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  1. #361
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    Always wondered why George's parents stayed together...not as much as I wonder why people bother to engage Walshie and Cheezy, but I did wonder...
    "No two people on Earth are alike, and it's got to be that way in music or else it isn't music."óBillie Holliday

  2. #362
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    ďMany people, especially ignorant people, want to punish you for speaking the truth, for being correct, for being you. Never apologize for being correct, or for being years ahead of your time. If youíre right and you know it, speak your mind. Speak your mind. Even if you are a minority of one, the truth is still the truth.Ē -Gandhi

    Rational skepticism is not the same thing as being a conspiracy theorist.

    Never forget that only dead fish swim with the stream. -Muggeridge

  3. #363
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    Quote Originally Posted by Marley View Post
    Numbers are numbers. If youíre asserting that pharma is hiding data, thatís an entirely different discussion.
    No problem. Tag it for later.

    If the FDA requires 2 studies be conducted, why would a company sink millions in creating 5? And whereís the cutoff? Is 10 enough? How about 12? You canít damn the pharma companies for adhering to the rules.
    The FDA requires 2 trials that result in a positive effect, thus if your first 2 trials don't achieve that result, you continue to do trials until you get the results you want.

    Which is why I think the prescribing guidelines should be re-examined but I donít think that prescribers should have the ability to prescribe taken away, which is what you have suggested.
    These drugs are often prescribed off-label. That should be criminal. If a drug is not demonstrated to treat X, you shouldn't prescribe it for X.

    Black box or black triangle warnings arenít meant to stop prescribers, itís meant to make them more aware. I feel comfortable with trained medical professionals using their medical judgment based on the scientific data that is available.
    Again, this is where your view of the medical/pharma relationship differs from mine. These doctors have no clue what the potential risks are, because they've been sold by pharma reps.

    Now, with the enormous rise in the use of serotonin-enhancing antidepressants, often taken in combination with other drugs that also raise serotonin levels, emergency medicine specialists are trying to educate doctors and patients about this not-so-rare and potentially life-threatening disorder. In March 2005, two such specialists, Dr. Edward W. Boyer of the University of Massachusetts Medical School and Dr. Michael Shannon of Childrenís Hospital Boston, noted that more than 85 percent of doctors were ďunaware of the serotonin syndrome as a clinical diagnosis.Ē
    http://www.nytimes.com/2007/02/27/he...rody.html?_r=0

    Iím not. You provided the data- 2:133, thatís 1.6% of those numbers. That percentage of participants experienced HI. Not statistically significant.
    I'd say that more than 1 out of 100 people taking a specific antidepressant having thoughts of killing people is significant, especially considering that not just 1 million but potentially millions of Americans are taking them. How many killers does that create?

    Here we agree. Drugs alone are never the answer- for any condition but you canít lay blame at the feet of pharma alone when this is a multifaceted issue.
    Pharma makes the drugs that cause the side effects, and markets them to doctors as "safe" and even pushes them for off-label prescriptions.

    Thatís non-sense. Past medical history is an important piece of the puzzle. If a patient had a history of SI or HI before taking medication, then itís quite possible that the medication is simply ineffective or dosed incorrectly and not causing the symptoms. You canít just write off history.
    There is a difference between incidence and prior history. I don't care if someone thought about killing someone as a 12-year old and then realized how awful it is. I care about the guy who took these meds and killed someone.

    Itís looking at what did happen in these specific cases without painting the entire picture. Whatís the incidence of aggression or violent events (which is really too broad of a term to be using) for each drug? Thatís data I need to make an informed decision. If Paxil is linked to 10% of itís population having suicidal ideation, thatís a giant flag but if itís under 2%, not so much.
    What is so bad about a study that looks for X amount of violent events reported to AERS, and examines the % increase in violence associated with specific high-ranking offending drugs? You're looking at reality and making the association.

    Youíre entitled to your opinion but I disagree.
    And I have no problem with that.

    Youíve never been in the medical field or pharma, have you? This was a model some years ago but has not been for at least 15 years. Does it occasionally happen? Probably but thatís not the SOP.
    I don't need to be in the medical field in order to know what goes on in the medical field. You are arguing from implied authority here, and you have not produced anything external to substantiate your claim.

    SSRIs to treat anorexia? Why?
    http://www.huffingtonpost.com/2013/0...n_2404772.html

    From 5 months ago, a pharma rep selling a doctor on off-label use of a drug and then getting off the hook-
    The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. He became the target of a federal investigation in 2005 and was caught on an audiotape discussing the unapproved uses of the drug with a doctor who was a government informant. He was convicted by a jury in 2008.
    http://www.nytimes.com/2012/12/04/bu...8kHr8FZvA&_r=0

    You are free to bury your head in the sand, almost every nurse or doctor I know willingly does so in order to avoid moral and ethical quandaries that would occur were they to actually attempt to dig down into these issues.

    Warnings for prescribers does not mean that drugs arenít safe of effective, itís something meant to focus the MD on the most critical information to help mitigate risk.
    And in Japan and the UK, they have stated outright that they cannot rule out causality from these drugs in violent outbreaks, and they do not suggest prescribing them to people under a certain age. Not everyone in the world bows to the throne of the FDA.

    I agree with some of this but you simply canít say that without drugs, these people would have not gone on massive killing sprees. Itís not an established fact and the data doesnít lend credence to your theory.
    A drug with side effects matching the psychological symptoms of these killers verbatim can't possibly be involved in producing their psychological symptoms?

    And this is on whom exactly? Pharma? Prescribers? The alcohol industry? The parents for not seeing this coming? The psych MD that didnít read the notebook? Again, multifacetedand complex issue with a ton of moving parts, each of which need to be orchestrated in order to avoid catastrophic failure. Just like the people simply focused on guns are wrong, so is focusing solely on pharma.
    It's on all of us, because we are letting our kids down by not protecting them, and we are letting our troops down by not protecting them either. At some point it will require courage and determination from a growing number of people before we stop breeding teenage or young adult monsters and suicidal veterans.
    ďMany people, especially ignorant people, want to punish you for speaking the truth, for being correct, for being you. Never apologize for being correct, or for being years ahead of your time. If youíre right and you know it, speak your mind. Speak your mind. Even if you are a minority of one, the truth is still the truth.Ē -Gandhi

    Rational skepticism is not the same thing as being a conspiracy theorist.

    Never forget that only dead fish swim with the stream. -Muggeridge

  4. #364
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    Quote Originally Posted by ThankGod4Walsh View Post
    The FDA requires 2 trials that result in a positive effect, thus if your first 2 trials don't achieve that result, you continue to do trials until you get the results you want.
    Sure, a company could but the FDA would be aware of all of those other studies.All studies are registered with the FDA.

    Quote Originally Posted by ThankGod4Walsh View Post
    Again, this is where your view of the medical/pharma relationship differs from mine. These doctors have no clue what the potential risks are, because they've been sold by pharma reps.
    Now, with the enormous rise in the use of serotonin-enhancing antidepressants, often taken in combination with other drugs that also raise serotonin levels, emergency medicine specialists are trying to educate doctors and patients about this not-so-rare and potentially life-threatening disorder. In March 2005, two such specialists, Dr. Edward W. Boyer of the University of Massachusetts Medical School and Dr. Michael Shannon of Childrenís Hospital Boston, noted that more than 85 percent of doctors were ďunaware of the serotonin syndrome as a clinical diagnosis.Ē
    http://www.nytimes.com/2007/02/27/he...rody.html?_r=0
    Quite clear that our views differ here. Doctors canít possibly know everything, thatís why there are continuing education requirements to maintain a license. Thatís why there are medical journals and published studies. Knowledge is ever evolving.

    Quote Originally Posted by ThankGod4Walsh View Post
    I'd say that more than 1 out of 100 people taking a specific antidepressant having thoughts of killing people is significant, especially considering that not just 1 million but potentially millions of Americans are taking them. How many killers does that create?
    Statistically, it is not significant and I would add that if the number were truly that high, weíd see more actual killers that are taking these meds.

    Quote Originally Posted by ThankGod4Walsh View Post
    Pharma makes the drugs that cause the side effects, and markets them to doctors as "safe" and even pushes them for off-label prescriptions.
    Anything you ingest causes side effects, intended or otherwise. Like I stated earlier, it is impossible for a pharma company to know all of the adverse effects of a drug before it hits the market. Products donít have enough of a sample size to get to those adverse events that happen infrequently. Thatís why companies do postmarketing evaluation of safety and why they have risk management.

    Quote Originally Posted by ThankGod4Walsh View Post
    There is a difference between incidence and prior history. I don't care if someone thought about killing someone as a 12-year old and then realized how awful it is. I care about the guy who took these meds and killed someone.
    Sure you care but youíre too quick to assign blame when you have no basis to do so. And past history is a piece of the puzzle that should not be ignored.

    Quote Originally Posted by ThankGod4Walsh View Post
    What is so bad about a study that looks for X amount of violent events reported to AERS, and examines the % increase in violence associated with specific high-ranking offending drugs? You're looking at reality and making the association.
    Youíre entitled to your opinion but I disagree.
    And I have no problem with that.
    What is wrong is that that type of study paints an incomplete picture and will often draw conclusions based on insufficient data.

    Quote Originally Posted by ThankGod4Walsh View Post
    I don't need to be in the medical field in order to know what goes on in the medical field. You are arguing from implied authority here, and you have not produced anything external to substantiate your claim.
    Iím not stating you know nothing but I am stating that your knowledge of the entire process from drug development to monitoring of the product once it hits shelves to how MDs prescribe is limited.

    Quote Originally Posted by ThankGod4Walsh View Post
    SSRIs to treat anorexia? Why?
    http://www.huffingtonpost.com/2013/0...n_2404772.html

    From 5 months ago, a pharma rep selling a doctor on off-label use of a drug and then getting off the hook-
    The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. He became the target of a federal investigation in 2005 and was caught on an audiotape discussing the unapproved uses of the drug with a doctor who was a government informant. He was convicted by a jury in 2008.
    http://www.nytimes.com/2012/12/04/bu...8kHr8FZvA&_r=0

    You are free to bury your head in the sand, almost every nurse or doctor I know willingly does so in order to avoid moral and ethical quandaries that would occur were they to actually attempt to dig down into these issues.
    Sales reps doing things that are unethical happens but painting an entire industry as shady because of the acts of a few is shortsighted. Almost like blaming the gun industry for the mass murders.

    Quote Originally Posted by ThankGod4Walsh View Post
    And in Japan and the UK, they have stated outright that they cannot rule out causality from these drugs in violent outbreaks, and they do not suggest prescribing them to people under a certain age. Not everyone in the world bows to the throne of the FDA.
    This is what I was talking about above. The FDA has become much less of a player in pharma. Sure, they still have bite but companies are much more aligned to who is really driving regulations- Europe. Japan is basically a mirror of European regulations and even the FDA has accepted and put into practice much of what Europe has suggested over the past 5 or 6 years.

    Quote Originally Posted by ThankGod4Walsh View Post
    A drug with side effects matching the psychological symptoms of these killers verbatim can't possibly be involved in producing their psychological symptoms?
    Itís possible but itís also possible that it is not.

    Quote Originally Posted by ThankGod4Walsh View Post
    It's on all of us, because we are letting our kids down by not protecting them, and we are letting our troops down by not protecting them either. At some point it will require courage and determination from a growing number of people before we stop breeding teenage or young adult monsters and suicidal veterans.
    Agreed but that wonít happen by eliminating pharma or neutering how MDs prescribe drugs. The entire system needs to be evaluated, gaps identified and appropriate actions taken.
    Occupying the handicap bathroom stall

  5. #365
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    Quote Originally Posted by Marley View Post
    Sure, a company could but the FDA would be aware of all of those other studies.All studies are registered with the FDA.
    Nothing you just said invalidates my point.

    Quite clear that our views differ here. Doctors can’t possibly know everything, that’s why there are continuing education requirements to maintain a license. That’s why there are medical journals and published studies. Knowledge is ever evolving.
    Again, we know that these drugs don't work at all except in the most severe cases and even then it's highly questionable whether the potential risks outweigh any clinical improvements. I just posted a link demonstrating that 85% of doctors don't even know that serotonin syndrome exists. They are not being educated. They are being sold.

    Statistically, it is not significant and I would add that if the number were truly that high, we’d see more actual killers that are taking these meds.
    Make up your mind. :)

    It's not statistically significant, but if it were as prevalent as the study demonstrates, you'd expect to see a lot more actual killers?

    Anything you ingest causes side effects, intended or otherwise. Like I stated earlier, it is impossible for a pharma company to know all of the adverse effects of a drug before it hits the market. Products don’t have enough of a sample size to get to those adverse events that happen infrequently. That’s why companies do postmarketing evaluation of safety and why they have risk management.
    At no point did you reference off-label prescriptions of these drugs nor did you address my point. I understand how things are supposed to work, but when you submit studies to the FDA that demonstrate no improvement and high incidence of side effects, and eventually land on a couple that show slight improvement and you verbally diminish the side effects, the doctors should be responsible enough to examine ALL the side effects before prescribing. Unless you want to make excuses for doctors by saying they're already too busy to spend time looking at side effects, sort of like you just made an excuse for drug companies pushing drugs with bad side effects as "safe."

    Sure you care but you’re too quick to assign blame when you have no basis to do so. And past history is a piece of the puzzle that should not be ignored.
    Medically speaking, you're right. But this is not about a medical condition. This is about a mental condition. I've already posted that lowering serotonin levels has just as much of an antidepressant effect as raising it when "treating" depression.

    What is wrong is that that type of study paints an incomplete picture and will often draw conclusions based on insufficient data.
    I'd say that "what is wrong" is that no study will meet your demand for comprehensiveness when you are already committed to justifying the use of these drugs.

    I’m not stating you know nothing but I am stating that your knowledge of the entire process from drug development to monitoring of the product once it hits shelves to how MDs prescribe is limited.
    Again, this is circular logic. You are assuming what you are trying to prove. I have limited knowledge about the process because you already presuppose I have limited knowledge about the process. What I have is an unbiased and objective approach to this topic because I am not vested in the success or safety of these drugs or the reliability of pharma sales reps' statements or the acumen of doctors. I will take the word of someone who examines dozens of studies over the word of someone who has to remain intentionally ignorant of the dangers of these drugs in order to avoid moral or ethical quandaries that could be career-threatening. Knowledge of "the entire process" is irrelevant to my overall point which is that these drugs are a) unsafe and b) ineffective. Your quote above is simply an appeal to self authority without any external backing. That's worthless. Do I need to know the specific temperature at which wood burns in order to make a fire in the woods?

    Sales reps doing things that are unethical happens but painting an entire industry as shady because of the acts of a few is shortsighted. Almost like blaming the gun industry for the mass murders.
    You are interchanging two disparate motivations- one is for financial gain and career security, the other is lack of empathy and self-control. You are ignoring the deterrent factor of each.

    Why does a pharma sales rep preach off-label prescription uses and safety of these drugs? Financial gain and career security.
    Why does a shooter kill someone with a gun? Lack of empathy and self-control.

    What is the punishment for suggesting off-label prescriptions and lying about safety? None.
    What is the punishment for mass murdering people? Death.

    This is like saying "Only a minority of used car salesmen will focus on positives of a car and attempt to avoid discussing negatives for the sake of making a sale with little risk of repercussions." Would you say that?

    This is what I was talking about above. The FDA has become much less of a player in pharma. Sure, they still have bite but companies are much more aligned to who is really driving regulations- Europe. Japan is basically a mirror of European regulations and even the FDA has accepted and put into practice much of what Europe has suggested over the past 5 or 6 years.
    Give specific examples. For instance, this is Japan's SSRI revision from 2009-

    After its investigation, the Ministry decided to revise the label warnings on SSRI antidepressant stating, "There are cases where we cannot rule out a causal relationship [of hostility, anxiety, and sudden acts of violence] with the medication."
    Yet you and others will go to great lengths NOT to even consider a causal relationship here. The Japanese Ministry of Health says they can't rule it out among people taking SSRIs. Would you say that you can't rule it out? If so, why are we arguing? Because I say "it's probably causal in some cases, particularly when administered to developing brains" and you say "it's probably not causal?" Did you read the term from the earlier linked research paper of "antidepressant-induced mania?" You are doing a lot of magic hand-waving (you don't understand the medical industry, you don't understand studies, your studies aren't up to my standards) and a lot of ignoring actual academics and medical experts who have said exactly what I'm saying for years and years. I'm offering up an "authority" that you and others might find acceptable in this argument. You are rejecting the authority of these people and relying on your own authority to trump my argument. That doesn't fly.

    It’s possible but it’s also possible that it is not.
    So it's possible that a drug whose warning states

    The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
    Is not responsible for increased incidence of those symptoms?

    Agreed but that won’t happen by eliminating pharma or neutering how MDs prescribe drugs. The entire system needs to be evaluated, gaps identified and appropriate actions taken.
    Comprehensive reform is not required for someone to say "Hey, these drugs are almost always being taken by one of these wackos who shoots up a public place. Maybe we should stop prescribing these drugs to __________" and figure out how big you want the "_________" population to be.

    You can't buy a beer until you're 21 but you can pop a Paxil when you're 12. There's a problem here. And I believe that problem needs to be resolved because these drugs are causative in most of these school-shooting wackos. When you lose your capacity for empathy, you lose the limiting point between your wacko desires and actually carrying out those desires.

    SSRIs blunt your emotions, all of them, they do not make you happier.
    Last edited by ThankGod4Walsh; 04-11-2013 at 06:06 PM.
    ďMany people, especially ignorant people, want to punish you for speaking the truth, for being correct, for being you. Never apologize for being correct, or for being years ahead of your time. If youíre right and you know it, speak your mind. Speak your mind. Even if you are a minority of one, the truth is still the truth.Ē -Gandhi

    Rational skepticism is not the same thing as being a conspiracy theorist.

    Never forget that only dead fish swim with the stream. -Muggeridge

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