ACR President Tindall's Statement for FDA hearing [on the COX-2 Inhibitors]
2/17/2005
The following is a statement by the American College of Rheumatology President, Dr. Betsy Tindall as posted on the ACR website here. It was prepared for the FDA hearing on COX-2 inhibitors.
Good morning. I am Dr Betsy Tindall and I am speaking today as a practicing rheumatologist from Portland, Oregon and as the president of the American College of Rheumatology. The ACR represents more than 6,000 physicians, scientists, and health care professionals who care for people with arthritis and other musculoskeletal diseases.
Our members are actively involved in treating the estimated 70 million Americans who are affected by osteoarthritis, rheumatoid arthritis, and other musculoskeletal diseases for which traditional nonsteroidal anti-inflammatory drugs and Cox-2 selective NSAIDs are used.
Limited and emerging data about the cardiovascular toxicity of Cox-2 and nonselective NSAIDs which has received widespread media coverage has caused anxiety among patients and the physicians who treat them. We are concerned that this controversy has damaged public confidence and trust in drug safety and we believe the following points are central to the continued discussion of this issue:
First, the FDA should lead the effort to ensure that patients and the public are made more aware of the most common and serious toxicities of all medications, including those of the traditional and Cox-2 selective NSAIDs. This information should be given to the public with information about what groups of patients may be at greatest risk - including age and underlying diseases - so that physicians and patients can make better decisions about what actions should be taken.
The American College of Rheumatology supports the FDA's effort to ensure clarification of the most important drug toxicities in all direct to consumer advertising in print and broadcast media, and the full disclosure of any advertising presented to the public as patient education material, such as the literature distributed at pharmacies which promotes the use of brand name medications.
We support the full disclosure of the results of all industry related trials for drugs that are FDA approved to allow public and scientific scrutiny of the data. And, we are encouraged by the formation of the independent Drug Safety Oversight Board, created to more aggressively monitor the safety of drugs on the market. We hope this Board will ensure that all recommended post-marketing surveillance occur in a timely manner, that the methods for these studies meet the highest standards, that the results are fully disclosed and discussed, and that the FDA take post-marketing regulatory action when appropriate.
The American College of Rheumatology believes that until more complete information about the risks of nonselective NSAIDs and selective Cox-2 inhibitors are available, physicians should have the option to prescribe these medications for patients when the physician and patient agree that the benefits outweigh the potential risks.
Finally, in the last decade there have been tremendous advances in the treatment of arthritis and related diseases that have led to important improvements in the quality of life and ability to work for people with arthritis. The ACR strongly supports new drug development for arthritis and musculoskeletal diseases as well as efforts to improve patient education and public safety. We hope that the current controversy surrounding NSAIDs and coxibs provides an opportunity for the nation's drug safety system to be improved. As experts in the field of arthritis and musculoskeletal conditions, we look forward to working with the FDA, patient advocacy groups, such as the Arthritis Foundation, and industry to assess the safety of all medications and then, to communicate with arthritis patients and their physicians about these issues.