I agree, hneiman.....Joe's level of intellect far exceeds that of any of the SHORTS on this MB! As a matter of fact, we have many very, very intelligent LONGS on this MB and all the SHORTS have is a bunch of "red thumbs!"
You can find what you want to find and read what you want to read but physician's being sued is a REAL possibility depending upon the circumstances:
Abstract and Introduction
Nurse practitioners (NPs) and other prescribing clinicians are in an odd position regarding off-label prescribing. Everyone seems to do it, and sometimes there is little choice but to do it, yet it is risky, and the messages to clinicians are decidedly mixed. Off-label prescribing does not violate FDA or state law. Except for the prescribing of physician-assisted suicide in Oregon, there is no legal requirement that clinicians write the intended use on a prescription.
Prescribing off-label is not malpractice. Case law supports clinicians' authority to do it. In the case of United States v Evers, the court held that a physician could prescribe a drug for a different dose than recommended in the prescribing guides if it was not contraindicated. In one court case, the opinion read, "In some circumstances, the off-label use of a particular drug or device may even define the standard of care." However, the presumed standard of care is to prescribe "on label." If an adverse event occurs and a plaintiff's attorney finds out that a drug was prescribed off-label, he or she likely will make an issue of it.
One court case against a physician gives us an indication of how judges view off-label prescribing. In that case, a physician used terbutaline sulfate, by infusion pump, to stop a woman's preterm labor at 35 weeks. Terbutaline sulfate has been used for this purpose for many years, though it is an off-label practice. The patient had a myocardial infarction and sued for malpractice. The appellate court held that the fact a drug was prescribed off-label could be introduced as evidence that the prescriber deviated from the standard of care. As this case and others became known, the FDA issued warnings against use of terbutaline for stopping preterm labor.
Off-label prescribing is an especially important issue for pediatric NPs and pediatricians. Approximately 75% of the drugs prescribed for children have not been tested in children, so the labeling approved by the FDA regarding dosing, indications, and precautions in the drug references are, for the most part, applicable to adults, not children. Prescribing drugs not approved for pediatric use is not the same as prescribing a drug for which there is a contraindication. In short, rather than saying, "We know there is a problem (contraindication)," the FDA is saying, "We just don't know."
In one case against a pediatric NP who prescribed off-label, a judge awarded a plaintiff $3,459,892. In that case, an NP saw a 15-year-old girl in a clinic, 2 days after the patient had visited an emergency department for nausea, abdominal pain, and vomiting. The NP prescribed anti-nausea medications and also fluoxetine for depression. Three weeks later the girl hanged herself. Her parents sued the NP, and among the points the plaintiff made was that the FDA had issued a warning specifying that fluoxetine increases the risk of suicidal thinking and behavior in adolescents.
The bottom line is that off-label use may be 1 factor leading a judge or jury to a conclusion that a clinician breached the standard of care. Further-more, if a clinician does not inform a patient that he or she is prescribing off-label, that lack of information may lead a patient to claim that he has not given his informed consent to take the medication. Courts have ruled that physicians do not have to reveal that a proposed use is off-label during the informed consent process. However, it makes sense for clinicians to tell a patient that they are prescribing off-label in order to give the patient a chance to refuse or agree to take the medication.
In a Consumer Reports article on off-label prescribing, the magazine advised consumers: "Although many doctors regularly discuss off-label drug use with their patients, your doctor is not obligated to do so. Ask your doctor when a prescription is written if the drug has been approved by the FDA to treat your condition. If the answer is 'no,' ask why he or she thinks it will work better than a drug that's already been approved for your condition. Also ask about the evidence that supports its use in your case and about the alternatives."
Prescribing off label requires a clinician to balance patient safety (protecting patient from unsafe or ineffective drugs) against the judgment of the clinician that the drug will benefit the patient. Any clinician prescribing off-label is taking on some risk, and is putting the patient at risk, as the clinician does not have benefit of the use, dosing and route information which is available when a medication is prescribed for an approved indication. And, the safety and efficacy of the drug may not have been established for the unapproved use. There is little or no opportunity for clinicians to share data on the successes or mishaps regarding their off-label use, as there are no requirements to keep or report such data.
When prescribing off-label, clinicians must weigh the risks to themselves and patients versus the benefits to the patient. And, if an NP is practicing under a protocol and off-label use is not covered by the protocol, the NP needs to avoid prescribing off-label.
A brand new ID who seems to appear on many different MB's giving your opinion on various cases, etc. And pray tell, what interest do you have in SPPI other than to voice your opinion???
I cannot answer your questions, Iome. If you feel as you do, I do not understand why you haven't sold and moved on to some other stock. In my wildest dreams (or nightmares) I sometimes think that at one time or another you knew Raj personally and are now jealous of him. You, and several other MB ID"s from overseas. I am not a psychiatrist......perhaps you should ask Charles Krauthammer (*~*) or the TROLLS and SHORTS on this MB!
Then you should be very happy that we're going up today, Iome. Quit bi**ing about Raj and SPPI and look for the positives, because I believe the positive far outweigh the negatives. If you're a LONG, act like a LONG, and we'll quit calling you a troll. I agree with TTB and a few others. At one time (a long time ago) you were a valued contributor to this MB. I am not, by nature, a disgruntled and unhappy person. I try to remain positive through all my trials and tribulations and I guarantee you, you have would never believe all the HELL I've been through!! GLTU.....stay positive!!
What do you do, Iome, when you know you're looking at nothing but PURE MANIPULATION smack in the face. Either you stand firm and go with your convictions or you bail. I choose to go with my convictions and I'm a long time investor......not a SHORT nor am I a DAY TRADER. You do as you wish and say what you please and I will do the same. So far, in the USA, we still have freedom of speech!!
Today, the buy and sell orders mostly end in "75". Is this some kind of signal to the SHORTS?? Check it out on the Order Book on YHOO. You will see what I mean!!
Right on, khp......we LONGS know it and so do the SHORTS. They are just trying to pinch every penny they can out of SPPI before they cover. Feel sorry for those who got scared and sold!!
Interesting, hneiman, and with the Nuclear Plant disaster at Fukushima in 2011, you know there are millions of people in that part of the world who are suffering from cancer and need the treatments SPPI and CASI have to offer!!
Not only should you have an order in for 24.99 or some high order in to keep the shorts from having access to your stock, but since we all know the HF's are MANIPULATING the stock, go on your respective trading platform and put in a buy......that's all......no amount or anything and just sit there and click on the buy off and on. If they are going to manipulate, so can we IMO!!!
Still one of the best posts of the week!!
atlcitizen7 • Feb 24, 2015 5:00 PM Flag
17users liked this postsusers disliked this posts30Reply
Nothing has materially changed
1. The patent ruling only affects the fusilev indication for osteosarcoma, which is less than 1% of the sales for fusilev. And it will be appealed, Dr. Raj estimates 14 month process for this. So will have absolutely no impact on Fusilev sales for 2015...at all. Fusilev sales has been stable over several quarters in a row and should continue this way through at least the end of this year.
2. According to Dr. Raj today, over 99.9% of Fusilev sales are from indication for colorectal cancer, which is under ORPHAN status protection, which is untouchable by courts. This protection ends in 2018. 2018 folks!
3. Dr. Raj says Spectrum has more than enough cash to cover operations and clinical trials, including trials for SPI 2012 which should take 2 years or less.
4. Meantime pipeline is advancing nicely. Expect approval CE melphalan around October. 100 million dollar market. Dr. Raj expects to get all of it.
File NDA for Apaziquone and start new phase 3 trial before end of 2015. We'll hear more about this from expert urologist analyst on March 13.
SPI 2012 data will be shared probably at ASCO before July. Expect that to be very positive.
IMO there is no reason for stock price to be less than a week ago, but the price has long ago been detached from the reality of what is going on with this company. Institutional investors will manipulate as they please until they can't do it anymore--that day is coming. So this is for the individual long investors--hang in there! Don't let institutional investors scare you out and cheaply scoop up your shares! Long and hanging strong. And shorties don't even bother responding as I'm ignoring you:-)
This is an interesting topic, hneiman. How nice of Cigan to bring it up. He is full of surprises now and then!!
Never thought about that, Joe, since I worked up until the very day I had my child and then was back to work within a couple weeks after. You're right.......my bad!!!
This is true, Ma......even if he doesn't always have his talking points right or the pastes he's given to post right. He does work hard at trying to convince everyone he's a LONG that absolutely hates this co. Never seen such a hater. Oh, but wait......yes I have seen many haters on this MB!! I'll never forget the morning that Iome, who can normally barely complete a sentence.......at any rate, he had about 7 or 8 posts he made all in a row B4 the opening bell, that were obviously cut and paste posts that someone had given him. Really quite funny; especially for Iome!!
Ha ha ha.....sluff just replaced ville.....bunch of trolls!!!