Indeed, these commercials, which feature wholesome looking girls and young women playing soccer and otherwise leading independent Oprah-style lives, completely fail to mention that the vaccine prevents many strains of HPV, an STD which causes genital warts that can then lead to cervical cancer much much later.
Merck must have gone to great lengths, quite possibly with the use of focus groups featuring the religious right, to de-sex this product. They did such a good job that I'm guessing most viewers, not just teen girls, will actually have no idea what this product is for or why they should ask their doctor about it. Wouldn't it be ever so much easier to side-step the moral handwringing, see it for the public health issue it is, make this vaccine required for school enrollment and call it a day? We'll stay tuned on that front.
But what I really wanted to say was that I just love the FDA website. I check it periodically to see if Mylan, the company that has initial exclusive rights to produce generic amlodipine, aka Norvasc the insanely expensive blood pressure medicine that Miss Kitty is taking, has actually started producing it. Pfizer has had Mylan and other pharmaceutical companies in non-stop litigation to extend their patent-which is of course already expired. Give it up already you greedy bastards! Affordable medicine for the people and the cats!
If you don't understand what the FDA does, and I sure don't, you must check out their warning letters. Any public airing of dirty laundry is of course fascinating but the scope and magnitude of the FDA's purview is just staggering. Many of the warning letters are about food--a lot of them seem to be about adulterated seafood, slightly frightening. But many of these letters are to pharmaceutical companies, taking them to task for a variety of things, but most notably for either overpromising what their drug can do or under-emphasizing nasty/fatal side effects.
There are so many to choose from but since I have an ongoing bug up my ass about Pfizer, check out this one addressed to Henry A. McKinnell, Pfizer Board Chair:
The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed three direct-to-consumer (DTC) print advertisements (ads) titled "Tired of your allergy medicine not working?" (airplane) (ID #ZY179738), "Tired of your allergy medicine not working?" (office) (ID #ZY182060A) and "Maybe it's time to switch allergy medicines" (ID #ZY182060) for Zyrtec® (cetirizine HCI) Tablets, Syrup, and Chewable Tablets submitted by Pfizer Inc . (Pfizer) under cover of Form FDA 2253. The print ads make superiority claims about Zyrtec by suggesting it is clinically superior to some other allergy medicines. To our knowledge, these claims have not been demonstrated by substantial evidence or substantial clinical experience. Therefore, these claims misbrand your drug product in violation of the Federal Food, Drug, and Cosmetic Act (Act) and FDA implementing regulations. See 21 U.S.C. § 352(n) ; 21 CFR 202.1(e)(6).
Later:
The three DTC print ads cited above make false or misleading claims that Zyrtec is clinically superior to some other allergy medicines, namely, that Zyrtec "works" and that at least some other allergy medicines do not work.
The "Tired of your allergy medicine not working?" (airplane) ad features a picture of two people seated on an airplane . A man is sneezing and the text next to his picture states : "In the right seat. On the wrong allergy medicine." The woman in the seat next to him, who is not sneezing, is looking at him . The text next to her picture states : "On top of things. On Zyrtec." The prominent callout headline below the picture states "Tired of your allergy medicine not working? Good thing there's Zyrtec."
The "Tired of your allergy medicine not working?" (office) ad features a picture of people in an office setting . A woman appears to be sneezing into a tissue, and the text next to her picture states: "On the wrong page. On the wrong allergy medicine ." The woman next to her is on the phone and is looking over at her, with the text next to her picture stating : "On the ball . On Zyrtec." The prominent callout headline below the picture states "Tired of your allergy medicine not working? Good thing there's Zyrtec."
The "Maybe it's time to switch allergy medicines" ad features the same office setting as the prior ad. The text next to the woman wiping her nose states : "Needs to switch allergy medicines." The text next to the woman on the phone states: "Needs to switch desks." The prominent callout headline below the picture states: "Maybe it's time to switch allergy medicines when your co-worker volunteers to swap seats with the intern."
For each of the ads, the text under the headline states : "Your allergy medicine should work on all of your indoor and outdoor allergies. Really work. Why put up with a medicine that only treats outdoor allergies? Shouldn't it cover both?" Each ad also tells the consumer to ask their doctor "about switching to prescription Zyrtec," "So you - and your seatmates - can feel good the whole flight" or "So you - and your co-workers - can feel good in the office," respectively.
The overwhelming message from the text and the visuals of these ads is the comparative claim that Zyrtec is more effective in treating allergies in general, or certain types of allergies, than some other allergy products, which are not effective . As noted above, FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Zyrtec is clinically superior to any other available OTC and prescription oral allergy medicine. In addition, it is misleading to suggest that patients taking Zyrtec would be "On top of things" or "On the ball" as compared to patients on other allergy drugs. Furthermore, FDA is not aware of substantial evidence or substantial clinical experience demonstrating that other antihistamines are not effective in treating PAR [Perennial Allergic Rhinitis i.e. allergies people] (i.e., have been tested and failed), as is suggested by these ads. Finally, FDA is not aware of substantial evidence or substantial clinical experience showing that patients who fail on other allergy drugs will be effectively treated by Zyrtec, as the ad suggests. Therefore, these claims are false or misleading.
FDA does not object to the dissemination of truthful, non-misleading statements about approved indications, and we acknowledge that Zyrtec is approved for a broader range of indications than many other antihistamines . Therefore, we do not object to the statement in the ads that, "No other antihistamine is approved to treat more allergies than Zyrtec." Rather, our concern is that this factual statement, which follows the other claims and visuals noted above, does not correct the overall misleading impression that superior effectiveness, not merely a comparison of indications, is being promoted in these ads. Absent substantial supporting evidence or clinical experience, the ads suggest that the absence of a particular claim in another antihistamine's labeling affirmatively means that the antihistamine does not work for that claim. Likewise, they also suggest that Zyrtec is more effective -- either in general or in specific cases -- than at least some other antihistamines.
Isn't this great? The FDA tells them what we all already know--their advertising is a bunch of bullshit. As a Professional Critic, I absolutely love the granularity of their nitpickiness--it knows no bounds.
Check out this excerpt from a warning letter to Gilead, maker of Viread, a hugely succesful HIV drug:
... a representative of Gilead made oral representations at Gilead’s promotional exhibit booth during the 15th National HIV/AIDS Update Conference in Miami, Florida, on March 31 - April 2, 2003, that minimized important risk information and broadened the indication for Viread. Your failure to disclose the fatal risks of lactic acidosis and severe hepatomegaly with steatosis reported with the use of nucleoside analogues raises significant public health and safety concerns. This conduct is particularly troubling because the more than 1,500 attendees of this conference included social workers, AIDS educators, and patients with HIV/AIDS, and you had previously been warned not to engage in such activities.
An FDA mole, infiltrating a medical conference posing as an earnest social worker?
Clearly my next job should be with the FDA.
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