The mothership is down?

[Gypsy]

Yawn. There have been 17 shutdowns of the gov't since 1976. You've seen them, they just didn't make an impression.

I share your concerns, though -- I'd call it severe distress over the state of things.

-- Laurie

You might not yawn if your husband was waiting anxiously for FDA approval of a drug that could literally save his life. Approval was expected this month, but will probably be impacted by the shutdown. We're hoping that he can hold out through the shutdown, but if not he'll have to go through another round of devastating chemo that probably won't do much good instead of getting a great new drug that has been shown to be highly effective for his cancer.

Oh no, Rainwood. That's terrible. I'm so sorry you must be angry as hell and scared too.

And I don't blame the U.S Government. I blame the House Republicans. The Affordable Care Act is a law that was passed by Congress, signed by the president, and ruled constitutional by the U.S. Supreme Court. The Republicans don't have the votes to overturn the law so they've decided to hold the federal government hostage instead. That's not what law-abiding, Constitution-respecting politicians do. That's what thugs do.

Totally agree with this 1000000000000000%

 

[rainwood]

Thanks Matata, Maria and Gypsy for the dust and kind words. It's incredibly frustrating to be so close and now have to wait longer because of the shutdown. The irony that my husband's health could be seriously impacted by the Repubs' unwillingness to admit they lost on the health care issue is not lost on me.

 

[TooPatient]

Thanks Matata, Maria and Gypsy for the dust and kind words. It's incredibly frustrating to be so close and now have to wait longer because of the shutdown. The irony that my husband's health could be seriously impacted by the Repubs' unwillingness to admit they lost on the health care issue is not lost on me.

Thinking of you!
I hope this is all sorted out and the drug works for your husband!

I'm not familiar with all of the processes, so this may sound silly. Is there any way the doctors would use it BEFORE the FDA approves it? Is there some form to sign saying you know it isn't approved and won't hold them responsible for any complications?

 

[VRBeauty]

Thanks Matata, Maria and Gypsy for the dust and kind words. It's incredibly frustrating to be so close and now have to wait longer because of the shutdown. The irony that my husband's health could be seriously impacted by the Repubs' unwillingness to admit they lost on the health care issue is not lost on me.

Thinking of you!
I hope this is all sorted out and the drug works for your husband!

I'm not familiar with all of the processes, so this may sound silly. Is there any way the doctors would use it BEFORE the FDA approves it? Is there some form to sign saying you know it isn't approved and won't hold them responsible for any complications?

Doctors might prescribe it, but insurance companies generally won't pay for unapproved drugs (or for using approved drugs to treat conditions they haven't been approved for - "off-label" uses).

 

[ksinger]

Thanks Matata, Maria and Gypsy for the dust and kind words. It's incredibly frustrating to be so close and now have to wait longer because of the shutdown. The irony that my husband's health could be seriously impacted by the Repubs' unwillingness to admit they lost on the health care issue is not lost on me.

Thinking of you!
I hope this is all sorted out and the drug works for your husband!

I'm not familiar with all of the processes, so this may sound silly. Is there any way the doctors would use it BEFORE the FDA approves it? Is there some form to sign saying you know it isn't approved and won't hold them responsible for any complications?

Doctors might prescribe it, but insurance companies generally won't pay for unapproved drugs (or for using approved drugs to treat conditions they haven't been approved for - "off-label" uses).

And if it's not even on the market yet, there would not be any doctors outside of the studies, to prescribe it at all. There's approved and then there's approved. Not to mention the fact that using unapproved drugs is still illegal, as far as I can determine. Hence the need for the government to be open so drugs can get approved. Aaaaand we're back to square one. :-\

 

[VRBeauty]

Government employees will probably get back pay eventually - they did last time - though that's little comfort for those who live paycheck-to-paycheck. At best government employees have to live with the stress of not knowing whether or how much they'll be paid - at worst there will be people who will not be able to make crucial payments. Private companies who do business with the government will have to wait to be paid - again that will hit some companies very hard, though larger companies may be able to weather the storm. The woman who offers daycare out of her house for anybody who's furloughed will lose a week/month's pay and that won't be made up later. Businesses in towns or states that have a lot of federal government employees or contractors will take a hit as those employees will not be spending as much on everything from groceries and entertainment to housing. To a large extent that's a permanent loss - the employees will not go out and buy twice as many clothes or see twice as many movies when they get their back pay. The cities that count on tax revenues from those businesses will suffer a permanent loss.

As one who loves to visit Washington DC, and who lives in a state that tourists love to visit, I also feel terrible for the tourists whose vacations are being impacted by this shutdown.

 

[Dee*Jay]

Thanks Matata, Maria and Gypsy for the dust and kind words. It's incredibly frustrating to be so close and now have to wait longer because of the shutdown. The irony that my husband's health could be seriously impacted by the Repubs' unwillingness to admit they lost on the health care issue is not lost on me.

Thinking of you!
I hope this is all sorted out and the drug works for your husband!

I'm not familiar with all of the processes, so this may sound silly. Is there any way the doctors would use it BEFORE the FDA approves it? Is there some form to sign saying you know it isn't approved and won't hold them responsible for any complications?

Doctors might prescribe it, but insurance companies generally won't pay for unapproved drugs (or for using approved drugs to treat conditions they haven't been approved for - "off-label" uses).

Is it possible to get the drug under the "compassionate use" provision? (That may not be the exact phrase... )

 

[movie zombie]

rainwood, please know that you and your hubby are in my thoughts.

 

[TooPatient]

Thanks Matata, Maria and Gypsy for the dust and kind words. It's incredibly frustrating to be so close and now have to wait longer because of the shutdown. The irony that my husband's health could be seriously impacted by the Repubs' unwillingness to admit they lost on the health care issue is not lost on me.

Thinking of you!
I hope this is all sorted out and the drug works for your husband!

I'm not familiar with all of the processes, so this may sound silly. Is there any way the doctors would use it BEFORE the FDA approves it? Is there some form to sign saying you know it isn't approved and won't hold them responsible for any complications?

Doctors might prescribe it, but insurance companies generally won't pay for unapproved drugs (or for using approved drugs to treat conditions they haven't been approved for - "off-label" uses).

Is it possible to get the drug under the "compassionate use" provision? (That may not be the exact phrase... )

I think that is what I was remembering. There was a story I read in the news at one point that had something like this. I don't remember the specifics.

What a system!

I hope they are able to figure something out soon (doctors or politicians!) so that your husband is able to get the needed treatment ASAP! Will be keeping you in my thoughts

 

[chrono]

I'm so sorry, Rainwood. I hope that there are ways around this mess that will allow your DH to get this medicine.

 

[ruby59]

My brother is a disabled vet who relies on his disability check - which he apparently won't be getting while this goes on.

My father in law is a vet retired with full benefits from the Navy, who now works full time for the VA in a professional capacity (though nonessential). I'm not sure, but I believe that means he won't be getting either of his paychecks while this goes on.

It's disgusting. It is personally affecting people I know and it makes me feel sick.

Veterans checks are going through. My mother gets aid and attendance for nursing homes through the VA. I just checked her balance and the money is in her account.

 

[rainwood]

Thanks to everyone for their thoughts and best wishes.

As other posters have mentioned, FDA approval is crucial for my husband to get the new drug for several reasons. First, FDA approval is needed before the drug can be made available in anything other than clinical trials. My husband isn't eligible for any of those because there is not yet a clinical trial open to post-transplant patients. There is no way for his oncologist to even get the drug outside a clinical trial until the drug is approved. Second, FDA approval is required before his oncologist can legally prescribe the drug for his type of cancer. There's no kind of compassionate care or other exception if the drug is not yet FDA-approved. Third, FDA approval is needed before our (or any) insurance company will approve the drug for coverage. Coverage by our insurance company is vital as the drug is likely to cost somewhere in the neighborhood of $120,000 a year in the U.S. Of course, countries with single payer health plans - pretty much the rest of the Western world - will pay far less but that is a another can of health care worms I won't go into now.

And once the drug gets FDA approval, we'll then have to get insurance company approval which also takes awhile so if the shutdown ended tomorrow, we'd be lucky to have all approvals in hand by Thanksgiving. Some people think shutting down the federal government is no big deal, but it is a HUGE deal for a lot of people. We happen to be two of them.

 

[ksinger]

For another non-yawn potential impact...

It'll be interesting to see, if this drags on for several weeks as it appears it will, if commercial flights are impacted. I hope the airlines have certed backup pilots to call, because airman medical certs are only happening as fast as a couple of docs with virtually no staffs, can address them. Having air traffic control is all well and good, but irrelevant if more and more of your pilots are grounded...

 

[TooPatient]

For another non-yawn potential impact...

It'll be interesting to see, if this drags on for several weeks as it appears it will, if commercial flights are impacted. I hope the airlines have certed backup pilots to call, because airman medical certs are only happening as fast as a couple of docs with virtually no staffs, can address them. Having air traffic control is all well and good, but irrelevant if more and more of your pilots are grounded...

I don't think there will be much of an issue here. There are thousands of doctors qualified by the FAA to complete these exams. The airlines require physicals so often (6 months and some do 3 months) that I doubt they require a pilot to quit flying until confirmation from the FAA.


I do hope some sort of solution is reached soon. I feel horrible for those stuck in situations of uncertainty.

 

[ksinger]

For another non-yawn potential impact...

It'll be interesting to see, if this drags on for several weeks as it appears it will, if commercial flights are impacted. I hope the airlines have certed backup pilots to call, because airman medical certs are only happening as fast as a couple of docs with virtually no staffs, can address them. Having air traffic control is all well and good, but irrelevant if more and more of your pilots are grounded...

I don't think there will be much of an issue here. There are thousands of doctors qualified by the FAA to complete these exams. The airlines require physicals so often (6 months and some do 3 months) that I doubt they require a pilot to quit flying until confirmation from the FAA.


I do hope some sort of solution is reached soon. I feel horrible for those stuck in situations of uncertainty.

Judging by the backchannel work stories I was getting yesterday (from a friend who is participating in the "orderly shutdown" of the aeromedical facilty here before HE goes home today in about half an hour now) of the panicked calls from commercial pilots to the aeromedical docs earlier this week, I think you're probably wrong on that one. The docs can do them all day long, but THEY aren't the ones issuing the certs, the FAA is. I guarantee you, they do not let a pilot with an expired cert, serve as PIC or other crew, at least not within the FAA proper. I can't speak as definitively for the airlines may let slide, but I would venture the pilots were panicked for a reason.

 

[TooPatient]

For another non-yawn potential impact...

It'll be interesting to see, if this drags on for several weeks as it appears it will, if commercial flights are impacted. I hope the airlines have certed backup pilots to call, because airman medical certs are only happening as fast as a couple of docs with virtually no staffs, can address them. Having air traffic control is all well and good, but irrelevant if more and more of your pilots are grounded...

I don't think there will be much of an issue here. There are thousands of doctors qualified by the FAA to complete these exams. The airlines require physicals so often (6 months and some do 3 months) that I doubt they require a pilot to quit flying until confirmation from the FAA.


I do hope some sort of solution is reached soon. I feel horrible for those stuck in situations of uncertainty.

Judging by the backchannel work stories I was getting yesterday (from a friend who is participating in the "orderly shutdown" of the aeromedical facilty here before HE goes home today in about half an hour now) of the panicked calls from commercial pilots to the aeromedical docs earlier this week, I think you're probably wrong on that one. The docs can do them all day long, but THEY aren't the ones issuing the certs, the FAA is. I guarantee you, they do not let a pilot with an expired cert, serve as PIC or other crew, at least not within the FAA proper. I can't speak as definitively for the airlines may let slide, but I would venture the pilots were panicked for a reason.

I was slightly incorrect on the required times. The airlines may require more frequently (and often do), but these are the FAA requirements (from the FAA.gov website):

1st class medical for ATP (airline transport pilot) -- highest physical requirements qualifies pilots to be pilot in command for airlines or other commercial passenger transport (assuming all other requirements met too):
over age 40 expires 6th month after the month of the date of the exam
under age 40 expires 12th month after the month of the date of the exam


I may be wrong, but the FAA website states that an FAA certified medical examiner (of which there are thousands in this country) performs an exam and (assuming you meet the requirements) issues a medical certificate.
It was my reading of this, when I went over it with my flight instructor, that it is the doctor who issues the certificate and then sends the information to Oklahoma City (FAA). IF you have a medical condition that makes you require an exception, I believe the doctor has to send your records and the FAA makes a determination. Even there, the exception remains in place for future certificates so you don't have to wait for them each time to make a determination.


The FAA regulations are super thick and can be hard to follow. I would not be surprised if many people are unfamiliar with the exact process. (I also admit that it is possible I am reading incorrectly -- will have to check with FI once he wakes up as he holds many licenses (including commercial and flight instructor) and has actually gone through the medical exception process personally.

 

[ksinger]

For another non-yawn potential impact...

It'll be interesting to see, if this drags on for several weeks as it appears it will, if commercial flights are impacted. I hope the airlines have certed backup pilots to call, because airman medical certs are only happening as fast as a couple of docs with virtually no staffs, can address them. Having air traffic control is all well and good, but irrelevant if more and more of your pilots are grounded...

I don't think there will be much of an issue here. There are thousands of doctors qualified by the FAA to complete these exams. The airlines require physicals so often (6 months and some do 3 months) that I doubt they require a pilot to quit flying until confirmation from the FAA.


I do hope some sort of solution is reached soon. I feel horrible for those stuck in situations of uncertainty.

Judging by the backchannel work stories I was getting yesterday (from a friend who is participating in the "orderly shutdown" of the aeromedical facilty here before HE goes home today in about half an hour now) of the panicked calls from commercial pilots to the aeromedical docs earlier this week, I think you're probably wrong on that one. The docs can do them all day long, but THEY aren't the ones issuing the certs, the FAA is. I guarantee you, they do not let a pilot with an expired cert, serve as PIC or other crew, at least not within the FAA proper. I can't speak as definitively for the airlines may let slide, but I would venture the pilots were panicked for a reason.

I was slightly incorrect on the required times. The airlines may require more frequently (and often do), but these are the FAA requirements (from the FAA.gov website):

1st class medical for ATP (airline transport pilot) -- highest physical requirements qualifies pilots to be pilot in command for airlines or other commercial passenger transport (assuming all other requirements met too):
over age 40 expires 6th month after the month of the date of the exam
under age 40 expires 12th month after the month of the date of the exam


I may be wrong, but the FAA website states that an FAA certified medical examiner (of which there are thousands in this country) performs an exam and (assuming you meet the requirements) issues a medical certificate.
It was my reading of this, when I went over it with my flight instructor, that it is the doctor who issues the certificate and then sends the information to Oklahoma City (FAA). IF you have a medical condition that makes you require an exception, I believe the doctor has to send your records and the FAA makes a determination. Even there, the exception remains in place for future certificates so you don't have to wait for them each time to make a determination.


The FAA regulations are super thick and can be hard to follow. I would not be surprised if many people are unfamiliar with the exact process. (I also admit that it is possible I am reading incorrectly -- will have to check with FI once he wakes up as he holds many licenses (including commercial and flight instructor) and has actually gone through the medical exception process personally.

Yeah. I''m IN OKC. There are only 2 docs in CAMI today, I'm told. Two doctors sans support staff. I And I bet there is no one working in the Registry building today either, and no one to enter the info that gets sent here, into the system that maintains medical cert currency or any other kinds of currency. I wouldn't be surprised if the medical examiners in the field were told NOT to certs, although that sounds unsafe. (If I ever see any of my work friend again...someday....I'll ask exactly how that works). In any case, I should have said, the FAA...holds? keeps record of? the certs. There is also an internal system that tracks and maintains the medical and other currencies of FAA flight inspection pilots and it has a web service that serves up that info when queried. I'm assuming they at least are still flying inspections during all this, since those would be considered safety issues, but right now, who knows. Not I.

All I know about the guy mentioned earlier, was that he was a pilot for American Airlines and needed to fly tomorrow (Friday). Apparently whatever personal medical maze he was in, required him to call CAMI, and he wasn't getting what he needed due to the shutdown, and he was panicked and PISSED.