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Monday, March 22, 2010

The Zyprexa Documents

In January 2009, drug company involvement in promoting the explosion of new and phony bipolar disorder diagnoses was clearly demonstrated by company memos that leaked out as part of a Justice Department settlement against the maker of the atypical antipsychotic Zyprexa (Ely Lilly) for off-label marketing of the drug. These memos were supposed to be kept secret, but were obtained by reporter Alex Berenson of the New York Times, as mentioned in an article in the paper on December 18, 2006. They were later put on the internet by another reporter, Philip Dawdy of the Seattle Weekly, on his Furious Seasons website (http://www.furiousseasons.com/zyprexadocs.html).

One of their strategies was marketing for “NCE’s” (New Clinical Entities) which were off-label indications. They specifically targeted doctors who would be seeing patients with substance-related disorders, anxiety, aggression, or borderline personality disorder. Family practitioners and other primary care doctors were singled out, but psychiatrists were also affected.

While admitting that Zyprexa was not indicated for "bipolar II," they nonetheless tried to convince doctors that relatively high functioning patients who were susceptible to "bouts of depression, low self esteem and pessimism about the future, then rebounding with bursts of high energy and social engagement" really had bipolar disorder. They knew doctors did not like using lithium and that they might feel that there was too much to manage with depakote, so that they could be easily convinced to use Zyprexa.

Their vision for primary care docs was to expand Lilly's market by "redefining how primary care physicians diagnose and treat complicated mood disorders." Marketing messages were to be aimed at "patient's symptoms and behaviors (rather than diagnosis)." The doctor was to be made to understand that the company reps were not talking about the seriously ill patient but the "complicated patient who has mood symptoms of irritability, anxiety, poor sleep and mood swings."

Fellow training director Aftab Khan describes a certain type of patient that he labels as having "Crappy Childhood Syndrome (CCS)." He says that whenever a particular patient has several of these diagnoses at the same time: Major depressive disorder, panic disorder, PTSD, generalized anxiety disorder, bipolar disorder not otherwise specified, bipolar II, intermittent explosive disorder, or somatoform pain disorder - or their diagnoses changes from one provider to the next or from one admission to next - then CCS is most likely what they really have.

I could not have said it better myself, although I would add that these patients continue to have highly negative interactions with their dysfunctional social systems even as adults.

7 comments:

  1. Anti-convulsants do not work for bipolar. They were pushed when there was no longer any money in lithium. A lot of that going on in psychiatry.

    Lithium carbonate takes out the kidney far too often, along with the thyroid (ironically, a key player in mood regulation). So, the price to pay for lithium is too high.

    So, what works?

    Natural approaches work.
    Large amts of fish oil (omega 3s), has to be large amts... Other nutrients, in combinations....

    I would encourage anyone who has been diagnosed with "bipolar" or has a friend or family member, to research orthomolecular medicine/pscyhiatry, along with meditation techniques, neurofeedback, exercise, and other lifestyle changes. These things tend to run "bipolar" out of town.

    "Bipolar disorder" is a collection of symptoms... Not a stand-alone illness, and/or disease, as conventional psychiatrists would have us believe.

    Duane Sherry, M.S.

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  2. Duane - Lithium can indeed affect the kidney, although much less often than your post would indicate, so good psychiatrists monitor kidney function on their lithium patients at least yearly and take them off the drug at the first sign of trouble.

    The thyroid problem (it can in some patients interfere with the so- called "thyroid pump") with lithium is reversible if you take the patient off the drug, and is easily handled by thyroid supplementation if necessary.

    In my experience, Depakote and Tegretol do seem to prevent mania, but not depression, but are not as effective as Lithium. Lamictal is a mystery drug; the studies submitted to the FDA were completely bogus with a crazy outcome measure called "time to next affective episode."

    Fish oil is interesting for depression, but the studies are somewhat ambiguous (and most of them were not done by the drug companies, BTW).

    With our current state of knowledge, it's hard to "prove" that true bipolar disorder (as opposed to the bullsh*t diagnoses of bipolar II and "soft' bipolar spectrum disorder - soft headed doctor is more like it) is a real brain disease - but I'd like to see anyone else stay up for a week with almost no sleep and still be sharp as a tack, but with behavior and poor judgment that is completely out of character for them.

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  3. Dr. Allen,

    I am talking precisely about the type of symptoms you describe... staying up for seven to ten days with little, or no sleep.

    And I am saying that the newer drugs do not work for this type of "bipolar" in the long-term...

    I continue to hold the argument that "bipolar disorder"... precisely the kind you are talking about is a collection of symptoms, and not a stand-alone disease, per say...

    A drug to help someone sleep may be needed in the worst situations...

    From my research... several thousand hours worth....nothing works better than some basic food, shelter, and a safe place to stay....

    Combinations of integrative treatments seem to work best - cognitive behavioral therapy, neurofeedback, meditation, orthomolecular psychiatry/medicine, lifestyle changes to overcome these symptoms, for the long-haul is highly successful.

    This comes not only from reading, but from personal contact with many people who have recovered from either "bipolar disorder" or "schizophrenia".... many have fully recovered.

    The week-long periods with no sleep can happen to a person when they are young adults, and never happen again... These can be caused by early trauma... also, drug interactions, sleep deprivation, a host of things...

    Fear-tactics about a "lifelong, incuarable" disease are hardly beneficial... Neither for the person who experiences this kind of "break" and/or the families...

    I have met many people who have undergone these symptoms, and are now doing fine... many years later... The common denominator is they put down their psychiatric medications years ago, and found other ways to stay well, and live productive lives.

    Peter Breggin, M.D. (vitae includes teaching Professor at Harvard Medical; Consultant, NIMH) and David Cohen, Ph.D. put out a book on how to slowly taper off psychiatric drug - "Your Drug May Be Your Problem: How and Why to Stop Taking Psychiatric Medication". There are additional links on my blog (listed below.

    Dr. Breggin and David Cohen are joined by other physicians, such as Joanna Moncrieff, David Healy, et al... There numbers are not large, but in my mind, they represent a movement that is beginning to take hold - empowerment and recovery...

    In my opinion, full recovery is not possible if someone stays with the conventional protocol, ie, medical "compliance."

    The long-term use of these drugs - lithium, the anti-convulsant group, and especially the neuroleptics (2nd generation, atypical antipsychotics) impede recovery

    Duane Sherry, M.S.
    http://discoverandrecover.wordpress.com

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  4. Duane,

    Thanks again for your comment.

    I sincerely hope that what you have done and are doing works well for you. I of course can't know if you, or who among the people you talk to, have been correctly diagnosed (yes, the diagnosis is based only on symtoms, but you have to have several symptoms all at the same time, not just sleeplessness by itself. Mania is not subtle), and as you point out, bipolar patients may only have a handful of manic episodes in their entire lifetime without any treatment at all.

    I've only read a little bit of what Breggin has said, but in the little I've seen, he twists the data about antidepressants considerably.

    If I myself had had a real manic episode, I'd go on lithium in a New York minute. Wouldn't chance potentially messing up my marriage, doing long-term harm to my finances, or ending up in a psych hospital.

    I sort of agree with you - IMHO long-term use of atypical antipsychotics for bipolar patients should be reserved only for those very few who can tolerate nothing else or who clearly don't respond to anything else. Those drugs are way overutilized today and they can do significant damage to people.

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  5. And another psychiatric drug bites the dust -

    http://www.pharmalot.com/2010/09/novartis-pays-422m-for-off-label-marketing-charges/

    Hardly the "life-saving medication" that psychiatry would have the American people believe...

    Psychiatry causes more harm than good.. Much more harm than good!

    Duane

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  6. Dr. Allen,

    Lithium is much more dangerous than you imply... Go to the FDA Metwatch Page, and type in "lithium" - hardly a safe drug....

    You mentioned that Omega 3s did not have much success... As I mentioned previously, it requires a lot of Omega 3s... One of the most successful clinical trials in history was at Harvard in 1999 - with 10,000 mg of fish oil per day... The key was 10,000 mg (not 1/10 that amt).

    Andrew Saul, Ph.D. worked closely with Abram Hoffer, M.D., Ph.D. (the father of Orthomolecular Medidine) until his death... He has a great website, full of some good research findings - doctoryourself.com (gotta love the title of the website, huh?)

    Not all of the research with naturals is done in the United States... some of the best nutrient studies are done in other parts of the world.... A good site to visit is vitasearch.com - type in key words, ie - bipolar disorder, alzheimers, attention deficit... some fascinating research... much of it has large sample size, lengthy trials, good solid research (unlike the prozac studies done in the United States)...

    So much of our psychopharmacological research is short-run work, with the fallout showing years later...

    Ironically, the real science is in the natural-side, if a person is willing to spend the time to find it.

    Duane Sherry, M.S.

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  7. Dr. Allen,

    Obviously, not all of the research cited on vitasearch is a large study group, some are very small, but overall it's worth taking a look at, especially for doctors who are not well-versed in nutrition.

    The other areas that really need more research are neurofeedback, mindfulness and meditation, along with therapies that use meridians, such as chinese acupuncture, and emotional freedom techniques (using something as simple as tapping parts of the body)....

    It's amazing that conventional psychiatry has come to believe that neuroleptics are the only way to relieve symptoms, when there are other ways to help the brain and body deeply relax and heal that don't involve the fallout of the long-term use of tranquilizers.

    Duane

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