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Telsa Rowe
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Nutritionist/MD/Biotech investor. I have little time to discuss the general market, anything I cannot change or other irrelevant topics that dominate seekingalpha and are the products of its top 100 members. I put my money where my mouth is and adhere to sound DD. Capitalism favors the bold and... More
  • Jazz hits a sour note 9 comments
    Aug 5, 2010 11:36 PM | about stocks: JAZZ

    Let's put the euphemisms aloof and have a brief conversation about JAZZ's illegal Schedule I drug candidate Jzp-6(GHB) yes? 

    Fibromyalgia has always been looked upon by myself and all of my colleagues with high suspiscion. We view it much the same as we do chronic fatigue syndrome (CFS). We look at CFS as a specious condition for what is actually hypochondria. 

    Hypochondria- a belief that real or imagined physical symptoms are signs of a serious illness, despite medical reassurance and other evidence to the contrary

    Fibromyalgia is no different. For an easier comparison think of the word "unicorn". It's a word that exists to describe something that doesn't actually exist. When patients come into the hospital complaining of pain fitting the fibromyalgia model or saying they have fibromyalgia, it's with relief that we write prescription's for Cymbalta or another similar placebo to keep them from coming back several times. Cymbalta and the other 4 fibromyalgia approved placebos serve the purpose of keeping medical costs down. They keep patients from perpetually coming back only to take up time, space and use of CT's and other pricey resources. Fibromyalgia to the medical community is the inverse same as what disorderley conduct (DC) is to cops. If you can't get them for anything real then slap 'em with a DC. For the FDA panel to recommend Jzp-6 (GHB an illegal schedule 1 drug infamous for it's use in date rape) to be used by potential millions for a fake disease is
    ludicrous. It would be a decision that is microcosmic of everything wrong with modern medicine. Many point out that it has been approved for narcolepsy. Yes it has and comparing the two diseases and their relative populations is like comparing K2 to Bunker Hill. People point to it's efficacy in phase 3 trials as well. No doubt that knocking someone half unconscious and quasi-comatose with a drug all the while they are partially asleep will produce a set of results. Fibromyalgia patients quite often ask for hardcore medications. I've had many beg for fentanyl patches for godssake. The panel will likely reject this ridiculousness unanimously. An illegal schedule 1 drug for the masses. What an original thought! This is known as the Mexican cartel model of profitability.

    The FDA panel is set to meet August 20th. JAZZ's pps has seen a recent runup from $7 to almost $10. The silver lining here is that because JAZZ only has 32M shares outstanding it's market cap is still below $300M so a rejection won't be as unfriendly to the pps as it was to ITMN or similar crisis. I assume JAZZ's pps will see $11-$12 just prior to the Panel. I will be buying option puts and shorting shares throughout the $11-$12 range. The panel's rejection should send the pps back to the $5 area which will be my target cover price and the price I close out my options position. 
    When I told my colleagues about what JAZZ was up to I was greeted with blank stares that quickly turned to laughter. They too became very interested in shorting JAZZ. They don't manage their own portfolios so Im not sure if they will (or can) short it.
     
    I do realize that many people will find my article contentious or downright vitriolic. I dont believe it is for what is attempting to be perpetrated by JAZZ. I am a young(er) doctor and do not buy into the fibromyalgia hype like many liberal and young doctors do. I buy into greedy pharma developing treatments for unknown diseases. When they(treatments) finaly become approved(because of a constantly changing FDA) they serve as a reinforcement to the general public and young birthing medical community that there is a disease. Meaning, there is a treatment for it therefore there must be a disease. It reminds me of the famous opera La Traviata. Many thought the disease "consumption" was a rare and deadly disease that struck the young and artistic. We found out decades later that consumption was a disease that had been around for a very long time- tuberculosis. Could it be that fibromyalgia is nothing more than hypochondria? NO NO NO! some "experts" try and tell us, there are biomarkers and all kinds of diagnostics that can confirm if somebody has fibromyalgia. Nonsense, but I recently have devised my own diagnostic test.

    ----------------------------------------------------------------------------------------------------------------------- 
    1.) Are you a Brit, Aussie, or American?

    Why did I ask this? Because we have yet to hear of anyone outside of this demographic complain about this disease.

    2.) Have you ever experienced pain or fatigue in your muscles?

    Why did I ask this? Because although everybody that works experiences this it is the most common symptom of those suffering from fibromyalgia.

    If you ansered YES to either of these questions please see your doctor . 
    -----------------------------------------------------------------------------------------------------------------------

    Fortunately placebos already exist for fibromyalgia so Jzp-6 is not necessary or a drug for an unmet need. I call the fibromyalgia treatments "placebos" because although they may have pharmacokinetic profiles that do effect physiology they are made to affect reality. 


         








    Disclosure: short jazz
    Stocks: JAZZ
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Comments (9)
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  • sonsrule
    , contributor
    Comments (15) | Send Message
     
    I share your skepticism of the diagnosis fibromyalgia. However, you must have failed your rheumatology course, since fibromyalgia is recognized by the American College of Rheumatology. It is also recognized by the FDA, hence their approval of 4 other drugs for this disease. So it really doesn't matter whether you or I believe this disease exist...it only matters whether the FDA believes that there is enough evidence to show that Jzp-6 improves the lives of this cohort of patients, with minimal risk. If JAZZ can show that they have "controls" in place to minimize abuse and firm distribution restrictions, then FDA will approve this.
    6 Aug 2010, 05:35 AM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » I am aware that it is a recognized disease. The Panel is too. Obesity is also recognized as a disease but that does not change my opinion that it is NOT. I think the panel will view Jzp-6 similar to the way the endocrinology panel recently viewed VVUS's Qnexa. Although it was effective in the 3 phases it was too hardcore for something with several other safer methods of treatment and something that is a quasi disease at best. Were talking about a schedule I drug here for a patient population that is exploding. The generic 505(b)(2) conflict of interest, gateway addiction when discontinuing use possibility, questionable authenticity of the disease and huge fake prescription problem are some huge hurdles for a Margaret Hamburg run FDA to ignore. It just causes far more problems than just saying NO does which is the opposite of what should be happening. And why wouldn't the FDA accept the NDA? They get paid $1.4M for each one.
    6 Aug 2010, 07:56 AM Reply Like
  • Supply side
    , contributor
    Comments (17) | Send Message
     
    Since you indicate you knowingly write prescription's for placebo, I assume your patients knowingly pay for their bills with NSF checks.

     

    Why not just be honest with your patients and tell them they have a fake disease?

     

    6 Aug 2010, 10:28 AM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » Thanks to certain medical regulating bodies and certain pharma companies it's not possible to tell them they have a "fake" disease. The pharma companies have several approved medications for the indication so like my article said this reinforces the legitimacy of their complaints. Who am I to say Cymbalta is a ruse? One could lose their license in some states or get sued talking like that.
    6 Aug 2010, 11:08 AM Reply Like
  • Supply side
    , contributor
    Comments (17) | Send Message
     
    Thanks for answering, but my question was rhetorical.

     

    Who are you to say Cymbalta is a ruse? Please tell us because you are saying so in your article.
    6 Aug 2010, 11:46 AM Reply Like
  • Telsa Rowe
    , contributor
    Comments (86) | Send Message
     
    Author’s reply » Right supplyside but Im speaking "off the record" to a community of investors not suffering patients. The fact is that if the panel recommends this then my portfolio will get roasted. If not then yours will get roasted. It's obvious neither of us is trading WalMart or Pepsi for the same reasons. I have disclosed my intentions and position publicly. We have a conflict of interest but not a conflict of principle(pay dirt). I wish you luck supply side.
    6 Aug 2010, 12:26 PM Reply Like
  • Supply side
    , contributor
    Comments (17) | Send Message
     
    Thanks for the response. I respect your position and opinion. One point that does bother me is that you disclose you are short, but your article only talks about going short.

     

    Good luck to you. Long or short holding through the meeting is very risky.
    6 Aug 2010, 12:31 PM Reply Like
  • tonythefreak
    , contributor
    Comments (20) | Send Message
     
    yea ok jerome--

     

    www.google.com/#hl=en&...
    18 Aug 2010, 07:24 PM Reply Like
  • 011010011
    , contributor
    Comment (1) | Send Message
     
    Interesting post, HOWEVER, you nor anyone you personally know has obviously not taken Cymbalta. It is hands down one of the most powerful drugs known to man. I note this because you implied that "it and other placebos" keep drug-fiendish hypochondriacs away from your divine medical advice. Everyone knows it causes suicide, all you have to do is watch t.v. commercials, which have been in heavy rotation now for a couple of years. I agree with you that you did not imply Cymbalta to be a ruse, but you did say it was a placebo, which is sad, scary, and your ignorance as a doctor is probably inadvertently related to why this country has so many bullshit (I beleive is the proper term you were looking for) ailments like fibromyalgia , depression, eating-disorders, insomnia, alcoholism, ect. I do have to say I commend your question of the pharmaceutical companies possibly developing drugs for ailments which don't exist, but my life has been ruined since my early twenties(5 years ago) due to this ailment, and I had no idea the condition had a name or that any drugs existed for it until fairly recently. And Cymbalta works,I was hobbling for a week, had to quit my job, and went brain dead and hated every second of it. But it works. It sucks so bad. Almost as bad as being laughed/scowled at by doctors who lived a privaleged life and didn't injue themselves for life at age 19 because his parents weren't dirt poor.
    19 Apr 2011, 04:07 PM Reply Like
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