Pfizer fined record $2.3B

[p_rushing]

Re: Pfizer fined record $2.3B

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</td> <td style="background-image: url(/vBulletin/images/quotes/00.gif); width: 100%; height: 1px;" width="100%"> The Justice Department said Pfizer sales people created sham requests from physicians asking for information about unapproved uses of certain drugs. The information was then mailed to doctors.
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I'm not sure what the issue the Justice department had here. The reps create request for mailings all the time, unless the doctor has requested not to be mailed. Pfizer can't openly market those uses, but if a doctor asks about them, then they can. If they ask about one of the drugs, they can send all the information.

Now with the unapproved uses, as long as it is stated as not approved, there shouldn't have been any issues. Now if they weren't saying that they weren't approved, then whoever created the mailings should be charged.

Pfizer and all drug companies encourage all doctors to prescribe their drugs whether they work or not. They are there to make money, they don't care which one works the best. That is why doctors need to do their own research. There's a fine line and this stuff goes on at all the big companies.

[J0nnD0ugh]

Re: Pfizer fined record $2.3B

I read this quote like three times and I'm not sure how it makes your point. Where did the information come from? The FDA? Pfizer?

I have no idea. But using my power of reasoning, I'm sure it wasn't the FDA. Cause then it would say not to use it for such-n-such.

Well yeah, and people should have had, and did have, an expectation that banks would make smart decisions. But look what happened... they didn't, and people lost huge sums of money. Trust without verification is never a good thing, and it seems to be the case now more than ever.

That's not the same.

1. The people investing in banks know there is always risk, no guarantee after a certain amount.

2. Bad investing is not illegal until fraud comes into play. it is illegal to use medicine beyond its intended purpose.

What you're asking is for each individual doctor to do his/her own experiments before ever using it. That's not feasible or reasonable. The medical community depends on honest research to inform them of the risk/benefit, harm/effectiveness of the medicine available. The docs didn't get that. You know if Pfizer was doing this to make a sale, they wouldn't put "the FDA hasn't approved of using this because...."

I'm not sure what the issue the Justice department had here. The reps create request for mailings all the time, unless the doctor has requested not to be mailed. Pfizer can't openly market those uses, but if a doctor asks about them, then they can. If they ask about one of the drugs, they can send all the information.

There are your keys!

The doctors didn't ask for this information. Again, "sham requests".

Also, Pfizer reps were not allowed to send mailings trumpeting their drugs for uses other than what the FDA allowed.

Now with the unapproved uses, as long as it is stated as not approved, there shouldn't have been any issues. Now if they weren't saying that they weren't approved, then whoever created the mailings should be charged.

Do you really think this would be an issue if Pfizer was telling MD's "don't use this for "X" purpose because it hasn't been approved"?

Pfizer and all drug companies encourage all doctors to prescribe their drugs whether they work or not. They are there to make money, they don't care which one works the best. That is why doctors need to do their own research. There's a fine line and this stuff goes on at all the big companies.

Drug companies are not supposed to be promoting drugs for treatment that doesn't work. That's why they have to go through the FDA 1st. If they can't prove it works, they can't well it for that purpose. That's why what they did was illegal. That's why what you're describing is no different than a pusher on the street. He's there to "make money". All he's done is eliminate the middle man, the doctor.

And again, it isn't practical to expect all doctors to treat patients and do research. They have to depend on the information they receive to be accurate & truthful.

[Laffer]

Re: Pfizer fined record $2.3B

Looking at this from a social-medical point of view rather than a strictly legal point of view is important also.

Doctors use pharmacuticals for off-label uses all the time, and it would be almost negligent of them not to if their is evidence suggesting it could help their patients. As individuals, we should want Pfizer informing MDs about all the possible uses of their products. Cases like these stigmatize the important exchange of clinical information b/w docs and drug companies.

On the other hand, the FDA can't look at individual outcomes, but has to look social outcomes. In this case, Pfizer was deemed to have crossed a very blurry line. And on a large scale, if companies continually step over the line, it can put large segments of the population at risk, at certain times (as was the case w/ Bextra). So the FDA is necessary to keep the public safe, although in that effort individuals can get trampled or not treated as well as they should.

[J0nnD0ugh]

Re: Pfizer fined record $2.3B

Doctors use pharmacuticals for off-label uses all the time, and it would be almost negligent of them not to if their is evidence suggesting it could help their patients. As individuals, we should want Pfizer informing MDs about all the possible uses of their products. Cases like these stigmatize the important exchange of clinical information b/w docs and drug companies.

But would the FDA deny that use for certain treatments if it was effective? Obviously not. If it's not been cleared, then its obvious that it doesn't work or is even life-threatening. Again, docs relied on Pfizer to give all information. The pluses & the minuses. Including the fact that it doesn't have FDA approval.

We know the pusher on the street is doing something illegal. We shouldn't have to question the drug company. Which makes Pfizer's act even more heinous. They are inticing people to unwittingly commit criminal acts. They are doing this on a national scale, not on their corner of the block. And they are affecting people looking to improve their health, not simply get high.

On the other hand, the FDA can't look at individual outcomes, but has to look social outcomes. In this case, Pfizer was deemed to have crossed a very blurry line. And on a large scale, if companies continually step over the line, it can put large segments of the population at risk, at certain times (as was the case w/ Bextra). So the FDA is necessary to keep the public safe, although in that effort individuals can get trampled or not treated as well as they should.

I don't believe the line was blurry @ all. It was clear as day. They crossed it, humped it, danced on top of it & kicked dust all over it. They got their money, put people @ risk & now get to sit back & not get punished, but let the entity take a hit. We don't even know their names. Where they live. All we see is a pic of the corporate building @ a statement from the PR department. No damage sustained, whatsoever.

[Laffer]

Re: Pfizer fined record $2.3B

But would the FDA deny that use for certain treatments if it was effective? Obviously not. If it's not been cleared, then its obvious that it doesn't work or is even life-threatening. Again, docs relied on Pfizer to give all information. The pluses & the minuses. Including the fact that it doesn't have FDA approval.

The FDA approves a drug, and then doctors are free to prescribe it as they wish, even for off-label uses. If the doc is prescribing it inappropriately, that is an issue for the Royal College (or equivalent American body) not the FDA. The classic example of why off-label uses are necessary for doctors is in regard to pediatric medicine. Many drugs are not approved for use in children, but docs still prescribe them to children because the kids need care. I'm sure the docs knew they were prescribing the drugs for off-label uses, the issue is that Pfizer advertised those uses unsolicited.

We know the pusher on the street is doing something illegal. We shouldn't have to question the drug company. Which makes Pfizer's act even more heinous. They are inticing people to unwittingly commit criminal acts. They are doing this on a national scale, not on their corner of the block. And they are affecting people looking to improve their health, not simply get high.

Legally you are right on, Pfizer broke the law. But what about on a purely ethical basis? Try to put yourself in a drug reps shoes- maybe you have an FDA approved medication for muscle pain, and then studies reveal that your product also has anti-dementia activity. Is it wrong to tell docs that your product could improve treatment for some patients? Legally, yes it is wrong. Ethically? Both telling and not telling the doc has moral implications.

I don't necessarily disagree with you Jon. But if I had a tic and it was cured by Geodon prescribed by my doc because a Pfizer rep marketed it illegally, I sure wouldn't mind.

[p_rushing]

Re: Pfizer fined record $2.3B

Once the drug is approved, they usually don't go back to the FDA to get it approved again for another use. The FDA test very specific uses, so you would have to go back many times and spend a lot of money testing. Why do that when the doctors can prescribe off label and you don't have to spend the money and potentially 5+ years to get it approved with the FDA. Plus you wouldn't be extending your patent rights, so its just throwing money away.

[J0nnD0ugh]

Re: Pfizer fined record $2.3B

The FDA approves a drug, and then doctors are free to prescribe it as they wish, even for off-label uses. If the doc is prescribing it inappropriately, that is an issue for the Royal College (or equivalent American body) not the FDA. The classic example of why off-label uses are necessary for doctors is in regard to pediatric medicine. Many drugs are not approved for use in children, but docs still prescribe them to children because the kids need care. I'm sure the docs knew they were prescribing the drugs for off-label uses, the issue is that Pfizer advertised those uses unsolicited.

I have no issue w/the doctors. I've said that over & over. I have a problem w/the Pfizer corporation. Instead of peeking into a car window in the ghetto, they pushed their drugs in a pamphlet handed out at a resort. They are no different from a drug pusher. They should be treated just the same.

Legally you are right on, Pfizer broke the law. But what about on a purely ethical basis? Try to put yourself in a drug reps shoes- maybe you have an FDA approved medication for muscle pain, and then studies reveal that your product also has anti-dementia activity. Is it wrong to tell docs that your product could improve treatment for some patients? Legally, yes it is wrong. Ethically? Both telling and not telling the doc has moral implications.

Laffer. Be honest, k? Do you really think all of these reps passed on this info, created "sham requests", for purely benevolent reasons? Like a dope dealer selling in a schoolyard just because he wants to see kids happy?

I don't necessarily disagree with you Jon. But if I had a tic and it was cured by Geodon prescribed by my doc because a Pfizer rep marketed it illegally, I sure wouldn't mind.

Again, no problem w/the doctors. If a doc asked a rep does "X" drug have any other potential use on some kind of cancer, the rep says there are some studies that looked into that, and the MD asks to see the info, no problem.

That wasn't what was happening. They advertised it, targeting doctors, w/o being asked, merely to increase sales.

That's a dope dealer.

Once the drug is approved, they usually don't go back to the FDA to get it approved again for another use. The FDA test very specific uses, so you would have to go back many times and spend a lot of money testing. Why do that when the doctors can prescribe off label and you don't have to spend the money and potentially 5+ years to get it approved with the FDA. Plus you wouldn't be extending your patent rights, so its just throwing money away.

Again, no problem w/the doctors. FDA evidently doesn't. It's Pfizer being taken to court & fined. They are the criminals responsible. They should be spending hard time.

[pfunk880]

Re: Pfizer fined record $2.3B

It's Pfizer being taken to court & fined. They are the criminals responsible. They should be spending hard time.

Okay, so let's put every member of the company in prison. I'm not really sure what you are looking for here.

[J0nnD0ugh]

Re: Pfizer fined record $2.3B

Okay, so let's put every member of the company in prison.

Those in sales & their superiors. You know they have records of who requested what. And you know it was a company wide policy. Do we just ignore drug cartels simply because they are so many in the chain? Or do they go to prison when caught? You guys keep looking @ the individual as just a business man trying to get ahead. Take off the Florshiems & put them in Lugz.

[p_rushing]

Re: Pfizer fined record $2.3B

Those in sales & their superiors. You know they have records of who requested what. And you know it was a company wide policy. Do we just ignore drug cartels simply because they are so many in the chain? Or do they go to prison when caught? You guys keep looking @ the individual as just a business man trying to get ahead. Take off the Florshiems & put them in Lugz.

The problem is that they don't know who created the fake requests. The doctors can call in or visit the website, but most of them don't. They will talk directly to the rep, the rep will then put the request in to mail info out. So you can't arrest all of them because some broke the law.

[pfunk880]

Re: Pfizer fined record $2.3B

I don't really see what we are accomplishing at this point in the discussion.

I think we can all agree that there was clear wrongdoing here. But beyond that, there's no way to figure out actual individuals to arrest and send to prison.

[Laffer]

Re: Pfizer fined record $2.3B

I don't really see what we are accomplishing at this point in the discussion.

I think we can all agree that there was clar wrongdoing here. But beyond that, there's no way to figure out actual individuals to arrest and send to prison.

Legally, yes there was wrong doing. But whenever large regulatory bodies make landmark decision, especially decisions that stigmatize the free flow of information, it is up to individuals to take a closer look, and try to decide whether not only whether the law was upheld, but whether justice was served.

[J0nnD0ugh]

Re: Pfizer fined record $2.3B

The problem is that they don't know who created the fake requests. The doctors can call in or visit the website, but most of them don't. They will talk directly to the rep, the rep will then put the request in to mail info out. So you can't arrest all of them because some broke the law.

I don't really see what we are accomplishing at this point in the discussion.

I think we can all agree that there was clear wrongdoing here. But beyond that, there's no way to figure out actual individuals to arrest and send to prison.

Again, "sham requests". I'm sure these guys work on commission. So I'm sure they kept records so they knew who to give credit on the sale. I can just about guarantee its traceable. Also, repeating myself once more, it had to be a company wide policy for multiple reps to be doing the same thing.

[p_rushing]

Re: Pfizer fined record $2.3B

Again, "sham requests". I'm sure these guys work on commission. So I'm sure they kept records so they knew who to give credit on the sale. I can just about guarantee its traceable. Also, repeating myself once more, it had to be a company wide policy for multiple reps to be doing the same thing.

I've worked with the systems that track this data and it is used to calculate the bonuses for the reps. The only way to trace if it was legitimate request is for the doctor to have made the request them self. That doesn't happen much. The rep will put the request in for the doctor because the doctor doesn't have time.

Also the reps do whatever they want. There are legal disclosures that must be shown every time they visit a doctor and discuss products. Some of the reps show it, some don't. I built a reporting system, at another company, that tracked different stuff, but that was one of them. They could then take action against the reps not following procedure.

[J0nnD0ugh]

Re: Pfizer fined record $2.3B

I've worked with the systems that track this data and it is used to calculate the bonuses for the reps. The only way to trace if it was legitimate request is for the doctor to have made the request them self. That doesn't happen much. The rep will put the request in for the doctor because the doctor doesn't have time.

Then they can look @ the requests sent, ask the doctors who received the info if they asked for it, and act accordingly. You guys are acting like this is so difficult. This is what prosecutors & investigators are paid to do. As if every criminal court case involves videotaped evidence or something. They seize data & follow the paper trail all the time. No one would come up w/all of these excuses if the guy was on the street corner. But put him in a cubicle & suddenly, we're playing Devil's advocate.

Also the reps do whatever they want. There are legal disclosures that must be shown every time they visit a doctor and discuss products. Some of the reps show it, some don't. I built a reporting system, at another company, that tracked different stuff, but that was one of them. They could then take action against the reps not following procedure.

Then they once more, investigate & punish accordingly.