2013

I´d like to believe you can´t do science if you´re a really evil person, but it´s probably a romantic view.

Peter Goodfellow, geneticist

„The patient must be treated as the student´s teacher, not as a training tool.“

World Medical Association (WMA) - Declaration on Physician Independence and Professional Freedom Adopted by the 38th World Medical Assembly Rancho Mirage, CA, USA, October 1986 and rescinded at the WMA General Assembly, Santiago 2005

Physicians must have the professional freedom to care for their patients without interference. The exercise of the physician's professional judgement and discretion in making clinical and ethical decisions in the care and treatment of patients must be preserved and protected.

World Medical Association (WMA) - Declaration on Physician Independence and Professional Freedom Adopted by the 38th World Medical Assembly Rancho Mirage, CA, USA, October 1986 and rescinded at the WMA General Assembly, Santiago 2005

Physicians must have the professional independence to represent and defend the health needs of patients against all who would deny or restrict needed care for those who are sick or injured.

Within the context of their medical practice and the care of their patients, physicians should not be expected to administer governmental or social priorities in the allocation of scarce health resources.

researcher x healer the best interest of the patient x the goal of

research

not all scientific progress is true human progress

Medical care Research

benefiting the individual patient

benefiting population to develop and test

hypotheses to collect data points to

generate generalizable knowledge

Nuremberg Code 1947 The Declaration of Helsinki 1964

revised by WMA in 16975, 1983, 1989, 1996, 2000, 2002, 2004 and 2008

The Belmont Report 1979 = American research Reguilation

Nazi Experiments

the deliberate infection of wounds to test the efficacy of newly developed antibiotics

the injection of prisoners with blood tainted with typhus to test the efficacy of vaccines

the shooting of inmates to study gunshot wounds

the deprivation of inmates of food and water to study the effects of malnutrition and dehydratation

immersion of prisoners in icy water to develop revival techniques for the benefit of pilots who were shot down

Paola, F.A., Walker, R., Nixon, L.L., (2010) Medical Ethics and Humanities. Jones and Bartlett Publishers. Sudbury, MA. p.183

1. The voluntary consent of the human subject is absolutely essential.

2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.

4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.

5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.

8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.

10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probably cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Declaration of Helsinki

32 paragraph: more detailed than Nuremberg Code´s ten requirements

incompetent human subjects: 18- subjects whose decisional capacity is not

intact as a result of physical and/or mental medical conditions.

Declaration of Helsinki

4. The Declaration of Geneva of the WMA binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act in the patient's best interest when providing medical care."

The Declarartion of Helsinki: Placebo

32. The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstances:

The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists; or

Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.

Therapeutic Research

is concerned witht the acquisition of generalizable knowledge

patient-subjects are themselves expected to benefit medically from the new drug, vaccine, treatment, or diagnostic procedure under investigation first patients on kidney dialysis machines first recipients of coronary bypass surgery

Nontherapeutic Research

= sole aim is to furnish data that contributes to generalizable knowledge

Degrazia, D., Mappes, T.A., Brand-Ballard, J., (2011) Biomedical Ethics. 7th ed. McGraw-Hill, NY. p.244

Searching for New Drugs

1. finding a molecule that appears to correct the disease

the compoundmust be absorbed (preferably by mouth)

it must reach levels high enough in the relevant tissues to have a therapeutic effect

it must have a reasonable half-life in the body (so that doses don´t have to be given more than four times a day at most)

it must not be toxic

Searching for New Drugs

preclinical phase aims to optimize all these features at once, using animals

application to the FDA PHASE I. first test is usually done with a low

dose on a small number of normal volunteers to look for any eveidence of unexpected toxicity

PHASE II. dozens or hundreds of individuals with the disease is initiated to look for eveidence of benefit and to define the optimum dose

PHASE III. hundreds or thousands of patients

Searching for New Drugs

PHASE III. the gold standard in such trials includes

randomizing the participants to receive either the new therapy or the previous standard, with neither the patients nor the doctors knowing which treatment they are receiveing („double blind“)

Collins, F., (2010) The Language of Life. Profile Books LTD. London, GB. p. 493

THE TUSKEGEE SYPHILIS STUDY

For forty years, from 1932 to 1972, 399 Afroamerican males were denied treatment for syphilis and deceived by officials of the United States Public Health Service

The test subjects were never told they had syphilis and they were never treated for it.

As a part of a study, sharecroppers were told that they were being treated for „bad blood“.

THE TUSKEGEE SYPHILIS STUDY

1932: 600 African American residents of Tuskegee, Alabama 399 of whom were diagnosed with syphilis 201 control objects who were not infected

all the study participants were black and largery illiterate

excellent opportunity to observe untreated latent syphilis from the time of diagnosis to the time of death the study was to last approximately six months, but

was extended past the initial study period and lasted forty years

THE TUSKEGEE SYPHILIS STUDY

At the start of the study, there was no proven treatment for syphilis. But even after penicillin became a standard cure for the disease in 1947, the medicine was withheld from the men. The Tuskegee scientists wanted to continue to study how the disease spreads and kills. The experiment lasted four decades, until public health workers leaked the story to the media.

the study yeielded no new insights regarding the development of syphilis and its effects because the effects of having untreated syphilis were already well known in the medical community

the subjects did not consent to be part of experimental research

they were told that they have „bad blood“

THE TUSKEGEE SYPHILIS STUDY Researches used various offers to

stimulate and sustain the subjects´interest in continued participation. these offers included free burial assistance

and insurance, free transportation to and from the examinations, and a free stop in town on the return trip

subjects received free medicines and free hot meals on the days of examination

THE TUSKEGEE SYPHILIS STUDY

In fact, the physicians in charge of the study ensured that these men went untreated

By then, dozens of the men had died, and many wives and children had been infected.

doctor injects subject with placebo

THE TUSKEGEE SYPHILIS STUDY

1965: Peter Buxtun, a social worker and epidemiologist in San Francisco, was hired by the Public Health Service to interview patients with sexually transmitted diseases. 

In the course of his work, Buxtun learned of the Tuskegee Syphilis Experiment.

In November 1966 he filed an official protest

In 1965, Peter BuxtUn learned of the study. He investigated further and found that the study had left men without treatment for four decades. Not only was it immoral to Buxtun, but it violated the Nuremberg Codes.  

In 1972, he went to the Associated Press to expose the study. The story was assigned to Jean Heller.

On July 25, 1972, the story was exposed to the world. 

„I pointed out that the Tuskegee Study could be compared to the German medical experiments at Dachau and the public disclosure of such a scandal could jeopardize congressional funding for other beneficial PHS projects.“

Peter Buxton

1974: the surviving study participants and their families were financially compensated for the deception by the government

„more was learned about racism than about syphilis“

Paola, F.A., Walker, R., Nixon, L.L., (2010) Medical Ethics and Humanities. Jones and Bartlett Publishers. Sudbury, MA. p.184-185

Summary

28 men died of syphilis, 100 men died from related complications at least 40 wives were infected 19 children contracted congenital syphilis

at birth.

Apology of Bill Clinton1997

" No power on Earth can give you back the lives lost, the pain suffered, the years of internal torment and anguish. "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."

Herman Shaw, Tuskegee Study participant:

"We were treated unfairly, to some extent like guinea pigs,"