Soon after his swearing-in, President Barack Obama issued a memorandum to all federal agencies advocating greater transparency
in government actions. Obama also called for high ethical standards for government officials, a stance that helped derail
the confirmation of Tom Daschle as Secretary of Health and Human Services (HHS).
Reformers regard transparency in healthcare costs, provider practices, and drug and medical product performance as critical
to informing prescribing decisions, driving down expenditures, and expanding access to affordable care. One problem with the
nation's healthcare system is a lack of transparency in financing, pointed out Robert Reischauer, president of the Urban Institute,
at a recent health policy meeting. "Few people understand what things cost or who pays the bill."
Proposals to expand adoption of health information technology and fund comparative-effectiveness research could also increase
transparency. And objective comparisons of treatment effects would supplement basic safety and efficacy information required
by FDA and support appropriate treatment.
The 411 on Safety and Pricing
Pharmaceutical companies are all too familiar with transparency requirements in drug research and marketing. Government agencies
and consumer groups seek drug price and coverage data to curb inappropriate drug utilization and steer patients to cost-effective
treatments. Manufacturers face multiple state and federal requirements for disclosing payments to researchers and medical
professionals, and Congress wants to broaden reporting on industry–practitioner relationships to uncover conflicts of interest
and discourage off-label marketing.
Too Much Transparency?
The FDA Amendments Act of 2007 (FDAAA) expanded manufacturer disclosure of clinical research activity, research study results,
and drug safety information. FDA is responding by posting lists of drug safety signals and issuing "early" notices on important
safety concerns. The agency recently announced that it is assessing reports on bleeding associated with Eli Lilly's sepsis
treatment Xigris (drotrecogin) and potentially serious drug interactions involving the blood thinner Plavix (clopidogrel).
However, these early communications raise questions about how extensively FDA should assess preliminary reports on safety
issues before going public, as sounding false alarms can unnecessarily prompt patients to discontinue treatment.
Public disclosure of drug prices is also being encouraged. Medicare now posts cost and coverage information to help beneficiaries
assess options. The scope of this information may expand as patient advocates examine beneficiary copays for pricey biotech
therapies and plan policies that require patients to pay the difference between generic and brand-name drugs. Government involvement
in negotiating Medicare drug prices may further expose marketers price and discount information to public scrutiny.
Payment Data and Public Domain
Requiring disclosure of company payments and gifts to healthcare professionals is another state strategy for assessing influences
driving prescriber behavior. Minnesota, Vermont, West Virginia, Maine, and Massachusetts have all enacted reporting requirements,
while California, Texas, Illinois, and New York, among others, are considering similar mandates. These statutes seek data
on fees, gifts, and educational grants to healthcare providers and organizations, but policies vary considerably as to which
expenditures have to be disclosed, and when.
Federal and state enforcement officials are also expanding drug company disclosures by including reporting requirements in
corporate integrity agreements (CIAs) negotiated to settle allegations of fraudulent promotional and pricing practices. Prosecutors
have put an emphasis on transparency in industry relationships with physicians and in results from clinical trials, said US
Attorney Michael Loucks at CBI's Pharmaceutical Compliance Congress in January. Under a comprehensive CIA negotiated as part
of Eli Lilly's record $1.4 billion Zyprexa settlement, Lilly will report payments to physicians, including speaker and consulting
fees, grants, gifts, food, and travel. Last year, Cephalon similarly agreed to report payments to physicians as part of its
$375 million settlement involving marketing practices for three medications. And Bristol-Myers Squibb's 2007 CIA requires
reporting of listed prices to state Medicaid programs.
A related trend involves broader disclosure of financial interests of investigators involved in clinical research. Here, the
aim is to minimize the role of money in shaping drug development and utilization, and to ensure that potential financial rewards
do not bias research results or medical opinions. FDA and the National Institutes of Health (NIH) have broadened financial
disclosure requirements for clinical investigators, but there has been pressure to stiffen reporting policies and to enforce
the rules more vigorously.
To boost financial reports from researchers involved in FDA-regulated trials, the HHS Office of the Inspector General (OIG)
issued a report in January recommending that trial sponsors disclose investigator financial information to FDA before studies
begin, instead of when the company files a new-drug application. Sen. Charles Grassley (R-IA) is also seeking expanded financial
disclosure of industry payments to scientists receiving NIH grants. Grassley has uncovered prominent academics who failed
to report millions in industry payments, particularly several leading psychiatrists involved in testing and promoting widely