Homeland Security Secretary Jeh Johnson said Congress must approve the money this month, saying that if nothing is done before lawmakers leave for a month long August vacation, one of his agencies will have to cut its other immigration enforcement in order to hold and transport the children.
But Mr. Johnson and other officials faced bipartisan complaints that Mr. Obama's plan is "incomplete." Democrats said it fails to compensate local communities who are having to face the problem, while Republicans said Mr. Obama needs to spell out details of how he wants to change the law to make sure the children can be quickly deported.
"He needs to work with us to get the right policy into effect - not just throw money at the problem," Sen. Mitch McConnell of Kentucky, the top Republican in the Senate, said on the chamber floor.
The Obama administration has been struggling for months to gain a handle on the surge of children and families crossing the border, and the president this week finally submitted an emergency spending request to Congress.
It would provide more money to social workers to house the children, add immigration judges to try to speed up cases so that those who are going to be deported can be sent home sooner and boost funding for immigration agents who are handling the surge at the border as well as detaining, processing and transporting the children.
Some of the $1.8 billion intended for the Health and Human Services Department will provide for education and extraordinary health care for children in desperate need, and both the HHS money and funding for the Justice Department will go to pay for legal representation for the children, officials told the Senate Appropriations Committee.
In sending the budget request to Congress, Mr. Obama said the pressure is now on Capitol Hill to solve the problem.
But he may not have anticipated the flood of ideas lawmakers said they want to see attached to the funding request.
Sen. Mark Kirk, Illinois Republican, said all the children should be put through criminal background checks with their home country embassies in order to make sure they don't pose a threat.
Meanwhile, Sens. John McCain and Jeff Flake, two Arizona Republicans who helped write the Senate's immigration legalization bill last year, said they'll introduce legislation they say will get tough on the latest surge.
Their proposal would allow for quick deportation of all illegal immigrants caught at the border, under a program known as "expedited removal."
It also would require mandatory detention or alternatives such as ankle monitoring bracelets for those awaiting deportation hearings to make sure they show up. It would also increase the number of refugee visas available to El Salvador, Honduras and Guatemala so that people truly fleeing horrendous conditions can apply from home rather than braving the dangerous journey and applying for asylum after they reach the U.S.
The point, the lawmakers said, was to send a signal that those trying to cross will not be able to gain a foothold along with the other 11 million illegal immigrants already here.
"This crisis will continue until the parents who paid thousands of dollars to smuggle their children north to the United States see planeloads of them landing back at home - their money wasted," Mr. McCain said.
Obama administration officials, who have for the most part blamed conditions on the ground in Central America for the surge, did concede that smugglers, known as coyotes, have been able to convince parents that their children can gain that foothold - mainly because the U.S. immigration system is so backlogged that children and families can disappear into the shadows for years.
The key, administration officials said, is to speed up deportations so the smugglers can't sell that claim anymore.
"What we want to do is make the coyotes' promise that [the families] are living off of not correct," said HHS Secretary Sylvia Mathews Burwell.
But some immigrant-rights groups and a handful of Democrats in Congresshave objected, saying that's a terrible way to treat children who may be fleeing unimaginable dangers back home.
"You know what my ears are hearing? Round 'em up and ship 'em back," said a disgusted Sen. Tom Harkin, Iowa Democrat. "It sounds like we're dealing with cattle or some kind of livestock."
Sen. Richard J. Durbin, Illinois Democrat, said the children end up facing a complex legal system here, and he said the money included for lawyers - about $15 million from the Justice Department - would only provide representation for about 10,000 of the 90,000 unaccompanied children expected to be caught along the border this fiscal year.
Ms. Burwell said her department has some additional money for extra representation but said it's not enough to cover everyone they encounter.
"You are right that we do not have the resources to provide counsel for all the children that pass through and go to sponsors. But there [is] a group that we do that for," she said.
Of the $1.8 billion that HHS is requesting, Ms. Burwell said 84 percent of that is to pay for housing the children, 2 percent is for administrative costs, and 12 percent is for other care expenses such as legal representation and health screenings.
She said it can cost between $250 and $1,000 for each bed space to house one of the children. She said nonprofit organizations are paid to provide the education and other services at those locations.
The surge of children has overshadowed the rest of the immigration debate in Congress. Some lawmakers have said passing the Senate's legalization bill could help combat the surge, but others say the bill is partly to blame, saying its promise of legal status has enticed a new wave of illegal immigrants.
On Thursday, Rep. Mario Diaz-Balart, a Florida Republican who had been working on a House version of the legalization legislation, said he'd been officially told by GOP leaders that his bill won't be brought up for a vote this year.
Mr. Diaz-Balart said he believed he had the backing of a majority of House Republicans and enough House Democrats to get his bill passed and blasted his party leaders for refusing to take action.
Here is a call to sustained intercession for truth to replace confusion. How our nation needs divine intervention! Pray that wisdom and statesmanship replace political maneuvering. President Obama's request for $3.7 billion is not being received with favor in either the House or (more surprisingly) the Senate. Some lawmakers are calling it irresponsible, as it does not address the issue of sending nearly 60,000 children home. Let us pray with biblical discernment.
"Thus says theLordof hosts: 'Execute true justice, show mercy and compassion everyone to his brother." (Zechariah 7:9)
"If a kingdom is divided against itself, that kingdom cannot stand. And if a house is divided against itself, that house cannot stand." (Mark 3:24-25)
The answer to all three questions should, unequivocally, be "no." But, sadly, 46 Democrats in the U.S. Senateare supporting a constitutional amendment to repeal the free-speech provisions of the First Amendment and give Congress carte blanche power to regulate political speech.
It's all because a group of conservative filmmakers made a documentary film in 2008 about then-Democratic presidential candidateHillary Clintonthat did not speak favorably about her record. Forty-four Senate Democrats are now supporting a constitutional amendment from Sen. Tom Udall of New Mexico to stop Americans from showing movies like the one Citizens United created during the 2008 election.
Forty-six Senate Democrats are willing to rewrite the Constitution to take away the right of Americans to speak or create art that is critical of politicians.
Forty-six Senate Democrats are actively working to silence political criticism ahead of the next presidential election.
They are the "Fahrenheit 451" Democrats.
Never before has Congresstampered with the First Amendment.
When a similar proposal was considered in 1997, the famed liberal lion of the Senate, Ted Kennedy, reminded his colleagues that never before had the Bill of Rights been amended and "now is no time to start."
I agree with Ted Kennedy. Where are the Democrats who agree with him today? Not a single one has spoken out against this. Groupthink has taken over their party.
The American Civil Liberties Union, however, has sounded the alarm. The ACLU says the Democrats' amendment would "severely limit the First Amendment and lead directly to governmentcensorship of political speech."
Floyd Abrams, perhaps the leading First Amendment litigator in the country and an outspoken Democrat, has, as well. He said the amendment "would limit speech that is at the heart of our First Amendment."
Senate Democrats would like to pretend they could draw the line between what they think is "reasonable" political speech and "unreasonable" political speech. To hear the Democrats tell it, all they want to do is stop "corporate influences" from unfairly influencing the political debate.
However, The New York Times is a corporation. Should they stop penning editorials? NBC is a corporation. Should it quit airing "Saturday Night Live"?
After all, wasn't Tina Fey influencing voters when she took on an Alaskan accent and declared "I can see Russia from my house - something Sarah Palin never even said?
Didn't Will Ferrell's hilarious portrayals of President George W. Bush as childlike and confused change public opinion of our 43rd president? Wasn't Seth Green swaying voters when he impersonated Vice President Al Gore as a dry, droning bore? Wasn't Darrell Hammond enforcing a certain kind of perception of Bill Clinton when he presented the president as a lusty, smirking cad?
The answer is yes, yes, yes and yes. That's what free speech gives Americans the power to do - mock, provoke, challenge and persuade. "Saturday Night Live" has a constitutional right to do so, but the Democrats' amendment would allow Congress to ban the show.
The hard-line liberal partisans who want to rewrite the Constitution to give their party a political advantage certainly do not have the same interests in mind as James Madison and Alexander Hamilton.
We should keep our faith in the Bill of Rights, rather than in politicians' intent on preserving their power.
There will always be political speakers who someone disagrees with. Democrats should be free to disagree with films made by Citizens United, just as many Republicans disagree with films made by Mr. Gore and Michael Moore.
That's a sign of a healthy and vibrant society. Banning films is not.
In Ray Bradbury's novel "Fahrenheit 451," - the temperature at which 'book paper' auto-ignites - Capt. Beatty, who is the chief book burner, said, "If you don't want a man unhappy politically, don't give him two sides to a question to worry him; give him one. Better yet, give him none."
That same sentiment was expressed by the Obama administration, which told the Supreme Court in Citizens United that, in its view, Congress could ban books.
When Justice Anthony Kennedy asked the Department of Justice if the Obama administration was truly arguing that, according to the Constitution, book sales could be prohibited, the Justice official replied, yes, "if the book contained the functional equivalent of express advocacy."
That was a shocking exchange. The government made an unabashed argument for the government being able to stop a book from being sold.
As the ACLU observed, under the Democrats' proposed amendment, Congress could ban Mrs. Clinton's new book, "Hard Choices."
It could ban anti-Hillary movies and pro-Hillarybooks alike. What then would become of our political debates? We would have only that which Congress would allow.
The Democrats, by working to shut down political speech, want to eliminate different sides of our most important questions, just as Capt. Beatty said.
Soon, Senate Democrats will hold their vote on a constitutional amendment to repeal our free-speech protections.
Sen. Cruz provides a commentary we can pray into with full confidence. The most mature and seasoned intercessors among us cannot recall the U.S. Congress being in debate on diluting or negating the First Amendment to the Bill of Rights with regard to free speech. Conservatives and the ACLU are suddenly in full agreement, which, to say the least, is a clue that something is awry. Please pray according to conscience, seeking divine wisdom. Can there be anything more un-American than tampering with the Constitution for political ends?
"Then they cried out with a loud voice, stopped their ears, and ran at [Stephen the Martyr] with one accord, and they casthimout of the city and stonedhim.... Then he knelt down and cried out with a loud voice, "Lord, do not charge them with this sin." (Acts 7:57-58, 60)
"I will stand my watch and set myself on the rampart, and watch to see what He will say to me, and what I will answer when I am corrected. Then theLordanswered me and said: 'Write the vision and make it plain on tablets, that he may run who reads it. For the visionisyet for an appointed time; but at the end it will speak, and it will not lie. Though it tarries, wait for it; because it will surely come, it will not tarry.'" (Habakkuk 2:2-3)
Islamic LEADER AL-BAGHDADI formerly a U.S. captive
A year later, the Multi-National Force-Iraqlabeled him a kidnapper and murderer. It boasted of probably killing him in an airstrike, only to find out it hadn't.
In 2010, the coalition announced his arrest. But whoever it held, it either was notAbu Bakr al-Baghdadi, or he somehow won quick release.
The elusiveal-Baghdadi, known then by his nom de guerre, Abu Du'a, would go on to become the most dominant figure in today's radical Islamic movement.
A Sunni mullah who is in his early 40s and reportedly hails from Fallujah or Samarra,al-Baghdadicommands his own terrorist army and controls much ofIraqnorth and west of the capital,Baghdad, as well as a smattering of towns inSyria.
He also has declared the establishment of a new country - the Islamic State.
Some suggest he is the nextOsama bin Ladenbut with his own expeditionary land force. Last week, Defense Secretary Chuck Hagel upped the ante on a possible war against the Islamic State by calling it an imminent threat to the United States.
"He's a hard-core jihadist," said retired ArmyLt. Gen. William Boykin, who was thePentagon's No. 2 intelligence official. "He has been able to appeal to those who have felt thatal Qaedawas on the ropes after the killing ofbin Laden, and he was able to step in and bring back the pride and the determination of those who really were hard-core jihadists.
"As a result, he's been able to build a strong network of pretty evil people."
On Sunday, Islamic State insurgents rolled unopposed into the town of Duluiyan, 45 miles north ofBaghdad, and seized the mayor's office, police station, city hall and courthouse, The Associated Press reported.
They also blew up a bridge that links the town with the predominantly Shiite city of Balad nearby.
Iraq's military launched a counterattack that drove the militants from part of Duluiyah, but clashes were still raging around the police station and mayor's office Sunday.
Al Qaeda in Iraq
Al-Baghdadibegan as a rank-and-file insurgent fighting Americans in Fallujah, then joinedal QaedainIraq(AQI) under Jordanian Abu Musab al-Zarqawi.Al-Baghdadispecialized in funneling foreign fighters and suicide bombers fromSyriaintoIraqto kill civilians, Shiites and Americans.
The U.S. killed al-Zarqawi in a 2006 airstrike, a death that moved al-Baghdadi up the chain of command.
In April 2010, the U.S. scored another big blow, killing al-Zarqawi's successor, Abu Abdullah Rashid Baghdadi as he hid in a safe house in Tikrit.
Iraqi Prime Minister Nouri al-Maliki personally announced the killing as officials spoke of the demise ofal QaedainIraq.
The assessment was premature. Abu Abdullah Rashid Baghdadi's death marked the last major hit against AQI and its new Islamic State ofIraq(ISI). The U.S. troop presence grew short, and counterterrorism was being handed over to the Iraqis, who would prove to be incompetent.
Al-Baghdadi, a reclusive leader rarely mentioned in the news media, took over. Based in Mosul, he showed himself to be as ruthless as his forerunners but perhaps more visionary. He viewed the organization as not just terrorists but as an army that could take territory and form an Islamic nation, or caliphate. And he assembled a potent propaganda machine.
He molded his fighters in his image - Muslims willing to inflict mass killings and beheadings on other Muslims in the name of Allah and harsh Shariah law.
Al-Baghdadi's work as a foreign fighter facilitator early in theIraqinsurgency provided the connections he needed to build a 10,000-strong army that could exploit the Syrian civil war across the border while surging for a major offensive insideIraq.
Waves of attacks
When U.S. troops leftIraqin 2011, he sprung a new war againstBaghdad, conducting assassinations and deploying car bombs in synchronized attacks.
As head of the then-ISI, he announced the start of the "Destroying the Walls" campaign of violence to wrest control of northern Iraqi cities.
"Two days later, a massive wave of attacks struck over 20 Iraqi [cities] and left more than 115 dead," said a report by the Washington-based Institute for the Study of War. "The 'Destroying the Walls' campaign indicates the degree to which ISI has grown in its ability to plan, coordinate and execute attacks since the withdrawal of U.S. forces."
Displaying a new ability to coordinate attacks, ISI detonated 30 vehicle bombs nearly simultaneously in 20 different cities. More waves of attacks followed as Iraqi forces showed themselves to be incapable of finding and targeting terrorists despite years of U.S. guidance.
A formerPentagonofficial called the Iraqis "the best checkpoint army in the world," meaning they had no stomach for dangerous counterterrorism raids.
Meanwhile,Syria's civil war had begun in the spring of 2011.Al-Baghdadi's fighters began moving freely fromIraqtoSyriaand back as his army swelled. Thus was born the Islamic State of Iraq and the Levant (ISIL), the precursor of the Islamic State.
"ISIL is the new face ofal Qaedaand radical Islam," said retired Army Gen. John Keane, an adviser to U.S. commanders during theIraqcounterinsurgency. "They are accomplishing what the 9/11al Qaedaalways dreamed about until they overreached and attacked the American people. ISIL intends to destabilize the Middle East and then dominate it regardless of whether a country [has] a Shia or Sunni majority."
'More capable, dangerous'
Analysts say the Islamic State is the most savvy terrorist group in exploiting social media and getting its messages and images out via the traditional press.
In April, two months before it launched the current offensive, the Islamic State took the unprecedented step of publishing a 400-page list of all its attacks - sort of an annual corporate report on murder and mayhem.
"The insights gleaned from the ISIL's accounting of its operations, even allowing for some exaggeration in their own reporting, indicate the group is more capable, dangerous and organized than most mainstream media outlets gave it credit for prior to this month's alarming activity, and it will likely remain so regardless of how the short-term military campaign ends," said a report by the Combating Terrorism Center at the U.S. Military Academy at West Point, New York.
The U.S. now has a $10 million bounty onal-Baghdadi's head for information leading to his capture.
But the hunt is limited. When the U.S. dispensed with al-Zarqawi and his successor, it employed the full might of Joint Special Operations Command and a host of intelligence assets. Those man hunting elements have since packed up and gone home.
If those assets could not killal-Baghdadibetween 2005 and 2011, there is doubt thatIraq's security forces, aided by limited U.S. intelligence, can find him today.
He has proven slippery.
The allies picked him up in February 2004 in Fallujah as Sunni militants were organizing a terrorist cell to seize the town. A month later, they killed four Blackwater security guards and mutilated the bodies - a harbinger of the long war that lay ahead for control ofIraq.
APentagonstatement last week referred to Fallujah asBaghdadi's hometown. Other sources say he is from Samarra, a town of 350,000 north of Fallujah, where he was said to preach and study Islam.
ThePentagonsaid authorities gave him an "unconditional release" 10 months later in December 2004 on the recommendation of what was called the Combined Review and Release Board.
There are no records to indicate he was ever held again in a coalition prison, thePentagonsaid. A former Army officer has been quoted in news stories as sayingal-Baghdadiwas held at Camp Bucca until 2009, when he was released as the prison was being shut down and captives transferred to Iraqi control.
The command in 2004 apparently did not know it controlled one of the most ruthlessly committed insurgents loyal tobin Laden.
Within months, he was going by the name Abu Du'a and was in the business of trying and executing Iraqis in Qaim, a border town near Syria.
Al-Baghdadi's reputation for kidnapping and murder was such that when the U.S. command thought it had killed him in October 2005, it put out a press release.
Hard to kill
"Coalition forces conducted an airstrike that hit a terrorist safe house and likely killed a senioral QaedainIraqforeign fighter facilitator in al Ushsh, near al Qaim, October 26," said the press release. "Intelligence sources indicate that Abu Du'a, who helped Syrian and Saudis enterIraqto intimidate and kill Iraqi citizens, was in the house at the time of the strike."
The command statement marked one of the most extensive public profiles ofal-Baghdadi until years later, when he emerged as AQI leader.
"According to intelligence sources, Du'a was connected to the intimidation, torture and murder of local civilians in the al Qaim area," the command press release said. "Du'a held religious courts to try local citizens charged with supporting the Iraqi government and coalition forces. He would kidnap individuals or entire families, accuse them, pronounce sentence and then publicly execute them."
It added: "While Abu Du'a's body has not yet been recovered, the airstrike effectively destroyed the building he was believed to be in."
Five years later, the coalition believed again that it had neutralizedal-Baghdadi.
In December 2010, an Iraqi general went on state-run TV to announce Abu Du'a's arrest in Anbar province.
"We managed to arrest most of the commanders of [the]al Qaedaorganization in [the] Al-Anbar Governorate," the general said, according to the BBC. "And this led us to arrest Dr. Ibrahim Awwad Ibrahim al-Samarra'i, who goes under the nom de guerre Abu Du'a, and who is considered to be the mastermind of this organization."
He added: "We affirm that the ISI has begun to collapse and, God willing, it will no longer have any presence on the Iraqi soil."
It appears no one is quite sure exactly who this international terrorist is, and whether the mystery relates to poor record-keeping or something more sinister in allowing a prisoner to slip through the U.S. justice system in the ongoing "war against terror." Pray for wisdom and clarity for U.S. officials in identifying, processing, and bringing such prisoners to trial more quickly in a just and humane way. While we may not take vengeance individually, God's Word gives the state the responsibility to seek just punishment for terrorist crimes.
"Let every soul be subject to the governing authorities. For there is no authority except from God, and the authorities that exist are appointed by God.... For rulers are not a terror to good works, but to evil. For [the law's representative] is God's minister to you for good. But if you do evil, be afraid; for he does not bear the sword in vain; for he is God's minister, an avenger toexecute wrath on him who practices evil." (Romans 13:1-4)
Although the study was conducted in mice, it does reinforce the idea that, in humans, maintaining an active mind may help delay or even prevent Alzheimer's disease.
"This has shown for the first time that using your brain can protect you physically," said Kim Green, co-lead author of the study and a postdoctoral researcher at the University of California, Irvine. "We show that when you do this, it causes changes in the brain, and these changes are protective."
"It's an interesting study, and part of what it does is advance the notion that mental exercise has a protective effect against Alzheimer's," said Dr. Gary Kennedy, director of geriatric psychiatry at Montefiore Medical Center in New York City.
According to the Alzheimer's Association, about 4.5 million Americans have the brain-robbing disorder, a number that has more than doubled since 1980. Many more suffer from cognitive impairment, which could be a harbinger of Alzheimer's.
Many experts believe that Alzheimer's is caused by a steady accumulation of amyloid plaque proteins in the brain.
Previous studies had shown that "mental exercise" could delay the onset of the disease, but the proof came only in the form of memory and other cognitive testing measures.
The authors of this study, which is published in the Jan. 24 issue of the Journal of Neuroscience, wanted to see if there was a biological correlation for those encouraging results.
The study involved hundreds of "transgenic" mice -- mice that had been genetically altered to develop human Alzheimer's disease.
Mice in a "learning" group were allowed to swim in a tank of water until they discovered a submerged platform on which to stand. This training took place four times a day for one week at two, six, nine, 12, 15 and 18 months of age. The other group of mice swam in the tank just once before their learning and memory skills were tested and their brains examined.
Mice up to 1 year old in the learning group developed 60 percent less of the proteins that form plaques and tangles compared to mice in the non-learning group, the researchers found.
"The sort of learning we gave the animals was fairly mild, yet it still had a big effect," Green said.
However, by 15 months of age, the learning mice had declined and were now physically and cognitively identical to the non-learning mice.
Can these findings be extrapolated to humans?
"We do find a lot of similarities, but clinical data also backs up what we've shown in this study," Green said.
"I think it's reasonable to extrapolate," Kennedy added. "The recommendation certainly is to keep your mind active."
"Think of the brain as a computer," Kennedy continued. "Alzheimer's degrades the hardware, and education enhances the software. The brain is also a muscle, and conditioning may protect it."
Green and his colleagues hope to use the information to one day develop a drug for the disease.
The emerging evidence is not surprising. God, as Creator, has given mankind a brain so complex that modern medicine, with associated research, is just beginning to understand its depths and intricacies. As more light emerges, pray that wisdom will accompany knowledge. Society should not be tucking seniors away in "storage" but should design activities to keep mental faculties alert and active. Churches and Christian nursing facilities can lead the way in this redemptive service. Pray that researchers with Christian faith will include praise and worship songs in such activities.
"Bless theLord, O my soul; aAnd all that is within me,blessHis holy name! Bless the Lord, O my soul, and forget not all His benefits: who forgives all your iniquities, who heals all your diseases, wWho redeems your life from destruction, who crowns you with lovingkindness and tender mercies, who satisfies your mouth with goodthings, so that thatyour youth is renewed like the eagle's. TheLordexecutes righteousness and justice for all who are oppressed." (Psalm 103:1-6)
'Right to try' not just bandage on chronic wound
'Right to try' gives hope to patients who have none. The public wants right-to-try laws, but the FDA does not like them. In a recent editorial in USA Today, FDA Commissioner Margaret Hamburg wrote, "The column 'Right to try experimental drugs: Column' misleads the public on the Food and Drug Administration's approach to allowing access to experimental drugs The agency is an important part of the process, helping to ensure that patients are protected from potentially harmful drugs or one that doesn't work ..."
The FDA response is at the heart of the problem. Notice the commissioner's use of the word "protected." When a patient is dying, who or what are they trying to protect? The benefit-to-risk ratio is overwhelmingly favorable in this setting with virtually any experimental product. According to Section 1003, Subpart 1 of the Federal Food, Drug, and Cosmetic Act, "The Administration shall promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner "
Oddly, this is not what theFDAsays about itself. Instead, theFDAwebsite states: "What We Do. [The]FDAis responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices."
"Promoting" and "protecting" are not synonyms that can be freely interchanged; they represent completely different ideologies. Protecting serves to further preserve the antiquated medical status quo. It assumes current medicine is always safe, when that is often not the case.
What about misleading the public? In a May piece inFDAVoice, the commissioner touted the fact that in 2013, the approval times for drugs was faster in the United States than in Europe and Asia. From 2003 to 2014, the median approval time in the United States was 304 days. The article omitted the fact that these are "review days," as opposed to "calendar days," that theFDAstarts and stops the review clock at its discretion and that the statutory requirement is 10 months for every drug, not a median performance metric for all drugs. This is the reason for incessant calls forFDAreform.
The commissioner went on to laud new legislation that was passed in July 2102 called FDASIA (FDASafety and Innovation Act), which included the new Breakthrough Therapy Designation. Since the enactment of this piece of legislation, 44 products (of the 178 that applied) were granted the designation and six products were approved. The piece highlights the approval of "a late-stage lung-cancer drug" four months ahead of its goal date (as defined by PDUFA - Prescription Drug User Fee Act).
The details about this product (Zykadia) were not mentioned. The drug is approved to treat patients with lung cancer that possess the ALK mutation, which make up 5 percent to 7 percent of all non-small-cell lung cancer, and who have failed or are intolerant to Xalkori. This is a very small number of patients - so small that the drug received Orphan Drug Designation. Not only that, the drug also received Priority Review and Accelerated Approval, rendering Breakthrough Therapy quite moot.
As Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, stated in May at a Friends of Cancer Research meeting, Breakthrough Therapy is intended for products that show "spectacular results" and would be "game changers." The circumstances in which this would most likely occur are in niche settings where there are no alternative treatments so that the benefit-to-risk ratio would be overwhelmingly positive.
Sure enough, 34 percent of drugs receiving this redundant and superfluous designation have been targeted cancer drugs. The travesty is that this program and the others encourage drug makers to develop products for small niche claims.
Americans want drugs for all conditions approved faster - that's what right-to-try is all about. They want theFDAto promote health, not to protect the medical status quo; to review all drugs quickly, not just those that could provide "spectacular results" in the estimation of theFDA.
Right-to-try is the latest Band-Aid on the chronic wound ofFDAperformance. Bandages before it that have failed include PDUFA, MDUFA, Breakthrough Therapy and the Transparency Initiative. The reason for failure is because none of them address the fundamental problem causing the wound; that is,FDA's ideology.
As with chronic wounds, when the fundamental medical condition is not addressed, amputation is the unfortunate next step to save the patient. (Contributor: Joseph V. Gulfo, M.D. for The Washington Times)
This doctor is arguing for more help for patients who have little hope and for whom the FDA's present regulations would cut off treatment as "hopeless cases." This is not arbitrary cruelty but prompted by the allocation of funds. However, the net result is that terminally ill patients, especially the elderly, are deprived of possible opportunities for a better quality of life, whether their months and years are greatly prolonged or not. Pray for honesty, equity, and fairness in FDA decisions. Pray that patients' rights do not become a political "lottery."
"Take away from Me the noise of your songs, for I will not hear the melody of your stringed instruments.But let justice run down like water, and righteousness like a mighty stream." (Amos 5:23-24)
"When Jesus saw this, He became furious and told them, 'Let the little children come to me..." (Matt.10:14 ISV). Other translations say He was "moved with indignation" or "became indignant." Why the intense display of emotion?
The old classic hymn makes it plain. "Jesus loves the little children. All the children of the world. Be they yellow, black or white, they are precious in His sight. Jesus loves the little children of the world."
After touching them as a token of affirmation and blessing (today He'd most likely give them a fist-bump and a high-five!), Jesus did what He always did after ministering to children - release them back to dad and mom.
Though the case could be made that these little ones would certainly fare better leaving parental ties to enjoy a better way of life by following the One who could heal any sickness, feed multitudes and provide extraordinary instruction, Jesus Christ modeled a maxim throughout His ministry: Express compassion. Honor authority.
A similar standard of conduct relevant to us today would be, "Demonstrate love. Uphold law."
In light of the continuing illegal immigration crisis and humanitarian crisis now exacerbated by the recent unprecedented surge of over 60,000 children from Central America crossing our border without parental oversight, we'd do well to follow the method of the Master before this steady flood becomes an overwhelming tsunami.
Many well-intentioned but I believe misdirected individuals (I respectfully include here our President, influential politicians and news commentators) seem to believe the compassionate solution to the escalating border crisis is to extend our arms and declare, "Ya'all come in!" Guilt is projected on those who sincerely disagree and dare to say, "You're missing it and not handling this the way Jesus would."
Boundaries and Borders
When it comes to immigration policy, there are many influential leaders whose philosophy is to have "open borders" removing limitations and giving access to all desiring to come.
Our President will cite our motto "E pluribus unum" (Out of many, one) and try to strike a sympathetic cord in saying "Don't make it harder for the best and the brightest to come here!"
While I pray for President Obama every single day (for 38 years I've served as a board member at Intercessors for America promoting prayer and fasting for our nation), I strongly yet respectfully disagree with his handling of this entire crisis over the years.
Here's the deal: Amidst all the turmoil and confusion, it's time to embrace scriptural counsel from the Good Shepherd who referred to himself as the "Gate" stating, "I tell you the truth, anyone who sneaks over the wall of the sheepfold rather than going through the gate, must surely be a thief and a robber" (Jn. 10:1).
3 Steps to Solve the Crisis
As we proceed, let's remember that immigration is a very volatile issue. Character is revealed when we listen respectfully to others with whom we disagree. We must choose to remain civil in the midst of spirited discussion. If we resort to name calling and arrogant attitudes, we'll experience the inevitable. "If you bite and devour one another, take heed lest you are consumed by one another" (Gal. 5:15).
1. Extend genuine love to all immigrants.
God commands us to love our neighbor as a directive not an elective. Love is not based on emotion or sentiment but an unselfish choice for the greatest good of another person. As the bumper sticker says, "Love is a verb."
God directs us to "help the weak and be patient with everyone" (1 Thess.4:13) plus care for the poor, widow and orphan (Jam.1:27-8; Gal.2:14).
In the Old Testament, immigrants were to be granted acceptance (Lev. 19:33-4; Ex.22:21); given opportunities to collect food (Lev.19: 9-10); and were to be treated justly (Lev. 1:16). This was not some blanket entitlement, as God required the immigrant to keep the laws of the land just like the native people (Ex. 12:48-9: Ex. 23:12).
2. Respect realistic limits.
Just as boundaries need to be determined and adhered to on the personal level, so too does this apply on the national level. Disregarding this principle brings disastrous results.
Idealism says, "Open the gates and let everybody in!" Realism says, "Assess our resources and capabilities to responsibly determine what we can do at this particular time."
"Lord you have assigned me my portion and my cup, you have made my life secure. The boundary lines have fallen for me in pleasant places, surely I have a delightful inheritance" (Ps. 16:5-6).
Individuals who discipline themselves to honor their God-given assignment and boundaries find security, a pleasant life and a delightful inheritance. This is why the apostle Paul wisely told a church, "We however will not boast beyond proper limits but will confine our boasting to the spheres of service God himself has assigned us, a sphere that also includes you" (2 Cor.10:13-14).
If a lifeboat has a sign stating Limit of 12, it may appear compassionate to try and rescue 25, but the result can be the drowning of everyone!
Headlines last week stated that it now takes approximately $130,000 yearly for a family of four to fulfill the American Dream. Assessing their current station in life, a couple decides that two, three or maybe four children are probably the limit for them. Is it right for someone to chide this couple for not being like the Duggard family with 19 children?
Today America faces over $17 trillion in debt. Cities are going bankrupt or on the precipice of insolvency. The welfare system is exploding. We are stretched to the max in our emergency rooms, schools, healthcare and social service agencies.
The New York Times on July 4 weekend said that we have added 300,000 more illegal immigrants since April 2014. At present, the floodtide shows no signs of receding.
Isn't it common sense that we appeal to those who may be well intentioned but could be taking us on the path to destruction if we are not responsible in setting realistic limits for immigration before it's too late?
3. Obey the government and its laws.
This point is so plainly simple yet blatantly disregarded, it's embarrassing that it has to be stated!
God tells us, "If you are willing (consent in your wills) and obedient (carry out the action) you shall eat the good of the land (reap abundant blessings)" (Is.1:19). One result of obedience is that immigrants shall not devour a nation's crops (see v.7). Sadly, hasn't this been happening?
It is unmistakable that the divine directive is for citizens to obey the governing authorities (Rom. 13:1-7; 1Pet.2:13-14). The one exception is if government forces us to violate a law of God (Acts 5:29). Why is this so difficult for many American citizens and illegal immigrants to grasp?
In our nation, when citizens sincerely believe that a law is unfair and should be changed, we have the recourse of doing it! Until such time, existing laws need to be obeyed or the result is lawlessness, which we are seeing increasingly in our country.
Be honest, what is your reaction when you have stood in line for 20-30 minutes for a ticket or restaurant seat and someone selfishly barges in line? "Hey! Hey! Excuse me, you need to wait in line like the rest of us!"
This is not an insurmountable task. Local post offices can be used for registration. Illegal immigrants can be told they have 30 days to comply, receive help in the 8-step process for citizenship, plus secure their identification card (green card) attesting to their permanent residence. Sponsors can be invited to come forth and serve as a "big-brother" or "big-sister" supporting our immigrant friends who are understandably insecure and apprehensive. And yes, failure to comply would result in fines and/or possible jail time to impress upon individuals the seriousness of getting this done once and for all. Only then can we as the American family begin to put this unfortunate chapter behind us to find a brighter future.
"But Larry, this would probably cost money. Can we afford it?"
Our President has recently asked for $3.7 billion to basically alleviate the humanitarian crisis on our southern border (which should never have happened in the first place!). Only 1.8% is suggested for bolstering border security which is critical to resolving this crisis and avoiding similar crises like this in the future. Why don't we direct a larger amount to support the immediate training of qualified Border Patrol agents; deploy at least a 1,000 National Guard troops to the southern border; utilize daily drone flights along the border to identify those involved in human trafficking and drug cartels; extend the long overdue border fence (Yes, walls and fences do work or why else do we have them around the White House? Israel and China have relied on them for decades). Finally, allocate generous amounts to compensate the kindhearted citizens who respond to the call for a national sponsorship service corps (N.S.S.C.).
Come on. Let's get going and get this done! Projections for unaccompanied immigrant children are currently 90,000 for this year and 150,000 for next year! The heinous crime of human trafficking is epidemic. Parentless children warehoused in close-knit conditions are an invitation for abuse of every kind, plus a breeding ground for communicable diseases like polio, tuberculosis, flu and measles. This public health risk is only exceeded by the national security risk of terrorists and drug cartel members slipping into our nation to link with sleeper cells.
This is a pivotal time and a defining moment in our history. We need a unified response here in America and among our Central American partners who need to know that we will severely curtail financial aid if they fail to cooperate. One leader has even called for a boycott of Mexico tourism until they comply.
Jesus loves all the little children of the world. He modeled the maxim of demonstrating love and honoring authority.
We've squandered enough time and treasure trying things our way. It's time we humble ourselves and embrace the method of the Master.
Larry Tomzcak presents an excellent summary from a biblical viewpoint. Our prayers should focus not on "either-or" but on "both-and." While these displaced children are in the U.S., they must be fed, clothed, protected from abuse, and treated medically. However, we must not assimilate 60,000 (soon to be more) simply because they have entered illegally. Airplane tickets for "home" would cost in the area of $10 million, while President Obama seeks $3.7 billion. Congress is asking "Why?" Pray fervently for a quick solution to resolve the impasse.
"The instant I speak concerning a nation and concerning a kingdom, to pluck up, to pull down, and to destroy it, if that nation against whom I have spoken turns from its evil, I will relent of the disaster that I thought to bring upon it. And the instant I speak concerning a nation and concerning a kingdom, to build and to plant it, if it does evil in My sight so that it does not obey My voice, then I will relent concerning the good with which I said I would benefit it." (Jeremiah 18:7-10)