Policy Background

States spend billions of dollars every year to provide prescription drugs for their residents – and have a responsibility to be sure those drugs are safe and that the state is spending its money wisely. Drug companies that sponsor clinical trials are currently free to publicize only positive findings. The Food and Drug Administration does not require that pharmaceutical companies make their clinical trials public, and in many cases the government cannot release clinical trial findings without drug company permission. This lack of transparency of clinical trial findings, mixed with the profit motive of pharmaceutical companies to focus their massive advertising and marketing budgets on publicizing only information that promotes sales and profits, has proved a dangerous mix.

Medical providers lack easy access to accurate information about the efficacy and safety of many drugs, at the same time that sophisticated marketing techniques are targeted at promoting the newest, most expensive – and least studied – medications. Direct to consumer advertising often glosses over safety issues or provides misinformation. TV ads in particular by their very nature are poor venues for conveying detailed information, and poorly communicate the risks associated with a particular drug. In 2004, the pharmaceutical industry vowed to voluntarily make clinical trials public. They established a website for this purpose, www.clinicalstudyresults.org. Many of the entries on that site do not disclose unpublished results of trials, information published doesn’t include phase I and II trials, which often reveal important information, and companies are not required to reveal detailed information about trials. There is also no enforcement mechanism. A few notable examples suggest the scope of the problem:

  • Vioxx: Merck published some clinical trial data reflecting on the efficacy of its pain killer Vioxx, but withheld information reflecting on the drug’s potential to increase risk of cardiovascular disease. Since 1999, when Vioxx was approved by the FDA, until it was withdrawn from the market in 2004, Vioxx was taken more than 80 million people worldwide and caused between 88,000 and 140,000 more cases of “serious coronary heart disease” in the U.S.
  • Zoloft: From 1999-2001 Pfizer conducted clinical trials that indicated that the depression drug Zoloft did not perform well on depressed children, but neither Pfizer nor the FDA disclosed the results of the tests.
  • Paxil: GlaxoSmithKline (GSK) clinical trials revealed that children and adolescents taking the anti-depression drug Paxil were “twice as likely to show behaviors that may be associated with suicide than children on sugar pills.” GSK did not release the information and GSK’s detailers told doctors and health care professionals that Paxil worked well in children.
  • Rezulin: Early trials of Rezulin, a diabetes medication, revealed that the drug may cause “important liver damage,” but its maker, Parke-Davis, did not disclose that information to FDA prior to approval. Subsequent to approval, Parke-Davis provided FDA with more details about those prior trials, but the information was not widely distributed. Rezulin stayed on the market for several years before being withdrawn in the US in March 2000, after 66 individuals died as a result of acute liver failure linked to taking the drug.
  • Vanlev: Bristol-Myers-Squibb Co. (“BMS”) paid $185 million to settle a securities fraud suit alleging it withheld material information about the incidence and severity of side effects in clinical test patients taking Vanlev, a hypertension medication. The settlement included a commitment by BMS to disclose the design and results of clinical trials for every drug it markets in the U.S. The information will be posted on its website, www.bms.com, and on an industry site, www.clinicalstudyresults.org.

With the federal government’s slow response and failure to require transparency, several states are trying to fill this gap through clinical trials disclosure rules and programs to provide evidence-based information to medical providers, called “academic” or “counter” detailing. A survey of state Medicaid programs in 2005 found that 22 states have programs to educate providers or provide some form of “counter detailing” to promote the use of generics instead of more expensive brand name drugs. More than a dozen states are involved in the Oregon Drug Effectiveness Review Project which assesses drug safety and efficacy studies and makes the materials available to states and other participants in the project.

The Pennsylvania Information Drug Information Service (www.rxfacts.org) initiated in 2006 is the most comprehensive of the state academic detailing programs. Vermont law gives authority for a detailing program termed an “evidence-based research education program” and required a report on how such a program could be implemented. West Virginia and Maine require pharmaceutical cost management councils in those states to consider implementing academic detailing. New York’s PDL law requires the state to join the Oregon project.

A recent Maine law requires internet posting of all clinical trial results, including adverse results, effective October 2005 (detailed implementation rules are still in development). The law requires that the information be posted to a free and publicly accessible Internet web site. Funding of the administration of the program, including a public education campaign by the Department of Health and Human Services, is through a fee assessed on manufacturers of prescription drugs provided through the state’s Medicaid program.

A benefit of academic detailing is to save money in state pharmacy programs, and it is likely to have spillover cost savings in the health care system generally and lead to better health outcomes. Although it is too early in the implementation of Pennsylvania’s program to be able to calculate savings, a formal benefit-cost analysis of a 4-state Medicaid study of academic detailing involving 435 doctors showed savings of $2 for every $1 the program cost, based on just Medicaid paid claims data. According to Dr. Jerry Avorn of Harvard University Medical School and Brigham and Women’s Hospital, who is coordinating the effort for the State of Pennsylvania, “We've only been in the field since mid-Oct, so the only 'outcome' data we have is the receptivity with which the docs are receiving our people, which is quite high.” The challenge in implementing this program is the need to invest money in order to save money, and figuring out how to come up with the initial financing. One option is to use funds collected in settlements in Medicaid fraud cases such as the 2004 global settlement of the Neurontin marketing case.

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