| FOOD AND DRUG ADMINISTRATION PULMONARY ALLERGY DRUGS ADVISORY COMMITTEE CDER OPEN PUBLIC HEARING SEPTEMBER 6, 2002 COPD-ALERT PRESENTATION BEFORE THE COMMITTEE Good afternoon, I am the Owner-Moderator of COPD-ALERT, a non-profit, Internet-based, support and advocacy group for COPD patients, caregivers, and medical professionals. COPD-ALERT is a member-driven organization. We do not receive any funds from any private organization or government agency. I also have a personal stake in your hearing. I have severe COPD and I was forced to retire on disability more than two years ago. On behalf of COPD-ALERT and many thousands of COPD patients in the United States I wish to thank the agency and this Committee for holding a hearing devoted to Spiriva and for making it possible for the patients and their advocates to participate in and contribute to your deliberations. The name Spiriva evokes strong emotions among COPD patients. Medical reports about successful clinical trials conducted around the world as well as comments about them have been proliferating exponentially. There is also quite a bit of anecdotal data from individual COPD patients which adds the human dimension to the formal clinical reports. This excitement is quite understandable. To this day there is hardly any COPD-specific drug available. This is despite the fact that COPD is the fourth major cause of death in the United States and that the morbidity and mortality figures continue to climb. There is a real danger that within the next decade COPD will move to the third place, if not higher. It is our hope that medical research accelerates the development of COPD-specific drugs, like Spiriva, which in addition to its proven therapeutic efficacy causes no major side effects. We must at least slow down the COPD deadly spiral, if we cannot stop it. But COPD is not only about death. This is a crippling, debilitating disease, tying patients to breathing support machines, and mercilessly destroying their lives, breath by breath. The World Bank study suggests that some 25 percent of COPD patients will die during their productive middle age, losing 20 to 25 years of life. At the same time, millions of COPD patients who continue to struggle with their disease are disabled and unable to work. The American Lung Association has described COPD as the second most disabling disease for American workers. Small wonder that the economic costs are enormous. According to the Centers for Disease Control, more than $50 billion per year (a conservative estimate) is spent on COPD-related medical expenditures, with an additional $50 billion in indirect cost. The primary source of medical expenses for COPD patients are extended hospital stays and expensive medications. The University of Washington alarming study shows that while COPD patients constitute 10 percent of the patient population, they account for more than 70 percent of all medical care costs. These costs continue to escalate. COPD is a neglected disease. Insufficient attention is being paid to the fact that there is an extreme shortage of viable treatment options. Physicians have only two choices: (a) to experiment with medicines developed for asthma; or (b) to consider surgery. Asthma medications relieve symptoms, but their effectiveness diminishes over time and they often have undesirable side effects. Surgery is an option for very few patients. That is why Spiriva has evoked so much interest and hope among COPD patients. After all, Tiotropium bromide is not a mysterious new substance. Both, asthmatics and COPD patients have been using its variation, Ipratropium bromide (Atrovent), for many years. Atrovent, unlike many other bronchodilators, is well tolerated and does not cause worrisome side effects. As the clinical trials in this and other countries have shown, Spiriva is well tolerated and provides a major relief for shortness of breath for as much as 24 hours without causing any harm to patient’s other organs and systems. It is my understanding that this Committee has received credible and uplifting testimonials from individual COPD patients, who take Spiriva under the supervision of their doctors. COPD patients expect that this Committee and the FDA will move fast forward toward the approval of Spiriva. We urge you to do so. Thank you for your attention. Vlady Rozenbaum, PhD This presentation is posted on the FDA site at http://www.fda.gov/ohrms/dockets/ac/02/transcripts/3890t1.htm |
| ON SEPTEMBER 6, 2002, THE PULMONARY-ALLERGY ADVISORY COMMITTEE OF THE FOOD AND DRUG ADMINISTRATION RECOMMENDED APPROVAL OF SPIRIVA FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) IN THE UNITED STATES |
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| COPD-ALERT 2002 |
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