Miami Herald; Thursday, October 10, 1991
Elinor Burkett, Herald Staff Writer

The Food and Drug Administration announced the licensing of DDI, dideoxyinosine, for use by AIDS patients who cannot tolerate or do not respond to AZT, until now the only drug approved to battle the human immunodeficiency virus.

Like AZT, DDI is not a cure for AIDS but is designed to slow the spread of HIV throughout the immune system, thus retarding the progress of the disease.

DDI will be available by prescription as Videx as soon as it arrives in pharmacies, said representatives of Bristol-Myers Squibb, its manufacturer. The retail price of DDI is expected to be under $2,000 a year for most patients -- about half the annual cost of AZT. Bristol-Myers will help subsidize the drug for AIDS patients who can't afford it.

The announcement was hailed by AIDS activists who have long criticized the FDA's lengthy approval process. But the licensing of DDI based on preliminary tests that suggest, rather than prove, its effectiveness has provoked concern that the FDA is caving in to political pressure by allowing relatively untested -- and potentially dangerous -- drugs to be given to the critically ill.

"If we want to get drugs out to the patients quickly, we have to move with limited information and be willing to amend the practice of medicine when more information is available," said Dr. Margaret Fischl, director of AIDS programs at the University of Miami Medical School, one of the DDI testing sites.

The approval was based on studies showing that DDI often increases, at least in the short run, an AIDS patient's CD-4 cells, a critical component of the immune system. However, the studies do not indicate whether that increase is long-lasting, whether it increases the length of time AIDS patients remain free of symptoms or whether the drug prolongs survival.

"We know this drug, DDI, affects CD-4 counts, and we know survival is tied to CD-4 counts," said FDA Commissioner David Kessler. "There is somewhat of a leap there, but patients are dying and we think that extrapolation makes a lot of sense and is in patients' interests."

Because it was sped into the marketplace in record time, little is known about DDI's long-term side effects. But many AIDS patients tested on the drug over a short period suffered from DDI-related pancreatitis, an often serious inflammation of the pancreas, or neurological complications. More than 1 percent of those patients evaluated for the drug's approval died from drug-related problems.

DDI caused a flurry of excitement in the summer of 1989 after researchers at the National Cancer Institute reported it to be more effective and less toxic than AZT. But enthusiasm waned when further research showed that up to 66 percent of those on DDI developed pancreatitis and up to 42 percent suffered from peripheral neuropathy, burning and numbness in the hands and feet. Pancreatitis seems to be dose-related; neuropathy is not.

Members of the FDA's Antiviral Drugs Advisory Committee, which met in July to consider DDI's approval, expressed concern that the data submitted to them were insufficient to evaluate the drug's effectiveness and safety. It showed that 37 percent of the adult AIDS patients treated with DDI experienced minor increases in their CD-4 counts and that almost half gained weight, but gave no information on the drug's usefulness in delaying illness or death.

"The precedent we've set is a bad one," said Dr. Deborah Cotton, one of two FDA committee members who voted against the recommendation. "We will see more drugs approved on the basis of very little data and we will have less ability to know how to choose among them or how to use them in combination."

But Dr. Donald Abrams of San Francisco General Hospital expressed the moral quandary of the committee: "As a scientist, I, myself, am not entirely convinced that the data that we have seen do demonstrate that DDI is effective in treating adults with HIV infection to date. However, as a clinician, I think that the benefits of having a drug available for people with HIV infection outweigh the potential risks of the drug at this time."

911010
MH911005

Always watch for outdated information. This article first appeared in 1991. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 1991. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .