his case alone — focused on his communication skills and adjusted his medication. He now lives in a group home near the Cordone family. He is “a success story,” Cordone said, albeit a rare one among children with severe autism.

James Cordone lived in a mesh-covered, protective Posey Bed during his seven-week stay at the Women & Children’s Hospital of Buffalo, starting in March 2015. (Courtesy of Debbie Cordone)

“This is a crisis,” she said, “and no one is recognizing it.”

Women & Children’s Hospital of Buffalo did not return calls seeking comment.

Mary Cohen, who also lives in the Buffalo area, has endured a similar struggle as a single mother. Ben’s 6-foot-1, 240-pound presence dwarfed her petite frame.

She began locking herself in a basement room to escape his outbursts, while still monitoring him via cameras she’d installed throughout the house to make sure he was safe. As the lock-ins became more frequent, she realized, “I can’t keep going like this.” She found a nearby group home, covered by his disability and Medicaid payments, that could accommodate Ben.

On Aug. 1, 2016, it all imploded. Medication changes and an ear infection triggered a rage, Cohen said, and Ben hurt one of the staff members. Someone called 911, he was taken to the psychiatric emergency room at Erie County Medical Center, and a waiting room there is where he lived until early this summer.

“Staff was on the other side of the window watching him 24 hours around the clock,” Cohen said.

Though a 304-day stay is a record there, cases like this have surged at the hospital, said Cummings, its executive director of behavioral health. They spurred him to launch a grant-funded home-visit program aimed at keeping families with autistic children from reaching a breaking point. He and his clinical partner have counseled nearly 400 families to help manage their youngsters’ medications and find services, and their ER visits have dropped by nearly 50 percent, he said.

“It’s money best spent now, because you’re going to spend it in the end,” stressed Scott Badesch, president of the Autism Society. The organization, well aware of what Badesch calls hospital “warehousing,” is pushing lawmakers nationally to spend more on behavioral counseling and in-home support for families.

A bed finally opened up for Ben at Baltimore’s Kennedy Krieger Institute — a private, highly regarded facility that offers intensive therapy, psychiatry and family coaching. Cohen held out for a placement there, hoping the staff could turn Ben’s behavior around. The teen and his mother made the 360-mile trip in June by ambulance and plane.

“I want to do the right thing for him,” Cohen said. “Because one day I’m not going to be there for him.”

KHN’s coverage of children’s health care issues is supported in part by a grant from The Heising-Simons Foundation and its coverage related to aging & improving care of older adults is supported by The John A. Hartford Foundation.

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Postcard From Capitol Hill: Health Care Hearing’s Action Was In Hallway

“Kill the bill, don’t kill us,” one woman screamed, inches from a U.S. Capitol Police officer’s face Monday afternoon in a marbled hallway of the U.S. Capitol at the start of the one and only public hearing on the GOP’s last-ditch effort to replace the Affordable Care Act.

The protesters had begun lining up at 5:30 a.m. — some paid others to hold their places — and by 2 p.m., hundreds of people were waiting for a coveted seat for the Senate Finance Committee’s hearing in Room 215 of the Dirksen Senate Office Building. Around lunchtime, Sen. Ron Wyden (D-Ore.) strolled through, passing out slices of pizza to some in line.

The line was a five-minute walk from end to end.

Dozens had come in wheelchairs. Others used walkers. Many wore the signature red T-shirts of the disability rights group ADAPT. One person was dressed as the Grim Reaper. Another wore a balloon painted like a face with extra-large eyes, so lawmakers would know “I have my eyes on them.”

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“All the people down here are relying on this health care bill to not go through,” said Shaylin Sluzalis, 22, from Pennsylvania, who accompanied her sister, Britney, who has cerebral palsy.

“If it does, we are going to nursing homes and institutions where we are going to be abused, used or violated,” Shaylin Sluzalis said.

Protesters, police officers and reporters jockeyed for elbow room in the cramped space, by now hot and claustrophobic.

Rowdiness broke out in the long line when the throng discovered that congressional staffers were going to admit only 20 or 30 people — the number of public spaces in the small room reserved for a crucial hearing.

Chants started. “No cuts to Medicaid — save our liberty,” they cried, over and over.

Some hurled themselves from their wheelchairs and laid on the floor, prostrating themselves in resistance at the feet of Capitol Police.

The police, who had come equipped with fistfuls of white plastic handcuffs, began arresting those on the ground. Police carried the ones unable to walk by their arms and legs and deposited them on the floor down the hall, to be later placed back in their power chairs and taken away.

Officers screamed at journalists and onlookers to clear the area in order to escort handcuffed activists out of the building.

This was the backdrop against which the bill’s authors, Sens. Lindsey Graham (R-S.C.) and Bill Cassidy (R-La.) made their way through the crowd to enter the hearing room’s back door to begin the proceedings. “Shame! Shame!” the protestors yelled.

As Senate Finance Committee Chairman Sen. Orrin Hatch gamely tried to call the hearing to order, chants of “No cuts to Medicaid — save our liberty” resonated from the hallway. He ordered that the door be closed.

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Republicans fail again to kill off Obamacare in U.S. Senate

WASHINGTON (Reuters) – A Republican attempt to dismantle Obamacare fell apart in the U.S. Senate on Tuesday for the second time in two months in a serious defeat for President Donald Trump’s domestic agenda.

The party was unable to win enough support from its own senators for a bill to repeal the 2010 healthcare law and decided not to put it to a vote, several Republicans said.

“We basically ran out of time,” said Senator Ron Johnson, a co-sponsor of the measure with Senators Bill Cassidy and Lindsey Graham, who told reporters the party would target healthcare again after trying to reform the U.S. tax code.

The latest failure to carry through on a seven-year effort to roll back the 2010 healthcare law is an embarrassing setback for Republicans. Trump vowed frequently in the 2016 election campaign to scrap Obamacare, the signature domestic policy of his Democratic predecessor, Barack Obama.

The Republicans may now struggle to achieve any major domestic policy successes in Congress this year, and they could be punished for it by voters at the November 2018 midterm elections.

After losing a Senate vote on repealing Obamacare in July,

Republicans tried again this month with a bill that would take

federal money and give it to the states in block grants to regulate their own healthcare systems.

But several Republican senators refused to back the latest bill, including Senator Susan Collins, who on Monday complained that it undermined the Medicaid program for the poor and disabled and weakened protections for people with pre-existing conditions, such as asthma, cancer and diabetes.

While Obamacare extended health insurance to some 20 million Americans, many Republicans attacked it as an unwarranted and costly government intrusion into healthcare, while also opposing taxes it imposed on the wealthy.

One main complaint by opponents of the Graham-Cassidy bill was that it would have meant sweeping cuts in Medicaid funding.

TRUMP DISAPPOINTED

Sen. Bill Cassidy (R-LA), accompanied by Sen. Ron Johnson (R-WI) at left, speaks with reporters ahead of the party luncheons on Capitol Hill in Washington, U.S., September 26, 2017. REUTERS/Aaron P. Bernstein

Trump said on Tuesday his administration was disappointed in “certain so-called Republicans” who did not support the bill.

Republicans hold a slim 52-48 majority in the Senate and

at least two other Republican senators, John McCain and Rand Paul, had earlier rejected the bill.

Republicans have tried for years to get rid of the Affordable Care Act, or Obamacare, but they were up against a Sept. 30 deadline to pass a bill with a simple majority, or face a much tougher path toward dismantling it.

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John Thune, a member of Republican leadership in the Senate, said the party would likely not try to undo Obamacare again until it was clear there were enough votes for it.

“I don’t anticipate that we’ll probably be picking it up again,” he told reporters.

“I think right now the focus is going to be tax reform and we try to be very clear-eyed about how challenging that is going to be but at the same time realize that this would be an important victory for the American people if we can get it across the finish line,” Thune said.

A CBS poll on Monday showed 52 percent of Americans disapproved of the Graham-Cassidy healthcare bill, while 20 percent approved.

“I will readily admit that the Republican Party has done a bad job of explaining what we’re for in terms of replace on Obamacare,” Republican Senator Ben Sasse said on the Senate floor.

Six protesters staged a “die-in” on the floor of a Senate office building on Tuesday, lying on the ground and covering their heads and bodies with a white shroud to represent what they said would be lives lost if the bill passed.

Police arrested 181 demonstrators on Capitol Hill on Monday.

The non-partisan Congressional Budget Office said the number of people with health insurance covering high-cost medical events would be slashed by millions if the latest Republican bill had it become law.

The CBO also found that federal spending on Medicaid would be cut by about $1 trillion from 2017 to 2026 under the proposal, and that millions of people would lose their coverage in the program, mainly from a repeal of federal funding for Obamacare’s Medicaid expansion.

Reporting by Susan Cornwell and Richard Cowan; Additional reporting by Susan Heavey; Writing by Alistair Bell; Editing by Kevin Drawbaugh and Bill Trott

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Pregnant women still unaware of epilepsy drug risks: EMA hearing

PARIS (Reuters) – More than three decades after links emerged between Sanofi’s epilepsy drug valproate and birth defects, many pregnant women remain unaware of the risks, patients, doctors and researchers said on Tuesday.

Prescribed globally for epilepsy and bipolar disorders – and in some cases migraines – valproate is included in the World’s Health Organisation list of essential medicines.

But the drug is also known to have caused birth malfunctions and slow neurological development after being taken during pregnancy.

“Measures have been taken … but these have largely been tick-box exercises with little regard for delivering real change,” Karen Keely, from Irish patient support group Fetal Anti-Convulsant Syndrome, told a public hearing in London hosted by the European Medicines Agency (EMA).

Tuesday’s hearing was the first time the EMA has held such an event, inviting EU citizens to share their experience with a particular medication.

Sanofi, which told the hearing there was clear data showing an increased risk of malformation when taking valproate during pregnancy, said it had always provided up-to-date advice.

But parents of those affected have repeatedly said health authorities worldwide as well as the French drugmaker were too slow to warn of the drug’s side effects. It is sold under brands such as Depakote and Epilim.

At the hearing, patients, medics and researchers said there were shortcomings all along the chain from the pharmaceutical provider to the patient, including healthcare authorities.

Valproate is also at the center of a health scandal in France, where parliament voted last year to create a compensation fund for claims relating to Depakine, the brand under which valproate was first approved in 1967.

DILEMMA FOR SUFFERERS

Restrictions and warnings about valproate have been strengthened across Europe during the last three years after a first review. But recent surveys in the United Kingdom showed almost 70 percent of women taking the drug had not received adequate advice.

Clare Pelham, speaking on behalf of Britain’s Epilepsy Society, said warnings on medicine packages and leaflets were insufficient and that patients needed “tailored conversations” with healthcare professionals.

Others called for public information campaigns as well as a Europe-wide census of patients on valproate.

Eric Teo, who is in charge of drug safety at Sanofi, said his company had always provided the most up-to-date scientific information with the approval of the authorities.

“Valproate is an important treatment that many women continue to rely on … It should be acknowledged that there is a real dilemma faced by doctors and women who have no other alternatives to control their seizures.”

The EMA launched a new review of valproate safety in March at the request of the French medicines regulator ANSM.

The process, which will incorporate the input of Tuesday’s hearing, is being conducted by the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). A final recommendation is expected in December.

National authorities typically follow the advice of the EMA but the agency has no legal power to enforce particular actions on authorized medications. Valproate medicines, for which Sanofi lost its patent in 1998, are prescribed in over 100 countries.

Editing by Richard Lough and David Clarke

Our Standards:The Thomson Reuters Trust Principles.

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Everyone Says We Must Control Exorbitant Drug Prices. So, Why Don’t We?

Of all the promises President Donald Trump made for the early part of his term, controlling stinging drug prices might have seemed the easiest to achieve.

An angry public overwhelmingly wants change in an easily vilified industry. Big pharma’s recent publicity nightmare included thousand-percent price increases and a smirking CEO who said, “I liken myself to the robber barons.” Even powerful members of Congress from both parties have said that drug prices are too high.

But any momentum to address prescription drug costs — a problem that a large number of Americans now believe government should solve — has been lost amid rancorous debates over replacing Obamacare and stalled by roadblocks erected via lobbying and industry cash.

“There is a very aggressive lobby that is finding any and all means to thwart any reform to a system that has produced very lucrative profits,” said Ameet Sarpatwari, an epidemiologist and lawyer at Harvard Medical School who follows drug legislation. “Everything that’s coming out is being hit and hit hard — even stuff that’s commonsensical.”

Those in Congress concerned with health policy have spent much of the year advancing proposals to overhaul the Affordable Care Act, none of which would affect pharmaceutical pricing. The latest Republican proposal, by Senators Lindsey Graham of South Carolina and Bill Cassidy of Louisiana, is no different.

Meanwhile, more than two dozen bills aimed at curbing drug costs have been introduced in this or the previous Congress, according to the Drug Pricing Lab, a Memorial Sloan Kettering Cancer Center program that has catalogued ideas for reducing prices. Many have bipartisan support.

Proposals include importation from other developed countries, where regulations keep prices down; allowing government to negotiate the price of Medicare-covered drugs; speeding approval of cheaper generics; requiring notification before raising drug prices; and restricting consumer drug ads.

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Other ideas that haven’t made it to legislation include banning patents for pills that simply copy or repackage existing medicines; and adjusting prices according to a drug’s effectiveness.

“There’s clearly no single solution out there that will solve this rapidly rising spending,” said Dr. Peter Bach, who leads the lab. But, he added, “there’s not a lot of fundamental disagreement about the direction this needs to move.”

Trump drew new attention to the issue last month by tweeting that Merck’s chief executive, Kenneth Frazier, “will have more time to LOWER RIPOFF DRUG PRICES!” after Frazier quit the president’s manufacturing council to protest his remarks about white supremacists in Charlottesville, Va.

Those comments matched Trump’s characterization earlier this year of drug companies as “getting away with murder.” That same January day, a dozen Republican senators, including Ted Cruz of Texas, John McCain of Arizona and Mike Lee of Utah, voted for the old liberal idea of letting Americans buy less-expensive drugs from Canada.

The measure was attached to a budget resolution and wouldn’t, by itself, have allowed importation. It failed 52 to 46 after 13 Democrats voted against it, with some citing safety concerns about foreign-sourced medicine — an idea promoted by American drugmakers.

Even so, the vote prompted speculation that a pharma price deal might be within reach.

Sen. Lee is one of the Republicans who favor importation as a way to increase competition. “When we’re talking about garden-variety, generic drugs that can be easily imported from another country that has regulatory procedures that make them safe?” he said in an interview. “I don’t see why not.”

In response to the new threats, the Pharmaceutical Research and Manufacturers of America, already one of Washington’s biggest-spending trade groups, increased member dues by half last year to prepare for battle.

The pharmaceutical and health products industries spent $145 million on lobbying for the first half of 2017, according to data from the Center for Responsive Politics.

Drug manufacturers gave $4.5 million to congressional campaigns in that period, including six-figure donations to House Speaker Paul Ryan; Rep. Greg Walden, head of the House Energy and Commerce Committee; and Sen. Orrin Hatch, head of the Senate Finance Committee, according to a Kaiser Health News analysis.

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PhRMA’s “Go Boldly” campaign, showing heroic researchers seeking cures, has spent $28 million so far this year on six ads shown on about 4,600 national TV channels, according to iSpot.tv, an ad tracker.

The industry hired former FBI director Louis Freeh to study the impact of importation. He concluded that it would “leave the safety of the U.S. prescription drug supply vulnerable to criminals seeking to harm patients.” Import proponents argue the Food and Drug Administration could easily ensure safety by licensing and inspecting Canadian suppliers.

Drugmakers say that high prices reflect heavy investment in innovation and drug development. They reject the notion that the industry wields too much influence in Washington.

“These are important issues with significant ramifications,” Holly Campbell, a PhRMA spokeswoman, said. “So we will continue to be engaged with the administration to advance solutions that improve the marketplace and make it more responsive to the needs of patients.”

The top 10 publicly traded U.S. drug companies made $67.8 billion last year, after taxes, regulatory filings show.

Efforts to restrain prices have made little progress in the executive branch, either.

The White House has long been expected to issue an executive order on drug costs. But leaked documents show that deliberations have focused on things the industry wants, such as extending overseas patents and changing a drug-discount program for hospitals, and not so much on lowering prices.

Gerard Anderson, a health policy professor at Johns Hopkins University, said Trump’s draft order “did not talk at all about branded drugs or about specialty drugs,” including for rheumatoid arthritis and cancer, that have seen especially steep price increases. “If that represents the administration’s thinking, then my guess is there is not much effort.”

Trump’s ongoing feud with congressional Republicans, especially Senate Majority Leader Mitch McConnell, means “you’re not going to get any strong direction or leadership out of the White House” on drug prices, said Vishnu Lekraj, who follows pharma stocks for Morningstar, an investment research firm.

Trump isn’t the only one in his administration criticizing drug companies. Scott Gottlieb, the FDA commissioner, has accused the industry of “gaming” the system to delay the appearance of cheap generics after patents expire. He has pledged to speed applications for generics when there is little competition as part of a “drug competition action plan” while opposing stronger measures like allowing importation.

But promoting generics is “reasonably small potatoes” compared with the money that could be saved by putting direct pressure on brand-drug prices, Anderson said. Gottlieb has served on the boards of several pharmaceutical companies and reaped large consulting and speaking fees from the industry.

Yet even small potatoes might be a long shot — despite widespread agreement that change is needed.

“It is sort of remarkable to see just how far the system can bend before meaningful reform is taken,” said Sarpatwari of Harvard. “If there ever was a time to strike while it’s hot, it’s now.”

Elizabeth Lucas and Sydney Lupkin contributed to this report.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Categories: Cost and Quality, Health Industry, Pharmaceuticals, Repeal And Replace Watch

Tags: Drug Costs, Legislation, Prescription Drugs, U.S. Congress

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