There’s something for every illness. Photo of shelves stocked with various medicinal products in a pharmacy.

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Last month the Trump Administration announced sweeping changes to the decades old rules that allow pharmaceutical manufacturers to advertise products direct-to-consumer. FDA Commissioner, Marty Makary, noted that since 1997 when the rules changed allowing drug promotion as long as ads described side effects along with clinical benefit, manufacturers have been spending billions to promote their drugs. The amount of money spent on advertising in the following decade increased 8-fold, from $700 million to $5.4 billion in 2006. That number today is around $10 billion and according to some estimates represents approximately 31% of what the U.S. pharma industry spends on bringing drugs to market.

The administration has also suggested that companies have spent approximately 14% more advertising drugs with modest benefit in contrast to those with greater clinical benefit. The FDA’s position in the face of these trends is that advertising today is generally designed to mislead, not reliably inform consumers of available options. In that regard, the practice is seen as deceptive, amplifying purported benefits while minimizing real risk. Accordingly, FDA has set in motion new guidance that requires greater focus on risk and announced that it will be more aggressive in its oversight. It has already issued thousands of letters warning companies to remain compliant with existing regulations. Approximately 100 cease-and-desist letters have also been issued targeting the most severe regulatory violations.

Perhaps of most concern to FDA is the belief that such advertising has distorted the relationship between patients and their doctors, encouraging patients to actively request treatments that may not be optimal for them. The agency is also concerned that ads divert funds away from new drug development that could bring benefits and lower drug prices.

Not surprisingly, the pharmaceutical lobbying group, PhRMA and various advertising associations, have pushed back, taking the position that such advertising has helped consumers become aware of various treatment options and increased their active participation in their care. While FDA cannot ban pharmaceutical advertising as it will violate free speech, it can regulate deceptive practice.

Pharmaceuticals are obviously not like traditional consumer products, but consumers need to be engaged in discussion of their health and the solutions that might be required to maintain or improve it, typically in concert with a discussion with their physician. But engaging with physicians has been negatively affected by constraints on available time and the reality of highly uncoordinated care across multiple specialties.

The traditional healthcare quarterback of healthcare, the primary care physician, is typically the one whose time is least valued by the medical establishment if one marker of value is compensation. An overwhelming majority of these physicians are employed, either by healthcare systems which are intended to find optimal solutions for patients who are associated with them or by the insurance companies who pay for the services the systems provide. The insurance companies, as I have written in this column before, have set up elaborate bureaucratic rules and regulations aimed at limiting financial exposure for the insurer, too often at the expense of the patient.

But even on the healthcare delivery side of the equation, incentives are not always aligned with patient interests. Even here financial incentives distort decision-making. The most egregious is the fact that PCPs too often just don’t have the time to spend reviewing alternative options, especially for complex, specialty conditions. So, the patient is referred to one specialist after another, increasing fragmentation, frustration, and total cost.

Where does pharmaceutical advertising fit into this mix? The industry (and others) would argue that it’s a legitimate vehicle to inform the patient-consumer of new options that might be appropriate for them. The ads typically encourage patients to talk with their doctor to see if ‘x’ might be right for them. Informed patients are a good thing—for the patients themselves and for society more broadly. But they must be sufficiently knowledgeable, and the healthcare expert must be committed to talking through the answers to the question, “Is this drug right for you?” And herein lies the problem.

In a world where the expert is under significant time pressure to see as many patients as possible without regard to clinical outcome for the patient panel, these are difficult conversations.

Too many doctors don’t have the time to engage in the discussion. Some, even if they have time, are not comfortable in a spirited discussion about the pros/cons. Patients often shop for doctors and look for those more willing to prescribe what they want vs what they need. (The opioid crisis was fueled in part by this dynamic.) To the extent physicians are evaluated on patient satisfaction and not clinical outcomes, behavior is geared to get a good grade on satisfaction. In this case, giving the patient what is requested may be a path to that grade.

All care is not equal. But when the incentives assume that it is and it’s perceived as too difficult to measure meaningful outcomes, the stage is set to reinforce the erroneous belief. Just as all care is not equal, neither are all drugs the same, even though several may be approved for the same condition.

Pharmaceutical manufacturers are bringing innovations to market. How one drug in a class performs vs other options (e.g., for maintaining blood pressure or lowering cholesterol) relies on scientific evidence and real-world experience. No ad, no matter how many disclosures are offered, can convey what’s right for a given patient.

Drug innovation enables more precise treatment decisions for patients. Only informed doctors in concert with informed patients can make those decisions.

To the extent DTC advertising helps raise patient awareness of new options, that is useful. But the healthcare ecosystem today with its misaligned incentives makes the application of that knowledge difficult. The future may be ready for a disease specific unbranded type of education rather than brand based marketing. This could mean less reliance on expensive TV ads to drive product awareness to increase pharmaceutical sales.