Foster child drug trials

 Foster child drug trials(medical research)  

Date	1992 - 2004
Location	New York City,  USA
Perpetrators	NIAID, Big Pharma, Boehringer Ingelheim, GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, Merck, Genentech, Biocine, MicroGeneSys
Interests	AZT
Description	National Institutes of Health and Big Pharma force fed experimental pharmaceuticals to infants, toddlers, children and teenagers in New York and elsewhere in the United States.

The Foster child drug trials fed infants, toddlers, children and teenagers experimental pharmaceuticals, in at least seven U.S. states. The National Institutes of Health clinical trial scandal originally broke in January of 2004. Government funded researchers were using New York city orphans in trials for combinations of highly toxic drugs. This research was reported in the BBC documentary Guinea Pig Kids, which aired on November 30, 2004.

Guinea Pig Kids

Incarnation Children's Center

In June, 2003, investigative journalist Liam Scheff got a call to investigate Incarnation Children's Center (ICC), a Catholic orphanage for HIV-positive children in New York City. He was told that "terrible things were happening there." Some of the children were orphans. Others had parents who were drug users unable to care for them. Still others had parents and families whose parents declined to enforce a heavy AIDS drug regimen. That is when city agencies bought the children to ICC, where their drug regimens are carried out without fail.

In 1992, ICC established an outpatient clinic for HIV-positive children, funded by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the NIH. That year, the clinic became also became a a sub unit of the Columbia University Pediatric AIDS Clinical Trials Unit. By 1996, under the direction of Dr. Stephen Nicholas, thirty-four children were participating in seven clinical trials. Dr. Nicholas was listed as one of the "Best Doctors in New York" in New York Magazine's 1996-97 edition of The Best Doctors in America. ICC received government trial funding through 2002. After Dr. Nicholas moved to Harlem Hospital, Dr. Katherine Painter became Medical Director. According to Dr. Painter:

"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."

Primary drugs used (antivirals)

Drugs used to treat HIV and AIDS are various classes of toxic chemotherapies known as "antivirals" or "antiretrovirals".

ICC is a foster home administered by the Catholic Home Bureau under the Archdiocese of New York. According to its website, ICC was established in 1987 to deal with the boarder baby crisis (children abandoned at the hospital.) In 1992, ICC established an outpatient clinic for HIV-positive children, with funding from the NIAID as well as a subunit of the Columbia's Pediatric AIDS Clinical Trials Unit. ICC went from being a home for poor children of drug-addicted mothers to a recipient of funds allowing the NIH to use foster children in drug tests. The ICC web page listed dozens of trials with AZT and Nevirapine conducted through the late 90s. The NIH site recently listed "five studies currently recruiting for drug trials", and "27 studies ongoing or recently completed"; all on ICC children. It also listed over 200 at Columbia Presbyterian, ICC's parent hospital. The studies are sponsored by NIH subdivisions and many are cosponsored by the companies which manufacture the drugs. The studies used the standard AIDS drugs: nucleoside analogues, protease inhibitors and Nevirapine.

AZT (Retrovir)

The primary drug used in trials at ICC was AZT, developed in 1964 in a cancer research lab. AZT is a chemotherapy drug used to kill the cells that make up living tissue and blood. It works by disrupting cellular replication at the genetic level. DNA is comprised of four bases that combining in pairs. The pairs line up and spiral into a double helix. AZT stops the spiral, breaks the chain and kills the cell. Considered too dangerous even for short term use, AZT was shelved and a patent was never filed. However, over 20 years later in 1986, Burroughs Wellcome (now GlaxoSmithKline) recycled AZT into an AIDS drug. Testing labs received the drug in a package bearing a skull and crossbones on a bright orange background with a "TOXIC" label and warnings against swallowing, inhaling and skin contact. Today, GSK sells AZT under the brand name "Retrovir" and as an ingredient in "Combivir" and "Trizivir." According to the warning label:

"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), Lactic Acidosis and Severe Hepatomegaly (liver swelling) with Steatosis (fat degeneration). Fatal Cases have been reported with the use of Nucleoside Analogues (AZT, 3TC, ddl, D4T) alone or in combination, including Retrovir and other Antiretrovirals."

Worse yet, AZT 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."

Drugs containing AZT as an ingredient accounted for about one billion British pounds (over 1. 5 billion dollars) in GSK's 2002 sales alone. Other nucleoside analogues provided another 470 million pounds (750 million dollars) in sales. In 1986, AZT was rushed through its Food and Drug Administration (FDA) approval trials in record speed. Overseen and funded by Burroughs Wellcome (now GSK), the trials were marred by false reporting and a total breakdown of study controls. Nevertheless, the drug was released to the market. Subsequent independent AZT studies revealed the obvious deadly nature of the drug. In English, Australian, and Dutch studies, AZT patients developed severe anemia, requiring multiple blood transfusions just to stay alive. In the Dutch study, three-quarters of the AZT patients died.

AZT has been given to hundreds of thousands of gay men in the US who tested HIV-positive, whether they were sick or not. U.S. deaths attributed to AIDS increased by thousands annually after the mass introduction of AZT in 1987, from 11,000 in 1986 to nearly 50,000 in 1994, the height of AZT use. Sharp criticism of AZT began appearing in the press. Patients and physicians complained openly and cut doses or discontinued it. Subsequently, the death rate declined (prior to the introduction of protease inhibitors, which the industry likes to credit.),

Nevirapine (Viramune)

The other drug used at ICC was Nevirapine, marketed under the brand name "Viramune" by German based drug giant Boehringer Ingelheim. Nevirapine functions similarly to AZT in that it interferes with the essential movement of genetic information in the cell. It blocks an enzyme which translates RNA into DNA. One alarming side effect of this drug is called Steven-Johnson Syndrome, which causes the skin to literally come off of the body. In pathetic images of the unfortunate sufferers, hands, abdomens, faces, and mouths are bursting with blood and flesh comes off like old paint steamed off a wall. According to its label:

"Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with Viramune (Nevirapine). These have included cases of Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions characterized by rash, constitutional findings, and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue Viramune as soon as possible."

"Severe, life-threatening and in some cases fatal hepatoxicity (liver damage), including hepatic necrosis (liver death) and hepatic failure, has been reported in patients treated with Viramune."

Nucleoside analogues & protease inhibitors

Nucleoside analogues, like AZT, work by stopping cell division. They stop the formation of new blood in the bone marrow; in some cases causing anemia and bone marrow death. They've caused death in pregnant mothers, spontaneous abortion, birth defects, liver failure, pancreatic failure, muscle wasting, developmental damage and death in children and adults. They also may cause cancer. Protease inhibitors interfere with the body's ability to build new proteins. Since we're made of protein, they have pronounced effects on physical appearance and organ function. The side effects can be bizarre, grotesque and often fatal: wasting in the face, arms and legs; fatty humps on the back and shoulders; distended belly, heart disease, birth defects, organ failure and death.

Summary of side effects & inefficacy

Almost all of this is found on warning labels. The first AIDS drug, AZT, was designed in the 60s as a chemotherapy drug for cancer patients, but never approved. Critics declared it too toxic even for short-term use. Yet, in 1987 it was pushed through for lifelong use in HIV-positive people. Although the trials were later revealed to be fraudulent, AZT remains on the market. Finally, there's Nevirapine, which also interferes with normal cell function. In test trials, it caused severe liver damage and death in dozens of patients. Most die from organ failure due to drug toxicity. Nevirapine can also cause a violent skin disorder called Steven-Johnsons Syndrome (SJS), a horrifying condition in which the skin blisters and ruptures or peels off in large swaths, leaving bloody, exposed flesh. Nevirapine is the main drug distributed in Africa for pregnant women who test HIV positive. In spite of serious medical issues, AIDS drugs don't even claim to work. Every AIDS drug label bears a version of this caveat:

"This drug will not cure your HIV infection. Patients receiving antiretroviral therapy may continue to experience opportunistic infections and other complications of HIV disease. Patients should be advised that the long-term effects are unknown at this time."

Toxic trials

According to ICC's published history:

"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."

According to ICC's Medical Director, Dr. Painter, children who "can't take" or refuse the drugs have a tube surgically implanted in their abdomens through which the drugs are administered, regardless of the child's wishes.

ICC is run by Columbia University’s Presbyterian Hospital, in affiliation with Catholic Home Charities through the Archdiocese of New York. It is a 4-story brick former convent in the Washington Heights area of New York city. The children have been removed from homes by the Agency for Child Services. They are black, Hispanic and poor and many have mothers with histories of drug abuse who have died. Once taken into custody, they become subjects of NIAID sponsored drug trials sponsored by the NIAID and the National Institute of Child Health and Human Development (NICHD) in conjunction with some of the world’s largest pharmaceutical companies. The drugs given to the children are toxic, known to cause genetic mutation, organ failure, bone marrow death, bodily deformations, brain damage and fatal skin disorders. If the children refuse the drugs, they’re held down and force fed. Should they continue to resist, they’re taken to Columbia University Presbyterian hospital, where a surgeon puts a plastic tube through their abdominal wall into their stomachs. The drugs are injected directly into their intestines. In 2003, two children, ages 6 and 12, had debilitating strokes due to drug toxicities. The 6-year-old went blind and they both died shortly after. Another 14 year old died later and an 8-year-old boy had two plastic surgeries to remove large, fatty, drug-induced lumps from his neck.

Children at ICC tested HIV positive or were born to were born to mothers who tested HIV positive. However, neither parents nor children were informed of the critical fact that HIV tests are extremely inaccurate., The HIV test cross reacts with nearly seventy common conditions, giving false positive results. They include common colds, herpes, hepatitis, tuberculosis, drug abuse, inoculations and most troublingly, current and prior pregnancy., ,

Factors that cause false positives in pregnant mothers can be passed to their children, who may also be given a false diagnosis. Most people have never heard of this undoubtedly best kept secret in medicine, though it is well known to HIV researchers. Researchers don’t tell the doctors. They certainly don’t tell unwilling child subjects for the next generation of profitable drugs.

Case studies

When Christine Maggiore tested HIV-positive in 1992, her doctor told her to "get ready to die." She was told that AIDS drugs would make her sick, so she skipped them and used natural methods to support her health. A year and a half later, she was so healthy that her doctor told her she should retest. The tests came back negative, indeterminate and positive. After investigating medical literature, Ms. Maggiore discovered that HIV testing was highly inaccurate. She also found "gaping flaws in the HIV hypothesis itself." She later founded Alive & Well AIDS Alternatives and had two children who were never tested for HIV. They were raised on organic food and naturopathy and were healthy, intelligent, active and drug free. They regularly saw a pediatrician. They were two of the thousands of healthy HIV-positive people on natural immune system support regimens.

Mona is a great aunt and guardian raising two children, Sean and Dana, who tested HIV-positive. As her niece was unable to care for them, the children were remanded to state foster care before she took them back to raise as her own. However, when the city agencies found out that the children weren't on the drugs, they took them away for mandatory treatment at a clinic and then back to ICC. She had been taking them to a naturopath. It didn't seem to matter that the children were healthy. At ICC, they were locked up and pumped full of drugs day and night. "AZT, Nevirapine, Epivir, Zerit. All kinds of drugs."

Description of drug trials

To read the list of drug studies conducted at ICC and sponsored by government agencies is to take a trip through the nightmare of pediatric drug research:"

"The Effect of Anti-HIV Treatment on Body Characteristics of HIV-Infected Children" is looking for the causes of "Wasting and Lipodystrophy (fat redistribution)" by using drugs known to cause wasting and lipodystrophy.

"The Safety and Effectiveness of Treating Advanced AIDS Patients between the Ages of 4 and 22 with Seven Drugs, Some at Higher than Usual Doses." The seven drugs in the study are all known to cause debilitating, potentially fatal side effects, yet they are administered at "higher than usual doses" in four-year-olds.

"Stavudine Alone or in Combination with Didanosine." (Stavudine plus Didanosine has killed pregnant women.)

A vaccine study to be administered to children "12 months to 8 years" using "live chicken pox virus." (One consequences of a live virus vaccine can be the disease itself.)

"HIV Levels in Cerebrospinal Fluid." (Cerebrospinal fluid can only be gathered from a spinal tap, a dangerous and invasive procedure.)

A study on HIV-negative children born to HIV-infected mothers that uses an experimental HIV vaccine.

HIV tests: highly inaccurate

People take AIDS drugs because they are "HIV-positive". However, HIV tests are highly inaccurate. Most of them are antibody tests, meaning they can cross-react with normal proteins in human blood. There are nearly 70 commonly occurring conditions known to cause these tests to come up as positive. They include include yeast infections, colds, flus, arthritis, hepatitis, herpes, recent inoculations, drug use and pregnancy. The remaining HIV tests, called viral load tests, can produce dozens of conflicting results, even from the same blood sample. In fact, HIV tests are so unreliable that they all bear a disclaimer, such as:

"At present there is no recognized standard for establishing the presence or absence of HIV-1 antibody in human blood."

"The AMPLICOR HIV-1 MONITOR (Viral Load) test is not intended to be used as a screening test for HIV or as a diagnostic test to confirm the presence of HIV infection."

"Do not use this kit as the sole basis of diagnosis of HIV-1 infection"

Positive test results can occur due to "prior pregnancy, blood transfusions...and other potential nonspecific reactions" ,

Inside ICC

Illegal non-drugging

Mona's son Sean was put on AZT in infancy and has lived in a virtual coma his entire life. He was fed by a tube through his nose until he was three. The drug made him ill and lethargic. He could not play without becoming exhausted. Sean became sicker every time Mona gave him the drugs, so she cut down the doses. His energy level began to improve as she continued to wean him off the drugs and started taking him to a naturopath:

"For the first time in his life, he became a normal boy. He could play with the other children, he could walk, he could run. He smiled and laughed. He was normal."

The Administration for Children's Services (ACS) came down hard on Mona for not drugging Sean. She was sent to an "AIDS specialist" at Beth Israel. Sean was put on a "miracle drug," Nevirapine. Within six months, he was on life support due to organ failure. At this point, the ACS decided that Sean should be put into ICC for four months. The child was imprisoned there for a year before Mona hire a lawyer to get him back. According to his medical records, he had been put administered AZT, Nevirapine in the Intensive Care Unit. Then they put Dana on drugs. At 13 years old, Sean was He was 4 feet tall, weighed 50 pounds and walked with a shuffle. He was an "AZT baby". He was stunted with cells damaged from the inside out.

A nurse, Jacqueline Hoerger tried to adopt two little girls from ICC to raise and care for with her husband. She administered the drugs "by the book" for about a year, watching them get steadily sicker. After much research and consultation, she discontinued the drugs. They girls improved remarkably and she documented their improvement with her doctor. When it was revealed to the adoption agency that she wasn't drugging the girls, the New York Administration for Children's Services returned them to foster care.

AZT children

ICC is a four story, brick, converted convent with barred windows. The children ranged in ages from a couple years old to almost adult. Except for a few Hispanic kids, the children are African American, with a number of children in wheel chairs. The wheelchair-bound kids are being fed or drugged, or both, with a milky-white fluid dispensed through tubes coming out of hanging plastic packs. The tubes disappeared beneath their shirts. Inside, children in wheelchairs stared ahead, unable to focus. One wheelchair bound child was about 12. His head was oddly shaped and his eyes were widely space. His limbs and torse were slightly warped, shortened and weak-looking. He was an "AZT baby". Other children had similar faces, arms and legs. Amir, boy of about 6 sat at one of the tables. He had a stomach tube. He had also undergone multiple surgeries to remove "buffalo humps", what AIDS doctors call large, fatty growths from the necks and backs of people who take protease inhibitors. Five months later, he died in a hospital.

Interview with Medical Director

According to Dr. Painter in October of 2003, the "biggest problem facing families with HIV-positive children is adherence." (A code word for people who don't take their medication). It does not mean illness, but obedience to a drug regimen. Even the Center for Disease Control (CDC), agrees that the majority of people with HIV aren't sick. Most AIDS patients are given the diagnosis because of a T-cell count rather than an actual illness. There are dozens of drug studies in which patients have died, specifically because of the drugs. According to the drugs own warning labels, risks include: heart attack, organ failure, wasting, bone loss, anemia, birth defects, skin loss, bloody rashes, deformation and death.

Complaint prompts nationwide investigation

On March 10, 2004, The Alliance for Human Research Protection (AHRP) filed a complaint with the FDA and the federal Office of Human Research Protection. That complaint prompted two separate investigations by the FDA and AHRP. Articles in the New York Post and a BBC documentary raised the alarm among the African-American and Latino community in NY; some of whom had already been protesting weekly in front of ICC. The complaint prompted an Associated Press (AP) investigation into over four dozen studies being conducted in "at least seven states." In Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas, the investigation found that 13,878 children had been enrolled in pediatric AIDS studies funded by the government since the late 1980s. Of these, officials estimated 5 to 10% were foster children from infants to late teens. According to AHRP, "the institutional culture of arrogance is demonstrably in evidence at both medical research centers and government agencies", as evidenced by Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center:

"Our position is that advocates weren't needed."

The children are reported to have suffered painful side effects, such as:

"such as rashes, vomiting and sharp drops in infection-fighting blood cells as they tested antiretroviral drugs to suppress AIDS or other medicines to treat secondary infections."

In one study testing the drug dapsone:

at least 10 children died from a variety of causes, including four from blood poisoning, and researchers said they were unable to determine a safe, useful dosage. They said the deaths didn't appear to be 'directly attributable' to dapsone but nonetheless were 'disturbing'. ...overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained.

Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Out of 52 children, 26 had moderate to severe reactions, nearly all infants. Side effects included rash, fever and a major drop in infection fighting white blood cell counts.

At least three states declined to use children in foster care in medical experiments: Tennessee, California and Wisconsin.

See also testimony of Vera Hassner Sharav, President of AHRP, at a hearing of the New York State Assembly Committee on Health and the Committee on Children and Families on September 8, 2005.

1983 federal protection for child wards

Since 1983, the government has required "special protections" for child wards. Oversight boards are required to appoint independent advocates for any foster child enrolled in a narrow class of studies that involve "greater than minimal risk and lacked the promise of direct benefit." Some foster agencies require the protection regardless of risks and benefits. Advocates must be independent of foster care and research agencies, have some understanding of medical issues and "act in the best interests of the child" for the duration of the research. However, foster children in the AIDS drug trials often weren't given advocates, after research institutions promised to do so in order to gain access to them. Illinois officials believe none of their nearly 200 foster children in AIDS studies had independent monitors. New York City records revealed that less than a third of the children involved in clinical trials (142 out of 465) had monitors required by city policy. Other facilities, including Chicago's Children's Memorial Hospital and Johns Hopkins University in Baltimore, concluded that foster children were not provided with advocates.

Links to NIH/ICC investigation & participating drug companies

See also NIH/ICC investigation for links to media coverage, follow up coverage, documentation and images related to the NIH clinical trial scandal.

Eight clinical trials were conducted at ICC between 1997 and 2004, all funded by NIAID and NICHD and co-sponsored by the following drug companies: GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, Merck, Genentech, Biocine and MicroGeneSys.

Interviews

NPR interview (audio & transcripts)

National Public Radio (NPR)'s Ed Gordon interviewed Dr. Jonathan Fishbein of the NIH and Baylor College of Medicine's Dr. Mark Kline on May 27, 2005.

Amy Goodman of Democracy Now! interviewed Guinea Pig Kids filmmaker Jamie Doran and Vera Sharav of the Alliance for Human Research Protection on December 22, 2004.

After the NIH/ICC scandal broke, German journalist Torsten Engelbrecht requested an interview with Columbia Presbyterian. He was answered by a public relations firm. In notated transcripts, their answers were compared with NIH documents, records from clinical trials, interview material, Medline articles and Department of Health statistics and published in July 2004.

Series of five excerpts of Liam Scheff's an October, 2003 interview with ICC’s medical director Dr. Katherine Painter.

External articles

• Michael Kane, Jamey Hecht, Michael C. Ruppert Another Attack on Authentic Investigative Journalism: An Open Letter to the New York Times in Defense of Liam Scheff, From the Wilderness, 2006
• Liam Scheff Inside Incarnation, New York Press, July/August 2005
• Jamie Doran New York's HIV experiment: HIV positive children and their loved ones have few rights if they choose to battle with social work authorities in New York City., November 30, 2004
• Jason Nisse GSK linked to trials forcing Aids drugs on deprived US children, The Independent, November 28, 2004
• Vera Hassner Sharav NIH Conflict of Interest Rules "Option of Corruption": children victimized, Alliance for Human Research Protection, May 2004
• Wendy McElroy Drug Tests on Foster Kids Spark Scandal in NYC, Fox News, March 10, 2004
• Liam Scheff The Nurse's Story, Altheal.org, January 2004
• Incarnation Children's Center, AIDS Wiki, accessed March 2010 (site contains other articles on foster child drug trials).
• Campaign Against Fraudulent Medical Research, accessed April 2010

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References

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