The House Energy & Commerce Subcommittee on Oversight convened a hearing May 8th to address Direct to Consumer (DTC) drug advertising by Johnson and Johnson, Pfizer and Merck Schering-Plough. C3 first raised questions in summer 2007 about Procrit® DTC advertising that ran from 1998 to 2005. Procrit is an anemia drug sold by Ortho Biotech, a subsidiary of Johnson and Johnson.
All of us have seen drug advertisements on TV, where benefits and risks of drugs are laid out. This type of advertising (Direct to Consumer, or DTC) is required to advertise only the benefits approved by the Food and Drug Administration (FDA), and must also include known risks of the drug.
Epogen, the original form of Procrit, was approved by the FDA in 1993 as a way to minimize the need for blood transfusions due to anemia caused by chemotherapy treatment. Ortho Biotech, the company which sells Procrit, did not complete FDA-approved research to prove that Procrit reduces fatigue and improves the quality of life for cancer patients.
However, DTC which implied that Procrit would improve a cancer patient’s quality of life by relieving fatigue ran from 1998 to 2005. Since Procrit was approved to help patients avoid transfusions, not to deal with fatigue, C3 believes that promoting Procrit for cancer fatigue was misleading.
In 2007, C3 filed a Freedom of Information (FOI) request with the FDA, and asked why these advertisements were allowed to run. The FDA’s response did not explain to C3’s satisfaction why these advertisements were allowed. Thus, C3 was very pleased when the House panel convened a hearing on DTC advertisements.
Members of the Committee solicited testimony from experts in patient communication, and from senior executives from Ortho Biotech, Pfizer and Merck/Schering Plough.
Testimony explored issues such as:
• Does DTC advertising influence the American public’s treatment choices in a supportive or detrimental way?
• Is current advertising done ethically, with full and appropriate disclosure risks and benefits?
“Congress should consider whether ads promoting medicines should be allowed to continue to target consumers in the United States,” said Congressman Bart Stupak. “We should make sure that pharmaceuticals companies conduct themselves responsibly.”
Ruth Day, head of Duke University’s Medical Cognition Laboratory, told lawmakers that “drug companies use a variety of tactics to highlight a drug’s benefits and downplay risks, including fast speech to visual effects.” She referred to TV commercials where the benefits are personally explained by a physician, while risks are explained by an anonymous voice speaking very rapidly.
The Government Accountability Office (GAO) criticized the FDA for not acting in a timely fashion when they suspected companies of violating DTC rules. Marcia G. Crosse, Director, Health Care, U.S. Government Accountability Office, referenced a report the GAO did in 2006 during her testimony, “By the time the agency issued regulatory letters, drug companies had already discontinued use of more than half of the violative advertising materials identified in each letter. In addition, FDA’s issuance of regulatory letters had not always prevented drug companies from later disseminating similar violative materials for the same drugs.”
The drug company executives consistently claimed that their advertisements were truthful and in line with FDA guidelines. When it came to Procrit, Stupak said, “This was clearly an instance of off-label marketing practice that is prohibited by FDA.” Ortho Biotech President Kim Taylor said, “Statements in the advertisements regarding the benefits of Procrit were true, responsible and substantiated by scientific studies.” (Newark Star-Ledger, 5/9)
Oddly, the FDA was not part of the hearing. The FDA is the agency that oversees these ads and decides whether they are appropriate for American consumers. One fundamental question asked but not answered is whether the FDA doing their job effectively.
Ranking Member John Shimkus of Illinois said since new legislation recently gave FDA additional power to regulate DTC advertising, it was too soon for lawmakers to intervene, “We gave the FDA power to act and we haven’t really given them time to really impose civil fines on false and misleading ads.”
Stupak disagreed. “The FDA is toothless,” declared Stupak. “Congress needs to decide whether the US should continue being one of only two countries in the world that allows direct-to-consumer ads, and if we continue to allow such advertising, whether any further limits on direct-to-consumer ads should be required.” New Zealand is the only other country that allows DTC advertising. (FDAnews, 5/12).
The end of the hearing did not bring closure to the DTC question. The democrats on the Committee concluded that an additional hearing that included the executive leadership of the companies was necessary; however, a date was not set. Congressman Stupak stated, “I think the issues in this hearing are more related to overall drug company clinical and claims behavior than DTC specifically. I do not expect any actions to come from the hearing that would affect DTC.”
C3 has led the patient advocate community on this issue by prodding the FDA and companies for answers. In addition, C3 worked with the Oversight Subcommittee on questions to be asked of Kim Taylor, President of Ortho Biotech.
The hearing and its material can be viewed online.