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)

Depression Overawareness and Overmedication Week

The Pursuit of Happiness

This post kicks off Depression Overawareness and Overmedication Week.

Two weeks ago, CLPsych and Gianna, among others, celebrated Bipolar Overawareness Week. To cap off Mental Health Awareness Month, I’ve declared this last week of May Depression Overawareness and Overmedication Week. Use this checklist to identify whether you may possibly be “overaware” and “overmedicated” for depression:

  • If you’re on Zoloft because you’ve never been sad or anxious.
  • If you get a prescription for Lexapro on Thursday because you had a bad day on Tuesday.
  • If you take Paxil because you’re never restless or irritable.
  • If you are on Pristiq as a result of sadness and guilt over your Wii-related injury (eg, throwing your shoulder out or tripping over the coffee table).
  • If you are on Celexa because you hate the job that you disliked anyway before you began the medication.
  • If you are on Cymbalta because you are tired after normal long, exhausting days at your job(s).
  • If you are on Effexor only because you overate during the holidays.
  • If you take Prozac because you’ve never had passing thoughts of suicide.

If you meet any of the criteria above, this is a medical emergency. You are overaware and overmedicated. Go see your doctor immediately and discuss treatment options that involve non-medication and/or talk therapy.

Now, the disclaimer.
The checklist above is satire. It is not intended to poke fun at those who suffer with real clinical depression (of which I am one). It is intended to mock the extremely high number of people in the U.S. who are diagnosed with depression and medicated with antidepressants. This is not a medically based checklist for anything. It is not a professional recommendation or intended for professional use. It is not intended to be serious. In fact, it is not intended to be seriously serious. If you take this to your doctor, he or she will probably diagnose you with something other than depression. If you have been offended by this post, don’t be; you shouldn’t come close to meeting the criteria above. And if you do, then you really should go to a doctor. While I meet the criterion for sadness over my Wii-related injury, I don’t take Pristiq for it. If you have something nice to say, click on the Comments link below. If you don’t have something nice to say, click on the Comments link below.

(comic from problogs.com)

Loose Screws Mental Health News

John Grohol at PsychCentral reports that the fate of the mental health parity bill is uncertain as its main champion, Sen. Ted Kennedy, takes a leave of absence to focus on treatment of his brain tumor. I echo John’s thoughts in hoping to see that other senators are willing to carry the torch and pass this important piece of legislation.


I came across a post from Kalea Chapman at pasadena therapist in which she linked to a WSJ article on whether veterans suffering from PTSD should be awarded the Purple Heart.

Supporters of awarding the Purple Heart to veterans with PTSD believe the move would reduce the stigma that surrounds the disorder and spur more soldiers and Marines to seek help without fear of limiting their careers.

Opponents argue that the Purple Heart should be reserved for physical injuries, as has been the case since the medal was reinstituted by Congress in 1932.

I side with the opponents. The Purple Heart should be awarded to be people who have visible evidence of bravery. With the rising number of PTSD prevalence, I’m afraid that the award would be handed out like candy. The rising number of veterans with PTSD on disability has caused enough of an issue that a Texas VA facility wanted mental health officials to stop diagnosing veterans with the condition.


Jordan Burnham, an 18-year-old student who survived a nine-story jump from a building, plans on walking at his graduation with the assistance of two canes. A family who used to attend my church knows this family and put him on my church’s prayer list. It’s a small world, after all.


Finally, it looks like expecting moms should have no fear of causing birth defects in their baby while taking antidepressants, according to a study being published in the British Journal of Psychiatry.

A research team from Montreal University studied more than 2000 pregnant women on antidepressants and discovered the drugs did not present any adverse effects. However, it sounds like they only oversaw the women while they were pregnant in their first trimester. I haven’t seen the actual study but it doesn’t seem to mention whether the women discontinued the antidepressants after the first trimester.

Poor Wyeth — New drug delayed in FDA approval

From Forbes.com:

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.

Analysis of "Depression: Out of the Shadows"


The show is essentially Depression 101 – for those new to learning
about the illness.
As someone who struggles with depression (within
bipolar disorder), I found a lot of the two hours pretty boring (90
minutes on personal stories and about 22 minutes for "candid
conversation"). The "a lot" comes from the stuff that I've either heard before or flies over my head, eg, how depression affects the brain, prefrontal cortex, neurotransmitters, synapses, etc. The personal stories were powerful: depressingly heartwarming. (Yes, I mean that.)

My heart sank as I heard the stories of Emma and Hart, teenagers who were diagnosed with depression and bipolar disorder, respectively. Both were such extreme cases that they needed to be sent away for special psychiatric care. They are on medications for their disorders; the specific drugs are never mentioned.

While watching Deana's story of treatment-resistant depression, I instantly thought of Herb of VNSDepression.com whose wife suffers from the same malady.

I tried to listen attentively for the antidepressant that Ellie, who suffered from PPD after the birth of her first child, would be taking during her next pregnancy. It was never mentioned.

My jaw nearly dropped to the carpet as Andrew Solomon, carefully plucked brightly colored pills from his pillbox that he takes every morning for his unipolar depression: Remeron, Zoloft, Zyprexa, Wellbutrin, Namenda, Ranitidine, and two kinds of fish oil. He might have even mentioned Prozac. He takes Namenda, an Alzheimer's drug to combat the effects of an adverse interaction between Wellbutrin and one of the other drugs that I can't remember. Solomon says he's happy. I'm happy for him and I'm happy that his drug cocktail works for him but I couldn't help but sit there and wonder, "Isn't there a better way?"

While I thought the stories covered the gamut, in retrospect, I'm surprised they didn't interview a veteran or U.S. soldier to discuss PTSD. If the producers were able to fit in dysthymia, I'm sure they might have been able to throw in a story about a soldier who struggles with depression and suicidal thoughts stemming out of PTSD. Considering all the stories coming out of the VA, it's rather relevant. It would have been more interesting than the Jane Pauley segment. But I'll get to that in a minute.

As I listened to the narrator, I couldn't help but wonder what alternate perspectives could have popped up. For what it was, I fear none. This was a Depression 101 show — a program designed to either get people to fight against fear and stigma and get help or to open the eyes of loved ones to this debilitating disorder. I'm not sure how to slip in an opposing view on medication from a doctor without confusing or scaring people away. What would Healy or Breggin say that would encourage people to seek appropriate care?

Holistic or natural treatment was not mentioned. It's not mainstream and it's not recommended by most doctors as first-line therapy. I would have been surprised had something been said about it.

The depression portion of bipolar disorder was briefly discussed in Hart's story then Pauley added commentary about her personal experience in the remaining 22 minutes of the program.

Pauley appears at the end of the show promising a "candid conversation" on the topic. The three experts: Drs. Charney, Duckworth, and Primm sit and smile politely as Pauley rattles on occasionally about herself. Some people might find her exchange endearing and personal. After the first 3 minutes, I found it annoying. As a journalist, I wish she would have taken the impartial observer approach rather than the "intimate discussion" approach. In my opinion, she seemed to have dominated the "discussion."

It ended up being a Q&A with each doctor. Her questions were focused and direct. I expected a little bit of an exchange between doctors, talking not only about the pros of medication and treatment like ECT and VNS but also the cons. (Should I apologize for being optimistic?) Charney interjected into the conversation maybe once or twice but was only to offer an assenting opinion. Primm spoke least of everyone on the panel. I think she was placed on the show solely to represent diversity.

There were no "a recent study said…" or "critics say such-and-such, how do you address that?" It was a straightforward emphasis on encouraging people to get help or for those suffering to get treatment. Pauley's segment didn't discuss any negatives (not with the medical director of NAMI there!). The closest the entire 2 hours gets to any cons is with ECT shock treatment and giving medication to growing children. The childhood medication thing isn't dwelt on. The basic gist is: Doctors don't understand how medication works in children but are working on trying to understand it and improve its efficacy.

Forgive me for being negative. The point of the program was designed to give hope to those suffering. Instead, it just made me feel even worse. Thoughts raced through my head: "Well, if this doesn't work, then it's on to that. And if that medication doesn't work then I'll probably be prescribed this therapy, and if that doesn't work, then I'm treatment-resistant at which point, I'll have to do…"

I hope the program does what it's designed to do and that's to get those suffering with depression to seek appropriate care. The one upside is that talk therapy was stressed. I'm a huge proponent of talk therapy myself. Let me know what you thought of the show if you were able to catch it.

In the meantime, this depressed girl is going to cure herself for the night by going to bed.

P.S. Is it really fact that depression is a disease?

Depression: Out of the Shadows: Live Blogging

I’m on EST so I’m watching the Depression PBS show. I’ll be live blogging about it because I have nothing better to do with my life. Probably no interesting observations but, like I said, I have nothing better to do right now.

UPDATE: Jane Pauley doesn’t appear until 10.25.

9.07 pm – Andrew Solomon, author of The Noonday Demon is sharing his story about his bout of depression. It doesn’t help that his mother, who suffered from a terminal illness, chose to end her life.

9.09 – Dr. Myrna Weissman says that depression "is a biological disorder. It’s not all in your head."

9.12 – The show highlights an adolescent named Emma who’s been struggling with depression since 5th grade. She began "acting out" as a form of self-medication. She ended up going to to an out-of-state psychiatric hospital.

9.15 – Cut to an adolescent male, Hart, who has been suffering from depression since 6th grade. After going to a hospital, he was diagnosed with bipolar disorder.

9.19 – Jed, a 20-year-old college student killed himself supposedly from undiagnosed depression. Dr. Thomas Insel says that suicide is almost twice as common as homicide in the United States.

9.21 – Drs. Geed(?) and Casey at NAMI are using MRI to further research in adolescent depression. An explanation on the neurochemical brain functions in adolescent depression follows.

9.25 – A narrative on postpartum depression begins. Ellie’s husband videotaped Ellie with the baby, Graham, shortly after his birth, and you could see the unhappiness of postpartum of depression on her face. In the homemade video, she holds her child while saying that she had suicidal thoughts the day before and wanted to die because she "couldn’t do this" anymore.

9.29 – Cut to Shep Nuland, author of Lost In America, and explains the circumstances that led to his depression.

9.32 – Dashaun, a member of the Bloods gang, suffered from early life trauma that led to his bouts of depression.

This probably goes without saying but so far, the program is replete with different doctors, none of which appear in segments other than the first one they were featured in.

9.37 – "When you gang bang, it’s just a form of suicide."

9.38 – Segue to Terrie Williams who not only helped Dashaun write his story and helped him recover from his depression, but also suffers from a mild form of depression, dysthymia. Dysthymia is estimated to affect 10-15 million Americans. One of the symptoms is overeating.

9.40 – Williams mentions that stigma of mental illness in the African American community prevents African Americans from seeking treatment.

9.41 – Philip Burguieres(?), a former CEO, suffers from depression and discusses the stigma of mental illness in corporate America.

They’re really covering the whole gamut.

The hubby is getting frustrated because the segments are really just that – segments and they never fully finish anyone’s story but jump back and forth.

9.45 – Back to Andrew Solomon from the beginning of the show. He’s currently taking Remeron, Zoloft, ZYprexa, Wellbutrin, Nemenda(? an alzheimer’s drug), Ranantadine(?), two kinds of fish oil. HOLY CRAP. (I think he’s also on Prozac but don’t hold me to that.)

9.47 – We’re being walked through the neurotransmitter explanation.

9.48 – Poor Andrew thinks he wouldn’t be on as many medications today if he had been on medication a long time ago.

9.48 – Ooh, look! It’s Richard Friedman, the psychologist/psychiatrist from the NYTimes.

9.52 – Back to adolescent Hart Lipton, who is in a special
school that gives him specialized attention. He has bipolar II. He is
on an antidepressant and a mood stabilizer.

9.52 – Emma takes one antidepressant and engages in talk therapy. She tried several different ones before she found one that worked.

9.53  – The Narrator admits that meds in young people isn’t
fully researched and may be a problem. He mentions the black box
warning on antid’s.

9.55 – NIMH docs are working on faster-acting meds for depression – as in 1 to 2-hour relief. Guinea pig patients were administered intravenous ketamine for depression. (WTF???) One of the patients, Carl, says he felt instantly better.

9.58 – Back to Shep. Doctors suggested performing a lobotomy but a resident intervened and suggested ECT. They cut to a scene from One Bird Flew Over the Cuckoo’s Nest in which Jack Nicholson got ECT. Shep says it was worth it and that he began to feel better by the 11th treatment.

10.00 – ECT especially works well on the elderly. A woman, Sue, who developed late onset depression at age 65 comes back for her 9th treatment of ECT. It helps her. Her husband says, "She’s back to her old self."

The next hour of the show under the cut…

Continue reading “Depression: Out of the Shadows: Live Blogging”

Celebrity Sensitivity: Christina Ricci, Mel Gibson, and Britney Spears

Liz Spikol has a new post on celebrities talking about mental disorders. This time, it’s Christina Ricci and Mel Gibson. Ricci has previously admitted to suffering from anorexia but now admits to suffering from depression. Gibson, on the other hand, said in a 2002 interview that he was bipolar (manic-depressive back in the day). Then she’s got a whole list of people who have recently admitted to depression.

Then there’s Britney Spears. If you don’t know who she is, be thankful. For the rest of us who spend our time following celebrity news, there have been rumors swirling around recently that she is pregnant because she’s got a big, protruding belly (bigger than the botched VMA’s last year) even though she’s been exercising regularly.

Britney SpearsAccording to the Daily Mail, Spears isn’t pregnant but seriously bloated as a result of her medication.

A source close to the family says that Britney has been struggling with her weight ever since she had her second son Jayden James, 20 months, and the medication has not helped.

The pop star has been back in training in preparation for a comeback, spending plenty of time on the treadmill – but despite all the effort, she is failing to regain the svelte figure which made her famous.

I wonder what antipsychotics she’s on. Seroquel?

Finally, ABC News wrote about celebrities who suffer from various mental illnesses. I’d been wanting to blog on this some time ago but never had the chance. BPD in OKC beat me to it.

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:

Continue reading “My official position on pharmaceutical companies and psychotropic meds”