by Lois Pearlman
"We want medicines just like the adults. We want to grow up"
Sam Fox has serious
things to say for a nine-year-old, but just try to make him stand still long enough to finish a sentence.
On a gray November afternoon in the courtyard of Oakland's Children's Hospital Sam disappears as soon as the grown-ups begin to talk, zipping along the walkways and corridors, a small, wiry perpetual motion machine.
The thing that finally captures his attention is a picture taking session. And he insists on being photographed with his brother Donovan, hanging from the branches of a magnolia tree.
It's hard to believe this pint-sized ball of energy swallows six medications a day just to stay alive and healthy, and that even these drugs might not do the trick . Blood tests reveal that the amount of HIV in his young body continues to swell.
What's even more difficult to understand is that there are new drugs that are reducing HIV infection -- or "viral load" -- in adult AIDS patients to practically zero. But these drugs are not available for kids like Sam who are under the age of 13. If they were, they could possibly make his dream of living long enough to grow up a reality.
In a letter to the FDA (Food and Drug Administration), the agency responsible for the approval of new drugs, he writes, "Hello. My name is Samuel Fox. I (have) AIDS. I would like to help us kids with HIV and AIDS. We want medicines just like the adults. We want to grow up."
Because the new drugs do not carry FDA approval for children, insurers refuse to pay for the drugs
for Sam and the estimated 10 to 20 thousand other youngsters with HIV/AIDS, only three of the nine drugs available to fight the virus have been approved for infants and children. And those -- AZT, DDI and 3CT -- are the oldest and least effective. The others, including three "protease inhibitors," a new class of drugs that promises, taken in combination with other drugs, to turn AIDS into a manageable rather than a life-threatening disease, are only approved for non-pregnant adults.
That the means to prolong their children's lives lies just outside their reach is a source of frustration to family members of young AIDS patients, people who are already overburdened by the endless regimen of medicines and doctors' appointments, the fear of losing their children to AIDS, and the sting of anti-AIDS discrimination.
"Wouldn't it be nice if Sam had a non-detectable viral load?" ponders his mother Marilyn Fox.
Sam is the youngest of her five children, three biological children and two adoptees. Also a former foster mother, Fox has already lost two foster children to AIDS. If she has anything to say about it, she will not lose any more.
"Please help save Sam's life," she writes in a letter to the FDA. I don't want to lose another child to this disease. My son is going to die if he doesn't receive this access."
Doctors who treat these kids are frustrated, too.
"We want to be able to do something, and there are drugs out there that they're using that I can't give to kids," said Sam's physician, Dr. Ann Petru, of Oakland Children's Hospital, who reportedly broke down and cried because she had run out of approved drugs for a seven-year-old AIDS patient. What's the problem?
Why aren't the newer drugs available to children? Technically they are, but since few pediatric studies have been completed on them, there are a lot of reasons why doctors are hesitating to prescribe them.
The scanty pediatric data available on the drugs makes it hard to what dosage to administer, whether the drug is as effective for children as it is for adults, and what side-effects to expect. And most of these drugs are only available in pill form, which means they can't be administered to children too young to swallow a pill.
Worse of all, from a kid's point of view, is that they taste so vile, they are repugnant to take.
There is also a financial hurdle. Because the new drugs do not carry FDA approval for children, medical insurers, both private and government programs like California's Medi-Cal, are refusing to pay for the drugs.
But the real question is, why haven't the drugs been approved for children?
With children accounting for only one percent of those diagnosed with AIDS, it doesn't pay for drug companies to fund research on children
While FDA officials
recognize the problem, they say they are hard-pressed to force companies seeking approval of new AIDS drugs to provide the information that would make them available to children.
"It's been a big problem at FDA," said Richard Klein, a public health specialist with the FDA's Office of AIDS and Special Health Issues. "It's a problem enrolling enough children for a study. It's is a small and diverse population. I think the companies perceive it as a small market, and shrinking. There is not a lot the agency can do. We can't say we won't approve drugs for adults without also approving them for children."
Advocates for young HIV/AIDS patients, such as Dr. Art Ammann, a Marin County, California-based physician who diagnosed the first children with AIDS in the early 1980's, say the issue boils down to money. With children accounting for only one percent of those diagnosed with AIDS (according to a September 30 report from the Center for Disease Control), it doesn't pay for drug companies to fund research on children.
Drug companies also face financial losses if they delay seeking approval for adults until the studies are completed on children.
"It costs the companies $150 million to $200 million (in revenues) every day the drugs are not approved," Ammann said.
Since the FDA appears reluctant to force the issue, medical professionals like Ammann are joining with families of HIV-infected children and others to advocate for equal access to AIDS therapies. In September he left the Pediatric AIDS Foundation, an agency he started with the late Elizabeth Glaser, an AIDS patient and wife of film film director Paul Michael Glaser, to work full time as a advocate.
These advocates face an uphill battle because the general public sees AIDS as a disease of gay men and intravenous drug-users. Children with AIDS are almost invisible. Compounding the problem, parents of children with AIDS are often poor, sometimes have AIDS themselves, and are afraid of rocking the system and losing the services they have.
And while the new drugs -- the protease inhibitors -- have become a front page item in the national media, the fact that they are not available to children has been largely ignored. A nine-page story on the new drugs in the December 2 issue of Newsweek never even mentions that they are only approved for adults.
To get children on the front page along with adults, two advocacy groups, Positively Kids founded by the mother of two young AIDS patients in upstate New York, and ACT Up Golden Gate in San Francisco, have joined together to form the Pediatric Advocacy Network (PAN). The group has formulated a list of demands which would make AIDS therapies more accessible to children.
"We need to really light a fire under the drug companies," said Positively Kids founder Diane Donovan, an upstate New York woman who adopted two youngsters with HIV after her biological children became adults.
Inaccessibility of AIDS drugs is only the tip of the iceberg -- approximately 80 percent of all drugs have been approved only for adults
PAN announced these demands to the FDA when it sent children with AIDS and their parents to an FDA Advisory Committee hearing on a new drug called delavirdine, manufactured by Pharmacia and Upjohn. As a result of this testimony, the FDA has agreed to require that companies seeking approval of AIDS drugs provide any available information on its use for children for the drug label. This new regulation was scheduled to take effect in mid-December.
Deb Sher of Monte Rio, a mother who spoke at the November hearing in behalf of her seven-year-old son Dillon, says the new rule is a good first step. It satisfies one of the six demands that she presented at the hearing. What can be done?
While advocates from within the AIDS community are beginning to speak up for children, in the political arena, a long-time republican senator has been fighting to pass legislation that could make not only AIDS drugs, but therapies for other serious, diseases more available to children.
As it turns out, the inaccessibility of AIDS drugs is only the tip of the iceberg -- approximately 80 percent of all available drugs have been approved only for adults.
Known as the "Better Pharmaceuticals for Children Act," the legislation would offer drug companies a six-month extension on patents for new drugs, if they are willing to seek approval for children as well as adults.
Part of a more comprehensive bill to reform the FDA, it was introduced separately at the end of the session by Senator Nancy Kassebaum, R-Kansas, who hoped to push the legislation through before she retired from the Senate at the end of the year.
Although the legislation failed, a spokesperson for Kassebaum says there is bi-partisan interest in seeing reintroduced in 1997.
Advocates for children with AIDS are also pushing for a Congressional hearing on the issue in the upcoming legislative session.
Although ritonavir may successfully lowers the boy's viral load as it has for some adults, MediCal will not pay for the unapproved drug
the government's failure to force the issue, drug companies have begun some protease inhibitor testing of young patients on their own.
Agouron, a small biotech firm based in La Jolla, California, plans to bring its new protease inhibitor Viracept before the FDA in the spring, seeking simultaneous approval for both children and adults.
Glaxo Wellcome, based in North Carolina, is testing two new drugs which it plans to market for both children and adults; a protease inhibitor identified by the number 141N94 and a new reverse transcriptase, numbered 1592U89, a drug similar to AZT. But, according to spokeswoman Ramona Jones, the company does not yet know when it will seek approval for the drugs.
Dr, Frank Duff, a pediatric research specialist with Hoffman La Roche in New Jersey said the firm has finally formulated a decent tasting version of its protease inhibitor invirase after three or four tries, and will begin early phase trials with children in the first quarter of 1997.
And Abbott Laboratories in Abbott Park, Illinois, has reported such promising results with its study administering the protease inhibitor ritonavir to a group of 47 children, that Dr. Petru of Oakland Children's Hospital agreed in late November to prescribe the drug for the seven-year-old AIDS patient who appeared to be at the end of his pharmaceutical rope.
Says the boy's mother, a San Francisco Bay Area woman who learned about the successful drug test results on the Internet, "He goes in tomorrow for his first test. I'm keeping my fingers crossed that every thing will be alright."
If the ritonavir successfully lowers the boy's viral load as it has for some adults, he will be able to eliminate some of the prophylactic drugs he takes to ward off opportunistic infections. Although MediCal will not pay for the unapproved drug, the state agency California Children's Services is footing the bill.
Merck and Company of Pennsylvania, the only other drug manufacturer with a protease inhibitor on the market, did not respond to calls from the Albion Monitor.
Even as some of the newer drugs become available to the epidemic's youngest sufferers, questions remain about how effective they will be in the long at helping AIDS patients to live a normal life span. Which leads Deb Sher, the mother of seven-year-old AIDS patient Dillon to what she believes is the bottom line in the fight against the disease.
"What we really need is a cure," she says.
And she fights to make sure that when the cure comes, it will also be available for children.
Albion Monitor December 14, 1996 (http://www.monitor.net/monitor)
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