An investigation of medical research records shows the U.S. government is still in the business of conducting and paying for tests on unsuspecting Americans
Do People Know the Truth About Experiments?
December 16, 1996
Day 2 of 4
By KEITH EPSTEIN and BILL SLOAT
Not long after school started in the fall of 1991, Sacheen White Tail came home with a note from her teacher.
It was addressed to her parents, and no, the sixth-grader wasn’t in any kind of trouble.
Her classwork was fine. She was still winning ribbons at swimming meets.
The note was an invitation almost too good to pass up: If her mother approved, Sacheen was eligible for a free hepatitis vaccination.
Two shots, a month apart, would “provide lifelong immunity.”
Something called the “Hepatitis A Vaccine Prevention Program” was behind the offer, sent to hundreds of parents on the Standing Rock Sioux Reservation that spreads across the grasslands of the Dakotas.
Without hesitating, Ella-Mae White Tail returned the accompanying form. Her 11-year-old would get the shots at school.
“I was interested in protecting my daughter,” she said.
Sacheen also wanted the gift researchers were offering. “It was an expensive mousse gel for my hair, good stuff,” she said.
What Sacheen’s mother didn’t realize then was that the “Hepatitis A Vaccine Prevention Program” wasn’t just a prevention program. It was a research project sponsored by the Centers for Disease Control and the Indian Health Service. The vaccine was being tested for a British pharmaceutical company.
“They were using our kids as guinea pigs,” White Tail said. “In the beginning, I thought it was approved by the ^Food and Drug Administration]. And then, I found out it wasn’t.”
Among other things, the government wanted to evaluate the vaccine’s “safety,” before allowing its use on all American children – a purpose that never appeared on the consent form distributed to the Sioux parents.
Neither did the word “experimental.” Or “research.”
“When you say “experimental,’ it scares off a lot of people,” said Tim Yellow, the tribe’s health director in Fort Yates, N.D., where a boulder marks the burial site of Sitting Bull.
Yellow had welcomed the researchers. His own daughter, Lisa, got the shot. Hepatitis A was endemic on the reservation. The contagious disease could be thwarted by better sewage and plumbing systems and more careful handwashing – and now, it seemed, also with the vaccine.
That the parents felt misled would be putting it mildly, said Yellow. His friendships grew strained. Traditional drummers at the Bear Soldier Hall appealed to the spirits to heal hard feelings and protect the children.
While the vaccine was eventually determined to be safe, Yellow said, the uproar has barely subsided on the reservation, where many raise buffalo and cattle a few miles south of Gen. George Custer’s old 7th Cavalry headquarters.
What happened at Standing Rock is not an isolated incident.
Decades after notorious syphilis experiments on blacks at Tuskegee, Ala., and radiation studies on civilians during the Cold War, the government is still in the business of conducting and paying for medical tests on unwary Americans.
In fact, a computer analysis shows that in medical research, the pharmaceutical industry is not the most likely abuser of basic human rights.
It is the U.S. government.
Researchers working for the government have camouflaged the truth. They have omitted vital information about risks. They have failed to properly obtain permission before testing unapproved drugs with uncertain effects.
Even with prescription drugs, whose effects are largely known, doctors are expected to disclose the pros and cons and allow patients a free choice. For experimental drugs and vaccines, federal law and professional medical ethics compel doctors to disclose what they know – and don’t know.
“Because the patient may not benefit. Because you may be doing harm; you don’t know what the risks might be. Because this is not veterinary medicine, this is another human being,” said Dr. Bernadine Healy, dean of the Ohio State University medical school and former director of the National Institutes of Health.
“In an experimental trial, you don’t have the answers; that’s why you’re doing an experiment. So you have the heightened obligation to tell the patient – someone who trusts you with their most precious possession, their life and well-being – you don’t know the answers.”
Yet American test subjects have been kept in the dark or only partially informed in 63 percent of all medical research that The Plain Dealer could identify as government-sponsored from 1977 through 1995. The newspaper’s analysis was based on internal FDA inspection records obtained under the federal Freedom of Information Act.
Consent forms were unclear; sometimes they were missing altogether. Such forms are like signed receipts, crucial evidence that patients were given all the information to which they were entitled.
Some forms described experimental drugs as “new therapies” or “treatments.”
FDA records show that consent forms were adequate in 37 percent of clinical trials at federal research sites, such as veterans hospitals and the National Institutes of Health. Others, such as private research contractors who test drugs for the pharmaceutical industry, gave full disclosure in 50 percent of their experiments. University and hospital researchers were only slightly better than the government: They disclosed complete information to their subjects 42 percent of the time.
“If there’s one principle firmly established,” said Case Western Reserve University bioethicist Thomas Murray, “it’s that you do not trim the truth or deceive people just because a research project is important. Some ethics questions are tough. That one’s a slam-dunk. It’s a short step from withholding information from subjects to what happened at Tuskegee.”
The Plain Dealer’s analysis parallels barely noted discoveries by a 1994 presidential advisory committee. That committee’s central focus was the Cold War era, a 30-year period from the mid-1940s when federal agencies sponsored 4,000 radiation experiments involving tens of thousands of subjects, many of whom had no knowledge they were test cases.
Yet President Clinton’s Advisory Committee on Human Radiation Experiments also uncovered more contemporary examples of research on unwitting Americans. “The most serious concerns focus on informed consent,” the committee reported 700 pages deep within an imposing volume, thick as a Sears, Roebuck & Co. catalog.
On page 717, the committee said, “Human subject protections may be more effective in radiation research than elsewhere” – in other words, patients could be more at risk nowadays in nonradiation experiments than in the kind that triggered the committee’s inquiry.
It was the radiation experiments that Clinton apologized for, agreeing to compensate some of the patients who had been exposed.
“Informed consent means your doctor tells you the risk of the treatment you are about to undergo. In too many cases, informed consent was withheld,” the president declared. “The deception extended beyond the test subjects themselves to encompass their families and the American people as a whole.”
Just last month, the government paid $4.8 million to 12 victims injected with uranium and plutonium without their consent. “When the government does wrong,” Clinton said, “we have a moral responsibility to admit it.”
Although the committee said its other discoveries involving nonradiation research were “findings that cannot be ignored,” the written evidence – disclosing locations of experiments, researchers’ names and the agencies involved – was boxed and shipped to a warehouse in Maryland, filed and forgotten. Some records were opened by National Archives lawyers at The Plain Dealer’s request.
“Human subjects,” as scientists refer to them, include the poor, the vulnerable, the medically dependent. They include former soldiers at hospitals of the Department of Veterans Affairs.
They include women with breast cancer at the National Cancer Institute. Alcoholics with hepatitis at the National Institutes of Health.
They include the Lakota people in the Dakotas, where parents like Ella-Mae White Tail effectively shut down the Centers for Disease Control’s hepatitis A experiment in 1992.
Although the vaccine, Havrix, was approved by the FDA in 1995 (based on tests involving 40,000 people elsewhere) the Pine Ridge Sioux sued the government.
A federal court in January 1993 tossed out the lawsuit by the parents as moot – the clinical trial had already been halted – but not before expressing “grave doubts” about the government’s conduct.
The court said the government failed to give parents “an adequate basis for informed consent.”
And the court added that it expected the government to be “less cavalier . . . on Indian reservations or anywhere else.”
Around then, far from the prairies, J. Thomas Puglisi had heard of a different Centers for Disease Control vaccine experiment on children, although in the barrios of inner-city Los Angeles, the CDC’s preferred word was “project.” As chief of the NIH’s compliance oversight branch of the division of human subject protection, Puglisi monitors government-sponsored clinical trials. In this instance, the CDC was the sole sponsor.
To the mothers in Los Angeles, it all seemed routine, just another trip to the neighborhood health clinic. Their babies, 24 to 45 weeks old, were weighed and measured. Nurses collected blood samples, administered free shots, filled out charts.
Where was the infant born? the nurses would ask the mothers, many of them immigrants. Date of birth? Race? Esta de Mexico? Esta de El Salvador? De donde esta?
There were at least 302 Hispanic babies, 245 black babies, 58 white babies.
Mothers signed forms that mentioned something about a “project” in which “public health policy-makers” wanted to “determine the best measles vaccine strain” and “the best schedule for age of measles vaccination.”
With the “E-Z vaccine,” the form assured the mothers, “your child may be protected earlier against measles.”
The mothers didn’t see the Centers for Disease Control documents that spelled out a reason the agency started inoculating infants with E-Z during May 1990: to test the vaccine’s “immunogenicity and safety.”
An FDA document the mothers never saw stressed that the mothers should be warned that the outcome was uncertain.
Paul D. Parkman, an FDA official, had cautioned the CDC well before the experiment began, in October 1989, that because unpublished data suggested effects on babies’ immune systems and “since the use of the E-Z measles vaccine is unlicensed in the United States and therefore experimental. . . it seems imperative that there be a strong warning on the consent form to the mothers . . . that their infants may not be protected.”
Specific neighborhoods were targeted: East Los Angeles, West Los Angeles and Inglewood – communities that had experienced measles outbreaks.
To combat this resurgence, government scientists confidently turned to E-Z in a dose up to 100 times more potent and administered much earlier than Moraten, the only measles vaccine approved for American children.
“It certainly was a good potential weapon,” said Stephen Hadler, director of the epidemiology and surveillance division of the national immunization program at the centers’ Atlanta headquarters.
But in their enthusiasm, government scientists seized upon a vaccine that backfired.
In Africa, children were dying.
Months before the first California baby got a shot, immunologists were making frightful discoveries in the former French, British and Portuguese colonies near Cape Verde: Some inoculated children were dying within three years.
A French researcher saw it in Dakar, Senegal, in 1989. A Danish immunologist in January 1990 pleaded with the World Health Organization to look at his numbers from Guinea-Bissau and Senegal. It did, and so did the Centers for Disease Control.
Scientists suspected the vaccine somehow weakened the immune system, making children more susceptible to a variety of ailments. Diarrhea and pneumonia were leading causes of death in Africa.
Researchers doubted children in relatively healthy U.S. environments would be harmed, although with weaker immunity they might still become sick.
By April 1990, the news out of Africa was even grimmer. As part of a data-monitoring safety team, the Centers for Disease Control knew that the “excess mortality” had become statistically significant.
But one month later, in May 1990, its Los Angeles test went forward.
In early November, the government quietly participated in a decision, with the European researchers, to stop giving high-dose E-Z to African infants.
Among those present: the CDC’s leading scientist overseeing the U.S. trial.
That same CDC scientist informed the FDA of the African deaths on March 6, 1991.
An FDA official’s notes said the CDC scientist reported “a large number of children who got hi-dose EZ died” in Africa. The notes indicate that about 52 out of 300 children died, compared with 32 out of 300 who got a placebo or another vaccine.
In Los Angeles, the experiment continued.
The evidence out of Africa, explains Hadler, was just “not compelling.”
Wasn’t compelling until Neal Halsey came along.
A Johns Hopkins University researcher under contract to the State Department’s Agency for International Development, Halsey had during the 1980s inoculated babies with E-Z in a Haitian shantytown. Doubting the findings in Africa, he went back to the shantytown, expecting to show the Haitian babies were better off.
“We actually set out to demonstrate there wasn’t an effect,” he said. “We found there was.” High doses of E-Z were associated with increased mortality.
Halsey dialed the CDC. The Los Angeles test was stopped.
By then, it was October 1991, and the mothers of 1,192 children had allowed their children to randomly receive two vaccines, one of which was E-Z. Four hundred and eighty-five babies had received the highest dose. Another 217 had been inoculated with a less-intense form of E-Z.
“So far, there’s no evidence of any untoward effects,” says Hadler. “In the U.S., there’s no evidence this vaccine causes a problem in healthy children.”
CDC internal data obtained by The Plain Dealer do show some changes in the immune systems of some vaccinated children, but the significance remains under study.
Then there was Ricardo Munoz, the son of a 21-year-old Mexican immigrant, Rafaela Lopez Barajas.
Ricardo, nearly 23 months old, died on July 14, 1992, of “clostridium dificile enteritis” and “probable viral gastroenteritis,” according to the coronor’s report.
The CDC has not publicly identified the boy it acknowledges died 15 months after receiving a standard dose of E-Z. CDC documents show the death occurred when the child was 23 months old in July 1992. A document states “causes of death per death certificate” were: “clostridum dificile enteritis” and “probable viral gastroenteritis.”
A search of California records showed no other death of a boy that age from those causes in July 1992.
“It came all of a sudden,” said Maria Socorro, Ricardo’s comadre, or godmother. She lived with the boy and his mother in a cramped, yellow stucco walkup in the largely Hispanic enclave of Bell Gardens, Calif.
“The little boy was nice and healthy, sweet fat cheeks. He was a happy child. And then all of a sudden . . . two days of vomiting, diarrhea and coughing, and this illness took him.”
On the evening of the second day, he was found unconscious, vomit like coffee grounds around his head. “Natural causes,” concluded the coroner.
The CDC, in public descriptions of the death, acknowledged only that a child vaccinated with a less intense dose of E-Z died of acute dehydration and shock following several days of diarrhea; bacteria were found in his stool. It also said the death was unrelated to the vaccine.
A month after The Plain Dealer interviewed CDC officials about the vaccine research, the agency issued a press release that for the first time publicly disclosed the measles study.
Once more, the agency stated categorically that “no problem is expected” among the children in Los Angeles.
“Disingenuous,” was how Brian Ward reacted to the government’s statements, after The Plain Dealer provided him with a copy of Ricardo’s autopsy report and the immunologic data on the Los Angeles children from the CDC’s internal files. Ward, in Montreal at McGill University’s Center for Tropical Diseases, is a leading expert in infectious diseases.
He theorizes that E-Z might rev up the immune system against certain ailments, while weakening it against others.
Ricardo’s death seems “compatible with the deaths that occurred” in Africa and Haiti, Ward said.
Yet neither is there proof the vaccine was to blame for Ricardo’s death; E-Z may have had nothing to do with it.
“Based on what I’ve seen, you can’t prove it either way. It’s an open, legitimate question,” said Ward.
And while the CDC points to research in other developed countries as evidence of safety, Ward cautions that too few children were involved to draw a firm conclusion.
Despite its pronouncements of certainty, the government is still collecting blood samples to learn whether the vaccine harmed or only insignificantly altered the children’s immune systems. Results are due in July.
“We fully acknowledge that it was a mistake” not to tell the families the vaccine was experimental, said Dixie E. Snider Jr., associate director of the Centers for Disease Control. “The major problem is that the consent form did not specifically identify the E-Z vaccine as being an unlicensed vaccine. Some people would call that experimental.”
Last summer, the government finally notified the parents in Los Angeles that the E-Z shots were experimental, thanking them for helping “benefit medical science by increasing our knowledge.”
In Atlanta, the CDC research staff was ordered to undergo training in “human subject protection.”
©1997 PLAIN DEALER PUBLISHING