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An FDA Panel Is Deciding Life or Death For My Wife
Fox News ^ | 6/28/11 | Terry Kalley

Posted on 06/28/2011 1:59:51 PM PDT by markomalley

December 16, 2010 will forever be the day that changed my life. I had just received a news flash across my monitor that the FDA had confirmed its advisory panel’s decision to ”de-label” the drug Avastin for breast cancer patients. The practical implication of this was that my wife Arlene was now at mortal risk.

My wife has stage IV or metastatic breast cancer. This is an incurable disease that claims the life of a woman every 14 minutes. A reported 17,500 women take Avastin for metastatic breast cancer and my wife is one of them. As Avastin is a unique drug that works by cutting off blood flow to tumors, we believe that the drug is saving my wife’s life and taking Avastin away is tantamount to a death sentence.

I picked up the phone to call my wife and tell her the news. When she answered, I was too choked-up to speak. The next five minutes were some of the worst moments of my life as I told my wife that bureaucrats in Washington were deciding to take away a drug that was keeping her alive.

I read a mountain of reports about the FDA’s Avastin decision and it become clear that it was corrupted with procedural problems (the Wall St. Journal referred to it as “rigged”), rendered almost meaningless by poor science and tainted by the bad faith of the FDA, which had moved the goalposts for approval of Avastin, almost after the game had been played.

The drug’s manufacturer, Genentech, said that it would file an appeal and the FDA granted a hearing for June 28 and 29 in Silver Spring, Maryland.

(Excerpt) Read more at foxnews.com ...


TOPICS: Editorial; Government
KEYWORDS: deathpanels; moralabsolutes; prolife
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A heart-rending story that will become more and more common as Obamacare phases in over the next few years.
1 posted on 06/28/2011 1:59:54 PM PDT by markomalley
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To: markomalley

If this Avastin was available on the free market, no prescription
or “titled” medical person needed in the loop, would folks pay for it?

I’ve often wondered why the arrogant medical profession needs to
place itself between people and cures.. other than to make bucks.


2 posted on 06/28/2011 2:05:43 PM PDT by humblegunner
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To: markomalley

It costs more to keep people alive with the proper meds than to take the mes away so they die quicker. Breast cancer treatment today, what will it be tomorrow? And we thought China was evil killing baby girls.
Welcome to the new Amerika.


3 posted on 06/28/2011 2:05:57 PM PDT by bgill
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To: humblegunner

Very good point, with the caveat that not many drugs can be administered DIY.


4 posted on 06/28/2011 2:10:29 PM PDT by Amberdawn
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To: humblegunner

I would suggest that one of the reasons prescription drugs are so expensive is the frequent unnecessary delays in approval by the FDA.


5 posted on 06/28/2011 2:11:16 PM PDT by rusty millet
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To: markomalley

I hate this MF’er SOB!

This stuff scares me! So “Soilent Green” like


6 posted on 06/28/2011 2:11:22 PM PDT by alice_in_bubbaland (DeMint /Palin, DeMint/Bachmann, DeMint/Cain, DeMint/Ryan 2012!!!!!!!)
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To: markomalley

is this drug available in canada? if so, a short trip to a canadian doctor and a prescription are in order


7 posted on 06/28/2011 2:13:04 PM PDT by joe fonebone (Project Gunwalker, this will make watergate look like the warm up band......)
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To: bgill
Avastin was thought to be useful in breast cancer. At the same time it was not thought to be useful in uterine cancer.

Even with studies in hand showing it's utility you couldn't get access to it for uterine cancer.

Then one day "they" decided it was OK for that kind of cancer, but shortly thereafter began withdrawing their approval of it for breast cancer.

People close to us were part of that story ~ but in the end Avastin is NOT and cannot be a cure. Patients' cancer cells develop a sort of resistance to it.

At best these drugs just stave off the end.

I'd like to note for you these are not casual drugs to just pop in your mouth and wash down with water.

8 posted on 06/28/2011 2:13:22 PM PDT by muawiyah
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To: markomalley

Of course, the drug Avastin will always be available to Obama, congresscritters and SCOTUS members. That’s why you don’t hear any protest from them.


9 posted on 06/28/2011 2:13:32 PM PDT by 353FMG
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To: markomalley

bttt


10 posted on 06/28/2011 2:13:45 PM PDT by tutstar
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To: humblegunner
http://www.avastin.com/avastin/hcp/lung/dosing/index.html Take a look at how this drug is administered ~ it's by "infusion" which means a needle/tube hookup in the arm, then it's pumped in there slowly under close supervision by a RN in a qualified cancer therapy medical facility.

I thought it was interesting that they have a problem with 1% to 3% of patients ~ per infusion.

What that means is it slops out somehow and gets pumped into your muscle tissues.

This is always bad.

You can get the drug on the open market ~ all that happened here is that it was no longer qualified for automatic Medicare (or other government) payment. People with private insurance could get it.

ObamaKKKare provides that you won't "get it" when it takes over everything including private insurance plans.

11 posted on 06/28/2011 2:20:06 PM PDT by muawiyah
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To: markomalley

“The FDA should never have approved Avastin for breast cancer to begin with,” said Fran Visco of the National Breast Cancer Coalition. “We don’t see evidence of benefit, but we do see evidence of harm.”

http://www.washingtonpost.com/wp-dyn/content/article/2010/08/15/AR2010081503466.html


12 posted on 06/28/2011 2:21:49 PM PDT by Raycpa
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To: markomalley

It’s likely he can find it in Mexico, India or China.


13 posted on 06/28/2011 2:31:41 PM PDT by Mariner (War Criminal #18)
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To: markomalley

It is heart rending. However, peoples reaction to the FDA’s action is the direct result of the fact that those in government so live and love to lie that they have lost all credibility. Those who have been allowed to sit in places of authority are financially and morally bankrupt. No one believes them. They have ruined our country and the only question remaining is whether America can recover.


14 posted on 06/28/2011 2:32:27 PM PDT by AEMILIUS PAULUS (It is a shame that when these people give a riot)
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To: humblegunner

What does the medical profession have to do with making it a prescription drug?

That would be the FDA that makes it hard for you to get what you want and what makes drug so expensive.

I am one of those arrogant medical professionals who helped to develop treatments for diseases and vaccines and who also happens to have MS.

If you are so smart. You dedicate your life to the development of cures and treatments, and then get back to me.


15 posted on 06/28/2011 2:53:03 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: markomalley

Bump!


16 posted on 06/28/2011 3:14:32 PM PDT by Mr. Silverback (Anyone who says we need illegals to do the jobs Americans won't do has never watched "Dirty Jobs.")
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To: markomalley

Does this fall under the Moral Absolutes or Pro-Life catagories?


17 posted on 06/28/2011 3:14:50 PM PDT by Clintonfatigued (Illegal aliens collect welfare checks that Americans won't collect)
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To: HonestConservative

“I am one of those arrogant medical professionals who helped to develop treatments for diseases and vaccines and who also happens to have MS.”

Avastin is also a drug that the FDA will not approve for wet macular degeneration—a disease which will eventually cause vision loss and which I happen to have. It can’t cure it, but can stop or slow down the progression of the disease. It’s cost would be $150-$200 per injection vs the FDA “approved” drug Lucentis which is about $2000/inj. Who’s pocket is the money getting into? Oh—one needs to have those injections frequently by the way.


18 posted on 06/28/2011 3:27:16 PM PDT by freeangel ( (free speech is only good until someone else doesn't like it)
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To: freeangel
So, where do you get your injections or infusions? In a special facility, a doctor's office, where?

That can make a whopping difference in the cost of any sort of medicine that requires special handling.

BTW, you may have missed it ~ fortunately you can enlarge the type on your computer so you'll be with us for many years ~ "they" are getting closer and closer to both electronic and biological replacements for the macula.

I can appreciate that myself.

Do we have a "blind guys" caucus list? We need it.

19 posted on 06/28/2011 3:34:43 PM PDT by muawiyah
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To: muawiyah

“So, where do you get your injections or infusions? In a special facility, a doctor’s office, where?”

Retinal specialist. Let me know of any updates on the “macula replacements”


20 posted on 06/28/2011 3:37:57 PM PDT by freeangel ( (free speech is only good until someone else doesn't like it)
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To: freeangel

The upfront investment for the development of a new drug is 1 BILLION dollars.
If the FDA wants more studies, more patients in the studies and as is often the plan dictated now, life long follow up on the patients status once it is approved.

Now if the drug is not approved, a couple billion down the tubes. Understand that the FDA knows and approves each step and each study of each stage of development and clinical testing of each drug. So after a couple billion is invested, someone says, eh, sorry, no thank you.

So that money necessarily must be recouped with the success and or approval of the next drug in addition to the money invested in development of the new drug.

Understand that the drug company sees only 18 cents on the dollar of each dollar charged at the drug store. The rest goes through the stores, overhead of the store employees, shipping, government and liability insurance for each person along the chain of possession. That is the big sucker.
AND the company has 7 years to make back the investment before it goes generic.

My MS infusion is once a month and is 2200 each treatment. Biologics are especially difficult to develop.


21 posted on 06/28/2011 3:40:46 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: markomalley
"The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure."
It can still be prescriped off-label.
22 posted on 06/28/2011 3:41:26 PM PDT by jimnm
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To: markomalley
[Art.] The next five minutes were some of the worst moments of my life as I told my wife that bureaucrats in Washington were deciding to take away a drug that was keeping her alive.

Please don't think me heartless or overly blunt, but he needs to spend the next five minutes getting his ass on the road to Mexico or Canada or the Bahamas or anywhere else where he can get Avastin for his wife, and smuggle a supply of it in and administer it to his wife himself if need be. Screw the bureaucrats. Who made them God? Certainly not that jughead Obama.

23 posted on 06/28/2011 3:43:45 PM PDT by lentulusgracchus (Concealed carry is a pro-life position.)
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To: muawiyah

Yes, I get my infusion in a local doctor owned clinic and the difference in cost is 500 per month.


24 posted on 06/28/2011 3:43:45 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: rusty millet
I would suggest that one of the reasons prescription drugs are so expensive is the frequent unnecessary delays in approval by the FDA.

Or to recoup losses from selling to various national health systems below cost.

25 posted on 06/28/2011 3:45:44 PM PDT by Trailerpark Badass (I'm sick of damn idiots)
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To: jimnm

I could be wrong but IIRC, Obamacare will be eliminating off label use to save money.


26 posted on 06/28/2011 3:46:03 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: HonestConservative

“My MS infusion is once a month and is 2200 each treatment”

It doesn’t seem to slow you down any. Thanks for all the work you do and the guests you have on your show are awesome!


27 posted on 06/28/2011 3:52:01 PM PDT by freeangel ( (free speech is only good until someone else doesn't like it)
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To: freeangel

It slows me down a lot. Some days I cannot walk or feed myself.

If I knew how much I could have done when I was well, I’d ‘ve been freakin’ dangerous. You don’t know what you’ve got until its gone.

As it is, one show a week is all I can do.


28 posted on 06/28/2011 4:00:56 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: Trailerpark Badass

excellent point, TpB


29 posted on 06/28/2011 4:02:39 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: markomalley; 185JHP; 230FMJ; AKA Elena; Albion Wilde; Aleighanne; Alexander Rubin; ...
Moral Absolutes Ping!

Freepmail wagglebee to subscribe or unsubscribe from the moral absolutes ping list.

FreeRepublic moral absolutes keyword search
[ Add keyword moral absolutes to flag FR articles to this ping list ]


30 posted on 06/28/2011 4:04:23 PM PDT by wagglebee ("A political party cannot be all things to all people." -- Ronald Reagan, 3/1/75)
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To: muawiyah

Most cancer patients have a portocath so the danger you are talking about hardly exists. Avastin is an expensive drug. It can cost up to $100k a yr and I am sure that has something to do with why no one wants to cover it.
I received avastin as part of a UCLA trial for breast cancer. Since I was part of the trial my insurance was never billed for it. UCLA is still tracking me.


31 posted on 06/28/2011 4:05:14 PM PDT by sheana
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To: sheana

Esactly sheana.

Tysabri is my drug which was taken off the market for treatment of MS because it was “too dangerous”, albeit very effective.

Well crap if you are going to be rendered useless by a progressive disease, wouldn’t you rather die trying?


32 posted on 06/28/2011 4:08:20 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: HonestConservative

I wish you good luck. So far I am clean. Recently had my yearly scans and haven’t got the results back yet. Fingers crossed.


33 posted on 06/28/2011 4:10:50 PM PDT by sheana
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To: sheana

But you have proven the government bs on Avastin to be a lie haven’t you?

I do not know how can NOT be effective. If it cuts the blood supply to the tumor, how can the tumor survive? Makes no sense. I can see that the tumor could develop alternate vessels but regular treatment would slow that effectively I would think.

The fact that you are still being “followed” proves that it was effective, doesn’t it?

I sit in the clinic for my infusion every month with mostly cancer patients.


34 posted on 06/28/2011 4:15:46 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: HonestConservative

Avastin was not the only drug I was given. I went through the regular chemotherapy with the add ons of Avastin and Herceptin. Apparently they are an effective combo for the type of breast cancer I had....HER2.
From everything I have read about Avastin, they really wanted it to be effective for other cancers plus they found out it was useful in prolonging the lives of Stage4 cancer patients.
I honestly don’t think they know that much about Avastin yet. There are still trials running everywhere on it.


35 posted on 06/28/2011 4:21:20 PM PDT by sheana
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To: sheana

Oh, I think they know plenty. Trials still running are an indicator of a desire to seek additional approvals for a broaded label.


36 posted on 06/28/2011 4:38:32 PM PDT by HonestConservative (http://www.freedomradiorocks.com)
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To: markomalley

Can you go to Mexico, Costa Rica, Grenada, Belize, India, wherever to get the drug? Bammycare will create a new boom in medical tourism.


37 posted on 06/28/2011 5:10:39 PM PDT by Nowhere Man (General James Mattoon Scott, where are you when we need you? We need a regime change.)
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To: Nowhere Man

What typical American has money to go globe-trotting after drugs? Especially considering one family member, the ill one, is already out of a job, and possibly another one (spouse, adult child) to care for the ill person. Then even in another country we still have to pay for the drug. And possibly pay a private nurse there or back home to administer it intraveiniously. Could be talking thousands of dollars.

But it’s not just the money. WE ARE ENTITLED to whatever drugs we want that our doctor approves, right here in America. The fight should be against the FDA and whatever other govt agencies are interfering with our rights. I hope people will focus on fixing our system, not creating a medical tourism boom.


38 posted on 06/28/2011 6:11:44 PM PDT by baa39 (If you can't take the heat, get out of FR.)
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To: sheana

Sounds good ~ to be tracked means you are still among your loved ones. Wish you the best.


39 posted on 06/28/2011 6:21:16 PM PDT by muawiyah
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To: Raycpa

Fran Visco is an American lawyer and activist.

Visco is the first president of the National Breast Cancer Coalition and Fund

Visco was a partner in a Philadelphia law firm before leaving law to focus on NBCC/F’s work.

In 1993, President Clinton appointed Visco as one of three members of the President’s Cancer Panel, and she was the first consumer to chair the Integration Panel of the Department of Defense Peer-Review Breast Cancer Research Program.


40 posted on 06/28/2011 6:28:35 PM PDT by kcvl
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To: freeangel
I will do that. The latest involved mice. They are "clones" for all practical purposes so they were able to grow a new retinal web from a stem cell and stick it in the eye ~ and detect electrical activity.

That was a quite astounding feat. We'd hope that it became commonly available particularly since I may well need one myself.

41 posted on 06/28/2011 6:31:29 PM PDT by muawiyah
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To: HonestConservative

Who do you believe, lawyer and activist, Fran Visco or Dr. John Durant?

FRAN VISCO: High-dose chemotherapy with bone marrow transplants for breast cancer is not an effective therapy.

DR. JOHN DURANT: It’s way premature to say this strategy doesn’t work. I think the strategy will continue to be of interest as a means of improving survival.


42 posted on 06/28/2011 6:34:59 PM PDT by kcvl
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To: muawiyah

Thanks!


43 posted on 06/28/2011 6:48:51 PM PDT by sheana
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To: baa39

If anyone actually read my post....in the USA Avastin is around $100k per year. Who can afford that, even if it is cheaper in another country?


44 posted on 06/28/2011 6:56:32 PM PDT by sheana
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To: baa39

Agreed. Yes, we need to be able to get all the care we need here at home, I was just pointing out alternatives until we get Old Jugears out of office and rein in these agencies. You are correct though.


45 posted on 06/28/2011 7:24:59 PM PDT by Nowhere Man (General James Mattoon Scott, where are you when we need you? We need a regime change.)
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To: Nowhere Man

What’s ironic is the USA is the “medical tourism” destination for whenever some Saudi Prince or European billionaire needs a highly specialized super-expensive operation. Just recently one of those Arabs was here at one of our prestigious hospitals. They create a huge luxury suite for these guys, gourmet food, top medical staff and attention. And probably a few floors down is some little old lady on Medicare shivering in a cold room desperately pushing her call button to ask for a blanket.


46 posted on 06/28/2011 8:29:02 PM PDT by baa39 (If you can't take the heat, get out of FR.)
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To: humblegunner
its not the "arrogant medical profession"....its the pharmacutical companies...

there's big money in drugs....who gets their drug out on the market, who doesn't and plenty of payoffs inbetween...

know any drug reps?....if you did, you'd know that they live the high life without the study, the anxiety, the long hours of actually being a doctor....

47 posted on 06/29/2011 1:02:16 AM PDT by cherry
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To: muawiyah
The first time I had Chemo to treat my Leukemia, the IV went through the side wall of the Vein in my forearm. It happened about a minute after they started the drip.

Since I had never had Chemo before, I thought the sensation was just part of it, them I looked down and saw some discoloration next to the IV.

I called for the Nurse and she ran in there like nobody’s business, turned off the drip and got the needle out of my arm before I knew what was going on.

I'll assume that is the same 1% to 3% problem they have with the Avastin, which has more to do with the IV Setup than the drug be utilized for the treatment.

Unfortunately, taking a promising drug off the market only leads desperate people to seek out alternative treatments like going to Mexico for a magic Cancer Cure. It didn't work out for Steve McQueen did it?

Government only causes havoc while stifling innovation.

48 posted on 06/29/2011 1:34:53 AM PDT by Kickass Conservative (If Sarah Palin was President, you would have a job by now.)
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To: Kickass Conservative

Questionable is how all manner of studies are thrown in the hopper and a blanket conclusion drawn — rather than looking for reasons why some seemed to show good success and others had no results or negative results. It’s darn hard to control all the factors with a disease as slippery as cancer and with nursing expertise in administering a drug as intended varying widely.


49 posted on 06/29/2011 2:03:30 AM PDT by HiTech RedNeck (Hawk)
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To: muawiyah
People close to us were part of that story ~ but in the end Avastin is NOT and cannot be a cure.

In the end, the HIV drug cocktail is not and cannot be a cure. Why stop one and not the other?

50 posted on 06/29/2011 7:06:24 AM PDT by Grizzled Bear ("Does not play well with others.")
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