Congressional hearing on drug shortages

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Gaelen
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Congressional hearing on drug shortages

Postby Gaelen » Wed Sep 28, 2011 12:25 am

The Energy and Commerce Committee's Subcommittee on Health has published the full video and written testimony from their special hearing, "Exploring Drug Shortages." It's a lot to get through - 2 1/2 hours of video testimony from a panel of eight experts including representatives from ASCO, cancer treatment centers, pharma manufacturers and regulatory agencies. But I slogged through all the written testimony and about half of the video to confirm the written testimony to sum up some key points, as did Kate Murphy for yesterday's Fight CRC Research & Treatment blog.

I know it's popular to blame the drug shortages of drugs like 5FU, Leucovorin and Irinotecan on pharma greed, saying that they'll never go out of their way to produce such low-cost/low-profit drugs. But revealed in the testimony are some surprises (at least to me) about why 54% of these drugs went into shortages. Many are made by only one company, so there's no backup if that company can't meet demand...and the biggest barrier to maintaining production (54%) is maintaining purity standards on drugs manufactured on increasingly older equipment and in older manufacturing plants. Other producers would have to make substantial investments in their infrastructure and plants, re-tooling to take on manufacturing shortage drugs. They'd also have to pass quality control standards as a new manufacturer.

When asked why supply and demand wouldn't just solve the issue, one of the expert witnesses (Dr. Koh) pointed out that most of these drugs are sold on contracts - and the manufacturers agree to provide them at X price. If they have a manufacturing problem, they have to eat any costs to bring the drugs in at the contracted prices - which come from (guess where? yep...the insurers and large-quantity purchasers.) Any new manufacturer coming to market with a shortage drug has to be able to produce it for what are often, in the light of the infrastructure of most plants, artificially low price ceilings.

It was a long read, but very interesting and much more revealing than you'd guess from the rhetoric and sound bytes about the drug shortage issue. Having worked for an older pharma manufacturing site (yep, the folks who patented penicillin), I know just how difficult it can be to maintain purity in a production line on old equipment. Manufacturing delays don't even begin to describe the problems.
Be in harmony with your expectations. - Life Out Loud
4/04: dx'd @48 StageIV RectalCA w/9 liver mets. 8 chemos, 4 surgeries, last remission 34 mos.
2/11 recurrence R lung, spinal bone mets - chemo, RFA lung mets
4/12 stopped treatment

rp1954
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Congressional hearing on excuses and special pleading

Postby rp1954 » Wed Sep 28, 2011 1:55 am

There are several problems here:
(1) over reliance on injectable drug forms, 5FU and LV come to mind. Both have inexpensive, effective oral forms.
(2) the US doesn't accept oral drugs from other countries efficiently
(3) citing old, small equipment with frazzled employees is like a protected 3rd world manufacturer excusing $18 per gallon gasoline
(4) the FDA's ways of forcing quality and distribution may suffer problems as in any command based system
(5) the FDA creates many barriers to entry to new competitors
(6) the FDA creates substantial costs for old generic drugs when they are working without complaints, leading to disappearances
(7) there are credible charges about senior FDA managers with conflicts of interest

The current systems breakdown suggests too many regulations and laws, not a deficiency, that favor the status quo for both FDA and various corporate players. Adding more regulations is likely to lead to more unintended failures, perhaps even collapses.
watchful, active researcher and caregiver for stage IVb/c CC. surgeries 4/10 sigmoid etc & 5/11 para-aortic LN cluster; 8 yrs immuno-Chemo for mCRC; now no chemo
most of 2010 Life Extension recommendations and possibilities + more, some (much) higher, peaking ~2011-12, taper chemo to almost nothing mid 2018, IV C-->2021. Now supplements

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Gaelen
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Re: Congressional hearing on excuses and special pleading

Postby Gaelen » Wed Sep 28, 2011 6:55 am

rp1954 wrote:...citing old, small equipment with frazzled employees is like a protected 3rd world manufacturer excusing $18 per gallon gasoline...


Just curious - have you read the transcribed testimony or viewed the video testimony presented on 9/23? I found rhetoric conspicuously absent, unlike some of the responses the testimony has generated.
Be in harmony with your expectations. - Life Out Loud
4/04: dx'd @48 StageIV RectalCA w/9 liver mets. 8 chemos, 4 surgeries, last remission 34 mos.
2/11 recurrence R lung, spinal bone mets - chemo, RFA lung mets
4/12 stopped treatment

bz45
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Re: Congressional hearing on drug shortages

Postby bz45 » Wed Sep 28, 2011 9:12 am

Gaelen, Thanks for posting this. I had just heard sound bites on tv which never give the whole story. It gave me some concern since I've just started up on another round of folfox. Your posts are always informative. Thanks again for sharing.
dx rc 4/09
Stage IIIC T4a N1 Mx
APR with perm. colostomy 6/09
FOLFOX + Avastin 9/09 - 2/10
Blood spotting 12/10
Biopsy 1/13 confirms re-occurence; unresectable
Chemorad 17tx 3/11-4/11
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Surroundedbylove
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Re: Congressional hearing on excuses and special pleading

Postby Surroundedbylove » Wed Sep 28, 2011 9:50 am

rp1954 wrote:There are several problems here:
(1) over reliance on injectable drug forms, 5FU and LV come to mind. Both have inexpensive, effective oral forms.



On the other hand I'd like to comment about Xeloda vs 5FU - Xeloda is very expensive when not adequately covered by insurance and insurance is covering less and less of the cost of oral forms of chemotherapy. My insurance policy changed to exempt oral chemotherapy (but not any other types of pharmaceuticals) from the patient out of pocket maximum. Thus the patient has no safety net of an out of pocket maximum.
Surroundedbylove

Rectal Cancer @ 43, '08
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jmarie
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Re: Congressional hearing on excuses and special pleading

Postby jmarie » Wed Sep 28, 2011 10:41 am

Surroundedbylove wrote:
rp1954 wrote:There are several problems here:
(1) over reliance on injectable drug forms, 5FU and LV come to mind. Both have inexpensive, effective oral forms.



On the other hand I'd like to comment about Xeloda vs 5FU - Xeloda is very expensive when not adequately covered by insurance and insurance is covering less and less of the cost of oral forms of chemotherapy. My insurance policy changed to exempt oral chemotherapy (but not any other types of pharmaceuticals) from the patient out of pocket maximum. Thus the patient has no safety net of an out of pocket maximum.


I plan on reading through Gaelen's link tonight when insomnia ie I. Full swing but I did want to quickly add that Xeloda, on top of costing me $210 per cycle compared to nothing for 5FU, hand/foot syndrome was very extreme on Xeloda. It was to the point I could hardly walk or do much with my hands. On 5fu I so have some mild hand/foot syndrome but nothing near what it was like on Xeloda. So although they may be considered equal in terms of effectiveness, if you have to delay treatment because you can't handle side effects it doesn't do you any good.
DX Stage IV 11/25/08
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rp1954
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Re: Congressional hearing on excuses and special pleading

Postby rp1954 » Wed Sep 28, 2011 10:48 am

Surroundedbylove wrote:
rp1954 wrote:There are several problems here: (1) over reliance on injectable drug forms, 5FU and LV come to mind. Both have inexpensive, effective oral forms.

On the other hand I'd like to comment about Xeloda vs 5FU - ...Thus the patient has no safety net of an out of pocket maximum.

In most of the world, there are other inexpensive oral 5FU tx choices. Some perhaps superior for some stages of CRC. In the US sphere, even experienced oncologists are often blank slates about these other options. Thanks to the FDA processes, such an effective curtain of silence is even possible.

Gaelen wrote:
rp1954 wrote:...citing old, small equipment with frazzled employees is like a protected 3rd world manufacturer excusing $18 per gallon gasoline...

Just curious - have you read the transcribed testimony or viewed the video testimony presented on 9/23?

I've listened to parts of the 2.5 hr, I found little exquisitely new and a lot of tiresome repetition. I've already seen some of Kate's writing, and others this past month or so. I mostly replied to parts of your statement.
watchful, active researcher and caregiver for stage IVb/c CC. surgeries 4/10 sigmoid etc & 5/11 para-aortic LN cluster; 8 yrs immuno-Chemo for mCRC; now no chemo
most of 2010 Life Extension recommendations and possibilities + more, some (much) higher, peaking ~2011-12, taper chemo to almost nothing mid 2018, IV C-->2021. Now supplements


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