Big Government obstructs a persons “Right to Try” [to stay alive]

If a ship was sinking, you would want the right to cling to anything that might save your life, even if not officially sanctioned by the government. If lifeboats were available but not Federally approved due to the possibility of leaking, should a person not be allowed access to that chance? Leftist government says no.

Opponents of the approach call it an ill-advised effort that circumvents federal law, undermines the drug development process and threatens to harm more people than it helps by providing access to medications that haven’t been proven safe and effective.

“The notion is based on the ‘Dallas Buyers Club’ — the idea that you have to get around the indifferent and cruel government to get access to drugs,” said Arthur Caplan, director of the bioethics division at New York University Langone Medical Center, referring to the Oscar-winning movie based on an AIDS patient who smuggled unapproved drugs into Texas during the 1980s.

The truth is that the system desperately needs reform.

For decades now the Food and Drug Administration has maintained an onerous and slow approval process that delays the debut of new drugs for fatal diseases, sometimes for years longer than the life span of the patients desperate to try them. Attorneys and scholars at the Goldwater Institute of Arizona have crafted legislation for the states that would allow terminally ill patients to try experimental drugs for cancer or degenerative neurological diseases earlier. These “Right to Try” bills are so scripted that they overcome the usual objection to delivery of such experimental drugs: safety. Under “Right to Try,” only drugs that have passed the crucial Phase 1 of FDA testing could be prescribed, thereby reducing the possibility of Thalidomide repeat. Second, only patients determined to have terminal cases would be eligible to purchase the drugs, making it harder to maintain that the drug will jeopardize their lives. Representatives in Colorado, Louisiana, and Missouri approved the “Right to Try” measure unanimously. Citizens of Arizona will vote on the effort to circumvent the FDA process this fall.

In cases of terminal illness, there is just no argument to ban access to potentially life saving medicine. This is not a case of the government protecting people from wasting time and money in unfounded “rhino horn” style scam cures. These are people trying to improve their terminal conditions with medicine that has been tested but continues to be tested for FDA approval, and in some cases approved in other countries.

Regulators and others in the pharmaceutical industry say sidestepping the later stages of testing exposes patients to unknown hazards. The first stage, usually involving only a few dozen subjects, is designed to learn whether a compound is safe for consumption. The laws would give patients medicines before rigorous second- and third-phase trials have established their safety and efficacy compared with placebos. Those later-stage studies help scientists determine proper dosages and understand how a drug affects sick patients who may be taking other medications. “These products have serious risks, and maybe even more concerning, we don’t even know what the risks are,” says Coleen Klasmeier, a former attorney for the FDA who represents drug companies at Sidley Austin. “You can’t just say, ‘Sure, take it. It might kill you, but vaya con Dios.’ ”

The new laws can’t compel pharmaceutical companies to make their newest drugs available before they’ve been vetted. It takes about 10 years and $1 billion to win FDA approval for a compound, and only 16 percent of treatments that begin clinical trials ultimately hit the market. Giving an experimental drug to terminally ill patients could tarnish the safety profile of a new drug out of the gate. “We have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the Food and Drug Administration and clinical trial process,” Sascha Haverfield, vice president for scientific and regulatory affairs at the Pharmaceutical Research and Manufacturers of America, wrote in an e-mail.

Everyone deserves the right to try


Hillary ¯\_(ツ)_/¯


Valerie Jarrett Confronted Over Unequal Pay for Women in White House

“Good morning, Valerie,” Fiorina said, speaking to Jarrett on MSNBC’s Morning Joe. “I think, certainly, every woman on this panel and every woman across the nation agrees that equal pay for equal work is absolutely required. I also think it’s just a fact that laws exist on the books today, and if a woman is being discriminated against because of her gender, she should use the full extent of that law. I am struck by the fact the president hasn’t really led in this regard. He’s not paying women equally by his own measures in his own White House. And I am also struck by the fact that the single greatest impediment to equal pay for equal work is this seniority system, which pays not on merit, not on performance, but on time and grade. And who is it who supports the seniority system? Unions, government bureaucracies, the vast majority of constituencies that the Democratic party represents and who support the Democratic party. So why wouldn’t the White House take on the seniority system and say let’s pay women by merit and by their results? Because based on my own experience, in those scenarios, women will be paid equally.”

h/t Weekly Standard


The American Comeback


GOP Wins Big…


Megyn Kelly debunks “misleading hysteria” on the Hobby Lobby decision

Nancy Pelosi is using the Democratic playbook of using Fear to gin up support for left wing ideology, going as far as to demonize the Supreme Court in factually meritless extreme ways:

“We should be afraid of this court. That five guys should start determining what contraceptions are legal or not. … It is so stunning,” Pelosi said during a press briefing in the Capitol.Pelosi said last week’s Supreme Court ruling that the birth control mandate under President Obama’s healthcare reform law is a violation of religious freedom was particularly egregious.

“That court decision was a frightening one,” she said. “That five men should get down to the specifics of whether a woman should use a diaphragm and she should pay for it herself or her boss. It’s not her boss’s business. His business is whatever his business is. But it’s not what contraception she uses.”

Megyn Kelly tears this fearmongering apart, fact by fact:

Further exposition of Nancy Pelosi’s comments, including Mrs Pelosi’s imaginary “illegalization of diaphrams” which would only affect 21 women in the entire Hobby Lobby workforce contained in this extended deconstruction from The Kelly File:

Jon Stewart helped spread the Hobby Lies as well, dutifully debunked by Kelly once again:

On the O’Reilly Factor:

The myth of the “Tea Party” take-ver in Eric Cantors primary loss

No organized Tea Party groups were particularly vocal in their support of the man who beat Eric Cantor in his primary race, yet the leftist headlines can’t stop sirening the alarms of the “Tea Party” looming clouds. Surprise:

In fact, however, the tea party had nothing to do with Brat’s victory. Only the small, local tea party groups stand for anything anymore, but they’re as different from the media-recognized “tea party” as lay Catholics are from the Catholic bishops.

National tea party groups did not contribute dime one to Brat. Not Freedom Works, not Club for Growth, not the Tea Party Express, not Tea Party Patriots. They were too busy denouncing Sen. Mitch McConnell — who has consistently voted against amnesty.

As I have been warning you, the big, national tea party groups are mostly shysters and con-men raising money for their own self-aggrandizement. (Today, they’re blast-faxing “media availability” notices to television networks claiming credit for Brat’s victory.)

The Tea Party Express, for example, “represents” the views of ordinary Americans by supporting Chamber of Commerce demands for cheap labor through amnesty.

As Eric Hoffer said, “Every great cause begins as a movement, becomes a business, and eventually degenerates into a racket.”

Nonetheless, the claim that Brat’s victory was a win for the tea party is everywhere — pushed with suspicious insistence by people who do not usually wish the Republican Party well. Democratic National Committee Chair Debbie Wasserman Schulz, for example, said: “Tonight’s result in Virginia settles the debate once and for all — the tea party has taken control of the Republican Party. Period.”

Liberals apparently want Brat’s victory to be seen as a win for the tea party, and not a defeat for amnesty.


Obama Administration sides with Big Business against your right to access content on Public Airwaves

Once again, the Obama administration backs Big Business against the rights of the people.

A service called Aereo allows people to access their free local broadcasts delivered over the public airwaves:

Subscribers in the cities Aereo serves pay a minimum of $8 a month. That gives them exclusive access to one of its thousands of dime-sized antennas that pick up free, local, over-the-air broadcasts. The company then streams the live programming in the same local market to subscribers’ Web-connected TVs, computers, or mobile devices.

Cool, right? The Democrats in power don’t think so.

The big boys came out today on the side of the broadcasters in their upcoming appearance in front of the Supreme Court in the Aereo case. The solicitor general’s office put the Obama administration solidly in the anti-Aereo camp with a 40-page amicus brief (read it here) filed with the SCOTUS today. The broadcasters say that Aereo infringes on their copyrights by streaming their over-the-air signals without licenses or compensation. Aereo says that it simply leases out antennas and technology that consumers can already use to watch broadcast TV for free.

If the Obama administration gets its way, it would create a legal precedent that could endanger the ability of consumers to store and access music or videos from cloud storage destinations such as Google Drive. The division:

The American Cable Association, Computer and Communications Industry Association, Consumer Electronics Association, Consumer Federation of America, Consumers Union, Dish Network, Electronic Frontier Foundation, Engine Advocacy, Mozilla, Public Knowledge, and some small broadcasters all filed briefs backing Aereo.

Another hit to the middle class coming along depending on the Supreme Courts ruling on the Aereo case. As with Obamacare’s grant to insurance companies, the Obama administration is siding with the billion dollar corporations

Those against your right to access content on publicly owned airwaves through Aereo’s service include:

ASCAP, the Copyright Alliance, International Center for Law and Economics, Major League Baseball, National Association of Broadcasters, the NFL, SAG, Time Warner, Viacom, and the Washington Legal Foundation 

The actual plaintiffs in the case:

Disney (ABC and Disney Enterprises), CBS (CBS Broadcasting and CBS Studios), Comcast (NBCUniversal Media, NBC Studios, Universal Network Television, and Telemundo Network Group), WNJU, WNET and Thirteen Productions, Fox (Fox Television Stations, Twentieth Century Fox Film Corp), WPIX, Univision (Univision Television Group and the Univision Network Limited Partnership), and the Public Broadcasting Service.

Big Media over the average citizen

The Obama administration is Aereo’s most powerful critic as the case approaches, with a brief submitted to the high court in March accusing the company of violating copyright law. A ruling against Aereo “need not threaten the legality of cloud computing,” the brief says, arguing that cloud-computing services providing access to legal content would be protected by law.

The brief comes from the office of Solicitor General Donald Verrilli, Jr., though he recused himself, and the U.S. Copyright office.


This April Fools Border Security Checkpoint Video will make you wish it were real

This is how government officials should handle such instances but the illustration of it only highlights the contrast from how different the reality really is.