FDA no help for hurt

By NANCY E. CAHILL Special to the Times
Published May 4, 2007

My friends and family know to stay away from me for the first two hours of every day. I'm not pleasant when I hurt. And I hurt until my pain drugs kick in. One drug is magical: Arcoxia, Merck's "Son of Vioxx, " which is sold in 64 countries but not the United States.

I am one of millions of Americans, a still-working baby boomer, with severe osteoarthritis. When I ran out of Vioxx in 2004 shortly after it was withdrawn worldwide, my days and nights were beyond painful. None of the advertised prescription, over-the-counter or self-help therapies matched my pain relief with Vioxx. My physician suggested I try Arcoxia.

I got the drug overseas. It worked just like Vioxx. For three years, I have gotten a year's supply with new prescriptions. I sleep great. I work long, sometimes arduous, hours. I can play again. For me, Arcoxia is safe because I have no risk factors for adverse effects and a careful physician who monitors my health.

I am lucky. Because of my work with government agencies and Congress on health care issues, I know how to take care of myself. Because of my work, I understand the politics of Vioxx. I expected FDA inaction on Arcoxia to continue despite growing acceptance of the drug worldwide. Even with that clear-eyed realism, however, I was dismayed by the FDA Advisory Panel's 20-1 vote against Arcoxia's approval, which FDA affirmed on Friday.

Why was the vote so lopsided? Even cardiologists who first called public attention to the cardiovascular risks with Vioxx have stated that Arcoxia would be a niche drug for people like me for whom all other alternatives are either unsafe or ineffective. Where was this individual risk/benefit context in these deliberations? Largely absent. Panel members' oft-stated belief that "there is nothing special about this drug, " that everyone has access to effective alternatives, is both strong and wrong.

With the FDA's rejection of Arcoxia, only the fortunate few like me will not hurt. I can avoid the "gray market" of online drug peddlers who sell garbage at rapacious prices. One source is selling sham drugs using "stanford.edu" as part of its Web address to reassure buyers. It offers a year's supply of Arcoxia for $1, 465, while pharmacies in Europe sell the genuine Arcoxia for less than $400. I can avoid these dangerous peddlers because I am supported by two physicians (one local, one overseas) who enable me to bring this life-altering drug from reliable pharmacies back to my breakfast table.

For me, FDA's nonapproval is simply an inconvenience. So why say anything? Because differential access to relief of suffering and disability based on one's personal resources is wrong.

My message to the FDA and physicians over 30-plus years of practice has not wavered: No medical technology or drug is inherently "safe" or "effective." It only becomes safe or effective with a fully informed weighing of risks and benefits, in the context of an individual patient's circumstances.

Patients with severe arthritis and their caregivers will go to great lengths to find pain relief, often without the aid or knowledge of their physicians. The FDA avoids creating a double standard in health care for arthritis sufferers, people with risk/benefit profiles just like me, only if it approves Arcoxia. The FDA fulfills its mission to protect patients from truly unsafe drugs, from costly and dangerous Internet peddlers, only by keeping patients tethered to their physicians to obtain Arcoxia prescriptions and to get essential follow-up care, just like me.

Nancy E. Cahill is a local lawyer who has practiced health law for more than 30 years. She has no business relationship with Merck & Co. She does represent clients in matters related to FDA regulatory compliance. The statements made here are her personal views only and should not be attributed to any client or other individuals.