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)

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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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Catching up: Furious Seasons

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."

Classic quote:

"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…

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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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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