Generic Drug Users Beware

[Monkei]

While we argue about the rights of Zimmerman and Martin, the guys in the black robes pass another law which we had all better know about.

I will include a link, but basically this law gives you absolutely no option to sue a generic drug manufacturer regardless of any harm the drug may cause you.

http://www.nytimes.com/2013/06/29/opinion/a-damaging-decision-on-generic-drugs.html?_r=0

In other countries we would be rioting in the street as each and every day our rights are given away. But here in the USA I guess we just accept it and move on, they are always, afterall, talking about the other guy, not me!

[Bavarian]

And we should continue to have the right to pay a bit more for Name brand when needed as the generics are ineffective. We are alking about one's life.

[Monkei]

And we should continue to have the right to pay a bit more for Name brand when needed as the generics are ineffective. We are alking about one's life.

Big business always seems to find a way to win.

[Bucco]

While we argue about the rights of Zimmerman and Martin, the guys in the black robes pass another law which we had all better know about.

I will include a link, but basically this law gives you absolutely no option to sue a generic drug manufacturer regardless of any harm the drug may cause you.

http://www.nytimes.com/2013/06/29/opinion/a-damaging-decision-on-generic-drugs.html?_r=0

In other countries we would be rioting in the street as each and every day our rights are given away. But here in the USA I guess we just accept it and move on, they are always, afterall, talking about the other guy, not me!

NO law was passed....a Supreme Court ruling was handed down...a HUGE difference..and your link is one persons OPINION on that ruling.

Did you read the ruling and the responsibility of the user ???

[getdul981]

NO law was passed....a Supreme Court ruling was handed down...a HUGE difference..and your link is one persons OPINION on that ruling.

Did you read the ruling and the responsibility of the user ???

Correctomundo!! The guys in black robes DO NOT pass laws.

[Happinow]

While we argue about the rights of Zimmerman and Martin, the guys in the black robes pass another law which we had all better know about.

I will include a link, but basically this law gives you absolutely no option to sue a generic drug manufacturer regardless of any harm the drug may cause you.

http://www.nytimes.com/2013/06/29/opinion/a-damaging-decision-on-generic-drugs.html?_r=0

In other countries we would be rioting in the street as each and every day our rights are given away. But here in the USA I guess we just accept it and move on, they are always, afterall, talking about the other guy, not me!


We should all know by now that its all about money.....we are just another human body. They don't care if we live or die. It's obvious because they can approve certain drugs to help people....... say with a life threatening decease such as cancer or AIDS or they can choose not to approve it, thus one may lose their life. If insurances choose not to cover a costly prescription, then one may die because they cannot afford it. It's really a sad state of affairs. Same with generic drugs....they don't approve the one you need....too bad.

[Monkei]

We should all know by now that its all about money.....we are just another human body. They don't care if we live or die. It's obvious because they can approve certain drugs to help people....... say with a life threatening decease such as cancer or AIDS or they can choose not to approve it, thus one may lose their life. If insurances choose not to cover a costly prescription, then one may die because they cannot afford it. It's really a sad state of affairs. Same with generic drugs....they don't approve the one you need....too bad.

That's part of it, the other part is this. If you become sick due to a drug you have no recourse. In the end, depending on your issue, the taxpayers end up paying for your care. The drug company gets a big get out of jail card.

[Monkei]

NO law was passed....a Supreme Court ruling was handed down...a HUGE difference..and your link is one persons OPINION on that ruling.

Did you read the ruling and the responsibility of the user ???

OK here is the history of Bartlett.

Karen Bartlett, the plaintiff in the original suit, and the respondent to Mutual’s petition, was issued a prescription of Clinoril, the name-brand version of sundilac – a nonsteroidal anti-inflammatory drug (NSAID). The pharmacist engaged in the common practice of exchanging the name-brand drug for the generic equivalent and provided Ms. Bartlett with sundilac. Ms. Bartlett suffered from toxic epidermal necrolysis; the condition disfigured Ms. Bartlett, leaving her disabled and nearly blind. When Ms. Bartlett took the drug, it did not carry a warning on its label for toxic epidermal necrolysis. Initially, the lower courts decided with Ms. Bartlett, that her pain, suffering and the wrong of of Mutual justified the jury’s award of $21 million. Unfortunately, the Supreme Court has now reversed those decisions.

Now you can nit pick my post, claim it is only one person's link or opinion, but I think anyone can read it or other sources and come to the conclusion that its a basic protect big business decision. Unbelievable that this country who went to war with England for the right to trial, now has it shot down by it's own Supreme Court.

[Bucco]

OK here is the history of Bartlett.

Karen Bartlett, the plaintiff in the original suit, and the respondent to Mutual’s petition, was issued a prescription of Clinoril, the name-brand version of sundilac – a nonsteroidal anti-inflammatory drug (NSAID). The pharmacist engaged in the common practice of exchanging the name-brand drug for the generic equivalent and provided Ms. Bartlett with sundilac. Ms. Bartlett suffered from toxic epidermal necrolysis; the condition disfigured Ms. Bartlett, leaving her disabled and nearly blind. When Ms. Bartlett took the drug, it did not carry a warning on its label for toxic epidermal necrolysis. Initially, the lower courts decided with Ms. Bartlett, that her pain, suffering and the wrong of of Mutual justified the jury’s award of $21 million. Unfortunately, the Supreme Court has now reversed those decisions.

Now you can nit pick my post, claim it is only one person's link or opinion, but I think anyone can read it or other sources and come to the conclusion that its a basic protect big business decision. Unbelievable that this country who went to war with England for the right to trial, now has it shot down by it's own Supreme Court.

IT IS NOT A LAW !!!!

Did you get that point..that is the major point...it was a court decision..NOT A LAW !!! That is what has to be clear to folks...NO LAW WAS PASSED BY ANYONE.

[Monkei]

IT IS NOT A LAW !!!!

Did you get that point..that is the major point...it was a court decision..NOT A LAW !!! That is what has to be clear to folks...NO LAW WAS PASSED BY ANYONE.

whatever, I think the issue is there for you to read. The basic premise it that we are no match for big business. Especially when we now have a court that rules in the favor of big business all the time it seems.

[ben rays]

A person convinced against their will is of the same opinion still..................

[BobnBev]

A person convinced against their will is of the same opinion still..................

Say WHAT????????????????????

[Monkei]

Law or not ... Someone tell me, inform how this ruling helps Joe Citizen the consumer? This is all about big business. Us consumers just sit back and accept.

[blueash]

all drugs have side effects. TEN is a known risk of every NSAID whether or not it is on the label. Severe adverse skin reactions to nons... [Am J Health Syst Pharm. 2010] - PubMed - NCBI (http://www.ncbi.nlm.nih.gov/pubmed/20101062) The medication she took was in every way identical to the brand name medication. It had the same ingredients, the same labeled risks, and the same unlabeled risks as the brand name. Had she been given the brand name drug rather than the generic it would have made no difference. The court held that since generics must be identical to brand name meds they cannot change the medication and call it a generic version. They also cannot change the label of benefits or of risks of that medication. The consumer has exactly the same protection whether you take a brand name or a generic. Keep in mind that because something bad happens does not mean a mistake was made. Every drug has benefit and risk which must be balanced. The risk however is never zero. So every time you take a motrin or a generic ibuprofen the risk is the same and TEN is one of the risks.

[ilovetv]

Law or not ... Someone tell me, inform how this ruling helps Joe Citizen the consumer? This is all about big business. Us consumers just sit back and accept.

If you don't want it to be all about "big business", then you'd want competition from smaller, lesser-known companies to be able to produce generics which cost the consumer a WHOLE lot less than the original/trade-name drug.

It certainly would not have benefited the consumer if a generic mfr. were put out of business because of a $21 million judgement against the smaller company competing with a giant one.....especially when the generic mfr. is (by law) making the exact same chemical product and labels it the same way the original mfr. does.

This, which blueash said it important to know and understand:

"The consumer has exactly the same protection whether you take a brand name or a generic. Keep in mind that because something bad happens does not mean a mistake was made. Every drug has benefit and risk which must be balanced. The risk however is never zero."

[Monkei]

If you don't want it to be all about "big business", then you'd want competition from smaller, lesser-known companies to be able to produce generics which cost the consumer a WHOLE lot less than the original/trade-name drug.

It certainly would not have benefited the consumer if a generic mfr. were put out of business because of a $21 million judgement against the smaller company competing with a giant one.....especially when the generic mfr. is (by law) making the exact same chemical product and labels it the same way the original mfr. does.

This, which blueash said it important to know and understand:

"The consumer has exactly the same protection whether you take a brand name or a generic. Keep in mind that because something bad happens does not mean a mistake was made. Every drug has benefit and risk which must be balanced. The risk however is never zero."

It is my understanding that there is a difference, you can still sue the brand name manufacturer but you don't have that option with the generic manufacturer. The bottom line is those who cannot afford the real thing and take a generic and get sick have no recourse but the well off person who can afford the real thing may still get sick but At least have a recourse to go to court. It's just another little perk but one I think we should all have. Now, and I don't know if it is available or not, maybe you can partner with the generic maker against the developer?

There have been cases where the drug manufacturer knew about certain issues and still proceeded to get their drug into the market.

My comments regarding big business were related to all of the them, big pharma, big oil, big you insert the name here. They all have their feet and their money up and down the halls of government. I am still waiting for the first big banker wall streeter to be charged with a crime ... There was a cartoon I saw the other day and it was relating to a felon who was on the loose trying to find a place to hide. The answer to the felon was Wall Street ... No one ever goes to jail from there.

[senior citizen]

.............

[buggyone]

"I told him he should call the Pharmacy to point out this issue.....and request the "real deal" meaning the real antibiotic and not the generic."

Would the name brand antibiotic be paid for by Medicare or was it only the generic that was paid for by your Medicare? Would your husband have been willing to pay for the name brand antibiotic himself if it was not covered by Medicare?

[senior citizen]

..............

[buggyone]

Was this here in The Villages? And, if so, which pharmacy ?

I always check at Walmart online to see if a prescribed drug is covered under their $10 program.

[dalecrenshaw]

I don't agree that generic drugs are exactly the same as the real drug. The main ingredients/chemicals might be the same, but they have fillers. I found this out when I took a generic drug and had a terrible allergic reaction from the filler in the drug. My whole body developed black and blue marks all over it within a couple of days, along with hives. It took weeks for it to get out of my system and the black and blue marks & hives to go away. I went to the Doctor and he told me I had an allergic reaction to the "filler" in the drug. He knew this since I had taken the real drug before for many years without any reaction. I still take some generic drugs, but I am careful about looking for any adverse side effects.

[senior citizen]

..............

[BarryRX]

As a pharmacist who has worked in both generic and name brand pharmaceutical manufacturing, I would like to address some of the concerns posted here. It is absolutely true that generic drugs contain "fillers", but so do the brand drugs. To use aspirin as an example, an aspirin tablet contains the active drug (acetylsalicylic acid), but also will contain a lubricant to help the powders flow through the tablet compression machines, a "binder" to help hold the tablet together after it is compressed, and an "expander" to help the compressed tablet break apart and dissolve in your body. While it is possible that you may be allergic to one of these excipients in the generic drug, it is just as possible you may be allergic to the excipients in the brand and not the generic. Fr those referring to generics as inferior, the generics are proven to contain the same active ingredient, dissolve in the body the same way, have the same bioavailability as he brand. The companies that manufacture generics must meet the exact same quality conditions as the brand companies. This legal requirement extends to the labeling that generic drugs use. An important part of the labeling is the patient package insert (ppi) that lists among other things, any side effects that may occur. It appears that in the Supreme Court case being discussed,the name brand company did not have this particular side effect listed. Since the generic company is legally required to have identical labeling, they also did not list this side effect. It seems to me that all the court did was to rule that the generic company was not liable for not doing something they were not allowed to do anyway. I would think that the plaintiff could probably still sue the brand company for not listing the side effect on their original ppi. For those that think this ruling is a reason to not use generic drugs, please consider taking a generic chill pill.

[Monkei]

As a pharmacist who has worked in both generic and name brand pharmaceutical manufacturing, I would like to address some of the concerns posted here. It is absolutely true that generic drugs contain "fillers", but so do the brand drugs. To use aspirin as an example, an aspirin tablet contains the active drug (acetylsalicylic acid), but also will contain a lubricant to help the powders flow through the tablet compression machines, a "binder" to help hold the tablet together after it is compressed, and an "expander" to help the compressed tablet break apart and dissolve in your body. While it is possible that you may be allergic to one of these excipients in the generic drug, it is just as possible you may be allergic to the excipients in the brand and not the generic. Fr those referring to generics as inferior, the generics are proven to contain the same active ingredient, dissolve in the body the same way, have the same bioavailability as he brand. The companies that manufacture generics must meet the exact same quality conditions as the brand companies. This legal requirement extends to the labeling that generic drugs use. An important part of the labeling is the patient package insert (ppi) that lists among other things, any side effects that may occur. It appears that in the Supreme Court case being discussed,the name brand company did not have this particular side effect listed. Since the generic company is legally required to have identical labeling, they also did not list this side effect. It seems to me that all the court did was to rule that the generic company was not liable for not doing something they were not allowed to do anyway. I would think that the plaintiff could probably still sue the brand company for not listing the side effect on their original ppi. For those that think this ruling is a reason to not use generic drugs, please consider taking a generic chill pill.

Thanks makes sense. Well written thanks for taking the time.

[Barefoot]

As a pharmacist who has worked in both generic and name brand pharmaceutical manufacturing, I would like to address some of the concerns posted here. It is absolutely true that generic drugs contain "fillers", but so do the brand drugs. To use aspirin as an example, an aspirin tablet contains the active drug (acetylsalicylic acid), but also will contain a lubricant to help the powders flow through the tablet compression machines, a "binder" to help hold the tablet together after it is compressed, and an "expander" to help the compressed tablet break apart and dissolve in your body. While it is possible that you may be allergic to one of these excipients in the generic drug, it is just as possible you may be allergic to the excipients in the brand and not the generic. Fr those referring to generics as inferior, the generics are proven to contain the same active ingredient, dissolve in the body the same way, have the same bioavailability as he brand. The companies that manufacture generics must meet the exact same quality conditions as the brand companies. This legal requirement extends to the labeling that generic drugs use. An important part of the labeling is the patient package insert (ppi) that lists among other things, any side effects that may occur. It appears that in the Supreme Court case being discussed,the name brand company did not have this particular side effect listed. Since the generic company is legally required to have identical labeling, they also did not list this side effect. It seems to me that all the court did was to rule that the generic company was not liable for not doing something they were not allowed to do anyway. I would think that the plaintiff could probably still sue the brand company for not listing the side effect on their original ppi. For those that think this ruling is a reason to not use generic drugs, please consider taking a generic chill pill.

I think we're very lucky on TOTV to have professionals like Barry who are so knowledgeable and willing to take the time to educate the rest of us. Thank you Barry!

[Bavarian]

As a pharmacist who has worked in both generic and name brand pharmaceutical manufacturing, I would like to address some of the concerns posted here. It is absolutely true that generic drugs contain "fillers", but so do the brand drugs. To use aspirin as an example, an aspirin tablet contains the active drug (acetylsalicylic acid), but also will contain a lubricant to help the powders flow through the tablet compression machines, a "binder" to help hold the tablet together after it is compressed, and an "expander" to help the compressed tablet break apart and dissolve in your body. While it is possible that you may be allergic to one of these excipients in the generic drug, it is just as possible you may be allergic to the excipients in the brand and not the generic. Fr those referring to generics as inferior, the generics are proven to contain the same active ingredient, dissolve in the body the same way, have the same bioavailability as he brand. The companies that manufacture generics must meet the exact same quality conditions as the brand companies. This legal requirement extends to the labeling that generic drugs use. An important part of the labeling is the patient package insert (ppi) that lists among other things, any side effects that may occur. It appears that in the Supreme Court case being discussed,the name brand company did not have this particular side effect listed. Since the generic company is legally required to have identical labeling, they also did not list this side effect. It seems to me that all the court did was to rule that the generic company was not liable for not doing something they were not allowed to do anyway. I would think that the plaintiff could probably still sue the brand company for not listing the side effect on their original ppi. For those that think this ruling is a reason to not use generic drugs, please consider taking a generic chill pill.

If it, a generics, do not work for you, you should not have to take it. Many drugs are OK in Generic, but for life threatening diseases, the name brands are required. Studies have shown it and my experience shows it. I am not risking my life to save a few bucks. I'll save money somewhere else.

[LatDoc]

Good try Barry. You can't win 'em all. Thanks for explaining the issue so well.

[blueash]

Thanks for that. Very interesting.
I've always had my suspicions re generic drugs......although I take none myself. I prefer to heal naturally.....
My husband recently called his dermatologist to request Cephalexon for a recurrent skin infection prior to our leaving on vacation.......
Cephalexon is a commonly given antibiotic that has worked on his finger infections (occupationally caused) in the past.
This time around, the pharmacist pointed out to him that "half of the bottle was one color and then from the "line down" the other half of the bottle would be a different color as it was from another manufacturer".....both generics. Well, nearing the end of the pills and they didn't work at all, period. I told him he should call the Pharmacy to point out this issue.....and request the "real deal" meaning the real antibiotic and not the generic. But, he decided to just stop taking them. I told him to call the dermatologist and request the real deal.... After what happened with that compounding incident not too long ago, one never really knows what they are taking...........

Alternative explanation...

In the past most skin infections were caused by stains of staph that were sensitive to many commonly used antibiotics including cephalexin. However over the last few years, due to the overuse of antibiotics by consumers (and doctors) almost all the strains of staph in the community are now resistant to cephalexin. By the way there is no such thing as brand name cephalexin, that is the name of the ingredient and is a generic. The most common brand name would have been Keflex. So it is very much more likely that your generic "failed" because it was the wrong medication to take for a 2013 skin infection. For further information I suggest google using the search term MRSA

[looneycat]

And we should continue to have the right to pay a bit more for Name brand when needed as the generics are ineffective. We are alking about one's life.

what research can you cite that says generics are ineffective?? I rely on generics every day, if they were ineffective I would be dead!