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meltdownman1 339 posts  |  Last Activity: 1 hour 31 minutes ago Member since: Aug 12, 1998
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  • Reply to

    Off Label Use

    by meltdownman1 1 hour 37 minutes ago
    meltdownman1 meltdownman1 1 hour 31 minutes ago Flag

    Off-label use is very common. Generic drugs generally have no sponsor as their indications and use expands, and incentives are limited to initiate new clinical trials to generate additional data for approval agencies to expand indications of proprietary drugs.[1] Up to one-fifth of all drugs are prescribed off-label and amongst psychiatric drugs, off-label use rises to 31%.[2]

    Among use of antipsychotic medications in the United States, a shift occurred from typical agents in 1995 (84% of all antipsychotic visits) to atypical agents by 2008 (93%). Atypical use has grown far beyond substitution for the now infrequently used typical agents.[3] New drugs are often not tested for safety and efficacy specifically in children and even when they are tested, the results of these trials may not be disseminated to practicing physicians. A 2009 study found that 62% of U.S. pediatric office visits included off-label prescribing, with younger children at higher risk of receiving off-label prescriptions. Specialist physicians also prescribed off-label more frequently than general pediatricians.[4][5]

    A study published in 2006 found that off-label use was the most common in cardiac medications and anticonvulsants. This study also found that 73% of off-label use had little or no scientific support.[2]

    By default use of non-approved drugs is common in obstetrics as, by 2010, during almost five decades of activity the Food and Drug Administration (FDA) had approved only two drugs for obstetrical indications, namely oxytocin and dinoprostone.[6] A small market and the high risk of medicolegal action, as exemplified by the Bendectin case, may explain the reluctance to develop drugs for approval.[6]

    Some drugs are used more frequently off-label than for their original, approved indications. A 1991 study by the U.S. General Accounting Office found that one-third of all drug administrations to cancer patients were off-label, and more than half of cancer patients received at least one drug for an off-label indication. A 1997 survey of 200 cancer doctors by the American Enterprise Institute and the American Cancer Society found that 60% of them prescribed drugs off-label.[5][7] In some cases, patients may perceive the efficacy of treatments for off-label purposes to be higher than for their indicated purpose.[8] Frequently, the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs. An example is the use of tricyclic antidepressants to treat neuropathic pain. This old class of antidepressants is now rarely used for clinical depression due to side effects, but the tricyclics are often effective for treating pain.

    Sentiment: Strong Buy

  • meltdownman1 by meltdownman1 1 hour 37 minutes ago Flag

    A caller asked Dr. Levitt whether the company would initiate further trials to seek approval of Aldox as a first-line treatment for soft tissue sarcoma, if they gain approval as a second-line therapy.

    The full answer is: There is no need to pursue this option. The current first line treatment is Doxorubicin. Since Aldox is a superior alternative, every doctor is going to use it off-label as their first choice anyway, in this indication, and then in every other indication that insurance will cover. Insurance will cover any indication for which two or more positive research articles have appeared in peer-reviewed medical journals. Management is presumably reluctant to use the no-no words, “off-label,” because numerous big pharma companies have gotten into trouble in recent years for any comment which could be interpreted as encouraging off-label use.

    Sentiment: Strong Buy

  • Reply to

    Welcome to Kriegsman Country!

    by avi.morax 23 hours ago
    meltdownman1 meltdownman1 20 hours ago Flag

    I hope your family gets the doxi treatment instead of the aldo treatment.

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 21 hours ago Flag

    The only thing giving is your wife.

    Sentiment: Strong Buy

  • Reply to

    CYTR being ROBO-PUMPED by Penny Biotech Swine?

    by avi.morax Jan 30, 2015 7:55 AM
    meltdownman1 meltdownman1 Jan 30, 2015 8:00 AM Flag

    Reason to used Aldo vs Doxi
    The risk of heart failure is significantly increased after total doses of 550 mg/m2 (350 to 400 mg/m2 if there is history of prior radiation therapy which included the heart or the area around it or use of other potentially cardiotoxic agents, such as cyclophosphamide). Doxorubicin-induced heart failure can present one month to one year or more after termination of therapy. It is increasingly common to note LATE cardiomyopathy, especially in patients who received doxorubicin as a child or adolescent. Prevention has focused on cumulative dose limitation, earlier diagnosis (radionuclide angiocardiography or echocardiography), alterations in the schedule of administration (substitution of prolonged, continuous IV infusion for bolus injection), the development of less cardiotoxic anthracyclines, and use of cardioprotectors (dexrazoxane).

    Sentiment: Strong Buy

  • meltdownman1 by meltdownman1 Jan 30, 2015 7:53 AM Flag

    Doxorubicin HCl is indicated for the treatment of

    •acute lymphoblastic leukemia
    •acute myeloblastic leukemia
    •Hodgkin lymphoma
    •non-Hodgkin lymphoma (NHL)
    •metastatic breast cancer
    •metastatic Wilms' tumor
    •metastatic neuroblastoma
    •metastatic soft tissue sarcoma
    •metastatic bone sarcoma
    •metastatic ovarian carcinoma
    •metastatic transitional cell bladder carcinoma
    •metastatic thyroid carcinoma
    •metastatic gastric carcinoma
    •metastatic bronchogenic carcinoma

    Aldo will eventually replace Doxi

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 Jan 29, 2015 5:30 PM Flag

    He isn't a doctor....now go get cancer and die.

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 Jan 29, 2015 5:28 PM Flag

    And you know him so well. So is he or isn't he..........cirkumsized?

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 Jan 29, 2015 9:41 AM Flag

    These guys have been putting out this same garbage over and over again and refuse to acknowledge the improvement with Aldo and therefore wish it to fail. So in essence they are wishing that people are stuck with an inferior medicine and wishing them an early death .TThey are the cynical oones

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 Jan 29, 2015 5:40 AM Flag

    Have your children get cancer and stick with Doxi instead of Aldo. See who's laughing.

    Sentiment: Strong Buy

  • Reply to

    KEREIGSMAN = Con artist - he is farud

    by rob1darwin1 Jan 28, 2015 4:47 PM
    meltdownman1 meltdownman1 Jan 28, 2015 6:44 PM Flag

    Go visit a cancer ward and take a look what "doxi" (aka "red death") does to people. They will be replacing doxi with Aldo before you know it to stop this tragedy.

    Sentiment: Strong Buy

  • Reply to

    KEREIGSMAN = Con artist - he is farud

    by rob1darwin1 Jan 28, 2015 4:47 PM
    meltdownman1 meltdownman1 Jan 28, 2015 6:41 PM Flag

    There is a 48% chance that you will get prostate cancer...why not do us all a favor and start on it now so you can't produce any offspring?

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 Jan 28, 2015 6:36 PM Flag

    Go get cancer and die!

    Sentiment: Strong Buy

  • Reply to

    KRIEGSMAN is the KINGPIN

    by avi.morax Jan 24, 2015 11:28 AM
    meltdownman1 meltdownman1 Jan 28, 2015 4:06 PM Flag

    For a minute there I thought you were complaining about your sore #$%$

    Sentiment: Strong Buy

  • meltdownman1 meltdownman1 Jan 28, 2015 4:05 PM Flag

    The only thing going down is your wife on the boys at the local bar.

    Sentiment: Strong Buy

  • Reply to

    Aegis Capital? Seriously?

    by avi.morax Jan 28, 2015 9:59 AM
    meltdownman1 meltdownman1 Jan 28, 2015 4:04 PM Flag

    Hope all your family gets brain cancer and dies a horrible death to eliminate your whole bloodline.

    Sentiment: Strong Buy

  • Reply to

    Keep staying in this stock

    by linkuofm Jan 28, 2015 11:08 AM
    meltdownman1 meltdownman1 Jan 28, 2015 4:00 PM Flag

    I hope your children get brain cancer.

    Sentiment: Strong Buy

  • Reply to

    Keep staying in this stock

    by linkuofm Jan 28, 2015 11:08 AM
    meltdownman1 meltdownman1 Jan 28, 2015 11:53 AM Flag

    Do us all a favor and go get cancer

    Sentiment: Strong Buy

  • Reply to

    Im considering buying 10,000 shares of CYTR ?

    by mlbox49 Jan 28, 2015 11:41 AM
    meltdownman1 meltdownman1 Jan 28, 2015 11:49 AM Flag

    You are depriving a village of an idiot

  • Reply to

    The Studies

    by meltdownman1 Jan 25, 2015 2:33 PM
    meltdownman1 meltdownman1 Jan 25, 2015 2:35 PM Flag

    Primary Outcome Measures: •Progression-Free Survival (PFS) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    PFS is defined as the time from the date of randomization to first documentation of objective tumor progression or to death due to any cause in the absence of previous documentation of objective tumor progression.

    Secondary Outcome Measures: •Overall Survival (OS) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization to date of death. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive.

    •Safety Measures [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The safety of aldoxorubicin compared to investigator's choice in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, vital signs, echocardiogram (ECHO) evaluations, electrocardiogram (ECG) results, and weight, as well as disease control rate and tumor response.

    Sentiment: Strong Buy

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