Fifth Annual Press Audit: Safety in the Spotlight - Pharmaceutical Executive


Fifth Annual Press Audit: Safety in the Spotlight

Pharmaceutical Executive

This coverage is summarized in "Companies under Watch," page 34.

Future Implications

This year's media coverage put emphasis where it needed to be: squarely on drug safety. More than half (79 of 147) of the articles addressed that topic. While some offered residual coverage about Vioxx, the majority drew attention to newly emerging safety issues, such as those related to the heparin supply. Furthermore, most of the 43 articles about FDA concerned the agency's ability to safeguard drugs. This means a full 83 percent (112 of 147) of press coverage in 2008 was directed to safety concerns.

Restoring confidence in the safety of drugs is paramount for industry. Under the leadership of Acting Commissioner Frank Torti, FDA seems poised to continue Andrew Von Eschenbach's emphasis on drug safety. A key question is whether FDA will get a budget that enables a greater separation from industry's funding of approval evaluations under the Prescription Drug User Fee Act (PDUFA). The recent expansion of PDUFA introduces goals to prevent look-alike and sound-alike proprietary names, as well as unclear label abbreviations and acronyms. Given FDA's limited resources, this has the potential to dilute their attention in areas crucial to drug safety, such as companies' production processes and ingredient suppliers.

This year's audit offers a perspective on the way different newspapers cover the industry. As mentioned earlier, The New York Times is clearly the most negative toward pharma, followed by USA Today. That being said, the negativity is often warranted, such as the coverage of overpromoted cholesterol drugs (New York Times, April 2, 2008). Furthermore, our data indicate the media at least mentioned the industry's position in every negative article of the last two years.

Given the changing times, no analysis would be complete without discussing the impact of healthcare reform on the pharmaceutical industry. In parallel with President Obama's work on the economy and foreign policy, proposed reforms for US healthcare are clearly topping the agenda. First, take Medicare Part D. Here, two options have important implications for pharma. One is closing the infamous doughnut hole. While such a measure would be popular with enrollees and a potential source of increased drug sales, its projected cost is about $300 billion over 10 years—suggesting that the hole may be made smaller but not necessarily close altogether. Second, Medicare may need the latitude to negotiate drug prices directly with pharma companies instead of allowing insurers to negotiate separately with pharma companies. Wal-Mart charges $4 for about 500 different drugs, and is making money on their pharmacy sales. Adjusting Medicare to conduct direct negotiations with pharmaceutical manufacturers would be more complex than Wal-Mart's negotiations with its pharma suppliers, but it could be done.

In both situations, Big Pharma would bear a substantial portion of the cost of these changes through lower negotiated drug prices. This means, as an industry, pharma would have to learn to operate on lower profits—a behavior not inconsistent with indicators in this business environment. While this may be challenging for the development of innovative new medicines, it may also help to reduce negative media attention, especially about drug pricing, and to avoid further governmental regulation such as price controls.

Along that line, the life sciences industry continues to make significant efforts to police itself, such as the introduction of more stringent PhRMA guidelines in January 2009. However, Eli Lilly's recent $1.4 billion fine for off-label promotion of Zyprexa isn't the way to convince the stakeholders concerned about healthcare in the United States. More about this in next year's pharmaceutical media audit.

Stephen J. Porth is an associate dean and a fellow and professor for the Arrupe Center for Business Ethics at Saint Joseph's University. He can be reached at
. George P. Sillup is an Arrupe Fellow and an assistant professor at Saint Joseph's University. He can be reached at
. Cynthia Slater, Molly Porth, Leanna Baselice, and Courtney Scardellette also contributed to this research.


blog comments powered by Disqus

Source: Pharmaceutical Executive,
Click here