Drug Safety: Failure to Communicate - Pharmaceutical Executive

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Drug Safety: Failure to Communicate
The new drug safety system won't be fixed until companies learn new approaches for teaching patients about their drugs


Pharmaceutical Executive


But consumers don't have much experience with combining disparate messages. Drug companies tend to communicate with patients through DTC or risk-communication tools. For mass-market messages and for drugs with mild to moderate risks, DTC can deliver a meaningful benefit message. However, companies marketing drugs with major risk concerns often limit their consumer promotion and, in particular, refrain from broadcast DTC. In both cases, patients don't get the full story.

In Search of Fair Balance

In the new Culture of Drug Safety, companies will come under greater pressure to increase the flow and usability of information to consumers. Regulators and others will use evaluation oversight (i.e., studies that measure if risk-communication tools are working) to judge if companies' efforts are adequate. These tools will evaluate how patients perceive risk information and how it influences their decisions and behavior. Key to this process for companies will be learning how to package information so that consumers can compare and evaluate benefits and risks, and make a reasoned decision about using a drug.

There are two elements to providing the risk/benefit context. First, the risks need to be fully explained in both relative and absolute terms. For example, for Avandia, we have heard that there is a 43 percent increased risk of having a heart attack. This is based on an "odds-ratio" (a similar index as the relative risk ratio). Patients have not been told about the absolute risk of a heart attack for people taking Avandia (about 6 in 1,000). Nor have they been told that the rate of heart attacks for Avandia patients is similar to the base rate for heart attacks in patients on placebo or other drugs (also about 6 in 1,000).

The second element is "fair balance." Traditionally, FDA and companies have relied on this risk statement to give patients a full understanding of the drug. Clearly, this approach doesn't work. To start with, neither FDA nor drug companies has ever really defined how to achieve fair balance (except, of course, by adding risk information to advertising).

Instead of worrying about what words to provide in a fair balance statement, it may be more important to present patients with a "fair perception" of the drug. This moves the focus off the individual elements of the message (i.e., the current FDA model) and toward understanding the outcomes of risk communication and the ideas about the drug's safety in the patient's mind. This will require companies to really understand how patients learn and comprehend risk. After all, the new safety system shouldn't run on what patients are told—it matters more what they learn and what they do based on that learning.

"Fair perception" can be measured. This can be done in small "copy tests" of the promotional information. Companies that provide prospective patients with draft promotions or risk-communication tools can learn how various materials influence risk and benefit knowledge and attitudes. Some pieces may favor risks to a greater extent than benefits, while other pieces do the opposite. Which perceptions are correct?

If we were to rely on the views of the company, we would select the material that favors benefits; if we were to rely on the views of FDA, we would choose material that favors risks. Instead, the fairest method for judging what's balanced information should come from independent experts—prescribing physicians. After all, they are the ones that must deal with patients' needs as well as the outcomes of a treatment decision.

Of course, one can always argue that physicians can be biased. However, FDA routinely relies on outside experts to form advisory committees, and procedures can be developed to screen physicians for such biases. This group can be further augmented by adding experts in consumer communication and risk management. At the end of the day, the point is that it's important to draw on outside perspectives to gain a better understanding of what is a fair and integrated risk/benefit message.


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