Link-O-Rama, Early March Edition

A few pieces of interesting news...

• Dr. Daniel Carlat has been busy. He aptly notes that Pristiq is an Effexor copycat that apparently provides no special benefits over soon to be generic venlafaxine. Hey, didn't I just write a piece or two about Effexor? In addition, Carlat continues to hammer the corrupting, I er, continuing medical education industry. He also documents the use of deceptive "surveys" to market antipsychotics. Excellent work -- keep it up! Dr. Grohol at PsychCentral pointed out another set of potential problems with the surveys.
  
• Furious Seasons puts forth Ye Olde Pimp Slappe on antidepressant use in bipolar disorder with a side dish of I Told You So. He has indeed questioned the use of antidepressants in bipolar disorder and the latest data continue to question the utility and safety of such practices. Philip Dawdy notes accurately that he is the only person in the USA to host the infamousZyprexa documents online. He also broke a number of excellent stories on said documents. All for the salary of zero dollars. So why not send him some money? He's doing a fundraiser currently. You can donate here. Hey, I'd like to rake in some donations for myself. I think I provide a somewhat valuable service, and my day job doesn't exactly make me rich. But when Dawdy is doing such work much more productively than myself and he doesn't even have a day job (file under journalism in crisis), I think he deserves your financial consideration, not I. So if you ever had the kindhearted intention of sending me cash to support my work, send your money to Philip Dawdy.
  
• Health Care Renewal is chronically excellent, as y'all know already. Recent stories include a fat conflict of interest involving the head of the Obesity Society, yet another chapter in the sordid University of Medicine and Dentistry of New Jersey affair, and a take on the baseless lawsuit from HipSaver.
• Speaking of HipSaver, Aubrey Blumsohn has also written eloquently on this case, which I hope receives scrutiny from many sources. He also reports unfavorably about the sham investigation of GSK. Bob Fiddaman and Seroxat Secrets were similarly unimpressed.
• Peter Rost is on the job market.
• As usual, Pharmalot and PharmaGossip have continued to provide all the news that's fit to print. Of particular interest to my readers (I think) was the marketing of Abilify. Perhaps yet more interesting, the 6th episode of RX -- Sex, Drugs, and Quarterly Goals is up. Everyone should check out all six episodes. I'm hooked.
• Pharma Giles has been generating his usual brand of dead-on satire. I was particularly amused by his take on the most recent Kirsch antidepressant meta-analysis.
• In "who cares?" news, bifeprunox is apparently dead in the water. Better hope that Pristiq sells in droves, Wyeth...

As for myself, I have at least one piece in the works involving a key opinion leader and cash. Stay tuned.

Is Wyeth's Psychiatric Ship Sinking?

Wyeth's attempt at an antipsychotic (bifeprunox) was rejected by the FDA today. Liz Spikol has a post on the topic that I found immensely entertaining. Daniel Carlat points out why the drug was rejected -- because it does not work very well. Yes, some doses showed a bit of improvement over placebo, yet bifeprunox did not impress when tried head-to-head against risperidone or olanzapine. Adding this drug to an already crowded antipsychotic market would seemingly do little for people with schizophrenia but would help Wyeth, which is looking a little desperate these days considering it has little to replace its flagship antidepressant Effexor.

What about Pristiq, the "son of Effexor," -- well, that ain't looking so promising (1, 2, 3). Good luck, Wyeth. It appears you're going to need it!

Son of Effexor: Good News

According to Reuters:

Wyeth on Thursday said low doses of its experimental drug Pristiq were effective against both depression and hot flashes and caused less nausea than seen in prior studies of higher doses, boosting prospects for the company's most important experimental drug.

Well, good. With antidepressants, we all know by now that "effective" means "slightly better than placebo" on average. Pristiq, a knock-off of Effexor, is hoping to nab FDA approval early in 2008. Can't wait to see the ad campaign. Depression Hurts is already taken, so with the depression/hot flash combo, I have the following idea:

Does Depression Make You Hot? Let Pristiq Cool You Down.

You like?

Hat tip: Pharmalot

More on Pristiq

Marissa Miller has a fine post about desvenlafaxine (Pristiq), Wyeth's attempt to cover up for their bestseller Effexor coming off patent in the near future. Coverup? Considering that desvenlafaxine is a clear knockoff of Effexor (venlafaxine), yes, I'm sticking with that descriptor. Why do research to develop an innovative medication when you can just sell one that is quite highly similar to the one that is already a sales blockbuster?

The idea is not new – make a drug that very closely resembles your existing product, then get it FDA-approved slightly before the old one goes off patent. Lexapro-Celexa, Invega-Risperdal, and now Effexor-Pristiq. The new drug offers no advantage over the drug that is about to go generic, and why would it – if you have a red 1975 Ford Pinto or a green 1975 Pinto, you still have the same crappy car.

Aren’t patents supposed to protect inventions that possess the potential to benefit people? Aren’t patents supposed to reward creativity? There is no creativity here – we’re talking a slight manipulation of a molecule to create a new compound that is no better than the first one.

But the blame does not just lie with the patent process. Why are physicians prone to fall for this game? Why do so many physicians prescribe Lexapro (escitalopram), which is pert-near a clone of Celexa (citalopram), when Lexapro is much more pricey? In fact according to Walgreens, 90 pills of 10mg generic citalopram will run $127.59, whereas the same supply of Lexapro costs $210.79. The marketing miracle that constitutes the heart and soul of modern psychiatry is damn good at convincing physicians that newer equals better.

Perhaps if physicians received adequate training in research methods and statistics during medical school, they could actually learn to critically review clinical trial data to discover that the ploy of near-clone medicines usually does nothing but increase costs. Then doctors could also laugh their way through continuing medical education or, better yet, insist that CME start to resemble education rather than advertising.

Chemical Imbalance Watch

I have ranted before about the alleged chemical imbalance in depression. Any time I've seen a commercial for any of the SSRI's, I've just shaken my head (0r banged it against the wall), as the ads love to tout how "experts" (i.e., their marketing department ?) believe that depression is caused by some sort of chemical imbalance. The evidence, as you can read here, is scant, at best, to support such an assertion.

Well, Wyeth is still on the chemical imbalance train with their knockoff of their current bestselling antidepressant Effexor, which may be gracing your pharmacy before long. The new drug is called Pristiq and Wyeth is offering up the following as part of its early PR campaign for the drug:

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.

Well, whoopee! Will it work any better than antidepressants that attempt to target either norepinephrine or serotonin? Nope. Why? Because a reliable imbalance of either neurotransmitter has never been found in depression. That's right -- never. But Wyeth continues to run with the chemical imbalance program because a lot of people have been indoctrinated, through advertising or perhaps through teachers who themselves lacked much education on the topic, to buy into this whole chemical imbalance deal.

I'm not saying that biology does not impact depression. I am saying that our current level of understanding in this area is much more speculation than it is fact. I do not believe there is a single serious scientist who would stick his/her name behind the simple "chemical imbalance" theory of depression.

And the name Pristiq? It would appear that Wyeth is aiming for a close resemblance to "Pristine," which is a bit ironic given the side effect profile of Pristiq (which will likely resemble that of Effexor closely).

More on Pristiq in an interesting post at Depression Introspection.