Thurs/Noon ~ TheFrontPageCover

The Front Page Cover
Fight over FDA and 'right-to-try' laws
moves from states to Congress
by Laurie McGinley
 Forcing 'Gender' Conformity 
On Friday, the Associated Press further embraced the transgender revolution via an email released to subscribers in which it listed updates for its style manual. These included an official redefinition to its understanding of the term "gender." The AP has concluded that "gender" is not "synonymous with sex," stating, "Gender refers to a person's social identity while sex refers to biological characteristics." The AP continued, "Not all people fall under one of two categories for sex or gender, according to leading medical organizations, so avoid references to both, either or opposite sexes or genders as a way to encompass all people." This has continued a long trend of redefining terms. But it's not just style manuals. It's forced conformity in life.
          At a high school in Jasper, Indiana, a creative student produced and displayed copies of a flier entitled "Straight Pride." The flier humorously and pointedly stated, "Celebrate being straight at JHS by not annoying the heck out of everyone about your sexual orientation! It's easy! Just come to the JHS, then you go about your day without telling everyone about how 'different' and 'special' you are!" School officials quickly removed the fliers, and superintendent Tracy Lorey told parents that the fliers did not represent the majority of the students: "It is our intent to provide students opportunities to express themselves in a way that helps them to be understanding of the unique qualities of all individuals." In other words, they only allow expressions of "diverse" thought which they find acceptable.
          And of course, there is no room for freedom of speech or religion when it comes to the Left's sacred cow of sexual deviancy. They seek to get one fired for holding the wrong opinion, whether it's Mozilla's Brendan Eich or the celebrated firing of an old coworker who wouldn't bow to using the "right" pronoun. They pressure companies and sports leagues to boycott an entire state over a common-sense bathroom law as in North Carolina. They shut down a mom and pop bakery for refusing to bake a cake for a same-sex wedding. They demand language usage be changed to accommodate the delusions of "non-binary" sexuality. Conformity, not diversity, is what the Rainbow Mafia and the Left demand.  ~The Patriot Post
Head Clown Schumer Quite Impressed
With Himself, Without Justification
by Rick Wells
{} ~ Lou Dobbs has a few thoughts “on the man President Trump has proclaimed as the head clown. Senate Minority Leader, Chuck clown-Schumer has caricatured himself with his over the top mendacity, his petty partisanship and just plain meanness... His powerful sense of self-importance was manifest in an interview with Politico today. How so, you ask, and clown-Schumer delivers.” Dobbs relates clown-Schumer’s story, how after the election “clown-Schumer was distraught and the divine, he says, interceded to lift his sagging spirit. He said it was like a thunderbolt hit me, almost a message from God.  I said to myself, if liar-Hillary won and you were majority leader job would be more fun and it would be a lot easier. But with Trump as President and you as Minority Leader, the job  is much more important.” Dobbs is impressed, noting, “Much more important, wow. The Minority Leader even going so far as to predict victory for Dems if there is a government shutdown, and in his resurgent mood and high-flying esteem he sees only good in the confirmation  battle over Supreme Court nominee Judge Neil Gorsuch.”...
Dem lawmaker tips off illegals in MS-13 hotbed
by Chelsea Schilling
{} ~ A Democrat state lawmaker in Massachusetts has been caught tipping off illegals – many of whom are violent street gang members, child sex offenders and drug traffickers... to imminent Immigration and Customs Enforcement raids Tuesday, even telling criminal targets not to open their doors, to stay silent, to refuse to sign anything and to “fight back” with an attorney. An Immigration and Customs Enforcement spokesman suggested to WND that the lawmaker is “doing a disservice to the community” and “endangering public safety” with her statements. Massachusetts State Rep. Michelle DuBois, a Democrat representing the 10th Plymouth District, warned illegals about imminent federal immigration raids scheduled for Tuesday and Wednesday in Brockton, a city just 25 miles outside of Boston. DuBois posted the warning on her Facebook page. She included a phone number illegal aliens may call if they’re caught in an immigration raid...This is Treason and should be charged.
Adam “Shifty” Schiff Should Recuse Himself
As Ranking Dem On Intel Committee
by Rick Wells
{} ~ Mark Levin tells his audience, “It’s time to go on offense. Let me show you how to play. I’m calling for Adam Schiff to recuse himself as the ranking Democrat on the House Intelligence Committee... given the fact that he was such an avid supporter of liar-Hillary Clinton for President of the United States.” Levin continues, “Given the fact that he was a cover up artist during the Benghazi operation, given the fact that he’s demonstrated his unwillingness to be bi-partisan by his calls for Jeff Sessions to step aside. He’s called for a special prosecutor,” Levin notes, “now he’s called for an independent committee, which he’s actually called for some time.” He says, “Adam Schiff has shown himself to be a radical leftist partisan hack, who cannot be trusted in an independent investigation of any sort, on the intelligence committee, quite frankly or on any other committee...I agree with Levin and others should also.
Lost Privacy Rights in America
by Stephen Lendman
{} ~ America is a total surveillance society. Big Brother is no longer fiction. Sophisticated technologies make total monitoring possible, everyone vulnerable, including presidents... All our moves, transactions and communications can be recorded, compiled and stored for easy access. Anything we say or do can be used against us. Bill of Rights protections no longer apply. Collecting meta-data communications on Americans is unrelated to national security. Judicial oversight is absent. Congressional members are told little about what goes on. The CIA, NSA, FBI and other US spy agencies operate ad libitum, doing whatever they wish unaccountably...
Why Intel Committees Not Investigating
liar-Clinton Real Russia Collusion Corruption?
by Rick Wells
{} ~ Sean Hannity sets up the segment with questions that those of us in the masses that are the silent majority have been screaming to have answered for over a year... He references a single “donation” of $31 million to the liar-Clinton Foundation by a Canadian who accompanied Bill liar-Clinton on a suspicious trip to Kazakhstan. There’s the other millions that were donated in addition to the doubling of the already outrageous speaking fees for the sexual predator ex-president, and his wife, the Secretary of State, liar-Hillary Clinton “signed off on Russia getting 20% of America’s uranium.” Any of these individually would  be cause for concern. Taken in their totality they spell fraud, conspiracy, racketeering and treason. Gingrich notes that “it is very strange that both the House and Senate Intelligence committees are chaired by Republicans, and yet all of the noise is about phony charges involving Donald Trump.”...
Fight over FDA and 'right-to-try' laws
moves from states to Congress
by Laurie McGinley
{} ~ "Where's Jordan?" asked Vice President Mike Pence as he walked into the White House meeting of terminally ill patients and their families. All eyes shifted, and Pence made a beeline for a 7-year-old boy from Indianapolis with a broad grin.

Back home, when Pence was Indiana's governor, Jordan McLinn and his battle with Duchenne muscular dystrophy had helped inspire passage of a state "right-to-try" law intended to give the desperately ill access to medications not yet approved by the Food and Drug Administration. Fast forward to Washington, D.C., where Pence is now in a position to encourage national right-to-try legislation.

"We're going to get this done," he assured Jordan's mother, Laura McLinn, and the other families gathered last month.

Thirty-three states have passed such laws, which ostensibly allow patients to take experimental medicines outside of clinical trials and without FDA oversight as long as the therapies have undergone preliminary safety testing. Many of the remaining states are considering such bills or are expected to do so.

And now, for the first time, federal legislation is gaining traction.

Congressional supporters may try to attach a measure - drafted with a unique and highly controversial restriction on the FDA - to the agency's must-pass funding bill this year. The anti-regulatory mood dominating Washington is boosting these efforts.

President Donald Trump recently weighed in, accusing the agency of denying drugs to patients with terminal conditions: "The FDA says, 'We can't have this drug used on the patient' . . . but the patient is not going to live more than four weeks!"

The right-to-try campaign is the ultimate in patient empowerment, according to its champion, the Goldwater Institute, a libertarian nonprofit organization that wrote the model legislation that has become the foundation of most statutes. "It represents a unanimous voice from the states and the people saying that patients ought to be able to make these life-or-death decisions to save their own lives," said the institute's executive vice president, Christina Sandefur.

But the increased momentum is raising alarms, with opponents saying that such laws largely offer false hope. That's because many drug companies are reluctant to provide medications outside of clinical trials - and why critics insist that the FDA is not the problem. In 2016, they note, the agency revamped its "expanded access" program to speed unapproved drugs to patients who have no alternatives and can't get into clinical trials. The FDA approves almost all such requests, the data shows.

"A lot of this is smoke and mirrors for some other agenda," said Andrew McFadyen, executive director of the Toronto-based Isaac Foundation, which assists U.S. and Canadian patients seeking access to medications. "A weaker FDA is what they are after."

The legislation pushed by Sen. Ron Johnson, R-Wis., and Rep. Andy Biggs, R-Ariz., would forbid the federal government from interfering with the state laws and would exempt doctors and drug companies from liability for prescribing or providing experimental drugs. It also would limit the FDA in an unprecedented way: If a patient were injured or killed by an unapproved treatment under a right-to-try law, agency officials would not be allowed to use the information to delay or block approval of the treatment.

Supporters say such a provision is crucial to spurring drug companies to make experimental drugs available to terminally ill patients, without worrying that an "adverse event" could prompt the agency to stop a trial conducted as part of the drug-approval process.

The notion that the FDA would be barred from considering all data has consumer advocates, ethicists and drug-safety experts in an uproar. If a person is harmed by an experimental drug, they say, that has implications for anybody who might eventually take the medicine.

"The idea that you blind the FDA to any negative side effects in using an investigational agent is just nonsensical," said Alison Bateman-House, a bioethicist at the New York University School of Medicine.

FDA Associate Commissioner Peter Lurie told the Senate Homeland Security and Governmental Affairs Committee at a hearing in September that the provision would "be detrimental and raise significant ethical issues." With 11,000 expanded-access requests over the past decade, he said, only twice did the agency temporarily halt clinical trials because of "adverse events." Both times, drug development resumed after the problems were resolved.

Right-to-try opponents are also skeptical that constraining the FDA would be enough to induce pharmaceutical companies to make unapproved drugs available. Manufacturers, they say, don't like to provide experimental therapies in part because they don't want to be besieged by desperate patients but also because of the potential cost involved.

The drug companies' main lobbying group, the Pharmaceutical Research and Manufacturers of America, is noticeably cool to right to try, saying that "any legislation should protect the integrity of clinical trials and the FDA oversight of expanded access to maintain the best interests of patients." Those interests, others say, include protecting terminally ill patients from spurious therapies.

Right-to-try supporters reject that latter point as paternalistic. Even if a federal law does not end up helping patients, it won't hurt them either, they insist. "We're asking for a very special carve-out for a very small exception that doesn't cost us any money," said Matt Bellina, a Navy veteran with amyotrophic lateral sclerosis, or Lou Gehrig's disease, who testified at last fall's hearing. "I'm not asking to build a wall. I'm asking you to make an exception for people who really need it."

He added, "At some point in the near future, I'm going to suffocate under the weight of my chest, so what difference does it make if we have a side effect?"

Traditionally, these patients have received unapproved treatments by enrolling in a clinical trial or, if that is not possible, by going through the FDA's expanded-access program. The program allows the agency to authorize use of an unapproved therapy if it determines that the drug's potential benefit justifies the treatment risk.

The FDA concedes that the program's requirements once were too complicated and time-consuming; its application form called for 26 types of information and seven attachments, Lurie wrote in a blog post. By contrast, officials say, the streamlined process takes doctors just 45 minutes. Last year, 99 percent of the almost 1,800 requests were approved, many in just hours or days.

Still, right-to-try supporters argue that the FDA should be getting far more requests and that the low numbers suggest many doctors still find the process too daunting.

Yet state right-to-try laws, with their minimal requirements, aren't being used much. There are almost no reports of doctors turning to the laws on patients' behalf. The one exception: Houston radiologist Ebrahim Delpassand, who treats patients who have lethal neuroendocrine tumors. The Goldwater Institute frequently points to him as an example of a physician utilizing right to try.

Delpassand said Friday that he turned to the Texas right-to-try law in 2015, not long after its passage, to increase the number of patients he was treating using an experimental radioisotope therapy. The FDA had earlier denied his request to add patients. Officials declined to comment, citing confidentiality rules.

In Indiana, Jordan McLinn was 3 years old when he was diagnosed with Duchenne muscular dystrophy. "We know what happens," his mother said recently. "You lose muscle function, and then you die."

A couple of years later, a friend pointed out a story in the local newspaper about a state legislative hearing on a right-to-try bill. Jordan testified and quickly became the public face of the legislation. When Pence signed the bill into law, the boy was at his side.

Laura McLinn initially hoped that the measure would help her son get an experimental therapy, but the manufacturer declined to make it available. Jordan is now participating in a clinical trial run by a different company.

Three infusions in, Jordan's mother thinks that he is much improved. On a family vacation, he was full of energy and raced past his parents to the beach. "That has not happened in two years," she said.

She plans to keep working on right to try, though it never benefited Jordan. "If even just one person finds the one doctor and one drug company to help," she said, "that's important to my son."
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