…and on to AstraZeneca's problems with Seroquel

Eli Lilly seems to be passing along its misfortune off to AstraZeneca, which now appears to be having issues with masking evidence of Seroquel side effects. From Furious Seasons:

A great article appeared in the St. Petersburg Times over the weekend, revealing that lawyers for AstraZeneca will argue in court later this month that the company wants documents introduced into a federal court hearing in a case over various allegations around Seroquel sealed and hidden from public view. They want an upcoming hearing in the federal class action lawsuit against AZ closed to the public as well. Lawyers argue that they are protecting patients and, oddly, the public at-large.

Read the rest of Philip's post.

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.)

intueri hits the spot

Oh. My. Goodness.

Abilify phone booth (side view)Intueri originally wrote the post about seeing Abilify on the side of a phone booth. I thought it was pretty funny and pretty stupid.

I still find it stupid, but even more so now.

I was on the bus heading to work today (I don’t normally take it) . When it reached a red light near the subway, I saw a telephone booth – akin to the one that you see on the right – draped in an Abilify ad. The ad is exactly what you see here. (If you can’t see it, go to Abilify.com and click on the “see our print adverisement!”)

I work near two major colleges with students who all have cell phones. Adults in the area are too busy thinking about their own problems while heading into the subway. (They, too, are likely to own cell phones.) Public telephones are rarely used anymore. So who’s going to read an ad on Abilify, let alone on a public telephone booth?

Some marketing person at Bristol-Myers Squibb probably thought it would be awesome to have an ad for Abilify near two major colleges. “All the college kids that walk by will see it!”

The readable text – from the bus, anyway – was “Treating bipolar disorder takes understanding.”

Understanding of what? Who’ll actually stand there and go, “Yeah, I need understanding” and walk right up to it to read more.

    • “where you’ve been
    • where you want to go
    • how you want to get there”

I’m ready to understand my history, my future, and the plans I should make. Uh-huh, Abilify will help me do that.

“Ask your doctor or health care professional if ABILIFY is right for you.” [emphasis mine]

The bus didn’t stay there long enough for me to see if they included the safety information, but here’s the gist of what they provide:

    • “Acute manic and mixed episodes associated with Bipolar I Disorder
    • Maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 6 weeks “

Someone can explain the last part to me a little better? I’m a mixed-episode case, do I qualify for Abilify?

I was under the impression that Abilify (aripiprazole) is an atypical antipsychotic. Antipsychotics should be prescribed for those who have psychosis. (I may be wrong here; I’m still trying to figure out the difference between typical and atypicals.) I don’t have psychosis. I don’t need Abilify. But the few bipolar people who will read that ad – they’re likely to be homeless – will be misled into thinking that they need Abilify to help them. They’ll go their doctors, saying, “I’ve heard Abilify helps people with bipolar disorder, could I perhaps try it?” PCPs will immediately churn out prescriptions and uneducated psychiatrists (yes, they are out there despite their degrees) will say, “Sure, Abilify works for bipolar disorder. Let’s see if it works for you.” The smart psych would say, “I’m not sure if it would be right for you. It’s an atypical antipsychotic that targets Bipolar I patients who have symptoms of psychosis. Let’s try something else instead.”

So I went on my soapbox. Again. But it angers me to see:

    • An Abilify ad on a phone booth. Period.
    • A misleading advertisement geared to all people with bipolar disorder (it doesn’t specify until you get to the fine print) that says, “Try this; it may work for you.”
    • An advertisement for medication. At all.

What’s next? A marketing blitz by Eli Lilly? “Zyprexa doesn’t cause diabetes! Check out zyprexafacts.com for more information!”

Big Pharma never fails to surprise me.

Loose Screws Mental Health News

According to a press release (I’m well aware what I’m saying), a recent study possibly shows that schizophrenia’s physical effects are more widespread in the body; researchers previously theorized that schizophrenia was limited to the central nervous system.

“The findings could lead to better diagnostic testing for the disease and could help explain why those afflicted with it are more prone to type II diabetes, cardiovascular diseases, and other chronic health problems.”

Apparently, those who suffer from schizophrenia have abnormal proteins in the liver and red blood cells. While schizophrenia’s most visible effects are psychological, researchers have noted that schizophrenics are at a higher risk for “chronic diseases.” The genetic and physical implications of such a study could prove interesting, especially for those suffering from and at risk for schizophrenia. Also in schizophrenia news, researchers have noticed an “excessive startle response.” The startle response, known as prepulse inhibition (PPI), is being considered as a biomarker for the illness.

Something Furious Seasons might like to argue if he hasn’t taken the following on:

“Lastly, but quite importantly, atypical antipsychotic were found to be more effective than typical antipsychotics in improving PPI, thus ‘normalizing’ the startle response. This led the authors to note:

‘Because an overwhelming number of patients with schizophrenia are currently treated with atypical APs, it is possible that PPI deficits in this population are a vanishing biomarker.”

What’s the advantage with atypicals vs. typicals? How do they work differently? *sigh* I need a pharmaceutical-specific wikipedia.

Schizophrenia News previously wrote about how proof is lacking in schizophrenia developing in those who have suffered from child abuse. (Excuse me for the awful construction of that sentence.) However, a new study shows that those at a high risk for schizophrenia benefit from having a good relationship with their parents during childhood. Read more.

Editor and Publisher has noted that suicides among Army soldiers doubled in 2005 compared to 2004.

Read the rest of this entry »

"Quetiapine comes from the root word 'quiet'"

[UPDATE: I had some funky issues with my table. It should be fixed now. Sorry about that.]

The first time I visited my psychiatrist for my initial evaluation, he gave me the option of choosing one of three medications: Seroquel, Lithium, or Lamictal. He handed me information about Seroquel and Lamictal. I did some research on both meds (lithium was out of the question because I don’t have time to get my blood checked constantly) and Lamictal sounded like a way better deal than Seroquel. I found mental health blog Furious Seasons (probably via The Trouble With Spikol) and read numerous posts on Seroquel’s adverse effects and all the good stuff AstraZeneca doesn’t tell anyone. From Philip Dawdy’s “Seroquel, The Bipolar Pill?” post, here’s what stood out to me:

“He told her that he didn’t think Seroquel worked benignly for patients and that the increased blood-sugar levels and cholesterol levels associated with its use were unacceptable to him. She broke out a recent paper which claimed that there were no metabolic syndrome problems with Seroquel.”

The post got me thinking. One of the materials I received from my psychiatrist was an article on how Seroquel seems to help the depressive part of bipolar disorder. He had a stack of these articles. My guess is not that he’s an overzealous reader of various newspapers but received the glowing article from – you got it! – a pharma rep. The article was taken from the August 2005 issue of Clinical Psychiatry News. (NOTE: I received the article in November 2006.)

Clinical Psychiatry News’ publication goals:

“Clinical Psychiatry News is an independent newspaper that provides the practicing psychiatrist with timely and relevant news and commentary about clinical developments in the field and about the impact of health care policy on the specialty and the physician’s practice.”

Good thing they didn’t say objectively.

I don’t know much about ClinPsych’s reputation and whether they are generally a good paper that reports things objectively. However, the article, “Atypical Quetiapine Appears Effective for Bipolar Depression,” reads like a press release. I’m not happy about receiving (practically) PR material from my doctor when trying to make an unbiased decision.

The article’s lede:

“The atypical antipsychotic quetiapine led to significantly greater reductions in bipolar depression than did placebo within the first week of treatment and throughout an 8-week randomized, controlled study of 511 patients, Andrew J. Cutler, M.D., said.”

Dr. Andrew CutlerDr. Cutler? Who IS Dr. Cutler? No research necessary; look no further than the article itself:

“The differences between the placebo group and each quetiapine group were significant at each weekly assessment, said Dr. Cutler of the University of South Florida, Tampa. He is a speaker and consultant for, and has received research grants from, the company that makes quetiapine: AstraZeneca.”

At least they disclosed his financial affiliations.

It is also worth noting that Dr. Cutler also founded a clinical research company, CORE Research, which runs many of the clinical trials that he’s involved in. CORE Research’s background details:

“CORE Research, Inc. is a private research company with three offices in the Central Florida area. CORE specializes in pharmaceutical research and psychopharmacology for mental illnesses such as Bipolar Disorder, Depression, Anxiety, Schizophrenia, Attention Deficit Disorder, and Insomnia.”

Private + Pharmaceutical research + Psychopharmacology = Funding from Big Pharma Companies

I sound like I’m touting some grand conspiracy theory. (OK, maybe I am.) CORE’s background bio makes the company sound objective and unaffiliated, which isn’t the case. If Dr. Cutler has “received research grants from” not only AstraZeneca, but other companies, it’s in his best interest to make sure that their pharmaceutical products turn out OK. Namely in the interest of AZ – remember: he’s a consultant for them.

How can I expect to make a decision about which medication to take (remember it’s between Lamictal and Seroquel now) based on promotional materials from pharm companies and – oh – an article touting the benefits of Seroquel with quotes only from the study’s lead author who is paid to say good things about the company’s products?

I didn’t.

Then how did I decide on Lamictal over Seroquel? Wikipedia‘s outline of each medication’s side effects, of course, in addition to other materials. (Don’t EVER overlook the Patient Safety Information of any medication. Unless you’re reading about the molecular structure – ignore that.)

Lamictal (lamotrigine) side effects Seroquel (quetiapine) side effects
Headaches Sedation
Insomnia Agitation
Insomnia Constipation
Major weight loss Memory problems (i.e. anterograde amnesia)
Blurred/double vision Headaches
Muscle aches Abnormal liver tests
Lack of coordination Dizziness
Sleepiness Upset stomach
Nausea Substantial weight gain
Vomiting Stuffy nose feeling
Rash (Stevens-Johnson syndrome) [uncommon in adults] Neuroleptic malignant syndrome [rare]
Binds to melanin-containing tissues (i.e. iris of the eye) Tardive dyskinesia [rare]
Diabetes [unclear]
Cataracts [possible]

Not that Lamictal’s side effects looked like a walk in the park, but considering that I’d already had awful trouble with weight gain on Paxil and Lexapro – nearly 50 lbs. – Seroquel was a serious no-go on my part. That and I don’t mind major weight loss from Lamictal. (Although I have been told Lamictal has no effect on weight.) Below is a copy of the article I received from my psychiatrist or you can just go and read the archived full text at Clinical Psychiatry News.

Quetiapine article