This story below (Fauci Tortured ORPHAN BABIES And CHILDREN In His AIDS Drug Experiments) is the latest in a series of stories on Dr. Fauci, implicating him in medical crimes — including his role in AZT deaths, his role in NIH-funded torture of dogs, and his role in lockdown deaths, and medical tyranny over the last two years.
As relates to children, Fauci pushed for mRNA drugs — which then were tested on children and approved for use on them, even though the risk of it killing them is greater than the risks from Covid-19 (to which they’re essentially immune).
The fact that AZT was tested on 85 black orphaned children reminds me of the infamous Tuskegee experiment performed on black people. The same thing is still going on in third-world countries, including Gates testing vaccines in India, and Pfizer testing on people in Nigeria.
It’s been termed “the global commerce in human experimentation.” The FDA is implicated as well:
“Over the past decade, the drug industry has quietly exported its clinical testing overseas, where oversight is slim and patients plentiful . . . An abundance of poor, undertreated and doctor-trusting patients in Eastern Europe, Latin America and Southeast Asia renders the quick, positive results corporate sponsors need to get new drugs approved fast.” Source. [full article below]
No wonder the FDA approved opioids, which kill about 50,000 Americans annually, and then approved mRNA shots for children, despite evidence from their own studies showing the danger of these drugs on them. In other words, the FDA is corrupt and those running have chosen to ignore the Hippocratic oath. This is why some officials in it have resigned in protest.
The fact that Fauci’s experiments were done to children entrusted to the state reminds me of the equally infamous Rotherham child sex exploitation operation, in which thousands of children under state protection were raped and turned into prostitutes. This was covered up by the police for years, just as the full impact of Fauci’s crimes is still being covered by the mainstream media today.
Despite all this, Fauci was the person advising President Trump (Trump was foolish not to fire him immediately and was foolish to take his advice), and now advising President Biden. As Senator Rand Paul has tried to remind us, Fauci funded the research to produce Covid-19 in the Wuhan lab and then lied to the public about it.
Fauci’s lies are numerous; some are noted in this short article titled “Fauci is a monster.” Fauci and his co-conspirators — including Bill Gates, those running the CCP, Big Pharma execs, and officials at the WHO, and owners of the MSM — are responsible and should be charged for perpetrating the following crimes:
(i) all the people who died from Covid-19, which he helped develop and which he predicted would befall the US, in 2017 (~ 5.4 million – though this number is probably inflated): Jan. 11, 2017 – “Fauci: ‘No doubt’ Trump will face surprise infectious disease outbreak“
(ii) all the people who died or were injured by the mRNA ‘vaccine’ (this number is unknown but it’s in the hundreds of thousands and estimated to be about 150,000 in the U.S.)
(iii) all the people who suffered from the lockdowns, including all the lockdown deaths; (again, an unknown number, but potentially in the millions, if one includes the impact of the economic downturn and disrupted supply chains. Lockdown deaths including lack of access to medical care, suicide, and drug overdose]
(iv) for helping to impose medical tyranny on the world, which is a crime against humanity.
In other words, Fauci should be arrested and tried for his crimes, as per the Nuremberg Code, since he is treating the entire world as a giant experiment. He is a megalomaniacal mass murderer who thinks criticism of him is criticism of science.
Instead, he continues to be well paid (the largest pension in federal government history) and lauded by Democrats and the MSM.
But his day of reckoning will come, if not in this life, then the next: God, at the Last Judgement, will say ‘whatever you did for one of the least of these brothers and sisters of mine, you did for me.’ Then he will say to those on his left, ‘Depart from me, you who are cursed, into the eternal fire prepared for the devil and his angels . . . whatever you did not do for one of the least of these [i.e. the children that Fauci experimented on], you did not do for me.’ Then they will go away to eternal punishment, but the righteous to eternal life.” – Matthew 25
That is what I believe anyway – but believing it does not make me neglect my moral duty to also advocate for justice in this life. Quite the opposite: it gives me the courage of conviction to say that our actions have consequences and they matter. We are moral beings who have a duty to help and not harm one another.
For some reason, Dr. Fauci doesn’t understand this and is harming many people, but is doing it in the name of good — and he is being supported by a vast array of journalists and other people in authority.
But that doesn’t make him (or them) right. It only means that a lot of these people are committing evil deeds in the name of a supposed greater good — but in fact are doing so for money and power. But this is no different than most evil done throughout human history, including that done by the church itself.
Source: Fauci Tortured ORPHAN BABIES And CHILDREN In His AIDS Drug Experiments, by Luis T, The World We Live In
“In 2003, 04, 05, I was investigating this story. Children in an NYC orphanage (and the foster care system) used in clinical trials. The Associated Press took it national and found it going on in seven or more states.
“Some states declined to participate in medical experiments. Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge’s order. And Wisconsin “has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system,” spokeswoman Stephanie Marquis said.
Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by NIH since the late 1980s were in foster care. More than two dozen Illinois foster children remain in studies today.” No medical records were ever made available to official investigators. You make up your own mind.” – Liam Scheff
A National Scandal: AIDS Drug Experiments On Foster Care Children – Associated Press
The article has been deleted from the AP website, but the archive survived here.
On March 10, 2004, The Alliance for Human Research Protection filed a complaint with the FDA and the federal Office of Human Research Protection about a series of AIDS drug experiments conducted on New York City children in foster care. That complaint prompted two separate investigations by the FDA and OHRP which are still on-going.
Articles in The New York Post and a documentary by BBC raised the alarm among the African-American and Latino community in NY-some of who have been protesting weekly in front of Incarnation Children’s Center, the site of some of the drug experiments.
The Associated Press AP has just released its investigative report: the problem is a national scandal–the experiments were conducted in “at least seven states — Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas — and involved more than four dozen different studies.
AP’s 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 that 5 percent to 10 percent were in foster care. Their age ranged from infants to late teens.
“More than two dozen Illinois foster children remain in studies today.”
Those who conducted the experiments in violation of federal regulations, are supported by taxpayers – thus they have a public responsibility which they violated. The children who were targeted to serve as human drug testing subjects – mostly poor children of color – were not afforded the protection of a personal advocate – as is mandated by federal regulations. (45 Code of Federal Regulations 46.409)
The institutional culture of arrogance is demonstrably in evidence at both medical research centers and government agencies: “Our position is that advocates weren’t needed,” said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.
And officials of NYC Administration of Child Services “defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities.”
The children are reported to have suffered painful side effects “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,” the researchers concluded.
“Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions — nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells.
At least three states declined to use children in foster care in medical experiments: Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge’s order. And Wisconsin “has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system,” spokeswoman Stephanie Marquis said.
Not addressed in the AP report is the amount of money that these trials generated for the institutions involved in the experiments.
***The NYC Council, general welfare committee is holding a hearing about the unethical experiments conducted in NYC. The hearing will take place at City Hall at 11:15.
by John Solomon, Associated Press, May 4, 2005
WASHINGTON – Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found.
The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren’t yet available in the marketplace.
The practice ensured that foster children — mostly poor or minority — received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also exposed a vulnerable population to the risks of medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown.
The research was conducted in at least seven states — Illinois, Louisiana, Maryland, New York, North Carolina, Colorado and Texas — and involved more than four dozen different studies. The foster children ranged from infants to late teens, according to interviews and government records.
Several studies that enlisted foster children reported patients suffered side effects 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, researchers reported a “disturbing” higher death rate among children who took higher doses of a drug. That study was unable to determine a safe and effective dosage.
The government provided special protections for child wards in 1983. They required researchers and their oversight boards to appoint independent advocates for any foster child enrolled in a narrow class of studies that involved greater than minimal risk and lacked the promise of direct benefit. Some foster agencies required the protection regardless of risks and benefits.
Advocates must be independent of the foster care and research agencies, have some understanding of medical issues and “act in the best interests of the child” for the entirety of the research, the law states.
However, researchers and foster agencies told AP that foster children in AIDS drug trials often weren’t given such advocates even though research institutions many times promised to do so to gain access to the children.
Illinois officials believe none of their nearly 200 foster children in AIDS studies got independent monitors even though researchers signed a document guaranteeing “the appointment of an advocate for each individual ward participating in the respective medical research.”
New York City could find records showing 142 — less than a third — of the 465 foster children in AIDS drug trials got such monitors even though city policy required them. The city has asked an outside firm to investigate.
Likewise, research facilities including Chicago’s Children’s Memorial Hospital and Johns Hopkins University in Baltimore said they concluded they didn’t provide advocates for foster kids.
Some states declined to participate in medical experiments. Tennessee said its foster care rules generally prohibit enlisting children in such trials. California requires a judge’s order. And Wisconsin “has absolutely never allowed, nor would we even consider, any clinical experiments with the children in our foster care system,” spokeswoman Stephanie Marquis said.
Officials estimated that 5 percent to 10 percent of the 13,878 children enrolled in pediatric AIDS studies funded by NIH since the late 1980s were in foster care. More than two dozen Illinois foster children remain in studies today.
Some foster children died during studies, but state or city agencies said they could find no records that any deaths were directly caused by experimental treatments.
Researchers typically secured permission to enroll foster children through city or state agencies. And they frequently exempted themselves from appointing advocates by concluding the research carried minimal risk and the child would directly benefit because the drugs had already been tried in adults.
“Our position is that advocates weren’t needed,” said Marilyn Castaldi, spokeswoman for Columbia Presbyterian Medical Center in New York.
If they decline to appoint advocates under the federal law, researchers and their oversight boards must conclude that the experimental treatment affords the same or better risk-benefit possibilities than alternate treatments already in the marketplace. They also must abide by any additional protections required by state and local authorities.
Many of the studies that enrolled foster children occurred after 1990 when the government approved using the drug AZT — an effective AIDS treatment — for children.
Arthur Caplan, head of medical ethics at the University of Pennsylvania, said advocates should have been appointed for all foster children because researchers felt the pressure of a medical crisis and knew there was great uncertainty as to how children would react to AIDS medications that were often toxic for adults.
“It is exactly that set of circumstances that made it absolutely mandatory to get those kids those advocates,” Caplan said. “It is inexcusable that they wouldn’t have an advocate for each one of those children.
“When you have the most vulnerable subjects imaginable — kids without parents — you really do have to come in with someone independent, who doesn’t have a dog in this fight,” he said.
Those who made the decisions say the research gave foster kids access to drugs they otherwise couldn’t get. And they say they protected the children’s interest by carefully explaining risks and benefits to state guardians, foster parents and the children themselves.
“I understand the ethical dilemma surrounding the introduction of foster children into trials,” said Dr. Mark Kline, a pediatric AIDS expert at Baylor College of Medicine. He enrolled some Texas foster kids in his studies, and doesn’t recall appointing advocates for them.
“To say as a group that foster children should be excluded from clinical trials would have meant excluding these children from the best available therapies at the time,” he said. “From an ethical perspective, I never thought that was a stand I could take.”
Illinois officials directly credit the decision to enroll HIV-positive foster kids with bringing about a decline in deaths — from 40 between 1989 and 1995 to only 19 since.
NIH, the government health research agency that funded the studies, did not track researchers to determine if they appointed advocates. Instead, the decision was left to medical review boards made up of volunteers at each study site.
A recent Institute of Medicine study concluded those Institutional Review Boards (IRBs) were often overwhelmed, dominated by scientists and not focused enough on patient protections. An ethicist who served 22 years on such boards said they lack the resources to ensure the safety of foster children.
“Over the last half century, IRBs have basically broken under the strain of some of the structural changes in research,” said Gregory E. Pence, a University of Alabama-Birmingham bioethicist.
The U.S. Office for Human Research Protections, created to protect research participants after the infamous Tuskegee syphilis studies on black men, is investigating the use of foster children in AIDS research. The office declined to discuss the probe.
NIH said it considers patient safety its top priority and awaits the outcome of the investigation. “If we find that patient protections need further strengthening, we will take action to do so,” spokesman John Burklow said.
AP’s review found that if children were old enough — usually between 5 and 10 — they also were educated about the risks and asked to consent. Sometimes, foster parents or biological parents were consulted; other times not.
“Our policy was to try and contact the (biological) parents because it was fairly common when we got done the foster kid would go back to the parents,” said Dr. Ross McKinney, a pediatrics AIDS expert at Duke University.
Research and foster agencies declined to make foster parents or children in the drug trials available for interviews, or to provide information about individual drug dosages, side effects or deaths, citing medical privacy laws.
Other families who participated in the same drug trials told AP their children mostly benefited but parents needed to carefully monitor potential side effects. Foster children, they said, need the added protection of an independent advocate.
“I don’t believe a foster care parent can do it,” said Vinnie DiPoalo, a New Jersey woman whose 10-year-old adopted son has participated in three AIDS drug trials. “There are informed consents that have to be signed. There are follow-up blood appointments.
“I think that’s the role the advocate should take, because a foster parent may only have this child for three months and then the child moves on and someone needs to be watching all the time,” she said.
Many studies that enlisted foster children involved early Phase I and Phase II research — the riskiest — to determine side effects and safe dosages so children could begin taking adult “cocktails,” the powerful drug combinations that suppress AIDS but can cause bad reactions like rashes and organ damage.
Some of those drugs were approved ultimately for children, such as stavudine and zidovudine. Other medicines were not.
Illinois officials confirmed two or three foster children were approved to participate in a mid-1990s study of dapsone. Researchers hoped the drug would prevent a pneumonia that afflicts AIDS patients.
Researchers reported some children had to be taken off the drug because of “serious toxicity,” others developed rashes, and the rates of death and blood toxicity were significantly higher in children who took the medicine daily, rather than weekly.
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.”
“An unexpected finding in our study was that overall mortality while receiving the study drug was significantly higher in the daily dapsone group. This finding remains unexplained,” the researchers concluded.
Another study involving foster children in the 1990s treated children with different combinations of adult antiretroviral drugs. Among 52 children, there were 26 moderate to severe reactions — nearly all in infants. The side effects included rash, fever and a major drop in infection-fighting white blood cells.
New York City officials defend the decision to enlist foster children en masse, saying there was a crisis in the early 1990s and research provided the best treatment possibilities. Nonetheless, they are changing their policy so they no longer give blanket permission to enroll children in preapproved studies.
“We learned some things from our experience,” said Elizabeth Roberts, assistant commissioner for child and family health at the Administration for Children’s Services. “It is a more individualized review we will be conducting.”
Researchers likewise defend their work, saying they often sat with foster families to explain the risks and benefits, and provided them literature and 24-hour phone numbers.
“We talk about it. Then they come the next time. There is no rush,” explained Dr. Ram Yogev, the chief pediatric AIDS researcher in Chicago whose patients include a large number of foster children.
Kline, the Texas researcher, added: “I never wanted a parent or guardian to ever say ‘yes’ simply because they thought that it was what I wanted them to do. I wanted it to be the right choice for them. I think there is not any single right answer for any family.”
Researcher Rachel Landau in Washington and reporter Carla K. Johnson in Chicago contributed to this story. On the Net:
Documents associated with this story are available here.
Liam Scheff’S BOMBSHELL Interview:
Includes nurses who participated in the experiments!
An excerpt below from Kennedy’s explosive book describing Fauci’s medical experiments on children:
Robert Kennedy sat for an interview this past month to journalist James Corbett where he laid out some key arguments from the book and specifically explained the facts on Fauci’s illegal testing on orphan children:
- Fauci tested harsh chemotherapy drugs on orphan children in order to determine its use for AIDS treatments in the 1980s
- Fauci got control of foster homes in 7 states
- Children were tortured to death
- Children were denied guardians and any kind of legal protector
- Children who refused to take Fauci’s drugs had feeding tubes installed so drug companies could administer the drugs even when the kids fought back
- Most of the children did not have HIV/AIDS, they were just used as guinea pigs to see if they could survive the harsh drug regimen
- At least 85 kids died as part of these experiments
The graveyard where these children were thrown into a pit, filled with hundreds of coffins sometimes stuffed with multiple children, is buried under an astroturf pit in New York. These are the victims of Fauci’s crimes, says Kennedy.
The Gateway Pundit was able to locate this memorial to the orphan children killed by Dr. Fauci and the NIH in New York State.
The orphans are not forgotten. There are toys and flowers left at the memorial.
The names of the orphans are listed on the memorial wall.
And an angel holds a stuffed Teddy Bear.
These photos were taken from Google.
RFK Jr.: Reporter Found Monument To Dead Orphans Tortured And Killed By Monster Fauci (VIDEO)
Robert F. Kennedy, Jr. joined The High Wire recently to discuss his best-selling book on monster Dr. Tony Fauci.
During the discussion, RFK Jr. revealed that reporter Cecelia Farber went to the cemetery in New York state where the tortured orphan children were buried. These victims were Fauci’s experimental patients.
The Gateway Pundit reported earlier on this monument and cemetery in New York State.
Fauci has a long history of mass death, barbarism and lies.
In 2004 Dr. Fauci’s NIH was also caught funding experiments on AIDS orphans at a New York City hospital. The Gateway Pundit reported on this dark Fauci chapter in October.
The Fauci NIH approved experiments on hundreds of New York City orphans. Government agencies and pharmaceutical companies used the orphans in deadly AIDS drug trials.
In 2005, the city of New York hired the VERA Institute to form a final report on the drug trials. VERA was given no access to medical records for any of the children used in trials. Their report was published in 2008.
They reported that twenty-five children died during the drug studies, that an additional fifty-five children died following the studies (in foster care), and, according to Tim Ross, Director of the Child Welfare program at VERA (as of 2009), 29% of the remaining 417 children who were used in drug studies had died (out of a total 532 children that are admitted to have been used). [LINK]
The WIKIPEDIA writers cover up all details, as is expected.
No payment or compensation has been paid to any of the children used in the trials, or to their families.
A hospital nurse later spoke out to reporters about the testing. She reported that children would immediately get sick, break out or throw up during the testing.
They were orphans at the Incarnation Children’s Center in New York City.
On Tuesday The Gateway Pundit reported on Dr. Fauci’s torture and medical murder of at least 85 orphan minority children in New York, children who were vulnerable, could not consent, and who would not be missed.
Ann Rosen at LifeSiteNews wrote a good recap of Fauci’s crimes against children earlier this month.
These children were buried in mass graves at the Gate of Heaven Cemetery in Hawthorne, NY in Westchester County and otherwise forgotten.
Robert F. Kennedy Jr. says that Anthony Fauci is America’s Joseph Mengele for what he did to poor orphan minority kids in the 1980’s.
These extreme claims are the subject of a new book by Robert F. Kennedy, Jr., called “The Real Anthony Fauci.” In Chapter 7, the Kennedy heir lays out “NIAID’s Barbaric and Illegal Experiments on Children”
Kennedy refers to Fauci as ‘America’s homegrown Mengele.’
Globalizing Clinical Research: Big Pharma tries out First World drugs on unsuspecting Third World patients
by Sonia Shah, The Nation, June 13, 2002
By the end of July, a US district court will decide whether drug giant Pfizer should stand trial in the United States for presiding over a coercive, botched 1996 experiment on Nigerian children with meningitis.
In a class-action suit filed last August, thirty Nigerian families say the company violated the Nuremberg Code by forcing an unapproved, risky experiment on unwitting subjects who suffered brain damage, loss of hearing, paralysis, and death as a result. Research support was provided by the Investigative Fund of the Nation Institute
If allowed, the case will open a rare window on a business generally shrouded in FDA and Big Pharma secrecy: the global commerce in human experimentation. Over the past decade, the drug industry has quietly exported its clinical testing overseas, where oversight is slim and patients plentiful.
According to a largely unnoticed Health and Human Services (HHS) report, the number of foreign investigators seeking FDA approvals increased sixteenfold between 1990 and 1999. The actual numbers are probably much higher–companies aren’t required to alert the FDA before taking their research overseas, nor does the FDA track research by location after approving new drugs.
Globalizing clinical research solves the pharmaceutical paradox that while the average American brings home more than ten prescriptions a year, just one in 350 is willing to play guinea pig for new drug testing. An abundance of poor, undertreated and doctor-trusting patients in Eastern Europe, Latin America and Southeast Asia renders the quick, positive results corporate sponsors need to get new drugs approved fast. According to one review, a whopping 99 percent of controlled trials published in China bestowed positive results upon the treatment under investigation.
Although the HHS report found that the “FDA cannot assure the same level of human subject protections in foreign trials as domestic ones,” industry officials say that companies have little interest in bending the rules. “Occasionally things go wrong,” allows Pharmaceutical Research and Manufacturers of America official Caroline Loew. But generally speaking, she says, “companies that are investing $800 million in every single drug are not going to waste money on trials that don’t meet [the FDA’s] exacting standards.” Loew says that companies test new drugs abroad so they can sell them to needy foreign patients.
Analysts disagree. “There may be a market” in some developing countries, says Tufts University’s drug-development expert Kenneth Kaitin, “but they are really interested in the United States, Europe and Japan,” which dominate more than 80 percent of the global drug market. Indeed, all this foreign experimentation can hardly be counted on to develop malaria vaccines or cure multidrug-resistant TB. “The diseases that are of most interest are mainly the degenerative diseases–arthritis, obesity, heart disease–the diseases of people in the developed world,” says South African bioethicist Dr. Solomon Benatar.
Just 0.3 percent of the drug industry’s much-touted R&D resulted in the handful of drugs approved for tropical diseases between 1975 and 1997, despite tens of thousands of industry-sponsored clinical trials conducted around the world every year. Currently, US companies are investigating treatments for oral cancer in China, lupus in Mexico and severe short stature in Eastern Europe, among other studies–not exactly a list of the world’s most pressing public health problems.
Even if Americans were willing to participate in trials, they take so many medications that they make poor lab rats anyway, clinical researchers say. To prove a new drug safe and effective, “you want patients with no other disease states and no other treatments. Then you can say relatively clearly that whatever happens to those patients is from the drug,” says MDS Pharma’s Simon Yaxley, whose company sells what industry PR folks call “patient recruitment solutions” in Eastern Europe, South Africa, Latin America and China. In developing countries, many people, because they are poor and don’t have access to clinicians and hospitals, aren’t taking any medicines for their illnesses.
Not only do experiments on such patients yield clearer results, but recruitment is rapid. “Say you need 1,000 patients in your trial. If you tried Western Europe, it would take you a long time to find untreated patients,” Yaxley says. In a developing country, “you might find those patients in half the time.” After all, “the healthcare systems aren’t as sophisticated,” he adds, and “because of that, there is an increased interest in accessing drugs via clinical research, and therefore we can leverage that interest.” Indeed, consumer health advocates say that clinical trials are the only way some poor patients can get any formal healthcare at all.
Government bureaucracy overwhelms clinical research in the United States, scientists complain, but in developing countries “there is tremendous government cooperation,” says Kaitin. “The governments of China, India and Taiwan are bending over backward to get these companies to conduct research and manufacture there. They are giving tax breaks, building facilities. In Taiwan, many hospitals have switched overall record-keeping to English, so if Western companies want to do a clinical trial there, they will have no problem.”
Conveniently, many of the FDA’s ponderous regulations stop at the border. For example, the FDA’s requirement that companies prove that their experimental drugs are safe on animals before starting tests on humans doesn’t apply for tests conducted outside the United States. And experiments on Americans must undergo painstaking, lengthy reviews by government-regulated “institutional review boards” (IRBs). But “if you go to some countries and say you want the IRB to review this, they say, ‘What is an IRB?’” comments Dennis DeRosia, chair of the Association of Clinical Research Professionals.
The FDA simply requires that foreign trials conform to the World Medical Association’s Declaration of Helsinki, a series of ethical recommendations that critics call rudimentary, nonbinding and ambiguous. Scientists routinely ignore Helsinki directives to publish negative results and make study designs public, and they liken Helsinki-required ethics committees in developing countries to rubber stamps. “No ethical questions are raised at all,” one investigator admitted to the National Bioethics Advisory Commission (NBAC).
What results is one set of acceptable risks for patients at home and quite another for patients abroad, a double standard that has left hundreds of preventable deaths in its wake. Most notoriously, in the mid- and late 1990s, the National Institutes of Health and the Centers for Disease Control funded and defended studies in which Western scientists withheld treatment from HIV-infected pregnant women in developing countries, even though they knew antiretroviral drugs would reduce the rate of HIV infection in their infants by two-thirds. Hundreds of infants “needlessly contracted HIV infection” while Western doctors presided over their care, according to an incendiary New England Journal of Medicine paper by Public Citizen’s Dr. Peter Lurie and Dr. Sidney Wolfe.
It wasn’t that the lifesaving antiretroviral drugs weren’t available to the scientists–the manufacturer offered them free to clinical researchers. Rather, the demands of scientific rigor required that some sick patients go untreated, as NIH and CDC officials explained in a later NEJM issue. Only by observing how these untreated patients fared and comparing their outcomes with those of experimental treatments could scientists quickly and decisively determine whether the experimental treatments worked, they wrote.
Comparing experimental treatments to antiretroviral therapy–standard in the West but deemed too expensive, risky and difficult to administer in poor countries–could only prove whether new treatments equaled or improved upon antiretroviral therapy. But in some cases, “the really relevant question is whether this quick, cheap, easy thing works. You don’t really care if the thing works better,” explains international-health ethicist Nancy Kass. “What you care about is, does it work, period.” Plus, since none of the study subjects could have afforded antiretroviral drugs at the time, NIH’s Dr. Harold Varmus and CDC’s Dr. David Satcher argued, “the assignment to a placebo group does not carry a risk beyond that associated with standard practice.”
Such justifications retorted former New England Journal of Medicine editor Marcia Angell, “are reminiscent of those for the Tuskegee study”–a kind of ethical relativism that results in “widespread exploitation of vulnerable Third World populations for research programs that could not be carried out in the sponsoring country.”
Government-funded scientists’ willingness to sacrifice a few African lives in search of a cheap, effective way to save many more backfired nastily when South African parliamentarian Peter Mokaba recently charged South Africa’s new AIDS-treatment programs with foisting dangerous and unnecessary Western drugs upon an unsuspecting African public. According to the New York Times, recent revelations of improper conduct in an NIH-funded HIV-transmission trial in Uganda intensified South Africans’ receptivity to Mokaba’s dangerous accusations. “You set yourself up for these kinds of problems if you don’t conduct your study properly,” says Lurie. “The researchers have to take responsibility for this.”
By all accounts, the quest for rapid results sent Pfizer scientists jetting to Nigeria in late March 1996. Pfizer scientists had been industriously collecting data on its experimental broad-spectrum antibiotic Trovan when one of the worst epidemics of meningococcal meningitis broke out in Nigeria. The scourge presented a golden opportunity to test their hot new drug, which they suspected could effectively treat meningitis in oral form, bypassing the painful injections their competitors’ drugs required. “We had to move quickly,” a Pfizer spokesperson told the Washington Post. In Nigeria, where the contagion infected more than 100,000, the company could test Trovan on hundreds of patients in a matter of weeks.
The Nigerian government was happy to cooperate, arranging for the company’s accommodation and silencing criticism from local physicians, according to court documents. The FDA granted permission to export the experimental medicine the very same day it was requested, Pfizer says. And a Nigerian hospital ethics committee sanctioned the study design, as required by Helsinki, the company claims.
Not so, confessed two Nigerian doctors to the Post in January 2001: “There was no ethical committee at the time of the trial, none met, and no approval was properly given for the trial,” said one. The “approval” document was cobbled together long after the experiment concluded and was then backdated, the other doctor said. And Pfizer’s study design was dangerously risky, critics say. One of Pfizer’s own scientists, Dr. Juan Walterspiel, warned management that the study methods were “improper and unsafe” before and after the study was conducted, acts of integrity that led to his swift dismissal.
The company, in a heady mix of haste and arrogance, planned to give 100 deathly ill Nigerian children experimental Trovan either orally or by injection, and compare their outcomes to 100 others given shots of competitor Roche’s FDA-approved Rocephin. But an oral form of Trovan, though convenient, was too risky to test on dangerously sick poor kids, Walterspiel complained. “Some of the children were in critical condition and most of them malnourished, which made oral absorption even more unpredictable,” Walterspiel wrote to Pfizer officials in a December 18, 1997, letter.
According to Nigerian families’ class-action suit against the company, Pfizer then forced sick children into its study, failing to inform them either of the experimental nature of the drug they’d be subjected to or the availability of WHO-approved meningitis treatment from a nearby Doctors Without Borders team. Not a single Helsinki-required informed-consent form was signed, the company admits. No witnesses signed statements attesting to the “verbal consent” Pfizer claims to have obtained either, the company admits on its website. “These people had no idea they were part of any clinical trial,” says Elaine Kusel, an attorney representing the Nigerian families suing Pfizer.
It wasn’t the first Third World trial involving lack of consent. One analysis of South African patients who had participated in a study of HIV transmission found that almost 90 percent felt forced into the trial. Thirteen percent of researchers interviewed by NBAC said they weren’t sure if their study participants were aware that they were in a research project. “Informed consent is a joke,” a clinical investigator who worked in developing countries commented to NBAC. Pfizer scientists took other liberties as well. When some children resisted the painful Rocephin shots, Pfizer scientists slashed the dose to one-third the FDA-approved levels. This unapproved, reckless deviation from the study protocol endangered lives, Kusel charges. Pfizer disputes the claim.
The extent of the damage from Trovan and the low dose of Rocephin remains unclear. Pfizer claims it lost just 6 percent of its patients in both the Trovan and Rocephin groups, proving that oral and injected Trovan worked as well as Rocephin. But the company didn’t adequately track the long-term recovery of its patients, Kusel says. Initial fatality rates may have been relatively low, but with only one follow-up visit (the FDA recommended two in 1998), nobody knows how many children ended up deaf, brain-damaged or dead–whether from meningitis, experimental Trovan or a low dose of Rocephin, she says.
Pfizer defends the study by stressing that the FDA itself found little seriously amiss when it reviewed the data in 1997, a fact may be more suggestive of the FDA’s selective oblivion than Pfizer’s propriety. While the agency did decline to consider Pfizer’s application, noting “discrepancies,” it didn’t object to the lack of signed consent forms or note problems with the ethics-approval letter, the company says. The agency’s approval of Trovan for no less than fourteen adult indications netted Pfizer more than $160 million until reports of liver damage led the FDA to pull the plug in 1999.
The trial would have remained Pfizer’s dirty little secret had the Washington Post not unearthed it in a late 2000 investigative series. The sensational, John le Carré-like story of coercive experimentation brought thousands of Nigerians into the streets, launching belated Nigerian and FDA inquiries. In a flurry of outrage, US Representatives Tom Lantos and Henry Hyde sponsored a patient-protection amendment to the Export Administration Act, which would make it more difficult for companies to export experimental medicines abroad.
But Pfizer stands by its study. On its website the company argues that given the impoverished, squalid conditions Pfizer found in Nigeria, patients ought to have deemed themselves lucky to get the cutting-edge medical care and upgraded local facilities that Pfizer’s trial offered. “Overall medical care substantially improved due to the presence of this clinical trial,” Pfizer says.
This specious argument, that “whatever we do is better than nothing,” as Nigerian physician Alphonsus Obayuwana put it, underpins ongoing attempts to rationalize shoddy treatment of poor patients in developing countries. In January 2001, for instance, as part of a trial of a new drug, Discovery Laboratories planned to administer saltwater or air placebos to 325 deathly ill premature infants–arguing that in the poorly equipped Latin American hospitals where the trial would be conducted, patients couldn’t afford effective drugs anyway. Discovery admitted to the FDA that its new surfactant drug, called Surfaxin, probably wouldn’t improve upon any of the four surfactants the agency had approved since 1990, according to internal FDA documents procured by Public Citizen.
But however marginal Surfaxin’s contribution to patient care, the drug would be easier to manufacture, the company says. Since the FDA only requires that new drugs prove effective–not more effective than already approved drugs–Discovery planned to seek FDA approval by showing that Surfaxin was better than nothing. The problem of finding parents of dying infants desperate enough to risk being assigned to a placebo group could be overcome by exporting the trial to impoverished Latin American hospitals, “where other drugs in its class are approved, but not standard of care because of financial limitations or government rationing,” FDA officials explained in an agency review of the study.
After Public Citizen stepped up pressure, the company redesigned the study without placebos in April 2001, but FDA medical policy associate director Dr. Robert Temple, who participated in an agency review of the study, defends the original study design. “At present nobody in the places where the study would have been done is getting surfactant,” he told me. “If they did, the trial half of the people would get surfactant and better perinatal care, and the other half would get better perinatal care. It seems to me all the people in the trial would have been better off.” Indeed, Public Citizen’s Lurie says, Discovery intended to upgrade research sites to the standards of a Western intensive-care unit–“they just wouldn’t squirt active drug down the tube.”
The international health advocates one would expect to mount a noisy campaign against shoddy corporate trials have been surprisingly muted. There’s a certain wariness about imposing impossible demands and idealistic ethical standards on companies that can easily take their business elsewhere.
Doctors Without Borders, the WHO and other international health organizations have made increasing corporate research interest in the Third World a primary goal, making critiques of such trials secondary, at least for now. “It takes half a second to look at how much more burdened the developing world is with ill health and disability. What we need, if anything, is more health research in the developing world, not less,” says Johns Hopkins bioethicist Ruth Faden. Plus, even when companies aim for rich Western consumers, testing new drugs on poor patients “brings benefits to the patients. They get special attention and potential therapy,” adds HIV researcher Arthur Ammann, who has tried to convince drug companies to run more trials in developing countries.
Watchdogs like Public Citizen’s Health Research Group vociferously decry unethical study designs but can do little to police study conduct, which both the FDA and the drug industry view as secret, “proprietary” information. Ethics documents issued by international associations such as the World Medical Association and the WHO/UNESCO’s Council for International Organizations of Medical Sciences, as important as they are, are alarmingly toothless. Pharma companies themselves have attempted a voluntary “harmonization” of clinical research standards abroad to meet FDA standards but, not surprisingly, such efforts are frighteningly nascent in many developing countries.
In the end, such voluntary endeavors, while crucial, are hardly sufficient to protect the would-be guinea pigs of the world sacrificed on the altar of Big Pharma profit. The IRB reviews, FDA approvals and the like that protect patients at home need to be not only universal but mandatory. With any luck, the class-action suit against Pfizer will strengthen the argument for such protections–at least until the gap between Western elites glutted on the latest medicines and a world majority lacking access to simple antibiotics somehow begins to close.
Satires and cartoons:
Tucker Carlson on Fauci’s lies: