Clinical studies are a very
important step in bringing any drug to the market. However, there are ethical
considerations to such studies that have all too often been ignored. The
Tuskegee syphilis experimental study was conducted between 1932 and 1972 by the
US Public Health Service. Its purpose was to study the natural progression of
untreated syphilis in rural African Americans in Alabama. These men were told
that they would get free healthcare from the US government, they would have meals
paid for and in addition to their free medical care they would also get free burial
insurance. Following the Great Depression of the 1930s this was an enticing
offer and 600 impoverished sharecroppers from Macon County, Alabama signed up.
399 had syphilis while 201 didn't have the disease. None of the men were told that they had the
disease syphilis and none were given treatment instead they were told “they had
bad blood”. In 1940 penicillin had become the standard treatment for syphilis
but the scientist prevented participants in the study from accessing syphilis
treatments available to others living locally. The study continued for 40
years and only ended on November 16, 1972 when the study was leaked to the
press. By then 28 men had died, 40 wives contracted syphilis and 19 children
were born with congenital syphilis. During the start of World War II, 250 of
the participants registered for the draft. During their medical inspection
syphilis was detected and they were ordered to take treatment before
reapplying. The scientists, even
then, tried to
stop them from getting treatment for their syphilis. On May 16, 1997, President Bill
Clinton formally
apologized and held a ceremony at the White House for surviving Tuskegee study
participants. He said:
"What
was done cannot be undone. But we can end the silence. We can stop turning our
heads away. We can look at you in the eye and finally say on behalf of the
American people, what the United States government did was shameful, and I am
sorry ... To our African American citizens, I am sorry that your federal
government orchestrated a study so clearly racist."
Five
of the eight study survivors attended the White House ceremony.
Meanwhile, syphilis was
also being given deliberately to some people by the US government. In 1946, under the guise of public health, hundreds of Guatemalan prison inmates were deliberately infected with syphilis.
Male prisoners were sometimes infected via direct injection—including right to
the penis. Still other prisoners got sick after visits from prostitutes who
were often also purposely infected. None of the research subjects were asked
for their consent. Up to the 1970’s, 85%
of stage 1 clinical trials were carried out on prisoners. This ranged from studying chemical warfare
agents to testing dandruff treatments.
Some six decades later Pres. Barack Obama called Álvaro Colom, Guatemala’s
president, to personally apologize for the abhorrent U.S. government–led
research.
During the
1950s and 1970s at the Willowbrook state school in Staten Island, New York
there were 6000 children with mental disabilities. They were intentionally given
hepatitis A to try and understand development of viral infection. Consent was
given by the authorities in charge of the institution. It was the biggest state
run institution for children with mental disability in the United States.
Hepatitis A was deliberately given to these vulnerable children without their
knowledge or consent.
Senator Robert Kennedy toured Willowbrook State School in
1965 and proclaimed that individuals in the overcrowded facility were
"living in filth and dirt, their clothing in rags, in rooms less
comfortable and cheerful than the cages in which we put animals in a
zoo"
In 1996 Pfizer was sued for
unethical clinical trials. During a meningitis outbreak in Africa the company
treated 100 Nigerian children with the antibiotic Trovan in order to test its
effectiveness. Of the hundred children
treated 11 children died, others were brain-damaged. Some were partially paralyzed
or left deaf. Dr Juan Walterspiel, a Pfizer infectious disease specialist was
assigned to the Trovan test and repeatedly flagged up, to management, that the
company was violating international law federal regulations and medical ethical
standards.
Dr. Walterspiel’s letter to Steere, dated Dec. 18,
1997, was not well received. Among the points he made:
“Some of the children
were in critical condition and most of them malnourished, which made oral
absorption even more unpredictable. At least one died after a single oral dose;
such a patient should never have received an experimental antibiotic orally.”
Shortly after publishing his
thoughts Dr Walterpiel was dismissed by Pfizer.
Between 1997 and 2002 clinical trials were conducted on
HIV infected children and infants who were under the guardianship of New York
City Agency for Children Services. The children were living in a foster care
centre in Harlem and were forced to take medication that made them severely ill
and had potentially lethal side-effects. New York City agency for children
services provided consent for this clinical trial themselves.
In 1997 unethical clinical trials aimed at preventing
the spread of HIV infection were targeting pregnant women in Africa Asia and
the Caribbean. This clinical study was funded by the US government. People were
randomly given placebo rather than the drug.
It was pointed out that such actions would have been deemed totally
unacceptable within the US but for some reason were seemed fine for the
developing world.
In case one feels that the situation today is free of
such unethical practices you need only look at an article in the Lancet in June
2014 to find quite the contrary. At a clinical trial in India they were
evaluating an experimental vaccine for preventing a life-threatening viral
infection, rotavirus. 2000 children received instead placebos of salt water. It
should be noted that two rotavirus vaccines had already been available for 10
years when this clinical research took place. In 2013 The World Health
organisation published findings, which showed that 450,000 children died from
rotavirus infection globally in one year. 90% of these deaths occurred in
Africa and Asia.
Sometimes it is not even the drug company’s
fault. A medical trial began in 2003,
when a dozen researchers at Imperial College London began trialing a new drug
on 38 asthma sufferers at St Mary’s Hospital, London. Unknown to the others working
on the clinical study, one of the staff, Dr Edward Erin was falsifying his data
and had been doing so for years. The search for a cure for asthma left one man
dead, 20 seriously ill with pneumonia and eight with cancer.
Worryingly in this world where doctors change data,
pharmaceutical companies set aside ethics and governments experiment on the
poor, disabled and vulnerable there is a new change in direction. Now, that prisoners are no longer available
for clinical trials, due to changes in legislation, others are being
targeted. Volunteering to undertake
phase 1 clinical studies can bring you as much as 3000 dollars for a few weeks
of injections and medical procedures. In
these harsh economic conditions more and more are stepping forward as drug
trial guinea pigs. Many have not thought
through the dangers they may face. In
2006 in a London hospital six healthy young men were treated for organ
failure after experiencing a serious reaction within hours of taking the
drug TGN1412 in a clinical trial.
‘After they were all admitted to intensive care, two
became critically ill, the worst affected lost his fingers and toes, and all
the men were subsequently told they would be likely to develop cancers or
auto-immune diseases as a result of their exposure to the drug.’
It seems drugs can be dangerous while you design them,
when you test them, after you use them and even after you’ve stopped using
them!
