DTCA: Beneficial or Harmful?
A new study published in the American Journal of Public Health claims that prescription drug direct-to-consumer advertising (DTCA) can be harmful to a person’s health. According to the researchers, prescription drug advertisements are “not doing a good job of helping consumers to make better decisions about their health”.
The study, A decade of Controversy: Balancing Policy with Evidence in the Regulation of Prescription Drug Advertising, explained that viewers of American television see as much as 16 hours of prescription drug advertisements every year. Living in the EU where DTCA for prescription drugs is banned, I have to say I was a little shocked at the number!
So what is it that the authors of the study dislike? First of all, it’s important to point out that the authors are not completely opposed to DTCA; on the contrary, they admit that it offers benefits. However, they also believe that improvements can be made to “minimize potential harm and maximize benefits”.
The authors concluded that the majority of prescription drug advertisements “fail to provide enough information to allow consumers to clearly identify whether the advertised drug is right for them”. They also added that the “over dramatization and emotional portrayal” of a drug’s benefits in advertisements can also be misleading.
As a solution, the authors proposed several guidelines: advertisements should help consumers identify whether the treatment is right for them; advertisements should provide accurate and specific information about the potential benefits of advertised drugs, and should state how the drug compares to placebo or other available treatments including generic drugs; and specific information should be provided regarding the potential risks associated with drugs without other visual or audio distractions.
This isn’t the first time DTCA has been in the spotlight. In 2008, the Government Accountability Office (GAO) published a report that called on the FDA to boost its enforcement of DTCA rules, while in 2009 voluntary Guiding Principles for DTCA laid down by the Pharmaceutical Research and Manufacturers of America (PhRMA) came into effect. Several members of US Congress, including Henry Waxman, have also called for changes to the FDA’s regulation of DTCA
As I mentioned before, DTCA in the EU is banned, but there have been moves by regulatory authorities to stick a toe into the DTCA pool. Earlier this year, Pharmaceutical Technology Europe reported on a proposal by the European Commission that would allow drugmakers to disseminate certain information on prescription drugs directly to European patients. The ban on DTCA would remain in place, but drugmakers would be able to provide factual, non-promotional information about the benefits and risks of their medicines using certain media (excluding television and radio). This could offer a compromise between allowing the pharma industry to advertise its products while avoiding the problems with DTCA highlighted in the study in the American Journal of Public Health.
In a press statement, the lead author of the study, Dominick L. Frosch, pointed out that: “If the pharmaceutical industry isn’t willing to change the ads to make them more useful to consumers, Congress should consider passing legislation that will regulate the ads to improve the information provided in order to help patients make more informed choices.”
DTCA… Without appropriate understanding and context, harmful is likely. Stick to the facts, defer to the Doctors and drop the sensationalism!
The UK MHRA has just completed its survey regarding the proposed EU changes to allow companies to provide factual, non-promotional information about their products to consumers using media other than TV and radio, with DTCA still completely prohibited.
The survey concludes that a large majority of stakeholders are in favor of a self-regulated system, (overseen by regulators with enforcement powers), for companies to provide such information.
The MHRA is also cautiously in favor, with certain caveats regarding the burdens on regulatory authorities.
This EU proposal probably represents the maximum allowable direct influence on consumers that companies could possibly be permitted to have without creating a large amount of regulatory and enforcement work e.g. to monitor internet sites and paper publications.
Personally speaking, I imagine that a simplified version of the key information and instructions in the PIL for a prescription medicine would probably be welcome to most consumers. And beneficial, because I guess that most patients STILL do not bother to read the instructions. I definitely do not want the marketing dept version (take our drug and get better!). I would expect my specialist physician to be both familiar with the contents of the EPAR (Labeling in the US) and knowledgeable about experience in practice.
However, if I had a serious condition, I would want to read the EPARs for the candidate drugs myself, especially as they are readily available on the European Medicines Agency website. The FDA labeling and medwatch alerts campaigns and numerous incidents during recent years have taught both insiders and outsiders to be very wary about side effects.
How do you say everything in 30 seconds? It’s not possible. Patients can go to the website to learn more or talk to their doctor. The system works. Furthermore, Frosch’s suggestions may chill free speech by violating the First Amendment:
“Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.”
S P:
You made your point well; a DTCA lasting 30 secs is an advertisement, neither more nor less than.
Let’s start by posting patient information leaflets (PILs, required by law in the EU, and needing approval by the authorities) on company websites and see where that gets us with legislators.
Perhaps authorities (FDA, EMEA, etc) could require companies to have, on their official website, a list of all drugs they sell prominently displayed with one click links to their PILs, as a consumer service.
The next step might be a quick reference version of the PIL, containing only essential information, for time-challenged and lazy people…..
I agree with the American Journal of Public Health. DTC ads are very misleading and not helpful to most consumers. A multi-colored cartoon butterfly for a sleeping pill? The first amendment argument made above really doesn’t apply to regulated health products. FDA should have the right to enforce strict standards for DTC ads. In the 1940s the Food, Drug and Cosmetic Act was challenged before the Supreme Court for violating the Constitution regarding facility inspections. The Court ruled that because of the nature of the industry that FDA should be given limited powers to conduct inspections, within the parameters of the Form FDA 482, Notice of Inspection. The same should apply to DTC ads.