…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.

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Study shows atypical antipsychotics pose a higher risk for cardiac arrest

The New York Times has reported that a recent study found atypical antipsychotics, which include the friendly family of Clozaril, Abilify, Risperdal, Zyprexa, and Seroquel (maybe Saphris soon), can increase a patient’s risk of dying from cardiac arrest twofold.

The study published in The New England Journal of Medicine also concluded that the risk of death from the psychotropic medications isn’t high. However, an editorial also published in the same issue “urged doctors to limit their prescribing of antipsychotic drugs, especially to children and elderly patients, who can be highly susceptible to the drugs’ side effects.”

A U.S. News & World Report article linked to the FDA’s atypical antipsychotics page for further patient information. If you’re on an atypical, I’d recommend reading each word in the patient safety info that applies to you. Proofreaders like me shouldn’t be the only ones tortured with reading all the fine print. *winks*

PharmaGossip tackles antipsychotics meds

Nice post by PharmaGossip on antipsychotics:

"Some newer antipsychotic medications approved to treat schizophrenia and bipolar disorder are being prescribed to millions of Americans for depression, dementia, and other psychiatric disorders without strong evidence that such off-label uses are effective, according to a new analysis by the Department of Health & Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ)." [emphasis kinda mine]

The rest of the post is quite informative. Head on over there to read more.

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 »

Keep an eye out for schizo/psychosis drug bifeprunox

Someone get this on Furious Seasons’ radar:

Wyeth is also in development for an atypical antipsychotic, bifeprunox, for schizophrenia. Bifeprunox has no trade name yet.

“Bifeprunox, a dopamine partial agonist, is an investigational atypical antipsychotic for the treatment of schizophrenia. Clinical data were presented from safety and efficacy studies that evaluated bifeprunox for the treatment of schizophrenia in both acutely psychotic patients and patients who have stabilized disease.

While bifeprunox has been shown to have a smaller mean effect in acute psychosis when compared with older atypical antipsychotics that have some well-known side effects, it may be particularly well-suited for patients who are experiencing side effects with their current therapy. The safety data for bifeprunox have consistently shown a favorable weight and metabolic profile in both short- and long-term studies, which is a common and serious side effect that can cause patients to stop taking their medication.”

A few questions on Wyeth’s schizo drug:

  • How long before this is marketed to bipolar I’s with psychosis?
  • Older atypical antipsychotics or older typical antipsychotics?
  • I’d like to see the data on weight and metabolic profiles on this. Most APs don’t have a good track record with weight, i.e. Seroquel, Abilify, Zyprexa.

Bifeprunox will developing over the coming months and years. I’ll probably check out clinicaltrials.gov in the future to check on updates.

Drugging of the Bipolar Mind

From Philip Dawdy's article, "The Drugging of the American Mind," originally published in the Seattle Weekly:

"Classically, the disorder is treated with a mood stabilizer. Lithium was long the gold standard. In recent years, there has been a shift to anticonvulsants like Depakote or Lamictal. Often, bipolars are also given an antidepressant like Paxil or Effexor to deal with bouts of depression. Until 2000, the mood stabilizer plus antidepressant approach was essentially the state-of-the-art treatment. It just doesn't knock down symptoms forever.

Bipolars can "break through" these meds and wind up having acute episodes of rage or suicidal depression."

Wow. The article was published just over a year ago and it describes me to a T today. Well done, Mr. Dawdy, for seeing my future.

"This is an awkward time for mental- health experts, researchers, and advocates. This month, a peer-reviewed academic paper was published on the Public Library of Science Web site pointing out that researchers still have not proved the serotonin-imbalance-in-the-brain hypothesis of depression. What proof there is, the authors claim, is mostly circumstantial. Two weeks ago, The Wall Street Journal ran an article covering the same points in relation to antidepressants."

That was in November 2005. It's good to know that I'm not the only one that sees the neurotransmitter link to mental illness as merely a hypothesis and NOT fact. Many people don't know that at the bottom of each psych med Web site and in the important safety information sheet that comes with a psych med basically says, "We're not exactly sure how this works." Well, gee, thanks for allowing me to take a risk about something you're not even sure about!

Praise to Dawdy, amazing blogger for Furious Seaons,  for uncovering much of this information that most people in America don't want to cover or are too lazy to educate themselves about.