Pharmalot… Pharmalittle… Catching Up
4 CommentsBy Ed Silverman // September 3rd, 2008 // 2:44 pm
Every so often, we like to bring you a few tidbits that are worth noting, if only briefly. This is especially true at lunch hour or during the time of day when a cat nap beckons. Rather than doze off, staying informed is a much better use of time, yes? So, here you go…
Hershey Adds Former Pfizer CFO Shedlarz To Its Board (Yahoo/AP)
Forest Labs Stock Sinks On Trial Results (Yahoo/AP)
ImClone Seeks FDA Ok To Market Erbitux For Head, Neck Cancers (Yahoo/Reuters)
OraSure AIDS Test Has High Error Rate (Bloomberg News)
finn
I pay more than 300.00 dollars amonth to have medicare and my supplement insurance. So why should they get a dime of the settlement money we almost died for? Vioxx has left me with dead heart tissue and I almost bled to death, It took 2 operations and 40 units of blood and 100 other I.V. fillers until the doctor could come back to fix me. This was 2001 when there was no warnings on the boxes of vioxx. Merck knew what was going on and wanted more money to line their pockets. We need to be paid for our losses and the extra time we might have had on this earth if it wasn’t for big business lies.
Dan A.
Sorry to hear about your situation, Finn, but it may not be a bad idea to testify what you have shared here with legislators to attempt to prevent pre-emption, if you have not done anything similar already regarding this situation.
Just A Thought
Here’s a tidbit- dated 10 months after the fact.
http://www.efnj.com/media/pdf/ezine/Epilepsy%20News%20Issue%205.pdf
This has never been about money for me- as no amount of money can reduce the damage that has been taxing my body for months. I’ve thought about it a bunch. How much would make it better? The truth is, when your wellbeing is stripped from you, you don’t much care if you have a prettier house or a nice vacation. It’s like having the flu and all you care about is feeling human. Or like having an impacted tooth and the only thing that matters is to be rid of the pain. Only those things are short lived.
Pfizer’s statement was made late and quietly (it took me over a month to come across it and I’m always looking). As the statute of limitations has been ticking away, with FDA preemption looming- it doesn’t matter. I know that I have been going about this all wrong. I am such a novice. There are violations involved here that make a product liability claim look like a picnic.
Pfizer is touting FDA bioequivalence as acceptable. There is no reason to not take generic medications. Heh.
They have made the leap from their excipients being ‘exactly the same’ to being ‘the same’.
So? Say you have a packet of Kool-Aid, some sugar, and some water. The mixing of that beverage has a countless possibility of end results. Dilantin has a different AUC than it did before. Something is different and if it is not in the list of ingredients then it has to be how they are put together. NMP. To give this drug the name of the innovator drug, based on a couple of insufficient studies, takes away from the good work that R&D does to provide safe medications. Just file an ANDA and call it good? ANDAs are not meant to be used in this manner.
The FDA asked them to do it- I have seen no other instance of Pfizer being so compliant. It sure doesn’t make them exempt from responsibility and they should have said NO. Yes, we know of their CRADA which names Dilantin specifically.
If what Pfizer says is true-
How often is it that the FDA requests that a drug maker potentially harm it’s consumers? They wanted consistency. What they did was to create an initial inconsistency in an effort to make a more consistent drug. Considering that some people have had to adjust their dosages with different lots (unlike with the old formula), I think it’s fair to assume that either the attempt to make the drug more consistent has failed, or there has been tweaking going on, causing more harm as a direct result of taking this medication that requires a consistent blood serum level be maintained.
They took a 69 year old medication and changed it to be ineffective for a percentage of their consumers.
“Last fall, Pfizer sent a letter to
health care professionals informing
them that the FDA had approved
manufacturing changes for Dilantin®
(phenytoin sodium).”
Please tell me that they don’t believe that a doctor who has been successfully treating a patient for years with Dilantin is supposed to search the net everytime he writes a refill for a prescription. The only warning that I am aware of is this document that was found online- after the fact. All I know is that my doctor didn’t know and neither did many others.
http://media.pfizer.com/files/products/PFZ_DIL_173_LetterHCP_D01.pdf
There should have been a wide campaign for the safety of consumers.
I have epilepsy and was used in an experiment without my doctor’s knowledge or my permission.
Just A Thought
“Patients taking phenytoin
should be advised to inform their
physician of any change in seizure
control, any new clinical condition or
any new medication.”
Any new medication? Yeah, I did inform him that Pfizer changed their medication. Was that my job?
No point in a prescription with ‘No Substitutions’ added anymore.