Invega has now come out with a different formulation: the sustained release. Apparently, this is the first atypical to be approved for the once-monthly injection formulation, though there are other neuroleptics used in this fashion. Personally, I’d love a once-monthly instead of the everyday pill. Bring it, yo evildoers at AstraZeneca! I’m ready for my Seroquel shot!

Or maybe not. A new Lancet study says older antipsychotics, like clozapine, are safer over the long term than Seroquel, Zyprexa and Risperdal. From the L.A. Times health blog:

Researchers in Finland, where clozapine is still widely prescribed for schizophrenia patients, found that users of the drug were less likely to die than those who took any one of three other second-generation (also called “atypical”) antipsychotics — Seroquel, Risperdal and Zyprexa — or those who took the first generation schizophrenia medication pherphenazine (once marketed as Trilafon).

…

Sufferers of schizophrenia have long been known to die earlier than the general population, markedly more often by suicide and by complications of diabetes. They are far more likely to engage in behaviors that lead to earlier death as well, including tobacco use, substance abuse and sedentary lifestyles. The Lancet article found that a schizophrenia patient who took any of the studied medications for seven to 11 years was less likely to die prematurely. And the longer she took it, the less likely she was to die an early death.

American physicians have largely abandoned Clozaril, which has been on the U.S. market since 1989, in favor of Zyprexa, Seroquel, Risperdal and Abilify — all newer drugs that have been aggressively marketed to doctors and patients as safer and more effective than the first-generation of antipsychotic drugs, including pherphenazine and haliperidol (better known by its commercial name, Haldol).

Meanwhile, the numbers of people being prescribed these powerful psychiatric drugs have skyrocketed. In 2008, 50 million prescriptions for antipsychotic drugs — overwhelmingly the newer ones — were filled.

First, be an informed consumer. Just like with a car or washing machine you can learn about medications and other treatments for mental health problems. Turn to websites like your state mental health agency or the National Institute for Mental Health, the National Mental Health Association and the National Alliance for Mental Illness. Google key words about what you want to know, as you would for breast or prostate cancer, diabetes, and heart disease. Ask others who have successfully navigated the mental health care system and taken medications. As has been said, caveat emptor — let the buyer beware — and be prepared.

Second, ask questions of your doctor and other health professionals. Rather than being a marketing arm of the pharmaceutical companies, be a prudent buyer. Don’t be shy — you are your best advocate. When you visit your doctor ask two questions: why are you suggesting this treatment for me and what alternatives do I have? When in doubt get a second opinion: any doctor who does not welcome a second opinion is not worth keeping.

Finally, recognize that medications for mental disorders often help but generally are not sufficient. Great reliance on medications has fostered inattention to individual and family therapy and skill building programs.

Emphases mine. For the rest of the article, click here.

Randall Robbins II, who pleaded guilty to second-degree murder in the 2002 strangulation of 17-year-old Brittany Eurek, argues that both Pfizer and his doctor should have known that Zoloft might have made him attempt suicide and commit murder.

He says the drug intensified his agitation, suicidal desires, hysterical behavior and hostility and diminished his self-control.

Those arguments are similar to claims made in a few other cases since 2004, when antidepressants gained new warning labels highlighting the risk of suicidal behavior in people under 18.

In 2007, the South Carolina Supreme Court upheld the conviction of Christopher Pittman, who is serving a 30-year sentence for killing his grandparents when he was 12. The court rejected his argument that he was involuntarily intoxicated by taking Zoloft and didn’t know what he was doing when he killed his grandparents and burned down their home in 2001.

A year earlier, the North Dakota Supreme Court affirmed the conviction of a man who killed a 19-year-old woman with a shotgun and later tried to blame the 2003 slaying on the antidepressant drug. Zachary Schmidkunz is serving a 35-year prison term.

What puzzles, somewhat, is the conflicting behavior of Pfizer, though their continuing legal victories do justify it. On the one hand, there is the black-box warning, which specifically concedes that this kind of reaction to the drug is possible. On the other hand, there’s the response to a case like Robbins’:

“Pfizer’s evaluation of Zoloft data never has revealed any signal of an increased risk of violence related to either use or discontinuation of use of Zoloft,” [spokesman Chris] Loder said.

The FDA also says the underlying mental illnesses that antidepressants are used to treat are the most important causes of suicidal thoughts and actions.

So is that tantamount to Pfizer saying they don’t believe their own warning? Robbins, who’s in prison for the murder, is now suing Pfizer for $1 million and serving as his own lawyer. (Isn’t that always a bad idea?) Go here for more.

We’ll all miss Steven so much, and I’ll say more about that later. For now, I’m wishing the best to all family and friends who are hurting. That’s what Steven really cared about in the end, though he was very passionately annoyed by knitting, as well.

Steven was often told he was anti-American. I loved his passion, and he cracked us the fuck up every day. This video was part of a series he did for PW called Steven Wells’ America, in which he took sacred cows and basically grilled them for dinner. Below, he reflects on the religiosity of an America that voted for Bush a second time (Steven was a staunch atheist). Toward the end he smiles a bit, so you know that he knows he’s being ridiculous. And that’s part of what was so cute about Steven — he’d rant, but then laugh at himself.

Ironically, Behrman used to be a spokesperson for Bristol-Myers Squibb, the maker of Abilify — which sort of mirrors my own experience as former (unpaid) speaker for Astra Zeneca about Seroquel. The Wall Street Journal has an article, “A Celebrity Patient’s Backing Turns Sour,” about Andy. It begins:

Bristol-Myers Squibb Co. has worked with hundreds of patients in its promotional efforts. The drug maker says every collaboration, except for one, has been positive for both Bristol-Myers and the patients who tell their stories.

Andy Behrman is the one.

In 2004, Bristol-Myers held a retreat for 1,250 sales representatives, to prepare them to market a powerful psychiatric drug for a new use — bipolar disorder.

A video of Mr. Behrman, a 42-year-old bipolar patient, filled a gigantic screen. He recounted how a Bristol-Myers drug, called Abilify, had changed his life. Unlike other medicines he had tried, Abilify had no …

And today Andy sent out an email:
 

Dear Friends,
 
Three years ago, after working as a spokesman for Abilify, a hugely profitable drug manufactured by Bristol Myers Squibb, I published an online article about the drug’s terrible side effects. I said it was the worst drug that I had ever been prescribed and that it had nearly killed me.  
Within twenty minutes of the article being posted on a website owned by the New York Times, the article came down. Turns out, BMS was a sponsor of the website.
 
Today I am preparing to sell a new book, Adventures in the Drug Trade, which details my nightmarish experience with Abilify, my treatment by Dr. Mark Frye, a former UCLA psychopharmacologist now at the Mayo Clinic and curiously no longer a medical consultant for BMS, and my experiences as a pusher of their not-so-wondrous wonder drug.  
 
I believe that BMS will go to almost any lengths to stop me and the publication of the book. It’s time to hold drug makers like BMS accountable for their corrupt practices and harmful products. Just as culpable, if not more so, are the licensed physicians that aid and abet them. Do no harm?  I don’t think so.
 
… 

The sad reality is that the drug companies won’t tell you the truth about the side effects of their drugs and for that matter, neither will your doctor.  Did you know that pharmaceutical companies actually send some of these doctors on an all-expense-paid ten-day Caribbean cruises just for “writing prescriptions?”

I suspect a lot of people who read this blog do know that, but now Behrman knows it too — and so will a lot of mainstream readers if he gets his book published.

The only thing I want to say here, aside from wishing Andy good luck with his fight, is that I wouldn’t want to tar all doctors with the same brush. My psychiatrist does tell me the truth and he refuses to take any Big Pharma compensation. He is very clear about his policies in that regard up front. Many of his colleagues are the same. They have integrity and passion for their patients and want to advocate for them.

I’d also like to point out that if you take a new medication and you’re concerned that your doctor is not being frank with you, do your homework. It is easy in the Internet age to find information about side effects. If you don’t have access to a computer, ask your pharmacist to give you the package insert for the medication. It clearly lists the possible side effects, along with statistical probability. If you feel such stats aren’t credible due to the source, you can be sure that at the very least the side effects listed are ones that people did experience.

Be careful out there, folks. Big Pharma — just like Big Oil or Big Tobacco or Big Anything — doesn’t give a shit about you.

This is why it’s better to do the right thing — because your body (told by your brain, of course) feels good. Here’s what I mean: Without getting into too much detail, an opportunity came my way to be part of a documentary. It would have been fun, and probably good for my career, whatever that means. But then I found out the funding for the doc would be coming from Astra Zeneca, with a sponsored by Seroquel button or something Though the producers swore up and down that the funding had nothing to do with content, I said I couldn’t do it if AZ or Seroquel were involved.

The funny thing is that as soon as I sent that email, my entire body relaxed and I felt elated, briefly. I just knew I was doing the right thing by turning down the opportunity, despite the fact that I very much respect the makers of the documentary and I would’ve enjoyed doing it.

I just felt like I can’t be part of an effort that promotes Seroquel — funny, I know, coming from someone who A. relies on the drug, and B. used to speak for AZ on just that topic. But times — and Big Pharma — sure do change, don’t they?

Grassley Probes Financing of Advocacy Group for Mental Health

For some reason that line comes to me sometimes, in childish I-told-you-so situations. So when I read the AP article titled: “Panel: Seroquel not 1st choice for depression,” I thought of that line. If Philip Dawdy saw the movie, he probably thought of that line too.

Of course Seroquel doesn’t work for depression. It’s an antipsychotic, people. It was created to treat schizophrenia, which — despite Big Pharma’s craven desires — IS NOT THE SAME AS DEPRESSION.

Here are some relevant tidbits, including some deliciousness about Seroquel causing diabetes. I went a little crazy with the bolds:

WASHINGTON (AP) — Federal health experts said overwhelmingly Wednesday that the side effects of AstraZeneca’s schizophrenia drug Seroquel are too worrisome to make it a first choice against depression.

However, the panel of Food and Drug Administration advisers also said the drug could be useful as a supplemental therapy for patients who are not finding relief with other antidepressant drugs.

Seroquel, which posted sales of $4.5 billion last year, is already approved to treat schizophrenia and bipolar disorder. Now the London-based drugmaker wants the FDA to approve it for patients with depression and anxiety disorder, a much larger population that includes more than 20 million U.S. patients.

But FDA regulators expressed concerns about allowing nearly 10 percent of the U.S. population to use a drug with side effects including weight gain, high blood sugar and potential heart problems.

Panelists voted unanimously that the drug was not safe enough for use as a first choice, stand-alone treatment of depression and anxiety disorder, given older, more established drugs.

“I saw no clear advantage demonstrated in efficacy,” said Dr. Wayne Goodman, an NIH researcher who chaired the panel. “There were side effects, and I would expect unintended consequences associated with wide-scale use of the drug.”

FDA is not required to follow the advice of its panels, though it usually does.

Seroquel is part of a new generation of psychiatric medications, called atypical antipsychotics, thought to be safer than older medications. But a paper published in the New England Journal of Medicine earlier this year found that patients taking newer medications have the same likelihood of dying of a sudden heart problem. The study from researchers at the Vanderbilt University found there were about three deaths per year for every 1,000 patients taking older or newer antipsychotics.

“Our study provides evidence that this drug may produce a side effect that is of extreme concern to patients,” said Vanderbilt’s Dr. Wayne Ray, who was invited by the FDA to present his findings.

Many physicians already prescribe Seroquel and other antipsychotic medications to manage depression and anxiety. But FDA approval would allow AstraZeneca to market its powerful antipsychotic for those uses.

The company said there is a significant need for new depression treatments, pointing out that the disease returns in a third of patients treated with existing antidepressants. Many patients stop using the drugs due to side effects like insomnia, sweating and decreased sex drive.

Largely absent from the panel’s discussion was the ongoing debate about Seroquel’s possible role in contributing to diabetes, a controversy that has generated thousands of lawsuits against AstraZeneca in recent years.

However, more than a dozen members of the public — including spouses of patients who died while taking the drug — called on the FDA panel to deny approval of Seroquel for depression, with many citing its metabolic side effects.

“It is your job to keep Seroquel off the market for this expanded use unless the company can conclusively prove that it does not increase the risk of diabetes,” said Dr. Diana Zuckerman of the National Research Center for Women and Families.

Lawyers representing some 15,000 former Seroquel users claim AstraZeneca knew nearly a decade ago that the drug caused diabetes, but kept that information secret.

A brief released by the plaintiffs attorneys Wednesday morning claims that internal AstraZeneca memos and data show Seroquel is both risky and not very effective.

One study showed Seroquel was not effective against depression but a comparator drug was. Several other studies of Seroquel failed to prove that depression symptoms stopped or waned significantly by six weeks, according to the brief.

“The bipolar child is purely an American phenomenon”: An interview with Philip Dawdy

Dawdy’s got an interesting post over at Furious Seasons critiquing the FDA’s recent approval process vis-a-vis the use of Lexapro in kids 12-17. He explains his opposition to the use of the med in teens quite clearly; the only thing I would quibble with is the assumption that withdrawal is the same in every case.

Many people who come off of Paxil, Effexor or Lexapro don’t get brain zaps, particularly if the withdrawal is done slowly. People lose patience with the tapering process and want to go faster, and sometimes do so to their detriment. At any rate, we shouldn’t assume that everyone who takes the meds has the same responses.

However, there’s a serious question here, in my opinion, about the safety and efficacy of initiating treatment with Lexapro to begin with. As Dawdy points out, the evidence is slim that it works in teens, and the brain is still developing at that age. Many people I know who grew up on meds are all fucked up, both in terms of their sense of self and their brain chemistry. They’ve been habituated to medications too early.

Go to Furious Seasons for more.

But whatever your fears, there may be some good news: Some non-addictive, non SSRI anticonvulsants may be useful in treating GAD — at least according to a new article in Psychiatric Times.

The rationale for the use of anticonvulsants in anxiety disorders is supported by neurobiological underpinnings that make these compounds a likely alternative for short-term treatment in patients who do not respond to benzodiazepines or who have a contraindication (an addiction disorder, respiratory problems, or who are at risk for falls). However, data are limited, and current criteria for levels of evidence and lines of treatment recommendations suggest strong evidence only for pregabalin in patients with GAD with or without comorbidity (Table 2).

Pregabalin and gabapentin have been shown to be promising in social phobia. Data about gabapentin in panic disorder are somewhat mixed; they suggest a possible role only in patients who are moderately to severely affected. In any case, these compounds must still be considered second- or even third-line treatment.

Further studies are needed on the neu­robiology of anxiety disorders and neuropharmacology of anticonvulsant drugs to develop pharmacological treatment strategies that target symptom patterns and patients’ needs.

The author of the study is Marco Mula, MD, PhD, a research associate and consultant in neurology and neuropsychiatry in the department of clinical and experimental medicine, section of neurology, The Neuro­psy­chi­atry Research Group at the Amedeo Avogadro University in Novara, Italy. At the top of the piece, it says, “Although he received no financial support for the prepa­ration of this article, Dr Mula reports that through the years he has received travel support and speakers fees from various pharmaceutical companies who are involved in the manufacture of antiepilectic drugs, in­cluding Novartis, Pfizer, UCB-Pharma, Janssen-Cilag, and Sanofi-Aventis.” You can decide for yourself if that disqualifies him for offering objective evidence. I take no position one way or the other.

Can Anticonvulsants Help Patients With Anxiety Disorders?

AstraZeneca, maker of the blockbuster anti­psychotic Seroquel, is battling to keep information about the drug out of the public’s view … for the public’s own good.

This month in Orlando, lawyers for the drugmaker will argue that unsealing company documents, including unpublished clinical trial data and letters from the FDA, could harm “a vulnerable patient population.”

“This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional,” lawyers for the drugmaker said in a recent filing in federal court.

This is utter and complete bullshit. AstraZeneca is running scared from revelations that could turn them into another Eli Lilly, so they’re inventing this ridiculous excuse to pretend they’re protecting People Like Us from learning the truth about their meds. To be clear: That’s the premise here—that I’m so mentally unstable that I can’t handle the truth.

So better to keep me in the dark about the dangers of my medication, otherwise I might run out and shoot people or jump off a building or something.

I am outraged by this. The article, by Times staff writer Kris Hundley, breaks it down further and examines all the issues. It also says, “The company said it is aware that the U.S. Attorney’s Office in Philadelphia is investigating Seroquel’s marketing practices, most likely based on whistle blower complaints.” I’ll try to get more information on that if I can.

Seroquel maker wants to seal info from you, “for” you

NEW YORK (MarketWatch) — GlaxoSimthKline PLC could announce a near 6% reduction to its workforce as it cuts costs in the wake of greater generic-drug competition and fewer new products, according to London’s Sunday Telegraph on Sunday. The British pharmaceutical giant is expected to announce the 6,000 job cuts on Thursday when it reports its fourth-quarter results, the newspaper said on its website. Rival AstraZeneca said last week it would cut 15,000 jobs by 2013. U.S. traded hares of GlaxoSmithKline closed Friday at $35.26, up 1.4%.

Not just bad for people losing their jobs, but also bad for the future of drug development: The industry will be even more desperate to create new and wholly unnecessary products.

For those who don’t know, metabolic syndrome is the name for the shitstorm of physical ailments that come from long-term use of antipsychotics. Well, that’s not exactly right. Let me quote a real authority, the American Heart Assn.:

The metabolic syndrome is characterized by a group of metabolic risk factors in one person. They include:

* Abdominal obesity (excessive fat tissue in and around the abdomen)
* Atherogenic dyslipidemia (blood fat disorders — high triglycerides, low HDL cholesterol and high LDL cholesterol — that foster plaque buildups in artery walls)
* Elevated blood pressure
* Insulin resistance or glucose intolerance (the body can’t properly use insulin or blood sugar)
* Prothrombotic state (e.g., high fibrinogen or plasminogen activator inhibitor–1 in the blood)
* Proinflammatory state (e.g., elevated C-reactive protein in the blood)

People with the metabolic syndrome are at increased risk of coronary heart disease and other diseases related to plaque buildups in artery walls (e.g., stroke and peripheral vascular disease) and type 2 diabetes.

So yes, it’s not just from psychotropics, but people with severe mental illnesses who take atypicals for more than 10 years are in an extremely high risk group. I’ve seen it too many times to count, and that doesn’t even begin to take into account what happens to a person psychologically when they’re not only overweight, but unable to be active in order to lose that weight.

Today Joe sent me this:

Metabolic monitoring in patients prescribed antipsychotics abysmal

Abysmal. That’s a serious word. From the piece:

Among insured patients newly prescribed second-generation antipsychotics, monitoring of blood glucose and lipid levels falls far short of 2004 American Diabetes Association (ADA) guidelines, researchers report [1].

The guidelines are based on substantial evidence that these drugs can increase risk for cardiovascular disease by affecting lipid and glucose metabolism and body weight.

However, this study showed that by 2006, just over 10% of patients newly prescribed second-generation antipsychotics received lipid monitoring and just over 20% received glucose monitoring.

“These numbers are unacceptably low, given that the ideal level of monitoring should be 100%,” lead author Dr Dan W Haupt (Washington University School of Medicine, St Louis, MO) said.

Joe suggests the following announcement:

Dear Psychiatrist,

You may not be aware that claims that SGAs are safer and more effective then FGAs turned out to be horse hooey. If not, you may have noticed that some of your patients just don’t come around anymore and when you attempt to call them threatening injectables to guarantee medication compliance, you find their phones are no longer in service. Well some of these folks are never coming back …. if you get what I mean. It may have something to do with Metabolic Syndrome.

First, it wasn’t your fault. Heck, you were just relying on what a pharma rep told you over the lunch brought from Panera. (Isn’t their Tomato & Mozzarella on Ciabatta Panini just great?)

Second, its been years since you practiced real blood and guts hands-on medicine and you’ve forgotten pretty much everything you learned in medical school. Third and most importantly, you value your home and you don’t want to loose it if some mental health patient a/k/a consumer, client, self-advocate, constituent, recipient – or his or her bereaved family has the audacity to sue you big time for malpractice.

So here is the skinny on Metabolic Syndrome:

Tools required to monitor for Metabolic Syndrome:
1. Blood collection set and syringe.
2. Tape measure.
3. Blood pressure cuff and stethoscope or an electronic device which does BP’s.

Skills required:
1. Ability to draw blood and and use a phone to call a lab for pick-up.
2. Ability to place a tape measure around patient’s waist and read circumference.
3. Ability to use blood pressure cuff and stethoscope or operate electronic BP device.

Alternative Procedure:
1. Grasp the same prescription pad and pen used to prescribe SGAs. (C’mon, you own a least 100 pharmaceutical labeled pens.)
2. Take pen and order the following – blood work, BP, waist circumference.
3. Direct patient to a local clinic.

Psychiatrists should be aware that their reliance on the alternative procedure is likely to cause some chuckles at the clinic, “And psychiatrists call themselves doctors,” but if our patients can stand a lot of humiliation we can certainly stand a little for the sake of our homes.

For the post, go here.

At any rate, it seems Singulair has been under suspicion of causing suicidal ideation and impulses, but Merck’s top-selling drug has—at least in this regard—been given a clean bill of health. From Bloomberg.com:

Merck & Co.’s asthma medicine Singulair and related treatments weren’t associated with an increased risk of suicide or suicidal urges, U.S. regulators said after a review of clinical trials. …

Merck reported in 2007 that it has seen an unusual number of reports of suicidal behavior in Singulair users. Those cases weren’t enough to prove a definitive link and were based of voluntary reports from patients and doctors, Merck said. …

The FDA reviewed 41 Merck-funded studies involving 17,709 patients who received Singulair or a placebo. Of those patients, one person taking Singulair had a suicidal thought compared with none on placebo. No suicides were reported in either group.

Yet the FDA is still analyzing the drug for other side effects and says doctors need to monitor patients who are taking it. So did this drug have an impact on my psychological symptoms? I don’t know; I guess I’ll never know, in fact. But it would have been nice to understand at the time what the implications were for a person with psychiatric illness. Or hell, maybe I was misdiagnosed, and I really just have Singulairitis!

Merck’s Singulair Not Associated With Suicide Risk (Update2)