Patients get bad information on drugs

Patients are receiving incomplete and potentially misleading information because the government has, in effect, put the fox in charge of guarding the sheep.
The U.S. Food and Drug Administration (FDA) allows the private sector to dictate the content of the information patients receive at the time that prescriptions are filled. In testimony before the FDA, Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, said the agency should be the one to regulate patient information leaflets, not the companies who make billions by selling them.

In 1995, the FDA proposed a rule requiring pharmacists to include leaflets with “scientifically accurate and useful written information” with all new and refill prescriptions. The sheets are supposed to include information about adverse effects and guidance on how to best use the drugs. The FDA said that by 2000, 75% of patients should be receiving patient information leaflets, and by 2006, 95% should be receiving them. The 1996 law passed by Congress adopted that timetable and required the private sector to design and implement the program.

However, a new survey by Public Citizen shows that the private-sector program is not meeting the FDA’s goal or the expectations of Congress. Public Citizen examined 23 top-selling drugs in 2002 that are required to carry black box warnings found that none of the patient drug information leaflets being distributed in a Washington, D.C. pharmacy complied with the 1996 law’s guidelines. “These results are extremely troubling because black box warnings are the most serious type of warning the FDA can require,” Public Citizen noted.

Further, information included in the leaflets, which had been downloaded from the National Institutes of Health’s MEDLINEplus website, was incomplete and inaccurate. It is irresponsible for the site to feature unregulated information that fails to meet minimum quality standards and the information should be removed from the site, Wolfe said.

Although 89% of consumers are receiving some sort of information, a study conducted by the University of Wisconsin for the FDA found that none of approximately 1,300 leaflets studied for four common drugs achieved minimum goals for useful, scientifically accurate drug information. As measured by eight objective criteria, the overall usefulness of information was about 50%.

“The notion that consumer drug information can be 50% useful is unfathomable,” Wolfe said in his testimony to the FDA. "Drug information that communicates only half of what it should is misleading, and misleading drug information is potentially dangerous."

Public Citizen filed suit against the U.S. Department of Health and Human Services (HHS) in February of this year because the FDA was refusing to hold a hearing on the matter. HHS signed a settlement agreement in April, agreeing to hold the hearing at which Wolfe’s testimony was given.

The hearing should be the agency’s first step in the process that will culminate in FDA regulation of the leaflets. A 1999 rule gave the FDA authority to regulate information distributed with certain drugs; a minor modification of the rule could extend that authority to all drugs. The already widespread distribution of substandard information means that it would be no more expensive to distribute information that would help patients.

“The research has been done and the history is clear,” Wolfe told the panel. “There is no longer any legitimate argument in continuing to consider voluntary private-sector programs as a solution for providing consumers with useful, scientifically accurate written drug information. This is a failed paradigm.”

SOURCE: “Patient Information Program is Failing Under Private Sector Management,” Public Citizen, July 31, 2003.