JULY 4, 1997

GAY PEOPLe's ChroniCLE

FDA notes a diabetes risk in protease inhibitors

by Bob Roehr Washington, D.C.-Protease inhibitors may contribute to the onset or worsening of hyperglycemia and diabetes among some people who take them. The troubling news came in a June 11 advisory from the Food and Drug Administration (FDA) to health care professionals.

The information is tentative, the numbers are small, and no causal link has been proven. However, the FDA is concerned enough to advise monitoring people on the new anti-HIV drugs for symptoms. It will gather information in order to determine the scope of the problem and will require that labeling for protease inhibitors be modified to carry a warning of this potential side effect.

Eighty-three

patients developed hyperglycemia or diabetes while on protease inhibitors, 21 required hospitalization. The reaction was observed across all four of the currently approved products. The incidents have occurred in significantly less than one percent of the estimated 150,000 people who take one or more of the drugs.

Low-grade symptoms include increased hunger, unexplained weight loss, increased urination, fatigue, and dry, itching skin. The acute phase of ketoacidosis is characterized by "a fruity mouth odor, nausea, dehydration, weight loss, confusion, and if untreated, death.” Onset was as rapid as four days in one instance, though the average is 76 days.

The FDA letter emphasized, "At the present time there exists no conclusive evidence establishing a definite causal relationship between protease inhibitor therapy and the incidence of diabetes and hyperglycemia.” The patients were on other drugs for HIV, and some used medications to prevent opportunistic infections or for other medical problems. Some of those other drugs "have been associated with the development of diabetes." The FDA is advising that doctors and pa-

tients monitor blood sugar levels-something which should already happen with quarterly blood work ups-and modify diet or initiate or modify treatment as appropriate to control diabetes. They are not advising a halt to use of protease inhibitors. As FDA AIDS chief David Fiegal put it, "HIV is harder to treat than diabetes."

Spencer Cox, with the Treatment Action Group in New York, saw "no cause for alarm." However, he strongly urged doctors and patients to "integrate this into the monitoring" of PWAs' health. He wants doctors to take the

time to report these developments, something they often do not do with lesser problems, because it is the only way we will gain knowledge of such a relatively low incidence problem.

He acknowledged that early symptoms of diabetes may be difficult to separate from others associated with HIV and its treatment. For example, "a patient on [the protease inhibitor] Crixivan should be having frequent urination" because of drinking the volume of water recommended to prevent formation of kidney stones.

The data released by the FDA were very limited and did not indicate whether these effects were seen over the entire spectrum of HIV disease. Ben Chang, with Project Inform in San Francisco, wonders if they are more likely to occur in people with advanced disease “where their body metabolism may be different."

He views the news with curiosity rather than alarm.

"It was only 83 people out of all of those on protease, the incidence is really very small."

7 ACT UP members booked in drug protest

ACTUP NEW YORK

A protester is hauled away by New York City police during an ACT UP demonstration.

by Tom Rappa

New York City-Seven AIDS activists from ACT UP were arrested following their seizure of the midtown Manhattan offices of Glaxo Wellcome, the pharmaceutical firm that makes AZT and Epivir (3TC).

The seven protesters were among 30 demonstrators who gathered in front of Glaxo's Park

Avenue offices protesting what they termed cor-

porate foot-dragging in the availability of a powerful new drug that could render AZT and 3TC obsolete.

Activists were also demanding the company adequately test the drugs on pregnant and non-pregnant women, after scientists found differences between men and women in the dosing of a significant number of drugs.

The new drug, abacavir, or 1592, is much more powerful than AZT, and does not have the older drug's side effects.

Demonstrators are angry that Glaxo's plans for an expanded access program for 1592, beginning in July, only includes 2,500 people worldwide.

Demonstrators demanded a written commitment from top company officials to immediately launch an expanded access program open to all in need for 1592.

Company officials refused to meet the demands, saying "there is a limited supply of the

drug because of manufacturing issues.”

ACT UP New York members called the drug company's actions "woefully inadequate," and representative Bill Bahlman said, "Glaxo Wellcome's slow development of 1592 is due to the pharmaceutical giant's desire to squeeze the very last profit dollars out of its cash cows AZT and 3TC until their patents run out."

Sales are high due to the new three-drug treatments, using the two older drugs with one of the new protease inhibitors.

These drugs retail for about $3,800, and $3,100 per year respectively.

Glaxo increased the drugs' price 3% last fall. Sales of AZT and 3TC are anticipated to drop after 1592 becomes widely available.

Glaxo officials are denying they are putting commercial considerations before compassion.

"We are making every available capsule of tablet available either through our clinical program or through our compassionate use program," said Glaxo spokesperson Jennifer McMillan.

White House AIDS czar Sandy Thurman is attempting to negotiate with Glaxo for larger supplies of 1592. ♡

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