Wednesday, January 25, 2012

Life On The Ranch: Winter Walk

I've been a total slacker when it comes to blogging lately. I just haven't had enough time to blog on a regular basis at the moment, although hopefully I'll be able to start picking up on the blogging.

For now, I will share some pictures from a walk I went on with the kiddos the other day. This winter has been so incredibly mild, I almost feel like I'm in a winter from the California High Desert again :).

We've had so many beautiful days that are 50-60 degrees.

Although the temperature doesn't feel like winter, it certainly looks like it with all the bare trees.

Peppy, the llama. He's a funny little character!

O wanted to play a hide-and-seek game on the walk, so we all did.

O's trying to find the rest of the kiddos!

O checking out something up high :).

Country Girl Designs

Tuesday, January 17, 2012

Pro-Life? 100% Pro-Life?

I typically do not post political topics on this blog, but because I feel this has a lot to do with the future of our country, including individuals with Down Syndrome, I feel this is necessary to share. I won't constantly post about this. I feel there may be some who won't like me for posting this, which is fine with me. And there are others who will be very glad I posted this.

What if there was a presidential candidate who was so pro-life, that he wanted to repeal Roe v. Wade? What if there was a presidential candidate who was so pro-life, that he wanted to make a Congressional Act that would define that life starts at conception?

Could you imagine, if the above two things were done, how many more babies could be born, because abortion would federally be illegal? Could you imagine instead of 9 out of 10 babies with Down Syndrome being aborted, that all of them may be born, because abortion would not be legal?

Right now, that seems like such a far cry and it is with the sad state of our nation. But, there is one candidate who wants to change that. He wants to give life & liberty to everyone, especially the unborn.

This man's name is Texas Congressman Ron Paul. He is the only candidate who is absolutely 100% pro-life. He is an OB/GYN who has delivered over 4,000 babies. He is right on with so much more and he wants to Restore Freedom to America. Please look into Ron Paul. Vote for Freedom. Vote Ron Paul 2012. You can find more details on my other blog here.

Country Girl Designs

Friday, January 13, 2012

Dr. Turkel's Book, Part 5: The Ruin of the U-Series By The FDA

Well, I know it's been much longer than I had wanted to get this 5th part of Dr. Turkel's book up. But, blogging has been slow the last few weeks.

You can see the first 4 parts covering his book at these links: Part 1, Part 2, Part 3, & Part 4.

As I mentioned in Part 4, even though Dr. Turkel had amazing success and great results with his U-Series, there was massive unacceptance by the "big wigs"....doctors, associations, the NIH, and even the FDA. But ultimately the FDA would cause the most damage to his U-Series.

Dr. Turkel started applying for New Drug Approval from the FDA in 1959. It was the start of many years of a saga. It ended with parents not being able to receive the U-Series from their doctors and eventually closing Dr. Turkel off to only supplying patients in Michigan with the U-Series.

There are two chapters that cover this full saga in Dr. Turkel's book. I will attempt to give a general overview, but it is quite involved.

The first requirement was that he have a clinical study for his U-Series. That's fair enough, but then the doctors who were supposed to be conducting this study, changed what the children in the study were receiving and were not giving them the full U-Series. They also did not cooperate with Dr. Turkel's approach, therefore causing more problems. There were many other problems with the conduction of the study and it was also terminated before it was supposed to end.

Instead of just a clinical study (which was attempted, but had problems, as mentioned above), the requirement then turned to needing to have the study be a double-blind clinical trial. Dr. Turkel argued that there was too much variance in individuals with DS to accurately do a double blind study. But, eventually he agreed to let it be done. There are many potential problems with a double blind clinical trial and Dr. Turkel's book discusses this.

Dr. Turkel attempted to comply with FDA regulations for 25 years without success.

In 1959 when Dr. Turkel went to the FDA to request the New Drug Approval, Trisomy 21 had just been discovered as being the cause of DS. But, many did not know the full implications that the extra genes and proteins caused on the triplicated chromosome. Because of this, the FDA did not consider the potential causes that could be caused by them. As Dr. Turkel's book states,

They [the FDA] dismissed the argument that the extra genes explained the presence of accumulations that the "U" Series was designed to reduce. They mistakenly concluded that since he "U" Series could not remove the chromosome, it could not help the patients.
 Some may wonder why Dr. Turkel attempted to get approval from the FDA. This is why,
Dr. Turkel admits that he was a novice in politics. He believed that if a physician developed an efficacious treatment for a devastating and previously untreatable disease, that the Federal agency charged with consumer protection and health would provide assistance. Former FDA Commissioner Edwards likewise stated that the agency existed to promote the approval of beneficial products. It was obvious to Dr. Turkel that the "U" Series was beneficial. The actions of the FDA bewildered him.
 Some of the roadblocks Dr. Turkel ran into from the beginning are as follows,

On page 210 of his book, it states
Between 1959 and 1962, the FDA failed to advise Dr. Turkel how to comply with the existing requirements. The FDA did inform him that a drug company had to be the sponsor of the IND and NDA. To comply, Ubiotica Corporation was formed to sponsor the "U" Series.
In 1962 the FDA created a new guideline for getting drug approval and that is where the "proof of efficiacy" (the clinical studies which he was told to do) come in. 

But, it wasn't until 1963, that Dr. Turkel was advised on what to do next by his attorney. He was advised to file an Investigational New Drug (IND) and New Drug Application (NDA). This is what happened after he did that,
November 26, 1963, FDA Commissioner Larrick sent Dr. Turkel a telegram and letter informing him that the IND had been withdrawn and, furthermore, that the "U" Series "should" be withdrawn from investigators, and that treatment of human beings "should" be discontinued.
Dr. Turkel, being a novice in politics and the workings of the FDA, took the above letter as saying that he had to stop treatment with the "U" Series. So, for 6 months he did not use it until there was a  meeting with a Senator to address the use of the "U" Series with a particular patient.

Once the IND was withdrawn, Dr. Turkel attempted to comply with the new regulations put into place in 1962. Yet, there were some problems with the cost, as is written on page 211,

He did not know that they were so "stringent" that it cost millions of dollars for new drug approval (the average cost in 1984 was $87 million over a period of seven to ten years).
Dr. Turkel went ahead to try to conduct animal studies in an FDA approved laboratory. Yet, he had some concerns.
Dr. Turkel expressed concern. He asked his attorney whether, having set up the protocol and approved it, the FDA might then later consider it inadequate. The legal opinion was "in the even such [studies and] amendments are accepted as suggested by the FDA, we do not contemplate that at any later date the FDA will take a position that said tests are insufficient for the purposes designated . . ."
...As it turned out, Dr. Turkel's forebodings were more accurate than the legal assurances.
The book states on pages 213-214,

Regardless of the outcome of the studies, the FDA seemed unwilling to approve the "U" Series:
"We think it will be difficult for Dr. Turkel to prepare a rational plan for the further distribution of the drug for investigational use." (Smart, 1/23/63)
"There is no basis for considering that the random, empirical and scientifically irrational choice of drugs and dosages contained in this NDA is either safe or effective in the management of Mongolism. It is our opinion that it may be impossible to write suitable labeling for efficacy for this product: in view of the cytogenetic basis of mongolism, we recommend that you abandon work on this application. " (Lockhart, 8/2/63)
"It is extremely unlikely that this product will ever meet the stringent requirements of the Food, Drug and Cosmetic Act, as amended." (Hodges, 12/12/66)
Common sense dictates that medication for the treatment of a serious disease should be not withheld solely for the above-cited reasons.
Unfortunately, common sense isn't so common. And Dr. Turkel would continue to find out the FDA had a serious resistance to his U Series, yet he wouldn't ever find out the exact reasons as to why they would not approve it, as is written on page 215,
...No reason has been given for the FDA's failure to assist a physician who sponsored a new drug,...
 Dr. Turkel eventually requested a hearing with the FDA as to why they would not allow approval of the "U" Series and his hearing eventually went all the way to the Supreme Court. The final ruling was by the Sixth Circuit Court and it was found the the "U" Series had no basis for use, because it could not remove the extra chromosome.

Dr. Turkel even attempted to get more recognition by the FDA by working in foreign countries and prescribing the "U" Series in Switzerland (many European countries were successfully using and approving the "U" Series for years). But, it was still to no avail.

Finally the FDA limited Dr. Turkel's shipment of the "U" Series between the states and allowed him only to use it with patients in Michigan...even though it was not regulated by the FDA, because they had never allowed approval of it.

It's a sad situation that Dr. Turkel ended up in. It's a shame and disgrace that an agency in the US has the ability to deny potentially helpful treatments to people with Down Syndrome.

Country Girl Designs

Thursday, January 12, 2012

Gluten-Free Flat Bread

Sorry for the lack of blog posts lately!

This is a new favorite recipe around here - Flat Bread. It's really easy and absolutely delicious. It goes great with soups, or even snacks. You can season it anyway you want, so you can make it sweet or savory!

The recipe below was done to make it savory, since we had it with soup for dinner.

Gluten-Free Flat Bread

1 1/2 cups flour
1 egg
3/4-1 1/2 cups water
1/2 teaspoon salt
Italian seasoning, Parsley, Cumin Powder, Pepper or whatever desired seasonings (optional)

*Preheat oven to 350 degrees.
1. Add all the ingredients together.

2. Mix until all combined.

3. Add any seasonings you would like at this point. I added Italian seasoning, Parsley, Cumin Powder and Pepper.

Mix the seasonings in (I had some help from a little O-man :)).

4. Oil the pan you will be baking it in, then spread the doe on the pan (it should be thin enough to spread well with just a little spreading help from a spatula). I used a regular cookie sheet and had the doe go 3/4 of the way up the side of the pan.

5. Place in the preheated oven. Bake for 15-25 minutes or until the flat bread is starting to crack, bubble and turn light brown on the edges.

The finished product with a few toppings added to it!

Country Girl Designs

Friday, January 6, 2012

Blog is On Facebook Now!

I thought I'd make a Facebook page for the blog, after I saw several other DS bloggers do it. Why not, it's just more exposure :)!

So, you can go over on the side of the blog and "like" us from the like box there, or go here to see the page.

I'm working on a few blog posts and hopefully will have more consistent blogs the next few days :)!

Country Girl Designs

Target Features A Child with Down Syndrome!

As many people have probably already seen, thanks to, Target has included a little boy, Ryan, with Down syndrome in one of their ordinary ads.

That is what is making the Down Syndrome community buzz. They didn't put him in a 'special ad for special people'. They didn't put any words to point him out on the page as anybody different. They just included him as one of the other cute little kids in the ad. That is pretty cool.

Ryan is one cute little boy! Nordstrom also featured him in one of their ordinary ads. Here's a picture of both of those ads:

The original post which started all the Buzz can be seen over at Noah's Dad's blog here. The Today Show also ran a story about and what Target and Nordstrom did, which you can view here.

Country Girl Designs

Tuesday, January 3, 2012

Life On The Ranch: New Years Party

I tried to put a post up yesterday, but the internet and blogger were tweaking out.

We had a neat New Years Party on Saturday. I'll just share a few pictures from it.

Confetti made for the kick-off of the party...

Some of the decorations...

The balloons which we dropped at midnight...

There was lots of yummy snacks for the night.

Coconut Cookies (recipe to come soon, Lord willing)

Deviled Eggs (a party favorite around here)

New Years Cakes

Jello snacks

Homemade refried bean dips (recipe to come soon on these as well, Lord willing!)

Since we had a karaoke & lip syncing contest for the night, we had to get the speakers and microphones set up.

The kiddos had fun doing funny things with their hair...dying it with a temporary dye :).

Hope you had a great New Years as well!

Country Girl Designs

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