Ten years ago, it was easy to spot. People with AIDS had "the look": AZT butt, a visible KS lesion or severe wasting.

When combination therapy began, "the look" went away. Now it's back.

"The look," a consequence of fat redistribution, is unmistakable. Subcutaneous fat from the face, arms and legs disappears, giving the eyes, temples and cheeks a sunken look. The major muscle groups and superficial veins in the legs become clearly defined. Fat accumulates in the abdomen and, in women, the breasts. A pad of fat in the upper back, cruelly called buffalo hump, can also develop.

"Lipodystrophy" and "fat redistribution syndrome" have been proposed names for this condition, and its causes remain unknown.

Unfortunately, some physicians minimize the impact of these changes on their clients and dismiss them as "merely" cosmetic concerns. Neither the Food and Drug Administration nor any Public Health Service official has issued any recommendation that people stop combination therapy because of lipodystrophy. The positive effects of highly active antiretroviral therapy outweigh these negative outcomes.

Bargaining for longevity

From a medical point of view, the consequences of looking like a concentration camp inmate may be of minimal significance. For people with HIV, they're not.

First, this is a significant quality of life issue. The value I assign myself, sometimes called self-esteem, determines the investments, risks and sacrifices I am willing to make in my health, relationships and work. Individuals may be less adherent with their meds, less invested in maintaining their health and a lot less happy when their quality of life is compromised.

Second, physicians who dismiss the external consequences of lipodystrophy may overlook the internal (subclinical) changes which can accompany the external.

Serious internal circumstances can accompany the external changes. Elevated triglycerides, increased cholesterol levels (including decreased "good" cholesterol readings) and cardiovascular disease may develop.

Because of fat redistribution syndrome, measuring these values has become as important as monitoring T-cell and viral load for the management of HIV disease. A recent small study of women on protease inhibitors suggests that even people on PIs without any noticeable body changes need to monitor serum lipid levels. In the study, women both with and without changes in body habits had serum lipid abnormalities. A variety of body measurements associated with the development of cardiovascular disease were the same in both groups.

That means two things: First, physicians need to run these blood tests and share these results with their patients. Secondly, consumers of health care services need to learn how to interpret these test results. An excellent way of understanding these issues is attending a class by a dietitian or treatment advocate from AIDS Project Los Angeles.

The emergence of a fat redistribution syndrome raises larger issues, also. Given that the phenomenon has been observed in people who do and do not take protease inhibitors, the syndrome may "simply" be a consequence of long-term infection with HIV. Its emergence may be associated with recent increases in longevity.

We may need to accept the external changes in our bodies as a trade-off for a longer life. And we may need to fight like hell to understand and develop strategies to deal with the internal changes which could kill us.

FDA: whose side are they on?

The initial reaction to lipodystrophy by various pharmaceutical companies was criminally slow. Many advocates believe that because manufacturers of protease inhibitors did not want adverse drug events associated only with their particular product, they were deliberately sluggish in reporting them to the FDA.

The FDA, on the other hand, was slow in demanding adequate plans for responsible Phase IV drug monitoring of protease inhibitors. During this post-approval phase of clinical trials, ongoing studies of how a drug actually functions in a significantly large patient population are to be conducted. At the same time, adverse drug events are to be reported by physicians and patients.

Many HIV advocates were opponents of the FDA reform movement that led to the passage of the Food and Drug Modernization Act of 1997 because of concerns that the act's requirements could lower FDA standards and authority to monitor situations like lipodystrophy.

Many think of the FDA as an enormous bureaucracy. The agency, in fact, is severely understaffed and underfunded. Fewer than 60 employees have a budget of approximately $6 million to monitor the safety of over 3,200 drugs that are used nationwide.

Health concerns discounted

The fact that lipodystrophy is not a high priority among pharmaceutical companies and government regulators is not surprising, it is dangerous.

APLA remains extremely concerned that the FDA maintain its role as a sentry of product safety. In public testimony last year, APLA joined other consumer advocates in calling for creation of an FDA Office of Drug Safety. Our hope remains that health concerns associated with the ongoing use of protease inhibitors and other antiretrovirals be documented as clearly as the dramatic effect they have had on restoring health and productivity.

Many issues associated with HIV disease today converge around lipodystrophy. Advocacy, both personal and communal, never ends.

Lee Klosinski directs AIDS Project Los Angeles' Education Division. He can be reached by-email at lklosinski@APLA.org.

This article has been reprinted at The Body with the permission of AIDS Project Los Angeles (APLA).