The Upside & Downside Of A DTC Moratorium
17 CommentsBy Ed Silverman // May 31st, 2011 // 8:57 am
Over the past several years, Congress has regularly considered legislation to restrict direct-to-consumer advertising of prescription drugs, perhaps for the first couple of years after a med has been approved by the FDA. The rationale has been that DTC ads encourage unnecessary use of some meds and lead to usage before risks are fully known. Nothing has passed yet, but the idea lives on.
And so the US Congressional Budget Office has issued a brief and found drugmakers would probably expand marketing to docs in order to substitute for any banned ads; the number of prescriptions filled for some drugs would probably decline, but for others, scrips may not change, since there would be other forms of promotion, and any change in prices would depend on changes in demand.
Moreover, a moratorium could affect public health, although the CBO concedes the impact is uncertain depending on whether the benefits of fewer unexpected side effects were larger than the health costs of possibly reduced use of new and effective drugs. The CBO also argues that a moratorium could mean it would take longer for risks to become known among the population at large.
To reach its conclusions, the CBO’s Microeconomic Studies Division examined data on promotional activities from 1999 to 2008 and on prescription sales from 2004 to 2008. This included 366 brand-name meds that were prmoted to docs and other healthcare professionals through detailing, journal ads, professional meetings, during the first two years following FDA approval.
What did the CBO learn? Of the 366 drugs, 73 were also advertised directly to consumers and drugmaker spent an average of $71 million per drug on DTC advertising during the two-year period that would correspond to a moratorium. To promote the larger set of drugs to docs, drugmakers spent an average of $54 million per drug over the two-year period, of which $46 million went to detailing.
“Thus, the average amount spent on advertising to physicians was less than the average amount spent on advertising to consumers for those drugs for which advertising to consumers occurred,” the CBO writes. By the way, DTC ad spending in 2008 totaled $4.7 billion, nearly one-fourth of all promotional spending by drugmakers.
Another nugget: Between 2004 and 2008, the average annual number of prescriptions for brand-name meds reviewed by the CBO with DTC advertising was nearly 14 times the average annual number of prescriptions for brand-name drugs without such advertising. However, the CBO acknowledgest that it can be difficult to distinguishing between cause and effect.
The CBO also notes that, between 2004 and 2006, when DTC advertising peaked as a share of promotional spending for new drugs, a large portion of the drugs that were reviewed were less than two years old and were among the top-selling drugs in the country. But the DTC share of advertising for new meds has declined, because recently drugs approved have not had broad potential markets.
What could a moratorium do? After a ban expires, a drugmaker may accelerate DTC ads to compensate, especially since a moratorium would bring a patented medicine closer to generic competition. And without the possibility of DTC ads, drugmakers “may see their opportunity to create a market for a first-in-class drug and to benefit from its monopoly status delayed or diminished. That outcome could, in turn, reduce their incentive to research and develop new breakthrough therapies,” the CBO writes.
You can read the CBO brief here. But what do you think?
Should There Be A Two-Year Moratorium On DTC Ads?
- Yes (69%, 74 Votes)
- No (31%, 34 Votes)
Total Voters: 108
Loading ...pic thx to mike licht on flickr
Salient point
CBO’s statement that “the average amount spent on advertising to physicians was less than the average amount spent on advertising to consumers for those drugs for which advertising to consumers occurred” is not completely accurate.
It’s based on a comparison of the mean DTC expenditure for the 73 drugs that ran ads to the overall mean professional promotional expenditure for all 366 drugs. The problem is that drugs that spend on DTC usually also have a disproportionately high spend on promotion to doctors.
A rigorous comparison would involve breaking out the promotional spend on physicians specifically for the 73 drugs that went DTC & using that mean.
EddieVos
The U.S. should ban DTC ads altogether like the rest of the civilized world. Is the per capita drug expenditure in the U.S. not the greatest but longevity number 30 something in the world?
DCT ads pollute people’s perceptions and are misleading if not plaint dishonest … “don’t kid yourself about cholesterol” says the 2011 Lipitor ad since X% of people with heart attacks have “HIGH” cholesterol [says who?]. In fact, 100% of people with heart attacks have 2 ears. Lipitor has conclusively shown NOT to reduce mortality [yours truly in 2010 JACC] but uninformed people logically assume a heart attack may well be game-over [but not the type MI prevented by Lipitor].
Drug ads belong in medical journals with all the caveats, not on TV or popular magazines.
These ads are like candy or junk food ads to kids: evil.
Ken Kramer
I believe we have said (again and again) that how an engaged and educated patient is something that is a necessity. If DTC is pushed back, how do we fill in these gaps and keep patients as active participants in their treatment?
EddieVos
Dear Ken Kramer, please us me know what is “educational” about Pfizer’s “do not kid yourself” ad. It does not inform patients but creates future patients by generating fear.
Grant you, this ad is not as frightening as the ad the World Health Organization called unethical when they ran it in France and that is lovingly called ‘feet in the morgue’ ad: ” Which would you rather have, a cholesterol test or a final exam? ”
Just add http://www. in front of health-heart.org/final_exam.jpg Education?
Justice in MI
Re: Ken’s comment, my sense is that most “active” pts get their info via the internet, not DTCA. Thus, I doubt there would be an impact in that regard, at least a negative one.
More generally, my initial response to the proposal was that it seemed silly not to make a real decision about DTCA rather than “kick the can down the road,” as everyone says about everything these days.
On the other hand, a moratorium might yield data–including some relevant to Ken’s point–that could be useful re: DTCA’s various impacts–on pt. care, costs, pt. involvement, etc.
As an experiment, therefore, I would endorse it. I also think there’s a snowball’s chance it will happen given the current make-up of the House.
Free Speech
Great idea, lets not worry about free speech that pesky bill of rights. Isn’t the field slanted enough currently for generics? About 72% of the market currently.
industry insider
Eddie, DTC ads are actually allowed these days in the UK on a limited basis, unless you don’t consider them to be part of the civilized world, which some folks do not, dating back to King George III and the American Revolution.
Justice in MI
Invoking George 3 puts a different slant on Free Speech’s comment.
As we all learned in fifth grade, there is nothing in the bill of rights that does not come relevant context.
Is Mr. Speech also ready to return cigarette ads to TV? “Bear arms” in courthouses?
Or is the issue, at core, not really about rights but, as he suggests, competition with generics?
Free Speech
Bear arms in the courthouse no, cigarette ads yes, I guess I believe people are less sheep like than you.
EddieVos
Insider, nice to touch base again: you’re someone I respect enormously.
That being said, and as a former Dutchman: those British isles are nothing more than some pieces of land on the Dutch continental shelf we simply and wisely have not bothered to reclaim.
To answer your question, what I know about the U.K and drugs, the NICE prescribing straight jacket and the fact doctors can effectively DOUBLE their income by blindly following their prescribing guidelines REGARDLESS of the patients needs, I suggest to you that the U.K. is no longer part of the civilized medical world.
DTC ads would be a natural part of that idiocy.
industry insider
Thanks, Eddie. Like the Flying Dutchman that never makes port, perhaps we are doomed to debate these issues without reaching conclusion.
Salient point
Congress could ban DTC advertising if it wanted. In fact, FDA could probably do so as well. The industry would probably fight it all the way to the Supreme Ct., though, on 1st Amendment grounds. There the ban might be upheld, or we could return to the status quo, or it could be found that FDA’s existing enforcement mechanism, DDMAC, doesn’t have as much right to regulate promotional speech as previously believed, which would enable the industry to promote much more aggressively on TV & in doctor’s offices.
It’s a game of chicken that neither the executive nor legislative branch seems eager to play.
Ken Kramer
I guess my point was not clear; for that I apologize. I think that not being able to legally speak to patients/consumers is wrong. A specific dialogue between consumer and manufacturer is allowed for such products as guns, alcohol, automobiles; all items which come with some dangers and do not have an active intermediary (physician) involved prior to purchase and use. My point, and I agree with EddieVos, is in the content. The content must be more regulated so that it does become more educational and empowering and less fear-mongering.
For me, it is a matter of access.
Thanks for letting me clarify my point.
EddieVos
Insider: I like that Flying Dutchman analogy. You’re a wise man. For consensus, my guess that a face-to-face and sufficient red wine would do.
industry insider
Eddie, I can tell you are a smart guy because you have a smart dog. Love the picture of your Border Collie on your web page.
EddieVos
Insider, he’s smart but I have not been able to contribute to blogs but will keep on trying. Best, Eddie
Captain Jack
I wonder if Pfizer would agree that the four doses of Prevnar required for infants and toddlers cause more risk of harm by the aluminum adjuvants alone, than the benefit of “pneumococcal disease” that it purports to prevent.
Not many more infants not people would contract this disease if Prevnar was never administered.
Just trust me on that one. Or, research it and find similar info. Not from “cafe pharma” either.
Pinheads…
CJ