Ross
Well-known member
Yes dear!perkicar said:
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G
Guest
Exactly the same thing chemically. The problem was with how they were made. I emphasize that these are not actual figures but are an example. The FDA specifies how much of a drug must be in each tablet. For instance when they take 10 tablets as a sample the total weight of the drug (any drug, not just warfarin) has to be between 95 and 105% of the labeled amount. DuPont was saying that this was not close enough for warfarin. They claimed that their tolerance was 97-103% so that you would get more precise dosing. Barr labs never made any claims about what theirs was. When an independent laboratory found that Barr's warfarin was 98-102% that should have settled dispute. However, DuPont went on saying that their was the best.
Think about what this means in reality
FDA says that for a 5 mg dose 4.75 mg to 5.25 mg is close enough.
DuPont Coumadin was 4.85 to 5.15.
Barr's warfarin was 4.9 to 5.1.
The court found that 0.1 mg tighter control by DuPont was not enough to justify saying that theirs was superior. Besides Barr's was 0.05 mg even better by this standard. So DuPont had to give several million dollars in refund coupons to people who purchased Coumadin between specified times.
You could make a case about whether or not the tablets were made so that they all dissolved correctly. This was never in contention. They evidently all dissolved OK.
Now think about all of the things that can throw the INR off.
Recovering from surgery
Exercise
Vitamin K in the diet (remember that these foods are as they occur in nature nobody standardizes them for vitamin K content - it will vary by time of the year, location, temperature etc.)
Missing a dose of warfarin
Taking an extra dose of warfarin
Taking cough syrup
Hundreds of different herbal products
Alcohol consumption
Changing brands of vitamin tablets
Diarrhea
on and on and on
The hundreds of variations that we cannot even recall in our daily lives have many times more influence than the barely visible speck warfarin that is the variation in different manufacturer's tablets.
That is why I say that doctors, or whoever, says the answer to all variation problems is brand vs generic is just believing the marketing materials of years ago without spending the time to think it through on their own.
If you want to say that it seemed to me that I did better on Coumadin than warfarin, then you had better be prepared to say that you ruled out many variables.
I ran the exact same distance over exactly the same course and the wind was blowing in exactly the same direction at the same speed during the whole time in question.
My vegetables were were grown on the same soil, the temperature was the same every day, the percentage of clouds in the sky never varied and they reached my mouth within the same number of hours after being harvested.
On and On and On. If you can't certify that those variables were accounted for then you cannot safely say that you did better on one or the other.
Think about what this means in reality
FDA says that for a 5 mg dose 4.75 mg to 5.25 mg is close enough.
DuPont Coumadin was 4.85 to 5.15.
Barr's warfarin was 4.9 to 5.1.
The court found that 0.1 mg tighter control by DuPont was not enough to justify saying that theirs was superior. Besides Barr's was 0.05 mg even better by this standard. So DuPont had to give several million dollars in refund coupons to people who purchased Coumadin between specified times.
You could make a case about whether or not the tablets were made so that they all dissolved correctly. This was never in contention. They evidently all dissolved OK.
Now think about all of the things that can throw the INR off.
Recovering from surgery
Exercise
Vitamin K in the diet (remember that these foods are as they occur in nature nobody standardizes them for vitamin K content - it will vary by time of the year, location, temperature etc.)
Missing a dose of warfarin
Taking an extra dose of warfarin
Taking cough syrup
Hundreds of different herbal products
Alcohol consumption
Changing brands of vitamin tablets
Diarrhea
on and on and on
The hundreds of variations that we cannot even recall in our daily lives have many times more influence than the barely visible speck warfarin that is the variation in different manufacturer's tablets.
That is why I say that doctors, or whoever, says the answer to all variation problems is brand vs generic is just believing the marketing materials of years ago without spending the time to think it through on their own.
If you want to say that it seemed to me that I did better on Coumadin than warfarin, then you had better be prepared to say that you ruled out many variables.
I ran the exact same distance over exactly the same course and the wind was blowing in exactly the same direction at the same speed during the whole time in question.
My vegetables were were grown on the same soil, the temperature was the same every day, the percentage of clouds in the sky never varied and they reached my mouth within the same number of hours after being harvested.
On and On and On. If you can't certify that those variables were accounted for then you cannot safely say that you did better on one or the other.
Al:allodwick said:
I'll contact the Texas A&M Vet School or the Savings & Clone Bank to get myself cloned. Then I can have a control "twin" -- one of us will take Coumadin, the other warfarin. We'll micromanage everything -- will live in a bubble so we won't be exposed to any bugs/germs, will get identical food/fluids measured out, same amount (if any) of alcohol on same day at same time, same identical amount/intensity of activity, same environmental temperature, etc. etc.
Then maybe we can tell if Coumadin produces more stable INR results than warfarin.
Seriously, there's no way to prove Coumadin does just that. Some people just aren't consistent in what they eat/drink, how active they are, medications they take/start taking/stop taking, etc. etc.
Some people's insurance plans are generous enough to allow them to use brand-name Rxes. Mine doesn't. 1mg Coumadin filled 90 tabs at a time via mail order would be $44.50 with my insurance plan -- $178 annually. 1mg warfarin is $20/90 tabs, $80 annually -- a savings of $98.
Many mechanical valvers need several strengths of warfarin to adjust as activity levels, meds, etc. affect INR, requiring more than just one $crip or $$crip, depending on whether you take warfarin or Coumadin.
G
Guest
I have maybe 2 people out of 500 who have more than one strength of warfarin. I always give instructions on breaking tablets. I would guess that over 50% of my patients break tablets. Our hospital is known for taking most of the poor and uninsured in the area. Early on I wanted to change warfarin strengths so that people could take whole warfarin tablets and was told. There is no money for another prescription this month. It will have to wait until next month. So I quickly changed my view on breaking tablets.
Marsha, Could you last long enough with a clone to have proof? I'd hate to live with a clone of myself.
Marsha, Could you last long enough with a clone to have proof? I'd hate to live with a clone of myself.
Al, my dad also always had one strength of coumadin. His INR was managed by the VA and sometimes he was told to basically take a little nibble each day on a half of a tablet but to make sure that the half was totally gone within 3-4 days. He used to joke when I would ask him about his coumadin dose and tell me that his dose that week was one tablet and a nibble each day. He has been gone for a few years now but he when he was alive he never stressed too much over having to take coumadin for his AF.
allodwick said:
I think so. But it would be very boring, agreeing with myself all the time.
Two TV sets with different satellite receivers would be a lifesaver. I've actually seen cloned cats. There's a cat show each August at Texas A&M University; 2-3 years ago the vet researchers trotted out "C.C." (Copy Cat), a female created from tissue/cells donated by another female cat. The cats were not mirror images. Seems the donor was a true calico (red, black & white); the clone was a dilute calico (cream, blue & white).
At last year's Cat Fanciers' Association's International Show in Houston TX, the Savings & Clone folks were there with the results of some of their work. I believe they claim to be able to create a virtual identical twin. This business is going after the pet owner who wants to spend megabucks to get an exact duplicate of their beloved Rover or Snowball.
G
Guest
I was just at the local VA today. They still have only the 5 mg tablets and still tell people to bite off a hunk. There was even an article in one of the pharmacy journals a few years ago about how efficiently they ran their clinics without having to worry about what strengths people were taking.
