SpinnyNuNu

She looked radiant!

"Located in Russia, this 400-square-foot home (37 square meters) was built in just a day, at a cost of just over $10,000... The main components of the house, including the walls, partitions and building envelope were printed solely with a concrete mixture. Fixtures like windows and furnishings were later added on, and a shiny coat of paint added to the exterior of the house.  The house consists of a hallway, bathroom, living room and kitchen."

Doesn't she look supercalifragilisticexpialidocious?

You have to start somewhere!

During Trump’s recent address to Congress he referred to 20 year-old Megan Crowley who has Pompe’s disease.

“Megan’s story is about the unbounded power of a father’s love for a daughter,” Trump said. “But our slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need.”

This statement, an unwarranted and factually-challenged attack on the FDA is all the more frightening when put into context. He has appointed to the FDA Jim O’Neill, who said in 2014:

“We should reform FDA so there is approving drugs after their sponsors have demonstrated safety—and let people start using them, at their own risk, but not much risk of safety. Let’s prove efficacy after they’ve been legalized.”

Not requiring evidence for efficacy for drugs would be an unmitigated disaster. It also makes not sense – the concept of “safety” cannot be entirely separated from efficacy. Drugs are evaluated and their use determined by risk vs benefit. You cannot do a risk vs benefit assessment if there is no data on benefit.

Also, how are you going to prove efficacy after a drug is already on the market? The incentive to invest in careful clinical research is now largely gone. Uncontrolled data is all but worthless in determining efficacy. We will go back to the patent medicine days where the public was subjected to countless dubious and largely worthless products with unfounded claims (basically the supplement industry of today).

Trump has indicated that he is serious about this. In a meeting with Pharmaceutical CEOs in January he said:

“We’re also going to be streamlining the process, so that from your standpoint, when you have a drug you can actually get it approved, instead of waiting for many, many years.”

and

“We’re going to get the approval process much faster. One thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.”

The Reality

It is no surprise that Trump’s ideological and simplistic view is at odds with reality.

First, do not assume that I am coming from a position of being pro-regulation or big government. I am not. I am for minimalist evidence-based regulations. The market needs regulations. But each regulation should be carefully constructed, evidence-based, and monitored for its actual effects in the real world (included unintended consequences).

Further, we need to consider the cumulative burden of all regulations. Even if each individual regulation is reasonable, in the aggregate they can represent an unreasonable burden.

So I get it – clearing the decks every now and then by seriously looking at regulations and pruning those that are not essential is necessary to keep the system from getting too sclerotic.

However, simplistically slashing needed regulations is reckless and dangerous.

It can be argued that the legislators and the FDA over the years has done a decent job of finding a near-optimal balance of protecting the public while streamlining the process (for drugs, not for supplements and certainly not for homeopathic products). If drugs are approved too quickly, then too many worthless or harmful drugs will make it to the market. If they are approved too slowly, then patients will miss out on needed medications. Creating the best outcome for the health of Americans is all about finding the best balance.

One way to assess the current balance of the FDA approval process is to compare it to other countries. A recent BMJ study did just that. They found:

From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval—of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons—including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns.

What this means is that, overall, the US is quicker to approve drugs than Canada and Europe. For those drugs in which the US was slower, or never approved the drug, many were unsafe and 2 were even withdrawn from the Market.

If you want a good historical example of this, think thalidomide, which was approved in Europe but never in the US because of safety concerns that eventually were vindicated.

So, on balance it looks like the FDA is more efficient than comparable agencies in Canada and Europe. American consumers get drugs faster, while simultaneously being protected from more harmful drugs, and only rarely have delayed access to useful drugs without existing alternatives.

Further, the FDA already has a program for expanded access (compassionate use). This allows terminal patients without options to gain access to experimental drugs before being approved. The FDA approves 99% of applications for expanded access.

So essentially, Trump is trying to fix a problem that does not exist. In the process he will destroy a system that is already near optimal.

Further still – even many pharmaceutical CEOs do not want deregulation. When an industry wants to be regulated, and is arguing against proposed deregulation, you have to take that seriously. (This also strikes a blow to common “Big Pharma” conspiracy theories.)

“People often argue that the FDA is too restrictive,” said Roger Perlmutter, head of research and development at Merck & Co Inc. “We have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile.”

The pharmaceutical industry understands their customers, which are as much doctors and insurance companies as patients. They are concerned that doctors will not prescribe drugs, and insurance companies will not pay for them, if there is not adequate evidence for efficacy.

“Any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach,” said Jeremy Levin, chief executive officer at Ovid Therapeutics Inc., which is developing drugs for rare diseases.

Trump, however, apparently believes in the magic wand approach to complex policy. Just slash regulations and everything will miraculously work out.

It is especially concerning that Trump gives no evidence of listening to experts. In fact, he tends to disparage experts and expertise in favor of his preferred (and often simplistic) narrative. This approach is what has led him to claim for at least a decade that vaccines cause autism, despite being publicly corrected many times. That is another policy disaster in the making.

"We had them pigs there almost 30 years, and never has this happened before."

Marshmallow Peeps are one of the most popular Easter candies out there. The sugar-coated, chick-shaped marshmallows have been largely unchanged for more than half a century and are loved by both kids and adults seeking a seasonal sugar fix. Peeps fans will definitely want to keep an eye out for Peeps Oreos, a limited edition treat that combines these two favorites.

The sandwiches start with Oreos’ vanilla wafer cookies and are filled with a bright pink, marshmallow-flavored creme. The pink filling does actually taste similar to Peeps, which are much more sugary than other marshmallows, and it even has a subtle sugary grittiness that evokes the sugar coating from the Peeps. The filling is actually balanced out well by the sturdy vanilla wafer cookies, so while these are quite sweet, they’re not so sweet that you won’t be able to eat two or three at a time. As a Peeps fan, I like this combination and think it works well. I’m also glad they went with pink for the filling. Not only is pink one of the original Peeps colors (along with white and yellow), it simply looks fun for a filling. These cookies will likely be available through Easter, so you have a couple of weeks to keep an eye out for them if you want to give the cookies a try yourself.

President Donald Trump's senior aide Jared Kushner and ousted adviser Michael Flynn met with the Russian ambassador to the United States at a time when the Trump administration's relationship with the Russians was under close scrutiny.

The student's mother said he was scared to speak out because of backlash.

Trump’s 10 Steps for Turning Lies into Half-Truths

Earlier this year the Wall Street Journal’s editor-in-chief insisted that the Wall Street Journal wouldn’t label Trump’s false statements as “lies.” Lying, said the editor, requires a deliberate intention to mislead, which couldn’t be proven in Trump’s case. 

But Donald Trump is the most lying president we’ve ever had, and he seems to get away with it. Here’s his 10-step plan for turning lies into near truths:

Step 1: He lies.

Step 2: Experts contradict him, saying his claim is baseless and false. The media report that the claim is false.

Step 3: Trump blasts the experts and condemns the media for being “dishonest.”

Step 4: Trump repeats the lie in tweets and speeches. And asserts that “many people” say he’s right.

Step 5: The mainstream media start to describe the lie as a “disputed fact.“

Step 6: Trump repeats the lie in tweets, interviews, and speeches. His surrogates repeat it on TV and in the right-wing blogosphere.

Step 7: The mainstream media begin to describe Trump’s lie as a "controversy.”

Step 8: Polls show a growing number of Americans (including most Republicans) believing Trump’s lie to be true.

Step 9: The media start describing Trump’s lie as “a claim that reflects a partisan divide in America,” and is “found to be true by many.”

Step 10: The public is confused and disoriented about what the facts are. Trump wins.

Don’t let Trump’s lies become near truths. Be vigilant. Know the truth, and spread it. The media should stop mincing words. Report Trump’s lies as lies.

No cameras for Dobby.

Travis Kalanick now admits he needs "leadership help."

Could a presidential run be on the horizon for the former talk show host?

The former Utah governor was an ambassador to Singapore and China under Obama.

In a statement, DeVos praised HBCUs as being 'pioneers' for school choice 'since their founding.'

According to the Financial Times, at least one of the bids surpassed $60 million, which is "a record sum for US presidential memoirs."

Bangers and mash originated in the United Kingdom. This dish consists of sausages and mashed potatoes and gravy. There are a variety of different sausage you can use for this recipe depending on what is available to you. Cumberland sausages would be a good choice, I personally used bratwurst because it was all I could find. The gravy gets a lot of its flavor from Guinness stout, Worcestershire sauce and mustard. The mashed potatoes use simple ingredients such as potatoes, milk and half-and-half. This is a delicious recipe to prepare for St. Patrick’s Day. Enjoy.

Bangers and Mash

Ingredients:

Mashed Potatoes-

• 3 cups Yukon gold potatoes (about 1.25lbs)
• ¼ cup milk
• 2 tablespoons half and half
• 2 tablespoons butter
• ¼ teaspoon salt
• ¼ teaspoon ground black pepper

Guinness Gravy-

• 2 tablespoons butter
• 2 tablespoons + 1 teaspoon all purpose flour
• ¾ cup beef stock
• ½ cup Guinness
• 1 tablespoon Worcestershire sauce
• ½ teaspoon yellow mustard
• ½ teaspoon salt
• ¼ teaspoon garlic powder
• ¼ teaspoon onion powder

Sausages-

• 6 British style bangers (or sausages of your choice)
• Olive oil (for sautéing)

 

Directions:

1. Peel and chop the potatoes into 1 inch cubes and place into a medium sized pot. Add cold water to cover the potatoes by about 2 inches. Cover with the lid and bring to a boil over high heat. Once the water boils, remove the lid, lower the temperature to medium and continue to boil until the potatoes are fork tender (about 12 minutes).
2. Drain the potatoes. Add milk, half and half, 2 tablespoons butter, salt and pepper. Mash the potatoes to the desired consistency.
3. To prepare the gravy—while the potatoes are cooking you can prepare the gravy. In a large deep skillet melt 2 tablespoons of butter over medium heat. Whisk in 2 tablespoons plus 1 teaspoon of flour. Allow the mixture to cook for about 2-3 minutes, whisking constantly.
4. Slowly add in ½ cup of Guinness and ¾ cup of beef stock whiling continuing to whisk. Add in mustard, Worcestershire sauce, ½ teaspoon salt, ¼ teaspoon garlic powder and ¼ teaspoon onion powder. Allow the gravy to come to a boil, continuing to whisk constantly. Once the gravy thickens, drop the heat to low, cover and keep warm.
5. Start to cook the sausages and when the potatoes have about 5 minutes left. Heat a medium skillet over medium heat. Add in 1 tablespoon of olive oil. Heat the oil, then add the sausages. Cook the sausages turning every couple of minutes until browned and fully cooked (the internal temperature has reached 160 degrees F. if using pork).
6. To assemble—Divide the mashed potatoes into serving bowls. Place a banger on top of potatoes and cover with gravy. 

 

Adapted from Renee Nicole’s Kitchen. 

The regulation was created under the Clean Water Act in the early 1970s

As a citrus fan, key lime pies make a regular appearance in my kitchen any time I have limes on hand. Key limes are a little more acidic than regular limes (Persian limes) and, while the pie can be made with regular limes, the key limes give it a uniquely bright flavor that makes the pie such a standout. This Lime Cream Pie is a toned down version of a key lime pie that is made using regular limes, which are more widely available and have a longer season than key limes. It’s a great option if you’re looking for something besides a traditional key lime pie for your next citrus dessert.

The pie filling is made with sweetened condensed milk, lime juice and egg yolks, but it also includes heavy cream and vanilla extract. The heavy cream tempers the zestiness of the lime juice to make the filling slightly less acidic and a little bit creamier. The vanilla rounds out the flavors from the dairy and the citrus. The filling is baked briefly in the oven and sets into a silky, creamy custard with lots of flavor. I used a graham cracker shell here, as I think a sweet crumb crust is a wonderful contrast for almost any citrus filling, though a baked and cooled pastry crust can also be used.

The pie is ready to eat as soon as it is chilled and you will pick out a hint of fresh cream in every bite. You could top the pie off with a layer of whipped cream before serving it if you want to make it even creamier, but I think the filling is balanced enough that it doesn’t need any extra additions to make it delicious.

Lime Cream Pie
1 9-inch graham cracker crust
1 14-oz can sweetened condensed milk
1/2 cup freshly squeezed lime juice
4 large egg yolks
1/4 cup heavy cream
1/4 tsp salt
2 tsp vanilla extract

Preheat oven to 350F. Place the graham cracker crust on a baking sheet.
In a large bowl, whisk together sweetened condensed milk, lime juice, egg yolks, heavy cream, salt and vanilla extract until smooth and well-combined. Pour into prepared pie crust.
Bake for 15 minutes, or until pie jiggles only slightly when the pie crust is gently nudged and does not appear to be liquid in the center. Allow pie to cool to room temperature then chill for at least 2 hours before serving.

Serves 8-10.

The fast food chain is fighting back against a claim that the chicken it serves up is only about half chicken.

High school student Luis Sanchez saved for years to buy trumpet

Donald Trump regularly assailed President Barack Obama for playing golf, then spent the first weekends of his own presidency doing just that. He attacked Obama for using Air Force One to campaign, and did it over the weekend just a month into the job. He mocked Obama for heading out of Washington at taxpayer expense, but appears to have no qualms about doing so himself...

"Donald Trump has zero worry about contradicting himself, because he does it all day long," said Douglas Brinkley, a presidential historian who has met with Trump. "He figures he can get away with it because he does it all the time. There is no worry about it. He says one thing and then does another, and his supporters don't hold it against him.

"Trump said last August that if he became president, he wouldn’t have time for golf. "I'm going to be working for you, I'm not going to have time to go play golf," he said at an event in Virginia.

Joseph Wapner has died at 97. He starred in 'The People's Court' from 1981 to 1993.

People use technology to honor iconic actor from "Twister."

Have you ever heard of Joe’s Special? This is a classic San Francisco diner dish dating back to the 1920s. It’s a hearty scramble of eggs, ground beef, spinach, mushrooms, and onions.

This scramble is great any time of day, but in my house growing up, we always had it for dinner, with thick slices of San Francisco sourdough bread alongside.

Continue reading "Joe’s Special (Scrambled Eggs with Spinach, Beef, and Mushrooms)" »

She started the video by saying “I have a message for the trans kids of America: You are winning. I know it doesn’t feel like it today or every day, but you are winning.”

The annual event will be held on April 29 at the Washington Hilton.