Atypical Antipsychotics: Patient Safety Information

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.)

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

Zyprexa

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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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)

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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.”

What?

“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.”

Whaa?

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.

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Patient Responsibility

“An article on brain shocks from about.com linked to a statement at socialaudit.org.uk on venlafaxine withdrawal. It seems that when coming off of venlafaxine, it is best to use fluoxetine (Prozac) in conjunction with it. Somehow, Prozac’s effects can minimize or negate the side effects of Effexor allowing for an uneventful withdrawal. I’m seeing my psychiatrist later today and I might bring up the idea with him. He might think one of two things: a) I’m crazy (pun not intended) or b) I don’t know what I’m talking about. My guess is he’ll choose the latter of the two.

Unlike most patients, I know more about meds than ‘the average bear.’”

UPDATE: I asked my doctor about going on fluoxetine to offset the effect of venlafaxine withdrawal. He looked up, somewhat shocked, and said, “Yeah.” So then I pushed and said, “Well, I’d like 10 mg then.” lol. He wrote out a prescription for 10 mg of Prozac in addition to bumping me up from 150 mg to 200 mg of Lamictal. I took the fluoxetine (Prozac is now a generic drug) last night and it has offset the intensity of the brain shocks. I experience them but they are much more mild compared to yesterday when they were moderate to severe. Yesterday, I was barely able to drive; today, I drove nearly an hour to work on a somewhat urban road with good reflexes and almost normal cognitive functioning. I can only hope that the Prozac continues to aid my withdrawal issues. And I was happy to wake up this morning without wondering why I dreamt that I was in a department store with parrots singing Gwen Stefani’s “Wind It Up” and swinging like moneys instead of flying.

You get the idea: Effexor causes some strange dreams.

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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.

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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