AP IMPACT: Past medical testing on humans revealed

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http://news./s/ap/20110228/ap_on_he_me/us_med_experiments_on_humans

AP IMPACT: Past medical testing on humans

revealed

By MIKE STOBBE, AP Medical Writer Mike

Stobbe, Ap Medical Writer – Sun Feb 27,

9:15 pm ET

ATLANTA – Shocking as it may seem, U.S. government doctors once

thought it was fine to experiment on disabled people and prison

inmates. Such experiments included giving hepatitis to mental

patients in Connecticut, squirting a pandemic flu virus up the

noses of prisoners in land, and injecting cancer cells into

chronically ill people at a New York hospital.

Much of this horrific history is 40 to 80 years old, but it is

the backdrop for a meeting in Washington this week by a

presidential bioethics commission. The meeting was triggered by

the government's apology last fall for federal doctors infecting

prisoners and mental patients in Guatemala with syphilis 65

years ago.

U.S. officials also acknowledged there had been dozens of

similar experiments in the United States — studies that often

involved making healthy people sick.

An exhaustive review by The Associated Press of medical journal

reports and decades-old press clippings found more than 40 such

studies. At best, these were a search for lifesaving treatments;

at worst, some amounted to curiosity-satisfying experiments that

hurt people but provided no useful results.

Inevitably, they will be compared to the well-known Tuskegee

syphilis study. In that episode, U.S. health officials tracked 600

black men in Alabama who already had syphilis but didn't give

them adequate treatment even after penicillin became available.

These studies were worse in at least one respect — they

violated the concept of "first do no harm," a fundamental

medical principle that stretches back centuries.

"When you give somebody a disease — even by the standards of

their time — you really cross the key ethical norm of the

profession," said Arthur Caplan, director of the University of

Pennsylvania's Center for Bioethics.

Some of these studies, mostly from the 1940s to the '60s,

apparently were never covered by news media. Others were

reported at the time, but the focus was on the promise of

enduring new cures, while glossing over how test subjects were

treated.

Attitudes about medical research were different then.

Infectious diseases killed many more people years ago, and

doctors worked urgently to invent and test cures. Many prominent

researchers felt it was legitimate to experiment on people who

did not have full rights in society — people like prisoners,

mental patients, poor blacks. It was an attitude in some ways

similar to that of Nazi doctors experimenting on Jews.

"There was definitely a sense — that we don't have today — that

sacrifice for the nation was important," said Stark, a

Wesleyan University assistant professor of science in society,

who is writing a book about past federal medical experiments.

The AP review of past research found:

_A federally funded study begun in 1942 injected experimental

flu vaccine in male patients at a state insane asylum in

Ypsilanti, Mich., then exposed them to flu several months later.

It was co-authored by Dr. Jonas Salk, who a decade later would

become famous as inventor of the polio vaccine.

Some of the men weren't able to describe their symptoms,

raising serious questions about how well they understood what

was being done to them. One newspaper account mentioned the test

subjects were "senile and debilitated." Then it quickly moved on

to the promising results.

_In federally funded studies in the 1940s, noted researcher Dr.

W. Havens Jr. exposed men to hepatitis in a series of

experiments, including one using patients from mental

institutions in Middletown and Norwich, Conn. Havens, a World Health Organization expert

on viral diseases, was one of the first scientists to

differentiate types of hepatitis and their causes.

A search of various news archives found no mention of the

mental patients study, which made eight healthy men ill but

broke no new ground in understanding the disease.

_Researchers in the mid-1940s studied the transmission of a

deadly stomach bug by having young men swallow unfiltered stool

suspension. The study was conducted at the New York State

Vocational Institution, a reformatory prison in West sackie.

The point was to see how well the disease spread that way as

compared to spraying the germs and having test subjects breathe

it. Swallowing it was a more effective way to spread the

disease, the researchers concluded. The study doesn't explain if

the men were rewarded for this awful task.

_A University of Minnesota study in the late 1940s injected 11

public service employee volunteers with malaria, then starved

them for five days. Some were also subjected to hard labor, and

those men lost an average of 14 pounds. They were treated for

malarial fevers with quinine sulfate. One of the authors was

Ancel Keys, a noted dietary scientist who developed K-rations

for the military and the Mediterranean diet for the public. But

a search of various news archives found no mention of the study.

_For a study in 1957, when the Asian flu pandemic was

spreading, federal researchers sprayed the virus in the noses of

23 inmates at Patuxent prison in Jessup, Md., to compare their

reactions to those of 32 virus-exposed inmates who had been

given a new vaccine.

_Government researchers in the 1950s tried to infect about two

dozen volunteering prison inmates with gonorrhea using two

different methods in an experiment at a federal penitentiary in

Atlanta. The bacteria was pumped directly into the urinary tract

through the penis, according to their paper.

The men quickly developed the disease, but the researchers

noted this method wasn't comparable to how men normally got

infected — by having sex with an infected partner. The men were

later treated with antibiotics. The study was published in the

Journal of the American Medical Association, but there was

no mention of it in various news archives.

Though people in the studies were usually described as

volunteers, historians and ethicists have questioned how well

these people understood what was to be done to them and why, or

whether they were coerced.

Prisoners have long been victimized for the sake of science. In

1915, the U.S. government's Dr. ph Goldberger — today

remembered as a public health hero — recruited Mississippi

inmates to go on special rations to prove his theory that the

painful illness pellagra was caused by a dietary deficiency.

(The men were offered pardons for their participation.)

But studies using prisoners were uncommon in the first few

decades of the 20th century, and usually performed by

researchers considered eccentric even by the standards of the

day. One was Dr. L.L. Stanley, resident physician at San Quentin

prison in California, who around 1920 attempted to treat older,

"devitalized men" by implanting in them testicles from livestock

and from recently executed convicts.

Newspapers wrote about Stanley's experiments, but the lack of

outrage is striking.

"Enter San Quentin penitentiary in the role of the Fountain of

Youth — an institution where the years are made to roll back for

men of failing mentality and vitality and where the spring is

restored to the step, wit to the brain, vigor to the muscles and

ambition to the spirit. All this has been done, is being done

.... by a surgeon with a scalpel," began one rosy report

published in November 1919 in The Washington Post.

Around the time of World War II, prisoners were enlisted to

help the war effort by taking part in studies that could help

the troops. For example, a series of malaria studies at

Stateville Penitentiary in Illinois and two other prisons was

designed to test antimalarial drugs that could help soldiers

fighting in the Pacific.

It was at about this time that prosecution of Nazi doctors in

1947 led to the "Nuremberg Code," a set of international rules

to protect human test subjects. Many U.S. doctors essentially

ignored them, arguing that they applied to Nazi atrocities — not

to American medicine.

The late 1940s and 1950s saw huge growth in the U.S.

pharmaceutical and health care industries, accompanied by a boom

in prisoner experiments funded by both the government and

corporations. By the 1960s, at least half the states allowed

prisoners to be used as medical guinea pigs.

But two studies in the 1960s proved to be turning points in the

public's attitude toward the way test subjects were treated.

The first came to light in 1963. Researchers injected cancer

cells into 19 old and debilitated patients at a Jewish Chronic

Disease Hospital in the New York borough of Brooklyn to see if

their bodies would reject them.

The hospital director said the patients were not told they were

being injected with cancer cells because there was no need — the

cells were deemed harmless. But the experiment upset a lawyer

named Hyman who sat on the hospital's board of

directors. The state investigated, and the hospital ultimately

said any such experiments would require the patient's written

consent.

At nearby Staten Island, from 1963 to 1966, a controversial

medical study was conducted at the Willowbrook State School for

children with mental retardation. The children were

intentionally given hepatitis orally and by injection to see if

they could then be cured with gamma globulin.

Those two studies — along with the Tuskegee experiment revealed

in 1972 — proved to be a "holy trinity" that sparked extensive

and critical media coverage and public disgust, said

Reverby, the Wellesley College historian who first discovered

records of the syphilis study in Guatemala.

By the early 1970s, even experiments involving prisoners were

considered scandalous. In widely covered congressional hearings

in 1973, pharmaceutical industry officials acknowledged they

were using prisoners for testing because they were cheaper than

chimpanzees.

Holmesburg Prison in Philadelphia made extensive use of inmates

for medical experiments. Some of the victims are still around to

talk about it. "Yusef" , featured in a book about

the studies, says he agreed to have a layer of skin peeled off

his back, which was coated with searing chemicals to test a

drug. He did that for money to buy cigarettes in prison.

"I said 'Oh my God, my back is on fire! Take this ... off me!'"

said in an interview with The Associated Press, as he

recalled the beginning of weeks of intense itching and agonizing

pain.

The government responded with reforms. Among them: The U.S.

Bureau of Prisons in the mid-1970s effectively excluded all

research by drug companies and other outside agencies within

federal prisons.

As the supply of prisoners and mental patients dried up,

researchers looked to other countries.

It made sense. Clinical trials could be done more cheaply and

with fewer rules. And it was easy to find patients who were

taking no medication, a factor that can complicate tests of

other drugs.

Additional sets of ethical guidelines have been enacted, and

few believe that another Guatemala study could happen today.

"It's not that we're out infecting anybody with things," Caplan

said.

Still, in the last 15 years, two international studies sparked

outrage.

One was likened to Tuskegee. U.S.-funded doctors failed to give

the AIDS drug AZT to all the HIV-infected pregnant women in a

study in Uganda even though it would have protected their

newborns. U.S. health officials argued the study would answer

questions about AZT's use in the developing world.

The other study, by Pfizer Inc., gave an antibiotic named

Trovan to children with meningitis in Nigeria, although there

were doubts about its effectiveness for that disease. Critics

blamed the experiment for the deaths of 11 children and the

disabling of scores of others. Pfizer settled a lawsuit with

Nigerian officials for $75 million but admitted no wrongdoing.

Last year, the U.S. Department of Health and Human Services'

inspector general reported that between 40 and 65 percent of

clinical studies of federally regulated medical products were

done in other countries in 2008, and that proportion probably

has grown. The report also noted that U.S. regulators inspected

fewer than 1 percent of foreign clinical trial sites.

Monitoring research is complicated, and rules that are too

rigid could slow new drug development. But it's often hard to

get information on international trials, sometimes because of

missing records and a paucity of audits, said Dr.

Schulman, a Duke University

professor of medicine who has written on the ethics of

international studies.

These issues were still being debated when, last October, the

Guatemala study came to light.

In the 1946-48 study, American scientists infected prisoners

and patients in a mental hospital in Guatemala with syphilis,

apparently to test whether penicillin could prevent some

sexually transmitted disease. The study came up with no useful

information and was hidden for decades.

The Guatemala study nauseated ethicists on multiple levels.

Beyond infecting patients with a terrible illness, it was clear

that people in the study did not understand what was being done

to them or were not able to give their consent. Indeed, though

it happened at a time when scientists were quick to publish

research that showed frank disinterest in the rights of study

participants, this study was buried in file drawers.

"It was unusually unethical, even at the time," said Stark, the

Wesleyan researcher.

"When the president was briefed on the details of the

Guatemalan episode, one of his first questions was whether this

sort of thing could still happen today," said Rick Weiss, a

spokesman for the White House Office of Science and Technology

Policy.

That it occurred overseas was an opening for the Obama

administration to have the bioethics panel seek a new evaluation

of international medical studies. The president also asked the

Institute of Medicine to further probe the Guatemala study, but

the IOM relinquished the assignment in November, after reporting

its own conflict of interest: In the 1940s, five members of one

of the IOM's sister organizations played prominent roles in

federal syphilis research and had links to the Guatemala study.

So the bioethics commission gets both tasks. To focus on

federally funded international studies, the commission has

formed an international panel of about a dozen experts in

ethics, science and clinical research.

Regarding the look at the Guatemala study, the commission has

hired 15 staff investigators and is working with additional

historians and other consulting experts.

The panel is to send a report to Obama by September. Any

further steps would be up to the administration.

Some experts say that given such a tight deadline, it would be

a surprise if the commission produced substantive new

information about past studies. "They face a really tough

challenge," Caplan said.

___

AP news researchers and Bell contributed

to this report.