Pristiq (desvenlafaxine) information

Here’s a list of compiled links providing information on Pristiq. These links include info from my blog and others.

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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.)

Pristiq's side effects: Too close to Premarin and Prempro for comfort?

Back in January 2007, I’d mentioned that Wyeth was not only seeking to market Pristiq (desvenlafaxine) for depression but also for the use of vasomotor symptoms in menopausal women.

I just learned that Wyeth produces two major menopause drugs, Premarin and Prempro, that allegedly has produced hormones causing cancer in more than 5,000 women. This added up to a loss of 40 million users and $1 billion annually.

With Effexor going generic in 2 years and the introduction of Pristiq to the market, Wyeth hopes to lure some of those customers back and net an annual $2 billion. However, serious questions linger about Pristiq’s side effects in menopausal women.

Why did two women in the study group taking Pristiq have heart attacks
and three need procedures to repair clogged arteries compared with none
taking placebo? How can Wyeth assure long term safety when 604 of the
2,158 test subjects took Pristiq for only six months and 318 for a year
or more? And what about serious liver complications seen in the studies?

Martha Rosenberg, reporting on Pristiq’s use as a menopausal drug, culled comments from CafePharma’s message boards and found one thread rife with mixed comments on the new drug. From an Anonymous commenter:

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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. 🙂

Women & Antidepressants

Pink, a magazine for business women, has an article in its April/May 2007 issue titled, “The Magic Pill.” (The only way to read this article is to get a hard-copy of the mag.) No, this isn’t about birth control. The subhead: “Antidepressants are now used for everything from migraines to menopause. But are women getting an overdose?”

Good question. The article, well-written by Mary Anne Dunkin, does a nice job of trying to present both sides of the coin. One subject, Pam Gilchrist, takes tricyclic antidepressants to relieve her fibromyalgia symptoms. “One of the [antidepressants] that allows her to keep going” is Effexor (venlafaxine). God forbid the woman should ever have to come off of that one. (It works well when you’re on it, but withdrawal is sheer hell.)

The other subject mentioned in the article, Billie Wickstrom, suffers from bipolar disorder, but had a therapist who diagnosed her with obsessive-compulsive disorder. The psychiatrist she was referred to promptly put her on Anafranil (clomipramine). We all know what antidepressants tend to do for those with bipolar disorder. Wickstrom blanked out at an interview that she says she normally would have aced. In another incident, she veered off-course after leaving town and spent the night on the side of the road with her daughter. “Search parties in three states” were out looking for them.

“Three years and three hospitalizations later, Wickstrom is finally free of clomipramine and has a job she loves as PR director for a $300 million family of companies. She says she’s happy, she’s focused and she feels great – consistently.”

Dunkin’s article uncovers a large, problematic use – by my standards, anyway – of off-label usage by doctors.

“Gilchrist… is one of the estimated one in 10 American women taking some type of antidepressant medication. And a considerable percentage of these prescriptions, particularly those for tricyclic antidepressants, are not used to treat depression at all.

A growing number of doctors today prescribe antidepressants for a wide range of problems, including anxiety, chronic pain, insomnia, migraines, high blood pressure, irritable bowel syndrome, premenstrual syndrome, menopausal hot flashes and smoking cessation.”

I’m sure the list goes on, but magazines have but oh so much space.

Melissa McNeilDr. Melissa McNeil at the University of Pittsburgh points out three things:

  1. Since depression is a prevalent (see common) condition, doctors are better detecting it.
  2. Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
  3. Clinical studies are finding that antidepressants can aid a number of medical issues apart from depression.

My take on McNeil’s points (I’ll try to keep them brief):

  • Depression is way too common to be abnormal. If a woman has a rough patch in life for 2 weeks or more, she’s got depression. As for doctors being better at detecting depression? Studies consistently show that doctors are great at overlooking depression in men.
  • Antidepressants haven’t proven jack squat. Placebos have proven more safety and efficacy than antidepressants. PCPs have no reservations prescribing them because they only know about the positive facts that pharma reps tell them instead of researching the potential side effects.
  • Clinical studies aren’t finding all those things out. Seroquel has FDA-approval to treat psychiatric symptoms (psychosis, for one). As far as I know, Seroquel is not FDA-approved to treat insomnia or crappy sleeping patterns. There are no specific clinical studies to see if Seroquel can treat insomnia. Seroquel is prescribed to treat insomnia/restless sleep because doctors have found that a major side effect of the drug is somnolence. If this is the case, Effexor should be prescribed for weight loss. It’d be the new Fen-Phen.

Dunkin cites two widely used antidepressants for nonpsychiatric uses: Wellbutrin (bupropion) and Prozac (fluoxetine). Zyban, used for smoking cessation is, well, bupropion. Sarafem, used to treat PMS symptoms is – you guessed it – fluoxetine.

Viktor BouquetteDr. Viktor Bouquette of Progressive Medical Group thankfully takes a more cautious approach:

“The widespread use – mostly misuse – by physicians of antidepressants to treat women for far-ranging symptoms from insomnia, chronic fatigue and irritability to PMS and menopause is merely another unfortunate example of the pharmaceutical industry’s tremendous influence on the practice of modern medicine. Take enough antidepressants and you may likely still have the symptoms, but you won’t care.”

Kudos to Dunkin for landing that quote. Since Bouquette is part of an alternative medicine group, he’s got a good motive for slamming pharma companies.

McNeil goes on to sound anti-d happy in the article. Not that it matters, but she is also a section editor for the Journal of Women’s Health, which has several corporate associates representing pharmaceutical companies. (She is also the only source in the article who sings anti-d’s praises.) Dunkin tracked down Dr. Scott Haltzman, a clinical professor at the Brown University Department of Psychiatry, who advocated patient responsibility.

“Just because antidepressants work for depression does not mean they should always be used. People need to learn skills to manage their depressive symptoms instead of depending on medication. When you take medicine for every complaint, you lose the opportunity to learn how to regulate your mood on your own.”

Oh, for more doctors like Haltzman and Bouquette.

UPDATE: Uh, alleged fraud suit pending against Progressive Medical Group. Bouquette is now part of Progressive Medical Centers of America.

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.

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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