Trump visits library of Congress, deems it a “good framework for something else”

President-Inevitable Donald Trump made a quick stop in Washington today to “do some business.” He’s excited about the opportunities available to a hard-charging mogul who just happens to be President of the United States as well. A spokesperson explained:

Mr. Trump has not yet been sworn-in as President so he is very much like anyone else who is not yet the President. He is excited to consider business opportunities in this great city until noon on January 20 after which he is precluded from doing so because of Democrat over-concern with Mr. Trump’s ability to manage so-called conflicts of interest between matters of state and all-American personal wealth enrichment.”

The crowd nodded that it had heard such talk and mumbled about it with some concern.

Consequently, upon becoming President Trump he will not consult about business matters with family members. They alone will run his businesses into the ground until he returns to private life and can once again do so himself. In the ten weeks before inaugural day, however, Mr. Trump, the mogul, will buy up whatever beautiful D.C.-area properties, businesses, and things he can arrange loans for.’

Of course, Trump’s spokesperson’s preface updates the ongoing negotiations about the structure of a “wall of separation” between the President-Inevitable and family members who will manage complex business deals and their subsequent bankruptcies. Some in the legislative branch (who appear to many as simply jealous) insist that this arrangement will prevent “wholesale robbery of public and international treasuries, consequent world economic depression, social upheavals, and wars of the old-fashioned sort,” a charge, I must in fairness note, level-headed Republicans deem “premature.”

In any event, today, President-Inevitable Trump visited numerous D.C. properties, and even held a festive “Open House” at the famed Library of Congress, from where I am reporting. Businessman Trump spoke from the portico of the Library of Congress to a large group of real estate magnates, world banks, government sovereign fund reps, a score of heads of state, and many persons on temporary leave from prisons around the world, all of them eagerly crying out “Me! Me! Me!” to his request for funding:

This decrepit eyesore, imagine it as a super luxury hotel, mall, and casino, full of restaurants, beauty parlors, and sports bars! Despite the looks of it now, the mechanical foundation this old-school Library building offers will provide a perfect foundation for the new property, and my people think there’s no need to do a single upgrade to its internal fittings, toilets, anything. Isn’t that great folks?”

The President-Inevitable pointed out that potential investors would realize financial benefits immediately upon the Library’s demolition:

“We will carefully – and folks, when I say carefully, I mean carefully – tear down the marvelous and historical facade in a way that will preserve all the gorgeous goo-gabs and foo-foos you see and admire now. We will monetize them, sell them off, and pass through the net-net profits, if any, to you, after expenses. You’re not gonna get a better deal than that. What better way to own a piece of American history too? I know the Russian sovereign fund is eager for that.”

Russian prisoners and officials laughed good-naturedly. A few onlookers, though, wondered aloud their belief the Library of Congress was firstly, a publicly owned building, secondly, a part of the legislative branch, not the executive branch, and thirdly, a national treasure unlikely to be approved for sale, ever. This, of course, if true would create difficulty in obtaining and then transferring legal ownership from the United States to a group of private citizens, heads of state, and inmates, some of whom represent countries inimical to our values, interests, and people. And, in real estate, title is everything. President-Inevitable Trump picked up on these nitty-gritty concerns:

I blame the Chinese. We’ll take care of that. Title to the Library is assured. And remember folks this is an obsolete building. Libraries. You got nothing to tell me about libraries. It’s all cyber now. My ten year-old son Barron tells me he has a dozen books on his little cyber phone. The entire Mein Kampf.Libraries. Twenty-first century losers! The congressmen I talk to have never checked out a book from the Library. Never. But they still throw tens and tens of millions a year at it. Obviously none of that money went to spiffing up the building, now did it folks? Who owns it. Ask around. It’s the Chinese! You ask. Well Chinese domination of the Library of Congress ends on January 20th! I’ve got the Army, the tanks, the bombers, the V-2 rockets. Believe me, I own it as of 12:01 pm on January 20th. No more Chinese. Everyone says so. And the Congress? How are they going to stand in the way? They have the Capitol Hill Police who still ride around on horseback, armed with civil war era flintlocks. So, look, the Library’s for sale! January 20th. Be there.”

His final flourish seemed to settle the issues, if absolute crowd silence represents assent, as I believe it does. In closing, President-Inevitable Trump recited the Gettysburg Address, “for no other purpose,” he said,

than to leave you with something to think about when you consider a respectful bid for the beautiful property you see in front of you.”

Trump Visits Library of Congress, Deems It A “Good Framework For Something Else”

Source Article from http://www.nationofchange.org/2016/11/30/trump-visits-library-congress-deems-good-framework-something-else/

Congress Prepares to Vote on Bill That Would Speed up Drug Approval

Congress will vote today on a nearly 1,000-page bill that holds drastic changes for the U.S. Food and Drug Administration (FDA). If the bill is approved, it would speed up the approval of new drugs and medical devices. The House has been heavily criticized for allegedly rushing piece of legislation through without sufficient scrutiny. [1]

Source: National Center for Health Research

The legislation, dubbed the 21st Century Cures Act, sets aside $6.3 billion for biomedical research, opioid abuse prevention, and support for the FDA, which oversees the safety of drugs. Multiple provisions are contained in the bill that are designed to loosen the requirements for drugmakers seeking approval from the agency to market their products.

Lawmakers on both sides of the aisle largely support the bill, but consumer advocates say major trade-offs in the legislation could actually strip the FDA of some of its regulatory power. Sen. Elizabeth Warren (D-Mass.) and other lawmakers argue the bill contains giveaways for the pharmaceutical industry.

In a tweet dated November 28, Sen. Warren said:

“Congress has been working on medical innovation legislation for yrs. But in the final days of 2016, Big Pharma hijacked 21st Century Cures.”

Drug and medical device companies are thrilled with the legislation, which lobbyists have been working overtime to try and get passed. According to the Center for Responsive Politics, more than 1,400 lobbyists have pushed for the bill’s passage, including drug companies and universities, which would all benefit from an increase in biomedical research funding.

A version of the bill that passed easily in Congress ended up dying in the Senate. The updated version, unveiled by House and Senate leaders over Thanksgiving weekend, has been altered to speed its passage through both houses.

Are Drugs Being Approved Fast Enough Now?

Dr. Michael Carome, director of Public Citizen Health Research Group, is concerned that, under the bill, drugs would be approved by the FDA even faster than they are today. And make no mistake about it, the agency already rushes medications to the market. [2]

Read: FDA: Drug Companies Faked Thousands of Drug Documents

There are 4 possible channels for the FDA to expedite approval for promising new drugs for the treatment of serious or life-threatening medical conditions. These programs were intended to be an exception to the rule; however, a 2015 study in the BMJ showed that the programs have become the rule themselves, with a statistically significant increase of 2.6% per year over the last 20 years in the number of drugs qualifying for the FDA’s expedited drug development and approval programs. [3]

Source: PharmExec.com

Read: 4 Crucial Ways the FDA has Failed us

The FDA can approve drugs based on the presumption that they work, but without proof of a long-term benefit. Researchers use a “surrogate endpoint,” such as a tumor’s response to a drug, even though that response might not translate into a longer or healthier life.

Most of these early approvals and developments rely on information gathered from early-stage trials that are generally small in size. The authors of the report wrote that “this trend is being driven by drugs that are not first in class and thus potentially less innovative.” In fact, according to Diana Zuckerman, head of the National Center for Health Research, 1 study revealed that 18 of the 36 the cancer drugs recently approved on the basis of surrogate endpoints failed to help people live longer. She says:

“What’s happening is we are flooding the market with medical products that don’t work very well, or we don’t know whether they work.” [2]

Zuckerman has a new study that is slated to be published in JAMA Internal Medicine which shows that often new cancer drugs fail to even improve patients’ quality of life, despite the drugs’ weighty price tags.

The authors of the BMJ study reached a similar conclusion, writing:

“Effectively, the FDA has been granting most supplemental approvals without evidence of meaningful clinical benefit.” [3]

Patients would like to see drugs approved faster, for obvious reasons, but doing so may jeopardize their health even more. Can the FDA assure patients that the new therapy they’ve just been prescribed is safe?

Even former FDA Commissioner Mark McClellan admits the FDA hasn’t done a very good job of following up on provisionally-approved drugs. McClellan said:

“A lot of follow-up studies have not been performed or have not been performed well because we don’t have good systems in place to learn about drugs once they are on the market.”

Despite the controversy, some advocates of the bill say the legislation is still a step in the right direction, including Fran Sasinowski, an attorney who notes that the FDA didn’t even mention patients until 2008, more than 100 years after the agency was founded. He said:

“This bill, if it were to become law, would even give more prominence to the role of the patient in this process.”

Fast-Tracking can be a Problem

But fast-tracking drugs has cost people their lives in the past. The best example of this is Vioxx, a non-steroidal anti-inflammatory drug (NSAID). During the review process for the pain reliever, an FDA medical officer looking at clinical trials noted a threefold increase in cardiovascular problems by people taking it, but could not definitively say Vioxx was the cause. [4]

At the time, Celebrex, a similar drug, was already on the market. Yet, the FDA fast-tracked Vioxx with the goal of making a decision within 6 months.

Source: NBC News

Within 6 months, another Vioxx clinical trial showed that people taking the drug had double the number of heart attacks and strokes. Merck, the maker of Vioxx, took the medication off the market. A standard review of Vioxx – and the FDA’s insistence on better studies, earlier in the process – could have led the agency to restrict who used the drug or delay its arrival on the market.

By the time Merck pulled Vioxx in 2004, more than 38,000 deaths related to its use had been reported, and as many as 25 million Americans had taken the drug. [5]

Sources:

[1] The Washington Post

[2] NPR

[3] Specialty Pharmacy Times

[4] Boston.com

[5] DrugWatch

National Center for Health Research

PharmExec.com

NBC News


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About Julie Fidler:

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Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.

Source Article from http://naturalsociety.com/congress-prepares-vote-bill-speed-drug-approval-1948/

Major Marijuana Opponent Jeff Sessions was Named New U.S. Attorney General

On November 18, President-elect Donald Trump named Alabama Senator Jeff Sessions as his attorney general. Sessions will be one of the most conservative U.S. lawmakers to to serve as the nation’s top law enforcement official. He is also staunchly opposed to marijuana legalization – ridiculously so. [1]

Sessions is a bit goofy and old-fashioned when it comes to his views on cannabis, to say the very least.

Thirty years ago, when Sen. Sessions was up for a federal judgeship, the soon-to-be attorney general allegedly used the ‘N-word’ and joked during testimony that he thought members of the Ku Klux Klan (KKK) were “okay, until he learned that they smoked marijuana.” (Right, because marijuana was what he should have taken offense to…) [2]

Then, in 2014, Sessions said he was “heartbroken” when President Barack Obama told the New Yorker“I don’t think [pot] is more dangerous than alcohol.” To counter the President’s opinion, Sessions responded:

“Lady Gaga says she’s addicted to it and it is not harmless.”

In April of this year, when Sessions spoke at a hearing of the Senate Caucus on International Narcotics Control, he devoted much of his energy to calling out what the speakers said were the harms caused by relaxing marijuana laws.

The Senator, who is a member of the caucus, testified about the need to encourage “knowledge that this drug is dangerous, you cannot play with it, it is not funny, it’s not something to laugh about… and to send that message with clarity that good people don’t smoke marijuana.

Yeah, that’s right. If you use marijuana you’re clearly a terrible human being – according to someone who thinks KKK members are “okay.”

Not scared yet? Sen. Sessions is the Senate’s leading opponent of ending mandatory minimum sentencing for drug crimes. He once said he missed the days when “[t]he federal government led the way with tough sentencing, eliminating parole, targeting dangerous drugs in effective ways, and states and local governments followed.” [3]

I wonder if he doesn’t have an issue with people doing life in prison for using marijuana.

And now he has the power to force states that have legalized marijuana into compliance with federal law – including the 28 states that have legalized its use for medical purposes.

During his campaign, Donald Trump repeatedly expressed that he would leave marijuana policies “up to the states.” If his administration goes back on that promise, it “would create huge political problems they don’t need and will use lots of political capital they’d be better off spending on issues the new president cares a lot more about,” as stated by Tom Angell, chairman of the pro-legalization group Marijuana Majority.

Hopefully Trump Will Leave Marijuana Alone

Let’s hope Trump does keep his promise because during current attorney general Loretta Lynch’s confirmation hearings, Sessions said that he considered opposition to state-level legalization as a core responsibility of America’s top prosecutor. He told her:

“I hope that you will cease to be silent, because if the law-enforcement officers don’t do this, I don’t know who will. And in the past, attorneys general and other government officials have spoken out and I think kept bad decisions from being made.”

Aaron Herzberg, a cannabis policy expert from California, says:

“Sessions is the worst pick that Trump could have made for attorney general as it comes to the marijuana issues and this selection bodes very poorly for the Trump administration to adopt a marijuana friendly policy.

It appears that he is intent on rolling back policy to the 1980’s Nancy Reagan’s ‘just say no on drugs’ days, he has displayed open hostility to efforts to legalize marijuana.”

Said Angell:

“While the choice certainly isn’t good news for marijuana reform, “I’m still hopeful the new administration will realize that any crackdown against broadly popular laws in a growing number of states would create huge political problems they don’t need and will use lots of political capital they’d be better off spending on issues the new president cares a lot more about.”

He went on to say that marijuana reform is far more popular with voters than politicians are (in 2014, dog poop, lice, and toenail fungus were more popular than Congress), so “officials in the new administration would do well to take a careful look at the polling data on this issue before deciding what to do.”

Sources:

[1] Bloomberg

[2] Oregon Live

[3] New York Magazine

The Wall Street Journal


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About Julie Fidler:

Author ImageAuthor Image

Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.

Source Article from http://naturalsociety.com/major-pot-opponent-jeff-sessions-named-us-attorney-general-1948/