Tuesday, May 25, 2010

So who’s reporting Gardasil to the FDA’s Bad Ad program?

I’m sure this makes me a Bad Person, but I’m still absolutely howling at the discomfiture of Pharma faced with the FDA’s ‘Bad Ad Program.’

As reported in Advertising Age by Rich Thomaselli: “’You've got more than a handful of doctors and medical professionals who maintain little to no use for DTC advertising. Christ, just look at any survey," said a brand-marketing director at one of the top five drug-makers, referring to surveys and studies that show some physicians feel pressured by patients to prescribe drugs they saw in an ad. "Tell me some of them aren't going to use this watchdog program to their advantage.’”

One can only hope.

The FDA’s new program asks doctors to report any ads that omit or downplay the risk, overstate the effectiveness, or promote off-label use, of any drug. They can do so anonymously, which of course opens things up to everyone—the average pissed-off consumer who’s fed up with his kids watching sleazy primetime Viagra and Cialis commercials; angry parents who have watched a child suffering from what they believe to be side-effects from the heavily-promoted Gardasil vaccine; or any number of people who were convinced by sophisticated ads that they were suffering from ‘social anxiety disorder’ or ‘overactive bladder disorder’ and then found themselves hooked on crappy meds.

Truthfully, all pharmaceutical ads are bad ads. They market never previously heard-of conditions or hype others to the point that you’re certain you must have whatever it is. They recite side-effects, as required by law, only while playing happy, hopeful music and showing scenes of relief, joy, hope, love and Hallmark-style family life—with never a mention of the estimated 270 Americans who, according to journalist Melody Petersen, die every day from prescription medicines used as prescribed.

It’s curious that we ban ads for cigarettes but allow ads for medications. ‘DTC’—direct to consumer—refers only to pharma advertising, because for no other business do advertisers need to score an end run around a gatekeeper. After all, shouldn’t it be your doctor saying, “oh, you’re occasionally incontinent? Hey, do some Kegels and knock it off on the coffee—and if things get really bad, there’s a drug I can prescribe,” rather than the patient saying, “Doctor, I suffer from a Overactive Bladder Disorder and I can cure it with this excellent drug I heard about during MacGyver—give it to me, now!”?

Heck, no. There’s no money in that.

And it’s not just the annual $5 billion in DTC advertising that’s a concern, although there are now terrifying rumblings about ‘product placement’ ads (how do you think they’ll get in those mandated risk disclosures? Don’t worry; they’ll think of something). Pharma markets deceptively to doctors, too.

There was the scandal about a very convincing fake medical journal designed to fool doctors into prescribing Vioxx (read about it here).

Then there was that study that found that much of the drug trial information that’s written up in medical journals is skewed and often ghost-written by Pharma (read about it here).

There was even a UM study that found that “where a potential conflict (of interest, due to pharma funding or financial interest) existed, randomized trials were more likely to link patient survival to a particular treatment.” Read about that here.

And I’ve recently been dipping into Melody Petersen’s fascinating book, Our Daily Meds. Read it and weep. (No, really. I wept from sheer frustration with the perversion of pharma's power to heal, and you will, too.)

So should we call the FDA about the Gardasil campaign? Eminently watchable girl-power ads with smart girls and slightly emo skateboarders, all taking charge of their health and vowing to be one less? Is that bad advertising?

Well, I’m not necessarily going to take issue with calling it a cancer vaccine, despite the inevitable inference that it will put an end to cervical cancer—which it certainly won’t—and despite the risk of replacement disease, alteration of natural immunity, etc. that could lead to new causes of cervical cancer. Accepting surrogate endpoints isn’t unreasonable, although so far Gardasil isn’t exactly setting the world on fire results-wise.

But I can certainly take issue with Merck’s overstatement of the case for Gardasil. Heck, even the Journal of the American Medical Association did that. Drs. Sheila and David Rothman wrote in JAMA that “by making the vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to adolescents was maximized, and the sub-populations most at risk practically ignored…the material [put out by Merck-funded PMAs] did not address the full complexity of the issues surrounding the vaccine and did not provide balanced recommendations on the risks and benefits.”

Here's my Truth in Advertising version of Gardasil ads from last year.

Anyway, if you’re, ahem, a doctor, and want to report a Bad Ad, here’s where to do it: email badad@fda.gov or call 877-RX-DDMAC. Be prepared to state your case; you’ll need to provide very specific and concise information about how the ad violates the law if you want to be taken seriously.

Now whether any Pharma ads at all should be legal—well, that’s another matter. You need to have a chat with your legislative representatives about that.

© 2010 http://www.gardasilhpv.com/  Permission is freely given to accurately reproduce the first five paragraphs of this article, along with a link back to this site and the entirety of the article.


Nina said...

Thank you Kristin for speaking up about DTC advertising. I have no confidence in the FDA's procedure especially when it comes to HPV Vaccines. Glaxo's Ceravix ad used cervical cancer in a even more outrageious manner than Gardasil and it entered the game later. Shame on 'em all.

Anonymous said...

LOL advertising drugs is awful. You are right, maybe this is a good time to try to get drug ads banned.

Anonymous said...

So why is the FDA less willing to accept surrogate endpoints for a drug to fight Alzheimer's than it was for a drug to fight cervical cancer? The NYTimes reported on the front page yesterday that the FDA is unwilling to approve drugs that reduce the plaque in the brain that is believed to cause or be a precursor to Alzheimer's unless the drug companies can show that "those who took the drug ended up with better memory and better ability to think than those who did not take the drug." The article goes on to report that the FDA's caution is warranted because of all the drugs where it turned out that not only did the drug not help, but it actually hastened death for patients who took it. Where was this caution in the case of Gardasil?

Kristin Johns said...

Thanks for an interesting comment. Without being an expert on the subject of Alzheimer's (not that that's ever stopped me from having an opinion)I'd guess that it's because we do know, pretty much for sure, that persistent HPV is the cause of almost all cases of cervical cancer; therefore it's reasonable to assume that if you prevent persistent infection by any HPV strain, you'll prevent cervical cancer caused by that particular strain. (Note: I have some very severe reservations about whether Gardasil will achieve this goal given the risk of replacement disease--but that's the theory).

However, researchers don't know for sure that the build-up of plaque in the brain is what causes Alzheimer's. People without plaque can get the disease, and some of those who do have Alzheimer's don't have plaque. Therefore a drug has to be shown to do more than just reduce plaque in order to be worth potential side effects.

Medicine is, frankly, a black art that is only as good as what we know so far. The FDA often gets things wrong, but it's not always totally illogical, and the side-effects of some drugs, known or unforseen, are appalling.

That's why I think we all have to be responsible for our own health rather than mindlessly accepting anything the doctor orders. Know the risks versus benefits. My doc is resigned to the fact that I question and research almost everything and will sometimes shoot him an email later telling him I'm not doing something and why, the poor sod!