Done deal: Pfizer buys Wyeth for $68 billion

Pfizer-Wyeth merger

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.

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Pfizer may be buying Wyeth

Pfizer-Wyeth merger

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.

Lamictal's generic equivalent, lamotrigine, has now hit the market

So much for Miss Up-on-Pharmaceuticals.

I’ve been paying so much attention to Pristiq that the very medication I take slipped out from right under my nose.

How did I find this out? It hit me where it hurt.

In the pockets, of course.

I went to CVS yesterday night for my Lamictal refill. Since I’ve been under my husband’s plan, we’ve been paying about $40 for the medication. So I nearly doubled over when the pharmacy cashier said $54.

WHAT?

I was in a bit of a foul mood about money anyway so the last thing I wanted to do was argue about the cost of my prescription that had jumped up by $14. (Which, in retrospect, I probably should have done because I could have saved $49 right there.)

I came home and made my husband’s day go from bad to worse. He flipped out and got on the phone with his insurance immediately. He said that the max he should pay on any medication is $50 so why was he paying $54 and why the cost rose so sharply.

“Well, sir, it’s because Lamictal has now gone generic and you’re paying the difference between the cost of the medication and the cost of the generic.”

Bob gets off the phone and goes straight to Google News to find out when Lamictal went generic.

Money & drugsAccording to MarketWatch.com, Teva Pharmaceuticals commenced shipment of lamotrigine tablets on July 22nd
. So instead of either the pharmacist asking me if I wanted a generic version or the insurance company letting us know a generic version would be available (it would have saved them money), we ended up paying $49 more than necessary. It appears that Teva’s generic is AB-rated, which means that it has similar strength, bioequivalence, and efficacy. Overall, it likely shouldn’t be a problem if I go from Lamictal to lamotrigine. At least I hope not. We’ll see.

Mood rating:
5

Breggin takes on Newsweek's "Growing Up Bipolar" article

Breggin’s post on Newsweek‘s "Growing Up Bipolar" article makes good points but steers clear into wackiness throughout. My only wish is that instead of pointing out the problems of the psychiatric industry, he would have offered some suggested solutions.

Oh, and he flat-out gets some things wrong:

Newsweek makes clear that Max’s parents have serious conflicts over how to raise their son, but they have not pursued therapy, marriage counseling or, apparently, not even parenting classes.

The article DID mention that they tried to pursue marriage counseling but dropped out.

He says he has never been to therapy. But late last year, Amy demanded that the two of them see a marriage counselor. Richie agreed. They went a few times, but there were "scheduling issues," says Richie, and they haven’t gone back. For the moment, they are getting help from the same people who help Max. Anything that makes his life easier makes theirs easier, too.

Then he applies a broad brush from the cases of "out-of-control" children that he’s seen:

In every case of an out-of-control child I have seen in my psychiatric practice, either the parents were unable to reach agreement on a consistent approach to disciplining their child, or a single working mom was trying to raise a young boy without the aid of a male adult in the child’s life.

I like Peter Breggin’s approach to psychotropic drugs for the most part, but sometimes he just gets a little off-base for me.

Pharma's "me-too" drugs face skeptical docs and health insurers

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.

InvegaCase 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.

Ouch.

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)

My official position on pharmaceutical companies and psychotropic meds

In previous posts, perhaps I’ve come off a little bit as “I hate Big Pharma.” I did. For a while.

I’m not in love with pharmaceutical companies either. I’ve quoted it before but “to whom much is given, much is required.” As a result of accumulating knowledge through reading and research, I know a whole lot more about pharmaceutical companies, the treatment options they put out there, and what lengths they go to get those treatments out there. Most of the things I read are negative. Much of what I’ve said is negative. Perhaps “ignorance is bliss.” My husband said this recently:

“The Internet is the great bitching ground. No one’s going to talk about how great medication is. Everyone’s going to go on and just bitch about side effects and bad experiences.”

I agree. “Effexor really helped me feel better today” doesn’t make for an interesting blog post. No one pays attention to medication when it’s working, however, everyone will complain if something is going wrong. The most “positive” drug comments I’ve seen are on my seemingly “negative” posts from people who are being helped by a drug.

Take, for instance, the following comment from Suffering:

Read the rest of this entry »

Alaska's "clinical" trial of Eli Lilly over Zyprexa

Since I've been gone, a trial has begun in Alaska against Eli Lilly because of its off-label drug marketing of Zyprexa. Then, Connecticut recently decided to join a growing list of states going after Lilly as a result of the Zyprexa deal. There is so much going on with this case I can't even keep up.

But that's what we keep Philip Dawdy around for. 🙂

Pregnancy is NOT a mental illness

I stumbled upon Yankee Cowgirl’s blog that mentioned Congress is working on the MOTHERS (Mom’s Opportunity to Access Health, Education, Research, and Support for Postpartum Depression) Act which would “strongly encourage pregnant women into mental health programs – that means drugs – to combat even mild depression during or after giving birth.”

She links to a column written by Byron J. Richards on newswithviews.com. He writes:

The Mothers Act is pending legislation that will indoctrinate hundreds of thousands of mothers into taking dangerous psych drugs.

He goes on to slam Big Pharma about how they control Congress and how mothers don’t need psych drugs for a natural birth process.

The Mothers Act (S. 1375: Mom’s Opportunity to Access Health, Education, Research, and Support for Postpartum Depression Act) has the net affect of reclassifying the natural process of pregnancy and birth as a mental disorder that requires the use of unproven and extremely dangerous psychotropic medications (which can also easily harm the child).

These are some serious accusations. I got pretty riled up myself and decided to see what Congress said in the bill.

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Blood test for efficacy of antidepressants in the future?

Scientists have found that a biomarker for depression could show whether a person's antidepressant is working. The discovery could lead to something everyone in the psych world has been waiting for: a blood test of some kind.

The researchers looked at the interaction of neurotransmitters and a protein called Gs alpha. In brain cells, the protein acts like a kind of butler, passing messages from neurotransmitters on the outside and amplifying their messages, [study co-author Mark] Rasenick explained.

When the protein is working properly, it's like a butler whose "hands are just flying, cooking and cleaning at the same time," he said. But when the brain is depressed, "it just sits there in the corner."

That's an interesting observation. This might finally explain the difference between "depressed" brain activity and normal brain activity on an MRI. (By the way, has anyone had an MRI performed for depression?)

Researchers compared the proteins in the brains of people who committed suicide as a result of depression to those who did not. "They found the protein would have worked less effectively in the brain cells of the suicide victims."

Dr. Gregory Simon conceded that doctors cannot determine which antidepressant will work for which person.

"There's a long history of research using patterns of symptoms or biological measures — chemicals measured in blood or spinal fluid — to predict response to a particular antidepressant. None of those hoped-for predictors have significant value.

[Genetic tests] would not eliminate trial-and-error, but it would reduce the waiting time with each trial. But it's a long way from a study like this one to a test that's useful to patients and doctors."

Good news for the skeptics about this research study: It was funded by the U.S. Public Health Service and the American Foundation for Suicide Prevention. But a test simply to see if an antidepressant is working has the smell of pharma somewhere on it.

(Hat tip: Ephphatha)

Blogs around the way

I’m catching up on reading my fellow bloggers’ posts (see Blogroll to the right), so if you’re not reading their site already, I’d encourage you to do so. Below  are some posts that caught my attention. Some might be a little dated.

Gianna at Bipolar Blast: Has a video up of Gwen Olsen, an ex-pharma rep who says that pharmaceutical companies aren’t in the  business of curing but in the business of "disease maintenance and symptom management." It’s nothing new but here are two quotes that caught my attention:

"And what I’m saying is provable is that the pharmaceutical industry doesn’t want to cure people. You need to understand specifically when we’re talking about psychiatric drugs in particular that these are drugs that encourage people to remain customers of the pharmaceutical industry. In fact, you will be told if you’re given a drug such as an anxiolytic, or an antidepressant, or an antipsychotic drug, that you may be on the drug for the rest of your life. And very frequently, people find that they are on the drug for a very long period of time, if not permanently, because they’re almost impossible to get off of. Some of them can have very serious withdrawal symptoms – most of them can have extremely serious withdrawal symptoms if they’re stopped cold turkey – but some people experience even withdrawal symptoms when they try to titrate or they try to eliminate the drug little by little, day after day."

"We have got to start making the pharmaceutical industry accountable for their actions and for the defective products they’re putting on the market. It won’t be long before every American is affected by this disaster and we need to be aware of what the differences are between diseases between disorders and between syndromes. Because if it doesn’t have to be scientifically proven, if there are no tests, if there are no blood tests, CAT scans, urine tests, MRIs – if there is nothing to document that you have disease, then you in fact, do not have a disease, you have a disorder and it has been given and has been diagnosed pretentiously and you need to get yourself educated and understand that there are options and those options are much more effective than drugs."

I’ve always wondered why doctors don’t run tests to diagnose any psychiatric disorders. From NIMH:

Research indicates that depressive illnesses are disorders of the brain. Brain-imaging technologies, such as magnetic resonance imaging (MRI), have shown that the brains of people who have depression look different than those of people without depression. The parts of the brain responsible for regulating mood, thinking, sleep, appetite and behavior appear to function abnormally. In addition, important neurotransmitters–chemicals that brain cells use to communicate–appear to be out of balance. But these images do not reveal why the depression has occurred.

If MRIs have shown that the people with depression have a part of the brain that functions abnormally then why isn’t it standard for all people diagnosed with depression to have an MRI done to confirm this? I have one of two hypotheses:  it’s too expensive to get an MRI done for each person and that insurance won’t pay for it or the abnormal functioning cannot be detected in the brain of every depressed person.  Therefore, is major depressive disorder really a made-up diagnosis?

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Pristiq receives approval from FDA

PristiqMore 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)

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The Zoloft-rage/violence connection

[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.

And another:

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.

Brynn and Phil HartmanI 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%).

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Blogs vs. Mainstream Media

“Mr. [James B.] Gottstein, [a lawyer from Alaska, who was pursuing unrelated litigation for mentally ill patients in his state], sends [Dr. David Egilman, a consulting witness in ongoing litigation against Lilly] a subpoena for copies. Hell begins breaking loose.” – Tom Zeller, Jr. in The New York Times

I think Furious Seasons originally linked to this (I can’t remember the source of the post), but I read this on the NYT and had a few thoughts, regarding brick-and-mortar courts vs. “teh Internets.”

Warning: Rant ahead.

I can’t help but think back to the 2004 showdown between Dan Rather and CBS (endearingly named Rathergate) vs. political blogs regarding a memo about George W. Bush’s service in the Texas Air National Guard. From NewsMax:

“Added [Matthew] Sheffield [of RatherBiased.com]: A virtual think-tank was born… Forty-seven posts later, a person who called himself ‘Buckhead’ offered the proposition that he thought the documents were forgeries.’

Sheffield and his Web site jumped on the bandwagon, searching the Web for experts on 1970’s typewriters. Another blogger site, PowerlineBlog.com, raised the question of forgery. ‘Matt Drudge and his DrudgeReport.com then linked to the Powerline piece, and the story took off,’ recounted Sheffield.”

Someone please tell Drudge about Zyprexa, Risperdal, Cymbalta, Seroquel, Abilify, and blah blah blah, psych med, blah blah blah.

“Some media observers now contend the “Blogosphere” is rapidly replacing CBS and the rest of the mainstream media.

“You’ll note that several blogs rank higher than mid-size daily newspapers and some are pushing the sites of papers in the top 50 (by daily circulation). The data suggest that the question isn’t “When will blogs arrive?” but rather “Blogs HAVE arrived, what now?” [said Kevin Aylward of Wizbangblog.]”

I’ll probably have a string of quotes from the newsmax article, but I will eventually get to my point.

I quoted this previously, but it’s worth requoting:

“It’s great that [Philip] Dawdy [of Furious Seasons] has stepped up for a huge, mainly voiceless population, but on the other hand, it’s weird to see citizen journalists so responsible for watchdogging our mental health industry. When we hear newspapers complain about declining readership, we can’t help but think it’s mainly because — gosh, this is awkward — the shit they’re reporting on isn’t newsworthy. And this shit is.” – Seattlest

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Eli Lilly: Zyprexa causes diabetes; Byetta can help

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.

Eli Lilly's Byetta

Loose Screws Mental Health News

According to a press release (I’m well aware what I’m saying), a recent study possibly shows that schizophrenia’s physical effects are more widespread in the body; researchers previously theorized that schizophrenia was limited to the central nervous system.

“The findings could lead to better diagnostic testing for the disease and could help explain why those afflicted with it are more prone to type II diabetes, cardiovascular diseases, and other chronic health problems.”

Apparently, those who suffer from schizophrenia have abnormal proteins in the liver and red blood cells. While schizophrenia’s most visible effects are psychological, researchers have noted that schizophrenics are at a higher risk for “chronic diseases.” The genetic and physical implications of such a study could prove interesting, especially for those suffering from and at risk for schizophrenia. Also in schizophrenia news, researchers have noticed an “excessive startle response.” The startle response, known as prepulse inhibition (PPI), is being considered as a biomarker for the illness.

Something Furious Seasons might like to argue if he hasn’t taken the following on:

“Lastly, but quite importantly, atypical antipsychotic were found to be more effective than typical antipsychotics in improving PPI, thus ‘normalizing’ the startle response. This led the authors to note:

‘Because an overwhelming number of patients with schizophrenia are currently treated with atypical APs, it is possible that PPI deficits in this population are a vanishing biomarker.”

What’s the advantage with atypicals vs. typicals? How do they work differently? *sigh* I need a pharmaceutical-specific wikipedia.

Schizophrenia News previously wrote about how proof is lacking in schizophrenia developing in those who have suffered from child abuse. (Excuse me for the awful construction of that sentence.) However, a new study shows that those at a high risk for schizophrenia benefit from having a good relationship with their parents during childhood. Read more.

Editor and Publisher has noted that suicides among Army soldiers doubled in 2005 compared to 2004.

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Pristiq posing as pristine

The Trouble With Spikol has linked to an article in the San Diego Union-Tribune (via Reuters) that covers Wyeth's new Effexor XR knock-off, Pristiq (desvenlafaxine succinate). Why are they launching Pristiq? Their patent on Effexor will expire in July 2010 when making generic versions of the drug will be up for grabs.

"Wyeth said in July, however, that it will not introduce Pristiq until it completes tests of a low 50-milligram dose of the drug, following trials of higher dosages in which about half the patients experienced nausea."

Too bad clinical trials don't test for withdrawal symptoms. Will Pristiq avoid the withdrawal hell issues that Effexor XR has?

“'We will wait for the results of the low-dose trials, which we've said we expect in early 2007, before making a decision' on when to launch Pristiq, company spokeswoman Gwen Fisher told Reuters on Friday.

She said nausea seen in the earlier trials was mild to moderate and generally went away within a week after treatment began.”

How long were these clinical trials and if the nausea was seen in the "earlier trials," what about the most recent trials?

Pending FDA approval, Wyeth would also like to use Pristiq for vasomotor symptoms in menopausal women.  Wyeth's unannounced strategy will be to introduce Pristiq long before Effexor's patent expires so they don't lose any of their $1 billion market share to an Effexor generic.

A Wyeth PR that went under my radar:

“Pristiq, a serotonin/norepinephrine reuptake inhibitor (SNRI) now is being studied with a specific focus on women. It initially was developed for two indications that currently are pending approval from the U.S. Food and Drug Administration (FDA) – the treatment of major depressive disorder (MDD) and vasomotor symptoms (VMS) associated with menopause. 

In the area of depression, Pristiq is expected to improve the balance of serotonin and norepinephrine as compared with serotonin reuptake inhibitors (SSRI) because of its pharmacologic profile as a dual reuptake inhibitor.”

Isn’t that what SNRIs are supposed to do?

“Clinical studies confirm that Pristiq is effective in both men and women. However, women over age 40 represent about 50 percent of the depression market and could benefit from an antidepressant that addresses their symptoms and physiology.”

No kidding – 50 percent of the depression market and the implication of all women over 40 years old? Sure, I believe that. Looks like Wall Street doesn't have much hope for the new drug either.

“Pristiq also may be a treatment option for patients who are on multiple medications. The compound has a low risk of drug-drug interactions. This is important when considering that depression often is a co-morbid condition in medically ill patients and that these patients frequently are taking multiple medications. The Company expects FDA action for the MDD indication in January 2007.”

The multiple medications thing. Um, I’m not a fan of that unless it’s absolutely necessary. It isn’t necessary in a lot of cases.

“FDA action for the second application for Pristiq for vasomotor symptoms associated with menopause is anticipated in April 2007. Pristiq is expected to provide significant relief of hot flushes (decrease in number and severity) associated with menopause.

If approved, Pristiq will be the first non-hormonal treatment indicated for relief of VMS.

The Company also plans to pursue indications for Pristiq that would include fibromyalgia syndrome and diabetic neuropathic pain.”

Wyeth certainly is attempting to milk this new drug for all it’s worth. I hope Furious Seasons or CLPsych take up on investigating this one since I simply don’t have the time, resources, or ability.

Pharmaceutical roundup

AbilifyNearly 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.

Loose Screws Mental Health News

Surprise, surprise — the likelihood of suicide attempts increases with antidepressants.

     “Suicidal patients taking antidepressants have a ‘markedly increased’ risk of additional suicide attempts but a "markedly decreased" risk of dying from suicide, a large Finnish study has found.
     “The research into nearly 15,400 patients hospitalized for suicide attempts between 1997 and 2003 showed that ‘current antidepressant use was associated with a 39 percent increase in risk of attempted suicide, but a 32 percent decrease in risk of completed suicide and a 49 percent reduced risk of death from any cause,’ the authors wrote in a report published in the Dec. 4 issue of Archives of General Psychiatry.
      “The Finnish study analyzed 15,390 suicidal patients of all ages for an average of 3.4 years. The authors said they did this ‘because previous suicide attempts are the most important risk factor for predicting suicide.’”

I think 15,390 patients is a sizeable, significant study that could probably yield semi-accurate statistics.

      “Among the 7,466 males and 7,924 females examined, there were 602 suicides, 7,136 suicide attempts requiring hospitalization and 1,583 deaths recorded during follow-up. The risk of completed suicide was 9 percent lower among those taking any antidepressants than among those not taking antidepressants.
     “But the picture was not so bright for all those who took SSRIs. It was for those taking fluoxetine (Prozac), who had a 48 percent lower risk of suicide than those not taking medication. But the study found that those taking another SSRI, venlafaxine hydrochloride (Effexor XR), had a 61 percent increased risk.”

So Prozac is better than Effexor XR in terms of suicidal risk. Nice, considering that I've had a 10-year history of suicidal attempts and this study seems to show that venlafaxine increases the risk of suicide attempts. Perhaps Effexor should be prescribed to those who aren't/have never been suicidal?

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Well-intentioned but not completely right

medicating the brainI read this commentary from the Philly Inquirer on mental illness and the author insists that mental illnesses are all “chemical imbalances.” While I do think many mental illnesses are the result of chemical imbalances, some mental illnesses are not physical. Some mental illnesses come from a spiritual and/or psychological battle. There are many people who recover from mental illness without medication. If a chemical imbalance was the case for these people, they would never get better. Pharma companies have sold the American public and countless mental health organizations on the idea that millions of people suffer from a “chemical imbalance.” I don’t buy that – well, come to think of it, actually, I do – my dollars contribute to Wyeth and GlaxoSmithKline‘s profits.

After suffering from bipolar disorder (or depression, depending on which psychiatrist I listen to) for 10 years, my husband and I are leaning toward the “chemical imbalance” theory that many doctors and pharmaceutical companies push. But a person who is depressed over a temporary situation does NOT have a chemical imbalance and simply may need psychological counseling.

America is overmedicated, drugged-up, and the victims of the smartest ad campaigns from pharma companies. What concerns me even more is that the FDA and mental health organizations like NIMH buy into many of the pharmaceutical companies’ lies and tactics. What further concerns me are the doctors involved in clinical trials who fail to disclose their affiliations with many of these pharmaceutical companies.

So yes, chemical imbalances do exist for many people. Millions? It’s possible. But unlikely. And I could go off on another rant about how PCPs shouldn’t be prescribing psych meds, but I’ll leave that argument for another day.

Absolutely crazy

PfizerThis has nothing to do with psych meds but I recently learned through the Clinical Psychology blog and Pharma Marketing blog that Pfizer supposedly spent more than $800 million on what was supposed to be their own competitor to Lipitor. The new drug, torcetrapib, needed to be halted because of safety concerns. It seems that quoted cost for the new drug is shady but it prompts the question of how much money pharmaceutical companies invest in new drugs.

Just another day: Part II

Originally written October 16, 2006 (Updated edits in bold red)

On the heels of discussing my cynicism about pharmaceutics and pharmaceutical companies (namely, psychiatric-related), I have a few questions regarding the approach of psychiatric evalutations:

1. Why aren’t people tested for biochemical imbalances?
2. Is there a way to determine from blood work or an MRI what kind of mental illness a person is suffering from (in conjunction with the patient’s psychiatric assessment)?
3. How do doctors know the appropriate dosage for a patient? Does s/he start a patient off on what is considered “normal” for an average person and then increase or reduce the dosage based on reactions and side effects?
4. How does a doctor know when to increase a dosage? (Figuring out when to reduce a dosage SHOULD be much easier.)


Psychiatry is an inexact science. For the most part, I think much of it — regarding medication, Freud, and now, the pharmaceutical industry — is a crock.

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