Safety Net - Pharmaceutical Executive


Safety Net
The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages.

Pharmaceutical Executive

Finally, we need to consider how the collection of information about the benefits of drugs can be communicated publicly. Any information that impinges on the safety of drugs must be incorporated into the product's label as rapidly as possible. But benefit information presents significant challenges. If companies want to be able to use it in labeling or promotions, they will have to employ careful study design, a systematic research program, and rigorous data-collection processes and analyses. FDA's recent guidance on PRO's incorporation in labeling demonstrates that FDA considers any benefit information equivalent to gaining a new indication. "Substantial evidence" in the form of adequate and well-controlled clinical trials is necessary to convince FDA that such measured benefits are real and worthy of incorporation on the label.

Even if the information is intended for promotional use and not incorporated into the label, FDA will insist on the same level of evidence. Thus, for specific promotional claims about a drug's effects, companies must collect sufficiently rigorous and reliable evidence. Without such evidence, companies will be limited to presenting the information at scientific meetings or publishing the data in scientific journals.

However, much of the new information pharmaceutical companies will need to collect about the benefits of drugs won't necessarily describe their drugs. Rather, it will measure patients' and prescribers' perception of those benefits and how those perceptions influence adoption decisions and use of the medicine.

For example, John Calfee, resident scholar at the American Enterprise Institute, recently published a survey of patients' perceptions of the risks and benefits of therapy for multiple sclerosis (MS). He asked patients if they would be likely or unlikely to use a medicine that was more effective at slowing down the progression of disability (or preventing relapses) but that caused 1 in 1,000 patients to die. He then modified the question to vary the number of people who would die from taking the drug (i.e., 1 in 500, 1 in 100, and 1 in 10). He found that slightly over half the patients (53 to 55 percent) probably would take the drug if 1 in 1,000 died, but that only a third or less would likely take the drug if the death rate was 1 out of 500 or fewer.

Such a study provides insight into how patients make trade-offs between the benefits and risks of therapy. Information of this sort does not have to be consistent with the product label in order to be communicated to the public. Yet it clearly has direct implications for how patients evaluate the risks and benefits of MS therapy.

It will be important to conduct further research into what types of patients are risk-sensitive or -insensitive and how to identify and communicate to them. Decades of research on risk perception has shown us that it's not just objective analyses of severity and probability that influence how people make decisions about undertaking risk. Patients also make use of their expectations about the perceived "dreadedness" of possible outcomes and their ability to control risks and cope with hazards. By understanding the criteria patients use to evaluate the risks and benefits of prescription medicines—and segmenting populations by risk/benefit perceptions—companies will be able to target prescribers and patients better and provide them with more meaningful information.


The pharmaceutical industry has perceived life cycle planning primarily as an aspect of marketing. We seek to jump-start product sales with a rapid introduction and uptake, we seek to maintain growth and sustain maturity of sales as long as possible, and we seek to stave off decline by morphing the product into some new use, with new dosage forms or delivery mechanisms or by switching the product to an OTC version.

In the new Culture of Drug Safety, life cycle planning will have new functions. It will need to define drug benefits in a much more structured and communicable form. It will need to place those benefits into a more logical and analytical framework along with drug risks. It will need to track public perceptions of the product in a fashion that will permit a better understanding of how attitudes about risks and benefits are formed. It will need to provide a much more complete understanding of how drug-use decisions are made and how various risk and benefit communications influence those decisions.


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