CER: Who Can Say What, and When Can They Say It?

E.V.I.dently, November 2011 By Robert W. Dubois, MD, PhD, Chief Science Officer, National Pharmaceutical Council

With billions of dollars in comparative effectiveness research (CER) set for completion in coming years, there will be broader discussions about the findings and what those findings might mean for patients and other health care decision makers. A parallel discussion will be conducted around questions regarding who can discuss and share these CER findings publicly? Who has access to the data that was used to generate the CER? These are just some of the pressing questions that are being raised by health care stakeholders as CER becomes more prevalent. Let's take a closer look at these issues:

Access to Data

Today there are a number of databases that are mined for comparative effectiveness research and other health care studies. Some are proprietary databases operated by payers, academic research institutions, or the pharmaceutical industry, while others are taxpayer-funded and government operated (FDA AERS, NHANES). In anticipation of the wide range of CER, however, a number of new databases are being developed by both private and public sector organizations. 

What’s unclear is the nature of the access that will be granted to these new databases, particularly if different groups want to affirm or disprove the CER that was developed from that data or review the research methodology. In general, having access to this information could be important for optimal patient care management. With some oversight, broader access to public databases such as Sentinel and Janus, as well as databases funded by the Patient-Centered Outcomes Research Institute, could be a good start.

Communicating Information

The pharmaceutical industry is highly regulated when it comes to discussing health care information, while other groups have wide latitude—or even complete freedom—in what they can say. While there are valid reasons for the regulation of some communication (marketing messages and materials, for example), there also are instances where it would be in the greater interest of public health for the sponsor of a particular drug to be allowed to respond to research or easily correct misinformation beyond solicited medical information. When it comes to CER, would the industry be able to discuss or share those studies, or even call for corrections on ones with serious flaws?

Communicating to Physicians

CER will be further amplified through academic detailing initiatives, in which government or academic institutions train health experts to discuss CER with physicians. In the United States, the Agency for Healthcare Research and Quality is leading the multi-million dollar federal initiative that will start off by targeting 1,500 primary care physicians and health systems. The federal government is not alone in its efforts – states including Vermont, Pennsylvania, South Carolina and Maine have been conducting academic detailing for a number of years.

Additionally, CER information will be further disseminated via continuing medical education programs and payer review guides, which are currently in development.  

These programs can be useful in providing physicians and payers with information that they might not have been aware of otherwise. However, it is not clear as to where the checks and balances may exist in the oversight of government-sponsored detailing, in the same way it is required of industry. 

Challenges for Patients

There are thousands of pages of health information available on the Internet, in medical journals, and other sources. Sifting through the information is daunting for a health care professional, let alone a patient. With more information becoming available, it will be even more important to ensure that patients have access to a broad amount of correct, verified information and know where to find it.

Unfortunately, sometimes incorrect information is shared broadly—U.S. Rep. Michelle Bachmann’s recent public statements about a vaccine is just one example—and it can be difficult to quickly correct the misinformation and make sure that consumers are properly educated. Acting on poor or faulty information could lead to serious health consequences for patients.

What will it take to address these challenges? It’s too early to know for sure, but a decision on U.S. vs. Caronia, a case pending in the U.S. Court of Appeals for the Second Circuit, could have implications for the pharmaceutical industry. At issue in Caronia is whether the First Amendment protects the right of individuals to speak truthfully about off-label uses of FDA-approved products. The question is whether a decision in the case will have broader applicability to CER and other health-related studies.

Next Steps

The challenges related to conducting, disseminating and communicating CER won’t be solved overnight. But it is important to begin considering how these questions might be addressed, and to their credit, organizations like the Agency for Healthcare Research and Quality, are beginning to discuss these issues. To further the dialogue, NPC will be hosting a conference in early 2012 to explore the asymmetry of communications and data access issues in greater detail. It’s important to consider all of the aspects of this issue, because having the right information is critical for patients and health care providers.

For additional information on asymmetry, view our interviews with patients, health care and legal experts. 

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