PhRMA's Response

Critics have charged the pharmaceutical industry with being out of touch with the issues of greatest import to consumers. To get a reality check on the "issues" issue, in February we talked with Billy Tauzin, president and CEO of the the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA). Tauzin provided his views of media coverage, the issues of the day, and his priorities for PhRMA.

As it turns out, Tauzin's main issues match four of the top five identified by the audit as dominant in the coverage: drug safety, drug pricing, clinical design and sponsorship, and data disclosure. He says that the industry is focused on these issues, pointing to to http://www.clinicalstudyresults.org/, a Web site established by PhRMA in 2002 that reports trial results, as one way pharma is placing greater emphasis on "more discussion, more transparency, and more sharing of data."

Knowing the Negatives

The pharmaceutical industry not only continues to invest in the research and development of medicines but is committed to help society by funding corporate social-responsibility programs. So why does the industry continue to attract more negative than positive coverage in newspapers?

The following issues provide a cache of clues:

Pricing problems Over the three-year period of the audit, drug prices have consistently ranked first or second in priority of coverage. Consumers clearly don't like to pay more and more money out of pocket for their drugs—and blame pharma for the rising cost of healthcare. According to Tauzin, the industry needs to do a better job of educating the public about the economics of healthcare, given that drug prices are rising much more slowly than other healthcare expenditures.

Meantime, most of Big Pharma refuses to budge on its position on prices. They pumped up their bottom lines in 2006 by raising prices beyond the increase in manufacturing costs. What's more, they lobbied for legislation, such as Proposition 78, which is against capping states' drugs prices.

The industry must be profitable to continue to make the social and medical contributions it does, yet patients—even those who benefit from drug companies' patient assistance programs—want a low-cost alternative.

Safety suspicions There are connections among safety, the type of clinical study done to establish safety and efficacy, and the way FDA assesses those studies—they're called influence. Pharmaceutical companies and prestigious peer-reviewed publications like The New England Journal of Medicine are familiar with this topic, having come to a guarded understanding about publishing clinical studies by the same firms that pay to advertise.

But two significant adverse events reported in The Wall Street Journal last April raised more than a few eyebrows about the industry's influence on FDA. There were 25 sudden deaths of children being treated with at least one of the six drugs for attention deficit hyperactivity disorder. Then there was the re-approval of Tysabri (natalizumab), the multiple sclerosis drug that was removed from the market because two patients died from drug complication. Following on the Vioxx debacle, these deaths only deepened doubts about both FDA's and pharma's priorities.

FDA is requiring more testing, and approvals are taking longer. But even a perfectly designed study can't anticipate all potential negative effects when a drug is in wise use. Perhaps prospective product registries beyond the agency's required post-approval market surveillance have a better chance to identify any untoward complications before they become front-page news.

Generics Generics account for more than 60 percent of the prescriptions filled in the United States, and this trend is likely to grow as branded blockbusters continue to lose their patent status. Meanwhile, the generic pricing advantage is being fueled by pharmacy benefit managers' programs to motivate switching, such as waiving copayments and Wal-Mart's "150 cheaper than anywhere else generics" program.