Worldwide, about 57 million people will die this year. Few will make headlines like Pope John Paul II and Terri Schiavo did. Many will die as did Kianna Rowe Karnes of Indianapolis, attended by family but abused or neglected by the health profession.
Karnes was 44 when she died a few weeks ago from kidney cancer. She was not brain dead. She was not at the end of a long life, but in the rich, middle years where she could enjoy her family and career to the fullest. No extraordinary measures were taken to prolong her life. In fact, measures that might have given her a few more months or years were denied her by bureaucratic ineptitude.
Pharmaceutical companies develop drugs that can save lives. Those drugs need to be tested to prevent patients from being harmed when the intent is to relieve or cure disease and suffering. When is a drug ready for testing? Which patients should be allowed access to those drugs? What methods should be used to validate the results of the tests?
These questions are answered by the U.S. Food and Drug Administration and by your physician. Kianna Karnes had a terminal disease. She was denied access to two drugs that might have helped her because one physician told her she was not sick enough for participation in a clinical trial of the drugs. Later, another doctor pronounced that she was too sick for such participation.
Yet even if Karnes had been allowed to be part of the clinical trial of either of these drugs, she might not have gotten the medication.
Instead, she might have received a placebo, a pill that is without medicinal effect. Thus, although declared terminally ill, Kianna Karnes would have been denied the chance to live in order to satisfy the double-blind testing processes of the FDA.
A placebo test using terminally ill patients is procedurally questionable and ethically abhorrent. We can understand a placebo when testing a diet pill where attitude and expectations can be of importance in the results.
But will terminal kidney cancer respond to the positive-thinking effect of a placebo?
Once it is determined that a person is terminally ill, should we make every effort to save him or her? If we say “yes” for Terri Schiavo, we must say “yes” even more emphatically for Kianna Karnes.
Yet the differences are clear. Kianna Karnes was fully competent to make decisions for herself until her final days. There was no dispute about her determination to live. If the FDA had permitted the drug companies and her doctors to provide her with their medications, knowledge would have been increased, which is the purpose of testing. If that had happened, Kianna Karnes might be alive today and there would be hope for thousands more.
Some would have Congress pass a “Kianna’s law” to mandate that the FDA provide terminally ill patients access to clinical testing of yet-to-be certified drugs. Let us hope the FDA will make the necessary changes promptly on its own, without legislation. The intrusion of Congress into the domain of scientific validation is not to be encouraged.
However, the FDA is not known for its rapid response to the public’s interest. If the FDA does not act promptly, congressional action may be our only recourse. If the FDA does act promptly, Karnes’ family will have some solace from her legacy.
Why is prompt action needed? According to the California Kidney Cancer Foundation, 33 Americans die each day from metastatic kidney cancer.
That’s more than 12,000 people annually. Excessive caution and sluggish bureaucracy deny the possibility of life to those with kidney cancer and others who are terminally ill. The “right to life” must be extended to those for whom there is hope and from whom we can learn about the efficacy of new products or procedures.
For more information on this issue, contact the Abigail Alliance for Better Access to Developmental Drugs at www.abigailalliance.org.
Marcus taught economics more than 30 years at Indiana University and is the former director of IU’s Business Research Center. His column appears weekly. To comment on this column, go to IBJ Forum at www. ibj. com or send e-mail to mmarcus@ibj. com.