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How to Stop Direct-to-Consumer Prescription Drug Ads

— Milton Packer suggests a path to rein in a 20-year-old FDA policy

MedpageToday
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I rarely watch television, but when I do, I am overwhelmed by the number of direct-to-consumer commercials about prescription drugs.

The ads saturate the airways. In a single hour, it is possible to see six different drugs promoted.

Each commercial has a predictable formula. An actor plays the role of a patient afflicted with a certain disease -- often one that is exceptionally uncommon and not recognizable by the general public, or by many physicians.

The beginning of the ad superficially establishes the burden of the disease. An actor playing the role of the patient is sad and unable to engage in normal activities. But magically, following a description of the drug, the actor is now happy, active and surrounded by doting family members. The scenes are idyllic, and the music is uplifting.

The commercial ends with the required warnings, precautions and list of adverse events. The information is legally required, but it is not possible to understand what the risk-to-benefit relationship might be. Or what the drug costs.

There is always the central message: "Ask your doctor about ... "

Sounds noble? Not really.

The pharmaceutical industry might claim that these ads are intended to raise awareness, but the general public is not the intended audience. The only goal of these commercials is to prompt patients to initiate conversations with physicians.

Which doctor should that be? Your primary care physician? Many (maybe most) of the diseases being discussed are not treated in primary care.

In fact, ads often prompt unnecessary physician visits, especially when people do not have the disease that the commercial refers to.

Even if the patient actually has the disease and initiates the conversation, the physician may never have heard of the drug. This seems likely given the highly specialized nature of many of these pharmaceuticals.

Perhaps the physician is aware of the drug but does not think it is appropriate for the patient. Does the patient now wonder if the physician is out of touch with recent developments?

Often physicians might tell patients they are not comfortable prescribing the drug. It is new, and they have limited experience with it, and thus, do not know how to administer or monitor its use. What happens then?

And is it possible that some physicians might refuse to prescribe the drug because they are just annoyed at the pharmaceutical company for placing the ad and believe that it undermines the patient-physician relationship?

Regardless of the circumstances, the commercial is not informative; in fact, it is disruptive. But of course, that is its whole intent.

The FDA first allowed the practice of direct-to-consumer advertising in 1997, and since then, the number of TV commercials for prescription drugs has skyrocketed. Interestingly, only the United States and New Zealand allow for direct-to-consumer advertising for pharmaceuticals. The remainder of the world thinks it is inappropriate.

According to a , drug companies spend more than $5 billion a year pitching prescription medications directly to consumers. That is obscene. Industry spending on direct-to-consumer advertising is now comparable to its spending on marketing to physicians.

Studies report that consumers often place unwarranted trust in these TV prescription drug ads. Practitioners report being bombarded by patient requests, and many feel pressured to prescribe drugs that have been requested by patients, even if they believe it is inappropriate to do so. And the conversation often wastes the limited time the physician has allotted to the patient visit.

Think the situation is bad now? A year ago, pharmaceutical companies were seeking FDA permission to use direct-to-consumer advertising to promote off-label use of drugs for nonapproved indications.

What?

The FDA does not allow pharmaceutical companies to market drugs directly to physicians for non-approved indications. But might they allow companies to tell patients about such use? What purpose could that serve? What kind of patient-physician conversations would that lead to?

I condemn the current pricing structure that the pharmaceutical industry currently utilizes to determine the cost of most innovative products. Drug companies say that they must cover their research and development costs. But obviously, these revenues must also cover the considerable costs of TV advertising.

Several years ago, I stopped working with a pharmaceutical company specifically because of a profound disagreement about their efforts related to direct-to-consumer TV advertising.

I want to be clear. I strongly favor giving patients the information that they need to make informed decisions, but direct-to-consumer advertising for prescription drugs is not about patient empowerment. It is not about providing clarity, and it often does not enhance the physician-patient relationship. It undoubtedly contributes to the high prices of drugs.

Can direct-to-consumer advertising for prescription drugs be banned? Apparently that is legally difficult. The courts have ruled that product advertisements are a form of commercial free speech protected under the principle that a manufacturer has the right to market its products.

So here is a proposal to curtail direct-to-consumer advertising for prescription drugs -- legally. Right now, when a pharmaceutical company advertises, it is required to describe the major adverse effects of the drug. I would add two simple additional requirements.

First, I would require manufacturers to describe the size of the expected benefit. This can be a statement of the placebo-corrected effect on the primary endpoint of the pivotal trial(s) that led to approval. Second, I would require manufacturers to tell the public how much the drug costs. This should be the list price, not the discounted price (which companies do not disclose anyway).

Who could possibly argue that such information would not be extremely useful?

My prediction: Implementation of these two requirements would dramatically curtail direct-to-consumer advertising of prescription drugs. Drug manufacturers might hesitate to publicly disclose that many new drugs provide only modest effects or benefit only a small fraction of patients, even though they may be priced at more than $200,000 per year.

Do you agree with this idea? I want to hear from you.

(Anyone interested in a detailed discussion of this subject should read a paper by. Some of the points in this post are based on studies cited in this work.)

Disclosures

Packer recently consulted for Actavis, Akcea, Amgen, AstraZeneca, Boehringer Ingelheim, Cardiorentis, Daiichi Sankyo, Gilead, Novo Nordisk, Pfizer, Sanofi, Synthetic Biologics and Takeda. He chairs the EMPEROR Executive Committee for trials of empagliflozin for the treatment of heart failure. He was previously the co-PI of the PARADIGM-HF trial and serves on the Steering Committee of the PARAGON-HF trial, but has no financial relationship with Novartis.