December 25, 2012 at 11:01 am (Antidepressants, Depression, Loose Screws Mental Health News, Mental Health/Illness, Military)
Tags: antidepressant, anxiety, Army, Depression, disabilities, Military, siblings, Suicide, teens
According to an article in USA Today, researchers have found that siblings who argue could have negative effects on their mental health.
Researchers report that conflicts about personal space and property, such as borrowing items without asking and hanging around when older siblings have friends over, are associated with increased anxiety and lower self-esteem in teens a year later. And fights over issues of fairness and equality, such as whose turn it is to do chores, are associated with later depression in teens.
I’d like to tell these siblings to get over it, but I don’t have any siblings of my own to relate my experience to.
PBS’s Frontline reports that most soldiers who commit suicide have never seen combat or even been deployed. According to the Defense Department, the Army has the sharpest rate of suicides of all the military branches. About 53 percent of military personnel who took their lives in 2011 had no history of deployment to active combat zones such as Iraq or Afghanistan. Even more troubling is that 85 percent of those who committed suicide may have been deployed but not involved in direct combat. Even though the military has invested $50 million to study mental health and suicide, a stigma of getting help still remains. It seems as though military personnel would rather take their own lives than seek help.
An antidepressant called GLYX-13, currently under study, appears to work within hours and last for up to a week. The lead researcher reports little to no side effects on the drug, which is injected intravenously. The drug is in phase 2, which means that its effectiveness and safety are still being tested. I have my doubts about an intravenous drug. If doctors are not currently testing patients’ serotonin levels, how would they be able to prescribe an intravenous antidepressant?
Depression has passed asthma as the top disability among North American (U.S. and Canadian) teens.
Asthma had been the largest contributor to YLDs (years lived with disabilities) for youths in that age range in the US and Canada in 1990, but the study published in The Lancet on Thursday led by researchers at the Institute of Health Metrics and Evaluation (IHME) at the University of Washington, Seattle showed that in this group depression surpassed asthma to claim the number one spot in 2010.
Back in the 1990s, depression was not widely regarded or evaluated among teens. It was still “suck it up” and “pull yourself up by your bootstraps.” My depression was viewed as laziness or “senioritis” among my teachers. I had no sympathy and very little leeway. Now, mental health is being taken more seriously for teens, and I think that’s a good thing.
See you if you can keep an elder person in mind during this holiday season. Senior depression is always on the rise during the holiday season due to problems with health, loneliness, or finances.
February 17, 2009 at 3:53 pm (Uncategorized)
Tags: antidepressant, drugs, medication, psych drugs, psych med, psych meds, psychotropics, rage, sertraline, violence, zoloft
I’ve received a lot of hits from people looking to find a connection between Zoloft and rage/violence/irritability. Here’s what I have so far:
February 17, 2009 at 3:07 pm (Uncategorized)
Tags: Adverse Effects, antidepressant, Antidepressants, Daniel Carlat, Depression, desvenlafaxine, drug, Effexor, Effexor XR, estrogen therapy, generic, hormone therapy, hormones, hot flashes, medication, meds, menopausal, menopause, off-label, off-label usage, Premarin, Prempro, Pristiq, psych drugs, psych meds, psychotropic, side effects, vasomotor, venlafaxine, Wyeth
Here’s a list of compiled links providing information on Pristiq. These links include info from my blog and others.
July 28, 2008 at 5:32 am (Adverse Effects, Antidepressants, Depression, Medicine/Meds, Pharma)
Tags: Adverse Effects, antidepressant, Antidepressants, Daniel Carlat, Depression, desvenlafaxine, drug, Effexor, Effexor XR, estrogen therapy, generic, hormone therapy, hormones, hot falshes, medication, meds, menopausal, menopause, off-label, off-label usage, Premarin, Prempro, Pristiq, psych drugs, psych meds, psychotropic, side effects, vasomotor, venlafaxine, Wyeth
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:
Read the rest of this entry »
May 29, 2008 at 1:24 pm (Antipsychotics, Bipolar Disorder, Depression, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: Adderall, Adderall XR, ADHD, antidepressant, big pharma, Daniel Carlat, Depression, desvenlafaxine, doctors, drugs, Effexor, FDA approval, health insurance, health insurers, Invega, J&J, Janssen, Johnson & Johnson, lisdexamfetamine, medication, meds, paliperidone, Pharma, pharma companies, pharmaceutical companies, pharmaceuticals, Pristiq, psych drugs, psych meds, Risperdal, Risperidone, Shire, The Carlat Psychiatry Report, venlafaxine, Vyvanse, Wyeth
As patents expire on a variety of drugmakers’ moneymakers, pharma companies have gone to great lengths to structurally reinvent the successful drugs then tout the benefits that differ from their predecessors.
Case in point — Johnson & Johnson’s Invega. Invega is the successor to the popular antipsychotic drug, Risperdal, and competitor to AstraZeneca’s widely used antipsychotic Seroquel. Scott Hensley at The Wall Street Journal’s Health Blog (WSJ) reports that Risperdal is going generic in June. Gianna at Beyond Meds recently said it will not. According to the Dow Jones Newswires (DJN), these “junior” drugs face skepticism from health insurers and doctors. California-based Kaiser Permanente and Minneapolis-based UnitedHealth Group Inc. (UNH) are example of companies that have somewhat discouraged use of the drug. Kaiser doesn’t cover Invega at all, and members of UNH are required to pay higher copays for the brand name. The wire reports New York-based psychiatrist Jeffrey Lieberman wasn’t “buying it” the difference between Invega and Risperdal.
Invega is “basically a me-too drug, and the company hasn’t done the studies that would be required to really distinguish it,” Lieberman, chairman of the psychiatry department at Columbia University’s medical school told Peter Loftus of Dow Jones Newswires.
The blog also quotes Daniel Carlat from the The Carlat Psychiatry Report.
Dan Carlat, a psychiatrist and a tough critic of Invega, wrote that J&J’s “marketing team apparently missed the fact that the word in the English language that sounds most like “Invega” is “inveigle,” meaning “to entice, lure, or ensnare by flattery or artful talk or inducements.’ ” He asked doctors: “Will you be doing your patients a favor by taking the plunge? Or will you simply be giving them the same wine in a fancier bottle?”
Even J&J’s Group Chairman of Pharmaceuticals, David Norton, admitted that Invega is a tough sell.
“We need to do a better job at drawing a differentiation in a difficult-to-treat population.”
So far, Invega sales have been incredibly disappointing compared to the Risperdal blockbuster.
Wyeth (antidepressant Effexor XR cum Pristiq) and Shire (ADHD drug Adderall XR cum Vyvanse) face the same uphill battle. Wyeth’s Effexor faces generic competition from Teva Pharmaceuticals despite efforts to halt generic sales of the drug and the patent on Shire’s Adderall is set to expire next year.
Hensley, in his analysis, raises a question in which the answer remains to be seen:
Cheap generics abound to treat a broad assortment of illnesses these days. What’s the point, the critics ask, of paying more for drugs that are at best only slight improvements over tried and true medicines available at bargain prices?
It’s something that I’ve questioned myself.
In an attempt to have the “me-too” drugs compete with its derivative, both Wyeth and Shire are slashing their prices, or as the DJN reported, “emphasizing improved dosing for the newer drugs.” Although Pristiq’s efficacy comes at higher doses, it’s being priced 20 percent lower than Effexor.
[Deutsche Bank pharmaceutical analyst Barbara Ryan] thinks the odds of
Pristiq’s success are slim because it appears to offer few benefits
beyond those of Effexor.
That remains to be seen. So far, a few patients have commented on my blog that Pristiq has already begun to help them. I haven’t seen any DTC ads for Pristiq so I can only assume that drug reps are doing a fine marketing job at selling the different benefits of the drug to doctors.
Vyvanse, on the other hand, is looking promising for Shire, already having 7 percent of U.S. ADHD drug prescriptions. Chief Executive Matthew Emmens says the drug is chemically different from Adderall (aren’t they all?) and has better pricing. Shire expects to beat Adderall’s 26 percent peak market share. Seems like a lofty goal to me.
As for Invega, J&J is currently seeking FDA approval to use the drug for bipolar disorder and not just treatment for schizophrenia. It is also l0oking to get approval for an injectable Invega XR.
(Invega logo from Janssen.com)
April 22, 2008 at 1:51 pm (Antidepressants, Medicine/Meds, Pharma)
Tags: American Home Products, antidepressant, AstraZeneca, CNN Money, cost, desvenlafaxine, discount, drug, drugs, Effexor, Effexor XR, Eli Lilly, Fluoxetine, heartburn drug, insurance, insurance companies, medication, meds, patients, Pfizer, Prilosec, Pristiq, profits, Protonix, Prozac, revenue, sertraline, SNRI, Sun Pharmaceuticals, Teva Pharmaceuticals, venlafaxine, Wall Street Journal, WSJ, Wyeth, zoloft
The Wall Street Journal reports that Wyeth, desperate to make money off of its Effexor XR-knockoff, Pristiq, says it will slash the antidepressant at a 20% discount compared to Effexor’s price. The price slash, CNN money reports, is a result of less-than-impressive clinical trial data on Pristiq’s “safety and effectiveness.”
Wyeth SVP Joe Mahady told analysts that Pristiq will sell for a flat $3.41 per tablet for both mid- and high-dose, Dow Jones Newswires’ Peter Loftus reports.
Wyeth, apparently, has done this in the past. Back when it was known as American Home Products, the company slashed its price on Protonix, its heartburn drug, to compete with AstraZeneca’s Prilosec. The drug generated $1.9 billion in profits for Wyeth last year. CNN Money reports that Teva Pharmaceuticals and Sun Pharmaceuticals began selling the generic version of the drug and handily cut into Wyeth’s profits: the company reported a 4.6% decline in profit and a 66% drop in sales for the drug for the first-quarter. What will happen with Pristiq remains to be seen. I’m not sure that doctors in 2010 will want to dole out prescriptions for Pristiq when they can save patients—and insurance companies—money by prescribing what will then be known as venlafaxine. WSJ also notes:
A month’s supply of sertraline (Pfizer’s old hit Zoloft) or fluoxetine (Lilly’s Prozac) goes for 50 cents a day at drugstore.com.
$3.41 or $0.50 per tablet. It wouldn’t surprise me if some insurance companies choose to exclude Pristiq from its list of covered drugs. Regardless, Wyeth expects sales of the drug to exceed $1 billion in its first year.
The drug will hit the shelves in May.
March 10, 2008 at 2:31 am (Antidepressants, Blogs, Medicine/Meds, Pharma)
Tags: antidepressant, approval, Depression, desvenlafaxine, drug, FDA, medication, menopause, Pharmalot, Pristiq, psych med, PsychCentral, vasomotor symptoms, Wyeth
I hate to brag, but…
February 28, 2007
Pristiq's FDA Chances: Depression – Yea; Menopause – Nay
It wouldn't surprise me if they said yea to antidepressant use and nay to vasomotor use because of lack of evidence in improved symptoms.
April 19, 2007
Wyeth looking for Pristiq's FDA approval in 2008
I'll follow Pristiq as the information continues to trickle out but don't expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.
This is one of the few times I can actually say I was right. (Teenage-like "squee!" goes here.)
More recent posts from:
March 9, 2008 at 2:56 pm (Blogs)
Tags: Abilify, antidepressant, antipsychotic, anxiolytic, atypical antipsychotics, bifeprunox, big pharma, Bipolar Blast, Blogs, brain, Bristol-Myers-Squibb, depressed, Depression, Diagnoses, diagnosis, diagnostic tests, disease, diseases, disorder, disorders, drugs, DTC, DTC advertising, Ed Silverman, Eli Lilly, Furious Seasons, Gwen Olsen, major depressive disorder, marketing, medication, meds, MRI, Olanzapine, Pharma, pharma rep, pharmaceutical companies, pharmaceutical industry, pharmaceuticals, Pharmalot, Philip Dawdy, side effects, soulful sepulcher, trial, video, weblogs, withdrawal, withdrawal symptoms, YouTube, Zyprexa
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?
Read the rest of this entry »
February 26, 2008 at 11:05 am (Antidepressants, Anxiety/Stress, Depression, Medicine/Meds, Statistics)
Tags: antidepressant, Antidepressants, anxiety, clinical depression, Depression, major depressive disorder, MDD, placebo
Despite all the hype surrounding antidepressants and their effectiveness, the AP has reported on a new study from the University of Hull in Britain that says antidepressants only help severely depressed people and “work no better than placebos in many patients.”
The drugs used in the study: Prozac (fluoxetine), Effexor (venlafaxine), Paxil/Seroxat (paroxetine), and Serzone (nefazodone).
Irving Kirsch, who headed the study, said: “Although patients get better when they take antidepressants, they also get better when they take a placebo, and the difference in improvement is not very great. This means that depressed people can improve without chemical treatments.” (AP)
This is a pretty controversial finding considering the widespread use of antidepressants among those who have been diagnosed with clinical depression and other forms of mental illness, i.e. anxiety.
According the NIH, depression (the clinical term is major depressive disorder) affects an estimated 14.8 million American adults. CNN cites a study from the U.S. Centers for Disease Control and Prevention that says 2.4 billion drugs were prescribed in 2005; of those, 118 million were antidepressants. I can only imagine as “awareness” of depression increases, the number of prescribed antid’s has increased as well.
Adult use of antidepressants almost tripled between the periods 1988-1994 and 1999-2000.
Between 1995 and 2002, the most recent year for which statistics are available, the use of these drugs rose 48 percent, the CDC reported.
Many psychiatrists see this statistic as good news — a sign that finally Americans feel comfortable asking for help with psychiatric problems. (CNN)
CNN quoted Dr. Kelly Posner, an assistant professor at Columbia University College of Physicians and Surgeons in New York City, who said that “25 percent of adults will have a major depressive episode sometime in their life, as will 8 percent of adolescents.” If 25 percent of adults have a “major depressive episode,” does that mean that those 25 percent will require antidepressants as well? I’m concerned about the relatively high number for adolescents. I’m not a fan of throwing pills at growing children.
In light of the U of Hull study, the first course of treatment regarding depression should be non-medicated therapy of some kind. Whether it be “talk” therapy or cognitive behavior therapy, tackling depression really should first be treated with psychologic therapy. Posner says “25 percent of adults will have a major depressive episode.” Major depressive episode does not equal clinical depression or major depressive disorder, for that matter. A major depressive episode could mean anything: bereavement, loss of employment, or a difficult situation without an immediate resolution. I am strongly against prescribing antidepressants to help people cope with “normal” life events. People feel as though that their grief is too much to bear so they go to the doctor in the hopes that an antidepressant will help “dull” their emotions. I can only hope that a doctor will be able to differentiate between true clinical depression and a difficult situation that could be helped without the use of psychiatric medication.
P.S. I looked up Dr. Posner’s conflicts of interest and they were “TBD.” I would feel better had it listed “no conflicts of interest to disclose.”
July 4, 2007 at 6:15 am (Antidepressants, Celebrities, Medicine/Meds, Mental Health/Illness)
Tags: antidepressant, Benoit, Chris Benoit, delusions, hallucinations, mental health, psychosis, rage, sertraline, wrestler, WWE, zoloft
Furious Seasons has a post on WWE wrestler Chris Benoit, who possibly may have taken Zoloft shortly before he committed the murder of his wife and child. The article on pwtorch.com that FS linked to refers to the possibility that Benoit's friend and doctor, Phillippe Astin III, may have prescribed the drug to Benoit on Friday, the day before he killed his wife.
There are definitely some funky mental issues behind Benoit's motives for killing his family, but it wouldn't surprise me if the Zoloft played a part in influencing him to do so. I recently mentioned Christopher Pittman who killed his grandparents in 2001 then proceeded to set their house on fire when he was on an adult dosage of 200 mg of Zoloft. He was 12. Stephany of soulful sepulcher commented that her daughter suffered from a similar problem while on 150 mg Zoloft:
Pittman was about the same age my daughter was then, and she was on 150mg of Zoloft a day, and that med changed her personality into a full blown all day raging person. She had to go inpatient to get off of it, and once off of it, she's never raged like that again. The Pittman story is very sad, as are all of the others associated with antidepressant use and teen violence. Columbine had Luvox, there's Accutane–it's beyond me how this can be overlooked in connection.
I wonder if there are other stories floating out there now about how Zoloft – an antidepressant – has caused similar behaviors. It'd be interesting to observe whether Zoloft causes hallucinations, delusions, and psychosis.
January 29, 2007 at 4:18 pm (Adverse Effects, Antidepressants, Blogs, Medicine/Meds, PTSD)
Tags: antidepressant, Blogs, celexa, citalopram, Holly Finch, medication, meds, psych meds, PTSD, withdrawal effects
Holly Finch’s blog “Am I Still Me?” is worth taking a look at. She was a survivor in the London bombing that occurred on July 7, 2005 and as a result, blogs about her daily life while suffering from PTSD.
She recently blogged about coming off citalopram (U.S. trademark name: Celexa) and is experiencing some awful withdrawal effects. This makes me glad that I skipped Celexa in the hospital before I met my doctor. He recommended Effexor instead.
Not that it makes a difference really. I just had the privilege of not having two withdrawal symptoms in succession.
January 25, 2007 at 11:39 am (Antidepressants, Medicine/Meds, Pharma)
Tags: antidepressant, clinical trials, Depression, desvenlafaxine, Effexor XR, FDA, generics, hot flashes, medication, meds, menopause, nauses, non-hormonal treatment, Pharma, pharmaceutical companies, Pristiq, psych meds, vasomotor, venlafaxine, Wyeth
FDA approval for Pristiq (I'll refer to it as Pq occasionally) is contingent upon Wyeth's handling of "quality control problems… made to the satisfaction of federal inspectors." As I'd previously mentioned before, Wyeth has built an amazingly similar medication based on Effexor. Wyeth is trying to market Pristiq as an antidepressant and treatment for vasomotor symptoms (hot flashes during menopause). Wyeth is significantly banking on Pristiq since their $3.5 billion Effexor XR will lose its patent in a few years, allowing other companies to make venlafaxine generics.
Some of the "quality control" problems Wyeth is experiencing:
- unclear whether Pq keeps depressive episodes at bay
- efficacy at low doses and in young kids
- severe nausea in 50 percent of patients in the clinical trials
Reuters' article notes this, though:
"But the studies do not need to be completed prior to approval of the new depression pill."
While Wyeth has admitted that Pq is "structurally related" to Effexor, it "has not yet disclosed if Pristiq has any advantages over Effexor XR, other than to say it would be an alternative to existing treatments."
But it has acknowledged the newer drug caused nausea in about one-half of patients in clinical trials.
Wyeth is banking on patients sticking out the nausea for one week (it supposedly subsides after that) or a 50 mg pill that would be more effective than the whopping 400 mg they used in earlier phases of the clinical trials.
"The company said it will not launch Pristiq until it obtains results from the low-dose trials. Moreover, Wyeth said the timing of the launch also will depend on progress of the FDA's ongoing review of Pristiq as a possible non-hormonal treatment for hot flashes. The FDA is scheduled to decide on the hot flashes indication in April."
Wyeth wants to be absolutely sure they can cover all of their bases in an effort not to lose a single portion on their market share — from those who can tolerate low doses at 50 mg to those who need to go 400 mg and up.
"A G Edwards analyst Joseph Tooley has predicted Pristiq will garner annual sales of $1.4 billion by 2011 — about $1 billion from use against depression and the remainder for menopausal symptoms."
Getting not only psychiatrists to prescribe the drug, but also OB/GYNs is a clever move on their part.
January 22, 2007 at 3:14 pm (Antidepressants, Depression, Medicine/Meds)
Tags: antidepressant, clinical trials, Depression, desvenlafaxine, Effexor, Effexor XR, generic, MDD, medication, menopausal, menopause, Nausea, patent, pharmaceuticals, Pristiq, psych meds, side effects, SNRI, vasomotor, women's health, Wyeth
The Trouble With Spikol has linked to an article in the San Diego Union-Tribune (via Reuters) that covers Wyeth's new Effexor XR knock-off, Pristiq (desvenlafaxine succinate). Why are they launching Pristiq? Their patent on Effexor will expire in July 2010 when making generic versions of the drug will be up for grabs.
"Wyeth said in July, however, that it will not introduce Pristiq until it completes tests of a low 50-milligram dose of the drug, following trials of higher dosages in which about half the patients experienced nausea."
Too bad clinical trials don't test for withdrawal symptoms. Will Pristiq avoid the withdrawal hell issues that Effexor XR has?
“'We will wait for the results of the low-dose trials, which we've said we expect in early 2007, before making a decision' on when to launch Pristiq, company spokeswoman Gwen Fisher told Reuters on Friday.
She said nausea seen in the earlier trials was mild to moderate and generally went away within a week after treatment began.”
How long were these clinical trials and if the nausea was seen in the "earlier trials," what about the most recent trials?
Pending FDA approval, Wyeth would also like to use Pristiq for vasomotor symptoms in menopausal women. Wyeth's unannounced strategy will be to introduce Pristiq long before Effexor's patent expires so they don't lose any of their $1 billion market share to an Effexor generic.
A Wyeth PR that went under my radar:
“Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) now is being studied with a specific focus on women. It initially was developed for two indications that currently are pending approval from the U.S. Food and Drug Administration (FDA) – the treatment of major depressive disorder (MDD) and vasomotor symptoms (VMS) associated with menopause.
In the area of depression, Pristiq is expected to improve the balance of serotonin and norepinephrine as compared with serotonin reuptake inhibitors (SSRI) because of its pharmacologic profile as a dual reuptake inhibitor.”
Isn’t that what SNRIs are supposed to do?
“Clinical studies confirm that Pristiq is effective in both men and women. However, women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology.”
No kidding – 50 percent of the depression market and the implication of all women over 40 years old? Sure, I believe that. Looks like Wall Street doesn't have much hope for the new drug either.
“Pristiq also may be a treatment option for patients who are on multiple medications. The compound has a low risk of drug-drug interactions. This is important when considering that depression often is a co-morbid condition in medically ill patients and that these patients frequently are taking multiple medications. The Company expects FDA action for the MDD indication in January 2007.”
The multiple medications thing. Um, I’m not a fan of that unless it’s absolutely necessary. It isn’t necessary in a lot of cases.
“FDA action for the second application for Pristiq for vasomotor symptoms associated with menopause is anticipated in April 2007. Pristiq is expected to provide significant relief of hot flushes (decrease in number and severity) associated with menopause.
If approved, Pristiq will be the first non-hormonal treatment indicated for relief of VMS.
The Company also plans to pursue indications for Pristiq that would include fibromyalgia syndrome and diabetic neuropathic pain.”
Wyeth certainly is attempting to milk this new drug for all it’s worth. I hope Furious Seasons or CLPsych take up on investigating this one since I simply don’t have the time, resources, or ability.
December 18, 2006 at 11:31 am (Anxiety/Stress, Celebrities, Depression, Loose Screws Mental Health News, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: antidepressant, antipsychotic, anxiety, atypical, bipolar, Bipolar Disorder, Bracco, canada.com, clinical anxiety, clinical depression, clinical trials, Depression, diabetes, Dr. Melfi, Eli Lilly, high blood sugar, hyperglycemia, Lorraine Bracco, med, medications, mental health, mental illness, New York Times, Olanzapine, psych meds, Schizophrenia, side effects, survey, The Sopranos, winter, zoloft, Zyprexa
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 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.”
Read the rest of this entry »