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)

So why is it that when PCPs prescribe antidepressants and antipsychotics, most people don’t bat an eye? PCPs are not trained to provide these kinds of medications and it bothers me to no end that they do so. There are so many instances where patients have experienced severe side effects as a result of being placed on the wrong medication. Let’s take my own experience.

I’d been struggling with depression for a long time as a teenager and it hit me again during my later years in college. I was 21 and cut off from my health insurance – despite the fact that I was still in school and should have remained covered – so I had no choice but to go to a PCP. I told her I was struggling with depression and she proceeded to
hand me samples of Paxil. After three months, I told her Paxil didn’t work so she provided me with samples of Lexapro. After nearly a year of worsening symptoms under Lexapro, she became dubious as to whether I was consistently taking my medication (I’d been bad about that on Paxil) and finally decided to switch me to Zoloft. At that point, it became clear to me that I’d be spending time after time jumping from drug to drug to see what would work. I didn’t fill the prescription she’d handed to me because I was tired of the inexact science I was being put through.

Wyeth is trying to distinguish Effexor Jr. as different from other drugs on the market. However, even Wyeth’s vice president for neuroscience said that it would have “similar benefits” to Effexor.

Dr. Philip Ninan, a Wyeth vice president for neuroscience, said he thought that Pristiq, which is chemically similar to Effexor, would have similar benefits in treating major depression. But the company said the drug had distinct advantages over its existing product.

The distinct advantages:

  • Patients can start taking Pristiq right at 50 mg instead of a lesser dose then moving up.
  • The drug avoids a “major metabolic pathway in the liver” that would not interact with other medications that are processed by the liver.

That’s it. Those are the significant distinctions between Pristiq and the rest of the antidepressants on the market including Effexor.

“I think what’s important to understand in the depression category is that many patients fail to respond to anything that’s available,” said Geno Germano, Wyeth’s president of pharmaceuticals for the United States. “What’s important is that physicians and patients need multiple options available.”

Germano should have said, “What’s important is that physicians and patients need duplicate options available so pharmaceutical companies can continue to make significant profits once the patent on their drugs expires.” Wyeth
hopes to make a killing on Pristiq, but as the NYT article wisely pointed out, insurance companies will be unlikely to cover the exorbitant cost of a drug that seems to have little difference compared to its generic predecessor. Effexor is currently $120 for a month’s supply; Reporter Stephanie Saul discovered that the generic version is already priced at less than half for the same amount.

To read more on the less-than-pristine drug, see this post on Dr. Carlat’s blog. He absolutely KILLS it.

At least with Effexor XR, when you keep increasing the dose, efficacy improves, meaning it actually has an efficacy advantage over Pristiq, because when you increase the dose of Pristiq, you lose efficacy, according to the U.S. study data.

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1 Comment

  1. Prester John said,

    March 9, 2008 at 1:09 pm

    I totally agree with you on the presciption of antidepressants. No one but a psychiatrist should be allowed to prescribe them, at least for more than the month or so it might take to get in to see a shrink. (My internist recently “re-started” me on Welbutrin. I was feeling much better by time I got in to see the psychiatrist my insurance company will pay for.)
    “At that point, it became clear to me that I’d be spending time after time jumping from drug to drug to see what would work. I didn’t fill the prescription she’d handed to me because I was tired of the inexact science I was being put through.”
    I’m sure you already realize this is the same thing the actual shrinks do, or at least they have with me. The difference IMHO is that perhaps they’re making a more educated guess on what might work than the non-specialist.
    I’m glad I ran across your blog. You’re willingness to share your experiences is very helpful. Plus you’re very informed on what’s going on.


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