Getting the Voice of Millions Heard
Arthritis Today, August 2005

The Arthritis Foundation’s strong stand to keep drugs available

As the sometimes day-to-day drama with COX-2 drugs has played out over the last months – first with Vioxx being pulled from the market by its manufacturer and then Bextra being pulled by the Food and Drug Administration (FDA) – the Arthritis Foundation leadership became concerned that the needs of millions of people who use those drugs were not being considered.

Last winter, John H. Klippel, MD, the president and CEO of the Arthritis Foundation, testified before the FDA Arthritis Advisory Panel that made recommendations to the FDA. Since then the uncertainty has continued over the fate of the drugs on which people with arthritis depend. To ensure people’s needs are met, Dr. Klippel recently sent a letter to the FDA commissioner, and the Foundation released these statements:

• The Arthritis Foundation believes most of the decisions that have been made were to improve and protect the health of people with arthritis.
• Because all medications have risks and benefits, the Arthritis Foundation supports better and more fully informing people about the relative risks associated with COX-2 inhibitors. This will allow people to work more effectively with their doctors to make individual treatment decisions that best meet their needs.
• The Arthritis Foundation, however, urges the FDA and Merck (manufacturer of Vioxx) to review their decisions on Bextra and Vioxx, respectively, and to consider putting these drugs back on the market. COX-2 inhibitors are an important and valuable class of drugs for many people with arthritis. A large number of people stand to benefit from these drugs, and will decide to use them and fully accept the risks.
• In addition, the Arthritis Foundation asks the FDA to reconsider the decision to require label warnings about cardiovascular risks on over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin) and naproxen (Aleve). There is not sufficient or conclusive evidence to justify this action. NSAIDs, together, are a very valuable and cost-effective class of drugs used by millions to relieve pain. The additional warnings contribute to confusion and concern that may impact beneficial treatment.
• The Arthritis Foundation supports efforts to increase surveillance of drugs once they are available in the marketplace to better understand the risks of side effects and to communicate these risks clearly and quickly to the public and health-care providers.
• The Arthritis Foundation supports improving the educational content of direct-to-consumer (DTC) drug advertising, so the public has a realistic expectation of benefit and risk. Appropriate DTC advertising is a valuable resource that helps people inititate a conversation with their doctors about potential treatments.
• The Arthritis Foundation believes continued study is needed to learn more about the benefits and risks of long-term use of drugs in people with arthritis. Most forms of arthritis are chronic and people typically use these drugs for months or even years. Additionally, we encourage greater efforts to inform people about all available treatment options.
• Finally, the Arthritis Foundation urges increased public input into the processes involved in the evaluation or assessment of drugs used for the treatment of arthritis.