House rejects GOP bill easing use of unproven drugs

Published: Tuesday, March 13, 2018 @ 3:33 PM
Updated: Tuesday, March 13, 2018 @ 3:31 PM

The House rejected legislation Tuesday easing how experimental drugs are provided to people with terminal illnesses, as Democrats calling the bill risky and misleading overcame support from President Donald Trump and emotional arguments by Republican lawmakers and ailing constituents.

The vote for the measure was 259-140, but that fell short of the two-thirds majority the GOP needed to prevail under special procedures. Since the Senate approved similar legislation last August, Republicans could revisit the legislation under rules that would require only a simple majority for passage, perhaps after reworking the measure.

"The House will not let this be the end," said Majority Leader Kevin McCarthy, R-Calif.

Republicans brought patients with fatal diseases to the House chamber, including Jordan McLinn, 8, of Indianapolis, a muscular dystrophy sufferer who sat beside Energy and Commerce Committee Chairman Greg Walden, R-Ore. McLinn appeared two years ago with then Indiana Gov. Mike Pence, now vice president, as Pence signed state legislation reducing restrictions.

Rep. Brian Fitzpatrick, R-Pa., cited a message from fellow Pennsylvanian Matthew Bellina, a Navy veteran diagnosed with amyotrophic lateral sclerosis, also called Lou Gehrig's disease. Bellina's message was, "A vote against this is essentially a vote to kill me."

All but two voting Republicans backed the measure while Democrats were opposed by a margin exceeding 4-to-1.

Democrats, backed by scores of patients' and research organizations, said the bill would achieve little since the federal Food and Drug Administration already approves 99 percent of the 1,000 requests it receives annually for an existing program that lets patients use unproven treatments. They said the proposal would create risks by rolling back the FDA's oversight role in the process and noted that most experimental drugs don't work.

"The last thing I want to do is give patients false hope and to put them at risk" by reducing the FDA's powers, said Rep. Frank Pallone of New Jersey, top Democrat on the Energy and Commerce panel.

GOP lawmakers rejected that argument.

"There is no such thing as false hope. You either have hope or you have no hope," said Rep. Andy Biggs, R-Ariz.

"If I had a terminal diagnosis, I'd even consider injecting monkey urine if I thought it would give me a few more months, a few more years with my children," said Rep. Morgan Griffith, R-Va.

Under the "Right to Try" legislation, the FDA would no longer need to sign off if a doctor and pharmaceutical maker agree that a patient with no other options should try an experimental treatment.

The agency would have to be notified after treatment begins, manufacturers would have to report if problems arose and drug makers and doctors would be broadly shielded from legal liability. Manufacturers would still not be required to provide their pharmaceuticals.

More than 70 patient and research groups sent a letter of opposition Monday to House leaders saying the bill "would not increase access to promising therapies" and "is still less safe" that the FDA's existing process.

Critics said the measure misleadingly suggests the FDA is the bottleneck to providing the experimental treatments. They say the more common hurdle is manufacturers, which often prefer to use their limited quantities of early-stage drugs for clinical trials needed to gain final FDA approval for wide-spread sales or worry that a setback could damage the product's marketability.

Scott Gottlieb, FDA commissioner and a Trump appointee, told Congress in October that 70 percent of the experimental drugs his agency currently lets seriously ill patients use are never approved.

"The vast majority of people" granted access to unproven treatments "are using a drug that doesn't work," he said.


This story corrects the age of Jordan McLinn. He is 8, not 7.

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With retirement of acting chief, NASA finds itself in leadership limbo

Published: Saturday, March 17, 2018 @ 1:00 AM

After operating for more than a year with a temporary chief, NASA faces an unprecedented leadership bind as its acting Administrator announced this week that he would retire at the end of April, with no hint that the Senate will vote by then on President Donald Trump’s nominee to lead the space agency.

“It has been a long process but we are optimistic that the vote will come soon,” said Sheryl Kaufman, the Communications Director for Rep. Jim Bridenstine (R-OK).

“We hope that happens soon,” said Rep. Bruce Babin (R-TX), as House Republicans and Vice President Mike Pence pressed the Senate for action on Bridenstine.

The problem for Bridenstine is that just one Republican has refused to support him for the job as NASA Administrator – that being Sen. Marco Rubio (R-FL) – and with only a bare majority, and the absence of Sen. John McCain (R-AZ), Bridenstine does not have the votes to win.

Since President Trump took office in January of 2017, NASA has been led by Robert Lightfoot, a well-respected NASA veteran who has drawn bipartisan praise.

But with Lightfoot announcing this week that he is retiring – effective April 30 – it’s possible that NASA could be forced to dig deeper down the depth chart for another temporary leader at the space agency.

“Robert Lightfoot has served NASA exceptionally well for nearly 30 years,” said Rep. Lamar Smith (R-TX), the head of the House Science Committee.

Apart from a couple of major issues, Bridenstine in 2017 did not cast votes on regular legislation in the House – while waiting for his Senate confirmation.

This year has been different – Bridenstine is voting on most legislation in the House, except for measures that deal with NASA.

“He will represent his constituents as fully as possible while awaiting the confirmation vote by the full Senate,” said his spokeswoman.

But without enough support, there’s no hint of a vote on Bridenstine in the Senate.

“The facts of this nomination have not changed,” said Sen. Bill Nelson (D-FL) back in January – and two months later, that statement is still true.

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Russia investigation: Special counsel Mueller subpoenas Trump Organization

Published: Friday, March 16, 2018 @ 3:57 PM
Updated: Friday, March 16, 2018 @ 3:48 PM

Robert Mueller - Fast Facts


Special counsel Robert Mueller has subpoenaed the Trump Organization for documents as part of his investigation into Russian meddling in the 2016 presidential election and its possible ties to President Donald Trump and his associates, according to multiple reports.

>> Read more trending news

The subpoena is the first directly connected to one of Trump’s businesses, The New York Times reported Thursday. The newspaper was the first to report on the subpoena, citing two unidentified sources briefed on the situation.

The breadth of the subpoena was not immediately clear, although some documents sought were related to Russia, the Times reported. According to the newspaper, the subpoena was served “in recent weeks.”

>> More on Robert Mueller's investigation

The Trump Organization has already provided investigators with a range of documents, most focused on the period between when Trump announced his candidacy for president, in June 2015, to his inauguration, in January 2017, CNN reported in January. Citing an unidentified source familiar with the situation, the news network reported that the recently issued subpoena was meant “to ‘clean up’ and to ensure that all related documents are handed over to the special counsel.”

In a statement released to several news outlets Thursday, Alan Futerfas, an attorney representing the Trump Organization, said reports of the subpoena were “old news.”

>> Related: Former Trump campaign aide Rick Gates to plead guilty in Mueller investigation

“Since July 2017, we have advised the public that the Trump Organization is fully cooperative with all investigations, including the special counsel, and is responding to their requests,” Futerfas said. “This is old news and our assistance and cooperation with the various investigations remains the same today.”

The decision to subpoena the Trump Organization, which is owned by the president and managed by his children, appeared to mirror the strategy employed by Mueller with the Trump campaign, The Wall Street Journal reported. The newspaper noted that the campaign “voluntarily gave documents to the special counsel for months before receiving a subpoena in October.”

>> Related: Mueller indicts 13 Russians, 3 Russian entities in election meddling probe

Mueller, who headed the FBI from 2001 to 2013, was appointed by the Justice Department in May 2017 to oversee the investigation into Russian interference in the 2016 election. His investigation has thus far led to several indictments and a handful of guilty pleas from people connected to Trump.

Mueller indicted 13 Russians and three Russian entities last month on accusations that they interfered with American elections and political processes, starting in 2014. On Twitter, Trump claimed that information in the indictments proved his innocence on allegations of colluding with Russia to win the election.

Five people have pleaded guilty to charges levied against them in Mueller's investigation. Most recently, former Trump campaign aide Rick Gates pleaded guilty to making false statements and conspiring against the United States.

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Ohio lawmaker wants military to assist Puerto Rico cleanup

Published: Thursday, March 15, 2018 @ 10:07 AM

            Volunteers are instructed on how to assess damaged trees in the El Yunque National Forest in Puerto Rico, Jan. 17, 2018. Researchers are studying the damage wrought by Hurricane Maria to this lush, 28,000-acre tropical rainforest to better understand how forests could be changed permanently as the world continues to warm. (Erika P. Rodriguez/The New York Times)
            ERIKA P. RODRIGUEZ
Volunteers are instructed on how to assess damaged trees in the El Yunque National Forest in Puerto Rico, Jan. 17, 2018. Researchers are studying the damage wrought by Hurricane Maria to this lush, 28,000-acre tropical rainforest to better understand how forests could be changed permanently as the world continues to warm. (Erika P. Rodriguez/The New York Times)(ERIKA P. RODRIGUEZ)

In the aftermath of a whirlwind two-day trip to Puerto Rico, Rep. Brad Wenstrup will push for but the active duty and reservists to help assist in the rebuilding of Puerto Rico.

Wenstrup, a Cincinnati Republican who serves on the House Veterans Affairs Committee and who is an Army Reservist, flew into Puerto Rico last Sunday for a field hearing on the VA’s role in the recovery effort. Puerto Rico is still reeling from two back-to-back hurricanes that struck the island six months ago and 11 percent of the island is out of power.

RELATED: Puerto Rican community here still battling the ‘monster’

Wenstrup said the VA plays an outsize role in the island – 72 percent of military veterans there who are eligible for VA care use it – nearly double the usage on the mainland United States.

Along with Rep. Phil Roe, R-Tenn., who chairs the House Committee on Veterans Affairs, and Rep. Jenniffer Gonzalez Colon, R-Puerto Rico, Wenstrup toured several VA clinics on the island and also met with representatives from Veterans Service Organizations. Their field hearing was aimed at determining how best to maximize VA resources in Puerto Rico.

RELATED: Ohio National Guard sends medical equipment to Puerto Rico

He said conditions on the island are still grim, with debris stockpiled along the roads and roofs still covered with tarps, but the people are working to recover. However, he said, a shortage of doctors is imperiling the recovery effort because the island’s lackluster economy has spurred many doctors to move away in order to seek better pay and opportunities.

Wenstrup, who chairs the VA Committee’s Health Subcommittee, said the island might be an ideal place for a reservist or guardsman who wants to practice his or her skills as well as provide a service. “This may be an opportunity for a win-win,” he said.

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No direct answer from White House on future of VA chief

Published: Thursday, March 15, 2018 @ 4:08 PM

The White House on Thursday refused to directly say if Veterans Secretary David Shulkin will stay in his post, as the VA chief tried to reassure lawmakers that he remains the right person to carry out Trump Administration plans to improve the quality of care at the VA.

“I’ve pubilcly acknowledged that the distraction that has happened is something I deeply regret,” Shulkin told a House panel on Thursday, as the first question at a budget hearing was about persistent news reports of palace intrigue at the VA.

“I do feel that I have to acknowledge the proverbial elephant in the room,” said Rep. Charlie Dent (R-PA), who pressed Shulkin on reports that Shulkin’s own staffers were at times pitted against him in a fight with the White House over private care for veterans.

“I’ve come here for one reason, and that’s to improve the lives of veterans,” Shulkin said, saying ‘others’ were more interested in playing politics than getting the job done.

Both before the hearing on Capitol Hill – and after – Shulkin refused to answer questions from reporters about his future in the job.

When the question was posed to the White House a few hours later, there was not a direct answer on the VA Secretary’s job security.

“I don’t have any personnel announcements,” said White House Press Secretary Sarah Huckabee Sanders, as she stressed that the Trump Administration was looking for the right mix of people and policies at the VA.

For much of the President’s first year in office, Mr. Trump was a very public fan of Shulkin, and his efforts to foster change at the VA.

“I’d like to begin by thanking Secretary David Shulkin for the incredible progress that he’s making at the VA, tremendous strides,” the President said in August of 2017 at a veterans event in the White House.

But in recent months behind the scenes, Shulkin – who was a top holdover from the Obama Administration – has been in a pitched battle with officials at the VA, even reportedly fighting with his chief spokesman, mainly over the direction that the VA should go in how much health care for veterans should be shifted away from VA facilities and to private doctors, what’s known as Veterans Choice.

Add to that, an internal watchdog report criticized Shulkin for how he got the VA to pick up some of the travel costs of his wife, who joined Shulkin on a 10-day government trip to Europe last summer.

The inspector general report also found that Shulkin wrongly accepted a gift of tickets to the Wimbledon tennis tournament, that a VA employee was basically used by Shulkin as a “personal travel concierge to plan tourist activities,” and that not enough documents were ever turned over to investigators to figure out the true cost of the trip to the VA.

In a mid-February hearing, Shulkin defended the trip but admitted, “I do recognize the optics of this are not good.”

For now, Shulkin is still the Veterans Secretary – but there wasn’t much in the way of a public vote of confidence in him from the White House in recent days.

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