So you caught the news recently that Merck’s Gardasil was approved by the FDA for use in boys ages 9 to 26. No one really expects much from this news—ie, doctors aren’t expected to be offering it to their male patients (or their parents as the case may be). But I find it interesting none the less.
First, the background…Gardasil is the vaccine that’s supposed immunize young girls (ages 9 – 26) from the HPV virus—aka, human papillomavirus, the sexually transmitted one that can lead to cervical cancer. There’s a lot of heated debate on Gardasil in girls–we’ve blogged on it as well–and the New York Times recently reported that in order to be effectively immunized with Gardasil, it requires a series of three injections, each costing $130 (translation, around $400; translation, it ain’t cheap).
But now let’s just take a look at that NYT report again. I read on through the whole article…la dee da blah blah blah…WHOOMPH! The kicker is actually at the end of the article…and here it is:
Harrell W. Chesson, a health economist at the disease control centers, said that to reduce HPV, it would be more cost-effective to increase vaccination among girls than among boys.
The committee said it would take up the issue of the vaccine’s effectiveness in preventing HPV-related male cancers at its next session in February, when more data should be available. Merck plans to present studies sometime next year on the efficacy of the vaccine against anal pre-cancers in men who have sex with men, a company spokeswoman said.
Ok, the first comment pertains to the fact that the vaccine would prevent genital warts in boys/young men—not a cancer, as it is intended to do in girls/women. Genital warts clearly must not be a fun-to-have for guys, but hey, it’s better than waking up to find out that good time you had last night has left you with cancer.
The second comment—and let me repeat it—is this: “Merck plans to present studies sometime next year on the efficacy of the vaccine against anal pre-cancers in men who have sex with men…” Take note of this one. Why? Well, it sounds good-intentioned and diversity-supportive and all (gay men, take note). And I’m all for any drug research that can potentially lead to a reduction in cancer. But why is Merck really going down this path?
Well, maybe we need to look no further than Zetia for the answer: survival. What happens when a drug you’ve invested millions of dollars in comes under fire? Do you ditch the drug entirely and lick your wounds? Or, do you try to come up with every alternative use possible that will allow you redeem part of that investment and hope for a new revenue stream?
It’s human nature—and Real Simple magazine has a great monthly column that speaks to this very thing. They highlight several ordinary household products each month that can be used—quite cleverly I might add—in alternative ways. Useful and cost-effective—can’t beat that.
And so, that’s what Merck appears to be doing with Zetia. Not cutting it with Vytorin? hmm…let’s see what would happen with Lipitor! Only the FDA wasn’t quite accepting that one (yet)…and now we’ll see what happens this week when Arbiter 6 reveals the showdown of Zetia vs. Niaspan.
So what’s happening with Gardasil? My guess is that sales results didn’t quite “take off” as much as Merck may have wanted. If you recall, when Gardasil launched, it was fairly ground-breaking—imagine, a drug that could prevent some cervical cancers!—but fast-forward to today when the NYT report states that only “about 37 percent of girls ages 13 to 17 started the HPV vaccine series, a national immunization survey showed, and about half of them completed it.” (my emphasis)
Not a huge immunization rate.
Recent reports also show a “big drop in sales of Gardasil” (boston.com, 10/23/09).
So what’s a company to do? Look, Merck still has quite a bullpen (e.g., Claritin, Fosamax, Janumet, Januvia, Propecia, Singulair, Varivax, Zocor…to name a few). But there’s competition out there, patents that expire, and hey, a little heated debate goes a long way to killing market share…