TOXIC
Meanwhile, we have gone about trying to "cure" AIDS based on Robert Gallo's 1984 press-conference announcement that it is caused by the virus called HIV.
Drug companies around the world spend millions of dollars each year developing new drugs. Sometimes these new drugs are purely speculative -- their chemical compound works, but they have no specific disease that they cure. These "discoveries" are then relegated to the back shelf of a closet somewhere, waiting for the right disease to show up for which they are the miracle cure. The whole process is a big waste of time and money for the drug company unless a new disease appears somewhere in the world and this new drug can be proven to be effective against it.
In 1964, in an attempt to find a cure for cancer, an English drug company called Burroughs Wellcome invented a chemical compound called azidothymidine, commonly known as AZT. Cancer, remember, is the abnormal and uncontrolled multiplication of cells, which often group together in tumors. The theory was that if we could find a drug that would stop cells from multiplying, we could stop cancer.
Ironically, the easiest way to stop cells from multiplying is to stop them from dividing -- from creating new cells. Burroughs Wellcome discovered a way to interfere with the normal DNA reproduction of a cell, called a DNA-inhibitor -- AZT. Unfortunately, there is no way for a DNA-inhibitor to tell the difference between a useful, healthy cell and a diseased cell. It simply interferes with them all. A cell will die trying to reproduce itself (as virtually all cells want to do), stopped by the DNA-inhibitor.
(This is how most chemotherapy works for cancer patients today. The drugs stop cells from dividing, and the cells die. All the cells. The death of those cells that normally divide most frequently -- like hair cells -- is noticed first; therefore, hair loss. What isn't so noticeable are the normal, healthy cells that are killed in the process, including the T-cells of the immune system. Most cancer patients die of the opportunistic diseases that result from immune suppression rather than from the cancer tumors themselves.)
However, Burroughs Wellcome didn't even try to get AZT approved for manufacture or use. Standard testing of the drug found that it was so powerful in destroying cells -- so toxic -- that it would kill the patient faster than the disease would. When Jerome Horwitz, head of a lab at the Detroit Cancer Foundation in 1964, tested AZT on cancer-ridden mice, it failed to cure the cancer. The mice died all right, but from the extreme toxicity of the drug itself and not from the cancer. AZT was quickly put on the shelf.
Twenty years later, along comes Robert Gallo, announcing to the world that his Human T-cell Leukemia Virus Type III causes AIDS (even though in AIDS, the T-cells are diminished rather than multiplying uncontrollably). Well, if a virus that causes cancer is causing AIDS, then a drug that cures cancer should cure AIDS. Burroughs Wellcome pulled AZT off the shelf in 1985 and submitted it to the Food and Drug Administration of the United States (the FDA) for approval, claiming it would specifically kill only HIV-infected T-cells.
Normally, for a drug to be approved by the FDA, it takes about a year of research and testing -- including carefully monitored double-blind studies -- and then another year of FDA red tape. And while waiting for an FDA approval, the pharmaceutical company usually cannot manufacture or sell the drug. But AZT was a very special drug for a very special disease, backed by very special people. So it got very special attention. (It also helped to have Burroughs Wellcome paying $10,000 per study patient to each clinic involved.)
The short story is that the double-blind studies broke down within weeks. "A move to stop the trial began immediately. The toxicity of AZT was proving to be extremely high," says Bruce Nussbaum in his 1990 book, Good Intentions. "The FDA inspector found multiple deviations from standard protocol procedure," an official later commented. Another FDA official admitted, "Whatever the 'real' data may be, clearly patients in this study...reported many disease symptoms from possible adverse drug experiences." Martin Delaney, founder of Project Inform, added, "The multi-center trials of AZT are perhaps the sloppiest and most poorly conducted trials ever to serve as the basis for an FDA drug licensing approval."
No matter. Burroughs Wellcome responded by requesting special permission to go ahead and sell AZT while the FDA decided whether or not to approve it. Five days later, thanks to some highly-placed political pressure, that permission was granted. The FDA also dropped the normal requirements that AZT be tested on mice. Six months later, AZT had full approval by the FDA. It could now be sold as a treatment for AIDS.
(Later, AZT was also tested as a cure for psoriasis. As one English reporter put it, "Burroughs Wellcome must be commended for creative marketing, producing [AZT] that can kill any rapidly replicating cells in one lot of patients [psoriasis sufferers] and selectively kill only HIV-infected cells in another lot of patients [AIDS]."
Want to know how all this could happen? Listen to Jerry McGuire: SHOW ME THE MONEY!
Of course, Burroughs Wellcome (and other manufacturers, like Sigma) still have to put the correct warnings on the drug labels. Here's what it says for AZT....
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TOXIC Toxic by inhalation, in contact with skin,
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Yes, be careful. Be sure to wear suitable protective clothing while swallowing AZT that is toxic when swallowed.
The skull and crossbones signify an unusual chemical hazard. This label must appear on bottles containing 25 milligrams of AZT -- a small fraction of a patient's recommended daily dose.
What does AZT do that makes it so dangerous? AZT kills dividing cells anywhere in the body, but especially (as the warning label says) in the bone marrow where new red blood cells and white blood cells are made. (Remember that T-cells are white blood cells that form the backbone of the body's immune system.) And it does the best job at killing these cells than any other drug discovered to date.
Apparently at Burroughs Wellcome, the thinking was that AZT would kill HIV-infected T-cells and thus be a cure for AIDS. It does do that. It kills T-cells extremely well, but all T-cells, whether or not they are HIV-infected -- healthy cells as well as sick cells. Repeat: AZT is dramatically effective in killing virus-infected and uninfected T-cells alike. And since only 1 in about 1000 T-cells of an HIV Positive person is ever "infected", AZT must kill 999 good T-cells in the process.
Let's think about this for a moment. We've got a patient with AIDS -- a patient with a T-cell deficiency, suffering from an opportunistic disease. The immune system is already shot. So we're going to cure them by giving them a drug (AZT) that kills all their remaining T-cells faster than anything else in the world. Are we nuts?
Giving AZT to an AIDS patient is the kiss of death. If they don't die from the opportunistic disease they started with, they'll surely die from the other diseases that appear as their immune system is destroyed even further by the drug.
Continue with "The Tragedy"