It is my understanding that off-label use of Revlimid and other myeloma drugs is common and has helped many multiple myeloma patients battle this disease.
A former sales rep for Celgene is suing Celgene under the whistle blower law because he/she is claiming Celgene encouraged the promotion of Revlimid for off-label uses.
Does anybody know or have an educated guess as to how that will impact our cancer treatment options? I've always viewed the "off label" use as the reason why Americans usually get to use some therapies years before patients from other countries. But I may be misinformed.
This is a link to a news story about the lawsuit:
"Judge refuses to toss off-label Revlimid marketing lawsuit against Celgene", FiercePharma.com, July 23, 2014.
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Re: Lawsuit - off-label marketing of Revlimid
I don't think this is going to go very far.
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dnalex - Name: Alex N.
- Who do you know with myeloma?: mother
- When were you/they diagnosed?: 2007
- Age at diagnosis: 56
Re: Lawsuit - off-label marketing of Revlimid
The issue of prescribing drugs off-label in the USA is completely separate from the issue of a company promoting a drug for off-label use. The former is perfectly legal and is quite commonplace (thankfully, IMHO) in the USA. The latter is forbidden by law in the USA, which is why Celgene is in the hot seat. Also note that Celgene has simply joined a long list of big pharma companies that have either been tagged or fined for this behavior. This is also not the first time they've been taken to court for this practice.
It really is quite a double standard between our medical and legal system when you think about it.
My take is even if Celgene does lose the lawsuit, it won't change our access to Revlimid or any other multiple myeloma drugs.
It really is quite a double standard between our medical and legal system when you think about it.
My take is even if Celgene does lose the lawsuit, it won't change our access to Revlimid or any other multiple myeloma drugs.
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Lawsuit - off-label marketing of Revlimid
Multibilly's take on the situation is correct. Off-label prescribing is completely legal in the U.S. and wouldn't be affected by Celgene losing this lawsuit (just as it hasn't been affected by other companies having lost lawsuits, and having paid substantial fines, for doing off-label marketing of drugs in the U.S.).
Actively marketing a drug for off-label purposes in the U.S. is, however, illegal, which is the entire reason lawsuits about it are filed and fines end up being paid.
That said, there may not be as much of a disconnect here as it seems. The legal situation basically says:
On the one hand, we (the government) will allow physicians to use their professional judgment to decide what is the appropriate use of a drug that the FDA deems sufficiently safe to approve for use outside of clinical trials.
On the other hand, we won't allow companies that manufacture and sell a drug to make claims about the efficacy and/or safety of the drug unless those claims have been vetted and approved by the FDA.
You can think of the second requirement as being basically a stricter-than-usual, more-formal-than-usual "truth in marketing" regulation.
Admittedly, the rules lead to an odd situation. A drug company representative in the U.S. can't go into a physician's office and say, unprompted, "Let me tell you about this off-label use of our drug." However, the same representative is permitted to answer questions a physician asks about off-label use of a drug.
Actively marketing a drug for off-label purposes in the U.S. is, however, illegal, which is the entire reason lawsuits about it are filed and fines end up being paid.
That said, there may not be as much of a disconnect here as it seems. The legal situation basically says:
On the one hand, we (the government) will allow physicians to use their professional judgment to decide what is the appropriate use of a drug that the FDA deems sufficiently safe to approve for use outside of clinical trials.
On the other hand, we won't allow companies that manufacture and sell a drug to make claims about the efficacy and/or safety of the drug unless those claims have been vetted and approved by the FDA.
You can think of the second requirement as being basically a stricter-than-usual, more-formal-than-usual "truth in marketing" regulation.
Admittedly, the rules lead to an odd situation. A drug company representative in the U.S. can't go into a physician's office and say, unprompted, "Let me tell you about this off-label use of our drug." However, the same representative is permitted to answer questions a physician asks about off-label use of a drug.
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Boris Simkovich - Name: Boris Simkovich
Founder
The Myeloma Beacon
Re: Lawsuit - off-label marketing of Revlimid
...ahhh, the "Learned Intermediary" exception to the FDA approved use of a drug or device...
A story to illuminate:
Zyban is a drug Rx'd to aid cessation of smoking. (Current drug)
An early version of an Anti-depressant (A/D) was developed for use in Depressed patients. (1978-82) It was used and studied (Double-Blind) at a closed accessed facility, with severely depressed in-patients. While it was noted to basically be a sh-tty A/D, the staff noticed the patients were smoking much less,...and some had even quit, completely.
Quietly, many MD's prescribed it for it's anti-smoking effect--rather than it's A/D effects which were not very effective. ( ie. Off-label use) Amidst further studies, a Canadian Company bought up the patent rights, tweaked the formulary by adding a molecule of oxygen to the mix, and voila--Zyban was born--and later FDA approved ( and marketed ) for smoking cessation. (1985)
Zyban is relatively cheap, readily available, and effective, but suffers the stigma of being an orphan child of an A/D.
( ie. I may be a smoker--but I ain't taking no crazy pills !) Otherwise, it would be marketed much heavier, as it is a proven "quit smoking" drug, with few side effects.
Drug Companies can indeed suggest, but not market, Off-label uses.
A grey area, as the usual disclaimer by the Big Pharma ie. "Method of action in man, is poorly understood", ( to protect them from lawsuits) prevents them from marketing (Falsely) what off-label uses a Drug can possess. The FDA's position is you (Big Pharma) are bound by your patent, data, intended use, and regulatory filings. ( ie. Do you understand the method of action..or not ??)
Off-label is a use that only Licensed DEA Providers/ MD's /ARNP's/ PA's can make, while applying the "learned Intermediary" exceptions to the Federal Regs, Rulings, and Patent grants.
As to Revlimid, I'm kind of surprised that Celgene would try to Off-market /Off-Label it's "cash-cow" formulary, given current favorable studies and it's currently absurd price, given it's Patent protection until 2020 or so. Who is going to RX a $14K drug for ...halitosis ???
No one, I would suggest.
Perhaps other B cell afflictions, such as leukemia, Lymphomas ?
The only rational conclusion is that the newer.."_______nab" ( pick your drug) formulates are about to kick Revlimid's market share to the curb / create downward price pressures.
Good for Myelomers....bad for some Big Pharma folks.
The folks at Celgene may indeed be nervous, beating the butts too much (smoking), and soon reaching for the Zyban....methinks.
Ironic, isn't it ?
A story to illuminate:
Zyban is a drug Rx'd to aid cessation of smoking. (Current drug)
An early version of an Anti-depressant (A/D) was developed for use in Depressed patients. (1978-82) It was used and studied (Double-Blind) at a closed accessed facility, with severely depressed in-patients. While it was noted to basically be a sh-tty A/D, the staff noticed the patients were smoking much less,...and some had even quit, completely.
Quietly, many MD's prescribed it for it's anti-smoking effect--rather than it's A/D effects which were not very effective. ( ie. Off-label use) Amidst further studies, a Canadian Company bought up the patent rights, tweaked the formulary by adding a molecule of oxygen to the mix, and voila--Zyban was born--and later FDA approved ( and marketed ) for smoking cessation. (1985)
Zyban is relatively cheap, readily available, and effective, but suffers the stigma of being an orphan child of an A/D.
( ie. I may be a smoker--but I ain't taking no crazy pills !) Otherwise, it would be marketed much heavier, as it is a proven "quit smoking" drug, with few side effects.
Drug Companies can indeed suggest, but not market, Off-label uses.
A grey area, as the usual disclaimer by the Big Pharma ie. "Method of action in man, is poorly understood", ( to protect them from lawsuits) prevents them from marketing (Falsely) what off-label uses a Drug can possess. The FDA's position is you (Big Pharma) are bound by your patent, data, intended use, and regulatory filings. ( ie. Do you understand the method of action..or not ??)
Off-label is a use that only Licensed DEA Providers/ MD's /ARNP's/ PA's can make, while applying the "learned Intermediary" exceptions to the Federal Regs, Rulings, and Patent grants.
As to Revlimid, I'm kind of surprised that Celgene would try to Off-market /Off-Label it's "cash-cow" formulary, given current favorable studies and it's currently absurd price, given it's Patent protection until 2020 or so. Who is going to RX a $14K drug for ...halitosis ???
No one, I would suggest.
Perhaps other B cell afflictions, such as leukemia, Lymphomas ?
The only rational conclusion is that the newer.."_______nab" ( pick your drug) formulates are about to kick Revlimid's market share to the curb / create downward price pressures.
Good for Myelomers....bad for some Big Pharma folks.
The folks at Celgene may indeed be nervous, beating the butts too much (smoking), and soon reaching for the Zyban....methinks.
Ironic, isn't it ?
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Rneb
Re: Lawsuit - off-label marketing of Revlimid
Perhaps folks don't realize it, but Revlimid is not FDA approved as a front-line treatment for multiple myeloma, even though it is very often prescribed for just that very situation. So, marketing it for even this use is in violation of the FDA rules.
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf
"Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (multiple myeloma) who have received at least one PRIOR therapy."
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021880s038lbl.pdf
"Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (multiple myeloma) who have received at least one PRIOR therapy."
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Multibilly - Name: Multibilly
- Who do you know with myeloma?: Me
- When were you/they diagnosed?: Smoldering, Nov, 2012
Re: Lawsuit - off-label marketing of Revlimid
A couple of things.
Soon, Side-effects and Adverse event information from the FDA will be available and on-line.
http://www.businessweek.com/articles/2014-02-27/fda-opens-its-files-on-drug-side-effects-to-public
This will be new...
Second, to be clear about what was posted above re: Revlimid and Front-Line Use.
---"Prior use" often includes standard regimes of Induction Therapy (ie. Velcade, Dex, thalomide, etc ) OR RADIATION, Surgery, etc
So for most Myelomers, after a few doses of Velcade / Dex (Induction) or radiation, Revlimid can be legally Rx'd and used. No violation occurs.
Nothing new here...
Soon, Side-effects and Adverse event information from the FDA will be available and on-line.
http://www.businessweek.com/articles/2014-02-27/fda-opens-its-files-on-drug-side-effects-to-public
This will be new...
Second, to be clear about what was posted above re: Revlimid and Front-Line Use.
---"Prior use" often includes standard regimes of Induction Therapy (ie. Velcade, Dex, thalomide, etc ) OR RADIATION, Surgery, etc
So for most Myelomers, after a few doses of Velcade / Dex (Induction) or radiation, Revlimid can be legally Rx'd and used. No violation occurs.
Nothing new here...
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Rneb
Re: Lawsuit - off-label marketing of Revlimid
Rneb, five years ago this September I was diagnosed and within one month I was on Revlimid / dex. Later Velcade was added. So Revlimid is used as front line treatment. And I'm pretty sure the 4 multiple myeloma people I'm closest too all had same upfront Revlimid.
As Beacon pointed out it's a grey line.
If I were a sales rep for Velcade and saw early research showing that subcutaneous Velcade vs. infusion reduced or eliminated neuropathy, I'd tell my clients (doctors) about it. And not feel unethical about it, even though it wasn't officially approved. I'd actually be enthusiastic about it! What sales rep wouldn't?
Of course you'd want to present it as "research shows that ...," and not present it as "if you inject Velcade your patients will not get neuropathy".
It's good to keep a lid on snake salesmen of these drugs, but I don't want it to be too restrictive. I do not know details on this particular case ... possibly salesman was being pushed into unethical territories. But quite possibly we do have access to some of these drugs because companies do push the envelope when promoting their products.
I also would think the insurance companies would be the first to point out when a product is not FDA approved for off label use.
As Beacon pointed out it's a grey line.
If I were a sales rep for Velcade and saw early research showing that subcutaneous Velcade vs. infusion reduced or eliminated neuropathy, I'd tell my clients (doctors) about it. And not feel unethical about it, even though it wasn't officially approved. I'd actually be enthusiastic about it! What sales rep wouldn't?
Of course you'd want to present it as "research shows that ...," and not present it as "if you inject Velcade your patients will not get neuropathy".
It's good to keep a lid on snake salesmen of these drugs, but I don't want it to be too restrictive. I do not know details on this particular case ... possibly salesman was being pushed into unethical territories. But quite possibly we do have access to some of these drugs because companies do push the envelope when promoting their products.
I also would think the insurance companies would be the first to point out when a product is not FDA approved for off label use.
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stann
Re: Lawsuit - off-label marketing of Revlimid
Furthermore, it sounds like it may be a similar story for Viagra? Heart patients were being given a certain medication for something or other, and doctors noticed that patients weren't giving back the medication when finished with heart treatment. And some of the heart patients volunteered "you know doc, about an hour after I take this ... well ... you know ... yeah. Can I keep it"
(That's the story I've heard).
Celgene stock is up over 300% in last 5 years. I wouldn't bet against them!
(That's the story I've heard).
Celgene stock is up over 300% in last 5 years. I wouldn't bet against them!
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stann
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