Just as academic medical centers are under pressure to tighten up their control of faculty speakers, so too, are drug companies.
Whistleblower lawsuits in recent years have accused the firms of using doctors to push their pills for unapproved uses during dinner talks. All told, at least 10 firms have settled such cases for nearly $7 billion in the past three years and have pledged reforms under threat of further punishment.
As a result, the companies are leaving little to the speakers’ control. All seven companies whose payments are listed in ProPublica’s Dollars for Docs database say that physicians must use the slides they provide.
These requirements are designed to ensure speakers comply with U.S. Food and Drug Administration regulations and only discuss approved uses for drugs.
Adhering to the drug company rules, however, can put speakers in violation of their universities’ policies.
At GlaxoSmithKline, for example, the rules permitted physicians to use some of their own presentation slides in 2009, along with Glaxo’s slides on a drug’s uses, effectiveness and risks, documents show. This year, Glaxo issued a new rule requiring speakers to only use its slides—in the order it specified.
Despite the companies’ firm public stance, some academic physicians identified by ProPublica said that they had full control of their talks and did not use company slides, according to officials at several universities.
“Many companies may overstate the extent of their involvement in such activities to avoid the potential of running afoul of FDA regulations,” Julie Gottlieb, associate dean of policy coordination at Johns Hopkins University School of Medicine, said in an e-mail. She said she believed that was the case with some of the Johns Hopkins faculty listed as speakers in Dollars for Docs.
This is how each of the companies listed in ProPublica’s databases responded to questions about its speaker requirements:
"Merck Medical Forums are ‘non-independent.’ This means Merck organizes programs and provides content which is in compliance with FDA regulations and approved product labeling. For U.S. programs, Merck-contracted speakers are required to use content approved by Merck. Content may include slides for a formal presentation about a particular subject, or they could be in the form of learning objectives that need to be followed in a discussion group format.
“Depending on the type of speaking program, a physician could lead a smaller discussion group without the use of slides, but in that case the content presented would still need to be consistent with the learning objectives provided by Merck. Merck approves learning objectives and other content based on compliance with FDA regulations as well as our internal policies and guidelines that relate to speaker activities.”
“GSK chooses the speaker, topic and program content. All information presented must be consistent with the approved U.S. label for the product(s) discussed. GSK prepares the slides. GSK reviews all information to be presented to ensure that it is consistent with the approved U.S. label for the product(s) discussed. All slide decks are reviewed by an interdisciplinary copy approval team at GSK that includes Legal and Medical representatives. Launch-related materials for newly approved products are pre-cleared with FDA, and these generally include a slide presentation.”
Eli Lilly and Company
Lilly specifies that it has two types of speaking programs: those about a disease that do not mention any drugs by name, and those about a particular brand-name medication.
“Our speakers must use materials approved through Lilly's promotional materials review process—used for all promotional materials, not just speaker programs—which includes review by company medical, legal and regulatory representatives.
“We believe this is critically important to ensure appropriate, on-label discussion of our medicines in accordance with FDA regulations—and demonstrates our commitment to providing physicians with accurate, reliable and balanced information about our products.
“Our speakers are always entitled to suggest modifications or additions to materials we propose be used—but they can't use such new material without our first reviewing and approving for that use—again, to remain in compliance with FDA regulations on promotional materials.”
“AstraZeneca prepares the presentations, and we have implemented measures to ensure that our speaker programs are balanced, address only FDA-approved uses of the medications, and comply with the applicable FDA regulations. All presentations go through a rigorous review process, including medical, legal, and promotional regulatory affairs.”
“We require speakers to use Pfizer slides that have all been cleared by Review Committee for fair balance and then filed with the FDA. … Each speaker at a Pfizer-sponsored educational program is required to: Be aware of the laws and regulations that promote quality and honesty; be fully briefed on the laws and regulations that apply to Pfizer-sponsored presentations about our products to ensure that any information discussed is grounded in science and FDA requirements; avoid presenting any inaccurate or misleading information; clearly identify that Pfizer is sponsoring the presentation, that the speaker is presenting on behalf of Pfizer, and that the speaker is presenting information that is consistent with FDA guidelines.
“In addition, all Pfizer-sponsored presentations must be consistent with FDA-approved product labeling and must fairly balance the benefit and risk information relating to any Pfizer product discussed.”
Johnson & Johnson
“The FDA regulates the materials used in peer-to-peer educational sessions and they hold sponsoring companies accountable for ensuring the content is in line with approved product labeling. Our educational materials are reviewed by a multi disciplinary internal team from the areas of regulatory, compliance, legal and medical affairs. In addition to being in line with FDA labeling, we also ensure our educational materials include fair balance … both the benefits and the risks associated with our products. … Speakers engaged in our peer-to-peer educational activities are not permitted to create their own materials nor are they permitted to edit in any way the materials provided by the company.”
“As all participants in the speaker’s bureau are presenting on behalf of the company, they must utilize slides prepared by the company that have been reviewed from medical, legal, and regulatory perspectives to assure consistency with the approved labeling for our medications. The speakers are trained on the use of these materials to assure full compliance with the regulations and guidances under which pharmaceutical companies are permitted to communicate. They are not permitted to modify the slides, they must use all the slides and they cannot add any of their own slides.”