AZT On Trial - By Celia Farber

By Celia Farber
Spin July '96

The treatment for AIDS stands accused of being deadlier than the disease itself.

Kananack, Murgatroyd, Baum & Hedlund is one of the nation's leading "mass disaster" law firms, generally handling plane crashes, train wrecks, and other types of accident litigation. It also handles product liability: The firm has instigated several lawsuits alleging damage caused by such drugs as Prozac, Ritalin, and the experimental hepatitis drug FIAU, which resulted in the death of five people in a government drug trial.

Now it's taking on AZT.

The firm represents several people who are convinced that they or their loved ones have been injured or killed by AZT, a drug whose effectiveness and toxicity have been hotly debated since its release onto the market in 1987.

AZT is a chemotherapeutic agent, and as such it massively and unselectively destroys cells, causing "side effects" ranging from bone-marrow toxicity to muscle wasting, anemia, neuropathy, and more. The drug was approved by the Food and Drug Administration after a quick and flawed study indicated that those who took the drug lived longer, and was rushed onto the market following demands by AIDS activists who were accusing the government of foot-dragging. According to defenders of the drug, it served a vital function--despite its limitations--at a time when there was nothing at all doctors could prescribe for AIDS. But to detractors, AZT represents the most cynical medical scandal of modern times.

"What it really comes down to here," says Paul Hedlund, the lead attorney on the AZT cases, "is that AZT was sold to us as a bill of goods. The drug not only turned out not to be good, it turned out to be bad. We believe that the manufacturer has known this all along and has tried to deceive everyone, and we think that's really wrong." Ramona Jones, a spokeswoman for Glaxo Wellcome, told SPIN that the company had not yet been notified of the possible litigation and so could not comment directly on it. "I can tell you," said Jones, "that the drug went through clinical trials and was renewed by the FDA. It had an acceptable clinical safety profile."

A pivotal legal point will be that the manufacturer's own data promoted the initial misconception that AZT would prolong life in people who were HIV-positive but had no symptoms of AIDS. Following this research, Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, officially recommended in 1989 that people who are HIV-positive, even if healthy, start taking AZT as soon as their T cells fall below the mark of 500. This was an expansion of the original patient group that AZT was approved for: those who were far along in their illness.

The drug has fallen from grace somewhat in the past few years, largely due to negative publicity from the 1993 European "Concorde" trial, which demonstrated that many of the claims made for AZT were false. But doctors are still widely prescribing the drug. Though most AIDS doctors no longer believe AZT prolongs life, they do not, by and large, believe that it shortens life either. That is what will now be hammered out in court. Recent studies have indicated that those who take AZT die up to a year faster than those who do not take it, and Hedlund claims that the Concorde team has yet-to-be-released toxicity data confirming that AZT can, in certain cases, shorten life. His team is eagerly awaiting the release of this data.

As long as doctors can find any medical rationale for AZT, damage litigation will be exceedingly difficult, particularly since AIDS is broadly defined to include up to 27 different symptoms and diseases. And AZT itself has up to 50 side effects listed, several of which overlap with AIDS symptoms, as AZT causes immune deficiency like that seen in AIDS.

But Hedlund stands firm that if even the slightest acceleration of death can be proven, Glaxo Wellcome is in trouble, a stance that radically departs from the cynical assumption that people with HIV are "going to die anyway." "Anything that shortens a person's life is actionable," says Hedlund.

AZT litigation is already underway in Britain, and at least two cases have been filed there by lawyer Graham Ross. Ross's primary case is that of the widow of a hemophiliac who was relatively healthy, but weakened and died shortly after beginning AZT therapy.

Hedlund plans to file a number of cases against Glaxo Wellcome, and possibly against involved physicians and hospitals as well. One case is that of Jak McDonnell, who, says Hedlund, was HIV-positive but asymptomatic when he started AZT, and who then died much sooner than expected. McDonnell's surviving partner, Chris Michaels, says, "Jak took a nosedive when he started on AZT. That was the beginning of the end." Hedlund says point-blank that McDonnell's death was a "tragic death caused by AZT."

Hedlund's star client, however, is five-year-old Lindsey Nagel. Lindsey was born in the Romanian coal-mining town of Petrosani, deep in the Transylvanian Alps, to an impoverished mother of three who gave her up at birth. She was adopted as an infant by Steve and Cheryl Nagel, who, after weeks of wrangling over the adoption process in Romania, took her home to Minneapolis. Once home, Lindsey was taken in for a routine check-up and was found to be HIV-antibody-positive, presumably, like so many Romanian children, from a blood transfusion. Noting that she was a "very bright, smiling, happy girl," Lindsey's doctor nonetheless prescribed Septra, a powerful anti-pneumonia drug, and told the Nagels that their child would probably not live to be two years old.

At about three months of age, Lindsey was put on AZT, in the form of fruit-flavored syrup, four times a day. A month later, she started to decline, losing her appetite and falling behind her proper growth rate. Because AZT kills all dividing cells in the body, Lindsey soon stopped growing altogether. Her parents grew anxious, but Lindsey's doctors were adamant about the necessity for AZT treatment and, in fact, praised her "progress" at each visit. By Lindsey's second birthday, she was waking up at night, clutching her legs, and screaming in pain. This continued each night for a month. The Nagels knew that this was due to muscle wasting, a known side effect of AZT. "While she was on AZT, Lindsey looked exactly like an AIDS patient," says Cheryl. "She was so sick. She was emaciated. She cried all the time. She never smiled. And all the time her doctors were telling us that these were the symptoms of her 'AIDS'."

By chance, the couple stumbled upon an article featuring molecular biologist Peter Duesberg, who contests the idea that HIV is a deadly virus and calls AZT "AIDS by prescription," arguing that the treatment produces the same symptoms as the disease it is intended to combat. "I called Duesberg," Cheryl recalls, "and he said, 'Take her off that drug.' He sent us documentation of everything he said. We researched AZT, found out how unsubstantiated all the claims for it were, and took her off it."

Lindsey's health improved immediately. According to Cheryl, her daughter became a new child almost overnight. She stopped screaming; she gained weight; her appetite came back. "She's a perfectly healthy little girl now. I'm sure he has his flaws, but Peter Duesberg saved my daughter's life," says Cheryl. Lindsay, now almost six, is still in perfect health.

Oddly enough, at this point it is not clear whether Lindsey is in fact infected with HIV. Examining her daughter's medical records after discharging the physicians, Cheryl found that although Lindsey had indeed been antibody-positive to HIV, her viral-culture test--the test that measures the actual virus--was negative. "It said Negative in big bold letters across the page," says Cheryl. "I was so shocked." Why had the Nagels been told that this particular test was positive? "We don't know," she says. "There are a lot of questions we still have to sort out."

Lindsey's story encapsulizes the absurdity of current HIV and AIDS medical practice. Many of the complications stem from the faulty HIV-antibody test, which, because of cross-reactions with several other microbes and underlying blood conditions, has a high false-positive rate. All too frequently, a barrage of toxic drugs are prescribed at the first hint of a positive result, soon making the distinction between toxic effects and AIDS symptoms impossible to determine.

Dr. Michael Lange, associate chief of infectious diseases at St. Luke's-Roosevelt Hospital in New York and one of the doctors the FDA consulted when evaluating AZT in 1987, says even he sometimes has trouble differentiating between AZT's toxic effects and AIDS itself: "There are a number of things where it is difficult to sort out whether it's HIV- or AZT-related. When you know that it could be AZT-related, the first thing usually is to stop the AZT, to see if the problems persist."

Lange, who has a large AIDS-treatment practice and has been treating the disease since its inception, is cautious about using AZT. "This is not a particularly good drug. I have never said that AZT is the worst poison and that it should never be used. But knowing how little it did, I've always felt it should be very judiciously used. The side effects that can happen are potentially quite serious. If you're on death's doorstep, you might be willing to take that kind of risk, just like you may be willing to take chemo when you've got bad cancer."

Hedlund points out that Lindsey, far from being "on death's doorstep," was perfectly healthy until she took AZT. "What we are going to sue for is the extreme pain and suffering that this small child had to go through. Not just her but her whole family.

"I think that the overwhelming information is that AZT is deadly and it just hurts people," Hedlund continues. "We have to at least alert people so they can make an informed choice." *