Neurontin 0, Placebo 1. Pfizer loses, Placebo wins.

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.”

The conclusion?

“No scientifically acceptable clinical trial evidence supports use” of the drug in bipolar disorder.

Ouch. Hitting Pfizer where it hurts.

Neurontin: Pfizer and Eli Lilly share a common history

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.

Neurontin (gabapentin)

Read the rest of this entry »

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

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).

Andre WatersI’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.

doggieAs 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.

SSRIs

Selective Serotonin Reuptake Inhibitors
(from monstersandcritics.com)

  • present fewer side effects than their predecessors
  • less likely to be lethal even in large quantities (important for someone who may be suicidal)
  • the
    Federal Drug Administration (FDA) wants SSRI dosage minimized to
    decrease risk of overdosage and close monitoring of younger patients on
    the drug
  • suicide rates overall have declined since SSRI market introduction
  • side effects ma include insomnia, rashes, headaches, joint and muscle pain, upset stomach, nausea or diarrhea
  • mixed with painkillers, SSRIs can pave the way for stomach or uterine bleeding

In the Hindustan Times,
an article ran on a girl who committed suicide because she had not
received the grades she had hoped on a test. One highlight (if you can
consider it that) of reading world news is that they'll report local
suicides more often than U.S. media. The HT story reminds me that there
is no excuse too small or too big for people to commit suicide.

Indian focus recently has been on eliminating suicide scenes from films to prevent copycat cases. In one incident,
a mother dragged her four kids out o the train tracks to die with her.
Two of them were able to escape and survive before a train pummeled the
rest of the family to death.

Ireland is also tackling suicide – they've set a 20 percent reduction target by the year 2016. A published report notes that suicide rates are rising in males younger than 35 and in females under 25. Wisconsin
is battling youth suicide, much like Ireland, and hopes to reduce its
current rate of one young adult committing suicide per week by 10
percent. No time frame for the reduction has been set.

An anti-seizure drug, Neurontin, is being blamed for nearly 300 suicides nationwide.
It is the best-selling anticonvulsant medicine in the U.S. and Pfizer –
Neurontin's maker – posted profits of more than $2.6 billion in 2004.
The FDA has not pushed to have Neurontin taken off the market, but in
2005, simply ordered a review. The results have never been made public
as of today.

A man who killed himself after being turned away from the hospital has drawn worldwide attention to the inadequacies of Australia's mental health system. Although I'm sure similar events have occured in the U.S., it likely does not get widespread coverage.