Lisa Seachrist

Washington Editor

WASHINGTON -- A survey of oncologists indicates that 74 percent believe FDA rules about the dissemination of off-label information hinders their efforts to get the most up-to-date information on cancer therapies.

The survey of 200 cancer physicians conducted by the American Enterprise Institute (AEI), a conservative think-tank, found that 91 percent believed if they used cancer therapies only as they are labeled by the FDA, their patients would suffer.

"Our survey showed that off-label use is so extensive that physicians are actually unaware of the extent to which they are using drugs off-label," said Jack Calfee, a researcher for AEI. "One-third of the doctors surveyed found the PDR (Physicians' Desk Reference) is just too out of date."

Calfee also found that 99 percent trusted the information they gleaned from studying medical journals as the best source of information for treating patients. The study was funded by Amgen Inc., of Thousand Oaks, Calif., and the American Cancer Society and employed Roper Starch Worldwide to conduct the phone interviews.

Product Labels Narrowly Worded

In establishing a drug as safe and effective, a pharmaceutical company will often focus on a specific disease and a specific stage of the disease that will strongly show the drug works, Calfee noted. The studies performed to support approval of the drug ultimately serve as the basis for the product label.

As a result, product labels are very specific in describing not only the illness that the drug is meant to treat, but the stage of the illness, the therapeutic context, age groups and dosages. However, once a product is approved for marketing, a physician may use it for any indication.

"It is not unreasonable to expect that as a company gets experience using the product they are going to find new dosages and indications," Calfee said. "But the agency prohibits companies from informing doctors about the new uses and dosages of their products."

Calfee maintained that because the FDA is a reactionary agency -- that is, it has nothing to work on in the absence of a drug application -- it can't stay on top of advances in medical knowledge. As a result, he believes the agency needs to rethink its stranglehold on the dissemination of medical information.

"The agency can't provide the information in the package insert," Calfee said. "They should permit more in the way of using information in the literature. They are already moving in that direction."

Even though the information a company gives out is inherently biased, Calfee noted the survey indicates physicians view the information with a healthy degree of skepticism.

"FDA views doctors as credulous," Calfee said. "Our survey indicates that physicians take a rather jaundiced view of the information they receive from pharmaceutical companies."

Sidney Wolfe, president of Public Citizen, a consumer advocate organization, questions whether the survey says anything at all.

"The response rate of 28 percent is too low to determine whether you are getting a representative sample," Wolfe said. "And the questions are designed to inflame respondents about issues that don't exist."

Wolfe said doctors aren't required to follow the package insert in treating patients, so questions about using the package insert as the sole guide to prescribing are disingenuous. In addition, a fair number of respondents didn't realize the Physicians' Desk Reference and the package insert provide identical information. Physicians' Desk Reference is published by Medical Economics Co Inc.., of Montvale, N.J., which is the parent company of BioWorld Today.

"Ninety-nine percent claim that they trust journal articles as their best source of information. Why would [physicians] need information from drug companies for things that they are already reading?" Wolfe asked.

Wolfe went on to note that "the idea of going to an oncologist who doesn't read the medical journals is preposterous. Who would want to go to such a person?"

Congress Considering Off-Label Promotions

Nevertheless, concerns that the FDA is preventing doctors from receiving the best information have received attention from Congress.

Sens. Connie Mack (R-Fla.) and Bill Frist (R-Tenn.) intend to introduce an amendment to the FDA Modernization Act, S. 830, when it hits the Senate floor for debate on Thursday. The amendment will allow pharmaceutical companies to distribute information on off-label uses.

The Mack-Frist amendment would permit companies to submit peer-reviewed studies that they wish to distribute to the FDA along with a bibliography detailing all references to the product in the peer-reviewed literature. If the agency agrees it is a scientifically sound study and representative bibliography, the company could distribute both to physicians. The company would then have to keep an up-to-date bibliography on the product.

"We are trying to place as much balance and filters on off-label information as possible," Mark Mills, a spokesman for Sen. Mack, told BioWorld Today. "We would like to have the amendment ready for the floor action, but the timing of this legislation and the exact language is still in question. We want this to be a bipartisan effort." *