Eli Lilly settles with U.S. Gov't for $1.42 billion over illegal Zyprexa off-label marketing

payoutYes, you read that right. Eli Lilly has reached a settlement for $1.42 billion with the U.S. government over the illegal off-label marketing of Zyprexa. The company also pleaded guilty to criminal misdemeanor charges. Basically this is how I see it:

U.S. Gov’t: Eli Lilly, you did a bad, bad thing by doing illegal things. Pay a fine, please, and then you can go.

Eli Lilly: Okayyyy. [reluctantly hands over $1.42 billion to the government]

U.S. Gov’t: [slaps Eli Lilly on the hand] Now, don’t you ever, ever do this again!

It’s a record settlement for a whistleblowing case. According to Philip Dawdy at Furious Seasons, Eli Lilly has paid over $2.7 billion in settlement payouts so far. (With certainly more to come.)


Wyeth Pushing Pristiq Hard

PristiqThe Wall Street Journal reports that Wyeth, desperate to make money off of its Effexor XR-knockoff, Pristiq, says it will slash the antidepressant at a 20% discount compared to Effexor’s price. The price slash, CNN money reports, is a result of less-than-impressive clinical trial data on Pristiq’s “safety and effectiveness.”

Wyeth SVP Joe Mahady told analysts that Pristiq will sell for a flat $3.41 per tablet for both mid- and high-dose, Dow Jones Newswires’ Peter Loftus reports.

Wyeth, apparently, has done this in the past. Back when it was known as American Home Products, the company slashed its price on Protonix, its heartburn drug, to compete with AstraZeneca’s Prilosec. The drug generated $1.9 billion in profits for Wyeth last year. CNN Money reports that Teva Pharmaceuticals and Sun Pharmaceuticals began selling the generic version of the drug and handily cut into Wyeth’s profits: the company reported a 4.6% decline in profit and a 66% drop in sales for the drug for the first-quarter. What will happen with Pristiq remains to be seen. I’m not sure that doctors in 2010 will want to dole out prescriptions for Pristiq when they can save patients—and insurance companies—money by prescribing what will then be known as venlafaxine. WSJ also notes:

A month’s supply of sertraline (Pfizer’s old hit Zoloft) or fluoxetine (Lilly’s Prozac) goes for 50 cents a day at drugstore.com.

$3.41 or $0.50 per tablet. It wouldn’t surprise me if some insurance companies choose to exclude Pristiq from its list of covered drugs. Regardless, Wyeth expects sales of the drug to exceed $1 billion in its first year.

The drug will hit the shelves in May.

Alaska's "clinical" trial of Eli Lilly over Zyprexa

Since I've been gone, a trial has begun in Alaska against Eli Lilly because of its off-label drug marketing of Zyprexa. Then, Connecticut recently decided to join a growing list of states going after Lilly as a result of the Zyprexa deal. There is so much going on with this case I can't even keep up.

But that's what we keep Philip Dawdy around for. 🙂

Blogs around the way

I’m catching up on reading my fellow bloggers’ posts (see Blogroll to the right), so if you’re not reading their site already, I’d encourage you to do so. Below  are some posts that caught my attention. Some might be a little dated.

Gianna at Bipolar Blast: Has a video up of Gwen Olsen, an ex-pharma rep who says that pharmaceutical companies aren’t in the  business of curing but in the business of "disease maintenance and symptom management." It’s nothing new but here are two quotes that caught my attention:

"And what I’m saying is provable is that the pharmaceutical industry doesn’t want to cure people. You need to understand specifically when we’re talking about psychiatric drugs in particular that these are drugs that encourage people to remain customers of the pharmaceutical industry. In fact, you will be told if you’re given a drug such as an anxiolytic, or an antidepressant, or an antipsychotic drug, that you may be on the drug for the rest of your life. And very frequently, people find that they are on the drug for a very long period of time, if not permanently, because they’re almost impossible to get off of. Some of them can have very serious withdrawal symptoms – most of them can have extremely serious withdrawal symptoms if they’re stopped cold turkey – but some people experience even withdrawal symptoms when they try to titrate or they try to eliminate the drug little by little, day after day."

"We have got to start making the pharmaceutical industry accountable for their actions and for the defective products they’re putting on the market. It won’t be long before every American is affected by this disaster and we need to be aware of what the differences are between diseases between disorders and between syndromes. Because if it doesn’t have to be scientifically proven, if there are no tests, if there are no blood tests, CAT scans, urine tests, MRIs – if there is nothing to document that you have disease, then you in fact, do not have a disease, you have a disorder and it has been given and has been diagnosed pretentiously and you need to get yourself educated and understand that there are options and those options are much more effective than drugs."

I’ve always wondered why doctors don’t run tests to diagnose any psychiatric disorders. From NIMH:

Research indicates that depressive illnesses are disorders of the brain. Brain-imaging technologies, such as magnetic resonance imaging (MRI), have shown that the brains of people who have depression look different than those of people without depression. The parts of the brain responsible for regulating mood, thinking, sleep, appetite and behavior appear to function abnormally. In addition, important neurotransmitters–chemicals that brain cells use to communicate–appear to be out of balance. But these images do not reveal why the depression has occurred.

If MRIs have shown that the people with depression have a part of the brain that functions abnormally then why isn’t it standard for all people diagnosed with depression to have an MRI done to confirm this? I have one of two hypotheses:  it’s too expensive to get an MRI done for each person and that insurance won’t pay for it or the abnormal functioning cannot be detected in the brain of every depressed person.  Therefore, is major depressive disorder really a made-up diagnosis?

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The Zoloft-rage/violence connection

[This post is quite lengthy so I suggest you grab a cup of coffee or tea and sit down and read it. The following is not for the faint of heart (or those with a lack of time).]

It’s been amazing to me that I’ve received numerous comments on Zoloft inducing rage. I’m humbled by having a Pittman supporter visit my site and post some comments from the ChristopherPittman.org forums. Read the following:

In my senior year in high school I was diagnosed as being severely depressed and put on medication. The first medication that I was on I took for 5 months and it made me really aggressive. My friends and family noticed the change and I told my doctor about it and she changed my meds. After that I was fine. I am normally a very passive person and will let just about anything fly. But the medication made me really aggravated and aggressive toward my friends and family and it seemed that I wasn’t overcoming my depression. I just got done watching the 48 hours investigation on the Discovery Times Channel and felt a connection with Chris. I felt that I had to write this to let you know that Chris is not the only one out there that had these side effects. I think there should be a study done to see how many people that take antidepressants have increased aggression. The problem is that the pharmaceutical industry has deep pockets and many lobbyists. I hope this helps in some way.

And another:

I remember the case when it happened.

At the time I thought, “Zoloft right”.

Let me tell you my physician put me on Zoloft and it took about three weeks for my to become psychotic and I’m a 50 year old woman.

I have three children and I don’t make a lot of money but please let me know if I can do anything for the Pittman boy.

The jury should have been placed on Zoloft before they made they decision. Unless you’ve experience it you simply cannot believe its’ effect.

Brynn and Phil HartmanI did a bit of quick reading/research into Zoloft triggering violence in people who otherwise would have never been violent and it seems that are a few stories out there to support the assertion. I found a few comments on depressionblog.com that mentioned a link between Zoloft and rage fits. A Salon.com article published a story antidepressants inducing rage in 1999. Apparently, Brynn Hartman, the wife of famous comedian Phil Hartman, killed herself and her husband while taking Zoloft. While close friends attribute the sudden behavior on the antidepressant, others attribute it to a combination of the medication with cocaine and alcohol in her system. (Zoloft does have a warning against alcohol use in conjunction with the drug.)

One interesting thing I learned from the article is that this kind of behavior is often labeled under the name akathisia on patient safety guides. Most – if not all – of the major antidepressants list akathisia as a side effect. Here’s the initial description of this condition from Wikipedia:

Akathisia, or acathisia, is an unpleasant subjective sensation of “inner” restlessness that manifests itself with an inability to sit still or remain motionless… Its most common cause is as a side effect of medications, mainly neuroleptic antipsychotics especially the phenothiazines (such as perphenazine and chlorpromazine), thioxanthenes (such as flupenthixol and zuclopenthixol) and butyrophenones (such as haloperidol (Haldol)), and rarely, antidepressants.

Akathisia may range in intensity from a mild sense of disquiet or anxiety (which may be easily overlooked) to a total inability to sit still, accompanied by overwhelming anxiety, malaise, and severe dysphoria (manifesting as an almost indescribable sense of terror and doom).

No real mention of extreme anger or irritability mentioned there. But if you read on…

The 2006 U.K. study by Healy, Herxheimer, and Menkes observed that akathisia is often miscoded in antidepressant clinical trials as “agitation, emotional lability, and hyperkinesis (overactivity)”. The study further points out that misdiagnosis of akathisia as simple motor restlessness occurs, but that this is more properly classed as dyskinesia. Healy, et. al., further show links between antidepressant-induced akathisia and violence, including suicide, as akathisia can “exacerbate psychopathology.” The study goes on to state that there is extensive clinical evidence correlating akathisia with SSRI use, showing that approximately ten times as many patients on SSRIs as those on placebos showed symptoms severe enough to drop out of a trial (5.0% compared to 0.5%).

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Hirschfeld developed MDQ for GSK

“GlaxoSmithKline, one of the world’s leading research-based pharmaceutical healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.”

Quetiapine articleOK, I’ll be honest. I can’t keep up with my own posts and have no idea whether or not I’ve posted on this yet. Judging from the fact that I still have this bp booklet, I’m going to guess not. If I have, then there’s more.

When my psychiatrist diagnosed me with bipolar disorder in November, he handed me a bunch of material: a mood tracker (PDF), an article touting the benefits of Seroquel, and a booklet titled, “Bipolar Disorder,” which refers the reader to www.1on1.health.com.

The booklet seems pretty harmless to a patient newly diagnosed with bipolar disorder:

“Highs and lows can be part of life. But, with bipolar disorder, they can be severe. You may feel too depressed to get out of bed one day. Soon after, you may feel full of energy. You may have normal times between the highs and lows. When people have mood symptoms, it’s more likely to be depression.

Mood swings can be hard to predict. But you may have warning signs. You may even learn what can trigger your symptoms. You’ll read about this and more in this booklet.

Bipolar disorder is complex. Doctors docn’t know what causes it. They know that genes play a role. The illness may be linked to brain chemicals. These chemicals can get out of balance.

There are treatments to help control the symptoms. Learn about your condition. Get help for it. This booklet is a good first step.”

Thank you, GlaxoSmithKline.

GSK, the provider of such psych drugs as Lamictal, Paxil, and Wellbutrin, issues a series of booklets for patients referring them to 1on1health.com. The topics include depression, anxiety disorders, epilepsy, type 2 diabetes mellitus, high cholesterol, among others. The tips seems pretty simple and straightforward:

“Health and lifestyle chances may trigger your symptoms. Some common changes are:

Not having a sleep schedule
Misusing alcohol or drugs
Stopping your medicine, or starting medicine for depression or another illness
Having thyroid or other health problems”

Then it gets into the general stuff about the difference between mania, depression and further clarifies what hypomania and mixed moods are. Then, the kicker follows:

“If you think you may have bipolar disorder, fill out the checklist on the next two pages. Share it with your doctor. He or she can use it to help diagnose you.”

Bipolar questionnaireFurious Seasons posted a link about a fake drug named Havidol (which I totally got suckered into because I skimmed the post and missed the “OK, it’s a gag” part), but the hilarity stems from similarly stupid (and vague) questions. I’ve put a screenshot of the PDF GSK provides on their Web site to the right. My issue is not so much with the questions necessarily, but with the lead-in to them:

Has there been a time when...” [emphasis mine]

It doesn’t matter whether you were 3 years old or 46 years old, if you answered “yes” to more than one “there’s ever been a time when” question, guess what? You MAY qualify for bipolar disorder! A sampling:

Has there ever been a time when…

  • You were easily angered that you shouted at people or started fights?
  • You felt much more sure of yourself than usual?
  • You talked or spoke much faster than usual?
  • You were so easily distracted that you couldn’t focus?
  • You had much more energy than usual?
  • You were much more active or did many more things than usual?
  • You were much more social than usual?
  • You were much more interested in sex than usual?

Guaranteed everyone reading this said “yes” to at least TWO questions. If not, I question whether you’re breathing. (Sadly enough, this makes me realize how easy it was for me to get fooled by the phony Havidol quiz.)

The follow-up to the questions above asks, “If you checked YES to more than one of the questions above, have several of these things happened during the same period of time?” Then, “How much of a problem did any of these things cause you (like not being able to work, or having money or legal troubles)? Choose one[:]

  1. No problem
  2. Minor problem
  3. Moderate problem
  4. Serious problem”

The multiple choice question above may not matter. Answering some of the lead-in questions in the affirmative may qualify you for the disorder.

Here’s a nice little tidbit. The questionnaire was “adapted with permission from Robert M.A. Hirschfeld, M.D.” So as an uninformed patient reading this (which I was at the time), I’m thinking, “Oh, this must be legit since they got permission from a doctor to use this checklist.” There’s more than meets the eye here.

On the surface, Dr. Hirschfeld seems like an awesome doctor – and he very well may be. Dr Hirschfeld’s bio from the University of Texas Medical Branch at Galveston (UTMB) extols the “Professor and Chair” of its psychiatry deparment. He has history of working with various national organizations such as the National Depressive and Manic-Depressive Association,  National Institute of Mental Health (NIMH), and National Alliance for Research on Schizophrenia and Depression (NARSAD). He’s written all kinds of articles and blah blah blah. He’s considered a leader in his research of bipolar disorder.

In fact, because Dr. Hirschfeld is so great, he’s a member of pharmaceutical boards and has acted as a consultant for pharmaceutical companies, according to ISI Highly Cited.com. Some of our favorite guys appear here: Pfizer, Wyeth, Abbott Labs., Bristol-Myers Squibb, Eli Lilly, Forest Labs, Janssen, and – lookee here! – GSK.

The duration of Dr. Hirschfeld’s affiliations with these pharmaceutical companies are unspecified. All other “appointments/affiliations” have assigned years, i.e. 1972-1977, 2001-Present. His consulting affiliations follow his internship in 1968-1969. It looks a bit misleading to follow the consulting jobs after, oh say, 1969, and not provide dates of when he became a consultant for all of these pharma companies. Toward the end of the document that I found, his affiliations from 1986-Present are listed with various boards, associations, journals, and a slew of pharmaceutical companies.

Hello, hello, hello. He is a MEMBER of the Zyprexa U.S. Bipolar Academic Advisory Board, the Celexa/Excitalopram [sic] Executive Advisory Board, the Lamictal National Advisory Board, and the Zoloft Advisory Board.

Humor me here. His clinical trials include:

  • 1994 Paroxetine for Dysthymia (SmithKline Beecham)
  • 1995-97 Several (I found five) double-blind studies on sertraline and imipramine in patients qualifying for the DSM-III definition of major depressive disorder
  • 1996-98 Gabapentin therapy for bipolar patients

And the list, including mirtazapine, fluoxetine, venlafaxine, lamotrigine, goes on. You can also find the “grants” pharma companies gave to fund these clinical trials.

From 1997-2000, Hirschfeld received a $100K grant from Abbott Labs to develop “a new checklist for bipolar symptoms.” (I’m not sure what the old one was.) In 2001, he received a $142K grant for the “Bipolar Prevalence and Impact MDQ Project.”

I don’t even need to look MDQ up. It’s Mood Disorder Questionnaire. The grant came from GSK, who “adapted” the questionnaire with Hirschfeld’s “permission.” That sounds simply gravy.

To understand more about bipolar disorder, you can listen to the stories of Greg, Stuart and Leslie – all your classic bipolar cases and how medication and/or therapy has helped them so much. You can also watch the bipolar
disorder animation
that regurgitates all the things that we’ve become skeptical about.

In the meantime, remember the instructions included in Seroquel’s safety information that no one reads (excuse the crappy “Paint” job):

Seroquel warnings

Decision Resources attempts to restore confidence in Big Pharma's atypicals


Whee for self-promotion!

“Eli Lilly’s Zyprexa Will Remain the Clinical Gold Standard for the Treatment of Schizophrenia Through 2015”

“Clinical Gold Standard,” huh?

I can’t bring anything new to the table on this. Maybe I’m wrong, but here I go:

“For almost three decades, Decision Resources has provided in-depth research on the trends, emerging developments, and market potential in various healthcare industry sectors.  Our client base is diverse – including large pharmaceutical companies, emerging biotechnology concerns, financial services, managed care organizations, and medical device manufacturers who turn to Decision Resources to help shape their strategy and master their chosen markets.

The privately-owned company offers a rich array of research publications advisory services, and consulting that make it second to none for quality, analytical depth and insight. With access to almost 10,000 thought leaders, specialists, HMO formulary directors, and general practitioners, Decision Resources’ highly-credentialed analysts are able to reconcile real-world practice with hard numbers from the industry’s most respected data sources.  The resulting analysis and insights drive business decisions and commercial success within the biopharmaceutical, managed care, medical device, and financial markets.”

Here’s my assessment, take it with a grain of salt: In an attempt to fight the decline in sales from the NYT-induced Zyprexa backlash, Eli Lilly has gone on the offensive and hired Decision Resources to reinvent its star medication.

Decision Resources (DR), a privately owned company (no hyphen if a modifier ends in “-ly”), has a client base that includes large pharmaceutical companies. Ta-da! Don’t get it?

Decision Resources is not a public company; hence, in addition to not receiving federal money, it doesn’t need to report its financial dealings to the SEC. Therefore, no publicly accessible financial records of DR’s clients. They haven’t said they are an “independent” organization. Perhaps this is implied. Whatever the case may be, DR gets paid by its client base to research their products and “help shape their strategy and master their chosen markets.”

This isn’t brain science; this is on their “About Us” section of their Web site. Therefore, if Eli Lilly turns to DR and pays them to – I like DR’s wording here – “shape their strategy and master their chosen markets,” then DR is essentially a PR loudspeaker letting everyone know that Zyprexa is the “clinical gold standard” for schizophrenia.

What a bunch of hooey.

Not too long ago, it seems that AstraZeneca (AZ) may have had DR engineer its new marketing strategy to give Seroquel a boost. Why not? Mental health media watchdogs are hatin’ on the atypical antipsychotics.

“According to a new report entitled Schizophrenia: Turning Physician Insight into Projected Patient Share, Zyprexa is superior in efficacy to all other current therapies, particularly on measures that are most important to prescribers, such as impact on global symptoms and responder rate.”

Holla at me if you’ve got your hands on that report mentioned above.

“In spite of scoring* less favorable than the other drugs in terms of safety and lower than risperidone in terms of delivery features, Zyprexa is the gold standard.”

OK – so it’s not safe and it doesn’t deliver as well as Risperdal – whatever that means – but Zyprexa is still “the gold standard”?

“This overall advantage for a drug with significant safety concerns highlights the importance of efficacy to prescribers.”

I want you to reread that: ” This overall advantage for a drug with significant safety concerns highlights the importance of efficacy to prescribers.” Let’s attempt to paraphrase this: The benefit of this potentially harmful drug shows the importance of how effective it is to those who receive the drug. Although Zyprexa has “significant safety concerns,” the drug works well enough for doctors to prescribe it to patients. Uh, no. Positives don’t outweigh the negatives. It was nice jargon for a second there, though. (If this is effed up enough for adults, why subject children to this crap?)

“The report also finds that the most commercially important emerging antipsychotics (Janssen’s Invega, Organon BioSciences’ asenapine, and Wyeth/Solvay/Lundbeck’s bifeprunox) score* lower than Zyprexa, indicating that Zyprexa will remain unsurpassed during Decision Resources’ forecast period.”

I know I’m doing a play-by-play but this is important. I need to find out how DR decided that Zyprexa would be the “gold standard” until 2015. (What’s the significance of this year? Does EL’s patent on Zyprexa expire then? Nope, Eli Lilly’s patent on Zyprexa expires in 2011. Expect a similar molecularly structured olanzapine before then. Biolexapine?) So basically, in this report, DR’s conclusion is Zyprexa beats every other atypical antipsychotic for schizophrenia by far. Notice that AZ’s Seroquel (the soon-to-be “gold standard” of bipolar meds),  an atypical also used for schizophrenia, is not listed. Not coincidence.

The little asterisk (*) next to the word “score” prompts me to wonder: Just how did they come up with these scores? Well, the asterisk tells me that I need to contact DR for the methodology behind the product scores. I just might. Then send it off to CL Psych or Furious Seasons to decipher the crap out of it.

Another thing to note on this PR:

“”Invega is a metabolite of risperidone and is likely to have efficacy similar to that of risperidone, which scored* slightly lower than Zyprexa overall,” said Nitasha Manchanda, Ph.D., analyst at Decision Resources. “Asenapine also lacks the differentiation to replace Zyprexa as the gold standard because it does not make as significant an impact on global symptoms, and bifeprunox is significantly inferior to Zyprexa in all primary efficacy measures and is not capable of surpassing Zyprexa.””

Dr. Manchanda, analyst for DR, pulled bifeprunox – not yet on the drug market – into the Zyprexa comparison and somehow was able to call it “significantly inferior to Zyprexa” with an incapability to “surpass” it. How many people have used bifeprunox, Ms. Manchanda? OK, now tell me how many people have used Zyprexa? And you’re telling me that a drug that hasn’t yet hit the market is “significantly inferior” to a drug that has been on the market for the past couple of years and has 1,200 lawsuits still pending in addition to the millions that have already been paid?

As for AZ, DR has determined that Seroquel will become the “gold standard” for bipolar medication by 2010, knocking Lamictal out of its current “gold standard” status. Like Furious Seasons, I had NO idea Lamictal was held up so highly for bipolar meds. Considering that lithium has always been the king of bipolar meds and treats both acute mania and depression better than Lamictal, I’m surprised to read this.

“According to the new DecisionBase report entitled Bipolar Depression: Turning Physician Insight into Projected Market Share, Seroquel’s advantages over Lamictal include the more profound effect on depressive symptoms seen in short-term trials.”

My doctor precribed Lamictal to me for management of depressive symptoms in bipolar disorder. He conversely prescribed Seroquel for mania (and to help me get sleep).  Getting back to the short-term trials, Lamictal was tested for 18 months for long-term management of bipolar disorder. Seroquel, however, was tested for 8 weeks. Effective for the short-term? Perhaps. But most patients on atypicals take them long-term. And that’s precisely where Seroquel fails.

“The drug’s efficacy on this measure differentiates it from other therapies, according to thought-leading psychiatrists, and the importance assigned to this measure by prescribing psychiatrists drives Seroquel’s product score above Lamictal’s.*”

According to thought-leading psychiatrists who probably function as consultants and analysts for “large pharmaceutical companies.” Seroquel may have the potential to sell more than Lamictal by 2010 – if this is what DR’s gauging. However, it seems like DR is trying to push Seroquel, not just as a better market share, but as a better product. In this “report,” DR also fails to compare Seroquel’s efficacy to Zyprexa’s. What a convenient absence for a product used for psychosis in bipolar disorder.

(ignore any spelling errors in this post. it’s late and i bumped my forehead against the edge of a car door in the rain. ouch.)

Catching up: Furious Seasons

I’ve been out of it. Really out of it.

In my backlog of reading, Furious Seasons has posted the results of what he’s entitled, "The Zyprexa Chronicles."

The judge ruled in favor of Lilly.

Holy crap. I knew this would happen, but hoped it wouldn’t.

This all occurred on Feb. 13, so I’m really behind the times here. (Did Punxsawtawney Phil see his shadow yet?) But it’s a reminder to, not just the blogosphere, but also to the media that, well, pharma companies are more powerful and have more sway in court.

After reading a bit more on the situation (ok – I’m getting all my info from ONE blog), it seems that the judge hasn’t really ruled against blogs using or disseminating these documents (MindFreedom.org being the exception apparently) but these leaked documents could cause Lilly "irreparable harm." What? Documents that need to be made public would harm Lilly? It’s David against Goliath. Mainstream media — CBS, ABC, NBC, AP — haven’t picked up on this story. The majority of Americans – I’d venture to say the majority of Zyprexa consumers – don’t know about the proven side effects of this drug. I highly doubt it would cause "irreparable harm."

Classic quote:

"The way reporters work is a good deal for the public. We get paid like school teachers, think like lawyers and detectives, fight like Marines when necessary and write like… oh, nevermind."

Man, ain’t it the truth. Especially the schoolteacher pay. Except in Brooklyn, NY where they’ll pay a starting teacher at $40K because they need teachers in the inner city. But I digress.

"So, Ms. [Marni] Lemons (Eli Lilly spokeswoman), what I reported on yesterday — that your company was talking about potentially downplaying glucose increases noted in studies used to approve Zyprexa for long-term use in bipolar disorder — was based on these documents and it sure looks to me like your employees were strategizing all over the Lilly email system. I contacted your press office on Monday and asked them to respond to several questions about that document. Your people never responded….

The same goes for you people at the FDA. Stop telling me to file FOIAs in order to get basic public information that affects millions of people that should already be freely available on your website."

For those who don’t know, FOIA stands for Freedom of Information Act, in which anyone can write to a governmental agency and appeal for documents that have been made public. The nice part about this? The agency can black out information that don’t want you to know. They can deny your request, block out some data, or block out so much that the document ends up being useless. Oh, and FOIAs take forever and freaking day to arrive because the gov’t sends them when it’s convenient for them.

Furious Seasons has also been following the NYT’s coverage about a child diagnosed with ADHD and bipolar, who was killed and supposedly overdosed on medication. Riiight. Unfortunately, from what I can see – perhaps I’ll find a bit more – the NYT is extensively covering mental health issues. Perhaps they’re getting a ton of hits on the Zyprexa series and have figured out that people actually care about mental health topics. Whatever the reasoning, I’m glad they’re doing it.

Astute observation from Furious Seasons:

"This whole diagnose-medicate-blame-the-"illness"-for-bad-outcomes nonsense has got to stop. It’s bad enough in adults and teens, but in kids it is a complete outrage. It is interesting to me, though, that when a child dies, the skeptical questions are asked. When an adult has awful results from taking Zyprexa, say, or Paxil, the media is largely silent."

More to come on other blogs…

Blogs vs. Mainstream Media

“Mr. [James B.] Gottstein, [a lawyer from Alaska, who was pursuing unrelated litigation for mentally ill patients in his state], sends [Dr. David Egilman, a consulting witness in ongoing litigation against Lilly] a subpoena for copies. Hell begins breaking loose.” – Tom Zeller, Jr. in The New York Times

I think Furious Seasons originally linked to this (I can’t remember the source of the post), but I read this on the NYT and had a few thoughts, regarding brick-and-mortar courts vs. “teh Internets.”

Warning: Rant ahead.

I can’t help but think back to the 2004 showdown between Dan Rather and CBS (endearingly named Rathergate) vs. political blogs regarding a memo about George W. Bush’s service in the Texas Air National Guard. From NewsMax:

“Added [Matthew] Sheffield [of RatherBiased.com]: A virtual think-tank was born… Forty-seven posts later, a person who called himself ‘Buckhead’ offered the proposition that he thought the documents were forgeries.’

Sheffield and his Web site jumped on the bandwagon, searching the Web for experts on 1970’s typewriters. Another blogger site, PowerlineBlog.com, raised the question of forgery. ‘Matt Drudge and his DrudgeReport.com then linked to the Powerline piece, and the story took off,’ recounted Sheffield.”

Someone please tell Drudge about Zyprexa, Risperdal, Cymbalta, Seroquel, Abilify, and blah blah blah, psych med, blah blah blah.

“Some media observers now contend the “Blogosphere” is rapidly replacing CBS and the rest of the mainstream media.

“You’ll note that several blogs rank higher than mid-size daily newspapers and some are pushing the sites of papers in the top 50 (by daily circulation). The data suggest that the question isn’t “When will blogs arrive?” but rather “Blogs HAVE arrived, what now?” [said Kevin Aylward of Wizbangblog.]”

I’ll probably have a string of quotes from the newsmax article, but I will eventually get to my point.

I quoted this previously, but it’s worth requoting:

“It’s great that [Philip] Dawdy [of Furious Seasons] has stepped up for a huge, mainly voiceless population, but on the other hand, it’s weird to see citizen journalists so responsible for watchdogging our mental health industry. When we hear newspapers complain about declining readership, we can’t help but think it’s mainly because — gosh, this is awkward — the shit they’re reporting on isn’t newsworthy. And this shit is.” – Seattlest

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Depression Checklist

The following is brought to you by Eli Lilly:

depression checklist

Depression hurts. But you don’t have to.” Feel free to check Furious Seasons’ post featuring YouTube videos on Eli Lilly’s latest depression campaign.

Eli Lilly: Zyprexa causes diabetes; Byetta can help

I found this Bloomberg chart in the Metro Philly newspaper and thought it showed an interesting paradox. I tried to find a link for it on the Internet but as of yesterday, there was none.

Eli Lilly's Byetta

Neurontin: Pfizer and Eli Lilly share a common history

My mother-in-law was telling me yesterday about how her hairdresser’s daughter has been diagnosed bipolar with OCD characteristics. She says her daughter’s on “Neo-something” – she couldn’t quite remember the name.

I racked my brain for a bipolar med name that began with “n.” Nothing really came to mind except for neurontin. I told myself, “No, that can’t be right. Isn’t that associated with VNS?”

Nope; Neurontin really is a medication associated with bipolar disorder. Neurontin’s generic name is gabapentin.

Neurontin (gabapentin)

Read the rest of this entry »

Pharmaceutical roundup

AbilifyNearly every mental health blog I know is talking about this post from intueri.org. It’s definitely worth the read. I don’t know much about Abilify, but I don’t think most uneducated bipolars know that it is prescribed specifically for those with psychosis. On the flip side, I don’t think uneducated PCPs know that tidbit either. A person with bipolar without symptoms of psychosis who asks for Abilify may be in for a rude awakening. [UPDATE: Who paid this chick? I only skimmed the post but I don’t see any negative side effects listed.]

I’m not deep into the pharmaceutical industry like all of these heavyweights: CL Psych, PharmaGossip, and Furious Seasons, among many others whom I may have failed to mention. However, there’s a wealth of information to be found. My newest discovery:

“The approach is called ‘ethical pharmaceuticals,’ and it was unveiled on January 2 by Sunil Shaunak, professor of infectious diseases at Imperial College, and Steve Brocchini of the London School of Pharmacy, the Guardian reports. Their team of scientists in India and the UK, financed by the prestigious Wellcome with technical assistance from the UK government, have developed a method of making small but significant changes to the molecular structure of existing drugs, thereby transforming them into new products, circumventing the long-term patents used by the corporate giants of Big Pharma to keep prices – and profits – high. [emphasis mine] This will give the world’s poorest and most vulnerable people access to life-saving medicines – now priced out of reach – for mere pennies.”

I read the above on CLPsych’s blog (originally from Chris Floyd at truthout) and couldn’t believe what I was reading. It somewhat ties into what I’ve been researching about Neurontin (which will probably be posted later in the day):

“Pfizer has developed a successor to gabapentin [Neurontin’s generic name], called pregabalin (being marketed as Lyrica®). Structurally related to gabapentin [emphasis mine], pregabalin is effective for neuropathic pain associated with diabetes and shingles, and for the treatment of epilepsy and seizures.”

Pfizer, in an attempt to distance itself from the trouble surrounding Neurontin, developed another medicine – pregabalin, which is similarly structured to gabapentin. Pfizer can now claim, “Don’t like Neurontin? You can have Lyrica instead!” Pfizer also tried to pass off the (illegal) off-label marketing practices with Neurontin off to their acquired division Parke-Davis. So now we’ve got two options: Pfizer either has learned from Parke-Davis’ issues with Neurontin or is pretty stupid and pushing Lyrica for off-label usage similar to that of Neurontin’s. No evidence to support either option… yet. But CLPsych delves into an interesting practice that Pharma companies use to circumvent a drug patent running out:

“News Flash — PhRMA does NOT believe in the free market: While PhRMA likes when the market works in their favor, they also believe in circumventing that same market when it comes to competition. When drugs are slated to come off-patent, which would allow generic version of the drug to be made, PhRMA members have increasingly turned to buying off the competition. That’s right; they simply pay the generic manufacturer to not make a generic version of the patented drug, so that the consumer can continue to pay a hefty price for the drug which is still under patent. [emphasis sorta mine]

Wow. That bit of information has left me speechless. Screw the consumer that can’t afford psych meds without health insurance; we as Big Pharma need our DAMN money!!! [end rant]

This practice, called “reverse payments,” is not something new and, at the current moment, is relatively legal. Supposedly, the FTC and the Department of Justice are keeping their eyes on reverse payments and patients can only imagine what might occur in the future. PharmaGossip has more, but slips this bit of info before linking to the Star-Ledger:

“And with the patents on 70 blockbuster drugs — with a total of $48 billion in annual sales — set to expire by 2011, the industry expects reverse-payment deals to proliferate further.”

The FTC and Justice Department better hurry up and step in so we can finally have a generic version of Lipitor!

In all honesty, my mind can’t simply fathom the depths to which Pharma will stoop to make money. (Perhaps because I don’t work directly within the medical industry.) It has me wondering if Pharma is worse than gas companies. Is OPEC more trustworthy than Eli Lilly? I’ll leave it up to you to decide.

Loose Screws Mental Health News

Yay for the New York Times! Alex Berenson, doggedly keeping up on the Zyprexa story, has written an article about how state prosecutors in Vermont and Illinois are now demanding that Eli Lilly submits documents to them about their marketing practices of Zyprexa. Something I didn’t know:

“Federal prosecutors in Philadelphia have also recently accelerated their own investigation into Lilly’s marketing of Zyprexa.”

My residence in the Philly area has prompted me to follow this closely now. More juicy information:

“In a statement yesterday, Lilly said it would cooperate with the investigations and had done nothing wrong. ‘We intend to cooperate with the Illinois attorney general’s civil investigative demand relating to Zyprexa,’ the company said.

While the investigation being led by Illinois is civil, other investigations into Lilly’s conduct are both civil and criminal. [emphasis mine] Attorneys general in California and Florida may seek to recover Medicaid payments that the states made for Zyprexa. Any fine or cost recovery could be sizable, because Zyprexa has been a commercial success.”

Because investigators need to search through more than 10,000 documents relating to Zyprexa and its marketing and talk to former and current employees about the matter, it could take years for anything to happen. Berenson’s last paragraph at the end brought my excitement to a quick halt:

“As long as drug makers comply with federal requirements to provide data about their products to the Food and Drug Administration, companies have a relatively strong defense against criminal prosecution, according to lawyers who are experts in drug marketing.”

Great. So as long as Lilly complies with the FDA and state and federal prosecutors, they can escape criminal prosecution. Please don’t tell families who have loved ones who died over this medication. Lilly’s settlements are nice and all, but money is never restitution for someone’s death. I’ll soon have a post up about how Pfizer had this issue with Neurontin from 2002-2004. They, too, had to pay more than $430 million to settle lawsuits on civil and criminal charges. Pfizer plead guilty; let’s see if Eli Lilly follow suit (no pun intended).

Andre WatersI’ve been a little late on the bus with this, but I’ve previously written about Andre Waters who killed himself in November. Despite theories of depression surrounding his suicide, a neurologist has claimed that Waters sustained brain damage from playing football which triggered his depression and led to his death. Dr. Bennet Omalu, an expert in forensic pathology, says that Water’s brain tissue “had degenerated into that of an 85-year-old man with similar characteristics as those of early-stage Alzheimer’s victims.” Omalu gets pretty grim though:

“If [Waters] had lived, within 10 or 15 years ‘Andre Waters would have been fully incapacitated.'”

The NFL has no comment.

doggieAs I’ve been trying to tell my husband recently, pets can relieve symptoms of depression. Come on, who can be sad when you’ve got an happy little dog wagging its tail at you with bundles of love? (I’m thinking cute little Yorkies or friendly Golden Retrievers.) Owning a pet can have great mental health benefits:

  • Can reduce anxiety
  • Induce social contact
  • Promote a better quality of life
  • Help kids develop higher self-esteem and lower levels of fear

The only downside: animals can cause stress. But it seems like the stressors can be addressed, i.e. animal training, neutering. (source: The Trouble With Spikol)

Also linked to by Liz Spikol, another interesting mental illness combatant: sports therapy. It seems that it can help those suffering from PTSD, abuse, amnesia, and shyness. Italian doctors, however, a testing to see if soccer can treat illnesses like depression and schizophrenia. This should be interesting.

Oh, and NOTHING to do with mental illness, but I found this NYT article on weight loss and maintaining it quite interesting.

Zyprexa Documents Hearing

Looks like Weinstein might redeem himself:

"The judge is asking Eli Lilly’s lawyers to now justify why the court documents that slipped out into the world last month should continue to come under the court’s seal. Good call by the judge."

Ooh, this should be interesting. (Furious Seasons)

Loose Screws Mental Health News

Starting off with some crazy (npi) mental health news, psychotherapists are now beginning to diagnose depression and anxiety in infants. Yes, infants. Before you know it, newborns will begin suffering from post-traumatic stress disorder after enduring complications during delivery. Fetuses will suffer from depression due to lack of exposure to light.

I’m all for diagnosing mental illness in children, but infant depression? Unless it’s mistreated, the concept is ridiculous.

“He says he doesn’t put babies on the couch. Instead, he observed Jayda through a one way mirror. He was looking for clues on why she wouldn’t bond with her mother, Kari Garza.”


“Psychologist Douglas Goldsmith says ‘even by the first birthday, some of the research is saying we should be able to start to see signs of more serious social disorders.’

There are some warning signs to look out for, such as a lack interest in sights and sounds. Others include of lack of desire to interact; listlessness; or excessive crying.”

I can’t help but think it’s rooted in a physical rather than a mental problem. I excessively cried for six months as an infant; no knew that I’d developed eczema and the itching was unbearable because I wasn’t able scratch.

“Figuring out what’s depression versus normal behavior is hard, according Pediatrician Linda Nelson of the Franciscan Children’s Hospital, because ‘the crankiness and all of that, teasing that out from true depression, it’s very difficult.'”

Josh of “We Worrywrites:

“I may be way off the mark on this one, but if I’m not mistaken, an infant’s cognitive abilities are incredibly limited and, for the most part, are dictated entirely by instinctual behaviors. It seems that it would be impossible to determine if an infant had depression or anxiety because it’s impossible to ask them.”

Nope, not off the mark at all.

Want to know what dealing with a bipolar is like? The following is dead on:

“Bipolar is a hell of a disease, and I wonder if patients [at my community health center job] knew how devastating it is, whether they’d choose to label themselves that way.

Bipolar used to be called manic-depression. People with bipolar disorder are constantly on a roller coast ride between severe depression and mania. On the depressed end, this can include feelings of worthlessness, excessive guilt, changes in eating (over- or under-), changes in sleep patterns (can’t go to sleep or can’t wake up), and recurrent thoughts of death.

On the manic end, bipolar people experience feelings of grandiosity, believing they’re capable of things nobody can do. At this end of the spectrum they often sleep very little, their thoughts race, and they can’t stop talking. They tend to get involved in risky activities, such as unrestrained buying sprees, sexual indiscretions, or foolish business investments. Some feel more angry than expansive in their manic phase, or when they’re on their way up or down.”

Congrats. You get the gold star. You’ve just learned something today (if you’re not bipolar).

I recently read Graham’s Blog and among a list of meds, I saw “Zispin.”


It’s trademarked as Remeron in the U.S. and Zispin in Great Britain. The generic name is mirtazapine. Sounds like a name for a German lady €“ Fraulein Mirtazapine.

According to the wonderful wikipedia, mirta treats “mild to severe” depression.” That’s a wide spectrum of patients to cover. Mirta is as effective for people with mild depression as it is for those who are dang near suicidal everyday? I’m not convinced.

Of course, since it’s a med, it’s used off-label for panic disorder, GAC, OCD, and PTSD among other health problems.

If you’re you suffer from bipolar and get a prescription for this stuff, get another doctor quick: mania is a side effect.

I won’t get into the fine details of how mirta works, but it appears that it enhances neurotransmitter actions rather than affect serotonin levels directly.

There’s my new medication lesson of the day.

I’m late on the bandwagon, here. I’m sure Furious Seasons, CL Psych, and other blogs have railed on the injustice of Judge Weinstein’s stupid yes, it is stupid decision to uphold his gag order (he imposed it so why would he change it?) that keeps blogs from “dissemination” Eli Lilly’s leaked documents. Basically, the judge wants to block wiki Zyprexa Kills from showing this info. Any other blog that has the documents, links to it, or publishes it is — well — subject to a gag order as well. *gag*

I have a personal opinion on the matter and since you’re reading this blog, you’ll be subjected to it.

Read the rest of this entry »

Loose Screws Mental Health News

Yeah – the copy editor in me wants to try “Loose Screws News.” For now.

Clinical Psychology and Psychiatry is among many of my favorite blogs to read. In this particular post, he rips on Eli Lilly’s zyprexafacts.com, which was set up in response to NYT articles that alleged Lilly drug reps pushed Zyprexa to physicians for off-label uses. I hope to just have a stupid ol’ time and rip on each Eli Lilly press release in response to each NYT article, but we’ll see what happens. I’ve already got one lined up with notes scribbled on the printout; I just need to transfer it into electronic form. (Oh, the joys of being a transit commuter.)

Liz Spikol linked to an article originally published in bp magazine about how difficult marriages are when one spouse suffers from bipolar disorder. The saddest statistic I’ve ever read:

“In the United States and Canada, at least 40 percent of all marriages fail. But the statistics for marriages involving a person who has bipolar disorder are especially sobering—an estimated 90 percent of these end in divorce, according to a November 2003 article, ‘Managing Bipolar Disorder,’ in Psychology Today.”

Um, joy considering that I’m I suffer from bipolar and have been married for just over a year now. This strikes incredible fear in my heart. It’s not that we don’t love and care for each other, but I can only imagine how much a spouse who doesn’t suffer from bipd can take. I hate to say it, but I keep waiting for my husband to walk out on me. Not because I’m pessimistic (OK, I am, but that’s beside the point), but because I fear that he’ll reach a point where he’ll say, “I can’t take anymore of this! I’ve dealt with this for 10 years and nothing’s changed, nothing’s getting better. I’m sorry, but I can’t be married to you and deal with this anymore.” Just waiting.

Kelly Osborne Retarded celebrity story of the day: Kelly Osborne suffers from depression because she’s so privileged. But hey! — she’ll pose for Playboy and get photoshopped so she can feel better. *gags*

If you’re mentally ill and fired for it, don’t bother suing. It looks like the mentally ill don’t have a case unless there’s a physical illness to somehow “prove” it:

“Sixteen years after Congress enacted the Americans with Disabilities Act (ADA), people with psychiatric disabilities are faring worse in court cases against employers for discrimination than are people with physical disabilities, researchers have found in a national study.

‘People with psychiatric disabilities were less likely to receive a monetary award or job-related benefit, more likely to feel as though they were not treated fairly during the legal proceedings and more likely to believe they received less respect in court,’ said Jeffrey Swanson, Ph.D., a study investigator and an associate professor of psychiatry at Duke University Medical Center.”

I’m not sure how to solve this problem. Psychiatric disabilities are less tangible and harder to prove than a physical disability. It’s easier to wage war against a company if you suffer from a bad back vs. if you suffer from depression. (Whether or not the bad back is a fictional illness is up to you.)

Another oy moment. (The Long Islander in me is coming back full force.) Got a pet that’s misbehaving? Put him or her on an antidepressant. Double oy.

New Zealand is being introduced to lamotrigine (trade name Lamictal in the U.S.). Good luck, bipolar New Zealanders. Best wishes.

And finally, a study has discovered that about half of patients who suffer from some kind of severe burn suffer from clinical depression. (Shouldn’t someone diagnose this as PTSD? That’s pretty traumatic, if you ask me.) While the finding isn’t surprising, the study highlights the need not only to treat the physical ailment, but also to address the mental healing necessary to overcome stress from the injury.

Eli Lilly settles with 18,000 people!

Holy crap.

In a stunning move by Eli Lilly, yesterday they agreed to pay $500 milion to settle lawsuits from 18,000 people who said they'd developed diabetes among other health problem on Zyprexa.

According to the company, 1,200 lawsuits are still pending.

Furious Seasons is doing some extensive blogging on this.

More on Zyprexa

More on Zyprexa, folks. It just isn't going to go away.

NYT reporter Alex Berenson, continuing his stellar coverage of Zyprexa's risks and exposing Eli Lilly's deceitfulness, has uncovered a recent case of a man who died using Zyprexa. John Eric Kauffman has a complicated medical, which might have led to his death. However, he was a mentally ill patient on Zyprexa and as a result of his death, Eli Lilly must report his death to "federal regulators," which it is required to do under law. However, despite his heavy smoking, he gained 80 lbs. on Zyprexa – which possibly led him to develop heart disease and become sedentary after being active most of his life. His mother says that Zyprexa did help him stave off the psychosis of his bipolar disorder, but his mother wonders if the risk was worth the early death of her son. Kauffman at 41 years old weighed 259 lbs. at the time of his death. He was 5' 10".

Which leads to the question of whether mentally ill patients should choose between taking Zyprexa – which CAN help mentally ill people – and dealing with its significant side effects or risk not taking Zyprexa when other medications won't work. In light of all this, should a doctor even continue to prescribe Zyprexa after seeing its awful side effects but left with no other choice (given that a patient is treatment-resistant to most medications)?

Eli Lilly's response to this continues to be appalling:

"Zyprexa is a lifesaving drug and it has helped millions of people worldwide with schizophrenia and bipolar disorder regain control of their lives."

It may be true that it helps people "regain control of their lives," but as for being a lifesaving drug – that's unlikely. Zyprexa has been shown to induce diabetes, obesity, hyperglycemia, and now, heart disease and death. I commend Australian regulators for looking into the details of Lilly downplaying the risk of Zyprexa and hope that they will make the information public – a different course than what the U.S. federal government seems to be taking. Lilly's 2006 settlement with patients who developed diabetes and other health problems is pure evidence that despite their constant denials, Lilly's hiding something in an effort to make profits.

My prediction: The FDA will eventually slap a black-box warning on Zyprexa, warning patients that it makes them more prone to diabetes and its other ill health effects.

NYT video on age-related health

The NYT video on health includes a story about how health programs are aimed at baby boomers who are intent on staving off age-related problems such as dementia. (Related to Zyprexa being used off-label for dementia and all…)

NYT report

ADDENDUM: Eli Lilly wins Round 1 in court. According to the NYT, a federal appeals court has ruled in favor of Lilly in a challenge to its patent on Zyprexa. Ivax (affiliated with Teva Pharmaceutical Industries) and Dr. Reddy’s Laboratories filed a suit saying that a lower court ruling in Lilly’s favor was wrong. Lilly’s patent on Zyprexa expires in 2011. And random Zyprexa data because Seroquel actually looks better in this instance:

“Sales of Zyprexa dropped 16 percent and fell behind AstraZeneca’s Seroquel as America’s best-selling antipsychotic in 2005, according to IMS Health, which provides data on drug sales.”

An Interesting Observation

Time’s Quote of the Year:
“Actually, I thought we were going to do fine yesterday – shows what I know.” – President Bush on the midterm elections


An interesting observation I don’t know if anyone has already made or if anyone will pay attention to – Time‘s 2006 POTY issue carried 14 medically- or pharmaceutically-related ads. Two of those ads were full-color spreads related to two major pharma companies: AstraZeneca (an ad letting you know they can help/care) and Eli Lilly (touting the benefits of Cymbalta). I couldn’t help but stop and stare at Ambien CR’s ad pages. Ambien CR, a version of the popular sleep aid developed sanofi aventis has a WHOPPING 3.5 pages. Three-quarters of the first page is the Ambien CR color ad and the bottom quarted is  “Important Safety Information” in a blue box. Turn the page and there is nothing but fine print black text streaming across TWO pages. As if a quarter-page of safety information and a FULL two pages weren’t enough, flip the page again, and more “information for patients” continues for a half-page. I’d like to  know someone that’s actually read ALL those warning/safety information things. How many people actually READ all two and three-quarters (2 3/4) of safety information? I’ll be honest with you; I sure don’t. I skip all that stuff. But it’s there so when people suffer side effects, the company can say, “Hey! We  included this in our advertisement! It’s everywhere; you have no basis to sue.”

AstraZeneca, the maker of antipsychotic drug, Seroquel, writes in its ad (click on the thumbnail to see the modified scanned version):

AZ“A pharmaceutical company saving you the money on the medicines it makes.Imagine that. [larger font]

If you take any AstraZeneca medicines, you may be surprised that there’s someone you can turn to for help if you can’t afford them: Us. A family of four without prescription covrage making up to $60,000 per year may qualify for patient assistance. The AstraZeneca Personal Assistants can assist you in signing up for programs that can provide you free medicines or significant savings IF you qualify. [emphasis mine]
We’ll be the first to admit we don’t have all the answers. But as a pharmaceutical company, we recognize that when you trust us to help you, we feel we owe you the same trust in return. That’s what AZ&Me is all about. A place we’re creating to put the personal touch back into healthcare.

Please visit AZandMe.com or call 1-800-AZandMe.”

AstraZeneca Personal Assistants??? What is this? A department store? I can hear it over the loudspeaker now: “Now, calling all patients who use AstraZeneca medicines, we have personal assistants who can help you select the right care and plan to help you get the medicines you need.” And the cute slogan AZ&Me slogan. How adorable. It just makes you want to cuddle right up to Big Pharma! Because remember, they’re putting the “care” back in “healthcare.”  (sarcasm)

If anyone has used AZ&Me to get Seroquel for free or at a discount, e-mail me ASAP at suicidal.recovery AT gmail.com. I’d love to communicate with you.

Catching up…

After a hectic week between work and excessive blogging, I've finally caught up to the latest NYTimes articles on Eli Lilly's troubles with Zyprexa.  I also read the NYT's editorial on the issue. The last paragraph caught my eye:

"Lilly contends that it has never promoted Zyprexa for unapproved uses and has always shown its marketing materials to the Food and Drug Administration, as required by law. Both claims ought to be tested in Congressional hearings that should focus on how well the industry complies with existing laws and how effectively the F.D.A. regulates the industry’s marketing materials."

Furious Seasons and CL Psych beat me to the punch on the skepticism. Congressional hearings would do nothing and I am even more skeptical of the FDA. Pharma companies like Lilly probably slip Dr. Andrew C. von Eschenbach some money to get their stuff approved. But I'm merely speculating because I'm tired and haven't done more research on this at the moment.

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NYT plunges ahead with Eli Lilly story; Furious Seasons on the case

While the court is ordering the lawyer who released internal Eli Lilly docuemnts to hand them back, the New York Times is plunging ahead with more shocking revelations concerning the documents. God bless The New York Times and Alex Berenson for taking this story, running with it, and making it public. Even if the company documents become confidential, the story is out and people WILL sue in an attempt to make it public. Patients have a right to know what is affecting their bodies and why Zyprexa causes more medical complications than it helps overcome mental illness.

And God bless Furious Seasons. I don't have time to blog on it, but he does. Head over there to read his critical analysis on the whole situation.

Loose Screws Mental Health News

More than likely, I’ll be doing short, quick updates today since I have a LOT of work to get to… you know, at work.

I found a new forum that discusses drug-related items, mainly Paxil: http://www.paxilprogress.org/forums/ It uses one of my more favored layout of forum versions, vBulletin. But they have a worthwhile discussion on the whole Eli Lilly/Zyprexa thing going so it’s worth checking out.

Time's 2006 Person of the Year According to the Toronto Sun, Sienna Miller told the UK Mail that she went to a psychiatrist to deal with Jude Law cheating on her — but ended up insulting her when the psych asked a difficult question. Therapy won’t work, dear, if you don’t put any effort into it.

More later on goodies like Christians and depression (what Liz Spikol linked to) and Time‘s Person of the Year. (Okay, Time has NOTHING to with depression but it’s sooo lame it requires a post/rant.)

BTW – I’ll get to everyone’s comments soon. I’m having e-mail issues and once I get them sorted out, I’ll start responding.

PCPs Don't Know Jack From Zyprexa

Eli Lilly’s actions continue to be appalling.

LillyApart from trying to hide the fact that Zyprexa induces weight gain, diabetes, and hyperglycemia, they also had sales reps encourage primary care physicians to prescribe Zyprexa for patients who did not have schizophrenia or bipolar disorder (basically off-label usage).

It seems that Lilly told marketing reps to suggest Zyprexa for dementia in the elderly. Lilly denies this, of course, since olanzapine (Zyprexa’s generic name) is not approved for that kind of use since it increases the risk of death in seniors with psychosis associated with dementia. Lilly also attempted to market olanzapine to patients with mild bipolar disorder who suffer mainly from depression. (In actuality, Zyprexa is approved to treat those who suffer from mania.)

This issue with Eli Lilly delves into precisely why I am against PCPs prescribing psychiatric medicines. Primary care physicians don’t know enough about the various psychiatric conditions to prescribe the appropriate kind of medication. This type of prescription should be left to specialists like psychiatrists. PCPs should focus on the things they deal with on a daily basis that no one else can take care of: the common cold, the flu, annual physical, etc. It should be the job of the PCP to refer a patient to a psychiatrist should they present symptoms of mental illness (depression, schizophrenia, etc.). I have been burned by having a PCP prescribe antidepressants for me and as a result, attributed my horrible experience with drugs to that.

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Loose Screws Mental Health News

Canada.com reports that a Canadian mental health survey found that more than 75 percent of people diagnosed with clinical anxiety or depression experience a severe relapse during the winter months, namely December and January.

“Among the symptoms those people reported, more than half said they experienced ‘feelings of worthlessness,’ ‘inappropriate guilt’ and difficulty thinking or concentrating during the winter holiday season.”

The survey also found that decreased daylight hours and increased debt during the holiday season contribute to stress among those with chronic mental illness. At least the article didn’t say there was a spike in suicides…

Lorraine BraccoLorraine Bracco, known as Dr. Melfi on The Sopranos, has written a book about her struggle with clinical depression. She notes the difference between how she functioned before her depression hit and after. She cites Zoloft as the antidepressant that helped her overcome the hump and a mental realization that she needed to get help. She no longer uses antidepressants but she feels that the antidepressant got her to a place where she could find herself again, “I found my joie de vivre, my spirit, my voice.”

And finally, it’s time to be pissed off at Eli Lilly. Documents obtained by a mental health lawyer, given to The New York Times, show that Lilly execs tried to downplay the risk of obesity and hyperglycemia in Zyprexa. The two side effects can lead to a significantly increased risk for diabetes. Lilly material even included statements to sales reps telling them to downplay those risks when pitching the atypical antipsychotic to doctors. Zyprexa, Lilly’s best-selling drug, has been sold to 2 million people and has raked in $4.2 billion worldwide. The drug is primarily prescribed for schizophrenia and bipolar disorder. Of course, Lilly execs, aware that the side effects would keep patients away from the drug, downplayed the risks and even went so far as to say, “There is no scientific evidence establishing that Zyprexa causes diabetes.”

Lawsuits speaks differently, however. Lilly has agreed to pay $750 million to 8,000 people who claim that Zyprexa has caused them to develop diabetes or other medical problems. According to the Times, “thousands more suits against the company are pending.”

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