January 15, 2013 at 11:36 am (Antidepressants, Bipolar Disorder, Depression, Loose Screws Mental Health News, Medicine/Meds, Mental Health/Illness, Pharma, Suicide)
Tags: Antidepressants, Bipolar Disorder, CTE, Dave Duerson, Depression, domestic violence, ebselen, gays, gender dysphoria, gender identity disorder, Junior Seau, ketamine, lesbians, medication, mental illness, NFL, NHL, Pregnancy, Ray Easterling, soccer players, SSRI, stillbirth, Suicide, transgender
Ebselen, an experimental bipolar disorder drug, has been found by British researchers to work like lithium but without lithium’s side effects. In mice. In testing, mice that were somehow made manic with “small doses of amphetamine” were placated with ebselen. Researchers are now moving on to testing on healthy human volunteers before studying those suffering with bipolar disorder.
A study, published in JAMA Neurology, discovered that retired NFL players were more likely to suffer from depression and brain impairment. The study comes on the heels of the suicides of Dave Duerson, Ray Easterling, and Junior Seau. Researchers suspect a link between “hard hits to the head and depression.” These problems have also been noted in NHL players and combat soldiers who have suffered a brain injury. Many of the retired NFL players developed a type of brain damage called chronic traumatic encephalopathy (CTE). Duerson and Easterling were found to have CTE during autopsy. In related sports news, the UK’s Telegraph reports that depression is a problem for soccer players in England and Scotland.
According to Time magazine, ketamine—a drug that induces hallucinations and other trippy effects—may hold potential as an antidepressant.
And now scientists report on two formulations of drugs with ketamine’s benefits, but without its consciousness-altering risks, that could advance the drug even further toward a possible treatment for depression.
Ketamine is seen as a fast-acting antidepressant for those at high risk for suicide. GLYX-13, mentioned here previously
, is a ketamine-like antidepressant currently in clinical trials. AstraZeneca has AZD6765, a “ketamine mimic” that does not appear to be as effective as actual ketamine.
New research has discovered that people with mental illness are more likely to be victims of domestic violence. Even though the study evaluated men and women, the results for women were overwhelmingly striking.
It finds that women with symptoms of depression were 2.5 times more likely to have experienced domestic violence over their lifetimes than those in the general population, while those with anxiety disorders were more than 3.5 times more likely to have suffered domestic abuse. The extra risk grew to seven times more likely among those with post-traumatic stress disorder.
An analysis of more than 1 million Scandinavian women has shown that taking SSRIs during pregnancy may not increase the risk of stillbirth. This study could help revolutionize treating depression in pregnant women.
“From our study, we don’t find any reason to stop taking your medication, because untreated depression may be harmful for the pregnancy and the baby,” [Dr. Olof Stephansson, the lead author of the new report] told Reuters Health.
Finally, “gender identity disorder” has been removed from the DSM-V and has been replaced by “gender dysphoria,” a condition in which people are concerned about their gender identity. “Gender identity disorder” seemed to stigmatize gays, lesbians, and transgender individuals. The continuing inclusion of “gender dysphoria,” however, ensures that people suffering with gender identity disorder still have access to health care treatment. (In my opinion, the renaming of “gender identity disorder” to “gender dysphoria” is really a politically correct change. Homosexuality was removed from the DSM back in 1973.)
September 3, 2009 at 6:32 pm (Pharma)
Tags: AstraZeneca, Seroquel, Seroquel XR, sponsorship, WebMD
… the makers of Seroquel XR. Just sayin’. (Click on the image to bring it full size.)
March 6, 2009 at 11:21 am (Antidepressants, Depression, Loose Screws Mental Health News, Medicine/Meds, Pharma, Suicide)
Tags: Antidepressants, BusinessWeek, court case, depressed, Depression, drugs, medication, medicines, meds, Pharma, pharmaceutical companies, preemption, Suicide, Supreme Court
Portland, Oregon has been recently declared the most depressed city in the country. BusinessWeek determined this based on “antidepressant sales, suicide rates, unemployment, divorce, and crappy weather.” Philly didn’t make the top 20 list. That’s because we’re too busy enjoying the highest suicide rate in the country.
A great way to avoid depression, however, is to simply stop breathing. Yes, that’s right. Just stop breathing. A new study presented at an American Psychological Society meeting shows people who are consistently exposed to secondhand smoke are twice as likely to suffer from depression
. So that’s my recommendation to you: STOP BREATHING
. I guarantee you won’t be depressed after a while. (By the way, that’s a joke so you can go ahead and take a deep breath now.)
Apparently all this talk of an economic depression is causing people to be depressed enough to buy more antidepressants. I don’t get how it works but it seems as though antidepressant prescriptions (along with sleeping aid prescriptions) are rising alongside the unemployment rate in this country
. Big Pharma isn’t filing for bankruptcy anytime soon. And if they do, it’s their own freakin’ fault.
In what appears to be a landmark ruling (correct me if I’m wrong), the U.S. Supreme Court ruled that pharmaceutical companies are still liable for injuries cause by FDA-approved drugs and devices and juries can legitimately award damages
. The buzzword I’ve learned for this case is preemption
A woman who was injected with an antinausea drug (Phenergan, if you’re wondering) brought a damage suit against Wyeth after her arm had to be amputated. After a jury awarded her with $6.7 million, Wyeth took the case to the U.S. Supreme Court, expecting a cool victory after the court sided with Medtronic in last year’s Riegel v. Medtronic case. Wyeth, the defendant in the case, hoped the Supreme Court would rule in their favor since the FDA had already evaluated their product for safety—a preemptive act. However, this time the court ruled 6-3 in favor of allowing the woman to keep her award money. The decision also sets a precedent for pharmaceutical consumers to sue pharmaceutical companies for injuries despite FDA approval—striking down preemption. For further information, check out Doug Bremner’s and Philip Dawdy’s blogs that have already covered this. In the meantime, I leave you with this:
Ronald Rogers, a spokesman for Merck, said, “We believe state courts should not be second-guessing the doctors and scientists at the F.D.A.”Merck was hit with several huge damage awards over its painkiller Vioxx before agreeing to a $4.85 billion settlement in 2007. Allowing juries to make determinations about drug risks, Mr. Rogers said, would cause “mass confusion.”
Hm. Make of that what you will.
March 3, 2009 at 4:59 pm (Antipsychotics, Bipolar Disorder, Blogs, Loose Screws Mental Health News, Medicine/Meds, Mental Health/Illness, Pharma, Suicide)
Tags: AstraZeneca, Beyond Meds, big pharma, bipolar, Bipolar Disorder, commit suicide, Dawdy, Furious Seasons, hanging, hot air, mental illness, Pharma, Philip Dawdy, quetiapine, Seroquel, studies, Suicide
As reported by The New York Times, people with bipolar disorder have a higher risk of suffering from fatal illness according to a study (that reviewed 17 other studies involving more than 331,000 people) reported in the February issue of Psychiatric Services.
In the larger studies, almost every cause of death was higher among bipolar patients: cardiovascular, respiratory, cerebrovascular (including strokes), and endocrine (like diabetes). In the smaller studies, mortality from cerebrovascular disease was higher among those with bipolar illness, but they showed inconsistent results, probably because they used smaller samples or less representative populations.
Gianna at Beyond Meds provides here take here.
Some crazy nurse in Minnesota convinced a Canadian college student to kill herself and walked her through the process of appropriately hanging herself. Ed Morrissey of Hot Air calls the nurse "the first serial suicide-inciter of the modern age." Couldn't have said it better myself.
Philip Dawdy at Furious Seasons is on a roll, holding AstraZeneca accountable for its actions regarding hidden information about Seroquel and now he hosts the Seroquel documents — alongside Lilly's Zyprexa documents — that indicate buried studies. Dawdy's also running a spring fundraiser and I suggest you get your butt in gear and donate to him if it's important to you that someone holds pharmaceutical companies accountable for their actions. I've already done my part.
Sorry this post isn't filled with my normal snark and cynicism. I'm behind on a lot personally — still trying to get the hang of this self-employment thing — and this is what I can throw out for now.
February 19, 2009 at 7:10 am (ADHD, Pharma)
Tags: ADD, ADHD, advertisement, Concerta, Concerta ad, drugs, marketing, medication, meds, psych drugs, psych meds
Of all the examples to use for an ADHD medication ad, I thought the “before” symptoms were terrible. I’m not ashamed to admit I did all of those things at one time or another (not in the same sequence). But then again, teachers tried to tell my mother I had (what used to be known as) ADD. Whatever. People these days call it ADHD. I call it being a normal kid. (Side rant: Teachers these days don’t want to deal with disciplining children in school when they misbehave or act out of turn so they recommend medicating them as a way to keep them docile and under control. And parents go along with it since they feel it will make their lives easier at home too. Not to say that some children don’t legitimately suffer from ADHD, but based on casual conversations I’ve had with a few people, it seems as though the number is rising.)
Below is a photo that I snapped of a Concerta ad which recently appeared in Shape magazine followed by 2 pages of side effects and indications. (Click on the picture to view its full size.) Feel free to post your thoughts in the comments.
February 17, 2009 at 2:14 pm (Antipsychotics, Bipolar Disorder, Depression, Medicine/Meds, Pharma)
Tags: antipsychotic, AstraZeneca, atypical antipsychotic, atypicals, AZ, medications, psych drugs, psych meds, psychotropics, quetiapine, Seroquel, St. Petersburg Times
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.
February 16, 2009 at 11:30 pm (Adverse Effects, Antidepressants, Depression, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: acceptability, Adverse Effects, antidepressant rankings, Antidepressants, buproprion, celexa, citalopram, cognitive functioning, Cymbalta, Depression, drugs, duloxetine, effectiveness, Effexor, efficacy, escitalopram, Fluoxetine, fluvoxamine, irritability, Lexapro, luvox, medications, meds, milnacipran, mirtazapine, paroxetine, Paxil, primary care doctors, primary care physicians, Prozac, psych drugs, psych meds, psychiatry, psychotropics, rage, reboxetine, remeron, savella, Seroxat, sertraline, side effects, somnolence, Traci Johnson, venlafazine, vestra, violence, Wellbutrin, withdrawal, withdrawal effects, withdrawal symptoms, zoloft
A number of antidepressants were recently ranked in different surveys:
Zoloft and Lexapro came in first for a combination of effectiveness and fewer side effects, followed by Prozac (fluoxetine), Paxil (paroxetine), Cymbalta, and Luvox among others.
The first was efficacy — or how likely patients were to experience the desired effects of the drug.
1. Remeron (Mirtazapine)
2. Lexapro (Escitalopram)
3. Effexor (Venlafaxine)
4. Zoloft (Sertraline)
5. Celexa (Citalopram)
6. Wellbutrin (Buproprion)
7. Paxil (Paroxetine)
8. Savella (Milnacipran)
9. Prozac (Fluoxetine)
10. Cymbalta (Duloxetine)
11. Luvox (Fluvoxamine)
12. Vestra (Reboxetine)
The second was acceptability — the likelihood that a patient would continue using a drug for the duration of the study (it is generally assumed that a high ratio of patients dropping out indicates the presence of undesirable side effects for a drug).
1. Zoloft (Sertraline)
2. Lexapro (Escitalopram)
3. Wellbutrin (Buproprion)
4. Celexa (Citalopram)
5. Prozac (Fluoxetine)
6. Savella (Milnacipran)
7. Remeron (Mirtazapine)
8. Effexor (Venlafaxine)
9. Paxil (Paroxetine)
10. Cymbalta (Duloxetine)
11. Luvox (Fluvoxamine)
12. Vestra (Reboxetine)
My experience with Lexapro was a disaster and I’ve written about Zoloft’s connection with irritability and rage. Paxil’s side effects are especially rough (see Bob Fiddaman’s Seroxat page) while Effexor’s withdrawal effects proved to be significantly challgenging. Although Prozac offset Effexor’s withdrawal symptoms, it causes severe somnolence that can impair cognitive functioning. And last but not least, Cymbalta contributed to the unfortunate death of Traci Johnson who had no history of depression.
These drugs may be effective for many people but it’s still a guessing game. Dr. Mark I. Levy, quoted in ABC News’s article on the rankings, mentioned that while psychiatrists may not have much use for the rankings, he sees them as beneficial for primary care physicians. And Dr. Harold G. Koenig, a professor at Duke University Medical Center, adds:
“I would be likely to start patients on either Zoloft [because it’s cheaper] or Lexapro … Unfortunately, that is almost none of my patients. By the time they get to me [a psychiatrist], the primary-care doctors have tried Zoloft and other antidepressants, so my patient are not the “new to medication” kind of patients,” he said.
I won’t rehash my thoughts on PCPs prescribing antidepressants and other psych meds. You can read about them here.
January 26, 2009 at 5:24 pm (Medicine/Meds, News, Pharma)
Tags: big pharma, desvenlafaxine, drugs, Effexor, Lipitor, medication, meds, merger, Pfizer, Pharma, pharmaceuticals, pipeline, Pristiq, psych drugs, psych meds, venlafaxine, Wyeth
The New York Times puts it this way:
The deal, if completed, would not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government. [emphasis mine]
Funny the writers decided to add that. A year ago, that clause would have never been considered yet alone thought of.
Pfizer isn’t doing badly; in fact, despite the credit crunch, they’ve been able to snag $22.5 billion in loans since they also have $26 billion cash on hand. The NYTimes also reports that this merger would be the biggest since AT&T and BellSouth merged back in March 2006. But of course, with mergers always come layoffs. And what a time to have layoffs. Pfizer today announced that they’ll be cutting 8,000 jobs.
But as I said in a previous post, Pfizer’s biggest challenge is get some pipeline products out to market soon since some of the patents on their big names (ie, Lipitor) are expiring soon. Don’t hold me to this but I think Wyeth has a bit more sitting in their pipeline, hence why the merger would make sense. But I hope Wyeth can produce a new blockbuster drug for Pfizer otherwise Pfizer’s really going to be hurting for money. Especially since Wyeth’s best-selling drug, Effexor, is now generic and Pristiq isn’t completely cutting it.
January 23, 2009 at 3:57 pm (Medicine/Meds, Pharma)
Tags: big pharma, Pfizer, Pharma, pharmaceuticals, Wyeth
Is Wyeth being hurt by the failing economy? I’m not so sure but Pfizer may be buying up Wyeth for up to $60 million. According to news reports, this could help the pharmaceutical giant by bringing in some of Wyeth’s brand name products while many of Pfizer’s own manufactures (think Lipitor) go generic. However, it could also be a drawback as one of Wyeth’s biggest sellers—our favorite antidepressant Effexor (venlafaxine)—has gone generic. Also, Pfizer doesn’t have the best track record of buying up other companies and turning them into blockbuster gold. Should be interesting to see what happens in the next few years if the deal does go through.
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)
May 23, 2008 at 2:12 pm (Antidepressants, Medicine/Meds, Pharma)
Tags: bazedoxifene, blood clots, desvenlafaxine, drug, Effexor, FDA approval, Forbes.com, medication, meds, myocardial infarctions, osteoporosis, postmenopausal, postmenopause, Pristiq, strokes, venlafaxine, Wyeth, Wyeth Pharmaceuticals
Wyeth Pharmaceuticals just can't seem to catch a break. The company is not only increasingly worried that it will lose a large chunk of its revenues to generic competition, it also faces the ongoing threat that its pipeline is starting to go dry. A further delay in the approval of its postmenopausal osteoporosis drug has become one more nail in the pharma company's coffin.
The drug, bazedoxifene, has had a hard time getting approval from the FDA since April 2007. The FDA is concerned about bazedoxifene's effects on causing myocardial infarctions or blood clots.
This is some pretty disheartening (to say the least) news considering that Effexor will soon be going generic and Pristiq has received some less-than-stellar reviews.
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.
April 21, 2008 at 5:14 am (Anticonvulsants, Bipolar Disorder, Blogs, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: articles, bipolar, Bipolar Disorder, echo chamber effect, epilepsy, Fierce Pharma, gabapentin, journals, Neurontin, off-label usage, Pfizer, soulful sepulcher, Tim Carey, WSJ blog
Stephany at soulful sepulcher has a post up on how Neurontin has not shown itself to be more effective for bipolar disorder than placebo in clinical trials.
It's actually kind of funny that this discovery has been made in April 2008 because I'd reported on this back in January of 2007:
So let's recap: gabapentin is FDA-approved for epilepsy ONLY. But gabapentin has a slew of off-label uses.
Don't know what off-label means? It means "not FDA-approved to be prescribed for this use."
Now that we've got that out of the way, gabapentin is prescribed off-label for migraines, bipolar disorder, social anxiety disorder, OCD, treatment-resistant depression, insomnia, multiple sclerosis, neuropathic pain, and in some instances, post-operative chronic pain.
Where did this off-label usage come from? Basically, one journal article published data on beneficial effects for patients on Neurontin for bipolar disorder and then other articles would cite that article as supporting evidence then more articles cited all the other articles that published the positive efficacy data on the drug, creating what UNC researcher Tim Carey calls the "echo chamber effect." From Fierce Pharma:
Hearing it over and over, doctors were led to believe that Neurontin worked for bipolar patients, and prescribed it to lots and lots of them.
These articles that touted the benefits of Neurontin were cited 400 times. Carey:
It “becomes a rumor mill in which physicians may be exposed to these types of articles, and citations of articles, which then gives credibility to off-label use.”
“No scientifically acceptable clinical trial evidence supports use” of the drug in bipolar disorder.
Ouch. Hitting Pfizer where it hurts.
April 21, 2008 at 3:44 am (Antidepressants, Blogs, Medicine/Meds, Pharma)
Tags: carlat, carlat psychiatry blog, desvenlafaxine, drug reps, drugs, Effexor XR, marketing, medication, meds, passion, people, performance, Pristiq, psych drugs, psychiatry, slogans, venlafaxine, Wyeth
Oof. I'm just starting to read The Carlat Psychiatry Blog and stumbled upon this post about Wyeth drug reps trashing Pristiq. Wow. Carlat pulled an excerpt of a Wyeth rep mocking Pristiq's new marketing slogan: "People, Passion, Performance… Pristiq!"
"PEOPLE – 1/2 of you will be gone in less than 27 days
PASSION – There is no passion now, but for those that remain with Wyeth, we will bribe the passion out of you by taking you to Vegas for 4 days.
PERFORMANCE – You thought it was hard to reach your performance incentive before? Wait until 2nd quarter
PRISTIQ – Good luck selling both Effexor XR and Pristiq at the same time. So Dr., would you like to hear about my antidepressant that has been around for 12 years, with proven efficacy with the ability to titrate the dose as need to better care for each patient's needs that will have generic competition in 4 months, or would you like to hear about my brand new antidepressant with one dose, less indications and less evidence of efficacy? You want me to choose, let me check with my bonus plan to see which one pays more."
If this is the typical attitude within the Pristiq sales force, Wyeth may end up a little shy of the blockbuster they were hoping for!
I couldn't have said it better myself.
March 18, 2008 at 5:42 pm (Antipsychotics, Depression, Loose Screws Mental Health News, Medicine/Meds, Pharma, PPD, Pregnancy, Suicide)
Tags: AstraZeneca, big pharma, bill, bipolar, Bloomberg, clinical trial data, clinical trials, CPAP, creative, Depression, drugs, extended-release, FDA, GlaxoSmithKline, GSK, legislation, mania, medication, meds, mental health, mental illness, MHRA, MOTHERS Act, new moms, nondisclosure, paroxetine, patents, Paxil, pharmaceutical companies, poets, postpartum depression, postpartum psychosis, Pregnancy, pregnant, psych drugs, psych meds, quetiapine, scare tactics, Seroquel, Seroquel XR, Seroxat, sleep apnea, Suicide, treatment, UK, US, withholding, writers
I recently wrote about the MOTHERS Act and the unnecessary scare tactics surrounding it. A Dallas-Fort Worth TV station picked up on the story and provided a short one-sided view of the issue, continuing to purport that the bill is solely about drugging new moms. I don’t discount Ms. Philo’s terrible experience with her medication. In fact, I’d be against the act if its sole purpose was to force treatment on pregnant women – medicated or not. Again, I’d like to reiterate that the bill’s purpose is to educate moms about postpartum depression and postpartum psychosis – not to shove unnecessary pills down women’s throats.
If you have sleep apnea, your CPAP (Continuous Positive Airway Pressure) machine may alleviate depression symptoms. My husband has sleep apnea and hasn’t been able to use the CPAP machine because of sinus problems. When he doesn’t use it (he hasn’t for a while), he’s noticeably moodier and prone to depressive symptoms. But then again, anyone who doesn’t get good sleep for several days is pretty moody.
AstraZeneca (AZ) is going after Teva Pharmaceutical Industries and Novartis AG’s Sandoz unit after the two companies applied to make cheaper version of Seroquel available. AZ’s patent on Seroquel expires in 2011. The trial date for patent litigation is August 11. In the meantime, according to the Bloomberg report, the FDA is considering approval of Seroquel XR for bipolar depression and bipolar mania.
What is it about the U.K. that they seem to take pharma’s power more seriously than the U.S.? The UK Medicines and Healthcare products Regulatory Agency (MHRA) charged GlaxoSmithKline (GSK), the maker of Seroxat (Paxil in the U.S.), with not fully disclosing their clinical trial data that downplayed serious side effects such as increasing suicidal tendencies among those 18 years and younger. The MHRA also asserts that Seroxat didn’t alleviate depression as much as GSK’s initial data showed. GSK, of course, denied manipulating the data to show favorable results:
GSK denies withholding data, claiming the risks did not come to light until the results of nine studies were pooled.
The UK minister of public health, Dawn Primarilo, promised to address the issue of Big Pharma hiding negative clinical trial data.
“Notwithstanding the limitations that may exist in the law, pharmaceutical companies should disclose any information they have that would have a bearing on the protection of health,” she says.
In other news, I shouldn’t be a successful writer or novelist. The correlation between creative writers and suicide is ridiculously high. More than 70 well-known writers and poets have successfully committed suicide. How much more “unknown” writers and poets have as well?
(Image from Monthly Prescribing Reference)
March 17, 2008 at 3:39 pm (Books, Medicine/Meds, Pharma)
Tags: ads, big pharma, book review, Books, drugs, DTC, DTC marketing, marketing, medication, meds, Melody Petersen, New York Times, Pharma, pharmaceutical companies
An book review in the NYTimes today focuses on Melody Petersen, a former reporter of the Times, who has written a book against Big Pharma's marketing tactics called Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves Into Slick Marketing Machines and Hooked the Nation on Prescription Drugs. In the book, she asks:
“Could drugs be killing people but escaping all blame, leaving them to harm even more Americans until someone, finally, catches on?” Ms. Petersen asks.
Few of us have. Most of America hasn't. Petersen outlines in great detail – the point of repetition according to Janet Maslin's review – Big Pharma's propensity for skewing clinical trial results so that their drugs perform better than placebo, the increased and ubiquitous DTC marketing, and the "payola-dispensing drug company representatives."
(“Hotel too cold inside,” one said, in an evaluation of a June 1998
drug company program, adding, “Resort places preferred.” From a
different doctor, miffed at the lack of a chauffeur at another event:
“Hired car would have been much preferable.”
Petersen also covers Big Pharma's tactic of fixing side effects of medications by creating medications to fix the side effects leading to medication on medication.
And when the side effects of sleeping pills or antidepressants mean
more elderly people fall down, the solution is not likely to be the
scaling back of such prescriptions. “Instead,” she writes, “the
companies have used the statistics on falls to create a new blockbuster
pharmaceutical market for drugs they claim will reduce the chances of
breaking a bone.”
According to the Maslin's review, the book calls for non-government watchdog agencies and closer oversight on published studies, which Petersen says are ghostwritten by pharma spokespeople. Overall, Petersen's book sounds like a must-read for anyone who is skeptical of Big Pharma's activities. However, I doubt her book will get much press or coverage considering that you can't read any major publication without turning the page and seeing a drug ad then the required 2-page side effect warning that everyone skips over. If anyone reads the book, I'd like to know your thoughts about it.
Sorry if this post sounds hastily written. I'm off to an interview to freelance for a company.
March 16, 2008 at 10:50 pm (Antipsychotics, Medicine/Meds, Pharma)
Tags: Alaska, big pharma, Connecticut, drugs, Eli Lilly, Furious Seasons, lawsuits, off-label, off-label marketing, Olanzapine, pharmaceuticals, Philip Dawdy, trial, Zyprexa
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 7:48 am (Antidepressants, Medicine/Meds, Pharma)
Tags: Antidepressants, big pharma, carlat, desvenlafaxine, drugs, Effexor, medication, NYT, patients, PCP, Pharma, pharmaceutical companies, pharmaceuticals, primary care physicians, Pristiq, psych drugs, SNRI, venlafaxine, Wyeth, XR
More than a year ago, I promised to keep tabs on Wyeth’s new (renamed, rather) drug Pristiq. So I’m living up to it.
On February 29, 2008, the FDA granted Wyeth approval to move forward with putting the drug out on the market.
Wyeth said the company planned a big sales effort to introduce the product to psychiatrists and primary care doctors.
There’s a problem with that sentence. I’ll give you a second to figure out what’s wrong with it. Haven’t got it yet?
Primary care doctors. PCP should not be in the business of prescribing or providing psych meds. I’ve gone on and on about it at length before, but I’ll mention it again. PCPs are trained to treat overall conditions that have no need of referral to specialists. Think about it this way: If your psychiatrist prescribed anti-inflammatory medication because you mentioned that you’ve been having problems with your foot, you’d be taken aback, right? If a dermatologist prescribed heartburn medication after a patient mentioned he’d been having heartburn trouble, that would seem almost illogical, wouldn’t it?
(Pristiq logo from Pristiq.com)
Read the rest of this entry »
February 28, 2008 at 2:10 pm (Antidepressants, Medicine/Meds, Pharma)
Tags: Antidepressants, drugs, medication, meds, Pharma, psych drugs, psych meds
After the release of the U of Hull study on Tuesday, the AFP has written an article about doctors who are urging patients on antidepressants to continue taking them.
Louis Appleby, national clinical director for Mental Health, told the Press Association: "… the message to patients and doctors remains the same — anti-depressants are an appropriate treatment for moderate or severe depression."
I agree that patients on antid's should not cease medication cold turkey. (Trust me on this one. Even with proper tapering, the side effects are not pretty.) I waver on the idea that antid's are "appropriate treatment" for moderate-to-severe depression rather than a "form of treatment." Antidepressants can help, but I'm not sure I like the term "appropriate." But I likely am arguing semantics.
Since the results of the study originate from Britain (despite the fact that it also includes data from the FDA), I can only assume that news reports on this are more widespread over there. In my Philadelphia, USA-world, it seems a little bit off the radar to me. Let me know if I'm wrong.
To Mr. Appleby's credit, he has acknowledged that the British government plans to rigorously pursue routes of alternative treatment in light of the study.
The government has plans to expand the availability of psychological therapies as an alternative to drugs, Appleby explained, with extra investment and more psychological therapists.
"The evidence shows that these therapies are effective and often preferred by patients."
WebMD also covered the recent study. Dr. Nada Stotland of the American Psychiatric Association insists that the study is not reflective of real psychiatry.
"We know that many people who are depressed do not respond to the first antidepressant they try," she says. "It can take up to an average of three different antidepressants until we find the one that works for a particular individual. Therefore, testing any single antidepressant on a group of depressed individuals will show that many of them do not improve."
Stotland has a point. Patients usually do not respond to the first antidepressant that is prescribed to them. About 30 percent of patients do not respond to antidepressants or experience no improvement until several weeks later. Even then, patients who are on antidepressants for long-term maintenance, experience the return of depressive symptoms. An article from The New England Journal of Medicine evaluated the selective publishing of antidepressant trials with a positive efficacy:
Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive.
The authors' conclusion: "Selective reporting of clinical trial results may have adverse consequences for researchers, study participants, health care professionals, and patients." It's an obvious statement; so obvious, it can be easily overlooked.
While it's important to shed light on the issue of treating depression with antidepressants, it seems as though many authors are cherry-picking favorable results to publish. Considering that much of these research studies are backed by drug companies, it's no surprise. Also, I can't fault the authors only. I recently freelanced for a medical publication and learned that many of the submitted articles are heavily rewritten by the editors. Editors are hard-pressed (and probably loath) to publish a piece that criticizes antidepressants when their biggest advertisers include such big names as Wyeth, Eli Lilly, and GlaxoSmithKline. Run enough of those pieces and a publication is quickly on its way to folding.
That's why it's stunning to read the U of Hull study that has somewhat of a negative slant toward antidepressants' effectiveness. While doctors are wisely advising patients to continue any antidepressants they may be on, currently drug makers have launched into damage-control mode.
In a statement, GlaxoSmithKline (GSK) representatives express "disappointment" at how the study was being reported by the media, suggesting that news reports may have caused "unnecessary alarm and concern for patients."
Of course these news reports are "unnecessary" to GSK. Letting patients know that their antidepressants might not work better than sugar pills isn't good for business. However, GSK's reps were kind enough to balance out their statement, adding "counseling and lifestyle changes" also are important aspects of treating depression. Then, the company accuses the researchers of selectively reporting their data:
"GSK fully endorses public disclosure of clinical trial results for its medicines and is actively committed to communicating data relevant to patient care," the statement reads. "All the data related to GSK's clinical trial results of [Paxil], regardless of study outcome, are available at the company's clinical trials register at 20 www.gsk.com."
Tell that to the estimated 5,000 Americans who have filed a lawsuit against GSK regarding Paxil. Still, Kirsch, who has received consulting fees from Squibb and Pfizer, insists "the [drug companies] certainly do publish selectively."
I'm inclined to agree.
July 6, 2007 at 11:12 am (Adverse Effects, Antidepressants, Depression, Medicine/Meds, Mental Health/Illness, Pharma, Suicide)
Tags: adolescents, adults, adverse effect, aggression, agitation, AHRP, akathisia, alcohol, anger, Antidepressants, behavior, big pharma, blog, Brynn Hartman, Children, Christopher Pittman, clinical trials, comments, confidence interval, David Healy, death, Depression, drugs, dyskinesia, Eli Lilly, Fluoxetine, GlaxoSmithKline, guide, homicide, hostile, hostility, hyperkinesis, information, irritability, kids, kill, lawsuits, major depressive disorder, MDD, medications, meds, murder, OCD, patient safety, patients, pediatrics, Pfizer, pharma companies, pharmaceuticals, Phil Harman, Pittman, placebo, placebos, Prozac, psych drugs, psychiatry, psychology, rage, restlessness, Salon.com, sertraline, side effects, SSRI, studies, suicidal risk, suicidality, Suicide, teens, violence, violent, volunteers, Web site, zoloft
[This post is quite lengthy so I suggest you grab a cup of coffee or tea and sit down and read it. The following is not for the faint of heart (or those with a lack of time).]
It’s been amazing to me that I’ve received numerous comments on Zoloft inducing rage. I’m humbled by having a Pittman supporter visit my site and post some comments from the ChristopherPittman.org forums. Read the following:
In my senior year in high school I was diagnosed as being severely depressed and put on medication. The first medication that I was on I took for 5 months and it made me really aggressive. My friends and family noticed the change and I told my doctor about it and she changed my meds. After that I was fine. I am normally a very passive person and will let just about anything fly. But the medication made me really aggravated and aggressive toward my friends and family and it seemed that I wasn’t overcoming my depression. I just got done watching the 48 hours investigation on the Discovery Times Channel and felt a connection with Chris. I felt that I had to write this to let you know that Chris is not the only one out there that had these side effects. I think there should be a study done to see how many people that take antidepressants have increased aggression. The problem is that the pharmaceutical industry has deep pockets and many lobbyists. I hope this helps in some way.
I remember the case when it happened.
At the time I thought, “Zoloft right”.
Let me tell you my physician put me on Zoloft and it took about three weeks for my to become psychotic and I’m a 50 year old woman.
I have three children and I don’t make a lot of money but please let me know if I can do anything for the Pittman boy.
The jury should have been placed on Zoloft before they made they decision. Unless you’ve experience it you simply cannot believe its’ effect.
I did a bit of quick reading/research into Zoloft triggering violence in people who otherwise would have never been violent and it seems that are a few stories out there to support the assertion. I found a few comments on depressionblog.com that mentioned a link between Zoloft and rage fits. A Salon.com article published a story antidepressants inducing rage in 1999. Apparently, Brynn Hartman, the wife of famous comedian Phil Hartman, killed herself and her husband while taking Zoloft. While close friends attribute the sudden behavior on the antidepressant, others attribute it to a combination of the medication with cocaine and alcohol in her system. (Zoloft does have a warning against alcohol use in conjunction with the drug.)
One interesting thing I learned from the article is that this kind of behavior is often labeled under the name akathisia on patient safety guides. Most – if not all – of the major antidepressants list akathisia as a side effect. Here’s the initial description of this condition from Wikipedia:
Akathisia, or acathisia, is an unpleasant subjective sensation of “inner” restlessness that manifests itself with an inability to sit still or remain motionless… Its most common cause is as a side effect of medications, mainly neuroleptic antipsychotics especially the phenothiazines (such as perphenazine and chlorpromazine), thioxanthenes (such as flupenthixol and zuclopenthixol) and butyrophenones (such as haloperidol (Haldol)), and rarely, antidepressants.
Akathisia may range in intensity from a mild sense of disquiet or anxiety (which may be easily overlooked) to a total inability to sit still, accompanied by overwhelming anxiety, malaise, and severe dysphoria (manifesting as an almost indescribable sense of terror and doom).
No real mention of extreme anger or irritability mentioned there. But if you read on…
The 2006 U.K. study by Healy, Herxheimer, and Menkes observed that akathisia is often miscoded in antidepressant clinical trials as “agitation, emotional lability, and hyperkinesis (overactivity)”. The study further points out that misdiagnosis of akathisia as simple motor restlessness occurs, but that this is more properly classed as dyskinesia. Healy, et. al., further show links between antidepressant-induced akathisia and violence, including suicide, as akathisia can “exacerbate psychopathology.” The study goes on to state that there is extensive clinical evidence correlating akathisia with SSRI use, showing that approximately ten times as many patients on SSRIs as those on placebos showed symptoms severe enough to drop out of a trial (5.0% compared to 0.5%).
Read the rest of this entry »
July 3, 2007 at 4:55 pm (Pharma)
Tags: big pharma, intueri, psychiatrists
>> Psychiatrists Top List in Drug Maker Gifts. This kind of thing makes me embarrassed to be a psychiatrist. I’m glad that the Times is publishing this information—transparency is good and should be encouraged—and it’s painful to read. Many of us in the younger crew view Big Pharma with a disdain that borders on disgust, but how are other people supposed to know this? Average newspaper readers may now believe that I’m a skanky whore for Big Pharma upon learning my profession. I could prattle on, but I won’t.
It's good to know that the new breed of psychiatrists aren't as loyal to Big Pharma as the old ones are.
July 3, 2007 at 6:44 am (Antipsychotics, Bipolar Disorder, Loose Screws Mental Health News, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: biotech, bipolar, bipolar children, bipolar kids, CombinatoRx, companies, disease, drug makers, drugs, generics, medication, medicine, meds, NYT, payment, payola, Pharma, pharmaceutical, psychiatrists, safety, side effects
"Can an antipsychotic drug from the 1950s be paired with a 1980s antibiotic to shrink 21st-century tumors?"
That's the first line from the NYT's recent article on biotech companies mixing two unrelated generic drugs to treat medical problems. Alexis Borisy, the executive of CombinatoRx, is spearheading the movement to mix and match two different generic drugs in the hopes that the combo will cure or effectively treat a disease that may be unrelated to the drugs' initial purposes.
"Orexigen, in creating its obesity drug Contrave, took a treatment used for drug and alcohol addiction and combined it with an antidepressant sometimes used to help people quit smoking." (My guess is that the antid was Zyban.)
It's a nice concept, but I'd hate to see risk of side effects doubled. One med can be a doozy; coupled with another could turn out to be problematic.
More from the NYT: Pharmaceutical companies pay psychiatrists (to push their products) more than doctors in any other specialty.
"For instance, the more psychiatrists have earned from drug makers, the more they have prescribed a new class of powerful medicines known as atypical antipsychotics to children, for whom the drugs are especially risky and mostly unapproved."
The bipolar child paradigm.
Vermont officials disclosed Tuesday that drug company payments to psychiatrists in the state more than doubled last year, to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program.
Over all last year, drug makers spent $2.25 million on marketing payments, fees and travel expenses to Vermont doctors, hospitals and universities, a 2.3 percent increase over the prior year, the state said.
The number most likely represents a small fraction of drug makers’ total marketing expenditures to doctors since it does not include the costs of free drug samples or the salaries of sales representatives and their staff members. According to their income statements, drug makers generally spend twice as much to market drugs as they do to research them.
Doesn't the last sentence make you feel all warm and fuzzy inside? It's great to know that getting people to use drugs are more important to these companies than making sure these drugs are safe to use. Yeah, yeah, I know, it's a company and companies are only out to make profits. Whatever kind of optimist is in me wants to believe that maybe there's one doctor out there who is more motivated by helping others than by pharma-backing money. But I'm only a slight optimist.
June 25, 2007 at 4:01 pm (Antidepressants, Antipsychotics, Bipolar Disorder, Depression, Loose Screws Mental Health News, Medicine/Meds, Mental Health/Illness, Pharma, Schizophrenia, Suicide)
Tags: Bipolar Disorder, Depression, disabilities, disability, dosage, FDA, job, Johnson & Johnson, Lexapro, manslaughter, Mary Winkler, murder, psychiatry, Risperdal, Schizophrenia, settlement, Starbucks, Suicide, teenagers, teens, zoloft
Let’s start off small and build up, shall we?
A blog I came upon, Providentia, has a post on the suicide rate in Kentucky over a 10-year period. Male schizophrenics have the highest rate of suicide. The leading methods of suicide in the state are firearm use, overdose, and hanging.
Mary Winkler, the preacher’s wife who killed her husband, has been moved from jail to a mental health facility
, where she will serve the remainder of her three-year sentence.
East meadow, a poster on the drugs.com message board, asks about Lexapro’s correlation to suicide
. Her sister committed suicide while on Lexapro and questions whether the Lexapro might have affected her in that way. As a former Lexapro user, I can empathize with the change in her sister’s behavior.
The Depression Calculator
: see how much depression is costing your company and see if treatment is worth your while. I went through it for kicks and basically, I walked away feeling like it cost too much to hire someone with depression, especially if I were running a small business. Blah.
Apparently, bipolar disorder is
covered under the Americans with Disabilities Act (ADA). Starbucks is settling an $85,000 lawsuit with Christine Drake
, a former Starbucks employee who suffers from bipolar disorder. It seems that Drake’s first manager was willing to work with her “psychiatric impairment” and allow her to gain “extra training and support.” Then, get this:
“But, during her third year, new management told her she was “not Starbucks material,” refused to continue the accommodation and ultimately fired her for discriminatory reasons, the agency alleged.”
Starbucks probably put up one helluva fight, but in the end, they’ve tried to put a good face and good spin on the situation:
Starbucks agreed to pay Drake $75,000 and donate another $10,000 to the Disability Rights Legal Center, which provides legal representation for low-income people with disabilities facing discrimination, as part of the settlement.
“The facts of this case illustrate how relatively minor accommodations are often all that disabled people need to be productive members of the work force,” said the EEOC’s San Francisco district office director, Joan Ehrlich. “It is important that all of Starbucks’ managers understand their legal duties regarding disabled employees and provide them with the tools necessary to succeed. This is in everyone’s best interest.”
Ms. Drake, who seems to be more than capable of handling a job well, has probably eeked out several years of a barista’s salary from the Starbucks suit.
I’m amused, but it’s not necessarily a good thing.
Johnson & Johnson is gearing up to put Risperdal for children on the market. I’m sure other blogs have beat me to the punch on this, but I just came across this info and found it absolutely retarded. (But what do drug companies care?)
The FDA has approved “expanded use” for Risperdal in teenagers who suffer from schizophrenia and the short-term treatment of bipolar mania in kids ages 10-17. I’m leery enough about antidepressants in kids let alone antipsychotics.
“J&J said the agency has not requested the company perform any additional studies, implying that it need only agree with the FDA on acceptable labeling for the expanded uses in order to gain final approval.”
I wasn’t sure what “expanded use” was so I looked it up. This was the best I could come up with:
“Applications for a new or expanded use, often representing important new treatment options, are formally called “efficacy supplements” to the original new drug application.”
Well, I didn’t know what efficacy supplements were so I looked that up too:
“The legislative history indicates that this provision was directed at certain types of efficacy supplements (i.e., supplemental applications proposing to add a new use of an approved drug to the product labeling).”
So – correct me if I’m wrong – it sounds like the studies performed that led up to this “expanded use” are not as rigorously evaluated by the FDA as the initial studies that allowed the drug to be released on the market in the first place. It just seems like a company and the FDA simply need to agree on “acceptable labeling.” So if we’re following the theory that I’m still correct, the FDA doesn’t follow up on the clinical trials performed on these children, they just agree with J&J on the “acceptable labeling.” Doesn’t that thought make you feel all warm and fuzzy inside about your health?
On the subject of children and psychotropic medications, 12-year-old Christopher Pittman shot and killed his grandparents and then set their house on fire in November 2001 all while on an adult dosage of Zoloft
. It looks like the drama is still playing out in June 2007
According to CourtTV.com, Pittman suffered from hallucinations while on the 200 mg dose and while in jail, displayed symptoms of mania.
“Three years after the killings, Pittman was tried in adult court and convicted of murder. He was sentenced to 30 years in prison. He was then 15 years of age.”
No doubt Pittman should be held responsible for what occurred, especially if he admitted to the killings (which he did). However, the situation raises a few questions. First of all, why was he on 200 mg of Zoloft when he was TWELVE? Why wasn’t he considered mentally ill and placed in a mental health facility? I could go on and on. While Pittman “did the crime and needs to do the time,” why isn’t the doctor who prescribed this not present in any of the reported stories? If this incident was 2001, it can only be worse for antidepressants and other psych meds today.
June 4, 2007 at 11:41 am (Blogs, Medicine/Meds, Pharma)
Tags: Blogs, meds, Pharma
We seem to have a lot of contenders today. Kevin M.D. has a post (linking to PharmaGossip which links to Advertising Age) about the video "exposés" on pharmaceutical companies that have been popping up.
GlaxoSmithKline now has its own one minute, 43-second video on YouTube for Restless Legs Syndrome. Ms. Wetzel said she believes more drug companies and ad agencies will adopt such an approach. "The conversation about health care goes on," she said, "and we're going to have to deal with it."
My job blocks YouTube so I can't see the video
, let alone link to the one I'd like to reference, but the other day, I saw (at least) a minute-long TV ad for Celebrex, but oh man, was it awful. See the craptasticness of it at celebrex.com. While I'm all for pharmaceutical companies being upfront and honest about their products, from a marketing standpoint, this commercial is an unbelievable disappointment. (Who agreed to this?) It's one of the most boring commercials I've ever seen and goes on and on for – oh say, a minute – about all the side effects of Celebrex before getting to the positive aspects about the drug. Has the FDA changed the rules on advertising NSAIDS that I'm not aware of? Here's your sampling:
"Lately, there has been some confusion about arthritis pain treatments. It is important to know that there are risks with all pain medicines, including the 3 most common NSAIDs: CELEBREX, naproxen, and ibuprofen. In fact,the FDA requires all these NSAID pain relievers, including CELEBREX, to have the same cardiovascular warning. Understanding the risks and benefits of different NSAIDs is important. All NSAIDs, including CELEBREX, help relieve arthritis pain, but only you and your doctor can decide which one is right for you. An NSAID like CELEBREX might be an option."
* I just timed it: It was 2½ minutes long.
May 22, 2007 at 10:11 am (Medicine/Meds, Pharma)
Tags: drugs, illegal medication, meds, non-prescribed medication, online medications, online pharmacy, Pharma, pharmacy, prescription medication, prescriptions
I went to retrieve a printed document at the main office copier/printer/fax yesterday and noticed two unsolicited faxes sitting on the upper tray. The first one was the generic tropical vacation deal; the second was from myfirstpharma.com encouraging whomever to order “prescription medication without a prescription.”
You can go on the site and order the prescription medication they offer:
“Just fill out our online questioner [sic] and one of our doctors will write your prescription. Our pharmacy will then fill your order and ship it overnight to your Door.”
First, let’s address the online “questioner.” It doesn’t ask for your symptoms or why you want the drug. The only exception is purchasing a weight-loss drug. You fill in your height, weight, and BMI to verify obesity. So of course, you can’t lie and say you’re 5′ 4″ and 210 lbs when you’re really 5′ 4″ and 110 lbs. [sarcasm] Click the “Buy now” button and all of the shipping and billing information pops up with the “questionnaire” at the end. You must agree or disagree with the questionnaire that consists of the following:
- I agree not to take any over-the-counter medicines without approval from my pharmacist. If you disagree, please explain why.
- I agree not to take medication if I am pregnant, breast-feeding, or trying to get pregnant. If you disagree, please explain why.
- Please list all current medical conditions.
- Is there anything in your medical history that you consider to be relevant?
- Please list all over-the-counter and prescription medications that you are currently taking and the length of time for each.
- Please list all medication that you plan to take while on this program.
- Please list all past or present allergies including allergies to any medications.
- Please list all past surgeries and provide details including the condition that was treated with each surgery.
- Please explain the specific medical reason for ordering this medication. The physician must know the exact nature of your medical problem in order to prescribe this medication. This cannot be left blank.
- Are you currently taking this medication? If yes. How frequent do you take the medication in one day?
If you disagree with any of the above, you need to specify why. (Not sure if you get denied, but it’s what the site requires.) Need an anxiety medication? You can buy Buspar. Want to try different antidepressants without having to go through the hassle of seeing your doctor and dealing with insurance? You can choose from Bupropion, Fluoxetine, Wellbutrin, Paxil, Effexor, and Lexapro.
I highly getting recommend Effexor on your own. [sarcasm]
Needless to say – but I’ll say it anyway – this is ridiculously dangerous. It’s cheaper to go through your doctor ($15 copay, most likely) and insurance (probably a $20 copay), but if you can’t afford that and can somehow afford prescription medication on your own, you’d better cough up some serious dough. Here’s the going rate for effexor on the site:
30 pills at 37.5 mg – $191.00
30 pills at 75 mg – $209.00
30 pills at 150 mg – $217.00
90 pills at 37.5 mg – $361.00
90 pills at 75 mg – $447.00
90 pills at 150 mg – $427.00
In KBTX.com’s article about the subject, Dr. Garth Morgan of University Family Medicine makes a few good points:
“It’s actually very scary for this type of website to actually exist. You have no way of knowing the physician that is prescribing this to you, or if they’re actually a physician,” [Morgan] said. “Looking at the website there is nothing on there that tells you who the doctors are that are prescribing it.”
“Medicines on the site are addictive, medicines on there have a black market value, and people could sell them on the black market,” said Morgan. “If people get on these sites and start ordering these medications and taking them incorrectly they’re going to be coming to the emergency rooms or my office and I won’t have an idea what they’re taking.”
“The medicines that are meant for prescriptions mean you have to have someone follow over you, look over your shoulder, work with you,” said Morgan. “It doesn’t mean it’s just an inconvenience that you have to have a piece of paper to get the medication.”
I found some more information on panicdisorder.about.com (of all places) about the risks involving the purchase of non-prescribed medications:
What is dangerous about buying medications online?
You may find yourself facing the following dangers if you purchase drugs online without a prescription:
- Web sites offering medications without prescriptions are illegal and are not regulated in any way. The medication you purchase may be contaminated. It may not be the correct product or it may not even be a medication. You may be given the wrong dose.
- Wrong medications and dosages put you at risk for drug interactions and other health consequences.
- Both the FDA and the American Medical Association agree that it is unsafe to take prescription medication without seeing a doctor for a prescription. These illegal Web sites often will provide you with medication after you have filled out a questionnaire. A questionnaire cannot determine if a treatment is appropriate for you nor can it figure out if you have any underlying medical conditions that may be complicated by the medication.
- If you purchase medications without a prescription from a foreign Web site, you are at risk for being ripped off financially and there will be little you can do about it. It is generally illegal to import most drugs purchased from these kinds of sites.
I’d like some illegal Percocet, but I’d be too much of a scaredy-cat to give any of my credit card info online.
Here’s the lesson, kiddies: Don’t purchase meds online, even if your PCP is clueless to the risks of psych drugs. It’s worth adding that you shouldn’t even purchase psych meds if your PCP is prescribing them.
(photo from The Red State)
May 3, 2007 at 9:34 am (Pharma)
Tags: BOLDER I, BOLDER II, CATIE, STAR D, STAR*D, studies
All right, I think I asked this before and I know one of my readers sent me a few links to the STAR*D study (which I haven’t had the chance to read). Does anyone know where I can get my hands on CATIE and BOLDER (I and II)? Will this PDF from The New England Journal of Medicine suffice? (I believe it’s phase 1.)
Otherwise, I’ll cross my fingers and hope – oh crap, wait! Maybe I can use the library at my job! Geez, why didn’t I think of this before?
Well, if anyone’s got an electronic copy, that’s preferable. Many thanks in advance.
UPDATE: I just checked the medical library in my building and apparently, I do have access to medical publications that require subscription online. It’s probably unethical to disseminate business material for personal purposes (especially since my other duties require me to work with confidential material), but I can always read the articles and try to pass along bits and pieces that jump out at me here and there.
More during the summer…
April 30, 2007 at 2:17 pm (Antidepressants, Bipolar Disorder, Depression, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: Anafranil, Antidepressants, anxiety, April 30, big pharma, bipolar, Bipolar Disorder, bupropion, chronic pain, clinical studies, clomipramine, Depression, Effexor, fatigue, FDA, FDA approval, Fluoxetine, high blood pressure, hot flashes, IBS, insomnia, irritable bowel syndrome, Journal of Women's Health, magazine, magic pill, medications, meds, Melissa McNeil, menopause, migraines, off-label, off-label prescriptions, patient, patient education, patient responsibility, Pharma, pharmaceutical companies, pharmaceutical industry, Pink, pink magazine, PMS, premenstrual syndrome, Progressive Medical Centers of America, Progressive Medical Group, Prozac, psych meds, quetiapine, quit smoking, Sarafem, Scott Haltzman, Seroquel, smoking, somnolence, symptoms, tricyclic antidepressants, venlafaxine, Vikor Bouquette, weight loss, Wellbutrin, women, Zyban
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.
Dr. Melissa McNeil at the University of Pittsburgh points out three things:
- Since depression is a prevalent (see common) condition, doctors are better detecting it.
- Since antidepressants have proven their safety and efficacy, primary care physicians have no reservations prescribing them.
- 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.
Dr. 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.
April 27, 2007 at 1:12 pm (Celebrities, Medicine/Meds, Pharma)
Tags: Alonzo Mourning, BrandweekNRX, Celebrities, endorsing, Holly Marie Combs, Lorraine Bracco, pharmaceutical ads, pharmaceutical companies, Sally Field, stars, Terry Bradshaw
This is old news, but I found it interesting enough to put up here because of my obsession with celebrities (although I haven’t been keeping up with them recently).
BrandweekNRX posted about the FTC investigating pharmaceutical companies paying stars “undisclosed” amounts of money to endorse medication. BrandweekNRX has the entire list, but here are some of my favorites:
- Alonzo Mourning of basketball team Miami Heart – Johnson & Johnson’s (J&J’s) Procrit for anemia
- Sally Field, an outspoken activist for osteoporosis awareness – Roche Therapeutics’ Boniva
- Holly Marie Combs of Charmed – Ortho contraceptives for J&J’s subsidiary, Ortho McNeil
- Terry Bradshaw, my beloved football commentator – GlaxoSmithKline’s (GSK) Paxil
- Lorraine Bracco of The Sopranos – Pfizer’s Zoloft
April 19, 2007 at 10:06 pm (Antidepressants, Medicine/Meds, Pharma)
Tags: Depression, desvenlafaxine, dosages, dose, Effexor, escitalopram, Lexapro, Nausea, Pristiq, venlafaxine, Wyeth
Depressed Americans will be spared of Pristiq for 1 year. According to an article from Reuters, "positive" data has raised investors’ hopes in Wyeth’s future star drug.
"The trial data showed low doses of Pristiq were effective against both depression and hot flashes and caused less nausea than was seen in prior studies of higher doses. Although the new data will take more time for regulators to analyze, it could bolster prospects for eventual approval and commercial success of the drug."
My best guess? Pharma reps will push Pristiq at higher dosages and doctors will prescribe it at higher dosages with a minimal warning of nausea. I’d like to know the highest dosage tolerated with the least amount of nausea. And really, what is considered a low dosage anyway? The difference between 37.5 mg of Effexor and 300 mg of Effexor is significant despite the fact people told me that the dosages didn’t compare to that of Lexapro’s. (It was supposedly less powerful than Lexapro.)
Anyway, I’ll stop my rants. 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.
March 13, 2007 at 9:44 am (Antipsychotics, Medicine/Meds, Pharma)
Tags: psych drugs, meds, medication, Risperdal, Janssen, Johnson & Johnson, J&J, natrecor, topamax
I was reading the business section of my Metro paper this morning and noticed that Johnson & Johnson was subpoenaed in Boston, San Francisco, and Philly. According to the Associated Press, it is in relation to “sales and marketing of three drugs.” The drugs? Risperdal, Topamax and Natrecor. Risperdal is used for schizophrenia and bipolar mania, Topamax is an epilepsy drug (if not approved for bipolar use, probably used off-label for that purpose), and Natrecor is used for patients with heart disease.
The latest subpoenas seek information about the corporate supervision and oversight of J&J’s Janssen, Ortho-McNeil and Scios subsidiaries, which sell the drugs, J&J said.
J&J posted Risperdal sales of $4.18 billion last year, an 18 per cent increase from 2005. In November 2005, Janssen received a subpoena from the U.S. Attorney’s Office in Philadelphia seeking information about Risperdal marketing and adverse reactions to the drug.
Topamax sales were $2.03 billion last year, a 21 per cent increase from 2005. Ortho-McNeil received a subpoena from the U.S. Attorney’s Office in Boston in December 2003 seeking documents relating to the drug’s marketing, including alleged “off-label” marketing, J&J said in the SEC filing. Doctors often prescribe drugs for uses not described on U.S. Food and Drug Administration-approved labels, but pharmaceutical companies cannot market products for off-label usage.
Do we have another Zyprexa case on our hands?
Between the Risperdal investigations, the Zyprexa lawsuits, the Seroquel lawsuits, BMS’s recent mysterious settlement with the US Attorney in New Jersey (it’s not clear if that was related to Abilify, but I bet it was), plus the pending Congressional investigation of Zyprexa and Seroquel, it looks like the wonder drugs are in a world of trouble. In my adult life, I cannot recall a class of drugs that have ended up in such a pickle before. Nor have I seen such a class of drugs that were once touted as cures turn into such duds. The whole thing is just weird.
The wonder drugs are probably in trouble, but they won’t get pulled off the market and I doubt they’ll get more coverage than how the situation affects the company’s stocks. (This is one area where I’d like to be wrong.) But I agree with Dawdy’s assessment that a class of drugs have never been more criticized than atypicals. There have been individual instances of investigations within a class of drugs, but not a whole slew of them. What leads companies to shady practices in this area when it comes to mental health? Perhaps it’s because the drugs have not been conclusively proven to be the savior they are touted as. Or maybe it’s because the hypotheses – that’s really what the explanations of how these drugs work are – have enough of an effect from clinical trials to market and make a substantial profit. I’d venture to say that psych drugs are the only class of drugs that are marketed based on hypothesis only and not conclusive evidence.
Read more at Furious Seasons.
March 8, 2007 at 1:10 am (Bipolar Disorder, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: affiliations, bipolar, Bipolar Disorder, board, celexa, checklist, citalopram, clinical trials, consultant, Eli Lilly, escitalopram, gabapentin, GlaxoSmithKline, grants, GSK, Havidol, Hirschfeld, imipramine, Lamictal, lamotrigine, Lexapro, MDQ, member, Mood Disorder Questionnaire, paroxetine, Paxil, Pharma, pharmaceutical, pharmaceutical companies, pharmaceutical grants, questionnaire, quetiapine, Robert Hirschfeld, Schizophrenia, Seroquel, sertraline, UTMB, zoloft, Zyprexa
“GlaxoSmithKline, one of the world’s leading research-based pharmaceutical healthcare companies, is committed to improving the quality of human life by enabling people to do more, feel better, and live longer.”
OK, I’ll be honest. I can’t keep up with my own posts and have no idea whether or not I’ve posted on this yet. Judging from the fact that I still have this bp booklet, I’m going to guess not. If I have, then there’s more.
When my psychiatrist diagnosed me with bipolar disorder in November, he handed me a bunch of material: a mood tracker (PDF), an article touting the benefits of Seroquel, and a booklet titled, “Bipolar Disorder,” which refers the reader to www.1on1.health.com.
The booklet seems pretty harmless to a patient newly diagnosed with bipolar disorder:
“Highs and lows can be part of life. But, with bipolar disorder, they can be severe. You may feel too depressed to get out of bed one day. Soon after, you may feel full of energy. You may have normal times between the highs and lows. When people have mood symptoms, it’s more likely to be depression.
Mood swings can be hard to predict. But you may have warning signs. You may even learn what can trigger your symptoms. You’ll read about this and more in this booklet.
Bipolar disorder is complex. Doctors docn’t know what causes it. They know that genes play a role. The illness may be linked to brain chemicals. These chemicals can get out of balance.
There are treatments to help control the symptoms. Learn about your condition. Get help for it. This booklet is a good first step.”
Thank you, GlaxoSmithKline.
GSK, the provider of such psych drugs as Lamictal, Paxil, and Wellbutrin, issues a series of booklets for patients referring them to 1on1health.com. The topics include depression, anxiety disorders, epilepsy, type 2 diabetes mellitus, high cholesterol, among others. The tips seems pretty simple and straightforward:
“Health and lifestyle chances may trigger your symptoms. Some common changes are:
Not having a sleep schedule
Misusing alcohol or drugs
Stopping your medicine, or starting medicine for depression or another illness
Having thyroid or other health problems”
Then it gets into the general stuff about the difference between mania, depression and further clarifies what hypomania and mixed moods are. Then, the kicker follows:
“If you think you may have bipolar disorder, fill out the checklist on the next two pages. Share it with your doctor. He or she can use it to help diagnose you.”
Furious Seasons posted a link about a fake drug named Havidol (which I totally got suckered into because I skimmed the post and missed the “OK, it’s a gag” part), but the hilarity stems from similarly stupid (and vague) questions. I’ve put a screenshot of the PDF GSK provides on their Web site to the right. My issue is not so much with the questions necessarily, but with the lead-in to them:
“Has there been a time when...” [emphasis mine]
It doesn’t matter whether you were 3 years old or 46 years old, if you answered “yes” to more than one “there’s ever been a time when” question, guess what? You MAY qualify for bipolar disorder! A sampling:
Has there ever been a time when…
- You were easily angered that you shouted at people or started fights?
- You felt much more sure of yourself than usual?
- You talked or spoke much faster than usual?
- You were so easily distracted that you couldn’t focus?
- You had much more energy than usual?
- You were much more active or did many more things than usual?
- You were much more social than usual?
- You were much more interested in sex than usual?
Guaranteed everyone reading this said “yes” to at least TWO questions. If not, I question whether you’re breathing. (Sadly enough, this makes me realize how easy it was for me to get fooled by the phony Havidol quiz.)
The follow-up to the questions above asks, “If you checked YES to more than one of the questions above, have several of these things happened during the same period of time?” Then, “How much of a problem did any of these things cause you (like not being able to work, or having money or legal troubles)? Choose one[:]
- No problem
- Minor problem
- Moderate problem
- Serious problem”
The multiple choice question above may not matter. Answering some of the lead-in questions in the affirmative may qualify you for the disorder.
Here’s a nice little tidbit. The questionnaire was “adapted with permission from Robert M.A. Hirschfeld, M.D.” So as an uninformed patient reading this (which I was at the time), I’m thinking, “Oh, this must be legit since they got permission from a doctor to use this checklist.” There’s more than meets the eye here.
On the surface, Dr. Hirschfeld seems like an awesome doctor – and he very well may be. Dr Hirschfeld’s bio from the University of Texas Medical Branch at Galveston (UTMB) extols the “Professor and Chair” of its psychiatry deparment. He has history of working with various national organizations such as the National Depressive and Manic-Depressive Association, National Institute of Mental Health (NIMH), and National Alliance for Research on Schizophrenia and Depression (NARSAD). He’s written all kinds of articles and blah blah blah. He’s considered a leader in his research of bipolar disorder.
In fact, because Dr. Hirschfeld is so great, he’s a member of pharmaceutical boards and has acted as a consultant for pharmaceutical companies, according to ISI Highly Cited.com. Some of our favorite guys appear here: Pfizer, Wyeth, Abbott Labs., Bristol-Myers Squibb, Eli Lilly, Forest Labs, Janssen, and – lookee here! – GSK.
The duration of Dr. Hirschfeld’s affiliations with these pharmaceutical companies are unspecified. All other “appointments/affiliations” have assigned years, i.e. 1972-1977, 2001-Present. His consulting affiliations follow his internship in 1968-1969. It looks a bit misleading to follow the consulting jobs after, oh say, 1969, and not provide dates of when he became a consultant for all of these pharma companies. Toward the end of the document that I found, his affiliations from 1986-Present are listed with various boards, associations, journals, and a slew of pharmaceutical companies.
Hello, hello, hello. He is a MEMBER of the Zyprexa U.S. Bipolar Academic Advisory Board, the Celexa/Excitalopram [sic] Executive Advisory Board, the Lamictal National Advisory Board, and the Zoloft Advisory Board.
Humor me here. His clinical trials include:
- 1994 Paroxetine for Dysthymia (SmithKline Beecham)
- 1995-97 Several (I found five) double-blind studies on sertraline and imipramine in patients qualifying for the DSM-III definition of major depressive disorder
- 1996-98 Gabapentin therapy for bipolar patients
And the list, including mirtazapine, fluoxetine, venlafaxine, lamotrigine, goes on. You can also find the “grants” pharma companies gave to fund these clinical trials.
From 1997-2000, Hirschfeld received a $100K grant from Abbott Labs to develop “a new checklist for bipolar symptoms.” (I’m not sure what the old one was.) In 2001, he received a $142K grant for the “Bipolar Prevalence and Impact MDQ Project.”
I don’t even need to look MDQ up. It’s Mood Disorder Questionnaire. The grant came from GSK, who “adapted” the questionnaire with Hirschfeld’s “permission.” That sounds simply gravy.
To understand more about bipolar disorder, you can listen to the stories of Greg, Stuart and Leslie – all your classic bipolar cases and how medication and/or therapy has helped them so much. You can also watch the bipolar
disorder animation that regurgitates all the things that we’ve become skeptical about.
In the meantime, remember the instructions included in Seroquel’s safety information that no one reads (excuse the crappy “Paint” job):
March 3, 2007 at 1:25 am (Antidepressants, Antipsychotics, Bipolar Disorder, Medicine/Meds, Pharma, Schizophrenia)
Tags: anxiety, bifeprunox, bipolar, Bipolar Disorder, clinical trials, Depression, desvenlafaxine, diabetic, Effexor, Effexor XR, fibromyalgia, GAD, Generalized Anxiety Disorder, hot flashes, learn and confirm, levonorgestrel, lybex, MDD, menopause, neuropathic apin, PMDD, premenstrual dysmorphic diroder, Pristiq, Schizophrenia, vasomotor symptoms, venlafaxine, Wyeth
News stories on Wyeth’s Pristiq, Effexor’s “knockoff”, have focused on the drug’s uses that are pending FDA-approval: vasomotor symptoms accompanying menopause (see hot flashes) and depression. (“Knockoff” term courtesy of CLPsych.) The major media has failed to pick up on Wyeth’s Phase III clinical trials to use Pristiq for fibromyalgia and neuropathic pain (injured tissue or damaged nerve fibers) in diabetics. A search for Pristiq on Wyeth’s Web site yields no results. Desvenlafaxine yields two very meager results.
In related matters, bifeprunox is pending FDA-approval for the use of schizophrenia and is still in Phase III for use of bipolar disorder. They are also in Phase III of testing Lybrex (levonorgestrel) for use for Premenstrual Dysmorphic Disorder in addition to the drug functioning as an oral contraceptive. (I’ll be honest; I had NO clue that diagnosis existed.) In any event, I’ve been misdiagnosed because according to the symptoms, I qualify. I think I also qualify for OOPS – Overdiagnosed and Overmedicated Patient Syndrome.
I’d like expound on Wyeth’s Learn and Confirm phase that’s supposed to replace Phase I and II of clinical trials. It sounds like a speedier way to just get drugs to Phase III of clin. trials, but it’s late and I’m working on something else, so I’ll save that for another day.
Also something to tackle in the future: All these interesting clinical trial results for Effexor XR involving depression and GAD. We’ll see…
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March 2, 2007 at 11:49 am (Antipsychotics, Medicine/Meds, Pharma)
Tags: AstraZeneca, bipolar, Decision Resources, Eli Lilly, gold standard, Lamictal, lamotrigine, meds, Olanzapine, PR, psych meds, psychosis, quetiapine, Schizophrenia, Seroquel, Zyprexa
Whee for self-promotion!
“Eli Lilly’s Zyprexa Will Remain the Clinical Gold Standard for the Treatment of Schizophrenia Through 2015”
“Clinical Gold Standard,” huh?
I can’t bring anything new to the table on this. Maybe I’m wrong, but here I go:
“For almost three decades, Decision Resources has provided in-depth research on the trends, emerging developments, and market potential in various healthcare industry sectors. Our client base is diverse – including large pharmaceutical companies, emerging biotechnology concerns, financial services, managed care organizations, and medical device manufacturers who turn to Decision Resources to help shape their strategy and master their chosen markets.
The privately-owned company offers a rich array of research publications advisory services, and consulting that make it second to none for quality, analytical depth and insight. With access to almost 10,000 thought leaders, specialists, HMO formulary directors, and general practitioners, Decision Resources’ highly-credentialed analysts are able to reconcile real-world practice with hard numbers from the industry’s most respected data sources. The resulting analysis and insights drive business decisions and commercial success within the biopharmaceutical, managed care, medical device, and financial markets.”
Here’s my assessment, take it with a grain of salt: In an attempt to fight the decline in sales from the NYT-induced Zyprexa backlash, Eli Lilly has gone on the offensive and hired Decision Resources to reinvent its star medication.
Decision Resources (DR), a privately owned company (no hyphen if a modifier ends in “-ly”), has a client base that includes large pharmaceutical companies. Ta-da! Don’t get it?
Decision Resources is not a public company; hence, in addition to not receiving federal money, it doesn’t need to report its financial dealings to the SEC. Therefore, no publicly accessible financial records of DR’s clients. They haven’t said they are an “independent” organization. Perhaps this is implied. Whatever the case may be, DR gets paid by its client base to research their products and “help shape their strategy and master their chosen markets.”
This isn’t brain science; this is on their “About Us” section of their Web site. Therefore, if Eli Lilly turns to DR and pays them to – I like DR’s wording here – “shape their strategy and master their chosen markets,” then DR is essentially a PR loudspeaker letting everyone know that Zyprexa is the “clinical gold standard” for schizophrenia.
What a bunch of hooey.
Not too long ago, it seems that AstraZeneca (AZ) may have had DR engineer its new marketing strategy to give Seroquel a boost. Why not? Mental health media watchdogs are hatin’ on the atypical antipsychotics.
“According to a new report entitled Schizophrenia: Turning Physician Insight into Projected Patient Share, Zyprexa is superior in efficacy to all other current therapies, particularly on measures that are most important to prescribers, such as impact on global symptoms and responder rate.”
Holla at me if you’ve got your hands on that report mentioned above.
“In spite of scoring* less favorable than the other drugs in terms of safety and lower than risperidone in terms of delivery features, Zyprexa is the gold standard.”
OK – so it’s not safe and it doesn’t deliver as well as Risperdal – whatever that means – but Zyprexa is still “the gold standard”?
“This overall advantage for a drug with significant safety concerns highlights the importance of efficacy to prescribers.”
I want you to reread that: ” This overall advantage for a drug with significant safety concerns highlights the importance of efficacy to prescribers.” Let’s attempt to paraphrase this: The benefit of this potentially harmful drug shows the importance of how effective it is to those who receive the drug. Although Zyprexa has “significant safety concerns,” the drug works well enough for doctors to prescribe it to patients. Uh, no. Positives don’t outweigh the negatives. It was nice jargon for a second there, though. (If this is effed up enough for adults, why subject children to this crap?)
“The report also finds that the most commercially important emerging antipsychotics (Janssen’s Invega, Organon BioSciences’ asenapine, and Wyeth/Solvay/Lundbeck’s bifeprunox) score* lower than Zyprexa, indicating that Zyprexa will remain unsurpassed during Decision Resources’ forecast period.”
I know I’m doing a play-by-play but this is important. I need to find out how DR decided that Zyprexa would be the “gold standard” until 2015. (
What’s the significance of this year? Does EL’s patent on Zyprexa expire then? Nope, Eli Lilly’s patent on Zyprexa expires in 2011. Expect a similar molecularly structured olanzapine before then. Biolexapine?) So basically, in this report, DR’s conclusion is Zyprexa beats every other atypical antipsychotic for schizophrenia by far. Notice that AZ’s Seroquel (the soon-to-be “gold standard” of bipolar meds), an atypical also used for schizophrenia, is not listed. Not coincidence.
The little asterisk (*) next to the word “score” prompts me to wonder: Just how did they come up with these scores? Well, the asterisk tells me that I need to contact DR for the methodology behind the product scores. I just might. Then send it off to CL Psych or Furious Seasons to decipher the crap out of it.
Another thing to note on this PR:
“”Invega is a metabolite of risperidone and is likely to have efficacy similar to that of risperidone, which scored* slightly lower than Zyprexa overall,” said Nitasha Manchanda, Ph.D., analyst at Decision Resources. “Asenapine also lacks the differentiation to replace Zyprexa as the gold standard because it does not make as significant an impact on global symptoms, and bifeprunox is significantly inferior to Zyprexa in all primary efficacy measures and is not capable of surpassing Zyprexa.””
Dr. Manchanda, analyst for DR, pulled bifeprunox – not yet on the drug market – into the Zyprexa comparison and somehow was able to call it “significantly inferior to Zyprexa” with an incapability to “surpass” it. How many people have used bifeprunox, Ms. Manchanda? OK, now tell me how many people have used Zyprexa? And you’re telling me that a drug that hasn’t yet hit the market is “significantly inferior” to a drug that has been on the market for the past couple of years and has 1,200 lawsuits still pending in addition to the millions that have already been paid?
As for AZ, DR has determined that Seroquel will become the “gold standard” for bipolar medication by 2010, knocking Lamictal out of its current “gold standard” status. Like Furious Seasons, I had NO idea Lamictal was held up so highly for bipolar meds. Considering that lithium has always been the king of bipolar meds and treats both acute mania and depression better than Lamictal, I’m surprised to read this.
“According to the new DecisionBase report entitled Bipolar Depression: Turning Physician Insight into Projected Market Share, Seroquel’s advantages over Lamictal include the more profound effect on depressive symptoms seen in short-term trials.”
My doctor precribed Lamictal to me for management of depressive symptoms in bipolar disorder. He conversely prescribed Seroquel for mania (and to help me get sleep). Getting back to the short-term trials, Lamictal was tested for 18 months for long-term management of bipolar disorder. Seroquel, however, was tested for 8 weeks. Effective for the short-term? Perhaps. But most patients on atypicals take them long-term. And that’s precisely where Seroquel fails.
“The drug’s efficacy on this measure differentiates it from other therapies, according to thought-leading psychiatrists, and the importance assigned to this measure by prescribing psychiatrists drives Seroquel’s product score above Lamictal’s.*”
According to thought-leading psychiatrists who probably function as consultants and analysts for “large pharmaceutical companies.” Seroquel may have the potential to sell more than Lamictal by 2010 – if this is what DR’s gauging. However, it seems like DR is trying to push Seroquel, not just as a better market share, but as a better product. In this “report,” DR also fails to compare Seroquel’s efficacy to Zyprexa’s. What a convenient absence for a product used for psychosis in bipolar disorder.
(ignore any spelling errors in this post. it’s late and i bumped my forehead against the edge of a car door in the rain. ouch.)
March 1, 2007 at 9:59 pm (Pharma)
Tags: clinical trial phases, clinical trials, clinicaltrials.gov, FDA, phases
Some of my readers may not have any clue about the difference between Phase I, II, or III of clinical trials, except that they’re, uh, different. Here’s info courtesy ClinicalTrials.gov:
Most clinical trials are designated as phase I, II, or III, based on the type of questions that study is seeking to answer:
* In Phase I clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
* In Phase II clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
* In Phase III studies, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
* In Phase IV studies, the post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations."
I’m sure a pharma blog will pick up on Pristiq soon enough.
February 28, 2007 at 9:53 pm (Antidepressants, Depression, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: clinical trials, Depression, desvenlafaxine, Effexor, Effexor XR, FDA, hot flashes, MDD, menopausal, menopause, Newsday, Pristiq, vasomotor symptoms, venlafaxine, Wyeth
As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.
While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."
"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."
Read the rest of this entry »
February 26, 2007 at 4:07 pm (Antipsychotics, Bipolar Disorder, Blogs, Medicine/Meds, Pharma)
Tags: ADHD, bipolar, Bipolar Disorder, Blogs, Dawdy, Eli Lilly, FOIA, Furious Seasons, medication, meds, mental health, NYT, Olanzapine, Pharma, pharma companies, psych meds, Zyprexa
I’ve been out of it. Really out of it.
In my backlog of reading, Furious Seasons has posted the results of what he’s entitled, "The Zyprexa Chronicles."
The judge ruled in favor of Lilly.
Holy crap. I knew this would happen, but hoped it wouldn’t.
This all occurred on Feb. 13, so I’m really behind the times here. (Did Punxsawtawney Phil see his shadow yet?) But it’s a reminder to, not just the blogosphere, but also to the media that, well, pharma companies are more powerful and have more sway in court.
After reading a bit more on the situation (ok – I’m getting all my info from ONE blog), it seems that the judge hasn’t really ruled against blogs using or disseminating these documents (MindFreedom.org being the exception apparently) but these leaked documents could cause Lilly "irreparable harm." What? Documents that need to be made public would harm Lilly? It’s David against Goliath. Mainstream media — CBS, ABC, NBC, AP — haven’t picked up on this story. The majority of Americans – I’d venture to say the majority of Zyprexa consumers – don’t know about the proven side effects of this drug. I highly doubt it would cause "irreparable harm."
"The way reporters work is a good deal for the public. We get paid like school teachers, think like lawyers and detectives, fight like Marines when necessary and write like… oh, nevermind."
Man, ain’t it the truth. Especially the schoolteacher pay. Except in Brooklyn, NY where they’ll pay a starting teacher at $40K because they need teachers in the inner city. But I digress.
"So, Ms. [Marni] Lemons (Eli Lilly spokeswoman), what I reported on yesterday — that your company was talking about potentially downplaying glucose increases noted in studies used to approve Zyprexa for long-term use in bipolar disorder — was based on these documents and it sure looks to me like your employees were strategizing all over the Lilly email system. I contacted your press office on Monday and asked them to respond to several questions about that document. Your people never responded….
The same goes for you people at the FDA. Stop telling me to file FOIAs in order to get basic public information that affects millions of people that should already be freely available on your website."
For those who don’t know, FOIA stands for Freedom of Information Act, in which anyone can write to a governmental agency and appeal for documents that have been made public. The nice part about this? The agency can black out information that don’t want you to know. They can deny your request, block out some data, or block out so much that the document ends up being useless. Oh, and FOIAs take forever and freaking day to arrive because the gov’t sends them when it’s convenient for them.
Furious Seasons has also been following the NYT’s coverage about a child diagnosed with ADHD and bipolar, who was killed and supposedly overdosed on medication. Riiight. Unfortunately, from what I can see – perhaps I’ll find a bit more – the NYT is extensively covering mental health issues. Perhaps they’re getting a ton of hits on the Zyprexa series and have figured out that people actually care about mental health topics. Whatever the reasoning, I’m glad they’re doing it.
Astute observation from Furious Seasons:
"This whole diagnose-medicate-blame-the-"illness"-for-bad-outcomes nonsense has got to stop. It’s bad enough in adults and teens, but in kids it is a complete outrage. It is interesting to me, though, that when a child dies, the skeptical questions are asked. When an adult has awful results from taking Zyprexa, say, or Paxil, the media is largely silent."
More to come on other blogs…
January 29, 2007 at 9:15 am (Depression, Pharma)
Tags: assessment, checklist, Depression, depressionhurts.com, Eli Lilly
The following is brought to you by Eli Lilly:
“Depression hurts. But you don’t have to.” Feel free to check Furious Seasons’ post featuring YouTube videos on Eli Lilly’s latest depression campaign.
January 26, 2007 at 10:17 am (Antipsychotics, Bipolar Disorder, Medicine/Meds, Pharma)
Tags: Abilify, advertisements, Antipsychotics, Aripiprazole, atypical antipsychotic, atypicals, bipolar, Bipolar Disorder, bipolar I, intueri, manic, marketing, medication, meds, mixed episodes, pharmaceutical companies, phone booth, psych meds, psychosis, public telephones
Oh. My. Goodness.
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.
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 24, 2007 at 11:26 pm (Depression, Loose Screws Mental Health News, Medicine/Meds, Pharma, Quotes)
Tags: card, dopamine, drugs, fashion jewelry, generics, graham's blog, Gretchen Rubin, happiness project, lawsuit, made with molecules, Merck, neurotransmitters, patents, Pfizer, Pharma, pharmaceutical company, plaintiff, serotonin, torcetrapib, Vioxx
Wow. I learned something new – “Women are over-represented in all cases of” depression, anxiety, dysthymia and panic attacks. Read more here.
An interesting observation
from Gretchen Rubin, blogger of The Happiness Project
“Studies showed that depressed people have as many nice experiences as non-depressed people, but they remember them less well.”
Graham’s Blog has linked
to interesting fashion jewelry: Made with Molecules
. For only $20, you can:
“Display your favorite neurotransmitters close to your brain!”
Erhm. The very thought of this disturbs me. Also feel free to purchase a serotonin-happiness card or a dopamine-heart card – just in time for Valentine’s Day.
Pfizer is cutting 10,000 from its workforce
citing nothing other than loss of profits:
“The drug giant Pfizer said Monday that it would lay off 10,000 workers and close several manufacturing and research sites in an effort to bolster earnings hurt by the loss of patent protection on certain drugs and by setbacks in developing new products.”
I’ve mentioned patent protection before but it seems that Pfizer isn’t generating enough “structurally related” drugs to prevent the loss of its profits to generics. The two biggest losses: Zoloft and Zithromax.
“Pfizer said the moves would save $1.5 billion to $2 billion a year in pretax expenses.
Pharmaceutical industry analysts have generally been welcoming cutbacks by Pfizer but have said that while cost-cutting is beneficial, the company needs to resume growth by bringing new products to market.”
Pfizer’s a big company; I’m sure they’ll have no problems rebounding. However, I have no doubt that the failed torcetrapib factored into Pfizer’s decision to cut staffers.
A Philly plaintiff in the Vioxx suit against Merck has willingly withdrawn
her suit. She cannot refile against Merck.
“Merck has consistently said it will fight each case on a one by one basis rather than submit to a large settlement.
In trials that have reached a jury verdict so far, Merck has won nine and lost four, including one Merck victory that since has been thrown out.”
The legal fees surrounding the Merck case must be astounding, but is it really worth it for Merck to drag these cases out against 27,000 other plaintiffs? I would assume on Merck’s part that it would be cheaper to settle. But then again, maybe it’s the whole “we need to clear our name” thing. That’s a fast way to lose profits for a pharma company.
January 24, 2007 at 2:00 pm (Antipsychotics, Medicine/Meds, Pharma)
Tags: Bloomberg, Byetta, chart, diabetes, drug companies, drugmakers, Eli Lilly, exenatide, medication, Metro, Metro newspaper, Metro Philly, Olanzapine, Pharma, pharmaceuticals, psych meds, Schizophrenia, Zyprexa
I found this Bloomberg chart in the Metro Philly newspaper and thought it showed an interesting paradox. I tried to find a link for it on the Internet but as of yesterday, there was none.
January 22, 2007 at 9:32 am (Adverse Effects, Anticonvulsants, Bipolar Disorder, Medicine/Meds, Mental Health/Illness, Pharma, Suicide)
Tags: bipolar, Bipolar Disorder, Eli Lilly, epilepsy, gabapentin, Lyrica, marketing off-label, medication, Neurontin, neuropathic pain, non-FDA approval, OCD, off-label, off-label prescription, off-label uses, Olanzapine, Parke-Davis, Pfizer, postherpetic neuralgia, pregabalin, side effects, Suicide, Warner-Lambert, Zyprexa
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.
Read the rest of this entry »
January 22, 2007 at 7:00 am (Antipsychotics, Medicine/Meds, Mental Health/Illness, Pharma)
Tags: Abilify, big pharma, bipolar, Bipolar Disorder, bipolar I, CLPsych, Eli Lilly, Furious Seasons, gabapentin, generic drugs, intueri, Lyrica, Neurontin, Parke-Davis, patented drugs, Pfizer, pharmaceuticals, PharmaGossip, pregabalin, psych meds, reverse payments
Nearly every mental health blog I know is talking about this post from intueri.org. It’s definitely worth the read. I don’t know much about Abilify, but I don’t think most uneducated bipolars know that it is prescribed specifically for those with psychosis. On the flip side, I don’t think uneducated PCPs know that tidbit either. A person with bipolar without symptoms of psychosis who asks for Abilify may be in for a rude awakening. [UPDATE: Who paid this chick? I only skimmed the post but I don’t see any negative side effects listed.]
I’m not deep into the pharmaceutical industry like all of these heavyweights: CL Psych, PharmaGossip, and Furious Seasons, among many others whom I may have failed to mention. However, there’s a wealth of information to be found. My newest discovery:
“The approach is called ‘ethical pharmaceuticals,’ and it was unveiled on January 2 by Sunil Shaunak, professor of infectious diseases at Imperial College, and Steve Brocchini of the London School of Pharmacy, the Guardian reports. Their team of scientists in India and the UK, financed by the prestigious Wellcome with technical assistance from the UK government, have developed a method of making small but significant changes to the molecular structure of existing drugs, thereby transforming them into new products, circumventing the long-term patents used by the corporate giants of Big Pharma to keep prices – and profits – high. [emphasis mine] This will give the world’s poorest and most vulnerable people access to life-saving medicines – now priced out of reach – for mere pennies.”
I read the above on CLPsych’s blog (originally from Chris Floyd at truthout) and couldn’t believe what I was reading. It somewhat ties into what I’ve been researching about Neurontin (which will probably be posted later in the day):
“Pfizer has developed a successor to gabapentin [Neurontin’s generic name], called pregabalin (being marketed as Lyrica®). Structurally related to gabapentin [emphasis mine], pregabalin is effective for neuropathic pain associated with diabetes and shingles, and for the treatment of epilepsy and seizures.”
Pfizer, in an attempt to distance itself from the trouble surrounding Neurontin, developed another medicine – pregabalin, which is similarly structured to gabapentin. Pfizer can now claim, “Don’t like Neurontin? You can have Lyrica instead!” Pfizer also tried to pass off the (illegal) off-label marketing practices with Neurontin off to their acquired division Parke-Davis. So now we’ve got two options: Pfizer either has learned from Parke-Davis’ issues with Neurontin or is pretty stupid and pushing Lyrica for off-label usage similar to that of Neurontin’s. No evidence to support either option… yet. But CLPsych delves into an interesting practice that Pharma companies use to circumvent a drug patent running out:
“News Flash — PhRMA does NOT believe in the free market: While PhRMA likes when the market works in their favor, they also believe in circumventing that same market when it comes to competition. When drugs are slated to come off-patent, which would allow generic version of the drug to be made, PhRMA members have increasingly turned to buying off the competition. That’s right; they simply pay the generic manufacturer to not make a generic version of the patented drug, so that the consumer can continue to pay a hefty price for the drug which is still under patent. [emphasis sorta mine]“
Wow. That bit of information has left me speechless. Screw the consumer that can’t afford psych meds without health insurance; we as Big Pharma need our DAMN money!!! [end rant]
This practice, called “reverse payments,” is not something new and, at the current moment, is relatively legal. Supposedly, the FTC and the Department of Justice are keeping their eyes on reverse payments and patients can only imagine what might occur in the future. PharmaGossip has more, but slips this bit of info before linking to the Star-Ledger:
“And with the patents on 70 blockbuster drugs — with a total of $48 billion in annual sales — set to expire by 2011, the industry expects reverse-payment deals to proliferate further.”
The FTC and Justice Department better hurry up and step in so we can finally have a generic version of Lipitor!
In all honesty, my mind can’t simply fathom the depths to which Pharma will stoop to make money. (Perhaps because I don’t work directly within the medical industry.) It has me wondering if Pharma is worse than gas companies. Is OPEC more trustworthy than Eli Lilly? I’ll leave it up to you to decide.
January 20, 2007 at 5:07 pm (Antipsychotics, Celebrities, Depression, Loose Screws Mental Health News, Mental Health/Illness, Pharma, Suicide)
Tags: Andre Water, Berenson, brain damage, Eli Lilly, FDA, gabapentin, lawsuits, mental illnesses, Neurontin, New York Times, NFL, NYT, Olanzapine, pets, settlements, Spikol, sports therapy, Suicide, the trouble with spikol, Zyprexa
Yay for the New York Times! Alex Berenson, doggedly keeping up on the Zyprexa story, has written an article about how state prosecutors in Vermont and Illinois are now demanding that Eli Lilly submits documents to them about their marketing practices of Zyprexa. Something I didn’t know:
“Federal prosecutors in Philadelphia have also recently accelerated their own investigation into Lilly’s marketing of Zyprexa.”
My residence in the Philly area has prompted me to follow this closely now. More juicy information:
“In a statement yesterday, Lilly said it would cooperate with the investigations and had done nothing wrong. ‘We intend to cooperate with the Illinois attorney general’s civil investigative demand relating to Zyprexa,’ the company said.
While the investigation being led by Illinois is civil, other investigations into Lilly’s conduct are both civil and criminal. [emphasis mine] Attorneys general in California and Florida may seek to recover Medicaid payments that the states made for Zyprexa. Any fine or cost recovery could be sizable, because Zyprexa has been a commercial success.”
Because investigators need to search through more than 10,000 documents relating to Zyprexa and its marketing and talk to former and current employees about the matter, it could take years for anything to happen. Berenson’s last paragraph at the end brought my excitement to a quick halt:
“As long as drug makers comply with federal requirements to provide data about their products to the Food and Drug Administration, companies have a relatively strong defense against criminal prosecution, according to lawyers who are experts in drug marketing.”
Great. So as long as Lilly complies with the FDA and state and federal prosecutors, they can escape criminal prosecution. Please don’t tell families who have loved ones who died over this medication. Lilly’s settlements are nice and all, but money is never restitution for someone’s death. I’ll soon have a post up about how Pfizer had this issue with Neurontin from 2002-2004. They, too, had to pay more than $430 million to settle lawsuits on civil and criminal charges. Pfizer plead guilty; let’s see if Eli Lilly follow suit (no pun intended).
I’ve been a little late on the bus with this, but I’ve previously written about Andre Waters who killed himself in November. Despite theories of depression surrounding his suicide, a neurologist has claimed that Waters sustained brain damage from playing football which triggered his depression and led to his death. Dr. Bennet Omalu, an expert in forensic pathology, says that Water’s brain tissue “had degenerated into that of an 85-year-old man with similar characteristics as those of early-stage Alzheimer’s victims.” Omalu gets pretty grim though:
“If [Waters] had lived, within 10 or 15 years ‘Andre Waters would have been fully incapacitated.'”
The NFL has no comment.
As I’ve been trying to tell my husband recently, pets can relieve symptoms of depression. Come on, who can be sad when you’ve got an happy little dog wagging its tail at you with bundles of love? (I’m thinking cute little Yorkies or friendly Golden Retrievers.) Owning a pet can have great mental health benefits:
- Can reduce anxiety
- Induce social contact
- Promote a better quality of life
- Help kids develop higher self-esteem and lower levels of fear
The only downside: animals can cause stress. But it seems like the stressors can be addressed, i.e. animal training, neutering. (source: The Trouble With Spikol)
Also linked to by Liz Spikol, another interesting mental illness combatant: sports therapy. It seems that it can help those suffering from PTSD, abuse, amnesia, and shyness. Italian doctors, however, a testing to see if soccer can treat illnesses like depression and schizophrenia. This should be interesting.
Oh, and NOTHING to do with mental illness, but I found this NYT article on weight loss and maintaining it quite interesting.
January 19, 2007 at 8:27 am (Antipsychotics, Pharma)
Tags: Dawdy, Eli Lilly, Furious Seasons, Olanzapine, Zyprexa, zyprexa documents
Looks like Weinstein might redeem himself:
"The judge is asking Eli Lilly’s lawyers to now justify why the court documents that slipped out into the world last month should continue to come under the court’s seal. Good call by the judge."
Ooh, this should be interesting. (Furious Seasons)
January 18, 2007 at 9:18 pm (Antidepressants, Antipsychotics, Bipolar Disorder, Children, Depression, Loose Screws Mental Health News, Medicine/Meds, Mental Health/Illness, Personal, Pharma)
Tags: anxiety, bipolar, Bipolar Disorder, black-box warning, blood sugar, dementia, depressed, Depression, diabetes, Eli Lilly, FDA, hyperglycemia, infant depression, Jack B. Weinstein, Lilly, mania, manic, manic-depression, mental health, mental illness, mirtazapine, off-lable, Olanzapine, psychosis, psychotic, PTSD, remeron, weight gain, zispin, Zyprexa
Starting off with some crazy (npi) mental health news, psychotherapists are now beginning to diagnose depression and anxiety in – infants. Yes, infants. Before you know it, newborns will begin suffering from post-traumatic stress disorder after enduring complications during delivery. Fetuses will suffer from depression due to lack of exposure to light.
I’m all for diagnosing mental illness in children, but infant depression? Unless it’s mistreated, the concept is ridiculous.
“He says he doesn’t put babies on the couch. Instead, he observed Jayda through a one way mirror. He was looking for clues on why she wouldn’t bond with her mother, Kari Garza.”
“Psychologist Douglas Goldsmith says ‘even by the first birthday, some of the research is saying we should be able to start to see signs of more serious social disorders.’
There are some warning signs to look out for, such as a lack interest in sights and sounds. Others include of lack of desire to interact; listlessness; or excessive crying.”
I can’t help but think it’s rooted in a physical rather than a mental problem. I excessively cried for six months as an infant; no knew that I’d developed eczema and the itching was unbearable because I wasn’t able scratch.
“Figuring out what’s depression versus normal behavior is hard, according Pediatrician Linda Nelson of the Franciscan Children’s Hospital, because ‘the crankiness and all of that, teasing that out from true depression, it’s very difficult.'”
Josh of “We Worry” writes:
“I may be way off the mark on this one, but if Iâm not mistaken, an infantâs cognitive abilities are incredibly limited and, for the most part, are dictated entirely by instinctual behaviors. It seems that it would be impossible to determine if an infant had depression or anxiety because itâs impossible to ask them.”
Nope, not off the mark at all.
Want to know what dealing with a bipolar is like? The following is dead on
“Bipolar is a hell of a disease, and I wonder if patients [at my community health center job] knew how devastating it is, whether they’d choose to label themselves that way.
Bipolar used to be called manic-depression. People with bipolar disorder are constantly on a roller coast ride between severe depression and mania. On the depressed end, this can include feelings of worthlessness, excessive guilt, changes in eating (over- or under-), changes in sleep patterns (can’t go to sleep or can’t wake up), and recurrent thoughts of death.
On the manic end, bipolar people experience feelings of grandiosity, believing they’re capable of things nobody can do. At this end of the spectrum they often sleep very little, their thoughts race, and they can’t stop talking. They tend to get involved in risky activities, such as unrestrained buying sprees, sexual indiscretions, or foolish business investments. Some feel more angry than expansive in their manic phase, or when they’re on their way up or down.”
Congrats. You get the gold star. You’ve just learned something today (if you’re not bipolar).
I recently read Graham’s Blog
and among a list of meds
, I saw “Zispin.”
It’s trademarked as Remeron in the U.S. and Zispin in Great Britain. The generic name is mirtazapine. Sounds like a name for a German lady – Fraulein Mirtazapine.
According to the wonderful wikipedia, mirta treats “mild to severe” depression.” That’s a wide spectrum of patients to cover. Mirta is as effective for people with mild depression as it is for those who are dang near suicidal everyday? I’m not convinced.
Of course, since it’s a med, it’s used off-label for panic disorder, GAC, OCD, and PTSD among other health problems.
If you’re you suffer from bipolar and get a prescription for this stuff, get another doctor quick: mania is a side effect.
I won’t get into the fine details of how mirta works, but it appears that it enhances neurotransmitter actions rather than affect serotonin levels directly.
There’s my new medication lesson of the day.
I’m late on the bandwagon, here. I’m sure Furious Seasons
, CL Psych
, and other blogs have railed on the injustice of Judge Weinstein’s stupid –
yes, it is stupid –
decision to uphold his gag order
(he imposed it so why would he change it?) that keeps blogs from “dissemination” Eli Lilly’s leaked documents. Basically, the judge wants to block wiki Zyprexa Kills
from showing this info. Any other blog that has the documents, links to it, or publishes it is â well â subject to a gag order as well. *gag*
I have a personal opinion on the matter and since you’re reading this blog, you’ll be subjected to it.
Read the rest of this entry »
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