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Breaking the blogging-hiatus for a moment here :).
Jenny Marrs, who I have shared articles from before, wrote me the beginning of March and said the following:
Hello all my blog followers! There haven't been any posts for about a month now...wow. Time flies. Life gets busy. And sometimes blogging gets put on the back burner.
This pretty much sums up the last month:
Ranch Life...lots of new babies
Political campaigning
Family Life
Website design jobs
That has left little time for blogging. Or should I say, I haven't wanted to take the time to blog, since the other stuff has taken up enough of my time!
Hopefully things will slow down some here and I can start regularly blogging again. I have lots of yummy recipes to blog and lots more. If I can just get a day or two where I can put some scheduled posts together, that'd be great :).
Lord willing that'll be sooner rather than later!
Just wanted to say "Hi" real quickly!
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This month O and his twin sister, Yo, turn 7 years old! It's amazing to think they are already 7. Wow, times flies!
It feels like just yesterday that we had that chaotic and stressful, yet joyful day at the hospital.
My sister and I waited outside the operating room where my mom was having the twins (she was in the OR in case she had to have a C-section) to hear the news of if they had been born yet or not. Soon enough, two nurses rolled the twins by in a little cart, slowing down just enough to let us take a peek at them, as they continued on their way to the NICU.
That day changed our lives for the better. Within minutes my dad came out of the NICU and told us it looks like there might be some "bad news." Our hearts sank, not knowing what he was going to say. He then continued, "it looks like the little boy might have Down syndrome." Hearing him say that was to our immediate relief. We both thought, "oh, that's not bad." That's where our journey began and Lord willing, He will give us many more blessed years with O (& Yo).
The twins would stay in the NICU for 2 weeks (Yo was released after 6 days). It was a trying 2 weeks to say the least. O came home on oxygen and had oxygen for 6 weeks after coming home. That was a new challenge as well, but we learned how to cope with it quickly.
Now....
Yo is a blessing and a big helper, both for O and the rest of the family. She's a very independent little girl (in a good way) who learns things quickly.
O brings much laughter and fun to the family. He most certainly takes life a little slower and laid back, but it's good to slow down in life sometimes :).
It's neat to have a little boy who at 7 years old......still likes to be cozy and cuddly with his siblings when he wakes up in the morning (he normally sits on my lap while I'm doing work at the computer when he wakes up in the morning). And who likes to have someone be cozy with him when he goes to bed at night.
We find ourselves doing the funniest things sometimes, because O gets so excited over it and it makes us all laugh. For their birthday, we had a little picnic in the forest on our property. It was O's idea and he was so excited. Little Yo was pretty thrilled as well, but O's a little goofier than Yo. So while O claps while jumping up and down with excitement, Yo will just be smiling.
The last 7 years have had their share of trials, but more importantly, many blessings.
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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.
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.
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,
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.
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.
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.
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
Ingredients:
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)
Directions:
*Preheat oven to 350 degrees.
1. Add all the ingredients together.
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 :)!
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As many people have probably already seen, thanks to NoahsDad.com, 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:
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...
