Topical Retinoids: An Update Symposium Medical College of Georgia AAD Retinoids Symposium and Main Therapeutics Symposium Honorarium Reimbursement for expenses incurred Reimbursement for expenses incurred Honorarium and reimbursement of expenses incurred Honorarium Honorarium Honorarium and reimbursement of expenses incurred Reimbursement for expenses incurred *Travel and/or lodging expenses covered under master account AAD Postgraduate Session Meeting Harvard Field Trail Closed Symposium Photodamage Severity Prints Texas Osteophathic Medical Association Meeting Harvard Video JAAD Supplement Reimbursement for expenses incurred American Academy of Family Physicians Tretinoin Scientific Exhibit Cancer Symposium AAD Scientific Exhibit-- Honorarium Reimbursement for expenses incurred *Travel and/or lodging expenses covered under master account Honorarium for preparation of Reimbursement for expenses incurred APPENDIX 4.-CDC REVIEW OF COLLAGEN AND PM/DM Enclosed is a copy of our review of the reports received by your division and/or the We were first notified of these cases in August when the Texas Department of Health, which had been in discussion with your staff, requested our review of their analysis. At that point, we also contacted Dr. Tom Lowe of your staff. Because the initial report information was incomplete, our staff contacted the physicians involved in the diagnosis of these cases and requested materials from the medical records that could be used to more fully characterize the cases. Over the past several months, our staff have been working together with yours, people in the Texas Health Department, and in California to pull together this information for review. As you will see in the report, the evidence suggests that there is a problem, but the current number of confirmable case reports are at too low a level to indicate this with certainty. We believe that the analysis your staff conducted in the past-that suggested an increased number of cases-was appropriately conducted. Like you, we believe that there is an increase, but with the current data this increase does not achieve conventional standards of statistical significance. Thus, we believe the investigation has gone as far as it can, given the data currently available. We continue to be concerned that this may be a real risk associated with these injections. However, we have seen some similar instances of temporal clustering of relatively rare conditions that turned out to be real and turned out to be merely an artifact of reporting. For example, the temporal association of sudden infant death syndrome with injection of DTP vaccine in infants, after extensive investigation, turned out to be merely a clustering due to chance. (367) It is our conclusion that nothing more definitive can be done with the information currently available on PM/DM and beef collagen. However, because suspicions remain, we would urge you to continue those activities that FDA carries on when suspicion exists over potential risks associated with regulated devices. We will inform you immediately if we hear of any additional cases and are willing to assist you further should additional cases or concerns arise. I hope this information is helpful and hope that we can be of assistance in the future. Sincerely yours, Enclosure Jeffrey P. Koplan, M.D., M.P.H. Assistant Surgeon General Director Center for Chronic Disease Prevention March 19, 1990 Review of CDC's preliminary investigation of injectable beef collagen (IBC) and polymyositis/dermatomyositis (PM/DM) CDC's involvement with this issue began in August, 1989, when the Texas Department of Health (TDH), contacted Jim Marks requesting technical assistance in investigating the possible development of PM/DM among patients receiving injectable beef collagen. A TDH memo to CDC and FDA dated September 7 reviewed TDH's analysis of observed vs. expected cases, which found a three-fold increase in risk of PM/DM, and suggested further investigation by TDH, CDC, and FDA. During October, CDC staff reviewed Collagen Corporation (the only manufacturer of the device) studies relevant to the problem and concluded that the company studies had little power to detect an increase in PM/DM risk that would be of clinical and public health importance. CDC began a preliminary investigation of the problem with the intent to review the medical records of ten suspected PM/DM cases and all systemic adverse reaction reports on the device for any pattern of adverse reactions, and to obtain estimates of the prevalence of device use among the states. 1 In late October, CDC staff met with Dr. Tom Lowe (FDA), who reviewed the regulatory history of the device and in November provided available information on the nine suspected cases, on the 700+ systemic adverse reaction reports, and on marketing data provided by the Collagen Corporation. The available information on the 10 suspected PM/DM cases was inadequate to allow case confirmation, so CDC staff contacted patients or their physicians directly to obtain more detail. |