Saturday, January 15, 2011

HAART (pronounced like "heart") and Life Lotteries


We've all heard about the mega-million lottery. Two winners had to split the hundreds of millions right in the middle. But what if you're dying and a lottery--a drug lottery that is--is the only way you can stay alive? Then, all of a sudden, the millions cease counting, become meaningless... 
Drug lotteries became more... popular... if you may, during the mid-nineties, at a turning-point in the fight against the AIDS pandemic. Because of the newly introduced, life-saving medications known today as HAART (pronounced like "heart") many AIDS patients could put their names on the list and, a few lucky ones, got to be winners. The reward? They didn't only get to survive the disease, but to thrive and, in time, begin to live active, normal lifespan lives. Here's a short excerpt from a survivor's story and experience with drug lotteries, as he told it to me. The survivor is award-winning photographer Kurt Weston. AIDS has left him legally blind, but winning the drug lottery has saved his life... or so he believes.

Hope you enjoy this excerpt from Journeys Through Darkness. As always, thanks for visiting.

Alina Oswald

Excerpt from Journeys Through Darkness
Chapter Five: Losing the Light


[...] [By the beginning of 1996] a new life-saving medication was coming on the market. It was one of the first protease inhibitors (or P.I.s) medications called Crixivan, and it was part of a new treatment called HAART (pronounced like “heart”) regimen, otherwise known as “the cocktail,” which was going to radically change patients’ lives, turning AIDS from a definite death sentence into the manageable disease that AIDS is today.  
The Highly Active Anti-Retroviral Treatment was (and continues to be) a revolutionary triple-drug therapy made possible by Doctor Ho of the Aaron Diamond AIDS Research Center in New York City. HAART put Doctor Ho on the cover of Time magazine and made him “man of the year” in 1996.
These new kinds of medications first started coming out in December 1995, so during the previous months, drugs like Crixivan were still under last, or phase three, of testing and on the verge of getting FDA approved. Because there were not enough medications for everybody needing them, some drug companies offered to give them to patients on a compassionate use basis only, otherwise known as expanded access programs.
EAP was (still is) a program through which pharmaceutical companies distributed upcoming medications that were already in the pipeline but yet to be FDA approved to people who needed them most. This process had been very rare and extremely difficult before the AIDS years. Usually, a doctor had to call the manufacturer and then the FDA, fill out hours-worth of paperwork and wait for months to get a drug sample, enough only for one patient. And then start all over again, for the next patient. And so on.
Fortunately AIDS has changed all that. The epidemic has forced people living with the disease and AIDS organizations to learn fast the drug industry regulations, to meet with people from the industry and with government officials and to draw proposals. But nothing really happened until people living with AIDS went out in the streets and demonstrated, literally, for their lives. A familiar example is the 1988 ACT-UP demonstration on Wall Street, New York City. [ACT-UP, or AIDS Coalition to Unleash Power was founded in 1987 (www.actupny.org).]
Only then, the FDA started allowing drug companies to open trial programs as soon as they had available at least some safety information on the drug. That’s how the “drug lotteries” started in 1989. There were several such lotteries and participants had to meet several criteria.
For example, in 1995 Glaxo provided a (then) upcoming medication called 3TC to over thirty-two thousand people in the United States. It was the largest expanded access program ever.
Merck announced its Crixivan lottery in July 1995. The company was giving away drugs to eleven hundred people in the U.S. and an additional seven hundred fifty patients from twenty-nine countries in Europe, South America, Canada, and Australia. Merck was to pay for the drug, including shipping, and also for post-selection central laboratory tests and the urine pregnancy tests when and if needed. To be able to participate in Merck-organized P.I. lottery, AIDS patients had to meet several criteria, including to be clinically stable, to be able to follow directions and have certain T cell counts and viral loads. [...]
The lottery took place in August 1995. In Chicago, Kurt’s doctor put his patient’s name in the program. By December, Kurt’s new doctors in California received a phone call from his former physician: Kurt had won the lottery. He was one of the eleven hundred AIDS patients approved to receive the new drug. Winning the drug lottery literally saved his life. To this day, the photographer seriously doubts his ability of staying alive if it wasn’t for the new medication.