Is it time to be more balanced about fair balance?

A recent New York Times editorial asserts that the PDUFA act, which allows the FDA to collect industry-paid user fees to expedite the drug-approval process, has resulted in a “cozy” fiscal relationship that may undermine objectivity and weaken the FDA’s resolve to put public safety first.

There is no arguing that the safety of drugs and devices should be rigorously and objectively monitored in the interest of public safety. To that end, robust systems have been put in place over the last two decades to facilitate the tracking and publicizing of emerging risks associated with prescription drugs, such as compulsory reporting of side effects to the FDA, well-publicized channels encouraging patients to report side effects on their own, and Risk Evaluation and Mitigation Strategies (REMS). At the same time, the FDA has steadily increased the scope of requirements for maintaining a fair balance of efficacy and safety in all communications that fall under the broad umbrella of product promotion.

Yet, as two physicians pointed out in a letter of response to the Times editorial, the ever-growing emphasis on safety and risks required in marketing communications has, in some cases, crossed a line that is no longer fair or balanced and may in fact be undermining the well-being of the patients they are trying to protect. Indeed, with today’s fair balance requirements, the amount and prominence of safety information in a journal ad, brochure, website, or TV ad can be so predominant that important drug benefits become eclipsed. Add to that the stringent limitations on efficacy or benefit claims, and a product ad may become little more than a drug risk manifesto intended to scare patients away from starting or staying on treatment.

This can have serious implications for patients with any chronic condition that, left untreated, significantly increases the risk of disease-related morbidity and mortality. In the realm of serious diseases like cancer or HCV, this is particularly troubling. Because of the complex and cagey nature of these diseases, they have proven very difficult to treat. In fact, AIDS and many types of cancer were considered untreatable until the relatively recent discovery of therapies that could rise to the challenge and make a difference. Sure, many of these treatments are associated with some potentially serious toxicities that require vigilant monitoring and proactive management, but they also have the potential to save or significantly extend lives—otherwise they would not have been approved in the first place. However, both the amount and prominence of safety information required in promotion tends to be foreboding and overwhelming. Many of the warnings are detailed only enough to sound ominous, but are too vague for patients to understand what this really means relative to their chances of developing a serious side effect, and whether or not it can be predicted, avoided, or managed. Permissible information about efficacy and potential benefits is often scant, buried in a thicket of safety, and confusingly ambiguous.

Take, for example, a patient website for an oral oncology product that I reviewed recently. On the landing page, aside from the drug indication and a photo of a smiling patient, the only information about the drug is its safety, risks, and warnings. Many of the potentially serious side effects listed in the warnings occurred in only a small percentage of patients, and were severe in an even smaller percentage of the treated population. Yet there is no mention of this, nor is there any information about how often and in whom they are likely to become serious, and what steps can be taken to reduce or mitigate the risk of certain side effects.  Missing, too, is any reference to managing less serious but unpleasant side effects that may discourage a patient from staying on therapy. Yet effective interventions do exist for many of them. Drug benefit is only briefly mentioned on two pages within the entire site, pointing out that mean survival in patients who took the drug was a couple of months longer than in those who took standard treatment only. A definition of “mean” is provided, but it probably does not mean much to the average non-statistician, leaving the impression that the drug’s benefits are minimal while the side effects and risks are substantial. Recommending that patients consult with their physicians regarding the relevance of the efficacy data would be helpful—after all, don’t patients have the right to thoroughly understand how a drug may benefit them? Nonetheless, this type of recommendation is generally not permitted in prescription drug advertising.

Many of these pitfalls spilled over onto the professional website—pages are crowded with broad and vague safety statements that are elucidated only in the adverse events section of the site, and while there is information about monitoring for certain side effects, information about interventions is missing entirely. These omissions and gaps in information are by no means intentional on the part of the drug companies—they are mandated by regulatory in the name of “fair balance.”

This is only one example of many. By and large, branded ads, brochures, and websites, and patient education booklets representing drugs for serious conditions are crowded with safety, obscuring or completely displacing other important information—not just about the rationale for and benefits of the treatment, but also information about side effect management and patient support programs that can encourage recognition and reporting of potentially serious, but manageable, side effects. Focusing on management rather than just laundry-listing risks would likely reduce risks while encouraging, rather than discouraging, adherence. This, in turn, would likely improve treatment results and outcomes, which is the point of prescribing a drug in the first place.

So what is the solution to the increasingly imbalanced way in which safety information is presented in drug promotion? Disclosure about side effects and risks should, of course, always remain a priority; every doctor and patient deserves to know the risks or side effects that may occur with any given treatment. But is there a way to disclose this information so that it does not threaten to nullify the drug’s therapeutic benefits? Is it time to rethink how and when safety is presented and in what context? Rather than barraging doctors and patients with an ever-expanding litany of possible risks in a venue that does not allow for full disclosure about what those risks really mean, wouldn’t it be better to streamline and shift the weight of the safety discussion so that it focuses more on recognition, reporting, and intervention? Is it possible that the industry and the FDA partner and negotiate a middle ground that more effectively and fairly communicates the ways in which treatment may help, rather than just harm, patients?


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