European Animal Health Scares
Taint Pharma Products in U.S.

by Chris Nelson

Writing dramatic news stories - stories with victims and villains - is what sells newspapers today, and corporations are often cast as the villains whose hidden practices need to be exposed.

The resurgence of bovine spongiform encephalopathy (BSE), or mad cow disease, and the recent outbreaks of swine fever and foot-in-mouth disease in livestock in the United Kingdom and elsewhere have provided fodder for such dramatic stories focusing on agriculture and the pharmaceutical industry. If pharmaceutical marketers expect to maintain their credibility so they can reassure patients, they need to anticipate vulnerabilities and the types of questions the media is likely to ask and take operational steps that allow them to demonstrate they are protecting patients.

The ingredients used to make pharmaceutical products, often too esoteric for consumer awareness, can be surprising to patients - and sometimes cause panic - when exposed in the media, especially when they involve animal byproducts. With all the lingering questions about whether spongiform encephalopathies could be transmissable, hidden manufacturing practices that involve animal byproducts have created lightning rods for media scrutiny and sparked safety questions among consumers.

In February, the New York Times reported that the US Food and Drug Administration had discovered five major pharmaceutical companies were still using cattle byproducts from countries affected by BSE as ingredients in their vaccines, despite FDA requests that they abandon the use of such materials.

U.S. federal health officials consider these vaccines safe, according to the Times, and they estimate that, at worst, "the odds of these vaccines passing on the disease ... are between one in 40 million and one in 40 billion doses." The risk factors for diseases like foot-in-mouth are even lower because they rarely affect humans and are not serious when they do. However, the scientific levels of risk are often downplayed in the interest of dramatic reporting.

The Times reporters quickly jumped to ask what other products FDA might have overlooked, stating, "Nonetheless, the fact that these suspect materials slipped into the nation's vaccine supply - and that the FDA did not discover it for seven years - raises questions about the agency's ability to ensure that all medicines are free of the infectious proteins that can cause mad cow disease."

A host of drugs, such as those packaged as gel-caps, are made using gelatins created from the bones or hooves of cows, and dietary supplements often include a number of ingredients from cattle and other animals. Without the proper context to understand safety measures, simple facts like these can be worrisome to patients.

In the Washington Post, Abigail Trafford recently wrote that remote risks that grab our attention often have three characteristics: mystery, lethality, and unpredictability. Media coverage of esoteric manufacturing practices such as those uncovered by the Times story, and the awareness that media coverage generates, could easily lead to a wariness among patients that prevents them from complying with prescriptions or accepting medications recommended by their doctors. Or, it could produce panic about doses already taken.

If consumer fears do escalate, companies will have an increasingly difficult time reassuring the public, especially if it is difficult or impossible to source materials from alternative "safe" countries.

In order to avoid the being positioned as the villains in news coverage, pharmaceutical executives should start thinking about and preparing their responses to media questions long before they receive calls from the press. Companies should take the responsible steps to ensure patient safety and prepare clear, concise communications documents to explain the scientific rationale underlying those steps. The companies that do this will have a fighting chance to escape the villain characterization in news coverage and balance stories that could otherwise be very emotional.

Following are a few tips to help pharmaceutical executives, issues managers, and communicators stay ahead of this issue:

• Ensure you know where the company's vulnerabilities lie: how and where are products manufactured and what ingredients are used at each step in the process?

• If animal products are involved, learn where those ingredients are sourced and work to understand what screening measures are available or in place.

• Consider alternative sources of ingredients in case the country where materials are currently being sourced has or develops a BSE problem.

• Take steps to verify quality and safety programs using third-party experts who might be credible independent spokespeople if the company had to suddenly reassure consumers about the risks.

• Find simple ways to explain risk factors and complex processes like protective screening and prepare fact sheets and background materials that will give reporters a clear picture of all the efforts the company has taken to protect patients.

About the author

Chris Nelson is Vice President, Issues Management in the Issues and Crisis Management group at Ketchum in New York City, USA. He specializes in helping clients deal with contentious or explosive situations ranging from facility disasters to activist attacks to consumer and pharmaceutical product safety and liability issues to Internet issues. E-Mail: chris.nelson@ketchum.com.

First published in Crisisnavigator (ISSN 1619-2400):
Volume 2 (2001) - Issue 4 (April)