It seems we are going soft on Pharma these days, if coverage of the FDA marketing clearance of the drug named Brisdelle is any indication. Manufactured by Noven Pharmaceuticals, Brisdelle was cleared last week by the FDA—despite an advisory committee recommending against it—for treating hot flashes in post-menopausal women. Brisdelle is a low-dose (7.5 mg) formulation of paroxetine, the active ingredient in the antidepressant Paxil, whose lowest dose is 10 mg, and which has been around since the mid-1990s.
Contrary to most of the consumer press coverage, this is not a new drug. Brisdelle is the latest example of a tried-and-true tactic that Pharma companies use to extend the shelf life—and revenues—of old products by extending their patent protections, which typically last 15 to 20 years. All they have to do to accomplish this is get FDA approval of a new indication (say, use for “severe vasomotor symptoms,”—ie, hot flashes—instead of depression) or a new formulation (a 7.5 mg pill versus a 10 mg pill), and voila! It’s like a whole new product has hit the market. Unfortunately, the media just eats it up, throwing the word “new” around as if we’ve forgotten how this works.
This FDA action, which will create a new patent for a paroxetine-based product from Noven, is great news for the company, because it prohibits generic manufacturers from producing an equivalent product and cutting into Noven’s market share. The news is not as great for consumers, who will likely have to pay more for Brisdelle as a brand name drug than they already do for generic paroxetine. Moreover, clinicians have been prescribing paroxetine and other, similar drugs for hot flashes and other hormonally mediated women’s health problems for years.
The consumer press and even the trades have been lazy in their coverage, many paraphrasing or quoting directly from FDA and Noven press releases, not even bothering to find their own experts to interview. Local TV websites, including but by no means limited to San Diego’s KUSI, published verbatim what Noven sent over PR Newswire. A live spot on CBS This Morning and its companion piece by Amanda Cochran on CBSNews.com did a little better, offering a Mount Sinai gynecologist as an analyst of the news, although I lost count of the times Norah O’Donnell used the word “new.” Tracy Miller misspelled the name of the drug (come on!) in her New York Daily News story—twice. In his New York Times piece, Andrew Pollack, no stranger to covering Big Pharma and its shenanigans, made no mention of this marketing maneuver in his straight-on FDA reporting.
It’s sad that the only discussion of the backstory I was able to find came from a mental health counselor, Bill White, on his (unvetted, I admit) cyber-therapy site Chipür. As folksy as it is and naïve as it may sound, he offered his audience a clear-eyed perspective on Brisdelle, excerpted here:
…I really have to wonder why Big Pharma continues to seek new FDA approvals for existing drugs. And antidepressants are all too often the drugs of choice.
I mean, are the pharmaceutical companies that altruistic, wanting to do all they can to bring relief to the suffering masses? Or is it about profits? I’m just asking.
For example, Noven Therapeutics’ patent on Pexeva (same drug as Brisdelle, but way lower paroxetine portion) expires June 2017. ‘Course, at that time a generic could become available. So is the introduction of Brisdelle driven by the fact that Pexeva’s patent will expire in four years? Is this about brand name profits? And how did Novena manage to get the FDA to approve the drug, in spite of its advisory committee saying “No way!”? Again, just asking.
Look, I would never deny anyone the right to choose whatever they want to remedy what ails them. And that certainly applies to someone enduring hot flashes or other menopausal symptoms. I guess I just get suspicious when out of nowhere an antidepressant becomes a miracle drug for something beyond depression (actually, that’s an often over-hyped concept).
Here’s hoping there’s a whole lot of informed consent goin’ on when it’s scrip cuttin’ time…
White may not be an authority on this topic, but at least he cares enough about his audience to help inform their news consumption. That’s more than I can say about some of the seasoned health reporters who cover this industry, who know that even as Big Pharma companies pursue market clearance for a primary indication, they are already planning their patent-protection strategy. Patent extension is a goal from day one.
A cogent description of this dynamic by Aaron Smith ran on CNN Money way back in 2005. He described GlaxoSmithKline’s strategy, which should look familiar by now:
GlaxoSmithKline lost its patent on Paxil in 2003. Sales of the former blockbuster totaled $172 million in 2004 in the U.S., about one-fifth the sales for the newly-available generic version, paroxetine, according to Drug Topics, an industry publication, and Verispan, a healthcare information provider.
GlaxoSmithKline has stayed in the game with Paxil CR, a once-a-day “controlled release” drug that had $824 million in U.S. sales last year. Even with Paxil CR, the company lost half its revenue to the generic market. But the daily capsule “tends to prevent overall erosion of the flagship product,” said Amusa, who rates GlaxoSmithKline a buy.
The big advantage of once-a-day Paxil CR over twice-a-day generic is that “patients with depression don’t always take their pills,” said Amusa. “The generics can’t do once-a-day but Glaxo can, and that permits a lot of patients to continue to be loyal to the branded product.”
Yes, loyal to a branded product. And also stuck with a higher price tag.