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3/97

There's a lot to be said for being in the right place at the right time.

Through a series of events which involved another news reporter canceling out of an assignment to cover a Sonoma County AIDS Foundation dinner, a last minute call from the editor of "We the People" to cover for the reporter, a chance meeting with an old acquaintance at the dinner and an invitation to sit at her table, I ended up working on one of the most important and exciting news stories I have ever encountered.

You may have been reading in the newspapers lately about the new AIDS drugs called protease inhibitors, which appear to be capable of keeping people with AIDS alive and well into a ripe old age. These new drugs were the subject of a speech presented at the dinner by Bay Area resident Jeff Getty, the man who received a baboon marrow transplant as an experimental AIDS treatment.

The transplant didn't work, but radiation therapy that accompanied the operation appears to have wiped out the opportunistic diseases that were threatening his life, and the new protease inhibitors are keeping him healthy.

These new break-throughs in AIDS treatments are good news for tens of thousands of men and women with AIDS, but the bad news is that children with AIDS are still dying needlessly because the drugs are not available to them.

That's what I learned that night at the dinner because I was sitting with a group of people who run Camp Sunburst, a special program for children with HIV and their families.

So now I'm hot on the trail of this story.

What it all boils down to, is that the Food and Drug Administration (FDA) has approved for adults, so far, nine drugs for keeping the AIDS virus at bay, but only three of the have been approved for children. And those three are the least effective.

The bottom line is that when drug companies go before the FDA for approval of new drugs, the agency is not requiring studies to usage by children, even though it has a mandate to require that drugs receiving its approval are proven to be safe and effective for everyone who might benefit for them. And the drug companies are not voluntarily testing the drugs for children themselves because it is not cost effective. The pediatric AIDS population is much smaller than the numbers of adults with AIDS, so the companies stand to make a lot less money selling the drugs to kids than to adults.

Doctors can still prescribe the drugs for kids, but they are taking a risk in terms of dosage and safety. And some of the drugs are only available in pill form, which renders them unsuitable for infants and other children who cannot swallow pills.

Further inhibiting the doctors' ability to treat their young AIDS patients with the new drugs is the fact that most insurance companies, and government health programs like Medicare, will not pay for drugs unless they are approved by the FDA.

Even worse, parents with young AIDS patients are often poor, overworked, sometimes have AIDS themselves, and have traditionally been the most overlooked by AIDS activists who advocate for AIDS treatment.

But all that is changing. There is a movement among parents of kids with AIDS, and doctors who treat young AIDS patients, to force the FDA to change its ways.

In northern California parents are organizing with assistance from Virge Parks of ACT UP Golden Gate in San Francisco, and long-time pediatric AIDS researcher Dr. Art Ammann in Marin County. At the same time, a group has formed on the east coast called Positively Kids, which is working in conjunction with the west coast advocates under the banner, Pediatric Advocacy Network. These advocates are attempting to work with the drug companies, the FDA, and the US Congress, to make the already approved drugs, and any new drugs that are being considered for approval, as accessible to children as they are to adults.

One of their goals is to initiate a congressional hearing on the entire subject of drugs for kids, because children with other life-threatening disease such as cancer are apparently facing the same problems. Earlier this fall, Republican Senator Nancy Kassebaum introduced legislation which would have provided perks for companies that include the required children's data simultaneously with adult studies when seeking FDA approval of a new drug. Although the legislation failed, and Kassebaum will not be returning to the senate next year, a spokesperson in her office said there is a lot of interest among legislators in both parties to reintroduce the bill.

It certainly would be helpful if anyone concerned about this issue fired off a little note to their senator and/or representative asking them to support legislation and a hearing. There are several legislators in the northern California area who would probably rise to the challenge with a little prodding, such as Lynn Woolsey or Nancy Pelosi.

This really is magic bullet time. These drugs can save the lives of kids who are dying now without them. All they need is a little seal of approval.