The panel will make recommendations today that could lead to stricter labeling of coxibs and restrictions on their use or even the complete withdrawal of the remaining drugs in the class.
Likening the controversy to recent corporate scandals, David P. Matthews, a Houston attorney representing patients who claim harm from coxibs, called for personal accountability. "I urge Congress to enact legislation for more severe penalties for [providing] false, misleading, or deceptively modified drug safety data to the FDA, physicians, or patients," he said.
Many physicians and patient advocates called for more attention to the adequate treatment of pain. W. Hayes Wilson, MD, a practicing rheumatologist in Atlanta, Georgia, urged the panel to consider the role of coxibs in helping patients who suffer from chronic pain when making their recommendations. "Pain matters," he said. "It may not kill you, [but] it may make you wish you were dead." He told the panel that limiting medication choice based on evolving data is unfair. "Ideally, a patient deserves to decide based on information provided to him or her by the physician."
Nicole Kelly of the American Chronic Pain Association, based in Rocklin, California, implored the panel to look beyond the science and to see the human face of pain. Chronic pain patients "need to know the risks and weigh them against the benefits and retain the right to make the decisions by themselves," she emphasized. "Many [patients] would rather live 10 years with manageable pain than 20 in agony."
Jack Klippel, MD, President and CEO of the Arthritis Foundation in Atlanta Georgia, called for informed patient choice. "Allow patients with arthritis to choose for themselves whether or not the benefits of a particular medication and treatment outweigh the risks," he advised the panel, pointing out that a more balanced discussion of risks and benefits of the coxibs is needed, as recent attention has focused almost exclusively on their CV safety profile.
Patient perspective
"I am the patient that you are addressing," Amye Leong, a rheumatoid arthritis (RA) patient told the panel. Ms. Leong, president and CEO of Healthy Motivation and spokesperson for the UN-endorsed Bone and Joint Decade 2000–2010, has been on numerous arthritis medications and undergone 16 surgeries, including 12 joint replacements. "While we look at the risk, we really have to look at the benefit," she asserted. "My choice is to work with my doctor."
"Vioxx saved my life," said Robert Thibadeau, PhD, who has had RA and ankylosing spondylitis since 1973. "It acts in an hour and made the pain and stiffness go away." Merck & Co has said that it will consider selling its arthritis drug Vioxx again if the FDA decides the CV risks are similar to those of related prescription pain relievers. Betsey Chaney, a patient who has several cracked vertebrae in her neck, pleaded with the panel on behalf of celecoxib. "Please don't take away this medication that works so well for me," she urged them.
Others presented opposing testimony, including a 57-year-old woman who said she had no known risk factors for heart disease, yet had had an acute myocardial infarction after years of coxib use.
Still others providing testimony were concerned that the coxib controversy and the sharp criticism of the FDA in the wake of the rofecoxib withdrawal will result in a dearth of effective new drugs. "Patients need expeditious approval of medications and we are concerned that the FDA may become timid or gun shy," Michael Paranzino, president of Psoriasis Cure Now, based in Kensington, Maryland, pointed out to the panel.
Reference:
US Food and Drug Administration. Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; February 16–18, 2005; Gaithersburg, Md.