U.S. Food and Drug Administration
FDA Consumer magazine
November-December 2000
Table of Contents
In the article "Human Gene Therapy: Harsh Lessons, High Hopes" (September-October 2000 FDA Consumer), you describe the illness of my son, Jesse Gelsinger. I would like to correct your description of the status of my son's illness during his lifetime. In your description of Jesse, you said, "during his youth, he had many episodes of hospitalization, including an incident just a year before the OTCD trial in which he nearly died from a coma induced by liver failure. But a strict diet that allowed only a few grams of protein per day and a pile of pills controlled his disease to the point where he appeared to be a normally active teenager." That shows how little you know about him.
Jesse had only three hospitalizations in his lifetime for his disorder: When he was first diagnosed in March 1984; in October of 1991 following a protein load; and in December 1998, following decompensation as a result of medication non-compliance and a probable problem with one of his medications causing hypoglycemia. In the 1998 experience, Jesse's metabolic geneticist changed Jesse's medications entirely. Upon an impressive recovery following administration of the new drugs, Jesse was non-symptomatic of his illness from that time until he signed himself into the care of the Institute for Human Gene Therapy at the University of Pennsylvania. Jesse even had a serious case of influenza in February 1999 and suffered no ill effects from his metabolic disorder, delighting us to no end. He was healthier than he had ever been in his life. In addition, sixty grams of protein a day, Jesse's allowance at the time of his death, was easily manageable. He did need to take a lot of pills all his life ... and we thanked God every day for them because they allowed him to live as normal a life as you and I most of the time. In fact, Jesse probably lived a better life than you and I. He had a greater awareness of death, something that we all tend to ignore until it is upon us.
Paul L. Gelsinger
Tucson, Ariz.
The article "Make No Mistake: Medical Errors Can Be Deadly Serious" (September-October 2000 FDA Consumer) indicates that name confusion and sloppy handwriting are the most common causes of drug-related errors.
The problems of drugs with similar names and sloppy handwriting clearly indicate another type of description is needed!
It appears most of these problems could be solved by giving each drug a numerical ID. If sloppy handwriting is a problem, the number assigned to the drug would be unique--not subject to error. The numbers would also allow the use of bar codes for easy scanning. This technique would allow the use of many devices that are now available and being used to solve similar problems.
Whitney A. Brown
Winter Haven, Fla.
In FDA Consumer's September-October 2000 article, "Reusing Medical Devices: Ensuring Safety the Second Time Around," the story's sensationalistic tone served only to distract and alarm readers, without providing them with the real news about reprocessing. Unfortunately, the article neglected to report that medical device reprocessing enjoys overwhelming support from the clinical community, reprocessed devices have an outstanding 20-year record of safe use (as good as, if not better than, original equipment), and they cost half as much as new devices. These savings help contain the always increasing cost of healthcare. Furthermore, only a very small number of the thousands of devices used by hospitals are reprocessed.
Particularly troubling was FDA Consumer's misrepresentation of the safety record of reprocessing. The article noted that FDA's Medical Device Reporting (MDR) system contains 245 reports of adverse events associated with reprocessed devices. However, what FDA Consumer failed to report is that FDA receives 100,000 MDR reports every year. Thus, when put in its proper context, the tiny number of reports associated with reprocessed devices confirms the outstanding safety record of mece of the real story that FDA Consumer missed was the meaning of the single-use label itself. Indeed, the article failed to clarify that the "single-use" label is not an FDA requirement. Rather, it is a designation chosen at the discretion of device manufacturers--more often for marketing reasons than for patient safety concerns. This means hospitals throw away millions of dollars a year in otherwise functional medical devices. Clearly, manufacturers have no commercial incentive to recommend that a "single-use" device be reused.
The truth is that third-party reprocessing is a safe, FDA-regulated industry. We strongly support vigorous FDA oversight of reprocessing, and we look forward to complying with the agency's new guidelines.
Pamela J. Furman
Executive Director, Association of Medical Device Reprocessors
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