Pharmaceutical giant Bristol-Myers Squibb Co. recently got the jump on a group of resolutions that last week got derailed on their way through the AMA House of Delegates. The issue: direct-to-consumer drug advertising.
The New York-based pharmaceutical manufacturer announced June 14 it would refrain from running any DTC ads about its new medications for one year after their release. The self-imposed moratorium is just one of several measures contained in the company's new Direct-to-Consumer Communications Code. (PDF file: 1 page / 113 KB. More about PDFs.)
Drug Company Self-Imposes Curbs on DTC Ads
While the Bristol-Myers Squibb announcement is definitely a step in the right direction, according to AAFP President Mary Frank, M.D., of Mill Valley, Calif., it's by no means a panacea.
"I think the positive step that Bristol-Myers Squibb has taken is to say, 'Hmm, maybe we should reassess how we are approaching this, and perhaps revise our approach to direct-to-consumer advertising,'" Frank said. "Prior to this, the industry attitude has seemed to have been, 'People have the right to know and we're going to tell them,' without any kind of modulation on what the impact might be on patients or physicians or on the cost to the health care system of pushing new medications that may or may not be better than older medications."
The DTC issue, however, goes beyond curtailing ads on only the newest drugs, said Frank.
"It's true that as pharmaceutical companies have rolled out these new medications, they've been in the lay press almost before the physicians hear about them, and it's true that the pharmaceutical companies been fairly aggressive on DTC to the public about these new medications," Frank noted. "But many of the medications they're being aggressive on -- medications that we use, such as anti-inflammatory or allergy medicines, or medications that are also used by other specialists, such as Procrit (epoetin alfa) for severe anemia in patients on chemotherapy -- those are not brand-new medications.
"The industry is creating a demand on the part of patients that puts the physician in the position of having to explain, 'Yes, you have A, B and C, but this is not the right medication for you.'"
"I think the positive step that Bristol-Myers Squibb has taken is to say, 'Hmm, maybe we should reassess how we are approaching this, and perhaps revise our approach to direct-to-consumer advertising,'" Frank said. "Prior to this, the industry attitude has seemed to have been, 'People have the right to know and we're going to tell them,' without any kind of modulation on what the impact might be on patients or physicians or on the cost to the health care system of pushing new medications that may or may not be better than older medications."
The DTC issue, however, goes beyond curtailing ads on only the newest drugs, said Frank.
"It's true that as pharmaceutical companies have rolled out these new medications, they've been in the lay press almost before the physicians hear about them, and it's true that the pharmaceutical companies been fairly aggressive on DTC to the public about these new medications," Frank noted. "But many of the medications they're being aggressive on -- medications that we use, such as anti-inflammatory or allergy medicines, or medications that are also used by other specialists, such as Procrit (epoetin alfa) for severe anemia in patients on chemotherapy -- those are not brand-new medications.
"The industry is creating a demand on the part of patients that puts the physician in the position of having to explain, 'Yes, you have A, B and C, but this is not the right medication for you.'"
Acknowledging the Problem
Several resolutions submitted to this year's annual meeting of the AMA House of Delegates tackled the DTC issue. One such measure -- introduced by the American Academy of Child and Adolescent Psychiatry, American Psychiatric Association, and American Academy of Psychiatry and the Law -- directed the association to "review and evaluate strategies designed to minimize the potential negative impact of direct-to-consumer advertising of pharmaceutical products, including, but not limited to, proposals to establish a time-limited moratorium on such advertising following initial approval of a medication."
Delegates referred all of the resolutions on June 21 to the AMA Board of Trustees for further study. It is expected the House of Delegates will within the next year receive back a report and possibly recommendations to guide AMA policy on the issue.
Numerous studies in recent years have demonstrated a link between DTC drug advertising and physicians' prescribing behaviors. One such study, published in the April 27 Journal of the American Medical Association, involved 152 family physicians and general internists. Findings from that trial suggested DTC ads had competing effects -- averting prescription drug underuse in certain settings and promoting overuse in others. The study abstract is available online.
Meanwhile, the Pharmaceutical Research and Manufacturers of America, or PhRMA, representing nearly 60 research-based pharmaceutical and biotechnology companies -- including Bristol-Myers Squibb -- is currently re-examining its approach to DTC advertising, although few industry insiders expect much change from the organization's current DTC stance.
In a DTC advertising overview on its Web site, PhRMA maintains that DTC advertising has a valid role in stimulating physician-patient interaction and helps educate patients about medical conditions and treatment options. "Studies show DTC advertising brings patients into their doctor's office and starts important doctor-patient conversations about health that might otherwise not have happened," says the Web site.
Delegates referred all of the resolutions on June 21 to the AMA Board of Trustees for further study. It is expected the House of Delegates will within the next year receive back a report and possibly recommendations to guide AMA policy on the issue.
Numerous studies in recent years have demonstrated a link between DTC drug advertising and physicians' prescribing behaviors. One such study, published in the April 27 Journal of the American Medical Association, involved 152 family physicians and general internists. Findings from that trial suggested DTC ads had competing effects -- averting prescription drug underuse in certain settings and promoting overuse in others. The study abstract is available online.
Meanwhile, the Pharmaceutical Research and Manufacturers of America, or PhRMA, representing nearly 60 research-based pharmaceutical and biotechnology companies -- including Bristol-Myers Squibb -- is currently re-examining its approach to DTC advertising, although few industry insiders expect much change from the organization's current DTC stance.
In a DTC advertising overview on its Web site, PhRMA maintains that DTC advertising has a valid role in stimulating physician-patient interaction and helps educate patients about medical conditions and treatment options. "Studies show DTC advertising brings patients into their doctor's office and starts important doctor-patient conversations about health that might otherwise not have happened," says the Web site.
Wanted: Evidence-Based Guidelines
During the one-year DTC ad moratorium Bristol-Myers Squibb has pledged to observe for its new drugs, the company says it will focus its efforts on educating physicians about those new medications and seeking input about their experiences prescribing the drugs.
While some of the drug maker's intentions may be laudable, said Frank, it's not industry's place to educate physicians about which drugs to use when.
"We need evidence-based guidelines on when a certain medication is the appropriate one to use and when it's not," Frank said. "Should that education be coming from the pharmaceutical company? I don't think so. It should be coming from our professional organizations and from groups like the FDA and NIH -- groups that are studying these medications. The organizations together with those researchers should be putting together the clinical guidelines."
From Frank's perspective, it's time for a reality check on the entire DTC issue.
"I think the pharmaceutical industry as a whole has to step back, take a breath, and assess how it is handling direct-to-consumer advertising and what the impact is in terms of the quality of patient care, in terms of the cost of that care, and in terms of its image with the public and with the medical profession," Frank said.
While some of the drug maker's intentions may be laudable, said Frank, it's not industry's place to educate physicians about which drugs to use when.
"We need evidence-based guidelines on when a certain medication is the appropriate one to use and when it's not," Frank said. "Should that education be coming from the pharmaceutical company? I don't think so. It should be coming from our professional organizations and from groups like the FDA and NIH -- groups that are studying these medications. The organizations together with those researchers should be putting together the clinical guidelines."
From Frank's perspective, it's time for a reality check on the entire DTC issue.
"I think the pharmaceutical industry as a whole has to step back, take a breath, and assess how it is handling direct-to-consumer advertising and what the impact is in terms of the quality of patient care, in terms of the cost of that care, and in terms of its image with the public and with the medical profession," Frank said.
