AZT, Nevirapine - Children In New York Orphanage Given Toxic Drugs
CategoriesA Catholic orphanage in New York - Incarnation’s Children Center - has allowed its charges, mostly orphans and children removed from their mothers' care, to be used in cruel experiments with drugs that are known to kill most of the patients taking them. This tragedy has taken place under our very noses - we weren't looking.
Journalist Liam Scheff has written about this scandal before and you can see that previous article here. Now, Crux Magazine has taken up the story with another instalment from Scheff. The matter is all the more serious, when we find out that toxic drugs have not always been the treatment of choice. The Children's center, in their own published history, relates that early on in the epidemic, when AZT and other toxic drugs were not yet available, children did well and actually got better with good nutrition and care:
"Early in the epidemic, HIV disease of childhood was considered to be a down-hill course leading to death. But in the late 1980's, before AZT was available, many very ill children admitted to ICC got dramatically better with proper nurturing and high-quality medical and nursing care."
So let us not forget, immunity is a function of a healthy body, and sufficient nutrients are essential to maintain that function. Something our pharma-oriented medical machine seems to have completely forgotten. Wonder Why...
In contrast to a healthy body and good nutrition, read about the history of AZT in this article by Beldeu Singh.
HIV Negative - "Noble Doctors Try New Drugs on AIDS Orphans"
by Liam Scheff
Crux Magazine. November, 2004.
In June, 2003, I got a call to investigate a place called Incarnation’s Children Center (ICC), a Catholic orphanage for HIV-positive children in New York City. I was told that terrible things were happening there.ICC is a home for children who test HIV-positive. Some of the children are orphans; their parents use drugs and can’t care for them. Some of the children have parents and families, but the parents have trouble enforcing the heavy AIDS drug regimen. When that happens, the city agencies bring the children into ICC, where their drug regimens are carried out without fail.
Their press page describes ICC as an "Ellis Island . . . envisioned as a sanctuary of love, a home-like nurturing residence where HIV-positive children would receive the best possible nursing and medical care while awaiting placement into foster homes."
That didn’t sound so terrible.
ICC was also receiving federal funds for running drug trials with the children. "In 1992, an outpatient clinic for HIV-positive children was established; the same year, with funding from the National Institute of Allergy and Infectious Diseases [a subdivision of the NIH], the clinic became a sub unit of the Columbia University Pediatric AIDS Clinical Trials Unit." In 1996, "under the direction of Dr. Stephen Nicholas, thirty-four children [were] participating in seven clinical trials . . . ."
Dr. Nicholas was listed among "The Best Doctors in New York in New York Magazine and in the 1996-97 edition of The Best Doctors in America." ICC received government trial-funding through 2002. Dr. Nicholas has since moved to Harlem Hospital. ICC’s new medical director is Katherine Painter. She told me that children at ICC are now enrolled in clinical trials at one of a dozen area hospitals that work in conjunction with ICC. "Children participating in a drug trial undergo monitoring, testing, and supply of an experimental drug through their outpatient clinic, and we maintain that treatment here," she said.
If I wrote for the New York Times, I would have had my story: "Noble Doctors Try New Drugs on AIDS Orphans."
On the surface, it sounds innocuous and slightly tragic, but also heroic and perhaps hopeful. New drugs—that can’t be a bad thing, can it? AIDS orphans. Well, if anyone deserves a new drug, it’s AIDS orphans, right?
But I had doubts and lingering questions. What exactly are the "new drugs?" Do they have any effects that are deleterious? The ICC webpage listed them. It turned out that the drugs weren’t really new at all—they were old—nearly 40 years old. The primary drug used in trials at Incarnation Children’s Center is called AZT. It was developed in 1964. So, not a new drug. Does that matter? No, if the drug helps the kids. But there was a problem.
AZT isn’t a very helpful drug—unless, I suppose, you enjoy funerals. AZT has a very special use. It’s a chemotherapy drug used to kill the cells that make up living tissue and blood. It was designed in a cancer research lab in 1964 as a potent cell-killing agent called a nucleoside analogue. It works by disrupting cellular replication at the genetic level.
Our DNA is made up of four bases that combine in pairs. These line up, spiraling into a double helix. DNA codes for all our proteins; it’s a blueprint for our building blocks. AZT stops the spiral; it breaks the chain and kills the cell. Not so innocuous, after all.
AZT never got out of the lab. It was far too effective at killing cells even for short-term use. It was shelved, and no patent was filed.
In 1986, Burroughs Wellcome (now GlaxoSmithKline) was interested in entering the AIDS drug market. Recycling an old drug was cheaper than designing a new one. So AZT was brought out of storage. Test labs that ordered the drug for experimentation received it in a package bearing a skull and crossbones on a bright orange background. The label read "TOXIC. Toxic by inhalation in contact with skin and if swallowed. Target organ(s): Blood bone marrow. If you feel unwell, seek medical advice (show the label where possible). Wear suitable protective clothing."
Today, Glaxo sells AZT under the brand name "Retrovir" and as an ingredient in "Combivir" and "Trizivir." But the warning label tells the same story: "Retrovir [AZT] has been associated with Hematologic Toxicity [blood toxicity], including Neutropenia [loss of neurophils, an essential component of blood] and Severe Anemia [potentially fatal lack of blood production] . . . . Prolonged use of Retrovir has been associated with Symptomatic Myopathy [muscle wasting]."
"LacticAcidosis and Severe Hepatomegaly [liver swelling] with Steatosis [fat degeneration], including Fatal Cases, have been reported with the use of Nucleoside Analogues [AZT, 3TC, ddl, D4T] alone or in combination, including Retrovir and other Antiretrovirals (see warnings)."
The most surprising thing about AZT is that it doesn’t even claim to work: "Retrovir is not a cure for HIV infection . . . The long-term effects of Retrovir are unknown at this time . . . The long-term consequences of in utero and infant exposure to Retrovir are unknown, including the possible risk of cancer."
This wasn’t so wonderful for the kids at ICC. But it was good for Glaxo. They make a lot of money with their AIDS drugs. Drugs containing AZT as an ingredient account for about one billion British pounds (over 1. 5 billion dollars) in Glaxo’s 2002 sales alone. Other nucleoside analogues provide another 470 million pounds (750 million dollars) in sales.
We know that something doesn’t have to be good for you to be profitable. Think of cigarettes or alcohol or fast-food. But it’s medication we’re talking about, not French fries. You’d think that a drug with such terrible toxicities would simply never get approved for use by the US Food and Drug Administration (FDA).
Unless, of course, the FDA approval process was easily corrupted. For example, a bad drug might get approval if a trial were heavily influenced, and even overseen, by the very pharmaceutical companies that produced the drug. That would mean that pharmaceutical reps, with a vested interest in getting the drug to market, would oversee and direct the recording process during the drug trial—or perhaps that CEOs of drug companies would go work at the FDA for a stint, approving drugs, then turn around and get back into the company.
Or perhaps doctors would be given favors—I don’t know, expensive trips, monetary rewards, that sort of thing—to be loyal to a particular product, or to review it favorably. Or that doctors fell victim to peer pressure from inside their academic community to support an ongoing paradigm, and not to rat out a bad public health policy.
But even suggesting that sort of thing is ridiculous, isn’t it? I mean, there’s no corruption in pharmaceutical-driven medicine. Is there?
Here’s a hint.
In 2000, Dr. Marcia Angell, editor of the New England Journal of Medicine (NEJM), resigned from the journal. In her parting May 2000 editorial, "Is Academic Medicine for Sale?" Angell wrote, "[Y]oung physicians learn that for every problem, there is a pill (and a drug company representative to explain it). [Physicians] become accustomed to receiving gifts and favors from an industry that uses these courtesies to influence their continuing education . . ." She added, "[T]he costs of the industry-sponsored trips, meals, gifts, conferences, and symposiums and the honorariums, consulting fees, and research grants are simply added to the prices of drugs and devices."
Angell asked, "What is the justification for this large-scale breaching of the boundaries between academic medicine and for-profit industry?"
ABC News reported that in 2000 pharmaceutical companies sponsored over 314,000 promotional events for doctors—from lunches to travel weekends—at a cost of nearly 2 billion dollars.
In 2002, the new editor of the NEJM, Dr. Jeffrey Drazen, officially dropped the journal’s 190-year restriction against medical authors accepting money from drug companies. The journal’s editors claimed that there simply weren’t enough doctors who didn’t have ties to drug company money. The new policy allows rev
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