By Angelica Leicht
By Dianna Wray
By Aaron Reiss
By Camilo Smith
By Craig Malisow
By Jeff Balke
By Angelica Leicht
By Jeff Balke
Gathe agrees that if the tests are paid for by public funds, there should be certain regulations on how and when they can be ordered. And while Medicaid's Hellerstedt declined to say whether the state would pay only for tests that have been approved by the Food and Drug Administration, FDA officials are hoping their recent approval of one genotype test will help make the tests safer.
"We felt these tests were getting out there in an unregulated fashion and being introduced into interstate commerce, and we felt there needed to be standardization and uniformity," says the FDA's Andrew Dayton, who wrote the first draft of guidelines for the tests in August 2001. After about a year of review, the FDA approved the Trugene genotype test, marketed by Visible Genetics Inc., last September.
According to Dayton, it's only a matter of time before more companies try to compete with Trugene and also get approved.
"We've written the guidance documents to sort of lower the bar so it's possible to get these things cleared by a variety of different kinds of data," says Dayton. "The experts will disagree, but the key thing to remember is that we truly believe anything we clear, you're better off using it than not using it, and there's clinical data to support that."
Indeed, Visible Genetics spent six years in research and development to refine the Trugene test before it was approved, says CEO Richard Daly. And unlike home brews, Daly says, the Trugene test -- which costs around $350 -- will be easy for doctors to read. The company even promises color-coded test results: red text for resistance, amber italics for possible resistance, green for no resistance and so on.
Daly acknowledges the concerns of doctors such as Vanek and Shandera, and admits that his company's tests are just one part of treating HIV-positive patients and selecting the best drugs for them. He thinks only doctors with training in HIV should be working with HIV-positive patients. But in the end, he says, there must be room for these tests -- if they are done the right way.
"It's like what it must have been like to be a doctor who was trying to set a broken leg right after they invented the X-ray," says Daly. "Prior to that, you were wondering, 'I wonder how broken this leg really is.' And you did the best job you could. Well, this test is essentially a picture of the virus, and it allows the doctor to accurately direct the therapy. From that point of view it's incredibly cost-effective."
John Termine is in mixed spirits. The lymph nodes they removed from his body were not cancerous, but shortly after that good news, Termine learned his spleen and gall bladder were enlarged and would have to be removed. Doctors guess that their unusual growth is a side effect of long-term medication.
It's been a little over a week since the surgery to remove his two organs, and Termine is mostly resting at home, going outside a few times a day to take his two dogs for a walk. Schrader calls Termine a star patient because he does as much of his own research as he can, reading magazines for HIV-positive people and surfing on the computer, hunting down information on his condition. Ever vigilant, since the surgery he's been doing lots of fact-finding.
"I've looked everything up on the Internet," he says. "The gall bladder had so much information, but the spleen didn't have very much." He called his sister, a nurse, and she said she wasn't quite sure of the spleen's function either. But doctors have reassured Termine. He can live without it.
The kitchen is full of flower arrangements sent by friends and family. Termine almost doesn't have room for all the bouquets he received after the operation. He appreciates the good wishes, he says, although he wonders if his friends are acting too quickly.
"I'm not dying!" he says, in a good-natured voice. "It's not the funeral yet."
Termine says he was worried that going in for surgery might disrupt his pill-taking schedule. He took all of his bottles to the hospital, just in case. He was especially concerned that some pills that needed to be refrigerated would not be stored properly. So he called Schrader, who told him not to worry -- the pills could stay at room temperature for a few hours.
Sometimes Termine talks about the pills like a worried father. But there is another, more difficult dynamic at play. The pills have been a best friend and a cruel enemy. Because of the pills he has lived long enough to travel, fall in love and take his dogs for a walk this afternoon. And because of the pills he has suffered rashes, diarrhea, unexpected surgery and the jarring disappointment that comes when they just stop doing their job.
"It's a love-hate relationship," he says.
And for now, it's also a waiting game, until the fall, when he hopes Schrader will put him on a new expanded-access drug. Until then there is a life to be lived, doctor's visits to schedule and the frequent trips to the breadbox in the kitchen.
"There have been a couple of times when I just go there and stand in front of them and think, 'I cannot do this today,' " says Termine. "But then you just do it. You take them in."