Wyeth Reps Trash Pristiq

Read this message board over at Cafe Pharma for an interesting though rather alarming thread about Wyeth's newly approved antidepressant, Pristiq. Cafe Pharma is a site frequented by drug reps, although because postings are anonymous, one never knows whether a given comment is actually from a rep or from an outsider with an agenda. Nonetheless, this particular thread sounds real, because it involves Wyeth reps grousing about upcoming layoffs (layoffs which the company has, in fact, announced) and about the new Pristiq sales force tag line: "People, Passion, Performance...Pristiq!"

Here is one rep's snide take on his company's upcoming campaign:

"PEOPLE - 1/2 of you will be gone in less than 27 days

PASSION - There is no passion now, but for those that remain with Wyeth, we will bribe the passion out of you by taking you to Vegas for 4 days.

PERFORMANCE - You thought it was hard to reach your performance incentive before? Wait until 2nd quarter

PRISTIQ - Good luck selling both Effexor XR and Pristiq at the same time. So Dr., would you like to hear about my antidepressant that has been around for 12 years, with proven efficacy with the ability to titrate the dose as need to better care for each patient's needs that will have generic competition in 4 months, or would you like to hear about my brand new antidepressant with one dose, less indications and less evidence of efficacy? You want me to choose, let me check with my bonus plan to see which one pays more."

If this is the typical attitude within the Pristiq sales force, Wyeth may end up a little shy of the blockbuster they were hoping for!

Liebowitz Sets the Record Straight on Pristiq Views

I recently posted this critique of Wyeth's newly approved antidepressant Pristiq, and in that article I quoted Dr. Michael Liebowitz, who was the lead investigator on some of the Pristiq clinical trials. Dr. Liebowitz contacted me because he felt I had mischaracterized his opinions. I invited him to send me a clarification, which I offered to print in full. In reviewing this issue, I plead guilty to having taken some of his comments out of context, and I apologize to Dr. Liebowitz for having done so. These are his views on Pristiq, in his own words:

"Your blog posting suggesting I was unenthusiastic about Pristiq mischaracterized my views. It is very useful for clinicians to have another serotonin-norepinephrine reuptake inhibitor (SNRI) available to treat depression. This class of antidepressants is very useful for treating an often disabling and sometimes life threatening condition, and the more tools we as clinicians have available, the better we can serve our patients. In addition, Pristiq's very tolerable starting dose of 50 mg per day may also turn out to be its usual therapeutic dose, avoiding the need for dose escalation. If so, this would differentiate it from Effexor XR and Cymbalta, the two previously marketed SNRI's.

With regard to my remark that if Pristiq was useful, it would make money for Wyeth, this was in response to your question about whether the company was marketing it for altruistic or commercial reasons. The intent of my comment was twofold. First, I believe that it was not an either-or proposition. Rather, if the drug turned out to be highly useful, it would also be highly profitable, so a company can be motivated both by wanting to advance science and health care and make a profit. Secondly, how widely a given drug will be used is not always something one can usually predict until a drug is marketed and clinicians have a chance to test it out in daily clinical situations. For example, who would have predicted that Celexa or Lexapro, marketed for depression after numerous other SSRI's, would turn out to be very useful, popular and widely used drugs.

Sincerely yours,

Michael Liebowitz M.D.
Professor of Clinical Psychiatry
Columbia University"

Top 5 Reasons to Forget about Pristiq

Yesterday, the FDA gave official approval to Wyeth's antidepressant Prisiq. Here are the top 5 reasons for doctors to keep it off their prescription pads.

1. It’s a blatant patent extender. Effexor XR, which brought in $3.8 billion for Wyeth in 2007, is losing patent protection this year, and Wyeth is introducing desvenlafaxine, which is simply Effexor’s main metabolite, as a “novel antidepressant.” There’s nothing novel about it. Every patient who takes Effexor produces Pristiq in their own body, at no additional charge.

2. It’s not very effective. In the studies released so far, Pristiq just barely squeaks by placebo on the Hamilton Depression scale. In the U.S. study, Pristiq decreased the HamD by only 2 points (-11.5 vs. -9.5 for placebo), and in the European study, the differences was 2.5 points. And for the higher 100 mg dose, there was no difference between drug and placebo for U.S. patients.

3. It is not more easily dosed than Effexor XR. The main Wyeth marketing point for Pristiq is that patients can get better by taking the beginning dose of 50 mg, eliminating the need for a complicated upward dose titration process. Sorry, but this is not different from Effexor. If you look at one of the original fixed-dose studies of Effexor, comparing patients taking 75 mg, 225 mg, or 375 mg, you’ll find that the 75 mg dose separated from placebo as well as Pristiq’s 50 mg. Psychiatrists typically begin Effexor at either 37.5 or 75 mg/day. 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.

4. It has no meaningful metabolic advantages. Wyeth will highlight the fact that Pristiq is not metabolized by the P-450 system and therefore does not have any drug-drug interactions. Well, guess what, Effexor has no clinically meaningful drug-drug interactions either.

5. Wyeth’s own lead investigator is unimpressed. I spoke briefly with Dr. Michael Liebowitz, the Columbia University psychiatrist who led the major Pristiq trials. Pristiq, he said, “is another SNRI--it is not a revolutionary drug.” It may be more tolerable at the starting 50 mg dose, he said, but only time will tell if it truly is clinically useful. “If it is useful, then it will make money for the company, and if it is not, it won’t.”